{"id":598819,"date":"2023-11-24T22:00:00","date_gmt":"2023-11-24T19:00:00","guid":{"rendered":"https:\/\/en.buradabiliyorum.com\/patients-need-access-to-critical-medication-information-a-new-fda-rule-would-limit-it\/"},"modified":"2023-11-24T22:00:00","modified_gmt":"2023-11-24T19:00:00","slug":"patients-need-access-to-critical-medication-information-a-new-fda-rule-would-limit-it","status":"publish","type":"post","link":"https:\/\/buradabiliyorum.com\/en\/patients-need-access-to-critical-medication-information-a-new-fda-rule-would-limit-it\/","title":{"rendered":"#Patients need access to critical medication information. A new FDA rule would limit it."},"content":{"rendered":"<p><img decoding=\"async\" src=\"https:\/\/thehill.com\/wp-content\/uploads\/sites\/2\/2023\/01\/AP586143934094-e1674849225779.jpg?w=900\" \/><\/p>\n<div>\n<p>            <iframe title=\"Audio Article\" id=\"instaread_iframe\" name=\"instaread_playlist\" scrolling=\"no\" allow=\"autoplay\" style=\"display:block\" width=\"100%\" height=\"100%\" frameborder=\"no\"><\/iframe><\/p>\n<p>Medical professionals know that sharing clear and accurate health information with patients empowers them to make wise decisions that set them on a path to healthier living. Educating patients about their pre<a href=\"https:\/\/buradabiliyorum.com\/en\/category\/download-scripts-themes-apps\/\" data-internallinksmanager029f6b8e52c=\"9\" title=\"Download Scripts &amp; Themes &amp; Apps\" target=\"_blank\" rel=\"noopener\">script<\/a>ion medications is especially important. Since millions of Americans rely on prescription medication, effective patient medication information (PMI) is more important than ever.\u00a0<\/p>\n<p>PMI is the pamphlet dispensed with prescriptions at the pharmacy that includes critical details like side effects, directions for use and common mistakes to avoid. Receiving PMI at the pharmacy allows patients to engage with their pharmacist, ask questions and review the information about taking their medications correctly. For patients with complex prescription regimes, having this information on hand can be the difference between staying healthy and ending up in the emergency room.<\/p>\n<aside class=\"ad-unit ad-unit--mr1_ab\"><\/aside>\n<p>As a former regulator who worked at the Food and Drug Administration (FDA), I am baffled that the FDA recently proposed a rule that would likely limit access to this critical information. It seems like the FDA is attempting to shift PMI exclusively to a digital format. And while this seems to be a good-faith effort, PMI doesn\u2019t have to be either digital or print \u2014 it should be both.\u00a0<\/p>\n<p>In addition to being a practicing doctor who regularly treats patients, I serve as the chief medical officer at WebMD, the nation\u2019s leading online health education platform. I would not work with WebMD if I did not believe in the value of digital tools in educating patients.<\/p>\n<p>But that doesn\u2019t mean all information must be entirely online. There\u2019s a reason some of the most important documents in our lives are physical \u2013 from birth certificates to car titles \u2013 and why printed books still\u00a0<a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.weforum.org\/agenda\/2021\/04\/printed-books-vs-e-books-which-is-the-most-popular\/\">vastly outsell<\/a>\u00a0e-books. For many people, a printed format simply\u00a0<a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S1747938X18300101?via%3Dihub\">works better<\/a>\u00a0at conveying information, which is why it makes little sense that the FDA would rip life-saving printed information from patients\u2019 hands. At a time of rampant misinformation for which the FDA expressed an explicit priority to combat, the FDA should be making it easier for patients to learn about their medications, not harder.<\/p>\n<p>It\u2019s a <a href=\"https:\/\/buradabiliyorum.com\/en\/category\/general\/\" data-internallinksmanager029f6b8e52c=\"3\" title=\"General\" target=\"_blank\" rel=\"noopener\">general<\/a> principle of medical practice that when educating patients, it\u2019s important to meet them where they are. While some may be comfortable using an online link to access their PMI, many elderly or poor patients lack the technological skills necessary to do so.<\/p>\n<p>Also, if a patient is taking multiple medications simultaneously, cross-referencing can be quite difficult electronically. Merely handing patients a digital link to use later ignores that health care information is best communicated at the point of care, when patients are most likely to be interested and engaged. The FDA is all but ensuring that many patients will struggle to access that information.\u00a0<\/p>\n<p>The FDA tried to account for this by requiring pharmacists to print PMI upon request. But this is flawed thinking that is impractical and unrealistic. Most patients will not know or remember to ask their pharmacist for PMI anyway. In fact, asking for PMI shouldn\u2019t be the patient\u2019s responsibility at all. As a health care community, it\u2019s our collective duty to provide patients with everything they need to stay healthy \u2014 not create new barriers to life-saving information.<\/p>\n<aside class=\"ad-unit ad-unit--mr2_ab\"><\/aside>\n<p>The FDA\u2019s own calculations about this rule show that requiring pharmacists to print PMI would pile on an additional 81 million hours of labor and cost pharmacies an extra $1.6 billion annually. Given that pharmacists are already overworked, this added burden would seriously jeopardize pharmacy care and patients\u2019 lives. We say we are committed to addressing burnout \u2014 how does adding more work address that?