tag:theconversation.com,2011:/us/topics/adverse-events-2565/articlesAdverse events – 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/1969372022-12-22T04:47:26Z2022-12-22T04:47:26ZHow common are severe side effects from COVID vaccines? And how are they detected?<figure><img src="https://images.theconversation.com/files/502490/original/file-20221221-25-frh3sg.jpg?ixlib=rb-1.1.0&rect=282%2C183%2C7897%2C5273&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://unsplash.com/photos/fMM5chAxU64">Unsplash/Engin Akyurt</a></span></figcaption></figure><p>Former federal MP Dr Kerryn Phelps has <a href="https://www.theage.com.au/politics/federal/not-anti-vaxxers-dr-kerryn-phelps-says-she-suffered-covid-vaccine-injury-calls-for-more-research-20221220-p5c7ry.html">talked this week</a> about the medical problems she and her wife had after their COVID-19 vaccinations around 18 months ago. </p>
<p>In her <a href="https://www.aph.gov.au/Parliamentary_Business/Committees/House/Health_Aged_Care_and_Sport/LongandrepeatedCOVID/Submissions">submission</a> to the parliamentary inquiry into long COVID, Phelps said her wife Jackie Stricker-Phelps had ongoing neurological problems after her first vaccine. Phelps herself experienced breathlessness and blood-pressure fluctuations after her second dose. </p>
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<p>This has prompted public discussion about severe side effects, known as “adverse events”, after COVID-19 vaccines. </p>
<p>We’re vaccine experts and while we can’t specifically comment on Phelps’ concerns, here’s how adverse events are tracked, confirmed and prevented. </p>
<h2>Understanding new health concerns</h2>
<p>In any new large vaccine rollout, some people will experience a serious medical problem in the period after the new vaccine is given, and wonder “was it from the vaccine?”. </p>
<p>This is particularly the case when the problem has an uncertain cause, is not well understood or is only recently described. People naturally want to know the cause of a problem. </p>
<p>Good vaccine safety systems address these questions. The condition occurring in a window of time after vaccination is an obvious criterion. But other factors are crucial when determining whether one thing caused another. </p>
<p>It’s important to consider these other factors, because not everything that happens after a vaccine is <a href="https://www.health.gov.au/topics/immunisation/about-immunisation/vaccine-safety?language=und">due to the vaccine</a>. Heart attacks, strokes, new autoimmune diseases, and death can all occur shortly after a vaccine. The key question is whether a vaccine caused or worsened the risk of a condition. </p>
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Read more:
<a href="https://theconversation.com/just-because-someone-had-covid-before-they-had-a-heart-attack-doesnt-mean-it-was-the-cause-194644">Just because someone had COVID before they had a heart attack doesn’t mean it was the cause</a>
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<h2>Tracking new adverse events</h2>
<p>Strong vaccine safety systems are designed to identify and investigate potential new health issues related to a vaccine. </p>
<p>Safety assessments start early in product development then proceed to clinical trial assessments. Clinical trials, including for COVID-19 vaccines, compare a group who receive the vaccine with another receiving a placebo (or another vaccine). </p>
<p>These trials are large – around 20,000-30,000 people are closely monitored for many months – but can only detect relatively common side effects. </p>
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<img alt="Nurse puts bandaid on person's arm after vaccination" src="https://images.theconversation.com/files/502491/original/file-20221221-16-1eo9th.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/502491/original/file-20221221-16-1eo9th.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/502491/original/file-20221221-16-1eo9th.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/502491/original/file-20221221-16-1eo9th.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/502491/original/file-20221221-16-1eo9th.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/502491/original/file-20221221-16-1eo9th.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/502491/original/file-20221221-16-1eo9th.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">Initial clinical trials can only detect relatively common side effects.</span>
<span class="attribution"><a class="source" href="https://unsplash.com/photos/90ejoVTj2-M">CDC/Unsplash</a></span>
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<p>More than <a href="https://ourworldindata.org/covid-vaccinations">13 billion COVID-19 vaccine doses</a> have been given globally. As vaccines are given to the wider population, many countries (including Australia) monitor for rare and serious side effects. </p>
<p>Safety monitoring has occurred across the whole populations in more than 190 countries. Detailed epidemiological studies have also included many millions of people. These studies look at whether the risk of a condition is increased in people shortly after vaccination, compared to other times or in unvaccinated people. </p>
<h2>So what have they found?</h2>
<p>Some rare but serious events caused by COVID-19 vaccines were detected within months of the vaccine rollout. </p>
<p><a href="https://www.health.gov.au/our-work/covid-19-vaccines/advice-for-providers/clinical-guidance/tts">Thrombosis with thrombocytopenia syndrome</a> is a serious but rare clotting disorder. It occurs in around one in 50,000 doses of the AstraZeneca COVID-19 vaccine, <a href="https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-15-12-2022#vaxzevria-astrazeneca-vaccine">with 173 cases</a> reported in Australia. This was rapidly reported and its detection shaped the COVID-19 vaccine rollout.</p>
<p><a href="https://www.health.gov.au/sites/default/files/documents/2022/11/covid-19-vaccination-guidance-on-myocarditis-and-pericarditis-after-covid-19-vaccines.pdf">Myocarditis</a> (inflammation of the heart muscle) has been seen more frequently, particularly in teenage boys and young men after mRNA vaccines (around two to ten cases for every 100,000 second Pfizer COVID-19 vaccine doses). While most people with myocarditis related to vaccine have mild symptoms and recover over days or weeks, a small number have more serious disease or prolonged symptoms.</p>
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Read more:
<a href="https://theconversation.com/what-happened-to-the-astrazeneca-vaccine-now-rare-in-rich-countries-its-still-saving-lives-around-the-world-181791">What happened to the AstraZeneca vaccine? Now rare in rich countries, it’s still saving lives around the world</a>
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<p>Other rare conditions related to COVID-19 vaccines include anaphylaxis, Guillain-Barré syndrome and immune thrombocytopenia. However, <a href="https://www.ncirs.org.au/covid-19/covid-19-vaccines-frequently-asked-questions">the risk for these events is lower</a> than the serious risks from COVID-19 itself in the absence of vaccination. </p>
<p>There are many “signals” or suggestions that other conditions are linked to COVID-19 vaccines. A <a href="https://www.nature.com/articles/s44161-022-00177-8">recent study</a>, for example, suggests a common syndrome call postural orthostatic tachycardia syndrome (POTS) occurred after vaccination but was five times more common after COVID-19 itself. However, as the authors of the study pointed out, further studies are needed. </p>
<p>Other signals have not been substantiated by evidence at all.</p>
<p>The <a href="https://www.who.int/groups/global-advisory-committee-on-vaccine-safety">WHO Global Advisory Committee on Vaccine Safety</a> releases regular statements as any new vaccine safety signals are investigated and confirmed.</p>
<h2>So how does Australia track vaccine problems?</h2>
<p><a href="https://www.tga.gov.au/sites/default/files/covid-19-vaccine-safety-monitoring-plan.pdf">Australia</a> monitors and assesses vaccine safety through the Therapeutic Goods Administration (TGA) and health departments, with close involvement of independent vaccine safety scientists and a range of clinical experts, by:</p>
<p><strong>1) Asking clinicians and patients to report any adverse event after vaccination to the <a href="https://aems.tga.gov.au/">TGA</a></strong> </p>
<p>The TGA examines many severe adverse events in detail, sometimes through an expert panel. Others are tracked and classified to see if they’re being reported at unusually high rates. </p>
<p>The TGA has processed more than <a href="https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-15-12-2022#vaxzevria-astrazeneca-vaccine">136,000 reports</a> for COVID-19 vaccines up to mid-November 2022. Not all reports represent events caused by the vaccine but reporting helps identify unusual patterns, including by <a href="https://www.ncirs.org.au/health-professionals/vaccine-safety">comparing</a> rates of a condition after vaccination to that seen usually in the population without vaccines (the background rate).</p>
<p>The TGA acknowledges receipt of reports but does not routinely give feedback on individual cases. In some cases, the person reporting is contacted if further information is required to either complete or assess the adverse event report. </p>
<p><strong>2) Using active surveillance systems including <a href="https://ausvaxsafety.org.au/">AusVaxSafety</a></strong></p>
<p>Researchers survey millions of people at regular intervals after vaccination to look for new signals and publish fortnightly real-time <a href="https://ausvaxsafety.org.au/vaccine-safety-data/covid-19-vaccines">reports</a>. </p>
<p>These reports and <a href="https://www.mja.com.au/journal/2022/217/4/short-term-safety-covid-19-vaccines-australia-ausvaxsafety-active-surveillance">peer-reviewed studies</a> show COVID-19 vaccines have a very good safety profile, including in people with a range of pre-existing medical conditions. These people benefit most from vaccination as they are at highest risk of complications from COVID-19.</p>
<p><strong>3) Monitoring for conditions that could theoretically be a risk after vaccination</strong></p>
<p>This occurs in all phases of vaccine development, clinical trials and program rollouts, often using specially designed studies and long term follow-up.</p>
<figure class="align-center ">
<img alt="Older man in waiting room" src="https://images.theconversation.com/files/502492/original/file-20221221-12-yavcg1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/502492/original/file-20221221-12-yavcg1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/502492/original/file-20221221-12-yavcg1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/502492/original/file-20221221-12-yavcg1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/502492/original/file-20221221-12-yavcg1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/502492/original/file-20221221-12-yavcg1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/502492/original/file-20221221-12-yavcg1.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">We need to monitor for adverse events is several different ways.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/elderly-man-sitting-doctors-office-hospital-1675478047">Shutterstock</a></span>
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</figure>
<p><strong>4) Getting information and safety reports from other countries, <a href="https://www.icmra.info/drupal/en">multinational groups</a> and vaccine manufacturers</strong></p>
<p>This is done continuously. Thrombosis with thrombocytopenia syndrome (the rare clotting disorder), for example, was first reported in Europe and myocarditis in Israel. </p>
<p><strong>5) Looking at studies using large <a href="https://www.globalvaccinedatanetwork.org/">electronic health databases</a> to check for for positive or negative links between vaccination and health conditions</strong></p>
<p>These types of studies showed <a href="https://www.nejm.org/doi/10.1056/NEJMoa021134">no link</a> between measles, mumps and rubella vaccines and autism. They must take into account many factors, such as having COVID-19 itself. </p>
<p>A <a href="https://www.medrxiv.org/content/10.1101/2022.10.12.22280990v2">recent Danish study</a>, yet to be peer-reviewed, for example, showed fewer new health problems four months after Omicron infection in people given a booster compared to those given only two doses of COVID-19 vaccine. </p>
<p><strong>6) Using a national <a href="https://www.ncirs.org.au/health-professionals/specialist-immunisation-services">network of specialist clinicians</a> to support GPs and specialists to assess patients with complex immunisation questions</strong></p>
<p>This includes questions about health conditions before or after vaccines, and how to approach additional vaccine doses.</p>
<h2>What if you have an adverse effect after vaccination?</h2>
<p>The first thing to do is report it. Either patients or clinicians <a href="https://aems.tga.gov.au/">can report</a> adverse events to the TGA. </p>
<p>Second, ensure your health care is managed by a GP and/or specialist who can investigate all possible causes, and seek expert support as needed.</p>
<p>When rare adverse events are shown to be caused by a vaccine, people should be compensated. </p>
<p>In August 2021, the Australian government <a href="https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/no-fault-covid-19-indemnity-scheme">announced a scheme</a> to support individuals suffering from serious health conditions caused by a COVID-19 vaccination, joining <a href="https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0233334">many other countries</a> in doing so. </p>
<p>Despite the slow implementation, <a href="https://www.health.gov.au/our-work/covid-19-vaccine-claims-scheme">no-fault vaccine compensation</a> is a key component of a comprehensive vaccine safety program. We recommend ensuring this scheme is optimised and also includes all vaccines, not just those for COVID-19.</p>
<h2>Transparency is essential</h2>
<p>It’s important to have <a href="https://www.crikey.com.au/2022/12/21/vaccine-safety-side-effects-covid-19/">open and evidence-informed discussions</a> about the benefits and risks of vaccination – both for COVID-19 and other vaccine-preventable diseases. </p>
<p>Vaccines are clearly life-saving. A recent study estimated there were <a href="https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(22)00320-6/fulltext">20 million fewer deaths</a> in the first year of program rollout thanks to COVID-19 vaccines. </p>
<p>However, a key to achieving high coverage is confidence, which requires transparency about vaccine safety, as well as factual and empathic communication.</p><img src="https://counter.theconversation.com/content/196937/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Kristine Macartney receives salary in her role as the Director of the National Centre for Immunisation Research and Surveillance (NCIRS). NCIRS receives funding from the Australian and state and territory government departments of health and DFAT, the WHO, Gavi the Vaccine Alliance, the NHMRC and MRFF. She is a member of the WHO Global Advisory Committee on Vaccines (GACVS), the Australian Technical Advisory Group on Immunisation (ATAGI) and the Advisory Committee on Vaccines (ACV) and other advisory groups.</span></em></p><p class="fine-print"><em><span>Allen Cheng receives funding from the Australian Health and Medical Research Council. He is the Chair of the Advisory Committee for Vaccines (advising the Therapeutic Goods Administration) and is a member of the Australian Technical Advisory Group on Immunisation. </span></em></p><p class="fine-print"><em><span>Christopher Blyth receives funding from the NHMRC and MRFF. He is a member of the COVID-19 SITAG and past member of the Australian Technical Advisory Group on Immunisation.</span></em></p><p class="fine-print"><em><span>Julie Leask receives funding from the World Health Organization, UNICEF, NHMRC and the National Centre for Immunisation Research and Surveillance. Funds go to her institution. She has previously received a sitting fee from the Therapeutic Goods Administration for participation in an expert advisory group. </span></em></p>Former MP Dr Kerryn Phelps’ COVID vaccination experience has prompted discussion about severe side effects after COVID vaccines. Here’s how they’re tracked, confirmed and prevented.Kristine Macartney, Professor, Discipline of Paediatrics and Child Health, University of SydneyAllen Cheng, Professor in Infectious Diseases Epidemiology, Monash UniversityChristopher Blyth, Paediatrician, Infectious Diseases Physician and Clinical Microbiologist, Telethon Kids Institute, The University of Western AustraliaJulie Leask, Professor, Susan Wakil School of Nursing and Midwifery, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1921592022-10-13T01:49:23Z2022-10-13T01:49:23ZCOVID or COVID vaccination can cause dermal fillers to swell up<figure><img src="https://images.theconversation.com/files/488933/original/file-20221010-26-zr4sy.jpg?ixlib=rb-1.1.0&rect=26%2C35%2C5955%2C3332&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://images.pexels.com/photos/9157201/pexels-photo-9157201.jpeg?auto=compress&cs=tinysrgb&w=1260&h=750&dpr=2">Pexels/Youssef Labib</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span></figcaption></figure><p>The growing list of COVID complications is long and surprising – from <a href="https://theconversation.com/even-mild-covid-can-cause-brain-shrinkage-and-affect-mental-function-new-study-shows-178530">brain changes</a> and <a href="https://theconversation.com/even-mild-covid-raises-the-chance-of-heart-attack-and-stroke-what-to-know-about-the-risks-ahead-190552">heart disease</a> to <a href="https://theconversation.com/8-ways-the-coronavirus-can-affect-your-skin-from-covid-toes-to-rashes-and-hair-loss-144483">skin rashes and COVID toes</a>. </p>
