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Published on 26 April 2012

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UK upholds stance on off-label prescribing


The medical council in the UK will uphold its rules regarding the prescription of non-approved drugs. 


Recommendations of the General Medical Council state that a doctor may prescribe an off-label medicine when no licensed option is in circulation and when another option, in the doctor’s judgement, would better suit the patient’s needs than the licensed treatment. 


But off-label prescribing will not be permitted as a cost-saving initiative, the pharmaceutical website InPharm reports.


The GMC has reached this decision after a year of consultation. The possibility of relaxing the off-label prescribing rules was discouraged by both the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Association of the British Pharmaceutical Association.



In a related study from Canada, use of electronic prescribing revealed the high level of off-label prescribing and the potential of e-prescribing to stem its use. 


Canadian authors reviewed electronic prescriptions of 113 primary care physicians using the Medical Office of the XXI Century electronic health record network in Quebec, where healthcare professionals must record treatment indication, and found that 11.0% of prescriptions were made out for drugs that lacked a license for the indication. 

This also revealed that off-label prescriptions were most commonly made out to treat the central nervous system (26.3%), and treatments with only one or two approved indications were more likely to be prescribed off-label than those with three or four licensed uses (6.7% vs 15.7%).

The study, by Tewodros Eguale (McGill University, Montreal, Quebec, Canada) and colleagues, also showed that old drugs approved for their indication before 1981 were more than twice as likely as drugs approved after 1995 to be prescribed off-label, at 17.0% versus 8.0%.

In view of their findings, the authors suggest that electronic prescribing “should document treatment indication to monitor off-label use”. 








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