Direct reporting of side effects by the patient:favourable experience in the first year

OBJECTIVE: To determine the results of establishing a station at which patients can report the side effects of drugs.DESIGN: Descriptive.METHOD: Since 1 April 2003, patients may submit reports of possible adverse drug reactions directly to the Netherlands Pharmacovigilance Centre Lareb. The reports submitted during the period from 1 April 2003 to 31 March 2004 were analysed and compared with the reports submitted by doctors and pharmacists.RESULTS: In the first year, 276 reports were submitted by patients and 3131 by doctors and pharmacists. The reports from patients usually contained sufficient medical information and more frequently referred to serious adverse reactions than reports by health professionals. The reports from patients relatively often concerned psychotherapeutic agents, notably antidepressants.CONCLUSION: Based on the positive results during the first year, the Netherlands Pharmacovigilance Centre Lareb has decided to continue the reporting station for patients. Reports submitted by patients are currently part of the core responsibility of Lareb: the detection of signals of new adverse drug reactions.