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Executive Summary

Incidences of patient morbidity and mortality associated with improperly prepared or contaminated sterile preparations have prompted the FDA to consider regulating or even banning pharmacy compounding.[1]  The first official, enforceable sterile preparation compounding requirement in the United States took effect on January 1, 2004, when United States Pharmacopeia published USP Chapter <797>.  This Chapter is now the US standard for pre-administration manipulations of compounded sterile preparatons (CSPs), which includes compounding, transportation, and storage.  <797> focuses on protecting patients and therefore applies not only to pharmacies but to all sites where CSPs are compounded and to all personnel who compound sterile preparations, regardless of practice setting or profession.[2]

The following article discusses the history of sterile compounding in pharmacy practice, current state, and the need for a purpose-built facility that provides practical, hands-on training in pharmacy preparation and regulatory compliance in order to achieve the level of patient safety and performance excellence required in today’s pharmacy environments.

History

Compounding is an integral part of today’s pharmacy practice.  However, this has not always been the case.  As the pharmaceutical industry expanded during the early to mid-20th century, the need to perform pharmaceutical compounding became less important as the pharmaceutical industry provided many different dosage forms for most of the drugs available; including oral solids, oral liquids, parenterals, topicals, suppositories and so on.[3]  Therefore, the role of the USP, which once set standards for drug products prescribed by physicians and prepared (compounded) by pharmacists, changed from that of setting practice standards for pharmacists to setting industry standards for manufactured drug products.

During the 1960’s and 1970’s, intravenous (IV) admixture services were incorporated into hospital pharmacy departments from nursing services.  Then, compounding primarily consisted of manipulating commercially available dosage forms.[4]  Operations were low risk, and few patients experienced problems with the final sterile preparations.  Pharmacists believed they were fulfilling their responsibility to ensure CSP sterility, safety, and efficacy.[5]  Pharmacies grew complacent about aseptic preparation of IV products, and the USP and NF, formerly required textbooks and reference books in colleges of pharmacy, were removed from the curriculum.[6]  Though much of their content continued to set standards of practice for the dispensing pharmacy, the books no longer reflected information used in contemporary pharmacy practice.[7]

During the 1980’s and 1990’s, the increasing demand from home health care, total parenteral nutrition, hospice care (in particular, pain management) combined with pharmaceutical manufacturers decreasing the number of available dosage forms led to an increasing number of compounded prescriptions.[8]  In addition, many physicians prescribed therapeutic agents or alternative dosage forms that were not commercially available and therefore, required compounding.[9]

Aseptic knowledge and skills, however, had not kept up with marketplace demand and were not being taught in schools of pharmacy, with subsequent carryover to standards of practice.  This, coupled with the growing complexity of drugs and drug products made it inevitable that pharmacies would commit errors while preparing and distributing compounded sterile products (CSPs).[10]

Link to Baxa Corporation's Patient Safety and Peak Performance Through Pharmacy Training Technical Paper