Browsing by Author "Chimimba, Frider"

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    Assessing the impact of training and remodeling of adverse drug reaction reporting systems on the practice of pharmacovigilance in Malawi
    (Kamuzu University of Health Sciences, 2021-06-16) Chimimba, Frider
    Pharmacovigilance (PV) system is essential in every country to ensure patient safety and public health in relation to medication. Strong and effective PV is achievable if there are collective efforts from well trained and informed health care professionals who are able to monitor, detect and report suspected adverse drug reactions (ADRs) using convenient and effective reporting tools. Type of the study This is a cross sectional survey that will use quantitative approach to assess the ADR reporting rates, knowledge, attitudes and practices and qualitative approach to seek opinions of healthcare workers on pharmacovigilance. Problem In Malawi and other low- and middle-income counties (LMICs), PV systems are weak and reporting of adverse drug reactions is still low. Furthermore, the currently used traditional paper-based ADR reporting tools face logistical challenges which result in delays in transmission of information and compromise confidentiality. As a way of continued efforts to counter these challenges, the Malawi Pharmacy and Medicines Regulatory Authority (PMRA) with support from the World Health Organization (WHO) have been conducting PV training among Health Care Professionals (HCPs) on basic principles of PV. They are also in the process of establishing Unstructured Supplementary Service Data (USSD) system for reporting of adverse drug reactions and other medicine related problems. However, the impact of the training and use of USSD reporting system on PV in Malawi is not known. Objectives Our main objective of this study is therefore to assess the impact of the training on knowledge, attitudes and practices (KAP) of Pharmacovigilance and use of USSD reporting system on the ADRs reporting rate. The specific objectives are to:  To assess the KAP of healthcare professionals on Pharmacovigilance after undergoing PV training  To investigate the preferences of healthcare professionals on the reporting tools for ADRs  To evaluate the improvement on ADR reporting rate after introducing USSD system training HCP on PV Methodology We will recruit HCPs who participated in PV trainings conducted by PMRA, from randomly selected districts in Malawi. Quantitative data will be collected using a structured questionnaire from all participants who participated and responded to a similar questionnaire before the training to assess the KAP after the training. Face-to-face interviews will be conducted to conveniently sampled participants using a semi-structured questionnaire to collect qualitative data on the usability of USSD system and preferences of HCPs on ADR reporting tools. Quantitative data will be analyzed using both descriptive and analytical statistics in Statistical Package for Social Sciences (SPSS) while qualitative data will be analyzed manually or using NVivo by content thematic analysis. Expected findings We hope that there will be improved level of knowledge, attitudes and practices among healthcare workers after undergoing training and also an improved rate of ADR reporting after launching USSD system as compared to the paper-based reports. In addition, the opinions and preferences of healthcare workers on PV tools will also be known from the study. Dissemination of results The results of this study will be shared with stakeholders such as WHO, Ministry of Health, Pharmacy and Medicines Regulatory authority, members of the academia and COMREC through conferences, meetings and publications. Key words: Adverse drug reactions, drug safety monitoring, Pharmacovigilance