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
Future opportunities are selected based on priority indications from an FDA-commissioned National Academies of Science, Engineering, and Medicine report (Table 7-1) and emerging needs.
To see past listings and any open applications, bookmark this search and check back. New opportunities are typically posted in spring/summer and 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
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.
Lower Back Pain Guideline
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.
2022
Postoperative Obstetric Pain Guideline
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.
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 University of Pittsburgh and the American Dental Association were awarded a 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. 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)
- Clinical Practice Guideline for the Pharmacological Management of Acute Dental Pain in Children
- 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, 4) Corticosteroids for managing acute pain subsequent to surgical extraction of mandibular third molars, 5) Patient values and preferences for managing acute dental pain