Article

Risk Evaluation and Mitigation Strategies (REMS): red tape, or a remedy for opioid abuse?


 

Unfortunately, there is no guarantee that deaths and overdoses will stop with the opioid REMS. The only guarantee is you will not be able to prescribe these medications at some point if you do not participate in the REMS.

So act now. To be notified when the opioid REMS training becomes available go to www.opioidREMS.com and register. It’s vital that you do ... and relatively painless.

REFERENCES

1. U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality, Food and Drug Administration. Summary of public workshop. Implementation of risk minimization action plans (RiskMAPs) to support quality use of pharmaceuticals: opportunities and challenges. June 25-26, 2007.

2. US. Food and Drug Administration. FDA acts to reduce harm from opioid drugs. Consumer Updates. Available at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm251830.htm.

3. Governale L. Outpatient Prescription Opioid Utilization in the U.S., Years 2000 – 2009. Food and Drug Administration, Division of Epidemiology. July 22, 2010. Avilable at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/UCM220950.pdf

4. Marchand H, moderator. Opioid drugs and risk evaluation and mitigation strategies (REMS) Podcast/transcript. April 20, 2011. Available at: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm252649.htm.

5. U.S. Food and Drug Administration. Opioid drugs and risk mitigation strategies (REMS) Available at: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm.

6. Epidemic: responding to America’s prescription drug abuse crisis. Available at: http://www.whitehousedrugpolicy.gov/publications/pdf/rx_abuse_plan.pdf.

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