tag:theconversation.com,2011:/au/topics/pharmaceuticals-639/articlesPharmaceuticals – The Conversation2024-02-18T19:51:14Ztag:theconversation.com,2011:article/2193942024-02-18T19:51:14Z2024-02-18T19:51:14ZTaking expensive medicines or ones unavailable in Australia? Importing may be the answer<figure><img src="https://images.theconversation.com/files/572982/original/file-20240202-17-nh9fym.jpg?ixlib=rb-1.1.0&rect=2%2C1%2C995%2C664&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/redhead-nutritionist-working-home-on-laptop-2264305089">shurkin_son/Shutterstock</a></span></figcaption></figure><p>The cost-of-living crisis may be driving some Australians to look for cheaper medicines, especially if those medicines are not subsidised or people don’t have a Medicare card. Options can include buying their medicines from overseas, in a process called
“<a href="https://www.tga.gov.au/products/unapproved-therapeutic-goods/personal-importation-scheme">personal importation</a>”.</p>
<p>Others also use this option to import medicine that is not available in Australia.</p>
<p>Here’s what’s involved and what you need to know about the health and legal risks.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/medicare-turns-40-since-1984-our-health-needs-have-changed-but-the-system-hasnt-3-reforms-to-update-it-217264">Medicare turns 40: since 1984 our health needs have changed but the system hasn't. 3 reforms to update it</a>
</strong>
</em>
</p>
<hr>
<h2>Cost-of-living crisis bites</h2>
<p>Many Australians, particularly those with long-term illnesses, are finding it increasingly hard to afford health care.</p>
<p>The <a href="https://www.abs.gov.au/statistics/health/health-services/patient-experiences/latest-release#barriers-to-health-service-use">Australian Bureau of Statistics</a> reports the proportion of people who delayed or did not see a GP due to cost doubled in 2022-23 (7%) compared with 2021-22 (3.5%). </p>
<p>A <a href="https://australianhealthcareindex.com.au/wp-content/uploads/2022/11/Australian-Healthcare-Index-Report-Nov-22.pdf">survey</a> published in 2022 of over 11,000 people found more than one in five went without a prescription medicine due to the cost. </p>
<p>For those with a Medicare card it’s usually best (and cheapest) to get medicines locally, especially if you also have a concession card. However, for some high-cost medicines, personal importation may be cheaper. That’s when an individual arranges for medicine to be sent to them directly from an overseas supplier.</p>
<p>A 2023 study found <a href="https://www.publish.csiro.au/AH/AH23143?jid=AHv47n6&xhtml=5AA1F839-38C8-45E8-A458-79DCDB7597FB">1.8%</a> of Australians aged 45 or older had imported prescription medicines in the past 12 months. That indicates potentially hundreds of thousands of Australians are importing prescription medicines each year. </p>
<p>Almost half of the survey respondents indicated they would consider importing medicines to save money.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/last-year-half-a-million-australians-couldnt-afford-to-fill-a-script-heres-how-to-rein-in-rising-health-costs-178301">Last year, half a million Australians couldn't afford to fill a script. Here's how to rein in rising health costs</a>
</strong>
</em>
</p>
<hr>
<h2>What’s involved?</h2>
<p>Australia’s drug regulator, the Therapeutic Goods Administration (TGA), allows individuals to import up to three months’ supply of medicines for their own personal use (or use by a close family member) under the <a href="https://www.tga.gov.au/products/unapproved-therapeutic-goods/personal-importation-scheme">personal importation scheme</a>.</p>
<p>This often involves ordering a medicine through an overseas website. </p>
<p>If the medicine would require a prescription in Australia, you must also have a legally valid prescription to import it. </p>
<p>Selling or supplying these medicines to others outside your immediate family is strictly prohibited.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/572985/original/file-20240202-15-68qdfj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Female doctor looking at computer screen, female patient looking on" src="https://images.theconversation.com/files/572985/original/file-20240202-15-68qdfj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/572985/original/file-20240202-15-68qdfj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/572985/original/file-20240202-15-68qdfj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/572985/original/file-20240202-15-68qdfj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/572985/original/file-20240202-15-68qdfj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/572985/original/file-20240202-15-68qdfj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/572985/original/file-20240202-15-68qdfj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">If the medicine would require a prescription in Australia, you must also have a legally valid prescription to import it.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/consultant-discussing-test-results-patient-284516642">Monkey Business Images/Shutterstock</a></span>
</figcaption>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/heres-what-new-60-day-prescriptions-mean-for-you-and-your-hip-pocket-211412">Here's what new 60-day prescriptions mean for you and your hip pocket</a>
</strong>
</em>
</p>
<hr>
<h2>How could this help?</h2>
<p>For some high-cost medicines, personal importation may be cheaper than having the medicine dispensed in Australia. This is most likely for medicines not subsidised by the <a href="https://www.pbs.gov.au/info/about-the-pbs">Pharmaceutical Benefits Scheme</a> (the PBS). People who do not hold a Medicare card may also find it cheaper to import certain medicines as they do not have access to PBS-subsidised medicines.</p>
<p>For example, for people with a specific type of leukaemia, treatment with sorafenib is not covered by the PBS. For these patients it could be up to about ten times more expensive to have their treatment dispensed in Australia as it is to import. That’s because there is a cheaper generic version available overseas.</p>
<p>Personal importation may also allow you to access medicines that are available overseas but are not marketed in Australia.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/how-we-can-overcome-the-lack-of-treatment-options-for-rare-cancers-83486">How we can overcome the lack of treatment options for rare cancers</a>
</strong>
</em>
</p>
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<h2>What are the risks?</h2>
<p>All medicines carry risks, and medicine sold online can pose additional dangers. The TGA does not regulate medicines sold overseas, so the safety and quality of such medicines can be uncertain; they may not be produced to <a href="https://www.tga.gov.au/what-tga-regulates">Australian standards</a>. </p>
<p>While similar regulatory agencies exist in other countries, when ordering medicines from overseas websites it can be difficult to determine if the product you are buying has been assessed to ensure it is safe and will do what it says it will do.</p>
<p>The medicines purchased could be counterfeit or “fake”. Products bought through unverified or overseas websites may have undisclosed ingredients, contain a dose that differs from that on the label, or lack the active ingredient entirely. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"842375297823571969"}"></div></p>
<p><a href="https://www.tga.gov.au/importing-therapeutic-goods">Not all medicines</a> can be legally imported through the personal importation scheme. Certain medicines are never allowed to be imported into Australia, and others can only be imported by a medical professional on behalf of a patient. </p>
<p>So if you attempt to import a restricted medicine, the Australian Border Force <a href="https://www.abf.gov.au/entering-and-leaving-australia/can-you-bring-it-in/categories/medicines-and-substances">may seize it</a>. Not only would you lose your medicine, but you could also receive a fine or face <a href="https://www.tga.gov.au/news/blog/can-i-import-medicine-personal-use#:%7E:text=If%20you%20try%20to%20import,a%20fine%20or%20jail%20time.">jail time</a>.</p>
<p>As with any purchase from an overseas business, there is also a risk you may lose your money and you might not be protected by Australian consumer laws. </p>
<p>If you do choose to import medicines by buying them from an overseas website, you should also consider what could happen if delivery is delayed and you don’t get your medicine in time.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/how-fake-drugs-end-up-in-our-public-health-system-and-how-to-spot-them-73594">How fake drugs end up in our public health system (and how to spot them)</a>
</strong>
</em>
</p>
<hr>
<h2>Where can I get more advice?</h2>
<p>If you are thinking about importing medicines you should first discuss this with a health professional, such as your GP or pharmacist. </p>
<p>They can help you determine if personal importation is permitted for the medicine you need. You can also discuss if this is the best option for you. </p>
<p>If you are having difficulty covering the cost of your medicines your doctor or pharmacist can also explore other potential alternatives to ensure you are receiving the most cost-effective treatment available in Australia.</p>
<h2>Where do I go online?</h2>
<p>If you then decide to import, here are some reputable sites to help navigate the global online medicines market: </p>
<ul>
<li><p><a href="https://everyone.org/">everyone.org</a> helps people everywhere in the world access the latest medicines not available in their own countries</p></li>
<li><p><a href="https://buysaferx.pharmacy/">Alliance for Safe Online Pharmacies</a> is a not-for-profit organisation that collates information on how to find safe online pharmacies based in different regions of the world</p></li>
<li><p><a href="https://www.pharmacychecker.com/accredited-online-pharmacies/">PharmacyChecker</a> has also collated a list of trusted online pharmacies that ship medicines internationally.</p></li>
</ul>
<p>Australian government websites about importing medicines include those from <a href="https://www.tga.gov.au/news/blog/can-i-import-medicine-personal-use">the TGA</a> and on what to consider when buying medicines online from <a href="https://www.healthdirect.gov.au/buying-medicines-online#overseas">overseas</a>.</p><img src="https://counter.theconversation.com/content/219394/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jacinta Lee Johnson is employed as the Senior Pharmacist for Research within SA Pharmacy and is a Board Director for the Society of Hospital Pharmacists of Australia. In the last five years, she has received research funding or consultancy funds (for development and delivery of educational materials) from SA Health, the Medical Research Future Fund, the Hospital Research Foundation – Parkinson's, the Pharmaceutical Society of Australia, the Pharmacy Guild of Australia, the Society of Hospital Pharmacists of Australia, the Australian College of Pharmacy, Mundipharma Pty Ltd, Aspen Pharmacare Australia Pty Ltd, Reckitt Benckiser (Australia) Pty Ltd and Viatris Pty Ltd.</span></em></p><p class="fine-print"><em><span>Kirsten Staff does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>But this comes with legal and health risks. Here’s what you need to know before importing medicine for yourself or your immediate family.Jacinta L. Johnson, Senior Lecturer in Pharmacy Practice, University of South AustraliaKirsten Staff, Senior Lecturer in Pharmacy, University of South AustraliaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2222802024-02-13T19:08:35Z2024-02-13T19:08:35ZA patch a day? Why the vitamin skin patches spruiked on social media might not be for you<figure><img src="https://images.theconversation.com/files/573945/original/file-20240207-18-9hjka6.jpg?ixlib=rb-1.1.0&rect=26%2C26%2C5824%2C4149&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/capsules-on-light-beige-top-view-2193561733">Shutterstock</a></span></figcaption></figure><p>Vitamin patches are <a href="https://www.tiktok.com/search?lang=en&q=vitamin%20patch&t=1707260917256">trending on social media</a> and advertised in <a href="https://www.instagram.com/reel/C0VBXJOrObo/">posts</a> and podcasts. </p>
<p>With patches marketed for sleep, detox, immunity and hangovers, they are being talked up as near magical fix-all stickers. Manufacturers claim they are easy-to-use, convenient and ethical when compared with other types of vitamin products. Some even come with <a href="https://www.vogue.com/article/barriere-vitamin-patches">cute floral designs</a>.</p>
<p>So do they work, are they safe, and why would you use one instead of just taking a vitamin tablet? </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/should-i-be-getting-my-vitamin-d-levels-checked-211268">Should I be getting my vitamin D levels checked?</a>
</strong>
</em>
</p>
<hr>
<h2>What are vitamin patches?</h2>
<p>Vitamin patches are adhesives designed to deliver vitamins or nutrients to your bloodstream directly through the skin.</p>
<p>You peel away the backing, place it on a hairless area of skin where it is less likely to be bumped, and then the patches release their vitamins over a period of 12 to 24 hours.</p>
<p>Two dominant <a href="https://thepatchremedy.com/">brands</a> that <a href="https://www.ultimatepatch.com.au/">market</a> in Australia sell patches that contain various chemical and plant ingredients. </p>
<p>There are patches for <a href="https://thepatchremedy.com/products/menopause">menopause symptoms</a> that claim to include plant extracts of gotu kola, damiana, black cohosh, valerian, skull cap, oat seed and ginger. Patches promising an <a href="https://www.ultimatepatch.com.au/products/energy-patch-vitamin-patches">energy boost</a> offer caffeine, taurine, gluconolactone, green tea extract and vitamins B3, B5 and B6. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/can-taking-vitamins-and-supplements-help-you-recover-from-covid-182220">Can taking vitamins and supplements help you recover from COVID?</a>
</strong>
</em>
</p>
<hr>
<h2>Do they work and are they safe?</h2>
<p>In Australia, vitamins are considered pharmaceutical products and are regulated by the Therapeutic Goods Administration. Vitamins are generally approved as listed medicines, meaning the ingredients have been assessed for safety but not for efficacy (whether they do what they promise).</p>
<p>Being a listed medicine also means vitamins are manufactured in a factory with <a href="https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medicine/good-manufacturing-practice-gmp#:%7E:text=Good%20Manufacturing%20Practice%20(GMP)%20describes,into%20a%20batch%20of%20product">good manufacturing practices</a>, so you can be assured the ingredients listed on the packaging have been sourced properly and are provided at the correct concentration.</p>
<p>However, there are no items listed as vitamin patches on the Australian Register of Therapeutic Goods. This means they currently can not <a href="https://www.tga.gov.au/news/blog/how-are-vitamins-regulated-australia#:%7E:text=Depending%20on%20the%20vitamin%20and,their%20safety%20and%20quality%20only.">legally be supplied or purchased in Australia</a>. It doesn’t matter if they are being sold from a physical store or online within the country. The TGA won’t <a href="https://www.tga.gov.au/sites/default/files/australian-regulatory-guidelines-complementary-medicines-argcm.pdf">stop you from buying them from overseas</a>, but they advise you not to do so because you can’t be assured of quality and safety.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/573949/original/file-20240207-30-751n5r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="clear capsules being produced by machine" src="https://images.theconversation.com/files/573949/original/file-20240207-30-751n5r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/573949/original/file-20240207-30-751n5r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=338&fit=crop&dpr=1 600w, https://images.theconversation.com/files/573949/original/file-20240207-30-751n5r.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=338&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/573949/original/file-20240207-30-751n5r.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=338&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/573949/original/file-20240207-30-751n5r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=424&fit=crop&dpr=1 754w, https://images.theconversation.com/files/573949/original/file-20240207-30-751n5r.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=424&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/573949/original/file-20240207-30-751n5r.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=424&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Vitamins and supplements listed by the TGA are produced in factories with stringent quality standards.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/fish-oil-gelatin-capsules-production-vitamins-2299877737">Shutterstock</a></span>
</figcaption>
</figure>
<p>There is also insufficient evidence that vitamins delivered in this way work. Not all drugs and chemicals can be delivered through the skin. Ordinarily, to be absorbed through the skin a chemical needs to be <a href="https://www.merriam-webster.com/dictionary/lipophilic">lipophilic</a>, meaning it likes fats and oils more than water. </p>
<p>So, the form in which the vitamins have been produced and supplied will dictate whether they will get into the skin. For example, a water extract of a plant is less likely to be absorbed when compared with an oil-based extract.</p>
<p><a href="https://pubmed.ncbi.nlm.nih.gov/31302845/">A small 2019 study</a> of patients at risk of nutrient deficiencies after bariatric (weight-loss) surgery gave some of them a daily multivitamin patch for a year. Those patients had lower blood concentrations of several vitamins and were more likely to have vitamin D deficiency when compared with patients given oral vitamins. The study concluded transdermal vitamin patches were not as effective as oral supplements. </p>
<p>Another issue with vitamin patches is that they contain very low concentrations of ingredients and you may therefore get an ineffective dose, even if all the vitamin in the patch is 100% absorbed through the skin. </p>
<p>For example, one particular patch that is marketed for immunity states that it contains 3 milligrams of vitamin C, which is likely insufficient if taken to supplement a low vitamin C diet. The health condition called <a href="https://www.ncbi.nlm.nih.gov/books/NBK493187/">scurvy</a> is thought to occur when daily vitamin C intake drops lower than <a href="https://www.healthdirect.gov.au/vitamin-c-and-your-health">7 milligrams per day</a>. </p>
<p>In contrast, a typical vitamin C tablet contains 500 milligrams. The recommended daily intake of vitamin C is around <a href="https://www.healthdirect.gov.au/vitamin-c-and-your-health">45 milligrams per day</a> – more if a woman is breastfeeding. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/573947/original/file-20240207-22-3nunzy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="person puts clear patch on skin of upper arm" src="https://images.theconversation.com/files/573947/original/file-20240207-22-3nunzy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/573947/original/file-20240207-22-3nunzy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=399&fit=crop&dpr=1 600w, https://images.theconversation.com/files/573947/original/file-20240207-22-3nunzy.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=399&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/573947/original/file-20240207-22-3nunzy.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=399&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/573947/original/file-20240207-22-3nunzy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=501&fit=crop&dpr=1 754w, https://images.theconversation.com/files/573947/original/file-20240207-22-3nunzy.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=501&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/573947/original/file-20240207-22-3nunzy.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=501&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Nicotine patches work by providing a sustained release of the drug into the skin.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/nicotine-patch-on-skin-quitting-smoking-438277147">Shutterstock</a></span>
</figcaption>
</figure>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/is-tiktok-right-will-eating-three-carrots-a-day-really-give-me-a-natural-tan-214270">Is TikTok right – will eating three carrots a day really give me a natural tan?</a>
</strong>
</em>
</p>
<hr>
<h2>Why not just take a tablet?</h2>
<p>When other medicines are supplied in a patch formulation it is usually because a constant supply of the drug is needed in the body; think smoking replacement nicotine patches, <a href="https://www.healthdirect.gov.au/hormone-replacement-therapy">menopausal hormone therapy</a> and some types of <a href="https://www.nps.org.au/radar/articles/fentanyl-patches-durogesic-for-chronic-pain">pain relief</a>.</p>
<p>There is no reason why you would need the slow release, continuous supply of vitamins that patches promise – but there may be other reasons to choose them over tablets and gummy products.</p>
<p>One selling point used by the marketers is that patches are a “cleaner” form of vitamins. A vitamin in tablet or gummy form will contain inactive ingredients called <a href="https://australianprescriber.tg.org.au/articles/pharmaceutical-excipients-where-do-we-begin.html">excipients</a>. Excipients do various tasks in medicines from binding ingredients together, making the medicine look and smell nice, to ensuring drugs don’t break down during storage. The presumption is that patches don’t contain and release any, or very few, excipients into your body. </p>
<p>But many patches don’t list all their ingredients – just the active vitamins – so this claim can not be tested. Some patches may still contain a large number of excipients, some of which may irritate the skin.</p>
<p>For example, one type of <a href="https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=203285&agid=%28PrintDetailsPublic%29&actionid=1">nicotine patch</a> contains 12 excipients including acrylic acid and vinyl acetate, which are chemicals used to help stick the patch to the skin.</p>
<p>A patch may be worth investigating for people who have trouble swallowing or chewing. In this instance it could be <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7810703/">difficult to take a solid tablet</a> or gummy to get your vitamins. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/paracetamol-versus-ibuprofen-which-works-best-and-when-207921">Paracetamol versus ibuprofen – which works best and when?</a>
</strong>
</em>
</p>
<hr>
<h2>Should you buy them?</h2>
<p>As there are no vitamin patches approved by the TGA in Australia, you should not buy them. </p>
<p>If at some point in the future they become listed medicines, it will be important to remember that they may not have been assessed for efficacy. </p>
<p>If you remain curious about vitamin patches, you should discuss them with your doctor or local pharmacist.</p><img src="https://counter.theconversation.com/content/222280/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nial Wheate in the past has received funding from the ACT Cancer Council, Tenovus Scotland, Medical Research Scotland, Scottish Crucible, and the Scottish Universities Life Sciences Alliance. He is a Fellow of the Royal Australian Chemical Institute, a member of the Australasian Pharmaceutical Science Association, and a member of the Australian Institute of Company Directors. Nial is the chief scientific officer of Vaihea Skincare LLC, a director of SetDose Pty Ltd a medical device company, and a Standards Australia panel member for sunscreen agents. Nial regularly consults to industry on issues to do with medicine risk assessments, manufacturing, design, and testing.</span></em></p><p class="fine-print"><em><span>Jasmine Lee does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>There are no vitamin patches listed on the Australian Register of Therapeutic Goods and there’s not enough evidence to show they work better than tablets.Nial Wheate, Associate Professor of the School of Pharmacy, University of SydneyJasmine Lee, Pharmacist and PhD Candidate, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2204982024-01-16T14:14:16Z2024-01-16T14:14:16ZDangerous chemicals found in recycled plastics, making them unsafe for use – experts explain the hazards<p>Plastic pollution is a menace worldwide. Plastics are now <a href="https://www.science.org/doi/10.1126/science.abg5433">found</a> in every <a href="https://pubs.acs.org/doi/10.1021/acs.est.1c04158">environment</a> on the planet, from the deepest seas to the atmosphere and human bodies. </p>
<p>Scientific evidence <a href="https://doi.org/10.5334/aogh.4056">describing harm</a> to the environment and humans is growing. Hence, the United Nations has <a href="https://wedocs.unep.org/bitstream/handle/20.500.11822/39812/OEWG_PP_1_INF_1_UNEA%20resolution.pdf">resolved</a> to <a href="https://enb.iisd.org/negotiations/international-legally-binding-instrument-plastics-pollution-including-marine#:%7E:text=The%20United%20Nations%20Environment%20Assembly,pollution%2C%20including%20in%20the%20marine">negotiate</a> a legally binding instrument to end plastic pollution. </p>
<p>Strategies to achieve this goal include provisions throughout the plastics lifespan: production, use, waste management and remediation. </p>
<p>In designing rules for managing plastic, it’s important to understand that plastic materials and waste streams are complex. Not all plastics are the same. And recycled plastics are not necessarily “better” – less harmful – than virgin plastics. If they contained harmful chemicals to begin with, recycling doesn’t make them less harmful. And sometimes they are contaminated by other substances.</p>
<p>We conducted a <a href="https://www.sciencedirect.com/science/article/pii/S2352340923008090?via%3Dihub">study</a> identifying and measuring the concentration of contaminants in recycled pellets from 28 small-scale recycling facilities in the global south. Plastic waste is often exported from high income countries to less developed countries, with few to no requirements for reporting their makeup.</p>
<p>Our investigation covered facilities in Cameroon, Mauritius, Nigeria, Tanzania and Togo in Africa as well others in Asia, Europe and South America. </p>
<p>We found 191 pesticides, 107 pharmaceuticals and 81 industrial compounds among many others in the recycled plastic pellets. Many of these chemicals could be hazardous and make the plastics unsuitable for reuse.</p>
<p>This finding can inform regulations for recycled plastics. The chemical composition of the plastic should be checked before it is recycled. </p>
<h2>Chemicals used in production of plastics</h2>
<p>More than <a href="https://www.unep.org/resources/report/chemicals-plastics-technical-report">13,000 chemicals</a> are currently used in the production of plastic materials and products. They can include thousands of plastics additives – but also substances that are added unintentionally. Some unwanted chemicals form during the production or life of plastics. Thousands of these chemicals have dangerous properties. The health risks of some others are unknown. </p>
<p>Throughout the plastics value chain, during production, use, waste and recycling, other chemicals can contaminate the material too. The result may be recycled materials whose chemical composition is unknown. </p>
<p>Previous studies have reported the presence of <a href="https://doi.org/10.1016/j.jhazmat.2017.10.014">plastics additives</a> in recycled materials. Among them were chemicals that are <a href="https://www.unep.org/explore-topics/chemicals-waste/what-we-do/emerging-issues/endocrine-disrupting-chemicals">known</a> to have <a href="https://www.epa.gov/endocrine-disruption/overview-endocrine-disruption">negative effects on health</a>. Examples include <a href="https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0055387">phthalates</a> (plastic softeners), bisphenols like <a href="https://www.sciencedirect.com/science/article/pii/S0303720706002292">BPA</a>, and <a href="https://www.sciencedirect.com/science/article/pii/S0048969721044478?via%3Dihub">UV-stabilisers</a> used to protect plastics from sun damage and yellowing.</p>
<p>In our work, we established the presence of chemicals in recycled plastic that can cause harm to humans or other organisms. They include pesticides, pharmaceuticals and fragrances. Others are chemicals that result from burning natural materials, man-made organic chemicals used for industrial applications like paint, and ultraviolet filters.</p>
<p>We quantified a total of 491 different chemical substances. Some had specific uses and others formed from the breakdown of products.</p>
<p>Some national and regional policies <a href="https://www.basel.int/Implementation/Plasticwaste/Globalgovernance/tabid/8335/Default.aspx">regulate</a> the allowable concentration of hazardous chemicals in specific plastic products. But only 1% of plastics chemicals are subject to international regulation in existing multilateral environmental agreements. Policies don’t adequately address the issue of transparent reporting of chemicals in plastics across their value chain. Also, there are no laws to govern monitoring of chemicals in recycled materials. This is a <a href="https://www.science.org/doi/10.1126/science.adk9846">serious gap</a> in oversight. Stronger and more globally coordinated measures are necessary. </p>
<p>Our findings emphasise the importance of regulating mechanical recycling, as many of the substances measured were contaminants and not plastic additives. Many of the chemicals we identified may have contaminated the materials during use. For example, a jug used for storing pesticides will absorb some of the pesticides and will contaminate the recycling waste stream. Plastics in the environment are also known to absorb <a href="https://www.sciencedirect.com/science/article/pii/S0025326X11005960">organic pollutants</a>. </p>
<p>To assess the quality of recycled plastics, it’s crucial to know which chemicals are present and in what concentrations. This information can guide regulations about how recycled plastics may be used. It will also be valuable for plastics producers, waste management workers (including recyclers), consumers, and the scientific community.</p>
<h2>A path towards safer reuse of plastics</h2>
<p>To recycle more materials safely, several changes are necessary. These include:</p>
<ul>
<li><p>increased transparency regarding the use of chemicals and their risks </p></li>
<li><p>chemical simplification of the plastics market, so that fewer and less toxic chemicals are permitted for use</p></li>
<li><p>improved waste management infrastructure with separated waste streams </p></li>
<li><p>improved recycling methods, including monitoring of hazardous chemicals.</p></li>
</ul>
<p>Chemical simplification of plastic additives will promote sustainability, safety and regulatory compliance. It will help manufacturers to minimise the environmental impact and adverse health effects of complex chemical formulations. Simpler chemical structures also improve the recycling potential of plastics and make recycling more efficient and cost-effective.</p>
<p><a href="https://pubs.acs.org/doi/full/10.1021/acs.est.1c04903">Chemical simplification</a> can also reduce potential health risks in the disposal of plastic materials. </p>
<p>From a regulatory perspective, chemical simplification supports clearer and more enforceable safety guidelines.</p>
<p>It’s is a crucial step towards the sustainable production and use of plastics, as countries work towards a legal instrument to end pollution.</p><img src="https://counter.theconversation.com/content/220498/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Bethanie Carney Almroth receives funding from the Swedish Research Council for Sustainable Development
FORMAS (grant number 2021-00913) and The Carl Tryggers Foundation (grant number 21:1234).
