tag:theconversation.com,2011:/us/topics/prescription-1045/articlesPrescription – The Conversation2023-04-24T12:23:40Ztag:theconversation.com,2011:article/2016342023-04-24T12:23:40Z2023-04-24T12:23:40ZPrescription drugs’ fine print is important – a toxicologist explains how to decode package inserts to take medications safely and increase their effectiveness<figure><img src="https://images.theconversation.com/files/521891/original/file-20230419-14-q2jf4i.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2121%2C1412&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Package inserts contain information on the pharmacology of a drug.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/senior-woman-reading-package-insert-close-up-of-royalty-free-image/945662858">Kathrin Ziegler/DigitalVision via Getty Images</a></span></figcaption></figure><p><a href="https://www.kff.org/health-reform/issue-brief/data-note-prescription-drugs-and-older-adults/">Many adults</a> take prescription drugs, and usage rates are <a href="https://www.statista.com/statistics/238702/us-total-medical-prescriptions-issued/">continually increasing</a>. With <a href="https://www.cdc.gov/medicationsafety/adult_adversedrugevents.html">approximately 1.3 million emergency department visits</a> in the U.S. caused by adverse drug events each year, patient education is becoming increasingly important.</p>
<p>All prescription drugs come with instructions on how to safely and effectively use them. Depending on the medication, there may be <a href="https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/patient-labeling-resources">several types of information</a> included: the patient package insert, medication guide and instructions for use. One or more of these documents could be folded up in the box or attached as a printed page provided by your pharmacist.</p>
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<p><a href="https://www.engr.colostate.edu/cbe/people/brad-reisfeld/">I am a scientist</a> who studies how drugs and other chemicals affect human health. While they may look intimidating, package inserts – and particularly the prescribing information – can help patients better understand the science inside the pill bottle and blister pack, among others.</p>
<h2>What can I learn from package inserts?</h2>
<p>An often overlooked part of the package insert is the <a href="https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/prescribing-information-resources">prescribing information</a>. Though written primarily for health care professionals, it contains a wealth of information regarding the ways in which the medication interacts with the body.</p>
<p>If the prescribing information was not included with your prescription, you can often find a copy on the National Institutes of Health’s <a href="https://dailymed.nlm.nih.gov/dailymed/index.cfm">DailyMed website</a> or <a href="https://www.drugs.com">other drug information websites</a>.</p>
<p>As an example, let’s consider one of the <a href="https://clincalc.com/DrugStats/Drugs/Atorvastatin">most widely prescribed medications in the U.S.</a>, atorvastatin (Lipitor). Among other effects, it reduces elevated levels of cholesterol overall as well as levels of low-density lipoprotein cholesterol – LDL, or <a href="https://www.webmd.com/heart-disease/ldl-cholesterol-the-bad-cholesterol">“bad” cholesterol</a>.</p>
<p>Reading the insert can answer a few important questions about the drug. If you’d like to follow along, a copy of the prescription information for Lipitor <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020702s073lbl.pdf">can be found here</a>.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/522202/original/file-20230420-17-slnlgo.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Close-up of Lipitor prescription label" src="https://images.theconversation.com/files/522202/original/file-20230420-17-slnlgo.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/522202/original/file-20230420-17-slnlgo.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=350&fit=crop&dpr=1 600w, https://images.theconversation.com/files/522202/original/file-20230420-17-slnlgo.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=350&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/522202/original/file-20230420-17-slnlgo.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=350&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/522202/original/file-20230420-17-slnlgo.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=440&fit=crop&dpr=1 754w, https://images.theconversation.com/files/522202/original/file-20230420-17-slnlgo.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=440&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/522202/original/file-20230420-17-slnlgo.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=440&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">Atorvastatin (Lipitor) is one of the most commonly prescribed drugs in the U.S.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/prescription-bottle-label-of-pfizers-lipitor-known-as-news-photo/55908498">Tim Boyle/Getty Images</a></span>
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<h2>How does the drug work?</h2>
<p>To answer this question, you can refer to the “Mechanism of Action” and “Pharmacodynamics” subsections of the prescription insert.</p>
<p>The mechanism of action and pharmacodynamics are related concepts. The <a href="https://www.cancer.gov/publications/dictionaries/cancer-terms/def/mechanism-of-action">mechanism of action</a> describes the chemical and molecular interactions that cause a drug’s therapeutic or toxic effects. <a href="https://www.ncbi.nlm.nih.gov/books/NBK507791/">Pharmacodynamics</a> refers to “what the drug does to the body,” which includes the mechanism of action as well as how other factors like drug concentration influences its effects.</p>
<p>Often the mechanism of action of a drug is related to how it <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">interacts with cell receptors and enzymes</a> involved in mediating specific signals and biochemical reactions in the body.</p>
<p>In the case of Lipitor, the prescribing information tells us three important things about how the drug works. First, the liver is the primary site that produces cholesterol in the body and the area the drug is meant to target. Second, the drug works by inhibiting an enzyme involved in cholesterol production called <a href="https://www.ncbi.nlm.nih.gov/gene/3156">HMG-CoA reductase</a>. And third, the drug increases the number of LDL cholesterol receptors on cell surfaces, ultimately increasing the <a href="https://www.britannica.com/science/catabolism">catabolism</a>, or metabolic breakdown, of LDL cholesterol.</p>
<h2>Where does the drug go in my body?</h2>
<p>Before we answer this question, let’s start with some background information in the “Pharmacokinetics” subsection.</p>
<p><a href="https://www.ncbi.nlm.nih.gov/books/NBK557744/">Pharmacokinetics</a> can be thought of as “what the body does to the drug.” It focuses on four major processes the body undergoes in response to the chemical: absorption, or how the drug gets into the body; distribution, or how the drug is dispersed throughout the body; metabolism, or how the drug is converted into other chemical forms; and excretion, or how the drug is eliminated from the body.</p>
<p>The pharmacokinetics of a drug are <a href="https://theconversation.com/why-prescription-drugs-can-work-differently-for-different-people-168645">determined by factors</a> related to the chemical itself and the person taking the medication. For instance, disease state, age, sex and genetic makeup can all cause the same medication to work differently in different people.</p>
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<a href="https://images.theconversation.com/files/522203/original/file-20230420-18-4x8eyn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Two people read a package insert together with a weekly pill organizer on the table before them" src="https://images.theconversation.com/files/522203/original/file-20230420-18-4x8eyn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/522203/original/file-20230420-18-4x8eyn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=401&fit=crop&dpr=1 600w, https://images.theconversation.com/files/522203/original/file-20230420-18-4x8eyn.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=401&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/522203/original/file-20230420-18-4x8eyn.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=401&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/522203/original/file-20230420-18-4x8eyn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/522203/original/file-20230420-18-4x8eyn.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/522203/original/file-20230420-18-4x8eyn.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">Understanding what factors influence how a drug works in the body can aid in safer administration.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/senior-couple-medicating-at-home-royalty-free-image/1344980750">andreswd/E+ via Getty Images</a></span>
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<p>Now, let’s look at the “Distribution” subsection.</p>
<p>For Lipitor, the prescription insert does not specifically say where the drug goes in the body, but it does note that the <a href="https://www.ncbi.nlm.nih.gov/books/NBK545280/#article-31259.s1">volume of distribution</a> is 381 liters. The volume of distribution is the ratio of the amount of the drug in the body overall to its concentration in the blood. A value greater than about 30 liters suggests that the drug has <a href="https://www.merckmanuals.com/professional/clinical-pharmacology/pharmacokinetics/drug-distribution-to-tissues">entered body tissues</a> and is not confined to the bloodstream. For reference, the drug <a href="https://www.ncbi.nlm.nih.gov/books/NBK470313/">warfarin</a>, which prevents blood clots, is tightly bound to proteins in the blood and has a volume of distribution of only 8 liters. On the other hand, <a href="https://www.ncbi.nlm.nih.gov/books/NBK551512/">chloroquine</a>, an antimalarial drug that enters body fat, has a value of 15,000 liters. </p>
<h2>Does the drug cause the effects or its byproducts?</h2>
<p>Though the therapeutic effects of most drugs come from the chemical compound it’s made of, many break down into <a href="https://doi.org/10.1021/jm040066v">active metabolites</a> in the body that also have some relevant biological effects.</p>
<p>Some medications are administered in an <a href="https://doi.org/10.1038/nrd.2018.46">inactive form called a prodrug</a> that the body converts into metabolites with the desired therapeutic effects. Drugmakers generally use prodrugs because they have better pharmacokinetics – such as improved absorption and distribution in the body – than the active form of the drug.</p>
<p>In the case of Lipitor, the “Metabolism” subsection under “Pharmacokinetics” tells us that the drug is broken down into several products and that these metabolites contribute significantly to its therapeutic effect.</p>
<h2>How long will the drug be in my system?</h2>
<p>A key drug property to consider in this case is its <a href="https://www.ncbi.nlm.nih.gov/books/NBK554498/">half-life</a>, which is the length of time required for the concentration of the drug to decrease to half of its initial amount in the body. Information about a drug’s half-life is found in the “Excretion” subsection under “Pharmacokinetics.”</p>
<p>The half-life for Lipitor is approximately 14 hours. If you were to stop taking the medication, 97% of the drug would be gone from your blood after about three days, or five half-lives.</p>
<p>The prescription insert provides another interesting piece of information: because Lipitor’s active metabolites have a longer half-life than the drug itself, the half-life for its cholesterol enzyme inhibiting effects is 20 to 30 hours. This means that the drug’s effects may last even after the drug itself is out of your system.</p>
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<figcaption><span class="caption">Drugs can interact with one another and certain foods in harmful ways.</span></figcaption>
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<h2>Why do I need to take medications with food or at certain times?</h2>
<p><a href="https://theconversation.com/explainer-why-must-some-medications-be-taken-with-food-34649">Eating food</a> can change the amount and rate at which a drug is absorbed into the body in several ways, including changing the acidity of the digestive system, altering the release of bile and increasing blood flow to the gut.</p>
<p>For Lipitor specifically, the answer to this question can be found in the “Absorption” subsection under “Pharmacokinetics.” Food decreases the rate and extent of Lipitor’s absorption but doesn’t significantly affect LDL cholesterol reduction.</p>
<p>Interestingly, the insert also states that the blood concentration of the drug is significantly lower when taken in the evening than in the morning, but reduction in LDL cholesterol levels is the same regardless of when the drug is taken.</p>
<p>The upshot of all of this is written on the drug label on the outside of the package: Lipitor can be taken with or without food. Morning or evening is not specified, but the recommendation is to take it at the same time every day.</p>
<h2>Why does my doctor ask about other drugs I’m taking?</h2>
<p>Drugs can <a href="https://theconversation.com/watch-out-for-dangerous-combinations-of-over-the-counter-cold-medicine-and-prescription-drugs-two-pharmacoepidemiology-experts-explain-the-risks-195167">interact with one another</a> in ways that affect their safety and efficacy. For instance, two drugs may rely on the same enzyme system in the body to break them down. Taking them at the same time can ultimately lead to higher-than-anticipated levels of either or both drugs in the body.</p>
<p>Information to answer this question can be found in the “Drug Interactions” section. </p>
<p>One of the drug categories of concern for Lipitor are “strong inhibitors of CYP 3A4,” an enzyme that plays a key role in <a href="https://theconversation.com/why-prescription-drugs-can-work-differently-for-different-people-168645">metabolizing many drugs</a>. Because Lipitor itself is broken down by this enzyme, taking it alongside drugs that inhibit CYP 3A4, such as the antibiotic clarithromycin or the fungal infection drug itraconazole, can lead to its increased concentration in the blood and potentially result in adverse effects.</p><img src="https://counter.theconversation.com/content/201634/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Brad Reisfeld 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>Don’t be intimidated by the package insert that comes with your medication. Learning how to read it can help you better understand how drugs work.Brad Reisfeld, Professor of Chemical and Biological Engineering, Biomedical Engineering, and Public Health, Colorado State UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1671782021-09-02T05:27:41Z2021-09-02T05:27:41ZThinking of trying ivermectin for COVID? Here’s what can happen with this controversial drug<figure><img src="https://images.theconversation.com/files/419019/original/file-20210902-18-njx5bl.jpg?ixlib=rb-1.1.0&rect=1%2C1%2C997%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/clamart-france-august-22-2021-box-2028959327">Shutterstock</a></span></figcaption></figure><p>Westmead Hospital in Sydney’s west says it has treated a patient <a href="https://www.news.com.au/lifestyle/health/health-problems/westmead-hospital-patient-overdoses-on-online-cure-for-covid19/news-story/d5cc0998a98791af3b43bcaef42578b9">who overdosed</a> after taking the drug ivermectin, an unproven and potentially dangerous treatment for COVID-19.</p>
<p>The person went to hospital seeking treatment for diarrhoea and vomiting side-effects, after taking the drug, which is usually used to treat parasites. The person had ordered this and other unproven COVID “cures” online.</p>
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<p>While the patient did not die, <a href="https://www.tga.gov.au/covid-19-treatments-information-consumers-and-health-professionals">health authorities are concerned</a> at the number of people taking ivermectin, and warn against it for anyone else who may have COVID symptoms or has been diagnosed with the virus.</p>
<p>Other known ivermectin side-effects range from mild to the life-threatening, including seizures and coma.</p>
<h2>Why are people taking it?</h2>
<p>Ever since researchers showed ivermectin could kill SARS-CoV-2 (the virus that causes COVID-19) in the laboratory, there has been interest in whether the drug would also work to kill the virus <a href="https://theconversation.com/head-lice-drug-ivermectin-is-being-tested-as-a-possible-coronavirus-treatment-but-thats-no-reason-to-buy-it-135683">in the human body</a>.</p>
<p>So far, there is <a href="https://theconversation.com/a-major-ivermectin-study-has-been-withdrawn-so-what-now-for-the-controversial-drug-164627">no clinical evidence</a> it works to treat or prevent COVID-19. And there is widespread consensus people should not take ivermectin at home for COVID-19. </p>
