Collaborative Approaches to Establishing and Implementing Pharmacovigilance Systems

Pharmacovigilance is neither one single discipline nor is it confined to a single professional group. The concept of pharmacovigilance originated with clinical pharmacologists based on the principles of clinical examination of a patient for evidence of causality and then blending these ideas with epidemiological concepts. This was triggered by the thalidomide catastrophe in the 1960s and the need to identify safety signals for medicines much more promptly. Initially, the main priority was the detection of serious and unexpected adverse reactions primarily through analysis of spontaneous reports. Now it is a multidisciplinary topic which requires collaboration from various stakeholders within a complex system to demonstrate that the benefit–harm arm profiles of healthcare products remain acceptable for millions of patients throughout the life cycle of a medicine. These stakeholders include all types of healthcare providers, industry professionals, regulatory agencies, patients and their families, and the wider public. To optimise the use of medicines, we need to understand the role of each stakeholder and strive towards closer cooperation. This requires a flexible and adaptable approach to implementing pharmacovigilance systems in various settings according to different regulatory requirements and the needs of public health both nationally and internationally. It is important for professionals during their development, throughout their career starting as an undergraduate, to understand and appreciate the steps involved in setting up and collaborating within the pharmacovigilance systems at different levels. As ISO 9001 states, a system is how a certain set of processes operate to work towards a particular goal which for pharmacovigilance is to optimise benefit and mitigate harm of medicinal products to enhance patient safety. Unfortunately, the importance of effective implementation of pharmacovigilance as a system based on organisational science including human factors remains under-recognised by many responsible for education and development. Putting human performance at the heart of the pharmacovigilance system design is critical for success. This chapter charts how our current pharmacovigilance system arose based on principles of surveillance and regulation and discusses what should happen now and in the future using systems thinking based on organisational science using a collaborative approach.