Development and content validation of an assessment tool for medicine compounding on hospital wards

Background Medicines should be compounded by using an aseptic technique to assure patient safety. The parenteral administration of microbiologically contaminated doses can result in bacteriaemia, other morbidity and even death. Objective The purpose was to develop and content validate an assessment tool for medicine compounding on hospital wards suitable for self-assessment and external audit to ensure the safety of medicine compounding on wards. Setting Finland as setting. Method The first draft of the tool was based on ISMP "Guidelines for safe preparation of sterile compounds" and a systematic literature search. The tool was validated by using a two-rounded Delphi-method with a panel of 19 experts. Suitability and feasibility of each item was evaluated. Main outcome measure An agreement of ≥70% on each item was required. Results The final tool comprises of 64 items under the following topics: (1) general principles of good compounding practices (23 items), (2) recording and confirming medicine orders on the wards (5 items), (3) storage of medicines on the wards (7), (4) aseptic compounding of intravenous medicines (25 items) and (5) quality assurance (4 items). Most items related to General principles of good compounding practices and Compounding of IV medicines (36 and 38% of the items, respectively). Conclusion It was possible to develop and content validate, by the Delphi method, an assessment tool for safe aseptic compounding on hospital wards. A two-round Delphi process yielded consensus on 64 items for this purpose.