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 medicatio
    '/>"/>

SOURCE Pinney Associates
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

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:10/20/2014)... , Oct. 20, 2014  AnaptysBio, Inc., a ... antibodies, today announced the appointment of Marco ... Londei will lead the preclinical and clinical development ... "We are pleased to welcome Dr. Londei to ... , President and Chief Executive Officer of AnaptysBio. ...
(Date:10/20/2014)... , Oct. 20, 2014   Mary,s Medicinals ... Caring, is a 4-Star Sponsor of Operation Grow4Vets ... with unique products, programs and services to assist them ... Key Facts: , An ever-increasing ... a safe and effective treatment for pain, Post-traumatic Stress ...
(Date:10/19/2014)... , Oct. 20, 2014 CTI BioPharma Corp. ... will report its third quarter 2014 financial results on ... U.S. financial markets. Following the announcement, members of the ... discuss the results and provide a general corporate update ... the event can be obtained as follows: ...
Breaking Medicine Technology:AnaptysBio Appoints Dr. Marco Londei to Newly Created Chief Development Officer Position Clinical Immunologist to Lead AnaptysBio's Pipeline Advancement 2Mary's Medicinals Announces 4-Star Sponsorship of Operation Grow4Vets 2Mary's Medicinals Announces 4-Star Sponsorship of Operation Grow4Vets 3CTI BioPharma to Report Third Quarter 2014 Financial Results on October 29, 2014 2
... FORT WORTH, Texas, Sept. 30 Wound Care,Innovations, ... (OTC,Bulletin Board: WNDM), announced today that it will ... and Economical Realities in Boston. This,seminar is presented ... Wound Clinic, Podiatry Today and producers of the ...
... Sept. 29 Obese school-age,kids and teens can ... they,participate in medium- to high-intensity behavioral management programs,according ... Agency for Healthcare,Research and Quality., Children in ... for more than 25 hours, usually once or ...
Cached Medicine Technology:Wound Management Technologies, Inc. Announces Conference Plans in Boston and Additional Clinical Research on CellerateRx(R) 2Behavioral Modification Programs Help Obese Children Manage Their Weight 2Behavioral Modification Programs Help Obese Children Manage Their Weight 3
(Date:10/20/2014)... Myoderm announced today ... of their CentralSource service. Matthew will ... turnkey drug sourcing, distribution, and management service for ... years of industry experience, in both business development ... of their international success to help clients manage ...
(Date:10/20/2014)... (PRWEB) October 20, 2014 Final Cut Pro ... release of the Citrus theme for FCPX filmmakers . ... use to describe the Citrus theme” Says Christina Austin, CEO ... to look so professional.” , Citrus comes with all the ... the template are: four transitions for added style, a title ...
(Date:10/20/2014)... Spring, Maryland, USA (PRWEB) October 20, 2014 ... or to track interventions? Here comes a wonderful app ... mobile app development company helped its client ... Intervention more efficiently. The app is designed for iOS ... and iPod touch. This app is optimized for iPhone ...
(Date:10/19/2014)... This report provides comprehensive information on ... comparative analysis at various stages, therapeutics assessment by ... administration (RoA) and molecule type, along with latest ... also reviews key players involved in the therapeutic ... late-stage and discontinued projects. , Partial Seizures are ...
(Date:10/19/2014)... 19, 2014 Visual Impact Frequency ... just been released to the public generating a ... building and fitness community. The commotion surrounding the ... Vin Delmonico prompting an investigative review. , "Many ... what is commonly known as a training 'plateau' ...
Breaking Medicine News(10 mins):Health News:Myoderm Hires Matthew Voicheck to Lead Turnkey Drug Sourcing Service 2Health News:Today Pixel Film Studios Announced the Release of the Citrus theme for Final Cut Pro X 2Health News:Metassessor App Launched: an RTI tool for Teachers & Parents 2Health News:Metassessor App Launched: an RTI tool for Teachers & Parents 3Health News:Partial Seizure Therapeutic Pipeline Market Review H2 2014 in a New Report Available at RnRMarketResearch.com 2Health News:Partial Seizure Therapeutic Pipeline Market Review H2 2014 in a New Report Available at RnRMarketResearch.com 3Health News:Partial Seizure Therapeutic Pipeline Market Review H2 2014 in a New Report Available at RnRMarketResearch.com 4Health News:Visual Impact Frequency Training Review: Rusty Moore's Latest Fitness Guide Released 2
... , , BOSTON, Sept. 14 Americans ... Currently, there are five million people living with this disease ... an important role in the cause and prevention of Alzheimer,s ... can do to stave off this devastating illness. , ...
... years later, study finds , MONDAY, Sept. 14 (HealthDay ... go into combat are more likely to develop high ... serve in supporting roles, a new military study finds. ... a unique risk factor for newly reported hypertension," Nisara ...
... MONDAY, Sept. 14 (HealthDay News) -- Decades of steady progress ... with a new study showing that only 7.5 percent of ... heart disease risk factors. , The continuing U.S. obesity epidemic ... researchers added. , "Our results raise the concern that a ...
... up chances of other cancers, clots , MONDAY, Sept. ... high risk for developing breast cancer do reduce their ... a new analysis suggests. , That was the conclusion ... randomized clinical trials and a head-to-head assessment of the ...
... ... St. Louis , ... 15, 2009 -- , , ,WHO: American Association of Radon Scientists and Technologists, , ,WHAT: ... Union Station Marriott (near Scottrade Center) ,One St. Louis Union Station, , ,WHY: Radon ...
... Sept. 14 Misonix, Inc. (Nasdaq: MSON ), ... in Europe is used for the ablation of tumors and ... patient, who wishes to remain anonymous, donated the majority of ... Fe, NM, to purchase a SonicOne(R) Ultrasonic Wound Cleansing and ...
Cached Medicine News:Health News:Senior Living Residences Launches Innovative Nutrition Program to Promote Cognitive Health and Lower the Risk of Alzheimer's Disease 2Health News:Combat Exposure Tied to Chronic High Blood Pressure 2Health News:Most Adult Americans at Some Risk for Heart Disease 2Health News:Most Adult Americans at Some Risk for Heart Disease 3Health News:Medications That Lower Breast Cancer Risk Carry Other Dangers 2Health News:Medications That Lower Breast Cancer Risk Carry Other Dangers 3Health News:21st International Radon Symposium 2Health News:Misonix Equipment Funded By Anonymous Patient Donation 2Health News:Misonix Equipment Funded By Anonymous Patient Donation 3
... Single use curved circular stapler ... titanium staples., ,The Auto ... is used throughout the alimentary ... end-to-end, end-to-side and side-to-side anastomoses ...
... is a two-site immunoradiometric assay (IRMA) for ... polyclonal antibodies to human calcitonin have been ... for well-defined regions on the calcitonin molecule. ... in human serum. For in vitro ...
Calcitonin RIA Kit...
... digital camera system by KARL STORZ, a ... camera systems. Digital Source Sampling technology, applied ... fully digital transfer of information with no ... as well as loss-free data storage on ...
Medicine Products: