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	<title>Legislative and Regulatory &#8211; Pharmacy Update Online</title>
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	<title>Legislative and Regulatory &#8211; Pharmacy Update Online</title>
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	<item>
		<title>Study suggests mental health policy is emerging as a key voting issue for Americans</title>
		<link>https://pharmacyupdateonline.com/2026/03/study-suggests-mental-health-policy-is-emerging-as-a-key-voting-issue-for-americans/</link>
		
		<dc:creator><![CDATA[Charlie King]]></dc:creator>
		<pubDate>Thu, 26 Mar 2026 08:00:45 +0000</pubDate>
				<category><![CDATA[Legislative and Regulatory]]></category>
		<category><![CDATA[Medicines and Therapeutics]]></category>
		<category><![CDATA[Mental Health]]></category>
		<category><![CDATA[Practices and Services]]></category>
		<category><![CDATA[America]]></category>
		<category><![CDATA[health policy]]></category>
		<category><![CDATA[mental health]]></category>
		<category><![CDATA[policymakers]]></category>
		<category><![CDATA[political science]]></category>
		<category><![CDATA[voting issues]]></category>
		<guid isPermaLink="false">https://pharmacyupdateonline.com/?p=20241</guid>

					<description><![CDATA[A new University of Missouri study suggests mental health policies can play a significant role in how Americans choose political candidates. Past scholarly research has found that most [&#8230;]]]></description>
										<content:encoded><![CDATA[<p>A new University of Missouri study suggests mental health policies can play a significant role in how Americans choose political candidates.</p>
<p>Past scholarly research has found that most Americans say they support mental health policies. Jake Haselswerdt, an associate professor of political science in Mizzou’s <a href="https://coas.missouri.edu/">College of Arts and Science</a>, wanted to take the topic a step further by asking whether mental health policies actually matter when people choose to vote for a political candidate.</p>
<p>Drawing on a nationally representative sample of 1,000 adults from the 2024 Cooperative Election Study, Haselswerdt asked participants to choose between competing priorities. The results showed that even small differences could sway voters, and mental health was often the issue that tipped the scale in a candidate’s favor.</p>
<p>The results indicate mental health issues influence political decision making in substantive ways, Haselswerdt said.</p>
<p>“I assumed mental health would rank below topics that typically dominate public discussion, like border security,” he said. “But that’s not what I found. I found that people consider this to be as important as other issues that get a lot more news coverage.”</p>
<p>Mizzou’s study comes during a time when concerns about Americans’ mental well-being remain elevated across the country. Recent polling from the National Alliance on Mental Illness shows one in six adults reporting poor mental health, largely influenced by the cost of living, personal health concerns and the demands of daily life.</p>
<p>Haselswerdt said the findings point to a significant and often under-recognized opportunity for policymakers to take stronger action on mental health policies.</p>
<p>“If there’s one takeaway, it’s that political leaders should pay more attention to addressing the deepening mental health crisis in America,” he said.</p>
<p>The study, “<a href="https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0342486">Who cares about mental health? Benchmarking the issue importance of mental health for American voter</a>s” was published in <em>PLOS One</em>.</p>
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		<title>Can pharmacy-driven medication reconciliation reduce errors and improve patient safety?</title>
		<link>https://pharmacyupdateonline.com/2026/03/can-pharmacy-driven-medication-reconciliation-reduce-errors-and-improve-patient-safety/</link>
		
		<dc:creator><![CDATA[Christine Clark]]></dc:creator>
		<pubDate>Wed, 04 Mar 2026 06:00:25 +0000</pubDate>
				<category><![CDATA['In Discussion With']]></category>
		<category><![CDATA[Legislative and Regulatory]]></category>
		<category><![CDATA[Practices and Services]]></category>
		<category><![CDATA[Rita Shane]]></category>
		<category><![CDATA[Service Developments]]></category>
		<category><![CDATA[christine clark]]></category>
		<category><![CDATA[in discussion with]]></category>
		<category><![CDATA[medication]]></category>
		<category><![CDATA[medication reconciliation]]></category>
		<category><![CDATA[patient safety]]></category>
		<guid isPermaLink="false">https://pharmacyupdateonline.com/?p=20030</guid>

