Teaching pharmacovigilance: a comprehensive modular curriculum

Thanks to the global access to information on the Internet, patients have become more and more critic and sometimes worried about the potential adverse reactions to drugs. This situation has enhanced the necessity for their doctors and other health professionals to update their knowledge on pharmacovigilance. In this scenario, the biggest challenge is the multidisciplinarity of the topics, which include molecular mechanisms of adverse drug reactions, clinical medicine, pharmacoepidemiology, information technology, pharmaceutical production, pharmaceutical legislation, public healthcare and traditions in different regions of the world. In addition, theoretical knowledge needs the support of experience and practical skills.
Many health professionals involved in pharmacovigilance activities need refresher courses, in particular those working for pharmaceutical industries, health associations or regulatory agencies, sector politicians, affiliates to non-governmental health associations, researchers in pharmacology or other fields related to health, professors who teach in universities or hospitals, both in developed and developing countries. Consequently, the type of course and the level of analysis requires to be specifically tailored for the recipients.
Every year, several institutions, companies and commercial providers offer different seminars in pharmacovigilance and educational programmes. Information on these courses are often available on the Internet from their online brochures. Despite several overlapping, there are often significant differences and courses focussing on the same topic can have very different designs.
For this reason, health professionals working in the drug safety sector and in charge of teaching it might struggle to select which topics they should covered in a course. Also, it would be very useful to know how much time should be devoted to a certain topic, what type of resources and what type of expertise teachers should have.
On these basis, experts affiliated to the International Society of Pharmacovigilance (ISoP) and associates of the Uppsala Monitoring Centre (UMC) of the World Health Organisation (WHO) have worked together to create a pharmacovigilance curriculum the most possible complete, detailed and balanced.¹
The Curriculum has been developed from the revision of the information available online about the pharmacovigilance courses offered all over the world from important institutions, ISoP and UMC-WhO especially, but also Drug Safety Research Unit (DRSU), London School of Hygiene and Tropical Medicine, EU2P, International Society of Pharmacoepidemiology (ISPE) and Drug Information Agency (DIA). Besides, the analysis evaluated the contents of the most used pharmacovigilance textbooks, the journals Drug Safety and Pharmacoepidemiology and Drug Safety and the guidelines and recommendations of institutions like the Council of International Organizations of Medical Sciences (CIOMS) and the International Conference on Harmonization (ICH). Developing this Curriculum took many years and several debates among experts.
The final product includes a main component, with a series of theoretical lectures, and a secondary component with practical sessions. The theoretical component is organised hierarchically over 15 main chapters of similar dimensions (hierarchy level 1) with four sections each, for a total of 60 sections (hierarchy level 2). All sections have from four to six subsections for a total of around 300 subsections (hierarchy level 3).
The first three chapters are only theoretical, whilst chapters 4 to 15 provide a series of practical exercises developed to assess the learning of the discussed topics. In detail, the chapters discuss the following topics:

• Chapter 1 - What is pharmacovigilance and why do we need it: it explains and discusses definition and goals of pharmacovigilance, its history, adverse reactions and public healthcare and the predictive capability of molecular analogy studies, pre-clinical and pre-authorisation trials. 
• Chapter 2 - The fundamental clinical characteristics of adverse drug reactions: it describes classification and mechanisms of adverse drug reactions, pharmaco-genetics of adverse drug reactions, non-genetic variability factors in drug responses and interactions, clinical management of adverse drug reactions. 
• Chapter 3 - Relevant adverse reactions and important adverse drug reactions: it addresses type B reactions and involved drugs, type A reactions and involved drugs, adverse reactions to antibiotics and vaccines, risks associated to drugs for common diseases and chronic diseases, biological drugs and officinal herbs. 
• Chapter 4 - Individual case reports: medical, physiological and regulatory fundaments of adverse drugs reactions and reasons to report them, contents, structure and validity of reports and report procedures, causality evaluation, reporting vaccines, herbal products and specific situations. 
• Chapter 5 - Pharmacovigilance in clinical trials: it debates the characteristics of pharmacovigilance in clinical trials, data collections, risk evaluation, guidelines and regulatory framework. 
• Chapter 6 - Counterfeit medicines, lack or mistakes in medical treatments: it addresses the theme of counterfeit and poor-quality drugs, medical errors, reporting and prevention measures. 
• Chapter 7 - Spontaneous adverse drug reactions reporting: it provides a definition of spontaneous reporting and discusses its limits, database characteristics, data entry and transmission procedures, descriptive statistics and privacy related aspects. 
• Chapter 8 - Signal analysis and management: it discusses the concept of signal and its detection through statistics and not statistics methods, disproportion researches, priority procedures, validation, confirmation and communication.
• Chapter 9 - Post authorisation studies and clinical trials in pharmacovigilance: it defines the goals of the post authorisation studies, the general requisites, the design of observational studies, the strengths and limits, bias, confounding factors, effect modification and data sources. 
• Chapter 10 - Evaluation risks-benefits: it debates definitions and methodological approaches of the risk-benefit evaluation, analysing, weighing and combining the risks components of the drug. 
• Chapter 11 - Risk management systems in pharmacovigilance, risk management plans and inspections: it describes the management systems of general and product-specific risks, involved actors and operativity. It deepens the theme of inspections, audits and quality check. 
• Chapter 12 - Industry and regulatory Agencies, compulsory procedures by law: it describes all the regulatory aspects of pharmacovigilance, from those related to industry to regulatory agencies. 
• Chapter 13: Organisation of pharmacovigilance and public healthcare: it describes adverse reactions detection, documentation and reporting at a local level, the relationship between local and national pharmacovigilance, pharmacovigilance projects. 
• Chapter 14 - Communication: it deals with the delicate topic of communication in pharmacovigilance, users, media, channels, instruments and processes. 
• Chapter 15 - Information source: primary data, figures, facts, terminology and cases; secondary data, evaluation, judgements, decisions. It dedicates part of the programme to data mining methods on the Internet and social media and to the resources for courses in specific geographic areas or political contexts.

The Curriculum has been used to create a crowdsourcing systems of teaching resources available online on the several websites that offer training and education,² which is available on the ISoP website (https://isoponline.org/training/pv-curriculum/). In the last few months, the Curriculum and the management system of the educational resources available online have been undergoing a revision with that might be published next year.