Methodological approaches to ADR detection in out-patient children.

Drugs are extensively used in both ill and healthy people, all over the world and at all ages. But, in fact, children are prone to receive a drug after every consultation. As drugs are not just "healing substances" but also chemicals able to interfere with the body and cause harm, the physician has to keep a balance between effects and side-effects: a risk/benefit analysis. Two potential ways of causing harm can be distinguished: the classical "Adverse Drug Reactions" (ADR), based upon the biochemical and physiological interactions between the drug and the body, and the so called "Drug Related Problems" (DRP). The last ones are situations in which a patient gets worse because a good medication has been stopped or the adequate treatment was never prescribed, overdosages and intoxications, or even the changes in the patient's conceptions and attitudes to drugs due to an unhealthy use of medicines. The incidence of ADR in children is very low (0.7 to 4% in outpatient children), but some methods for detecting and controlling these adverse effects must be at hand for making it possible to discover new, serious, unexpected ADRs. The most important characteristics of the main system used, such as the "Spontaneous Reporting System", "Record Linkage in Computerized Databases", "Prescription-Event Monitoring" or the "Sample Monitoring" and Therapeutic Audits", are discussed in the paper. (Fig. 2, Ref. 29.)