Development of a practice-based drug monitoring approach for assessing appropriateness and outcomes of new drug prescribing

This project tests the value of a monitoring approach that can assess relevant aspects of the use, and early effects of new medicines using routinely collected primary care data. Medicines are usually allowed on the market based on results from trials showing relatively short-term effects in study populations that usually do not correspond with the population exposed to the medicine in practice. Yet, post-approval information on safety and effectiveness is only collected incidentally. This project studies the opportunities for the routine surveillance of pharmaceuticals in the early years post-authorization. It makes a retrospective study of primary care data on the prescription of aliskiren and corresponding population characteristics.

Aliskiren is a novel antihypertensive therapy, for which post-approval indications point to adverse effects in subgroups of patients. This study shows that routinely available primary care data can be used to generate relevant and timely signals of adverse effects in practice. Implementing a surveillance procedure based on primary care data, can improve the safety and efficacy of the regulatory system in an easy and efficient way.