WHO strategy for collecting safety data in public health programmes: complementing spontaneous reporting systems

Abstract

Globally, national pharmacovigilance systems rely on spontaneous reporting in which suspected adverse drug reactions (ADRs) are reported to a national coordinating centre by health professionals, manufacturers or patients. Spontaneous reporting systems are the easiest to establish and the cheapest to run but suffer from poor-quality reports and underreporting. It is difficult to estimate rates and frequencies of ADRs through spontaneous reporting. Public health programmes need to quantify and characterize risks to individuals and communities from their medicines, to minimize harm and improve use, to sustain public confidence in the programmes, and to track problems due to medication errors and poor quality medicines. Additional methods are therefore needed to monitor the quantitative aspects of medicine safety, to better identify specific risk factors and high-risk groups, and to characterize ADRs associated with specific medicines and in specific populations. The present paper introduces two methods, cohort event monitoring and targeted spontaneous reporting, that are being implemented by the WHO, in its public health programmes, to complement spontaneous reporting. The advantages and disadvantages of these methods and how each can be applied in clinical practice are discussed.

Fig. 1

The relationship between spontaneous reporting, TSR and CEM. All medical incidents (events) that patients experienced while on treatment can be captured by CEM. Those events considered noxious and unintended and suspected to be caused by the medicine are reportable as ADRs through spontaneous reporting. TSR focuses on the collection of information on specific ADRs, with specific medicines, in defined patient groups. ADRs adverse drug reactions, CEM cohort event monitoring, TSR targeted spontaneous reporting