In wake of meningitis scandal, Massachusetts changes CE requirements
Monday, June 01, 2015
When a tragedy on the scale of what happened in 2012 regarding the Massachusetts-based New England Compounding Center (NECC) meningitis contamination and the subsequent fallout on the Board of Pharmacy (BOP), you can expect that certain changes will occur.
Among those changes are the new regulations issued by the BOP concerning the CE requirements for pharmacists engaged in certain types of compounding. For the most part, these latest requirements are a step in the right direction.
David Sencabaugh, the executive director of the Massachusetts BOP, explained the new expectations related to compounding pharmacists' continuing education in a May 19 communication.
The new policy will require all pharmacists engaged in "sterile" compounding to obtain at least five contact hours of education in the area sterile compounding each year. For pharmacists engaged in what the board calls "complex nonsterile compounding," the law requires three contact hours of education specifically in complex nonsterile compounding.
In preparation for these new requirements, the Massachusetts BOP increased the total number of continuing education hours required by pharmacists, beginning in 2015. According to the latest publication of the Massachusetts CE requirements for pharmacists (from the Acts of 2014, chapter 159): "A registrant seeking renewal of a personal registration shall complete a minimum of 20 contact hours each calendar year of the two-year renewal cycle."
This move to 20 contact hours per year puts Massachusetts tied for the highest continuing education requirements for pharmacists in the nation with Ohio (which requires 60 hours on a three-year cycle). Most states require 15 contact hours per year. Mississippi comes in last as only requiring 10 hours per year.
But all these changes do raise some important and unanswered questions.
First, does raising the number of continuing education hours in sterile and complex compounding actually decrease the likelihood of repeated events like what happened at NECC? Was it an educational issue that led to the tragedy?
Frankly, I doubt it. I wholeheartedly embrace educational standards, but I'm skeptical that education alone is what we need. To be fair, the requirements never suggest that education alone is enough. Maybe requiring a few CEUs in medical ethics might be more appropriate.
Second, will continuing education programs be available of a sufficient quality and quantity to meet these new requirements? I have been doing pharmacist CEs for 20 years now. I don't really recall seeing many entitled, "A refresher on complex nonsterile compounding."
Maybe they are out there, or maybe now there will be more on the way. It reminds me of the requirement last year that pharmacists take a CE on the new prescription monitoring program. I think only one or two programs qualified.
Finally, can any amount of continuing education replace the ongoing need for open interaction with and communication from the BOP? One of the greatest needs in Massachusetts, as well as in many other states, is access, transparency and clarity in the oversight of the practice of pharmacy. Many pharmacists get frustrated by the lack of communication they receive to help them practice in a way that is fully compliant with existing laws.
As pharmacists, we practice in what is likely to be the most heavily legislated branch of healthcare. Regulatory education and communication are essential to carry on our profession in a way that promotes the health and safety of our communities.
The vast majority of pharmacists are eager to do this. But whether the answer is adding compounding education requirements or increasing the total number of CEs needed remains to be seen.
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