Legislature-Based Reforms
New Jersey
In 2022, the New Jersey state legislature introduced a bill that could become the standard for legislation that regulates the prescription of benzodiazepines. The multifaceted bill contains several important provisions that will help improve prescribing practices by mandating the provision of information and providing important resources for patients. Some highlights from the legislation include:
- Establish protocols for practitioners to follow including a slow, patient controlled taper, and encouraging the use of the Ashton manual.
- Produce and distribute an ‘informed consent’ document that provides adequate warnings on the risks of extended benzodiazepine use.
- Prohibit benzodiazepine prescriptions over four weeks.
Click here to read the entire contents of the proposed legislation.
Massachusetts
Alliance Science Advisor Dr. Sumit Agarwal and Director Bernie Silvernail testified in favor of adoption of Massachusetts H.2117/S.1260, An Act Relative to Benzodiazpines and Non-Benzodiazepine Hypnotics. This bill is the first of its kind, requiring informed consent for all benzodiazepine and Z-drug prescriptions, among other restrictions. This is the fourth legislative attempt at such legislation. All have been headed by long-time benzo safety advocate Geraldine Burns, and BIC advisor Sonja Styblo was instrumental in garnering testimony.
Dr. Agarwal submitted detailed written testimony that outlines the evidence-based need for this bill. Mr. Silvernail both delivered testimony in front of the Joint Committee on Mental Health, Substance Use and Recovery and submitted written testimony which presented Carrie Silvernail’s benzodiazepine injury story, followed by an evidence-based appeal for informed consent. Oral testimony on the bill can be found here (Silvernail is at 3:13). There was no oral testimony opposed to the bill, but written oppositional testimony may have been received.
No other state has legislated regulation of benzodiazepines.
Global and Internet-Based Initiatives
A benzodiazepine-focused petition was submitted in Scotland in 2017. The submission summary is “Calling on the Scottish Parliament to urge the Scottish Government to take action to appropriately recognise and effectively support individuals affected and harmed by prescribed drug dependence and withdrawal.” It has a list of previous actions, and many compelling firsthand stories involving benzodiazepines are in the list of written submissions.
Several groups are attempting to reform the use of benzodiazepines, particularly in the UK and Australia. Many of these are most visible through their internet presence. For a list of the most active, click here.
Previous Attempts at Reform
The Kennedy Senate Hearings
There was no change in policy.
Benzodiazepine and Z-Drug Boxed Warnings
The FDA was petitioned in 2010 to add a black box warning and make several other labeling changes on benzodiazepines as a class. The petition was finally reviewed by the FDA and rejected in its entirety in 2015.
As a result of the opioid crisis, a boxed warning was placed on benzodiazepines and nonbenzodiazepine hypnotics (Z-drugs) in 2016, but it is limited to the dangers of co-prescription with opioids.
In 2015, a petition was sent to the FDA seeking labeling changes to “sedative hypnotics”, which includes Z-drags and the shortest half-life benzodiazepines. Written by Dr. Daniel Kripke, one of the pre-eminent experts on these drugs, this was a large and well-supported (113 references) petition. In 2018, it was reviewed and, except for one minor change, rejected by the FDA.
On September 23, 2020, the FDA announced that it is placing a boxed warning on all benzodiazepines. From the announcement, it appears that this is a step in the right direction. However, as of our latest update, the labeling changes are not available for review, much less implementation.
Based on our current understanding of the evidence, the Alliance for Benzodiazepine Best Practices is supporting initiatives to repetition the FDA to consider further changes in labeling and the initiation of a Risk Evaluation and Mitigation Strategies (REMS) requirement for the benzodiazepines as a class – and perhaps the Z-drugs as well.