<p>Organisations that recommend against it include: the <a href="https://www.who.int/news-room/feature-stories/detail/who-advises-that-ivermectin-only-be-used-to-treat-covid-19-within-clinical-trials">World Health Organization</a>, Australia’s <a href="https://covid19evidence.net.au/faqs/#Ivermectin">National COVID-19 Clinical Evidence Taskforce</a> and <a href="https://www.nps.org.au/ivermectin-and-covid-19">NPS Medicinewise</a>, the United State’s <a href="https://www.fda.gov/animal-veterinary/animal-health-safety-and-coronavirus-disease-2019-covid-19/cvm-letter-veterinarians-and-retailers-help-stop-misuse-animal-ivermectin-prevent-or-treat-covid-19">Food and Drug Administration</a>, and the <a href="https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD015017.pub2/full">Cochrane Library</a>.</p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/a-major-ivermectin-study-has-been-withdrawn-so-what-now-for-the-controversial-drug-164627">A major ivermectin study has been withdrawn, so what now for the controversial drug?</a>
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<h2>How are people getting hold of it?</h2>
<p>Despite this, <a href="https://www.theguardian.com/australia-news/2021/sep/01/australian-pharmacists-report-rise-in-customers-refusing-to-say-what-ivermectin-prescription-is-for">community pharmacists</a> have reported increased demand for ivermectin, with people seeking the drug as a possible COVID treatment.</p>
<p>In Australia, ivermectin is <a href="https://www.tga.gov.au/covid-19-treatments-information-consumers-and-health-professionals">approved to treat parasite infections in humans</a>. It’s also widely used in veterinary medicine to treat and prevent parasite infections.</p>
<p>However, as a prescription-only human medicine (known as <a href="https://www.healthdirect.gov.au/medicines/brand/amt,3069011000036101/stromectol">schedule 4</a>), you can only access ivermectin legally in Australia after approval from a doctor.</p>
<p>This is because, like all medicines, ivermectin is not 100% safe. It does have possible harmful side-effects and a doctor’s judgement is necessary to decide if ivermectin is safe and appropriate for each patient.</p>
<p>So ivermectin is currently only recommended to treat and prevent COVID-19 when used <a href="https://covid19evidence.net.au/faqs/#Ivermectin">as part of a clinical trial</a>, where patients can be more safely selected and carefully monitored.</p>
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<p>As well as more patients presenting to pharmacies with scripts, the Therapeutic Goods Administration <a href="https://www.tga.gov.au/media-release/risks-importing-ivermectin-treatment-covid-19">warns</a> about the danger of importing ivermectin products of unknown quality, bought over the internet.</p>
<p>This is risky because products may not contain the stated drug, may contain dangerous contaminants or much more of the drug than thought, which may result in an overdose.</p>
<p>Of most concern are reports from <a href="https://www.abc.net.au/radio/programs/worldtoday/warnings-against-ivermectin/13524184">Australia</a> and <a href="https://www.theguardian.com/commentisfree/2021/aug/31/a-human-is-not-a-horse-so-why-is-a-livestock-drug-sweeping-america-covid-ivermectin">overseas</a> of people buying and taking ivermectin products intended for animal use. People may be resorting to these types of products where they have been unable to access a script for human formulations of ivermectin.</p>
<h2>What does it do to your body?</h2>
<p>We know very little about what the drug does to humans, and the little we do know mostly comes from <a href="https://pubmed.ncbi.nlm.nih.gov/34149064/">its use in animals</a>.</p>
<p>When taken at the recommended dose, the drug is generally well tolerated. But ivermectin is known to cause mild side-effects such as diarrhoea, nausea, dizziness and sleepiness. Less common, but serious, side-effects include severe skin rashes and effects on the nervous system (causing tremor, confusion and drowsiness). </p>
<p>In higher doses, and overdose cases, these side-effects can be <a href="https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19">more severe</a>. These include low blood pressure, problems with balance, seizures, liver injury, and it can even <a href="https://www.nejm.org/doi/full/10.1056/NEJMc1917344">induce comas</a>.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/coronavirus-misinformation-is-a-global-issue-but-which-myth-you-fall-for-likely-depends-on-where-you-live-143352">Coronavirus misinformation is a global issue, but which myth you fall for likely depends on where you live</a>
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</em>
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<h2>The take-home message</h2>
<p>The public is understandably interested in medicines to treat and prevent COVID-19. However, <a href="https://theconversation.com/au/topics/covid-misinformation-103292">misinformation about ivermectin and others continues to circulate</a>. </p>
<p><a href="https://theconversation.com/how-well-do-covid-vaccines-work-in-the-real-world-162926">COVID-19 vaccination</a> remains the best way to reduce the risk of serious illness and death from COVID-19. Australia’s <a href="https://covid19evidence.net.au/">National COVID-19 Clinical Evidence Taskforce</a> provides the most up-to-date information about COVID-19 treatments and is a reliable source of information as new knowledge emerges.</p>
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<p><em>If you or a family member take ivermectin and have strong side-effects you should seek medical advice. Call the <a href="https://www.health.gov.au/contacts/poisons-information-centre">Poisons Information Centre</a> on 131 126. For life-threatening symptoms, call 000 for an ambulance.</em></p><img src="https://counter.theconversation.com/content/167178/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 Fellow of the Royal Australian Chemical Institute and a member of the Australasian Pharmaceutical Science Association. Nial is science director of the medicinal cannabis company Canngea Pty Ltd, a board member of the Australian Medicinal Cannabis Association, and a Standards Australia committee member for sunscreen agents.</span></em></p><p class="fine-print"><em><span>Andrew McLachlan receives research funding from the NHMRC and the Sydney Pharmacy School receives research scholarship funding from GSK for a PhD student under his supervision. Andrew has served as a paid consultant on Australian government committees related to medicines regulation. Andrew does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article.</span></em></p><p class="fine-print"><em><span>Slade Matthews has served the Australian Therapeutic Goods Administration as an external evaluator for the Therapeutic Goods Evaluation Panel. He also serves on the NSW Poisons Advisory Committee as the pharmacologist member. Slade does not work for, consult or own shares in or receive funding from any company of organisation that would benefit from this article.</span></em></p>Side-effects for this unproven and potentially dangerous treatment range from vomiting and diarrhoea to seizures and a coma.Nial Wheate, Associate Professor of the Sydney Pharmacy School, University of SydneyAndrew McLachlan, Head of School and Dean of Pharmacy, University of SydneySlade Matthews, Senior Lecturer, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1061632018-11-25T19:06:01Z2018-11-25T19:06:01ZAmbulance call-outs for pregabalin have spiked – here’s why<figure><img src="https://images.theconversation.com/files/246806/original/file-20181122-182071-2lpqex.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">At higher-than-prescribed doses, pregabalin causes sedation and euphoria.</span> <span class="attribution"><a class="source" href="https://unsplash.com/photos/i4rOpdj444c">Bruno van der Kraan</a></span></figcaption></figure><p>Pregabalin (sold under the brand name Lyrica) is prescribed as an anti-epileptic and a painkiller for nerve pain. Australian prescriptions of pregabalin have risen significantly in the past five years. It’s now in the <a href="https://www.nps.org.au/australian-prescriber/articles/top-10-drugs-2015-16">top ten most expensive medications for the Pharmaceutical Benefits Scheme</a> (PBS). </p>
<p>We’ve also seen a rise in “off-label” prescription of pregabalin. This means it’s being prescribed for conditions for which there is limited evidence of effectiveness. Pregabalin is <a href="https://www.nejm.org/doi/full/10.1056/NEJMp1704633">often prescribed</a> for chronic or persisting pain, for example, even when there is no clear nerve-related cause. </p>
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<a href="https://theconversation.com/explainer-why-are-off-label-medicines-prescribed-44783">Explainer: why are off-label medicines prescribed?</a>
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<p>Pregabalin is thought to have effects in the brain similar to those of benzodiazepines such as diazepam (Valium) by indirectly increasing levels of the neurotransmitter GABA. </p>
<p>Until recently, researchers and doctors <a href="https://europepmc.org/abstract/med/24849194">did not think pregabalin was addictive</a>. But now studies suggest pregabalin may also have an indirect effect on the brain’s reward chemical, dopamine. </p>
<p>Our research, published today in the <a href="https://www.mja.com.au/">Medical Journal of Australia</a>, shows ambulance call-outs associated with the misuse of pregabalin have increased tenfold in Victoria since 2012. This mirrors an increase in prescription rates.</p>
<h2>Growing evidence of misuse</h2>
<p>In 2010, the <a href="https://link.springer.com/article/10.1007/s00228-010-0853-y">first study</a> was published that reported on a trend of pregabalin misuse. </p>
<p>Since then, several <a href="https://link.springer.com/article/10.1007/s40263-014-0164-4">international research articles</a> have documented misuse, including <a href="https://link.springer.com/article/10.1007/s40265-017-0700-x">using higher doses than are recommended</a>. At higher-than-prescribed doses, pregabalin causes sedation and euphoria.</p>
<p>People who use opioids – painkillers like oxycodone, or illicit opioids such as heroin – have a particularly <a href="https://link.springer.com/article/10.1007/s40263-014-0164-4">high risk</a> of misusing pregabalin. So do those with a history of substance use problems. </p>
<p>People who use illicit drugs report often using pregabalin in combination with other drugs. Pregabalin <a href="https://link.springer.com/article/10.1007/s40263-014-0164-4">has been implicated</a> in drug-related deaths in individuals who weren’t prescribed the medication, and often in combination with other sedative medications or illicit drugs. </p>
<p>High rates of pregabalin use are also reported in secure environments, such as prisons, in both <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4657313/pdf/austprescr-38-160.pdf">Australia</a> and <a href="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/385791/PHE-NHS_England_pregabalin_and_gabapentin_advice_Dec_2014.pdf">the United Kingdom</a>. </p>
<h2>What did we find?</h2>
<p>We analysed a unique database (<a href="https://www.turningpoint.org.au/research/population-health">the Ambo Project</a>) that documents all ambulance attendances related to alcohol and drug use and mental health in Victoria. </p>
<p>We found pregabalin-related ambulance attendances increased tenfold between 2012 and 2017, from 0.28 cases per 100,000 population to 3.32 cases per 100,000. Pregabalin misuse contributed significantly to 1,201 call-outs from 2012 to 2017. </p>
<p>Pregabalin has a sedative effect, which can be compounded when used with other drugs that cause sedation, including alcohol, or other prescribed medications such as benzodiazepines and sleeping tablets (such as Valium). </p>
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Read more:
<a href="https://theconversation.com/despite-escalating-prescriptions-nerve-pain-drug-offers-no-relief-for-sciatica-74699">Despite escalating prescriptions, nerve pain drug offers no relief for sciatica</a>
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<p>More than two-thirds of pregabalin-related ambulance call-outs were for people who also used other sedatives. Almost 90% required transport to hospital. In some situations, such sedation could be life-threatening.</p>
<p>Our findings of rising harms, especially from co-use with other drugs, echo findings from a <a href="https://onlinelibrary.wiley.com/doi/abs/10.1111/add.14412">New South Wales</a> research group that used data from poisons hotline calls, hospital admissions, and coronial reports from drug-related deaths. </p>
<h2>How to reduce the harms</h2>
<p>Doctors need to ensure patients are provided with the opportunity for careful and considered informed consent.</p>
<p>Pregabalin is a high-risk medication, especially when used with other sedatives. Although some doctors are aware of the side effects and harms associated with pregabalin, many are not. </p>
<p>The <a href="https://www.racgp.org.au/yourracgp/faculties/queensland/newsletter/september-2018/">Royal College of General Practitioners recently warned doctors</a> to carefully assess the risks when prescribing these medications, particularly for people who are also prescribed opioids or benzodiazepines. <a href="https://www.nps.org.au/news/gabapentinoid-misuse-an-emerging-problem">NPS MedicineWise</a> also recently highlighted the need for prescribers to exercise caution.</p>
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Read more:
<a href="https://theconversation.com/health-check-why-can-you-feel-groggy-days-after-an-operation-74989">Health Check: why can you feel groggy days after an operation?</a>
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<p>Better regulation is also needed. </p>
<p>Some Australian states including Victoria plan to implement <a href="https://www2.health.vic.gov.au/public-health/drugs-and-poisons/safescript">real-time prescription monitoring (RTPM)</a>. This would allow authorities to monitor and regulate access to high-risk medications such as opioid painkillers (oxycodone or similar) or benzodiazepines. </p>
<p>But pregabalin is not on the list of medications that will be captured by real-time prescription monitoring. To reduce the high risk of harm from pregabalin misuse, we should consider adding this drug to the list.</p>
<p>In the United Kingdom, pregabalin will become a “scheduled” or <a href="https://www.bmj.com/content/363/bmj.k4364">controlled medication</a> from April 2019. This means doctors will need to apply for a permit before prescribing it. </p>
<p>If this is found to be successful, Australia should consider following suit.</p><img src="https://counter.theconversation.com/content/106163/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>We would like to acknowledge the contribution of our co-authors Karen Smith, Debbie Scott and Paul Dietze. Thanks to Ambulance Victoria for providing the data and the Population Health team at Turning Point who code it to create this unique data set.
Shalini Arunogiri has previously received a scholarship from the National Health and Medical Research Council (NHMRC), and the Society for Mental Health Research (SMHR).
</span></em></p><p class="fine-print"><em><span>Dan Lubman has received funding from the National Health and Medical Research Council, the Australian Research Council, beyondblue, Movember, Victorian Department of Health and Human Services, Commonwealth Department of Health, Victorian Gambling Research Foundation and the Victorian Health Promotion Foundation. He has also received speaking honoraria from AstraZeneca, Indivior, Janssen, Servier, Shire and Lundbeck and has provided consultancy advice to Lundbeck and Indivior. </span></em></p><p class="fine-print"><em><span>Rose Crossin has previously received an RTP scholarship from the Australian Department of Education and Training. </span></em></p>Ambulance call-outs associated with the misuse of pregabalin (Lyrica) have increased tenfold in Victoria since 2012, mirroring an increase in prescription rates.Shalini Arunogiri, Addiction Psychiatrist, Lecturer, Monash UniversityDan Lubman, Director, Turning Point Alcohol and Drug Centre & Professor of Addiction Studies, Monash UniversityRose Crossin, Research Officer in Addiction Studies , Monash UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/935222018-04-13T13:49:21Z2018-04-13T13:49:21ZRepeat prescriptions are expensive and time consuming – it’s time for an NHS rethink<figure><img src="https://images.theconversation.com/files/211738/original/file-20180323-54863-99b0bv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">And repeat.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/drug-prescription-treatment-medication-pharmaceutical-medicament-544348294?src=Pt2C-eiYews1VpI5kIYHZA-1-33">Shutterstock</a></span></figcaption></figure><p>Over a billion NHS prescription medicines are issued by pharmacists in England every year – at a <a href="https://digital.nhs.uk/catalogue/PUB23631">cost of over £9 billion</a>. Many of these are prescribed by GPs to manage long-term health conditions, such as diabetes or cardiovascular disease.</p>
<p>The current “repeat prescription” system allows patients to request a further supply of medicines without the inconvenience of another doctor’s appointment. </p>
<p>The <a href="http://webarchive.nationalarchives.gov.uk/+/www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/Browsable/DH_4892136">UK Department of Health advises</a> that the frequency of repeat prescriptions should “balance patient convenience with clinical appropriateness, cost-effectiveness and patient safety”. </p>
