Jan 19, 2022
The distribution of medicine in the United States is based on a two-class system: prescription (Rx) and over-the-counter (OTC) medicines. An OTC medicine is one that the U.S. Food and Drug Administration (FDA) has found to be safe and effective for direct consumer use based on the label instructions and warnings. In the absence of physician supervision, FDA requires a wider margin of safety for OTC medicines than for Rx drugs.
The current two-class system of drug distribution empowers consumers with a widening choice of safe and effective medicinal healthcare options conveniently available at competitive prices. This emphasis on consumer empowerment in matters of healthcare directly serves two of the most fundamental demands of any workable healthcare system: access and affordability.
A third class of drugs means a category of medicines available without a prescription but only in pharmacies or through a pharmacist. These medicines in a pharmacy-only category would not be available in other convenient retail outlets, such as grocery stores without a pharmacy, hotel gift shops, or shops at the airport.
Most developed countries around the world have inherited a pharmacy-only category of medicines and have either significantly or fully limited OTC medicines sold outside pharmacies in general retail outlets. These systems arose from historic, centuries-old practice. In Europe, for example, the norm had long been for all medicines to be sold only from pharmacies. These older, European systems predated the modern trend of consumers taking a more active and informed role in their own healthcare decisions.
The U.S. Government Accountability Office examined other nations’ experience with a third class of drugs, or pharmacy class, in 1995 and again in 2009. In the 2009 report, the GAO said “we did not find an association between the restrictions placed on the availability of particular drugs in our sample by the study countries and the presence of a behind-the-counter drug class. The United States gave more restrictive classification to some drugs and less restrictive classification to other drugs when compared to the other four study countries.” In its 1995 final report to Congress, the GAO concluded that “the evidence . . . tends to undermine the contention that major benefits are being obtained in countries with a pharmacist or pharmacy-only class.”
Many countries are slowly expanding access beyond pharmacies to some OTC medicines. Japan, the Netherlands, Denmark, Italy, the United Kingdom, and Argentina all have been part of a trend toward granting consumers greater access to medications in more outlets.
Many government agencies and health and consumer organizations oppose a third class of drugs in the United States, including the American Medical Association.
No. A third class of medicines would not speed Rx-to-OTC switch. Regulatory officials in countries with a pharmacy-only category are neither more nor less likely to switch products from prescription status.
The important aspect for American consumers regarding switching prescription medicines to nonprescription status, known as Rx-to-OTC switch, is that the U.S. system is a scientifically rigorous process based on data. In the United States, switch comes about when a company submits an application to FDA, supported by clinical studies, labeling studies, and frequently, actual use studies which seek to replicate real world consumer use as closely as possible. FDA uses all the data — including the drug’s prescription use history — and closely considers the product’s safety, effectiveness, and labeling in making a scientific determination about the regulatory status of that medication. The agency frequently convenes an outside expert advisory committee for its input about the appropriateness of a switch application.
As a result of this system, consumers have more than 80 ingredients, indications, or dosages of formerly prescription medications available without a doctor’s prescription. These include proven safe and effective products such as Prilosec OTC, Claritin, Nicorette, and Advil, just to name a few. A complete list is available online.
Under the U.S. system, manufacturers and FDA have room for flexibility and innovation. Manufacturers can, and do, develop inventive and novel ways to ensure consumers can have access to even more resources for safe and effective OTC medicines. Website information centers, point-of-sale kiosks, audio tapes, or distribution restrictions are a few examples of approaches in the market today to ensure consumers have access to even more resources for safe and effective self-care solutions.
No. The federal law imposing placement restrictions on pseudoephedrine (PSE)-containing OTC medicines is part of the U.S. Drug Enforcement Administration’s (DEA’s) Controlled Substances Act. While FDA maintains that PSE is a safe and effective medication appropriate for over-the-counter sales, the ingredient’s current status reflects the fact that criminal elements are diverting it in order to manufacture the illegal and dangerous drug, methamphetamine. By placing medicines with PSE behind pharmacy counters or in locked cases and limiting the amount of product that can be purchased, the DEA in effect is requiring pharmacists and other retailers to assist law enforcement in curbing the criminal production of illicit methamphetamine. It has nothing to do with utilizing pharmacists to provide consumers with any health information regarding the appropriate use of PSE-containing medicines.