Society Encourages FDA To Consult Pharmacists For Drug Safety Planning

Main Category: Pharmacy / Pharmacist
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 23 Jun 2008 - 4:00 PDT

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ASHP urged the Food and Drug Administration (FDA) to include the expertise of health-system pharmacists as the agency develops a five-year plan to boost and modernize its new drug safety program.

In a comment letter in support of the Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan, ASHP told the FDA that pharmacists are in the best position to determine how to preserve the pharmacist-patient relationship and ensure continuity of care as the agency develops and implements requirements for Risk Minimization Action Plans and Risk Evaluation and Mitigation Strategies.

The FDA should confer with pharmacists as it generates industry best practices for naming, labeling and packaging medications and biologics to reduce medication errors, which is detailed in the plan. ASHP urged drug manufacturers and the FDA to inform pharmacists about drug names, labels and packages that have a documented association with medication errors.

The Society applauded the FDA for expanding its access to external data sources, particularly by entering into an interagency agreement with the Centers for Medicare & Medicaid Services to obtain Medicare data.

The plan also includes strategies to improve adverse drug event reporting and enhance post-market information technology systems.

http://www.ashp.org