\n<\/p>\n
The U.S. Food and Drug Administration is reportedly mulling whether more prescription drugs should be sold over the counter (OTC) at pharmacies. In an interview on Wednesday, FDA commissioner Martin Makary told CNBC that \u201ceverything should be over the counter\u201d except drugs that are deemed unsafe or addictive or that require clinical monitoring.<\/p>\n
Makary said the agency is reviewing how it decides which drugs can be sold with or without a prescription from a health care practitioner. He suggested prescription vaginal estrogen or antinausea medications, for example, could become OTC.<\/p>\n
Those specific drugs may be \u201creasonable\u201d to make OTC, says Gina Moore, a pharmacy law expert at the University of Colorado Anschutz, but she adds, \u201cI think \u2018everything\u2019 is certainly an overstatement.\u201d<\/p>\n
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It\u2019s unclear exactly how the FDA is reviewing the rules around OTC drugs or what the timing will be, but in the same interview, Makary said the agency is going through \u201cthe proper regulatory processes.\u201d The FDA declined a request for comment from Scientific American.<\/p>\n
To understand how the move could change access to medication, Scientific American spoke with pharmacy experts about the proposed change in prescription drug policy, the drugs that may be affected and potential safety concerns.<\/p>\n
Over-the-counter medications require an FDA-approved monograph\u2014a standard set of rules that applies to all manufacturers of the drug in question.<\/p>\n
There are some exceptions that require a prescription, such as using an OTC drug at a higher dose or treating a different medical condition than what is indicated on the label, Moore explains.<\/p>\n
Companies can also request to sell a prescription drug fully or partially as a nonprescription drug through a process called an \u201cRx-to-OTC\u201d switch. These applications undergo careful, rigorous scientific review to ensure that the medications can be safely given to people without clinical supervision.<\/p>\n
The move could make some medications more accessible, but Moore and other pharmacy experts worry that it could also put more medical responsibility on the individual\u2014potentially increasing the risk of safety issues or drug misuse.<\/p>\n
\u201cThere\u2019s no end to the nuances here that you\u2019re asking patients to be more aware of,\u201d from understanding how to take the drugs correctly to clarifying what drug-to-drug interactions may occur, says Paul Beninger, a retired professor of public health and community medicine at Tufts University.<\/p>\n
The FDA hasn\u2019t revealed a list of drug candidates that could transition to OTC.<\/p>\n
But Moore says prescription drugs that have previously gone through the FDA\u2019s Rx-to-OTC track could give insight on others that might receive similar treatment in the future. Birth control medications, such as \u201cOpill,\u201d switched from prescription to nonprescription. Some nasal steroids for allergies have also become OTC. \u201cAnd those make a lot of sense, because they\u2019re just acting locally in the nose, and you\u2019re not really worried about absorption and systemic side effects,\u201d Moore says.<\/p>\n
\u201cThere\u2019s general agreement on a number of types of drugs that would be [sold] over the counter, such as birth control pills, allergy medications, heartburn drugs,\u201d Beninger says. \u201cThe reason is: there\u2019s understanding about how those drugs are used and how they interact in the body when they\u2019re developed.\u201d<\/p>\n
In the interview with Makary, he said prescription drugs that require additional monitoring or that are addictive or considered unsafe wouldn\u2019t become eligible for OTC. But those criteria can be difficult to evaluate without further clarification.<\/p>\n
\u201cWhen you say, \u2018Every drug except if they\u2019re not safe,\u2019\u201d Moore says, \u201cit\u2019s a hard question to answer.\u201d<\/p>\n
Regulators may consider some broad factors\u2014from side effects to drug administration\u2014the experts say.<\/p>\n
For example, a very important safety factor, Beninger says, is a drug\u2019s \u201ctherapeutic window,\u201d the range between the lowest dosage needed to see drug activity in the body and the highest level before the drug becomes toxic. Drugs with very tight therapeutic windows, such as heart and pulmonary drugs, require more diligent monitoring and administration.<\/p>\n
\u201cThe lower end just shows some activity, but then you don\u2019t have to go much higher before you find toxicities,\u201d so for those therapeutic windows, you need a very careful titration to the proper dose, Beninger says.<\/p>\n
And some drugs can be extremely toxic, he says. For example, drugs to treat addiction, such as opioids and benzodiazepines, can cause significant health issues if they are taken for extended periods without monitoring. \u201cAnything that’s a controlled substance has some degree of abuse or misuse or addictive potential,\u201d Moore says. Even aspirin or acetaminophen (the active ingredient in Tylenol) can be toxic in high enough doses.<\/p>\n
Generally, Moore says that drugs intended for occasional use, such as cold or allergy medications, might make more sense to sell OTC than those that need to be taken routinely for a chronic condition, such as blood pressure medication. The latter drugs \u201ctend to require more monitoring,\u201d she says. And drugs with more complicated delivery systems, such as injections or intravenous drips, may also require supervision.<\/p>\n
Drugs can also interact with certain foods or substances\u2014such as other medications. \u201cIf you have a drug that impairs another drug, that means that you need to [either] take them at different times of the day or increase the dose of one of the drugs,\u201d Beninger says. \u201cBy the same token, there are some drugs that, when you take them with another drug, it can enhance the activity of the [first] drug and become toxic.\u201d<\/p>\n
Warnings about these risks can be put on medication labels, but \u201cit can get really complicated, really quickly,\u201d Moore says.<\/p>\n
Making more drugs available over the counter could increase access, but there are nuances, Moore says.\u201cMany, if not most, prescription plans won\u2019t pay for over-the-counter drugs,\u201d she says.<\/p>\n
Most people don\u2019t often run purchases of OTC medications through their insurance, even if they are covered, she says. \u201cFor some people, that\u2019s totally fine, but others might be like, \u2018Well, I can\u2019t afford something that I\u2019m used to paying $10 for that I\u2019m going to have to pay $30 for now,\u2019\u201d she says.<\/p>\n
Any changes to allow more prescription drugs to become eligible to be sold OTC need to be done in an open forum, he adds.<\/p>\n
\u201cMaybe we can find more drugs that could be put into the Rx-to-OTC switch, but to say, wholesale, that so many more drugs can go there, I don\u2019t know. I don\u2019t see it,\u201d he says.<\/p>\n","protected":false},"excerpt":{"rendered":"
The U.S. Food and Drug Administration is reportedly mulling whether more prescription drugs should be sold over the counter (OTC) at pharmacies. In an interview on Wednesday, FDA commissioner Martin Makary told CNBC that \u201ceverything should be over the counter\u201d except drugs that are deemed unsafe or addictive or that require clinical monitoring. Makary said<\/p>\n","protected":false},"author":1,"featured_media":44850,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[50],"tags":[2974,10276,542,320,249,8969,253],"class_list":{"0":"post-44849","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-environment","8":"tag-concerns","9":"tag-counter","10":"tag-drugs","11":"tag-experts","12":"tag-fda","13":"tag-raised","14":"tag-safety"},"_links":{"self":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts\/44849","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=44849"}],"version-history":[{"count":0,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts\/44849\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/media\/44850"}],"wp:attachment":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=44849"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=44849"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=44849"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}