Challenges and Opportunities in Pharmacovigilance Implementation in Bangladesh: A Review of Reporting Systems, Awareness, and Regulatory Frameworks

Abstract

Pharmacovigilance (PV) plays an important role in the work for safeguarding public health which includes ensuring medications are safe and effective. The pharmacovigilance framework in Bangladesh is at a very early stage of development where the emergence and success of this program in Bangladesh has been hindered due to lack of awareness among healthcare professionals, weak regulatory system and under resources. The challenges and the opportunities of pharmacovigilance in Bangladesh is summarized based on the current state of pharmacovigilance in Bangladesh in this literature review. Reporting of ADRs is perceived as a heavy burden, lack of training, there is lack of infrastructure and poor enforcement of pharmacovigilance regulations. These problems are further aggravated by low awareness of the public and poor collaboration amongst stakeholders. Since, Bangladesh has many opportunities to further solidify its pharmacovigilance. Consequences to this obstacle could embrace the unification of pharmacovigilance learning in the training platforms for healthcare specialists, exploitation of digital platforms for ADR commentary and public awareness movements. Furthermore, government agencies, health care providers, pharmaceutical companies and international organizations working together can build a solid pharmacovigilance framework. Using the successful models in India and Nigeria as a case study for close examination of the lessons learned, the analysis offers useful lessons in how to construct comprehensive ADR monitoring systems, boost reporting rates, and strengthen regulatory oversight. The policy reforms necessary, the building of capacity, and the integration of technology are just three things that the country will need to do in order to achieve these goals. This research will strengthen pharmacovigilance practices in Bangladesh and ultimately it will make its drug safety monitoring system conform to global standards. The review demonstrates how a collaborative and technologies leading strategy is necessary to overcome existing barriers and seek the optimal outcomes in pharmacovigilance.

Keywords

Introduction

Scientifically speaking, PV refers to the science and practice of detecting and assessing, understanding, and preventing adverse drug effects and other medication linked problems [1]. PV helps minimize drug risk, and drugs cannot be guaranteed to be safe without PV. The functions of Pharmacovigilance continue to remain of vital importance to protect patients and optimize results of treatment, and guide drug approval and market removal decisions [3]. However, due to the evolving pharmacovigilance, governments across the world today still continue to fashion out ways on how to build advanced systems of monitoring medication safety practices. The weak regulatory backing in combination with poor reporting mechanisms and unawareness about pharmacovigilance among healthcare professional poses several challenges to the pharmacovigilance framework of Bangladesh [4]. The objective of this literature review is to discuss how pharmacovigilance in Bangladesh is implemented and what strategies, along with opportunities to enhance the effectiveness of pharmacovigilance, are possible. This research integrates data from across these studies to illustrate a thorough understanding of pharmacovigilance operations in Bangladesh.

Challenges in Pharmacovigilance Implementation in Bangladesh

Pharmacovigilance is not effectively implemented in Bangladesh due to fundamental obstacle that healthcare professionals do not have adequate knowledge about ADR reporting [5]. Research has shown that doctors and pharmacists have only a limited understanding of pharmacovigilance principles which in turn result in deficient report activities [6]. Moreover, the analysis clarified that users lack the education leading to non-submitting of reports on ADR, significant defects in training form a critical obstacle in awareness formation [7]. Fewer registered healthcare professionals report ADRs the more they perceive their reporting requirement to be extra work in addition to their official duty [8]. As a major challenge for the monitoring system, regulatory policies for pharmacovigilance operations in Bangladesh have not been sufficient. However, the country does not have sound pharmacovigilance policies and regulations that are meant to forestall the establishment of reporting procedure [9]. Regulatory gaps are disclosed as one of the main reasons for the slow progress of pharmacovigilance seen in other low- and middle-income countries (LMICs) [10]. For more, healthcare institutions find it harder to monitor ADR because pharmacovigilance is never allocated dedicated resources, which does not have the necessary infrastructure nor funding to implement critical ADR reporting activities [11].

