Navigation Links
Process for Planning Safe Pain Treatment Outlined in Presentation at FDA Meeting
Date:5/28/2009

WASHINGTON, May 28 /PRNewswire-USNewswire/ -- Part of the answer in ensuring safe patient use of opioid medications lies in first identifying the ways the process of prescribing and dispensing medications may fail to protect patients from the risks of those products, and this can best be accomplished by conducting a failure mode and effects analysis or FMEA, Jeffrey Fetterman, a specialist in designing systems for preventing medication errors, told a public meeting held in Washington today by the Food & Drug Administration.

The FDA is working with pharmaceutical manufacturers of opioids, a type of medication that temporarily relieves severe pain but can also be very addictive, to reduce opioid misuse and abuse as part of its mandated Risk Evaluation and Medication Strategy (REMS) process.

Fetterman told the meeting that he had convened a small working group of pharmaceutical industry specialists to conduct the study in order to construct a standardized REMS process that would be effective for most types opioids, regardless of manufacturer. Any such system, he said, should assure that any patient in need of opioid treatment would be able to receive and safely use the necessary medication.

"The process of prescribing and dispensing opioids is complex," he said. "In our analysis, there were five process steps and 25 sub-process steps defined. In a detailed analysis of only three of the 25 sub-process steps, we identified 14 discrete failure modes and 50 possible causes of those failures." Under his adapted process, called RxFMEA(R), all parties involved, including patients, prescribing physicians and manufacturers, help identify interventions that will prevent these failures as well as assure redundant or back-up interventions.

Fetterman is CEO of ParagonRx, a Delaware-based company that specializes in designing REMS and other programs to ensure appropriate use of needed medications, and is co-author of the two basic books about REMS and risk management of drugs, biologics and medical devices.

A copy of Mr. Fetterman's presentation is available by contacting Roger Morris at londonbritain@msn.com.


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

Related medicine news :

1. Transatlantic Regulatory Integration of Drug Approval Process Vital for the Global Pharmaceutical Industry, Notes Frost & Sullivan
2. Passage of Illinois House Bill 2290 Adds Crucial Due Process Protection Governing Sterilization of Adults With Disabilities
3. First-of-its-Kind Study Released at the SGNA 36th Annual Conference Reveals Inconsistency in GI Endoscope Reprocessing
4. AllMed's New PeerPoint Medical Review Portal Improves Medical Review Process
5. Cord Blood America CEO Matthew Schissler Expands on Thought Process in Owning Stem Cell Laboratory
6. Boston Scientific Announces European Approval and First Implants of New Defibrillation Lead System Designed to Simplify the Surgical Process
7. Leading Italian Pharmaceutical Group Deploys TrackWise(R) Solution to Improve Quality Processes
8. Medical University of South Carolina Automates Grants Allocation Process with Lombardi Business Process Management Software
9. First-Ever Standardized Scales to Measure the Skins Aging Process Are Introduced at the American Society for Aesthetic Plastic Surgerys Annual Meeting
10. Reprocessed Device Market Booming During the Economic Crisis
11. Process controlling T cell growth and production identified
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/20/2017)... ... , ... ChenMed , a leading provider of value-based care for seniors, ... as Richmond Chief Medical Officer. Dr. McCarter, formerly Associate Professor of Family Medicine ... Ambulatory Services for the UVA Health System, brings 30 years of highly relevant experience ...
(Date:7/20/2017)... (PRWEB) , ... July 20, 2017 , ... ... a telemedicine platform, in which their iMedSecure™ comes included with each system installation. ... encrypted live images to remote participants for real-time collaboration and immediate decision-making requirements. ...
(Date:7/20/2017)... ... July 20, 2017 , ... ... FDAnews Webinar**, Aug. 9, 2017 — 1:30 p.m. – 3:00 p.m. ET, ... inspections and boosting quality. , It’s known as the “CY2016 Annual FDA Medical ...
(Date:7/20/2017)... , ... July 20, 2017 , ... ... protection services since 2014, top travel insurance solution company VisitorsCoverage Inc. has launched ... sell all major international travel insurance products online, under their own brand. The ...
(Date:7/20/2017)... ... 19, 2017 , ... At Creekwood Dental Arts, Drs. Donna G. Miller and ... dental implants in Waco, TX, using the latest dental technology for digital ... they can capture details in the oral cavity for accurate diagnoses and customized care ...
Breaking Medicine News(10 mins):
(Date:6/20/2017)... Inc. (NYSE: HRC), will host its fiscal third quarter 2017 ... beginning at 7:30 a.m. (CDT) / 8:30 a.m. (EDT). ... the conference call, dial (877) 304-8969 (domestic) or (631) 291-4543 ... prior to the start to allow time to connect. The ... Webcast: A simultaneous webcast of the call will be ...
(Date:6/16/2017)... Datascope Corp. is voluntarily performing a worldwide field correction of certain Intra-Aortic Balloon ... ... CS100i ... 0998-UC-0446HXX; 0998-UC-0479HXX 0998-00-3013-XX;  0998-UC-3013-XX 0998-00-3023-XX;  ... This field correction also applies to any System 98 ...
(Date:6/14/2017)... Va. , June 14, 2017  ivWatch LLC, ... and effectiveness of intravenous (IV) therapy, is pleased to ... the category of Nonsurgical Hospital Supplies and Equipment at ... awards program for the medtech industry. The award was ... the Jacob K. Javits Center in New ...
Breaking Medicine Technology: