The US Food and Drug Administration is reportedly considering whether more prescription drugs should be sold over the counter (OTC) in pharmacies. In an interview on Wednesday, FDA Commissioner Martin Macri told CNBC that “everything should be on the counter“Except for drugs that are considered unsafe or addictive or that require clinical monitoring.
Macri 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 that, for example, prescription vaginal estrogen or anti-nausea drugs could become OTC.
Gina Moore, a pharmacy law expert at the University of Colorado Anschutz, says it might be “reasonable” to make those specific drugs OTC, but she adds, “I think ‘everything’ is definitely an exaggeration.”
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It’s not clear exactly how the FDA is reviewing regulations on OTC drugs or what the timing will be, but in the same interview, Macri said the agency is going through the “appropriate regulatory processes.” FDA declined request for comment scientific American.
To understand how this move could change access to medicine, scientific American Talked to pharmacy experts about the proposed changes to prescription drug policy, the medications that will be affected, and potential safety concerns.
How are medications currently designated as over-the-counter?
Over-the-counter drugs require an FDA-approved monograph – a standard set of rules that apply to all manufacturers of the drug in question.
Moore points out that there are some exceptions that require a prescription, such as using an OTC medication at a higher dosage or treating a different medical condition than indicated on the label.
Companies may request to sell all or part of a prescription drug as a non-prescription drug through a process called “”.Rx-to-OTC” Switch. These applications undergo careful, rigorous scientific review to ensure that the drugs can be safely given to people without clinical supervision.
How will changing FDA rules to make more drugs available OTC affect access?
The move could make some medications more accessible, but Moore and other pharmacy experts worry it could also put more medical responsibility on the individual—potentially increasing the risk of safety issues or drug abuse.
“There’s no end to the nuances that you’re asking patients to be more aware of,” says Paul Benninger, professor emeritus of public health and community medicine at Tufts University, “from understanding how to take medications correctly to clarifying what drug-to-drug interactions might be.”
Which drugs will potentially be available OTC?
The FDA has not disclosed a list of drug candidates that may be transitioned to OTC.
But Moore says prescription drugs that have previously gone through the FDA The RX-to-OTC track may provide information about other people who may receive similar treatments in the future. Birth control medications, such as “Opill”, changed from prescription to non-prescription. Some nasal steroids for allergies have also become OTC. “And these make a lot of sense, because they’re just working locally in the nose, and you’re not really worried about absorption and systemic side effects,” says Moore.
“There is general agreement on many types of medications that will be sold over the counter, such as birth control pills, allergy medications, heartburn medications,” says Benninger. “The reason for this is: there is an understanding about how those drugs are used and how they react in the body as they are developed.”
Which drugs should not become OTC?
In the interview with Macri, he said that prescription drugs that require additional monitoring or that are addictive or considered unsafe would not be eligible for OTC. But those criteria can be difficult to evaluate without further explanation.
“When you say, ‘Every drug, except if they’re not safe,'” Moore says, “that’s a hard question to answer.”
Experts say regulators may want to consider a broader range of factors — from side effects to drug administration.
For example, a very important safety factor, Benninger says, is a drug’s “therapeutic window,” the range between the lowest dose needed to see the drug’s activity in the body and the highest level before the drug becomes toxic. Drugs with very strong therapeutic potential, such as cardiovascular and pulmonary drugs, require more diligent monitoring and administration.
“The low end just shows some activity, but then you don’t have to go very high before you detect toxicity,” says Benninger, “so for those therapeutic windows, you need very careful titration to the appropriate dose.”
And some drugs can be extremely toxic, he says. For example, drugs used to treat addiction, such as opioids and benzodiazepines, can cause significant health problems if taken for long periods of time without monitoring. “Anything that is a controlled substance has some degree of potential for abuse or misuse or addiction,” Moore says. Even aspirin or acetaminophen (the active ingredient in Tylenol) can be toxic in large enough doses.
In general, Moore says drugs meant for occasional use, such as cold or allergy medications, may make more sense to sell OTC than drugs that need to be taken regularly for a chronic condition, such as blood pressure medication. “The latter drugs require more monitoring,” she says, and drugs with more complex delivery systems, such as injections or intravenous drips, may also require supervision.
Medicines may also interact with certain foods or substances-such as other medications. “If you have a drug that interferes with another drug, that means you have to (either) take them at different times of the day or increase the dosage of one of the drugs,” says Benninger. “Similarly, there are some drugs that, when you take them with another drug, can enhance the activity of the (first) drug and become toxic.”
Warnings about these risks may be on the drug’s label, but “it can get complicated really, really quickly,” Moore says.
How might this affect insurance coverage?
Moore says making more drugs available over the counter could increase access, but there are some nuances. “Many, if not most, prescription plans will not pay for over-the-counter medications,” she says.
She says most people often don’t purchase OTC medications through their insurance, even if they are covered. “For some people, that’s totally fine, but other people might be like, ‘Well, I can’t buy something that I’m used to paying $10 for that I now have to pay $30 for,'” she says.
He further said that any changes to enable more prescription drugs to be sold OTC need to be done on an open platform.
“Maybe we can find more drugs that can be put into the Rx-to-OTC switch, but wholesale speaking, that many more drugs could go there, I don’t know. I don’t see it,” he says.