Opportunities for Improvement

However, despite present challenges, there are several improvement opportunities for advancement of pharmacovigilance in the Bangladesh context. Teaching pharmacovigilance at health professional educational institutions is an appealing approach [12]. Early teaching of pharmacovigilance methods during healthcare provider education will encourage responsible reporting of adverse drug reactions [13]. It is important to launch continuous professional development programs with workshops for healthcare workers, with the aim to improve their awareness on practice of pharmacovigilance and their skill set [6]. Pharmacovigilance operation gets a big boost from technology adoption. [14] finds that digital platforms, using mobile app technology to make ADR reporting more convenient, translate into more healthcare professional participation. Scientists can advance ADR detection and analysis using artificial intelligence and machine learning than can be integrated into pharmacovigilance systems that produce faster and more effective responses to safety concerns [15].

Recommendations for Strengthening Pharmacovigilance

Pharmacovigilance in Bangladesh is yet to be strengthened by the establishment of a detailed national pharmacovigilance strategy which describes protocols and guidance for reporting ADRs [16]. Stakeholders including healthcare providers and regulatory authorities, and academic institutions must work cooperatively to develop mutually clear pharmacovigilance practices [17], and such strategic plans should ensure that such an approach is implemented. Public education-based awareness campaigns with patients should be launched, teaching them to report adverse drug reactions as such increase’s participation of the community in pharmacovigilance [5].

Current Status of Pharmacovigilance in Bangladesh

Historical Background and Development of Pharmacovigilance Systems in the Country

Bangladesh's pharmacovigilance framework, by means of the medical safety and treatment effectiveness requirements has produced in time chronicled as use allopathic patterns expanded in addition to escalating ADR risks. In 1982, DGDA has taken the charge of central authority to regulate pharmaceuticals in Bangladesh and to establish the pharmacovigilance systems [18]. When there was public health recognition of the importance of ADRs the DGDA started putting more focus on drug safety surveillance as well as drug registration and quality control that remained a central focus of the DGDA [19]. During 2011, the DGDA set up the National Pharmacovigilance Program (NPVP), which was the core collecting and analyzing system for adverse drug reactions. Under this new development, it possessed the development of a potent drug safety monitoring system and to safeguard public health [18]. The country uses World Health Organization's (WHO) pharmacovigilance guidelines to improve its capabilities in dealing with drug related matters; [19].

Role of the Directorate General of Drug Administration (DGDA) and Associated Organizations

As the sole regulatory body in Bangladesh the DGDA leads drug safety monitoring and pharmacovigilance activities throughout the country. Through partnerships with healthcare providers and medical facilities and academic training centers the organization works together to advance medication safety reporting practices and secure drug treatments [20]. Through its nationwide ADRMC (Adverse Drug Reaction Monitoring Center) network the DGDA functions as the primary point of collection for ADR (Adverse Drug Reaction) analysis [19]. The existing ADR reporting centers stand as key facilities that build safety culture while creating positive conditions for healthcare workers to notify authorities about drug side effects. Pharmacovigilance efforts in Bangladesh receive support from both the DGDA and the Bangladesh Medical Research Council (BMRC) together with academic institutions through ADR reporting studies alongside training initiatives and educational efforts [18]. Multiple groups in Bangladesh need to work together in order to improve their pharmacovigilance system.

Overview of Existing Adverse Drug Reaction (ADR) Reporting Systems

In Bangladesh the ADR reporting system operates through spontaneous reporting which depends on healthcare providers to submit suspected ADRs to the DGDA along with ADRMCs. An insufficient number of ADR reports persist despite the creation of the NPVP and ADRMCs because professionals lack awareness about reporting policies and experience inadequate training and view reporting as an unnecessary additional task [20]. A study revealed that healthcare professionals demonstrate minimal understanding of the ADR reporting mechanics thus creating an urgent requirement for special educational interventions [21]. The DGDA established different training sessions to advance healthcare provider's abilities for pharmacovigilance and ADR reporting knowledge and skills [18]. Through digital platforms and mobile applications healthcare professionals and patients now have access to a simplified process for reporting ADRs as described in [19].

Challenges in Pharmacovigilance Implementation in Bangladesh

All pharmacovigilance practice in Bangladesh is challenged by many problems, which block effective ADR monitoring and reporting. These challenges can be categorized into four principal areas: reporting issues, regulatory barriers, and resource constraints, or awareness gaps.

