Pharmacist groups asked FDA to create a few common templates for risk evaluation and mitigation strategies so they can better anticipate and implement the programs into their practices.

REMS seem to be recreated for each drug that needs one. Steven Russek, a pharmacist with Medco Health Services and Accredo Health Group, said creating three or four templates will allow his colleagues to continue supporting the REMS program and make it more efficient and effective.

Russek said REMS are adding to costs because of their inconsistency. Templates that pharmacists could learn to anticipate before a REMS is unveiled would help, he added.

FDA and industry groups spoke in favor of REMS templates July 27, the first day of a two-day agency workshop gathering comments on the program. FDA expects to use the comments to help formulate more guidance for REMS on drugs.

Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, also offered support for a limit in the number of REMS types that can be implemented.

Woodcock said an effort will begin in the fall to develop a standard REMS system.

"Each program is proposed by the drug sponsor and then it's negotiated between the sponsor and the FDA and is uniquely tailored to the risks of that particular drug," Woodcock said. "So we don't have the kind of standardization and consistency of the programs that would be ideal."

Additional REMS changes already have been proposed, including allowing medication guides to be developed outside the REMS process (Also see "PhRMA Wants MedGuides Developed The Pre-FDAAA Way, Not Through REMS" - Pink Sheet, 26 July, 2010.). The Pharmaceutical Research and Manufacturers of America testified during the hearing that FDA should use its independent authority to develop them.

It was representatives of pharmacists associations who pointed out several problems with the administration and implementation of the REMS process that led to the calls for a standardized format.

Scott Reid, of CVS Caremark, gave an example of one drug which posed a known risk to women of child-bearing age. But he said every REMS associated with that risk has a different approach to dealing with it.

Reid said that presents difficulties with cost as well as development for systems that pharmacists on a large network can use to dispense the prescriptions.

"The whole purpose is through greater standardization, through greater uniformity, you can develop much more reliable systems that guide how we execute these REMS," he said.

Reid and several other organizations said pharmacists should be allowed to have an advisory role in REMS development discussions between FDA and sponsors. Reid said pharmacies do not have an opportunity to implement a REMS in the framework of their existing systems and must accept the REMS interpretation provided by the sponsor.

REMS operations were the primary concern for Kevin Nicholson of the National Association of Chain Drug Stores. He said FDA should use the same systems for all pharmacist education and provider registration associated with REMS programs. He also wanted a standard system for determining whether patients were part of REMS registries.

"At some point in the future there may be a way for by the time a prescription reaches the pharmacy, that ... whoever is involved in the REMS process has made sure that ... all the hurdles with respect to that prescription have been achieved," Nicholson said. "That is sort of a futuristic pie in the sky type of issue, but these are things we're thinking about."

-Derrick Gingery (d.gingery@elsevier.com)

REMS Templates Get Nod From FDA, With Nudge From Pharmacists

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