AMCP pleased FDA exploring benefits of expanding availability of OTC drugs

March 22, 2012

The Academy of Managed Care Pharmacy (AMCP) is pleased that FDA is exploring the public health benefit of approving certain drugs that would otherwise require a prescription for nonprescription use under conditions of safe use, an AMCP official said in written testimony Thursday.

The Academy of Managed Care Pharmacy (AMCP) is pleased that FDA is exploring the public health benefit of approving certain drugs that would otherwise require a prescription for nonprescription use under conditions of safe use, an AMCP official said in written testimony Thursday.

AMCP Director of Pharmacy Affairs Marissa Schlaifer, RPh, provided the written comments at a public meeting titled Using Innovative Technologies and other Conditions of Safe Use to Expand Which Drug Products Can Be Considered Nonprescription.

“In general, AMCP is in favor of expanding the availability of certain over-the-counter (OTC) medications when conditions of safe use are provided,” Schlaifer said. “These conditions would be specific to the drug product and might include assistance with self-selection of an appropriate medication or provide follow up monitoring during continued use. Other conditions could include requiring pharmacist intervention to ensure appropriate nonprescription use, and the use of innovative technologies, such as diagnostics, kiosks and/or technical aids with selection algorithms.”

She indicated that decisions on which drugs are selected for this status must be based on clinical effectiveness and safety. Criteria for this OTC status would include products:

• With low risk when appropriately used.

• With sufficient testing/experience to ensure safety and effectiveness.

• With uncomplicated instructions for use.

Schlaifer noted the availability of OTC drugs under conditions of safe use could lead to increased disease awareness by a patient and greater participation in his/her health treatment.

“Making certain drugs available over-the-counter could also lead to a reduction of the burden on hospital emergency departments, as patients may seek treatment at a pharmacy instead of the hospital emergency room,” she added.

Schlaifer said that there are many questions yet to be answered about the specifics of the program and urged FDA to be guided by “the benefits to the health of all patients … as it pursues this initiative.”