<p>Those who get dermal fillers injected into their face have the possibility of an additional complication: swelling and discomfort if they get COVID or a dose of a COVID vaccine. So should they take extra precautions, or time their treatments? </p>
<h2>What are dermal fillers?</h2>
<p>Fillers are now one of the most common <a href="https://plasticsurgery.org.au/procedures/non-surgical-procedures/">non-surgical cosmetic procedures</a>. Adding fillers to the face can address facial drooping; injections into the high cheekbone area lift the face. </p>
<p>Today’s patients might receive soft fillers in the lips and mouth areas, combined with <a href="https://www.plasticsurgery.org/cosmetic-procedures/botulinum-toxin">botulinum toxins</a> (botox) in overactive facial muscles, and lasers and light sources on the skin.</p>
<p>Dermal fillers are used to <a href="https://www.liebertpub.com/doi/abs/10.1089/fpsam.2020.0148">address facial asymmetry</a>, which can cause functional, psychological/social, and reduced quality-of-life issues. Cosmetically, dermal fillers may give an immediate confidence boost.</p>
<p>Soft tissue fillers are usually hyaluronic acid products. Some <a href="https://www.betterhealth.vic.gov.au/health/conditionsandtreatments/cosmetic-treatments-injectables">other formulations</a> that stimulate tissues are also used.</p>
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<figcaption><span class="caption">Fillers can only be prescribed by a registered medical practitioner.</span></figcaption>
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<p>Although soft tissue fillers are considered safe, several studies have shown <a href="https://onlinelibrary.wiley.com/doi/10.1111/jocd.14840">complications</a> occur with all filler types. Delayed inflammatory reactions – such as red and/or firm lumps possibly with swelling – are among the most common. The cause of these reactions is unknown, so treatments will vary. </p>
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<strong>
Read more:
<a href="https://theconversation.com/8-ways-the-coronavirus-can-affect-your-skin-from-covid-toes-to-rashes-and-hair-loss-144483">8 ways the coronavirus can affect your skin, from COVID toes, to rashes and hair loss</a>
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<h2>Puffy reactions</h2>
<p>From 2020 to August 2021 there were around 19 reports in the medical literature of late inflammatory reactions in people who had previously <a href="https://onlinelibrary.wiley.com/doi/10.1111/jocd.14840">had COVID or a COVID vaccine</a> occurring between weeks and years after filler treatment. The general incidence of such complications after the injection of soft tissue fillers sits between 0.01% to 4.25% of procedures.
Not all cases are reported.</p>
<p>The reasons for <a href="https://www.liebertpub.com/abs/doi/10.1001/jamafacial.2017.1888">such reactions</a> are not fully understood. There are many theories on how they can occur including immune reactions to filler triggered by infection, trauma or vaccination.</p>
<p>So it makes sense that late inflammatory reactions have been reported after infection with SARS-CoV-2 (the virus that causes COVID) and vaccination to protect against it. </p>
<p>The first US Food and Drug Administration (FDA) reports on the Moderna vaccine showed <a href="https://www.fda.gov/media/144434/download">adverse events</a> in three patients with soft tissue fillers. These complications can occur between 15 days and six months after filler injections. And they can occur three to four weeks after COVID infection. Filler complications can begin quickly after receiving a mRNA COVID vaccination, between 13 hours and three weeks post-injection. </p>
<p>Clinical symptoms are redness, swelling, formation of lumps and discomfort in the filled areas. Some of the patients with <a href="https://onlinelibrary.wiley.com/doi/10.1111/jocd.14840">reported complications</a> have had a history of spontaneous facial swelling after a filler injection, previous vaccinations, or after other medical treatments.</p>
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<p>It is not the first time adverse events after filler treatment have been reported after a viral infection, for example <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6501047/">after an influenza-like illnesses</a>. </p>
<p>The condition generally has a good response to oral corticosteroids, while some patients need <a href="https://www.cancer.gov/publications/dictionaries/cancer-terms/def/hyaluronidase">hyaluronidase</a> injections to dissolve the filler.</p>
<p>It has been <a href="https://pubmed.ncbi.nlm.nih.gov/33681439/">suggested</a> treatment with an angiotensin-converting enzyme inhibitor (ACE-1, usually prescribed to manage blood pressure), which plays a crucial role in SARS-CoV-2 binding properties, can reduce swelling in late inflammatory reactions. </p>
<p>Genetic factors are likely to play a role in who gets complications after dermal filler injections generally, with studies <a href="https://onlinelibrary.wiley.com/doi/10.1111/dth.14644">pinpointing the genes</a> responsible in those who experience reactions. These individuals might have a lower threshold to infections, vaccines, or other factors that trigger an immune response.</p>
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<h2>What patients can do</h2>
<p>Although small in number, the cases so far show adverse reactions with soft tissue filler occur <a href="https://www.health.harvard.edu/staying-healthy/should-i-get-a-covid-19-vaccine-if-ive-had-dermal-fillers">after COVID infection and vaccination</a>. The relationship between these factors seems likely, as they occur within a few hours or up to several weeks afterwards. </p>
<p>To prevent possible complications, the following recommendations have been suggested for those wishing to proceed with a filler: </p>
<ul>
<li><p>ideally, allow a two- to four-week window between filler injections and vaccination in general, and two months longer for immunocompromised patients (those taking immunosuppressive medications, having chemotherapy, or with immune disorders) or after COVID infection</p></li>
<li><p>proceed with caution if there is a history of allergies, filler-related adverse events or problems after other types of implants</p></li>
<li><p>because vaccination protects against severe COVID, long COVID and death, delay the filler rather than the vaccination</p></li>
<li><p>if a reaction does occur, then your doctor can consider starting treatment with oral steroids, provided there is no infection.</p></li>
</ul>
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Read more:
<a href="https://theconversation.com/friday-essay-toxic-beauty-then-and-now-84267">Friday essay: toxic beauty, then and now</a>
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<p><em>Correction: this article has been updated to show the quoted percentage of late inflammatory reactions is a general one, rather than referring to the percentage of people who had reactions post COVID or post COVID vaccine.</em></p><img src="https://counter.theconversation.com/content/192159/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Michael Freeman is the founder of The Skin Centre, a private dermatology practice which also offers dermal fillers.</span></em></p>A small number of case reports indicate some people who have had dermal filler injections can experience swelling and discomfort after COVID infection or vaccination.Michael Freeman, Dermatologist, Associate Professor, Bond UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1803312022-04-27T02:00:17Z2022-04-27T02:00:17ZAnticipating a side effect makes it more likely you’ll experience it – this could contribute to vaccine hesitancy<figure><img src="https://images.theconversation.com/files/459469/original/file-20220425-61522-s6tiqh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">nocebo</span> </figcaption></figure><p>The COVID pandemic has highlighted several interesting features of modern medical practice – most recently the “nocebo” response, which may account for a significant number of side effects people experience following vaccination.</p>
<p>Nocebo responses (from Latin noci: to harm) are the opposite of the better known <a href="https://jamanetwork.com/journals/jama/article-abstract/303530">placebo</a>. While the latter describes <a href="https://www.nature.com/articles/d41586-021-02939-z">improvements in symptoms</a> following inert medication, the nocebo response heightens symptoms if a person anticipates them. It can increase pain if someone expects something will hurt.</p>
<p>A fascinating <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2788172">meta-analysis</a> examined data from 12 clinical trials of COVID vaccines, involving over 45,000 participants, and found about two-thirds of common side effects people experience after vaccination could be due to a nocebo response, rather than the vaccine itself.</p>
<p>Nocebo responses can be troublesome and significant. They include headaches, fatigue, muscle pains, nausea or diarrhoea. Such symptoms may be related to anxiety or negative expectations, or day-to-day sensations being <a href="https://pubmed.ncbi.nlm.nih.gov/19781854/">incorrectly attributed to a treatment</a>.</p>
<p>While <a href="https://pubmed.ncbi.nlm.nih.gov/30526685/">previous analysis</a> in other fields had already confirmed the presence of nocebo responses in randomised trials, COVID vaccine research dramatically highlights its frequency. </p>
<p>The latest study found up to 35% of patients in the placebo arm of vaccine trials had adverse events such as headaches and fatigue. Mathematical analysis showed 50-75% of patient symptoms after the real vaccination (not placebo) may have been caused by those nocebo responses. </p>
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Read more:
<a href="https://theconversation.com/its-still-not-fully-understood-how-placebos-work-but-an-alternative-theory-of-consciousness-could-hold-some-clues-165999">It's still not fully understood how placebos work – but an alternative theory of consciousness could hold some clues</a>
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<p>A different group of researchers from Italy reviewed other COVID vaccine trials and <a href="https://pubmed.ncbi.nlm.nih.gov/34729549/">confirmed these conclusions</a>. These findings are potentially significant, as <a href="https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0170550">vaccine hesitancy and refusal</a> have been linked to patient concerns about side effects or major adverse events. Knowing how frequently self-limiting nocebo responses happen may reduce vaccine hesitancy. </p>
<h2>The ‘meaning response’</h2>
<p>Together, the placebo and nocebo effects are better understood as two aspects of what medical practitioners call a “meaning response”. Both occur in relation to the importance and <a href="https://pubmed.ncbi.nlm.nih.gov/11900500/">meaning patients place on their illness</a>, their relationship with their healthcare providers, and their thoughts and beliefs about proposed treatments. </p>
<p>Nocebo responses are now being recognised as potentially important contributors to patient outcomes. For example, if a doctor or nurse give pessimistic or negative information about pain, various studies have demonstrated the <a href="https://www.sciencedirect.com/science/article/abs/pii/S0304395908000699">patient’s pain can worsen</a>, regardless of the degree of tissue damage. </p>
<p>Not feeling validated or respected by the doctor may also <a href="https://www.tandfonline.com/doi/full/10.1179/1753614614Z.00000000083">inhibit the efficacy of medications</a> and increase side effects.</p>
<p>Previous research in New Zealand has also illustrated how negative media coverage may increase patients’ experiences of adverse events after compulsory changes to their medication regimes. For example, <a href="https://pubmed.ncbi.nlm.nih.gov/27230704/">brand switches of thyroxine</a> in 2007 and of an <a href="https://cpe.psychopen.eu/index.php/cpe/article/view/2361">antidepressant</a> in 2018 were followed by increased reporting of side effects and adverse events.</p>
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<p>Acknowledging and publicising the potential contribution of nocebo responses may be useful for further <a href="https://bpac.org.nz/2019/nocebo.aspx">generic substitutions</a>. </p>
<h2>Implications for COVID vaccinations</h2>
<p>Vaccinators need to avoid inadvertently contributing to nocebo responses when advising their patients. They could use <a href="https://pubmed.ncbi.nlm.nih.gov/30894815/">positive framing</a> about the very low risk of serious adverse events. They could also briefly explain that nocebo responses are common and self-limiting.</p>
<p>However, my own experience as a patient receiving three COVID vaccinations was disconcerting. No one in the various vaccinating teams said anything positive about the vaccine or its efficacy in preventing me or my family from catching the virus, or reducing the severity of the illness if we did. </p>
<p>And just after receiving the third injection, I was further disquieted by warnings about chest pain and reminders I should seek immediate medical attention if I experienced any. This extra information on heart problems as a potential adverse event followed recent concerns about <a href="https://www.medsafe.govt.nz/safety/Alerts/comirnaty-myocarditis-alert.htm#profs">rare cases of myocarditis after vaccination</a>.</p>
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Read more:
<a href="https://theconversation.com/coronavirus-could-reading-about-the-pandemic-cause-harm-135585">Coronavirus: could reading about the pandemic cause harm?</a>
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<p>All the vaccinating staff were conscientious and kind, but it seemed odd they hadn’t been instructed to discuss the benefits of vaccination. It might have been a useful approach to country-wide vaccine hesitancy. </p>
<p>While well intended, it is possible their emphasis on serious side effects from the vaccine may increase the incidence of nocebo responses in a population already <a href="https://pubmed.ncbi.nlm.nih.gov/33682603/">primed</a> for them. This could mean more patients will present to their doctors or emergency departments with symptoms unrelated to the vaccine itself. </p>
<h2>How to improve awareness</h2>
<p>Anecdotally, advice from vaccinators appears to be quite variable. It may be helpful if they incorporated an understanding of potential placebo and nocebo responses into their <a href="https://pubmed.ncbi.nlm.nih.gov/30110575/">vaccination advice to each patient</a>.</p>
