Pharmacoepidemiological research at the Medicines Monitoring Unit, Scotland: data protection and confidentiality.

The Medicines Monitoring Unit (MEMO) is a University-based organization that uses record-linkage techniques to construct an observational database for the population of Tayside, Scotland (approximately 400,000 people). This contains healthcare data indexed by a unique identifier, including data on all prescriptions dispensed, which facilitates pharmacoepidemiological (and other) research. It has hitherto been possible to carry out drug safety studies in the entire population, with access to original medical records of patients where necessary, that have satisfied ethical concerns and confidentiality legislation. However, the recent UK Data Protection Act 1998 (which enforces the 1995 European Directive on Data Protection) has important implications for MEMO's research. The Act has necessitated changes to the way in which research studies are carried out, with MEMO's objective being to ensure that research can continue while protecting the rights and privacy of individual patients. This involves anonymization of data, seeking specific ethical approval for research studies and obtaining relevant permissions from 'Caldicott Guardians', as described in this article.