Pharmacists’ Commitment to Patient Safety and Compounding Quality

November 12, 2012

As national organizations of pharmacists caring for patients in all settings, we offer our deepest sympathy and condolences to patients and families affected by the fungal meningitis outbreak due to contaminated injectable products. The pharmacy profession is dedicated to ensuring patient safety and access to quality medications that meet patients’ needs. Based on our understanding of this tragedy, the entity involved was engaged in unauthorized manufacturing of drug products, not traditional pharmacy compounding.

Compounding is integral to all aspects of pharmacy practice. Pharmacists compound medications in response to a prescription from a physician or other prescriber to customize a patient’s therapy and meet patient-specific needs. Patients may receive compounded medications when they have a need for a customized medication, when a drug shortage or product discontinuation occurs, when the needed strength or dosage form is not available from a manufacturer, or when an allergen-free version of a medication is needed. Pharmacists also compound prescriptions for veterinary needs.

Patients must continue to have access to high quality compounded medications that are not available from a manufacturer. Pharmacists working in all practice settings such as hospitals and health systems, community pharmacies, long-term care and assisted-living, and the facilities serving our nation’s uniformed services work to ensure that quality compounding standards are met and to comply with state board of pharmacy regulations. Importantly, all practice settings and health professionals providing sterile compounding must follow quality standards. Pharmacies and pharmacists may also be held to accreditation and certification requirements when compounding preparations to further ensure quality and compliance.

The undersigned national pharmacy organizations and our colleague state pharmacy associations are committed to working with state legislatures, and state boards of pharmacy which regulate the practice of pharmacy. In addition, we will work with Congress, the Food and Drug Administration (FDA) which regulates pharmaceutical manufacturing, and the Drug Enforcement Administration (DEA) which regulates controlled substances. We will also collaborate with physicians, other prescribers, and key stakeholders to prevent further tragedy.

We are a resource for policymakers and stakeholders in identifying a clear delineation between drug manufacturing and traditional pharmacy compounding. We will advocate for state pharmacy boards and FDA to have the resources they need for enforcement, and to ensure an appropriate balanced approach for public safety and continued access to compounded medications.

Thank you.

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