<p>Health authorities and health professionals need to understand meaning responses and their <a href="https://pubmed.ncbi.nlm.nih.gov/22318275/">role in clinical practice</a>. Incorporating those insights into healthcare communication may <a href="https://eprints.whiterose.ac.uk/161546/3/Nocebo_systematic_review_manuscript_260616.pdf">prevent unnecessary patient anxiety</a>, worrisome symptoms and considerable healthcare expenditure. </p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/vaccine-resistance-has-its-roots-in-negative-childhood-experiences-a-major-study-finds-180114">Vaccine resistance has its roots in negative childhood experiences, a major study finds</a>
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<p>Respecting autonomy means <a href="https://jme.bmj.com/content/47/9/590">patients need to be asked</a> if they want to receive information about side effects or adverse events. The juggle is how to inform patients about the very low risk of serious harm while not increasing their apprehension. </p>
<p>Pandemic research is now also <a href="https://www.sciencedirect.com/science/article/pii/S2090123221002320">exploring potential parallels</a> between long COVID and other chronic conditions such as Myalgic Encephalitis/Chronic Fatigue Syndrome as well as tentative associations between <a href="https://bmjopen.bmj.com/content/12/2/e053915">adverse childhood experiences</a> and vaccine hesitancy. </p>
<p>Without intending to minimise the pandemic’s devastating impact, it is providing us with useful insights into wider current medical and sociological issues.</p><img src="https://counter.theconversation.com/content/180331/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Hamish Wilson 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>Studies show if medical staff talk about potential side effects in negative terms, the patient’s experience can worsen. We need to consider this ‘nocebo’ effect when talking about COVID vaccinations.Hamish Wilson, Associate Professor in General Practice, University of OtagoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1664012021-08-25T12:27:47Z2021-08-25T12:27:47ZUnverified reports of vaccine side effects in VAERS aren’t the smoking guns portrayed by right-wing media outlets – they can offer insight into vaccine hesitancy<figure><img src="https://images.theconversation.com/files/417267/original/file-20210820-19-1ul7s7t.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2121%2C1412&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Studying trends in public adverse event reporting could help researchers address vaccine hesitancy and misinformation.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/symbol-of-the-manipulation-of-information-on-royalty-free-illustration/1287191706">Pict Rider/iStock via Getty Images Plus</a></span></figcaption></figure><p>Chances are you may not be not familiar with <a href="https://vaers.hhs.gov/about.html">the Vaccine Adverse Event Reporting System, or VAERS</a>. Co-managed by the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration, VAERS was established in 1990 to detect possible safety problems with vaccines.</p>
<p>Unfortunately, the anti-vaccine movement has used this once-obscure database to spread <a href="https://www.vice.com/en/article/qjpmp7/anti-vaxxers-misuse-federal-data-to-falsely-claim-covid-vaccines-are-dangerous">misinformation about the COVID-19 vaccine</a>.</p>
<p>VAERS is ripe for exploitation because it relies on unverified self-reports of side effects. Anyone who received a vaccine can submit a report. And because this information is publicly available, misinterpretations of its data has been used to <a href="https://www.npr.org/sections/health-shots/2021/06/14/1004757554/anti-vaccine-activists-use-a-federal-database-to-spread-fear-about-covid-vaccine">amplify COVID-19 misinformation</a> through <a href="https://www.npr.org/sections/health-shots/2021/06/14/1004757554/anti-vaccine-activists-use-a-federal-database-to-spread-fear-about-covid-vaccine">dubious social media channels</a> and mass media, including one of the <a href="https://www.factcheck.org/2021/05/scicheck-tucker-carlson-misrepresents-vaccine-safety-reporting-data/">most popular shows on cable news</a>.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1389966364530515970"}"></div></p>
<p>We are <a href="https://scholar.google.com/citations?user=v6UjvxIAAAAJ&hl=en">political scientists</a> <a href="https://scholar.google.ca/citations?user=05S4uMoAAAAJ&hl=en">who study</a> the social, political and psychological underpinnings of vaccine hesitancy in the U.S. In our <a href="https://doi.org/10.1371/journal.pone.0256395">recently published research</a>, we argue that VAERS, despite its limitations, can teach us about more than just vaccine side effects – it can also offer powerful new insights into the origins of vaccine hesitancy in the U.S.</p>
<h2>What the side effects database was designed to do</h2>
<p>Medical experts at the Department of Health and Human Services are <a href="https://apnews.com/article/fact-checking-afs:Content:9957832237">well aware of</a> <a href="https://vaers.hhs.gov/data/dataguide.html">VAERS’ limitations</a>. Rather than taking each individual report at face value, regulators remove clearly fraudulent reports. Demonstrating this, anesthesiologist and autism advocate James Laidler once used the system to report that a vaccine <a href="https://www.beckershospitalreview.com/data-analytics/some-self-reported-cdc-data-fueling-the-anti-vaccination-movement.html">turned him into the “Incredible Hulk,”</a> which was only removed <a href="https://web.archive.org/web/20130419004549/http://neurodiversity.com/weblog/article/14/chelation-autism">after he agreed to have the data deleted</a>.</p>
<p>Regulators also look for <a href="https://www.bloomberg.com/news/features/2021-04-28/is-covid-vaccine-safe-doubt-around-shots-threatens-to-extend-the-pandemic">reporting patterns</a> that can be corroborated by additional evidence. For example, reports of Guillain-Barré syndrome should be <a href="https://www.cdc.gov/vaccinesafety/concerns/guillain-barre-syndrome.html">more common in people over 50</a> than in younger adults. This can <a href="https://theconversation.com/new-covid-19-vaccine-warnings-dont-mean-its-unsafe-they-mean-the-system-to-report-side-effects-is-working-164455">help researchers</a> identify potential adverse events that were not detected in clinical trials.</p>
<p>Because VAERS claims are self-reported, they tell us something about what ordinary people, as opposed to doctors and medical researchers, think about vaccine safety. In other words, people who feel that a vaccine is responsible for a side effect they might be experiencing can log that concern with the federal government, whether or not those claims would stand scrutiny in rigorous clinical testing.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/417462/original/file-20210823-17-1mp2j8y.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Red breaking news banner behind two vials of COVID-19 vaccine." src="https://images.theconversation.com/files/417462/original/file-20210823-17-1mp2j8y.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/417462/original/file-20210823-17-1mp2j8y.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=338&fit=crop&dpr=1 600w, https://images.theconversation.com/files/417462/original/file-20210823-17-1mp2j8y.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=338&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/417462/original/file-20210823-17-1mp2j8y.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=338&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/417462/original/file-20210823-17-1mp2j8y.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=424&fit=crop&dpr=1 754w, https://images.theconversation.com/files/417462/original/file-20210823-17-1mp2j8y.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=424&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/417462/original/file-20210823-17-1mp2j8y.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=424&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Media stories on vaccine side effects can influence public sentiments toward vaccination.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/covid-19-vaccine-in-the-tv-studio-royalty-free-image/1288842567">MikeMareen/iStock via Getty Images Plus</a></span>
</figcaption>
</figure>
<p>Consequently, VAERS reports might not only document people’s negative experiences with vaccination, but also their attitudes toward vaccination. People may be more likely to report side effects, for example, in response to media stories about vaccine safety concerns. If reports to VAERS increase following these stories, then the reporting system may be functioning similarly to a public opinion poll. It could reflect, in part, public attentiveness to and concern about potential side effects. To see if this is the case, we examined a well-known case of vaccine misinformation: the since-retracted paper that claimed a link between the Measles, Mumps, and Rubella (MMR) vaccine to childhood autism.</p>
<h2>Is a fraudulent study responsible for MMR vaccine skepticism?</h2>
<p>In 1998, former physician Andrew Wakefield and his colleagues published a <a href="https://dx.doi.org/10.1503%2Fcmaj.109-3179">since-retracted</a> paper claiming that the MMR vaccine could cause autism in children. Although the study was rife with unreported conflicting interests and data manipulation, it nevertheless garnered <a href="https://doi.org/10.1542/peds.2007-1760">significant media attention</a> in the late 1990s. <a href="https://time.com/5175704/andrew-wakefield-vaccine-autism/">Some journalists</a> and <a href="https://doi.org/10.1016/j.vaccine.2010.02.052">researchers</a> have since argued that the paper played a major role in inspiring <a href="https://doi.org/10.1016/S1473-3099(20)30522-3">MMR vaccine hesitancy</a>.</p>
<p>While this is plausible, there hasn’t been evidence to support the argument. <a href="https://doi.org/10.1371/journal.pone.0256395">Virtually no opinion polling about MMR</a> existed prior to the publication of Wakefield’s paper. Consequently, researchers have not been able to directly observe whether or not the study influenced how Americans think about the MMR vaccine.</p>
<p>VAERS data, however, could offer some clues. In our study, we examined whether the number of VAERS reports following publication of Wakefield’s paper was significantly greater than expected based on typical report numbers prior to its publication. We found that the number of adverse event reports for MMR <a href="https://doi.org/10.1371/journal.pone.0256395">increased by about 70 reports per month</a> following publication of the paper. This is significantly greater than what we would expect by chance based on previous reporting frequencies. Notably, we did not find a similar effect for other childhood vaccines in the same time period. This further underscores the power this since-debunked study has had in shaping public opinion about the MMR vaccine.</p>
<p>Importantly, we also found that adverse event reporting rates <a href="https://doi.org/10.1371/journal.pone.0256395">rose in tandem with negative media coverage</a> of the MMR vaccine. Following the publication of Wakefield’s paper, television and print news published significantly more stories about MMR than before the paper was published. These results suggest that Wakefield’s article influenced how much more attentive Americans were about the MMR vaccine.</p>
<h2>VAERS: A double-edged sword</h2>
<p>In recent months, interest in the side effects reporting system has been growing exponentially. Google search engine trends suggest that more <a href="https://trends.google.com/trends/explore?geo=US&q=VAERS">Americans have been looking up VAERS</a> than ever before. The trend began shortly after <a href="https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19">emergency use authorization of the first COVID-19 vaccines</a> in the U.S. and has continued to increase until a peak in early August.</p>
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<p>This search behavior is likely a result of increased media attention to VAERS, particularly by right-leaning news outlets. According to the data from media research platform <a href="https://mediacloud.org/about">Media Cloud Explorer</a>, there have been 459 stories in mainstream national news outlets, such as CNN or the USA Today, mentioning VAERS since December 2020. In right-wing media outlets such as Fox News, The Daily Caller and Breitbart, however, coverage soared to 3,254 stories – over seven times more than mainstream news media.</p>
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<p>Consequently, VAERS data could be seen as something of a double-edged sword. On one hand, it has been <a href="https://doi.org/10.1126/science.abj6981">weaponized by the anti-vaccine movement</a> and <a href="https://doi.org/10.1017/S0008423920000396">political actors on the right</a> to sow doubt and distrust about COVID-19 vaccinations. On the other hand, this data could also tell public health researchers something useful about how American vaccine skepticism might ebb and flow in response to events like the brief <a href="https://www.fda.gov/news-events/press-announcements/fda-and-cdc-lift-recommended-pause-johnson-johnson-janssen-covid-19-vaccine-use-following-thorough">pause in Johnson & Johnson COVID-19 vaccine administration</a>, or fluctuations in the tone of media coverage about COVID-19 vaccines.</p>
<p>VAERS data may even offer an important advantage over public opinion polls which, with the exception of <a href="https://morningconsult.com/covid19-vaccine-dashboard/">weekly vaccine uptake polls</a>, have typically been administered much less frequently. Our research cautions that media attention to discredited vaccine-related claims may undermine public confidence in vaccination.</p>
<p>[<em>Understand new developments in science, health and technology, each week.</em> <a href="https://theconversation.com/us/newsletters/science-editors-picks-71/?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=science-understand">Subscribe to The Conversation’s science newsletter</a>.]</p>
<h2>How to avoid another wave of misinformation</h2>
<p>To ensure that VAERS is used properly, journalists and scientific researchers can team up to guide the public on how to interpret new findings. Journalists should, in our view, contextualize their coverage within a broader body of scientific evidence. Scientific researchers can aid in this by helping journalists <a href="https://doi.org/10.1371/journal.pone.0248328">accurately portray studies on vaccine side effects</a>, clearly outlining their methodologies and results in accessible language.</p>
<p>By <a href="https://www.aaas.org/resources/communication-toolkit">working together</a>, researchers and journalists can take constructive action to address vaccine hesitancy before it has a chance to germinate.</p><img src="https://counter.theconversation.com/content/166401/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Anti-vaccine activists are using the side effect reporting system to spread fear and misinformation about the COVID-19 vaccines. But the database could also be used as a gauge for public concerns.Matt Motta, Assistant Professor of Political Science, Oklahoma State UniversityDominik Stecuła, Assistant Professor of Political Science, Colorado State UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1644552021-07-19T12:11:41Z2021-07-19T12:11:41ZNew COVID-19 vaccine warnings don’t mean it’s unsafe – they mean the system to report side effects is working<figure><img src="https://images.theconversation.com/files/411706/original/file-20210716-21-lunh2y.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C5000%2C3366&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Put into context, the benefits of vaccination still far outweigh the risks of rare adverse events.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/vaccine-vial-over-squared-board-with-its-royalty-free-illustration/1263990592">PenWin/iStock via Getty Images Plus</a></span></figcaption></figure><p>While the COVID-19 vaccines currently available in the U.S. have been <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html">proved to be safe and effective</a>, recent reports of rare <a href="https://www.cancer.gov/publications/dictionaries/cancer-terms/def/adverse-event">adverse events</a>, or side effects, have raised concerns. On July 12, 2021, the Food and Drug Administration approved an update to the Johnson & Johnson COVID-19 vaccine <a href="https://www.fda.gov/media/150723/download">fact sheet</a> to include an increased risk of the rare nerve condition <a href="https://www.cdc.gov/campylobacter/guillain-barre.html">Guillain-Barré syndrome</a>. This follows previous reports linking the J&J vaccine with a <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/JJUpdate.html">rare blood clot</a>. </p>
