Generic Prescription Drug Info

The American Society of Health-System Pharmacists (ASHP) has published a new statement outlining appropriate criteria for a proposed intermediate category of medications that would be available from pharmacists in outpatient settings without a prescription. Drug products appropriatefor this intermediate category would have proven public healthbenefits and should be identified by processes that include the inputand advice of experts, such as pharmacists, physicians, andother licensed health care professionals. Medications in this category would only be available to patients after an assessment by and consultation with the pharmacist.

The ASHP Statement on the Criteria for an Intermediate Category of Drug Products appears in the March 1, 2009, issue of the American Journal of Health-System Pharmacy.

The statement recommends criteria to ensure the category would contain safe and effective medications with proven public health benefits, such as drug therapies for hypertension and osteoporosis. ASHP advises pharmacies to adopt standardized processes, adhere to quality measures, and report adverse-drug events. The statement also suggests the Food and Drug Administration (FDA) evaluate those events to ensure patient safety.

ASHP, which has long proposed the creation of an intermediate category, believes pharmacist oversight of and collaboration with patients using medications in the category is essential. “An intermediate category of drug products would increase patientaccess to and benefit from medications that would otherwisebe available only by prescription,” said ASHP President Kevin J. Colgan, M.A., FASHP. “Choosing appropriate drug products for an intermediate category-inconjunction with patient assessment,counseling, and monitoring by a pharmacist-would improve public healthwithout compromising patient safety.”

In testimony to the FDA, ASHP voiced support for the creation of an intermediate category. The Society also told the agency that pharmacists should receive appropriate payment for the services they provide to patients using medications in the category.

The statement recommends additional criteria for the intermediate category, including:

- Medications should meet many of the criteria for reclassifying prescription drugs to nonprescription status,
- Pharmacists should offer laboratory monitoring for patients,
- Patient therapy should include information on needed lifestyle changes, and
- Patient medical records should include care provided by pharmacists.