November 28, 2012
Pharmacy Compounding Differs From Process Leading to Meningitis Outbreak
Washington, D.C.—Comments submitted to two congressional committees outline the significant differences between the customized medications pharmacies prepare through traditional compounding and large-scale manufacturing by companies such as the New England Compounding Center (NECC), whose practices have been blamed for a widespread meningitis outbreak.
Information from the National Community Pharmacists Association (NCPA) was 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).
NCPA also submitted results of a recent survey of 400 independent community pharmacists. While it indicated that 85% offer traditional compounding, 72% said they provide only nonsterile medications. Of the respondents who offer any compounding services, 62% said those services constituted no more than 5% of their business.
“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,” said B. Douglas Hoey, RPh, MBA, NCPA’s chief executive officer. “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.”
The NCPA statement pointed out that community pharmacists typically provide compounding services to fulfil special needs that cannot be met by commercially available medications, such as hormone replacement medication, progesterone suppositories to prevent miscarriages, and medications for cystic fibrosis patients as well as flavoring products for pediatric patients.
The group argued that companies such as NECC engage in manufacturing under the guise of compounding, adding that those types of enterprises should be required to register as manufacturers. The statement quotes an FDA warning letter to NECC saying that “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.”
NCPA’s survey also found 70% of community pharmacists report participating in ongoing training/educational courses related to compounding techniques, even though that usually is a small part of their practice.
The Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, raised several questions about compounding at community pharmacies, however.
“When local communities need compounded medications, they turn to their neighborhood pharmacy. Local independent drugstores need to assure patients and policymakers they apply the highest patient safety standards when compounding medications,” said Mark Merritt, PCMA president and chief executive officer.
Among the questions posed to Congress were whether independent drugstores should manufacture sterile drugs, such as injectable pain medication, or eye drops and hormone replacement therapy, and whether higher fees play a role in compounding by community pharmacies.
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