Klin Farmakol Farm. 2011;25(3):102-111

Pharmacovigilance in a changing world

Ronald H.B.Meyboom

Department of pharmacoepidemiology and clinical pharmacology,

University of Utrecht, The Netherlands

Pharmacovigilance is concerned with the set of activities and actions that take place after the approval of a medicine and aims at expanding

knowledge and encouraging safe and rational pharmacotherapy. Halfway through the last century, in an attempt to monitor

the safety of medicines and in the absence of other options, practising physicians were called on to report to the health authorities their

experiences with suspected adverse drug reactions. Today, 50 years later, this ‘spontaneous monitoring’ system, be it in a changed and

regulated way, still plays a central role in pharmacovigilance. The core data of spontaneous monitoring typically are case reports of patients

with disorders that are suspected to be related to the use of medicines. Straightforward as it may seem, the use of medical histories

is complex and difficult – scientifically, technically and ethically – and the interpretation of such data is often ambiguous and uncertain.

Drug safety is a shared concern of various parties – notably patients, clinicians, companies, insurers and governmental agencies. While

the main goal of pharmacovigilance is the generation and dissemination of additional clinically helpful knowledge, enabling a better or

safer use of a drug, its findings are often regarded as bad news, as something negative. Different parties may have different interests and

priorities, and news about a medicine is often a cause of tension or trouble. For the success and effectiveness of pharmacovigilance a fair

amount of independence – scientifically and financially – is necessary. In the past few decades, the possibilities for the scientific study of

medicines, before as well as after approval, have improved tremendously as regards methodology as well as technical feasibility. Likewise

the execution of pharmacovigilance, in the widest sense of the word, has changed and continues to change. In a time of continuing

changes, it is important to reconsider what the expected – current and future – contributions of spontaneous monitoring are and what

the most appropriate form of organisation of the reporting system will be, in order to enable and to ensure that these data – derived

from real patients – will be used effectively and efficiently and to their best advantage. Whatever methods and tools come into use in

future pharmacovigilance, the original function of the spontaneous monitoring system – the early detection of new and unexpected drug-related problems – is likely, at least in part, to continue.

Klíčová slova: pharmacovigilance, adverse drug reactions, reporting.

Zveřejněno: 1. prosinec 2011  Zobrazit citaci