Supporting Clinical Practice Guidelines for Drugs with Abuse Potential
FDA considers advancing the availability of evidence-based guidelines for opioid analgesics and other medications with abuse potential a high-impact opportunity to support the safe use of these products. In alignment with FDA’s priority of primary prevention, FDA awards cooperative grants for the development and dissemination of guidelines that will help resolve critical knowledge gaps and ensure appropriate prescribing of medications with abuse potential.
These guidelines are intended to help inform clinical decision making by prescribers and patients. They are not intended to be used for the purposes of restricting, limiting, delaying, or denying coverage for, or access to, a prescription issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.
In support of this critical work, FDA commissioned a National Academies of Science, Engineering, and Medicine reportto identify priority acute pain indications for guideline development. Additionally, FDA and the Reagan-Udall Foundation for the FDA convened a roundtable on Best Practices in Clinical Practice Guideline Development to explore shared challenges and strategies in the development of clinical practice guidelines involving controlled substances.
FDA-Funded Clinical Practice Guidelines
The University of Minnesota and the University of California, San Francisco were awarded a grant to develop a guideline that will serve as a standard of care for the management of postoperative pain after diagnostic and procedural laparoscopic abdominal surgeries. Standardizing pain management care for these common procedures will support patients while reducing opioid over-prescribing.
The Oregon Health & Science University, Aggregate Analytics, Inc., and the American Academy of Pain Management were awarded a grant to develop a guideline that will serve as a standard of care for the management of acute low back pain. Standardizing pain management care with consideration of pharmacological and nonpharmacological treatment options aims to improve patient outcomes and reduce the risk of continued opioid use.
The University of Michigan was awarded a grant to develop a guideline that will serve as a standard of care for the management of postoperative pain in obstetric and postpartum patients. For all surgical procedures in obstetric patients, ensuring adequate pain management while balancing the special considerations on the amount and timing of opioid dosing is needed to ensure patient safety.
Safe tapering of benzodiazepines has been identified as a priority area for guideline development in consultation with patients, providers, and other stakeholders, including at the 2021 Duke-Margolis Public Workshop on Safe Use of Benzodiazepines. The grant to develop a guideline that serves as a standard of care for safe tapering of benzodiazepines was awarded to the American Society of Addiction Medicine. This guideline supports reducing risks associated with benzodiazepines, such as dependence and withdrawal.
The University of Pittsburgh and the American Dental Association were awarded a grant to develop a guideline that serves as a standard of care for the management of surgical and nonsurgical acute dental pain for dentists and other health care providers. The published guidelines support patients in obtaining safe and effective relief from acute dental pain and health care providers in helping reduce the risk of opioid diversion, opioid use disorder, and overdose.