Compounding after the meningitis tragedy: NCPA responds

May 15, 2013

NCPA is working with healthcare leaders in Congress to ensure development of appropriate measures

DISPENSED AS WRITTEN

The National Community Pharmacists Association (NCPA) is actively working with healthcare leaders in Congress who are considering new drug-compounding legislation in response to last year’s tragic fungal meningitis outbreak. The deaths and sickness caused by tainted injectable methylprednisolone have forced the reexamination of existing authority and caused intense pressure for Congressional legislation.

Throughout this process, NCPA is dedicated to advocating for sufficient patient access to customized, pharmacist-compounded medications. NCPA has made the preservation of patient access to compounding pharmacies a top priority and included it as a plank in NCPA’s 2013 Independent Community Pharmacy Checklist for federal and state policymakers.

A vital service

Two key messages are among the points NCPA continues to make with policymakers, the media, and others.

First, every day thousands of patients benefit tremendously from the services of medications compounded by pharmacists, whose practice is regulated by the state Boards of Pharmacy. Without these services, many patients would not have access to necessary compounded medications.

  • ŸCompounded medications provide solutions to patients when they have few or no options. They provide alternative medication delivery routes, help avert allergic reactions, and fill gaps in demand not fulfilled by mass-produced medications. They also meet countless veterinary needs for companion animals and livestock.

  • ŸThe Food and Drug Administration (FDA) itself has endorsed the role of compounding pharmacists in alleviating drug shortages, as with Tamiflu during the 2009 H1N1 flu outbreak. The liquid version used by children was in short supply, so compounding pharmacists converted Tamiflu capsules into liquid for dispensing.

  • Ÿ According to some estimates, 40% of intravenous medications used in hospitals are pharmacist-compounded.

In March, NCPA sent a letter to FDA about the role of compounding pharmacists in mitigating drug shortages. We asserted that “Compounding pharmacists have filled gaps in patient care during drug shortages in the past and should be allowed, through compounding and under existing rules and authorities, to continue to fill these gaps in these critical times of drug shortages to preserve access to medications.”

NECC not typical

Second, federal and state policies should reflect the fact that the actions of the New England Compounding Center (NECC) were vastly out of step with compounding as practiced by community pharmacists. The allegations of NECC’s misconduct include failure to adhere to standard practice for compounding, sterility procedures, and record-keeping requirements.

Existing state and federal authority could have prevented the tragic events that unfolded. Why that authority was not exercised should be examined as the first step in determining whether new oversight is needed. If it is needed, the type of oversight and who should conduct it must also be addressed.

A November 2012 NCPA survey of more than 400 community pharmacists provides a snapshot of the role of compounding in a traditional community pharmacy.  While 85.5% of respondents said they offer compounding services, 62% of those pharmacists said sales of traditionally compounded medications make up 5% or less of their pharmacy practice. Survey respondents also said that 70% of pharmacists participate in training/educational courses related to compounding techniques beyond what the state already requires to sustain their pharmacist license. In other words, most independent community pharmacists readily offer compounding in response to specific patient needs and do so with a seriousness of purpose.

Our goal

Some in Congress are pushing for sweeping federal legislation regulating all forms of compounding, which could compromise the state’s role in overseeing pharmacy practice. NCPA believes that states should continue to oversee the practice of pharmacy. If certain activities go beyond the practice of pharmacy, only then should another regulating body have oversight.

While our messages - the preservation of patient access to traditional compounding and the more forceful exercise of existing powers - are being delivered to lawmakers, we continue to address these issues. Finding solutions for patients through the appropriate use of compounded medications is foundational to our profession. Whether or not you compound products, robust advocacy for the art of compounding is a must. We encourage concerned pharmacists to contact their U.S. senators and representatives and make their voices heard.

B. Douglas Hoeyis CEO of the National Community Pharmacists Association (www.ncpanet.org).