					<description><![CDATA[When a lack of proper medication reconciliation (MedRec) led to a sharp deterioration in her father’s health Dr Rita Shane (Vice President and Chief Pharmacy Officer at Cedars [&#8230;]]]></description>
										<content:encoded><![CDATA[<p><iframe title="Can pharmacy-driven medication reconciliation reduce errors and improve patient safety?" width="500" height="281" src="https://www.youtube.com/embed/2-vgAfbG3NA?feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" referrerpolicy="strict-origin-when-cross-origin" allowfullscreen></iframe><br />
<iframe style="border-radius: 12px;" src="https://open.spotify.com/embed/episode/3w7AXrECrsIhRVBARlaBn0?utm_source=generator" width="100%" height="152" frameborder="0" allowfullscreen="allowfullscreen" data-testid="embed-iframe"></iframe></p>
<p>When a lack of proper medication reconciliation (MedRec) led to a sharp deterioration in her father’s health Dr Rita Shane (Vice President and Chief Pharmacy Officer at Cedars Sinai Medical Center, Los Angeles, California) promised herself that she would ‘fix’ the problem before she retired. Just 20 years later she succeeded &#8211; MedRec by pharmacy staff became a legal requirement in California.</p>
<p>In 1998 Dr Shane’s father underwent a craniotomy for a brain metastasis associated with lung cancer. He developed “intractable agitation” and was transferred to a geriatric-psychiatric unit where his condition became much worse. When Dr Shane asked about his medication it became apparent that the steroids that he had been prescribed after the craniotomy had been abruptly discontinued when he was transferred.  “I knew you can&#8217;t just ‘cold turkey’ discontinue a steroid in a patient. Ultimately, I had him transferred back to Cedars Sinai because he ended up febrile. He was getting a decubitus [ulcer] and I was concerned that he would die of sepsis in a gero-sych unit due to what I considered an iatrogenic issue”, she says.</p>
<p>Medication reconciliation is often viewed as a simple clerical task. In fact, making an accurate record of current medication is an important procedure because the list becomes the basis for future prescribing decisions. Dr Shane has spearheaded a decades-long campaign to transform this process, arguing that pharmacy staff &#8211; pharmacists and technicians &#8211; are the only professionals with the specific expertise required to ensure medication safety during transitions of care. This effort recently culminated in California law SB 1254 and subsequent regulatory changes that mandate pharmacy-led MedRec for high-risk patients at both admission and discharge.</p>
<p><strong>The &#8220;poly problem&#8221; and iatrogenic risk</strong></p>
<p>One important reason for specialised pharmacy intervention is what Dr. Shane calls the &#8220;poly problem&#8221;: poly-disease, poly-doctor, and poly-pharmacy<strong>.</strong> As patients over 65 tend to have multiple chronic conditions, they often receive prescriptions from multiple providers and pharmacies. This fragmentation can create a chaotic medication history. In many ambulatory settings, medication histories are entered into the electronic health record (EHR) by medical assistants who, while vital to practice support, may lack in-depth training in pharmacology. These entries then become the &#8220;source of truth&#8221; for hospital admissions. For example, “When we first implemented our electronic health record, we would see orders like “methotrexate daily” [instead of weekly] that the pharmacist would intercept &#8211; and that&#8217;s really just a lack of knowledge and skills on the part of people that are transcribing orders without the benefit of the clinical knowledge”, she notes. Dr. Shane compares a medication order to a complex sentence: it requires the correct drug, dose, dosage form, route, rate, and duration. The pharmacist serves as a guardian angel over this process, making sure that orders are complete and accurate in the context of the whole patient, she says.</p>
<p><strong>The evidence: Why pharmacy ownership matters</strong></p>
<p>The push for legislative change was based on rigorous research evidence. Dr. Shane and her team conducted a randomised controlled trial in the emergency department, comparing &#8220;usual care&#8221; (medication histories taken by busy physicians or nurses) with those taken by trained pharmacy staff. The results were stark: pharmacists and technicians were significantly more accurate, identifying up to eight errors per high-risk patient.</p>
<p><strong>The business case for pharmacy-led MedRec</strong></p>
<p>For healthcare administrators, the argument for pharmacy-led MedRec extends beyond clinical outcomes to financial sustainability. Adverse drug events (ADEs) are a primary driver of increased hospital costs and. Data indicates that an ADE can increase a patient’s length of stay (LOS) – and therefore hospital costs &#8211; by an average of 3.1 days. At the time of the evaluation, the cost of a single admission or readmission due to these errors was estimated at $12,000 to $14,000.</p>
<p>By leveraging pharmacy technicians to transcribe histories accurately into the EHR, hospitals can achieve significant savings while allowing nurses and physicians to practice at the highest level of their licenses. One organisation demonstrated savings of $830,000 by utilising technicians for this function. Furthermore, reducing the 40 minutes of nursing time typically spent per patient on medication histories provides a major relief to frontline clinical staff.</p>
<p><img fetchpriority="high" decoding="async" class="aligncenter wp-image-20132 size-thumbnail" src="https://pharmacyupdateonline.com/wp-content/uploads/2026/03/Call-to-Action-Discharge-Medications-ASHP-Midyear-640x360.jpg" alt="" width="640" height="360" srcset="https://pharmacyupdateonline.com/wp-content/uploads/2026/03/Call-to-Action-Discharge-Medications-ASHP-Midyear-640x360.jpg 640w, https://pharmacyupdateonline.com/wp-content/uploads/2026/03/Call-to-Action-Discharge-Medications-ASHP-Midyear-768x432.jpg 768w, https://pharmacyupdateonline.com/wp-content/uploads/2026/03/Call-to-Action-Discharge-Medications-ASHP-Midyear.jpg 1280w" sizes="(max-width: 640px) 100vw, 640px" /></p>
<p>All of this information was brought together in an infographic that was used to educate the State Board of Pharmacy and the California legislature about the problem. “Timing is everything” says Dr Shane and it turned out that one of the California senators was a pharmacist and he enthusiastically supported Dr Shane’s initiative. After a number of hearings, the bill was signed into law in September 2018, just two years and four days after her father’s death. “It was an exciting journey and really an outstanding opportunity to educate legislators”, she recalls. Moreover, during her discussions with legislators, “Everyone seemed to have an example of a family member having a problem with an inaccurate medication list &#8211; and that brought it home”, she adds.</p>
<p>Following the passage of SB 1254 (the bill in question) in 2018, a larger study involving 11 California hospitals (ranging from university-based to community hospitals) further validated these findings. Over a six-week period, the study captured approximately 16,000 errors across 2,300 medication histories. Notably, 94% of medication lists contained at least one error, and 25% of those errors were classified as serious or life-threatening. These findings were verified by independent physician reviews, ensuring that the severity of the errors was not overstated. Reflecting on the findings, Dr Shane says, “We demonstrated that we prevented significant harm in the state of California for the hospitals that implemented this new law”.</p>
<p><strong>Closing the loop: MedRec at discharge</strong></p>
<p>While the 2018 legislation focused on admission, Dr. Shane realised that the &#8220;back end&#8221; of the hospital stay remained a point of extreme vulnerability. She uses the analogy of a totally wrecked car (the patient) that is painstakingly repaired in a body shop (the hospital), only to be driven off a cliff at discharge because the final medication list was inaccurate.</p>
<p>Studies showed that even with accurate admission medication lists, patients still experienced an average of two medication errors at discharge. Approximately 20% of hospital admissions are medication-related, and at least 40% of patients have an error on their discharge medication list, she says. These errors, such as the inadvertent omission of anticoagulants or antibiotics, are then perpetuated by community pharmacists who, lacking access to patient records, have no way of recognising the mistakes.</p>
<p>To address this, Dr. Shane successfully advocated for a regulatory change through the California State Board of Pharmacy’s &#8220;sunset review&#8221; process. As of January 1, 2026, the law was expanded to include medication reconciliation at discharge for high-risk patients.</p>
<p><strong>A new paradigm: The &#8220;high-alert patient&#8221;</strong></p>
<p>Perhaps the most transformative concept proposed by Dr. Shane is the shift from focusing solely on high-alert medications to identifying the &#8220;high-alert patient&#8221;. This designation would apply to the most vulnerable individuals &#8211; those with multiple diseases and complex regimens &#8211; who should be &#8220;tagged&#8221; for prioritised pharmacist attention across all providers.</p>
<p>Dr. Shane’s vision is to see these California-led successes become a national standard. Through collaboration with the National Association of Boards of Pharmacy (NABP) and the Joint Commission, she continues to advocate for model legislation that designates pharmacy staff as the clear &#8220;owners&#8221; of the medication list. For health professionals, the message is clear: ensuring an accurate medication list is not a secondary task; it is a foundational element of patient safety that requires the specialised clinical lens of the pharmacy profession.</p>
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		<title>How well are international guidelines followed for certain medications for high-risk pregnancies?</title>
		<link>https://pharmacyupdateonline.com/2026/03/how-well-are-international-guidelines-followed-for-certain-medications-for-high-risk-pregnancies/</link>
		
		<dc:creator><![CDATA[Charlie King]]></dc:creator>
		<pubDate>Mon, 02 Mar 2026 08:00:31 +0000</pubDate>
				<category><![CDATA[Legislative and Regulatory]]></category>
		<category><![CDATA[Medicines and Therapeutics]]></category>
		<category><![CDATA[Obstetrics, Gynaecology and Genito-Urinary System]]></category>
		<category><![CDATA[Practices and Services]]></category>
		<category><![CDATA[high-risk pregnancy]]></category>
		<category><![CDATA[international guidelines]]></category>
		<category><![CDATA[medications]]></category>
		<category><![CDATA[Prenatal magnesium sulfate]]></category>
		<category><![CDATA[steroids]]></category>
		<guid isPermaLink="false">https://pharmacyupdateonline.com/?p=20111</guid>

