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:2/9/2016)... Blood Monitoring & Cardiac Monitoring Devices Market Assessment & Forecast: 2015-2019" ... market for blood monitoring & cardiac monitoring devices was valued at ... 24,830.1 million by 2019 at a CAGR of 6.8% from 2015 ... Europe , Asia-Pacific , Latin ... Africa . The three major factors determining growth of the ...
(Date:2/9/2016)... , Feb. 9, 2016 The life of Dr. ... Center, has been anything but ordinary.  Twists of fate, combined ... War II and the constraints of communist Czechoslovakia to ... he would go on to make history by playing a ... best-selling drugs in the world, Remicade.  Dr. Vilcek brings readers ...
(Date:2/9/2016)... KONG , Feb. 9, 2016 Athenex, Inc. ... Athenex as Vice President of Corporate Strategy and Business Development ... MSc, MBA has joined as Senior Director and Deputy Head of Clinical ... . Simon Pedder stated, "Athenex has ... for a while. Coupled together with their unique business model ...
Breaking Medicine Technology:
(Date:2/10/2016)... ... ... Gout is like no other joint pain. It strikes suddenly, like flicking on ... redness. It is triggered by the crystallization of uric acid within the joints. It ... to the February 2016 issue of Harvard Men's Health Watch. , The large joint ...
(Date:2/10/2016)... ... February 10, 2016 , ... AHRA: The Association for ... speaker Jan Fox will serve as keynote speaker at the organization’s 2016 Spring ... tools to more effectively communicate with their own organizational staff and leadership. ...
(Date:2/10/2016)... , ... February 10, 2016 , ... ... will attend the Ohio Safety Congress and Expo event March 9-11, 2016. Hosted ... Greater Columbus Convention Center. , As the longest running and largest worker's ...
(Date:2/10/2016)... , ... February 10, 2016 , ... ... biocompatible columns and accessories. These PEEK-lined stainless steel (PLS) columns combine the strength ... solution that ensures the integrity of biological samples while operating at ultra-high pressures ...
(Date:2/10/2016)... CA (PRWEB) , ... February 10, 2016 , ... Workrite ... based company that has evolved from humble beginnings to being an internationally recognized leader ... company that we are today”, said Charlie Lawrence, President of Workrite. “Workrite recognized ...
Breaking Medicine News(10 mins):