</span></em></p><p class="fine-print"><em><span>Eric Carmona Martinez received funding from Carl Trygger Foundation. </span></em></p>Recycled plastics are not safe if the chemicals used in creating them in the first place are harmful.Bethanie Carney Almroth, Associate Professor, Department of Biological and Environmental Sciences, University of GothenburgEric Carmona Martinez, Scientist, Helmholtz Centre for Environmental Research-UFZLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2148952023-11-30T17:23:43Z2023-11-30T17:23:43ZBuvidal: is it really a ‘game changer’ in the treatment of problematic opioid use?<p>To overcome problematic opioid use, traditional forms of opioid substitution therapy, such as <a href="https://www.nhs.uk/medicines/methadone/">methadone</a> and <a href="https://www.nhs.uk/medicines/buprenorphine-for-pain/">oral buprenorphine</a>, have become valuable tools. <a href="https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD002209.pub2/full?highlightAbstract=opioid">Research</a> shows that patients receiving substitution therapy are more likely to stay in treatment and stop using heroin than patients receiving treatments that do not involve substitutes – such as counselling or group therapy.</p>
<p>But not all those on substitute medication are able to stop using illicit opioids. Some continue to use them in addition to the substitute. One <a href="https://www.sciencedirect.com/science/article/abs/pii/S0376871621001460">barrier</a> to success is the need to attend a clinic or pharmacy every day, or every few days, to obtain the substitute. </p>
<p>In early 2019, a new form of substitute treatment, long-acting injectable buprenorphine, was approved for use in the UK. Unlike methadone and oral buprenorphine, <a href="https://www.nice.org.uk/advice/es19/evidence/evidence-review-pdf-6666819661#:%7E:text=Buprenorphine%20prolonged%2Drelease%20injection%20is,buprenorphine%20prolonged%2Drelease%20injection%20subcutaneously.">long-acting injectable buprenorphine</a> is administered via an injection either weekly or monthly. The treatment – also known by its brand names Buvidal or Sublocade – has been heralded as a “<a href="https://nation.cymru/news/welsh-university-carries-out-game-changer-drug-treatment-research/">game changer</a>” by both doctors and patients. </p>
<h2>Opioids</h2>
<p>In 2021, nearly 5,000 drug-related deaths were <a href="https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/bulletins/deathsrelatedtodrugpoisoninginenglandandwales/2021registrations">registered</a> in England and Wales. About half of those involved an opioid. </p>
<p>Opioids are a class of drugs that include substances derived from the opium poppy. They include <a href="https://www.nhs.uk/medicines/morphine/">morphine</a> and <a href="https://www.emcdda.europa.eu/publications/drug-profiles/heroin_en">heroin</a>, as well as synthetic alternatives that mimic the effects of naturally occurring opioids such as <a href="https://www.nhs.uk/medicines/tramadol/">tramadol</a> and <a href="https://bnf.nice.org.uk/drugs/fentanyl/">fentanyl</a>.</p>
<p>Opioids work in the brain to produce a variety of effects, including pain relief. They also produce feelings of euphoria, joy and pleasure. Opioids have a depressant effect on the body, so if someone overdoses, they can stop breathing and may die. Overdose is a particular risk for those who use illegally obtained opioids of unknown strength, such as heroin.</p>
<p>Often people are unable to stop using opioids despite the risk of death and the serious negative health and social consequences. Such drugs are hard to give up, partly because stopping causes painful physical and psychological withdrawal symptoms.</p>
<h2>Opioid substitution therapy</h2>
<p>An effective form of treatment for problematic opioid use is opioid substitution therapy, where illegally obtained opioids are substituted for prescribed alternatives. </p>
<p>Providing a legal substitute of known purity is useful in many ways. Most notably, it removes the need to buy and use illicit opioids. This reduces the risk of <a href="https://www.bmj.com/content/357/bmj.j1550">overdose</a> and the need to commit crimes like <a href="https://academic.oup.com/bjc/article-abstract/49/4/513/2747197">theft and shoplifting</a> to get money to pay for drugs.</p>
<p>But while daily attendance and supervised consumption may help to minimise the risk of misuse, it also has its drawbacks. For example, it can bring patients into regular contact with their former drug-using networks and can require time-consuming journeys that interfere with employment, education and other responsibilities.</p>
<p>Long-acting injectable buprenorphine does not have these drawbacks. It is not unlike <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8369037/">long-acting</a> forms of contraception, in that the medicine releases slowly over time, thereby avoiding the peaks and troughs associated with oral formulations.</p>
<p>When the pandemic broke and the UK went into lockdown, <a href="https://www.emcdda.europa.eu/publications/topic-overviews/covid-19-and-people-who-use-drugs_en">concerns</a> were raised by experts that daily attendance at clinics or pharmacies for opioid substitution medication might increase the risk of COVID transmission. </p>
<p>Keen to stop the spread of the virus while also providing safe and continuous treatment to patients, the Welsh government <a href="https://committees.parliament.uk/writtenevidence/107535/pdf/">agreed</a> to fund the roll-out of long-acting injectable buprenorphine to drug services across Wales. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/WlWJxfHVY9I?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Two doctors discuss Buvidal from the perspective of lived experience.</span></figcaption>
</figure>
<p>That decision was supported by <a href="https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-023-01348-5">emerging evidence</a> of the effectiveness of the medication from a drug service in south Wales that had been piloting the medicine before the pandemic. </p>
<h2>Results</h2>
<p>While the primary aim at that time was to stop the spread of COVID, it quickly became clear that the medication was benefiting patients in many other ways. </p>
<p>Patients taking part in a <a href="https://kaleidoscope68.org/app/uploads/2022/05/Kaleidoscope-Peer-led-Buvidal-Review..pdf">survey</a> about the new medication reported reductions in cravings, lower levels of anxiety, reductions in offending and abstinence from illicit opioids. They described rebuilding their lives, getting jobs, reconnecting with family members and heralded long-acting injectable buprenorphine as a “game changer”, “life changing” and even a “miracle”. </p>
<p>Positive results have also been reported in <a href="https://www.jsatjournal.com/article/S0740-5472(22)00058-7/fulltext">systematic reviews</a> that summarise the findings of the currently small, and not very robust, body of evidence on the effectiveness of the medication.</p>
<p>However, alongside the reports of success, less positive <a href="https://kaleidoscope68.org/app/uploads/2022/05/Kaleidoscope-Peer-led-Buvidal-Review..pdf">stories</a> have emerged suggesting that the treatment may not be a silver bullet. Some patients have found the transition onto the medication challenging because it required them to be in full withdrawal before their first dose. </p>
<p>Others have been overwhelmed with emotions because the medication made them feel so clear-headed that their past traumas – suppressed by years of illicit opioid use – had begun to resurface. There have also been <a href="https://kaleidoscope68.org/app/uploads/2022/05/Kaleidoscope-Peer-led-Buvidal-Review..pdf">reports</a> of an increase in crack cocaine use among some patients and concerns about the reduced amount of contact (from daily to monthly) with drug services.</p>
<p>Even though there is a “<a href="https://pubmed.ncbi.nlm.nih.gov/16764215/">ceiling effect</a>” that reduces the risk of overdose, this medication still carries a risk of respiratory depression. This risk is <a href="https://pubmed.ncbi.nlm.nih.gov/15957155/">greater</a> among those using alcohol, benzodiazepines or other opioids such as heroin.</p>
<p>Long-acting injectable buprenophine is still in its infancy worldwide, so the evidence for its effectiveness is slim. To determine if it really is a “game changer”, experts will need to look at its impact across a wider range of outcomes, over longer periods and with larger samples than have been considered to date.</p><img src="https://counter.theconversation.com/content/214895/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Katy Holloway receives funding from Welsh Government and is a member of Welsh Government's National Implementation Board for Drug Poisoning Prevention. </span></em></p><p class="fine-print"><em><span>Fabrizio Schifano receives funding from Welsh Government. Currently a World Health Organization (WHO) member of the Expert Committee on Drug Dependence (ECDD; 2023). Previously, Schifano was a member of the ACMD UK and an expert advisor of the European Medicines Agency (EMA) for Psychiatry. </span></em></p>Long-acting injectable buprenorphine is also known by the brand names Buvidal or Sublocade.Katy Holloway, Professor of Criminology, University of South WalesFabrizio Schifano, Chair in Clinical Pharmacology and Therapeutics, University of HertfordshireLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2086302023-09-05T15:17:02Z2023-09-05T15:17:02ZWegovy was inspired by Gila monster venom – here are some other drugs with surprising origins<figure><img src="https://images.theconversation.com/files/544065/original/file-20230822-5769-ebr25z.jpg?ixlib=rb-1.1.0&rect=5%2C0%2C3489%2C2331&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The inspiration for Wegovy and Ozempic</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/lizard-gila-monster-heloderma-suspectum-696050818">Vaclav Sebek/Shutterstock</a></span></figcaption></figure><p>Many of the drugs we use today started their journey from bench to bedside in a computer. But this is certainly not the case for all drugs. Indeed, many have <a href="https://www.sciencedirect.com/science/article/abs/pii/B9780123864543012410">exotic origins</a>, including the blockbuster drugs <a href="https://www.mdpi.com/2077-0383/12/3/772">Wegovy and Ozempic</a>, which were inspired by the venom of the Gila monster.</p>
<p>Scientists found that a hormone in the Gila monster’s venom called exendin-4 could be used to treat type 2 diabetes. Exendin-4 is similar to a hormone found in humans called GLP-1, which is released after eating and is important for <a href="https://www.sciencedirect.com/science/article/abs/pii/B9780128001011000028">controlling blood sugar levels</a> in humans. </p>
<p>Research into <a href="https://link.springer.com/article/10.1007/s00125-023-05929-0">extendin-4</a> yielded <a href="https://link.springer.com/article/10.1007/s11095-022-03302-1">semaglutide</a>, a derivative of the molecule but one that will stay in the body for far longer, producing the desired pharmacological effect. And that’s how Wegovy and Ozempic, which <a href="https://www.newscientist.com/article/2371780-everything-you-need-to-know-about-the-drugs-ozempic-and-wegovy/#:%7E:text=Ozempic%20and%20Wegovy%20are%20brand,people%20with%20type%202%20diabetes.">both contain semaglutide</a>, came into being. </p>
<p>The Gila monster is not the only reptile to inspire groundbreaking drugs. Indeed, the venom of the Brazilian pit viper inspired a class of drugs known as ACE inhibitors. </p>
<p>In the late 1960s, researchers were studying this snake’s venom and its effects on blood pressure. They isolated a peptide from the venom, which could inhibit an enzyme called angiotensin-converting enzyme (ACE) and lead to a decrease in blood pressure. This resulted in the development of a synthetic version of the peptide being created called captopril. </p>
<p>Although captopril is rarely prescribed today, it led to the next generation of ACE inhibitors, such as <a href="https://www.ncbi.nlm.nih.gov/books/NBK557708/">enalapril</a>, which are widely prescribed to treat high blood pressure and heart failure.</p>
<p>Venoms from both land and sea creatures provide a rich source of medicinal compounds. <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6214764/">Cone snails</a> are known for producing a variety of venom peptides that they use to immobilise their prey. A synthetic version of one of the peptides found in their venom is used in the painkilling drug
<a href="https://go.drugbank.com/drugs/DB06283">ziconotide</a>.</p>
<p>Another sea creature, the Caribbean sea squirt, has provided us with the anti-cancer drug <a href="https://www.cancerresearchuk.org/about-cancer/treatment/drugs/trabectedin">trabectedin</a>. <a href="https://link.springer.com/article/10.1007/s12325-016-0344-3">Studies</a> conducted with trabectedin showed positive results in treating advanced soft-tissue cancers, such as liposarcoma and leiomyosarcoma. In 2015, the US Food and Drug Administration granted accelerated approval for trabectedin for treating <a href="https://classic.clinicaltrials.gov/ct2/show/results/NCT03074318">these cancers</a> in patients with advanced soft tissue cancer who failed to respond to chemotherapy.</p>
<h2>Anticoagulants</h2>
<p>Medical leeches have also provided humanity with life-saving drugs. When these creatures latch on to a person to suck their blood, they inject compounds such as hirudin and calin to stop their victim’s blood from clotting. </p>
<p>The anticoagulant drugs <a href="https://pubmed.ncbi.nlm.nih.gov/9777138/">bivalirudin and desirudin</a> are derived from hirudin. These drugs are given to people at a high risk of getting blood clots – such as those with atrial fibrillation, a type of heart arrhythmia. If a blood clot jams up an artery, it can cause a stroke or heart attack.</p>
<figure class="align-center ">
<img alt="A medical leech sucking blood from a human" src="https://images.theconversation.com/files/545314/original/file-20230829-19-wn1ky4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/545314/original/file-20230829-19-wn1ky4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=338&fit=crop&dpr=1 600w, https://images.theconversation.com/files/545314/original/file-20230829-19-wn1ky4.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=338&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/545314/original/file-20230829-19-wn1ky4.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=338&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/545314/original/file-20230829-19-wn1ky4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=425&fit=crop&dpr=1 754w, https://images.theconversation.com/files/545314/original/file-20230829-19-wn1ky4.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=425&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/545314/original/file-20230829-19-wn1ky4.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=425&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Leech saliva contains useful anticoagulant compounds.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/medical-leeches-on-human-body-drink-1851433564">Vital9s/Shutterstock</a></span>
</figcaption>
</figure>
<p>The story of another anticoagulant called <a href="https://www.acs.org/education/whatischemistry/landmarks/warfarin.html#:%7E:text=Warfarin%20sodium%20was%20approved%20for,blood%20thinner%20in%20the%20world.">warfarin</a> dates back to the 1920s when cattle in the US and Canada began dying from a mysterious bleeding disorder. It turned out that the cause was the mouldy sweet clover hay the cattle were eating. The harmful compound in the mould that caused the bleeding, called dicoumarol, was eventually developed into warfarin. </p>
<p>Warfarin was initially sold as rat poison as it was so effective at causing internal bleeding in rodents. However, researchers soon realised its potential therapeutic use in humans as an <a href="https://www.bhf.org.uk/informationsupport/heart-matters-magazine/medical/drug-cabinet/warfarin">anticoagulant</a>. The drug really took off in 1955 after US president <a href="https://www.nature.com/articles/nrcardio.2017.172">Dwight Eisenhower was successfully treated</a> with it following a heart attack.</p>
<h2>Explosive finding</h2>
<p><a href="https://pubmed.ncbi.nlm.nih.gov/10779131/#:%7E:text=1.,work%20with%20Theophile%2DJules%20Pelouze.">Nitroglycerin</a> was first discovered in the 19th century, and is derived from glycerol where its explosive properties were initially noted. However, its medicinal properties were soon recognised. </p>
<p>Middle-aged men who worked with explosives – such as those building the rail networks – would <a href="https://www.medscape.com/viewarticle/987903#vp_2">sometimes note</a> that their chest pain subsided after handling sticks of dynamite. Medical researchers got wind of this story and developed nitroglycerin into a drug to relieve angina symptoms by dilating the blood vessels and improving blood flow to the heart.</p>
<p>The drug is still used today and is known for the annoying side-effect of triggering explosives scanners at airports. </p>
<p>Finally, there is chemotherapy. We have the deadly chemical warfare agent mustard gas to thank for this. During the first world war, scientists noticed that mustard gas <a href="https://medicine.yale.edu/ycci/clinicaltrials/learnmore/tradition/chemotherapy/">destroyed lymphatic tissue</a>, they wondered if it might destroy cancer cells in lymph nodes. But it wasn’t until the 1940s that nitrogen mustard (<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5325736/">a derivative of mustard gas</a>) was first used to treat a patient with blood cancer. Several drugs derived from mustard agents were subsequently developed. </p>
<p>While modern drugs will continue to be mostly designed on computers – and, increasingly, <a href="https://www.technologyreview.com/2023/02/15/1067904/ai-automation-drug-development/">artificial intelligence</a> – drug researchers will continue to look for inspiration for new meds in weird and wonderful places.</p><img src="https://counter.theconversation.com/content/208630/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Craig Russell does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>From rat poison to explosives, many of the drugs we use have interesting origin stories.Craig Russell, Lecturer, Aston UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2114122023-08-31T21:39:50Z2023-08-31T21:39:50ZHere’s what new 60-day prescriptions mean for you and your hip pocket<figure><img src="https://images.theconversation.com/files/545417/original/file-20230829-19-mvx2g4.jpg?ixlib=rb-1.1.0&rect=1%2C0%2C997%2C666&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/customer-paying-bill-by-cell-phone-623126426">Shutterstock</a></span></figcaption></figure><p>From today, there are significant <a href="https://www.health.gov.au/our-work/60-day-prescriptions">changes</a> to how some common medicines are prescribed and dispensed in Australia. This means you could walk away from the pharmacy with 60-days’ worth of your usual medicine from a single prescription.</p>
<p>Until now, most long-term medicines were only available for 30 days at a time. So the price of these medicines for some patients may effectively halve. </p>
<p>You would also need fewer trips to the GP for a prescription and fewer visits to the pharmacy to have your medicine dispensed.</p>
<p>But not all medicines are yet eligible for 60-day scripts and not everyone is prescribed 60-days’ worth of medicine at a time. Here’s what the changes mean for you.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/last-year-half-a-million-australians-couldnt-afford-to-fill-a-script-heres-how-to-rein-in-rising-health-costs-178301">Last year, half a million Australians couldn't afford to fill a script. Here's how to rein in rising health costs</a>
</strong>
</em>
</p>
<hr>
<h2>Can I get a 60-day script today?</h2>
<p>If you have a current prescription, you need to use this prescription first before you get a new one. To be eligible for a prescription that provides medicine for 60 days your medication needs to be on the <a href="https://www.pbs.gov.au/industry/listing/elements/pbac-meetings/pbac-outcomes/2022-12/Increased-Dispensing-Quantities-List-of-Medicines.pdf">approved list</a>.</p>
<p>Your doctor also needs to assess if you are stable on it. This is to avoid wastage. We know new treatments can result in frequent changes to medication regimens, which would result in wasted medicines if they don’t end up being used.</p>
<p>Your doctor may also give you “repeat” prescriptions for 60-days’ worth of medicines at a time. Under the new rules, this could mean up to <a href="https://www.health.gov.au/resources/publications/60-day-prescriptions-information-kit-for-prescribers?language=ha">12 months’ supply</a> of medicine (the initial script plus five “repeats”). You would have to pay for each of these repeat scripts when your medicine is dispensed every 60 days.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/what-time-of-day-should-i-take-my-medicine-125809">What time of day should I take my medicine?</a>
</strong>
</em>
</p>
<hr>
<h2>Is my medicine on the list?</h2>
<p>The roll-out of 60-day scripts will be in three stages. The first stage, which begins today, <a href="https://www.health.gov.au/our-work/60-day-dispensing/pbs-medicines-current-item-codes">includes</a> medicines for cardiovascular disease (such as heart disease and stroke), heart failure, high cholesterol, gout, osteoporosis, and the gut conditions Crohn’s disease and ulcerative colitis.</p>
<p>This includes some of the most common medicines prescribed in Australia, such as atorvastatin for lowering cholesterol, and perindopril for lowering blood pressure.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/545419/original/file-20230829-21-3sh11g.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Person adding medications to pill organizer" src="https://images.theconversation.com/files/545419/original/file-20230829-21-3sh11g.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/545419/original/file-20230829-21-3sh11g.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/545419/original/file-20230829-21-3sh11g.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/545419/original/file-20230829-21-3sh11g.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/545419/original/file-20230829-21-3sh11g.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/545419/original/file-20230829-21-3sh11g.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/545419/original/file-20230829-21-3sh11g.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Not all your medicines may be affected by the changes.</span>
<span class="attribution"><a class="source" href="https://unsplash.com/photos/1TL8AoEDj_c">Laurynas Mereckas/Unsplash</a></span>
</figcaption>
</figure>
<p>The following stages, set to be rolled out over the coming 12 months, include medicines for diabetes, epilepsy, glaucoma, asthma and Parkinson’s disease. </p>
<p>When fully implemented, these changes will affect more than 300 prescription medicines available on the Pharmaceutical Benefits Scheme (PBS).</p>
<p>These medicines have been chosen because they are appropriate treatments for people living with stable, chronic health conditions, they meet clinical safety criteria, and are considered cost-effective.</p>
<p>Medicines not available for 60-day dispensing are those only for short-term use and medicines known to be at risk of overuse. These <a href="https://www.nps.org.au/australian-prescriber/articles/pharmaceutical-drug-misuse-in-australia#information-sources-for-prescribers">include</a> pain medicines and some medicines for mental health conditions.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/heres-why-pharmacists-are-angry-at-script-changes-and-why-the-government-is-making-them-anyway-204028">Here's why pharmacists are angry at script changes – and why the government is making them anyway</a>
</strong>
</em>
</p>
<hr>
<h2>Will I save money?</h2>
<p>The government has brought in these changes mainly to try to make medicines more affordable. We know people do not seek medical care or fill prescriptions <a href="https://www.abs.gov.au/statistics/health/health-services/patient-experiences/latest-release">due to cost</a>. </p>
<p>The <a href="https://www.pbs.gov.au/info/healthpro/explanatory-notes/front/fee">maximum price you pay</a> at the pharmacy for a PBS script (known as the co-payment) is not changing. <a href="https://www.pbs.gov.au/info/about-the-pbs">It’s still</a> A$7.30 for concession card holders and $30 for non-concession card holders. But by having 60-day dispensing, you’ll only be charged this every two months instead of every month.</p>
<p>But not everyone will save money from a 60-day prescription because in some cases your pharmacy may already be discounting your medicine. If the price for 60-days’ supply would not take the price over $30, you may not be getting two scripts for the price of one. </p>
<p>For example, a commonly discounted medicine is atorvastatin. In Australia, a non-concession patient generally pays between $8 and $22 for 30-days’ supply. But it’s likely that a 60-day supply would cost between $15 and $30.</p>
<p>The amount you or your family need to pay to reach the <a href="https://www.pbs.gov.au/info/general/faq#WhatisthePBSSafetyNet">PBS safety net</a> is also not changing. This is the threshold you need to reach before medicines become free (for concession card holders) or discounted (non-concession card holders) for the rest of the calendar year. In some instances, 60-day dispensing may result in you or your family reaching the safety net threshold later, or not at all.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/545421/original/file-20230829-15-pcnddr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Older woman looking into purse, holding coin" src="https://images.theconversation.com/files/545421/original/file-20230829-15-pcnddr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/545421/original/file-20230829-15-pcnddr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=401&fit=crop&dpr=1 600w, https://images.theconversation.com/files/545421/original/file-20230829-15-pcnddr.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=401&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/545421/original/file-20230829-15-pcnddr.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=401&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/545421/original/file-20230829-15-pcnddr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=504&fit=crop&dpr=1 754w, https://images.theconversation.com/files/545421/original/file-20230829-15-pcnddr.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=504&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/545421/original/file-20230829-15-pcnddr.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=504&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">The changes are meant to make medicines more affordable.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/hands-old-person-senior-hold-wallet-1844510152">Shutterstock</a></span>
</figcaption>
</figure>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/what-is-the-pbs-safety-net-and-is-it-really-the-best-way-to-cut-the-cost-of-medicines-180315">What is the PBS safety net and is it really the best way to cut the cost of medicines?</a>
</strong>
</em>
</p>
<hr>
<h2>How should I store my medicine?</h2>
<p>If you don’t store your medicines correctly at home they can become degraded and not work so well. With a 60-day supply, correct storage is even more important. </p>
<p>As a general rule of thumb, never store your medicines in hot rooms or your car (even in winter) and don’t store them in direct sunlight. If your medicine needs to be stored in the fridge, your pharmacist will let you know.</p>
<p>One example is <a href="https://media.healthdirect.org.au/medicines/GuildLink_Information/58775/CMI/ujcxalae10320.pdf">latanoprost</a>, which are drops for the eye condition glaucoma. You can keep the bottle you are using in the cupboard but you need to store the unopened, second bottle in the fridge.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/health-check-what-should-you-do-with-your-unused-medicine-81406">Health Check: what should you do with your unused medicine?</a>
</strong>
</em>
</p>
<hr>
<h2>In a nutshell</h2>
<p>Remember, 60-day dispensing is only available for new prescriptions. When you next see your doctor, if your condition is stable and your medicine is suitable, you will be provided a 60-day script. Your pharmacist will then dispense a 60-day supply.</p>
<hr>
<p><em>If you have any questions about the new rules, ask your local pharmacist. Information is also available from the <a href="https://www.health.gov.au/our-work/60-day-prescriptions">Commonwealth health department</a> and the <a href="https://www.60dayscripts.com.au/">Consumers Health Forum</a>.</em></p><img src="https://counter.theconversation.com/content/211412/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Andrew Bartlett is a member of the Pharmaceutical Society of Australia, a previous director of Blooms the Chemist management services and remains a shareholder.</span></em></p><p class="fine-print"><em><span>Associate Professor Nial Wheate in the past has received funding from the ACT Cancer Council, Tenovus Scotland, Medical Research Scotland, Scottish Crucible, and the Scottish Universities Life Sciences Alliance. He is a Fellow of the Royal Australian Chemical Institute, a member of the Australasian Pharmaceutical Science Association, and a member of the Australian Institute of Company Directors. Nial is the chief scientific officer of Vaihea Skincare LLC, a director of SetDose Pty Ltd a medical device company, and a Standards Australia panel member for sunscreen agents. Nial regularly consults to industry on issues to do with medicine risk assessments, manufacturing, design, and testing.</span></em></p>The price you pay at the pharmacy for your long-term medicines may effectively halve. But not all medicines or patients qualify.Andrew Bartlett, Associate Lecturer Pharmacy Practice, University of SydneyNial Wheate, Associate Professor of the Sydney Pharmacy School, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2068482023-07-20T12:29:04Z2023-07-20T12:29:04ZBlame capitalism? Why hundreds of decades-old yet vital drugs are nearly impossible to find<figure><img src="https://images.theconversation.com/files/537557/original/file-20230714-29-wo8n77.jpg?ixlib=rb-1.1.0&rect=0%2C17%2C6000%2C3970&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">There is presently no end in sight to the drug supply shortage. </span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/young-pharmacist-checking-the-shelves-with-a-royalty-free-image/1344251576?phrase=generic+drugs&adppopup=true">FG Trade/E+ via Getty Images</a></span></figcaption></figure><p><a href="https://www.npr.org/sections/health-shots/2019/12/31/792617538/a-decade-marked-by-outrage-over-drug-prices">Past public ire</a> over high drug prices has recently taken a back seat to a more insidious problem – <a href="https://pharmanewsintel.com/features/drug-shortages-a-growing-concern-for-the-healthcare-industry-worldwide">no drugs</a> <a href="https://www.nytimes.com/2023/05/17/health/drug-shortages-cancer.html">at any price</a>.</p>
<p>Patients and their providers increasingly face <a href="https://www.nytimes.com/2023/06/26/health/cancer-drugs-shortage.html">limited or nonexistent supplies of drugs</a>, many of which treat essential conditions such as cancer, heart disease and bacterial infections. The American Society of Health System Pharmacists now <a href="https://www.ashp.org/products-and-services/database-licensing-and-integration/ashp-drug-shortages">lists over 300 active shortages</a>, primarily of decades-old generic drugs no longer protected by patents.</p>
<p>While this is not a new problem, the number of drugs in short supply has increased in recent years, and the average shortage is lasting longer, with more than 15 critical drug products <a href="https://www.hsgac.senate.gov/wp-content/uploads/2023-03-20-HSGAC-Majority-Draft-Drug-Shortages-Report.pdf">in short supply for over a decade</a>. Current shortages <a href="https://www.ashp.org/drug-shortages/current-shortages/drug-shortages-list?">include widely known drugs</a> such as the antibiotic amoxicillin; the heart medicine digoxin; the anesthetic lidocaine; and the medicine albuterol, which is critical for treating asthma and other diseases affecting the lungs and airways.</p>
<p>What’s going on?</p>
<p>I’m a <a href="https://scholar.google.com/citations?user=3jf-nyIAAAAJ&hl=en&oi=ao">health economist</a> who has studied the pharmaceutical industry for the past 15 years. I believe the drug shortage problem illustrates a major shortcoming of capitalism. While costly brand-name drugs often yield high profits to manufacturers, there’s relatively little money to be made in supplying the market with low-cost generics, no matter how vital they may be to patients’ health. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/aXbYGfz2ATE?wmode=transparent&start=17" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">The shortage includes chemotherapy drugs, antibiotics, medications to treat ADHD and other critical drugs. Some patients are able to get their drugs, while others are not, and in some cases patients are getting ‘rationed care.’</span></figcaption>
</figure>
<h2>A generic problem</h2>
<p>The problem boils down to the nature of the pharmaceutical industry and how differently the markets for brand and generic drugs operate. Perhaps the clearest indication of this is the fact that <a href="https://www.rand.org/pubs/research_reports/RR2956.html">prices of brand drugs in the U.S. are among the highest</a> in the developed world, while generic drug prices are among the lowest. </p>
<p>When a drugmaker develops a new pill, cream or solution, the government grants the company an exclusive patent for up to 20 years, although most patents are filed before clinical testing, and thus the effective patent life is closer to eight to 12 years. Nonetheless, patents allow the drugmakers to cover the cost of research and development and earn a profit without the threat of competition from a rival making an identical product.</p>
<p>But once the patent expires, the drug becomes generic and any company is allowed to manufacture it. Since generic manufacturers are essentially producing the same product, profits are determined by their ability to manufacture the drug at the lowest marginal cost. This often results in low profit margins and can lead to cost-cutting measures that can compromise quality and threaten supply. </p>
<h2>Outsourced production creates more supply risks</h2>
<p>One of the consequences of generics’ meager margins is that drug companies outsource production to lower-cost countries.</p>
<p>As of mid-2019, 72% of the manufacturing facilities making active ingredients for drugs sold in the U.S. <a href="https://www.fda.gov/news-events/congressional-testimony/safeguarding-pharmaceutical-supply-chains-global-economy-10302019">were located overseas</a>, with India and China alone making up nearly half of that. </p>
<p>While overseas manufacturers often <a href="https://openknowledge.worldbank.org/server/api/core/bitstreams/3842481d-7bc7-532b-8cd2-ab30f57c6519/content">enjoy significant cost advantages</a> over U.S. facilities, such as easy access to raw materials and lower labor costs, outsourcing production at such a scale raises a slew of issues that can hurt the supply. <a href="https://www.nytimes.com/2011/08/13/science/13drug.html?pagewanted=al">Foreign factories are more difficult</a> for the <a href="https://theconversation.com/the-fdas-lax-oversight-of-research-in-developing-countries-can-do-harm-to-vulnerable-participants-170515">Food and Drug Administration to inspect</a>, tend to have more production problems and are far more likely than domestic factories to be shut down once a problem is discovered. </p>
<p><a href="https://www.fda.gov/news-events/congressional-testimony/safeguarding-pharmaceutical-supply-chains-global-economy-10302019">In testimony to a House subcommittee</a>, Janet Woodcock, the FDA’s principal deputy commissioner, acknowledged that the agency has little information on which Chinese facilities are producing raw ingredients, how much they are producing, or where the ingredients they are producing are being distributed worldwide. </p>
