Drug products typically fit into two segments: over-the-counter and prescription. However there are a small number of drugs that fit in a segment called “behind the counter.” These drugs require the consumer to get the attention of the pharmacy staff in order to obtain the medicine. Typically a drug would not need the high level of doctor supervision but still raises concern for direct consumer access.
The FDA has been discussing the possibility of formalizing a behind-the-counter (BTC) product segment since the 1970’s. Even without specifically establishing a third class of drugs, there is potentially more pharmacists can do to help patients. Currently there are select products such as Mucinex, a cough medicine, and Plan B, an emergency contraceptive, available through BTC status. These products can be purchased without a prescription and customers have better access to them than prescription products.
In mid 2002, Adams Laboratories made a bold move to put its new cough tablet Mucinex in this unique third drug category. For the first time, consumers can buy a cough medicine tablet that contains guaifenesin, a powerful phlegm-releasing ingredient. The drug is available OTC but can be obtained only by getting the attention of someone at the pharmacy counter. The company considered placing the product next to the standard OTC cough preparations such as Vicks and Robitussin, but that would have required the company to spend millions of dollars in print and TV ads. The company opted for the third drug category, dispatching its sales force to lobby doctors about Mucinex and its unusual location in stores.
Drugs containing pseudoephedrine (a decongestant found in various OTC and prescription products), ephedrine and phenylpropanolamine have been moved behind the counter due to use in illegal methamphetamine production. This process was started in 2005 and continued in 2006 with the Patriot Act signed by President Bush in March of 2006. Some states in the U.S. have required that products containing the drug be limited to prescriptions only.
Another argument for the addition of BTC products is the availability of more products at lower prices. The growing consumer trend in using OTC products would also be seen in the BTC category. The improved access over prescription medicines could provide consumers with a source for treatments that only requires a kiosk or pharmacist involvement. Pharmacists could potentially provide support either through counseling before the purchase or by limiting the purchase quantities. Pharmacists have the knowledge to advise patients about drug interactions as well.
Drug companies have also shown an interest in a BTC option for marketing a product. This may be a good way to provide access in a way that fits products better, and gives companies more options. In effect a product may not be safe enough for OTC status but not unsafe enough for physician monitoring.
The FDA has continued to look at several ways to increase access to medicines but also remove the burden on physicians. Physicians offices must take time to see a patient, send in prescriptions orders, or schedule a second visit even for some routine cases which takes time away from more critically ill patients. Physicians are considered the most qualified personnel to make health decisions but there is continued pressure to change the system in a safe and effective manner.
Insurance companies have reported mixed feelings about reimbursement for BTC medicines. Some companies say that if the medication is medically necessary and/or covered under the patient’s formulary, they would provide reimbursement. However, other health insurers may be less likely to provide reimbursement if this segment of medicine materializes. Some of the reimbursement options would likely follow a certain decision by the FDA concerning the specific type of access granted.
Product classes which could benefit from a third class of drug include oral contraceptives, influenza antivirals, sexual dysfunction treatments, bladder treatments, osteoporosis prevention, and hormone replacement drugs.
An industry evaluation of these potential costs savings indicates that some of the savings would be shifted to the pharmacists to pay for added consultation and to the manufacturers. If a product requires diagnostics the savings may be limited. Expanding OTC access is likely to be more beneficial on a product-by-product basis. If a consumer is looking for a simple product that requires only a kiosk, the costs could be less than if they require a blood test administered at a pharmacy.
Kalorama's Reprot, Rx to OTC Switches, discusses this topic.