Development and validation of a quality system for community pharmacy practice

Abstract

Quality performance instruments focusing on different service aspects are developed for community pharmacy practice. This study aimed to design, validate, and implement a community pharmacy quality framework (CPQF) and standard operating procedure (SOP) templates covering quality aspects. It also aimed to test the feasibility of implementing the developed quality system. The methodology involved: (1) a literature review to identify the main quality aspects in community pharmacy practice, (2) design of the CPQF and SOPs through Maltese Legislation and published global pharmacy practice standards, (3) validation of the documentation through a focus group, (4) thematic analysis, (5) design and validation of a Feasibility Questionnaire and (6) questionnaire dissemination to 14 community pharmacies identified through stratified random sampling. Data analysis was undertaken and the Friedman Test and Kruskal Wallis Test were applied. The literature analysis performed led to the determination of quality aspects in relation to community pharmacy practice: (1) Care, (2) Safety, (3) Improvement and (4) Services. The four quality aspects were each subdivided into pertinent sections. Four SOPs related to these quality aspects were designed. Five main findings were noted from the Feasibility Questionnaire (N=14): (1) eight participants strongly agree and five agree that the quality system designed can help standardise quality aspects in community pharmacy practice in Malta, (2) eight participants strongly agree and six agree that the SOPs cover all aspects checked within an inspection, (3) nine participants strongly agree and four agree that they will pass the inspection when using these SOPs, (4) A significant difference between the mean rating scores of the statements within the Layout (p=0.013) and Use (p=0.006) section was noted. There was no significant difference between the mean rating scores within the Applicability (p=0.146) section, (5) The mean rating scores vary significantly between the different districts with regards to CPQF ease of use (p=0.040) and SOP use prior to an inspection (p=0.013). This variability can be attributed to the low scores provided by the Northern Harbour district. The study has delivered a validated Framework and interlinked SOPs for the assessment of quality of community pharmacy services.