Teaching Pharmacovigilance

TEACHING PHARMACOVIGILANCE

AT UNDERGRADUATE LEVELS

For all healthcare disciplines involved with prescribing, administering and monitoring effects of pharmacotherapies, there is a well-recognized body of knowledge seen as being necessary for professional practice. This body of knowledge has its basis in studies of human behaviour including communication, ethics and philosophy; physiology, patho-physiology, clinical and laboratory sciences including pharma-cology. Preparation for practice in medicine, nurs-ing, pharmacy, dentistry and other such professions requires admixtures of each of these disciplines to a greater or lesser degree depending on the profession itself and the scope and nature of subspecialisation.

Building onto these basic health sciences, pharma-cotherapeutics education needs to be solidly grounded on principles of benefit and risk from drug therapies. This paradigm of benefit and risk needs to be the foun-dation for understanding of both absolute and relative effects of medicines used in therapeutics.

The judicious and effective management of the benefits and risks of pharmacotherapy then needs to be taught as a key skill to be mastered by all health professionals. Whilst differing health professions in different settings will have different roles to play in this management process, the concept of benefit/risk management is fundamental to sound preparation for practice in any of the disciplines that are involved in pharmacotherapy processes.

The current structure, methods and operational imperatives of the global pharmaceutical industry also need to be taught to undergraduates in an open and unexpurgated fashion. The real benefits to humanity from this enterprise need to be projected clearly in the context of the inevitable risks to health, which also accompany the benefits.

Coupled with the paradigm of benefits and risks of drug therapies, the undergraduate health professional needs to be instructed at the outset in the realities of both error and uncertainty in health care. Tech-niques for purposefully dealing with error and person-ally managing the breadth of uncertainty involved in ongoing healthcare practice need to be instilled at the earliest opportunity. Equally, the complex nature of the public’s expectations for ‘safety’ of pharmaceuti-cals needs to be the backdrop against which evolving  knowledge of benefits and risks of medicines will always be viewed.

In this context, each of the professions participat-ing in pharmacotherapy needs to leave the under-graduate setting with expectations of a future lifelong learning experience. Suggestions for effective adult learning in the field of pharmacovigilance have been outlined above.

Building on this approach to pharmacotherapy at the undergraduate level, pharmacovigilance and a contin-ually refreshed knowledge of benefits and risks from pharmacotherapy can become central to the experi-ence of all healthcare clinicians.

The benefits of ongoing pharmacovigilance research will only be able to be fully realized when healthcare practitioners have consistent expectations for this ongoing learning experience.

AT POSTGRADUATE LEVELS

Pharmacovigilance professionals are generally drawn from a wide range of disciplines not all of which necessarily have a basis in the health professions. In particular, statisticians and computing profession-als are key personnel needed for effective operation of large-scale spontaneous reporting systems as well as for the increasingly important activity of mining large data sets of longitudinal healthcare records for pharmacovigilance intelligence.

A range of educational authorities in different countries have developed and continue to deliver valuable educational programmes for professionals working within the discipline of pharmacovigilance itself.

The International Society of Pharmacovigilance (ISOP: http://www.isoponline.org) is a non-profit organization whose stated aims are to foster Phar-macovigilance both scientifically and educationally, and enhance all aspects of safe and proper use of medicines, in all countries. Educational courses in pharmacovigilance principles are periodically avail-able through ISOP, which acts as a key global meet-ing place for those specifically engaged in collecting, assessing and disseminating information about risks of medicines in broad use in whole populations.

Another organization having a rather broader remit for the evaluation of both benefits and risks of pharmacotherapies is the International Society for Pharmacoepidemiology (ISPE: http://www.pharmacoepi.org). ISPE is an inter-national organization dedicated to advancing the health of the public by providing a forum for the open exchange of scientific information and for the development of policy; education; and advocacy for the fields of pharmacoepidemiology and therapeutic risk management. ISPE has developed important guidelines for good pharmacoepidemiological practice (Epstein, 2005). Greater confidence can be placed in inferences drawn from observational studies of drug benefit and risk when such studies conform to these guidelines. The guidelines are now formally recog-nized in many countries by reference in Government regulatory requirements. International Society for Pharmacoepidemiology also provides periodic training courses and educational programmes both in sound pharmacoepidemiological methods and, more recently, in therapeutic risk management.

There are many other authorities that provide disci-plined training for professionals who work specifically in the fields of pharmacovigilance and therapeu-tic risk management: e.g. the Drug Information Association (DIA: http://www.diahome.org); The United Kingdom Drug Safety Research Unit (DSRU: http://www.dsru.org) and the London School of Hygiene and Tropical Medicine (http://www.lshtm.ac.uk/courses). The European Agency for the Evaluation of Medicinal Prod-ucts (EMEA: http://eudravigilance.emea.eu.int) in collaboration with the DIA is now also providing training for pharmacovigilance professionals. These DIA programmes are particularly relevant for pharma-covigilance professionals who work within the pharmaceutical industry.

Pre-eminent and leading for many years in this field of education for professional pharmacovigilists has been the World Health Organization Collaborat-ing Centre for International Drug Monitoring. This remarkable centre now located in Uppsala, Sweden, has since the 1960s been active in setting global operational standards for public health–oriented phar-macovigilance activities (WHO, 2004). Staff from this centre have developed benchmark training programmes, which since 1993 have inspired and fed the development of many national spontaneous ADR reporting systems around the world (Table 49.1).

Table 49.1 provides a summary of curricular mate-rials included in training programmes of the Uppsala Monitoring Centre. These programmes are regularly delivered both in Sweden and also periodically in different parts of the world.