Pharmacy Journal Publishes Analysis of Infections Related to Compounding Pharmacies
(June 17, 2013) In the wake of the deadly infections in 2012 from drugs compounded at the New England Compounding Center (NECC), a new study examines similar outbreaks in the U.S. over the last 12 years in an effort to discover factors that may hinder outbreak detection. The article, Description of Outbreaks of Health-Care-Associated Infections Related to Compounding Pharmacies, 2000-12, by Catherine Staes, M.P.H., Ph.D.; Jason Jacobs; Jeanmarie Mayer, M.D.; and Jill Allen, Pharm.D., BCPS; is published by the American Journal of Health-System Pharmacy (AJHP) online, ahead of print, because of its significant contributions concerning this current public health issue.
The study, which is the first of its kind, is based on a literature review of 850 articles, as well as content on the Food and Drug Administration (FDA) website. The analysis focuses on outbreaks due to drugs that were likely contaminated during preparation at compounding pharmacies outside the hospital setting. The authors discovered 12 outbreaks resulting in 65 deaths, including the recent outbreak associated with NECC. The authors then identified key factors of the outbreaks, including triggers that lead to detection, number and location of patients involved, drug name and route of administration, infectious organisms and clinical outcomes, name and location of the compounding pharmacy, and findings from the investigation.
Some affected patients lost their vision; some required hospitalization, surgeries, or treatments; and about seven percent died. Each of the 12 outbreaks had root causes that could have been prevented, according to the authors.
Key findings include:
- Types of drugs: Three outbreaks involved ophthalmic drugs. Three outbreaks involved steroidal suspensions used primarily for epidural injections. Two outbreaks involved heparin solutions for catheters. Others involved cardioplegia solution, i.v. magnesium sulfate, total parenteral nutrition, and fentanyl.
- Infectious organisms: Six outbreaks were caused by organisms commonly implicated in health care-associated infections. One outbreak was caused by an organism that is not a common source of infection. Five outbreaks were caused by organisms that are rarely a source of health care-associated infections.
- Causes of death: Thirty-eight patients died of meningitis and fourteen others died of either meningitis or other causes after epidural injections of steroidal suspensions. Ten patients died of bloodstream infections after i.v. administration of magnesium sulfate or total parenteral nutrition. Three patients died of systemic inflammatory response syndrome after the administration of a cardioplegia solution during heart surgery.
- Sources of contamination: Sources included problems with autoclaves, lack of sterility testing, inadequate cleanroom or environmental sampling practices, failure to follow recommended filter-sterilization processes, and inadequate staff training and quality-assurance practices. After investigation, sterility could not be ensured for any products from the compounding pharmacies associated with half of the outbreaks, leading to a recall of all of the companies’ sterile products. Sources of contamination were not established for five outbreaks.
- Outbreak detection: Two outbreaks were discovered when an astute clinician or laboratory worker reported one or two cases of rare infections that triggered active surveillance and a public health response. Ten outbreaks were identified only when a cluster of patients from a common hospital or clinic presented with similar characteristics.
To help prevent future outbreaks, the authors recommend addressing the root causes, including regulatory gaps, compounding processes, awareness among clinicians, and the public health systems required to monitor compounding practices and identify and respond to outbreaks. They also recommend that compounding pharmacies fully comply with USP chapter 797, the standard for sterile compounding safety in the U.S. In addition, they call for enhancing electronic health record systems to recognize links between compounded drugs and infections.
In addition, AJHP is concurrently publishing a related article, History of Sterile Compounding in U.S. Hospitals: Learning from the Tragic Lessons of the Past, by Charles E. Myers, M.S., M.B.A., that examines the evolution of sterile compounding in the U.S. and explores what measures are needed to better ensure the safety of compounded products.