Understanding off-label prescriptions for antidepressants

Understanding off-label prescriptions for antidepressants

All drugs sold and marketed in the United States bear a specific FDA-approved label, which is a written report covering elaborate guidelines pertaining to approved uses and doses. These usage and dosage instructions are based on evidence from clinical studies and research labs, which the drug maker submits to the FDA. Before a drug is approved for prescription, the FDA ensures the company has clinically proven its safety and efficacy for intended use. However, ‘safe’ does not always mean it has no side effects. Instead, it represents the FDA assurance that benefits of the drug for a particular use outweigh the potential risks.

“Off-label” prescription is a scenario when a physician does not strictly abide to the FDA-approved guidelines while prescribing a medication. It may include a case when the FDA approves a dose of one tablet every day for a particular drug but the prescriber tells the patient to take two tablets every day. Health care providers might also prescribe the drug for a disease that it is not medically approved to treat.

There is a lack of clinical evidence for physicians prescribing antidepressants for off-label indications, possibly due to the absence of practice of documenting treatment indications for most prescriptions. However, the introduction of electronic prescribing (e-prescribing) systems has encouraged the practice of formal documentation of prescription-based treatment. Special attention and oversight is required for off-label prescribing due to the risk of drug abuse. Furthermore, inefficacious antidepressant use is associated with unnecessary costs and side effects.

Antidepressant use witnessed a huge jump over the last few years in the United States. Considering the lack of scientific evidence favoring off-label indications, scientists recently carried out an extensive study aimed at examining the extent of off-label indications for antidepressants. The study was carried out on patients (aged 18 years or older), who visited a physician during January 2003–September 2015 and were prescribed an antidepressant through the e-prescribing system.

Findings of the study

The study, published in The BMJ in February 2017, reported a 29 percent prevalence of antidepressant prescriptions written for an off-label indication. While tricyclic antidepressants (TCAs) reported highest incidence of off-label indications, serotonin-norepinephrine (noradrenaline) reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs) had comparatively less prevalence of being prescribed for an off-label indication.

Only 16 percent of all off-label antidepressant prescriptions had strong scientific evidence supporting drug’s use for the intended use. Surprisingly, around 40 percent off-label prescriptions had no strong evidence favoring drug’s use for the condition prescribed; however, another drug in the same class had strong scientific evidence backing the drug use. The remaining 44 percent off-label prescriptions lacked evidence-based backing for the prescribed drug as well as the other drugs in the class.

The researchers highlighted many factors that might force physicians to prescribe antidepressants for off-label indications. Some of the important factors include limitations related to insurance coverage of the drug, complexities involved in keeping track of new indications, and concerns regarding the safety and efficacy of alternative pharmacological options.

Furthermore, they discussed the potential of technologies such as electronic health records and indication based e-prescribing systems in ensuring effective post-market drug surveillance while helping supervision and evaluation of off-label antidepressant use. According to the authors, “This should include whether the intended use is off-label, but more importantly prescribers should discuss the strength of the evidence base underlying their recommendation.”

Treating depression in the right manner

A 2016 study had also suggested that around 29.4 percent antidepressants are prescribed for off-label indications; however, the study failed to explain the if these off-label prescriptions are adequately supported by scientific evidence.

Though antidepressants are one of the most preferred treatment methods to treat depression, their misuse for purposes other than the prescribed condition can cause severe complications. There is also the risk of people becoming addicted to antidepressants. The Texas Depression Treatment Help offers assistance to people battling depression and related problems. If you are looking for comprehensive depression treatment in Texas, you can contact us over an online chat or call our 24/7 helpline number 866-827-0282 number. Our experts can connect you to one of the finest depression disorders clinic in Texas.