<\/p>\n<p>There\u2019s another issue with the FDA\u2019s rule, and that is the format of PMI itself. Currently, there\u2019s no standard for formatting PMI, which means much of it is confusing, bloated, too small to read and too complicated to understand. While the FDA is standardizing PMI format in this rule, it never once tested the new format on patients to gauge whether it will be an effective educational tool.<\/p>\n<p>This is odd given the importance of this information and given that in other areas, the FDA\u2019s Office of Prescription Drug Promotion\u00a0<a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.fda.gov\/about-fda\/center-drug-evaluation-and-research-cder\/completed-research-projects-office-prescription-drug-promotion-opdp-research\">extensively studied<\/a>\u00a0how patients respond to pharmaceutical advertising. It is deeply troubling that they aren\u2019t allocating similar resources to understanding patient education.\u00a0<\/p>\n<aside class=\"ad-unit ad-unit--mr3_ab\"><\/aside>\n<p>This issue may seem trivial, but make no mistake: It will impact thousands, if not millions, of people. Already,\u00a0<a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.uspharmacist.com\/article\/medication-adherence-the-elephant-in-the-room#:~:text=Nonadherence%20can%20account%20for%20up,chronic%20medications%20is%20around%2050%25.\">one in four hospitalizations and more than 125,000 deaths<\/a>\u00a0each year are the result of medication errors or adverse drug interactions. By limiting access to critical medication information, the FDA may inadvertently push these numbers higher.<\/p>\n<p>Everyone at the FDA, including Commissioner Robert Califf, does incredible work to make our nation safer and healthier. But the recently proposed rule is seriously out of touch because it lacks a fundamental understanding of\u00a0the process for when patients receive medications and their interactions with the pharmacy.<\/p>\n<p>The FDA\u2019s mission is to put patients first, but this new rule abandons that mission by limiting patient access to critical information. The FDA should protect printed medication information for every patient in America.<\/p>\n<aside class=\"ad-unit ad-unit--mr4_ab\"><\/aside>\n<p><em><a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.webmd.com\/john-whyte\">John\u00a0Whyte, MD, MPH<\/a> is chief medical officer at WebMD.<\/em><\/p>\n<\/div>\n<p>Copyright 2023 Nexstar <a href=\"https:\/\/buradabiliyorum.com\/en\/category\/social-mediaa\/\" data-internallinksmanager029f6b8e52c=\"1\" title=\"Social Media\" target=\"_blank\" rel=\"noopener\">Media<\/a> Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.<\/p>\n<blockquote><p><strong><span style=\"color: #ff6600;\">If you liked the article, do not forget to share it with your friends. Follow us on\u00a0<span style=\"color: #ff0000;\"><a style=\"color: #ff0000;\" href=\"https:\/\/news.google.com\/publications\/CAAqBwgKMLG0nwswvr63Aw\" target=\"_blank\" rel=\"nofollow noopener noreferrer\">Google News<\/a><\/span>\u00a0too, click on the star and choose us from your favorites.<\/span><\/strong><\/p><\/blockquote>\n<blockquote>\n<p style=\"text-align: center;\">For forums sites go to <span style=\"color: #ff9900;\"><a style=\"color: #ff9900;\" href=\"https:\/\/forum.buradabiliyorum.com\/\" target=\"_blank\" rel=\"noopener\">Forum.BuradaBiliyorum.Com<\/a><\/span><\/strong><\/p>\n<\/blockquote>\n<blockquote>\n<p style=\"text-align: center;\"><strong>If you want to read more <a href=\"https:\/\/buradabiliyorum.com\/en\/category\/news\/\" data-internallinksmanager029f6b8e52c=\"2\" title=\"News\" target=\"_blank\" rel=\"noopener\">News<\/a> articles, you can visit our <span style=\"color: #ff9900;\"><a style=\"color: #ff9900;\" href=\"https:\/\/en.buradabiliyorum.com\/news\/\" target=\"_blank\" rel=\"noopener\">News category.<\/a><\/span><\/strong><\/p>\n<\/blockquote>\n<p><span style=\"color: black;\"><a style=\"color: #ff9900;\" href=\"https:\/\/thehill.com\/opinion\/healthcare\/4325878-patients-need-access-to-critical-medication-information-a-new-fda-rule-would-limit-it\/\" target=\"_blank\" rel=\"noopener\">Source<\/a><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Medical professionals know that sharing clear and accurate health information with patients empowers them to make wise decisions that set them on a path to healthier living. Educating patients about their prescription medications is especially important. Since millions of Americans rely on prescription medication, effective patient medication information (PMI) is more important than ever.\u00a0 PMI&#8230;<\/p>\n","protected":false},"author":1,"featured_media":598820,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"fifu_image_url":"https:\/\/thehill.com\/wp-content\/uploads\/sites\/2\/2023\/01\/AP586143934094-e1674849225779.jpg?w=1280","fifu_image_alt":"","footnotes":""},"categories":[70897],"tags":[117,134418,134353,74873,84149,80445,90482,124783,115,147226,147227],"class_list":["post-598819","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-business","tag-congress-blog","tag-court-battles","tag-fda","tag-food-and-drug-administration","tag-healthcare","tag-house","tag-international","tag-news","tag-pharmacies","tag-prescription"],"_links":{"self":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts\/598819","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/comments?post=598819"}],"version-history":[{"count":0,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts\/598819\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/media\/598820"}],"wp:attachment":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/media?parent=598819"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/categories?post=598819"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/tags?post=598819"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}