Navigation Links
Classwide Opioids REMS: A Good Idea, Implement Carefully
Date:5/26/2009

BETHESDA, Md., May 26 /PRNewswire/ -- On May 27 and 28, 2009, the Food and Drug Administration (FDA) will hear testimony about the FDA-guided effort to develop a classwide Risk Evaluation and Mitigation Strategy (REMS) for all controlled-release opioids from more than 70 patients, scientists, public health professionals, and representatives of pharmacist groups, prescriber groups, and pharmaceutical companies. Controlled-release opioids include prescription pain medications that release the medication over a period of several hours and contain fentanyl, hydromorphone, methadone, morphine, oxycodone, or oxymorphone. More than 21 million prescriptions are written every year for these medications.

Congress established REMS in the Food and Drug Administration Act of 2007 (FDAAA). Under FDAAA, for the first time FDA can require pharmaceutical companies to develop communication plans and other tools to minimize the risks associated with a medication while maintaining the medication's benefits. These tools may be educational, such as letters to prescribers reminding them of certain safety precautions. FDA can also, for example, require special certification of prescribers, limit dispensing to certain pharmacies, or require that prescribers or patients enroll in a registry.

Unlike most REMS, in which it is the patient who both benefits and is potentially at risk, for this REMS the people at risk include patients and non-patients, those who misuse or abuse the drug and are not prescribed the medication. This raises important questions about whether a REMS can both protect patients to whom a medication is prescribed and minimize use by non-patients.

  • Will it be harder for patients in pain to get the medications they need if prescribers need additional certification to prescribe?
  • Will prescribers prescribe the best pain medication for the patient, or instead prescribe medications with no REMS to avoid the burdens REMS impose on them?
  • Will pain medication costs increase?
  • Will important pain medications be removed from formularies?
  • Will drug abusers shift their abuse to other licit or illicit substances?
  • Will a controlled-release opioid REMS discourage innovation in the development of new pain medications?

"We run the risk of serious unintended consequences to people living with chronic pain in the effort to prevent misuse and abuse of these important medications. It would be of great concern if the REMS led health care providers to prescribe drugs not encumbered by the REMS even though they might be less optimal, and put patients at risk for adverse consequences like gastrointestinal bleeds or liver disease," said Sidney H. Schnoll, M.D., Ph.D., Vice President, Risk Management, Pinney Associates, and Clinical Professor, Internal Medicine and Psychiatry, Medical College of Virginia, Virginia Commonwealth University. "Critical to the opioid REMS will be having in place comprehensive scientific methods to measure both positive and negative effects on patients and non-patients."

A central element of the Food and Drug Administration Act of 2007 (FDAAA), REMS can be an important tool in ensuring patient safety. Outside of pain treatment, FDA has applied REMS to make available medications to patients with few or no alternatives, such as people with leprosy and narcolepsy. Ultimately, the classwide, controlled-release opioids REMS has the potential to greatly benefit public health, but should be carefully implemented so as to protect patient access to these crucial pain medications while reducing unintended consequences such as accidental overdose and abuse.

Pinney Associates counsels the pharmaceutical industry on science, public health and health policy issues related to drug development, regulatory submissions, risk assessment, and implementation of risk management. For more information, please visit www.pinneyassociates.com.


'/>"/>
SOURCE Pinney Associates
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
2. Test for Life Commends North Carolina Rules Commission for Implementing CDC Recommendations for HIV Testing
3. Perceptive Informatics Survey Results Reveal Top Barriers to Implementing Adaptive Trial Designs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... , Australie, le 24 février 2017 ITL Limited, ... santé diversifiée innovante, est ravie d,annoncer les excellents résultats ... la période précédente correspondante. Une présentation complète « Résultats et ... être consultée ici . Faits ... de 2,12 millions $ (Déc. 2015 : 1,04 million $ ; en hausse de ...
(Date:2/24/2017)... 2017 Medivir AB (Nasdaq Stockholm: ... new Board of Directors that will be submitted to ... comprises representatives of the company,s three largest shareholders at ... have accepted a seat on the Nomination Committee, and ... 2016-2017 Nomination Committee was as follows:  ...
(Date:2/23/2017)... NEW YORK , Feb. 23, 2017  Genesis ... HME Company. The announcement was made by Bill ... David Hartley and Nathan Feltman , ... of Genesis Healthcare Services, LLC. This ... nation,s largest provider of technology enabled durable medical equipment ...
Breaking Medicine Technology:
(Date:2/24/2017)... ... February 24, 2017 , ... With ProGlass Prism users now have ... Users have total control over position, rotation, distortion, edge softness, edge blur, chromatic aberration, ... Pro X. , With ProGlass Prism users are given the tools and effects ...
(Date:2/24/2017)... ... , ... Indiana Fiber Network (IFN) President and CEO Kelly C. Dyer recently ... as the Chairman of the Management Committee when IFN was originally formed in 2002 ... of investor/owners and development of the business plan. He became the first paid ...
(Date:2/24/2017)... ... February 24, 2017 , ... ... again hosted their Military Wedding Giveaway, with the winning couple announced on Feb. ... with services generously donated from local vendors: A Matter of Taste, Ryan Rousseau ...
(Date:2/23/2017)... ... 2017 , ... The Lymphoma Research Foundation (LRF) – the ... the lymphoma community through a comprehensive series of education programs, outreach initiatives and ... Beach to host its Swirl: Miami Wine Tasting Event on March 28, 2017. ...
(Date:2/23/2017)... ... 23, 2017 , ... Hamlin Dental Group and Dr. Hamid Reza, dentist ... Throughout the month of February, patients who visit Hamlin Dental Group will receive a ... for two at the Cheesecake Factory. , Tickets are available for routine dental ...
Breaking Medicine News(10 mins):