Awareness Gap: Limited Knowledge Among Healthcare Professionals and the Public

One of the biggest problems in pharmacovigilance is the relative lack of awareness and knowledge of the importance of ADR reporting among healthcare professionals and the public. It has been shown that many healthcare providers (physicians, pharmacists, …) do not have adequate training in pharmacovigilance principles and practices [22][23]. For example, a survey showed that a high percentage of healthcare professionals lacked knowledge of the pharmacovigilance system and its objectives which influences their willingness to report ADR’s [23]. In addition, public awareness about the importance of reporting ADRs is also low, so there are missed opportunities for collecting data that would inform drug safety [24]. Furthermore, pharmacovigilance is not included in a structured educational program within medical or pharmacy curricula [22] thus widening this knowledge gap. Reporting Issues: Similarly, ADRs are underreported because there is little motivation, training, and infrastructure for patients, caregivers, and healthcare providers to report ADRs. There have been no reports of ADRs in Bangladesh due to reporting underreporting of ADRs is quite common in Bangladesh and due to lack of motivation of healthcare professionals to do reporting. However, many practitioners perceive ADR reporting as just one more burden instead of a professional obligation, [25]. Further to this, lack of training in how to report ADRs correctly also adds to this underreporting. However, a study found that healthcare workers received formal training on ADR reporting, essential for creating a culture of safety, only in fraction [23][24]. Also, the existing infrastructure for reporting ADRs is often insufficient, many healthcare facilities lack resources and systems to expedite and complete ADR reporting [26][22]. All these together create a big discrepancy between the true incidence of ADRs and the number of reporting to regulatory authorities.

Regulatory Barriers: Weak Enforcement of Pharmacovigilance Regulations and Policies

The Bangladesh pharmacovigilance regulatory framework comprises of weak enforcement of existing regulations and policies. While there are guidelines by the Directorate General of Drug Administration (DGDA) for ADR reporting [27][28], they have not been implemented and followed consistently. There are also clear impediments as major barriers to the effective ADR reporting, which include a lack of clear pharmacovigilance rules and inadequate regulatory surveillance [27]. This regulatory gap does not only undermine the credibility of the pharmacovigilance system but also does not have influence on the public trust in the safety of drugs that are being marketed [25][27]. In addition, the frequent prevalence of inadequate cooperation between the various health authorities and stakeholders complicates enforcement of pharmacovigilance policies [28].

Resource Constraints: Limited Funding, Manpower, and Technological Support

Pharmacovigilance in Bangladesh is faced with serious resource constraints. Thus, the pharmacovigilance system has limited funding that does not allow training to provide public awareness campaigns and necessary infrastructure development [29]. Moreover, under trained personnel assigned to perform pharmacovigilance activities are short and limit ADR reports monitoring and analysis [29]. Technological support is also inadequate as ADR reporting cannot still be digitalized or not be taken on modern reporting systems at many healthcare facilities [29]. Resource limitations of these constraints lead to an overall ineffectiveness of pharmacovigilance efforts and a compromise of patient safety.

Opportunities for Improvement in Pharmacovigilance Implementation in Bangladesh

On the pharmacovigilance landscape in Bangladesh, there are plenty of areas that can be improved upon to sure up the safety and efficacy of medications. These opportunities can be categorized into five key areas: Global standards, training and education, adaptive digitization, public participation, and collaborative work.

Global Standards: Pharmacovigilance Guidelines of Bangladesh were adapted according to the context of the country

Adapting the World Health Organization (WHO) pharmacovigilance guidelines to local context is one of the most important opportunities to improve pharmacovigilance in Bangladesh. WHO has developed overall guidelines to enhance drug safety monitoring and reporting systems at a global level [30][31]. Tailoring these guidelines to the Bangladeshi nationwide healthcare landscape, regulatory surroundings and cultural context, can improve development of a powerful pharmacovigilance framework for the nation. In this context, adapting to this system could entail developing localized protocols of adverse drug reaction (ADR) reporting as well as establishing well defined communication channels among the stakeholders to have a more robust pharmacovigilance system [32].

Training and Education: Increasing Awareness Among Healthcare Team and Medical Students

Improvement in pharmacovigilance reporting rates and system effectiveness require raising awareness and education of the pharmacovigilance among healthcare professionals and medical students. Targeted training programs have been shown to greatly improve healthcare providers’ knowledge and attitudes about ADR reporting [33], [34]. Structured educational initiatives should be implemented in the medical and pharmacy curricula, and continuous professional development workshops should be conducted to empower health care professionals to effectively recognize and report ADRs [35]. Moreover, educating around implemented safety culture may play a role to change how healthcare providers look at ADR reporting as being a professional responsibility as opposed to another burden [36].