					<description><![CDATA[Prenatal magnesium sulfate and steroids can reduce the risks of cerebral palsy and respiratory complications in preterm infants. A review in the International Journal of Gynecology &#38; Obstetrics found that [&#8230;]]]></description>
										<content:encoded><![CDATA[<p>Prenatal magnesium sulfate and steroids can reduce the risks of cerebral palsy and respiratory complications in preterm infants. A review in the <a href="https://obgyn.onlinelibrary.wiley.com/journal/18793479"><em>International Journal of Gynecology &amp; Obstetrics</em></a> found that despite being recommended internationally for pregnant women at risk of preterm delivery, these medications are used variably between and within countries.</p>
<p>When they analyzed 2012–2024 information on 45,619 babies born at 24–32 weeks&#8217; gestation at 1,111 hospitals in an international network, along with information from the UK National Neonatal Research Database and a literature review, investigators found that on average, less than half of infants had been exposed to preterm magnesium sulfate in middle-income countries, and approximately three-quarters in high-income countries. Even within high-income countries, there were large discrepancies in care. Preterm steroids were used more frequently with less variation, although treatment gaps were still apparent.</p>
<p>“Our study has highlighted the international disparities in how two key treatments to protect pre-term babies are implemented. These gaps aren’t because of a lack of evidence,” said corresponding author Hannah B. Edwards, MA, MSc, of the University of Bristol, in the UK. “Lessons can be learned from successful implementation programs like PReCePT, which has transformed use of magnesium sulphate in pre-term births in England. The bigger-picture goal should now be to ensure that no matter where a baby is born, their mother has access to the evidence-based treatments that offer the best start in life.”</p>
<p><strong>URL upon publication: </strong><a href="https://onlinelibrary.wiley.com/doi/10.1002/ijgo.70832?utm_source=muckrack&amp;utm_medium=email&amp;utm_campaign=publicity_wly&amp;utm_content=wrh_2_23_26&amp;utm_term=ijgo"><strong>https://onlinelibrary.wiley.com/doi/10.1002/ijgo.70832</strong></a></p>
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		<title>New JAMA Commentary calls for evidence-backed dietary guidelines</title>
		<link>https://pharmacyupdateonline.com/2026/02/new-jama-commentary-calls-for-evidence-backed-dietary-guidelines/</link>
		
		<dc:creator><![CDATA[Charlie King]]></dc:creator>
		<pubDate>Tue, 10 Feb 2026 08:00:45 +0000</pubDate>
				<category><![CDATA[Legislative and Regulatory]]></category>
		<category><![CDATA[Medicines and Therapeutics]]></category>
		<category><![CDATA[Nutrition]]></category>
		<category><![CDATA[Practices and Services]]></category>
		<category><![CDATA[diet guidelines]]></category>
		<category><![CDATA[diet quality]]></category>
		<category><![CDATA[food legislation]]></category>
		<category><![CDATA[JAMA network]]></category>
		<category><![CDATA[nutrition]]></category>
		<guid isPermaLink="false">https://pharmacyupdateonline.com/?p=19951</guid>

					<description><![CDATA[A new JAMA commentary says the new Dietary Guidelines for Americans give undue prominence to meat, dairy, and “bad” fat and risk the public’s health. The Viewpoint, “When Nutrition Science is Ignored/Potential [&#8230;]]]></description>
										<content:encoded><![CDATA[<p>A new <a href="https://jamanetwork.com/journals/jama/article-abstract/2844638">JAMA commentary</a> says the new <a href="https://cdn.realfood.gov/DGA.pdf">Dietary Guidelines for Americans</a> give undue prominence to meat, dairy, and “bad” fat and risk the public’s health.</p>
<p>The Viewpoint, “When Nutrition Science is Ignored/Potential Public Health Cost of the 2025 Dietary Guidelines,” expresses concerns that the new guidelines ignored the advice of the 2025 Dietary Guidelines Advisory Committee, which emphasized limiting meat, added sugars, and high-sodium foods in favor of fruits, vegetables, whole grains, legumes, nuts and plant proteins, and, instead, release guidelines that was not based on scientific evidence.</p>
<p>“This is more than a scientific concern—it represents a regression in evidence-based public health policy,” the article says. “Poor diet, specifically a dietary pattern high in sodium, saturated fat, fried food, refined grains, animal protein, cholesterol, and added sugar is the leading cause of death and disability in the US, surpassing tobacco and inactivity.”</p>
<p>The authors urge future dietary guidelines to follow scientific-backed recommendations. When they don’t, the rationale should be explained, and any commercial or political considerations should be revealed, they wrote.</p>
<p>“In the meantime,” the commentary says, “clinicians, health systems, and advocacy organizations must reaffirm the science. Diets rich in whole grains, fruits, vegetables, legumes, nuts, and seeds are foundational to cardiovascular and metabolic health, and have been shown to reduce systemic inflammation and favorably influence the composition and function of the gut microbiome.”</p>
<p>Dr. Neal Barnard, one of the piece’s three authors and president of the Physicians Committee for Responsible Medicine, says the new guidelines should be rewritten to reflect evidence-based nutrition standards.</p>
<p>“As currently written,” Dr. Barnard says, “the Dietary Guidelines dangerously promote animal products, the biggest cause of chronic disease. They must be revamped to eliminate industry influence and comport with the science, which shows the healthiest diet is one that focuses on plants.”</p>
<p>The Physicians Committee <a href="https://pcrm.widen.net/s/p6qggt8j6n/dietary-guidelines-usda-hhs-complaint-physicians-committee-for-responsible-medicine">filed a petition Jan. 8</a> with the Offices of Inspector General for the Department of Health and Human Services and the U.S. Department of Agriculture asking for the 2025-2030 Dietary Guidelines to be withdrawn and reissued because of rampant industry influence, including by the meat and dairy industries. Of nine authors of a new scientific report underlying the guidelines, at least seven had industry ties. The authors <a href="https://cdn.realfood.gov/Scientific%2520Report.pdf">declared receiving research funding or other compensation </a>from the National Cattlemen’s Beef Association, the Texas Beef Council, General Mills, the National Dairy Council, and the National Pork Board, among other companies.</p>
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		<title>Green light for six new medicines in the EU</title>
		<link>https://pharmacyupdateonline.com/2026/02/green-light-for-six-new-medicines-in-the-eu/</link>
		