<p>However, it does not recommend a specific time period. As a result, local health service commissioners have developed their own guidance, with many encouraging GPs to issue short-term supplies of repeat medications, typically 28 days in length. This is supported by the UK’s <a href="http://psnc.org.uk/services-commissioning/psnc-briefings-services-and-commissioning/psnc-briefing-05416-medicines-wastage-and-prescription-duration-october-2016/">Pharmaceutical Services Negotiating Committee</a>.</p>
<p>One of the key reasons for issuing monthly supplies is the opportunity to reduce medication waste, which has been previously estimated to cost the NHS <a href="https://www.bristolccg.nhs.uk/media/medialibrary/2016/02/Report_Medicines_Waste_in_Bristol.pdf">around £300m a year</a> in England alone. If patients have fewer pills in their possession, it is harder to mislay or stockpile them. </p>
<p>It is also possible that fairly frequent contact with the doctor may aid the discovery of potential drug intolerance, and provide more chances for medication review.</p>
<p>But is this approach the right one? From the perspective of patients, shorter prescriptions also mean more opportunities to forget to reorder supplies, and often necessitate additional trips to the GP and pharmacy. </p>
<p>Time and effort spent dispensing pills in community pharmacies is also considerable, and arguably an inefficient use of pharmacists’ valuable skills. Shorter prescription time frames exacerbate this. The workload for GPs authorising further prescriptions can also be substantial.</p>
<p>Our <a href="https://njl-admin.nihr.ac.uk/document/download/2011885">recent research</a> challenges the current practice of shorter repeat prescriptions. We identified evidence from <a href="https://bjgp.org/content/early/2018/03/12/bjgp18X695501">nine reports</a> suggesting that longer duration prescriptions are associated with better adherence by patients to their medications (in other words, patients are more likely to take their pills the way the doctor intended). </p>
<p>A <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3534845/">single American study</a> of statins, a drug commonly prescribed to patients with cardiovascular disease, even found improvements in lipid control with longer term prescriptions. (However, other studies examining health outcomes or patient experience were lacking.)</p>
<p>In analysing 11 years of UK <a href="http://bmjopen.bmj.com/content/7/12/e019382">GP prescribing data</a>, we found that shorter prescriptions were indeed associated with reduced medication waste. But those savings were more than offset by greater costs due to the additional work required by GPs and pharmacists. </p>
<p>Consider, for example, the impact of switching statins – the most widely prescribed drugs in UK primary care – to longer durations of around three months. This has the potential to save over £500m per year in doctor and pharmacist time – precious GP time which could be ploughed back into a struggling health service, seeing patients rather than signing bits of paper. </p>
<p>One could argue that the growth of electronic repeat dispensing, where GPs can authorise multiple repeat prescriptions at a time, could help deal with this issue. But there is still the opportunity for over £60m in savings through reduced dispensing costs for these drugs alone. </p>
<p>An <a href="https://link.springer.com/article/10.1007%2Fs40258-018-0383-9">economic modelling exercise</a> found longer term prescriptions to be more cost-effective than shorter ones, driven primarily through health gains due to better medication adherence. </p>
<p>Medications are a daily part of the lives of millions, and in many cases unavoidable. Yet the current recommendations that require patients to make monthly trips to pick up more pills are simply not justified by the evidence. </p>
<p>There is the potential for longer prescriptions to lead to important benefits, by improving patients’ adherence and thus the effectiveness of the drugs, lessening workload for health care professionals, and reducing inconvenience and costs to patients.</p>
<h2>A bitter pill?</h2>
<p>News that issuing longer prescriptions is more cost effective is likely to be welcomed by most GPs. But pharmacists may be less enthusiastic. </p>
<p>Community pharmacies receive dispensing fees for each NHS prescription, so reducing the frequency could lead to a large reduction in income. The NHS may save money, but critical pharmacy services could suffer. Changes to national policy around the length of repeat prescriptions would therefore need to consider how pharmacies are reimbursed. </p>
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<img alt="" src="https://images.theconversation.com/files/214249/original/file-20180411-570-819oki.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/214249/original/file-20180411-570-819oki.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/214249/original/file-20180411-570-819oki.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/214249/original/file-20180411-570-819oki.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/214249/original/file-20180411-570-819oki.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/214249/original/file-20180411-570-819oki.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/214249/original/file-20180411-570-819oki.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">
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<span class="caption">What if the drugs don’t work?</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/newbury-berkshire-england-november-3-2017-755878630?src=pTc5K-y3YVlW_UbMQZXYIQ-1-4">Shutterstock</a></span>
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<p>Simply increasing the dispensing fee will not be straightforward, as some drugs may be more suitable for switching to longer prescriptions than others. It may not be possible, either, to recommend a new, standardised, longer prescription length. </p>
<p>Further research is likely to show that the one-size-fits-all model of 28 day blanket prescription policy is unsustainable. Different conditions, drugs and patient profiles may require different prescription lengths. </p>
<p>There are undoubtedly limitations to the work we have carried out so far, and it is necessary to make assumptions about the degree to which improvements in adherence lead to health gains – although evidence <a href="http://www.nejm.org/doi/full/10.1056/NEJMra050100">suggests a clear link</a>. </p>
<p>The only way to provide a definitive answer to this question is to conduct a clinical trial. This is a potentially significant challenge that would require strong support from practices and service commissioners. Given patients frequently report irritation in the process of ordering regular medications, a trial would also offer the opportunity to compare and contrast the “customer” experience.</p>
<p>Until then, we must accept that the evidence does not support the current 28 day prescribing policy. The NHS needs to reconsider its approach – both to reduce costs and improve patient care.</p><img src="https://counter.theconversation.com/content/93522/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Rupert Payne receives funding from the National Institute for Health Research. </span></em></p><p class="fine-print"><em><span>Céline Miani was involved in research projects funded by the National Institute for Health Research.</span></em></p>Current guidance is not leading to cost-effective practice.Rupert Payne, Consultant Senior Lecturer in Primary Health Care, University of BristolCéline Miani, Junior research group leader, Social epidemiology, Bielefeld UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/816012017-10-05T00:56:11Z2017-10-05T00:56:11ZThe opioid epidemic in 6 charts<figure><img src="https://images.theconversation.com/files/188871/original/file-20171004-11777-9931ii.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Michelle Holley holds a photograph of her daughter Jaime Holley, 19, who died of a heroin overdose in November 2016.</span> <span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Opioids-Cycle-Of-Fraud/d3321ee9fb0d40e9b0c551e5d743fd1f/1/1">Lynne Sladky/AP Photo</a></span></figcaption></figure><p>Drug overdose deaths, once rare, are now <a href="https://www.nytimes.com/interactive/2017/09/02/upshot/fentanyl-drug-overdose-deaths.html?_r=0">the leading cause</a> of accidental death in the U.S., surpassing peak annual deaths caused by motor vehicle accidents, guns and HIV infection.</p>
<p>As a former public health official, clinician and researcher, I’ve been engaged in efforts to control the opioid addiction epidemic for the past 15 years. </p>
<p>The data show that the situation is dire and getting worse. Until opioids are prescribed more cautiously and until effective opioid addiction treatment becomes easier to access, overdose deaths will likely remain at record high levels.</p>
<h1>How the crisis started</h1>
<p>Opioids are drugs that stimulate the brain’s opiate receptors. Some are made from opium and some are completely synthetic. In the U.S., the most commonly prescribed opioids are hydrocodone and oxycodone, which are classified as semi-synthetic because they are synthesized from opium. Heroin is also a semi-synthetic opioid. The effects of hydrocodone and oxycodone on the brain are indistinguishable from the <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3787689/">effects produced by heroin</a>. </p>
<p>Opioids are essential medicines for palliative care. They are also helpful when used for a couple of days after major surgery or a serious accident. Unfortunately, <a href="http://annals.org/aim/article/2646632/prescription-opioid-use-misuse-use-disorders-u-s-adults-2015">the bulk of the opioid prescriptions</a> in the U.S. are for common conditions, like back pain. </p>
<p>In these cases, opioids are more likely to harm patients than help them because the risks of long-term use, such as addiction, outweigh potential benefit. Opioids have not been proven effective for daily, long-term use. Evidence suggests that chronic use of opioids can even make pain worse, a phenomenon called <a href="https://books.google.com/books?hl=en&lr=&id=_VrvBQAAQBAJ&oi=fnd&pg=PP1&dq=opioid+hyperalgesia&ots=D2aeoQx3T3&sig=TZVXFcavoT5xbd0pOomTurcAhxE#v=onepage&q=opioid%20hyperalgesia&f=false">hyperalgesia</a>. </p>
<p>Over the last two decades, as prescriptions for opioids began to soar, rates of addiction and overdose deaths increased in parallel. </p>
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<p>The increase in opioid prescription was fueled by a <a href="http://archive.jsonline.com/watchdog/watchdogreports/painkiller-boom-fueled-by-networking-dp3p2rn-139609053.html/">multifaceted campaign</a> underwritten by pharmaceutical companies. Doctors heard from their professional societies, their hospitals and even from state medical boards that patients were suffering needlessly because of an overblown fear of addiction. </p>
<p>The campaign minimized opioid risks and exaggerated the benefits of using opioids over the long term for chronic pain. Several states and counties have recently filed <a href="https://theconversation.com/a-look-inside-ohios-lawsuit-against-opioid-manufacturers-79322">lawsuits against opioid manufacturers</a> for the role they played in causing the opioid addiction epidemic by misleading the medical community.</p>
<h1>The rise of heroin</h1>
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<p>Until 2011, most opioid overdose deaths involved prescription opioids. Then prescription opioid overdose deaths leveled off, while overdose deaths involving heroin began to soar. </p>
<p>Why did this happen? A common misconception is that so-called “drug abusers” suddenly switched from prescription opioids to heroin due to a federal government “crackdown” on painkillers. </p>
<p>There is a kernel of truth in this narrative. It’s true that the vast majority of people who started using heroin after 1995 switched from prescription opioids because heroin was easier to obtain. But heroin use among young whites has been increasing since before 2011. From the beginning of the opioid crisis, young adults who became addicted to prescription opioids would <a href="https://source.wustl.edu/2014/05/drug-users-switch-to-heroin-because-its-cheap-easy-to-get/">switch to heroin</a>, a less expensive option. </p>
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<a href="https://images.theconversation.com/files/188639/original/file-20171003-31723-15njcpn.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/188639/original/file-20171003-31723-15njcpn.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/188639/original/file-20171003-31723-15njcpn.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=351&fit=crop&dpr=1 600w, https://images.theconversation.com/files/188639/original/file-20171003-31723-15njcpn.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=351&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/188639/original/file-20171003-31723-15njcpn.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=351&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/188639/original/file-20171003-31723-15njcpn.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=442&fit=crop&dpr=1 754w, https://images.theconversation.com/files/188639/original/file-20171003-31723-15njcpn.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=442&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/188639/original/file-20171003-31723-15njcpn.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=442&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="attribution"><a class="source" href="https://www.samhsa.gov/data/sites/default/files/2014_Treatment_Episode_Data_Set_National_Admissions_9_19_16.pdf">Substance Abuse and Mental Health Services Administration</a></span>
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<p>As young people switched to heroin, the heroin supply also became more dangerous. This caused the sharp increase in heroin overdose deaths in 2011. Increasingly, <a href="https://www.cdc.gov/mmwr/volumes/66/wr/mm6634a2.htm">fentanyl</a>, a potent and inexpensive synthetic opioid, was <a href="https://theconversation.com/fentanyl-widely-used-deadly-when-abused-60511">mixed with heroin</a> or sold as heroin. </p>
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<p>Until 2013, medical examiners didn’t routinely test heroin overdose victims for the presence of fentanyl, but once they did, an alarming trend appeared. Preliminary data indicate that, in 2016, <a href="https://www.nytimes.com/interactive/2017/09/02/upshot/fentanyl-drug-overdose-deaths.html">deaths involving fentanyl</a> surpassed deaths involving prescription opioids and heroin. </p>
<h1>Treating the crisis</h1>
<p>There’s another reason not to believe the narrative about a “crackdown” on painkillers leading to a sudden shift to heroin: There hasn’t been a crackdown on prescription opioids. Despite some slowdown, the medical community continues to overprescribe opioids.</p>
<p>In fact, U.S. per capita opioid consumption is much higher than other developed nations. Our oxycodone consumption has started to decline, but it remains much higher than oxycodone consumption in Europe.</p>
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<p>To bring the opioid addiction epidemic under control, the medical community must be more cautious about prescribing opioids. Federal and state governments also have to ensure that the millions of Americans now suffering from opioid addiction can access effective addiction treatment.</p>
<p>Buprenorphine and methadone maintenance – also known as medication-assisted treatment – are preferred <a href="http://www.bmj.com/content/357/bmj.j1550">treatments for opioid addiction</a>. When patients with addiction take these medications, they are able to function and have an improved quality of life. These treatments also reduce the risk of overdose death and injection-related infectious diseases.</p>
<p>Buprenorphine is safer than methadone and other opioids, so it can be prescribed from a doctor’s office. Methadone maintenance is administered under supervision in clinics that patients visit daily. </p>
<p>Unfortunately, many patients are <a href="http://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2016/02/11/waiting-lists-grow-for-medicine-to-fight-opioid-addiction">unable to access these treatments</a>. Despite a sharp rise in opioid addiction over the past decade, there has been only a slight increase in referrals for medication-assisted treatment in state-licensed drug treatment programs. Patients who are able to obtain treatment with buprenorphine must often visit <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5473522/">private practice physicians</a> who don’t accept commercial insurance or Medicaid. </p>
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<p>Until effective treatment for opioid addiction is easier to access than opioid painkillers, heroin or fentanyl, opioid overdose deaths are likely to remain at record high levels.</p><img src="https://counter.theconversation.com/content/81601/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Andrew Kolodny receives funding from the United States Food and Drug Administration for research on prescription drug monitoring programs. He is also the director of Physicians for Responsible Opioid Prescribing, a nonprofit group with a mission to reduce opioid-related morbidity and mortality caused by opioid overprescribing.
