Pharmacovigilance and Study Medication

Pharmacovigilance and study medication

Frances Shiely,
University College Cork, Ireland

Lenka Součková, Jitka Rychlíčková, Zora Čechová, Kateřina Nebeská
Masaryk University, Czech Republic

This chapter aims to give postgraduate students sufficient information to describe the importance of pharmacovigilance, why we need to monitor drug safety, and how it fits with the lifecycle of a medicinal product. The lesson will also describe the issues around investigational medicinal products and their handling, regulatory requirements, including responsibilities of team members. We will also focus on the broader perspective of using unauthorized products.

In order to prevent or reduce harm to patients and thus improve public health, mechanisms for evaluating and monitoring the safety of medicines from early development to clinical use are vital. In practice, this means having in place a well-organized pharmacovigilance system with a number of interconnected levels and pillars. But the safety of medicines starts long before they are actually administered to the patient. Well-established processes for monitoring the movement of the drug and the conditions in which it is kept are key to ensuring the quality of the drug, which of course, goes hand in hand with its safety and efficacy. Thus, the topic of pharmacovigilance will be taken together with the management of investigational medicinal products and other products.

In the context of a clinical trial, the World Health Organisation (WHO) defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects, all of which contribute to the protection of patients and public health and promote safe and effective use of medicinal products. Therefore, this lesson aims to provide the trialists of the future with adequate information to deeply understand and describe the importance of pharmacovigilance and its practical implementation in a clinical trial.

An investigational medicinal product acts as a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial. These include products already with marketing authorization but used or assembled (formulated or packaged) in a way different from the authorized ones or products with no approval. Study medication is a key component of most clinical trials, so it is not surprising that there is a plethora of regulations, strict mechanisms for monitoring the product flow, but also, for example, the conditions of its storage and use by the patient, and associated documentation. The chapter aims again to simplify the orientation of future trialists in this area. In addition, differences between an investigational medicinal product and an auxiliary medicinal product will be defined as well as information on the provision of the medication after the end of the clinical trial.


Chapter 5- Pharmacovigilance and Study Medication (University College Cork, Cork, Ireland, and Masaryk University, Brno, Czech Republic)

Final chapter

Chapter 5- Pharmacovigilance and Study Medication (University College Cork, Cork, Ireland, and Masaryk University, Brno, Czech Republic)