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Congress gets NCPA's input on compounding
November 14th, 2012
ALEXANDRIA, Va. – The National Community Pharmacists Association has provided comment and research on compounding pharmacy services to two congressional committees holding hearings on the meningitis outbreak at the New England Compounding Center (NECC).
NCPA submitted its comments and a compounding pharmacist survey on Wednesday to the House Energy and Commerce Subcommittee on Oversight and Investigations and to the Senate Committee on Health, Education, Labor & Pensions (HELP), respectively.
In its comments, NCPA said it emphasized the differences between custom medications that prescribers ask independent pharmacists to prepare through traditional compounding for specific patients versus the large-scale manufacturing that NECC appears to have engaged in and allegedly led to the meningitis cases.
An NCPA survey released earlier this week of 400 independent community pharmacists found that while 85% provide traditional compounding, and 72% provide only nonsterile medications, as opposed to sterile medications mass-produced by NECC.
"Independent community pharmacists are working constructively with policymakers to help ensure that a tragedy like this doesn't happen again," NCPA chief executive officer B. Douglas Hoey said in a statement. "The overwhelming majority of independent community pharmacies offer traditional compounding services as a small, but vital, niche service that meets patients' specific health needs, often reduces costs and alleviates drug shortages. Congress and others addressing the meningitis outbreak should preserve patients' access to traditional compounding services while taking any appropriate action to rein in any rogue drug manufacturers like NECC."
NCPA's comments to the House and Senate committees made the following points:
• Independent pharmacists typically provide compounding services for special patient needs not met by commercially available medications. Examples include hormone replacement medications, flavoring medications for pediatric patients, progesterone suppositories to prevent miscarriages and medications for cystic fibrosis patients.
• The Food and Drug Administration has previously said in congressional testimony that "we believe that the vast majority of pharmacies engaging in pharmacy compounding provide a valuable medical service that is an integral part of our modern health care system."
• NCPA supports a state-based approach to informing patients (such as via labeling) that a compounded drug was made by the pharmacist at the behest of a prescriber, but the association would oppose any labeling requirement suggesting a compounded drug was "unapproved, potentially unsafe or not prepared correctly."
• Compounded medications have repeatedly proven to help reduce costs, while ultimately boosting health outcomes.
In addition, NCPA said that in the case of NECC, current state and federal laws and regulatory bodies were "sufficient enough, if properly enforced and utilized, to have averted or at least lessened the impact of the tragedy that has occurred."
NPCA noted that the crux of the issue is "manufacturing under the guise of compounding," which could be solved by requiring any company engaged in such activity to register as a manufacturer. According to the association, an FDA warning letter to NECC stated, "These actions are not consistent with the traditional practice of pharmacy compounding, in which pharmacists extemporaneously compound reasonable quantities of drugs upon receipt of valid prescriptions from a licensed practitioner to meet the unique medical needs of individual patients."
Hoey added, "Ultimately, we want to avoid scenarios where independent community pharmacists are not able to help in timely and often profound ways. In addition to the help they provide individual patients every day, a couple of years ago during the H1N1 outbreak, these local health care providers alleviated a critical shortage of the liquid version of Tamiflu for children through traditional compounding."
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