January 11, 2011

Off-Label Drugs: Need More Monitoring?

(Ivanhoe Newswire) -- A new editorial article, published in the Canadian Medical Association Journal, suggests physicians should be more careful when prescribing drugs "off-label." The use of the drug recombinant activated factor 7 (rFVIIa), despite its potential for adverse events, shows the serious shortcomings of Canada's current drug surveillance system, according to the commentary.

Off-label use of this therapy, which is a blood product, was driven by key physician opinion leaders who thought rFVIIa could be used to treat or prevent bleeding in patients without hemophilia who were at risk of death. This shows how promising case reports can change practice prematurely before more data is available.

The use of recombinant factor VIIa in patients without hemophilia is expensive, marginally effective and risky, according to the article.

"Off-label use of drugs can be beneficial, however, without a process for ongoing evaluation, deaths, disabilities and costs may be accruing without being obvious at the bedside," Paul H©bert, Editor-in-Chief, CMAJ, with coauthors, was quoted as saying. "With recombinant factor VIIa, physicians were too eager to believe the anecdotes and did not push for the appropriate studies."

Monitoring drug use and safety is complicated and lacks a simple solution. Several changes should be considered including improved collaboration between payers and insurers who approve and track usage as well as manufacturers, prioritizing higher risk drugs in an improved drug surveillance system, better evaluation of new drugs, and greater surveillance powers for regulatory bodies.

SOURCE: CMAJ (Canadian Medical Association Journal), published online January 10, 2010