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:12/2/2016)... ... December 02, 2016 , ... Mediaplanet’s ... ostomy patients, standing as living proof that attitude and determination can combine into ... issues that spike around the holidays. This campaign will offer patients a new-found ...
(Date:12/2/2016)... Hawaii (PRWEB) , ... December 02, 2016 , ... ... 2016 at the Hyatt Regency Waikiki Beach Resort and Spa in Honolulu, offering ... in the field of pain management. , The demand for supplemental training ...
(Date:12/2/2016)... Viejo, California (PRWEB) , ... December 02, 2016 , ... ... will allow FCPX editors to create versatile lower third titles with just a few ... , Pro3rd Accents Volume 2 includes 30 lower third animations. Choose from various styles ...
(Date:12/2/2016)... , ... December 02, 2016 , ... ‘Tis the season ... of $1,000 each from the National Family Partnership and the Drug Enforcement Administration as ... decorated their homes and the 10 winning schools who decorated their campuses with this ...
(Date:11/30/2016)... ... November 30, 2016 , ... Center For ... announced the opening of a new eating disorder treatment center location in Palm ... for adults and adolescents, both males and females ages 10 and older with ...
Breaking Medicine News(10 mins):
(Date:12/2/2016)... 2, 2016 In the first ever attempt ... those derived from C. sativa, the Hebrew University in ... Napoli Federico II , the Universita` del Piemonte Orientale ... critical, integrated and unified inventory of phytocannabinoids of different ... on the remarkable chemical and structural diversity of phytocannabinoids. ...
(Date:12/2/2016)... Columbia , December 2, 2016 bioLytical Laboratories, ... INSTI HIV-Selbsttest, bei den Mitgliedern des Apothekenbundes von Kenia eingeführt. ... ... INSTI HIV Self Test! (PRNewsFoto/bioLytical Laboratories) ...      (Photo: http://photos.prnewswire.com/prnh/20161201/444905 ) ...
(Date:12/2/2016)... 2016   CytoSorbents Corporation (NASDAQ: CTSO ... Union approved CytoSorb ® cytokine adsorber to treat ... announced that Dr. Phillip Chan , Chief Executive ... Micro Main Event investor conference held from December ... Sunset Boulevard Hotel in Los Angeles, California ...
Breaking Medicine Technology: