The purpose of the public workshop is to have scientific discussions on methods to evaluate the Opioid Analgesics Risk Evaluation and Mitigation Strategy (OA REMS).
The workshop has three main objectives:
- The first objective is to discuss what specific, measurable outcomes might demonstrate that training based on the Opioid Analgesics REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients With Pain (FDA Blueprint) is effective in educating prescribers and other health care providers (including pharmacists and nurses) involved in the treatment and monitoring of patients in pain about recommended pain management practices and the appropriate use of opioid analgesics.
- The second objective is to discuss the feasibility of conducting a study to specifically evaluate the effect of OA REMS-compliant continuing education (CE) on prescriber behavior and patient outcomes amidst the numerous concomitant strategies to combat the opioid crisis at the Federal, State, and local levels.
- The third objective is to discuss whether there might be suitable alternative study approaches to better understand the influence of CE, more broadly, on pain management practice and patient outcomes, if a study to directly measure the impact of REMS-compliant CE is thought to be infeasible.
To assist in the workshop discussion, FDA is making available an issues paper that provides a brief overview of the REMS background and challenges with evaluating the REMS education intervention.
December 11, 2020, from 9:00 a.m. to 5 p.m.
For optimal viewing use Chrome or Firefox web browsers
WEBCAST OF THE PUBLIC WORKSHOP:
Morning: Webcast Session
Afternoon: Webcast Session
COMMENTS ON THE PUBLIC WORKSHOP
Please refer to the Federal Register Notice on instructions for submitting either electronic or written comments on this public workshop. The deadline for comments is February 11, 2021.
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
10903 New Hampshire Avenue
Building 22, Room 4462
Silver Spring, Maryland 20993-0002
|Issues Paper REMS Public Workshop, December 11, 2020||pdf (2.83 MB)|
|Panelist Biosketches, December 11, 2020||pdf (76.13 KB)|
|Panelist Disclosure Forms, December 11, 2020||pdf (2.37 MB)|
|List of Panelists, December 11, 2020||pdf (15.54 KB)|
|List of FDA Participants, December 11.2020||pdf (9.86 KB)|
|Questions to Panelists, December 11, 2020||pdf (127.68 KB)|
|Agenda, OA REMS Workshop, December 11, 2020||pdf (93.46 KB)|
|Rethinking study designs to quantify REMS effectiveness, G. Caleb Alexander, MD||pdf (768.54 KB)|
|Opioid Analgesic REMS Assessment plan: Additional indicators of success, Doris Auth, PharmD||pdf (1.05 MB)|
|Can We Improve Physician Performance and Patient Health Outcomes Through CME/CPD?, Ronald M. Cervero, PhD||pdf (1.69 MB)|
|Blueprint for Heath Care Providers Involved in the Treatment and Monitoring of Patients with Pain: An Overview, LCDR Mark Liberatore, PharmD, RAC||pdf (219.90 KB)|
|A Role of Large Data Sources in Assessing Efforts to Improve Opioid Prescribing, Alec Walker, MD, DrPH||pdf (333.85 KB)|
|Considerations for studying the impact of the OA REMS on practice behaviors and patient outcomes, Jana McAninch, MD, MPH, MS||pdf (410.65 KB)|
|Safer/Competent Opioid Prescribing Education (SCOPE of Pain): Putting the Blueprint into Action, Julie L. White, MS||pdf (1.85 MB)|
|Developing and Implementing EHR-based Quality Improvement Opioid Measures, Jan Losby, PhD, MSW||pdf (1.51 MB)|
|Background on the OA REMS and overview of the day, Claudia Manzo, PharmD||pdf (864.86 KB)|
|Outcomes Report – The Collaborative for REMS Education, Robin Heyden||pdf (1.49 MB)|