		<dc:creator><![CDATA[Gary Finnegan]]></dc:creator>
		<pubDate>Mon, 09 Feb 2026 08:00:35 +0000</pubDate>
				<category><![CDATA[Legislative and Regulatory]]></category>
		<category><![CDATA[Practices and Services]]></category>
		<category><![CDATA[committee on human medicines]]></category>
		<category><![CDATA[drug approval]]></category>
		<category><![CDATA[European Medicines Agency]]></category>
		<category><![CDATA[Fylrevy]]></category>
		<category><![CDATA[Ilumira]]></category>
		<category><![CDATA[Kayshild]]></category>
		<guid isPermaLink="false">https://pharmacyupdateonline.com/?p=19957</guid>

					<description><![CDATA[The European Medicines Agency (EMA) has given its approval for six new medicines, with another nine products receiving extensions for their therapeutic indications. The decisions came as the [&#8230;]]]></description>
										<content:encoded><![CDATA[<p>The European Medicines Agency (EMA) has given its approval for six new medicines, with another nine products receiving extensions for their therapeutic indications. The decisions came as the Agency’s key Committee on Human Medicines (CHMP) met for the first time in 2026.</p>
<p><strong>Newly-approved products </strong></p>
<ul>
<li><strong>Fylrevy</strong> (estetrol), a hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women who have had a hysterectomy. This medicine is indicated to alleviate symptoms such as a hot face, neck and chest, also known as ‘hot flushes’.</li>
<li><strong>Ilumira</strong> (lutetium (177Lu) chloride), a radiopharmaceutical precursor, for the radiolabelling of carrier medicines that have been specifically developed and authorised for radiolabelling with lutetium chloride.</li>
<li><strong>Kayshild </strong>(semaglutide), a GLP1 receptor agonist for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis, a serious disease where fat deposits accumulate in the liver causing inflammation.</li>
<li><strong>Kygevvi</strong> (doxecitine / doxribtimine), the first treatment for thymidine kinase 2 deficiency, a rare, life-threatening genetic disease that affects fewer than one in a million people and for which there was no authorised treatment.</li>
<li><strong>Supemtek</strong> (trivalent influenza vaccine (recombinant, prepared in cell culture)), a vaccine for the prevention of influenza in adults and children from nine years of age.</li>
<li><strong>Rezurock</strong> (belumosudil), a medicine intended for the treatment of chronic graft-versus-host disease, a condition in which donor cells of a bone marrow or stem cell transplant attack the host body. The committee concluded that this medicine is to be used when other treatment options provide limited clinical benefit, are not suitable or have been exhausted.</li>
</ul>
<p>The committee recommended extending the use of <strong>Zynyz </strong>(retifanlimab) for the treatment of adults with squamous cell carcinoma of the anal canal (SCAC) that cannot be removed by surgery and is metastatic or locally recurrent. The CHMP also adopted a positive opinion on <strong>Eurneffy</strong> (epinephrine) with a new strength (1 mg nasal spray, solution) indicated for children with a body weight of 15 kg to less than 30 kg. Eurneffy is the first emergency treatment against allergic reactions that is administered as a nasal spray, not as an injection.</p>
<p>Finally, the committee recommended another seven extensions of indication for medicines that are already authorised in the EU: <strong>Akeega, Efmody, Iclusig, Imfinzi, Kerendia, Noxafil </strong>and <strong>Opdivo.</strong></p>
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		<title>EU regulator: paracetamol can be used in pregnancy</title>
		<link>https://pharmacyupdateonline.com/2026/02/eu-regulator-paracetamol-can-be-used-in-pregnancy/</link>
		
		<dc:creator><![CDATA[Gary Finnegan]]></dc:creator>
		<pubDate>Sat, 07 Feb 2026 08:00:40 +0000</pubDate>
				<category><![CDATA[Legislative and Regulatory]]></category>
		<category><![CDATA[Medicines and Therapeutics]]></category>
		<category><![CDATA[Obstetrics, Gynaecology and Genito-Urinary System]]></category>
		<category><![CDATA[Practices and Services]]></category>
		<category><![CDATA[acetaminophen]]></category>
		<category><![CDATA[drug safety]]></category>
		<category><![CDATA[EU regulator]]></category>
		<category><![CDATA[European Medicines Agency]]></category>
		<category><![CDATA[paracetamol]]></category>
		<category><![CDATA[pregnancy]]></category>
		<guid isPermaLink="false">https://pharmacyupdateonline.com/?p=19955</guid>

					<description><![CDATA[The European Medicines Agency (EMA) has released a statement designed to clear up any remaining uncertainty about the use of paracetamol. In the EU, the drug watchdog says, [&#8230;]]]></description>
										<content:encoded><![CDATA[<p>The European Medicines Agency (EMA) has released a statement designed to clear up any remaining uncertainty about the use of paracetamol. In the EU, the drug watchdog says, paracetamol (also known as acetaminophen) can be used for reducing pain or fever during pregnancy if clinically needed.</p>
<p>There is no new evidence that would require changes to the current long-standing recommendation, the Agency stressed. It cited a recent systematic review and meta-analysis published in <em>The Lancet Obstetrics, Gynaecology &amp; Women’s Health</em> which found no evidence linking paracetamol to autism, ADHD or intellectual disability in children.</p>
<p>‘Paracetamol remains an important option to treat pain or fever in pregnant women,’ said EMA’s Chief Medical Officer, Steffen Thirstrup. ‘Our advice is based on rigorous assessment of the available scientific data and we have found no evidence that taking paracetamol during pregnancy causes autism in children.’</p>
<p>The unusual decision to issue a statement – which announces no change in advice and no new evidence to review – comes in response to misinformation which falsely linked the common pain reliever with developmental changes. This idea was repeated by senior politicians in the United States in recent months, sparking widespread concern worldwide.</p>
<p>Without naming those who have perpetuated the myth, the EU regulator pushed back against the baseless medical claim which has potential to cause distress and avoidable physical suffering for pregnant women with a fever.</p>
<p>The EMA said it has a large amount of data from pregnant women who used paracetamol during pregnancy, over a very long period of time, and has seen no evidence of any risk of malformations in the developing foetus or in newborns.</p>
<p>‘When needed, paracetamol can be used during pregnancy. As with any medicine for acute treatment, it should be used at the lowest effective dose, for the shortest possible time and as infrequently as possible,’ the EMA statement said. ‘Pregnant women should speak to their healthcare professional if they have questions about any medication during pregnancy.’</p>
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		<title>EU and US regulators publish Ten Commandments for AI</title>
		<link>https://pharmacyupdateonline.com/2026/02/eu-and-us-regulators-publish-ten-commandments-for-ai/</link>
		
		<dc:creator><![CDATA[Gary Finnegan]]></dc:creator>
		<pubDate>Fri, 06 Feb 2026 08:00:42 +0000</pubDate>
				<category><![CDATA[Artificial intelligence]]></category>
		<category><![CDATA[Devices and Technology]]></category>
		<category><![CDATA[Legislative and Regulatory]]></category>
		<category><![CDATA[Practices and Services]]></category>
		<category><![CDATA[artificial intelligence]]></category>
		<category><![CDATA[European Medicines Agency]]></category>
		<category><![CDATA[Food and Drug Administration]]></category>
		<category><![CDATA[medical regulation]]></category>
		<category><![CDATA[pharmaceutical legislation]]></category>
		<guid isPermaLink="false">https://pharmacyupdateonline.com/?p=19953</guid>

