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Since 1998, the Food & Drug Administration has had the regulatory authority to require pharmacies to distribute Medication Guides to patients getting certain high-risk drugs. MedGuides, which provide written information to patients on their Rxs, are prepared by drug manufacturers and approved by the FDA. To date, the FDA lists more than 75 drugs on its Web site that require the distribution of a MedGuide from a community pharmacy or upon hospital discharge. They include antidepressants, nonsteroidal anti-inflammatory drugs (NSAIDs), and others. Manufacturers of these high-risk drugs are responsible for ensuring that a sufficient number of MedGuides are available in pharmacies.

Are pharmacists dispensing these critical documents? Are patients getting this needed drug safety information?

Sana R. Sukkari, B.Sc.Pharm., M.Phil.

Anecdotally, interacting with practicing R.Ph.s, we've heard that MedGuides are not routinely being distributed to patients. To determine if this is the case, we conducted a survey of 21 Pennsylvania community pharmacies identified from the local telephone directory. There were 17 chain, three independent, and one franchise pharmacy, each within a medium-sized municipality. The 17 chain pharmacies were operated by six different corporations.

An undercover patient presented a prescription for celecoxib to these pharmacies between Nov. 30 and Dec. 8, 2005. For economic reasons, the survey was limited to only one NSAID. All written drug information distributed at the time of celecoxib dispensing was collected. The patient purposely did not solicit information on celecoxib from the pharmacy staff. One of the 21 pharmacies intended for inclusion in the study had ceased operation, so the final number of pharmacies surveyed was 20.

 

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