Asynchronous Validation and Documentation of Sterile Compounding in a Hospital Pharmacy

Abstract

The US Pharmacopeial Convention published the USP Guidebook to Pharmaceutical Compounding— Sterile Preparations in 2008. This publication, which is based on the USP Revised General Chapter , sets practice standards to help ensure that compounded sterile preparations are of high quality. Although these guidelines have not yet been enforced by the Quebec regulatory authority, they will be the basis of revised guidelines to be published in 2011 by l’Ordre des pharmaciens du Quebec. The release of the USP Revised General Chapter is prompting pharmacists and technicians to substantially revise their practice to reduce potential contamination, to limit access to the sterile zone whenever possible, and to appropriately document all steps of the compounding process. In our institution, pharmacy technicians prepare sterile products several times a day. Each of these products must be verified by a pharmacist, which entails the pharmacists entering and exiting the clean room repeatedly, in addition to carrying out their other duties. This time-consuming practice increases the risk of microbiological and particulate contamination. Furthermore, each visual inspection performed in the clean room interrupts the workflow of both the pharmacist and the technician. Interruptions and distractions are a documented cause of medication errors in pharmacies. Traditionally, telepharmacy has been defined as the use of various telecommunications systems to provide pharmaceutical services and care to remote or rural areas or to provide such services during times when pharmacists are not readily available on site (e.g., at night). When the photographic system described in the current article was being developed, there were no published reports on the use of cameras as an aid during sterile compounding. We analyzed our procedures and set the following objectives: (1) to develop an asynchronous workflow that would reduce interruptions (and thereby reduce the risk of medication errors) and (2) to develop a technological solution that would enable pharmacy technicians to capture images of the various steps in preparing medications, which would in turn allow the pharmacist to asynchronously verify the accuracy of the pharmaceutical ingredients, materials, and quantities and would serve as documentation for subsequent reference. This article describes the development, implementation, and use of a photographic system that allows pharmacists to supervise and document the activities of pharmacy technicians according to a time-delayed approach.