Pharmacovigilance Service in Bangladesh
Pharmacovigilance, which includes the science and activities associated with detecting, assessing, understanding, and preventing adverse effects or drug-related problems, is an essential aspect of healthcare systems worldwide. Bangladesh has a rapidly developed pharmacy manufacturing industry, and healthcare services have recently been upgraded. However, the importance of pharmacovigilance services to this country has never been considerable. This paper deeply explores the pharmacovigilance situation in Bangladesh, including its importance, present situation, regulation scenarios, and future scope. It has been optimized for SEO and the end user, equally catering to professionals, students, healthcare providers, and researchers.
What is Pharmacovigilance?
PV is primarily concerned with:
- Surveillance of drug safety.
- Identification of ADRs.
- The benefit-risk ratio of prescription drugs.
- Reducing harms from drug use.
Protecting public health through the safety of marketed medicinal products is crucial.
Relevance of Pharmacovigilance
- Ensures Patient Safety
- Enhances Public Health Results
- Assistance with the Establishment of Regulations
- They Strengthen Healthcare Confidence
Drug Safety in Bangladesh: An Introduction
Bangladesh has achieved remarkable success in health and pharmaceuticals in recent years. The country has more than 300 drug companies and is a major exporter of generic drugs. However, pharmacovigilance is still a young and growing discipline.
Key Milestones
- Formation of DGDA’s PV Cell: The Directorate General of Drug Administration (DGDA) formed a pharmacovigilance cell to investigate drug safety.
- National PV Guidelines: Bangladesh adopted national pharmacovigilance guidelines based on WHO guiding principles.
WHO Programme Fulfillment: Bangladesh is a member country of the WHO PIDM
Regulatory Framework
Regulatory authority for pharmacovigilance in Bangladesh is primarily handled by:
Drug Administration Director General (DGDA)
- National drug policies are implemented.
- Responsible for the safety and quality of medicine.
CentersBangladesh Pharmacovigilance Centre (BPVC)
- Located at the DGDA.
- Collects and evaluates ADRs.
- Syncs with WHO Uppsala Monitoring Center (UMC).
Key Regulations
- Drug Act 1940 and Rules 1945
- Drug (Control) Ordinance 1982
- National Drug Policy
Elements of Pharmacovigilance Service
The mechanism for effective pharmaco-vigilance in Bangladesh involves the following elements:
ADR Reporting
- Adverse reactions should be reported by healthcare practitioners, pharmacists, and consumers.
- Forms are online and at health places.
Signal Detection
- Trend analysis of reported data- to detect new safety signals.
Risk Management
- Taking action to mitigate risk, such as updating drug labels or issuing safety warnings.
Post-Marketing Surveillance
- Surveillance for the safety of drugs aftermarket release.
Education and Training
- Continual workshops, seminars, and training for health workers on submitting ADRs are also needed.
Stakeholders Involved
Government Bodies
- DGDA, MoHFW
Pharmaceutical Companies
- Obligations related to pharmacovigilance system and PSURs: You must maintain a pharmacovigilance system as described in Module 1. Pharmacovigilance system (see section 3).
Healthcare Institutions
- Hospitals and outpatient departments are key places for ADR detection and reporting.
Academia
- PV training is part of the curricula in medical and pharmacy schools.
Consumers and Patients
- Imperative to directly report adverse reactions.
Obstacles on the Way of Introducing Pharmacovigilance in Bangladesh
Despite some recent developments, several challenges need to be overcome to promote pharmacovigilance in Bangladesh:
Lack of Awareness
- In both the medical community and among patients.
Underreporting of ADRs
- Because it’s often too time-consuming, unrewarding , or dangerous legally.
Limited Infrastructure
- The requirement for more robust enterprise IT to facilitate management of PV data.
Resource Constraints
- Lack of skilled personnel and economic support.
Barriers: Language and culture.
- PROs, including patient communication and ADR recording.
Opportunities and Future Perspective
Digital Reporting Tools
- Apps and web portals for mobile and easy submission of ADRs.
Capacity Building
- Additional training programs and credentials for PV practitioners.
Working with International Agencies
- Collaboration with WHO, UMC and other international agencies.
Safety Monitoring in Clinical Trials
- Incorporation of PV in preclinical drug development and clinical trials.
Expanding to Herbal and Traditional Medications
- Surveillance of complications of complementary therapies.
Pharmacovigilance Providers in Bangladesh
Pharmacovigilance services are provided by different organizations as follows in Bangladesh:
Regulatory Bodies
- DGDA, BPVC
CROs (Contract Research Organizations)
- Provide a fast and efficient pharmacovigilance service to manage the process from end to end.
Pharmaceutical Companies
- Have in-house PV departments.
Academic Institutions
- Provide research assistance and education programs.
Freelance Consultants
- Offer cost-effective and adaptable pharmacovigilance backing.
Best Practices for PV Service Implementation
Standard operating protocols (SOPs)
- Well-established ADR processing workflows.
Continuous Monitoring
- Real-time ADR data monitoring.
Regular Audits
- Meeting both local and international PV standards.
Stakeholder Engagement
- Intersectoral collaboration in the implementation of the strategy.
Public Awareness Campaigns
- Informing the public of the need to report side effects.
FAQs
What is pharmacovigilance?
Pharmacovigilance is the science of tracking the safety of medicines and identifying adverse drug reactions.
Who can report Adverse Drug Reactions in Bangladesh?
ADRs can be reported by healthcare professionals, pharmacists and consumers.
How would I report a side effect from a drug?
You can also report it on forms obtained from hospitals or the DGDA’s online portal twice a year.
Is pharmacovigilance compulsory for pharma pharmaceutical companies in Bangladesh?
Yes, the industry must have preparations in place to record and report safety data.
Explain the role of DGDA in pharmacovigilance.
She further added, “The DGDA oversees drug safety through its PV cell, and we work with global agencies.”
Do herbal remedies come under the ambit of pharmacovigilance?
There are attempts to integrate herbal and traditional medicines into PV programs.
Are there any training events in Bangladesh for solar professionals?
Workshops, university courses and international certifications are also offered.
What are the barriers to pharmacovigilance?
Drivers include ignorance, underreporting, and insufficient facilities.
Can patients involved in pharmacovigilance participate?
Yes, patients are asked to report any side effects.
What lies ahead for pharmacovigilance in Bangladesh?
The future looks bright, with digital tools, global partnerships and expanded training efforts leading the way.
Conclusion
Pharmacovigilance is one of the significant public health activities that ensures and informs the safe use of medicine. Bangladesh’s pharmacovigilance system is undergoing rapid transformation with the assistance of the regulatory authority, pharmaceutical industry, and academic institutions. There are hurdles to surmount, but the future is bright with technological innovation, awareness, and worldwide partnerships. Strengthening the pharmacovigilance system will ensure patient safety and contribute to the international reputation of Bangladesh’s health and pharmaceutical sector.