Book Review: Special Issues in Pharmacovigilance in Resource-Limited Countries
Edited by Syed Rizwanuddin Ahmad
Springer Nature Singapore, 2025. 378 pp. ISBN: 978-981-96-6153-4 (hardcover)
Also available as ebook: https://link.springer.com/book/10.1007/978-981-96-6154-1
Possibly you can access the ebook through your institution.
The table of content of the book is available here: https://link.springer.com/book/10.1007/978-981-96-6154-1#toc
Special Issues in Pharmacovigilance in Resource-Limited Countries, edited by Syed Rizwanuddin Ahmad, former E-Drug moderator (!) and Pharmacovigilance & Regulatory System Strengthening Consultant, is a timely and highly valuable contribution to the fields of pharmacovigilance, regulatory science, and global public health.
Published by Springer Nature in 2025, the volume addresses one of the most pressing challenges in modern healthcare: ensuring the safety of medicines and vaccines in low- and middle-income countries where healthcare resources, regulatory capacity, and pharmacovigilance infrastructures are often limited. Bringing together contributions from experts from different regions of the world, the book provides a comprehensive examination of the unique obstacles and opportunities associated with pharmacovigilance in resource-constrained settings.
The central strength of this volume lies in its recognition that pharmacovigilance cannot be implemented through a universal model. While medicine safety surveillance systems have evolved considerably in high-income countries, many developing nations continue to face significant barriers, including underreporting of adverse drug reactions, inadequate regulatory frameworks, limited technical expertise, insufficient funding, and fragmented healthcare systems.
Syed and the contributing authors convincingly demonstrate that effective pharmacovigilance requires approaches tailored to local realities rather than the simple adoption of systems developed elsewhere.
The foreword by the former Pakistani Health Minister and WHO/EMRO adviser Zafar Mirza details the grassroot basis of Syed’s work. From 1980 to 1995 Syed worked in Pakistan to improve access to effective, affordable and good quality essential medicines. Syed was a good writer and networker. He joined E-drug immediately after its start in 1995 and posted more than 200 messages between 1995-1997 and 2014-2017 as moderator but also as author.
Syed’s preface provides an excellent foundation for the book. Drawing on decades of professional experience in drug regulation and pharmacovigilance, including service at the United States Food and Drug Administration (FDA), Syed explains the motivation behind the project and the urgent need to strengthen medicine safety systems in resource-limited countries. His reflections highlight the growing importance of pharmacovigilance as access to medicines expands globally and emphasize the ethical responsibility of healthcare systems to protect patients from preventable harm. The preface successfully frames the volume as both a scholarly contribution and a practical guide for improving public health outcomes.
One of the book’s most notable achievements is its genuinely global perspective. Rather than focusing on a single healthcare system, the volume presents detailed analyses of pharmacovigilance practices across a diverse range of countries and regions. The chapters examine experiences from Pakistan, India, countries in the Arab world, Pacific Island nations, Brazil, Latin America and the Caribbean, Sierra Leone, and other African settings.
In addition to these country-specific discussions, several chapters address broader themes such as vaccine pharmacovigilance, medication errors, substandard and falsified medicines, signal detection, and pharmacovigilance capacity building. The extensive geographical coverage allows readers to compare different regulatory environments, healthcare infrastructures, and reporting systems while identifying common challenges that transcend national borders. The comparative perspective is one of the book’s greatest strengths, illustrating both the universal importance of medicine safety and the need for locally adapted solutions.
The country-focused chapters are particularly informative and provide valuable insights into the realities of pharmacovigilance implementation. The chapter on Pakistan, for example, traces the development of the country’s pharmacovigilance system, highlighting achievements such as the establishment of national and regional monitoring centres while also identifying continuing challenges related to adverse drug reaction reporting, stakeholder engagement, and regulatory oversight. Real-world case studies involving medicine contamination incidents and regulatory responses effectively demonstrate the consequences of inadequate surveillance systems and the importance of strengthening medicine safety frameworks.
Similarly, the chapter on India offers a detailed overview of the Pharmacovigilance Programme of India (PvPI), quite an ambitious pharmacovigilance initiative in the developing world. The authors describe substantial progress in adverse drug reaction reporting, capacity building, and regulatory decision-making while acknowledging the difficulties posed by India’s vast population, linguistic diversity, and complex healthcare landscape. The inclusion of case studies involving drugs such as nimesulide and pioglitazone further illustrates how pharmacovigilance data can influence regulatory decisions and improve patient safety.
