Identifying, evaluating and quantifying adverse drug reactions in children: opportunities and obstacles for the manufacturer.

: The monitoring of the safety of its marketed products is a recognized responsibility of the pharmaceutical manufacturer. He has the advantage to concentrate efforts on a relatively small number of compounds and to include a large number of sources and methods. Drug monitoring is especially crucial for the vulnerable groups of patients (children, pregnant women, mentally incompetent and elderly) for whom adequate controlled clinical trials are often lacking with the notable exception of pediatric oncology and vaccinations. The surveillance of adverse drug reactions (ADR) in children represents a special challenge, because of the limited opportunity for usual post marketing surveillance studies. There is a surprising scarcity of epidemiologic projects on ADRs and even of drug usage data in younger age groups. Spontaneous reports are therefore still of great importance. Because of the development of national ADR reporting systems and concomitant regulations and guidelines direct reports to manufacturers account today in the Western world only about 50 percent of the accessible reports, 40% are addressed to national authorities and with only limited access to the manufacturer, sometime even information on age and sex is not provided. The proportion of these reports is increasing and it is important that a better exchange of information can be developed. Reports in the literature account today for about 10 percent of the ADR case reports. Spontaneous reports provide early signals, they can, however, not quantify a risk and need validation. Traditional investigations are often too onerous and time consuming. A promising approach has developed on the basis of computerized health insurance data that enable record linkage of prescriptions and subsequent health events.(ABSTRACT TRUNCATED AT 250 WORDS)