XVI.Add.II.2. Data sources

Depending on the context and objectives of RMM effectiveness evaluation, primary data may be specifically generated to evaluate effectiveness, or secondary (pre-existing) data originally collected for other purposes may be used. Applying qualitative, survey or pharmacoepidemiological methods (see XVI.Add.II.3.) requires different data sources. The ENCePP Guide on Methodological Standards in Pharmacoepidemiology3 provides further guidance on approaches to data collection.

For pharmacoepidemiological studies, relevant information on clinical actions including prescribing behaviour and health outcomes may be extracted from routinely collected data in electronic healthcare databases of (electronic) medical records, registries, or administrative claims records, for secondary data analyses (1–3). Suitable electronic healthcare databases are described in the literature (4) or may be identified from the HMA-EMA Catalogue of Real-World Data Sources4 , which is a publicly available tool. Medical records do not usually capture whether the prescribed medicine has actually been taken, a limitation which applies to all secondary healthcare data collected for a different purpose, as well as for administrative claims data (see XVI.Add.II.2.5. ).

Databases of spontaneous reports of suspected adverse reactions are a further source for pharmacoepidemiological studies.