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:2/18/2017)... ... ... Butler Mobility invited Ken Matthews to visit its manufacturing facility and showroom ... impressed with the safety and reliability of the Stannah Stairlift as well as with ... endorsement by Ken Matthews can be heard on News Radio WHP 580 weekdays from ...
(Date:2/17/2017)... , ... February 17, 2017 , ... Smiles by Seese ... Center in Davidson, NC. Dr. Brian Seese leads the practice as a skilled and ... under one roof. Smiles by Seese serves patients of all ages with excellence in ...
(Date:2/17/2017)... ... February 17, 2017 , ... ... Feb. 22, 2017 — 1:30 p.m. – 2:30 p.m. ET, http://www.fdanews.com/deviceapproval ... asking before selecting an FDA approval pathway? , How should they evaluate ...
(Date:2/17/2017)... ... February 17, 2017 , ... Program will ... Trinity Health and the U.S. Soccer Foundation announced today that they have awarded ... Soccer for Success, the Foundation’s soccer mentoring program, teaches kids the fundamentals of ...
(Date:2/17/2017)... ... ... Like most hospitals across the nation, Onslow Memorial Hospital is looking for ... Reduction Program (HRRP), the return of a patient to the hospital within 30 days ... many providers are struggling to leverage limited resources and technology, Onslow Memorial Hospital has ...
Breaking Medicine News(10 mins):
(Date:2/18/2017)... 17, 2017   Parker Waichman LLP, ... rights of victims injured by medical devices, comments ... call for better reporting. Congress required hospitals to ... concerns involving power morcellators and duodenoscopes prompted the ... how hospitals report injuries and deaths related to ...
(Date:2/17/2017)... CINCINNATI , Feb. 17, 2017  Ethicon, ... Torax Medical, Inc., a privately held medical device ... Reflux Management System, a novel minimally invasive ... acquisition of Torax Medical will enable Ethicon to ... the anatomy-altering laparoscopic Nissen fundoplication surgical procedure. 1 ...
(Date:2/17/2017)... (NYSE, TASE: PRGO) today announced it has received final approval ... and homatropine methylbromide oral solution (syrup), 5 mg/1.5 mg per ... oral solution (syrup), 5 mg/1.5 mg per 5 mL is ... children 6 years of age and older. Annual sales for ...   ...
Breaking Medicine Technology: