Risk Evaluation and Mitigation Strategies

Published on:
Thursday, April 20, 2017

The ACCME submitted a letter to Sen. McCaskill, Ranking Member, Committee on Homeland Security and Governmental Affairs, to address her investigation of the opioid epidemic. In the letter, Graham McMahon, MD, MMSc, President and...

Published on:
Friday, September 9, 2016

The ACCME submitted these comments to the US Department of Health and Human Services (HHS) in response to HHS’ request for information about opioid analgesic prescriber education and training opportunities to prevent opioid...

Published on:
Tuesday, December 16, 2014

The ACCME, the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), issued this joint response to the Food and Drug Administration (FDA) report Standardizing and Evaluating...

Published on:
Friday, November 22, 2013

The REMS Program Companies (RPC) are responsible to the FDA for fulfilling the requirements for long-term evaluations.  The RPC will provide funding to...

Published on:
Friday, November 22, 2013

The Food and Drug Administration Amendments Act of 2007 gave the FDA the authority to require manufacturers of drugs and biological products to put in place special programs if the FDA determines that safety measures are needed...

Published on:
Friday, November 22, 2013

Accredited CME providers that are interested in conducting the long-term evaluations might provide service in support of the ER/LA Opioid Analgesics REMS in the following ways:

  1. Providers can...
Published on:
Friday, November 22, 2013

REMS-related accredited CE activities meet some but not all of the requirements established by the FDA in its definition of a REMS-compliant...

Published on:
Friday, November 22, 2013

The FDA has provided the following description of the REMS Long-Term Evaluations in its ER/LA Opioid Analgesics REMS Supporting Document:

“A subset of CE providers capable of conducting evaluations of long-term performance...

Published on:
Friday, November 22, 2013

According to the FDA, the goal of REMS is to ensure that the benefits of a drug or biological product outweigh its risks. The FDA may require a...

Published on:
Friday, November 22, 2013

The CE community addresses prescription drug abuse in many ways. One way is by developing and presenting education that is explicitly part of the RPC-funded ER/LA Opioid Analgesics REMS that meets all the specific REMS requirements...

Published on:
Friday, November 22, 2013
  • CME in Support of REMS: This ACCME Web Page provides updates and resources for accredited CME providers that...
Published on:
Friday, November 22, 2013

The companies that have come together as a consortium of opioid manufacturers, the REMS Program Companies (RPC), are the entities responsible to the FDA.

...
Published on:
Friday, November 22, 2013

The FDA has required long-term evaluations of the ER/LA prescribers who complete REMS-compliant CE activities. Specifically, the FDA is requiring the evaluation of knowledge retention and practice change in ER/LA opioid prescribers...

Published on:
Friday, November 22, 2013

The RPC has hired the Campbell Alliance, Ltd. to manage the commercial support. So, in this complicated case, for simplicity, the ACCME is allowing providers to specify the “RPC/Campbell Alliance, Ltd.” as the commercial supporter...

Published on:
Friday, November 22, 2013

For the ER/LA Opioid Analgesics REMS, the FDA writes that: Training will be...

Published on:
Tuesday, August 27, 2013

This fact sheet for accredited providers within the ACCME system answers questions about the FDA Extended-Release and Long-Acting Opioid Analgesics REMS and explains the role of accredited continuing education, the ACCME, and...

Published on:
Thursday, October 25, 2012

No. The ACCME information applies only to the ER/LA Opioid Analgesics REMS. The ACCME appreciates that the FDA recognizes the value of accredited  education and believes that accredited CME should be considered as a strategic asset...

Published on:
Thursday, October 25, 2012

No. An accredited CME provider cannot use content developed by an ACCME-defined commercial interest in CME activities because that would be noncompliant with Standard for Commercial Support 1: Independence.

It is acceptable...

Published on:
Thursday, October 25, 2012

Yes. There is no ACCME prohibition against including product-specific content in accredited CME. Accredited providers can develop and distribute product-specific content for activities based on the FDA blueprint for the Extended-...

Last Revised:
January 23, 2012
Published on:
Monday, January 23, 2012

This presentation slide set was delivered by representatives from the ACCME, the Food and Drug Administration, and AstraZeneca during the session entitled "Risk Evaluation and Mitigation Strategies:  Developing REMS (CE) in...

Published on:
Friday, December 2, 2011

2011_12_ACCME response to FDA call for comment about REMS
 

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