The FDA’s plans to develop the behind-the-counter (BTC) drugs may face hurdles because of certain provisions of the 2007 Food and Drug Amendments Act. The Act especially includes a Risk Evaluation and Mitigation Strategy (REMS) requiring drugs to be dispensed only in “certain health care settings” such as hospitals. The Act also prohibits the dispensation of medicines unless they provide evidence or other documentation of safe-use conditions, such as laboratory test results.
Experts say that it is unlikely that a drug could meet these requirements and also be eligible for non-prescription status.
However, the FDA’s rejection of Merck & Co’s application for its cholesterol-lowerer Mevacor daily (lovastatin) to be switched from prescription to OTC status have highlighted the need for a third class of drugs, available without prescription but backed up with pharmacist advice.
The American Pharmacists Association (APhA) has also urged the establishment of a BTC class citing studies which showed that the pharmacists’ assistance to the patients in managing their prescription and non-prescription medications led to increase in patient compliance, safety and health outcomes.
PharmaTimes has quoted Winnie Landis president of APhA, as saying: “As consumers have become more aware of product risks, they are asking for more and better information to make decisions about their healthcare needs. Making some medications available after pharmacist intervention could increase available therapy options, improve therapeutic outcomes and enhance patient safety.”
However the American Medical Association (AMA) opposed the BTC availability of medicines and said that such a practice may adversely affect patient safety and quality of care as patient assistance may be beyond the scope of a pharmacist’s training.