</span></em></p>Your guide to a public health crisis that’s likely to get worse.Andrew Kolodny, Co-Director of Opioid Policy Research, Brandeis UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/826232017-08-28T02:44:58Z2017-08-28T02:44:58ZThe opioid epidemic is finally a national emergency – eight years too late<figure><img src="https://images.theconversation.com/files/183347/original/file-20170824-18740-l5137a.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">People without ID, like Steven Kemp, are sometimes turned away from the country's already threadbare system of drug treatment centers.</span> <span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/APTOPIX-Addicted-Without-ID/adcb4b23ab414c9dba8220d049ded453/25/0">Matt Rourke/AP Photo</a></span></figcaption></figure><p>“It has been many long, hard, agonizing battles for the last few years and you fought like a warrior every step of the way. Addiction, however, won the war. To the person who doesn’t understand addiction, she is just another statistic who chose to make a bad decision.”</p>
<p>Despite working nearly two decades as an addiction scientist, I cannot read <a href="https://www.facebook.com/notes/kathleen-errico/kelsey-grace-endicott-eulogy/10154023124488818/">Kelsey Grace Endicott’s mother’s eulogy</a> without crying. The opioid epidemic has turned those who lost their lives to addiction into statistics, while leaving their families in sorrow. </p>
<p>Overdose deaths in the U.S. have tripled since 2000, with 52,404 deaths in 2015 as the highest ever recorded. While the Centers for Disease Control and Prevention (CDC) has yet to release official statistics for 2016, <a href="https://www.nytimes.com/interactive/2017/06/05/upshot/opioid-epidemic-drug-overdose-deaths-are-rising-faster-than-ever.html">early estimates</a> put the number of deaths at as many as 65,000.</p>
<p>In a speech on October 26, President Trump declared the opioid epidemic a national emergency. Nearly a decade into this epidemic, this national emergency was declared at least eight years too late. Policymakers have missed opportunities to implement strategies scientifically demonstrated to reduce overdose deaths and help people recover.</p>
<p>His announcement was vague on details and did not specify how much money would be dedicated to reducing overdose deaths. The President restated many initiatives that have already been initiated and focused on supply-reduction efforts that, while important, do little for the millions of Americans who are struggled with opioid addiction. We have proven prevention and treatment services that we need to significantly expand, and states need the money to do this. </p>
<h1>The right treatments</h1>
<p>Declaring the opioid epidemic a <a href="http://www.npr.org/sections/health-shots/2017/08/11/542767898/president-trump-to-declare-national-opioid-emergency">national emergency</a> expands the availability of federal funding; frees up public health workers to address the issue; and makes it possible to remove regulatory barriers to lifesaving medications. </p>
<p><a href="http://wchstv.com/news/raw-news/raw-news-sessions-addresses-opioid-problems-at-west-virginia-summit">In a speech on May 11</a>, Attorney General Jeff Sessions suggested that tools like “Just Say No” and Drug Abuse Resistance Education (DARE) can help fight the opioid epidemic. </p>
<p>However, <a href="https://www.ncbi.nlm.nih.gov/pubmed/10450631">addiction science</a> has repeatedly proven that such drug prevention programs are <a href="https://www.scientificamerican.com/article/why-just-say-no-doesnt-work/">ineffective</a>. Some would argue that we are biologically wired to try new things, so education alone is not sufficient to prevent repeated drug use. </p>
<p>Prevention efforts are part of the solution, but we need more immediate solutions for people already ensnared by addiction. <a href="http://www.huffingtonpost.com/entry/naloxone_b_1475812.html">Naloxone</a>, known by the brand name Narcan, is usually the only thing that can prevent death when someone has overdosed on opioids. Science has <a href="http://www.nejm.org/doi/full/10.1056/NEJMra1202561">unequivocally demonstrated</a> that naloxone can reverse an opioid overdose, if administered in time and in an adequate dose. </p>
<p>When patients with opioid use disorders are treated with FDA-approved medications like methadone and buprenorphine, they not only reduce their use of opioids but they are also less likely to overdose. When these drugs are used to treat addiction, they are referred to as medication-assisted treatment. Medication-assisted treatment helps many people, particularly early in recovery, when otherwise their brains seem to focus only on using more drugs. In fact, <a href="http://ctndisseminationlibrary.org/protocols/ctn0030.htm">a National Institute on Drug Abuse study</a> found that only about 7 percent of patients can stop using opioids without buprenorphine.</p>
<p>We need drugs like naloxone and buprenorphine to prevent deaths and help people recover from addiction. In the past few years, state governments have taken significant steps to remove regulatory barriers and expand community access to naloxone.</p>
<p>But policies are infrequently aligned with addiction science. In 2015, only 11 percent of <a href="https://www.samhsa.gov/data/sites/default/files/report_2716/ShortReport-2716.pdf">people who needed addiction treatment</a> received it. There are not enough medication-assisted treatment treatment slots available: A recent study estimated that the U.S. was short 1.3 million treatment slots for medication-assisted treatment in 2012. Demand has <a href="http://ajph.aphapublications.org/doi/pdf/10.2105/AJPH.2015.302664">only increased since then</a>. </p>
<p>There is an entrenched belief that people choose to use drugs and that this choice reflects a moral failing. Even the director of the U.S. Department of Health and Human Resources – which cites medication-assisted treatment as part of its strategy – <a href="https://www.hhs.gov/about/news/2017/06/19/sec-price-meets-opioid-addiction-specialists-providers-and-treatment-facilities-stakeholders-readout.html">has been quoted saying</a>: “If we’re just substituting one opioid for another, we’re not moving the dial much.”</p>
<h1>Moving too slowly</h1>
<p>Early on, everyone believed that the epidemic was fueled by widely available <a href="http://www.latimes.com/opinion/op-ed/la-oe-hari-prescription-drug-crisis-cause-20170112-story.html">prescription pain relievers</a>. Books like <a href="http://johntemplebooks.com/books/american-pain/">“American Pain”</a> by John Temple described “drug tourists” routinely traveling from states like Kentucky and West Virginia to Florida, where millions of prescription pills were dispensed at “pill mills.” </p>
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<p>Such overprescribing and doctor-shopping <a href="https://www.cdc.gov/drugoverdose/pdf/hhs_prescription_drug_abuse_report_09.2013.pdf">did contribute</a> to the current epidemic. States <a href="https://www.cdc.gov/media/releases/2017/p0706-opioid.html">have been successful</a> at dispensing fewer prescription opioids, but this doesn’t help the nearly 2.6 million Americans <a href="https://www.samhsa.gov/data/sites/default/files/NSDUH-FFR1-2015/NSDUH-FFR1-2015/NSDUH-FFR1-2015.pdf">already addicted</a>, or the 329,000 who report currently using heroin. </p>
<p>And, since 2014, it has become clear that the epidemic is no longer just about prescription opioids. In addition, heroin is frequently mixed or substituted with <a href="http://www.herald-dispatch.com/_recent_news/dealer-behind-huntington-s-overdoses-sentenced-to-years-in-prison/article_4e22304c-2398-11e7-bcd1-97ce0311d81c.html">powerful synthetic opioids</a> like fentanyl or carfentanil. They require far more of the overdose reversal drug naloxone than is routinely dispensed in communities.</p>
<p>Meanwhile, in <a href="http://www.npr.org/2017/06/29/534916080/ohio-town-struggles-to-afford-life-saving-drug-for-opioid-overdoses">poor and rural areas</a>, community resources for public services are being <a href="https://www.nbcnews.com/news/us-news/too-many-bodies-ohio-morgue-so-coroner-gets-death-trailer-n733446">exhausted</a> by the costs of the epidemic.</p>
<p>Areas that have been disproportionately impacted by the epidemic, like West Virginia, have woefully inadequate access to harm-reduction services like syringe exchange programs and specialty addiction treatment. A clinic at our university that dispenses buprenorphine has more than 600 people on its waiting list. We will soon open a second clinic that will help reduce but not eliminate the waiting list. </p>
<p>A bill passed by President Obama, <a href="https://www.samhsa.gov/newsroom/press-announcements/201612141015">the 21st Century Cures Act</a>, is making approximately US$1 billion in funding available to help states combat the opioid epidemic. But, as <a href="https://www.vox.com/science-and-health/2017/8/1/15746780/opioid-epidemic-end">Dr. Keith Humphreys at Stanford University</a> has said: This is not enough. We likely need <a href="https://www.nytimes.com/2017/06/30/health/drug-treatment-opioid-abuse-heroin-medicaid.html?mcubz=1">50 times that</a>, as Ohio spent $1 billion in 2016 on the opioid epidemic. </p>
<h1>Fighting back</h1>
<p>It can be hard to grasp the devastation of the opioid epidemic. As the President’s Commission on Combating Drug Addiction and the Opioid Crisis <a href="https://www.whitehouse.gov/sites/whitehouse.gov/files/ondcp/commission-interim-report.pdf">has described it</a>, in the scale of deaths, it’s like the September 11 terrorist attacks happening every three weeks. A national emergency would have been declared 10 years ago if such a disaster occurred every three weeks. And it can be even harder to imagine the emotional turmoil and the depth of sorrow felt by the families who’ve lost their daughters, sons, brothers, sisters, mothers and fathers. </p>
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<a href="https://images.theconversation.com/files/183346/original/file-20170824-28045-3by7iw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/183346/original/file-20170824-28045-3by7iw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/183346/original/file-20170824-28045-3by7iw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=408&fit=crop&dpr=1 600w, https://images.theconversation.com/files/183346/original/file-20170824-28045-3by7iw.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=408&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/183346/original/file-20170824-28045-3by7iw.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=408&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/183346/original/file-20170824-28045-3by7iw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=512&fit=crop&dpr=1 754w, https://images.theconversation.com/files/183346/original/file-20170824-28045-3by7iw.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=512&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/183346/original/file-20170824-28045-3by7iw.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=512&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">Joe Fitzpatrick looks at a portrait of his daughter, Molly, at an exhibit honoring those who have died in New Hampshire’s opioid epidemic.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Angels-of-Addiction/90769b4151664523b3effc0158f9c704/23/0">Holly Ramer/AP Photo</a></span>
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</figure>
<p>I think it’s fair to say that we all want a simple solution – something that we can wrap our arms around. Something that can be done in one legislative session. But that has not worked and it will not work, just as declaring a national emergency is not enough. </p>
<p>Addiction scientists know what needs to be done to turn the tide. While we may not understand every aspect of the epidemic and certainly need more research to understand these <a href="https://www.brookings.edu/bpea-articles/mortality-and-morbidity-in-the-21st-century">deaths of despair</a>, we are eager to collaborate with communities to find empirically informed solutions, such as medication-assisted treatment. The President’s <a href="https://www.whitehouse.gov/ondcp/presidents-commission/members">Commission on Combating Drug Addiction and the Opioid Crisis</a> consists of four politicians and one addiction scientist. It might help to start by asking an expert, rather than politicians, what should be done.</p>
<p><em>This is an updated version of an article originally published on August 27, 2017.</em></p><img src="https://counter.theconversation.com/content/82623/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Erin Winstanley receives funding from the Hilton Foundation, CDC, and NIH. </span></em></p>President Trump declared the opioid epidemic a national emergency. But we need to do a lot more to prevent this crisis from escalating even further.Erin Winstanley, Associate Professor of Pharmacy, West Virginia UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/603002016-06-21T10:01:02Z2016-06-21T10:01:02ZTo fight antibiotic resistance, we need to fight bad prescribing habits<figure><img src="https://images.theconversation.com/files/126555/original/image-20160614-22388-nb92ko.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">shutterstock</span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-432400009/stock-photo-antibiotic-resistance-concept-antibiotic-resistance-is-one-of-the-most-important-worldwide.html?src=kAi8ZzwIV4O9C_Bj-JkHug-1-0">Antibiotics image via www.shutterstock.com.</a></span></figcaption></figure><p>May’s announcement that a strain of bacteria <a href="http://www.cnn.com/2016/05/26/health/first-superbug-cre-case-in-us/">with genes conferring resistance</a> to colistin, our antibiotic of last resort, was identified in the United States, is just the latest report highlighting the growing threat of antibiotic resistance. </p>
<p>Antibiotic resistance is driven by many factors, the most significant of which is <a href="http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6432a3.htm">inappropriate prescribing</a>. This is when patients get a prescription for an antibiotic that they don’t really need, or get a prescription for the wrong antibiotic, the wrong dose or the wrong duration. And doctors know that inappropriate prescribing feeds the problem. So why do they keep doing it?</p>
<p>As a clinical pharmacist who has studied antimicrobial resistance and developed intervention programs to reverse the trend, I know firsthand how challenging this problem is to solve.</p>
<p>I believe there are two reasons inappropriate prescribing is so hard to curb. First, there is a philosophical disconnect between the data about antibiotic resistance and what drives prescriber behavior. The second is that physicians may bend to patient demand for antibiotics, even if the physician knows it won’t help or isn’t really needed.</p>
<h2>Physicians: Does your hospital have a resistance problem?</h2>
<p>Typically, antibiotic resistance data is captured at the population level. Reports about resistance look at what is going on in <a href="http://gis.cdc.gov/grasp/PSA/MapView.html">countries, states or regions</a>. But antibiotics are prescribed by individual physicians to individual patients. So looking at population-level data makes it easy to deny that it’s a problem in your clinic or hospital, and that your behavior is contributing to it. </p>
<p>That means one of the solutions to curbing antibiotic resistance is to personalize the problem for doctors to get them to change their prescribing habits. And, at least in hospitals, this approach has been shown to work.</p>
<p>In the 1990s, I led a group at the University of Florida College of Pharmacy that established the <a href="http://www.armprogram.com/">Antimicrobial Resistance Management (ARM) Program</a>. ARM worked with over 400 hospitals nationwide and in Puerto Rico. We sent customized reports to hospitals that included their antibiotic use over at least the past three years, which was compared to resistance levels for several types of bacteria that commonly cause infections. That meant we could determine if there was any statistically significant relationship between antibiotic prescribing habits and resistance at the hospital level. </p>
<p>Because the data was institution-specific, providers couldn’t deny that their hospital had a resistance program, and that they may be contributing to it. </p>
<p>What does that mean in practice? ARM examined the relationship between imipenem, a broad spectrum antibiotic, and Pseudomonas, a bacteria that often causes healthcare-acquired infections, at a particular medical center. The program found that if the medical center did not change their prescriber behavior for this antibiotic, resistance would rise one percent for every 30 average daily doses in adults.</p>
<p>This tells prescribers much more about the chance that a key antibiotic will become less effective against a common infection than <em>general</em> population-level data would. Knowing this, hospital staff and individual providers might think carefully about when to prescribe antibiotics, and to prescribe the right dose, the right frequency of dose and the right duration if and when they do.</p>
<p>Those behavior changes have a big effect. For example, at the same medical center, these reports helped to change prescribing habits for ciprofloxacin, a widely used antibiotic that you may know as Cipro, to the point that it became <a href="http://www.ahcmedia.com/articles/15665-using-antibiotic-stewardship-programs-to-curb-resistance-in-fight-against-hai">26-76 percent more effective</a> at treating infections caused by certain organisms, especially those associated with hospital-acquired infections. </p>
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<img alt="" src="https://images.theconversation.com/files/126785/original/image-20160615-14016-1dgk1tr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/126785/original/image-20160615-14016-1dgk1tr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/126785/original/image-20160615-14016-1dgk1tr.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/126785/original/image-20160615-14016-1dgk1tr.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/126785/original/image-20160615-14016-1dgk1tr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/126785/original/image-20160615-14016-1dgk1tr.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/126785/original/image-20160615-14016-1dgk1tr.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">
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<span class="caption">Patients get prescriptions for illness that don’t require them.</span>
<span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-296155079/stock-photo-prescription-form-clipped-to-pad-lying-on-table-with-keyboard-and-stethoscope-medicine-or-pharmacy.html?src=IZCi9ksi8NB30BW2R8IWeg-1-14">Prescription pad image via www.shutterstock.com.</a></span>
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<h2>Patients play a role</h2>
<p>So there’s a way to get physicians in hospitals to think about how they prescribe antibiotics. But most antibiotics are prescribed in <a href="http://www.cdc.gov/getsmart/community/programs-measurement/measuring-antibiotic-prescribing.html">outpatient clinics</a>.</p>
<p>In fact, a <a href="http://jama.jamanetwork.com/article.aspx?articleid=2518263">recent sample of outpatient visits</a> in the United States revealed that there were about 506 antibiotic prescriptions per 1,000 people in the U.S. Of these, about 69.7 were deemed appropriate. The rest weren’t, and were often prescribed for diseases include bronchitis, sinusitis, ear infections and sore throats, which will often go away on their own. And many of these diseases are often caused by viruses, which won’t respond to antibiotics. </p>
<p>So to really combat inappropriate prescribing, we also need to reach physicians in outpatient clinics. Targeted data could help here. But the problem is that the systems that monitor antibiotic resistance and prescribing rates do not collect quality data on outpatient clinics. Even if they did, there is no standardized mechanism to deliver that information back to the community-based provider.</p>
<p>Beyond that, we also need to reach their patients. Part of the reason physicians prescribe antibiotics is that they bend to the expectations of their patients.</p>
<p>If a patient with a chest cold decides to see his provider, the patient most likely took off work, spent time in a waiting room, then more time waiting in the exam room until the provider finally came in to spend a few minutes of face-to-face time with him. The last thing the patient wants to hear is that he should get some rest, drink plenty of fluids and take Tylenol. He feels as if he made an investment, and for his investment, he wants a return. Hence a prescription, often for an antibiotic. Providers know this and realize that patients will leave sooner <a href="http://dx.doi.org/10.3399/bjgp15X688105">and happier</a> if the provider gives patients what <a href="http://www.ncbi.nlm.nih.gov/pubmed/19799568">they want</a>. </p>
<p>The challenge for patients is complicated by the fact that numerous pharmacies will now provide them <a href="http://thekrazycouponlady.com/tips/finance/6-pharmacies-offer-free-antibiotics/">free antibiotics</a> with a proper prescription. This not only increases the demand from patients for an antibiotic from their provider but it also increases the demand for select antibiotics since not all antibiotics are offered free of charge. </p>
<p>The increased demand for a select group of antibiotics speeds up the development of resistance against those drugs and cuts down on the time before they become useless. </p>
<p>While physicians should avoid prescribing antibiotics to patients unless they are truly necessary, patients must also accept the fact that <a href="http://www.cdc.gov/Features/GetSmart/index.html">not all infections require an antibiotic</a>. </p>
<p>Patients have to take responsibility for the retention of antibiotic efficacy for future generations. They should share with their provider that they want to partner with him or her toward a more responsible level of infectious disease care. </p>
<p>There are solutions, but to realize them, we need to stop discussing antibiotic resistance as an abstract, population-level problem and drive the solutions down to where the problem started, the patient-provider relationship.</p><img src="https://counter.theconversation.com/content/60300/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>John Gums 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>Doctors know that inappropriate prescribing can lead to antibiotic resistance. So why do they keep doing it?John Gums, Associate Dean for Clinical Affairs and Professor of Pharmacy and Medicine, University of FloridaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/447832015-09-03T04:22:53Z2015-09-03T04:22:53ZExplainer: why are off-label medicines prescribed?<figure><img src="https://images.theconversation.com/files/91686/original/image-20150813-18068-omd1r8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Off-label use is when an approved medicine is prescribed for a different reason, at a different dose, or in different patient groups than originally intended.</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/benny_lin/4249354055/">Benny Lin/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc/4.0/">CC BY-NC</a></span></figcaption></figure><p>The off-label use of medicines is not illegal and it doesn’t mean regulators have specifically “disapproved” its use. But there are a number of issues to consider before using a medicine off-label.</p>
<p>Before prescription medicines can be used in Australia, the drug company must apply for approval from the government-run <a href="https://www.tga.gov.au/prescription-medicines">Therapeutic Goods Administration</a> (TGA). The same goes for the Food and Drug Administration in the United States, the European Medicines Agency in the European Union, and similar agencies elsewhere in the world.</p>
<p>The drug company has to specify the health conditions the medicine will be used for (also called “indications”), the doses, the routes of administration (tablet, injection, lotion, for instance) and the types of patients who will use the medicine (adults or children).</p>
<p>The drug company has to provide the TGA with evidence to support the use of the medicine in this way, including clinical trial data. The <a href="https://www.tga.gov.au/australian-regulation-prescription-medical-products">TGA then evaluates this evidence</a>. If it supports the request, the medicine will be approved for use as requested in the application.</p>
<p>If a prescription medicine is used for a different reason, at a different dose or route of administration, or in different patient groups from those approved by the TGA, then this is referred to as “off-label” use. </p>
<p>You might have heard that there are concerns about people using <a href="http://www.afr.com/lifestyle/health/mens-health/risks-of-sleeping-with-seroquel-and-other-psychiatric-drugs-20150210-139em9">antipsychotic medicines off-label</a>, for instance, to help with sleeping problems or anxiety.</p>
<h2>Why are medicines prescribed off-label?</h2>
<p>Doctors should prescribe medicines off-label only when there are no suitable TGA-approved medicines to treat a patient. There also needs to be <a href="http://www.catag.org.au/wp-content/uploads/2012/08/OKA9963-CATAG-Rethinking-Medicines-Decision-Making-final1.pdf">evidence to show</a> the medicine is safe and effective for the off-label patient groups or conditions. </p>
<p>Evidence to support use of a medicine for a new indication or in different patient groups often becomes available years after a medicine is first approved. To change the TGA approval to reflect such evidence, the drug company needs to make an application for approval for these new uses. </p>
<p>The TGA approval process is expensive and it may not be in the commercial interests of the drug company to pay the fees to extend the listing, especially for older medicines. </p>
<p>Medicines are also frequently used off-label in groups of <a href="http://www.australianprescriber.com/magazine/36/6/article/1459.pdf">patients who weren’t included</a> in clinical trials for the medicine. This includes children, pregnant women and people receiving palliative care, who are usually excluded from clinical trials. Off-label use of medicines is also common in psychiatry and cancer.</p>
<h2>What are the risks?</h2>
<p>One of the risks with using medicines off-label is that the quality of evidence to support such use may be lower than for approved indications. </p>
<p>The effectiveness of a medicine used for an off-label indication might not have been tested in clinical trials, so the extent to which patients will benefit from using the medicine might be unknown. <a href="http://www.ncbi.nlm.nih.gov/pubmed/14664664">Studies have shown</a> that when medicines are used off-label, they are less effective than medicines used for approved indications.</p>
<p>If the medicine is used for an off-label patient population, the risks and side effects in these patients might be unclear. <a href="http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500004021.pdf">Off-label medicine use is more likely</a> to be associated with side effects.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/91687/original/image-20150813-18068-1y9ts82.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/91687/original/image-20150813-18068-1y9ts82.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=401&fit=crop&dpr=1 600w, https://images.theconversation.com/files/91687/original/image-20150813-18068-1y9ts82.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=401&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/91687/original/image-20150813-18068-1y9ts82.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=401&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/91687/original/image-20150813-18068-1y9ts82.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=504&fit=crop&dpr=1 754w, https://images.theconversation.com/files/91687/original/image-20150813-18068-1y9ts82.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=504&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/91687/original/image-20150813-18068-1y9ts82.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">
<figcaption>
<span class="caption">Medicines are frequently used off-label in groups of patients who aren’t included in clinical trials.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/hippie/2435316806/">Philippa Willitts/</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc/4.0/">CC BY-NC</a></span>
</figcaption>
</figure>
<p>The cost of using medicines off-label may also be prohibitive. Most prescription medicines in Australia are subsidised on the <a href="http://www.pbs.gov.au/info/about-the-pbs">Pharmaceutical Benefits Scheme</a> (PBS). Patients pay a co-payment for PBS medicines, with the government subsidising the remainder of the cost. Medicines prescribed off-label <a href="http://www.nps.org.au/publications/consumer/medicines-talk/2012/medicinestalk-no39-january-2012/off-label-off-limits">aren’t subsidised</a> on the PBS, so the patient has to pay the full cost. Depending on the medicine, this can be expensive. </p>
<h2>What are the benefits?</h2>
<p>Although there are risks associated with off-label use of medicines, in some situations off-label use may be the best or only treatment option for patients, particularly children, pregnant women and palliative care patients.</p>
<p>Off-label prescribing also allows medicines to be used for new indications or in different patient groups as soon as new evidence becomes available, rather than having to wait for the TGA approval process to occur, which can take some time. </p>
<p>Off-label use of medicines can play an important role in health care, particularly when this is the only treatment option for patients. But it’s important to remember that we still need evidence to show the medicine works for the off-label condition and that the benefits of using the medicine outweigh the risks.</p><img src="https://counter.theconversation.com/content/44783/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Lisa Kalisch Ellett 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>The off-label use of medicines is not illegal and it doesn’t mean regulators have specifically “disapproved” its use. But there are a number of issues to consider before using a medicine off-label.Lisa Kalisch Ellett, Research Fellow, Quality Use of Medicines and Pharmacy Research Centre, University of South AustraliaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/346492015-01-08T03:22:31Z2015-01-08T03:22:31ZExplainer: why must some medications be taken with food?<figure><img src="https://images.theconversation.com/files/68256/original/image-20150106-13855-1sn6tar.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Food can prevent certain medicines being absorbed into the bloodstream.</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/szb78/3662875596">Bertalan Szürös/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span></figcaption></figure><p>Have you ever been advised to take a medicine with food? How about taking a medicine with cola or avoiding grapefruit?</p>
<p>Hundreds of medicines have food-related dosing instructions. With four out of five Australians aged above 50 taking <a href="https://www.mja.com.au/journal/2012/196/1/national-census-medicines-use-24-hour-snapshot-australians-aged-50-years-and">daily medication</a>, most people will encounter instructions about medicines and food at some point in their lives – some of which may seem rather strange.</p>
<p>If a medicine isn’t taken as recommended with respect to food, the medicine may not have an effect. Worse, it could lead to side effects. The timing of the meal, the size of the meal, and the types of food and drinks consumed can <a href="http://www.ncbi.nlm.nih.gov/pubmed/10511919">all affect</a> the body’s response to a medicine.</p>
<h2>Absorption of medicines from the gut</h2>
<p>Eating food triggers <a href="http://deepblue.lib.umich.edu/bitstream/handle/2027.42/97269/1_ftp.pdf?sequence=1">multiple physiological changes</a>, including increased blood flow to the gut, the release of bile, and changes in the pH (acidity) and motility of the gut. These physiological changes can affect the amount of medicine absorbed from the gut into the bloodstream, which can then impact on the body’s response to a medicine.</p>
<p>Certain medicines are recommended to be given with food because the physiological changes after eating can increase the amount of medicine absorbed by the body. <a href="http://www.nps.org.au/medicines/infections-and-infestations/antifungal-medicines/itraconazole">Itraconazole</a> capsules (used to treat certain fungal infections), for instance, should be taken with food, and in some cases acidic drinks <a href="http://www.ncbi.nlm.nih.gov/pubmed/9208361">such as cola</a>, because this product needs an acidic environment to be absorbed.</p>
<p>In other cases, changes in gut secretions and the digestive process can reduce the effectiveness of a medicine. Certain antibiotics, such as <a href="http://www.nps.org.au/medicines/infections-and-infestations/antibiotics/for-individuals/types-of-antibiotics/penicillin-antibiotics/phenoxymethylpenicillin-potassium">phenoxymethylpenicillin</a> (also known as penicillin V), are best taken on an empty stomach as they can be less effective after prolonged exposure to acidic conditions.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/68259/original/image-20150106-13848-1vjfubf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/68259/original/image-20150106-13848-1vjfubf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/68259/original/image-20150106-13848-1vjfubf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=401&fit=crop&dpr=1 600w, https://images.theconversation.com/files/68259/original/image-20150106-13848-1vjfubf.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=401&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/68259/original/image-20150106-13848-1vjfubf.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=401&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/68259/original/image-20150106-13848-1vjfubf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=504&fit=crop&dpr=1 754w, https://images.theconversation.com/files/68259/original/image-20150106-13848-1vjfubf.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=504&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/68259/original/image-20150106-13848-1vjfubf.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">Skip the breakfast grapefruit when taking certain medications.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/calliope/147056989">liz west/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p>Food can act as a <a href="http://www.ncbi.nlm.nih.gov/pubmed/8980916">physical barrier</a> to the surface of the gut wall and prevent certain medicines being absorbed into the bloodstream. </p>
<p>Specific components of food, such as calcium or iron, may also bind to certain medicines. This can reduce absorption into the bloodstream, and lead to reduced effectiveness. For this reason, osteoporosis medicines <a href="http://www.nps.org.au/medicines/hormonal-and-metabolic-system/calcium-and-bone-metabolism-medicines/risedronate-sodium">risedronate</a> and <a href="http://www.nps.org.au/medicines/hormonal-and-metabolic-system/calcium-and-bone-metabolism-medicines/alendronic-acid">alendronate</a> must be taken on an empty stomach with water only.</p>
<p>Taking certain medicines with food can <a href="http://www.australianprescriber.com/magazine/29/2/40/2">reduce the risk</a> of side effects. Diabetes medicines such as gliclazide or glimepiride (belonging to the group of medicines known as <a href="http://www.nps.org.au/conditions/hormones-metabolism-and-nutritional-problems/diabetes-type-2/for-individuals/medicines-and-treatments/sulfonylureas">sulfonylureas</a>), for example, should be taken with food to reduce the risk of low blood sugar. </p>
<p>Taking medicines such as <a href="https://theconversation.com/health-check-how-do-you-choose-over-the-counter-painkillers-18399">ibuprofen</a> (for pain and inflammation) or <a href="http://www.nps.org.au/conditions/hormones-metabolism-and-nutritional-problems/diabetes-type-2/for-individuals/medicines-and-treatments/metformin">metformin</a> (for diabetes) with food is also recommended to reduce nausea and stomach upset.</p>
<h2>Does size really matter?</h2>
<p>The <a href="http://www.ncbi.nlm.nih.gov/pubmed/10511919">relationship</a> between meal size and medicine effect has not been widely studied. If you need to take a medicine with food and it’s not mealtime, sometimes a snack is enough. But for some medicines, the size of the meal is important. <a href="http://www.nps.org.au/medicines/nutrition/weight-loss-medicines/orlistat">Orlistat</a>, for example, reduces the absorption of fats from food to assist weight loss, so it’s important to take this medicine with main meals for optimal effect.</p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/68257/original/image-20150106-13827-jm0rou.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/68257/original/image-20150106-13827-jm0rou.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/68257/original/image-20150106-13827-jm0rou.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=600&fit=crop&dpr=1 600w, https://images.theconversation.com/files/68257/original/image-20150106-13827-jm0rou.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=600&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/68257/original/image-20150106-13827-jm0rou.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=600&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/68257/original/image-20150106-13827-jm0rou.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=754&fit=crop&dpr=1 754w, https://images.theconversation.com/files/68257/original/image-20150106-13827-jm0rou.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=754&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/68257/original/image-20150106-13827-jm0rou.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">Always follow the advice of your health professional.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/13519089@N03/4746653392">Taki Steve/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p>Meal composition can also be important. Eating foods high in fibre, protein or fat <a href="http://www.ncbi.nlm.nih.gov/pubmed/10511919">can impact</a> on the absorption of some medicines. </p>
<p>Drinks such as tea, coffee, milk and fruit juice can <a href="http://www.ncbi.nlm.nih.gov/pubmed/23033114">also affect</a> the way certain medicines act in the body. </p>
<p>Dairy products should be avoided within two hours of taking antibiotics such as <a href="http://www.nps.org.au/medicines/infections-and-infestations/antibiotics/for-individuals/types-of-antibiotics/quinolone-antibiotics/ciprofloxacin-quinolone-antibiotics">ciprofloxacin</a> or <a href="http://www.nps.org.au/medicines/infections-and-infestations/antibiotics/for-individuals/types-of-antibiotics/quinolone-antibiotics/norfloxacin">norfloxacin</a>, however they can be eaten at other times. </p>
<p>You may need to avoid grapefruit altogether as it can <a href="http://www.cmaj.ca/content/185/4/309.long">interfere with the metabolism</a> (processing) of certain medicines in the body, leading to side effects.</p>
<h2>Medicine labels demystified</h2>
<p>Check medicine labels carefully for advice about food or drinks. Unless otherwise advised, tablets or capsules should be swallowed with water. </p>
<p>If the label states “take with or after food”, it means the medicine should be taken during the meal, or within half an hour of eating. </p>
<p>To take a medicine “on an empty stomach”, check you have not eaten in the past two hours, and wait at least half an hour after taking the medicine before eating again, unless the label states otherwise.</p>
<p>Finally, it’s <a href="http://www.australianprescriber.com/magazine/29/2/40/2">important</a> to take medicines at the same time each day and be consistent with respect to food and drinks. </p>
<p>If you have specific questions about taking medicines with food, ask your pharmacist for further advice, check the <a href="http://www.nps.org.au/topics/how-to-be-medicinewise/finding-information-on-medicines/what-is-consumer-medicine-information">consumer medicines information</a> (CMI) for each medicine, or call <a href="http://www.nps.org.au/contact-us/medicines-line">Medicines Line</a> on 1300 633 424.</p><img src="https://counter.theconversation.com/content/34649/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Janet Sluggett has received funding from the Australian Commission on Safety and Quality in Health Care, and works on a national quality improvement program funded by the Australian Government Department of Veterans' Affairs.
Janet is a member of a national working group that makes recommendations about the advisory labels affixed to medicines when they are dispensed.</span></em></p>Have you ever been advised to take a medicine with food? How about taking a medicine with cola or avoiding grapefruit? Hundreds of medicines have food-related dosing instructions. With four out of five…Janet Sluggett, Research Fellow: Quality Use of Medicines and Pharmacy Research Centre, Sansom Institute for Health Research, University of South AustraliaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/338452014-12-22T19:18:59Z2014-12-22T19:18:59ZGreat expectations: our naive optimism about medical care<figure><img src="https://images.theconversation.com/files/67327/original/image-20141216-24294-ifo3h9.jpg?ixlib=rb-1.1.0&rect=0%2C310%2C3510%2C2306&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Most people overestimate the benefits and underestimate the harms of medical intervention. </span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/cannnela/4614340819">Barbara M./Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span></figcaption></figure><blockquote>
<p>“It might do me some good and it won’t hurt to give it a go.”</p>
</blockquote>
<p>How often have you heard a phrase like this?</p>
<p>Most people have naïve optimism about medical care. That’s the finding of a systematic review of all available research on common medical treatments we <a href="http://archinte.jamanetwork.com/article.aspx?articleid=2038981&resultClick=1">published</a> today in the journal JAMA Internal Medicine.</p>
<p>We set out to synthesise all the research to date that asked people to quantify the benefits, and/or harms, of common medical treatments, tests and screens (where people are tested for a disease without any symptoms or signs). We also aimed to compare, where possible, people’s expectations with the actual benefits and harms that are derived from research. </p>
<p>Most screening studies were about cancer screening and conclusions were similar regardless of the cancer of focus (breast, cervical, prostate, bowel). </p>
<p>Expectations for various treatments had been studied and included surgery (such as hip and knee replacement, back surgery, cataract surgery), medications (such as those for inflammatory bowel disease, osteoporosis, statins for cardiovascular disease), and other things like cardiopulmonary resuscitation (CPR). </p>
<p>This was a big search: we screened over 15,000 papers to find the 35 studies which met our inclusion criteria. Together these had studied over 27,000 people. </p>
<p>In the majority of studies, most people overestimated benefits and underestimated the harms. There was only one study where the majority of participants underestimated the benefit and one where the majority overestimated the harm. Across most studies, the proportion of people who correctly estimated intervention benefits and harms was generally low.</p>
<p>In other words, people appear to have set a halo around medical care, expecting it to deliver better outcomes than is reality. In marketing terms, we clinicians have a dream sell: our “product” is thought to be far better than it really is. </p>
<p>For the most part, this finding was echoed across various interventions, settings (primary care and hospitals), and countries. </p>
<p>The first question, of course, is why do people have such great expectations about medical management? The answers can only be speculative. </p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/67329/original/image-20141216-24313-tnoceh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/67329/original/image-20141216-24313-tnoceh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/67329/original/image-20141216-24313-tnoceh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=805&fit=crop&dpr=1 600w, https://images.theconversation.com/files/67329/original/image-20141216-24313-tnoceh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=805&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/67329/original/image-20141216-24313-tnoceh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=805&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/67329/original/image-20141216-24313-tnoceh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1011&fit=crop&dpr=1 754w, https://images.theconversation.com/files/67329/original/image-20141216-24313-tnoceh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1011&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/67329/original/image-20141216-24313-tnoceh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1011&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Why are we so optimistic about medical care? The answers may be patient-related, or clinician-related.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/soozed/9877628084">soozed/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p>There may be patient-related factors, such as: assumptions that more health care is better; optimistic bias (when individuals perceive that are at less risk than their peers); and unrealistic expectations may allow psychological needs such as hope and reassurance to be met. </p>
<p>Over-selling is something we come to expect in everyday marketing transactions and we are used to wearing a protective shield of scepticism, if not downright cynicism. But we seem to be generally less sceptical of medical care.</p>
<p>There are also probably clinician-related reasons, such as: clinicians wanting to convey hope and encouragement; the <a href="http://www.bmj.com/content/328/7438/474">strong drive</a> to do something rather than nothing, and the related fear of litigation; and clinicians themselves sometimes being unaware of the true effectiveness or benefit-harm trade-offs of interventions. </p>
<p>But there may also be more subtle factors such as the regression-to-the-mean-effect. This means that as even when an intervention is ineffective, clinicians often see patients improve anyway and this can lead to the false belief that the intervention provided was responsible for the improvement.</p>
<p>Greed on the part of some clinicians who are less scrupulous is probably involved too, especially in largely fee-for-service environments. </p>
<p>But clinicians’ enthusiasm for their speciality is also likely to be a larger contributor. To the man with a hammer in his hand, the world looks like nails. Surgeons are more likely to recommend surgery, radiotherapists radiation oncology, physiotherapists to suggest physiotherapy, and so on. </p>
<p>The next question is does this matter? </p>
<p>Very much so. Overly optimistic expectations undoubtedly contribute to the ever increasing use of health services and the growing problem of over-diagnosis, where disease labels are given even though the latent disease might not have ever caused symptoms, and over-treatment, where unnecessary treatments given. </p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/67331/original/image-20141216-24294-ifkj6s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/67331/original/image-20141216-24294-ifkj6s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/67331/original/image-20141216-24294-ifkj6s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=800&fit=crop&dpr=1 600w, https://images.theconversation.com/files/67331/original/image-20141216-24294-ifkj6s.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=800&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/67331/original/image-20141216-24294-ifkj6s.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=800&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/67331/original/image-20141216-24294-ifkj6s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1005&fit=crop&dpr=1 754w, https://images.theconversation.com/files/67331/original/image-20141216-24294-ifkj6s.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1005&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/67331/original/image-20141216-24294-ifkj6s.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1005&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Every intervention has benefits and harms and both should be acknowledged and communicated.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/tojosan/4308897037">Tojosan/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-sa/4.0/">CC BY-NC-SA</a></span>
</figcaption>
</figure>
<p>There seems to be a <a href="http://www.ncbi.nlm.nih.gov/pubmed/17353491">vicious cycle</a> in which people have overly optimistic expectations about interventions and request them from their clinicians, who then provide them because it was requested, even if doing so causes the clinician discomfort. Receiving the intervention subsequently reinforces people’s belief that the intervention is beneficial and necessary and so the cycle continues. </p>
<p>Many payment systems favour providing an intervention rather than “just” talking with patients and there is the efficiency appeal of ordering a test or writing a prescription rather than taking the time and effort to explain to a patient why it may not be needed.</p>
<p>A third question is what can be done to counteract these unrealistic expectations? </p>
<p>Many groups have a role to play. Every intervention has benefits and harms and both should be acknowledged and communicated. This applies to: </p>
<ul>
<li><strong>researchers</strong> – harms are <a href="http://www.bmj.com/content/348/bmj.f7668">notoriously under-reported</a>, and even in our review, many more studies assessed expectations of benefit than harm, or benefit and harm</li>
<li><strong>journalists</strong> – media stories <a href="http://www.nejm.org/doi/full/10.1056/NEJM200006013422206">often portray</a> interventions in a misleading way</li>
<li><strong>health services and the pharmaceutical industry</strong> – for example, <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1388137/">screening invitations</a> and <a href="http://www.vaoutcomes.org/wp-content/uploads/2012/11/drug_ads.pdf">drug advertisements</a> often present information tilted towards or only about the benefits</li>
<li><strong>clinicians</strong> – conversations between patients and clinicians tend to focus on the benefits of interventions and may not address, or downplay, the harms. </li>
</ul>
<p>Patients, and indeed any individual who is considering a screen, test, or treatment, can also be involved in the solution. Beyond being aware of this tendency to assume that interventions help a lot and harm little, asking their clinician three questions before consenting to any intervention is a good habit to acquire. They are: </p>
<ul>
<li>what are my options?</li>
<li>what are the possible benefits and harms of each option?</li>
<li><a href="http://www.askshareknow.com.au">how likely</a> is it that each of those benefits and harms will happen to me?</li>
</ul>
<p>Asking these questions can trigger a conversation between clinician and patient that hopefully enables an informed decision to be made. </p>
<p>Similarly, the <a href="http://www.choosingwisely.org">Choosing Wisely campaign</a> underway in many countries (and on its way to Australia) provides evidence-based information for the public about interventions that are commonly used, yet may be unnecessary, and encourages a conversation between clinicians and patients. </p>
<p>Modern medicine is slowly moving towards a commitment to true partnerships between clinicians and their patients. Realising that people often come to consultations with preconceptions and expectations is a step closer to achieving this. </p>
<p>In the process of negotiating the best clinical option, clinicians should elicit the patient’s expectations and preconceptions about what they are expecting from the intervention, discuss any misperceptions, and provide accurate information about the benefits and harms of each management option. </p>
<p>Only then can any genuine “<a href="https://www.mja.com.au/journal/2014/201/1/shared-decision-making-what-do-clinicians-need-know-and-why-should-they-bother">shared decision making</a>” start to occur and perhaps the impact of these great expectations lessened.</p><img src="https://counter.theconversation.com/content/33845/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Tammy Hoffmann receives research funding from the NHMRC and book royalties for evidence-based practice books. </span></em></p><p class="fine-print"><em><span>Chris Del Mar receives research funding from the NHMRC, and book royalties.</span></em></p>“It might do me some good and it won’t hurt to give it a go.” How often have you heard a phrase like this? Most people have naïve optimism about medical care. That’s the finding of a systematic review…Tammy Hoffmann, A/Prof Clinical Epidemiology, Bond University; NHMRC Research Fellow, The University of QueenslandChris Del Mar, Professor of Public Health, Bond UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/349012014-12-11T11:02:57Z2014-12-11T11:02:57ZDrug shortage crisis puts public health at risk<figure><img src="https://images.theconversation.com/files/66913/original/image-20141210-6033-17jwksf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Why are hospitals running out of critical drugs?</span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-135106793/stock-photo-closeup-of-silhouette-iv-drip.html?src=UWWm2UvTuiRTYFzBRvdVWA-3-92">IV drip via Bhakpong/Shutterstock</a></span></figcaption></figure><p>Hospitals and pharmacies around the country are facing severe shortages of essential drugs. These shortages can limit access to critical medications and compromise patient safety, resulting in serious illness and even death. In a 2011 survey, the American Hospital Association reported that <a href="http://www.aha.org/presscenter/pressrel/2011/110712-pr-rxshortage.shtml">82% of hospitals</a> had to delay therapy due to a drug shortage. And the consequences of drugs shortages go beyond delays. A 2010 report by the Institute for Safe Medication Practices <a href="http://www.ismp.org/pressroom/PR20100923.pdf">implicated</a> drug shortages in medication errors, adverse drug reactions and several deaths.</p>
<p>I’ve seen this happen while working in a hospital in the Washington, DC area. We were forced to use alternative drugs to sedate and paralyze a patient for placement of a breathing tube because we were out of the standard drugs. And those alternative were being rationed, so we had to change to yet another set of drugs to keep the patient sedated.</p>
<p>Shortages often impact generic injectable drugs, like sodium bicarbonate, the anesthetic propofol and the painkiller fentanyl, but any medication can be affected. For example, during last year’s influenza epidemic, there were shortages of both the influenza vaccine and antiviral medications, contributing to more cases of influenza and complications from the disease.</p>
<p>Cancer drugs are commonly affected by shortages, often resulting in <a href="http://www.ncbi.nlm.nih.gov/pubmed/24644117,%20http://www.nejm.org/doi/full/10.1056/NEJMc1307379">delayed chemotherapy</a>. Patients may also receive less effective or more toxic alternative chemotherapy regimens. This has been associated with decreased cancer survival and cure rates. </p>
<h2>Replacement and risk</h2>
<p>Providers often memorize details about medications they commonly prescribe or administer. So when alternatives must be used, providers may not as be as familiar with the proper dosing, administration procedures, and contraindications to these medications. All of this can lead to errors.</p>
<p>Pharmacy purchasers may need to obtain medications in different concentrations during a drug shortage. This can lead to dosing errors when providers are administering medications in concentrations they are not used to. </p>
<p>In one reported case, in a hospital’s gastroenterology suite, there was a shortage of the anesthetic ketamine in the concentration the hospital usually stocked. The pharmacy was stocking a much higher concentration of the same drug because that was the only dosage concentration that they could obtain. The provider did not properly dilute the medication and a patient was overdosed, experiencing confusion and delirium.</p>
<p>Shortages also mean that some pharmacies are compounding products from raw materials. This can introduce calculation and measurement errors during preparation and the risk of microbial contamination. Although unrelated to drug shortages, the outbreak of <a href="http://www.bostonglobe.com/lifestyle/health-wellness/2012/10/27/doctors-piece-together-rare-cases-fungal-meningitis-uncover-outbreak/55SIHvy58Pf8lCB0yFvpHJ/story.html">fungal meningitis</a> associated with injections made at the New England Compounding Center in 2012 highlights the potential risk improper compounding poses to patient safety.</p>
<p>Medication vials that are meant for single use are re-used multiple times, which can lead to microbial contamination and even infectious disease transmission between patients. </p>
<p>And shortages often drive drug prices up several-fold, which can make it harder for patients to afford their medications, sometimes forcing them to go without treatment. </p>
<p>Health-care spending also increases as hospitals, pharmacies and providers devote additional resources to managing medication shortages. More manpower is devoted to managing medication shortages rather than treating patients. It is estimated that managing drug shortages costs <a href="https://legacy.premierinc.com/about/news/11-mar/drugshortage032811.jsp">hundreds of millions</a> of dollars annually. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/66915/original/image-20141210-6030-d7tw7x.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/66915/original/image-20141210-6030-d7tw7x.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/66915/original/image-20141210-6030-d7tw7x.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/66915/original/image-20141210-6030-d7tw7x.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/66915/original/image-20141210-6030-d7tw7x.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/66915/original/image-20141210-6030-d7tw7x.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/66915/original/image-20141210-6030-d7tw7x.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">Running out?</span>
<span class="attribution"><a class="source" href="http://www.shutterstock.com/cat.mhtml?lang=en&language=en&ref_site=photo&search_source=search_form&version=llv1&anyorall=all&safesearch=1&use_local_boost=1&search_tracking_id=9tcKQCZTvnNqGT6TMrQALA&searchterm=syringe&show_color_wheel=1&orient=&commercial_ok=&media_type=images&search_cat=&searchtermx=&photographer_name=&people_gender=&people_age=&people_ethnicity=&people_number=&color=&page=1&inline=235884964">Syringe via Africa Studio/Shutterstock</a></span>
</figcaption>
</figure>
<h2>Prescription for change</h2>
<p>So, why do these drug shortages occur and why are they so widespread? There are several reasons. To cut production costs manufacturing facilities have been consolidated, which means there isn’t much slack in the system when a shortage happens. On top of that there are raw material shortages, manufacturing problems, product discontinuation, and unanticipated demand for medication. </p>
<p>Market factors also play in a role. Making injectable drugs is costly and generic companies do not get as much return on their investment and Medicare pays fixed prices for some generic drugs. </p>
<p>And even though there are significant public health consequences, the US Food and Drug Administration (FDA) has limited authority to address drug shortages. The problem is complex enough, that there isn’t a single solution.</p>
<p>In 2012 some progress was made when Congress passed the Food and Drug Administration Safety and Innovation Act (<a href="http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm313121.htm">FDASIA</a>). This act, which builds upon previous legislation, requires all drug manufacturers to report anticipated drug discontinuations and shortages. Although it’s a step in the right direction, the act won’t solve the problem. The FDA does not have authority to require pharmaceutical companies to manufacturer a particular drug and there are no penalties for manufacturers who do not comply with current reporting requirements. </p>
<p>The FDA has a <a href="http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm">Drug Shortages Program</a>, which it has expanded to play a more active role in managing shortages, and prevent them from happening. On a policy level, incentives should be provided to manufacturers to encourage compliance with good manufacturing practices and early reporting of potential shortages. More stringent reporting requirements for pharmaceutical companies are needed and the FDA should be given enforcement authority.</p><img src="https://counter.theconversation.com/content/34901/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Maryann Mazer-Amirshahi 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>Hospitals and pharmacies around the country are facing severe shortages of essential drugs. These shortages can limit access to critical medications and compromise patient safety, resulting in serious…Maryann Mazer-Amirshahi, Assistant Professor of Emergency Medicine , MedStar Washington Health CenterLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/324762014-11-03T05:30:30Z2014-11-03T05:30:30ZPregnant women must be studied too<figure><img src="https://images.theconversation.com/files/61295/original/twtgxmzy-1412868444.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Pills ok during pregnancy? We can't know if we don't study them.</span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-18257989/photo-pregnant-woman-holding-medicine-nine-month-third-trimester.html?src=8pEa9Ry2emMCWlis6N3KJg-1-93">Medications image via www.shutterstock.com</a></span></figcaption></figure><p>Imagine being pregnant while having a chronic health condition such as diabetes, hypertension, depression or asthma, or being diagnosed with an illness while pregnant. Amazingly, your doctor may not know exactly what treatments or drugs, or what dose, will work best for you. This is a reality faced by <a href="http://www.ncbi.nlm.nih.gov/pubmed/21514558">millions of American women</a> every day.</p>
