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When a drug is approved by FDA, there is a large volume of data available for review, but once the drug is being used in the market, new safety data are not as forthcoming, according to Gerald J. Dal Pan, MD, director, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), U.S. Food & Drug Administration (FDA).
WHEN A DRUG IS APPROVED by FDA, there is a large volume of data available for review, but once the drug is being used in the market, new safety data are not as forthcoming, according to Gerald J. Dal Pan, MD, director, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), U.S. Food & Drug Administration (FDA). "But that's when we want to know more about how well drugs are performing to find problems that may not have been evident during clinical trials," he says.
In the United States, providers are not required to report adverse drug events (ADEs) to the FDA or to the drug manufacturer. If healthcare professionals, patients or family members want to report an event, they can do it through the FDA's MedWatch program or contact the manufacturer directly.
Unfortunately, Dr. Dal Pan says, there is not sufficient FDA staff to conduct routine followups of each report. Only 5% of ADE reports come through MedWatch, mostly from pharmacists.
"The precise number isn't as important as the content and the quality of the reports," Dr. Dal Pan says. "That is what we focus on when reviewing and analyzing the reports.
"Many healthcare practitioners are not as aware of reporting to the FDA as they could be. We only hear about 1% to 10% of the ADEs that occur," he continues. "That's our biggest challenge-getting practitioners to report ADEs. The number, however, is increasing annually, although ADEs are still underreported."
MedWatch provides summaries of changes made in labeling of boxed warnings, contraindications, warnings, precautions and adverse reactions that result from ADE reports. More detail is available through a link.
HEALTH PLANS REPORT
Health plans also submit reports to MedWatch on behalf of a patient regarding a potential ADE. Ruth Ann C. Opdycke, PharmD, MS, with TPG Healthcare Consulting LLC, Glastonbury, Conn., says that plans with case management programs are more likely to learn about patients and drug-specific ADEs.
"Health plans do pay attention to nationally reported ADEs as part of their ongoing drug utilization management activities," Opdycke says. "In cases where there are significant risks associated with a particular medication, such as the COX-2 safety scare, plans will send targeted letters to prescribers and members taking the medication of concern. Alerting a patient about the risk and benefits of drug therapy, as well as the signs of potential ADEs, however, is primarily the responsibility of the prescribing physician and dispensing pharmacist."
Although physicians and community pharmacies report ADEs to MedWatch, Marissa Schlaifer, director of pharmacy affairs for the Academy of Managed Care Pharmacy (AMCP), says that they often do not communicate the information to insurers. She believes a slight paradox exists between plans/PBMs and physicians: plans and PBMs want to receive reports on ADEs from physicians but they also want to ensure that the information is evidence-based. "However, more plans are starting to report to the FDA even if the information is anecdotal," Schlaifer says.