REMS safety summit: Risk management gets its third checkup

December 15, 2010

At the Third Annual Risk Management and Drug Safety Summit, attendees and presenters discussed the latest issues related to risk and safety, and examined how REMS and drug safety have fared since 2007.

Key Points

Since the 1999 publication of the Institute of Medicine (IOM) report "To Err is Human: Building a Safer Health System," both public and private interests have made patient safety a priority. Pharmacists can play a critical role in patient safety by ensuring that correct medications be dispensed appropriately. But necessary patient counseling, along with interaction with physicians and payors, often goes uncompensated. While recent FDA safety policies give the agency more authority to demand post-marketing accountability from manufacturers, they present an increasing burden for pharmacists.

Manufacturer risk reduction

Part of the 2007 FDA Amendment Act (FDAAA) was the Risk Evaluation and Mitigation Strategy (REMS) requirement for manufacturers, "to ensure that the benefits of a drug or biological product outweigh its risks."

Annette Stemhagen, DrPH, FISPE, senior vice president of safety, epidemiology, registries, and risk management for United BioSource Corporation, a Summit sponsor, said that most REMS (70%) are "a medication-guide-only REMS."

Pharmacist fact-checking

"The pharmacist has the responsibility of dispensing the medication guide along with the prescription, but there's a bigger responsibility for the pharmacist when there's a REMS communication plan," Stemhagen said, explaining that when FDA requires a manufacturer to provide a communication plan, the pharmacist will have to confirm whether the patient is eligible to receive a specific product and whether certain tests are needed before the patient can obtain a drug or drug refill, as with Accutane, which requires a pregnancy test.

Risk management

Before REMS legislation, manufacturers of Accutane and its generics operated iPLEDGE, a program designed to reduce risk of fetal exposure. On October 22, 2010, FDA approved the iPLEDGE program as an official REMS. The program has continued as before; the only change was in its official designation.

FDA representative Crystal Rice said that pharmacists could help communicate with physicians who are new to REMS and "help them complete the needed processes for a particular product," but that pharmacists should not be expected "to be the primary source of information regarding the correct prescribing choice for a physician's patients."

Summit keynote speaker Peter Pitts, co-founder and president of the Center for Medicine in the Public Interest (CMPI) and a Summit sponsor, said that "the REMS issue is part of the larger conversation of postmarket safety."

He added that he suspects pharmacists are probably much more knowledgeable about REMS than are physicians, whose "awareness of REMS is slim to none."