Poster Presentations A

Drug Safety 2007; 30 (10): 919-990

A BSTRACTS

© 2007 Adis Data Information BV. All rights reserved.

Poster Presentations

P.091 Lareb Intensive Monitoring: An Interim Analysis

Netherlands Pharmacovigilance Centre Lareb,

‘s-Hertogenbosch, The Netherlands

Background: In 2006 the Netherlands Pharmacovigilance Centre Lareb started with Lareb Intensive Monitoring (LIM). LIM is a new, web-based system using patients as a source of information. The main objective of LIM is to monitor the safety of new drugs. After registration on the LIM- website, questionnaires are sent to the patient at specific points in time.

Patients eligible for participation are identified using the first dispensing signal in the pharmacy. This system gives the opportunity to follow drugs more closely than with the current spontaneous reporting system. On August 1st 2006, Lareb Intensive Monitoring started with the monitoring of pregabaline and on November 1st 2006, the monitoring of the second drug, duloxetine was started.

Objective/aim: The aim of this paper is to describe the feasibility, exper- iences and level of participation of the Lareb Intensive Monitoring pro- gramme.

Methods: Using the internal web application of Lareb Intensive Monitor- ing and the Lareb Intensive Monitoring database an interim analysis was performed.

Results: More than half of the Dutch pharmacies participate in the LIM programme.

Currently, more than 1000 patients using pregabaline or duloxetine are participating in this intensive monitoring scheme. An interim analysis showed that approximately half of the patients had experienced an adverse reaction while using the drug. About ten serious events were reported. As expected, the majority of the reported adverse reactions are mentioned in the Summary of Product Characteristics of both drugs. The LIM system gives a clear insight of the use of these drugs in daily practice. The LIM programme is easy to incorporate into the daily routine of the pharmacies without any substantial effect on the work load.

Conclusion: A web based intensive monitoring system shows to be a valuable and feasible supplementary system to the existing spontaneous reporting system in the Netherlands. The system has effortless implement- ed in the majority of the Dutch pharmacies and is easy to incorporate into their daily routines. Special attention is paid to instructing the pharmacy- assistants to optimise the response of the system. Pharmacists and patients are satisfied about this additional form of Pharmaceutical Care.