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# Pharmacist Group Offers REMS Suggestions
- URL: https://www.fdaweb.com/pharmacist-group-offers-rems-suggestions/
- Published: 2016-06-07T12:00:00.000Z
- Updated: 2026-09-14T21:07:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135863

Commenting on the 5/3-5/4 joint meeting of FDA’s Drug Safety and Risk Management Advisory Committee and Analgesic Drug Products Advisory Committee, which discussed possible changes to REMS (Risk Evaluation and Mitigation Strategies) for extended release/long acting (ER/LA) opioid analgesics, the American Pharmacists’ Association [said](https://www.regulations.gov/?ref=fdaweb.com#!documentDetail;D=FDA-2016-N-0820-0027) it has recommendations and suggestions to maximize program efficacy, minimize systemic and clinical burden, and help curb prescription drug abuse. The group’s ideas included: 

- FDA working with other local, state, and federal entities to make education available, beyond the REMS program, that is both comprehensive and targeted to address the knowledge gaps of relevant stakeholders;
- using evidence-based approaches with pilot projects to better understand REMS program effectiveness;
- when modifying the REMS for ER/LA opioids, consider the additional burden placed on practitioners;
- if a REMS is developed for immediate release opioids, harmonize it with the ER/LA REMS;
- standardize REMS program elements to potentially yield results in stronger, less burdensome REMS programs;
- integrate REMS into clinical workflows; and
- provide ongoing reassessment of the ER/LA opioid REMS program and its tools.

The CME Coalition [noted](https://www.regulations.gov/?ref=fdaweb.com#!documentDetail;D=FDA-2016-N-0820-0026) that continuing medical education as part of REMS is helpful to practitioners because FDA controls the needs assessment and content requirements, and because it encourages evidence-based debate on risk versus benefits. The coalition recommended that the agency consider standardizing the REMS process while allowing more flexibility in content. It also said it agrees with the agency’s stated position that REMS should be expanded to short-acting/immediate-release products, leading to a single blueprint for all opioids.

The Alliance for Patient Access [said](https://www.regulations.gov/?ref=fdaweb.com#!documentDetail;D=FDA-2016-N-0820-0025) it is concerned that expansion of the ER/LA REMS “may unduly burden patient access to necessary pain therapies due to restrictions in payment coverage as well as the potential impact it may have on increasing physician shortages.” It said that while it appreciates the benefits of physician training and continuing medical education, “mandatory participation in REMS educational programming for ER/LA or short-acting formulations could result in fewer primary care physicians who are able to prescribe pain therapies.”

Finally, the Researched Abuse, Diversion, and Addiction-Related Surveillance System (RADARS) operated by the Denver Health and Hospital Authority, [reported](https://www.regulations.gov/?ref=fdaweb.com#!documentDetail;D=FDA-2016-N-0820-0024) that its evaluation of the current and proposed ER/LA opioid REMS found that the programs are “not only informative but essential in studying prescription drug misuse and abuse.”