OTC drugs include pain relievers, heartburn medications, or allergy medications. Some of these OTC drugs have always been sold over the counter, while others started out as prescription drugs before being sold OTC.
A few of the more popular OTC drugs that used to require a prescription are heartburn medications like Pepcid, Prilosec OTC, and Zantac, and allergy medications like Allegra, Claritin, and Zyrtec.
The FDA and Prescription to Non-Prescription Status
Sometimes, prescription drugs amass enough post-marketing information concerning the safety of the medication that the manufacturer of the drug chooses to submit an application to the US Food and Drug Administration (FDA) to have the medication changed from prescription-only to OTC. When such an application is received by the FDA, the administration reviews the information they already have about the medication and asks the manufacturer for additional information so a decision can be made about making it OTC.
Direct OTC Approval for Drugs
Some drugs are approved for OTC sales without having been sold as prescription drugs before. In many cases, these products have been approved and used in foreign markets broadly enough that the FDA is satisfied with the safety data and approves it to be sold OTC in the US.
Most non-prescription drugs that weren’t previously prescription-only are brought to market through the FDA’s drug monograph system. A drug monograph is a document that states basic information like what ingredients in the drug treat particular conditions or symptoms, appropriate dosage, and usage instructions. The OTC drug monograph is updated if ingredients or labels are changed. When a drug meets OTC monograph requirements, it may be sold over the counter.
Whether a drug is directly approved for OTC use under the OTC monograph system or is changed from prescription-only to non-prescription status, the drug must meet the same effectiveness standards as prescription drugs. Safety standards for OTC drugs are generally higher than the safety standards for prescription drugs. After a drug is approved for OTC sales, the FDA conducts further studies to find out if OTC consumers understand the “Drug Facts” label carried on the product, and if they can use it according to directions.
Possible Changes in the Works
Getting medications into the hands of patients has become more challenging in the last several years. Two reasons are the high cost of health care and less generous insurance coverage (including prescription drug coverage). Approximately 20% of patients with prescriptions do not get them filled. The FDA believes that some of the hassle of returning to doctors for prescription refills can be eliminated in many instances and is exploring ways to make drugs for more conditions available without a prescription. Under a proposed new FDA paradigm, the agency would approve some drugs that would otherwise require a prescription for OTC sales as long as certain conditions are met.
If proposed changes are adopted, some drugs may be sold OTC if the consumer consults with a pharmacist first. Another possibility is that patients may need to see a physician to obtain the first prescription, but not to receive medication refills. Informational kiosks in pharmacies or online questionnaires could help consumers understand their symptoms and select a product, while providing consumers with all applicable warnings about specific OTC drugs.
Benefits of Making More Drugs OTC
The benefits to consumers of making more drugs available without a prescription are numerous, and include lower healthcare costs, earlier access to medications, and more consistent treatment of common health conditions. According to the FDA, rules for OTC status came about in an age when widespread information access didn’t exist. Now, with information resources widely available, consumers may benefit from self-diagnosis tools and access to medications that may have required a doctor’s visit and prescription before.
The most obvious concern in making more drugs available OTC is patient safety. To that end, the FDA is gathering information about what rules and regulations would need to be implemented in order for patients to take a wider range of OTC drugs safely. Liability and increased burden on already-overworked pharmacists are other concerns. However, according to Executive VP of the American Pharmacists Association Tom Menigham, the pharmaceutical world is “in the mindset of ‘yes, if’ instead of ‘no, but,’” and this is encouraging news for many Americans concerned over the financial and time costs of access to healthcare.
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