ASHP To FDA: Pharmacists Needed To Guide Use Of Nonprescription Statins

Main Category: Pharmacy / Pharmacist
Article Date: 14 Dec 2007 - 4:00 PDT

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The Food and Drug Administration (FDA) should explore alternative models for dispensing HMG co-reductase inhibitors, or statins, instead of reclassifying the medications to over-the-counter status, according to the American Society of Health-System Pharmacists (ASHP).

The Society offered its perspectives during a meeting of two FDA advisory committees considering over-the-counter (OTC) use of lovastatin, which is currently available only as a prescription under the brand name Mevacor.

"After statin therapy starts, ongoing evaluations are needed to assess the patient's response and to monitor for adverse drug events, said Cynthia Reilly, ASHP director of clinical standards and quality. "The existing model for OTC medications would place the entire burden for performing these functions on the patient and would likely result in increased adverse drug events. However, pharmacist managed behind-the-counter availability of these medications would provide a significant health benefit to consumers, who would be able to draw on the education, training, and experience of pharmacists to help them assess their need for the medication, and its appropriate use in the context of a comprehensive disease management program."

ASHP policy opposes reclassification of statins to over-the-counter status and calls for the use of alternate dispensing models, such as behind-the-counter (BTC), to increase patient access and to offer important safeguards that will protect patients from harm.

ASHP also submitted written testimony to the advisory committees. To view it, click here.

American Society of Health-System Pharmacists

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