Should the US emulate our S3 schedule?


Pharmacist choosing stock from shelves

Angel Gonzalez takes a look at life without a Pharmacist Only schedule

The controversial topic of introducing a third class of drugs in the United States has been ongoing for at least five decades.

While drugs are classified as prescription or nonprescription by the FDA, the practice of pharmacy is typically regulated by states. The 1951 Durham-Humphrey Amendments to the Federal Food, Drug, and Cosmetic Act provided the statutory basis for the two-tier drug classification system currently in place.

Since then, there have been a number of proposals to introduce a third category of drugs – known variously as pharmacist-legend, pharmacist-only, third class of drugs, or behind the counter (BTC).  Although there is some variation between proposals, the basic idea is the same: introducing a new class of drugs, available without a prescription, but only in pharmacies.

The BTC idea would require that these drugs be sold only in pharmacies, and that a pharmacist’s intervention with a consumer must occur before the drug could be dispensed, as it is in Australia today.

The debate is open in the US: some academics and representatives of drug manufacturers, have raised concerns that such a BTC class could harm public health by decreasing the availability of nonprescription drugs. Overall, they believe that the current two-tier drug classification system works well and provides consumers with an appropriate level of drug dispensing options.

Prescription drugs that may have switched to OTC might instead be placed reclassified as BTC, resulting in decreased consumer access compared to OTC accessibility. Drugs might also remain in a BTC drug class even if suitable for OTC use.

Another concern is the ability to effectively communicate the availability of BTC drugs through public campaigns and within pharmacies. Underserved and rural communities with few or no pharmacies might also experience barriers to accessing BTC drugs, which would only be available through pharmacies.

Detractors of a BTC drug class have argued also that pharmacy costs could increase as the result of new services required for establishing such a class.  Furthermore, restricted competition could also increase costs, as fewer outlets for BTC drugs would be available and would drive up prices.

Ensuring that pharmacists meet their responsibilities for dispensing BTC drugs, including providing necessary counselling, would be an important issue to resolve. One potential purpose of classifying drugs as BTC is for pharmacists to ensure that consumers meet specified criteria for using these drugs and then to provide education on their proper use.

Failure to ensure that such counselling occurs would diminish the value of a BTC drug class.

With a greater number of medicines being made available to the public without prescription in the US, there is a need for pharmacists to take greater responsibility for the sale of OTC medicines and to ensure that the increased access is balanced with safety and quality outcomes.

Systems are required to assist consumers to make appropriate choices either to self-medicate, to choose a non-medication-related option or to seek medical advice. Consumer education becomes a more relevant role for pharmacies.

The issue remains unsolved, as to which system provides the widest range of benefits to public health. Meanwhile, a new set of questions is added to the mix when we consider what is relevant in today’s digital age: Which model is a better fit for the technology savvy, health aware consumer of today?

Dr. Angel Gonzalez is a Senior Associate with XPotential™ and Director of SymptoMapp. A qualified medical practitioner and anaesthetist in his home country, he is the owner of his own medical consulting business in Latin America. Angel’s deep medical knowledge, commitment to improving consumer health literacy and creativity provides unique insight into opportunities to improve healthcare in Australia.

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