					<description><![CDATA[The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have jointly published a set of ten principles for the ‘good use’ of artificial intelligence [&#8230;]]]></description>
										<content:encoded><![CDATA[<p>The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have jointly published a set of ten principles for the ‘good use’ of artificial intelligence in the lifecycle of medicines.</p>
<p>Amid growing adoption of new AI tools across the industry, the regulators have set out broad guidance on how the technology can be used to generate evidence, manufacture products and monitor safety.</p>
<p>The principles are relevant for those developing medicines, as well as for marketing authorisation applicants and holders, the regulators said in a joint statement. They will underpin future AI guidance in both jurisdictions and support enhanced international collaboration. The development of formal guidelines in the EU is already underway, building on the <a href="https://www.ema.europa.eu/node/244999#ai-in-medicinal-product-lifecycle-reflection-paper-68368">EMA AI reflection paper</a> published in 2024.</p>
<p>‘The principles are a good showcase of how we can work together on the two sides of the Atlantic to preserve our reading role in the global innovation race, while ensuring the highest level of patient safety,’ said European Commission for Health and Animal Welfare, Olivér Várhelyi.</p>
<p>The <a href="https://health.ec.europa.eu/publications/proposal-regulation-establish-measures-strengthen-unions-biotechnology-and-biomanufacturing-sectors_en">European Commission’s Biotech Act</a> proposal, published in December, notes the promise of AI as a tool to accelerate innovation. <a href="https://www.ema.europa.eu/en/about-us/what-we-do/reform-eu-pharmaceutical-legislation">New pharmaceutical legislation</a>, meanwhile, aims to accommodate the broader use of AI in regulatory decision-making, and creates additional possibilities for testing AI-driven methods for medicines in a controlled environment.</p>
<p>To realise these benefits, say regulators, AI needs to be expertly managed, including the mitigation of risks. Ethics should be at the forefront of policymaking and regulations, it noted.</p>
<p>As AI continues to evolve, a principles-based approach will help regulators, pharmaceutical companies and medicines developers harness the potential of these technologies while ensuring patient safety and regulatory compliance.</p>
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		<title>£13m NHS bill for ‘mismanagement’ of menstrual bleeds</title>
		<link>https://pharmacyupdateonline.com/2025/12/13m-nhs-bill-for-mismanagement-of-menstrual-bleeds/</link>
		
		<dc:creator><![CDATA[Charlie King]]></dc:creator>
		<pubDate>Wed, 24 Dec 2025 08:00:07 +0000</pubDate>
				<category><![CDATA[Legislative and Regulatory]]></category>
		<category><![CDATA[Medicines and Therapeutics]]></category>
		<category><![CDATA[Obstetrics, Gynaecology and Genito-Urinary System]]></category>
		<category><![CDATA[Practices and Services]]></category>
		<category><![CDATA[female health]]></category>
		<category><![CDATA[Gynaecology]]></category>
		<category><![CDATA[menstrual bleeds]]></category>
		<category><![CDATA[mismanagement]]></category>
		<category><![CDATA[NHS]]></category>
		<category><![CDATA[uterine fibroids]]></category>
		<guid isPermaLink="false">https://pharmacyupdate.online/?p=19502</guid>

					<description><![CDATA[A landmark UK study has revealed that acute heavy menstrual bleeding (HMB) is placing a significant hidden burden on the NHS, with around £13 million spent annually on [&#8230;]]]></description>
										<content:encoded><![CDATA[<p>A landmark UK study has revealed that acute heavy menstrual bleeding (HMB) is placing a significant hidden burden on the NHS, with around £13 million spent annually on hospital admissions and post-discharge care.</p>
<p>The study, led by Dr Bassel Wattar of Anglia Ruskin University and published in <em>The Lancet Obstetrics, Gynaecology, &amp; Women’s Health</em> journal, is the first UK-based multicentre study to evaluate the prevalence of acute HMB and number of women requiring red blood cell transfusion.</p>
<p>The observational study analysed data from 98 NHS gynaecology units between January and June 2024. Researchers found that 1,332 women were admitted to receive a total of 3,025 units of red blood cells as a last measure to manage acute HMB.</p>
<p>The average hospital stay was two days, with most patients receiving additional treatments such as tranexamic acid, iron supplements, or hormonal therapy. Nearly half of the women had uterine fibroids, and 20% were discharged while still anaemic.</p>
<p>The authors believe many of these cases could be handled in the community or by outpatient services, reducing the need for expensive hospital admissions.</p>
<p>The study estimates the mean cost per admission at £2,972 and the average cost of post-discharge management at £1,735. When extrapolated over 12 months, the total cost to the NHS is estimated to be £13,018,448.</p>
<p>The findings highlighted a lack of standardised pathways for managing acute HMB, which differs from chronic menstrual disorders. Despite existing NICE guidelines for chronic HMB, there is no specific coding or national strategy for acute cases, making it difficult to track and treat effectively.</p>
<p>The study also found wide regional variation in admissions and treatment approaches, with London regions reporting the highest numbers.</p>
<p>Heavy menstrual bleeding affects approximately <a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC5829848/#R1">one in four women</a> of reproductive age.</p>
<p>Researchers are calling for urgent investment in community-based gynaecology services, including one-stop clinics with access to diagnostics and minor surgical procedures. They also recommend developing national guidelines and coding systems to better identify and manage acute HMB.</p>
<p>Dr Wattar, Associate Professor of Reproductive Medicine at Anglia Ruskin University (ARU), said: “This is a silent crisis in women’s health. We are seeing thousands of women admitted to hospital for a condition that could often be managed earlier and more effectively in the community.</p>
<p>“Current guidelines and services offered in the NHS do not offer a clear pathway for managing acute heavy menstrual bleeding efficiently.</p>
<p>“This mismanagement leads to women are being discharged with temporary fixes, often still anaemic, and left to navigate long waiting lists for definitive care. We need to shift from reactive to proactive care.”</p>
<p>The study involved over 100 NHS clinicians and researchers through the UK Audit and Research Collaborative in Obstetrics and Gynaecology (UKARCOG).</p>
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		<title>Helping health care providers navigate social, political, and legal barriers to patient care</title>
		<link>https://pharmacyupdateonline.com/2025/12/helping-health-care-providers-navigate-social-political-and-legal-barriers-to-patient-care/</link>
		