<p>While reports like these can be scary, they’re a sign that the vaccine safety reporting system is working. They also highlight how the relative risks of rare side effects like these need to be put into context.</p>
<p>As a pharmacist who has been managing operations for the University of Virginia Health System’s COVID-19 vaccine program for the past seven months, I’ve seen how uncertainty and fear over potential side effects can drive vaccine hesitancy. Understanding how information about adverse events is collected and what it means for vaccine safety may help people make informed decisions about their health.</p>
<h2>Tracking safety before, during and after approval</h2>
<p>The FDA enforces rigorous testing and approval processes that manufacturers must follow before a new vaccine can be made available to the public. Regardless of whether a vaccine is approved through the <a href="https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-development-101">typical FDA approval process</a> or an <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">Emergency Use Authorization (EUA)</a>, the steps required to test a new drug for safety and effectiveness are the same. An EUA can get a vaccine to the public more quickly by <a href="https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained">streamlining the regulatory process</a>, but no shortcuts are taken. Every step is taken to ensure the vaccine is both safe and effective.</p>
<p>Vaccine clinical trials occur in <a href="https://www.fda.gov/patients/drug-development-process/step-3-clinical-research">four sequential phases</a>. In the first three phases, study investigators are the ones who identify, quantify and document safety issues. Phase 1 typically introduces the vaccine to fewer than 100 people over several months under controlled conditions. Typically, the majority of potential adverse events are identified in this stage. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="People getting vaccinated at various vaccine stations in a clinic." src="https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=347&fit=crop&dpr=1 600w, https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=347&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=347&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=436&fit=crop&dpr=1 754w, https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=436&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=436&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Everyday people can contribute to vaccine safety monitoring even after it is approved by the FDA.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/people-get-vaccinated-at-a-vaccination-clinic-at-save-max-news-photo/1233919589">Xinhua News Agency via Getty Images</a></span>
</figcaption>
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<p>After the FDA reviews phase 1 data and deems the vaccine safe enough to be studied further, the vaccine moves on to phases 2 and 3, where it will be given to larger numbers of people over longer periods of time. Here, investigators determine optimal dosage and screen for rare side effects. </p>
<p>If phase 2 and 3 data meets FDA approval standards, the vaccine will then move on to phase 4 and become available to the public. The vaccine is observed over much larger populations and extended periods of time, and manufacturers are required to regularly check and report potential safety concerns to the FDA.</p>
<p>What’s different about this final phase is that the public can also contribute to safety reporting. The <a href="https://vaers.hhs.gov/about.html">Vaccine Adverse Event Reporting System (VAERS)</a> is a national safety monitoring system run by the FDA and Centers for Disease Control and Prevention. While certain types of adverse events, such as injuries during vaccine administration and serious complications, are <a href="https://vaers.hhs.gov/docs/VAERS_Table_of_Reportable_Events_Following_Vaccination.pdf">mandatory for health care providers to report</a>, anyone can submit a report. Recent adverse events associated with the COVID-19 vaccine, including <a href="https://theconversation.com/rare-neurological-disorder-guillain-barre-syndrome-linked-to-covid-19-141511">Guillain-Barré</a> and thrombosis for Johnson & Johnson and <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-june-25-2021">myocarditis</a> for Pfizer, were identified through VAERS.</p>
<h2>Serious adverse event risk from vaccines is small</h2>
<p>A rare adverse event may take months or years to identify for a simple reason: It’s rare. For some drugs that are less commonly used, new safety data takes longer to discover because a relatively small number of patients use the drug. For example, though the shingles vaccine Shingrix was approved 2017, it wasn’t until <a href="https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-warning-about-guillain-barre-syndrome-gbs-be-included-prescribing-information-shingrix">March 2021</a> after over 3.7 million patients had gotten the shot that the FDA announced a potential increased risk of Guillain-Barré. And it still hasn’t been confirmed that the Shringrix vaccine causes the nerve condition.</p>
<p>For cases like the COVID-19 vaccine, however, millions of people will receive the drug shortly after it’s released to the public, and new issues or patterns often emerge more quickly. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/zBkVCpbNnkU?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Adverse events that occur closely following vaccination may not be caused by or even related to the vaccine.</span></figcaption>
</figure>
<p>This can lead to two problems.</p>
<p>First, <a href="https://doi.org/10.1038/d41586-021-00880-9">not every reported adverse event is directly related to the vaccine</a>. For example, many of the tens of millions of people who have received the Pfizer vaccine have likely experienced a sunburn. People might report that they experienced a sunburn to VAERS, but the vaccine has no effect on your skin’s ability to protect against the sun. <a href="https://vaers.hhs.gov/about.html">VAERS is very clear</a> that it “is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting.” Correlation does not imply causation.</p>
<p>Second, a plausibly identified adverse event does not necessarily make the vaccine unsafe. According to CDC, there have been <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-july-13-2021">100 preliminary reports</a> of Guillain–Barré out of 12.5 million J&J doses, or 0.0008% of people who received the vaccine. Administering one vaccine to a huge sample of people can make it easier to identify a possible connection between the shot and a side effect. But that doesn’t mean the risk of getting that side effect is very likely, or that it outweighs the benefit of getting vaccinated.</p>
<p>These risks, while real and potentially life-threatening, must be viewed in context with the much larger risk of negative outcomes from the diseases vaccines protect people from. For example, <a href="https://doi.org/10.2165/00002018-200022060-00003">1%-7% of patients</a> who take cholesterol drugs called statins are likely to experience potentially harmful muscle injury. However, these drugs are still taken by millions of people because they are highly effective at <a href="https://doi.org/10.1002/14651858.CD004816.pub4">preventing heart disease and stroke</a>. And in the case of Guillain–Barré, about <a href="https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Guillain-Barr%C3%A9-Syndrome-Fact-Sheet">one in 100,000</a> people, or 0.001%, develop this condition yearly in the U.S. from any cause. By comparison, the U.S. has had more than <a href="https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days">33 million cases of COVID-19, and over 600,000 deaths</a> caused by this disease.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Close-up of three Johnson & Johnson vaccine vials." src="https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=395&fit=crop&dpr=1 600w, https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=395&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=395&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=497&fit=crop&dpr=1 754w, https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=497&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=497&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">While the Johnson & Johnson vaccine has been linked to a possible increased risk of certain rare adverse events, the vaccine is still safe to use.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/this-picture-taken-on-april-24-shows-vials-of-the-single-news-photo/1232493543">Ramon Van Flymen/AFP via Getty Images</a></span>
</figcaption>
</figure>
<h2>COVID-19 is a bigger risk than vaccine side effects</h2>
<p>In such extraordinary times as during a pandemic, it’s understandable that people may be hesitant to take on any more risk than they have to. But there are safety nets in place to monitor the COVID-19 vaccines, and they are still working as they should.</p>
<p>The COVID-19 vaccines are proven to be overwhelmingly safe for most people. <a href="https://clinicaltrials.gov/ct2/show/record/NCT04505722">More than 40,000</a> patients participated in J&J’s clinical trials before the company applied for emergency use authorization, mirroring <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine">Pfizer’s</a> and <a href="https://www.modernatx.com/covid19vaccine-eua/providers/clinical-trial-data">Moderna’s</a> study sample sizes. Some <a href="https://doi.org/10.1056/NEJMoa2101544">0.4% of participants</a> in the J&J trial experienced serious adverse events unrelated to COVID-19 infection. In contrast, the trial demonstrated that people who get the vaccine are <a href="https://doi.org/10.1056/NEJMoa2101544">85% less likely to get severe COVID-19</a> than those who remain unvaccinated.</p>
<p>The extremely rare side effects associated with the COVID-19 vaccines were discovered because safety reporting tools were used appropriately. Being aware of the risks of a treatment, however rare, can help people make health decisions that work best for them. However, these risks must be viewed in context. And in the case of the COVID-19 vaccines, they must be weighed against the consequences of remaining unvaccinated and letting the pandemic rage on.</p>
<p><em>Article updated to correct a typo in the percentage of Guillain-Barré cases identified among recipients of Johnson & Johnson COVID-19 vaccine.</em></p>
<p>[<em><a href="https://theconversation.com/us/newsletters/science-editors-picks-71/?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=science-corona-important">The Conversation’s most important coronavirus headlines, weekly in a science newsletter</a></em>]</p><img src="https://counter.theconversation.com/content/164455/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Justin Vesser 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>Ongoing tracking is meant to spot very rare risks – like the connection between the Johnson & Johnson shot and Guillain-Barré syndrome. And it relies on public reporting.Justin Vesser, Manager of Ambulatory Pharmacy Services, University of VirginiaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1615872021-05-31T14:25:00Z2021-05-31T14:25:00ZSecond dose of AstraZeneca COVID-19 vaccine: FAQs about blood clots, safety, risks and symptoms<figure><img src="https://images.theconversation.com/files/403099/original/file-20210527-21-1ne4g5u.JPG?ixlib=rb-1.1.0&rect=257%2C56%2C3924%2C2877&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A healthcare worker holds up a vial of the AstraZeneca vaccine at a COVID-19 vaccination clinic in Montréal, on March 18. </span> <span class="attribution"><span class="source">THE CANADIAN PRESS/Paul Chiasson </span></span></figcaption></figure><p>Rare but serious blood clots that have been linked the AstraZeneca COVID-19 vaccine have many people — especially those who have already had one dose of the vaccine — looking for information. Here are answers to some key questions.</p>
<h2>If I had a first dose of the AstraZeneca COVID-19 vaccine, should I have concerns about safety?</h2>
<p>As long as there is a risk, you should always be aware and informed. A risk of very serious harm, including death, does exist, though it is very small: about <a href="https://doi.org/10.47326/ocsat.2021.02.28.1.0">one in 55,000 for the first dose</a>. </p>
<p>We now have a much better understanding of how to diagnose and treat clotting due to COVID-19 vaccines, called vaccine-induced thrombotic thrombocytopenia, or VITT (also sometimes called vaccine-induced prothrombotic immune thrombocytopenia, or VIPIT) when it does occur. Death rates among people who experience <a href="https://doi.org/10.47326/ocsat.2021.02.17.2.0">VITT have been estimated at 20 to 50 per cent</a>, but may be improving as knowledge increases. The Public Health Agency of Canada <a href="https://health-infobase.canada.ca/covid-19/vaccine-safety/#specialInterest">monitors all adverse events</a> following COVID-19 vaccination.</p>
<p>It’s important that everyone who has had the AstraZeneca vaccine understands that it was the right thing to do. It is an excellent and effective vaccine, and being vaccinated is an important act to protect not just yourself, but your community by slowing and eventually stopping the pandemic.</p>
<h2>Should I get a second dose of AstraZeneca? If so, when?</h2>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/403102/original/file-20210527-15-537au9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Doug Ford in a T-shirt and face mask, with his sleeve rolled up, getting vaccinated" src="https://images.theconversation.com/files/403102/original/file-20210527-15-537au9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/403102/original/file-20210527-15-537au9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=415&fit=crop&dpr=1 600w, https://images.theconversation.com/files/403102/original/file-20210527-15-537au9.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=415&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/403102/original/file-20210527-15-537au9.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=415&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/403102/original/file-20210527-15-537au9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=521&fit=crop&dpr=1 754w, https://images.theconversation.com/files/403102/original/file-20210527-15-537au9.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=521&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/403102/original/file-20210527-15-537au9.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=521&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Ontario Premier Doug Ford receives the AstraZeneca COVID-19 vaccine on April 9.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Nathan Denette</span></span>
</figcaption>
</figure>
<p>Getting the second dose of any two-step vaccine is very important. That’s what cements the memory of the immune response. We know from <a href="https://theconversation.com/covid-19-vaccine-faq-6-things-to-look-for-in-clinical-trial-results-150843">clinical trials</a> that the first dose does not prevent all infections. It prevents death from infection. The second dose boosts the immune response to almost completely protect you from getting any infection. That second dose also greatly reduces your ability to carry or spread the virus at all.</p>
<p>In terms of timing, evidence is still emerging, but the best guidance regarding AstraZeneca is that a <a href="https://doi.org/10.1136/bmj.n326">12- to 20-week gap</a> between <a href="https://www.health.gov.on.ca/en/pro/programs/publichealth/coronavirus/docs/vaccine/COVID-19_AstraZeneca_Vaccine_admin.pdf">first and second doses</a> is ideal, much as it is with most vaccines.</p>
<h2>Are the risks different for a second dose?</h2>
