When Prescription Drugs Go Over-the-Counter: Where are the Boundaries?

Abstract

Objective:

To determine local pharmacists' willingness to recommend/allow the use of OTC ibuprofen when prescription-strength ibuprofen had been prescribed for symptomatic relief of rheumatoid arthritis, to examine the evidence-based medicine supporting the use of ibuprofen for rheumatoid arthritis treatment, and to determine the impact this evidence has for nonprescription ibuprofen drug labeling.

Methods:

Sixty community pharmacies in the southeastern US were surveyed via the “shopper” method. Then a literature search was conducted using MEDLINE (1966–June 2003), International Pharmaceutical Abstracts (1970–June 2003), Current Contents (1966–June 2003), Lexis-Nexis (2001–2003), and Cochrane Database of Systematic Reviews (2000–June 2003). Articles that examined the efficacy and safety of low-dose ibuprofen (<400 mg every 4–6 h not to exceed 1200 mg/day) were reviewed. Clinical practice guidelines were obtained to determine the standard of care for rheumatoid arthritis treatment.

Results:

All pharmacists stated that it was completely acceptable to substitute OTC ibuprofen for the prescription formulation. Little to no counseling occurred at the point of service. These recommendations do not coincide with clinical practice guideline recommendations for the use of nonsteroidal antiinflammatory drugs versus disease-modifying antirheumatic drugs for long-term rheumatoid arthritis treatment.

Conclusions:

Results of this survey and literature review suggest the need for nonprescription educational initiatives regarding the role of nonprescription analgesics geared toward pharmacists. Clarification from the FDA as to the role of nonprescription drug therapy for chronic disease states is needed.

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