• Written Informed Consent - An Introduction and Action Plan

    April 1, 2024
    Views: 3689
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    Guest post by John Spagnola

    Currently, our veterans are faced with rising suicide, polypharmacy and overdose rates.
    In fact, suicide rates have unfortunately maintained for over 10 years, in spite of billions of dollars being spent on various programs and administrative modifications.

    Sometimes it is simplicity that can be most effective. Many veterans and Veterans Service Organizations believe that the overall health of veterans and their longevity can be greatly enhanced by simply ensuring that our veterans are fully informed about the side effects of high risk medications, such as Antipsychotics, Antidepressants, Benzodiazpines, Anxiolytics and Narcotics.

    Along with providing our veterans with informed consent about medication side effects, it is equally important that our veterans be informed that they have treatment options and that the final decision is theirs - not their doctor's. It is true that their doctor must provide the risk/benefit comparison to the veteran and in a language that he understands. This is all already mandated per the Veteran Administrative Handbook. However, the VHA Handbook only requires that Verbal Consent be employed. The problem with Verbal Consent, is that it cannot be monitored or enforced. It includes no accountability. Therefore, it is conceivable that most veterans are not being provided with informed consent.

    That is why Written Informed Consent must be employed by the Veterans Administration. In this way, the veteran confirms, with his signature, that he was informed of the side effects and he was informed of the treatment options, prior to receiving any high risk medications.

    Focus: Saving lives by reducing/eliminating veteran (and potentially military) suicide using Written Informed Consent only for certain 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 chief 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).

    Problem: 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, foundational, 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.”

    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.

    Solution: 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 any 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.

    Federal Legislation: Congressman Cory Mills has a veteran draft bill that will implement written informed consent for these high risk medications. His activity is supported by Veterans Service Organizations, including: the American Legion, VFW, Association of the US Navy, Marine Corps Reserve Association, Vietnam Veterans of America, Jewish War Veterans, Fleet Reserves Association, Special Operations Association of America, Reserve Organization of America, Military-Veteran Advocacy, First Sargeants' Association of the Air Force and The Navy Seal Foundation.

    If you would like to assist in getting this Federal Legislation introduced, please contact the following congressional members of the US House VA Subcommittee on Health and urge them to sign on to the "Informed Consent Act" by Congressman Cory Mills:

    Miller-Meeks (IA), Bergman (MI), Radewagen (AL-AS), Murphy (NC), Van Orden (WI), Luttrell (TX), Kiggans (VA)
    Brownley (CA), Levin (CA), Deluzio (PA), Budzinski (IL), Landsman ((OH).

    You can email, fax or preferably call them at the Congressional Switchboard at 202-224-3121.
    Of course, the biggest impact would come from a personal meeting of one or more of you.

    Anyone can reach out to the Congressmen above. You can also ask your Congressman to join: https://www.house.gov/representatives/find-your-representative.

    If you could let me know of your responses, that would be helpful - [email protected].

    John

    PS. I'm also attaching 3 VSO recently passed resolutions in support of Written Consent. (JWA P 19)

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    Michele Sarkisian

    Thank you for this article. So important for ALL Americans but particularly our admired Veterans. Signature based informed consent will foster better healthcare and lifestyle decisions for certain.

    Amy Williams

    If Dr. Peter Breggin were treating out Veterans, the suicide rate would immediately drop. He is retired, and no one is filling his “Psychiatry Shoes”- this is tragic.

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