http://drugtopics.modernmedicine.co...dGuides/ArticleStandard/Article/detail/314981
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?
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.
Of the 20 pharmacies surveyed, a MedGuide for celecoxib was distributed by only one chain pharmacy (5%). The purpose of the MedGuide was not communicated to the patient. But all 20 pharmacies did distribute to the patient other written drug information about celecoxib, produced by three different commercial information vendors.
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:
* First, pharmacists may not be aware of the MedGuide regulations for celecoxib and other drugs.
* Second, pharmacists may believe that the written drug information they are distributing, produced by commercial vendors, meets the FDA's regulatory requirements.
* Third, the manufacturer of celecoxib may have failed to ensure that sufficient quantities of the MedGuide are reaching pharmacies for distribution to patients.
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.
For more information about MedGuides, check out FDA's Office of Drug Safety Web site at:
http://www.fda.gov/cder/Offices/ODS/labeling.htm.
