News in Review
Bevacizumab Use Falls After Regulatory Changes in Ohio
One year after Ohio mandated patient-specific prescriptions (PSPs) for off-label compounded medications, bevacizumab use decreased by nearly 33% in one retina specialty practice.1 A survey of its 9 physicians found that 89% made the switch to ranibizumab or aflibercept because of the burdens of PSPs, rather than concerns about the efficacy or safety of bevacizumab.
Impact of tighter controls on compounded drugs. The Ohio Board of Pharmacy had tightened its regulation of off-label medications after a 2012 outbreak of fungal meningitis linked with drugs from a single compounding pharmacy in New England. The new requirements for labels with individual patient names and dates on preloaded syringes precluded bulk purchases and resulted in extra patient visits and practice expenses, said coauthor David G. Miller, MD, at Retina Associates of Cleveland.
“At the end of the month, we would end up with dozens of unused syringes containing names of patients who never came back to use them.” For these reasons, the move to on-label medications was expected, he said. However, he was surprised by the magnitude of the shift in such a short time, which added a significant burden to the health care system. Between the 2 study periods, the mean cost per injection increased from $808 to $1,365.
Stay tuned for future developments. Passage of the federal Drug Quality and Security Act of 2013 now supersedes state laws like those in Ohio. Although the FDA requires PSPs for compounded medications nationwide, certified outsourcing facilities regulated by the FDA are now allowed to repackage bevacizumab without PSPs, thus easing its use. But perhaps not for long: The FDA is considering a proposal to add 72-hour expiration dates on bevacizumab labels.
1 Holfinger S et al. JAMA Ophthalmol. Published online Nov. 5, 2015. doi:10.1001/jamaophthalmol.2015.4331.
Relevant financial disclosures—Dr. Miller: None.
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