Affiliation:
1. American Society of Health-System Pharmacists, Bethesda, MD
Abstract
Abstract
Purpose
The evolution of sterile compounding in the context of hospital patient care, the evolution of related technology, past incidents of morbidity and mortality associated with preparations compounded in various settings, and efforts over the years to improve compounding practices are reviewed.
Summary
Tightened United States Pharmacopeial Convention standards (since 2004) for sterile compounding made it difficult for hospitals to achieve all of the sterile compounding necessary for patient care. Shortages of manufactured injections added to the need for compounding. Non-hospital-based compounding pharmacies increased sterile compounding to meet the needs. Gaps in federal and state laws and regulations about compounding pharmacies led to deficiencies in their regulation. Lapses in sterility led to injuries and deaths. Perspectives offered include potential actions, including changes in practitioner education, better surveillance of sterile compounding, regulatory reforms, reexamination of the causes of drug shortages, and the development of new technologies.
Conclusion
Over the years, there have been numerous exhortations for voluntary better performance in sterile compounding. In addition, professional leadership has been vigorous and extensive in the form of guidance, publications, education, enforceable standards, and development of various associations and organizations dealing with safe compounding practices. Yet problems continue to occur. We must engage in diligent learning from the injuries and tragedies that have occurred. Assuming that we are already doing all we can to avoid problems would be an abdication of the professional mission of pharmacists. It would be wrong thinking to assume that the recent problems in large-scale compounding pharmacies are the only problems that warrant attention. It is time for a systematic assessment of the nature and the dimensions of the problems in every type of setting where sterile compounding occurs. It also is time for some innovative thinking about ensuring safety in sterile compounding.
Publisher
Oxford University Press (OUP)
Subject
Health Policy,Pharmacology
Reference188 articles.
1. Centers for Disease Control and Prevention. Multi-state meningitis outbreak—current case count. www.cdc.gov/hai/outbreaks/meningitis-map.html (accessed 2013 Apr 3).
2. Adams Drugs. The history of compounding. www.adamsdrugs.net/pharmacy-services/history-of-compounding.php (accessed 2012 Nov 29).
3. University Compounding Pharmacy. History of compounding. www.ucprx.com/history_of_compounding (accessed 2012 Dec 29).
4. Riley
RJ
. The regulation of pharmaceutical compounding and the determination of need: balancing access and autonomy with patient safety. www.leda.law.harvard.edu/leda/data/646/Riley.html (accessed 2012 Dec 29).
5. Kowalczyk
L
Lazar
K
. Supervision of pharmacies is questioned. www.bostonglobe.com/metro/2012/10/05/compounding-pharmacy-oversight-questioned/Ia56kr4Kz2eP1U0exViaGK/story.html (accessed 2012 Dec 1).
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