Tuesday, February 23, 2010

Antidepressant FDA Suicide Warning Prescribing Patterns

I want to take a short break from discussing the proposed changes in the new Diagnostic and Statistical Manual of Psychiatry-5to review a recently published study on what changes have been made in antidepressant prescribing patterns of physicians since the " black box warning" was issued by the US Food and Drug Administration (FDA) regarding increased risk of suicide in children and adolescents taking antidepressant medication.

In 2003 and 2004 the FDA issued 5 warnings about the increased risk of suicidality in children and adolescents taking antidepressants. This increased risk was very small and the majority of practitioners felt that not using antidepressant medication would actually increase the suicide rate among this age group. In late 2004 the FDA directed all manufacturers of antidepressants to issue a black box warning and laid out monitoring recommendations. The black box means that the first thing a physician sees when looking up a particular medication is a bold highlighted box with safety and warning information. It cannot be missed. The warning specifically called for "weekly, face-to-face contact with patients or their family members or caregivers during the first 4 weeks of treatment".

A study supported by the Nnational Institute of Health (NIH) and published in Psychiatric Services tried to take a look at how this monitoring recommendation was actually being carried out. To do this they looked at claims data from 2001-2005 of 22,689 episodes of major depression an a national sample of privately insured patients. They found a 19% decrease in antidepressant prescriptions after the warning. Interestingly enough the national suicide rate increased in this population during the same period although no direct cause has been confirmed. They found no evidence however for increased face-face-contact with patients after the FDA advisory recommendation coming to the conclusion that physicians either don't know or are simply ignoring the recommendations.

Why are physicians not following through with the FDA recommendation? There are probably several factor involved. One is the relative lack of accessibility of child and adolescent psychiatrists. There are simply not enough psychiatrists in this field to serve our needs. Therefore many of the prescriptions for these antidepressant medications are given from pediatricians or other primary care providers who tend to have busy overloaded practices and have either not the time or the perception of not enough time to provide weekly follow-up. Another factor is that these patients are usually brought in by the parents who both may be working full time and cannot get off work once per week. Another factor is that many families cannot afford the repeated required co-payments they need to make for weekly follow-up. The other factor that always comes in is reimbursement. Many insurance companies do not provide reimbursement for antidepressant follow-up on anything less than a monthly basis. The situation is not a good one but goes beyond the idea that this is just physicians ignoring recommendations.

Weekly follow-up after a new prescription of an antidepressant is just good clinical practice for adults as well as children. Many patients suffer from various side effects, are often under the mistaken impression that the medication should work right away, and will discontinue their medication. Regardless of the different reasons for not following the FDA recommendations they should be followed and I think it is poor clinical practice to not do so. There are always ways to work around the various obstacles.

Thought for the day

Where there is a will there is a way.

No comments:

Post a Comment

Thank You For Your Comment!

CARF - Commission on Accreditation of Rehabilitation FacilitiesNATSAP | National Association of Therapeutic Schools and ProgramsNBCCNAADAC