Pharmacy Daily | Pharmacists’ role shake-up

PHARMACISTS across the US could be in for a position shake-up, if the Food and Drug Administration decides to go ahead with its proposal to allow the over-thecounter sale of certain drugs that would otherwise require a prescription, for nonprescription use under conditions of safe use. Examples of these conditions would include: requiring pharmacist intervention to ensure appropriate nonprescription use; and the use of innovative technologies, such as diagnostics approved or cleared by FDA for use in the pharmacy or “other settings”. “Kiosks or other technological aids in pharmacies or on the Internet could lead consumers through an algorithm for a particular drug product,” the FDA said. In addition, for some drug products that require an initial prescription, the FDA suggested that the product could be made available as a nonprescription product with a condition of safe use for the purpose of product refills; whilst some drug products that would otherwise require a prescription could be approved as nonprescription drug products with some type of pharmacist intervention as their condition of safe use. “Some diseases or conditions might require confirmation of a diagnosis or routine monitoring using a diagnostic test (e.g., a blood test for cholesterol levels or liver function) that could be available in a pharmacy,” the FDA said. “A pharmacist, or consumer, could then use the results to determine whether use of a certain drug product is appropriate,” the FDA added. Other potential roles for the pharmacist, according to the FDA, could include assessing whether the consumer has any conditions or other risk factors that would indicate that the drug should not be used, or assisting the consumer in choosing between various drug products. “For drugs that require use of a diagnostic test, creating a pathway for nonprescription use may result in the development by industry of diagnostics suitable for use by the patient,” the FDA said. In addition, the FDA is also considering whether the same drug product could be simultaneously available as both a prescription and nonprescription product with conditions of safe use. “Dual availability could help ensure greater access to needed medications by making obtaining them more flexible,” the FDA said. MEANWHILE the plan has not been met with widespread welcome, with the American Academy of Family Physicians saying that allowing pharmacists to dispense drugs for nonprescription use could endanger patient health and their relationship with their GP. “Allowing the pharmacist authority to dispense medication without consulting with the patient's physician first could seriously compromise the physician's ability to coordinate the care of multiple problems of many patients,” the AAFP said. Pharmacists, according to the AAFP, should work in collaboration with GP’s to “optimise the therapeutic effect of pharmaceutical agents in patient care to achieve the desired outcomes while maintaining overall efficiency”.

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