The pharmacists suggested to differentiate between types of PIs for the classification, in other words to align the classification level of detail with the complexity of the PI:

R7: “It depends on the type of intervention. I have a pharmacy software with only pharmaceutical records that allows to briefly document interventions such as adjustment of drug package size with a line or with key words. In contrast, when I need to talk to two specialists for a dose adjustment, then a more precise documentation is necessary. It really depends on the complexity.”

Question 4: The pharmacists suggested factors which could enhance the implementation of the PharmDISC system in daily community pharmacy practice. A notable suggestion was the automatic integration of the PI classification form into the patient file:

R1: “It should be integrated into the software. That when you close the prescription assessment in your software, the question ‘Was there an intervention?’ pops up. This appears automatically and you have to choose ‘yes’ or ‘no’.”

The pharmacists further discussed the involvement of pharmacy technicians to complement the pharmacists. This would require the team to be trained and a descriptive manual for the PharmDISC system. A person in charge should be determined who, besides analysing the obtained data, has the ability to motivate and teach the team how to use the PharmDISC system. This approach could facilitate the implementation of the PharmDISC system and overcome issues such as lack of motivation or understanding from team members:

R6: “Someone who is responsible and who understands the importance of it. Every week he/she discusses the results with the team and sometimes he/she can bring an example.”

R8: “There are some interventions, like delivery of adherence aid, which the pharmacy technician can carry out, and others, depending of the intervention type intervention, have to be handed over to the pharmacist.”

PhD Thesis Karen Maes 73 Discussion

The findings of the study confirmed that the PharmDISC system was valid and reliable. Further qualitative results indicated an overall favourable acceptance of the system. This positively answered the research question, which was to investigate whether the PharmDISC system is suitable to classify PIs in community pharmacies.

The PharmDISC system (version 1.0) reached good interrater reliability. The average user agreement was substantial (Κ=0.61). All Κ-coefficients of the classification categories were above the threshold of Κ=0.40, indicating that the results were widely independent of the observers and that the categories were mutually exclusive. Furthermore, the PharmDISC system reached higher interrater reliability than both, the GSASA system (Κ=0.53) [81] and the DOCUMENT system (Κ=0.53) [63]. This shows that the modifications made to the GSASA system were suitable for the community pharmacy setting. The study showed that the majority (94.6%) of the 725 PIs were completely documented with the PharmDISC system which demonstrated its clarity and completeness. These results demonstrated that the PharmDISC system fulfilled the requirements of a valid and reliable classification system.

To our knowledge, this is the first development of a classification system that combines a quantitative and qualitative approach in a mixed methods study. Integrating data from different sources is a challenging and labour-intensive task, but the application of diverse methods provides in-depth and complementary information, and can compensate for inherent weaknesses in single study designs [97, 98]. The Medical Research Council framework [95] proposed the application of diverse methodologies for each stage, which was the case in our piloting stage. Both, the observational study and interrater reliability study provided the quantitative baseline which was used in a qualitative phase to gain the pharmacists’ opinion using a focus group. Although only a limited number of highly motivated and qualified pharmacists participated in the focus group, the findings highlight the factors which positively influenced the PI documentation, while limited insight in possible opposing factors was addressed.

The focus group confirmed the need for a classification system which is compatible with the electronic patient file by pointing out the importance of PI traceability. Similar observations in a survey with community pharmacies in the United States were made, in which the advantages of a computerised system compared with paper charts were highlighted [99]. Pharmacists wished to distinguish the type of intervention depending of the PI complexity. This could be solved by separating technical and clinical PIs. Technical PIs such (e.g. generic substitution) are routine and non-complex PIs that require little time expenditure as opposed to clinical PIs (e.g. dose adjustment). We also discovered that pharmacists are highly motivated to document PIs, as it provides a tangible proof of their work, improves the communication within the team and with other healthcare professionals, and maintains

PhD Thesis Karen Maes 74 quality management. They also mentioned that issues with the quality of PI documentation (e.g.

repeated mistakes) could be improved by the analysis of frequent PIs. Conclusions of such analyses could be included in team training and learning. The increased visibility and transparency of PI-related activities by the pharmacist could provide strong arguments when negotiating a remuneration-based service for PI documentation, which is currently in effect in Australia with the DOCUMENT system [63].

Points for optimisation of the PharmDISC system were discovered in this study. The community pharmacists frequently misinterpreted the subcategory ‘information to the physician’ as the PI.

Therefore, a clear distinction between the PI itself and the communication was needed.

Communication was also a predominant topic discussed in the focus group, finally leading to the creation of a category ‘communication: person involved’ (e.g. introduction of a drug is correctly classified as ‘therapy started’ and not as ‘information to the physician’ although this PI needs communication with the physician, which is additionally documented in category ‘communication’). In Switzerland, the pharmacist is required to inform the prescriber in the case of any change in the prescribed medicines. In Germany, the validation study of the PI-Doc® system showed that the prescriber was contacted in 60.5% of the cases [54]. It could be more convenient to refer all patient to the prescriber once DRPs are detected. It seems that Swiss community pharmacists in most cases decide to initiate the intervention themselves, but in collaboration with the prescriber. With respect to the practice of pharmaceutical care, pharmacists should take responsibility for the patient’s drug-related needs together with other healthcare professionals [100].

In this piloting stage of the project (Part 1), we refined and validated the PharmDISC system within an academic environment, where the PI documentation was performed by trained pharmacy students.

The pharmacists understood the importance of PI documentation. The next step is to validate the herein established PharmDISC system (version 1.1) in real-life daily practice in community pharmacies.

Therefore, Part 2 of the PharmDISC development process highlights the evaluation stage by performing an observational study with practicing community pharmacists, and enabling discussions of implementation aspects.

PhD Thesis Karen Maes 75 Conclusion

The hospital-specific GSASA classification system for PIs was modified into the PharmDISC system for the application in community pharmacies. The PharmDISC system proved to be valid and reached substantial interrater reliability. Almost all PIs could be classified using the PharmDISC system. The system was refined based on the results from the piloting stage and the pharmacists’ suggestions, resulting in a final version which will be tested in an observational study with community pharmacists.

As stated by the pharmacists, PI documentation should enhance traceability and information flow within team and with other healthcare professionals, improving so the visibility of pharmacists’

activities. Documentation can also have a teaching and learning effect and therefore increase quality and performance.

Acknowledgements

We thank the participating fifth-year pharmacy students and their community pharmacies offering internship for collecting prescriptions and documenting the cases. The authors thank the members of the focus group (Dr. Patrick Eichenberger, Dr. Patrick Imfeld, Andrea Studer, Dr. Fabienne Böni, Pascale Prétot, Renate Allemann, Eva Franz, Dr. Jérôme Berger, Sara Zehnder) who contributed to our findings.

We thank Dr. Roland Preston for proof-reading.

Funding

No grants from any external funding body were received to conduct this study.

Conflict of interest None.

Appendix

A2.1.1 Study protocol for Ethics committee

A2.1.2 Study information sheet for the master pharmacy students A2.1.3 Case Report Form PharmDISC Part 1

A2.1.4 Two model pharmaceutical interventions, adapted from Ganso et al. for the training with the online voting (Movo.ch)

A2.1.5 Three model pharmaceutical interventions, adapted from Ganso et al.

PhD Thesis Karen Maes 76 Supplementary Fig.: The PharmDISC system (version 1.1)

PhD Thesis Karen Maes 77

B2 Documentation of pharmaceutical care: validation of an intervention oriented