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Renewed Interest in BTC Drugs
GAO conducts international study on behind-the-counter drugs
By Gary C. Messplay, J.D., and Colleen Heisey, J.D., M.P.H.
The U.S. Government Accountability Office (“GAO”) recently completed an update of its 1995 assessment regarding non-prescription drugs and the value to the country of a pharmacist-controlled class of pharmaceutical products. While most non-prescription products are available “over-the-counter” (“OTC”) in the U.S., some have suggested the formal development and implementation of another class of non-prescription pharmaceutical products, a group that would be maintained “behind-the-counter” (“BTC”) and in the control of a pharmacist until such product is provided to the appropriate individual. This class of drugs currently exists but is severely limited, including for example, the emergency contraceptive, Plan B® (levonorgestrel) and cold and cough medicines containing the decongestant pseudoephedrine.
The GAO originally assessed the development of a BTC class in 1995, providing an analysis in its report, Nonprescription Drugs: Value of a Pharmacist-Controlled Class Has Yet To Be Demonstrated. Given renewed interest in the area, Representatives John Dingell (D-MI) and Bart Stupak (D-MI) requested that the GAO update its earlier assessment. In a January 2008 letter to GAO, they suggested that the FDA was considering development of a BTC class that would allow certain medications — previously requiring a prescription — to be made available without a prescription but with the involvement of a pharmacist, as indicated by the 2007 public meeting held by FDA on the topic. Based on the notice of public meeting released in the Federal Register, FDA held the public meeting to obtain “public comment as it explores the public health benefit of certain drugs being available without a prescription but only after intervention by a pharmacist . . . [and] to solicit information and views from interested persons on specific issues associated with BTC availability, including the impact on patient access to safe and effective drug products.”
Pursuant to the Congressmen’s request, the GAO updated its 1995 evaluation in a report released in early 2009, Nonprescription Drugs: Considerations Regarding a Behind-the-Counter Drug Class. In the report, GAO summarizes the arguments for and against the development and implementation of a BTC class of drug products simply: proponents suggest that the class would lead to improved public health through increased availability of non-prescription products and enhanced reliance on pharmacists’ expertise while opponents contend that such a class would stymie switching of prescription products to OTC use by becoming the default for such potential products and question reliance on pharmacists who are not trained in clinical diagnosis and may lack time to counsel patients. Both factions focus on the potential influence of a BTC class of products on healthcare costs. Possible scenarios affecting healthcare costs include decreasing costs through reduced number of physician visits, reductions in drug prices associated with non-prescription status, increased out-of-pocket costs for consumers due to lack of third-party coverage for the class, and new fees associated with pharmacist counseling.
To complete this analysis, the GAO consulted with pharmaceutical experts and reviewed documents; it also assessed comparative availability of 86 different drugs in five modernized countries: Australia, Italy, the Netherlands, and the UK, as well as the U.S. These countries were selected because each has evaluated its own drug classification system since the GAO’s 1995 report.
While all five countries have increased the availability of non-prescription products since that time, the GAO determined that effect of restrictions on classes of such non-prescription products is unclear. The countries increased availability of drug products either by switching some drugs to less restrictive classes or by changing their drug classification system. In the first instance, the U.S., U.K., and Australia have each moved drugs from more restrictive to less restrictive drug classes, which has increased overall drug availability. With respect to the latter mechanism, both Italy and the Netherlands have adjusted their drug classifications systems. By way of example, in 2006, Italy modified its non-prescription drug classification system to expand availability of certain non-prescription products by allowing these products to be sold in non-pharmacy venues, such as grocery stores. Prior to 2006, the sale of all drugs was limited to pharmacies, regardless of the need for a prescription.
In exploring the respective countries’ classification systems, the GAO evaluated how 86 specific drugs were treated across the five countries.