<p>The risk of a blood clot <a href="https://www.canada.ca/content/dam/phac-aspc/documents/services/immunization/national-advisory-committee-on-immunization-naci/recommendations-use-covid-19-vaccines/recommendations-use-covid-19-vaccines-en.pdf">after a second dose is about one in 600,000</a>, which is one-tenth the risk of clotting after an initial dose. If you were comfortable getting the first dose, you should feel good about going ahead and continuing to help the community bring the pandemic closer to its end. In addition, knowing the symptoms associated with the vaccine-related clots allows for timely recognition and immediate treatment.</p>
<h2>How serious a health risk are blood clots that can follow a vaccine?</h2>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/403104/original/file-20210527-16-u6b35c.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Hand in a purple glove holding a vial of vaccine" src="https://images.theconversation.com/files/403104/original/file-20210527-16-u6b35c.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/403104/original/file-20210527-16-u6b35c.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/403104/original/file-20210527-16-u6b35c.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/403104/original/file-20210527-16-u6b35c.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/403104/original/file-20210527-16-u6b35c.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/403104/original/file-20210527-16-u6b35c.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/403104/original/file-20210527-16-u6b35c.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">It’s important that everyone who has had the AstraZeneca vaccine understands that it is an excellent and effective vaccine.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Carlos Osorio</span></span>
</figcaption>
</figure>
<p>In those very rare cases where blood clots follow vaccination, they can be very serious, even fatal. The good thing is that knowledge is advancing quickly, especially in terms of diagnosing and treating these clots when they do occur.</p>
<p>Earlier in the vaccine rollout, the risk of death in the rare cases of clotting was 60 to 80 per cent. Today, it’s 20 per cent. </p>
<p>At the beginning of the rollout, patients had no way of knowing what a vaccine-related clot was or what to look for. That may have been a key factor in the higher death rate. Now that this issue is known and the symptoms can be identified, the risk of death is much lower. As we’ve progressed in understanding how this issue presents itself, people are being diagnosed and treated much sooner and more effectively.</p>
<h2>Is it safe to get a different vaccine for my second dose?</h2>
<p>Canada’s <a href="https://www.canada.ca/content/dam/phac-aspc/documents/services/immunization/national-advisory-committee-on-immunization-naci/recommendations-use-covid-19-vaccines/recommendations-use-covid-19-vaccines-en.pdf">National Advisory Committee on Immunization</a> (NACI) recommends that for a second dose, you should stay with a vaccine made with the same <a href="https://theconversation.com/covid-19-vaccine-update-pfizer-may-be-the-frontrunner-but-canada-has-hedged-its-bets-149962">technology “platform</a>” as the first. If you first got AstraZeneca, which is a form of viral vector vaccine, it’s recommended that you get it again. If it is not available, Johnson and Johnson is another viral vector vaccine.</p>
<p>If you had a vaccine based on an mRNA technology platform — Pfizer or Moderna — you can have either one of those two for your second dose. More data is emerging, and mixing and matching platforms could ultimately be proven to be safe and effective, but for now, the recommendation is to stay with the same technology.</p>
<p><strong>Update</strong>: NACI issued a new recommendation on June 1, 2021. People who received a first dose of AstraZeneca vaccine may now get an mRNA vaccine as a second dose. The discretionary recommendation is based on safety profiles, emerging data on mixing vaccine doses and expert opinion on immune response to different vaccines for the same disease.</p>
<h2>Are there any symptoms people should be on the lookout for that may indicate a blood clot?</h2>
<figure class="align-center ">
<img alt="A woman lining up vials on a shelf" src="https://images.theconversation.com/files/403103/original/file-20210527-21-vv00tc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/403103/original/file-20210527-21-vv00tc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=409&fit=crop&dpr=1 600w, https://images.theconversation.com/files/403103/original/file-20210527-21-vv00tc.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=409&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/403103/original/file-20210527-21-vv00tc.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=409&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/403103/original/file-20210527-21-vv00tc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=513&fit=crop&dpr=1 754w, https://images.theconversation.com/files/403103/original/file-20210527-21-vv00tc.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=513&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/403103/original/file-20210527-21-vv00tc.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=513&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Pharmacist Barbara Violo arranges all the empty vials of the AstraZeneca COVID-19 vaccine that she has provided to customers at the Junction Chemist pharmacy in Toronto, on April 19.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Nathan Denette</span></span>
</figcaption>
</figure>
<p>The <a href="https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75389a-eng.php#:%7E:text=symptoms%20of%20blood%20clots%20such,vaccination%20after%20a%20few%20days.">symptoms of VITT</a> are <a href="https://www.thestar.com/opinion/contributors/2021/04/17/understanding-the-blood-clot-issue-behind-the-astrazeneca-vaccine-and-its-safety.html">well documented</a> and include the following, which occur four or more days after vaccination: </p>
<ul>
<li>Severe and persistent headaches. </li>
<li>Severe and persistent blurry vision. </li>
<li>Leg swelling. </li>
<li>Difficulty breathing. </li>
<li>Abdominal pain.</li>
<li>Bruising beyond the vaccination site.</li>
</ul>
<p>It is important to seek prompt medical care in these cases. It is also important to note that <a href="https://www.canada.ca/en/public-health/services/diseases/coronavirus-disease-covid-19/vaccines/what-expect-vaccination.html#a4">minor fever, headache, fatigue and pain at the site of the vaccination</a> are common with all vaccines in the first one or two days and are not causes for concern.</p>
<h2>Who is at risk from clotting related to the AstraZeneca vaccine?</h2>
<p>Clotting events are still so rare that it is very difficult to identify any particular risk factors. Although it appears that a <a href="https://www.cbc.ca/news/health/vaccines-covid-blood-clots-research-1.5989719">slightly higher number of women have experienced clotting</a>, the number of cases isn’t large enough to accurately assess whether sex might affect risk. </p>
<p>The AstraZeneca vaccine is not recommended for people who have had a previous case of <a href="https://doi.org/10.1136/bmj.g7566">heparin-induced thrombocytopenia</a>, or of rare cerebral venous sinus thrombosis clots. A family history of clotting does not appear to be relevant to vaccine risks since the mechanisms are completely different.</p><img src="https://counter.theconversation.com/content/161587/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Answers to key questions about rare blood clots linked to AstraZeneca’s COVID-19 vaccine, including risks, symptoms and whether people who have had one AstraZeneca shot should have a second.Dawn ME Bowdish, Canada Research Chair in Aging & Immunity, McMaster UniversityIshac Nazy, Associate Professor of Medicine and Scientific Director of McMaster Platelet Immunology Laboratory , McMaster UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1600002021-05-06T04:52:19Z2021-05-06T04:52:19ZHow do we actually investigate rare COVID-19 vaccine side-effects?<figure><img src="https://images.theconversation.com/files/399109/original/file-20210506-14-wffzox.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C1000%2C666&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/smiling-young-woman-tshirt-showing-plaster-1954104319">from www.shutterstock.com</a></span></figcaption></figure><p>Investigations <a href="https://www.abc.net.au/news/2021-04-29/nsw-two-men-die-after-receiving-covid-19-vaccination/100103076">are under way</a> to determine whether the deaths of two people in New South Wales who developed blood clots are linked to the AstraZeneca vaccine.</p>
<p>We’ve also heard today that <a href="https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-06-05-2021">11 Australians</a> have so far developed blood clots (thrombosis with thrombocytopenia syndrome) linked with the vaccine.</p>
<p>But what are these investigations? And who decides whether events like these are actually linked to COVID-19 vaccines, or something else?</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/im-over-50-and-can-now-get-my-covid-vaccine-is-the-astrazeneca-vaccine-safe-does-it-work-what-else-do-i-need-to-know-159814">I'm over 50 and can now get my COVID vaccine. Is the AstraZeneca vaccine safe? Does it work? What else do I need to know?</a>
</strong>
</em>
</p>
<hr>
<h2>What triggers the process?</h2>
<p>There is a lot of interest in the safety of COVID-19 vaccines. So the public and health-care workers are “highly tuned in” to reporting suspected side-effects. </p>
<p>Anyone can <a href="https://www.tga.gov.au/covid-19-vaccine-safety-monitoring-and-reporting">report these</a> to Australia’s drug regulator, the Therapeutic Goods Administration (TGA). Alternatively, people who have been vaccinated can do so when prompted with a survey via the <a href="https://www.ausvaxsafety.org.au/">AusVaxSafety</a> system.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1369167449086554116"}"></div></p>
<p>This is a good thing as it means we are likely to pick up any serious or unusual events. Every report is valuable and contributes to our safety monitoring. However, just because an event happened after a vaccine does not mean the vaccine <em>caused</em> it.</p>
<p>A serious event could be caused by an underlying medical condition, a medication the person was taking at the time, or some other factor unrelated to the vaccine. </p>
<p>For example, before COVID-19 and vaccines against it, dozens of people across Australia developed blood clots, in their <a href="https://www.racgp.org.au/download/documents/AFP/2010/July/201007ho.pdf">legs, lungs</a>, <a href="https://www.ahajournals.org/doi/pdf/10.1161/strokeaha.116.013617">brain</a> and other parts of the body, every day, often without warning or clear cause. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/covid-vaccines-have-been-developed-in-record-time-but-how-will-we-know-theyre-safe-153888">COVID vaccines have been developed in record time. But how will we know they're safe?</a>
</strong>
</em>
</p>
<hr>
<h2>What happens next?</h2>
<p>When a person has a suspected vaccine side-effect it is usually <a href="https://www.tga.gov.au/reporting-adverse-events">reported</a> to the state or territory health department; some reports go directly to the TGA. </p>
<p>Most reactions reported after vaccination are mild to moderate. <a href="https://www.ausvaxsafety.org.au/safety-data/covid-19-vaccines">AusVaxSafety surveys</a> in more than 365,000 people in Australia confirm what we saw in vaccine trials. Up to two-thirds of people experience symptoms such as fever, muscle aches, joint pains and headache within the first one or two days after vaccination, which go away without treatment. This is the immune system responding to the vaccine.</p>
<h2>What if it’s serious?</h2>
<p>If the person dies or had a serious event needing hospitalisation within the days to weeks after vaccination — like the clotting cases you will have heard about, or there was an unusual unexpected event — there are further investigations. </p>
<p>Health department and TGA staff gather as much information as possible about the person, including their medical history, risk factors, any medications they are on, details and timing of the vaccine, hospitalisation records, any laboratory test results and whether they have recovered or have any ongoing issues. This will involve liaising with the person’s GP, specialists and the hospital.</p>
<p>Many states and territories then convene an <a href="https://www.health.nsw.gov.au/Infectious/covid-19/vaccine/Pages/clinicians.aspx">expert panel</a> of doctors to discuss a serious case. These panels often include the treating doctor, discuss the case in detail and may advise extra tests that may help them understand the event. </p>
<p>A full clinical dossier is then provided to the TGA, which then further reviews the case and decides whether a group of independent expert advisors, known as a “vaccine safety investigation group” or VSIG, is needed to review the case in detail and assess if the vaccine caused it.</p>
<p>The VSIG <a href="https://www.tga.gov.au/alert/astrazeneca-chadox1-s-covid-19-vaccine-2">often includes</a> independent medical experts in vaccine safety, infectious diseases, haematology, public health and vaccine confidence, other medical specialists, and a consumer representative.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Socially distanced meeting, with videocall" src="https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">An independent panel of advisers meet to review the case in detail and to report to the TGA.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/online-video-conference-social-distancing-webinar-1818069497">from www.shutterstock.com</a></span>
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<p>The group reviews the clinical details of the event. It then uses an <a href="https://www.who.int/vaccine_safety/publications/CausalityAssessmentAEFI_EN.pdf?ua=1">internationally accepted method</a> to rate the level of certainty of a link between the serious event and the vaccine.</p>
<p>First, the group determines if there is enough clinical information to come to a decision, and if not, will request further information from the state/territory health department and may need to reconvene when that information is available.</p>
<p>The group then determines if the case is classified as:</p>
<ul>
<li><p>caused by the immunisation process (such as errors in vaccine technique) or the vaccine itself (the official terminology is “consistent causal association to immunisation”)</p></li>
<li><p>uncertain if the vaccine or immunisation process caused the event (“indeterminate”)</p></li>
<li><p>a coincidence (“inconsistent causal association to immunisation”). This could when because an underlying condition or something other than vaccine was the cause.</p></li>
</ul>
<p>The TGA then <a href="https://www.tga.gov.au/alert/astrazeneca-chadox1-s-covid-19-vaccine-3">publishes</a> the results of this independent assessment on its website. This is accompanied by a summary of the case(s) and extra clinical advice for doctors. The TGA also feeds the results back to the state/territory health department and treating doctor.</p>
<p>This information will also be included in <a href="https://www.tga.gov.au/communicating-covid-19-safety-information">weekly updates</a> published on the TGA website and is reviewed by other key advisory groups, including the <a href="https://www.health.gov.au/committees-and-groups/australian-technical-advisory-group-on-immunisation-atagi">Australian Technical Advisory Group on Immunisation</a> and the government, who monitor the progress of immunisation programs, including for COVID-19. </p>
<h2>Here’s the context</h2>
<p>While such serious vaccine-related events <a href="https://www.abc.net.au/news/2021-04-29/nsw-two-men-die-after-receiving-covid-19-vaccination/100103076">grab the headlines</a>, it’s important to remember they are <a href="https://theconversation.com/what-is-thrombocytopenia-the-rare-blood-condition-possibly-linked-to-the-astrazeneca-vaccine-158522">rare</a>. Most side-effects are mild-to-moderate and short-lived. On the other hand, the <a href="https://www.health.gov.au/resources/publications/covid-19-vaccination-weighing-up-the-potential-benefits-against-risk-of-harm-from-covid-19-vaccine-astrazeneca">benefits of COVID-19 vaccination</a> in ending the pandemic are enormous. </p>
