Pharmacovigilance is monitoring the safety of a drug product through mechanisms such as Adverse Event Reports. Drug manufacturers must collect all reports and provide them to the appropriate regulatory body, which evaluates drugs' risk–benefit ratios and restricts the use of products when necessary.
Each chapter begins with an editor's note that describes its topic and provides important contextual information. The chapters are sufficiently limited in scope to provide adequate focus and detail without becoming overwhelming. Each chapter is easily digestible and includes terrific examples to illustrate and reinforce the content. For instance, the authors present common inspection findings (i.e., failures) for contracts and quality-management systems and thereby draw attention to areas that are often overlooked.The chapters cover the expectations of the qualified person responsible for pharmacovigilance in the European economic area, including collecting and managing data; evaluating data; developing risk-management plans, spontaneous, periodic, and required reports; and interactions within companies and with contractors.
The chapters about spontaneous case reporting and interactions within a company hold particularly useful information. The authors explain the likely sources of reports, the appropriate way to record events, and how to respond to the reports. The chapter also focuses on the details of case assessments. By defining the criteria to evaluate the seriousness and cause of a report, the book demystifies a common source of confusion. The authors also provide a decision tree to help define to whom and how a report should be given after the seriousness and cause of the report are evaluated. In addition, the chapter includes information about exceptions, several examples of the use of the decision tree, and the typical failures that have been found in existing systems.
Another important aspect of the pharmacovigilance system is the ability to receive reports from anywhere in the company, and the pharmacovigilance professional needs to maintain connections with the correct levels of an organization. Although every organization is unique, the general information included in the chapter titled "Interactions between Pharmacovigilance and Other Functions" is useful and provides a checklist for new pharmacovigilance professionals. The chapter describes the 10 most important connections and the types of information that should be exchanged, focusing particularly on interations with regulatory affairs departments. This section of the chapter covers the many types of reports and commitments that should be exchanged between functions.
The book's four annexes bring together information from many divergent sources and may well be one of the greatest values of the publication. They include an introduction to pharmacovigilance inspections, an explanation of relevant legislation and guidance, a table of UK Pharmacovigilance offenses and penalties, and safety reporting requirements for clinical studies. These annexes were developed specifically for the publication and are not available in this form from other sources.
Despite being one of the best written guidance documents available, the book has a few problems that detract from its overall quality. The first problem is the overuse of acronyms. Although this is a relatively minor point, the preponderance of acronyms can become extremely distracting. For example, the first chapter states, "Even if a MAH with products authorized in the EU has not submitted a DDPS, the MAH should provide ..." With effort, the reader can decipher this code and understand the meaning.