Introduction

Pharmacovigilance is concerned with the study of medicines after their approval and with the use of the ensuing information for education and drug regulation. Its ultimate aim is to foster the rational and safe use of medicines. The expertise needed in pharmacovigilance includes pharmacology, epidemiology, clinical medicine and drug legislation. A further need is the skill to write drug safety information in a clear but balanced way, to ensure that healthcare practitioners and patients are given reliable information that they can understand and use. Here is a link with the drug information profession.

Pharmacovigilance is not an established academic specialism and the current curricula of the training programmes of professions such as clinical medicine, clinical pharmacy, clinical pharmacology or medical biology do not cover all the skills needed in pharmacovigilance. Therefore, there is a need for the provision of special training packages for the (further) education of professionals in pharmacovigilance, either working at health authorities, pharmaceutical companies, universities, hospitals or health maintenance orga nisations. Another reason is that pharmacovigilance is in a comparatively early phase of development. Its procedures frequently change and novel approaches are enriching our armamentarium. One of the tasks of a pharmacovigilance centre is the creation of a ''reporting culture''. Healthcare professionals need to be made aware that all medicines can cause adverse reactions and that they have a responsibility to participate in the national pharmacovigilance system and to contribute to other drug evaluation studies, recommended by the health authorities or the professional associations. Therefore, already in the curricula of undergraduate medical and pharmaceutical students attention should be paid to adverse drug reactions (ADRs) and pharmacovigilance.

Up till the present day, national and international ''spontaneous reporting'' schemes for suspected ADFs have been a major source of information in pharmacovigilance. As is shown in Table 41.1, spontaneous reporting has four different "layers". First, there is the organisational structure needed to ensure that the necessary data are reported, assessed, stored, processed and distributed. Second, there is the use of these data

Table 41.1. Spontaneous reporting has four different ''layers''.

1. The collection, assessment, processing and distribution of data (organisation, routines)

2. Drug regulation (risk management, legislation)

3. Science: methodology and procedures, data interpretation

4. Communication and education (feed-back)

for the postmarketing evaluation of medicines by a country's regulatory authority, in dialogue with the pharmaceutical companies. Here the emphasis is on prompt risk management, i.e. the taking of timely and appropriate actions (ranging from a data sheet change to the suspension or withdrawal of a licence). Third is the scientific basis of spontaneous reporting: the principles underlying the method, the appropriateness of procedures and routines, and the credibility of data interpretation. Finally, there is communication and education, in particular the dissemination of information to prescribers, pharmacists and patients.

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