<p>The simple fact is, pregnant women get sick and <a href="http://www.un.org/apps/news/story.asp?NewsID=47735">sick women</a> get pregnant. Meanwhile, rates of <a href="http://www.fightchronicdisease.org/sites/fightchronicdisease.org/files/docs/PFCDAlmanac_ExecSum_updated81009.pdf">chronic disease are rising</a> and women are having children at an <a href="http://www.cdc.gov/nchs/data/nvsr/nvsr62/nvsr62_09.pdf">older age</a>. Stopping medication or avoiding new treatments is not always the optimal approach. Significant knowledge gaps exist because pregnant women have historically been <a href="http://dij.sagepub.com/content/48/2/145.abstract">excluded from medical research</a>, mainly due to concerns about the effect on the fetus. But even a normal pregnancy has risks.</p>
<h2>Medication conundrum</h2>
<p>There is a common belief that medication during pregnancy is unhealthy and unwise. Past tragedies – such as the limb-reduction birth defects related to first trimester thalidomide exposure – serve to support careful consideration of the risks and benefits of drug treatment. But avoiding all medication use is not a realistic possibility.</p>
<p>Failing to take medication, taking inappropriate doses or not being prescribed a needed treatment can be harmful or fatal for a mother or her unborn child. Today, an American woman will take at least one and on average four <a href="http://www.sciencedirect.com/science/article/pii/S0002937811002195">medications</a> during her pregnancy. Health care professionals, though, often have inadequate information about how a drug works during pregnancy because most medications <a href="http://onlinelibrary.wiley.com/doi/10.1002/pds.3495/full">have not been evaluated</a> in pregnant women. </p>
<p>Confronted with this lack of data, a woman who is pregnant or nursing may stop taking drugs or breastfeeding, even though that may not be the best course of action. With more information about both the benefits and risks of drug exposure, she might choose to continue medications that improve her short-term and long-term health and quality of life while minimizing harm to herself or her baby.</p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/61296/original/rw5qz79s-1412868885.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/61296/original/rw5qz79s-1412868885.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=899&fit=crop&dpr=1 600w, https://images.theconversation.com/files/61296/original/rw5qz79s-1412868885.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=899&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/61296/original/rw5qz79s-1412868885.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=899&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/61296/original/rw5qz79s-1412868885.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1130&fit=crop&dpr=1 754w, https://images.theconversation.com/files/61296/original/rw5qz79s-1412868885.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1130&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/61296/original/rw5qz79s-1412868885.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1130&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Without the data, pregnant women are left guessing.</span>
<span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-131704958/photo-pregnant-woman-taking-supplements-at-home.html?src=8pEa9Ry2emMCWlis6N3KJg-1-61">Woman image via www.shutterstock.com</a></span>
</figcaption>
</figure>
<p>Moreover, newer medications shown to be effective in non-pregnant patients have the potential to improve disease outcomes in pregnancy, but have not yet been tested in pregnant women. For example, newer treatments for hepatitis C may help prevent the <a href="http://www.healthline.com/health-slideshow/hepatitis-c-and-pregnancy#1">mother-to-child transmission of hepatitis C</a>, but they need to be studied in pregnancy.</p>
<p>Unfortunately, this lack of new scientific information leads to <a href="http://www.ncbi.nlm.nih.gov/pubmed/23359404">uncertainty</a> for health care professionals about how to prescribe needed medications and sometimes results in no treatment at all for pregnant or breastfeeding patients with an illness. Worse, in the search for answers, many pregnant women turn to the internet and social media, which often results in conflicting, confusing and just plain wrong advice.</p>
<h2>Rx: collect more data</h2>
<p>Our nation must do better. Currently women – pregnant or not – are vastly underrepresented in clinical trials. Pregnant women should determine what level of risk they are willing to take. A robust, transparent informed consent process can help them make this decision. Though pregnant women have participated in some studies, most research protocols continue to exclude pregnant or breastfeeding women, and this just has to change. </p>
<p>Additionally, we need to improve data collection related to drugs and pregnancy, which is currently inadequate to make informed decisions. For example, the US Food and Drug Administration keeps a list of what are called <a href="http://www.fda.gov/ScienceResearch/SpecialTopics/WomensHealthResearch/ucm134848.htm">Pregnancy Exposure Registries</a> that collect health information, mostly on birth defects and infant health, from researchers and drug companies about women who take medicines or vaccines while pregnant.</p>
<p>Existing data from these registries should be standardized and easily accessible to support sound decision-making by providers and patients. Pregnancy registries should be required for new drugs, and registries must capture not just adverse events but healthy outcomes to create a baseline of both positive and negative medical data. </p>
<p>Also the US Office of Management and Budget should finalize the long-pending FDA <a href="http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093307.htm">Pregnancy and Lactation Labeling Rule</a>, which would provide patients and prescribers detailed, updated information about fetal risk, clinical considerations and the quality of studies available for each drug.</p>
<p>Federal policymakers and the medical community must re-evaluate the <a href="http://www.fda.gov/ScienceResearch/SpecialTopics/WomensHealthResearch/ucm133348.htm">near-exclusion</a> of pregnant women from medical research and strengthen requirements to collect as much data as possible, including follow-up with women who become pregnant and drop out of a study.</p>
<p>Incentives, such as longer exclusivity clauses or fast track designation for an unmet need, must be created for pharmaceutical companies to perform lab research and clinical trials focusing on pregnancy when seeking approval for new drugs that may be used by pregnant women.</p>
<p>By taking these actions, pregnant women will be better served by medical research. With <a href="https://www.cia.gov/library/publications/the-world-factbook/geos/us.html">62 million women</a> in the United States of childbearing age and <a href="http://www.cdc.gov/nchs/data/nvsr/nvsr62/nvsr62_01.pdf">4 million births</a> each year, getting the best possible health care is vitally important now and for generations to come. </p>
<hr>
<p><em>This piece was co-authored by Martha Nolan, JD, Vice President of Public Policy at the <a href="http://www.womenshealthresearch.org/site/PageServer?pagename=homepage">Society for Women’s Health Research</a>.</em></p><img src="https://counter.theconversation.com/content/32476/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Katherine Wisner has received funding from NIMH, NICHD, and the Department of Psychiatry at Northwestern receives Consultation Fees from Dr. Wisner's work with Quinn-Emanuel Law firm, which represents pharmaceutical companies. </span></em></p><p class="fine-print"><em><span>Vincenzo Berghella 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>Imagine being pregnant while having a chronic health condition such as diabetes, hypertension, depression or asthma, or being diagnosed with an illness while pregnant. Amazingly, your doctor may not know…Katherine Wisner, Professor in Psychiatry and Behavioral Sciences and Obstetrics and Gynecology, Northwestern UniversityVincenzo Berghella, Professor of Obstetrics and Gynecology, Thomas Jefferson UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/330012014-10-27T09:13:17Z2014-10-27T09:13:17ZOlder people abuse drugs because they’re in pain, but there are better ways to help<p>It should be no surprise that <a href="http://www.cdc.gov/nchs/data/databriefs/db42.pdf">older adults are the largest users</a> of prescription medication. After all, older adults are far more likely to have chronic health conditions than are younger people. It follows, then, that the misuse or abuse, of prescription and over-the-counter medications is a <a href="http://www.ncbi.nlm.nih.gov/books/NBK64422/">significant problem</a> among older adults.</p>
<p>The medications they misuse include painkillers, especially opiates; sleep aids and anti-anxiety agents, especially <a href="http://abcnews.go.com/Health/AnxietyTreating/story?id=4659977">benzodiazepines</a>, and various psychiatric medications such as anti-depressants and anti-psychotics.</p>
<p>For the most part, older adults are not using these drugs to get high. They are using them in the hopes of quelling pain, sleeplessness, anxiety, or depression. And they may also be given them to reduce dangerous, disruptive, or annoying behavior, especially among those older adults who have severe mental disorders, including dementia (often called, accurately or not, Alzheimer’s disease).</p>
<p>Overuse of medications that may be useful in the right dose for certain specific conditions creates a variety of serious problems including: </p>
<ul>
<li>Increased risk of falls – a major cause of disability and premature mortality among older people.<br></li>
<li>Drug related cognitive impairment including memory loss that can be confused with dementia.<br></li>
<li>Discord in important relationships.<br></li>
<li>Inactivity.<br></li>
<li>Social isolation.<br></li>
<li>Loss of independence.</li>
</ul>
<p>Certain medications also create significant risks of illness and premature mortality among people older than 65. For example, anti-psychotic medications create <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2327229/">increased risks</a> of obesity, diabetes, high blood pressure, heart disease, and more. Anti-depressant medications also are associated with health risks including higher rates of death, attempted suicide, falls, fractures, upper gastro-intestinal bleeding, and heart attacks.</p>
<p>So what can be done to reduce the risk of misuse or abuse of medications by older adults? To some extent, misuse of medications results from the ignorance of older adults, their caregivers, and of those who prescribe medication for them about the appropriate use of medication. This includes ignorance about dosage, which is generally less for older adults than for younger people, the potential side-effects, the value of limiting prescriptions, alternative treatments and the dangers of using medication to control “difficult” behavior.</p>
<p>It is widely believed that better public education and professional training would result in significantly less misuse of medications. </p>
<h2>Legal and regulatory constraints</h2>
<p>Reducing abuse of prescription painkillers and other drugs has become a major item on the public health agenda in the United States. In part, public health officials have tried to educate patients and providers. </p>
<p>But in large part they have pressed for legal and regulatory constraints that discourage providers from prescribing these medications. The impact has been measurable but not remarkably high.</p>
<p>Unfortunately, there has been little attention paid to reducing the demand for the medications that are too often and easily over-used. People take painkillers because they are in pain. People take sleep aids and anti-anxiety agents because they cannot sleep or because they live in fear. People take anti-depressants because they are depressed. (Actually they are often prescribed by physicians for people who are not depressed, but are sad or sleepless.)</p>
<p>Overcoming medication misuse and abuse by older adults will not be easy because the problems these medications treat are serious and very troubling to those who have them. They want and need the drugs to avoid suffering and to be able to lead lives that they find at least tolerable. </p>
<p>The point is that we need a major push to help people with pain, sleeplessness and anxiety without excessive reliance on medications that are dangerous when they are misused, as they too often are. This will take far greater research to find effective alternatives to dangerous medications.</p><img src="https://counter.theconversation.com/content/33001/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Michael B Friedman 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>It should be no surprise that older adults are the largest users of prescription medication. After all, older adults are far more likely to have chronic health conditions than are younger people. It follows…Michael B Friedman, Adjunct Associate Professor, School of Social Work, Columbia UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/324352014-10-09T19:04:04Z2014-10-09T19:04:04ZWhy I don’t see drug reps – a GP’s take on Big Pharma spruiking<figure><img src="https://images.theconversation.com/files/61137/original/rw63cq29-1412745846.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Drug reps form a huge part of the industry's marketing strategy.</span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-116744095/stock-photo-hand-of-doctors-holding-many-different-pills.html?src=pp-photo-182523617-JM69ZOvKaTT4KtYSPgu8MQ-6">Alexander Raths/Shutterstock</a></span></figcaption></figure><p>Here’s what I remember. It was 14 years ago, and I was a junior doctor working in psychiatry. Some colleagues planned a dinner as an end-of-term celebration and, despite reasonable incomes, they decided that the dinner should be “free” – sponsored by a drug company, and thus attended by the company’s representative (a “drug rep”).</p>
<p>I went, and during the meal the drug rep stood up to deliver the “educational” content for the evening. “Did you know,” he asked, “that my drug is good at preventing malnutrition?” This seemed a puzzling claim for an antipsychotic medicine. He continued: “Because when you prescribe my drug, I get paid, and I can feed my family.” To an audience of strained smiles, he sat down, indicating that the evening’s educational formalities were complete.</p>
<p>At the time I thought this was an embarrassingly poor example of education. But I am now thankful to that drug rep, as this incident helped to expose for me the charade that industry-sponsored education can sometimes be. It helped me decide to avoid drug reps and to instead get my prescribing information from independent sources. </p>
<p>A <a href="http://noadvertisingplease.org/">new campaign</a>, launching today, encourages more doctors to do the same. </p>
<h2>Problems with medicines</h2>
<p>I am not a critic of the entire pharmaceutical industry. Some medicines are very useful, and many of my encounters with my patients involve prescribing. Without medicines, many of my patients would be more unwell.</p>
<p>But problems exist with the development of medicines, and with our knowledge of how best to use them. In a for-profit environment, drug research follows potential profits. It may focus on production of <a href="http://jama.jamanetwork.com/article.aspx?articleid=645581">“me-too” drugs</a> (those offering little or no advance on existing drugs) rather than tackling more pressing but less profitable global health needs. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/61140/original/k8w4jv6s-1412746707.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/61140/original/k8w4jv6s-1412746707.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=399&fit=crop&dpr=1 600w, https://images.theconversation.com/files/61140/original/k8w4jv6s-1412746707.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=399&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/61140/original/k8w4jv6s-1412746707.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=399&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/61140/original/k8w4jv6s-1412746707.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=502&fit=crop&dpr=1 754w, https://images.theconversation.com/files/61140/original/k8w4jv6s-1412746707.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=502&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/61140/original/k8w4jv6s-1412746707.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">
<figcaption>
<span class="caption">Drug research follows profits, not need.</span>
<span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-218558989/stock-photo-old-woman-is-taking-pills-in-her-country-style-kitchen.html?src=alor4aSxOYa4lGdqZnMl0w-1-89">Halfpoint/Shutterstock</a></span>
</figcaption>
</figure>
<p>The results of trials of medicines are <a href="http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0066844">not always published</a>, meaning we don’t know the <a href="http://www.alltrials.net/find-out-more/why-this-matters/">whole truth</a> about effectiveness or safety of some drugs.</p>
<p>And a lot of research studies rely on the assumption that changes in easily measurable things will translate into real benefits to patients – for example, that a drug that lowers blood sugar will prevent complications in patients with diabetes, or that a drug that improves cholesterol readings will avert heart attacks. These assumptions can sometimes be right, but sometimes are <a href="http://www.ncbi.nlm.nih.gov/pubmed/20656674">quite</a> <a href="http://www.ncbi.nlm.nih.gov/pubmed/17984165">wrong</a>.</p>
<p>These problems are systemic, and can’t be entirely blamed on the pharmaceutical industry. But the industry is a key player, and these issues seriously beleaguer attempts at practising good evidence-based medicine. And with <a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.0050001">US$7-20 billion</a> spent annually on drug reps in the United States alone, reps form a huge part of the industry’s marketing strategy. </p>
<h2>Drug reps</h2>
<p>In many doctors’ offices around the world today, drug reps will be setting out food on a table for hungry doctors, in the hope of some promotional lunchtime chatter. </p>
<p>Why do doctors see drug reps? <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1314573/">Research</a> says GPs find drug reps a convenient and timely source of information, with some appreciating the personal, social interaction with the reps. Many doctors are aware of possible biases in information from reps, but many believe they are capable of sorting “the wheat from the chaff” themselves, even if they think many of their colleagues are <a href="http://www.ncbi.nlm.nih.gov/pubmed/11347622">suckers</a>.</p>
<p>I don’t think drug reps are evil people; in fact, many of them are pleasant people who are no doubt doing their job well. But the purpose of that job is to increase medication sales. My responsibility is to prescribe medicines in a manner optimal for the health of my patients. These two purposes may conflict. Doctors need impartial, evidence-based information on medications. We should not confuse education for marketing.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/61138/original/djs99vpt-1412746478.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/61138/original/djs99vpt-1412746478.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/61138/original/djs99vpt-1412746478.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/61138/original/djs99vpt-1412746478.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/61138/original/djs99vpt-1412746478.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/61138/original/djs99vpt-1412746478.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/61138/original/djs99vpt-1412746478.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">There’s no such thing as a free lunch.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/mr_t_in_dc/3217250896">Mr.TinDC/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
</figcaption>
</figure>
<p>Are we told the whole truth about medicines by drug reps? The evidence says we are not. A recent study from the US, Canada and France found that only a <a href="http://www.ncbi.nlm.nih.gov/pubmed/23558775">small minority</a> of drug rep visits included “minimally adequate safety information”. Another recent study from Australia and Malaysia found that information about medication risks was <a href="http://www.ncbi.nlm.nih.gov/pubmed/21118551">often missing</a>.</p>
<p>Drug reps often promote the newest medicines, still under patent and ripe with potential profit. But the newer the drug, the less we may know about long term side effects – and sometimes these can cause serious harm. It is often wise to be <a href="http://www.australianprescriber.com/magazine/28/3/54/5/">slow to prescribe</a> new drugs.</p>
<p>Those free lunches aren’t really a gift – ultimately they are paid for by patients and taxpayers. And it’s hard not to feel cynical about drug reps when I learn about their methods. Retired drug reps share illuminating insights about their <a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.0040150">tactics for influencing doctors</a>, tailored to various personality types. Doctors may find reps friendly, but according to these accounts, they are being manipulated. </p>