		<dc:creator><![CDATA[Charlie King]]></dc:creator>
		<pubDate>Sun, 21 Dec 2025 08:00:53 +0000</pubDate>
				<category><![CDATA[Legislative and Regulatory]]></category>
		<category><![CDATA[Pharmacy Services]]></category>
		<category><![CDATA[Practices and Services]]></category>
		<category><![CDATA[Service Developments]]></category>
		<category><![CDATA[asylum system]]></category>
		<category><![CDATA[health care providers]]></category>
		<category><![CDATA[healthcare delivery]]></category>
		<category><![CDATA[legal barriers]]></category>
		<category><![CDATA[patient care]]></category>
		<guid isPermaLink="false">https://pharmacyupdate.online/?p=19486</guid>

					<description><![CDATA[In November, The Lancet, one of the world’s most esteemed medical journals, launched a new monthly series of case studies that goes beyond clinical diagnoses to illuminate the social and cultural forces [&#8230;]]]></description>
										<content:encoded><![CDATA[<p>In November, <em>The Lancet, </em>one of the world’s most esteemed medical journals, launched a <a href="https://news.berkeley.edu/2025/12/04/beyond-biology-why-social-context-is-the-key-for-improving-modern-medicine/">new monthly series</a> of case studies that goes beyond clinical diagnoses to illuminate the social and cultural forces that contribute to each patient’s condition.</p>
<p>Clinical case studies have long been a fixture in medical journals and are a primary way doctors and other health professionals continue learning after their initial training. Typically, case studies are short summaries of a patient’s predicament alongside a clinician’s assessment, diagnosis, and treatment, reviewed exclusively through medical frameworks. But the new series from <em>The Lancet</em> taps experts from the social sciences and humanities to unpack concepts that health care practitioners, leaders, and policymakers can use to address the social and structural causes of global health inequities.</p>
<p>The second case study in the series, published<a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)02423-7/fulltext"> on Thursday</a>, was led by medical anthropologist Carlos Martinez, an assistant professor of Latin American and Latino Studies and core faculty member in the Global and Community Health Program UC Santa Cruz. Martinez and his coauthors describe the difficulties that asylum seekers face when trying to access health care and argue that health system leaders need to know how and when to call in outside resources and organizations to help overcome social, political, and legal challenges in patient care.</p>
<p>“Addressing these nonbiological determinants of health is increasingly being recognized as the most significant way to improve patient health outcomes, particularly among marginalized communities,” Martinez explained. “But clinicians are still not being provided with the knowledge base and tools they need to act on these determinants. Our case study encourages clinicians to partner with community-based advocacy and mutual aid organizations that are already doing a lot of the heavy lifting in supporting marginalized communities and to become familiar with and draw from their expertise in order to better serve patients.”</p>
<p><strong>Revealing the health risks of a broken asylum system</strong></p>
<p>Martinez’s case study focuses on a 45-year-old man seeking asylum in the U.S. who was suffering from kidney stone complications. A volunteer doctor at a clinic in Tijuana diagnosed the man and explained that he would need treatment with a specialized medical procedure called lithotripsy, which neither the clinic nor the public health system in Mexico could provide. The doctor prescribed medication to temporarily stabilize the condition, and the man then crossed into the U.S., where both he and his doctor assumed he would be able to get prompt medical care. Unfortunately, that’s not what happened.</p>
<p>The man was placed in an Immigration and Customs Enforcement (ICE) detention facility, where he was held for three weeks without a medical consultation, despite experiencing extreme pain. He then called a hotline telephone number operated by non-profit human rights organization Migrant Advocates. The organization submitted complaints to the facility’s warden, after which ICE offered a medical consultation from a jail physician but still did not provide adequate pain control, medication, or a specialist referral. That’s when the nonprofit reached out to the doctor in Tijuana who had initially diagnosed the man to request his medical records.</p>
<p>The doctor had never worked with an advocacy organization in this manner before and was worried about potentially running afoul of privacy laws by sharing patient medical information. But he also knew that his patient was at risk of infection and permanent kidney damage if the kidney stone was left untreated. The doctor decided to work with Migrant Advocates, contributing to a series of letters and court petitions advocating for the man to receive appropriate specialty care. The process took more than a year. The patient was eventually released from ICE custody and received the procedure he needed 5 months afterward at a hospital in Los Angeles. But treatment delays left him with moderate permanent kidney damage.</p>
<p>The whole ordeal took place back in 2022, when strict COVID-era public health rules initially implemented by the first Trump Administration were still in effect, reducing entry into the U.S. and allowing for quick expulsion of would-be immigrants, including asylum seekers. The situation has further deteriorated under the second Trump Administration, Martinez says, and migrants with medical needs now face more threats than ever.</p>
<p>“As Amnesty International <a href="https://www.amnesty.org/en/latest/news/2025/02/the-right-to-seek-asylum-does-not-exist-at-u-s-mexico-border/">has documented</a>, all pathways to legally request asylum at the border are now blocked,” he said. “As a result, asylum seekers at the border are now stuck in permanent limbo in highly precarious environments, requiring more long-term support and medical care. This requires more collaborations between medical professionals, social service organizations, and legal groups documenting these experiences who are seeking to challenge the Trump Administration’s policies in court.”</p>
<p><strong>Teaching clinicians how to call for backup</strong></p>
<p>Martinez’s case study demonstrates the need for health care providers to develop what he and his coauthors call “structural intercompetency.” The term refers to both having a strong awareness of social, political, legal, and economic impacts on patient health and being ready and able to effectively collaborate with non-clinicians, such as legal and community advocates, to improve patient outcomes.</p>
<p>The practice is valuable in any setting where health care providers are working with marginalized populations, ranging from asylum seekers to patients who experience negative health impacts associated with racial or gender-based discrimination, political persecution, domestic violence, homelessness, incarceration, or occupational-related harms. Martinez and his coauthors lay out several pathways to supporting structural intercompetency in these cases.</p>
<p>First, doctors, hospital administrators, and public health officials can focus on developing and funding medical-legal partnerships, in which legal professionals are embedded in health care settings. These types of partnerships can reduce patient stress, readmission rates, and emergency department visits by helping patients access essential services, rights, and benefits. Health care leaders should also seek to expand partnerships to grassroots organizations, which can often provide both immediate material support for patients and lead advocacy efforts to advance long-term policy change.</p>
<p>“Currently, the partnership-building work of structural intercompetency is often being led by clinicians themselves, rather than by hospital administrators,” Martinez said. “Providers across California are currently collaborating with lawyers and community organizations to develop and advocate for the adoption of hospital policies and protocols that better protect undocumented patients and those who are being brought to hospitals by ICE officials.”</p>
<p>Medical schools also have a role to play. The case study argues that medical schools should integrate experts and practitioners beyond the health professions throughout their curricula, so that students build an awareness of the work of these experts, how it impacts patients, and how physicians can collaborate with them to advance health. This type of training could help students understand the limitations of clinical medicine and the need to work constructively with patients, communities, and outside experts to respond to social and political inequalities.</p>
<p>“Despite the benefits, many medical schools are currently rolling back curricula that address the social determinants of health amidst a political crackdown on so-called DEI in higher education,” Martinez said. “Our hope is that this series on global social medicine in <em>The Lancet</em>, considered one of medicine’s most prestigious journals, will encourage medical schools to restore and expand this kind of curriculum. By better preparing providers to engage collaboratively around social issues, medical schools and health systems could have broader impacts in improving patient and community outcomes and reducing strain on health systems.”</p>
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		<title>New UK guideline for clopidogrel recommends pharmacogenetic testing for all patients before prescription</title>
		<link>https://pharmacyupdateonline.com/2025/12/new-uk-guideline-for-clopidogrel-recommends-pharmacogenetic-testing-for-all-patients-before-prescription/</link>
		
