Beyond the foundational concepts, the book presents detailed insights into signal detection, risk management plans, and the real-world application of pharmacovigilance through case studies from both high- and low-middle-income countries. It examines the pivotal role of pharmacists and the importance of tailored approaches for special populations, while emphasizing effective communication of medicines safety.
Table of Contents
1. Introduction to medicines safety and pharmacovigilance2. Regulatory framework for pharmacovigilance
3. Healthcare professionals’ experiences and expectations with regards to medicines safety
4. Safety surveillance methods
5. Signal detection and management
6. Risk management plans
7. Medicines safety system: case studies from high income countries
8. Medicines safety system: case studies from low and middle income countries
9. Medicines safety and the role of the pharmacists
10. Pharmacovigilance in special populations
11. Communicating medicines safety: A global interface
12. Ethical considerations in pharmacovigilance
13. Technology in pharmacovigilance
14. Advancing medicines safety science through public-private partnerships
15. Future directions in pharmacovigilance
16. Causality assessment methods in pharmacovigilance
17. Pharmacovigilance in clinical trials and advanced therapies
18. Insights from the Industry in pharmacovigilance
Authors
Rabia Hussain Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia.Dr. Rabia Hussain is a Senior Lecturer at the School of Pharmaceutical Sciences, Universiti Sains Malaysia, located in Penang. She is a renowned researcher in the field of medicine safety, pharmacovigilance, medication adherence, and clinical pharmacy. Her research has been published in high-impact journals and focuses on pharmacovigilance, research methods in pharmacy practice, clinical pharmacy, and issues related to medicines use.
Dr. Hussain has collaborated with ReAct - Action on Antibiotic Resistance and Health Action International, Asia Pacific, to improve the use of antibiotics. She is the Section Editor for the Journal of Pharmaceutical Policy and Practice (JoPPP) and has edited "Encyclopaedia of Evidence in Pharmaceutical Public Health and Health Services Research in Pharmacy (Elsevier)". Dr. Hussain is a fellow of the Royal Society for Public Health, and she has been nominated as the Apex Young Scholar by Universiti Sains Malaysia.
