VA Expands Informed Consent Requirements for Psychotropic Medications Starting in 2027

The US Department of Veterans Affairs (VA) has announced new informed consent guidance that adds patient education and documentation requirements before veterans are prescribed psychotropic medications, including antipsychotics, stimulants, antidepressants, anxiolytics, and opioids.¹ The requirements take effect in 2027. The VA said the change will require tens of thousands of patients in its health care system to have documented discussions with their clinicians before receiving certain prescriptions.²

VA practitioners already discuss the risks, side effects, benefits, and alternatives of psychotropic medications with patients.¹ Signature consent is currently required for long-term opioid therapy, which the VA defines as 90 or more days of treatment for noncancer pain.³ According to the VA, the new guidance adds education about the benefits and risks of certain medications so veterans can weigh treatment decisions more fully with their clinicians and families.¹

New Requirements

Starting in 2027, the VA will add 4 informed consent requirements:

• Patient education and signature consent before any concurrent prescription of opioids and benzodiazepines, for veterans of any age.
• Patient education and signature consent before prescribing an antidepressant to a veteran younger than 30.
• Standardized patient education for veterans prescribed psychotropic medications, including those that require only oral consent.
• Documented informed consent discussions covering risks, side effects, benefits, alternatives, and how to safely discontinue the medication, including for psychotropic medications that require only oral consent.

The last requirement makes discontinuation a formal part of the consent discussion. Prescribers will need to document how a medication can be safely stopped, as well as why it is being started, even for agents that previously needed only verbal agreement.

Clinical Context

Two of the new signature-consent triggers match areas already covered by FDA boxed warnings. In 2016, the FDA required boxed warnings on opioid analgesics, opioid cough products, and benzodiazepines about serious risks when the drugs are combined, including profound sedation, respiratory depression, coma, and death.⁴

Antidepressants carry a boxed warning for increased risk of suicidal thinking and behavior in children, adolescents, and young adults. The FDA extended that warning to young adults aged 18 to 24 years in 2007.⁵ The VA's age threshold of 30 is broader than the age range in the FDA labeling. The VA announcement does not explain how it chose that cutoff.

Opioid risk remains a particular concern in this population. According to data cited by Disabled American Veterans, the VA issued more than 3 million opioid prescriptions to about 577,000 veterans in fiscal year 2021. According to the National Institutes of Health, veterans are twice as likely as the general population to die of an opioid overdose.²

"America's Veterans should get as much information as possible as they are deciding what treatment is best for them," said VA Secretary Doug Collins. "The guidance we're announcing today will ensure that happens."¹

Clinician Perspective

Charles Garbarino, a retired US Army colonel and former combat physician who receives his care through the VA, said putting more emphasis on clinician-patient discussions should make it easier for veterans to learn about their medications and ask questions before filling prescriptions.² He noted that clinicians in both the public and private sectors rarely go through side effects in detail. Instead, they typically leave that information to printed pharmacy materials or QR codes.

"No one discusses all the [adverse] effects. I'm talking about all physicians," said Garbarino.²

Garbarino also cautioned that patients with chronic pain or serious mental illness may feel overwhelmed by large amounts of written information about their medications. He added that some veterans may decline a prescription after reviewing its risks, and clinicians would then have to document the refusal in the medical record.²

Next Steps

The VA will spend the rest of 2026 communicating the new requirements to staff, training employees on the new procedures, and updating its policies and procedures. The VA has not yet released the patient education materials or specified an implementation date within 2027.

References

1. US Department of Veterans Affairs. VA moves to strengthen informed consent transparency for Veterans. News release. September 28, 2026. Accessed September 30, 2026. https://news.va.gov/press-room/va-moves-to-strengthen-informed-consent-transparency-for-veterans/

2. Hersey LF. VA is tightening rules for prescribing certain psychiatric drugs and painkillers. Stars and Stripes. September 29, 2026. Accessed September 30, 2026. https://www.stripes.com/veterans/2026-09-29/va-rules-psychiatric-drugs-painkillers-23007315.html

3. VA to expand consent rules for psychotropic drugs: 3 notes. Becker's Behavioral Health. Accessed September 30, 2026. https://www.beckersbehavioralhealth.com/pharmacy/va-to-expand-consent-rules-for-psychotropic-drugs-3-notes/

4. US Food and Drug Administration. FDA Drug Safety Communication: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning. August 31, 2016. Accessed September 30, 2026. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-about-serious-risks-and-death-when-combining-opioid-pain-or

5. FDA proposes new warnings about suicidal thinking, behavior in young adults who take antidepressant medications. News release. May 2, 2007. Accessed September 30, 2026. https://www.fiercebiotech.com/biotech/press-release-fda-proposes-new-warnings-about-suicidal-thinking-behavior-young-adults-who