Competencies for the position of the Responsible Person in good distribution practice
DOI:
https://doi.org/10.46542/pe.2023.231.3038Keywords:
Competency, Good distribution practice, Pharmacy education, Responsible person, SkillAbstract
Defined competencies are not currently established for technical personnel working in the pharmaceutical wholesale distribution setting who must adhere to Good Distribution Practice (GDP). Educational development for the Responsible Person (RP) position is topic-driven and not competency based. This research aimed to establish a validated tool to identify competencies relevant for the role of the Responsible Person (COMP-RP tool). There were 62 criteria based on competencies, knowledge, and skills across six domains which were included in the draft COMP-RP tool developed. The tool was based on a Likert scale ranking. Two Delphi rounds by a panel of experts were applied for validation. Data were statistically analysed and passed through cut-off points to reach final version of the COMP-RP Tool. The selection of wholesale distribution, quality and leadership skills, knowledge and competencies were consistently rated both Delphi rounds. The final validated COMP-RP Tool consisted of 58 criteria across the six domains.
References
Akparobore, D., & Omosekejimi, A. (2020). Leadership qualities and style: a panacea for job productivity and effective service delivery among library staff in academic libraries in South South, Nigeria. Library Management, 41(8/9), 677-687. https://doi.org/10.1108/LM-02-2020-0025
Anderson, C., Bates, I., Beck, D., Brock, T., Futter, B., & Mercer, H. et al. (2008). The WHO UNESCO FIP Pharmacy Education Taskforce: Enabling Concerted and Collective Global Action. American Journal Of Pharmaceutical Education, 72(6), 127. https://doi.org/10.5688/aj7206127
Atkinson, J., Rombaut, B., Pozo, A., Rekkas, D., Veski, P., & Hirvonen, J. et al. (2014). The Production of a Framework of Competences for Pharmacy Practice in the European Union. Pharmacy, 2(2), 161-174. https://doi.org/10.3390/pharmacy2020161
Atkinson, J., Crowley, P., De Paepe, K., Gennery, B., Koster, A., & Martini, L. et al. (2015). A European Competence Framework for Industrial Pharmacy Practice in Biotechnology. Pharmacy, 3(3), 101-128. https://doi.org/10.3390/pharmacy3030101
Atkinson, J., De Paepe, K., Pozo, A., Rekkas, D., Volmer, D., & Hirvonen, J. et al. (2016). A Study on How Industrial Pharmacists Rank Competences for Pharmacy Practice: A Case for Industrial Pharmacy Specialization. Pharmacy, 4(1), 13. https://doi.org/10.3390/pharmacy4010013
Bajis, D., Chaar, B., Penm, J., & Moles, R. (2016). Competency-based pharmacy education in the Eastern Mediterranean Region-A scoping review. Currents In Pharmacy Teaching And Learning, 8(3), 401-428. https://doi.org/10.1016/j.cptl.2016.02.003
Bhaskaran J & Venkatesh MP. (2019). Good Storage and Distribution practices for Pharmaceuticals in European Union. J. Pharmaceutical Sciences and Research. 11(8): 2992-2997
Croft, H., Gilligan, C., Rasiah, R., Levett-Jones, T., & Schneider, J. (2019). Current Trends and Opportunities for Competency Assessment in Pharmacy Education-A Literature Review. Pharmacy, 7(2), 67. https://doi.org/10.3390/pharmacy7020067
Deshpande, P. (2013). Should the PharmD Degree Be the Basic Educational Requirement in India for Pharmacists?. American Journal Of Pharmaceutical Education, 77(6), 132. https://doi.org/10.5688/ajpe776132
Henman, M. (2020). Pharmacy Education; Competency and Beyond. Pharmacy, 8(2), 104. https://doi.org/10.3390/pharmacy8020104
Jeong, S., & Ji, E. (2017). Global perspectives on ensuring the safety of pharmaceutical products in the distribution process. International Journal Of Clinical Pharmacology And Therapeutics, 56(01), 12-23. https://doi.org/10.5414/CP203151
Martin, L., Donohoe, K., & Holdford, D. (2016). Decision-Making and Problem-Solving Approaches in Pharmacy Education. American Journal Of Pharmaceutical Education, 80(3), 52. https://doi.org/10.5688/ajpe80352
Stoimenova A, Kirilov B, Zaykova K. (2019). Analysis of good distribution practice inspection deficiency data of pharmaceutical wholesalers in Bulgaria. Pharmacia. 66 (3):85-89
The European Parliament and the Council of the European Union. (2011). The code relating to medicinal products for human use European Directive, 2001/83/EC. Official Journal of the European Communities; L 311/67-128. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004481.pdf
Vetiutneva, N., Ubohov, S., & Fedorova, L. (2018). Methodological substantiation of the professional functions of Responsible persons of pharmaceutical and hospital institutions. Current Issues In Pharmacy And Medicine: Science And Practice, 0(1). https://doi.org/10.14739/2409-2932.2018.1.123723
Volmer, D., Sepp, K., & Raal, A. (2021). Students' Feedback on the Development of a Competency-Based Pharmacy Education (CBPE) at the University of Tartu, Estonia. Pharmacy, 9(1), 45. https://doi.org/10.3390/pharmacy9010045
Von Brockdorff B, Azzopardi LM. (2022). Requirements for the good distribution practice of medicinal products. Regulatory Rapporteur. 19 (1): 26-28
Wadelin, J., Travlos, D., Janke, K., Zellmer, W., & Vlasses, P. (2017). Current and Future Opportunities and Challenges in Continuing Pharmacy Education. American Journal Of Pharmaceutical Education, 81(3), 44. https://doi.org/10.5688/ajpe81344