Web-based intensive monitoring a patient based pharmacovigilance tool

PhD ceremony: Ms. L.V.D.H. Härmark, 12.45 uur, Academiegebouw, Broerstraat 5, Groningen

Dissertation: Web-based intensive monitoring a patient based pharmacovigilance tool

Promotor(s): prof. A.C. van Grootheest, prof. J.J. de Gier

Faculty: Mathematics and Natural Sciences

The collection of adverse drug reaction (ADR) reports from healthcare professionals and patients, also known as a spontaneous reporting, has been the backbone of pharmacovigilance since the 1960s. As a complement to this system, a new method has been developed, which follows first-time users of certain drugs over time by means of web-based questionnaires. This method, known as Lareb Intensive Monitoring (LIM), has been developed by the Netherlands Pharmacovigilance Centre Lareb. Linda Hármark evaluated the use of this new method.

The studies in her thesis show that the LIM system is feasible and that it works well in daily practice. With the LIM system it is possible to collect more detailed information about the user of the drug (demographic data and indication for use), drug use (dosage, use and co-medication) as well as adverse drug reactions (new ADRs, time course of ADRs). Patients are positive towards LIM participation and the most important motive for participation is altruism. Because not all patients eligible for inclusion participate, it is important to know if the participating patients are representative for the whole group of patients using the drug under study. A comparison with a reference population shows that the LIM population on average is younger and healthier. The outcomes from Härmarks study allows for correction for these differences when generalising results of LIM studies to a broader population.

Härmark concludes that web-based intensive monitoring is a valuable addition to the current methods used in pharmacovigilance. The method needs to be further developed but hold the promise to become an important pharmacovigilance tool.