Evaluation of Glibenclamide Quality and Stakeholders’ Perception of Medicine Quality in the Clinical Settings of the Ministry of Interior in Saudi Arabia
Alghannam, Abdulaziz Fahad A
Aim: To explore medicine quality and perception among the stakeholders in the Ministry of Interior Medical Services (MOI-MSD) clinical settings in Saudi Arabia using glibenclamide as an indicator. Method: A mixed method approach was used in two phases. Phase one involved chemical analysis for identity and quantity of the active pharmaceutical ingredient (API), visual analysis and authentication of source of a popular diabetes medicine (glibenclamide) collected from MOI-MSD general warehouse in Riyadh, Saudi Arabia. Phase two contained a focus group discussion, self-completed survey questionnaires and semi-structured interviews to explore the perceptions of various stakeholders including commissioners, physicians, pharmacists and patients in the MOI-MSD settings in Saudi Arabia about medicine quality and related problems. Data analysis: Phase one collected quantitative data of API quantity from the chemical analysis of glibenclamide samples using a high performance liquid chromatography apparatus (HPLC) based on United States Pharmacopoeia (USP 36) method. The visual inspection of glibenclamide samples was performed using tool kit developed by The World Health Professions Alliance (WHPA) and The International Pharmaceutical Federation (FIP). The authentication of glibenclamide source was performed by on-site comparison of available samples in the general MOI-MSD warehouse with the available official reception documents. Phase two collected quantitative and qualitative data regarding perceptions about medicine quality and related problems and subsequently analysed them using SPSS for descriptive statistics and NVivo version 10 for thematic analysis following data coding and the development of themes and sub-themes. Subsequently, stakeholders’ data were triangulated to establish common and specific themes and sub-themes among MOI-MSD stakeholders. Findings: Phase one of the study found that all glibenclamide samples were within acceptable USP limits in terms of identity and quantity between 90-110%. It was also found that all available glibenclamide batch numbers were present in the official reception documents and the visual analysis of samples revealed no visible errors on the medicine samples or its packaging. Phase two of the study found that most stakeholders, particularly commissioners and physicians, believed that medicine quality was good or excellent in Saudi Arabia. However, the commissioners, physicians and pharmacists believed that the quality of medicines in the MOI-MSD was less than what is available in Saudi Arabia but patients mostly disagreed with these views. Most patients believed that the quality of medicines was high in both the Saudi Arabian market and in the MOI-MSD settings. Limited knowledge about good quality medicines and counterfeit medicines was found among most stakeholders where the quality of medicines was commonly associated with the effect rather than technical attributes of medicines including content, appearance and source. The stakeholders in this study reported a wide range of behaviour when in doubt about medicine quality such as reporting these doubts to authorities, finding alternative medicines, stopping the medicine use and taking no further action regarding these doubts. Furthermore, all stakeholders have identified medicine procurement focusing on price rather than quality, difficulty in reporting medicine quality problems and medicine storage conditions as challenges to medicine quality in the MOI-MSD. Patients, particularly chronic patients from Jeddah city, have complained about medicine non-availability in their local MOI-MSD primary clinic and expensive medicine prices. Conclusions: Glibenclamide quality in the MOI-MSD settings was found to be acceptable in terms of API identity and quantity, source and visual appearance. The perception about medicine quality in these settings seems to be low particularly from commissioners and pharmacists but not the patients. There is an urgent need to implement quality assurance steps to increase the commissioners and pharmacists trust in the quality of their medicines at the medicine selection, procurement, storage and transportation stages in addition to improving the accessibility to report medicine quality problems to all stakeholders. Subsequently, future research is needed to measure and evaluate the impact of these quality assurance steps on the confidence of commissioners and pharmacists trust in the quality of the MOI-MSD medicines. Furthermore, patients’ issues about medicine non-availability need to be addressed rapidly as it could result in patients’ acquiring medicines from unknown sources and/or cause additional financial burdens.