Off-label prescription of benzodiazepines: a retrospective cohort study
of prescribing prevalence in primary care.
Abstract
Background Benzodiazepines are commonly prescribed medications approved
for and used in the treatment of anxiolytic and sleep disorders, as well
as for seizures, and alcohol withdrawal. However, benzodiazepines are
also controlled substances (schedule IV in Canada) because of their
potential for abuse and personal harms, which are especially prevalent
among older people. It is therefore important to understand how
benzodiazepines are being prescribed, and the prevalence of off-label
benzodiazepine prescribing, of which very little is known due to
challenges in documenting treatment indication. Methods Data from the
MOXXI (Medical Office of the XXIst century) electronic health record
system in Quebec Canada was used, where specifying the treatment
indication for each prescription is required, to estimate the prevalence
of off-label prescribing and indications for off-label use of
benzodiazepines. Each drug indication was retrospectively classified as
either on-label or off-label according to the Health Canada drug
database. Off-label prescriptions were further classified as having
class evidence supporting their prescription if another benzodiazepine
had been approved for the indication by Health Canada. Results There
were 20,125 (17.0%) adult patients prescribed benzodiazepines out of
the 118,227 patients enrolled in the MOXXI system. The patients were
predominantly female (65.6%), and tended to be older with an average
age of 60.14 years (standard deviation = 15.68) at the time of the first
benzodiazepine prescription. A total of 101,583 unique prescriptions
were written for 14 different benzodiazepines to these patients. An
approximately equal number of benzodiazepines were prescribed on and
off-label (49.3% on-label, 49.2% off-label), with clonazepam having
the highest prevalence of off-label prescription (99.5%). Most
off-label prescription indications were classified as having class
evidence (95.2%). The most common off-label indication was insomnia;
31.6% of all off-label benzodiazepine prescriptions were for insomnia.
Conclusions We found that benzodiazepines were frequently prescribed in
the province of Quebec and were prescribed off-label approximately half
of the time. When prescribed off-label we found that the majority of
these prescriptions were for indications that were approved for at least
one benzodiazepine. These findings indicate the importance of reminding
physicians on the important differences between benzodiazepines that can
substantially impact patient outcomes, particularly in older people.