Background information in the report explains that off-label prescribing means using prescription medications for indications that have no regulatory approval. According to the authors, off-label prescribing could potentially be a contributing factor for some adverse medical events that could otherwise be prevented.
Tewodros Eguale, M.D., M.Sc., of McGill University in Montreal, Canada, and his team used the Medical Office of the XXI Century primary care electronic health record network research program in Quebec to examine off-label use and found that from January 2005 until December 2009, a total of 113 primary care physicians wrote 253,347 electronic prescriptions for 50,823 patients.
They discovered that 11% of all prescriptions were prescribed for off-label indications and that the results showed that 79% of off-label use lacked strong scientific evidence. The authors point out that off-label prescriptions were lower than those in a U.S. study.
Eguale, and his team found that the highest percentage of off-label prescriptions were for central nervous system medications (26.3%), with 17.1% for anti-infective agents followed by 15.2% for ear-nose and throat medications.
The findings reveal that drugs with three or four approved indications were linked to lower off-label use than those with one or two approved indications and that drugs approved after 1995 were also linked to lower off-label use, compared with those that were approved prior to 1981. Furthermore, physicians with high scores on evidence-based practice tended to prescribe less off-label drugs, compared with those with lower scores.
The authors summarize:
"In conclusion, our findings indicate that off-label prescribing is common in primary care and varies by drug class, the number of approved indications for the drug, the age of the drug, patients' sex and physicians' attitude toward evidence-based medicine. 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."
Editorial: What Does Off-Label Prescribing Mean?Patrick G. O'Malley, M.D., M.P.H. of the Uniformed Services University of the Health Sciences in Bethesda, Md. states in a linked editorial:
"The principles and goals of labeling are worthy in that they seek to systematically identify the benefits and harms associated with drugs in order to allow the public to optimize the trade-off between drug risk and harm. However, there is substantial room to grow in realizing these ideals in practice. The reality is that when faced with difficult symptom syndromes that are unresponsive to available treatments, clinicians resort to trying what seems reasonable in order to alleviate suffering."
"Here is my view about a way forward on this topic. First, the discourse needs to focus less on overuse or under use or off-label use and more on evolving toward better measurement of use, better assessment of appropriate use based on linkage to clinical outcomes and better processes to optimize use."
Written By Petra Rattue