REMS – A Paper Tiger?


MedGuides are pieces of paper that are shoved into a bag with your prescription to warn a patient about possible side effects.  I take some prescriptions myself that come with MedGuides.  I never have read one all the way through, despite what one might consider to be a pretty adequate level of health literacy.  I have noticed that the number of MedGuides seems to be increasing.  So it seemed worth a little research about MedGuides and their efficacy.    The results were somewhat shocking.

First, research led to a paper put out by the National Association of Chain Drug Stores in April of 2007 which confirmed that indeed, the number of MedGuides is on the rise.  According to the paper, in 2004 there were 123 drugs that had MedGuides.  By 2007 there were 3896!  That's a faster growth rate than Twitter!  

So one must assume from that kind of increase that there is a perception that MedGuides must be a really effective means of addressing risk.  Right?  

Well the FDA apparently thinks so.  Under the Food and Drug Administration Amendment Act (FDAAA), the FDA is now authorized to require Risk Evaluation Management Strategies (REMS) programs for a drug to address risk.  One would assume that this would involve a pronounced effort that might include a multifaceted program including monitored communications and interventions that are evaluated periodically for effectiveness.  Certainly for some drugs like Accutane, that is true, where there has been put into place several tools to guard against risk.  

In 2007, the FDA held a two-day hearing to explore MedGuides.  It must have reassured the agency.  But is this one of those many instances in which there is a great deal of stock put into the theory of something without regard to the facts?  And while many recommendations were made at the meeting, the role of MedGuides seems to continue unchanged.  

There are currently 57 drugs that have approved REMS programs under the FDA's new authority. Of those, 46 are REMS programs that have the sole requirement of a MedGuide.  It would seem that the significance of REMS programs are getting watered down by an over-reliance on MedGuides. Particularly since, with what scant evidence there is out there, they don't seem to work very well.

In fact, a search for studies that would demonstrate that MedGuides have any impact whatsoever on patient behaviors could not be found.  However, in 2006, the National Council on Patient Information and Education (NCPIE) conducted two focus groups among patients who were taking prescriptions to assess the role of MedGuides.  One of the groups was comprised of people who regularly took drugs that would be required to have MedGuides.  Among both groups, only two people were even aware that MedGuides existed.  That says a lot.  

FDA is an agency driven by data.  Yet there is virtually no data to demonstrate that the main pillar of their risk management philosophy is in fact effective, and some to suggest that it is not.  The FDA's lack of sophistication in digital and social media may be not only an inconvenient truth, but in not exploring digital media and its potential uses in risk management (a field by the way, rich in measureable metrics), it may in fact be to the detriment of good REMS program planning.  Pharma companies should not wait for the FDA to innovate, but rather should explore the potential uses for digital media in risk management on their own and lead the FDA to water.  
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