Regulatory Focus™ > News Articles > Study: Canadian Off-Label Prescribing Common, Lacks 'Strong Scientific Evidence'

Study: Canadian Off-Label Prescribing Common, Lacks 'Strong Scientific Evidence'

Posted 17 April 2012 | By Alexander Gaffney, RAC 

A new study released in the medical journal Archives of Internal Medicines finds nearly one-in-ten prescriptions written "off-label" in Canada lacked "strong scientific evidence" to support their prescribing, reports Health Day News.

Off-label prescribing refers to applications for medicinal products that are not approved on its regulatory agency-approved label. In Canada, prescription drugs are regulated by Health Canada.

The study, led by Dr. Tewodros Eguale of McGill University, followed 113 doctors over five years (2005-2009) as they wrote 250,000 electronic prescriptions for more than 50,000 patients.

Of the 250,000 prescriptions, roughly 11% were prescribed for off-label use, and 79% of those off-label prescriptions were found to have been written despite lacking "strong scientific evidence," the authors wrote.

Three drug classes accounted for the majority of off-label prescriptions: central nervous system drugs (26%), anti-infective agents (17%) and ear-nose-throat medications (15%).

This information could be used by regulators in the future, Eguale argued, as they would have a better idea of how drugs were actually being used.

"Electronic health records can be used to document treatment indication at the time of prescribing and may pave the way for enhanced post-marketing evaluation of drugs if linked to treatment outcomes," wrote Eguale.

Read more:

Health Day News - 'Off-Label' Drug Use Appears Common

Regulatory Focus newsletters

All the biggest regulatory news and happenings.