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ASHP has urged FDA to create a centralized electronic system for all Risk Evaluation and Mitigation Strategy programs.
At a panel hearing last week, the American Society of Health-System Pharmacists (ASHP) urged the FDA to create a centralized electronic system for all Risk Evaluation and Mitigation Strategy (REMS).
Chris Topoleski“Centralized electronic submission and access to REMS data can contribute to seamless integration of a REMS requirement into the continuum of patient care – prescribing, authorizing, dispensing, and patient monitoring,” Chris Topoleski, director of federal regulatory affairs at ASHP, told Drug Topics. “A standardized format and routine communications can reduce redundancies in documentation and eliminate the need to consult various sources in order to determine the requirements under a given REMS.”
Topoleski said FDA also needs to engage pharmacists and other healthcare providers to determine which aspects of REMS communications are working well and which items can be improved. “In some cases, ASHP members have found it difficult to determine whether certain requirements of the REMS program apply to particular cases. For those unfamiliar with REMS, a structured survey could help healthcare providers better understand the requirements in various patient scenarios.”
While acknowledging that the FDA has made a signficiant number of improvements to the REMS program over the past five years, ASHP believes that a greater understanding of the limitations of current communications between the FDA and healthcare professionals could be reached if the agency asked pharmacists and other providers the following questions:
1. When new REMS medications are released, do you feel FDA communication to the marketplace is adequate.
2.When there are changes to REMS, do the FDA and manufacturers provide effective communications regarding these changes?
3. Is REMS information easily accessible to determine what your responsibilities are as a clinician including any associated documentation?
4. Are there cases where patient care has been negatively impacted due to a REMS?
5. Are there situations where REMS requirements have caused prescribers to not use a particular product?
6. Is the content of REMS-required patient education sufficient, and at the right literacy level and frequency?
ASHP believes that the goal for most REMS is not to achieve zero risk, but rather to provide information to pharmacists and other providers in a timely manner to support a risk-benefit discussion and decision, Topoleski told the panel. “For example, for some drugs, acceptable risk depends on patient-specific factors that range from disease severity and failure of alternative therapies, to an individual’s personal risk tolerance,” he said.