Bangabandhu Sheikh Mujib Medical University Journal

Volume 17, Issue 1, March 2024

COMMENTARY

Challenges and experiences in establishing a zonal pharmacovigilance centre at Bangabandhu Sheikh Mujib Medical University: A 10-month journey

Elora Sharmin¹ , Sheikh Foyez Ahmed²

¹Department of Pharmacology, Bangabadhu Sheikh Mujib Medical University, Dhaka, Bangladesh.

²Department of Cardiology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.

DOI: https://doi.org/10.3329/bsmmuj.v17i1.70375

Received: 14 Dec 2024; Revised version received: 26 Mar 2024; Accepted: 26 Mar 2024

Published online: 28 Mar 2024

Responsible Editor: M Mostafa Zaman ; Reviewer A: Anonymous

Pharmacovigilance, the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems, plays a crucial role in ensuring the rational and safe use of medicines.¹ The necessity of conducting pharmacovigilance studies in Bangladesh is important because almost all medicines possess beneficial and some adverse effects. The National Pharmacovigilance Programme by the Directorate General of Drug Administration (DGDA) began in September 2013 under the supervision of the World Health Organization. Many countries collect adverse drug reaction (ADR) reports through decentralized system such as regional centres.²^,³

A regional pharmacovigilance centre in a tertiary care teaching hospital may ensure effective monitoring of ADR to safeguard the public health. We emphasize the significance of having a zonal pharmacovigilance centre in hospital like Bangabandhu Sheikh Mujib Medical University (BSMMU) in collaboration with the national pharmacovigilance centre due to the concentration of healthcare professionals in such settings. Since the establishment of the zonal pharmacovigilance centre in BSMMU in 2023, we faced hurdles. There are lack of comprehensive ADR monitoring system among healthcare professionals and the general unawareness of reporting concepts. Factors such as fear of reporting, time constraints, and a lack of appropriate reporting guidelines contribute to the low reporting rates.

A comprehensive plan to consolidate and expand pharmacovigilance efforts includes making the reporting mandatory, enhancing collaborations, building networks, and integrating pharmacovigilance courses into university curricula. The focus should be on creating a culture of learning and proactive reporting among healthcare professionals, students, and other stakeholders by training programme, workshops, educational interventions for medical students, pharmacists, and nurses, and the supply of ADR reporting forms across the departments.

We emphasize the need for continued professional development programme and knowledge reinforcement in undergraduate education to enhance the efficiency of national pharmacovigilance systems. There is a need for expansion it’s nationwide through the formation of zonal and regional centres in medical universities and colleges. Educational intervention, training, and a provision of mandatory reporting should be the part of pharmacovigilance course curricula. The establishment of zonal pharmacovigilance centres is seen as a crucial step towards ensuring the safety of medicines and public health in Bangladesh.

HIGHLIGHTS

1. The establishment of a Zonal Pharmacovigilance Centre at BSMMU is crucial for concentrated and effective ADR reporting.

2. Steps taken involve training programs, educational interventions, and the distribution of ADR reporting forms with future plans for mandatory reporting, collaboration, network building and integrating pharmacovigilance courses in University curricula.

Acknowledgments

The authors would like to express the most profound gratitude to BSMMU admin for all providing support.

Author contributions

Conception and design: ES, SFA. Acquisition, analysis, and interpretation of data: ES, SFA. Manuscript drafting and revising it critically: ES, SFA. Approval of the final version of the manuscript: ES, SFA. Guarantor of accuracy and integrity of the work: ES, SFA.

Funding

The Integrated Health Science Research and Development Fund. Ministry of education government of Bangladesh.

Conflicts of interest

We do not have any conflict of interest.

Ethical approval

Ethical approval was taken from the Institutional Review Board of BSMMU (vide memo number BSMMU/2022/112011, dated 08/11/2022).

Data availability statement

Not applicable.

References

1. WHO Policy Perspectives on Medicines. Geneva: WHO; 2004. Geneva: World Health Organization. Looking at the Pharmacovigilance: ensuring the safe use of medicines. Available from: http://www.whqlibdoc.who.int/hq/2004/WHO_EDM_2004.8.

2. Kalaiselvan V, Srivastava S, Singh A, Gupta SK. Pharmacovigilance in India: Present scenario and future challenges. Drug safety. 2019; 42(3):339-346. DOI. https://doi.org/10.1007/s40264-018-0730-7.

3. Aagaard L, Strandell J, Melskens L, Petersen PS, Hansen EH. Global patterns of adverse drug reactions over a decade. Drug saf. 2012; 35(12):1171-1182. DOI: https://10.1007/BF03262002.