WASHINGTON, DC – Pharmacists nationwide express their sympathies for the patients and families who have been tragically affected by the recent outbreak of meningitis cases linked to the injectable steroid methylprednisolone acetate. News reports indicate that the product – distributed to medical facilities in 23 states – has raised questions about compounding practices in the U.S. The American Pharmacists Association (APhA) supports compounding that is done according to defined standards and within the triad relationship of the physician, pharmacist and patient working together to individualize care for maximum patient benefit.
Compounding is an important and long-standing practice that meets important patient needs in hospitals, nursing homes and many community settings. Many patients have unique medical needs that pharmacists and physicians cannot meet using commercially available medication dosage forms. Some patients need extremely low dosages, liquid dosage forms or combinations of ingredients that are not available from manufacturers. APhA recognizes that pharmacy compounding should not occur when a commercial product is available. Importantly, compounding is performed in response to a prescription from a licensed prescriber for an individual patient and allows pharmacists to use their extensive medication knowledge and expertise to produce individualized medication formulations that meet patient’s needs and improve health outcomes. Compounding has also served a critical role in recent years to supply needed medications in the face of numerous drug shortages.
The practice of compounding is regulated by state boards of pharmacy. The Food and Drug Administration (FDA) has oversight for the medication ingredients used in compounded products. Pharmacists engaged in compounding are expected to follow appropriate procedures for the types of products that are compounded. In the case of injectable medications, there are special procedures, tests and standards to ensure the sterility and integrity of the compounded product. The United States Pharmacopeia (USP) outlines standards for sterile compounding that must be followed regardless of practice setting. In addition, many compounding pharmacies earn accreditation through the Pharmacy Compounding Accreditation Board (PCAB), a standards body that maintains and updates standards that reflect contemporary best practices. PCAB provides compounding practices an opportunity to compare their practices against national standards and achieve accreditation that provides consumers an indicator of quality practices.
APhA is committed to our longstanding work with FDA, Centers for Disease Control and Prevention (CDC), PCAB, USP, the state boards of pharmacy and other industry stakeholders in ensuring good compounding practices and standards are enforced. Patient safety and access to quality medication are our utmost concern. In all cases, APhA encourages patients to talk with their prescribers and pharmacists to determine their best treatment option, including appropriately compounded medications.
We encourage pharmacists and other stakeholders to access FDA and CDC websites for the most current information on the outbreak, lists of facilities and states impacted, treatment guidelines, FAQ statements and other resources to assist health care providers and the public in addressing this issue.