		<dc:creator><![CDATA[Charlie King]]></dc:creator>
		<pubDate>Thu, 18 Dec 2025 08:00:57 +0000</pubDate>
				<category><![CDATA[Internal Medicine]]></category>
		<category><![CDATA[Legislative and Regulatory]]></category>
		<category><![CDATA[Medicines and Therapeutics]]></category>
		<category><![CDATA[Practices and Services]]></category>
		<category><![CDATA[Service Developments]]></category>
		<category><![CDATA[antiplatelet]]></category>
		<category><![CDATA[Clopidogrel]]></category>
		<category><![CDATA[pharmacogenetic testing]]></category>
		<category><![CDATA[prescription]]></category>
		<category><![CDATA[UK guidelines]]></category>
		<guid isPermaLink="false">https://pharmacyupdate.online/?p=19475</guid>

					<description><![CDATA[The UK Centre of Excellence in Regulatory Science and Innovation in Pharmacogenomics (UK CERSI-PGx), led by the University of Liverpool, has published its first clinical guideline focused on [&#8230;]]]></description>
										<content:encoded><![CDATA[<p>The UK Centre of Excellence in Regulatory Science and Innovation in Pharmacogenomics (UK CERSI-PGx), led by the University of Liverpool, has published its first clinical guideline focused on the use of the antiplatelet medication clopidogrel, widely prescribed in the UK to prevent blood clots. Pharmacogenomics looks at how differences in our genes can change the way medicines affect each person.</p>
<p>The guideline addresses CYP2C19 genotyping in patients prescribed clopidogrel for conditions such as coronary artery disease, cerebrovascular disease, and peripheral arterial disease. This is because clopidogrel does not work uniformly in all patients.</p>
<p>CYP2C19 is an enzyme in the liver that influences how clopidogrel is converted in the body into its active form. Different people have different levels of this enzyme because of variation in their CYP2C19 gene.  Those with low enzyme levels will activate clopidogrel less efficiently than those with “normal” levels making clopidogrel less effective— this variability can be detected by a simple genetic test.  A significant proportion of the population have lower enzyme levels: in white individuals it is 20-30%, but it can be as high as 50-60% in those of Asian descent.</p>
<p>Rather than duplicating existing international pharmacogenomic guidelines from CPIC and DPWG, the UK CERSI-PGx guideline provides a greater clinical focus, offering practical recommendations on:</p>
<ul>
<li>Eligibility for testing</li>
<li>Integration into current clinical pathways</li>
<li>Variants to test and turnaround times</li>
<li>Actions based on genotype</li>
<li>Health economic considerations</li>
<li>Evidence gaps and future research priorities</li>
</ul>
<p>The development of these guidelines is a first for the UK and has been undertaken by a committee with a representative group of specialists.  These guidelines will be important for regulators, for industry and for the NHS.  The NHS 10-year plan states that “pharmacogenomics will be integrated into routine clinical practice” – the current guideline, and the others which are currently in development by CERSI-PGx, will help with that ambition.</p>
<p>UK CERSI-PGx is funded by Innovate UK and the Medical Research Council, in conjunction with the MHRA, as part of the UK’s network of seven Centres of Excellence for Regulatory Science and Innovation. Collaborators in CERSI-PGx include The University of Manchester, Queen Mary University of London, Bangor University, The Office of Health Economics, The British Pharmacological Society, JS O’Brien Business Solutions, and Alderley Lighthouse Labs.</p>
<p><strong>Centre Lead the University of Liverpool’s Professor Sir Munir Pirmohamed</strong> said: <em>“With the new CERSI-PGx guideline for clopidogrel, we aim to ensure patients are prescribed the right treatment at the right dose, based on their genetics. By integrating CYP2C19 testing into routine pathways, we can improve efficacy, reduce adverse drug reactions, ease pressure on the NHS, and support cost-effective, precision prescribing.”</em></p>
<p><strong>MHRA’s Chief Safety Officer, Dr Alison Cave</strong>, said: “<em>This first clinical guideline from UK-CERSI-PGx for clopidogrel provides practical recommendations to accelerate the integration of pharmacogenomics into routine care. By analysing a patient’s genetic information, pharmacogenomics ensures they receive the most appropriate medication and dosage for their specific genetic profile minimising the risk of adverse drug reactions. Such approaches form part of MHRA’s long-term vision for more personalised medicine prescribing and will be a gamechanger for patient safety and wellbeing.”</em></p>
<p>The <a href="https://bpspubs.onlinelibrary.wiley.com/doi/10.1002/bcp.70370">guidelines</a> and a related <a href="https://bpspubs.onlinelibrary.wiley.com/doi/10.1002/bcp.70363">editorial</a> are published today (4 December 2025) in the British Journal of Clinical Pharmacology.</p>
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		<title>Concern over harmful medical advice from social media influencers</title>
		<link>https://pharmacyupdateonline.com/2025/12/concern-over-harmful-medical-advice-from-social-media-influencers/</link>
		
		<dc:creator><![CDATA[Charlie King]]></dc:creator>
		<pubDate>Tue, 16 Dec 2025 08:00:24 +0000</pubDate>
				<category><![CDATA[Diagnostics]]></category>
		<category><![CDATA[Legislative and Regulatory]]></category>
		<category><![CDATA[Practices and Services]]></category>
		<category><![CDATA[Influencers]]></category>
		<category><![CDATA[medical advice]]></category>
		<category><![CDATA[missinformation]]></category>
		<category><![CDATA[public health]]></category>
		<category><![CDATA[social media]]></category>
		<guid isPermaLink="false">https://pharmacyupdate.online/?p=19464</guid>

