Analyses of spontaneous adverse drug reaction reports focusing on specific patient groups and the type of information included in reports from physicians, pharmacists and consumers

Abstract

Drugs are used to prevent, alleviate and treat various diseases or to prevent their progression. Aside from its desired effects, every drug can cause noxious and unintended effects, so-called adverse drug reactions (ADR). ADR can range from mild symptoms to such requiring a hospitalisation or even causing the death of the patient. Beyond that, ADR have an impact on the healthcare system as well. According to a study published in 2011, around 434 million euros are spent annually for the treatment of ADR related hospitalisations only in Germany. Although any drug can theoretically cause an ADR, some patient specific factors increase the probability for it. These include for example the intake of multiple drugs and the presence of (co-)morbidities, which are particularly common in older people. Two other groups of patients, which tend to be affected by ADR as well are children and females. <br /> In order to prevent ADR it is decisive to gain the best possible knowledge of specific factors contributing to a more frequent occurrence of ADR in certain groups of patients. An important data source for initial assessments of such correlations are spontaneous reports. These unsolicited reports on potential ADR arise from everyday life situations and can be submitted by anyone. However, the main reporting sources are physicians, pharmacists, and consumers. The latter mentioned group includes patients and their relatives. Although only few information must necessarily be included when submitting a report, those reports containing as comprehensive information as possible are usually more valuable. They provide deeper insights, for example with regard to an assessment of the causal relationship between a suspected drug and a reported reaction. <br /> This thesis aims to analyse ADR in two selected demographic groups, children and females/males, in order to gain basic knowledge and to provide a basis for more in-depth analyses of age- and sex-specific ADR. Therefore, spontaneous reports from everyday life situations were compared to ADR reports systematically collected in two observational studies (KiDSafe, ADRED). Furthermore, spontaneous reports by the three most frequent reporting sources were analysed to determine the availability of certain information of specific interest for the assessment of potential ADR. These insights could help to identify reporter-specific, frequently missing information and serve as a basis for further studies aiming to define measures contributing to overall more complete reports.