FDA Risk Evaluation and Mitigation Strategies (REMS)

Published on:
Wednesday, August 12, 2015

The REMS Program Companies (RPC) assigns an ID (RPC ID) to each CME activity for which it provides commercial support.  Accredited providers that offer RPC- supported REMS activities are responsible for entering the RPC ID in the...

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:
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:
Tuesday, October 29, 2013

In order to provide an equitable process for all accredited CME providers within the ACCME system, the ACCME is assessing a per activity fee from accredited CME providers that receive commercial support from the REMS Program...

Published on:
Tuesday, October 29, 2013

The FDA has mandated that the REMS Program Companies (RPC) report to the FDA on the progress of implementing the ER/LA Opioid Analgesic REMS and that there be an independent audit of REMS-compliant accredited CE activities to...

Published on:
Tuesday, October 29, 2013

At the bottom of the Add an Activity screen, you will see a section called Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS). Follow the instructions to enter data about REMS-compliant and REMS-...

Published on:
Tuesday, October 29, 2013

Yes. ACCME will report this data, in aggregate, to the stakeholder community. 

Published on:
Tuesday, October 29, 2013

As a service to the CME community and to the FDA, the ACCME has agreed to contribute to fulfilling the data collection and auditing requirements for the ER/LA Opioid Analgesics REMS. The ACCME has modified its...

Published on:
Tuesday, October 29, 2013

Yes. You can download a report of the REMS-specific data associated with your REMS activities, by clicking on the Activities tab, and then clicking on Download REMS Activities from the left-hand navigation menu. Note that this...

Published on:
Tuesday, October 29, 2013

The ACCME has modified PARS to accept the data mandated by the FDA, including how many REMS CME activity participants prescribed ER/LA opioids within the last year, and a breakdown of these individuals by profession. Accredited CME...

Published on:
Tuesday, October 29, 2013

No. The ACCME does not require accredited providers to offer REMS-compliant or REMS-related CE activities. There are no new or special accreditation requirements for accredited providers within the ACCME system...

Published on:
Tuesday, October 29, 2013

Providers accredited by the ACCME or an ACCME Recognized Accreditor can participate in the data collection process by entering REMS data in the REMS section of the web-based interface in PARS for each REMS activity they provide....

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-...

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