<p>The COVID-19 pandemic underscored the country’s reliance on foreign suppliers – and the risks this poses to U.S. consumers.</p>
<p>India is the world’s largest producer of generic drugs but imports 70% of its raw materials from China. About <a href="https://www.cidrap.umn.edu/sites/default/files/downloads/cidrap-covid19-viewpoint-part6.pdf">one-third of factories</a> in China shut down during the pandemic. To ensure domestic supplies, the Indian government restricted the export of medications, <a href="https://www.nytimes.com/2020/03/03/business/coronavirus-india-drugs.html">disrupting the global supply chain</a>. This led to shortages of drugs to treat COVID-19, such as for respiratory failure and sedation, as well as for a wide range of other conditions, <a href="https://www.uspharmacist.com/article/drug-shortages-amid-the-covid19-pandemic">like drugs to treat chemotherapy</a>, heart disease and bacterial infections. </p>
<h2>Low profits hurt quality</h2>
<p>Manufacturing drugs to consistently high quality standards requires constant testing and evaluation. </p>
<p>A company that sells a new, expensive, branded drug has a strong profit motive to keep quality and production high. That’s often not the case for generic drug manufacturers, and <a href="https://www.statnews.com/2020/06/02/bring-manufacturing-generic-drugs-back-to-u-s/">this can result in shortages</a>. </p>
<p>In 2008, an adulterated version of the blood-thinning drug Heparin <a href="https://www.pharmaceutical-technology.com/features/generic-drug-safety-us-regulators-struggle-global-market">was recalled worldwide</a> after being linked to 350 adverse events and 150 deaths in the U.S. alone.</p>
<p>In 2013, the Department of Justice <a href="https://oig.hhs.gov/fraud/enforcement/generic-drug-manufacturer-ranbaxy-pleads-guilty-and-agrees-to-pay-500-million-to-resolve-false-claims-allegations-cgmp-violations-and-false-statements-to-the-fda/#">fined the U.S. subsidiary of Ranbaxy Laboratories</a>, India’s largest generic drug manufacturer, US$500 million after it pleaded guilty to civil and criminal charges related to drug safety and falsifying safety data. In response, the FDA banned products made at four of the company’s manufacturing facilities in India from entering the U.S., <a href="https://www.nytimes.com/2013/05/14/business/global/ranbaxy-in-500-million-settlement-of-generic-drug-case.html">including generic versions of gabapentin</a>, which treats epilepsy and nerve pain, and the antibiotic ciprofloxacin.</p>
<p>And while there may be multiple companies selling the same generic drug in the U.S., there may be only a single manufacturer supplying the basic ingredients. Thus, any hiccup in production or shutdown due to quality issues can affect the entire market.</p>
<p>A recent analysis found that approximately 40% of generic drugs sold in the U.S. <a href="https://ssrn.com/abstract=3011139">have just one manufacturer</a>, and the share of markets supplied by just one or two manufacturers has increased over time. </p>
<figure class="align-center ">
<img alt="A man in a suit points in front of a lectern that says $30 insulin, with fridges of insulin in the background." src="https://images.theconversation.com/files/537321/original/file-20230713-19-4vturh.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/537321/original/file-20230713-19-4vturh.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/537321/original/file-20230713-19-4vturh.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/537321/original/file-20230713-19-4vturh.jpeg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/537321/original/file-20230713-19-4vturh.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/537321/original/file-20230713-19-4vturh.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/537321/original/file-20230713-19-4vturh.jpeg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">California Gov. Gavin Newsom partnered with Civica Rx to manufacture insulin for the state.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/CaliforniaGovernor/fb9c46b454aa451b87d3120061aa4fd2/photo?Query=insulin%20california&mediaType=photo&sortBy=arrivaldatetime:desc&dateRange=Anytime&totalCount=27&currentItemNo=6">AP Photo/Damian Dovarganes</a></span>
</figcaption>
</figure>
<h2>Repatriating the drug supply</h2>
<p>It is hard to quantify the impact of drug shortages on population health. However, a recent survey of U.S. hospitals, pharmacists and other health care providers found that drug shortages <a href="https://www.usp.org/sites/default/files/usp/document/supply-chain/pediatric-oncology-drugs-and-supply-chain.pdf">led to increased medication errors</a>, delayed administration of lifesaving therapies, inferior outcomes and patient deaths. </p>
<p>What can be done?</p>
<p>One option is to simply find ways to produce more generic drugs in the U.S.</p>
<p>California <a href="https://nashp.org/california-enacts-law-to-produce-generic-prescription-drugs/#">passed a law</a> in 2020 to do just that by allowing the state to contract with domestic manufactures to produce its own generic prescription drugs. In March 2023, California <a href="https://californiahealthline.org/news/article/california-generic-insulin-contract-civica-rx-newsom/">selected a Utah company</a> to begin producing low-cost insulin for California patients.</p>
<p>Whether this approach is feasible on a broader scale is uncertain, but, in my view, it’s a good first attempt to repatriate America’s drug supply.</p><img src="https://counter.theconversation.com/content/206848/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Geoffrey Joyce does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The shortages, which have been going on for years, have typically affected only low-cost generics rather than profitable brand-name drugs.Geoffrey Joyce, Director of Health Policy, USC Schaeffer Center, and Associate Professor, University of Southern CaliforniaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2097662023-07-17T21:52:04Z2023-07-17T21:52:04ZHigh drug prices in Canada are just one side of a bad equation<figure><img src="https://images.theconversation.com/files/537866/original/file-20230717-241434-8l70pi.jpg?ixlib=rb-1.1.0&rect=310%2C525%2C4751%2C3302&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Canadians pay high drug prices, but the pharmaceutical industry claims it is a 'key partner in economic resilience, recovery and growth.'</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><iframe style="width: 100%; height: 100px; border: none; position: relative; z-index: 1;" allowtransparency="" allow="clipboard-read; clipboard-write" src="https://narrations.ad-auris.com/widget/the-conversation-canada/high-drug-prices-in-canada-are-just-one-side-of-a-bad-equation" width="100%" height="400"></iframe>
<p>The Canadian health-care system is under pressure as <a href="https://nationalpost.com/news/canada/the-life-boat-is-full-why-canadas-entire-health-care-system-is-failing">service levels decline</a> while <a href="https://www.cihi.ca/en/national-health-expenditure-trends-2022-snapshot">costs escalate</a>. Drugs are one of our <a href="https://www.cihi.ca/en/national-health-expenditure-trends-2022-snapshot">largest health-care expenditures</a>. A federal agency, the Patented Medicine Prices Review Board (PMPRB), is supposed to <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/legislation/about-guidelines/guidelines.html">control drug prices</a> for Canadians. </p>
<p>However, the last year has been marked by upheavals which prevented the PMPRB from enacting a <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/consultations/2022-proposed-updates-guidelines.html">proposed series of reforms</a> that would have saved Canadians billions of dollars. </p>
<p>Innovative Medicines Canada (IMC), an advocacy group for the brand name pharmaceutical industry, <a href="https://innovativemedicines.ca/resources/all-resources/suspension-reformulation-pmprb-guidelines-urgently-required-imc-response-pmprb-2022-guidelines-proposals/">lobbied extensively</a> to quash these reforms. Its lobbying campaign was one of several key events which prompted <a href="https://www.ourcommons.ca/DocumentViewer/en/44-1/HESA/meeting-65/evidence">parliamentary hearings</a> and concerns over <a href="https://www.cmaj.ca/content/195/10/E378">political interference</a> with the activities of the PMPRB. </p>
<p>The result of these upheavals is that Canadians do not currently have a fully functional body protecting their best interests around drug prices.</p>
<p>However, drug prices are just one side of the equation. We must also look at pharmaceutical investment to understand the impact of the industry on the Canadian economy. </p>
<h2>Pharma industry in Canada</h2>
<p>Not surprisingly, IMC paints the contribution of its members in a positive light, recently publishing a <a href="https://innovativemedicines.ca/newsroom/all-news/canadas-rd-pharmaceutical-sector-a-key-partner-in-economic-resilience-recovery-and-growth/">press release</a> highlighting Canada’s research and development (R&D) pharmaceutical sector as “a key partner in economic resilience, recovery and growth.” IMC used data from <a href="https://www150.statcan.gc.ca/n1/pub/11-621-m/11-621-m2023001-eng.pdf">Statistics Canada</a> to show how pharmaceutical investment in Canada compares to other countries.</p>
<figure class="align-center ">
<img alt="Green capsules coming off a manufacturing line" src="https://images.theconversation.com/files/537888/original/file-20230717-230628-45bhv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/537888/original/file-20230717-230628-45bhv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=338&fit=crop&dpr=1 600w, https://images.theconversation.com/files/537888/original/file-20230717-230628-45bhv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=338&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/537888/original/file-20230717-230628-45bhv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=338&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/537888/original/file-20230717-230628-45bhv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=424&fit=crop&dpr=1 754w, https://images.theconversation.com/files/537888/original/file-20230717-230628-45bhv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=424&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/537888/original/file-20230717-230628-45bhv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=424&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Drug prices are just one side of the equation. We must also look at pharmaceutical investment to understand the impact of the industry on the Canadian economy.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>Reports in <a href="https://breachmedia.ca/pharma-lobby-paid-statistics-canada-reports-used-industry-pr-push/">news media</a> and <a href="https://doi.org/10.12927/hcpol.2023.27037">scientific publications</a>, including one by <a href="https://www.cmaj.ca/content/re-pharmaceutical-industry-spending-rd-canada">one of us</a>, have expressed concerns about the data used and the degree of influence that IMC had over the published Statistics Canada report. </p>
<p>Other sources such as the <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2021.html">PMPRB annual report</a>, which includes pharmaceutical market statistics from the <a href="https://www.oecd.org/health/health-systems/pharmaceuticals.htm">Organization for Economic Co-operation and Development (OECD)</a>, cite lower numbers for the economic impact of the industry. However, disputes over absolute numbers do not need to be resolved, because the relative numbers can help us understand how the economic benefits to Canada from the pharmaceutical sector compare with peer countries.</p>
<h2>High drug prices in Canada</h2>
<p>Depending on the source, patented medicine prices in Canada are either <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2021.html#a6">fourth-</a> or <a href="https://www.canada.ca/en/health-canada/services/health-care-system/pharmaceuticals/costs-prices.html">third-highest</a> in the OECD (surpassed only by Germany, Switzerland and the United States), averaging <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2021.html#a6">18 per cent above the OECD average</a>. </p>
<p>Some authors suggest our small market and fragmented administration of health care by 13 different provinces and territories <a href="https://doi.org/10.12927/hcpap.2023.27000">contribute to high drug prices</a>.</p>
<p>However, when comparing the ratio of Canadian drug prices with those of <a href="https://www.statista.com/statistics/496169/price-ratio-canadia-to-foreign-drug-prices/">smaller countries</a> like Australia (price ratio 0.71 compared to Canada), and the Netherlands (price ratio 0.77 compared to Canada), it is clear that small market size does not automatically mean high drug prices.</p>
<p>Other countries with publicly funded health-care systems also have better prices, including the <a href="https://www.statista.com/statistics/496169/price-ratio-canadia-to-foreign-drug-prices/">United Kingdom</a> (price ratio 0.87). <a href="https://stats.oecd.org/index.aspx?DataSetCode=HEALTH_PHMC">Pharmaceutical sales data from 2020</a> shows that Canada spent US$723 per person per year on drugs, which is much higher than countries like Australia (US$447) and the Netherlands (US$368).</p>
<p>It is clear that Canada has very high drug prices relative to its peers — but what about the other side of the equation?</p>
<h2>Pharmaceutical investment and the Canadian economy</h2>
<p>Pharmaceutical trade balance is one indicator of the economic impact of the industry. Data from the industry itself shows the trade balance is positive for the European Union (EU) (<a href="https://efpia.eu/media/637143/the-pharmaceutical-industry-in-figures-2022.pdf">US$429.62 per person</a>) and also positive for individual countries with higher drug prices like Germany and Switzerland. Contrast this with the negative pharmaceutical trade balance in Canada, where the deficit was estimated at <a href="https://www150.statcan.gc.ca/n1/pub/11-621-m/11-621-m2023001-eng.pdf">US$351.14 per person</a> and increasing.</p>
<p>Canada fares better when looking at pharmaceutical employment. <a href="https://efpia.eu/media/637143/the-pharmaceutical-industry-in-figures-2022.pdf">Its own statistics</a> suggest the pharma industry provides one job for every 628 people in the EU overall. Looking at specific countries, it is not surprising that Switzerland has the highest level of pharmaceutical employment (one job for 185 people) but Germany (one job for 720 people) and France (one job for 682 people) also benefit.</p>
<p>Although <a href="https://innovativemedicines.ca/newsroom/all-news/canadas-rd-pharmaceutical-sector-a-key-partner-in-economic-resilience-recovery-and-growth/">IMC touts a figure of 107,000 Canadian jobs</a>, a look at the source from <a href="https://www150.statcan.gc.ca/n1/pub/11-621-m/11-621-m2023001-eng.pdf">Statistics Canada</a> shows that this includes both direct and indirect jobs. Still, the 49,403 direct jobs provided to Canadians by the pharmaceutical sector translates into one job for 774 people which is comparable with other countries.</p>
<h2>Investment in pharma R&D in Canada</h2>
<p>Not comparable however is the level of R&D investment. <a href="https://innovativemedicines.ca/newsroom/all-news/canadas-rd-pharmaceutical-sector-a-key-partner-in-economic-resilience-recovery-and-growth/">IMC cites a figure</a> of CAD$2.4 billion. However this figure differs from the <a href="https://www150.statcan.gc.ca/n1/pub/11-621-m/11-621-m2023001-eng.pdf">source data</a>, which actually provides an estimated range CAD$1.8-2.4 billion, and includes spending by the entire industry, not just IMC members.</p>
<figure class="align-center ">
<img alt="Collage showing a scientist in safety glasses and face mask, a bottle of capsules and molecules" src="https://images.theconversation.com/files/537890/original/file-20230717-231587-itq97k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/537890/original/file-20230717-231587-itq97k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=335&fit=crop&dpr=1 600w, https://images.theconversation.com/files/537890/original/file-20230717-231587-itq97k.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=335&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/537890/original/file-20230717-231587-itq97k.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=335&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/537890/original/file-20230717-231587-itq97k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=421&fit=crop&dpr=1 754w, https://images.theconversation.com/files/537890/original/file-20230717-231587-itq97k.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=421&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/537890/original/file-20230717-231587-itq97k.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=421&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">The ratio of pharmaceutical research and development to sales in Canada is the lowest among comparator countries.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>The ratio of R&D to sales is another way to gauge the economic impact of the industry. The <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2021.html#a6">PMPRB</a> noted that Canada had the worst ratio among comparator countries at 3.9 per cent. Countries with lower drug prices had ratios two to six times better than Canada (France 15.2 per cent, Italy 6.6 per cent, Sweden 25.6 per cent, United Kingdom 23.4 per cent), as did those with higher drug prices (Germany 20.9 per cent, United States 23.4 per cent, Switzerland 115.4 per cent).</p>
<p><a href="https://innovativemedicines.ca/newsroom/all-news/canadas-rd-pharmaceutical-sector-a-key-partner-in-economic-resilience-recovery-and-growth/">IMC disputes</a> the PMPRB estimates claiming they are based on an outdated definition of R&D. But even using figures from the <a href="https://www150.statcan.gc.ca/n1/pub/11-621-m/11-621-m2023001-eng.pdf">Statistics Canada publication</a> endorsed by IMC, its membership was spending <a href="https://www.cmaj.ca/content/re-pharmaceutical-industry-spending-rd-canada">5.6 per cent to 7.9 per cent of revenue on R&D</a>, putting Canada perhaps marginally ahead of Italy but well behind the other comparator countries.</p>
<p>Looking at both sides of the equation then, Canadians pay very high absolute drug prices and receive lower economic benefits relative to our peers.</p>
<h2>Realistic goals for Canadian drug prices and pharma industry</h2>
<p>Canada has traditionally been a <a href="https://natural-resources.canada.ca/science-and-data/data-and-analysis/key-facts-and-figures-on-the-natural-resources-sector/16013">resource-based economy</a>. Enhancing other economic avenues takes time and consistent government policies. It is not reasonable to expect pharmaceutical investment in Canada sufficient to match R&D to sales ratios with countries like Switzerland where pharmaceuticals are a major contributor to GDP. </p>
<p>However, Canada could try to achieve a balance of investment and prices closer to norms for similar countries. Using the median of <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/are-you-patentee/current/sources-foreign-prices-pmprb7.html">the countries PMPRB uses as comparators</a>, this would mean improving the <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2021.html#a6">ratio of R&D to sales by five-fold</a>.</p>
<p>Building on lessons learned from the pandemic, the federal government initiated a <a href="https://ised-isde.canada.ca/site/biomanufacturing/en/canadas-biomanufacturing-and-life-sciences-strategy">Biomanufacturing and Life Sciences Strategy</a> to “rebuild our biomanufacturing sector, and support our innovative and world-leading scientists.” </p>
<p>To ensure that Canadians receive similar benefits from the pharmaceutical industry as other countries, we need oversight of both sides of the equation: drug prices (which requires a renewed PMPRB fully protected from political influence), and follow-up to ensure any government programs intended to offer investment incentives for the pharmaceutical industry in the Canadian economy achieve their goals.</p><img src="https://counter.theconversation.com/content/209766/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Sandra Sirrs has received funding from CADTH and Health Canada for consultative services. She is affiliated with a provincial health authority in British Columbia. No funding support was received for this article. </span></em></p><p class="fine-print"><em><span>In 2019-2023, Joel Lexchin received payments for writing briefs on the role of promotion in generating prescriptions for two legal firms. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p>Canadians pay very high drug costs, but Canada also does not receive the same economic benefits from pharmaceutical industry investments as other countries do.Sandra Sirrs, Clinical Professor, UBC Division of Endocrinology, University of British ColumbiaJoel Lexchin, Professor Emeritus of Health Policy and Management, York University, CanadaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2074632023-06-26T19:51:26Z2023-06-26T19:51:26ZCanada’s misguided changes to drug regulation could fast-track unproven medications and divert funds from other health needs<p>The Canadian government is proposing a new “<a href="https://canadagazette.gc.ca/rp-pr/p1/2022/2022-12-17/html/reg1-eng.html">Agile Licensing</a>” framework to expedite pre-market regulation of pharmaceuticals. While Health Minister Jean-Yves Duclos claims this is part of the government’s strategy to offer Canadians “<a href="https://www.ourcommons.ca/DocumentViewer/en/44-1/HESA/meeting-64/evidence">access to quality and affordable medicines</a>,” the policy is likely to cause more harm than good.</p>
<p>Adoption of Agile Licensing would allow companies to market drugs up to six months earlier than under the current system. Fewer pre-market clinical trials would be required as long as firms continue studying their drugs’ effectiveness after they are already in use.</p>
<p>The government suggests this new approach will significantly improve Canadians’ quality of life, estimating the value of this improvement at <a href="https://canadagazette.gc.ca/rp-pr/p1/2022/2022-12-17/html/reg1-eng.html">$302 million over ten years</a>. However, the assumptions behind this estimate are flawed.</p>
<h2>Flawed assumptions</h2>
<p>By design, Canada will have less information about the risks of new medicines if those drugs enter the market with less pre-market clinical data. This will become a problem if a company fails to conduct promised post-market studies or if Health Canada does not remove unsafe or ineffective medicines from the market. </p>
<p>Unfortunately, <a href="https://doi.org/10.1136/bmj.n1898">the experience in the United States</a> shows that many fast-tracked drugs are not adequately studied after they are approved for sale and few are removed from the market, even if evidence shows they do not perform as suggested by their “promising” but incomplete pre-market trials.</p>
<p>Fast-tracking market approval for new, less-studied medicines is not only potentially wasteful in the first instance; it will inevitably divert money away from other uses in the health-care system to pay for costly but unproven drugs.</p>
<p>New medicines are (<a href="https://doi.org/10.1136%2Fbmj.38582.703866.AE">and have long been</a>) the primary driver of increasing spending on prescription drugs, for both private and public drug plans. In terms of budgets, new drugs do not simply replace older ones; <a href="https://www.canada.ca/en/patented-medicine-prices-review/news/2023/01/increased-use-of-higher-cost-medicines-continues-to-put-pressure-on-canadian-public-drug-plans.html">they increase the overall drug budget</a>, which necessarily means foregone opportunities to use those funds in other sectors of health care, such as improving access to joint replacements, nursing homes or mental health care.</p>
<p>There is a major flaw in Health Canada’s cost-benefit analysis of Agile Licensing: it overlooks the fact that accelerated access to — and therefore spending on — “promising” new medicines means less money for other forms of health care that Canadians need. </p>
<h2>Affordability</h2>
<p>Despite the Minister of Health’s assertions, the proposed framework contains no mechanism for making fast-tracked medicines “affordable.” This is extremely worrisome given the drugs that will be fast-tracked by this policy are patented, specialized medicines likely to be priced at levels that are unaffordable and <a href="https://doi.org/10.1136/bmj.l4627">arguably indefensible</a>.</p>
<p>Patents are government-granted time-limited monopolies that can stimulate innovation. However, they can also enable manufacturers of specialized medicines to charge exorbitant prices due to the life-or-death situations faced by patients who need such treatments. Pharmaceutical companies are using this market power to charge extraordinarily high prices with increasing frequency.</p>
<p>Before 2006, only four drugs approved in Canada had annual prices above $50,000 per patient — which is clearly a lot of money. Today, however, 67 medicines carry such a price tag, costing Canadians over <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2021.html">$3 billion per year</a> in total. Seven drugs now available in Canada are priced at an astonishing <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/npduis/analytical-studies/chartbook/expensive-drugs-rare-diseases-2011-2020.html">$1 million per patient</a>.</p>
<p>Higher drug prices do not guarantee more value or improvements to health and well-being. <a href="https://doi.org/10.1007/s40273-021-01087-6">Studies show</a> it typically costs <a href="http://www.pmprb-cepmb.gc.ca/CMFiles/Consultations/new_guidelines/Canada_report_2018-03-14_Final.pdf">around $30,000</a> to produce a measurable improvement in the health of one person, for one year in health-care systems like ours. However, new patented medicines often require hundreds of thousands of dollars for the same benefit.</p>
<h2>The harms of high drug prices</h2>
<p>This discrepancy between reasonable prices for generating health benefits and the prices charged for many new patented medicines indicates a failing system. It directly harms Canadians by preventing access to therapies due to prohibitive pricing, and it indirectly harms them by diverting funds from more effective investments that would yield greater health benefits per dollar spent.</p>
<p>Before fast-tracking drug approvals so that manufacturers can increase sales, policymakers should develop and enforce measures to ensure the prices charged will fall within reasonable limits. Unfortunately, the Canadian government recently <a href="https://doi.org/10.1016/S0140-6736(23)00956-X">backed down</a> from reforms that would have done just that.</p>
<p>Without a policy to ensure reasonable pricing of fast-tracked medicines, the government’s proposed Agile Licensing regulations will only hasten access to unproven therapies while drawing resources away from other forms of health care that Canadians need and that offer better value for money spent.</p><img src="https://counter.theconversation.com/content/207463/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Steven G. Morgan has received research funding from the Canadian Institutes of Health Research (CIHR), Health Canada, and other public organizations.</span></em></p><p class="fine-print"><em><span>Aidan Hollis receives funding from Canadian Institutes of Health Research (CIHR) and Hong Kong RGC Senior Research Fellowship Scheme. He is President of Incentives for Global Health. </span></em></p><p class="fine-print"><em><span>Christopher McCabe was previously CEO of The Institute of Health Economics, Alberta, which received research funding from a number of pharmaceutical companies during his tenure, including Astra Zeneca, Boerhinger Ingleheim, GSK, Novartis, Roche and Takeda.</span></em></p><p class="fine-print"><em><span>Matthew Herder receives funding from the Canadian Institutes of Health Research (CIHR), the Public Health Agency of Canada, and the not-for-profit foundation Arnold Ventures. He was previously a member of the Patented Medicine Prices Review Board (PMPRB), and received honoraria for his public service. </span></em></p><p class="fine-print"><em><span>Mike Paulden receives funding from the Canadian Institutes of Health Research (CIHR). He previously chaired a technical working group at the Patented Medicine Prices Review Board (PMPRB), and was a founding member of the Health Economics Advisory Council at the Canadian Agency for Drugs and Technologies in Health (CADTH).</span></em></p>The federal government’s proposed Agile Licensing drug approval regulations mean Canada will have less information about the risks of new medicines, and higher costs.Steven G. Morgan, Professor, School of Population and Public Health, University of British ColumbiaAidan Hollis, Professor of Economics, University of CalgaryChristopher McCabe, Professor of Health Economics, Queen's University BelfastMatthew Herder, Director of the Health Law Institute at the Schulich School of Law, Dalhousie UniversityMike Paulden, Associate professor, School of Public Health, University of AlbertaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2064572023-06-22T17:25:55Z2023-06-22T17:25:55ZListen: Widespread use of Ozempic for weight loss could change how we view fatness<figure><img src="https://images.theconversation.com/files/533549/original/file-20230622-19-53j2i3.jpg?ixlib=rb-1.1.0&rect=20%2C958%2C1943%2C1005&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Ozempic, a semaglutide drug being used for weight loss, could impact how society sees fat people. </span> <span class="attribution"><span class="source">(macrovector/Freepik)</span></span></figcaption></figure><iframe height="200px" width="100%" frameborder="no" scrolling="no" seamless="" src="https://player.simplecast.com/325083d9-aeee-49a3-a16e-2ef5bdce4fad?dark=true"></iframe>
<p>It seems like everywhere you look these days, on TikTok, on the sides of buses, in news headlines, you see Ozempic, the drug originally created as a diabetes treatment, but now being used as a weight-loss method.</p>
<p>Ever since it <a href="https://globalnews.ca/news/9618159/ozempic-diabetes-weight-loss-drug-policy/#:%7E:text=Novo%20Nordisk%20actually,yet%20in%20Canada.">arrived in Canada</a>, it’s been in incredibly high demand. </p>
<p>While Ozempic may just be the next in a long line of get-thin-quick fads, it’s already causing a lot of issues, many of which are especially felt by racialized communities.</p>
<p><a href="https://dont-call-me-resilient.simplecast.com/episodes/widespread-use-of-ozempic-for-weight-loss-could-change-the-way-we-view-fatness">In this episode of <em>Don’t Call Me Resilient</em></a>, we are joined by fat and disability studies professor Fady Shanouda, who examines anti-fat bias in medicine. As the use of Ozempic, a drug for diabetes, slams into the mainstream as a weight-loss method, will the drug’s use impact our concept of fatness? And how does fatness intersect with race and class? How might the craze for Ozempic deepen racial and class disparities?</p>
<h2>Higher risk for diabetes</h2>
<p>In the United States and Canada, Black, Indigenous and South Asian communities are at a higher risk of Type 2 diabetes. A <a href="https://news.umanitoba.ca/rate-of-children-diagnosed-with-type-2-diabetes-rises-over-50-over-last-10-years-mchp-study-finds/">recent report</a> revealed that First Nations children in Manitoba are 25 times more likely to be diagnosed with Type 2 diabetes than other children. </p>
<figure class="align-left ">
<img alt="A person with their shirt pulled up and stomach exposed, with an ozempic injection in their right hand" src="https://images.theconversation.com/files/533254/original/file-20230621-21-h6xfhj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/533254/original/file-20230621-21-h6xfhj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/533254/original/file-20230621-21-h6xfhj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/533254/original/file-20230621-21-h6xfhj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/533254/original/file-20230621-21-h6xfhj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/533254/original/file-20230621-21-h6xfhj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/533254/original/file-20230621-21-h6xfhj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A person prepares an Ozempic injection to use to control blood sugar levels.</span>
<span class="attribution"><span class="source">myskin/Shutterstock</span></span>
</figcaption>
</figure>
<p>The cost of Ozempic already puts certain communities at a disadvantage. In Canada, Ozempic costs around <a href="https://www.cbc.ca/news/canada/british-columbia/ozempic-canada-british-columbia-how-it-works-1.6794950">$300 a month</a> and in the U.S., the price is about <a href="https://www.webmd.com/obesity/news/20230503/ozempic-cost-coupons-and-ways-to-save-cash">$1,000 a month</a>. While many rely on health insurance for prescriptions, insurance for the most part does not cover Ozempic for non-diabetic use.</p>
<h2>The racist roots of fighting obesity</h2>
<p>Prof. Shanouda explains how fatness has been negatively associated with Blackness, both historically and currently. These harmful conceptions of fatness influences the treatment of racialized communities in health care. This includes <a href="https://www.newyorker.com/magazine/2023/03/27/will-the-ozempic-era-change-how-we-think-about-being-fat-and-being-thin">frequent misdiagnosis, under-treatment and frequent fat-shaming by doctors</a>.</p>
<blockquote>
<p>I imagine fat people will be asked all the time now: why they continue to be fat and why they’re not on Ozempic. It is presenting us with a supposed solution for a human variation that has existed for all time. There have always been fat people. There will always be fat people. - Fady Shanouda</p>
</blockquote>
<h2>Listen and Follow</h2>
<p>You can listen to or follow <em><a href="https://dont-call-me-resilient.simplecast.com/episodes/listen-to-an-american-canadian-trans-scholar-and-activist-explain-why-trans-rights-are-under-attack">Don’t Call Me Resilient</a></em> on <a href="https://podcasts.apple.com/ca/podcast/dont-call-me-resilient/id1549798876">Apple Podcasts</a>, <a href="https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zaW1wbGVjYXN0LmNvbS9qZFg0Ql9DOA">Google Podcasts</a>, <a href="https://open.spotify.com/show/37tK4zmjWvq2Sh6jLIpzp7">Spotify</a> or <a href="https://dont-call-me-resilient.simplecast.com">wherever you listen to your favourite podcasts</a>. </p>
<p><a href="mailto:DCMR@theconversation.com">We’d love to hear from you</a>, including any ideas for future episodes. Join The Conversation on <a href="https://twitter.com/ConversationCA">Twitter</a>, <a href="https://www.facebook.com/TheConversationCanada">Facebook</a>, <a href="https://www.instagram.com/theconversationdotcom/">Instagram</a> and <a href="https://www.tiktok.com/@theconversation">TikTok</a> and use #DontCallMeResilient.</p>
<figure class="align-right ">
<img alt="A book cover with an drawing of Sara Baartman, and African women displayed in a zoo in 1800s England, for her body shape" src="https://images.theconversation.com/files/533291/original/file-20230621-21-sf20hh.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/533291/original/file-20230621-21-sf20hh.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=900&fit=crop&dpr=1 600w, https://images.theconversation.com/files/533291/original/file-20230621-21-sf20hh.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=900&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/533291/original/file-20230621-21-sf20hh.jpeg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=900&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/533291/original/file-20230621-21-sf20hh.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1131&fit=crop&dpr=1 754w, https://images.theconversation.com/files/533291/original/file-20230621-21-sf20hh.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1131&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/533291/original/file-20230621-21-sf20hh.jpeg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1131&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Sabrina Strings’s book cover for ‘Fearing the Black Body: The Racial Origins of Fat Phobia’ published by New York University Press.</span>
