FDA – Cooperative Agreement to Support an Evidence-Based Clinical Practice Guideline for the Management of Postoperative Pain After Surgeries in Obstetric Patients (U01) Clinical Trials Not Allowed

June 13, 2022 by dld5dt@virginia.edu

Purpose:

The U.S. Food and Drug Administration (FDA) seeks applications to develop, disseminate, implement, and evaluate an evidence-based Clinical Practice Guideline (CPG) for the management of postoperative pain in obstetric patients who have undergone surgeries, including but not limited to cesarean delivery, vaginal delivery, and appendectomy during pregnancy. Applicants must propose a comprehensive evidence-based plan that advances safe prescribing of opioid analgesics for obstetric patients with postoperative pain.

Background:

FDA is working to confront the staggering human toll of the drug overdose crisis. Ensuring the availability of evidence-based, indication-specific prescribing information has always been part of FDA’s approach to ensuring the safe use of the products it regulates, including opioid analgesic products. However, the nation is facing a crisis: Millions of Americans are misusing and abusing opioids,[1] and in 2021 there were nearly 16,000 deaths involving prescription opioids.[2] FDA’s goal is to reduce the opportunities for opioid misuse and abuse while ensuring that its actions are tailored to patient needs and promote adequate treatment of pain.

Recognizing the critical role that health care providers play in addressing this public health priority, and consistent with the goals of Section 3002 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act),[3] FDA is re-examining the evidence on the use of opioids in the treatment of acute pain with a goal of improving opioid prescribing. Acute pain usually occurs suddenly and has a known cause like an injury, surgery, or infection. Examples of acute pain could be pain that occurs following a tooth extraction, broken arm, or surgical procedure.[4] By decreasing unnecessary and/or inappropriate exposure to opioid analgesics through refinement of prescribing practices for acute pain, health care providers may reduce the rate of new opioid use disorders (OUDs) as well as opioid-involved overdose, accidental poisoning, and death. To do this, health care providers need the most current and comprehensive guidance on the safe management of acute pain.

Some people who develop an OUD are first exposed to opioid analgesics through a lawful prescription from a health care provider. While the number of opioid prescriptions dispensed and the number of opioid morphine milligram equivalents they contain have been on a steady decline for the last few years, concerns remain about opioid analgesic prescriptions for larger quantities than appropriate for the medical need being addressed. Patients commonly report having unused opioid tablets, pills, or capsules following surgical procedures.[5] Unused pills may be diverted to illicit markets or misused or abused by friends or family members — 47% of people who report misuse or abuse of prescription pain relievers obtained the most recently misused drugs from a friend or relative.[6] In addition, patients who are prescribed more medication than necessary themselves have increased opportunities for misuse and abuse — 43% of people who report misuse or abuse of prescription pain relievers obtained their most recently misused drugs through their own prescription.[7]

The variation in opioid prescribing (including over-prescribing) for surgical and medical conditions suggests that guidelines for acute pain management for these conditions would be beneficial for health care providers, their patients, and public health. One approach to setting such standards would be to establish evidence-based clinical practice guidelines (CPGs) for opioids for acute pain management.

Key Dates:

Open Date (Earliest Submission Date): June 3, 2022
Letter of Intent Due Date(s): June 23, 2022
Application Due Date(s): August 3, 2022, by 11:59 PM Eastern Time.

URL for more information:

https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-22-028.html

Filed Under: Funding Opportunities