Digital Transformation: Adoption of Electronic Reporting Systems for ADRs

Electronic reporting of ADR presents transformational opportunity for pharmacovigilance in Bangladesh. Reporting ADR can be simplified with the application of digital platforms because it helps healthcare professionals and patients report the ADR faster and easier [37][38]. The use of user-friendly mobile applications and web-based reporting systems could enable real time collection and analysis of data, to enhance the efficiency and accuracy of pharmacovigilance [39]. Moreover, technology can also be used to facilitate an exchange of data and collaboration of stakeholders, thereby enabling better informed decision making around drug safety [40].

Public Engagement: Empowering Patients to Report ADRs Through Awareness Campaigns

Increasing rates of ADR reporting requires that the public participate in pharmacovigilance efforts. Raising awareness campaigns to empower patients to report ADRs is a crucial expectation for improving the pharmacovigilance system in that regard [41][42]. Increased participation in pharmacovigilance activities can be encouraged through a public education which informs patients to report ADRs and to know the channels through which they can do it [43]. Social media and community outreach programs can then be used to broadcast these efforts, bringing about a public with greater drug security information and the desire to participate in drug safety monitoring [44].

Collaborative Efforts: Partnership Between Government, Pharmaceutical Companies, and International Organizations

Pharmacovigilance in Bangladesh can be strengthened with collaborative efforts from various stakeholders including government agencies, pharmaceutical companies, and international organizations. Partnerships can help resource sharing and knowledge exchange and create comprehensive pharmacovigilance strategies [45][46]. For instance, international organizations can be an access to best practices and technical knowledge, whereas collaborations with pharmaceutical companies can improve reporting mechanisms and guarantee adherence to safety regulations [47]. The arising of such collaborative frameworks might enhance an integrated approach to pharmacovigilance and enhanced drug safety outcomes in Bangladesh.

Comparative Analysis of Other Developing Countries

Lessons from Similar Nations with Successful Pharmacovigilance Systems

A comparative analysis of pharmacovigilance systems in developing countries draws important lessons, which can be applied to improve the pharmacovigilance framework in Bangladesh. India, Nigeria, and Ghana have built robust pharmacovigilance systems but Bangladesh for one it is a long way to go. The Pharmacovigilance Program of India (PvPI) has integrated adverse drug reaction (ADR) reporting in the health care system in India with a network of monitoring centers, and public awareness campaigns, successfully [48]. The training of healthcare professionals and engaging the public through reporting ADRs has been emphasized in this program that has led to improved drug safety monitoring and higher reporting rates [49]. In addition, Nigeria's National Pharmacovigilance Centre has put efforts towards the improvement of healthcare providers' capacity building through training and awareness creation which has led to increased rate of reporting and improved data quality [50]. But Ghana has also achieved progress by integrating pharmacovigilance into its healthcare system and therefore enhanced reporting of, and monitoring of, ADRs [51]. Successful pharmacovigilance systems developed in these countries are shaped by extensive training programs, technological opportunity and public involvement. This will lead Bangladesh to learn from these examples to identify mechanisms that will allow the country to improve its own pharmacovigilance efforts.

This Chapter had some key takeaways, and their applicability is discussed in the Bangladeshi Context.

1. Strengthening Regulatory Frameworks: It is for pharmacovigilance to have a clear and enforceable regulatory framework. However, in light of the broad guidelines put in place by India and Nigeria around the roles and responsibilities of different stakeholders in the pharmacovigilance process [48][49], Bangladesh can fully benefit from similar policies.
2. Training and Capacity Building: To assist in improving ADR reporting rates, continuous training and the education of healthcare professionals are also deemed important. Like in India, training programs, with structured training in Bangladesh may enable healthcare providers to identify and report ADRs [50][51].
3. Public Awareness Campaigns: Awareness campaigns on the part of the public can hugely raise ADR (Adverse Drug Reactions) reporting rates. Nigeria and Ghana have successful public engagement strategies for pharmacovigilance that empowered patients to contribute to the pharmacovigilance efforts [50, 51]; Bangladesh can learn from that.
4. Utilization of Technology: The use of electronic reporting systems proposed in these successful pharmacovigilance frameworks has potential to streamline ADRs reporting process in Bangladesh. By helping to overcome the existing underreporting barriers and making data collection more effective [52], this technological transformation is an advantage.
5. Collaboration Among Stakeholders: The effectiveness of a pharmacovigilance system can be greatly enhanced by the establishment of partnership between the parties involved, such as different government agencies, healthcare providers and pharmaceutical companies. India and Nigeria offer examples of how collaboration in resource mobilization, knowledge sharing and capacity building is important [48][50].

