‘Off-Label’ Drug Use Appears Common

MONDAY, April 16 (HealthDay News) — Off-label prescribing of
medications is common, but the practice varies according to drug, and
patient and doctor characteristics, a Canadian study finds.

In off-label prescribing, a doctor prescribes drugs for uses that have
not been approved by regulators. For example, some medicines approved to
treat depression are also prescribed for chronic pain.

The practice, which is legal but unregulated, is believed to contribute
to preventable medication-related harm in patients, according to Dr.
Tewodros Eguale, of McGill University in Montreal, and colleagues.

For the study, they examined more than 250,000 electronic prescriptions
for more than 50,000 patients written from 2005 through 2009 by 113
doctors in a primary care network in Canada.

The study results were released online in advance of print publication
in the journal Archives of Internal Medicine as part of the
journal’s health-care reform series.

About 11 percent of the medications were prescribed for off-label use,
and 79 percent of off-label use lacked strong scientific evidence, the
researchers found. The amount of off-label use in this study was less than
in a previous U.S. study, the authors noted in a journal news release.

The investigators found that the highest rate of off-label use involved
central nervous system drugs (26 percent), anti-infective agents (17
percent), and ear-nose-throat medications (15 percent). The study also
found that drugs with three or four approved uses were less likely to be
prescribed off-label than those with one or two approved uses.

Medications approved after 1995 were less likely to be prescribed
off-label than those approved before 1981, and doctors with high scores on
evidence-based practice were less likely to prescribe off-label, the
findings showed.

“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,” the researchers concluded.

“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,”
Eguale and colleagues wrote.

More information

The U.S. Agency for Healthcare Research and Quality has more about off-label prescribing.

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