The Black Box Warning: Antidepressant Medication, Monitoring, HIPAA Confidentiality, and Suicide: A LETTER TO CONGRESS — (Mental Health Law and Policy Journal)

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Mental Health Law and Policy Journal:  A LETTER TO CONGRESS


Fall, 2013

On April 24, 2013, the staff of the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations, sent a Memorandum to Subcommittee members addressing the question: “Does HIPAA (The Health Insurance Portability and Accountability Act of 1996) Help or Hinder Patient Care and Public Safety?” A hearing on the subject was to be held in two days, April twenty-sixth. The Memorandum emphasized a finding based on testimony obtained during an earlier Subcommittee sponsored bipartisan public forum, on March 5th, an event inspired by the tragic December 12, 2012 school shooting at Newtown, Connecticut.  The forum concluded that “[t]he inability of families and caregivers to obtain crucial health information affecting the care of a loved one can have tragic consequences.”  The staff report cited a case where mental health care providers were unwilling to share with a father their concerns about the self-destructive tendencies of his son who eventually took his life.  The absence of communication with the parent was considered a contributing factor in the suicide.  This letter addresses a similar case.

Several years before the Newtown shooting and follow-up Congressional investigation, in November 2008, a woman – whom we shall call Paula  – was under treatment for depressive illness and took her life. Paula was a wife, mother, and grandmother.  She had been taking the antidepressant, Effexor.  Her doctor changed her prescription and placed Paula on Effexor XR four days before her death.   Several circumstances suggest that this tragedy could have been avoided with enhanced family awareness. This letter raises issues that both Congress and the mental health community should consider to prevent tragedies like Paula’s suicide from happening to other families. Congress should address the issues raised in this letter and amend HIPAA’s confidentiality rules to include a family awareness of patient mental health care section. These issues are identified and explained in four sections: (1) HIPAA confidentiality between doctor and patient; (2) the diagnosis of patient illness; (3) monitoring of the patient on medication; and (4) the current direction of HIPAA policy. The HIPAA Confidentiality Agreement Between Doctor and Patient HIPAA requires confidentiality between a doctor and his or her patient. When Paula began treatment, she understood that her sessions with the psychiatrist and social worker would be treated as confidential under HIPAA guidelines. She believed that confidentiality would apply only to the personal psychotherapy discussions that took place during office visits with her psychiatrist and social worker. The psychiatrist, however, held a different understanding and believed that HIPAA’s confidentiality requirement also extended to Paula’s prescribed medications, along with the content in the black box warnings that the manufacturer included with the drug.  Effexor XR carried a warning that stressed the importance of notifying family members if a loved one was prescribed Effexor XR.

Effexor XR’s black box warning stated that a person taking the antidepressant could have serious behavioral changes that may result in potential harm to the patient, even suicide. Thus, Effexor XR’s recommendation for family awareness creates a potential conflict with HIPAA’s confidentiality rules. Paula did not consider her medication information confidential. Paula told her husband- whom we shall call Jim – that she was taking anti-depressant and anti-anxiety prescriptions for her depression. Jim was fully aware of Paula’s psychiatric appointments but had neither met her medical team nor received a briefing from Paula’s psychiatrist or social worker on the danger signs as stressed in Effexor XR’s black box warnings. Paula’s doctor did not inform Jim about the possible side effects of Effexor XR or explain the black box warnings to him. The doctor was also unaware of Paula’s desire that Jim understand her medication schedule.  Thus, Paula’s doctor did not follow the manufacturer’s recommendations to inform family members about the possible side effects from taking Effexor XR.  Doctors are permitted, but not required, to use and disclose protected health information, with patient authorization.

The question becomes why did Paula’s doctor not seek permission from Paula to inform her husband of the possible side effects of her medication? Why are family members, such as Jim, not informed of this part of a loved one’s treatment?  Assuming Paula knew HIPAA’s provision permitting disclosure to family and others with patient permission, Paula’s doctor may have thought it unnecessary to raise the issue because Paula signed the standard HIPAA form at the beginning of treatment. So the extent of confidentiality coverage and the specific application of confidentiality was never discussed between Paula and her doctor. Another possibility is that Paula’s doctor-a foreign national-did not understand the HIPAA law and was fearful of large fines and jail terms resulting from noncompliance.  Whatever the thought process between doctor and patient in this case, there was no meeting of the minds regarding the HIPAA confidentiality agreement. To make an intelligent decision on HIPAA confidentiality, therefore, doctors and mental health patients might best consider several questions before a decision. For example, (1) Does the doctor realize that the medication black box warning may stress family awareness, especially if the drug carries a suicide risk? (2) If so, has the doctor explained the need for family awareness to the patient? (3) Does the doctor realize that the patient’s family may already know about the patient’s mental condition, perhaps in great detail? (4) Does the doctor understand HIPAA option for informing others with patient permission?