Since 1998, the Food & Drug Administration has had theregulatory authority to require pharmacies to distribute MedicationGuides to patients getting certain high-risk drugs. MedGuides,which provide written information to patients on their Rxs, areprepared by drug manufacturers and approved by the FDA. To date,the FDA lists more than 75 drugs on its Web site that require thedistribution of a MedGuide from a community pharmacy or uponhospital discharge. They include antidepressants, nonsteroidalanti-inflammatory drugs (NSAIDs), and others. Manufacturers ofthese high-risk drugs are responsible for ensuring that asufficient number of MedGuides are available in pharmacies.
Are pharmacists dispensing these critical documents? Are patients getting this needed drug safety information?
A clear limitation of our survey was the small sample size covered. Further study is needed before we can say that our results are projectable to the population at large.
Why did only one pharmacy distribute the MedGuide for celecoxib? We don't know, but here are some possible reasons:
Of note is the fact that the drug information produced by one commercial vendor and distributed by two pharmacy chains contained the statement, "Read the Medication Guide provided by your pharmacist before you start using celecoxib and each time you get a refill." Yet no MedGuide was distributed, nor any information concerning the existence of a MedGuide.
What are the consequences to pharmacists who fail to distribute a MedGuide? The MedGuide is part of the drug labeling, and failure to distribute it may be construed as a misbranding violation. There are no provisions in the regulations providing pharmacies with the option to distribute patient leaflets or written drug information produced by commercial vendors as a substitute when a MedGuide is required for a particular drug.
Even if the FDA or state pharmacy boards do not take pharmacies to task for failing to dispense MedGuides as mandated, pharmacists may be liable in another way. Experts believe that patients who did not receive a MedGuide and are injured may have strong grounds to file suit against their pharmacy and win the case.
In light of these legal concerns, we recommend that pharmacies set up a system to remind themselves to distribute this important document. Work with your computer vendor so that each time you dispense one of the 75 drugs involved, your system will alert you to the need to give out a MedGuide.