November / December 2012
Meningitis Outbreak Prompts State and Federal Action to Improve Safety
According to the Institute for Safe Medication Practices (ISMP), the fungal meningitis outbreak caused by contaminated products from a Massachusetts compounding pharmacy may be the most serious medication safety incident in recorded history. So far, this incident has resulted in more than 30 patient deaths and 400 serious illnesses. As this issue goes to press, state and federal hearings and investigations to determine accountability and prevention are ongoing.
In “Sterile Compounding Tragedy: Symptom of a Broken System” (pg. 14), ISMP describes previous sterile compounding “misadventures” and the current state of regulation, which is characterized by gaps between state and federal coverage and insufficient oversight and enforcement.
Soon after the meningitis outbreak was traced to the New England Compounding Center (NECC) in October, the Massachusetts Board of Registration in Pharmacy announced emergency regulations that require sterile compounding pharmacies to report the quantities of drugs they manufacture. The meningitis outbreak revealed that NECC was operating with poor quality control and manufacturing and distributing quantities of drugs far in excess of what was authorized. The emergency regulations will improve oversight while a special commission develops recommendations for permanent overhaul of regulations governing sterile compounding pharmacies in the state.
Hartman Appointed to Lead Regulatory Review in Massachusetts
Massachusetts Governor Deval Patrick has appointed Christian A. Hartman, PharmD, MBA, FSMSO, to chair the Special Commission on Compounding Pharmacies to review relevant state regulations and propose changes to ensure that compounding pharmacies in the state are held to best and safe practices.
Hartman is a member of the Editorial Review Board for Patient Safety & Quality Healthcare and founder and president of the American Society of Medication Safety Officers. Please see facing page for a conversation with Hartman and below for further information about the Special Commission and emergency regulations in Massachusetts.
On November 1, 2012, Massachusetts Department of Public Health (DPH) Interim Commissioner Dr. Lauren Smith announced Governor Patrick has named Christian A. Hartman, an expert in pharmacy practice and patient safety, to chair a Special Commission on compounding pharmacies. He will lead the commission, comprised of representatives from the Legislature and experts in pharmacy practice, regulatory affairs, and patient safety, in its work to examine potential changes to laws and regulations to fill the regulatory gray area between state and federal oversight.
The Special Commission’s recommendations will be due by December 31, 2012. The Commission will draw from investigations by the Department of Public Health and the U.S. Food and Drug Administration, while examining the best policies in other states. The Commission is also directed to coordinate with any relevant action taken by the federal government.
Also on November 1, the Massachusetts Board of Pharmacy approved emergency regulations to enhance oversight of compounding pharmacies. The emergency regulations will for the first time allow the state to track volume and distribution at compounding pharmacies to determine if they are operating more like a manufacturing facility subject to FDA licensing. The regulations also require pharmacies to report to the state when they are the subject of an investigation by another state or federal authority, among other requirements. Finally, the regulations create stiffer penalties if pharmacies fail to comply with rules and regulations.
From the Executive Office of Health and Human Services, Commonwealth of Massachusetts