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Saving lives by reducing/eliminating veteran (and potentially military) suicide using Written Informed Consent only for Black Box medications included in the VA formulary. Black Box medications are required by the U.S. Food and Drug Administration to carry special warnings for medications that have a high potential for serious safety risks. Often these warnings communicate potentially rare but dangerous side effects, or they may be used to indicate important instructions for the safe use of the drug.
Many of these drugs are prescribed for our most fragile veterans and they often carry suicidal ideation as one of their main side effects. Making matters worse, many of these same veterans are often prescribed more than one of these risky medications. We support using these medications if they are medically necessary, the benefits outweigh the risks, and the physician clearly explains the potential risks/alternate treatment options so that the veteran understands what to expect while taking the medication(s).
Imagine a fragile veteran, taking one or more of these powerful and risky medications, who is not prepared for possible side effects such as: vision problems (blurred or unfocused); hallucinations (seeing things or hearing voices); depression; anger issues; severe fatigue; being unable to think/function coherently, etc. Any or all of these could push them over the edge into a possible suicidal situation due to fear or confusion. Furthermore, they may be unable to work or support themselves and their families, they may be dealing with alcohol or drug addiction, or they might exhibit violent or unpredictable behavior.
Over the years, the VA (along with the DoD) has spent millions of dollars on veteran and branch-specific suicide prevention programs with little to no success in improving veteran (military) suicide statistics. Clearly, something is not working as planned. Continuing to do the same failed actions/programs and wasting finite financial resources is the definition of insanity. It is time to try something simple, different, and cost-effective.
As a first step we need to enforce what is already a part of the VHA Handbook: “Veterans must be informed of the side effects and the treatment options of medications and treatments they are prescribed.” Unfortunately, according to the VHA Handbook, Verbal Informed Consent is the standard for medications for veterans (see also – VHA Directive 1005: Informed Consent for Long-term Opioid Therapy for Pain). What is the problem with verbal only consent? There’s no way to track that sufficient and understandable information regarding medication is being provided to veterans. In fact, there’s no way to verify that the veteran is getting more information than what is provided, in unintelligible language, in the medication insert. Even VA pharmacists do not consistently provide in-depth information regarding side effects, etc.
Because Verbal Informed Consent cannot be monitored, it is not enforceable. This oversight causes our veterans and their families to be subject to a lack of vital information about medication side effects as well as their right to be aware of, and possibly choose other medications or treatment options.
Additionally, the veteran’s inability or desire to work, familial and spousal disputes, unanticipated health problems, and homelessness may also stem from the side effects of these Black Box medications and/or polypharmacy.
Written Informed Consent will help ensure that clinicians are providing all vital information, including risks and side effects, considering all available evidence-based treatment options and medications to each veteran as a means of minimizing or eliminating the potential risk of suicide. This extra step should not only increase adherence to the treatment regimen but will prepare veterans for what they may expect during their treatment thereby removing the fear factor that could push them toward suicide. The combination of patient education and Written Informed Consent prior to prescribing helps to ensure that patients and their providers have a shared understanding of the patient’s goals and the risks, benefits, and alternatives.