1. Reducing the risk of non-sterility of aseptic handling in hospital pharmacies, part A: risk assessment
- Author
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Paul P H Le Brun, Judith M Ris, Daan J Touw, F. A. Boom, Tjitske Veenbaas, Pharmaceutical Analysis, Biopharmaceuticals, Discovery, Design and Delivery (BDDD), Groningen Research Institute for Asthma and COPD (GRIAC), Critical care, Anesthesiology, Peri-operative and Emergency medicine (CAPE), and Medicinal Chemistry and Bioanalysis (MCB)
- Subjects
medicine.medical_specialty ,self-inspection ,protocols & guidelines ,Systematic survey ,audit ,Audit ,Pharmacists ,Risk Assessment ,risk management ,030226 pharmacology & pharmacy ,03 medical and health sciences ,0302 clinical medicine ,Humans ,Medicine ,030212 general & internal medicine ,General Pharmacology, Toxicology and Pharmaceutics ,Hospital pharmacy ,disinfection ,Risk management ,Pharmacies ,Relative value ,business.industry ,small scale ,Hospitals ,manufacturing ,Scale (social sciences) ,aseptic preparation ,Emergency medicine ,Good Manufacturing Practice (GMP) ,reconstitution ,validation preparation process ,Aseptic processing ,compounding (individualised preparation) ,Risk assessment ,business - Abstract
OBJECTIVES: To determine prospectively the sources of risk of non-sterility during aseptic handling and to quantify the risks of each of these sources.METHODS: A risk assessment (RA) of non-sterility according to Failure Mode and Effect Analysis was executed by a multidisciplinary team of (hospital) pharmacists and technicians, a consultant experienced in aseptic processing and an independent facilitator. The team determined the sources of risk of non-sterility, a 5 point scale for severity, occurrence and detection, and risk acceptance levels. Input about general applied risk reduction was collected by audits in 10 hospital pharmacies. The results of these audits were used for determining the remaining risks. The results, as well as scientific information and the experience of the team members, was used to determine scores for severity, occurrence and detection.RESULTS: Multiplying the scores for severity, occurrence and detection results in the risk prioritisation number (RPN) which is a relative value of the remaining risks of non-sterility for each source. Incorrect disinfection techniques of non-sterile materials and the chances of touching critical spots were estimated as the greatest risks. The risk of non-sterility via the airborne route was low. RPN values were helpful in prioritising measures for additional risk reduction (this will be described in an accompanying article).CONCLUSION: The RA, described here, was a systematic survey related to all sources of risk of non-sterility during aseptic handling. The determined RPN values were helpful in prioritising measures for additional risk reduction.
- Published
- 2020