Guest post by David Shulkin M.D.

Every day, veterans are prescribed medications that may increase their likelihood of worsening outcomes, suicide, self-harm, or addiction. Too often, this happens without veterans being fully informed of these risks. To improve pharmaceutical safety, the VA should standardize the practice of Written Informed Consent (WIC) for all high risk medications to help reduce the risk of inappropriate prescribing and its adverse consequences.

Written Informed Consent is a process where a veteran (or their caregiver) receives a summary of the risks, benefits, and alternative treatments and is given the chance to ask questions prior to having the prescription filled. This approach represents a cornerstone of ethical medical practice that empowers veterans and fundamentally can improve health outcomes.

To understand the urgency of this issue, it is critical to understand the threat posed to these veterans and those who care for them. The risks associated with opioids (addiction, overdoses, and erratic behaviors) are generally understood. However, benzodiazepines and other high-risk medications are far less understood. Since 2010, research has shown that there are significant risks associated with benzodiazepines for the treatment of PTSD. This includes risks such as increased aggression, disinhibition, and worsening of substance abuse. These risks alone would warrant the maximum level of informed consent, but the dangers extend even further. A veteran with PTSD is 60% more likely than a veteran without PTSD to be arrested for a violent crime. Additionally, a veteran co-prescribed benzodiazepines and opioids is more likely to die prematurely from multiple causes and specifically from suicide. Furthermore, a veteran taking benzodiazepines for PTSD may worsen their symptoms and interfere with cognitive therapies.

The VA currently employs written informed consent for some medications but has not applied this practice consistently across all high risk drugs. VHA’s Handbook 1004.01, and VHA Directive 1005 requires written informed consent for long-term opioid therapy, defined as opioid use for 90 or more days to treat non-cancer pain. VA has demonstrated strong results with this practice. From 2012 to 2023, as part of the VA's Opioid Safety Initiative (OSI), which employed written informed consent, reduced opioid prescriptions by 67%.  However, even with this limited scope requirement for informed consent across the VA, a Government Accountability Office study found that among 53 veterans prescribed long-term opioid therapy, 12 veterans did not have the required written informed consent, indicating gaps in adherence to this policy. More significantly, the VA's current written informed consent requirements do not extend to benzodiazepines and other high-risk psychotropic medications, despite their well-documented dangers for veterans with PTSD.

In Wisconsin however, broad use of WIC for high risk medications has been in place at VA for years and has resulted in significant reductions of high-risk medications.  This practice demonstrates that WIC could be standardized across the entire VA. 

The value of written informed consent for high-risk medications extends across multiple dimensions of healthcare quality and patient safety. Written consent ensures veterans are provided with the information necessary to make truly informed decisions about their care. When veterans understand the full spectrum of potential outcomes, they can weigh these against their personal values, life circumstances, and treatment goals. This leads to treatment decisions that are not only medically sound but also personally meaningful and sustainable.

From a clinical perspective, the informed consent process creates opportunities for enhanced for VA providers to thoroughly review the evidence base for their prescribing decisions, potentially identifying safer alternatives or non-pharmacological interventions that might be equally effective. This systematic review process can reduce prescribing errors and inappropriate medication use, while the documentation requirement creates a clear record of the decision-making process that can inform future care decisions.

Written informed consent also serves as a powerful risk mitigation tool. By ensuring that patients understand potential adverse effects, the process can improve medication adherence and monitoring of side effects. Veterans who are aware of warning signs are more likely to seek timely medical attention when problems arise, potentially preventing serious complications. The process also builds trust between veterans and their healthcare providers. When clinicians take the time to thoroughly explain treatment options and genuinely solicit patient input, it demonstrates a collaborative approach to care can  that can lead to better communication, improved treatment adherence, and more positive health outcomes overall. For veterans who may have experienced trauma or injury in military service, shared decision making can have profound psychological benefits that extend well beyond the specific medication decision at hand.

Medications, especially those that affect the brain, come with risks and dangers that are known even when they are not fully understood. Veterans deserve to fully understand these risks before choosing a course of treatment. Implementing standardized Written Informed Consent for high-risk medications is both a moral imperative and a proven strategy for improving veteran health outcomes.