(June 17, 2013) In the aftermath of last year’s compounding tragedy at the New England Compounding Center that caused the deaths of 48 people and sickened hundreds more, the American Journal of Health-System Pharmacy (AJHP) has published an article 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. The article is being published online, ahead of print, because of its significant contributions to this current public health issue.
In his article, History of Sterile Compounding in U.S. Hospitals: Learning from the Tragic Lessons of the Past, Charles E. Myers, M.S., M.B.A., gives a detailed history of the milestones and innovations that have influenced sterile compounding practices in the U.S., including technological advances in the preparation and administration of compounded products, the impact of Medicare reimbursement policies and drug shortages. Myers also examines the role of education and training, reference materials and clinical and professional guidelines and standards published by professional pharmacy organizations, and laws and regulations.
Myers concludes with a thought-provoking exploration of what future innovations and processes, as well as potential hazards, should be considered by experts who are working to improve the safety of sterile compounding. These considerations include:
The importance of avoiding complacency,
The need for unrelenting attention to ensuring sterility,
The future role of education and training,
The introduction of national public health goals related to sterile compounding,
The role of professional pharmacy organizations,
The threat and pressure of drug shortages, and
The importance of developing new methods of sterilization and testing for final preparations.
Myers calls for “innovative thinking,” as well as a “systematic assessment of the nature and the dimensions of the problems in every type of setting where sterile compounding occurs.”
In addition, AJHP is concurrently publishing a related 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, that studies outbreaks of infections related to sterile compounding in the U.S. over the last 12 years in an effort to discover factors that may hinder outbreak detection.