Dutch launch remote monitoring of new drug side-effects
The Dutch Pharmacovigilance Centre, Lareb, has officially launched the first project in the world for the remote monitoring of side-effects associated with newly launched medicines.
The Dutch Pharmacovigilance Centre, Lareb, has officially launched the first project in the world for the remote monitoring of side-effects associated with newly launched medicines.
The project is entitled Lareb Intensive Monitoring (LIM) and is in co-operation with the Dutch Medicines Evaluation Board (CBG) and the Royal Society of Pharmacists (KNMP). It works by the routine online questioning of patients taking new medicines.
The objective is to follow during the first few months of commercialisation the effects of newly launched medicines through a questionnaire which will have to be filled out by the patient on four occasions: two weeks after the beginning of treatment, six weeks, three months and then six months later. The questionnaires are sent by e-mail to Lareb and are recorded under a personal code supplied by the pharmacist.
LIM was implemented officially on 1 August with a follow-up of the antiepileptic treatment Lyrica from Pfizer (pregabalin).
"Currently, about 100 patients and 850 of the 1,750 pharmacies in the Netherlands are participating in our project. We have not yet observed anything alarming up to now," said Kees van Grootheest, director of Lareb. "However this is well below the actual number of people following treatment with Lyrica. From 1 September, other pharmacies should be connected and the general public will be made aware through an information campaign."
Initial focus will be on widely used medicines composed of a new chemical entity (NCE) because there is practically no data on the actual risks and the types of side effects, apart from clinical studies, explained van Grootheest.
Other follow-ups envisaged will involve Acomplia from Sanofi-Aventis (rimonabant) against obesity and Yentreve from Lilly (duloxetine) against incontinence, which is also offered by Boehringer Ingelheim under the name of Cymbalta against depression.
The LIM project is being financed for three months by the CBG. The data collected are continually being evaluated to gain an impression of the efficacy and of any possible modifications to be made. The system has already shown that the elderly are not under represented despite the use of internet and e-mail.