Off-Label Antidepressant Prescribing Increasingly Common

Fran Lowry

May 31, 2016

Off-label prescribing of antidepressants is increasing, particularly for insomnia and pain, even though their efficacy has not been established for these conditions, new research shows.

Investigators at McGill University, in Montreal, Canada, found that 45% of the antidepressants prescribed for more than 100,000 adults living in the province of Quebec were for conditions other than depression.

Furthermore, almost one third of these prescriptions were for an off-label indication, most commonly, insomnia and pain.

"Researchers want to assess the safety and effectiveness of different antidepressants, but one of the main problems standing in the way of that is that physicians are prescribing antidepressants for so many different indications now, not just depression," lead investigator Jenna Wong, a doctoral candidate at McGill University, told Medscape Medical News.

Jenna Wong

"However, they are not documenting what they are prescribing these antidepressants for. The indications are not even written in the patient's medical chart. If you are looking at effectiveness outcomes, but you do not know why the patient is taking the antidepressant in the first place, it is hard to learn the true effectiveness of the agent," she said.

The study was published in the May 24 issue of JAMA.

Off-Label Indications

The investigators analyzed the prevalence of treatment indications for antidepressants and assessed trends in such prescribing using data from an electronic medical record, the Medical Office of the 21st Century (MOXXI), used in Quebec.

"MOXXI includes physician-documented treatment indications, and all physicians in Quebec are required to enter the information," said Wong.

The researchers studied treatment indications and off-label prescribing for antidepressant prescriptions except monoamine oxidase inhibitors for the period 2006 to 2015.

In MOXXI, the physicians had to document at least one treatment indication per prescription, either from a drop-down menu containing a list of indications or by typing in the specific indication.

Prescriptions were classified as on-label or off-label, depending on whether the drug was approved for the indication by Health Canada or the US Food and Drug Administration by September 2015.

Between 2006 and 2015, 101,759 antidepressant prescriptions (5.9% of all prescriptions) were written by 158 physicians for 19,734 patients.

Only 55% of antidepressant prescriptions were written for depression; 45% were for nondepressive indications.

Physicians prescribed antidepressants for anxiety (18.5%), insomnia (10.2%), pain (6.1%), and panic disorders (4.1%).

"Prescriptions for insomnia and pain were off label," Wong noted.

Other off-label indications included migraine, menopausal hot flashes, attention-deficit/hyperactivity disorder, and digestive system disorders.

The analysis also showed that the percentage of antidepressants prescribed for depression decreased significantly between 2006 and 2015, with the exception of mirtazapine (Remeron, Organon Pharmaceuticals USA, Inc).

During that time, prescriptions of serotonin-norepinephrine reuptake inhibitors decreased by 9.73%; those of selective serotonin reuptake inhibitors decreased by 3.96%; and those of tricyclic antidepressants decreased by 2.99%. Prescriptions of mirtazapine increased by 2.36%.

"I think this study highlights the importance of accounting for treatment indications whenever you are doing something with antidepressants, because they are no longer just for depression," Wong said.

"Also, we are finding increasing off-label use, so we should look at the uses that are not supported by scientific evidence and push for more careful evaluation of those uses," she said.

Well-done, Worthwhile

"This is a well-done and worthwhile study," Gordon Schiff, MD, associate director, Center for Patient Safety Research and Practice, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, told Medscape Medical News.

"One of the most noteworthy aspects is the researchers' use of a unique data source, the Quebec MOXXI drug prescribing system, that reliably captures the indication for each prescription which is directly entered by the prescribing physician into the drug order," Dr Schiff said.

"Many pharmacy, physician, and policy groups have been striving for years to have such a system for recording the indication along with the drug order in a way that is both easy to do and captures accurate information. As this study shows, this helps inform epidemiologic studies of drugs use, and it can also make prescribing safer, as it helps pharmacists, patients, and other caregivers know and double-check the indication for each medication," he said.

The finding that drugs are being widely used off label, and often in cases in which there is little good evidence of their effectiveness and safety, is important, Dr Schiff added.

"Given the list of symptoms and problems the authors document that these antidepressants are being used for, you can't entirely blame the physicians. As a primary care physician, I see patients every day with these problems and often struggle with finding ways to try to help them. It is just that we need to be more cautious and more conservative when it comes to prescribing drugs where we truly lack good data on whether they are helping, more than harming, patients," he said.

The study was sponsored by a Vanier Canada Graduate Scholarship grant to Jenna Wong. Dr Schiff reports no relevant financial relationships.

JAMA. 2016;315:2230-2232. Full text

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