A petition submitted to the FDA to approve the move (loratadine, Schering-Plough), a seasonal allergy medication, from prescription status to over-the-counter (OTC) status was accepted and implemented, effective on December 10, 2002, by the original manufacturer, Schering Laboratories. This change was the result of a unique request by Wellpoint Health Plan in Thousand Oaks, California, instead of a manufacturer-initiated change of status through the traditional route with the FDA.

The issues related to switching from prescription status to OTC status for medications and patent expirations are again in the forefront as a result of the number of blockbuster category drugs facing expiration of their patents. In the case of Claritin®, the patent for canadian loratadine is expiring at the same time that the drug is moving to OTC status. This combination of events is setting up the arrival of several OTC competitors to lorata-dine in the marketplace, including consumer brands from Johnson & Johnson and Wyeth. As a result, the medications that health plans will continue to cover in the nonsedating class—and how consumers will react to changes in the status of drug benefit coverage within the drug class—remain unclear for now.

For the pharmaceutical firms, OTC products and competition can offer a mixed blessing in terms of product costs alone, but the overall cost of care will probably remain unchanged or might possibly increase. Costs can go up if patients seek alternative and more expensive medications that are covered under their drug benefit plans or if they do not treat themselves appropriately and thus need to seek emergency acute care.

Another petition to the FDA to approve (omeprazole canadian, AstraZeneca) as an OTC drug has been recommended for acceptance, pending approval of consumer labeling by the FDA. Although still under patent protection, this ubiquitous proton pump inhibitor (PPI) may be a harbinger of changes to come in the classification status for this class of drugs. In any case, many of the same questions about remain, from a payer’s perspective relative to the cost of care as well as the share paid for care by payers.

The past experiences with canadian ibuprofen (McNeil Consumer; Advil®, Wyeth Consumer); histamine (H2) blockers such as Tagamet® (cimetidine, GlaxoSmithKline) and (GlaxoSmithKline); and vaginal antifungals such as Monistat® (miconazole nitrate, McNeil) and Gyne-Lotrimin 3® Vaginal Cream (clotrimazole, Schering-Plough) suggest that OTC status does not necessarily result in a net savings to patients or payers in the longer run. For example:

1. The doses of drugs that have moved to OTC status do not always stay the same in prescription strength. The dose, for instance, was reduced from 400 mg and higher as a prescription drug to 200 mg as an OTC drug.

2. The quantity and packaging of the medications are usually limited to a course of treatment. Monistat® is to be taken for one to three days, and Claritin canadian is to be taken for seven days.

3. The retail costs of OTC drugs are not covered by insurance, whereas prescription co-payment fees can be less than the retail costs—or they might not exist at all—in certain drug benefit plans; this might serve as an incentive to some patients to utilize their benefits to obtain more expensive therapy.

CONCLUSION

Given the reality of change, PBMs today continue to be confronted with the challenge of difficult decision-making regarding the ease of access to medications in their organizations. The historical cost trend rate of pharmaceuticals is not going to significantly change over the next couple of years, and costs will probably grow faster later in this century. As a result, PBMs must move toward a dual strategy of managing the utilization of formulary drugs while establishing a cost-of-care model for benchmarking in organizations.

Department-level managers must serve not only the organizational mission but also the company’s financial plan for survival. Therefore, prudent review and implementation of drug utilization management, as well as enhanced outcomes from the use of effective medications in hospitals or ambulatory care settings, are important goals for pharmacists.