Recommendations for Enhancing Pharmacovigilance in Bangladesh

Based on this study a number of key recommendations have been discussed to strengthen the pharmacovigilance framework in Bangladesh that include reform of policy, establishment of robust monitoring system, facilitation of strong collaboration among all stakeholders and using technology for reporting ADR.

Policy Reforms for Stronger Enforcement and Oversight

The pharmacovigilance system is required to create a robust one which can only be achieved by implementing comprehensive policy reforms. These regulations need to be clear and require health care providers and institutions to report on any ADRs encountered, stating what courses of action are to be taken afterwards. These regulations will be strengthened to be enforced to attain compliance and accountability among these stakeholders. One such framework has successfully been set up in countries like India, leading to several fold increase in the rates of ADR reporting [48]. To improve pharmacovigilance efforts Bangladesh should also contemplate adopting similar regulatory measures.

A Robust ADR Monitoring Framework

Pharmacovigilance depends on a well-structured ADR monitoring framework. A centralized system for ADR reporting may be a good idea for Bangladesh: all healthcare facilities would report their ADRs into the same system. Furthermore, this system should have standardized reporting forms and protocols standardized such that all data would be collected and analyzed consistently. By learning from countries like Brazil, which has built a comprehensive national pharmacovigilance system, we can learn the way to do the same [50].

Enhancing Collaboration Among Stakeholders

Enhancing pharmacovigilance in Bangladesh requires collaboration between relevant stakeholders such as government agencies, healthcare providers, pharmaceutical companies, and academic institutions. Partnerships can be established to share resources, exchange knowledge, and to develop comprehensive strategies to monitor drug safety. Pharmacovigilance systems in Nigeria that work show the value of multi stake holder engagement in enhancing ADR reporting and monitoring [49]. Bangladesh should purposively stimulate such collaborations to strengthen its pharmacovigilance framework.

Technology for Simplicity and Encourage Report of ADRs

Integration of technology in pharmacovigilance systems has large potential to improve the efficiency of ADR reporting. Bangladesh should step up the investment in developing user friendly electronic reporting systems and Mobile App capable of real time reporting of ADRs by healthcare professionals and patients. By analyzing the case of India, who uses digital platforms to report ADR, we have been able to take advantage of such technological advancement [48]. Greater participation by healthcare providers and the public in pharmacovigilance is possible if Bangladesh simplifies the reporting process.

Continuous Training and Capacity Building

Healthcare professionals require continuous training and capacity building for improving pharmacovigilance practices. Furthermore, Bangladesh should carry out structured trainings programs related to pharmacovigilance principles ADR recognition, and reporting procedures. In places like Nigeria we can learn from how successful training initiatives can support Bangladesh to develop efficient programs to train healthcare providers on active engagement in pharmacovigilance [49].

CONCLUSION

The pharmacovigilance practice in Bangladesh combines promising possibilities with difficult hurdles. The National Pharmacovigilance Program (NPVP) and Adverse Drug Reaction Monitoring Centers (ADRMCs) have successfully established within the country, but systemic barriers still block efficient progress. The efficiency of pharmacovigilance systems faces substantial limitations because of healthcare professional awareness deficiencies and underreported adverse drug reactions and insufficient regulatory structures as well as restricted resources. The need for better training combined with increased awareness and better infrastructure emerges from these current obstacles. Improvement measures stand out as substantial opportunities because nationwide comprehensive reforms remain needed. Healthcare curricula should include pharmacovigilance education while digital reporting systems should utilize technology to enhance ADR reporting capabilities alongside public communication through awareness campaigns. Bangladesh should examine approaches from comparable developing and less developed nations to implement proven global pharmacovigilance methods for building an efficient drug safety network. Resource mobilization and knowledge sharing for pharmacovigilance success requires active collaboration from government agencies in addition to healthcare providers and pharmaceutical companies and international organizations. A combination of technological advancements with reporting platforms and ongoing public participation training would help solve present-day drug safety monitoring issues. Cutting-edge various initiatives enable Bangladesh to elevate patient safety while making pharmacovigilance practices follow international standards.

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