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 the FDA Overdose Prevention Framework priority of promoting 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.
Upcoming opportunities for clinical guideline development
To see past listings and any open applications, bookmark this search and check back. New opportunities are typically posted in spring/summer. Our guideline opportunities are typically titled, “Cooperative Agreement to Support an Evidence-Based Clinical Practice Guideline for...”
Past and ongoing clinical guideline development projects
2023
Laparoscopic Abdominal Surgeries Pain Guideline and Low Back Pain Guideline
On June 20 and 21, 2023, FDA announced an open period for applications to support the development of evidence-based, clinical practice guidelines for the management of two indications: (1) acute low back pain, and (2) postoperative pain following laparoscopic abdominal surgeries. These efforts support the FDA’s primary prevention priority under the Overdose Prevention Framework as a key opportunity to eliminate unnecessary initial prescription drug exposure and were identified as priority areas for guideline development in an FDA-commissioned National Academies of Science, Engineering, and Medicine report.
2022
Postoperative Obstetric Pain Guideline
The management of postoperative pain in obstetric patients was identified as a priority area for guideline development in an FDA-commissioned National Academies of Science, Engineering, and Medicine report. The grant to develop a guideline that will serve as a standard of care for the management of postoperative pain in obstetric and postpartum patients was awarded to the University of Michigan. 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 the safety of the patient and fetus.
Benzodiazepine Tapering Guideline
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 will serve as a standard of care for safe tapering of benzodiazepines was awarded to the American Society of Addiction Medicine. The guideline will support reduction of risks associated with benzodiazepines, such as dependence and withdrawal.
2020
Dental Pain Guideline
The management of dental pain was identified as a priority for clinical practice guideline development based on findings of an FDA-commissioned commissioned National Academies of Science, Engineering, and Medicine report. The grant to develop a guideline that will serve as a standard of care for the management of surgical and nonsurgical acute dental pain for dentists and other health care providers was awarded to the University of Pittsburgh and the American Dental Association. Patients will be better positioned to obtain safe and effective relief from acute dental pain, and health care providers will be better positioned to help reduce the risk of opioid diversion, opioid use disorder, and overdose.
- Clinical Prescribing Guideline on the Management of Acute Dental Pain (forthcoming)
- Systematic reviews: 1) Acute postoperative pain due to dental extraction in the adult population, 2) Injectable and topical local anesthetics for acute dental pain 3) Analgesics for the management of acute dental pain in the pediatric population