<span class="attribution"><span class="source">NYU Press</span></span>
</figcaption>
</figure>
<h2>Resources</h2>
<p><a href="https://www.scientificamerican.com/article/the-racist-roots-of-fighting-obesity2/">The Racist Roots of Fighting Obesity
</a> (<em>Scientific American</em>)</p>
<p><a href="https://www.nytimes.com/2023/06/14/health/obesity-drugs-wegovy-ozempic.html">New Obesity Drugs Come With a Side Effect of Shaming </a> (<em>The New York Times)</em></p>
<p><a href="https://news.yahoo.com/where-black-people-fit-ozepmic-140728627.html">Where do Black people fit into the Ozempic conversation?</a></p>
<p><a href="https://nyupress.org/9781479886753/fearing-the-black-body/"><em>Fearing the Black Body: The Racial Origins of Fatphobia</em></a> by Sabrina Strings</p>
<p><a href="https://www.inanna.ca/product/fat-studies-in-canada-remapping-the-field-in-canada/">Fat and Mad Bodies: Under, Out of, and Beyond Control</a> by Fady Shanouda in <em>Fat Studies in Canada: (Re)Mapping the Field</em></p>
<p><a href="https://www.huffpost.com/entry/why-im-nonbinary-but-dont-use-they-them_b_58ac875ee4b05e6b9b192c07">Why I’m Non-Binary But Don’t Use ‘They/Them’</a> by Hunter Ashleigh Shackelford</p>
<p><a href="https://www.press.umich.edu/11700274/queer_nightlife">Jockstraps and Crop Tops: Fat Queer Femmes Dressing for the Night</a> by Caleb Luna in <em>Queer Nightlife</em></p>
<h2>Read more in The Conversation</h2>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/ozempic-helps-weight-loss-by-making-you-feel-full-but-certain-foods-can-do-the-same-thing-without-the-side-effects-201870">Ozempic helps weight loss by making you feel full. But certain foods can do the same thing – without the side-effects</a>
</strong>
</em>
</p>
<hr>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/fatblaster-max-has-just-been-banned-why-heres-everything-you-need-to-know-about-diet-supplements-183347">FatBlaster Max has just been banned. Why? Here’s everything you need to know about diet supplements</a>
</strong>
</em>
</p>
<hr>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/is-it-true-the-faster-you-lose-weight-the-quicker-it-comes-back-heres-what-we-know-about-slow-and-fast-weight-loss-198301">Is it true the faster you lose weight the quicker it comes back? Here's what we know about slow and fast weight loss</a>
</strong>
</em>
</p>
<hr>
<img src="https://counter.theconversation.com/content/206457/count.gif" alt="The Conversation" width="1" height="1" />
As the use of Ozempic, a drug for diabetes, slams into the mainstream as a weight-loss method, will the drug’s use impact our concept of fatness? And how does fatness intersect with race and class?Vinita Srivastava, Host + Producer, Don't Call Me ResilientBoké Saisi, Associate Producer, Don't Call Me ResilientKikachi Memeh, Assistant Producer/Student Journalist, Don't Call Me ResilientLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2047872023-05-04T20:39:52Z2023-05-04T20:39:52ZHealth Canada should be transparent about how it’s monitoring drug safety<figure><img src="https://images.theconversation.com/files/524019/original/file-20230503-26-zdm4om.jpg?ixlib=rb-1.1.0&rect=586%2C439%2C5165%2C3388&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">When regulatory agencies like Health Canada approve a new drug, they require the drug company to continue monitoring the product's safety.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><iframe style="width: 100%; height: 100px; border: none; position: relative; z-index: 1;" allowtransparency="" allow="clipboard-read; clipboard-write" src="https://narrations.ad-auris.com/widget/the-conversation-canada/health-canada-should-be-transparent-about-how-it-s-monitoring-drug-safety" width="100%" height="400"></iframe>
<p>Regulatory bodies like Health Canada are intended to ensure that approved drugs go through a rigorous multi-stage process. However, clinical trials can’t detect every side-effect or risk. </p>
<p>Once new drugs are approved for marketing in Canada, Health Canada continues to monitor them. This is to determine if the health benefits identified in pre-market trials hold up to further scrutiny, new safety issues arise or known ones are more serious than initially anticipated, and if the drugs are being used outside of their approved uses and populations. </p>
<p>All of that information is important for doctors and pharmacists and for people who will be using the drugs and should be publicly available.</p>
<h2>Clinical trials</h2>
<p>Potential new drugs are assessed in <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-clinical-practices/guidance-documents/guidance-drugs-clinical-trials-human-subjects-gui-0100.html">clinical trials</a> before they can be authorized for sale in Canada. But in order to make it easier to clearly identify if the drugs are beneficial, these trials only enrol a very selective group of patients. </p>
<p>For example, people who are accepted into these trials need to have a definite diagnosis, they should only be suffering from the disease the drug is intended to treat, they shouldn’t be taking other drugs, they may have to live near the site where the testing is ongoing — and the exclusions go on. </p>
<p>By one estimate, <a href="https://doi.org/10.1176/appi.ajp.159.3.469">out of a potential 346 patients only 29</a> or fewer than 10 per cent, qualified for a trial looking at treating major depression. In addition, <a href="https://deainfo.nci.nih.gov/advisory/ctac/archive/0309/presentations/Williams_030409.pdf">clinical trials often leave out</a> children, the elderly, women, minority groups, people with disabilities and multiple other groups.</p>
<p>Usually <a href="https://www.healthline.com/health/clinical-trial-phases#phase-ii">only 3,000 to 5,000 people</a> are exposed to an experimental drug in clinical trials. The much larger trials conducted for the COVID-19 vaccines, <a href="https://www.nih.gov/news-events/news-releases/peer-reviewed-report-moderna-covid-19-vaccine-publishes">involving 30,000</a> to <a href="https://www.pfizer.com/science/coronavirus/vaccine/about-our-landmark-trial">46,000 people</a>, were an exception to this. </p>
<figure class="align-center ">
<img alt="White pills spilling out of a bottle forming the shape of a question mark against a pink background" src="https://images.theconversation.com/files/524020/original/file-20230503-444-eml4cj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/524020/original/file-20230503-444-eml4cj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/524020/original/file-20230503-444-eml4cj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/524020/original/file-20230503-444-eml4cj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/524020/original/file-20230503-444-eml4cj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/524020/original/file-20230503-444-eml4cj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/524020/original/file-20230503-444-eml4cj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">When drugs are finally approved, there are still unanswered safety questions, including about how drugs will affect demographic groups who were left out of the trials.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>Previous research has shown that in order to detect rare side-effects, a trial needs to use the <a href="https://blogs.bmj.com/bmjebmspotlight/2017/11/14/rare-adverse-events-clinical-trials-understanding-rule-three/">statistical rule of three</a>: For example, if a side-effect affects one in 1,000 patients, a trial would have to enrol at least 3,000 people (three x 1,000) to have a 95 per cent chance of seeing even a single case. This means that rare safety issues may be missed entirely. </p>
<p>The result is that when drugs are finally approved, there are still unanswered safety questions, including about how drugs will affect demographic groups who were left out of the trials.</p>
<h2>Drug safety programs</h2>
<p>That’s why when regulatory agencies like Health Canada approve a drug, they require the drug company to monitor post-market safety. These programs go by various names; in <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/guidance-document-submission-risk-management-plans-follow-commitments.html">Canada</a> and <a href="https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pharmacovigilance/risk-management/risk-management-plans">Europe</a> they are Risk Management Plans (RMP) and in the United States they are <a href="https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems">Risk Evaluation and Mitigation Strategies</a> (REM). </p>
<p>Canada’s current RMP system has been in place <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/guidance-document-submission-risk-management-plans-follow-commitments.html">since 2009</a>. According to <a href="https://www.canada.ca/en/health-canada/programs/consultation-proposed-agile-regulations-guidance-licensing-drugs-medical-devices/submitting-risk-management-plans.html">Health Canada documents</a>, RMPs are mandatory when there is a significant degree of uncertainty respecting the risks associated with a particular drug or when a drug “presents a serious risk of injury to human health that warrants measures … to reduce the probability or severity of such an injury.”</p>
<p>All new drugs that have never before been sold in Canada in any form, as well as all opioids, require RMPs to help safeguard the public. </p>
<p><a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/profile-guidance-document-submission-risk-management-plans-follow-commitments/notice-clarification-drug-manufacturers-sponsors.html">Under these plans</a> companies may have to conduct additional safety studies, set up registries to identify patients who are taking the drug, develop educational materials for health care professionals and/or patients, restrict access to the drug and commit to undertaking a number of other measures.</p>
<p>RMPs are not perfect and won’t resolve all the safety uncertainties about new drugs. <a href="https://doi.org/10.1038/clpt.2014.184">One European study</a> estimated that after five years, only about one in five issues was settled. More definitely needs to be done to monitor post-market safety. </p>
<p>But RMPs are still a significant tool. Issues that remained unresolved in some cases were whether theoretical risks were actually seen in practice and whether there was enough information to determine if long-term data revealed new safety concerns.</p>
<h2>Access to drug monitoring information</h2>
<p>Doctors who prescribe drugs, pharmacists who fill prescriptions, researchers who study drug safety and especially patients who take the drugs all should have a right to know how safety is being monitored. </p>
<p>In the U.S., people can turn to a <a href="https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm">Food and Drug Administration website</a> that lists all the drugs with REMS. There they can read about the goals of the REMS, a summary of the measures included in it, look at the materials that have been developed and how the effectiveness of the REMS plan is going to be assessed. </p>
<p>In European countries like <a href="https://laegemiddelstyrelsen.dk/en/licensing/licensing-of-medicines/medicines-authorised-with-a-summary-of-the-risk-management-plan/">Denmark there is a similar list of drugs</a> with a RMP. Click on a hyperlink and it takes you to a summary of the RMP for the drug in question.</p>
<p>Health Canada currently has no such website, and acknowledges that <a href="https://nlpb.ca/media/Health-Canada_QA-for-HCP_RMP_EN_Updated_2022-07-07.pdf">this is an information gap</a>. Two of <a href="https://www.canada.ca/en/health-canada/programs/consultation-proposed-agile-regulations-guidance-licensing-drugs-medical-devices/submitting-risk-management-plans.html">Health Canada’s stated goals</a> in implementing a system of RMPs are to “support Canadians’ timely access to safe, efficacious and high quality drugs and support ongoing evaluation of information that could have an impact on the benefit-risk profile of health products.” </p>
<p>But without access to current information on specific drugs, Canadians cannot assess those risks for themselves, nor can they evaluate the monitoring program. </p>
<p>On top of this lack of transparency, <a href="https://shpm.info.yorku.ca/files/2020/09/Health-Canada-funding-distribution-2004-2020.pdf">Health Canada spends only one-third as much money and has only one-third as many employees</a> monitoring drug safety compared to the amount of money and the number of people who are involved in approving new drugs.</p>
<p>Since February 2019, Health Canada has been a world leader in <a href="https://www.bmj.com/content/365/bmj.l1825">releasing the information that it used in deciding to approve new drugs</a>. It has a <a href="https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review.html?_ga=2.233746589.2014837886.1506726303-1326787507.1398655537#_Submissions_currently_under">website</a> that lists drugs that weren’t approved and what drugs it’s considering for approval. There is a <a href="https://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=B68C1BAF-1">website with RMPs for substances that are harmful</a> to the environment and human health, albeit with data from 2016. </p>
<p>It’s time for Health Canada to do the same for drug RMPs. <a href="https://canadagazette.gc.ca/rp-pr/p1/2022/2022-12-17/html/reg1-eng.html">When Canada’s Food and Drugs Act regulations are amended</a>, transparency for drug RMPs needs to be made mandatory. But Health Canada does not need to wait until then to make this information available to Canadians.</p><img src="https://counter.theconversation.com/content/204787/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2019-2022, Joel Lexchin received payments for writing briefs on the role of promotion in generating prescriptions for two legal firms. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p>Health Canada continues to monitor newly approved drugs to determine if the benefits identified in the pre-market trials hold up to further scrutiny. Canadians need better access to that information.Joel Lexchin, Professor Emeritus of Health Policy and Management, York University, CanadaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1990852023-02-10T01:50:05Z2023-02-10T01:50:05ZIs my medicine making me feel hotter this summer? 5 reasons why<figure><img src="https://images.theconversation.com/files/508796/original/file-20230208-24-lf74uh.jpg?ixlib=rb-1.1.0&rect=2%2C1%2C995%2C664&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/overheated-woman-sitting-on-couch-waving-1707953323">Shutterstock</a></span></figcaption></figure><p>If you’re really feeling the heat this summer, it might be down to more than the temperature outside.</p>
<p>Some types of medicines can increase your core body temperature or make you feel hotter than you really are. Some can affect your body’s ability to cool down.</p>
<p>Here’s what you need to know about heat intolerance and medicines.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/how-to-cope-with-extreme-heat-days-without-racking-up-the-aircon-bills-128857">How to cope with extreme heat days without racking up the aircon bills</a>
</strong>
</em>
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<h2>What is heat intolerance?</h2>
<p>Some people simply dislike the feeling of feeling hot, while others feel hot at temperatures most people find comfortable. Both are examples of
<a href="https://www.medicalnewstoday.com/articles/325232#symptoms">heat intolerance</a>.</p>
<p>Typical symptoms during warm weather include excessive sweating (or not sweating enough), exhaustion and fatigue, nausea, vomiting or dizziness, and changes in mood.</p>
<p>A number of factors can cause heat intolerance.</p>
<p>This includes the disorder <a href="https://my.clevelandclinic.org/health/diseases/6004-dysautonomia">dysautonomia</a>, which affects people’s autonomic nervous system – the part of the body that regulates the automatic functions of the body, including our response to heat. </p>
<p>Conditions such as diabetes, alcohol misuse, <a href="https://theconversation.com/what-causes-parkinsons-disease-what-we-know-dont-know-and-suspect-57579">Parkinson’s disease</a>, the autoimmune disease <a href="https://theconversation.com/explainer-what-is-guillain-barre-syndrome-and-is-it-caused-by-the-zika-virus-53884">Guillain-Barré syndrome</a> and <a href="https://theconversation.com/explainer-what-are-mitochondria-and-how-did-we-come-to-have-them-83106">mitochondrial disease</a> can cause dysautonomia. People in old age, those with some neurological conditions, or people less physically fit may also have it.</p>
<p>But importantly, medications can also contribute to heat intolerance.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/5-reasons-to-check-on-your-elderly-neighbour-during-a-heatwave-196218">5 reasons to check on your elderly neighbour during a heatwave</a>
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</em>
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<hr>
<h2>1. Your body temperature rises</h2>
<p>Some medicines directly increase your body temperature, which then increases the risk of heat intolerance. </p>
<p>These include <a href="https://bpspubs.onlinelibrary.wiley.com/doi/epdf/10.1111/bph.15465">stimulant medications</a> to treat ADHD (attention deficit hyperactivity disorder), such as methylphenidate, dexamfetamine and lisdexamfetamine.</p>
<p><a href="https://www.healthdirect.gov.au/antipsychotic-medications">Antipsychotic medications</a> (such as clozapine, olanzapine and quetiapine) used to treat mental health conditions, such as schizophrenia and bipolar disorder, are other examples. </p>
<p>These ADHD and antipsychotic medicines raise your temperature by acting on the hypothalamus, the region of the brain essential for cooling.</p>
<p>The drug levothyroxine, used to treat an under-active thyroid, also increases your body temperature, this time by <a href="https://www.ncbi.nlm.nih.gov/books/NBK500006/">increasing your metabolism</a>.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/508840/original/file-20230208-28-ki6965.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Medical illustration of hypothalamus region of brain" src="https://images.theconversation.com/files/508840/original/file-20230208-28-ki6965.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/508840/original/file-20230208-28-ki6965.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/508840/original/file-20230208-28-ki6965.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/508840/original/file-20230208-28-ki6965.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/508840/original/file-20230208-28-ki6965.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/508840/original/file-20230208-28-ki6965.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/508840/original/file-20230208-28-ki6965.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Some medicines raise your body temperature directly by acting on the hypothalamus region of the brain.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-illustration/3d-rendered-medically-accurate-illustration-hypothalamus-1292650669">SciePro/Shutterstock</a></span>
</figcaption>
</figure>
<h2>2. Your blood flow is affected</h2>
<p>Other medicines constrict (tighten) blood vessels, decreasing blood flow to the skin, and so prevent heat from escaping this way. This means your body can’t regulate its temperature as well in the heat. </p>
<p>Examples include <a href="https://www.healthdirect.gov.au/beta-blockers">beta-blockers</a> (such as metoprolol, atenolol and propranolol). These medications are used to treat conditions such as high blood pressure, angina (a type of chest pain), tachycardia (fast heart rate), heart failure, and to prevent migraines. </p>
<p><a href="https://www.nhs.uk/conditions/decongestants/">Decongestants</a> for blocked noses (for example, pseudoephedrine and phenylephrine), triptans for migraines (such as sumatriptan and zolmitriptan) and the ADHD medications mentioned earlier can also act to decrease blood flow to the skin.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/forget-nose-spray-good-sex-clears-a-stuffy-nose-just-as-effectively-and-is-a-lot-more-fun-167901">Forget nose spray, good sex clears a stuffy nose just as effectively — and is a lot more fun</a>
</strong>
</em>
</p>
<hr>
<h2>3. You can get dehydrated</h2>
<p>Other medicines can cause dehydration, which then makes you more susceptible to heat intolerance. The best examples are <a href="https://www.mayoclinic.org/diseases-conditions/high-blood-pressure/in-depth/diuretics/art-20048129">diuretics</a> such as furosemide, hydrochlorothiazide, acetazolamide and aldosterone.</p>
<p>These are used to control high blood pressure and heart failure by forcing your kidneys to remove more fluid from your body. </p>
<p>Laxatives, such as senna extract and bisacodyl, also remove water from your body and so have a similar effect.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/health-check-how-do-i-tell-if-im-dehydrated-107437">Health Check: how do I tell if I'm dehydrated?</a>
</strong>
</em>
</p>
<hr>
<h2>4. You can sweat less</h2>
<p>Other medicines have a drying effect. This can be needed for medicines to do their job (for instance, to dry up a runny nose). For others, it is an unwanted side effect. </p>
<p>This drying reduces the amount you sweat, making it harder to lose heat and regulate your core temperature. A number of medicines have these effects, including:</p>
<ul>
<li>some antihistamines (such as promethazine, doxylamine and diphenhydramine)</li>
<li>certain antidepressants (such as amitriptyline, clomipramine and dothiepin)</li>
<li>medicines used to treat <a href="https://www.healthdirect.gov.au/urinary-incontinence#:%7E:text=Urinary%20incontinence%2C%20or%20poor%20bladder%20control%2C%20is%20very%20common%20in,to%20cure%20or%20improve%20it.">urinary incontinence</a> (for example, oxybutynin and solifenacin) </li>
<li>nausea medicine (prochlorperazine)</li>
<li>medicines for stomach cramps and spasms (for instance, hyoscine) </li>
<li>the antipsychoptics chlorpromazine, olanzapine, quetiapine and clozapine.</li>
</ul>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/health-check-do-men-really-sweat-more-than-women-73903">Health Check: do men really sweat more than women?</a>
</strong>
</em>
</p>
<hr>
<h2>5. You don’t feel thirsty</h2>
<p>Finally, some medicines, such as the antipsychotics haloperidol and droperidol, can aggravate heat intolerance by reducing your ability to feel thirsty. </p>
<p>If you don’t feel thirsty, you drink less and are therefore at risk of dehydration and feeling hot.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/508849/original/file-20230208-31-oak7ni.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Woman staring at glass of water on counter" src="https://images.theconversation.com/files/508849/original/file-20230208-31-oak7ni.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/508849/original/file-20230208-31-oak7ni.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/508849/original/file-20230208-31-oak7ni.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/508849/original/file-20230208-31-oak7ni.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/508849/original/file-20230208-31-oak7ni.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/508849/original/file-20230208-31-oak7ni.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/508849/original/file-20230208-31-oak7ni.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">People taking some medications just don’t feel thirsty.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/upset-young-woman-looking-through-glass-754782025">Shutterstock</a></span>
</figcaption>
</figure>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/health-check-how-can-extreme-heat-lead-to-death-91480">Health Check: how can extreme heat lead to death?</a>
</strong>
</em>
</p>
<hr>
<h2>What can you do about it?</h2>
<p>If you are feeling hot this summer and think your medicine may be contributing, it’s very important you keep taking your medicine.</p>
<p>Speak to your pharmacist or doctor about your symptoms. They will offer advice and discuss alternatives.</p><img src="https://counter.theconversation.com/content/199085/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Associate Professor Wheate in the past has received funding from the ACT Cancer Council, Tenovus Scotland, Medical Research Scotland, Scottish Crucible, and the Scottish Universities Life Sciences Alliance. He is a Fellow of the Royal Australian Chemical Institute, a member of the Australasian Pharmaceutical Science Association, and a member of the Australian Institute of Company Directors. Nial is the chief scientific officer of Vairea Skincare LLC and a Standards Australia panel member for sunscreen agents.</span></em></p><p class="fine-print"><em><span>Jessica Pace does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>If you think your medicine may be contributing to overheating, it’s very important you keep taking your medicine. Discuss your symptoms with your pharmacist or doctor.Nial Wheate, Associate Professor of the Sydney Pharmacy School, University of SydneyJessica Pace, Associate Lecturer, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1966462022-12-21T19:11:54Z2022-12-21T19:11:54ZDrinking alcohol this Christmas and New Year? These medicines really don’t mix<figure><img src="https://images.theconversation.com/files/502253/original/file-20221220-22-w0zd44.jpg?ixlib=rb-1.1.0&rect=8%2C17%2C5742%2C3811&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/champagne-glasses-hands-people-party-1377409880">Shutterstock</a></span></figcaption></figure><p>A glass or two of champagne with Christmas lunch. A cool crisp beer at the beach. Some cheeky cocktails with friends to see in the New Year. There seem to be so many occasions to unwind with an alcoholic drink this summer.</p>
<p>But if you’re taking certain medications while drinking alcohol, this can affect your body in a number of ways. Drinking alcohol with some medicines means they may not work so well. With others, you risk a life-threatening overdose.</p>
<p>Here’s what you need to know if you’re taking medication over summer and plan to drink.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/do-different-drinks-make-you-different-drunk-88247">Do different drinks make you different drunk?</a>
</strong>
</em>
</p>
<hr>
<h2>Why is this a big deal?</h2>
<p>After you take a medicine, it travels to the stomach. From there, your body shuttles it to the liver where the drug is metabolised and broken down before it goes into your blood stream. Every medicine you take is provided at a dose that takes into account the amount of metabolism that occurs in the liver.</p>
<p>When you drink alcohol, this is also broken down in the liver, and it can affect how much of the drug is metabolised. </p>
<p>Some medicines are metabolised <em>more</em>, which can mean not enough reaches your blood stream to be effective. </p>
<p>Some medicines are metabolised <em>less</em>. This means you get a much higher dose than intended, which could lead to an overdose. The effects of alcohol (such as sleepiness) can act in addition to similar effects of a medicine.</p>
<p>Whether or not you will have an interaction, and what interaction you have, depends on many factors. These include the medicine you are taking, the dose, how much alcohol you drink, your age, genes, sex and overall health. </p>
<p>Women, older people and people with liver issues are more likely to have a drug interaction with alcohol.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/women-are-50-75-more-likely-to-have-adverse-drug-reactions-a-new-mouse-study-finally-helps-explain-why-195358">Women are 50–75% more likely to have adverse drug reactions. A new mouse study finally helps explain why</a>
</strong>
</em>
</p>
<hr>
<h2>Which medicines don’t mix well with alcohol?</h2>
<p>Many medicines interact with alcohol regardless of whether they are prescribed by your doctor or bought over the counter, such as <a href="https://www.drugs.com/article/herbal-supplements-alcohol.html">herbal medicines</a>.</p>
<p><strong>1. Medicines + alcohol = drowsiness, coma, death</strong></p>
<p>Drinking alcohol and taking a medicine that depresses the <a href="https://adf.org.au/drug-facts/depressants/">central nervous system</a> to reduce arousal and stimulation can have additive effects. Together, these can make you extra drowsy, slow your breathing and heart rate and, in extreme cases, lead to coma and death. These effects are more likely if you use more than one of this type of medicine. </p>
<p>Medicines to look out for include those for depression, anxiety, schizophrenia, pain (except <a href="https://www.nps.org.au/australian-prescriber/articles/alcohol-and-paracetamol">paracetamol</a>), sleep disturbances (such as insomnia), allergies, and colds and flu. It’s best not to drink alcohol with these medicines, or to keep your alcohol intake to a minimum. </p>
<p><strong>2. Medicines + alcohol = more effects</strong></p>
<p>Mixing alcohol with some medicines increases the effect of those medicines. </p>
<p>One example is with the sleeping tablet zolpidem, which is <a href="https://www.tga.gov.au/news/product-recalls/zolpidem-stilnox">not to be taken with alcohol</a>. Rare, but serious, side effects are strange behaviour while asleep, such as sleep-eating, sleep-driving or sleep-walking, which are more likely with alcohol.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/i-cant-sleep-what-drugs-can-i-safely-take-102343">I can't sleep. What drugs can I (safely) take?</a>
</strong>
</em>
</p>
<hr>
<p><strong>3. Medicines + craft beer or home brew = high blood pressure</strong></p>
<p>Some types of medicines only interact with some types of alcohol.</p>
<p>Examples include some medicines for depression, such as phenelzine, tranylcypromine and moclobemide, the antibiotic linezolid, the Parkinson’s drug selegiline, and the cancer drug procarbazine.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/502281/original/file-20221221-19-slbol7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Two young women drinking alcohol sitting on bench outside bar" src="https://images.theconversation.com/files/502281/original/file-20221221-19-slbol7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/502281/original/file-20221221-19-slbol7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=429&fit=crop&dpr=1 600w, https://images.theconversation.com/files/502281/original/file-20221221-19-slbol7.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=429&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/502281/original/file-20221221-19-slbol7.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=429&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/502281/original/file-20221221-19-slbol7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=539&fit=crop&dpr=1 754w, https://images.theconversation.com/files/502281/original/file-20221221-19-slbol7.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=539&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/502281/original/file-20221221-19-slbol7.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=539&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Drinking craft beer this summer? This can interact with some drugs to raise your blood pressure.</span>
<span class="attribution"><a class="source" href="https://www.pexels.com/photo/two-smiling-women-sitting-on-wooden-bench-1267696/">ELEVATE/Pexels</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
</figcaption>
</figure>
<p>These so-called <a href="https://www.mydr.com.au/medicine/monoamine-oxidase-inhibitors-maois-for-depression/">monoamine oxidase inhibitors</a> <a href="https://www.health.qld.gov.au/__data/assets/pdf_file/0020/145802/oncol_maoi.pdf">only interact with</a> some types of boutique and artisan beers, beers with visible sediment, Belgian, Korean, European and African beers, and home-made beers and wine.</p>
<p>These types of alcohol contain high levels of tyramine, a naturally occurring substance usually broken down by your body that doesn’t ordinarily cause any harm. </p>
<p>However, monoamine oxidase inhibitors prevent your body from breaking down tyramine. This increases levels in your body and can cause your blood pressure to rise to dangerous levels. </p>
<p><strong>4. Medicines + alcohol = effects even after you stop drinking</strong></p>
<p>Other medicines interact because they affect the way your body breaks down alcohol. </p>
<p>If you drink alcohol while using such medicines you may you feel nauseous, vomit, become flushed in the face and neck, feel breathless or dizzy, your heart may beat faster than usual, or your blood pressure may drop. </p>
<p>This can occur even after you stop treatment, then drink alcohol. For example, if you are taking metronidazole you should avoid alcohol both while using the medicine and for at least 24 hours after you stop taking it. </p>
<p>An example of where alcohol changes the amount of the medicine or related substances in the body is acitretin. This medication is used to treat skin conditions such as severe psoriasis and to prevent skin cancer in people who have had an organ transplant.</p>
<p>When you take acitretin, it changes into another substance – <a href="https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2017-CMI-02034-1&d=20221221172310101">etretinate</a> – before it is removed from your body. Alcohol increases the amount of etretinate in your body. </p>
<p>This is especially important as etretinate can cause birth defects. To prevent this, if you are a woman of child-bearing age you should avoid alcohol while using the medicine and for two months after you stop taking it.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/why-we-dont-know-what-causes-most-birth-defects-78592">Why we don't know what causes most birth defects</a>
</strong>
</em>
</p>
<hr>
<h2>Myths about alcohol and medicines</h2>
<p><strong>Alcohol and birth control</strong></p>
<p>One of the most common myths about medicines and alcohol is that you can’t drink while using <a href="https://youly.com.au/blog/sexual-reproductive-health/does-alcohol-make-the-pill-less-effective/">the contraceptive pill</a>.</p>
<p>It is generally safe to use alcohol with the pill as it <a href="https://www.healthline.com/health/womens-health/birth-control-and-alcohol#:%7E:text=There's%20a%20bit%20of%20good,a%20less%20effective%20birth%20control.">doesn’t directly affect</a> how well birth control works. </p>
<p>But the pill is most effective when taken at the same time each day. If you’re drinking heavily, you’re more likely to forget to do this the next day. </p>
<p>Alcohol can also make some people nauseous and vomit. If you vomit within three hours of taking the pill, it will not work. This increases your risk of pregnancy. </p>
<p>Contraceptive pills can also affect your response to alcohol as the hormones they contain can change the way your body <a href="https://americanaddictioncenters.org/alcoholism-treatment/birth-control">removes alcohol</a>. This means you can get drunk faster, and stay drunk for longer, than you normally would.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/502282/original/file-20221221-16-n1zjeb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Woman holding pack of contraceptive pills" src="https://images.theconversation.com/files/502282/original/file-20221221-16-n1zjeb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/502282/original/file-20221221-16-n1zjeb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=268&fit=crop&dpr=1 600w, https://images.theconversation.com/files/502282/original/file-20221221-16-n1zjeb.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=268&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/502282/original/file-20221221-16-n1zjeb.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=268&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/502282/original/file-20221221-16-n1zjeb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=336&fit=crop&dpr=1 754w, https://images.theconversation.com/files/502282/original/file-20221221-16-n1zjeb.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=336&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/502282/original/file-20221221-16-n1zjeb.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=336&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Yes you can drink while on the pill. But if you vomit within a few hours of taking it, the pill won’t work.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/woman-hands-opening-birth-control-pills-2139091435">Shutterstock</a></span>
