Role of pharmacists in adverse drug reaction reporting in Holy City of Makkah, Saudi Arabia. Characterisation of models for evaluating Pharmacovigilance in the Holy City of Makkah and attitude and awareness of pharmacists towards Adverse Drug Reaction Reporting.

Abstract

Health care systems in Saudi Arabia and elsewhere play a significant role in the lives of individuals as well as society at large. Although healthcare aims at enhancing the quality of life it can sometimes happen that treatment itself can lead to a diminution of the quality of life due to unexpected adverse effects. These problems may cause therapeutic failures or even drug-related morbidity and mortality. Consequently there is a need to have in place a system, conventionally known as Pharmacovigilance. The aims of Pharmacovigilance are to identify, quantify and continuously monitor all drug use through a system which would enable all health care professionals such as physicians, pharmacists, dentists and nurses to contribute. This thesis investigated the present knowledge of and use of, the Pharmacovigilance system in Makkah, in the Kingdom of Saudi Arabia. A mixed method yielded data that provided depth and breadth to the findings of this study. A questionnaire was designed for 170 community pharmacists and 310 respondents drawn from different medical roles across the seven hospitals in Makkah yielded some useful results. Resistance to change was identified in some groups but it was of interest to discover that 72% of respondents who admitted that their knowledge was insufficient were, nevertheless, agreed about its importance. Key issues from the analysis of the questionnaire were used to design the second phase of the sequential mixed method which involved semi structured interviews with seven senior pharmacists, one from each of the seven hospitals. Analysis yielded three overarching categories: Technology, Internalisation and Motivation. A follow up feedback survey at the end of a lecture, of a group of pharmacy students enhanced the overall findings of the study and revealed a very high degree of interest and acceptance of Pharmacovigilance reporting systems and an expressed desire for its inclusion as a subject in its own right in their training programme. Conflicting epistemological positions inherent in a mixed method are candidly admitted and no attempt is made to circumvent this difficulty. Rather, the enhanced nature of the findings is highlighted despite the opposing knowledge claims of both approaches. A key finding was that 59% of the respondents were unaware of the Saudi National Pharmacovigilance centre (NPC) and reporting arrangements. The problems of lack of internet access and of suitable reporting forms were important contributory reasons for the under-usage of the system. There is a need to raise awareness of all pharmacists of the importance of the knowledge and practice of Pharmacovigilance. Technological solutions should be implemented to facilitate reporting at all levels. Continuing professional development should include Pharmacovigilance. Resistance to change can be addressed by identifying the motivational factors that can lead to a more wholehearted acceptance of the importance of Pharmacovigilance for patient care and well-being. Indeed, these could well be the focus of future studies.