Introduction: In April 2003, the Netherlands Pharmacovigilance Centre Lareb successfully implemented patient reporting to their spontaneous reporting system. The number of reports by patients rapidly grew, prompting the need to evaluate the value of the patient reporting scheme and to compare experiences with other countries. The aim of this article is to summarize our 15-year experience of working with direct patient reporting in pharmacovigilance and to discuss necessary steps in order to optimize the use of patient reports in the future.
Areas covered: This article is based on Lareb studies on patient reporting from 2004 onwards and covers the evolution of the Dutch patient reporting system, the value of patient participation in pharmacovigilance, the impact of patient reporting on the spontaneous reporting system and future steps to strengthen patient reporting.
Expert opinion: After 15 years of experience with patient reporting we conclude that patients can add value to pharmacovigilance. We recognize that there is a big leap between allowing patients to report and actual patient involvement in pharmacovigilance. It is our belief that increased patient involvement in pharmacovigilance is a way to improve pharmacovigilance, enhancing the general public's trust in medicines.
Keywords: Patient reporting; patient participation; pharmacovigilance; signal detection; spontaneous reporting system.