The Department of Health and Human Services (HHS) just issued a report that criticizes the Food and Drug Administration (FDA) for how it administers its Risk Evaluation and Mitigation Strategies (REMs) program. REMS are structured plans to manage specific risks of drugs that are effective but associated with known or potential risks, such as death or injury. REMS help the FDA, drug manufacturers and prescribers make sure that the benefits of such drugs outweigh their risks.
The FDA is being called on the carpet for oversight problems. But truth be told, REMS are difficult to implement and monitor. Right now, the onus is on drug manufacturers to make sure prescribers follow REMS restrictions, monitor their compliance and report outcomes back to the FDA on whether the medications are being used safely by physicians and patients.
Needless to say, HHS found the process appears to be broken down—in large part because neither the FDA nor drug manufacturers have the authority to make sure doctors comply. Nearly half of the assessments for the 49 REMS that were reviewed did not include all information requested in FDA “assessment plans,” and 10 were not submitted timely. And only 7 met all of FDA’s requirements.
To our way of thinking, the FDA has opportunities for REMS process improvements that leverage health information technology (HIT). For example, electronic health records (EHRs) can provide more automated monitoring on the provider side by indicating whether a needed test has been done and what the resulting values are. ePrescribing and clinical decision support can help providers select from a wider range of alternatives. Patient portals and even mobile applications could be used to provide the required REMS patient education, as well certify that the patient has read the material and agrees with conditions of participation. These might include, for example, certification that the patient is not pregnant when first taking a REMS-required medication and that she agrees not to become pregnant during the course of the medication therapy. HIT could be leveraged to more quickly and easily transmit results to the FDA and pharmaceutical manufacturers. This in turn could help detect problems sooner or highlight success stories.
All in all, we see many opportunities for REMS to use HIT to improve the safety and efficacy of potentially problematic drugs, improve provider decision making and monitoring, and ensure that consumers have access to the medications they need and the knowledge to take them safely. That’s definitely a good thing all around.