The REMS Program Companies (RPC) assigns an ID (RPC ID) to each 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 Accreditation Council for Continuing Medical Education (http://www.accme.org)
FDA Risk Evaluation and Mitigation Strategies (REMS)
Published on:
Friday, November 22, 2013
The RPC has hired inVentiv Health, Ltd. to manage the commercial support. So, in this complicated case, for simplicity, the accreditor is allowing providers to specify the “RPC/inVentiv Health, Ltd.” as the commercial supporter....
Published on:
Friday, November 22, 2013
For the ER/LA Opioid Analgesics REMS, the FDA writes [4]that: “Training will be...
Published on:
Friday, November 22, 2013
The REMS Program Companies (RPC) [6]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:
- 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... [3]
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 [12]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 [15]: 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 [6]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:
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:
August 27, 2012
Yes. Accredited CME providers can base their activities on the FDA blueprint [22]and be in compliance with the...
Last Revised:
August 27, 2012
In the Extended-Release and Long-Acting Opioid Analgesics REMS, one of the elements to assure safe use is an education program for prescribers about the risks of opioid medications as well as safe prescribing and safe use practices...
Last Revised:
August 27, 2012
The ACCME appreciates that the FDA recognizes the value of accredited education and chose to leverage the CE system to carry out this important public health initiative. The ACCME has a long-standing commitment to supporting the...
Last Revised:
August 27, 2012
The ACCME views the FDA ER/LA Opioid Analgesic REMS as an important initiative for addressing a critical public health and patient safety concern. The ACCME believes that accredited CME can be an important factor in the success...
Last Revised:
August 27, 2012
The FDA delivered its Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting (ER/LA) opioid analgesics to the manufacturers in 2012. According to the...
Links:
[1] http://www.accme.org/ask-accme/what-rpc-id
[2] http://www.accme.org/ask-accme/what-entity-should-providers-designate-commercial-supporter-pars-rpc-funded-erla-opioid
[3] http://www.accme.org/ask-accme/what-are-rems-compliant-accredited-ce-activities
[4] http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM311290.pdf
[5] http://www.accme.org/ask-accme/what-organizations-are-responsible-fda-fulfilling-requirements-long-term-evaluations-erla
[6] http://www.er-la-opioidrems.com/IwgUI/rems/home.action
[7] http://www.accme.org/ask-accme/what-fda-risk-evaluation-and-mitigation-strategy
[8] http://www.accme.org/ask-accme/it-acceptable-accredited-cme-providers-conduct-long-term-evaluations-erla-opioid
[9] http://www.accme.org/ask-accme/what-are-rems-related-accredited-ce-activities
[10] http://www.accme.org/ask-accme/what-role-accredited-cme-providers-long-term-evaluations-erla-opioid-analgesics-rems
[11] http://www.accme.org/ask-accme/what-overall-goal-each-fda-risk-evaluation-and-mitigation-strategy
[12] http://www.fda.gov/AboutFDA/Transparency/Basics/ucm325201.htm
[13] http://www.accme.org/ask-accme/how-continuing-education-community-addressing-prescription-drug-abuse
[14] http://www.accme.org/ask-accme/what-resources-are-available-about-erla-opioid-analgesics-rems
[15] http://www.accme.org/cme-providers/cme-support-public-health/cme-support-rems
[16] http://www.accme.org/ask-accme/which-manufacturers-are-responsible-fulfilling-fda-rems-extended-release-and-long-acting
[17] http://www.accme.org/ask-accme/what-fda-requirement-long-term-evaluations-prescriber-training-component-erla-opioid
[18] http://www.accme.org/ask-accme/does-accme-information-about-erla-opioid-analgesics-rems-apply-all-rems
[19] http://www.accme.org/ask-accme/it-acceptable-include-content-developed-commercial-interest-activity-supports-erla-opioid
[20] http://www.accme.org/ask-accme/it-acceptable-accredited-provider-include-product-specific-content-activity-based-fda-erla
[21] http://www.accme.org/ask-accme/it-acceptable-providers-develop-cme-activities-based-fda-blueprint-extended-release-and
[22] http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM277916.pdf
[23] http://www.accme.org/ask-accme/what-role-accredited-continuing-education-fda-erla-opioid-analgesics-rems
[24] http://www.accme.org/ask-accme/what-accmes-position-role-accredited-cme-fda-opioid-rems
[25] http://www.accme.org/ask-accme/what-accmes-role-erla-opioid-analgesics-rems
[26] http://www.accme.org/ask-accme/what-fda-rems-extended-release-and-long-acting-opioids