Navigation Links
Process for Planning Safe Pain Treatment Outlined in Presentation at FDA Meeting

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

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:
(Date:11/25/2015)... , ... November 25, 2015 , ... On November 10, ... States District Court of Connecticut on behalf of a home health care worker who ... current or former home health care workers employed by Humana, Inc., Humana at Home, ...
(Date:11/25/2015)... ... , ... On November 25, 2015, officials of Narconon Arrowhead , the ... of a new cutting edge recovery program that has been 50 years in the ... alcohol-addicted individuals with the purpose to free addicts from the symptoms and negative behaviors ...
(Date:11/25/2015)... ... , ... SCOTTSDALE, AZ) - Today, Dr. Todd C. ... and non-surgical treatments, announced the expansion of his private practice capabilities with the ... Highly trained and nationally recognized for his natural approach, Dr. Todd Hobgood serves ...
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... Today, ... on our nation’s roadways has dropped below 10,000 for the first time since 2011. ... in 2013. , According to data released by the National Highway Traffic Safety Administration ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... of philanthropic seniors, is resulting in a way for homeless people to have ... Schaumburg have launched a new initiative whereby they are repurposing plastic bags into ...
Breaking Medicine News(10 mins):
(Date:11/24/2015)... , November 25, 2015 ... due to repeated failure of IVF cycles. After failure ... was totally dejected and had lost all hopes that she would be able ... Indian miracle child conceived after failure of over 15 ... abroad (UK) before they decided to take one last attempt with ...
(Date:11/24/2015)... SAN CARLOS, Calif. , Nov. 24, ... ), a leader in non-invasive genetic testing ... today announced that it will present at ... Conference in New York on Wednesday, December 2, 2015 at 1:00 p.m. ... discuss the Company,s financial results, business activities ...
(Date:11/24/2015)... /PRNewswire/ - ESSA Pharma Inc. ("ESSA" or the "Company") ... the first patient has been enrolled in ESSA,s Phase ... metastatic castration-resistant prostate cancer ("mCRPC"). the ... the United States and Canada.  ... trial, ESSA intends to demonstrate the safety, tolerability, maximum ...
Breaking Medicine Technology: