November 7, 2012
IACP Participating in U.S. Senate HELP Committee Hearing on November 15, 2012, at 10 am EST.
The International Academy of Compounding Pharmacists’ (IACP) David G. Miller, RPh, Executive Vice President & CEO, has been invited to testify before a U.S. Senate HELP Committee hearing, “Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak” on November 15, 2012 at 10 am EST, in 106 Dirksen Senate Office Building in Washington, D.C.
Please click here for more information on the Hearing and its panel participants.
“IACP appreciates the opportunity to provide input as the U.S. Senate HELP Committee seeks to better understand current federal and state oversight of pharmacy compounding and explore the possibilities for a legislative solution to the tragedy surrounding New England Compounding Center (NECC) business practices,” said IACP Vice President of Government Affairs Sarah Dodge. “We believe we share similar goals: an understanding of how this tragedy happened, what can be done to prevent it from ever happening again, and ultimately how do we assure that compounding pharmacists are able to practice their professional expertise without overly burdensome regulations which inhibit quality patient care."
The state and federal regulatory scheme for pharmacy compounding is complex – IACP members have valuable experience and technical understanding of the laws that govern our industry. IACP stands ready to help legislators and regulators to assist in conducting a thorough and complete assessment of state and federal laws governing the practice of pharmacy. We believe this assessment should also examine how regulators exercise their jurisdiction and discretion in enforcement. IACP strongly believes that, in Massachusetts and other states, many laws and regulations exist that – if they had been followed and compliance had been enforced - would have severely mitigated the potential for the tragic meningitis infections that have occurred.
The apparent and tragic results of NECC’s alleged behavior undermine the fundamentals of pharmacy, which include doing no harm. We are determined to help find the problem and solve it. Our profession stands ready to work with leaders from across the federal and state governments to make sure that what happened at NECC never happens again.
Not only does Massachusetts have state sterility requirements and United States Pharmacopeia (USP) Standard compliance requirements, but it retains the right to pull a pharmacy’s license, if that pharmacy is practicing outside the scope of its licensing requirements.
By all current indications, the operations of NECC were clearly outside of the scope of the state’s licensure requirements and their license should have been pulled long ago. The state and the FDA should have worked together to force the pharmacy to register as a manufacturer, but also to comply with Current Good Manufacturing Practice Guidelines (CGMP). Unfortunately, NECC showed a blatant disregard for existing rules and regulations (no matter what the law was, their behavior indicates that they would not have followed it). Additionally, and still to be answered by both regulatory agencies, was the fundamental question: if both the state and the FDA knew of problems at NECC – and did based on publicly disclosed documents – why did they fail to follow-up or take action? New regulations or new laws are meaningless if the regulatory agencies charged with upholding them simply fail to do their job.
IACP would support the following state actions to help mitigate further problems with sterility and other potential patient hazards:
- All Boards of Pharmacy must be adequately funded by state legislatures in a manner sufficient to hire trained/educated pharmacists to conduct regular inspections of all pharmacies. Too many Boards have been "de-funded" by legislatures that have funneled revenue from the Boards into the states' general funds leaving administrative gaps;
- Board inspectors conducting compounding pharmacy inspections in both community and institution settings must receive training in both the state regulations pertaining to compounding as well as the practice itself;
- All states must adopt mandatory compliance with USP 795/797 standards. Only 17 currently have that on their books;
- State Boards must "police" themselves and provide the necessary assurances to other state Boards which depend upon them for conducting inspections for non-resident pharmacies in a regular and consistent manner. Massachusetts’s Board obviously failed to execute its responsibilities both to its citizens as well as patients in other states in which NECC was licensed by not conducting regular inspections.
In addition to the U.S. Senate Hearing, the House Energy & Commerce Committee will hold its own hearing on November 14, 2012. Click here for more information.
The Academy will update the IACP Membership on both of these hearings in future communications
No comments:
Post a Comment