Active Surveillance

Active ADR surveillance provides a system that overcomes many of the shortcomings of voluntary ADR reporting. In the active surveillance network described here, trained surveillance clinicians, whose sole responsibility it is to identify and report ADRs, provide both the expertise and are ensured the dedicated time required to obtain detailed drug safety information.

 

In order to comprehensively assess the safety profile of a drug, nationwide surveillance and collection of clinical data on ADRs from multiple healthcare institutions is needed. An active ADR surveillance network can provide the necessary framework to coordinate data collection in a standardized manner, facilitating the interrogation of clinical data to determine factors that contribute to the risk of an ADR. Similarly, such a network, through its direct link to healthcare professionals in their respective institutions (e.g. hospitals, academic health centres, clinics), enables a coordinated and efficient communication of drug risk evaluation results to clinicians for a rapid uptake of safety alerts in clinical practice.

 

Moreover, active surveillance can capture ADRs across the entire population of patients exposed to drugs in a variety of clinical settings, and is thus able to inform health authorities on true drug risks in everyday clinical practice. At the same time, an active surveillance system allows targeted recruitment and follow-up of patients focused on a specific ADR, a specific drug, or a specific patient subpopulation (e.g. age groups, ethnic groups, gender). With such targeted investigations, relevant information on a specific drug safety question can be obtained very efficiently and within a relatively short time. Most importantly, active surveillance provides a means to evaluate drug safety particularly in “orphan populations”, often excluded from clinical trials, such as children, or women during pregnancy.

 

Of equal importance, active surveillance by trained clinicians enables the collection of standardized, detailed and high quality ADR reports, which are critical for the evaluation of drug risk. With detailed and high quality clinical data, thorough analyses of factors that increase the susceptibility of a patient to suffer from an ADR, are possible. The identification of susceptibility factors and those individuals at greatest risk for ADRs is key to an improved overall drug safety. Once such susceptibility factors are identified, this information can be incorporated into drug labels and clinical practice guidelines to inform clinicians about an increased drug risk in specific patient subpopulations, and thus contribute to better-informed clinical decision making through stratification of patients according to their risk of developing a specific ADR, reducing the occurrence of serious and life-threatening ADRs.