The fungal meningitis outbreak caused by contaminated medications from a Massachusetts compounding pharmacy show that quality standards must be raised, but decisions regarding new regulations should not be made hastily.
A meningitis outbreak linked to contaminated steroid injections has resulted in a nationwide concern over compounding practices. But in the aftermath of this developing story, we end up with more questions than answers.
The story began at the New England Compounding Center (NECC) pharmacy in Framingham, MA. This compounding pharmacy sold thousands of vials of contaminated methyprednisolone acetate 80mg/ml injections to thousands of customers in 23 states.
Soon after there were cases of an uncommon fungal meningitis that began to appear. As the cases spread and the outbreak became more severe, it was apparent the illnesses were linked to the injections compounded by NECC.
A recall was initiated by the pharmacy starting on September 26th to remove the suspected injections out of distribution. NECC is now recalling all of its compounded products from the same facility as a precaution.
The meningitis cases continues to rise nationally. According to the CDC, there are 137 meningitis cases in 10 states including 12 deaths in 5 states as of October 10th that are associated with the injections.
The result is a national media blitz that has focused attention on compounding pharmacies. Concerns are being raised over drug safety as well as pharmacy oversight.
For the most part, compounding pharmacies are regulated at the state level. But in the wake of a multi-state meningitis outbreak, politicians and consumer groups are questioning if more national oversight is in order.
For NECC, it appears they may have violated their Massachusetts permit stating they can only compound medications for a specific patient prescription. Instead, it appears this pharmacy was mass-producing large batches of products for national distribution.
I’d caution lawmakers before drafting any new pharmacy regulation. What may be a problem that affects a small percentage of large volume compounding pharmacies could translate into excessive oversight for every small town independent pharmacy that also compounds.
There is a huge difference between a mom-and-pop independent who compounds medications for local physicians and patients and the mass-producing compounding facilities such as NECC. Many independent pharmacies provide compounding services to compete with larger retail pharmacy chains.
The question becomes do we need more regulation over compounding pharmacies? And if so, who should oversee such an endeavor?
There is already a Pharmacy Compounding Accreditation Board (PCAB) that independently accredits pharmacies and certifies them according to a strict set of guidelines and rules. But according to the PCAB, only 165 pharmacies in 38 states are certified under their criteria.
The key word you will notice on PCAB’s website is voluntary. This quality accreditation organization is completely voluntary. Prospective pharmacies must apply to be accredited, become certified, and pay yearly accreditation dues to become and maintain certification with PCAB.
There is no federal equivalent of PCAB. The FDA has little oversight directly over the practice of compounding. And I’m not sure another federal regulatory agency or an expansion of the FDA’s responsibilities is the answer to better oversight for all compounding pharmacies.
It appears there were lapses in the enforcement of state regulations already in place for NECC. But can a state board of pharmacy effectively maintain quality control for all compounding pharmacies in their respective state?
I hope that everyone will cool off from the media campaign that has made this meningitis outbreak a national story before making regulatory decisions. Is this situation serious? Absolutely. People have died and valid questions about safety and oversight have been raised.
But as Steve Airens has wisely pointed out, medication errors are a much bigger problem that somehow doesn’t get the media attention that an infection outbreak garners. Thousands of deaths a year can be attributed to medication errors. Why aren’t we discussing that public health threat with the same urgency we now have for compounding pharmacies?
I worry that in the heat of a serious public health threat, we will hastily pass new rules that will do more to hinder the efforts of small town community pharmacies rather than protect the public from future preventable illness outbreaks. We should not control the larger compounding pharmacies at the expense of the small independents.
Compounding is a vital service that is one of the core funtions of the profession of pharmacy. I would caution anyone from regulating away a valuable service for patients and a way of life for many independent pharmacies.