Labeling of Patient Assistance Program Medications (Resolution No. 106-9-10)

June 2, 2010 9:41 AM Topics: Resolutions

Resolution No. 106-9-10
Title: Labeling of Patient Assistance Program Medications
Action: Pass

Whereas, the US Food and Drug Administration (FDA) regulates the manufacture and distribution of prescription drugs; and

Whereas, the state boards of pharmacy regulate the dispensing of prescription drugs to patients; and

Whereas, the FDA and the boards of pharmacy exist to protect the public health and safety; and

Whereas, the boards of pharmacy are concerned about eliminating quality related events related to prescription drug use; and

Whereas, some pharmaceutical manufacturers have created charitable programs called patient assistance programs, which aid low income, uninsured patients by providing them with free prescription drugs; and

Whereas, some pharmaceutical manufacturers ship stock bottles of medications directly to patient’s homes in violation of state and federal laws or to physician’s practices without patient specific labeling and without appropriate directions for use; and

Whereas, inappropriately labeled prescription medication has the potential to increase quality related events and, thus, are a risk to patients;

THEREFORE BE IT RESOLVED that NABP work with FDA and pharmaceutical manufacturers to ensure that medications provided by manufacturers for patient assistance programs are dispensed and labeled with patient specific information and appropriate directions of use in compliance with state pharmacy laws and regulations.

BE IT FURTHER RESOLVED that NABP work with FDA and pharmaceutical manufacturers to encourage the distribution to patients of product vouchers in lieu of dispensing medications directly to patients.

(Resolution passed at the NABP 106th Annual Meeting, Anaheim, CA)