NCPA Urges Congress to Preserve Patient Access to Traditional Pharmacy Compounding
Alexandria, Va. (Nov. 14, 2012) - The National Community Pharmacists Association (NCPA) submitted comments and an accompanying survey to two congressional committees holding separate hearings examining the meningitis outbreak at the New England Compounding Center (NECC). NCPA’s comments were submitted to the U.S. House Energy and Commerce Subcommittee on Oversight and Investigations and to the U.S. Senate Committee on Health, Education, Labor & Pensions (HELP), respectively.
NCPA’s comments outline the bright-line differences between customized 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.
A recent survey of 400 independent community pharmacists found that while 85 percent provide traditional compounding, 62 percent say it makes up no more than five percent of their business. In addition, 72 percent provide only non-sterile 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,” said NCPA CEO B. Douglas Hoey, RPh, MBA. “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.”
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.”
NCPA’s comments touched upon the following specific points:
- Independent community pharmacists typically provide compounding services to fulfill special needs that cannot be 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 (FDA) 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 expressed support for a state-based approach to informing patients (labeling, etc.) that a compounded drug was made by the pharmacist at the behest of a prescriber, but would oppose any labeling requirement suggesting a compounded drug was “unapproved, potentially unsafe or not prepared correctly”.
- Compounding drugs have repeatedly proven to help reduce costs, while ultimately boosting health outcomes.
- In the case of NECC, existing 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.
- Manufacturing under the guise of compounding is the real problem and should be solved by requiring any company engaged in such activity to register as a manufacturer. As a warning letter to NECC by the FDA states, “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.”