Introduction: Dispensing of prescription medicines to patients is a complex process, in which pharmacists have the aim to ensure the patient’s medication safety (MS). The process is supported by related preconditions, for instance interprofessional cooperation and digitalisation. Due to different implementation of such preconditions, process organisation and the way MS is ensured differs between countries. In addition, this can also have an impact on different risk potentials of the process steps. At present, the relationship between process steps, their risk potential and associated preconditions to ensure MS within dispensing is not analysed. Therefore the aim of this study is to develop a comprehensive generic model that describes the dispensing process in community pharmacies with the risk potential of the process steps on affecting MS as well as related preconditions to warrant MS. The model will be developed from the current situation in the Netherlands and presented to Dutch and German experts for a first assessment on clarity and applicability.

Methods: First, a desktop literature research was conducted to collect data from recent Dutch pharmacy practice research papers and additional international papers to assess completeness. Information on patients, situations and medicines with an increased risk for MS, as well as measures to enhance MS within dispensing was extracted. Second, practice observations and interviews were conducted in two Dutch community pharmacies to enquire relevant process steps and preconditions during dispensing. By applying the ‘Target Operating Model’, preconditions were categorised and a first model approach was designed using the first results achieved. Third, the first model approach was evaluated by Dutch dispensing experts who conducted a simplified ‘Failure Modes and Effects Analysis’ to assess the risk potential of dispensing steps and a focus group to prioritise process steps and preconditions for relevance. The second model approach was generated using the insights of the Dutch assessment and generic terms for process steps and preconditions. Fourth, the clarity and potential applicability of the second model approach was assessed by German dispensing experts. Finally, the dispensing model was designed using the suggestions for improvement from the German experts. 

Results: 18 Dutch PPR papers were included. Hospital discharge, antithrombotics and patients with limited health literacy were risk examples. A measure for enhancing MS was for instance patient education following discharge. Six papers from other countries did not contain any further information. Two Dutch community pharmacies were visited and each a community pharmacist and technician was interviewed. The first model approach consisted of twelve dispensing steps, seven domains for preconditions and was filled with Dutch practice examples. This was assessed by nine Dutch experts within the focus group. The second model approach was generated as a matrix, whereby the steps of dispensing were categorised into five main clusters consisting of 13 sub-steps and five domains for preconditions. Five process steps were assessed with a high risk for MS. Clarity of the second model approach was generally understood by German experts, whereby further exchange is needed to identify the challenges where the application is still difficult. The dispensing model was designed. 

Discussion: Dispensing process steps require specific preconditions to ensure MS, such as laws, a professional patient relationship or a digital infrastructure for patient information exchange, which is illustrated with the developed model. It could be useful for expanding dispensing competencies, professional discussions in politics or teaching purposes. Furthermore, it can help to prioritise preconditions and process steps for future implementations based on importance. The application of the model, e.g. to the German situation still needs to be investigated. It could be of interest for the current introduction of the electronic patient file in Germany, in order to see how the model can help to optimally implement the electronic patient file and thus ensure MS.

Conclusion and outlook: The developed generic dispensing model shows the essential relationship between the dispensing process and the associated preconditions required for warranting MS in community pharmacies. The model confirms and emphasises the importance of community pharmacists as well as the importance and complexity of the dispensing process. Areas of application could be the expanding of dispensing competencies, professional discussions in politics or teaching. Further application and transferability of the model should be investigated, i.e. in other countries or health areas.