A Cross-Sectional Pilot Study on Pharmacovigilance to Improve the Drug Safety in Bangladesh
Md. Akter Hossain1 and Md. Shah Amran*2

1Directorate General of Drug Administration, Mohakhali, Dhaka, Bangladesh.

2Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Dhaka, Dhaka-1000, Bangladesh.

Corresponding Author E-mail: amranms@du.ac.bd

Abstract: The monitoring of drug safety is a crucial element for the effective use of medicines to maintain high-quality medical care. The aim of this study was to analyze the adverse drug reactions (ADRs) as well as improve drug safety through pharmacovigilance (PV) in Bangladesh. The research work was conducted on the basis of a questionnaire by taking interviews of targeted stakeholders including academicians, doctors, pharmacists, manufacturers of drugs and directorate general of drug administration (DGDA) personnel. The study was conducted on 496 participants at Dhaka Metropolitan Dhaka, Rajshahi and Khulna Divisions from July 2015 to June 2018. Outcomes showed that among the interviewed populations 23% were female and 77% were male. Among participants, 66.9% of the interviewee was postgraduate degree holders. 62.7% respondents were familiar with the word element PV and 37.3% were ignorant of it. The major problem of DGDA to spreading the knowledge of PV was less manpower (73.9%). Among the factors that must be stopped to avoid the ADRs were the unethical practice of the healthcare professionals (50%). The topmost prioritized component was an education for knowledge (71.4%). It was found that many of the facilities for adverse drug reaction monitoring (ADRM) were absent in Bangladesh. The manpower and strength of DGDA must be increased to perform adequate monitoring and control as per the need of the country. We recapitulate that more research and development programs on PV activities in the country to improve the quality healthcare services is needed.

Keywords: Adverse Drug Reactions; Directorate General of Drug Administration; Drug Safety; Pharmacovigilance; Self-Medication

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