Browsing by Subject "aseptic technique"
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(2020)Parenteral products are sterile products that are administered as injection, infusion or implantation. Administration of the contaminated parenteral product can cause severe consequences such as sepsis meningitis and even death. Most of the parenteral products used at the hospitals needs to be compounded (e.g. dissolved, diluted) before administration. Whenever possible, compounding should be done in biological safety cabinet using aseptic techniques. According to previous studies errors in aseptic techniques are quite common. Aim of this study was to compare three different environments as compounding area and their effect to the sterility of the compounded parenteral product. Based on the results of this study, changes to the protocols of the hospital could be made. Altogether 220 samples were compounded at two pediatric wards at HUS Helsinki University Hospital. Six volunteers (one pharmacist and five nurses) participated from both wards and each compounded 18 samples in three different environments (patient room, medicine room, biological safety cabinet). The samples were tested for the sterility by membrane filtration within 4 hours or after 24 hours of storage in the refrigerator. The investigator used an observation form to observe the compounding procedures. Environmental monitoring (settle plates) and monitoring of personnel (glove samples) were conducted. Almost all compounded samples (99%, n=213/215) were sterile. There were no significant differences in the contamination rate of the compounded samples between different environments. Five of the collected samples were excluded, because they were contaminated during the sterility test. According to observations, aseptic techniques were well followed. However, disinfection of the septum of the medicine bottle, hand hygiene and cleaning of the compounding area were observed to be deficiently completed. Even though there were lot of variation in the environmental and personnel monitoring the results were quite good. Results from the environmental monitoring were compared to the recommended limits of EU GMP for clean areas. One compounded sample was contaminated with Diezia maris and Corynebacterium mycetoides but the contaminants from the other contaminated sample could not be identified. Aseptic techniques were mainly well followed, however compounding should be done in the biological safety cabinet, since the environmental monitoring results show that the biological safety cabinet was only environment which was within the recommendation limits of the EU GMP for the compounding area of parenteral products. Protocols of the hospital could be changed, since there was no correlation between higher contamination rate of settle plates or compounded samples and not wearing mask and hair cover while compounding in the biological safety cabinet.
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(2015)In hospital care many medicines should be usually prepared before they are administered to patients. In Finland Finnish Medicines Agency (Fimea) gives regulatory requirements and instructions for preparation of medicines in hospital pharmacies and action in hospital pharmacies is strictly controlled regularly by Fimea. According to Fimea's instructions hospital pharmacies should also ensure that medicines are prepared properly before they are administered to the patients in hospital wards. Preparing of medicines in hospital wards should be done in accordance with instructions given from the hospital pharmacy. Medicines should be prepared by using aseptic technique in order to protect patient safety. Aim of this study was to develop an assessment tool which can be used to assess the quality of ward- prepared medicines. The assessment tool should be suitable for self-assessment and external audit. Aim of the assessment tool is to ensure the safety of preparation of medicines in the wards and at the end improve patient safety. For the assessment tool ISMP Guidelines for safe preparation of sterile compounds were translated to Finnish. The assessment tool was then developed from the translated ISMP-guideline and other literature. The assessment tool was validated by using two-rounded Delphi-method. Delphi-method is a consensus method in which selected experts evaluate the data. At the first Delphi-round suitability and feasibility of the tool were evaluated and new items were created based on the consensus of experts. At the second round the feasibility of the tool items, which were developed by the first round, were evaluated once again. A total of 19 experts were participated to the Delphi-rounds. After the Delphi-rounds the developed assessment tool contained 64 items for safe preparing of medicines in hospital wards. The developed assessment tool reviews the entire process of preparing medicines and it can be used to identify which items are not followed in preparing of medicines before administering to patients in hospital wards. The developed assessment tool for safe preparation of medicines in hospital wards can be used widely in Finnish hospitals in order to ensure the quality of preparing medicines and detect the deficiencies and errors in preparation processes. By detecting deficiencies and errors in preparing medicines, they can be corrected and processes can be modified appropriate. In this way patient safety can be improved.
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