Academy of Managed Care Pharmacy

Risks, benefits, and issues in creating a behind-the-counter category of medications

“…Most pharmacy organizations, such as the American Pharmacists Association, 13 American Society of Health-System Pharmacists, 14 Academy of Managed Care Pharmacy, 15 and American College of Clinical Pharmacy 16 support a BTC medication category.…”

“…28 Criteria for prescription-to-BTC switch Careful definition, selection, and operationalization of criteria to guide consistent decision making are necessary before finalizing a BTC medication category. Organizations [13][14][15][16]21 have suggested that BTC classification is well suited for medications to treat medical conditions that require limited physical assessment and have easily interpreted lab tests and/or reliable selfdiagnosis. [13][14][15] Multiple health professional disciplines receive training and are competent in physical assessment and inter-SPECIAL FEATURE BEHiND-THE-COUNTER MEDiCATiONS preting lab tests.…”

“…Organizations [13][14][15][16]21 have suggested that BTC classification is well suited for medications to treat medical conditions that require limited physical assessment and have easily interpreted lab tests and/or reliable selfdiagnosis. [13][14][15] Multiple health professional disciplines receive training and are competent in physical assessment and inter-SPECIAL FEATURE BEHiND-THE-COUNTER MEDiCATiONS preting lab tests. The murkiest issue at this time is ordering and accessing lab test results.…”

“…23,24 A BTC transition category was proposed for medications ultimately destined for OTC status and should be decided on a case-by-case basis, depending on the nature of the medication. 8,9,14,15 Candidate medications should receive serious study and reverse transition (e.g., OTC to BTC) when warranted. For example, FDA recently informed patients and health professionals that it had finished reviewing information regarding the safety of OTC cough and cold medications in children younger than 2 years.…”

“…However, it is a legitimate concern, and the transition criteria should be driven by clinical findings and weighing benefits against risk. 15 Issues identified with reverse transition include decreased access, abuse reduction, 36 and the fact that locations without pharmacies would be unable to sell medications reversed from OTC to BTC status. 21 On the surface, looking at reverse transition purely as a movement from OTC to BTC status might appear to decrease access.…”