<p>When concerning events occur after vaccination, it’s important to know Australia has strong systems to properly investigate them, look at any possible link and communicate the results to the public.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/a-balancing-act-between-benefits-and-risks-making-sense-of-the-latest-vaccine-news-158634">A balancing act between benefits and risks: making sense of the latest vaccine news</a>
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</p>
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<img src="https://counter.theconversation.com/content/160000/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nicholas Wood receives funding from the NHMRC for a Career Development Fellowship. He holds a Churchill Fellowship.</span></em></p><p class="fine-print"><em><span>Kristine Macartney is the Director of the National Centre for Immunisation Research and Surveillance (NCIRS). NCIRS receives funding from the Australian and state governments, the WHO, the Gavi Vaccine Alliance and the NHMRC. She is a member of numerous vaccine advisory groups, including ATAGI, ACV, and an independent expert on the WHO Global Advisory Committee on Vaccine Safety.</span></em></p>A serious event such as a blood clot could be caused by an underlying medical condition, a medication the person was taking at the time, or some other factor unrelated to the vaccine.Nicholas Wood, Associate Professor, Discipline of Childhood and Adolescent Health, University of SydneyKristine Macartney, Professor, Discipline of Paediatrics and Child Health, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/898572018-01-15T00:35:38Z2018-01-15T00:35:38ZWhy you should avoid hospitals in January<figure><img src="https://images.theconversation.com/files/201455/original/file-20180110-48498-ig4kb7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Around 3,000 more Australian patients have a complication in their hospital care in January than in other months. </span> <span class="attribution"><a class="source" href="https://unsplash.com/photos/Xt1qMeOF29E">Rawpixel.com</a></span></figcaption></figure><p>January is the quietest month in Australia. But for hospitals, which provide care 24/7/365, January is a time of big transition. And for patients, that means January is when things are more likely to go wrong.</p>
<p>More than <a href="http://www.medicaldeans.org.au/wp-content/uploads/Table-4.pdf">3,000 newly graduated doctors</a> will enter the next phase of their training in January. New nurses and allied health professionals, such as physiotherapists and hospital pharmacists, also join the workforce in January.</p>
<p>These new staff fill the posts vacated by people one year ahead of them in the pipeline. Last year’s first-year-out doctor goes into his second year of training, and his predecessor goes into her third-year role or leaves the hospital to join a new workplace. </p>
<p>These new minds and hands, and the massive reshuffles of existing staff, disrupt hospitals. Old informal networks break down as new relationships are forged, and the less-experienced staff learn the hospital’s processes and expectations.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/reducing-medical-errors-one-patient-at-a-time-24125">Reducing medical errors, one patient at a time</a>
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<p>Not surprisingly, this staff disruption has an impact on patient care. Around the world, overblown descriptions of the changeover period as <a href="http://www.bmj.com/content/309/6970/1690.1.full">the “killing season”</a> and of doctors’ first day in the UK as <a href="https://theconversation.com/happy-black-wednesday-every-doctors-nightmare-16106">“Black Wednesday”</a> have become part of medical folklore. </p>
<p>More sober studies of the <a href="http://annals.org/aim/fullarticle/747098/july-effect-impact-academic-year-end-changeover-patient-outcomes-systematic">“July Effect”</a> (so named in the northern hemisphere) have indeed found evidence of worse patient outcomes during the changeover period. </p>
<p>The graph below shows the trend in complications in Australian hospitals over the past few years. It reveals a small but clear “January Effect”. On average, at least one complication occurs in just under 11% of hospital admissions in Australia. But each January, this rate ticks up by more than half a percentage point.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/201867/original/file-20180115-101483-12fkrh7.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/201867/original/file-20180115-101483-12fkrh7.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/201867/original/file-20180115-101483-12fkrh7.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=476&fit=crop&dpr=1 600w, https://images.theconversation.com/files/201867/original/file-20180115-101483-12fkrh7.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=476&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/201867/original/file-20180115-101483-12fkrh7.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=476&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/201867/original/file-20180115-101483-12fkrh7.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=598&fit=crop&dpr=1 754w, https://images.theconversation.com/files/201867/original/file-20180115-101483-12fkrh7.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=598&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/201867/original/file-20180115-101483-12fkrh7.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=598&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"></span>
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<h2>What goes wrong?</h2>
<p>New staff might be less adept at monitoring patients, leading to the patient becoming malnourished. Or the new staff may not have acquired sufficient technical skills leading to an accidental puncture or laceration during a procedure. </p>
<p>Other <a href="https://www.safetyandquality.gov.au/our-work/indicators/hospital-acquired-complications/">hospital complications</a> include pressure sores from not moving enough, infections from hygiene breaches, and being given the wrong dose or type of drug. </p>
<p>In January 2015, about 74,000 hospital patients in Australia had a complication of care, about 3,000 more than would have been expected if there were no January Effect. That is 3,000 people suffering complications that might not have arisen had they received care at “normal” times of the year.</p>
<h2>What hospitals can do</h2>
<p>Although the effect is clear, the causes – and therefore, solutions – are not. Is it the effect of the new doctors and other staff who are inadequately prepared for their new responsibilities? Or is it team disruption? Or is it that senior staff take their leave over January, resulting in weaker supervision just when it is needed most? Probably all of the above.</p>
<p>To the extent the problem is diminished supervision, start dates for new staff could be pushed back a month or so. Perhaps senior staff leave could be more evenly spread across the year. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/infections-complications-and-safety-breaches-why-patients-need-better-data-on-how-hospitals-compare-86748">Infections, complications and safety breaches: why patients need better data on how hospitals compare</a>
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</em>
</p>
<hr>
<p>If the problem is poorly prepared junior staff, then a longer and better induction might be the answer. Typically newly graduated doctors now have a one-week introduction, this could be extended or restructured to include more time to be introduced to the specific practices of units they will be joining.</p>
<p>If the problem is disrupted teamwork, the solution might involve better handover and induction processes, either as part of the formal induction period, or as a structured experience when they join their new unit.</p>
<p>Most likely, all facets will need to be improved. </p>
<h2>What patients and their advocates can do</h2>
<p>The January Effect underlines the fallibility of the people and systems that deliver our hospital care. Australia’s hospital system is staffed by motivated and highly trained people working in well-developed systems, often using state-of-the-art technologies and medicines. </p>
<p>But people can make mistakes, particularly when they are new to a task. Systems can break down. Patients in Australia can take comfort in the safety and quality of hospital care, but they should not assume it is perfect.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/blaming-individual-doctors-for-medical-errors-doesnt-help-anyone-28212">Blaming individual doctors for medical errors doesn't help anyone</a>
</strong>
</em>
</p>
<hr>
<p>The burden of fixing health system problems should never rest on the shoulders of those with least power – patients and their families and carers. But patients do have a role. Alert and active patients and their families and carers can help identify and prevent errors – and this role becomes slightly more important in January.</p>
<p>Patients often know when they are about to be given the wrong medication, or when their regular medication has been stopped, or when the care they are about to get has not been fully discussed with them so might be wrong. They can speak up and prevent the problem – but too often they feel put down, disempowered and dismissed.</p>
<p>So the simple message for patients is this: if you see something that doesn’t look right, speak up, and speak up again.</p><img src="https://counter.theconversation.com/content/89857/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Grattan Institute began with contributions to its endowment of $15 million from each of the Federal and Victorian Governments, and $4 million from BHP Billiton. In order to safeguard its independence, Grattan Institute’s board controls this endowment. The funds are invested and Grattan uses the income to pursue its activities.</span></em></p><p class="fine-print"><em><span>Greg Moran 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>New medical staff start in January and may not be as skilled or adept as their predecessors, meaning more things go wrong.Stephen Duckett, Director, Health Program, Grattan InstituteGreg Moran, Associate, Grattan InstituteLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/619442016-08-04T01:28:48Z2016-08-04T01:28:48ZDeadly medical errors are less common than headlines suggest<figure><img src="https://images.theconversation.com/files/129016/original/image-20160701-18325-1ynqw03.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Medical errors are not the third leading cause of death. </span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-284658377/stock-photo-surgery-team-in-the-operating-room.html?src=Jw1OB1L5MsAuAH4EEkc6yw-1-28">Surgeons image via www.shutterstock.com.</a></span></figcaption></figure><p>A report published in May from researchers at Johns Hopkins claims that medical errors are the <a href="http://www.bmj.com/content/353/bmj.i2139">third leading cause of death in the U.S.</a>, behind only heart disease and cancer. </p>
<p>According to the researchers, medical errors account for 251,454 U.S. deaths each year – and they regard this figure as an underestimate. </p>
<p>That’s the sort of finding that makes headlines. Indeed, you might have read about this report in the <a href="https://www.washingtonpost.com/news/to-your-health/wp/2016/05/03/researchers-medical-errors-now-third-leading-cause-of-death-in-united-states/">newspaper</a> or even seen it reported on the <a href="http://abcnews.go.com/WNT/video/research-medical-errors-3rd-leading-death-us-38856931">evening news</a>.</p>
<p>But as we’ll argue, the methods the researchers used to draw this conclusion are flawed, and that means that the conclusion that medical error is the third leading cause of death is highly questionable. </p>
<p>When a report like this gets broad media coverage, it can foster unwarranted mistrust of medicine, which could prevent people from seeking needed care – a concern to everyone who takes care of patients. </p>
<h2>What’s wrong with the methodology?</h2>
<p>A medical error can be defined as a decision or action that results in patient harm and that experts agree should have been made differently, given the information available at the time. But applying such a definition in reviewing patient records is fraught with difficulty.</p>
<p>The study’s authors argue that death certificates should be redesigned to recognize that more deaths are attributable to medical error. That’s a reasonable suggestion. But the implication of many media reports that these findings prove hundreds of thousands of people are dying each year due to medical errors is highly problematic.</p>
<p>First, the authors of the Johns Hopkins report did not collect any new data. Instead, they based their conclusions on studies performed by other authors. There is nothing wrong with that in principle. </p>
<p>But in this case, the results are highly misleading because they are based on large extrapolations from very small data sets. The authors based their conclusions on four studies that included a total of only 35 deaths attributable to medical error out of nearly 4,000 hospital admissions. Extrapolating from 35 deaths to a population of 320 million is quite a leap. </p>
<p>In addition, these studies frequently do a poor job of distinguishing between adverse events and errors. They are not the same thing. </p>
<p>An <a href="http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053087.htm">adverse event</a> is defined as any undesirable outcome after a drug or treatment is administered to a patient. Every medical test and therapy – from antibiotics to surgery – is associated with some risk of an adverse outcome. Adverse events can include death, although that is rare. While every adverse outcome is regrettable, it does not prove that an error was made – that based on what was known at the time, a medical professional should have made a different decision or acted in a different way. </p>
<p>Physicians typically cannot know in advance which patients will experience such reactions, so attributing such deaths to error is misleading. </p>
<p>There is another problem with the Hopkins report: two of the four studies it draws on use Medicare data, which generally include patients advanced in years, in relatively poor health and being treated in the hospital. Sad to say, many such patients are at substantially increased risk of death to begin with. Many will die during their hospitalization, no matter how well they are cared for. To attribute such deaths to error is to fail to account for the inevitability of death. </p>
<p>In fact, one of the <a href="http://www.ncbi.nlm.nih.gov/pubmed/23860193">studies</a> on which the Hopkins report is based even includes a prominent correction factor. The author estimates the number of deaths due to medical error at 210,000. Then, based on the fact that the tools used to identify errors are imperfect, the author chooses to double his estimate of the number of deaths due to error to 420,000. </p>
<p>The sort of medical chart review used in these studies is radically different from caring for patients. The uncertainty and stress associated with caring for the very sickest patients are often invisible to hindsight. Seriously adverse patient outcomes are associated with a greater tendency to blame someone. When a patient has died, we want someone to be responsible, even if every action taken appeared justifiable at the time.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/129273/original/image-20160704-19091-1sdxxk5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/129273/original/image-20160704-19091-1sdxxk5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/129273/original/image-20160704-19091-1sdxxk5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/129273/original/image-20160704-19091-1sdxxk5.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/129273/original/image-20160704-19091-1sdxxk5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/129273/original/image-20160704-19091-1sdxxk5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/129273/original/image-20160704-19091-1sdxxk5.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">Adverse events aren’t always errors.</span>
