Danish


With a wide range of possible patient conditions and responses, data obtained through clinical trials are often limited in the information they can provide on possible medicinal side effects or adverse reactions. Anna Demming speaks to Dr Vera Ehrenstein about how non-experimental epidemiology tackles some of the challenges in pharmacovigilance.


epidemiologist’s dream’.” She adds, “In fact, it’s a dream that came true thanks to a unique constellation of conditions in Denmark that enable collection of quality data quickly at relatively low cost.” The first condition is equal access to health


care. The satisfaction of the Danish public with their health care system has been the envy of public health care decision makers in other countries. The system is entirely publicly provided and ensures universal, free and equal access for everyone. The second condition is the systematic


population-based registration of major life and health events, such as births, deaths, diseases, migrations and use of prescription medications. Denmark not only has universal healthcare but thorough records exist of each individual’s contact with the health care system. As Dr Ehrenstein points out, in combination with universal health care, this ensures that that the entire population of Denmark is represented in the data recorded when people pass through the health care system. Finally, everyone in Denmark has a


epidemiologist’s dream


Monitoring medicine: Denmark, an


People are unique, and responses to treatments can vary widely. Add to that the common sense precaution that excludes high risk groups from clinical trials and the omission of extreme conditions from ‘ideal samples’ of typical patients and it is easy to see where gaps may exist in the data on the safety of new medication. “Clinical trials show that a given drug can work in principle,” explains Dr Vera Ehrenstein, associate professor at the Department of Clinical Epidemiology, Aarhus University, Denmark. “It is left to non-experimental post-marketing surveillance to determine whether a drug’s benefits actually outweigh its risks in practice, and if so, whether that


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holds for all patients or only for specific groups of patients.” Dr Vera Ehrenstein works in


epidemiology, the study of disease and health trends, and the causes, effects and correlations within populations. In particular the research of Dr Ehrenstein and her colleagues investigates effects of medication use using non-experimental studies. Non-experimental studies data allows epidemiologists to access data on patient groups that are excluded from clinical trials. For non-experimental epidemiologic


approaches, as Dr Ehrenstein points out, “Denmark


has been called ‘an


unique and universal personal identifier so that data from different sources can be linked. “It is possible to conduct life-course studies, whereby individual health trajectories can be traced literally from cradle to grave,” explains Dr Ehrenstein. The result is that Denmark has accumulated hundreds of different registries and databases that stretch over several decades, and can all be interlinked. One approach to non-experimental


epidemiological studies is analysis of data on the prescriptions dispensed. In Denmark, when the package barcode is scanned at a pharmacy, data including the patient’s unique identification number, date of sale, dose and form are automatically transmitted into a database, which is hugely valuable for non-experimental medical surveillance. By accessing this database, researchers can identify users of specific prescription medications as well as the people who suffer from certain chronic diseases,


such as


asthma, diabetes or osteoporosis. Pregnant women typify a group for which


non-experimental epidemiological research can be particularly valuable. Pregnant women rarely participate in clinical trials.


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