Assessing the impact of training and remodeling of adverse drug reaction reporting systems on the practice of pharmacovigilance in Malawi
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Date
2021-06-16
Authors
Journal Title
Journal ISSN
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Publisher
Kamuzu University of Health Sciences
Abstract
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
Description
Keywords
Research Subject Categories::PHARMACY