 | The 131st Annual Meeting (November 15-19, 2003) of APHA |
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| The 131st Annual Meeting (November 15-19, 2003) of APHA |
Sarah Sellers, PharmD, Department of Health Policy and Management, Bloomberg School of Public Health, 121 Rose Terrace, Barrington, IL 60010, 847-526-2248, ssellers@jhsph.edu
Under the current US regulatory framework, pharmacy compounding has grown into a multi-billion dollar industry. Respiratory dosage forms made by pharmacists are exempt from important regulations under the Food Drug and Cosmetic Act that ensure the safety and efficacy of drugs. In 2001, a large managed care pharmacy issued a Class I recall of thousands of doses of pharmacy-compounded respiratory medications. The dosage forms, intended to be sterile for administration to the lungs, were grossly contaminated with serratia liquifaciens. The recall likely reduced morbidity and mortality, but reliance on the recall process alone to protect the public from substandard drug exposure is inadequate. A joint inspection of the pharmacy with the California Board of Pharmacy and the FDA found the pharmacy did not have proper training, equipment or control procedures in place to ensure the quality of products produced; and testing of finished dosage forms was inadequate to ensure potency, purity and sterility. Additional concerns regarding substandard respiratory medications were raised when, in July of 2002, the US Attorney for the Southern District of Florida announced the convictions of two physicians, two pharmacists and four durable medical equipment company owners of Medicare fraud for their role in the large scale compounding of adulterated respiratory medications by unlicensed individuals under unsanitary conditions. During the trial, testimony from an expert witness highlighted larger respiratory compounding operations throughout the US, suggesting the invasive nature of this practice. A recent article in the trade journal Home Medical Equipment News sums up the incentive to compound well, noting that pharmacies will continue to compound respiratory medications for profit reasons, even if it is illegal: “Providers, especially smaller ones, will risk compounding before losing that kind of money, Letson said “Yes, it's illegal, but profitability often overrules what's legal and illegal.” Exposure to substandard drugs is responsible for significant morbidity and mortality worldwide. When treated with substandard respiratory drugs, patients with compromised lung function may: • Fail to respond to therapy • Experience exacerbation of disease • Develop infection • React adversely to intolerable levels of endotoxin and/or other contaminants. With the current absence of effective regulation, respiratory compounding is expected to persist and grow. Clear legal mandates, inter-agency and industry collaboration in conjunction with health provider and patient education are essential components for combating pharmacy compounding abuses and the associated threats to public health and safety.
Learning Objectives:
Keywords: Drug Safety, Pharmacies
Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.