<h2>Do drug reps affect prescribing?</h2>
<p>The issues above might not matter if doctors were immune to problematic information from the pharmaceutical industry. But are they? This is a question that several colleagues and I tried to answer recently in a <a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000352">systematic review</a>. We collected all the available studies looking at links between doctors’ exposure to information from drug companies and their prescribing.</p>
<p>We found that, where links were found between information exposure and prescribing changes, they tended to be in the direction of more prescribing, more expensive prescribing, and lower quality prescribing.</p>
<p>This doesn’t mean drug rep visits are never useful. I can imagine situations, when public health and commercial interests align, where reps might be helpful. But our thorough review of the world’s evidence gave us no confidence that this was usually the case.</p>
<h2>The No Advertising Please campaign</h2>
<p>For all these reasons, I’m one of several doctors throwing their weight behind the new <a href="http://noadvertisingplease.org/">No Advertising Please</a> campaign, vowing to avoid drug reps for a year. This should be reasonably easy for me, as I’ve been trying to avoid them for years – though no doubt I’ll be occasionally ambushed in tea rooms and corridors. Meanwhile, I’ll keep buying my own lunch, and relying on <a href="https://shop.amh.net.au/">independent</a> <a href="http://www.nps.org.au/">sources</a> of <a href="http://www.australianprescriber.com/">medicines</a> <a href="http://dtb.bmj.com/">information</a>.</p>
<p>If you’re a prescriber, you can sign up too. Otherwise, when you next find yourself being written a prescription, perhaps you could ask the person signing it where they get their information on medicines, and why.</p><img src="https://counter.theconversation.com/content/32435/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>As a GP, Brett Montgomery often prescribes medicines manufactured by pharmaceutical companies. He is affiliated in various ways with the No Advertising Please campaign, Healthy Skepticism, the Doctors Reform Society and the Australian Greens, all of which have taken critical stances on the relationship between doctors and pharmaceutical companies. However, he writes this article in a personal capacity.</span></em></p>Here’s what I remember. It was 14 years ago, and I was a junior doctor working in psychiatry. Some colleagues planned a dinner as an end-of-term celebration and, despite reasonable incomes, they decided…Brett Montgomery, Associate Professor in General Practice, The University of Western AustraliaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/270802014-05-27T05:15:14Z2014-05-27T05:15:14ZPrescription charging must balance health and budget benefits<figure><img src="https://images.theconversation.com/files/49369/original/n2bdjq9b-1400845230.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Do free prescriptions lead to waste?</span> <span class="attribution"><span class="source">David Smart/Shutterstock</span></span></figcaption></figure><p>The <a href="http://dtb.bmj.com/content/early/2014/05/12/dtb.2014.5.0250.full">call to abolish the prescription charge</a> in England by the Drug and Therapeutics Bulletin is the centre of great debate. Unsurprisingly so. The cost of making and buying pharmaceutical drugs is an emotive issue – and a complex one. And, the call came soon after a <a href="https://www.gov.uk/government/news/nhs-charges-from-april-2014">rise in prescription charges</a> from £7.85 to £8.05.</p>
<p>NHS prescriptions have been free across the board in Wales, Northern Ireland and Scotland since 2007, 2010 and 2011, respectively. But currently in England <a href="http://www.nhs.uk/NHSEngland/Healthcosts/Pages/Prescriptioncosts.aspx">only certain categories</a> of patients, such as the elderly, the young, some low-income groups and people with a specified, long-term medical condition, are entitled to free NHS medicines when prescribed by their GP. If prescriptions charges are to be abolished in England, this must benefit both patients and healthcare budgets.</p>
<h2>Funding debate</h2>
<p>The argument seems simple. Why should we be charged an additional tax on medicines when the NHS is already funded through general taxation? On the other hand the think-tank <a href="http://www.reform.co.uk/resources/0000/1069/The_cost_of_our_health__the_role_of_charging_in_healthcare.pdf">Reform argues</a> that prescription charges should be increased even further to raise much needed funds, in an attempt to recoup some of the billions spent on prescription services. The arguments are clear, but answers are less so.</p>
<p>The “abolitionists” make a strong case, especially when viewed through the eyes of the <a href="http://www.prescriptionchargescoalition.org.uk/">Prescription Charges Coalition</a>, which campaigns for equity across all long-term medical conditions. Why should those with diabetes, epilepsy and cancer receive free prescriptions while a whole host of patients with other conditions have to pay? </p>
<p>The problem is exacerbated when prescription costs become prohibitive for some people with long-term conditions, who then choose not to collect their prescriptions. The 2009 <a href="https://www.gov.uk/government/publications/prescription-charges-review-the-gilmore-report">Gilmore review</a>, which assessed how to implement exemptions from charges, recommended that a range of long-term medical conditions be considered. But many of these never happened.</p>
<h2>Spiraling prescriptions</h2>
<p>One of the arguments against removing prescription charges is the idea that prescribing rates could dramatically spiral as a result, further eating into the budget for drugs. But there doesn’t seem to be any evidence from Wales, Northern Ireland and Scotland to support this. Since making prescriptions free, they’ve not experienced a surge in demand. Interestingly, however, the <a href="http://bma.org.uk/news-views-analysis/news/2014/april/reintroduction-of-prescription-charges-under-consideration">Health Minister of Northern Ireland</a> has not ruled out the reintroduction of prescription charges for financial reasons.</p>
<p>The CAIS drug and alcohol rehabilitation centre in North Wales has <a href="http://www.bbc.co.uk/news/uk-wales-25460593">blamed free prescriptions</a> for a number of deaths arising from prescribed drug addictions. This is important as it highlights the potential for unwanted patient effects as a result of abolishing prescription charges.</p>
<p>The above example contradicts the argument that removing prescription charges will result in better access to medicines and therefore better health. Even with medicines that are freely available, patients do not take these as intended. It is accepted that up to 50% of medicines prescribed for long-term conditions are <a href="http://www.who.int/chp/knowledge/publications/adherence_report/en/">not taken by patients as prescribed</a> by their practitioner. Having access to medicines does not guarantee appropriate medicine-taking behaviour.</p>
<h2>Moral hazard</h2>
<p>An idea borrowed from the insurance and financial sectors, known as moral hazard, looks at how arrangements of good intention can create incentives for people to behave badly. So could the fact that 90% of NHS prescriptions dispensed in the community are currently free account for the problem of medicine waste in the UK? There is ample anecdotal evidence that patients automatically re-order medicines under current systems with no incentive to reflect on whether they still need to take these medicines and, if they do need to take them, whether they are doing so as prescribed.</p>
<p>The £300m cost to the NHS associated with medicine waste each year has been put down to a <a href="http://discovery.ucl.ac.uk/1350234/1/Evaluation_of_NHS_Medicines_Waste__web_publication_version.pdf">whole range of factors</a>, including patient motivations, practical difficulties, treatment-related effects and system failures. The prescription charge is only one of a host of reasons associated with medicine waste.</p>
<h2>Symbolic contract</h2>
<p>But what if prescriptions were not free <a href="http://www.biomedcentral.com/1472-6963/13/16">but much cheaper</a>? A nominal £1 prescription fee across the board might give patients the necessary incentive to think twice about re-ordering unwanted medicines, while providing the much-needed financial contribution towards the cost of medicines in the NHS.</p>
<p>Could a £1 charge enter people into a “symbolic contract” to take their medicines more effectively? There is so far little research into the effect that this type of nominal charge may have on public and patient perspectives and behaviour. This is necessary, as a symbolic agreement could strike the right balance and be the answer to the difficult problem of prescription charges that benefit both budgets and patient health. </p><img src="https://counter.theconversation.com/content/27080/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Parastou Donyai receives funding from Royal Pharmaceutical Society, Nuffield Foundation, the Wellcome Trust.</span></em></p>The call to abolish the prescription charge in England by the Drug and Therapeutics Bulletin is the centre of great debate. Unsurprisingly so. The cost of making and buying pharmaceutical drugs is an emotive…Parastou Donyai, Director of Pharmacy Practice, University of ReadingLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/192772014-04-16T04:31:42Z2014-04-16T04:31:42ZLeave prescribing to doctors and nurse practitioners<figure><img src="https://images.theconversation.com/files/46439/original/bbwkrk54-1397539773.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Australia already has a category of nurse specialists who can prescribe some medicines – nurse practitioners.</span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-133606469/stock-photo-man-reading-prescription-bottle.html?src=TZTbAlQ-RIprCa9_-9r9aA-1-3">Burlingham/Shutterstock</a></span></figcaption></figure><p>We started the week with a <a href="https://theconversation.com/hospital-workforce-reform-better-jobs-and-more-care-25488">new proposal by the Grattan Institute</a> to shake up the hospital workforce and allow nurses to take on more roles traditionally performed by doctors. But should registered nurses’ roles extend even further, to prescribing medication?</p>
<p>As the population ages and has a higher rate of chronic conditions such as diabetes, heart disease and arthritis, primary care needs will continue to grow. And as a <a href="http://grattan.edu.au/static/files/assets/31e5ace5/196-Access-All-Areas.pdf">previous Grattan report noted</a>, more than one in four Australians already feel they have to wait too long for an appointment with a general practitioner.</p>
<p>But extending registered nurses’ roles to prescribing, as the <a>Nursing and Midwifery Board of Australia</a> has proposed, isn’t the answer. Australia already has a category of nurse specialists who can prescribe some medicines – nurse practitioners.</p>
<h2>International prescription</h2>
<p>In the United Kingdom, suitably trained nurses have been able to act as <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1949441/">independent prescribers</a> since 2006, and some nurses had limited prescribing rights before that date. The UK government implemented the change in a bid to improve patient choice, provide better access to care and enhance multidisciplinary team care.</p>
<p><a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2653174/">Evidence from the UK</a> suggests that overall, nurse prescribing is currently of a high quality: it’s safe, clinically appropriate and educational programs adequately prepare nurses for this role. Patients are also <a href="https://www.gov.uk/government/publications/evaluation-of-nurse-and-pharmacist-independent-prescribing-in-england-key-findings-and-executive-summary">accepting</a> of nurse prescribing.</p>
<p>Nevertheless, a <a href="http://onlinelibrary.wiley.com/doi/10.1111/hex.12193/full">recent UK study</a> found that patients generally preferred to see their own doctor for minor illnesses; however, those who had previously seen a nurse were happy to consult a nurse.</p>
<p>The cost of drugs prescribed and assessment and diagnostic skills are seen as <a href="http://www.ncbi.nlm.nih.gov/pubmed/22734082">areas where nurse prescribers</a> need to improve. International evidence suggests that nurse practitioners in primary care tend to order more investigations than doctors. They also spend more time with patients and achieve better patient compliance to medication regimes.</p>
<h2>Nurse practitioners</h2>
<p>To become a <a href="http://www.nursing.health.wa.gov.au/career/np_what.cfm">nurse practitioner</a>, Australian nurses must undergo extended education at masters level, then complete a long and rigorous process of endorsement to prove their clinical competency in a specified area such as emergency care, wound management, palliative care, and so on.</p>
<p>Most nurse practitioners in Australia work within hospitals, but some work in areas of need such as aged care, palliative care and primary care (in collaboration with a doctor, though in some isolated communities, doctors only visit periodically).</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/46500/original/w4fq8n9r-1397608630.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/46500/original/w4fq8n9r-1397608630.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=398&fit=crop&dpr=1 600w, https://images.theconversation.com/files/46500/original/w4fq8n9r-1397608630.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=398&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/46500/original/w4fq8n9r-1397608630.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=398&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/46500/original/w4fq8n9r-1397608630.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=501&fit=crop&dpr=1 754w, https://images.theconversation.com/files/46500/original/w4fq8n9r-1397608630.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=501&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/46500/original/w4fq8n9r-1397608630.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">
<figcaption>
<span class="caption">Most nurse practitioners work in hospitals.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/ufv/10983712053">University of the Fraser Valley</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
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<p>Once endorsed, nurse practitioners can diagnose and treat conditions within their scope of practice. And, since November 2010, <a href="https://theconversation.com/australia-could-do-so-much-more-with-its-nurse-practitioners-17693">nurse practitioners</a> have had limited prescribing rights.</p>
<p>A nurse practitioner working in an aged care facility, for example, is able to diagnose conditions such as urinary tract infections and prescribe antibiotics in a timely manner. This means that the patient doesn’t have to wait for a doctor to visit and risk becoming more unwell or be transferred to hospital.</p>
<p><a href="http://www.publish.csiro.au/paper/AH12019.htm">Studies show</a> that nurse practitioners can address the needs of an ageing population with chronic and complex conditions. And they may be able to provide the most cost-effective care, if they can reduce the time they spend with patients and reduce their return consultation rate (which increase the cost of care). </p>
<p>There is obviously scope for nurse practitioners to provide more care in areas of geographic isolation, where it is hard to recruit doctors and in areas such as aged care, where patients have complex and high needs. </p>
<p>They are also able to provide effective care to patients with chronic and complex conditions. Such activities could include broadening the range of medications these nurses can prescribe and enabling them to review a patient’s medication.</p>
<h2>Proposal for nurse prescribing</h2>
<p>The <a href="http://www.nursingmidwiferyboard.gov.au/">Nursing and Midwifery Board of Australia</a>, the body responsible for registering nurses and developing professional standards, released a draft proposal in October to allow registered nurses and midwives to “supply and administer” scheduled medicines.</p>
<p>This applies to registered nurses and registered midwifes but not to nurse practitioners whose rights rest in legislation.</p>
<p>The proposal would see nurses administer a range of medicines:</p>
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<img alt="" src="https://images.theconversation.com/files/46502/original/2zwqdvs4-1397609032.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/46502/original/2zwqdvs4-1397609032.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=900&fit=crop&dpr=1 600w, https://images.theconversation.com/files/46502/original/2zwqdvs4-1397609032.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=900&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/46502/original/2zwqdvs4-1397609032.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=900&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/46502/original/2zwqdvs4-1397609032.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1130&fit=crop&dpr=1 754w, https://images.theconversation.com/files/46502/original/2zwqdvs4-1397609032.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1130&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/46502/original/2zwqdvs4-1397609032.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1130&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Nurses working in rural areas of Australia already have certain rights to supply and administer prescription drugs.</span>
<span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-99253892/stock-photo-senior-woman-patient-with-uk-nurse.html?src=pp-same_model-99253898-uIIcDf9bi_meO-XhWPnXLA-3">Shutterstock</a></span>
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<ul>
<li><p>schedule 2 and 3 medicines which are available from the pharmacy without prescription such as aspirin, paracetamol, ibuprofen, and cold and flu tablets</p></li>
<li><p>schedule 4 medicines that are available by prescription only, such as contraceptives and antibiotics</p></li>
<li><p>schedule 8 drugs, which doctors need a special permit to prescribe such as fentanyl, morphine, oxycodone, which are highly addictive.</p></li>
</ul>
<p>To be eligible for endorsement, the registered nurse or midwife would need to have “completed a program of study in medicines management, clinical assessment and differential diagnosis”.</p>
<p>The draft standards state that the endorsement of registered nurses and midwives to supply and administer medication is “intended to provide safe and timely health care when a medical practitioner or nurse practitioner is not immediately available”. But it’s not clear from the draft standards how “immediately available” is defined.</p>
<p>Nurses working in rural and isolated areas currently have certain rights to <a href="http://www.nursingmidwiferyboard.gov.au/Registration-and-Endorsement/Endorsements-Notations.aspx#registered">supply and administer scheduled medicines</a>. These are recognised areas of medical workforce shortages.</p>
<h2>Unanswered questions</h2>
<p>Nurse practitioners are a relatively new professional group in Australia and, in particular, in primary care. The public and even other health professionals often have little knowledge of their skills and scope of practice. Adding another level of prescriber may bring opposition from medical groups and confusion among the public.</p>
<p>While the proposals make it clear that nurses should be properly trained to administer medication, there is also a need for them to have skills in diagnostics, history taking and recognising adverse drug reactions. As we learnt from the UK experience, this is required for best practice.</p>
<p>There is also a concern that broader nurse prescribing rights would lead to fragmentation of care and an increase in the number of people seeking out different health professionals for the supply of medication. Unlike the UK, Australians aren’t registered with a particular GP practice and can seek primary care anywhere.</p>
<p>There is also the question of insurance. Nurses endorsed to supply medication would likely face higher insurance premiums. Nurses working in health services would be covered by their employer. But those working for private business, such as a general practice, would need to get their own insurance or the practice would need to agree to provide insurance cover under its policy.</p>
<p>Although nurse prescribing has been extended in the UK, the Australian health system is different enough for us to think carefully before following this lead.</p><img src="https://counter.theconversation.com/content/19277/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Rhian Parker receives funding from the Department of Health and Ageing, Australian Capital Territory Health, the Australian Medicare Local Alliance.</span></em></p>We started the week with a new proposal by the Grattan Institute to shake up the hospital workforce and allow nurses to take on more roles traditionally performed by doctors. But should registered nurses…Rhian Parker, Associate Professor and Senior Research Fellow, Centre for Research and Action in Public Health, University of CanberraLicensed as Creative Commons – attribution, no derivatives.