<span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-158328617/stock-photo-close-up-of-doctor-writing-on-a-medical-chart-with-patient-lying-in-a-hospital-bed.html?src=gxCTmBbMHTEwgC_Fq5JuoQ-1-73">Doctor and patient image via www.shutterstock.com.</a></span>
</figcaption>
</figure>
<h2>Other research suggests many fewer deaths from medical error</h2>
<p>This isn’t the first study to try to assess how often medical errors can lead to death. Other studies paint a very different picture of the number of deaths attributable to error. </p>
<p>In <a href="http://dx.doi.org/10.1001/jama.286.4.415">one</a> responding to claims of very high death rates due to medical error, physicians reviewed 111 deaths in Veteran’s Affairs hospitals, attempting to determine whether such deaths were preventable with “optimal care.” VA patients are generally older and sicker than the U.S. population, and thus somewhat comparable to studies based on Medicare data. Also, by using “optimal care,” the study may catch even more deaths than the “medical error” standards, resulting in a tendency to overestimate the number of deaths due to error. </p>
<p>At first, the researchers estimated that 23 percent of deaths could have been prevented. But when they were asked whether patients could have left the hospital alive, this number dropped to 6 percent. Finally, when the additional criterion of “3 months of good cognitive health after discharge” was added, the number dropped to 0.5 percent. Preventable deaths should be viewed in context, and there is a big difference between preventing death and restoring good health.</p>
<p>Applying the rates from the VA study to U.S. hospital admission data, medical error would drop down to number 7 of the top 10 causes of death in the U.S. Applying the additional criterion of three months of good cognitive health, medical error would not even rank in the top 20. Of course, doing so runs the same risks as the Johns Hopkins study; namely, extrapolating from a small study to the entire U.S. population.</p>
<p>To produce a truly balanced account of medicine’s role in causing death, it would be necessary to account not only for the risks but also the benefits of medical care. Many patients with heart disease, cancer and diabetes whose deaths such studies attribute to medical error would not even be alive in the first place without medical treatment, whose benefits vastly outweigh its risks.</p>
<p>Looking at medicine from this point of view, we are fortunate to be living in an era of unsurpassed medical capabilities, when the profession is doing more to promote health and prolong life than at any time in the past.</p>
<p>Perhaps the strongest evidence that such studies overestimate the role of medical error is that the fact that, when causes of death are ranked by authoritative organizations such as the <a href="http://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm">U.S. Centers for Disease Control and Prevention</a>, medical error is not even included in the top ten. Would adding medical error to death certificates change this? We doubt it.</p>
<p>There is no doubt that mistakes occur in medicine every day, and if we take appropriate steps, error rates can be reduced. </p>
<p>But inflated estimates of the number of deaths associated with error do nothing to advance understanding and may in fact make many patients more reluctant to seek care when they need it. A blinkered focus on error, without corresponding accounts of medicine’s benefits, contributes to a distorted understanding of medicine’s role in health and disease.</p>
<hr>
<p><em>This piece was coauthored with Jae Hyun Kwon, a student at the Indiana University School of Medicine.</em></p><img src="https://counter.theconversation.com/content/61944/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Richard Gunderman 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>A recent study suggesting that medical error is the third leading cause of death in the U.S. made headlines. But the methods researchers used to draw this conclusion are flawed.Richard Gunderman, Chancellor's Professor of Medicine, Liberal Arts, and Philanthropy, Indiana UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/282122016-04-12T20:11:02Z2016-04-12T20:11:02ZBlaming individual doctors for medical errors doesn’t help anyone<figure><img src="https://images.theconversation.com/files/107988/original/image-20160113-8413-17jcdk9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">We need to think about the environment that allowed the error to occur. </span> <span class="attribution"><span class="source">from www.shutterstock.com.au</span></span></figcaption></figure><p>In Australia, estimates suggest undesired harmful effects from medication or other intervention such as surgery, known as “adverse events”, occur in around <a href="http://www.ncbi.nlm.nih.gov/pubmed/7476634">17% of hospital admissions</a>. This results in up to 18,000 unnecessary deaths and 50,000 temporarily or permanently disabled patients each year.</p>
<p>Over <a href="http://www.nejm.org/doi/full/10.1056/NEJM199102073240605">50% of adverse events</a> are the result of medical error. Harms are physical, financial and psychological. Adverse events mean patients need to stay in hospital longer, have more treatment and incur financial loss.</p>
<p>Adverse events are the result of errors and violations (deviations from prescribed practice) of health-care professionals. Although the direct and most obvious causes of adverse events are errors and violations, the causes of adverse events we can control are the working conditions and organisational systems that cause people to make mistakes. </p>
<p>When the pace of work is too fast, health professionals can get distracted and feel under pressure. When supervisors turn a blind eye to non-compliance, teams aren’t functioning well, equipment is unavailable or opportunities for training rare, the willingness and ability of staff to perform reliably is reduced. </p>
<p>Safety cannot be assured by identifying the individuals who make an error. Safety can only be assured by creating conditions in which people can perform well.</p>
<h2>Blame is unhelpful</h2>
<p>Finding someone to blame and dealing with this person by assuming they are uniquely incompetent (a person-centred approach) is a comforting strategy for those managing risk and for society at large. Much less satisfying is the notion that the majority of health professionals, in the same situation, would make the same mistake and that perhaps the situation, not the professional, is to blame.</p>
<p>The human tendency to blame others’ mistakes on their personal characteristics (ability, personality, attitudes) is even stronger when the outcome of the mistake is more severe (such as a patient’s life being shortened). This makes it difficult to move away from blame even when there is no compelling evidence “person-centred” strategies reduce error rates.</p>
<p>A person-centred approach also exacerbates the feelings of <a href="http://qualitysafety.bmj.com/content/19/6/1.45.full">guilt, shame and anxiety</a> that plague health-care professionals in the aftermath of error. These negative emotions, in turn, can lead to denial, avoidance and a failure to learn about the causes of the error. The possibility of putting preventive strategies in place is then limited.</p>
<p>The health-care professional may feel defensive, and this doesn’t help patients or their families learn the truth about what has happened and, in many cases, compounds the distress they feel. Blame means a lost opportunity for learning and can be detrimental to open and honest patient-professional discussions.</p>
<h2>What are the alternatives?</h2>
<p>Although we can and should focus efforts to reduce the number of medical errors made, errors are inevitable and so we also need to prepare for them more effectively. Both health professionals and patients need better support.</p>
<p>For health professionals, building psychological resilience at an individual and team level may help. Psychological resilience is defined as an individual’s ability to adapt to stress and adversity; to be positive, optimistic and to learn from mistakes. Not everyone is equally resilient and this is where being part of a team or being able to access social support from others is important.</p>
<p>So, what can we do in health care to promote resilience? At present, there is no definitive answer to this question; there is little research evidence available and even fewer recommendations.</p>
<p>In the United States, rapid response teams <a href="http://www.muhealth.org/about/quality-of-care/office-of-clinical-effectiveness/foryou-team/">have been established</a> in acute hospital settings to provide individuals with the support they need after an error. Support is offered either informally within the unit, through trained peer supporters within the hospital or via referral to professional guidance.</p>
<p>Training staff in emotional resilience is one approach that has been <a href="http://www.ncbi.nlm.nih.gov/pubmed/22439496">reported as successful</a> among nurses transitioning from being students to staff. <a href="http://pmj.bmj.com/content/90/1066/439.full">Mentoring for physicians</a> has also been promoted as a strategy to enhance individual resilience and reduce burnout and stress. Neither approach has yet been evaluated at sufficient scale.</p>
<p>Minimising power differences between team members is important in <a href="http://link.springer.com/chapter/10.1007%2F978-90-481-2605-7_5">encouraging people</a>, no matter what their professional status, to speak up, ask questions and check understanding.</p>
<p>Training health-care leaders how to invite and appreciate contributions from all team members may provide a basis for greater equality and openness in health-care teams. When things go wrong in health care, blame is a rife but unhelpful response. What we need now are evidence-based strategies that support staff and organisations to use adverse events as an impetus for change.</p><img src="https://counter.theconversation.com/content/28212/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>In Australia, estimates suggest undesired harmful effects from medication or other intervention such as surgery occur in around 17% of hospital admissions. But blaming the doctors won’t help.Reema Harrison, Lecturer & Research Fellow: Patient Safety, University of SydneyRebecca Lawton, Professor, Psychology of Healthcare, University of LeedsLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/110072012-11-27T19:14:26Z2012-11-27T19:14:26ZPreaching to the unconverted: immunisation risks and public health<figure><img src="https://images.theconversation.com/files/18059/original/g466zf8s-1353995904.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Late 19th century lithograph by French artist Gaston Mélingue showing Edward Jenner vaccinating a boy on May 14, 1796.</span> <span class="attribution"><span class="source">Wikimedia Commons</span></span></figcaption></figure><p>The principle of prevention being better than the cure is at the heart of public health and social marketing efforts such as immunisation. But not everyone agrees and the challenge is how to address disagreement.</p>
<p>What I am about to say will almost certainly provoke ire, but here it is: immunisation <em>can be</em> dangerous to your health.</p>
<p>This truth is acknowledged in the Australian Academy of Science’s recent publication, <a href="http://www.science.org.au/policy/documents/AAS_Immunisation_FINAL_LR_v3.pdf">The Science of Immunisation: Questions and Answers</a>. Admittedly, the risks are small, maybe even “extremely small” as they state. But like many medications, there are risks – even if they’re written in small print.</p>
<p>But while in medical practice, the individual gets to read about the side effects and choose whether or not to take a drug or some other kind of therapy, in public health, this same option is not offered to that individual.</p>
<p>And as one might expect, public health agencies tend to emphasise the benefits and discount the risks. <a href="http://www.science.org.au/policy/documents/AAS_Immunisation_FINAL_LR_v3.pdf">The Science of Immunisation</a> report, for instance, tells us that “all vaccines in use in Australia provide benefits that greatly outweigh their risks”.</p>
<p>For personal medications, we choose for ourselves. But who makes the decision about what is good for us in public health? How do they make this decision? And why should we believe them?</p>
<p>Indeed, these questions are the heart of an important issue that confronts all public health and social marketing efforts. And it’s neatly crystallised in the debate about immunisation which has been going on for around 300 years.</p>
<p>In the 1720s, the inoculation of English children with powdered scabs from smallpox sores to prevent later infection by smallpox was promoted. Smallpox was undoubtedly a dangerous disease killing up to a third of those infected. But inoculation could also be dangerous, leading to the deaths of up to 2%.</p>
<p>Then, as now, the key question for individuals was whether or not to immunise.</p>
<p>Voltaire famously characterised the balancing of risks in his <a href="http://www.bartleby.com/34/2/11.html">Lettres Philosophiques</a></p>
<blockquote>
<p>[Europeans consider] the English are fools and madmen. Fools, because they give their children the small-pox to prevent their catching it; and madmen, because they wantonly communicate a certain and dreadful distemper to their children, merely to prevent an uncertain evil. The English, on the other side, call the rest of the Europeans cowardly and unnatural. Cowardly, because they are afraid of putting their children to a little pain; unnatural, because they expose them to die one time or other of the small-pox.</p>
</blockquote>
<p>Then <a href="http://en.wikipedia.org/wiki/Edward_Jenner">Edward Jenner</a> invented the original vaccine, inoculating his patients with cowpox to prevent infection by smallpox. His findings were <a href="http://open.jorum.ac.uk/xmlui/bitstream/handle/123456789/946/Items/S320_1_002i.jpg">mocked publically</a> by religious and scientific authorities.</p>
<p>Today, scientific authorities and public health interests argue that the benefits of immunisation far outweigh the pain of the few who may suffer from vaccination. And from a public health point of view, they are correct.</p>
<p>So why then do people refuse to immunise? Why are so many people reluctant to vaccinate?</p>
<p>Unfortunately for public health agencies, people are notoriously bad at estimating risks and probabilities. Few, if any, read meta-analyses or systematic reviews, and many are very bad at understanding science and statistics.</p>
<p>So just as some people in the 18th century believed that Jenner’s original vaccination might give rise to cows growing out of the body and was against God, today some people believe that the MMR (measles, mumps, rubella) vaccination can give rise to autism.</p>
<p>But despite their misguided beliefs, they have some reason on their side that ought to be acknowledged, even if only to better guide public health programs.</p>
<p>The first is that there are some risks associated with immunisation. Maybe not the risks identified by the anti-vaccinators, but risks nonetheless. Second, and perhaps more importantly, the public health agenda asks individuals to sacrifice their rights to the greater good. Is this just?</p>
<p>Perhaps it helps to make this personal. If you or your child suffered the rare adverse reaction to a vaccine, is it fair that you bear this burden for the greater good?</p>
<p>Public health practitioners have to act pragmatically but promotion efforts are likely better guided by a realistic view of the intended audience. And such practical matters shouldn’t prevent scientists, philosophers and academics continuing to debate these important issues. </p><img src="https://counter.theconversation.com/content/11007/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Stephen S Holden has previously conducted marketing research for pharmaceutical companies (including vaccine manufacturers), public health and government agencies covering a wide range of social marketing projects.
