Risk management - component of the pharmaceutical quality system

Abstract

Introduction. In the pharmaceutical field, quality management is very important, and risk management is a valuable component of an effective quality system. It involves anticipating hazards and controlling risk through a process of awareness, reduction and review of risks. By applying risk management methods, this research presents the risk of errors in the activities of community pharmacies. Aim of study. Research and demonstration of the usefulness of risk management strategies in optimizing the activity of the pharmacy and evaluating the impact of risk management in the provision of quality services by community pharmacies. Methods and materials. The causes that may lead to medication errors in community pharmacies have been identified using the Ishikawa diagram, the potential risks of errors have been analyzed and evaluated by applying the risk hierarchy method and the relationship diagram, highlighting activities in the pharmacy during which medication errors may occur. In order to establish the activities carried out by the pharmacist and to assess the causes that may lead to the risks of errors in the community pharmacy, brainstorming was used as a technique to stimulate creativity. Results. A number of 46 potential risks of medication errors were identified, of which 17 are present in the activity of dispensing medicines, 12 risks of errors in the activity of receiving medicines, 9 causes of errors in the activity of ordering medicinal products and 8 causes of errors in the activity of storing medicines. By applying the risk classification technique, values of probability of occurrence of risks and severity of the result for each risk were obtained, which provided a two-dimensional picture of the risks. The potential risks of error were highlighted using the relationship diagram. This resulted in the following risks, which had a higher score, for which urgent measures should be taken to minimize the risk: wrong release of medicines (score 9, extreme risk); erroneous counseling of the patient (score 6, high risk); release of the wrong amounts of drugs or expired drugs (score 6, high risk). Conclusion. The results of this study provide the basis for further research in order to develop a Risk Management Plan in the community pharmacy. The causes that can lead to errors in the pharmacy have been highlighted and quantified by highlighting pharmaceutical activities, during which risks of errors may arise. The work has practical utility, and the results of the research can be applied by pharmacies, contributing to the improvement of their performance.