Of the 86 selected drugs, the Netherlands restricted the most to prescription-only status (45 drugs), although Italy (43) and the U.S. (42) followed closely. The number of prescription-only products in the group for the UK and Australia was roughly half of that of the Netherlands (23 drugs). In turn, out of the 86 drugs, the U.K. had nearly twice as many non-prescription drugs (63), than the U.S. (44), Italy (43), and the Netherlands (41). Within each country, the non-prescription classification system varies. For example, as described earlier, the U.S. system makes non-prescription products generally available. Of the 44 non-prescription products in the U.S., 43 were available generally OTC while only one was available solely in pharmacies and requiring contact with a pharmacist (“Pharmacy” class). In the Netherlands, two were part of the Pharmacy class, 26 were available only in pharmacies or drugstores but no interaction with a pharmacist required (“Drugstore” class), and 13 were available for self-selection in pharmacies and other retail outlets, including those without pharmacists (“OTC” class). In contrast, in Italy, all 43 non-prescription products were available for self-selection in pharmacies or other retail outlets, but a pharmacist must be present (“OTC/pharmacist” class). In the UK, 34 of the 86 products were available BTC and 29 were available OTC. Rounding out the assessment, 11 were BTC, 29 were Pharmacy class, and 23 were OTC in the Netherlands.
Due to the grades of availability of the non-prescription products, ranging from BTC to OTC, the GAO determined that the availability of such products is determined by the definition of accessibility. For example, while Australia overall had a greater number of products available without a prescription than the U.S., a majority of the available products were still restricted in some fashion. On the other hand, while there were fewer non-prescription products available in the U.S., consumers had unfettered access to 98% of them. In due course, the GAO found that the impact of a restricted non-prescription product class on actual availability of non-prescription products to consumers was unclear.
The GAO identified several fundamental obstacles to development and implementation of a BTC drug class. These include:
- identifying and allocating roles and responsibilities, particularly as to dispensing pharmacists, and evaluating training needs for involved individuals;
- establishing appropriate infrastructure to support timely and private consultation and communication of patient information; and
- discerning the effects of the proposed class and associated counseling on product cost and third-party coverage.
The GAO report considers the feasibility and practicality of pursuing a BTC class of products in the U.S. However, the report does not consider other issues associated with the development and implementation of a BTC class, including whether the currently legal construct for drug approval supports and sustains a pharmacist-controlled class of non-prescription products.
The legality of such a class has been questioned by individuals suggesting that the Federal Food, Drug, and Cosmetic Act supports only a binary system: either a drug requires a prescription with physician interaction or it does not. In a case regarding the non-prescription availability of Plan B® tablets, which is manufactured by Duramed Pharmaceuticals, a unit of Barr Pharmaceuticals (now owned by Teva), before the U.S. District Court for the Eastern District of New York (Tummino v. Torti, E.D.N.Y., No. 05-cv-00366-ERK-VVP), a federal judge determined that FDA had acted in an arbitrary and capricious manner with respect to its decision to deny access to the product to those under 18 years of age.
The lawsuit, filed by the Center for Reproductive Rights in 2001, questioned the FDA’s decision to deny OTC status to Plan B® for women of all ages, including its denial of Barr’s application to make the pill available without a prescription to women ages 17 and older. FDA authorized a bifurcated prescription status in conjunction with the product. Currently, Plan B® is available without a prescription for consumers age 18 and over, and government-issued identification is required for proof of age at the time of purchase. It is available by prescription only for women under 17 and younger. In addition, Plan B® must be stocked behind the pharmacy counter. In a March 2009 decision, a federal judge has ordered FDA not only to make the emergency contraceptive available to 17-year-old girls without a prescription within 30 days, but also to reconsider whether minors under the age of 17 should be allowed nonprescription access to Plan B®.
As noted earlier, the presence of BTC drugs in the U.S. is severely limited, and subject to debate, on associated aspects ranging from feasibility to practicality to legality. Given the current focus on healthcare spending and the timing of the GAO report to Congress, renewed interest in development of a third class of products may emerge as a consideration.
