Development of a Danish electronic record surveillance system for drugs in Denmark for cooperation with other EU countries, initial focus on the first two years after marketing.
Henrik Enghusen Poulsen, Professor Chief, MD
Jon TrÃ¦rup Andersen, Ph.D, MD
Espen Jimenez Solem, Ph.D. MD
Niels HÃ¸jsgaard JÃ¸rgensen, MSc in Pharmaceutical Sciences
A collaboration with a pharmacoepidemiological group (DANTRIP with researchers from Gentofte Department of Cardiology, Rigshospitalet Department of Cardiology, Glostrup Department of Cardiology, University of Southern Denmark, Department of Biostatistic Department of Public Health, Copenhagen University and Laboratory of Clinical Pharmacology Rigshospitalet, Bispebjerg Hospital.
The objective of this project is to establish a surveillance system that detects adverse effects on new drugs by pharmacoepidemiology.
Voluntary reporting identifies only a small fraction of adverse drug events. Using incident reports for quality assurance/quality improvement will lead to significant bias when assessing quality of care. Access to electronic healthcare records will enable early detection and therefore more timely response to adverse events, including drug reactions. In Denmark, all drug prescriptions are registered by pharmacies, and stored electronically at Sundhedsstyrelsen, but utilizing a new system to detect side effects is needed.
Our goal is to initiate a database of pharmacoepidemiological research of new drugs. This database includes the registered side effects and the therapeutic indication. Our plan is to use the data in Danmarks Statistik to identify the number of doses of a new drug for each year. On such data it can be determined how many years of exposure to the Danish population to a new drug is needed to detect side effects of defined frequencies.
Financial Support Danish Agency for Science Technology and Innovation
Granting Period September 2007 - December 2009