Adverse Drug Reaction Reporting by Patients in the Netherlands Three Years of Experience
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Background: There has been discussion about the acceptance of adverse drug reactions (ADRs) reported by patients to spontaneous reporting systems. Lack of experience with patient reporting in real life was one of the main drawbacks in this debate. This study covers 3 years of experience with patient reporting in daily practice. We compared patient reports with reports from healthcare professionals. Although patients have the opportunity to report ADRs in several countries, little is published in the literature about the contribution that patient reports have in practice. To our knowledge, this paper is the first to describe long-term experiences with patient reporting as part of a spontaneous reporting system.
Methods: The number of reports received, age and sex of the reporters, characteristics of the most frequently reported drugs and characteristics of the ADRs (most frequently reported ADRs, seriousness, outcome) in a 3-year period (April 2004–April 2007) were compared between patient reports and reports from healthcare professionals.
Findings: During this 3-year period, the Netherlands Pharmacovigilance Centre Lareb received 2522 reports directly from patients, concerning 5401 ADRs. In the same period, healthcare professionals submitted 10 635 reports, concerning 16 722 ADRs. Differences were found in the categories of seriousness and outcome of the reported ADRs between patients and healthcare professionals. Conversely, similarities between patient reports and reports from healthcare professionals were found in age, sex, most frequently reported ADRs and most frequently reported drugs.
Interpretation: Our study highlights clearly that valuable differences between ADR reports from patients and reports from healthcare professionals exist. Differences in interpretation by patients and healthcare professionals may cause the observed disparities in seriousness and outcome of reported ADRs. However, the similarities between patient reports and reports from healthcare professionals in most frequently reported ADRs and most frequently reported drugs are striking. After 3 years of experience with patient reporting, we conclude that patient reporting in spontaneous reporting systems is feasible and that it contributes significantly to a reliable pharmacovigilance.
KeywordsHealthcare Professional Octreotide Acromegaly Pathological Gambling Patient Report
No funding was received for the conduct of this study or the preparation of this report.
The authors have no conflicts of interest that are directly relevant to the content of this manuscript. Joyce de Langen, Florence van Hunsel, Anneke Passier and Kees van Grootheest contributed to the design of the study, the analysis and interpretation of data, and writing and revising the manuscript. Lolkje de Jong-van den Berg critically reviewed the manuscript. Kees van Grootheest took overall responsibility for the study and the manuscript. All authors approved the final version of the manuscript.
- 5.BMA board of science. Reporting adverse drug reactions: a guide for healthcare professionals 2006 [online]. