Many pharmacies have found themselves in the news recently for failing to follow sterile compounding procedures--with devastating consequences for their reputations, business and patients. In the last two years, the Food and Drug Administration has inspected 150 compounding pharmacies and found issues with safety or sterility in 90% of them.1 State and federal agencies have also increased inspections of compounding pharmacies, increasing the risk of citations and fines. In today's environment, failure to properly follow the sterile compounding procedures presented in USP 797 can make or break your organization.
Large compounding pharmacies may make hundreds of doses of drugs for use by hospitals or clinics, often as injectable medications that must meet stringent preparation standards.
These compounded sterile preparations (CSPs) increase the risk of microbial contamination to patients.2 In the last 12 years, three separate--and fatal--outbreaks of meningitis have resulted from contamination of compounded steroid injections by fungus or bacteria. The compounding pharmacies involved have experienced recalls of products and suffered the loss of reputation and customers.
According to the Pew Charitable Trusts, 25 reported compounding errors were associated with more than 1,000 adverse events and 89 deaths reported by hospital, institutional and compounding pharmacies since 2001. In 17 of those cases, the problem was the contamination of sterile products for injection or IV use. 3
Other errors that result from failing to follow quality sterile compounding procedures include misidentification of medications and incorrect concentrations of ingredients. Like contamination, these errors can and do cause death and disability in patients and can be largely addressed by careful adherence to sterile compounding best practices.
In one study of the accuracy of hospital pharmacy preparation of injectables, chemotherapy solutions and parenteral nutrition showed that overall error rates approached 9% of dispensed products. In a 2009 State of Pharmacy Compounding Survey, 30% of hospitals reported a patient event associated with a compounding error in the previous five years.
To avoid the potentially catastrophic consequences of improperly prepared, mislabeled or contaminated medications, pharmacies of all types should ensure that all staff receive thorough training in USP Chapter 797 policies and procedures and that pharmacy practices are regularly reviewed to identify and address any areas of potential risk.
1 Eisler P and Schnaars C. Safety, sanitary problems prompt scores of drug recalls. USA Today. October 7, 2014.
2 Gudeman J, Jozwiakowsk M, Chollet J, Randell M. Potential risks of pharmacy compounding. Drugs RD. 2013 Mar;13(1):1-8.
3. US illness and deaths associated with compounded medications. The Pew Charitable Trusts. September 6, 2014.