Directly Speaking - The Fungal Meningitis Outbreak and Illinois
by Scott A. Meyers, Executive Vice President
December 17, 2012
By now everyone should be familiar with the New England Compounding Center (NECC) sterile product contamination scandal and the resulting fungal meningitis outbreak that has claimed 34 lives and infected nearly 500 patients nationwide at the time of this writing. It is truly a tragedy of enormous proportions, although even one death would truly be a tragedy. This is another black eye for pharmacy caused by a choice few interested only in the almighty dollar rather than the safety of the patients who would be their end-users. It doesn’t seem that long ago that pharmacy was placed in a similar yet perhaps not as wide and bright spotlight by the Kansas City Pharmacist Robert Courtney who was found guilty of diluting chemotherapy that probably cost several patients their lives.
So what will happen in Illinois as a result of this terrible tragedy and blatant disregard of state and federal regulations? The Illinois Department of Financial and Professional Regulation and the Illinois Board of Pharmacy have charged a task force with revising the Practice Act Rules regarding Compounded Sterile Preparation Standards (Section 1330.680 of the Rules). The Board has asked me to chair that task force – a responsibility I do not take lightly.
The task force is already taking shape with representatives from a wide variety of pharmacy practice settings stepping up to help. More will be asked to participate before this article goes to press. The task force will not exclude anyone who is truly interested in participating in the proposed regulation review. Our goal is to draft regulations that are not overly prescriptive and yet provide ample safety and quality assurance to ensure protection of Illinois’ citizens. The USP Chapter 797 will provide the foundation for these regulations, and the task force will be reviewing and possibly incorporating current regulations from one or more of the 25 states that currently use 797 or some form of it in their own regulations.
The good news is that of the 128 hospitals that responded to ICHP’s USP Chapter 797 survey in February and in October, 95% indicated that they are now or plan to be 797 compliant within two years. The concern I have is with the other 125 hospitals who did not respond. Are they compliant and too busy to send back the survey? Are they not compliant and concerned that returning the survey will place a spotlight on their facility or all facilities that are in the same situation? Are they not compliant and don’t believe their input would be valued (we asked them to identify the barriers keeping them from compliance so we could facilitate accommodations)? It’s hard to say why they chose not to respond, but as all surveys go, not everyone does.
One barrier that was identified by 21% of the respondents was a lack of support from administration. I have personally spoken with more than one pharmacy director who has told me that his administrators will not support the renovations required to meet the 797 standards until it is required by law. Well, maybe the new rules will help those well-intentioned by stymied pharmacy directors and managers in achieving what they believe to be important goals. We also know that cost is a huge issue with the implementation of USP 797, but this expense has been shown to now be more critically important than ever before. If NECC would have been 797 compliant, this tragedy would have been averted.
The task force will take these and all the identified barriers to implementation under consideration, but it will need to work quickly and effectively to draft regulations that pharmacy practitioners can comply with and state inspectors can enforce. More importantly, the Illinois public should be protected by standards that guarantee safe products. As dedicated professionals we should all do everything we can to insure that is the case. I urge each of you to read Bill Zellmer’s editorial “Toward atonement for pharmacy compounding tragedies” in the December 1, 2012 American Journal of Health-System Pharmacists to get a better perspective of what each of our responsibilities should be.¹ As you would expect from a Zellmer call to action, Bill provides a soundly structured approach for preventing future tragedies, and he calls for pharmacists to strive for stronger ethical and professional standards in their work places.
Whether or not your facility used the contaminated products from NECC and had patients who were infected, you as a pharmacist will be held in a new not so high regard because of the actions of a few reckless colleagues. It will be up to us to make sure this doesn’t happen again and that our efforts toward safe and effective use of medications are redoubled. This outbreak will have an impact on Illinois. We need to work together to make it a more positive one for the future.
¹ Zellmer WA. Toward atonement for pharmacy compounding tragedies. Am J Health-Syst Pharm. 2012;69:2055.
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