Another major strength of the volume is its successful integration of theory and practice. Rather than merely describing challenges, the contributors present practical strategies for strengthening pharmacovigilance systems. Topics such as signal management, risk communication, adverse event reporting, vaccine safety monitoring, and stakeholder engagement are discussed in a manner that is directly relevant to policymakers, regulators, healthcare professionals, and researchers. The emphasis on practical implementation makes the book highly useful for readers involved in designing, managing, or evaluating pharmacovigilance programmes.
The discussion of substandard and falsified medicines deserves particular recognition. In many resource-limited settings, poor-quality medical products represent a significant threat to patient safety and public confidence in healthcare systems. The authors demonstrate how weak regulatory oversight, supply-chain vulnerabilities, and insufficient quality control mechanisms can contribute to the circulation of unsafe medicines. By integrating discussions of medicine quality with pharmacovigilance activities, the volume adopts a holistic approach that reflects the realities faced by healthcare systems in many developing countries.
Equally important is the book’s treatment of vaccine pharmacovigilance. Recent global health emergencies, particularly the COVID-19 pandemic, have highlighted the critical importance of effective vaccine safety monitoring systems. The relevant chapters provide a detailed examination of the challenges associated with detecting, assessing, and communicating vaccine-related adverse events in settings with limited surveillance infrastructure. These discussions are particularly valuable because they emphasize the role of pharmacovigilance in maintaining public trust and supporting successful immunization programmes.
The final sections of the book focus on education, training, and capacity building, transforming the volume from a descriptive account into a practical roadmap for future development. The contributors emphasize that sustainable pharmacovigilance systems depend not only on regulations and technological platforms but also on a well-trained workforce capable of collecting, evaluating, and interpreting safety data. The discussions of international collaboration, professional training initiatives, and institutional development provide realistic and actionable recommendations for strengthening medicine safety systems in resource-constrained environments.
From an academic perspective, the volume is well organized and logically structured. The progression from country case studies to thematic analyses and capacity-building strategies creates a coherent narrative that guides readers through increasingly complex aspects of pharmacovigilance. The writing style is clear and accessible while maintaining an appropriate level of scholarly rigor. Each chapter is supported by relevant literature and practical examples, making the book suitable for both academic study and professional reference.
Another noteworthy feature is the multidisciplinary nature of the contributions. Pharmacovigilance intersects with clinical medicine, pharmacy, epidemiology, public health, health policy, and regulatory science. By bringing together experts from these various disciplines, the volume offers a comprehensive and nuanced understanding of medicine safety. This interdisciplinary approach reflects contemporary trends in global health, where complex healthcare challenges increasingly require integrated and collaborative solutions.
Despite its focus on challenges and limitations, the overall tone of the book remains constructive and forward-looking. Rather than portraying resource-limited countries solely in terms of deficiencies, the contributors highlight local innovations, successful interventions, and emerging centres of excellence. This balanced perspective is particularly valuable because it emphasizes progress, resilience, and the potential for sustainable improvement.
In conclusion, Special Issues in Pharmacovigilance in Resource-Limited Countries is an outstanding and highly relevant contribution to the literature on medicine safety and global health. Through its combination of country-specific case studies, thematic analyses, practical recommendations, and capacity-building perspectives, the volume provides a comprehensive understanding of pharmacovigilance in settings where resources are constrained but patient safety needs are substantial.
A particular strength of the book is its successful integration of experiences from Asia, Africa, Latin America, the Caribbean, the Arab region, and the Pacific Islands. By bringing together perspectives from countries with varying levels of healthcare development and regulatory maturity, the volume demonstrates that pharmacovigilance challenges are global in nature but require context-specific responses.
Syed Rizwanuddin Ahmad and the contributing authors deserve considerable recognition for producing a work that is both academically rigorous and practically useful. The book will serve as an essential reference for healthcare professionals, regulators, policymakers, researchers, and students interested in strengthening pharmacovigilance systems and improving public health outcomes worldwide. Its insights are likely to remain relevant and influential for years to come.
Thanks, Syed, for making this important reference available for us. If I had a hard copy, it would be standing in my library next to MSH’s “Yellow Bible” (Managing Drug Supply, 3rd edition, https://msh.org/wp-content/uploads/2014/01/mds3-jan2014.pdf).
May we call your book the “Blue Bible”?
Wilbert Bannenberg
E-Drug moderator