The Nov/Dec issue of PSQH included news coverage and commentary about the fungal meningitis outbreak caused in late 2012 by contaminated medications that had been shipped throughout the country by a compounding pharmacy in Massachusetts. In The New England Journal of Medicine, Smith et al. report that as of Dec. 10, 2012, the outbreak resulted in 590 reported cases of infection in 19 states and 37 patient deaths. According to the Institute for Safe Medication Practices, this outbreak is one of the most harmful adverse events ever associated with compounding pharmacies in the United States.
In November 2012, Massachusetts Governor Deval Patrick appointed a Special Commission on the Oversight of Compounding Pharmacies to review current state regulations and propose changes to improve oversight and ensure safety. The Commission’s report was released on Jan. 4 and is available here.
The report contains recommendations for comprehensive regulations affecting the state’s compounding pharmacy industry and better management of the Mass. Board of Pharmacy. Among other recommendations, the Commission’s report calls for adoption of “Just Culture” for evaluation of medication incidents and for Department and Health Professions Licensure Boards under the Department of Public Health.
Christian Hartman, PharmD, chair of the Special Commission, summarized the group’s work,
The Commission on Compounding comprehensively reviewed the meningitis outbreak, federal actions, national compounding standards, and Commonwealth of Massachusetts regulations. We concluded that the regulating body overseeing pharmacy compounding did not have adequate funding, training, expertise, and authority to provide comprehensive investigations. Our proposals provide a framework to improve compounding activities in the Commonwealth. Further, we recommended the adoption of a “just culture” for the Department of Public Health and open communication with the FDA.
In January Governor Patrick proposed new legislation based on the Commission’s recommendations.
In further follow up, investigators from the Centers for Disease Control and departments of health in eight states affected by the outbreak have studied various aspects of the event, including epidemiologic and laboratory data, and published a preliminary report in The New England Journal of Medicine. Their findings reinforce the need to ensure the safety and efficacy of sterile compounded medications, “essential for public health and the public confidence in the health care delivery system,” and the importance of
a strong public health infrastructure and collaboration among clinicians and public health officials at the state, local, and federal levels. These efforts played a critical role not only in alerting the public to an evolving health threat, but also in collecting, aggregating, and disseminating information in real time, which was used both to understand the scope and source of the outbreak and to drive efforts to reduce further morbidity and mortality.