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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
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