</figcaption>
</figure>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/always-forgetting-to-take-your-medicines-here-are-4-things-that-could-help-193717">Always forgetting to take your medicines? Here are 4 things that could help</a>
</strong>
</em>
</p>
<hr>
<p><strong>Alcohol and antibiotics</strong></p>
<p>Then there’s the myth about not mixing alcohol with any <a href="https://theconversation.com/mondays-medical-myth-you-cant-mix-antibiotics-with-alcohol-4407">antibiotics</a>. This only applies to <a href="https://www.healthdirect.gov.au/medicines/medicinal-product/aht,21161/metronidazole">metronidazole</a> and <a href="https://www.healthdirect.gov.au/medicines/brand/amt,1011571000168100/linezolid-apo">linezolid</a>. </p>
<p>Otherwise, it is generally safe to use alcohol with antibiotics, as alcohol does not affect how well they work.</p>
<p>But if you can, it is best to avoid alcohol while taking antibiotics. Antibiotics and alcohol have similar side effects, such as an upset stomach, dizziness and drowsiness. Using the two together means you are more likely to have these side effects. Alcohol can also reduce your energy and increase how long it takes for you to recover.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/mondays-medical-myth-you-cant-mix-antibiotics-with-alcohol-4407">Monday's medical myth: you can't mix antibiotics with alcohol</a>
</strong>
</em>
</p>
<hr>
<h2>Where can I go for advice?</h2>
<p>If you plan on drinking alcohol these holidays and are concerned about any interaction with your medicines, don’t just stop taking your medicines.</p>
<p>Your pharmacist can advise you on whether it is safe for you to drink based on the medicines you are taking, and if not, provide advice on alternatives.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/dont-let-your-pet-accidentally-get-drunk-this-silly-season-sorry-tiddles-87671">Don't let your pet accidentally get drunk this silly season (sorry Tiddles)</a>
</strong>
</em>
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<img src="https://counter.theconversation.com/content/196646/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Associate Professor Wheate in the past has received funding from the ACT Cancer Council, Tenovus Scotland, Medical Research Scotland, Scottish Crucible, and the Scottish Universities Life Sciences Alliance. He is a Fellow of the Royal Australian Chemical Institute, a member of the Australasian Pharmaceutical Science Association, and a member of the Australian Institute of Company Directors. Nial is the chief scientific officer of Vairea Skincare LLC and a Standards Australia panel member for sunscreen agents.</span></em></p><p class="fine-print"><em><span>Jessica Pace does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Drinking alcohol with some medicine means they may not work so well. With others, you risk a life-threatening overdose.Nial Wheate, Associate Professor of the Sydney Pharmacy School, University of SydneyJessica Pace, Associate Lecturer, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1898682022-12-05T13:27:20Z2022-12-05T13:27:20ZPharma’s expensive gaming of the drug patent system is successfully countered by the Medicines Patent Pool, which increases global access and rewards innovation<figure><img src="https://images.theconversation.com/files/498366/original/file-20221130-8007-d247y0.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2121%2C1412&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Drug patents don't necessarily spur companies to innovate so much as restrict access to their IP.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/medicines-and-money-the-cost-of-treatment-and-royalty-free-image/1129305852">Andrii Zastrozhnov/iStock via Getty Images Plus</a></span></figcaption></figure><p>Biomedical innovation reached a new era during the COVID-19 pandemic as drug development went into overdrive. But the ways that brand companies license their patented drugs grant them market monopoly, preventing other entities from making generics so they can exclusively profit. This significantly limits the reach of lifesaving drugs, especially to low- and middle-income countries, or LMICs. </p>
<p>I am an <a href="https://www.lucyxiaoluwang.com/">economist</a> who studies <a href="https://scholar.google.com/citations?user=M0QlVjcAAAAJ&hl=en">innovation and digitization</a> in health care markets. Growing up in a developing region in China with limited access to medications inspired my interest in institutional innovations that can facilitate drug access. One such innovation is a patent pool, or a “one-stop shop” where entities can pay one low price for permission to make and distribute all the treatments covered by the pool. My recent research found that a <a href="https://doi.org/10.1016/j.jhealeco.2022.102671">patent pool geared toward public health</a> can spur not only generic drug access in LMICs but also innovation for pharmaceutical companies.</p>
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<figcaption><span class="caption">Patent pools can help increase access to expensive drugs.</span></figcaption>
</figure>
<h2>Drug patents in the global landscape</h2>
<p>Patents are designed to provide incentives for innovation by granting monopoly power to patent holders for a period of time, <a href="https://www.wipo.int/patents/en/faq_patents.html">typically 20 years</a> from the application filing date. </p>
<p>However, this intention is complicated by strategic patenting. For example, companies can delay the creation of generic versions of a drug by obtaining additional patents based on slight changes to its formulation or method of use, among other tactics. This “<a href="https://doi.org/10.1016/j.jhealeco.2012.01.004">evergreens</a>” the company’s patent portfolio without requiring substantial new investments in research and development. </p>
<p>Furthermore, because patents are <a href="https://www.wipo.int/patents/en/faq_patents.html">jurisdiction-specific</a>, patent rights granted in the U.S. do not automatically apply to other countries. Firms often obtain multiple patents covering the same drug in different countries, adapting claims based on what is patentable in each jurisdiction.</p>
<p>To incentivize technology transfer to low- and middle-income countries, member nations of the World Trade Organization signed the 1995 <a href="https://www.wto.org/english/docs_e/legal_e/27-trips_01_e.htm">Agreement on Trade-Related Aspects of Intellectual Property Rights</a>, or TRIPS, which set the minimum standards for intellectual property regulation. Under TRIPS, governments and generic drug manufacturers in low- and middle-income countries may infringe on or invalidate patents to bring down patented drug prices under certain conditions. Patents in LMICs were also strengthened to incentivize firms from high-income countries to invest and trade with LMICs.</p>
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<iframe width="440" height="260" src="https://www.youtube.com/embed/RrN7IxvAJto?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Determining what is patentable can be complicated.</span></figcaption>
</figure>
<p>The 2001 <a href="https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm">Doha Declaration</a> clarified the scope of TRIPS, emphasizing that patent regulations should not prevent drug access during public health crises. It also allowed compulsory licensing, or the production of patented products or processes without the consent of the patent owner.</p>
<p>One notable example of national patent law in practice after TRIPS is Novartis’ anticancer drug imatinib (Glivec or Gleevec). In 2013, India’s Supreme Court <a href="https://doi.org/10.1186/1744-8603-10-3">denied Novartis’s patent application</a> for Glivec for <a href="https://www.upcounsel.com/patent-obviousness">obviousness</a>, meaning both experts or the general public could arrive at the invention themselves without requiring much skill or thought. The issue centered on whether new forms of known substances, in this case a crystalline form of imatinib, were too obvious to be patentable. At the time, Glivec had already been <a href="https://doi.org/10.1136/bmj.f2099">patented in 40 other countries</a>. As a result of India’s landmark ruling, the price of Glivec <a href="https://www.ip-watch.org/2018/05/20/five-years-indian-supreme-courts-novartis-verdict/">dropped from 150,000 INR (about US$2,200) to 6,000 INR ($88)</a> for one month of treatment.</p>
<h2>Patent challenges and pools</h2>
<p>Although TRIPS seeks to balance incentives for innovation with access to patented technologies, issues with patents still remain. Drug cocktails, for example, can contain <a href="https://doi.org/10.1038/s41587-021-01137-6">multiple patented compounds</a>, each of which can be owned by different companies. Overlapping patent rights can create a “<a href="https://doi.org/10.1086/ipe.1.25056143">patent thicket</a>” that blocks commercialization. Treatments for chronic conditions that require a stable and inexpensive supply of generics also pose a challenge, as the cost burden of long-term use of patented drugs is often unaffordable for patients in low- and middle-income countries.</p>
<p>One solution to these drug access issues is <a href="https://doi.org/10.1257/0002828041464641">patent pools</a>. In contrast to the currently decentralized licensing market, where each technology owner negotiates separately with each potential licensee, a patent pool provides a “one-stop shop” where licensees can get the rights for multiple patents at the same time. This can reduce transaction costs, royalty stacking and hold-up problems in drug commercialization. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Diagram of licensing markets with and without a patent pool" src="https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=264&fit=crop&dpr=1 600w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=264&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=264&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=332&fit=crop&dpr=1 754w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=332&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=332&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Patent pools create a one-stop shop for multiple patients, allowing multiple licensees to enter the market.</span>
<span class="attribution"><a class="source" href="https://doi.org/10.1016/j.jhealeco.2022.102671">Lucy Xiaolu Wang</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
</figcaption>
</figure>
<p>Patent pools were first used <a href="https://www.jstor.org/stable/43186442">in 1856 for sewing machines</a> and were once <a href="https://doi.org/10.1257/0002828041464641">ubiquitous across multiple industries</a>. Patent pools gradually disappeared after a <a href="https://supreme.justia.com/cases/federal/us/323/386/">1945 U.S. Supreme Court decision</a> that increased regulatory scrutiny, hindering the formation of new pools. Patent pools were later <a href="https://firstmonday.org/ojs/index.php/fm/article/view/1912/1794">revived in the 1990s</a> in response to licensing challenges in the information and communication technology sector.</p>
<h2>The Medicines Patent Pool</h2>
<p>Despite many challenges, the first patent pool created for the purpose of promoting public health formed in 2010 with support from the United Nations and Unitaid. The <a href="https://medicinespatentpool.org/">Medicines Patent Pool, or MPP</a>, aims to spur generic licensing for patented drugs that treat diseases disproportionately affecting low- and middle-income countries. Initially covering only HIV drugs, the MPP later expanded to include hepatitis C and tuberculosis drugs, many medications on the World Health Organization’s essential medicines list and, most recently, COVID-19 treatments and technologies.</p>
<p>But how much has the MPP improved drug access?</p>
<p>I sought to <a href="https://doi.org/10.1016/j.jhealeco.2022.102671">answer</a> <a href="https://dx.doi.org/10.2139/ssrn.4016897">this question</a> by examining how the Medicines Patent Pool has affected generic drug distribution in low- and middle-income countries and biomedical research and development in the U.S. To analyze the MPP’s influence on expanding access to generic drugs, I collected data on drug licensing contracts, procurement, public and private patents and other economic variables from over 100 low- and middle-income countries. To analyze the MPP’s influence on pharmaceutical innovation, I examined data on new clinical trials and new drug approvals over this period. This data spanned from 2000 to 2017.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Diagram of the Medicines Patent Pool licensing structure" src="https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=255&fit=crop&dpr=1 600w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=255&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=255&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=320&fit=crop&dpr=1 754w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=320&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=320&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">The Medicines Patent Pool works as an intermediary between branded drug companies and generic licensees, increasing access to drugs.</span>
<span class="attribution"><a class="source" href="https://doi.org/10.1016/j.jhealeco.2022.102671">Lucy Xiaolu Wang</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
</figcaption>
</figure>
<p>I found that the MPP led to a 7% increase in the share of generic drugs supplied to LMICs. Increases were greater in countries where drugs are patented and in countries outside of sub-Saharan Africa, where baseline generic shares are lower and can benefit more from market-based licensing.</p>
<p>I also found that the MPP generated positive spillover effects for innovation. Firms outside the pool increased the number of trials they conducted on drug cocktails that included MPP compounds, while branded drug firms participating in the pool shifted their focus to developing new compounds. This suggests that the MPP allowed firms outside the pool to explore new and better ways to use MPP drugs, such as in new study populations or different treatment combinations, while brand name firms participating in the pool could spend more resources to develop new drugs.</p>
<p>The MPP was also able to lessen the burden of post-market surveillance for branded firms, allowing them to push new drugs through clinical trials while generic and other independent firms could monitor the safety and efficacy of approved drugs more cheaply.</p>
<p>Overall, my analysis shows the MPP effectively expanded generic access to HIV drugs in developing countries without diminishing innovation incentives. In fact, it even spurred companies to make better use of existing drugs.</p>
<h2>Technology licensing for COVID-19 and beyond</h2>
<p>Since May 2020, the Medicines Patent Pool has become a key partner of the <a href="https://www.who.int/initiatives/covid-19-technology-access-pool">World Health Organization COVID-19 Technology Access Pool</a>, which works to spur equitable and affordable access to COVID-19 health products globally. The MPP has not only made licensing for COVID-19 health products more accessible to low- and middle-income countries, but also helped establish an <a href="https://medicinespatentpool.org/covid-19/mrna-technology-transfer-hub-programme">mRNA vaccine technology transfer hub</a> in South Africa to provide the technological training needed to develop and sell products treating COVID-19 and beyond.</p>
<p>Licensing COVID-19-related technologies can be complicated by the <a href="https://pubmed.ncbi.nlm.nih.gov/34194207">large amount of trade secrets</a> involved in producing drugs derived from biological sources. These often require additional technology transfer beyond patents, such as <a href="https://heinonline.org/HOL/LandingPage?handle=hein.journals/ilr101&div=32&id=&page=">manufacturing details</a>. The MPP has also worked to communicate with brand firms, generic manufacturers and public health agencies in low- and middle-income countries to <a href="https://medicinespatentpool.org/partners/how-to-get-or-give-a-licence">close the licensing knowledge gap</a>. </p>
<p>Questions remain on how to best use licensing institutions like the MPP to increase generic drug access without hampering the incentive to innovate. But the MPP is proving that it is possible to align the interests of Big Pharma and generic manufacturers to save more lives in developing countries. In October 2022, the MPP signed a licensing agreement with Novartis for the leukemia drug <a href="https://medicinespatentpool.org/news-publications-post/mpp-signs-licence-agreement-to-increase-access-to-nilotinib-for-the-treatment-of-chronic-myeloid-leukaemia">nilotinib</a> – the first time a cancer drug has come under a public health-oriented licensing agreement.</p><img src="https://counter.theconversation.com/content/189868/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Lucy Xiaolu Wang receives research funding from Cornell University and the Institute for Humane Studies.</span></em></p>The Medicines Patent Pool was created to promote public health, facilitating generic licensing for patented drugs that treat diseases predominantly affecting low- and middle-income countries.Lucy Xiaolu Wang, Assistant Professor of Resource Economics, UMass AmherstLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1937172022-12-05T03:18:34Z2022-12-05T03:18:34ZAlways forgetting to take your medicines? Here are 4 things that could help<figure><img src="https://images.theconversation.com/files/496080/original/file-20221118-14-4r4lvk.jpg?ixlib=rb-1.1.0&rect=0%2C15%2C5068%2C3434&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">ksenia yakovleva/unsplash</span>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span></figcaption></figure><p>Taking regular medicines is common, and it’s not unusual for people to miss an occasional dose or take it outside the regular time window. Forgetting to do something is normal, but in the case of medicines, forgetting to take them at the prescribed time can have <a href="https://pubmed.ncbi.nlm.nih.gov/29278439/">negative health effects</a>.</p>
<p>By one <a href="https://apps.who.int/iris/bitstream/handle/10665/42682/9241545992.pdf?sequence=1&isAllowed=y%20available%20from%20https://apps.who.int/iris/handle/10665/42682">estimate</a>, about half the population of people taking regular medicines don’t take them as prescribed. Is this a breakdown in communication? A lack of understanding of their importance? Forgetfulness? </p>
<p>Largely, reasons for not taking medicines as prescribed can be organised into two types: intentional and unintentional.</p>
<p>Unintentional is when a patient intends to follow the prescribed regimen but doesn’t due to factors outside their control, including forgetfulness, difficulties understanding dosing instructions, or cost.</p>
<p>But for some, a patient consciously decides not to follow the prescribed regimen. This could be due to side effects, or not believing in the necessity of the medicine.</p>
<p>Medication-taking is complex because each person is unique and the challenges to each person’s medication-taking can vary quite significantly. The most effective strategy is one that also considers why a person isn’t taking their medicine. What are some of the support strategies available, and are they actually helpful?</p>
<h2>Pill boxes</h2>
<p>The most <a href="https://pubmed.ncbi.nlm.nih.gov/30561486/">commonly used</a> methods to support medication adherance are organisational strategies such as days-of-the-week pill containers.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/496081/original/file-20221118-20-4r4lvk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Hands taking pills out of a container." src="https://images.theconversation.com/files/496081/original/file-20221118-20-4r4lvk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/496081/original/file-20221118-20-4r4lvk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/496081/original/file-20221118-20-4r4lvk.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/496081/original/file-20221118-20-4r4lvk.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/496081/original/file-20221118-20-4r4lvk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/496081/original/file-20221118-20-4r4lvk.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/496081/original/file-20221118-20-4r4lvk.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Pill containers labelled Monday to Friday can be filled at home.</span>
<span class="attribution"><span class="source">towfiqu barbhuiya/unsplash</span>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p>These are functional if a patient has to take many different medications. </p>
<p>But they’re not always suitable – if the user does not fill the container correctly or doesn’t remember to collect the prefilled pack (called a Webster-pak, blister pack or dosette box) from the pharmacy, this simple intervention quickly becomes ineffective.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/496082/original/file-20221118-22-8vm3kd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A medication box with many compartments" src="https://images.theconversation.com/files/496082/original/file-20221118-22-8vm3kd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/496082/original/file-20221118-22-8vm3kd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/496082/original/file-20221118-22-8vm3kd.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/496082/original/file-20221118-22-8vm3kd.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/496082/original/file-20221118-22-8vm3kd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/496082/original/file-20221118-22-8vm3kd.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/496082/original/file-20221118-22-8vm3kd.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">The pharmacy can also make up dosette boxes, with medications for different times of day.</span>
<span class="attribution"><span class="source">Shutterstock</span></span>
</figcaption>
</figure>
<p>Some medicines can’t be packed because their stability is compromised with repacking, and patients with reduced eyesight or dexterity can <a href="https://www.nps.org.au/australian-prescriber/articles/encouraging-adherence-to-long-term-medication">struggle to use</a> these containers. </p>
<p>So while they are an effective prompt, simple reminder cues such as days-of-the-week pill containers may not be ideal for everyone. </p>
<h2>Alarms</h2>
<p>Pre-set alarms are another commonly used reminder method. </p>
<p>However, this strategy is not infallible, and the <a href="https://pubmed.ncbi.nlm.nih.gov/36175739/">literature shows</a> many patients miss medication doses when out of routine because they turn their alarm off subconsciously when occupied with another task. </p>
<p>Reminder alarms only seem to be effective when they are interactive or personalised.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/496083/original/file-20221118-15-wkrws0.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Sketch of an automated tablet machine - a round device with padlock" src="https://images.theconversation.com/files/496083/original/file-20221118-15-wkrws0.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/496083/original/file-20221118-15-wkrws0.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=721&fit=crop&dpr=1 600w, https://images.theconversation.com/files/496083/original/file-20221118-15-wkrws0.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=721&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/496083/original/file-20221118-15-wkrws0.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=721&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/496083/original/file-20221118-15-wkrws0.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=905&fit=crop&dpr=1 754w, https://images.theconversation.com/files/496083/original/file-20221118-15-wkrws0.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=905&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/496083/original/file-20221118-15-wkrws0.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=905&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Automated pill dispensers are handy for those with memory issues, but they’re not cheap.</span>
<span class="attribution"><span class="source">Shutterstock</span></span>
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<p>For example, in a handy combination of both methods above, you can now buy automated pill dispensers with alarms that go off at predetermined times and only stop when the medication is removed.</p>
<p>These can be especially handy for those with memory issues such as dementia. However, they are not cheap, costing a few hundred dollars each, and so will not be accessible for everyone.</p>
<h2>Mobile apps</h2>
<p>The latest Apple iOS update allows you to track your medications and schedule reminders. </p>
<p>Medication reminder apps were first developed to support older adults and people with chronic diseases required to manage multiple medicines. </p>
<p>But they’ve now been embraced as a suitable support for anyone wishing to independently manage their own medicines, including those on short-term medicines such as antibiotics. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/496085/original/file-20221118-11-wkrws0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Phone with pill reminders on screen" src="https://images.theconversation.com/files/496085/original/file-20221118-11-wkrws0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/496085/original/file-20221118-11-wkrws0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/496085/original/file-20221118-11-wkrws0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/496085/original/file-20221118-11-wkrws0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/496085/original/file-20221118-11-wkrws0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/496085/original/file-20221118-11-wkrws0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/496085/original/file-20221118-11-wkrws0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Smart phone apps can help with medication reminders.</span>
<span class="attribution"><span class="source">Shutterstock</span></span>
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<p>They provide simple, practical health-specific information as well as supporting medication-taking through automation. </p>
<p>According to <a href="https://www1.racgp.org.au/newsgp/clinical/medication-reminder-apps-not-a-bitter-pill-to-help">The Royal Australian College of General Practitioners</a>, a lot of patients like receiving reminder prompts through an app, and it helps them remember to take their medication.</p>
<p>Although the platforms differ slightly, the general premise is a patient independently inputs their medication-taking and prescription refill schedule, and the app then generates automatic reminders for the patient. </p>
<p>The only downside is like any notification, they can be easily dismissed or overlooked.</p>
<h2>Habit stacking</h2>
<p>When our day changes, for example if we go out for brunch and we usually take our medicines with breakfast, or an unexpected visitor arrives at the usual 11am pre-lunch tablet time, often we forget our medications. This is where “habit stacking” may be beneficial. </p>
<p>Although habit stacking is a relatively new approach to fostering medication taking, habit formation has been repeatedly shown to <a href="https://pubmed.ncbi.nlm.nih.gov/30229557/">effectively support wellbeing</a>. Linking medication-taking to a behaviour that does not change from day to day, such as cleaning your teeth, or removing shoes when entering the house, can help you to remember medications. </p>
<p>Some more habit stacking examples to support medication taking may include:</p>
<p>• hygiene routine – shower, shave, swallow</p>
<p>• after dinner unwind – cuppa and meds</p>
<p>• morning mantra as you leave the house – keys, phone, wallet, meds.</p>
<h2>What else can we do?</h2>
<p>We are all unique, so to make sure we actually take our medicines we need to find what works for us, and consider why we weren’t actually taking them in the first place. </p>
<p>Reminders, gadgets, habit stacking, or a combination may help. We need strategies that can adapt to the unexpected.</p><img src="https://counter.theconversation.com/content/193717/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Amelia Cossart does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>About half the population of people taking regular medicines don’t take them as prescribed. Here are some tips to help you remember.Amelia Cossart, Postdoctoral Research Fellow, The University of QueenslandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1925902022-10-26T12:29:17Z2022-10-26T12:29:17ZDrugs – 4 essential reads on how they’re made, how they work and how context can make poison a medicine<figure><img src="https://images.theconversation.com/files/489907/original/file-20221016-16-3m74ut.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2121%2C1412&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Constraining drugs to a single function in the body may be limiting their full potential.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/red-and-white-pharma-pill-pattern-on-pastel-blue-royalty-free-image/1288588418">Israel Sebastian/Moment via Getty Images</a></span></figcaption></figure><p>Pandemics and disease outbreaks put a spotlight on the hurdles researchers face to get a drug on the shelves. From finding prospective drug candidates to balancing time and financial pressures with ensuring safety and efficacy, there are many aspects of drug development that determine whether a treatment ever makes it out of the lab. </p>
<p>Broadening the definition of “medicine” and where it can be found, however, could help expand the therapeutic options available for both researchers and patients.</p>
<p>Here are four facets of how drugs are developed and how they work in the body, drawn from stories in The Conversation’s archive.</p>
<h2>1. Matching drug to target</h2>
<p>The most effective drugs are, in a sense, the product of good matchmaking – they bind to a specific disease-causing receptor in the body, elicit a desired effect and ideally ignore healthy parts of the body.</p>
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<iframe width="440" height="260" src="https://www.youtube.com/embed/uOcpsXMJcJk?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Factors such as your age, genetics and diet can affect how well your body processes a drug.</span></figcaption>
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<p>Drugs <a href="https://theconversation.com/how-do-drugs-know-where-to-go-in-the-body-a-pharmaceutical-scientist-explains-why-some-medications-are-swallowed-while-others-are-injected-182488">travel through the bloodstream</a> to reach their targets. Because of this, most drugs circulate throughout the body and can bind to unintended sites, potentially causing undesired side effects.</p>
<p>Researchers can increase the precision and effectiveness of a drug by designing different ways to take it. An inhaler, for example, delivers a drug directly to the lungs without its having to travel through the rest of the body to get there.</p>
<p>Whether patients take drugs as prescribed is also essential to ensuring the right dose gets to where it needs to be often enough to have a desired effect. “Even with all the science that goes into understanding a disease well enough to develop an effective drug, it is often up to the patient to make it all work as designed,” writes pharmaceutical scientist <a href="https://www.researchgate.net/profile/Thomas-Anchordoquy">Tom Anchordoquy</a> of the University of Colorado Anschutz.</p>
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Read more:
<a href="https://theconversation.com/how-do-drugs-know-where-to-go-in-the-body-a-pharmaceutical-scientist-explains-why-some-medications-are-swallowed-while-others-are-injected-182488">How do drugs know where to go in the body? A pharmaceutical scientist explains why some medications are swallowed while others are injected</a>
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<h2>2. Searching for drug candidates</h2>
<p>Researchers have discovered a number of drugs by chance, including <a href="https://www.pbs.org/newshour/health/the-real-story-behind-the-worlds-first-antibiotic">penicillin</a> for bacterial infections, <a href="https://www.bbc.com/future/article/20200928-how-the-first-vaccine-was-born">vaccines for smallpox</a> and <a href="https://doi.org/10.1038/nrcardio.2017.172">warfarin</a> for blood clots. While serendipity still plays a role in modern drug discovery, most drug developers take a systematic approach.</p>
<p>Scientists typically start by identifying a particular molecular target, usually receptors that trigger a specific response in the body. Then, they look for chemical compounds that react with that target. Technology called <a href="https://theconversation.com/discovering-new-drugs-is-a-long-and-expensive-process-chemical-compounds-that-dupe-screening-tools-make-it-even-harder-175972">high-throughput screening</a> allows researchers to quickly test thousands of potential drug candidates at once. Compounds that match screening criteria advance to further development and refinement. Once optimized for their intended use, compounds go on to safety and efficacy testing in animals and people.</p>
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<iframe width="440" height="260" src="https://www.youtube.com/embed/xnM2hTXd1vE?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Scientists have been isolating medicinal compounds from natural products for centuries.</span></figcaption>
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<p>One way to ease the search for optimal drug candidates is to work with compounds that are already optimized to work in living beings. <a href="https://theconversation.com/nature-is-the-worlds-original-pharmacy-returning-to-medicines-roots-could-help-fill-drug-discovery-gaps-176963">Natural products</a>, derived from organisms like microbes, fungi, plants and animals, share similar structures and functions across species. Though not without their own development challenges, they could aid the search for related compounds that work in people.</p>
<p>“There are thousands of microorganisms in the ocean left to explore as potential sources of drug candidates, not to mention all the ones on land,” writes medical chemist <a href="https://scholar.google.com/citations?user=8_T1ueYAAAAJ&hl=en">Ashu Tripathi</a> of the University of Michigan. “In the search for new drugs to combat antibiotic resistance, natural products may still be the way to go.”</p>
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Read more:
<a href="https://theconversation.com/nature-is-the-worlds-original-pharmacy-returning-to-medicines-roots-could-help-fill-drug-discovery-gaps-176963">Nature is the world's original pharmacy – returning to medicine's roots could help fill drug discovery gaps</a>
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<h2>3. A drug by any other name may be just as effective</h2>
<p>Existing drugs can find a second (or third, fourth and fifth) life through repurposing. </p>
<p>Most drugs <a href="https://theconversation.com/many-medications-affect-more-than-one-target-in-the-body-some-drug-designers-are-embracing-the-side-effects-that-had-been-seen-as-a-drawback-184922">have many functions</a> beyond what researchers originally designed them to do. While this multifunctionality is often the cause of unwanted side effects, sometimes these results are exactly what’s needed to treat a completely unrelated condition.</p>
<p>Sildenafil, for example, failed to treat severe chest pain from coronary artery disease, but proved to be potent at inducing erections as Viagra. Similarly, thalidomide, a compound that caused birth defects in thousands of infants around the world as a morning sickness drug, found redemption as a cancer treatment. </p>
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<figcaption><span class="caption">While thalidomide was disastrous for morning sickness, it has proved effective for other diseases.</span></figcaption>
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<p>Because drugs inherently have more than one function in the body, <a href="https://theconversation.com/repurposing-generic-drugs-can-reduce-time-and-cost-to-develop-new-treatments-but-low-profitability-remains-a-barrier-174874">repurposing existing drugs</a> can help fill a gap where pharmaceutical companies and other developers cannot or will not. <a href="https://scholar.google.com/citations?user=iDKZaA4AAAAJ&hl=en">Gregory Way</a>, a researcher at the University of Colorado Anschutz, uses artificial intelligence to predict the various effects a drug can have and believes that this lack of specificity is something to explore rather than eliminate. Instead of trying to home in on one specific target, he suggests that scientists “embrace the complexity of biology and try to leverage the multifaceted effects drugs can offer.”</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/many-medications-affect-more-than-one-target-in-the-body-some-drug-designers-are-embracing-the-side-effects-that-had-been-seen-as-a-drawback-184922">Many medications affect more than one target in the body – some drug designers are embracing the 'side effects' that had been seen as a drawback</a>
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<h2>4. Poison as medicine</h2>
<p>If so many drugs can have toxic effects in the body, be it through side effects or taking the wrong dose or for the wrong condition, what determines whether a drug is a “medicine” or a “poison”?</p>
<p>Biomedical scientists evaluate drugs based on their active ingredient, or a specific compound that has a specific effect in the body. But reducing medicines to just a single molecule ignores another important factor that determines whether a drug is therapeutic – the context in which it is used. Opioids treat intractable pain but can lead to debilitating and lethal addiction when improperly administered. Chemotherapy kills tumors but causes collateral damage to healthy tissues in the process.</p>
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<a href="https://images.theconversation.com/files/410863/original/file-20210712-27-cocyqt.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Historical illustration of a plant with leaves and large tubers" src="https://images.theconversation.com/files/410863/original/file-20210712-27-cocyqt.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/410863/original/file-20210712-27-cocyqt.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=796&fit=crop&dpr=1 600w, https://images.theconversation.com/files/410863/original/file-20210712-27-cocyqt.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=796&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/410863/original/file-20210712-27-cocyqt.jpeg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=796&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/410863/original/file-20210712-27-cocyqt.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1000&fit=crop&dpr=1 754w, https://images.theconversation.com/files/410863/original/file-20210712-27-cocyqt.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1000&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/410863/original/file-20210712-27-cocyqt.jpeg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1000&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Aconite is a poisonous herb that was used to treat cold symptoms in ancient Chinese medical practice.</span>
<span class="attribution"><a class="source" href="https://www.loc.gov/resource/lcnclscd.2012402216.1A010/?sp=3">Library of Congress, Asian Division, Chinese Rare Books</a></span>
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<p>Another pharmaceutical paradigm, <a href="https://theconversation.com/poison-or-cure-traditional-chinese-medicine-shows-that-context-can-make-all-the-difference-163337">traditional Chinese medicine</a>, has historically acknowledged the malleability of drugs through the use of poisons as therapeutics. </p>
<p><a href="https://scholar.google.com/citations?user=4q0hYSwAAAAJ&hl=en">Yan Liu</a>, a medical historian at University of Buffalo who studies this practice, notes that ancient texts did not distinguish between poisons and nonpoisons – rather, Chinese doctors examined drugs based on a continuum of potency, or ability to harm and heal. They used different processing and administration techniques to adjust the potency of poisons. They also took a personalized approach to treatment, aware that each drug works differently based on a number of different individual factors.</p>
<p>“The paradox of healing with poisons in traditional Chinese medicine reveals a key message: There is no essential, absolute or unchanging core that characterizes a medicine,” Liu writes. “Instead, the effect of any given drug is always relational – it is contingent on how the drug is used, how it interacts with a particular body and its intended effects.”</p>
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<strong>
Read more:
<a href="https://theconversation.com/poison-or-cure-traditional-chinese-medicine-shows-that-context-can-make-all-the-difference-163337">Poison or cure? Traditional Chinese medicine shows that context can make all the difference</a>
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<p><em>Editor’s note: This story is a roundup of articles from The Conversation’s archives.</em></p><img src="https://counter.theconversation.com/content/192590/count.gif" alt="The Conversation" width="1" height="1" />
Despite technological advancements, many challenges remain in getting a drug from lab to pharmacy shelf. Reframing what is a “medicine” could expand treatment options for researchers and patients.Vivian Lam, Associate Health and Biomedicine EditorLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1886012022-08-18T01:20:30Z2022-08-18T01:20:30ZLying down, sitting, leaning over? What science says about the best way to take your medicine<figure><img src="https://images.theconversation.com/files/479516/original/file-20220817-18222-qj3sxa.jpg?ixlib=rb-1.1.0&rect=1%2C2%2C997%2C772&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/close-senior-man-taking-medicines-horizontal-62995330">Shutterstock</a></span></figcaption></figure><p>When pharmacists dispense tablets or capsules they commonly advise when and how often to take them, and if this needs to be with or without food. </p>
<p>You generally don’t hear them tell you to lean to one side when swallowing. But preliminary research from Johns Hopkins University in the United States <a href="https://aip.scitation.org/doi/full/10.1063/5.0096877">suggests</a> this might improve how fast your medicine is absorbed and gets to work.</p>
<p>The results are based on a computer simulation, rather than in actual patients, and may not equate to the real world. So it’s too early to suggest you strike a yoga pose when taking your medicine. </p>
<p>But your posture can be important when taking pills or capsules, for comfort or safety.</p>
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<p>
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Read more:
<a href="https://theconversation.com/what-time-of-day-should-i-take-my-medicine-125809">What time of day should I take my medicine?</a>
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<h2>What happens when you swallow your medicine?</h2>
<p>Once you swallow a tablet or capsule, it moves down the throat to the stomach. There, a tablet swells and disintegrates, or a capsule breaks open. The drug can then dissolve and your body can absorb it.</p>
<p>Most drugs do not start being absorbed until they reach the small intestine. However, some drugs, such as aspirin, are likely to be absorbed in the stomach because of its acidic environment.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"726886205082595328"}"></div></p>
<p>A number of other factors can also affect where and how a drug is absorbed. </p>
<p>These include how fast the tablet disintegrates to release the drug, how fast the swallowed contents move from the stomach to the small intestine, the amount of food and drink consumed before taking the medicine, and how easily the drug is absorbed across the gut lining.</p>
<h2>How about this latest study?</h2>
<p>The US researchers <a href="https://publishing.aip.org/publications/latest-content/body-posture-affects-how-oral-drugs-absorbed-by-stomach/">used computer simulations</a> to investigate how posture affects how drugs <a href="https://aip.scitation.org/doi/full/10.1063/5.0096877">are absorbed</a>. </p>
<p>The researchers used software they developed to simulate several ways of taking a pill: staying upright, leaning to the left or right, or leaning backwards.</p>
<p>They showed leaning 45 degrees to the right favoured a faster movement of stomach contents into the duodenum (the first part of the small intestine). This would allow the pill to be absorbed more quickly and start to take effect.</p>
<p>The results could be important for medicines that you’d want to act quickly, such as pain medicines, or ones used to treat a heart attack. </p>
<p>There is already some <a href="https://pubmed.ncbi.nlm.nih.gov/18936930/">earlier evidence</a> from real patients suggesting posture may influence how medicines are absorbed. This includes the option of leaning to the right. But the authors acknowledge many factors influence absorption, not just posture.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/health-check-is-it-ok-to-chew-or-crush-your-medicine-39630">Health Check: is it OK to chew or crush your medicine?</a>
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<h2>When is it best to sit or stand?</h2>
<p>Sometimes your pharmacist may advise you to swallow your medicine sitting, standing, or lying down for reasons other than speeding up absorption. </p>
<p>For example, certain drugs are more likely to cause side effects such as <a href="https://www.healthdirect.gov.au/gord-reflux">heartburn</a>, where stomach acid leaks from the stomach and moves up into the oesophagus (food pipe).</p>
<p>These include non-steroidal anti-inflammatory drugs, such as <a href="https://www.healthdirect.gov.au/ibuprofen">ibuprofen</a> (Nurofen), <a href="https://www.healthdirect.gov.au/medicines/medicinal-product/aht,20761/diclofenac">diclofenac</a> (Voltaren), and iron supplements. </p>
<p>So if this is a problem for you, it may help to take these medicines sitting or standing, and not lying down straight away afterwards. That’s because your stomach acid is less likely to leak back up into your oesophagus. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/479518/original/file-20220817-1490-bjhdxn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Elderly woman sitting down at table with pill and cup" src="https://images.theconversation.com/files/479518/original/file-20220817-1490-bjhdxn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/479518/original/file-20220817-1490-bjhdxn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=399&fit=crop&dpr=1 600w, https://images.theconversation.com/files/479518/original/file-20220817-1490-bjhdxn.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=399&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/479518/original/file-20220817-1490-bjhdxn.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=399&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/479518/original/file-20220817-1490-bjhdxn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=502&fit=crop&dpr=1 754w, https://images.theconversation.com/files/479518/original/file-20220817-1490-bjhdxn.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=502&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/479518/original/file-20220817-1490-bjhdxn.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=502&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Some medicines can irritate the throat or cause heartburn. So it’s best to take these upright.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/old-woman-taking-pills-her-country-218558989">Shutterstock</a></span>
</figcaption>
</figure>
<p>Some medicines can irritate the throat if they become stuck. This is because they damage the protective mucosal barrier that lines your oesophagus and stomach, causing irritation and inflammation. </p>
<p>For these medicines it is important to take these sitting up or standing, and remaining upright for 30 minutes afterwards.</p>
<p>These include the antibiotic <a href="https://www.healthdirect.gov.au/doxycycline">doxycycline</a>, and drugs known as bisphosphonates (for osteoporosis), such as <a href="https://www.healthline.com/health/drugs/risedronate-oral-tablet">risedronate</a> (Actonel) and <a href="https://www.healthdirect.gov.au/medicines/brand/amt,39580011000036106/alendronate-sandoz">alendronate</a> (Fosamax).</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/why-older-people-get-osteoporosis-and-have-falls-68145">Why older people get osteoporosis and have falls</a>
</strong>
</em>
</p>
<hr>
<h2>How about lying down?</h2>
<p><a href="https://www.healthdirect.gov.au/medicines/brand/amt,3285011000036105/nitrolingual">Glyceryl trinitrate</a> (Nitrolingual) is an under-the-tongue spray. It’s prescribed to people with <a href="https://www.heartfoundation.org.au/bundles/your-heart/angina">angina</a>, a type of chest pain caused by an underlying heart problem. </p>
<p>Pharmacists advise patients to sit or lie down before using this spray as it can cause a sudden drop in blood pressure, making you feel very dizzy. </p>
<p>Other heart medicines, such as diuretics, are also known to cause dizziness. Although you don’t usually need to take these medications lying down, if you do become dizzy it is best to sit or lie down, and ensure you stand up slowly afterwards.</p>
<p>There are also <a href="https://www.medsafe.govt.nz/profs/puarticles/march2017/medicineinducedvertigo.htm">medications</a> that can cause drowsiness or make you feel “woozy”. These can include strong pain killers (such as opiates), sleeping tablets, some epilepsy medications, or drugs for certain mental health conditions, such as anxiety or schizophrenia. </p>
<p>These don’t need to be swallowed while lying down, but lying down can help if you become dizzy or drowsy.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/479519/original/file-20220817-18377-wztyfz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Woman lying on side in bed holding glass of water and a pill" src="https://images.theconversation.com/files/479519/original/file-20220817-18377-wztyfz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/479519/original/file-20220817-18377-wztyfz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=389&fit=crop&dpr=1 600w, https://images.theconversation.com/files/479519/original/file-20220817-18377-wztyfz.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=389&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/479519/original/file-20220817-18377-wztyfz.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=389&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/479519/original/file-20220817-18377-wztyfz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=489&fit=crop&dpr=1 754w, https://images.theconversation.com/files/479519/original/file-20220817-18377-wztyfz.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=489&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/479519/original/file-20220817-18377-wztyfz.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=489&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Some medicines can make you dizzy. So you can lie down after taking them.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/mature-woman-taking-medicine-home-closeup-776225686">Shutterstock</a></span>
</figcaption>
</figure>
<h2>What if I’m not sure?</h2>
<p>Next time your pharmacist dispenses your medicine, unless they provide specific guidance about sitting, standing or lying down, you are generally safe to take it whichever way is most comfortable.</p>
<p>So how about this latest evidence suggesting leaning to the right might help? At this stage, you likely won’t hear your doctor or pharmacist recommend you should lean over to take your medicines until further research is done. </p>
<p>But next time you need to take a medicine for pain, as long as it is not uncomfortable, feel free to try this to see if your pain is relieved faster.</p><img src="https://counter.theconversation.com/content/188601/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Elise Schubert is a registered pharmacist and a PhD Candidate receiving scholarship from the University of Sydney and Canngea Pty Ltd.</span></em></p><p class="fine-print"><em><span>Associate Professor Wheate in the past has received funding from the ACT Cancer Council, Tenovus Scotland, Medical Research Scotland, Scottish Crucible, and the Scottish Universities Life Sciences Alliance. He is a Fellow of the Royal Australian Chemical Institute, a member of the Australasian Pharmaceutical Science Association, and member of the Australian Institute of Company Directors. Nial is the science director of Canngea Pty Ltd, chief scientific officer of Vairea Skincare LLC, and a Standards Australia panel member for sunscreen agents.</span></em></p><p class="fine-print"><em><span>Associate Professor Tina Hinton has previously received funding from the Schizophrenia Research Institute (formerly Neuroscience Institute of Schizophrenia and Allied Disorders). She is currently a Board member of the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists. </span></em></p>Sometimes, it’s best to take your medicine sitting up. Other times, lying down is safer. Here’s what we know so far.Elise Schubert, Pharmacist and PhD Candidate, University of SydneyNial Wheate, Associate Professor of the Sydney Pharmacy School, University of SydneyTina Hinton, Associate Professor of Pharmacology, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1860422022-08-17T02:38:06Z2022-08-17T02:38:06Z5 drugs that changed the world (and what went wrong)<figure><img src="https://images.theconversation.com/files/477820/original/file-20220805-19484-orrk38.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C1000%2C660&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/classic-drugstore-museum-interior-glass-bottles-1164873649">Shutterstock</a></span></figcaption></figure><p>It’s hard to measure the impact of any one drug on world history. But here are five drugs we can safely say made a huge difference to our lives, often in ways we didn’t expect.</p>
<p>They have brought some incredible benefits. But they’ve usually also come with a legacy of complications we need to look at critically. </p>
<p>It’s a good reminder that today’s wonder drug may be tomorrow’s problem drug. </p>
<h2>1. Anaesthesia</h2>
<p>In the late 1700s, English chemist Joseph Priestley <a href="https://www.ch.ic.ac.uk/rzepa/mim/environmental/html/n2o.htm">made a gas</a> he called “phlogisticated nitrous air” (nitrous oxide). English chemist Humphry Davy thought it could be used as pain relief in surgery, but instead it became a <a href="https://journals.physiology.org/doi/full/10.1152/ajplung.00206.2014">recreational drug</a>. </p>
<p>It wasn’t until 1834 that we reached another milestone. That’s when French chemist Jean-Baptiste Dumas named a new gas <a href="https://www.worldofmolecules.com/solvents/chloroform-molecule.html">chloroform</a>. Scottish doctor James Young Simpson used it in 1847 <a href="http://dx.doi.org/10.1136/fn.86.3.F207">to assist a birth</a>.</p>
<p>Soon anaesthesia was more widely used during surgery, bringing <a href="https://theconversation.com/a-short-history-of-anaesthesia-from-unspeakable-agony-to-unlocking-consciousness-74748">better recovery rates</a>. Before anaesthesia, surgical patients would often die of shock from the pain.</p>
<p>But any drug that can make people unconscious can also cause harm. Modern anaesthetics are still dangerous because of the <a href="https://www.betterhealth.vic.gov.au/health/conditionsandtreatments/general-anaesthetics">risks</a> of suppressing the nervous system.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/477576/original/file-20220804-16645-r90l2r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Chloroform bottle on display" src="https://images.theconversation.com/files/477576/original/file-20220804-16645-r90l2r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/477576/original/file-20220804-16645-r90l2r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/477576/original/file-20220804-16645-r90l2r.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/477576/original/file-20220804-16645-r90l2r.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/477576/original/file-20220804-16645-r90l2r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/477576/original/file-20220804-16645-r90l2r.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/477576/original/file-20220804-16645-r90l2r.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Before anaesthesia, surgical patients would die of shock from the pain.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/25182210@N07/5828813781">dynamosquito/flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
</figcaption>
</figure>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/a-short-history-of-anaesthesia-from-unspeakable-agony-to-unlocking-consciousness-74748">A short history of anaesthesia: from unspeakable agony to unlocking consciousness</a>
</strong>
</em>
</p>
<hr>
<h2>2. Penicillin</h2>
<p>What happened in 1928 to Scottish physician Alexander Fleming is one of the classic stories of accidental drug discovery. </p>
<p>Fleming went on holiday, leaving some cultures of the bacterium streptococcus on his laboratory bench. When he came back, he saw some airborne penicillium (a fungal contaminant) had <a href="https://academic.oup.com/jimb/article/36/6/775/5993612">stopped the streptococcus</a> from growing.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/477582/original/file-20220804-19-fruewv.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Penicillin growing on Petri dish" src="https://images.theconversation.com/files/477582/original/file-20220804-19-fruewv.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/477582/original/file-20220804-19-fruewv.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=383&fit=crop&dpr=1 600w, https://images.theconversation.com/files/477582/original/file-20220804-19-fruewv.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=383&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/477582/original/file-20220804-19-fruewv.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=383&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/477582/original/file-20220804-19-fruewv.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=482&fit=crop&dpr=1 754w, https://images.theconversation.com/files/477582/original/file-20220804-19-fruewv.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=482&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/477582/original/file-20220804-19-fruewv.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=482&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Antibiotics saved millions of lives but we’re now suffering from their popularity.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/86257416@N02/14720615367">Antony Scimone by MMU Engage/flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
</figcaption>
</figure>
<p>Australian pathologist Howard Florey and his team stabilised penicillin and <a href="https://www.nobelprize.org/prizes/medicine/1945/florey/biographical/">carried out the first human experiments</a>. With American financing, penicillin was mass-produced and changed the course of World War II. It was used to treat <a href="https://news.wisc.edu/d-day-invasion-was-bolstered-by-uw-madison-penicillin-project/">thousands of service personnel</a>.</p>
<p>Penicillin and its descendants are enormously successful front-line drugs for conditions that once killed millions of people. However, their widespread use has led to <a href="https://www.betterhealth.vic.gov.au/health/conditionsandtreatments/antibiotic-resistant-bacteria">drug-resistant strains of bacteria</a>.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/five-of-the-scariest-antibiotic-resistant-bacteria-in-the-past-five-years-100654">Five of the scariest antibiotic-resistant bacteria in the past five years</a>
</strong>
</em>
</p>
<hr>
<h2>3. Nitroglycerin</h2>
<p>Nitroglycerin was invented in 1847 and displaced gunpowder as the most powerful explosive in the world. It was also the first modern drug to treat <a href="https://www.betterhealth.vic.gov.au/health/conditionsandtreatments/heart-conditions-angina">angina</a>, the chest pain associated with heart disease. </p>
<p>Factory workers exposed to the explosive began to experience <a href="https://doi.org/10.1046/j.1440-1681.2000.03240.x">headaches and flushing in the face</a>. This was because nitroglycerin is a vasodilator – it dilates (opens) the blood vessels. </p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/477595/original/file-20220804-15-crz7lm.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Tweet about Dr Murrell's experimentation with nitroglycerin" src="https://images.theconversation.com/files/477595/original/file-20220804-15-crz7lm.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/477595/original/file-20220804-15-crz7lm.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=678&fit=crop&dpr=1 600w, https://images.theconversation.com/files/477595/original/file-20220804-15-crz7lm.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=678&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/477595/original/file-20220804-15-crz7lm.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=678&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/477595/original/file-20220804-15-crz7lm.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=852&fit=crop&dpr=1 754w, https://images.theconversation.com/files/477595/original/file-20220804-15-crz7lm.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=852&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/477595/original/file-20220804-15-crz7lm.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=852&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">London physician William Murrell experimented with nitroglycerin on himself and tried it on his angina patients.</span>
<span class="attribution"><a class="source" href="https://twitter.com/search?q=William%20Murrell%20nitroglycerin&src=typed_query&f=top">Twitter</a></span>
</figcaption>
</figure>
<p>London physician William Murrell <a href="https://www.acs.org/content/acs/en/molecule-of-the-week/archive/n/nitroglycerin.html">experimented</a> with nitroglycerin on himself and tried it on his angina patients. They got almost immediate relief.</p>
<p>Nitroglycerin made it possible for millions of people with angina to live relatively normal lives. It also paved the way for medications such as blood pressure-lowering drugs, beta-blockers and statins. These medicines have <a href="https://www.health.harvard.edu/heart-health/blood-pressure-drugs-may-extend-life-even-for-frail-older-people">extended lives and increased the average lifespan</a> in Western countries.</p>
<p>But because people’s lives are now extended, there are now higher rates of deaths from <a href="https://news.cancerresearchuk.org/2015/02/04/why-are-cancer-rates-increasing/">cancer and other non-communicable diseases</a>. So nitroglycerin turned out to be a world-changing drug in unexpected ways. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/how-australians-die-cause-2-cancers-58063">How Australians Die: cause #2 – cancers</a>
</strong>
</em>
</p>
<hr>
<h2>4. The pill</h2>
<p>In 1951, US birth control advocate Margaret Sanger asked researcher Gregory Pincus <a href="https://www.nma.gov.au/defining-moments/resources/the-pill">to develop an effective hormonal contraceptive</a>, funded by heiress Katharine McCormick. </p>
<p>Pincus found that progesterone helped to stop ovulation, and used this to develop a trial pill. Clinical trials were conducted on vulnerable women, notably in Puerto Rico, where there were <a href="https://www.pbs.org/wgbh/americanexperience/features/pill-puerto-rico-pill-trials/">concerns</a> about informed consent and side effects.</p>
<p>The new drug was released by GD Searle & Co as Enovid in 1960, with US Food and Drug Administration approval. This was granted because the risk of pregnancy was seen as <a href="https://www.pbs.org/wgbh/americanexperience/features/pill-us-food-and-drug-administration-approves-pill/">greater than</a> the risk of side effects, such as blood clots and strokes.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1523846612958814210"}"></div></p>
<p>It took ten years to prove a link between oral contraceptive use and serious side effects. After a 1970 US government inquiry, the pill’s hormone levels <a href="https://www.pbs.org/wgbh/americanexperience/features/pill-senate-holds-hearings-pill-1970/">were lowered dramatically</a>. Another outcome was the <a href="https://www.pbs.org/wgbh/americanexperience/features/pill-senate-holds-hearings-pill-1970/">patient information sheet</a> you will now find inside all prescription drug packets.</p>
<p>The pill caused <a href="https://www.nma.gov.au/defining-moments/resources/the-pill">major global demographic changes</a> with smaller families and increased incomes as women re-entered the workforce. However, it’s still raising questions about how the medical profession has <a href="https://www.journals.uchicago.edu/doi/abs/10.1086/715419">experimented on women’s bodies</a>. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/what-to-expect-when-coming-off-the-pill-and-5-things-to-do-before-you-do-183367">What to expect when coming off the pill, and 5 things to do before you do</a>
</strong>
</em>
</p>
<hr>
<h2>5. Diazepam</h2>
<p>The first benzodiazepine, a type of nervous system depressant, was created in 1955 and marketed by drug company Hoffmann-La Roche as <a href="https://pubmed.ncbi.nlm.nih.gov/24007886/">Librium</a>.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/477589/original/file-20220804-12-i4s7ip.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Valium bottles and dropper" src="https://images.theconversation.com/files/477589/original/file-20220804-12-i4s7ip.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/477589/original/file-20220804-12-i4s7ip.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=706&fit=crop&dpr=1 600w, https://images.theconversation.com/files/477589/original/file-20220804-12-i4s7ip.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=706&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/477589/original/file-20220804-12-i4s7ip.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=706&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/477589/original/file-20220804-12-i4s7ip.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=887&fit=crop&dpr=1 754w, https://images.theconversation.com/files/477589/original/file-20220804-12-i4s7ip.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=887&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/477589/original/file-20220804-12-i4s7ip.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=887&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Valium was onced used to help people engage with psychotherapy.</span>
<span class="attribution"><a class="source" href="https://collection.sciencemuseumgroup.org.uk/objects/co193001/bottled-valium-carton-plastic-pipette-instructions-sedative-controlled-drug-diazepam">Roche/Science Museum/flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-sa/4.0/">CC BY-NC-SA</a></span>
</figcaption>
</figure>
<p>This and related drugs were not sold as “cures” for anxiety. Instead, they were supposed to <a href="https://theconversation.com/how-to-reduce-dependency-on-drugs-like-valium-with-alternative-therapies-72571">help people engage in psychotherapy</a>, which was seen as the real solution.</p>
<p>Polish-American chemist Leo Sternbach and his research group chemically <a href="https://www.washingtonpost.com/archive/politics/1980/01/20/adventurous-chemist-and-his-pill/16cd98f6-00a6-4f5c-8e86-08451ed3451b/">altered Librium in 1959</a>, producing a much more powerful drug. This was diazepam, marketed from 1963 as Valium.</p>
<p>Cheap, easily available drugs like these had a huge impact. From 1969 until 1982, Valium was the <a href="https://drugabuse.com/benzodiazepines/valium/history-and-statistics/">top-selling pharmaceutical</a> in the United States. These drugs created a culture of managing stress and anxiety with medication.</p>
<p>Valium paved the way for modern antidepressants. It was more difficult (but not impossible) to <a href="https://pubmed.ncbi.nlm.nih.gov/29123931/">overdose on these newer drugs</a>, and they had fewer side effects. The first SSRI, or selective serotonin reuptake inhibitor, was fluoxetine, <a href="https://www.pbs.org/wgbh/aso/databank/entries/dh87pr.html">marketed from 1987 as Prozac</a>.</p>
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Read more:
<a href="https://theconversation.com/the-chemical-imbalance-theory-of-depression-is-dead-but-that-doesnt-mean-antidepressants-dont-work-187769">The chemical imbalance theory of depression is dead, but that doesn't mean antidepressants don't work</a>
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<img src="https://counter.theconversation.com/content/186042/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Philippa Martyr does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Each of these five drugs have brought some incredible benefits. But they’ve usually also come with a legacy of complications.Philippa Martyr, Lecturer, Pharmacology, Women's Health, School of Biomedical Sciences, The University of Western AustraliaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1884122022-08-16T14:41:17Z2022-08-16T14:41:17ZThe key to treating TB may be in a common carbohydrate. What we know so far<figure><img src="https://images.theconversation.com/files/479161/original/file-20220815-25-i854zg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">New remedies are needed as rates of multi-drug resistant TB rise.</span> <span class="attribution"><span class="source">Jarun Ontakrai/Shutterstock</span></span></figcaption></figure><p><a href="https://link.springer.com/article/10.1007/s00289-021-03860-1">Curdlan</a> is a popular carbohydrate in the food industry. Its name is derived from the word “curdle”, and as it suggests, it’s widely used as a thickener and stabiliser in everything from sausages to milk substitutes.</p>
<p>More recently, it has caught the eye of the <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8273257/">pharmaceutical industry</a>. That’s because curdlan, itself produced by bacteria, is able to trigger an antibacterial response in a range of environments and organisms. Among other uses, researchers are <a href="https://link.springer.com/article/10.1186/s13048-020-00626-7">looking at curdlan</a> as a possible treatment for cancers and <a href="https://www.sciencedirect.com/science/article/pii/S0144861714003828?casa_token=5A9L_uGxF5oAAAAA:56_9Q91nCk3cSJdLaXa0eZPp4iDXAs5b8XUUNQuwfhPdSl5Jg9w2wfxyjejHNCm7V8N5sH4iDrY">other diseases</a>.</p>
<p>One of those diseases is tuberculosis (TB), the infection responsible for <a href="https://www.frontiersin.org/articles/10.3389/fmicb.2017.02284/full">killing more people</a> than any other infectious disease in human history. <a href="https://www.nicd.ac.za/wp-content/uploads/2021/02/TB-Prevalence-survey-report_A4_SA_TPS-Short_Feb-2021.pdf">South Africa</a> has one of the world’s highest TB burdens – along with 29 other countries including India and China. These countries contribute 86% of the globe’s <a href="https://www.who.int/news-room/fact-sheets/detail/tuberculosis#:%7E:text=In%202020%2C%20the%2030%20high,Nigeria%2C%20Bangladesh%20and%20South%20Africa.">10 million annual TB cases</a>. South Africa’s combined burden of TB, TB/HIV and multi-drug resistant TB (MDR-TB), driven by socioeconomic factors and its high HIV <a href="https://worldhealthorg.shinyapps.io/tb_profiles/?_inputs_&entity_type=%22country%22&lan=%22EN%22&iso2=%22ZA%22">numbers</a>, is especially worrying.</p>
<p>Existing remedies made up of cocktails of antibiotics are not effective against MDR-TB. This has sparked interest in finding alternative treatments. It’s why our research group at the School of Pharmacy at the University of the Western Cape, and others, are beginning to test the efficacy of curdlan as a potential drug candidate. </p>
<p>In a <a href="https://pubmed.ncbi.nlm.nih.gov/34534573/">recent paper</a>, for instance, we show very promising results for the potential treatment of TB using curdlan-based nanoparticles.</p>
<h2>How TB infects</h2>
<p>Our work centres on developing host-directed therapies using curdlan. Such treatments essentially let the human <a href="https://www.frontiersin.org/articles/10.3389/fmicb.2017.02284/full">immune system</a> do the heavy lifting. This is done by activating its natural antibacterial mechanisms while controlling the inflammation that results from such activation. Inflammation is a signal that the immune system is working. But if inflammation is out of control it can cause major damage to human tissue, as seen in severe <a href="https://www.frontiersin.org/articles/10.3389/fimmu.2020.01446/full#:%7E:text=Accumulating%20evidence%20suggests%20that%20some,%2C%20TNF%2D%CE%B1%2C%20and%20VEGF">COVID-19 infections</a>.</p>
<p>Research has already shown that host-directed therapies hold <a href="https://www.frontiersin.org/articles/10.3389/fcimb.2020.618414/full">immense potential</a> for the <a href="https://link.springer.com/article/10.1007/s11095-018-2528-9">treatment of TB</a>.</p>
<p>To understand how these therapies work, it’s important to understand how TB infection unfolds in the human body.</p>
<p>Primary TB infection occurs when a person inhales aerosol droplets, released by contagious individuals, that contain <em>Mycobacterium tuberculosis</em> (<em>M.tb</em>). This is the bacterium that causes TB. Once inhaled, <em>M.tb</em> quickly makes its way to the lung’s alveolar space, made up of tiny air sacs that sit at the end of the bronchioles, which are the air passages inside the lungs.</p>
<p>Here it is absorbed by what’s known as alveolar macrophages, the lung cells that are usually the first line of defence against pollutants and pathogenic organisms. Typically these macrophages would trigger an immune response in the body. But <em>M.tb</em> has evolved so cannily that it eludes or switches off this immune-triggering response in the macrophages. These alveolar macrophages become its infection headquarters; the bacterium remains concealed within these cells.</p>
<p>For any treatment to be successful, it has to navigate a <a href="https://www.frontiersin.org/articles/10.3389/fcimb.2020.618414/full">host of obstacles</a> to reach <em>M.tb</em>. It must make its way through complex lung lesions, then penetrate the cell membrane of macrophages and other host cells, and finally be taken up by the <em>M.tb</em> sitting within these cells.</p>
<p>That’s where nanoparticles enter the picture.</p>
<h2>Tiny ‘snipers’</h2>
<p>Nanoparticles are extremely small. They range from between one to 100 nanometres; for some perspective, there are a million nanometres in a single millimetre. In theory, and as is being shown in <a href="https://iopscience.iop.org/article/10.1088/1361-6528/ac7885/meta?casa_token=FjKJlNwJcFYAAAAA:CzLeHNZ_j9uFpGYgd9UnvJr-RBFnO8NoKhxymb8JcyrujuK0bISE6sP6vEIeYC8NvPcPJkLuIMA">laboratories</a> and existing treatments for other conditions like <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2720743/">cancer</a>, nanotherapies allow drugs to target pathogens with sniper-like accuracy. They also have the potential to tackle patient non-compliance that can lead to drug resistant TB.</p>
<p>The <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4449995/">reasons</a> for non-compliance are varied and complex, but the duration of the therapy itself is a factor. Existing treatments require that, depending on the severity and progress of the disease, patients take many drugs over as many as six months. The <a href="https://www.who.int/news-room/fact-sheets/detail/tuberculosis">course of treatment</a> for MDR-TB lasts up to 24 months. </p>
<p>This high pill load, together with sometimes toxic side effects, has been shown to overwhelm patients. Many do not return to clinics and hospitals for check-ups, especially when they feel better after a few weeks. Some stop taking their medication. This could be behind the rise of drug resistant strains. Such non-compliance is also believed to be the cause of South Africa’s comparatively <a href="https://www.copenhagenconsensus.com/publication/south-africa-perspective-tuberculosis#:%7E:text=TB%20is%20South%20Africa's%20leading,to%20bring%20it%20under%20control.">high TB mortality</a>.</p>
<p>Traditional drugs are taken orally or intravenously. They travel throughout the body via the blood circulatory system. Many drug molecules do not reach their targets, staying in the body where they cause several negative side effects. That’s where nanoparticle-based treatments have the <a href="https://www.tandfonline.com/doi/abs/10.1517/17425247.2014.846905">upper hand</a>: they are extremely targeted and their release into the system is very controlled. Smaller doses are required and there is less dispersion around the body, meaning fewer side effects.</p>
<h2>Promising findings</h2>
<p>All these factors suggest that nanoparticle-based treatments may be the right approach to take against TB. And two interesting findings from our study bolster the case.</p>
<p>One, we observed the production of what’s known as pro-inflammation cytokines, a signalling molecule that triggers an antibacterial effect in immune cells. This meant that the nanoparticles were doing what they were meant to do.</p>
<p>Secondly, we found that the <em>M.tb</em> bacteria in the immune cells were considerably reduced over a 72-hour period. </p>
<p>These results suggest that curdlan nanotherapeutics are an avenue worth exploring in treating TB. There is much more work to be done, but it’s an important step towards tackling TB – in South Africa and everywhere else.</p><img src="https://counter.theconversation.com/content/188412/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Admire Dube receives funding from the Fogarty International Center of the National Institutes of Health (K43TW010371) and the National Institute of Allergy and Infectious Diseases (5R01AI152109). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.</span></em></p>As antibiotics lose their power to treat some forms of TB, interest in the antibacterial powers of curdlan is rising.Admire Dube, Associate Professor, Pharmaceutical Sciences, University of the Western CapeLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1641482022-07-19T12:26:00Z2022-07-19T12:26:00ZWhy are drug names so long and complicated? A pharmacist explains the logic behind the nomenclature<figure><img src="https://images.theconversation.com/files/474353/original/file-20220715-18-k6uzvb.jpg?ixlib=rb-1.1.0&rect=178%2C267%2C1886%2C1142&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Having multiple prescriptions is difficult enough to keep track of, let alone ones with complicated names.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/senior-man-staring-at-stack-of-prescription-bottles-royalty-free-image/523006070">Hill Street Studios/Stone via Getty Images</a></span></figcaption></figure><p>At some point in your life, you’ll likely find yourself with a prescription from your doctor to fill. While it’s important to keep track of all the medications you’re taking, that can be hard to do when the names of so many of these drugs are difficult to pronounce and even harder to remember.</p>
<p><a href="https://usf.discovery.academicanalytics.com/scholar/stack/299489/JASMINE-CUTLER">In my role as a pharmacist</a>, I’ve helped countless patients figure out exactly which medication they were taking for what ailment. Some wonder why they were prescribed the medication in the first place, or need help differentiating between drugs with names that seem like complete gibberish.</p>
<p>But there is a rhyme and a reason to drug names. All prescribed medications follow a standard nomenclature that describes what the drug is made of and how it functions.</p>
<h2>Who names drugs?</h2>
<p>Drugs get both a brand, or proprietary, name and a generic name that is nonproprietary. Each is assigned in a slightly different process.</p>
<p>As long as a drug compound isn’t trademarked, drug companies decide on a proprietary brand name for the medications they sell. Usually the brand name relates to the conditions the drug is intended to treat and is easy for both providers and patients to remember but doesn’t follow a standardized naming guideline. For example, the drug Lopressor helps lower blood pressure. </p>
<p>On the other hand, generic drug names all follow a standard nomenclature that helps medical providers and researchers more easily recognize and classify the drug. Lopressor, for example, has a generic name of metoprolol tartrate. The <a href="https://www.ama-assn.org/about/united-states-adopted-names/usan-council">U.S. Adopted Names Council</a>, composed of representatives from the Food and Drug Administration, American Medical Association, U.S. Pharmacopeia and American Pharmacists Association, works with the <a href="https://www.who.int/teams/health-product-and-policy-standards/inn">World Health Organization</a> to assign <a href="https://dx.doi.org/10.1021%2Facs.jmedchem.1c00181">international nonproprietary names, or INNs</a>, to drug compounds. Similar organizations <a href="https://doi.org/10.1016/B978-0-12-820007-0.00002-7">exist internationally</a>.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/474355/original/file-20220715-495-u2t6el.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Pharmacist organizing medicine drawer" src="https://images.theconversation.com/files/474355/original/file-20220715-495-u2t6el.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/474355/original/file-20220715-495-u2t6el.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/474355/original/file-20220715-495-u2t6el.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/474355/original/file-20220715-495-u2t6el.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/474355/original/file-20220715-495-u2t6el.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/474355/original/file-20220715-495-u2t6el.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/474355/original/file-20220715-495-u2t6el.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Generic drugs are named using standard guidelines intended to minimize confusion and aid in classification.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/pharmacist-organizing-the-medicine-drawer-royalty-free-image/1352512002">Marko Geber/DigitalVision via Getty Images</a></span>
</figcaption>
</figure>
<p>A globally recognized naming process makes an otherwise confusing name game more manageable. It helps the medical community easily learn and categorize newly approved medications and reduce prescribing errors by providing a unique, standard name that reflects each active ingredient in the drug.</p>
<p>For example, several Type 2 diabetes medications fall under one class called glucagon-like peptide-1 (GLP-1) receptor agonists. Although all medications in this class have different brand names, each of the generic versions ends in the suffix “-tide.” This helps health providers identify all the drugs that belong to this medication class. A few examples include Byetta (exenatide), Trulicity (dulaglutide) and Victoza (liraglutide).</p>
<h2>How are generic drug names assigned?</h2>
<p>The <a href="https://www.ama-assn.org/about/united-states-adopted-names/procedure-usan-name-selection">naming process</a> starts when a drug company submits an application to the U.S. Adopted Names Council with a proposed generic name. USAN considers a number of factors when evaluating a name, such as whether it relates to how the drug works, how translatable it is to other languages and whether it is easy to say. In general, the name should be simple – fewer than four syllables long – and should not be easily confused with other existing generic drugs. </p>
<p>Once a name is agreed upon by USAN and the drug company, it is then proposed to the <a href="https://www.who.int/teams/health-product-and-policy-standards/inn/inn_expert_group">INN Expert Group</a>. Sponsored by the World Health Organization, the INN Expert Group is composed of global specialists who represent the pharmaceutical, chemical, pharmacological and biochemical sciences. They may either accept the proposed name or suggest an alternative. Once the drug company, USAN and the INN Expert Group come to an agreement about a name, it is placed in the <a href="https://www.who.int/our-work/access-to-medicines-and-health-products/who-drug-information">WHO Drug Information journal</a> for four months for public comments or objections before final adoption. </p>
<h2>What’s in a generic drug name?</h2>
<p>Generic names follow a <a href="https://www.ama-assn.org/about/united-states-adopted-names/united-states-adopted-names-naming-guidelines">prefix-infix-stem system</a>. The prefix helps distinguish a drug from other drugs in the same class. The infix, used more occasionally, further subclassifies the drug. The stem at the very end of the name indicates the drug’s function and marks its place within the name game.</p>
<p><a href="https://druginfo.nlm.nih.gov/drugportal/jsp/drugportal/DrugNameGenericStems.jsp">Stems</a> are composed of one or two syllables that describe a drug’s biological effects as well as its physical and chemical qualities and structure. Drugs with the same stem share features like the conditions they treat and how they work in the body. The WHO publishes a regularly updated <a href="https://www.who.int/publications/i/item/who-emp-rht-tsn-2018-1">stem book</a> to keep everything in line.</p>
<p><iframe id="ENYG9" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/ENYG9/6/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<p>For example, the stem “-prazole” indicates that the drug is chemically related to a class of compounds called benzimidazoles that have similar functions. As a result, drugs such as lansoprazole (Prevacid), esomeprazole (Nexium) and omeprazole (Prilosec) all treat acid reflux, ulcers and heartburn. The “e” prefix of esomeprazole differentiates it from omeprazole, which has a slightly different chemical structure.</p>
<p>Another common example is drugs that use the stem “stat,” which means enzyme inhibitors. Atorvastatin (Lipitor), rosuvastatin (Crestor) and simvastatin (Zocor) all belong to the same class of inhibitors that block a key enzyme in the body’s cholesterol production process. As a result, these cholesterol-reducing “statins” are used to prevent cardiovascular conditions like heart attack and stroke.</p>
<h2>Are there exceptions to the name game?</h2>
<p>Although generic names stay consistent, there have been multiple <a href="https://www.pharmacytimes.com/view/5-notable-drug-name-changes">changes to brand names</a> over the past couple of decades after increases in prescribing and dispensing errors. Some examples include the acid reflux and stomach ulcer drug omeprazole, which was rebranded from Losec to Prilosec because it was frequently confused with the diuretic Lasix. Another example is when the antidepressant Brintellix was changed to Trintellix because it was commonly confused with the blood thinner Brilinta. </p>
<p>Some generic medications may work at <a href="https://theconversation.com/many-medications-affect-more-than-one-target-in-the-body-some-drug-designers-are-embracing-the-side-effects-that-had-been-seen-as-a-drawback-184922">multiple targets in the body</a> and be used for multiple conditions. For example, drugs with the stem “-afil,” such as tadalafil (Cialis), sidenafil (Viagra) and vardenafil (Levitra), belong to a class of drugs that relax smooth muscle and widen the blood vessels. Although commonly prescribed for erectile dysfunction, they can also be used to treat pulmonary arterial hypertension, a specific type of elevated blood pressure that affects the arteries in the heart and lungs.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/474354/original/file-20220715-24-38fv83.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Pharmacist showing patient a box of medications" src="https://images.theconversation.com/files/474354/original/file-20220715-24-38fv83.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/474354/original/file-20220715-24-38fv83.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/474354/original/file-20220715-24-38fv83.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/474354/original/file-20220715-24-38fv83.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/474354/original/file-20220715-24-38fv83.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/474354/original/file-20220715-24-38fv83.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/474354/original/file-20220715-24-38fv83.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Pharmacists and other health care professionals can help patients decipher complex drug names.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/young-pharmacist-helping-a-senior-lady-choose-the-royalty-free-image/1352510394">Marko Geber/DigitalVision via Getty Images</a></span>
</figcaption>
</figure>
<p>In addition, nomenclature guidelines <a href="https://www.who.int/teams/health-product-and-policy-standards/inn/guidance-on-inn">aren’t set in stone</a>, and the U.S. Adopted Names Council anticipates that they will continue to change as newer, more complex substances are discovered, developed and marketed.</p>
<p>For example, a rise in the number of drugs developed with different salts and esters has led to the use of a modified naming process to incorporate the inactive parts of the compound.</p>
<p>As you can guess, it takes health care providers countless months and years to learn and understand this naming process. We are taught the science behind each chemical structure and how it works, which makes it easier to know the rules of the name game. But for those without a background in chemistry and biology, it can be like reading a foreign language.</p>
<p>There are several resources that can help you navigate the drug name game, however. Ask your health care provider or pharmacist if you have questions about how your medication works or what it is used for. They are generally a phone call or visit away.</p><img src="https://counter.theconversation.com/content/164148/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jasmine Cutler does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Believe it or not, medication names are intended to be easy to remember and descriptive of the function they serve in the body.Jasmine Cutler, Assistant Professor of Pharmacotherapeutics, University of South FloridaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1824882022-06-17T12:33:45Z2022-06-17T12:33:45ZHow do drugs know where to go in the body? A pharmaceutical scientist explains why some medications are swallowed while others are injected<figure><img src="https://images.theconversation.com/files/469333/original/file-20220616-24-uw9qbz.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2121%2C1412&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">While pills come in many shapes and sizes, they all eventually reach your bloodstream and travel throughout your body.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/pop-art-medicine-pill-or-tablet-icon-royalty-free-illustration/1264546155">Vadim Sazhniev/iStock via Getty Images</a></span></figcaption></figure><p>When you take aspirin for a headache, how does the aspirin know to travel to your head and alleviate the pain?</p>
<p>The short answer is, it doesn’t: Molecules can’t transport themselves through the body, and they don’t have control over where they eventually end up. But researchers can chemically modify drug molecules to make sure that they bind strongly to the places we want them and weakly to the places we don’t.</p>
<p>Pharmaceutical products contain more than just the active drug that directly affects the body. Medications also include “inactive ingredients,” or molecules that enhance the stability, absorption, flavor and other qualities that are critical to allowing the drug to do its job. For example, the aspirin you swallow also has ingredients that both prevent the tablet from fracturing during shipping and help it break apart in your body.</p>
<p>As a <a href="https://www.researchgate.net/profile/Thomas-Anchordoquy">pharmaceutical scientist</a>, I’ve been studying <a href="https://www.nibib.nih.gov/science-education/science-topics/drug-delivery-systems-getting-drugs-their-targets-controlled-manner">drug delivery</a> for the past 30 years. That is, developing methods and designing nondrug components that help get a medication where it needs to go in the body. To better understand the thought process behind how different drugs are designed, let’s follow a drug from when it first enters the body to where it eventually ends up.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/469339/original/file-20220616-20-4bvdhf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Shelves of orange pill bottles" src="https://images.theconversation.com/files/469339/original/file-20220616-20-4bvdhf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/469339/original/file-20220616-20-4bvdhf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=600&fit=crop&dpr=1 600w, https://images.theconversation.com/files/469339/original/file-20220616-20-4bvdhf.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=600&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/469339/original/file-20220616-20-4bvdhf.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=600&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/469339/original/file-20220616-20-4bvdhf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=754&fit=crop&dpr=1 754w, https://images.theconversation.com/files/469339/original/file-20220616-20-4bvdhf.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=754&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/469339/original/file-20220616-20-4bvdhf.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=754&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Drugs aren’t sentient, but good design can help them get where doctors and patients want them to go.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/rows-of-pill-bottles-on-shelves-in-pharmacy-royalty-free-image/73092126">Andersen Ross/DigitalVision via Getty Images</a></span>
</figcaption>
</figure>
<h2>How drugs are absorbed in the body</h2>
<p>When you swallow a tablet, it will initially dissolve in your stomach and intestines before the drug molecules are <a href="https://www.britannica.com/science/drug-chemical-agent/Types-of-drugs">absorbed into your bloodstream</a>. Once in the blood, it can circulate throughout the body to access different organs and tissues.</p>
<p>Drug molecules affect the body by <a href="https://open.lib.umn.edu/pharmacology/chapter/introduction-to-drug-receptor-interactions-and-pharmacodynamics/">binding to different receptors</a> on cells that can trigger a particular response. Even though drugs are designed to target specific receptors to produce a desired effect, it is impossible to keep them from continuing to circulate in the blood and binding to nontarget sites that potentially cause unwanted side effects.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/uOcpsXMJcJk?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Many factors, like your age, genetics and diet, can affect how well your body processes a drug.</span></figcaption>
</figure>
<p>Drug molecules circulating in the blood also degrade over time and eventually leave the body in your urine. A classic example is the strong smell your urine might have after you eat asparagus because of how quickly your kidney clears <a href="https://theconversation.com/that-distinctive-springtime-smell-asparagus-pee-94696">asparagusic acid</a>. Similarly, <a href="https://www.getthegloss.com/article/ask-the-doctor-why-do-vitamins-make-my-pee-yellow">multivitamins</a> typically contain riboflavin, or vitamin B2, which causes your urine to turn bright yellow when it is cleared. Because how efficiently drug molecules can cross the intestinal lining can vary depending on the drug’s chemical properties, some of the drugs you swallow never get absorbed and are removed in your feces.</p>
<p>Because not all of the drug is absorbed, this is why some medications, like those used to treat high blood pressure and allergies, are <a href="https://www.healthymepa.com/2018/07/23/important-take-medications-time/">taken repeatedly</a> to replace eliminated drug molecules and maintain a high enough level of drug in the blood to sustain its effects on the body. </p>
<h2>Getting drugs to the right place</h2>
<p>Compared with pills and tablets, a more efficient way of getting drug into the blood is to inject it directly into a vein. This way, all the drug gets circulated throughout the body and avoids degradation in the stomach. </p>
<p>Many drugs that are given intravenously are “<a href="https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers">biologics” or “biotechnology drugs</a>,” which include substances derived from other organisms. The most common of these are a type of cancer drug called <a href="https://my.clevelandclinic.org/health/treatments/22774-monoclonal-antibody-therapy">monoclonal antibodies</a>, proteins that bind to and kill tumor cells. These drugs are injected directly into a vein because your stomach can’t tell the difference between digesting a therapeutic protein and digesting the proteins in a cheeseburger.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/469317/original/file-20220616-24-tpqvb8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Nurse checking infusion bag hanging on IV pole" src="https://images.theconversation.com/files/469317/original/file-20220616-24-tpqvb8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/469317/original/file-20220616-24-tpqvb8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=338&fit=crop&dpr=1 600w, https://images.theconversation.com/files/469317/original/file-20220616-24-tpqvb8.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=338&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/469317/original/file-20220616-24-tpqvb8.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=338&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/469317/original/file-20220616-24-tpqvb8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=424&fit=crop&dpr=1 754w, https://images.theconversation.com/files/469317/original/file-20220616-24-tpqvb8.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=424&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/469317/original/file-20220616-24-tpqvb8.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=424&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Sometimes the most effective way to deliver a drug is through an infusion.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/professional-black-head-nurse-wearing-face-mask-royalty-free-image/1321691597">gorodenkoff/iStock via Getty Images</a></span>
</figcaption>
</figure>
<p>In other cases, drugs that need very high concentrations to be effective, such as <a href="https://health.ucsd.edu/news/features/pages/2017-05-01-intravenous-antibiotics-q-and-a-ritter.aspx">antibiotics for severe infections</a>, can be delivered only through infusion. While increasing drug concentration can help make sure enough molecules are binding to the correct sites to have a therapeutic effect, it also increases binding to nontarget sites and the risk of side effects.</p>
<p>One way to get a high drug concentration in the right location is to apply the drug right where it’s needed, like rubbing an ointment onto a skin rash or using <a href="https://www.webmd.com/allergies/allergy-eye-drops">eyedrops for allergies</a>. While some drug molecules will eventually get absorbed into the bloodstream, they will be <a href="https://doi.org/10.1007/978-1-4471-3625-5_24">diluted enough</a> that the amount of drug that reaches other sites is very low and unlikely to cause side effects. Similarly, an inhaler delivers the drug directly to the lungs and avoids affecting the rest of the body.</p>
<h2>Patient compliance</h2>
<p>Finally, a key aspect in all drug design is to simply get patients to take medications in the right amounts at the right time. </p>
<p>Because remembering to take a drug several times a day is difficult for many people, researchers try to design drug formulations so they need to be <a href="http://dx.doi.org/10.1201/9781315111896-12">taken only once a day or less</a>.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/469327/original/file-20220616-15-393l9w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Person taking out pills from pill box" src="https://images.theconversation.com/files/469327/original/file-20220616-15-393l9w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/469327/original/file-20220616-15-393l9w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/469327/original/file-20220616-15-393l9w.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/469327/original/file-20220616-15-393l9w.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/469327/original/file-20220616-15-393l9w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/469327/original/file-20220616-15-393l9w.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/469327/original/file-20220616-15-393l9w.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Taking medications as instructed can help increase their effectiveness and reduce the risk of side effects.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/senior-woman-took-out-the-pills-from-pill-container-royalty-free-image/1289013876">violetphoto/Moment via Getty Images</a></span>
</figcaption>
</figure>
<p>Similarly, pills, inhalers or nasal sprays are more convenient than an infusion that requires traveling to a clinic for a trained clinician to inject it into your arm. The less troublesome and expensive it is to administer a drug, the more likely it is that patients will take their medication when they need it. However, sometimes infusions or injections are the only effective way that certain drugs can be administered. </p>
<p>Even with all the science that goes into understanding a disease well enough to develop an effective drug, it is often up to the patient to make it all work as designed.</p><img src="https://counter.theconversation.com/content/182488/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Tom Anchordoquy receives funding from the National Institutes of Health. </span></em></p>From tablets and patches to ointments and infusions, the best way to deliver a drug is the one that gets the right amount to the right place.Tom Anchordoquy, Professor of Pharmaceutical Sciences, University of Colorado Anschutz Medical CampusLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1819752022-05-11T13:40:23Z2022-05-11T13:40:23ZWhy import restrictions aren’t enough to help Nigeria industrialise<figure><img src="https://images.theconversation.com/files/461586/original/file-20220505-13-9o62op.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Nigeria is intent on increasing local manufacturing. </span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/nestle/5410107101">Nestle/Wikimedia Commons</a></span></figcaption></figure><p>Nigeria has a strong <a href="http://set.odi.org/wp-content/uploads/2017/10/SET-Nigeria_Backward-Integration_Final-report.pdf">ambition to industrialise</a>. It has relied heavily on the restriction of imports of certain goods targeted for domestic production. But for Nigeria’s industrialisation drive to succeed, it needs a broader array of industrial policy tools than simply import restrictions. </p>
<p>These tools should include addressing binding constraints in different sectors to raise productivity. And addressing the flaws in the design and implementation of industrial policies.</p>
<p>A further complicating factor is regional integration, specifically Nigeria’s approach to it, and a lack of capacity both in Nigeria and the Economic Community of West African States to manage illegal cross-border trade. </p>
<p>Nigeria’s neighbour, Benin, an entrepôt economy, is a major supplier of re-exported goods to Nigeria. With close ethno-cultural affinities there is thriving informal cross-border trade between these countries. At the same time, there is a fledgling smuggling economy in Benin with links to the highest echelons of government.</p>
<p>In Nigeria, the survivalist informal trade is seen as organised smuggling that jeopardises the country’s industrialisation ambitions. Curbing this trade therefore is a rather pressing political issue in a country trying to boost domestic production. </p>
<p>As a result, the interest on the Nigerian side is in heavily regulating, and not facilitating, trade. Nigeria perceives a greater threat from smuggling through neighbouring countries, than benefits by engaging in regional trade given limited markets.</p>
<p>We conducted <a href="https://ecdpm.org/publications/inconsistent-policies-political-realities-nigerias-trade-industrial-policy-imperatives/">research</a> focusing on the context of Nigerian government’s decision in 2019 to close its borders with its neighbours. </p>
<p>We found that it wasn’t a sudden event. Rather, that it was a continuation of policy decisions to curb smuggling, which was perceived to undermine the country’s industrialisation drive. This affects how trade facilitation is viewed, with implications for support programmes.</p>
<p>We looked at rice and pharmaceuticals because of their relevance to the Nigerian economy and the region. Through these two sectors, we analysed the shortcomings in Nigeria’s industrialisation policies and provided pointers for improvements. </p>
<h2>Nigeria’s trade and industrial policies</h2>
<p>Industrial policies have often been a response to economic crises following a fall in oil prices. Governments consequently tend to rely on import restrictions and foreign exchange controls to incentivise domestic production. Nigeria’s focus has been on the so-called <a href="http://set.odi.org/wp-content/uploads/2017/10/SET-Nigeria_Backward-Integration_Final-report.pdf">backward integration policy </a>. Under this approach imports of designated products are limited to a handful of companies through licences and quotas. Import licences are gradually phased out as these firms ramp up local production.</p>
<p>This policy was instituted for several sectors. One of them was rice. The measures included:</p>
<ul>
<li><p>putting in place a <a href="https://guardian.ng/features/foreign-rice-importers-game-to-return-nigeria-as-dumping-ground/">differential </a> import duty and levy system</p></li>
<li><p>banning rice imports through land borders, and</p></li>
<li><p>providing support to ramp up local production.</p></li>
</ul>
<p>But successive governments have not paid enough attention to the whole value chain. Rice milling capacity, for example, is constrained by continued electricity disruptions as well as lack of local markets for spare parts of milling equipment. This elevates the operating cost of mills, and increased disruptions. The effect is a reduction in the competitiveness of locally produced rice.</p>
<p>In addition, farmers struggle with high input costs. <a href="https://theconversation.com/nigerias-food-inflation-losers-winners-and-a-possible-solution-172313?utm_term=Autofeed&utm_medium=Social&utm_source=Twitter#Echobox=1637765361">Transport is expensive</a> and fuel prices are high.</p>
<p>Nigeria’s industrial policies have focused on self-sufficiency. But other <a href="https://theconversation.com/why-the-cost-of-food-is-not-yielding-to-nigerias-government-policies-178684">research</a> shows that top-down policies often lack the necessary groundwork and consultation with implementing agencies to determine their feasibility.</p>
<p>A similar pattern can be seen in the pharmaceutical sector. Firms have received support, mainly through import restrictions. But here too not enough has been done to overcome other binding constraints. These include poor infrastructure, a lack of access to finance and a restrictive regulatory environment.</p>
<p>Another problem we identified in this sector was that objectives weren’t clearly defined. This made performance monitoring inefficient. In turn this resulted in policies failing to provide an environment for interactive learning through, for example, joint ventures with foreign firms. As a result, development in the sector remains limited.</p>
<p>Other dynamics also affect the sector. Firms generally support government policies towards self-sufficiency. But – being both producers and importers – they also continued importing finished goods to ensure an uninterrupted access to medicines from a healthcare perspective. This circular flow and arbitrage has held back the sector, although it’s been profitable for the firms involved.</p>
<p>In addition, <a href="https://www.premiumtimesng.com/features-and-interviews/189328-interview-how-fake-and-substandard-drugs-get-to-nigeria-kristin-peterson.html">informal imports</a> remain a big concern.</p>
<p>We identified other major gaps in policy design.</p>
<h2>Design and implementation flaws</h2>
<p>Industrial policy should be about acquiring technology or tacit knowledge. But it should also be about dynamic <a href="https://theconversation.com/industrial-policy-paved-the-way-for-dangotes-empire-why-it-didnt-deliver-for-all-nigerians-170581">economies of scale</a>. That is, it is necessary to generate the demand for domestically-produced products, preferably through a form of export-orientation, and not just focus on increasing their supply. This consideration seems largely missing in Nigeria’s industrial policies. </p>
<p>In addition, the heavily politicised nature of policy formulation and execution means that there have been numerous policy shifts, negatively affecting continuity. <a href="https://www.tandfonline.com/doi/citedby/10.1080/14747731.2020.1714851?scroll=top&needAccess=true#metrics-content">In some cases</a>, firms run campaigns to make policy reversals difficult. </p>
<p>Another problem is the leakage of resources through corruption and other inefficiencies. For instance, the differential import duty and levy system in the rice sector, under Goodluck Jonathan, saw <a href="https://www.premiumtimesng.com/news/headlines/195509-investigation-inside-the-massive-fraud-in-nigerias-n117billion-rice-import-quota-scheme.html">significant corruption</a> and rent seeking. Large firms were the biggest beneficiaries. </p>
<p>There are also a number of other inefficiencies. For instance, the Anchor Borrower Scheme, under President Muhammadu Buhari, has relatively <a href="https://punchng.com/anchor-borrowers-cbn-incurs-n379bn-debt-farmers-battle-insecurity/">low repayment rates</a> on loans. The scheme was designed so serve farmers in Northern Nigeria - an important electoral constituency.</p>
<p>The procurement system for pharmaceuticals is also riddled with inefficiencies.</p>
<h2>What way forward?</h2>
<p>As long as industrial policies in Nigeria are introduced as a crisis response, import restrictions will continue to be the focus. Curbing smuggling is likely to remain a more pressing concern for the government, rather than trade facilitation. </p>
<p>In the absence of effective performance management, industrial policies are likely to be captured by interest groups without significant development of productive capacities. As our research shows, shortcomings in sector performance, rice being an example, will be blamed on rampant smuggling, without sufficient regard to production constraints in the wider value chain. Uncoordinated action and untargeted policy support, as has been the case with pharmaceuticals, will mean that firms continue to depend on import restrictions to remain competitive. </p>
<p>To break this cycle there is need for a multi-pronged approach that ensures the country’s industrialisation ambitions are supported along with trade facilitation given the close link between the two. </p>
<p>Given the different sector dynamics, a one-size fits all approach may not bring the desired benefits. Thus Nigeria needs a broader array of industrial policy tools to address the binding constraints in different sectors to raise productivity. This includes introducing the right balance between incentives (essentially targeted and time-bound learning rents) and compulsions (threat of withdrawal of support in case of non-performance), or credible commitments. </p>
<p>Given their political nature, the power structure within which industrial policies are introduced needs to be carefully examined to ensure optimal results. In short, industrial policies should entail <a href="https://eprints.soas.ac.uk/29911/1/Andreoni%20and%20Chang%20The%20Political%20Economy%20of%20Industrial%20Policy.pdf">strategic coordination</a> to resolve several organisational, structural and institutional challenges. This requires a <a href="https://panafricanreview.rw/it-is-time-to-switch-on-the-transformative-power-of-industrial-policy-in-africa/">whole-of-government</a> approach.</p>
<p>Regional commitments, such as trade facilitation, are implemented at the national level. For policymakers and development partners interested in trade facilitation as a tool to promote regional integration this means making sure there’s alignment with national industrialisation ambitions. Otherwise, there is a risk that previous efforts towards trade facilitation will be undone. </p>
<p>Apart from this, as a sector develops and matures, there is greater demand for rules based engagements, including trade facilitation. And, given Nigeria’s reservations, it is essential that interventions effectively addresses the problem of smuggling. This requires a problem-driven approach that is bottom-up and with political buy-in. </p>
<p>Ensuring the success of trade facilitation by generating the demand for regional cooperation also requires a sector-specific approach. In the case of rice this could include exploring opportunities for a regional value chain, and not just regional trade, through negotiated cooperation. In the case of pharmaceuticals, it would require compatibility in regulatory procedures so that domestically-produced medicines are easily traded in the region and there is quality assurance.</p><img src="https://counter.theconversation.com/content/181975/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>As long as industrial policies in Nigeria are introduced only as a crisis response, import restrictions will continue to be their focus.Michael E Odijie, Research associate, UCLPoorva Karkare, Policy Officer, ECDPMLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1822042022-05-09T12:05:35Z2022-05-09T12:05:35ZNonprofit drugmaker Civica Rx is taking aim at the high insulin prices harming people with diabetes<figure><img src="https://images.theconversation.com/files/461576/original/file-20220505-11-rf28d7.jpg?ixlib=rb-1.1.0&rect=552%2C0%2C2505%2C1949&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">High insulin prices are leaving some people who need the drug without access.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/advocates-with-t1internationals-new-york-new-jersey-and-news-photo/1166231700?adppopup=true">Erik McGregor/LightRocket via Getty Images</a></span></figcaption></figure><p>Doctors have been treating <a href="https://www.diabetes.org.uk/research/research-impact/insulin">diabetes with insulin</a> since <a href="https://www.cmaj.ca/content/167/12/1396">1922</a>. A century later, about <a href="https://www.cdc.gov/diabetes/data/statistics-report/index.html">1 in 5 of the 37 million Americans</a> living with diabetes take this medication – a hormone that helps cells absorb sugar from the blood.</p>
<p>This medication helps avert a host of medical problems including heart disease, kidney disease and stroke. Some <a href="https://familydoctor.org/insulin-therapy/">1.6 million Americans living with Type 1</a> diabetes, a condition in which people don’t produce any insulin, depend on it for their survival. So do millions more people with <a href="https://my.clevelandclinic.org/health/diseases/21501-type-2-diabetes">Type 2 diabetes</a> – a condition in which the body doesn’t make enough insulin.</p>
<p>But an estimated 1 in 4 of the Americans who need it have so much trouble affording this <a href="https://doi.org/10.1001/jamainternmed.2018.5008">lifesaving medication</a> that they skimp on doses because insulin prices have been skyrocketing for years. For example, the full cost – not counting insurance coverage – of about one month’s worth of a <a href="https://www.mayoclinic.org/drugs-supplements/insulin-glargine-recombinant-subcutaneous-route/description/drg-20067770">commonly used kind of insulin called glargine</a> has nearly tripled from US$99 in 2010 to <a href="https://www.businessinsider.com/insulin-price-increased-last-decade-chart-2019-9?r=US&IR=T">$284 in 2022</a>. </p>
<p>The exact amount Americans pay for insulin varies quite widely, <a href="https://www.commonwealthfund.org/publications/issue-briefs/2020/sep/not-so-sweet-insulin-affordability-over-time">depending on their insurance coverage</a> and which version of the <a href="https://www.kff.org/medicaid/issue-brief/pricing-and-payment-for-medicaid-prescription-drugs/">medication they’re prescribed</a>.</p>
<p><a href="https://civicarx.org/civica-to-manufacture-and-distribute-affordable-insulin/">Civica Rx</a>, a nonprofit that <a href="https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189">manufactures generic drugs</a>, is trying to help solve this problem. It’s planning to produce <a href="https://www.healthline.com/diabetesmine/why-is-there-no-generic-insulin">generic insulin</a> for no more than $30 for a month’s worth of the drug at a factory being built in Petersburg, Virginia. Eventually the drugmaker intends to sell all three of the most popular kinds of insulin, starting in 2024 with glargine.</p>
<p>Based on my <a href="https://scholar.google.com/citations?user=rTIsA4UAAAAJ&hl=en&oi=ao">research regarding the pharmaceutical industry</a> and my work as a doctor who treats patients with diabetes, I believe this effort, announced in March 2022, may greatly increase access to insulin for hundreds of thousands of people who need but can’t currently afford it.</p>
<p><iframe id="UW6jg" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/UW6jg/1/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<h2>Generic insulin competition is limited</h2>
<p>Americans rely on robust <a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/generic-competition-and-drug-prices">competition from low-cost generic drugs</a> to make pharmaceutical products more affordable. This system has historically been more successful with blockbuster drugs like atorvastatin – a cholesterol-controlling drug better known by the <a href="https://www.axios.com/lipitor-pfizer-drug-patent-sales-2019-6937cdfb-47f1-46bc-8cf0-39e6b88e235e.html">brand name Lipitor</a> – and azithromycin – an antibiotic sold under the <a href="https://www.vox.com/2016/2/16/11008134/generic-drugs-safe-effective-cheaper">brand name Zithromax</a>.</p>
<p>Unfortunately, this system has failed to restrain increases in insulin prices, which are <a href="https://pharmanewsintel.com/news/insulin-prices-8x-higher-in-the-us-compared-to-similar-nations">far higher in the United States than other countries</a>.</p>
<p>One reason this has been the case has to do with the fact that insulin is a <a href="https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers">biologic drug</a>, meaning that it’s produced using DNA technology by living organisms. Biologic drugs are harder to manufacture and are regulated by the Food and Drug Administration in a different manner than more conventional drugs.</p>
<h2>Seeing reasons for optimism</h2>
<p>I’m excited about this initiative because it promises to increase access to all people who require insulin in the U.S., regardless of insurance status or where they buy medications.</p>
<p>One reason is that Civica Rx is a nonprofit that will be more able than private-sector drugmakers to put the interests of those who pay for insulin – patients and health insurers – ahead of investors’.</p>
<p>Another is its pricing strategy. Civica Rx plans to charge only about 20% of the list prices for brand-name insulin products. <a href="https://corporate.walmart.com/newsroom/2021/06/29/walmart-revolutionizes-insulin-access-affordability-for-patients-with-diabetes-with-the-launch-of-the-first-and-only-private-brand-analog-insulin">Walmart and some other big-box retailers</a> already sell insulin at a discount, but their prices are still higher than what the nonprofit plans to charge. </p>
<p>And findings from <a href="https://doi.org/10.1016/S2213-8587(15)00364-2">my own research suggest</a> that intellectual property protections will not likely be a substantial barrier to Civica’s efforts. </p>
<p>I’m also optimistic because of support from large insurers like <a href="https://civicarx.org/civica-to-manufacture-and-distribute-affordable-insulin/">Anthem and Blue Cross Blue Shield Association</a> for this effort. It’s reassuring that Civica Rx’s leadership includes many people with decades of experience in the <a href="https://civicarx.org/board-of-directors/">pharmaceutical industry and in health policy</a>.</p>
<p>But I see some reasons to be less optimistic. </p>
<p>First, there have been prior attempts to manufacture generic insulin in the U.S. <a href="https://www.biopharma-reporter.com/Article/2013/06/17/Insulin-CMO-Sued-by-US-City-Over-Failed-Manufacturing-Plant">None have succeeded</a>.</p>
<p>Another possibility is that brand-name insulin manufacturers may try to push doctors to prescribe <a href="https://www.news-medical.net/health/Drug-Patents-and-Generics.aspx">newer patent-protected versions</a> of insulin, which would be harder for Civica Rx to market as a generic – at least initially.</p>
<p>Success is far from guaranteed, given that the established players all have a strong financial interest in seeing Civica’s efforts fail.</p>
<h2>Lawmakers are taking action</h2>
<p>Several state legislatures have also tried to deal with this problem. Some have enacted laws <a href="https://www.nashp.org/drug-price-transparency-laws-position-states-to-impact-drug-prices/">mandating drug price transparency</a> and provided funds to guarantee <a href="https://www.minnpost.com/state-government/2020/04/a-great-day-minnesota-legislature-finally-passes-emergency-insulin-bill/">emergency access to insulin</a>.</p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/461578/original/file-20220505-17-yssztk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Two women and two men in suits next to an 'affordable insulin' sign in front of the U.S. Capitol building." src="https://images.theconversation.com/files/461578/original/file-20220505-17-yssztk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/461578/original/file-20220505-17-yssztk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/461578/original/file-20220505-17-yssztk.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/461578/original/file-20220505-17-yssztk.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/461578/original/file-20220505-17-yssztk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/461578/original/file-20220505-17-yssztk.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/461578/original/file-20220505-17-yssztk.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Members of Congress – from left, Rep. Dan Kildee, D-Mich.; House Majority Whip James Clyburn, D-S.C.; Rep. Angie Craig, D-Minn.; and Rep. Lucy McBath, Ga. – express support for capping insulin prices at $35 a month or less in March 2022.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/InsulinCosts/37695cd7b2174975adfe0bc92170e895/photo?Query=insulin&mediaType=photo&sortBy=arrivaldatetime:desc&dateRange=Anytime&totalCount=364&currentItemNo=8">AP Photo/J. Scott Applewhite</a></span>
</figcaption>
</figure>
<p>But to date these assorted responses have <a href="https://www.goodrx.com/healthcare-access/research/how-much-does-insulin-cost-compare-brands">failed to lower prices for brand-name insulin products</a>, although I think it’s possible that prices would have risen faster without them.</p>
<p>Congress is also responding.</p>
<p>Four weeks after Civica Rx announced its plans to produce insulin at well below current prices, the U.S. House of Representatives <a href="https://www.npr.org/2022/03/31/1090085513/house-passes-bill-to-cap-insulin-prices">passed a bill that would limit insulin copays to $35</a> for insured patients. This measure was also in <a href="https://www.wusa9.com/article/news/verify/insulin-costs-about-10-to-make-but-retails-for-nearly-300-pharmaceutical-companies-eli-lilly-novo-nordisk-sanofi-pbms-insuli/65-73a3cafd-3340-45cd-8324-a5e3e1c78fa5">President Joe Biden’s</a> stalled <a href="https://www.youtube.com/watch?v=GJT_04kyv5I">Build Back Better</a> spending plan.</p>
<p>The House bill would leave out many patients – most <a href="https://khn.org/news/article/insulin-copay-cap-passes-house-hurdle-but-senate-looks-for-a-broader-bill/">notably the uninsured</a>. But this measure would also <a href="https://khn.org/news/article/insulin-copay-cap-passes-house-hurdle-but-senate-looks-for-a-broader-bill/">mark a positive step</a> should <a href="https://khn.org/news/article/insulin-copay-cap-passes-house-hurdle-but-senate-looks-for-a-broader-bill/">the Senate</a> <a href="https://rollcall.com/2022/04/06/with-senate-readying-vote-on-insulin-bill-advocates-seek-changes/">follow suit</a>.</p>
<p>People living with insulin-dependent diabetes have been waiting a long time for someone to do something to make it more affordable. It looks like that time may finally be arriving.</p><img src="https://counter.theconversation.com/content/182204/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Through his University, Jing Luo receives funding from The Leona M. and Harry B. Helmsley Charitable Trust and has previously received funding from Arnold Ventures. Both of these organizations have made contributions to Civica.</span></em></p>About 1 in 4 Americans with diabetes who need insulin struggle to pay for this lifesaving drug.Jing Luo, Assistant Professor of Medicine, University of PittsburghLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1819982022-04-28T12:17:46Z2022-04-28T12:17:46ZWhat is Paxlovid and how will it help the fight against coronavirus? An infectious diseases physician answers questions on the COVID-19 pill<figure><img src="https://images.theconversation.com/files/459834/original/file-20220426-18-d63m4y.jpeg?ixlib=rb-1.1.0&rect=11%2C11%2C7423%2C4793&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Paxlovid may help prevent severe illness in patients at highest risk for COVID-19 complications.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/march-2022-berlin-the-drug-paxlovid-against-covid-19-from-news-photo/1238868638">picture alliance/picture alliance via Getty Images</a></span></figcaption></figure><p><em>The Biden administration <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2022/04/26/fact-sheet-biden-administration-increases-access-to-covid-19-treatments-and-boosts-patient-and-provider-awareness/">announced plans</a> on April 26, 2022, to <a href="https://www.npr.org/2022/04/26/1094735822/biden-will-make-paxlovid-a-highly-effective-covid-drug-available-to-more-pharmac">increase the availability</a> of the COVID-19 drug Paxlovid, vowing to get more of the treatment pills into the hands of Americans.</em></p>
<p><em>An oral antiviral, Paxlovid has proved successful at reducing the chances of hospitalization among COVID-19 sufferers, but has suffered from a <a href="https://apnews.com/article/coronavirus-pandemic-science-business-health-pandemics-b2d1051842df779dfa6122f824bd0377">slow rollout to pharmacies</a> across the U.S.</em></p>
<p><em>Patrick Jackson, an <a href="https://uvahealth.com/findadoctor/profile/patrick-e-jackson">infectious diseases physician</a> <a href="https://scholar.google.com/citations?user=NAnp8WsAAAAJ&hl=en">and scientist</a> at the University of Virginia, has helped care for hundreds of COVID-19 patients and assisted in Paxlovid clinical trials. The Conversation asked him to explain what the drug does and what impact greater availability may have in the fight against the coronavirus.</em></p>
<h2>What is Paxlovid and how does it work?</h2>
<p>Paxlovid is a made up of two protease inhibitors, including one used in treating HIV as a booster medicine. Protease inhibitors are synthetic drugs that block enzymes that viruses need to replicate. The combination in Paxlovid basically prevents the coronavirus from completing its life cycle.</p>
<p>If left uninterrupted, SARS-Cov-2 would normally <a href="https://doi.org/10.1016/j.bbadis.2020.165878">create the proteins it needs</a> by making a polyprotein, or long strings of amino acids. Then protease, <a href="https://doi.org/10.1016/j.bmcl.2020.127377">a viral enzyme</a>, activates the polyprotein strings by cutting them into smaller parts. Paxlovid <a href="https://doi.org/10.1126/science.abl4784">blocks the protease</a> from doing this, thereby preventing the virus from becoming active. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/459836/original/file-20220426-24-7ndf0q.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A thumb and forefinger holding a COVID-19 testing tray and strip." src="https://images.theconversation.com/files/459836/original/file-20220426-24-7ndf0q.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/459836/original/file-20220426-24-7ndf0q.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/459836/original/file-20220426-24-7ndf0q.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/459836/original/file-20220426-24-7ndf0q.jpeg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/459836/original/file-20220426-24-7ndf0q.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/459836/original/file-20220426-24-7ndf0q.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/459836/original/file-20220426-24-7ndf0q.jpeg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Doctors prescribe Paxlovid after a positive test for COVID-19.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/detail-of-a-hand-holding-a-lateral-flow-test-that-shows-a-news-photo/1240227986">Richard Baker/In Pictures via Getty Images</a></span>
</figcaption>
</figure>
<h2>How much of a game-changer could it be in fighting COVID-19?</h2>
<p>It’s kind of limited. It could be beneficial for those at <a href="https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/coronavirus-who-is-at-risk/art-20483301">high risk of severe disease and possibly death</a>, such as people who are older or who have hypertension, diabetes, obesity, heart disease or who are immunocompromised. And that’s the population that we’re really the most worried about when it comes to COVID-19. </p>
<p>But the more medically complicated a person is – by which I mean the more health conditions they have and medications they take – the more likely it is that Paxlovid will <a href="https://hivinfo.nih.gov/understanding-hiv/fact-sheets/what-drug-interaction">interact with one of their drugs</a>. That means that one drug could alter or interfere with how another drug works, which can be dangerous.</p>
<p>Some of the really important Paxlovid interactions are with anti-rejection medications for people who have transplants. A lot of blood thinners have interactions with it that can be very serious. Medications that treat heart rhythm abnormalities can be a major issue if patients on those medications take Paxlovid. And there’s a whole range of other things that it just doesn’t mix well with in the body.</p>
<p>Some who could most benefit from Paxlovid are also at highest risk for <a href="https://labeling.pfizer.com/ShowLabeling.aspx?id=16474">drug interaction with Paxlovid</a>. That makes it somewhat less useful.</p>
<p>And Paxlovid was studied only in <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2118542">unvaccinated patients</a>. So it’s not clear how well it will work in a vaccinated population – that is, we don’t know what additional benefit it gives on top of vaccination. I think it would work, but we don’t know how much. And I do wonder how much of a game-changer this is when we can just vaccinate more people and probably get more benefit on a population level. </p>
<h2>Is Paxlovid available to everyone?</h2>
<p>It is a prescription drug, so you have to talk to your doctor. You have to have symptoms of COVID-19 and test positive for the virus – not necessarily with a PCR test; it can be with a home test. But you have to actually have a diagnosis. </p>
<p>And this drug has an <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">emergency use authorization</a> from the Food and Drug Administration, which has more restrictions than simply having full FDA approval. Pharmacies are responsible for making sure that the prescribed use is appropriate for this medication. So a lot of pharmacies will require some information from doctors who prescribe it – things like documentation of symptoms. So depending on the pharmacy, Paxlovid can be a little bit more complicated to get.</p>
<p>The No. 1 issue is probably going to be the hesitancy of physicians to prescribe it. I think part of that comes down to a lack of awareness, and part is the result of the complexity of making sure that you’re using it appropriately and not hurting your patient through the drug interactions.</p>
<p>I will certainly prescribe it for my patients when appropriate. But I have to go through their whole list of medications and check for drug interactions and double-check myself with another resource. </p>
<h2>Why has there been a problem in delivering the drug to pharmacies?</h2>
<p>Initially, I think the manufacturer and distributors were kind of trying to spread it around. So doctors and patients had to figure out which pharmacies had the drug and get to them early to secure Paxlovid. But pharmacies would run out even though they might have been listed on a website as having received a supply. </p>
<p>But that is becoming less of a concern, now that there is more drug supply. </p>
<h2>What has the White House said it will do to speed things along?</h2>
<p>The government is <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2022/04/26/fact-sheet-biden-administration-increases-access-to-covid-19-treatments-and-boosts-patient-and-provider-awareness/">purchasing more supplies</a> of the drug and distributing it into more pharmacies – that has helped to a certain extent. And the Biden administration has made some noises about trying to make the drug more readily available at test-to-treat sites and clinics – something that to date has been challenging.</p>
<p>[<em>Over 150,000 readers rely on The Conversation’s newsletters to understand the world.</em> <a href="https://memberservices.theconversation.com/newsletters/?source=inline-150ksignup">Sign up today</a>.]</p><img src="https://counter.theconversation.com/content/181998/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Patrick Jackson receives funding from the National Institutes of Health. He is affiliated with Indivisible Charlottesville.</span></em></p>An infectious disease doctor discusses the use, benefits and availability of a drug to prevent severe COVID-19.Patrick Jackson, Assistant Professor of Infectious Diseases, University of VirginiaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1759722022-04-21T12:17:32Z2022-04-21T12:17:32ZDiscovering new drugs is a long and expensive process – chemical compounds that dupe screening tools make it even harder<figure><img src="https://images.theconversation.com/files/458263/original/file-20220414-9097-gh18al.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C1989%2C1507&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Pan-assay interference compounds, or PAINS, often come up as false positives when researchers screen for potential drug candidates.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/scoring-and-efficacy-test-of-target-drugs-for-royalty-free-image/1163162170">unol/iStock via Getty Images Plus</a></span></figcaption></figure><p>Modern drug discovery is an <a href="https://dx.doi.org/10.1016%2Fj.trci.2017.10.005">expensive and complicated process</a>. Hundreds of scientists and at least a decade are often required to produce a single medicine. One of the most critical steps in this process is the first one – identifying new chemical compounds that could be developed into new medicines.</p>
<p>Researchers rely heavily on <a href="https://doi.org/10.1036/1097-8542.081700">bioassays</a> to identify potential drug candidates. These tests measure a compound’s ability to act on a biological target of interest. Candidates that show up as a “hit” by interacting with a target of interest (such as fitting into a binding site on the target) move on to further study and development. Advances in technology called <a href="https://doi.org/10.1038/nrd3368">high-throughput screening</a> have allowed researchers to run thousands of compounds through bioassays in a short time, significantly streamlining the process.</p>
<p>But some of these “hits” don’t actually interact with the target as intended. And for the unwary researcher, this can lead down a rabbit hole of lost time and money.</p>
<p>I am a <a href="https://www.ncbi.nlm.nih.gov/myncbi/martin.clasby.1/bibliography/public/">medicinal chemist</a> who has been working in the drug discovery field for over 26 years, and one of the greatest challenges I have faced in my research is selecting good candidates from drug screening tests. One particular category of compounds, known as <a href="https://doi.org/10.1038/513481a">pan-assay interference compounds, or PAINS</a>, is a common pitfall.</p>
<h2>What are PAINS?</h2>
<p><a href="https://doi.org/10.1036/1097-8542.081700">Bioassays</a> involve placing a chemical compound together with the target of interest and measuring the strength of their interaction. Researchers assess interaction strength using a number of methods depending on how the bioassay is designed. A common assay design emits light when there is an interaction, where the intensity of the light depends upon the strength of interaction.</p>
<p><a href="https://doi.org/10.1038/513481a">PAINS</a> refer to compounds that often come up as false positives during the screening process. Because of certain characteristics of these molecules, they can interact with a target in nonspecific or unexpected ways. Some can even react chemically with the target. So while PAINS may come up as a hit in a screen, it doesn’t necessarily mean they actually do what researchers hoped they’d do. <a href="https://doi.org/10.4155/fmc.10.237">Common worst offenders</a> include compounds like quinones, catechols and rhodanines.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/458252/original/file-20220414-16-5bia2r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Diagram comparing the specific interactions of druglike molecules with the nonspecific interactions of PAINS molecules with a target of interest" src="https://images.theconversation.com/files/458252/original/file-20220414-16-5bia2r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/458252/original/file-20220414-16-5bia2r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=185&fit=crop&dpr=1 600w, https://images.theconversation.com/files/458252/original/file-20220414-16-5bia2r.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=185&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/458252/original/file-20220414-16-5bia2r.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=185&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/458252/original/file-20220414-16-5bia2r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=232&fit=crop&dpr=1 754w, https://images.theconversation.com/files/458252/original/file-20220414-16-5bia2r.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=232&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/458252/original/file-20220414-16-5bia2r.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=232&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Unlike desired drug compounds that interact specifically with a target of interest, PAINS react nonspecifically with a wide variety of targets.</span>
<span class="attribution"><a class="source" href="https://commons.wikimedia.org/wiki/File:PAINS_Figure.tif">Bcary/Wikimedia Commons</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-sa/4.0/">CC BY-NC-SA</a></span>
</figcaption>
</figure>
<p>There are a number of ways that PAINS dupe bioassays. </p>
<p>Some PAINS have properties that cause them to emit light (or fluoresce) under certain conditions. Since many bioassays detect light as a signal for a hit, this can confuse the assay readout and result in a false positive.</p>
<p>Other PAINS can act as <a href="https://dx.doi.org/10.1016%2Fj.cbpa.2010.10.022">redox cyclers</a> in bioassays – producing hydrogen peroxide that can block the target and be misread as a hit.</p>
<p>Similarly, some PAINS form <a href="https://doi.org/10.1021/acs.jmedchem.5b01105">colloidal aggregates</a> – clumps of molecules that interfere with the target of interest by absorbing it or modifying the molecular structure. In rare cases, these clumps can even elicit a desired interaction with the target of interest because of their large size.</p>
<p>Trace impurities left over from manufacturing can also elicit a PAINS response. </p>
<p>To make things even more complicated, because PAINS react with targets much more strongly than most compounds that are true drug candidates, PAINS often appear as the most promising hits in screening. </p>
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<iframe width="440" height="260" src="https://www.youtube.com/embed/Zcy9bfAQ55c?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Curcumin, the bright yellow chemical commonly found in the turmeric in curry, is one notorious example of a pan-assay interference compound.</span></figcaption>
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<h2>What can be done about PAINS?</h2>
<p>An estimated <a href="https://doi.org/10.1021/jm901137j">5% to 12% of compounds</a> in the screening libraries academic institutions use for drug discovery consist of PAINS. Scientists misled by a false positive can waste considerable time if they try to develop these compounds into usable drugs.</p>
<p>Since researchers became aware of the existence of PAINS, medicinal chemists have identified frequent offenders and actively remove these compounds from screening libraries. However, some compounds will always fall through the cracks. It is ultimately up to the researcher to identify and discard these PAINS when they show up as false positives.</p>
<p>There are a few things researchers can do to filter out PAINS. In some cases, visually inspecting compounds for structural similarities with other known PAINS can be enough. For other cases, <a href="https://doi.org/10.1089/adt.2015.674">additional experiments</a> are necessary to eliminate false positives. </p>
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<p>Testing for the presence of hydrogen peroxide, for example, can help identify redox cyclers. Likewise, adding detergents can help break up colloidal aggregates. And bioassays that do not use light detection to register hits can circumvent PAINS that emit light.</p>
<p>Even the most experienced medicinal chemist needs to be cognizant of the dangers of these false positives. Taking steps to ensure that these types of compounds don’t make it to the next stage of drug discovery can avoid wasted time and effort and ultimately lead to a more efficient and cost-effective drug discovery process.</p><img src="https://counter.theconversation.com/content/175972/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Martin Clasby receives funding from the National Institutes of Health and Michigan Drug Discovery. </span></em></p>While technological advancements have quickened the drug discovery process, some chemical compounds remain a common thorn in a researcher’s side.Martin Clasby, Research Assistant Professor of Medicinal Chemistry, University of MichiganLicensed as Creative Commons – attribution, no derivatives.