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.
The United Kingdom's Medicines and Healthcare products Regulatory Agency published the Good Pharmacovigilance Practice Guide to help manufacturers and pharmacovigilance professionals ensure that their safety-monitoring systems are complete and that
reports are prepared properly. This authoritative book is surprisingly unintimidating and easy to understand. The authors
present information in a logical manner, starting with the responsibilities of a pharmacovigilance professional and moving
through the systems and reports designed to guide a company and professional through the creation and control of the pharmacovigilance
Good Pharmacovigilance Practice Guide, Medicines and Healthcare products Regulatory Agency, London, 2008, 256 pp., ISBN: 978-0-85369-834-0
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.