By Michael R. Cohen, R.Ph.
Pennsylvania is one of only 5 states in the US that lacks regulations for compounding pharmacies to follow when preparing and dispensing sterile medications. The state also has no regulations to protect patients when sterile products are prepared by out of state pharmacies and shipped here.
In the wake of 24 deaths and over 300 people who’ve been harmed from contaminated steroids made by a Massachusetts compounding pharmacy, questions have been raised about the lack of regulatory oversight of such pharmacies by state and federal officials.
The pharmacy in the current case, New England Compounding Center (NECC), is being investigated for crossing the line into full-scale manufacturing by taking bulk orders for injectable medications without proof of an individual prescription as required in state regulations, then shipping large batches of drugs nationwide. Such compounding requires registration with FDA as a manufacturer, which was not the case with NECC. Thus oversight was up to the Massachusetts Board of Registration in Pharmacy.
While it’s difficult to understand how the transition to full-scale manufacturing could have been overlooked by authorities, the pharmacy has been accused of misleading state regulators who licensed NECC as a pharmacy.
For sterile compounding, Massachusetts regulations spell out requirements for pharmacies to follow standards set forth by the US Pharmacopeia in Chapter <797>, entitled Pharmaceutical Compounding: Sterile Preparations. The chapter describes a network of systems and processes “to prevent patient harm and fatality from microbial contamination (nonsterility), excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in compounded sterile preparations.” The standard has the force of law in states that include mention of it in their regulations, as Massachusetts does.
It’s important for regulations to be in place so oversight agencies can inspect for basic compliance. But the board can’t be there 24 hours a day, so it still comes down to strict adherence to regulations by management and staff. A preliminary report issued by Massachusetts authorities indicates a number of important breakdowns in sterile procedures.
At least Massachusetts has regulations.
A 2012 research project conducted by CriticalPoint, LLC and the National Association of Boards of Pharmacy (NABP), indicates that Pennsylvania is one of only 5 states that lack sterile compounding regulations that pharmacies must adhere, including USP 797. These state pharmacy boards currently lack the ability to assure that safe practices are in effect. Currently 18 states require full compliance with USP 797. In other states, the standard isn’t mentioned but aspects of it are incorporated into a state regulation. Nothing exists in Pennsylvania. Not even when out of state pharmacies ship products into Pennsylvania.
Following 9 patient deaths in April, 2011 from contaminated intravenous nutrition solutions made by an Alabama compounding pharmacy, I contacted the PA State Board of Pharmacy to make sure that we had regulations in place to protect patients. I learned that there aren’t any. My April 2011 blog called attention to this but I certainly wasn’t the first to bring up this matter.
One of my most respected colleagues, who asked to remain anonymous, told me that she’s been asking the Board for years to address the lack of regulatory oversight. At one point she was told by a Board employee that, “It isn’t on our radar yet.” In fact, on October 11th, after wide media coverage of the meningitis outbreak, Board member Gayle Cotchen, the sole individual on the board representing hospitals, spoke to a gathering of the Pennsylvania Society of Health-System Pharmacists in Lancaster. Her topic was, “Pennsylvania Pharmacy Act and Regulations – Information for Pharmacists & Pharmacy Staff.”
Dr. Cotchen failed to mention anything about the Massachusetts situation or the need for compounding regulations. But she did ask for questions or suggestions for the Board. A member of the audience spoke up about the importance of sterile compounding regulations and the lack thereof and explained there had been requests made by state pharmacists for years. The board member gave thanks for the question but did not discuss it further. So I guess we'll have to see.