European primary and/or secondary care medical database - EMA/2015/51/PH.

closed

The Agency currently has access to UK general practice data including prescriptions and health events linked to unique patients through anonymising codes. However, a substantial number of European medicines are most often employed in secondary care settings and such use is not directly recorded in general practice data. Furthermore, to increase the generalisability of analyses and to increase the information concerning infrequently used products, it would be desirable to obtain further primary care data. Thus it is very desirable for the Agency to maintain a subscription to at least 1 additional high-quality source of primary and/or secondary care data. At a minimum this data source should allow quantitative assessments of the usage of drugs in a subset of European practices/hospitals. Ideally it would allow linkage of the drug prescription data to subsequent clinical events and to existing clinical status and demographic variables for individual patients.