Background The Spanish law indicates that sterile preparations technicians must have a minimum level of education. However, the requirements demanded by the USP are stricter than Spanish law, and, in some ways, stricter than GMP.
Purpose To evaluate the level of training of sterile preparations technicians in Spanish pharmacy services, and compare with the requirements of the USP. Second, to evaluate the level of implementation of other measures assumed by the USP.
Materials and methods The authors conducted a telephone survey with 15 multiple choice questions on the type of hospital, staff responsible for the different preparations (parenteral nutrition (PN), cytostatics (CIT), intravenous mixtures (IVMs), other sterile products (SPs) etc.). The type of training required of personnel to handle these products was investigated. In addition environmental monitoring was evaluated and operator aseptic technique was validated microbiologically. The hospitals surveyed were selected choosing at least one hospital with over 500 beds, and one of fewer than 500 beds from each region.
Results 31 hospitals responded to the survey (three of <100 beds, nine of 100–200 beds, 10 of 200–500 beds, eight of 500–1000 beds, and 1>1000 beds). In most, sterile preparation was performed by nurses (55% of hospitals with PN, 71% hospitals with CIT, 48% hospitals with IVM and 41% of other SPs). The experience of staff assigned to the preparation of sterile products was in all cases greater than 6 months. Only eight hospitals (26%) had an initial training plan. Other aspects covered by the USP, such as environmental control and microbiological control, were performed by 86% of hospitals surveyed. However the aseptic technique was only validated in three hospitals
Conclusions Nurses with more than 6 months experience are responsible for handling sterile preparations in most pharmacy services in Spanish hospitals. The majority of pharmacy services performed microbiological and environmental monitoring on the finished products. However, other aspects related to the quality of preparation and patient safety such as the accreditation of operator aseptic technique, were almost negligible, which is a clear opportunity for improvement.
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