Motives for reporting adverse drug reactions by pa

Authors: Florence van Hunsel Christine van der Welle Anneke Passier Eugène van Puijenbroek Kees van Grootheest

Publish Date: 2010/07/24

Volume: 66, Issue: 11, Pages: 1143-1150

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Abstract

The response rate was 765 after one reminder The main reasons for patients to report ADRs were to share their experiences 89 agreed or strongly agreed the severity of the reaction 86 agreed or strongly agreed to the statement worries about their own situation 632 agreed or strongly agreed and the fact the ADR was not mentioned in the patient information leaflet 576 agreed or strongly agreed Of the patientresponders 938 shared the opinion that reporting an ADR can prevent harm to other people 979 believed that reporting contributes to research and knowledge 907 stated that they felt responsible for reporting an ADR and 925 stated that they will report a possible ADR once again in the futureThe main motives for patients to report their ADRs to a pharmacovigilance centre were the severity of the ADR and their need to share experiences The high level of response to the questionnaire shows that patients are involved when it comes to ADRs and that they are also willing to share their motivations for and opinions about the reporting of ADRs with a pharmacovigilance centreAn increasing number of countries are incorporating the direct reporting of adverse drug reactions ADRs by patients into pharmacovigilance systems 1 Consequently knowledge of the factors influencing patient reporting to pharmacovigilance systems on a daytoday basis has been increasing in recent years 1 2 3 4The organization responsible for the management of the spontaneous reporting system for ADRs in the Netherlands is the Netherlands Pharmacovigilance Centre Lareb on behalf of the Medicines Evaluation Board Not only healthcare professionals and marketing authorization holders are able to report ADRs directly to Lareb since April 2003 patients can also report ADRs directly to Lareb Patients can report ADRs through an electronic reporting form available on the Lareb website that is identical in terms of content to that used by healthcare professionals Several mandatory fields in this form ensure the completeness of the information before it can be sent to the pharmacovigilance centre In rare cases where it is not possible for a patient to report electronically a paper reporting form can be sent upon request Patients’ and healthcare professionals’ reports are coded according to MedDRA Medical Dictionary for Regulatory Activities terminology individually assessed by trained assessors and stored in the same database All reporters both patients and healthcare professionals receive feedback information on their reported ADRs 2In 2008 the Netherlands Pharmacovigilance Centre Lareb published their experiences on 3 years of patient reporting 2 The Centre reported that patients’ reports contained different information than those of healthcare professionals with respect to categories of seriousness and outcome of the reported ADRs 2 When patients’ and healthcare professionals’ ADR reports on statins were compared following media attention patient reports were found to provide additional information on the different categories of adverse reactions the impact of ADRs on daily life and the patient–health professional relationship 3 In a study carried out in Denmark patients were also found to report different categories of ADRs for different types of medicines compared to other reporters 4 Based on these results the authors of this study concluded that consumers should be actively included in systematic drug surveillance systems A patient’s own firsthand report of his/her experiences with drugs can capture side effects that clinicians might miss 5 6 According to Foster et al ‘patientreporting can be an important source of information about side effects in the context of reallife clinical practice’ 7The motivations and attitudes of healthcare professionals towards ADR reporting to a pharmacovigilance centre have been studied extensively 8 9 10 11 12 13 14 15 16 17 18 19 20 In contrast the reasons why patients report ADRs are less well known As Aagaard et al 4 noted consumers’ experiences with and perspectives on ADRs should be further studied A qualitative study involving guided interviews with 21 patients in the Netherlands was performed to gain insight into the motivations of patients who report ADRs to a pharmacovigilance centre 21 Most patients expressed altruistic motives but also the severity of the ADR and the need for extra information about the ADR were mentioned as motives for reporting

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