Author:  Scott Lappetito

Increasingly, concerns from drug manufacturers and patients alike have called out the need for a new drug category that could open up access to the uninsured and those who can’t afford a doctor. On October 4, 2007 the FDA sent out a newsletter seeking comments on the “health benefits of drugs being available without a prescription but only after intervention by a pharmacist.” Effectively, they are considering a new drug classification dubbed ‘behind-the-counter’ (BTC), which would serve as an intermediary between prescriptions and over-the-counter (OTC) drugs.

Drug availability behind-the-counter is nothing new to the global drug industry. Many countries currently use a three-tiered drug dispensing system, rather than the largely two-tiered system that is used in the U.S. Across the globe, a three-tiered dispensing system is implemented in England, Canada, Australia, New Zealand, Germany, Italy, Sweden, Switzerland, Denmark, and in the Netherlands. 

In a BTC system, select current prescription and OTC drugs would be sold from behind the pharmacist’s counter without a physician’s prescription, thus making pharmacists more involved in the process of dispensing those medications that meet the criteria for BTC status. The National Association of Chain Drug Stores states that the change to a three tiered system, “could offer yet another way for pharmacists to serve their patients.” Likewise, the American Pharmacist’s Association said that “Pharmacists are prepared to play an expanded role in determining if medications are appropriate.” 

Currently, there are several examples of drugs with BTC status or appealing to BTC status in the U.S. drug industry:

•  One example of a drug already straddling the two tiered system is Barr Pharmaceutical’s “Plan B” emergency contraceptive. It is stored behind the counter as women attempting to purchase it are required to show identification proving they are over the age of 18. A representative from the Consumer Health Products Association noted, “You don’t need a class. You’ve got flexibility in the current system,” citing “Plan B” as an example. Either way, this is one example of a successful intermediate drug in the U.S.

•  Another example of drugs moving behind the counter are decongestants.  Under the Combat Methamphetamine Act, medicines which can be used in the production of methamphetamine must be kept behind-the-counter, limiting the quantity for sale to individual consumers. As a result of this act, some products switched to ‘BTC’, for example Advil Cold & Sinus, while others chose to remain OTC’s.  Many drug makers began switching the active ingredients of some of their over-the-counter nasal decongestants which were subject to change in order to avoid switching status. The problem: studies have shown that the replacement OTC active ingredients are limited in effectiveness at best. Now, the familiar household OTC name brands such as Dimetapp, Sudafed, Tylenol, Vicks and Benadryl may not be as effective as they once were.

The recent switch of active ingredient in nasal decongestants has triggered Congress’s attention, as well, as they are now pressuring the FDA to define a new BTC status for drugs in the US.  Rep. Henry Waxman (D-Calif.) is concerned about how the new active ingredient is not effective as a nasal decongestant.  In a letter to the FDA, he wrote, “I am extremely concerned about this recent switch to (the new active ingredient) and urge you to promptly investigate this issue. American consumers deserve to have confidence that the cold/allergy remedies on which they spend their hard-earned income will actually reduce their symptoms.”

•  There are several additional drug candidates for BTC status. Statins, such as Merck and J&J’s Mevacor, which was recently turned down by the FDA for an appeal for BTC status due to a lack of BTC classification, are possible additions to BTC status. The FDA did note that had a BTC classification been established it would have reconsidered this ruling. Many allergy medications, such as nasal steroids would also be potential BTC candidate drugs.

This possible switch to a three-tiered system includes many new regulatory challenges. Because of this, the FDA has not announced any drug categories that may be considered if a BTC system were to be fully rolled out in the U.S. As such, the criteria to be used for classifying which drugs will enter BTC status are unknown. Internationally, though, suitability for self-diagnosis and low-potential for serious side effects of overdose are used to classify drug candidates into the BTC status.

For the U.S. drug industry, there are two classes of argument for and against changing to a three tiered system. The first class regards transition from prescription to BTC, the other is from OTC to BTC.

•  For drugs transitioning from prescription to BTC there are several reasons why a three tiered system may be attractive. Proponents of the system believe that it will make drugs more accessible to patients who don’t have health insurance or can’t afford a doctor. Such a system could also act as a buffer period to effectively smooth drug transitioning from prescription status to OTC status. However, it opens up potential for incorrect medications and opens up new avenues for abuse. Also, marketers of the drugs would have to effectively prove that consumers can safely and effectively use the drugs without physician monitoring in order to render them BTC status.

•  Drugs transitioning from OTC to BTC also have their pros and cons. Support for the transition has already been shown in the Combat Methamphetamine Act, which will effectively limit avenues for drug abusers. On the opposing side, the new development for nasal decongestants has many pharma experts worried. Many fear that the new active ingredients available in the OTC form render the drug, “largely useless in clearing up nasal congestion.” Also, introducing new limitations on the drugs will make them harder to obtain, which could potentially decrease its availability for patients.

The FDA has considered proposals for implementing a three-tiered system, but has never acted upon them. On Nov. 14, 2007, however, the FDA held a hearing to receive input from the drug industry, medical community and advocate groups regarding a possible BTC system. Some of the issues discussed were the impact the system would have on patient’s use, the role pharmacists would have, storing and dispensing issues, how to reimburse pharmacists for the added responsibilities, and the criteria to be used to classify drugs into BTC status. No timetable for further action was announced.