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Fifteen years of patient reporting


18 June 2019

  • Patients’ reports can contribute to signal detection and add value to pharmacovigilance. However, Lareb recognizes that there is a big leap between allowing patients to report and a more integrated patient involvement in pharmacovigilance, where patients play a role in all facets in pharmacovigilance, from benefit-harm assessment to risk communication. This was concluded after an analysis of fifteen years of patient reporting in the Netherlands.

    In April 2003, Lareb successfully implemented patient reporting to their spontaneous reporting system. In the last 15 years, the number of reports by patients has rapidly grown as has their contribution to signal detection. By opening up to patients as reporters, the Netherlands Pharmacovigilance Centre Lareb shifted their focus from being drug-centered to patient-centered.

    In order to make the best use of patient-reported outcomes, methods used in pharmacovigilance still need to be optimized. This also means that methods and systems used for collecting, coding and analyzing patient-reported information need to be further developed. However, the scope of patient participation in pharmacovigilance should not be limited to that of reporter only. It is important to increase patient involvement in other aspects as well. This can be achieved by national pharmacovigilance centres enhancing their collaboration with patient organizations.

    Reference: van Hunsel F, Härmark L, Rolfes L. Fifteen years of patient reporting – what have we learned and where are we heading? Expert Opinion on Drug Safety