He chooses to vaccinate and believes that others wishing to choose for themselves deserve a hearing.</span></em></p>The principle of prevention being better than the cure is at the heart of public health and social marketing efforts such as immunisation. But not everyone agrees and the challenge is how to address disagreement…Stephen S Holden, Associate Professor, Marketing, Bond UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/108132012-11-25T19:06:34Z2012-11-25T19:06:34ZEnergy drinks and sudden death: US regulators investigate<figure><img src="https://images.theconversation.com/files/17893/original/bztswgym-1353551673.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A growing number of adverse events are reportedly linked to the consumption of energy drinks, such as Red Bull.</span> <span class="attribution"><span class="source">Nattu/Flickr</span></span></figcaption></figure><p>The <a href="http://www.fda.gov/">US Food and Drug Administration</a> (FDA) is <a href="http://www.fda.gov/Food/NewsEvents/ucm328536.htm">investigating a series of deaths</a> reportedly linked to the consumption of energy drinks and shots. The investigation comes amid a growing number of reports of various adverse events related to energy drink consumption.</p>
<p>Energy drink consumption has <a href="https://www.mja.com.au/journal/2012/196/7/energy-drinks-health-risks-and-toxicity">grown exponentially</a> over the past five to ten years. The main active ingredients of such drinks, which include Red Bull and Mother, are a combination of varying amounts of caffeine, guarana extract, taurine and ginseng. Other additives include carbohydrates, amino acids and vitamins. </p>
<p>The intended purpose of these drinks, according to the manufacturers, is to sustain alertness, so their target markets are athletes, students, and people in professions that require prolonged alertness. Energy drinks are also commonly consumed at nightclubs and dance parties, where they are often combined with alcohol, and recreational drugs, such as ecstasy. </p>
<p>The adverse effects of these energy drinks, either alone or in combination, are being increasingly reported <a href="http://www.ncbi.nlm.nih.gov/pubmed/21037046">worldwide</a>, and <a href="https://www.mja.com.au/journal/2012/196/7/energy-drinks-health-risks-and-toxicity">recently in Australia</a>.</p>
<h2>Caffeine and other additives</h2>
<p>The main component of energy drinks is caffeine and it has been associated with <a href="http://www.ncbi.nlm.nih.gov/pubmed/15691625">many adverse health outcomes</a> in susceptible individuals. In terms of heart health, there are three main effects – increased heart rate, increased blood pressure, and evidence of increasing blood viscosity that can lead to clots forming in the heart and beyond.</p>
<p>Three <a href="http://www.ncbi.nlm.nih.gov/pubmed/22001708">independent cases</a> where consumption of energy drinks led to <a href="http://www.ncbi.nlm.nih.gov/pubmed/22465350">catastrophic consequences</a>, including <a href="http://www.ncbi.nlm.nih.gov/pubmed/22704863">cardiac rhythm disturbances</a> and <a href="http://www.ncbi.nlm.nih.gov/pubmed/22056042">cardiac arrest</a>, have recently been described in medical literature.</p>
<p>To be clear, these are life-threatening cardiac rhythm disturbances that can lead to sudden death, particularly in young people. And these effects have been observed with the consumption of as little as one can of energy drink. </p>
<p>Energy drink consumption has also been linked to anxiety, insomnia, vomiting, nervousness, addictive behaviours, and panic attacks. In <a href="http://www.ncbi.nlm.nih.gov/pubmed/20306287">pregnant women</a>, caffeine consumption is associated with risk of late miscarriage, stillbirth, and small-for-gestational-age infants. </p>
<p>The other additives in energy drinks exacerbate many of these effects. And the manner in which these drinks are marketed – to be drunk fast and in high concentrations for a quick energy boost – magnifies their adverse effects. Indeed, the introduction of “energy shots”, the small volume, high-concentration shots of caffeine, guarana and taurine, available at petrol stations and the like, support this marketing strategy.</p>
<h2>What to do?</h2>
<p>The major challenges for both health professionals and the general community is the vast array of energy drinks on the market, the differences in their content, and that overall, the industry is largely unregulated. And the fact that the target of these types of energy drinks clearly includes children, adolescents and young adults is cause for great concern. </p>
<p>It’s likely that people will be unaware of the variations in the chemical composition and caffeine dosage in energy drinks. And with minimal and poorly stated warnings on energy drink cans, the potential for adverse effects, overdose, poisoning, and potentially death all remain distinct possibilities. </p>
<p>In Australia, energy drinks are regulated under <a href="http://www.comlaw.gov.au/Details/F2009C00814">Standard 2.6.4</a> of the Code by the <a href="http://www.foodstandards.gov.au/">Food Standards Australia New Zealand</a> (FSANZ), and the maximum amount of caffeine allowed is 320 milligrams per litre. But because many energy drinks are sold in small volumes, their numerous additional additives exceed this limit. </p>
<p>A typical can of energy drink contains up to 300 milligrams of caffeine, from added caffeine and natural sources such as guarana, but importantly, in volumes far less than a litre – usually 200 millilitres or less. This includes “energy shots”, which clearly also don’t meet the requirements of Standard 2.6.4. Many energy drinks are also marketed as “dietary supplements” or “conventional foods” in an attempt to circumvent standard requirements of both the FDA and FSANZ.</p>
<p>Given the potentially catastrophic consequences of energy drink consumption in susceptible young people, we clearly need greater community education and awareness. This may require somewhat drastic measures, such as clear, graphic warnings on energy drink cans to warn people of their potential dangers (much like the highly successful packaging of cigarette cartons which include images of the consequences of smoking, such as cancer). </p>
<p>Another initiative may be to restrict the sales of energy drinks to children and adolescents, who are often the target of energy drink advertising and who face significant peer influence. The collective goal of such measures is to protect the young by raising community awareness of the potential detrimental effects of energy drinks. </p>
<p>Needless to say, the outcome of the current FDA investigation into the 13 reported deaths will be followed in Australia with great interest.</p><img src="https://counter.theconversation.com/content/10813/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>No disclosures</span></em></p>The US Food and Drug Administration (FDA) is investigating a series of deaths reportedly linked to the consumption of energy drinks and shots. The investigation comes amid a growing number of reports of…Chris Semsarian, Professor of Medicine, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/58372012-03-14T19:47:31Z2012-03-14T19:47:31ZAll for one and one for all: no-fault compensation for vaccine reactions<figure><img src="https://images.theconversation.com/files/8614/original/hwgbzwhb-1331708092.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The community should look after the few unfortunate casualties of highly successful immunisation programs.</span> <span class="attribution"><span class="source">Sarah Gilbert</span></span></figcaption></figure><p>Reports on people suffering an adverse reaction to immunisation focus on the suffering of one over the safety of many. But immunisation benefits the whole community so we should all bear responsibility for those few who experience an adverse reaction to it.</p>
<p>Immunisation works and to the extent that we no longer see people suffering from diseases we immunise against, it is a victim of its own success. Until polio was effectively eradicated through the use of a vaccine, it was not uncommon to see its residual effect among the population. Such sights often motivated parents to immunise their children.</p>
<p>Another worthy example of the positive impact of immunisation is the story of measles in Australia. Only about half of all Australian children received measles vaccines in the 1980s and the illness circulated freely. From 1976 to 1995, 94 children (nearly five children a year) died from severe measles pneumonia or encephalitis (brain inflammation). </p>
<p>But since the 1990s, the proportion of children immunised against measles has risen to over 90%, and there’s only been one death from the illness since 1995 (in 2004). What’s more, there are now only occasional cases of measles in Australia imported from overseas.</p>
<p>About one in every thousand children who catches measles will develop encephalitis. This is fatal for about 5% to 10% and leaves 15% with brain damage. In contrast, only about one in a million children immunised with live measles vaccine (or the measles-mumps-rubella vaccine – MMR) develops encephalitis, which is one child every four years.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/8613/original/85yzc2nb-1331707980.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/8613/original/85yzc2nb-1331707980.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=600&fit=crop&dpr=1 600w, https://images.theconversation.com/files/8613/original/85yzc2nb-1331707980.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=600&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/8613/original/85yzc2nb-1331707980.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=600&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/8613/original/85yzc2nb-1331707980.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=754&fit=crop&dpr=1 754w, https://images.theconversation.com/files/8613/original/85yzc2nb-1331707980.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=754&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/8613/original/85yzc2nb-1331707980.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">
<figcaption>
<span class="caption"></span>
<span class="attribution"><span class="source">AJ Cann</span></span>
</figcaption>
</figure>
<p>In Australia, immunisation is not and doesn’t need to be compulsory because high rates of immunisation are already maintained voluntarily. Most parents recognise that the benefits of measles immunisation far outweigh the risks. Immunisation benefits individual children and the community because a large number of immunised kids means those who have contraindications to measles immunisation, such as those with immune deficiency or whose parents are conscientious objectors to immunisation, are also protected. </p>
<p>This protection is called “herd immunity” and it means when immunisation levels are high, a virus can no longer circulate so even unimmunised children will not be exposed and catch measles.</p>
<p>But suppose a child is unlucky enough to develop severe brain damage as a result of measles immunisation. Their family would inevitably incur out-of-pocket expenses for special needs, such as wheelchairs and modifications to their house and car. Is it fair that a family suffers because their child was inadvertently injured, through neither their fault nor health-care workers’, by a vaccine endorsed and paid for by the community? </p>
<p>By 2010, 19 countries around the world had accepted that society owes a duty of care (or of gratitude) to the very few individuals damaged by a vaccine and had introduced no-fault vaccine compensation schemes. Germany has had such a scheme for 50 years; New Zealand, the United States, Britain and most European countries have compensation schemes – Australia does not.</p>
<p>So what are the barriers to introducing a no-fault compensation scheme for vaccine injury? Would large numbers of people suddenly try to get vaccine compensation? This has not been the case in other countries, which generally appoint expert committees to consider whether cases of possible vaccine injury justify compensation. </p>
<p>Overseas schemes are funded by one of four methods: </p>
<ul>
<li><p>a vaccine tax; </p></li>
<li><p>special funding for the scheme from general taxes; </p></li>
<li><p>industry contribution; or </p></li>
<li><p>compensation as part of a broader national compensation scheme (as in New Zealand). </p></li>
</ul>
<p>In the United States, where compensation is funded through a vaccine levy, over 2,500 claimants have received compensation since 1989 and the compensation fund is in surplus by about US$3 billion.</p>
<p>Australia is proud of its emphasis on justice and the principle of giving people a “fair go”. It seems only fair someone injured by a vaccine offered and accepted in good faith to benefit the community should be compensated by that community. It’s certainly a better solution than having people not immunise their children and so expose the whole community to a virus. </p>
<p>High rates of immunisation reflect public trust in its benefits and such trust would only be strengthened by the knowledge that the community will look after the few unfortunate casualties of a highly successful immunisation program.</p><img src="https://counter.theconversation.com/content/5837/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>David Isaacs 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>Reports on people suffering an adverse reaction to immunisation focus on the suffering of one over the safety of many. But immunisation benefits the whole community so we should all bear responsibility…David Isaacs, Professor of Pediatric Infectious Diseases, University of SydneyLicensed as Creative Commons – attribution, no derivatives.