					<description><![CDATA[Biased or misleading medical advice shared by social media influencers can cause harm and requires coordinated action by governments and platforms to protect the public, argue experts in The [&#8230;]]]></description>
										<content:encoded><![CDATA[<p>Biased or misleading medical advice shared by social media influencers can cause harm and requires coordinated action by governments and platforms to protect the public, argue experts in <em><strong>The BMJ</strong></em> today.</p>
<p>Social media influencers are a growing source of medical advice, say Raffael Heiss and colleagues. More than 70% of young adults in the US follow influencers, and over 40% have purchased products based on their recommendations.</p>
<p>Yet they warn that influencer advice can be subject to four sources of bias: lack of medical expertise or relevant knowledge, industry influence, entrepreneurial interests, and personal beliefs.</p>
<p>“Such advice can cause psychological, physical, financial, and systemic harm—from inaccurate self-diagnosis and inappropriate treatments to unnecessary spending and higher healthcare costs,” they write.</p>
<p>A prominent example is celebrity Kim Kardashian, who encouraged her 360 million Instagram followers to have full body screening with magnetic resonance imaging—a test without proven benefits and linked to overdiagnosis, unnecessary interventions, and costs.</p>
<p>Influencers with health-related credentials can also provide misleading advice. For instance, Eric Berg, a US chiropractor with 14 million YouTube subscribers promotes high dose supplementation while selling his own brand of vitamin D and other supplements, some of which were subject to a legal warning for lead content above safety levels.</p>
<p>The effect of these biases is magnified by influencers’ ability to form real or one sided (often referred to as “parasocial”) bonds with followers, making them highly persuasive communicators, say the authors.</p>
<p>They acknowledge that some influencers do provide useful health advice including doctors and others who help to debunk common misconceptions, while influencers who are patients themselves may also provide valuable peer support, especially for stigmatised conditions, by creating safe spaces and sharing personal experiences, they write.</p>
<p>Nevertheless, they say maximising the benefits and minimising the harms of influencers’ medical advice will require collaboration between multiple stakeholders, particularly governments and social media platforms.</p>
<p>Strategies include effective regulation, stronger platform and influencer accountability, and user empowerment through targeted education and access to reliable, fact checked information.</p>
<p>The authors acknowledge that there is no one-size-fits-all solution, but conclude: “Together, these strategies can help create a safer information environment in which influencers are constructive rather than harmful sources of health advice.”</p>
<p>Regulating and moderating platforms and influencers is necessary, but fostering trust through verified communities, clinician-endorsed forums, and participatory public health campaigns, will be indispensable, say Tina Purnat and David Scales in a linked editorial.</p>
<p>They discuss how digital platforms, clinical encounters, and community spaces, both online and offline, shape what people see, believe, and do, including how evidence is negotiated in clinical consultations.</p>
<p>“Shared decision making must evolve for the digital age,” they write. “The key is structuring interventions around people’s information environments, where exposure, like exposure to physical environments, shapes health and deserves similar care.”</p>
<p>In a linked feature, Stephanie Santos Paulo speaks to ‘patient influencers’ who have amassed large followings on social media by sharing personal stories of their conditions and care that foster a sense of authenticity and emotional connection with followers.</p>
<p>“I think partly people are finding social media better for answers because it’s not easy to get hold of a medical professional,” says Liam Robertson, whose Instagram page @livingwithulcerativecolitis has 9,300 followers. “It’s almost like a strategy to help them,” he adds. “I don’t feel like they should need that, but we do.”</p>
<p>Lily Mae, whose Instagram account @chronicallylil details her life with Ehlers-Danlos syndrome, endometriosis, and vascular compression syndrome, says: “I wish healthcare professionals would listen and engage more with patient communities online. There’s such a wealth of firsthand knowledge being shared—real stories, symptoms, and lived experiences that could help improve care if more providers took the time to understand them.”</p>
<p>Jen Moore, who posts about endometriosis and adenomyosis on her Instagram account @jen.dometriosis, emphasises the role of patient influencers in signposting followers towards medical professionals. “Unless we involve clinicians in what we&#8217;re trying to do, nothing&#8217;s going to change,” she says.</p>
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		<title>Green light for 10 new medicines in November 2025</title>
		<link>https://pharmacyupdateonline.com/2025/12/green-light-for-10-new-medicines-in-november-2025/</link>
		
		<dc:creator><![CDATA[Gary Finnegan]]></dc:creator>
		<pubDate>Sun, 07 Dec 2025 08:00:01 +0000</pubDate>
				<category><![CDATA[Legislative and Regulatory]]></category>
		<category><![CDATA[Practices and Services]]></category>
		<category><![CDATA[biosimilars]]></category>
		<category><![CDATA[CHMP]]></category>
		<category><![CDATA[Dawnzera]]></category>
		<category><![CDATA[drug approval]]></category>
		<category><![CDATA[EMA]]></category>
		<category><![CDATA[new medicines]]></category>
		<category><![CDATA[Pharmacology]]></category>
		<guid isPermaLink="false">https://pharmacyupdate.online/?p=19353</guid>

					<description><![CDATA[The European Medicines Agency’s key committee on human medicines (CHMP) recommended ten medicines for approval at its November 2025 meeting. This brings to 97 the total number of [&#8230;]]]></description>
										<content:encoded><![CDATA[<p>The European Medicines Agency’s key committee on human medicines (CHMP) recommended ten medicines for approval at its November 2025 meeting. This brings to 97 the total number of products given the green light this year.</p>
<p>The committee recommended that the European Commission, which must now sign off on the advice, grant authorisation to the following products:</p>
<ul>
<li>Dawnzera (donidalorsen), for the routine prevention of recurrent attacks of hereditary angioedema (swelling) in adults and adolescents aged 12 years and older.</li>
<li>GalenVita (germanium (68Ge) chloride / gallium (68Ga) chloride), a radionuclide generator. GalenVita produces gallium (68Ga) chloride solution, that is used to label carrier molecules used for positron emission tomography (PET) diagnostic imaging of different types of tumours.</li>
<li>Inluriyo (imlunestrant) for the treatment of adults with locally advanced or metastatic breast cancer with a specific mutation in the gene ESR1.</li>
<li>Teizeild (teplizumab), a first-in-class treatment to delay the onset of stage 3 type 1 diabetes in adults and in children from eight years of age with stage 2 type 1 diabetes.</li>
<li>Vacpertagen (acellular pertussis vaccine), a vaccine used to prevent pertussis, often called whooping cough, a highly infectious disease that can occur at any age.</li>
<li>Waskyra (etuvetidigene autotemcel),the first gene therapy to treat Wiskott-Aldrich syndrome, a rare, inherited disease, seen almost exclusively in males, that affects blood cells and cells of the immune system.</li>
<li>Enzalutamide Accordpharma (enzalutamide) for the treatment of prostate cancer.</li>
</ul>
<p>The committee adopted positive opinions for two biosimilar medicines: Ondibta (insulin glargine), for the treatment of diabetes mellitus; and Osqay (denosumab), for the treatment of osteoporosis and bone loss.</p>
<p>A generic medicine, Teduglutide Viatris (teduglutide), was approved for the treatment of short bowel syndrome, a condition in which nutrients and fluids are not properly absorbed by the gut, usually because a large part of the intestine has been surgically removed.</p>
<p>The committee recommended extensions of indication for four medicines that are already authorised in the EU: Koselugo, Minjuvi, Veyvondi and Xerava.</p>
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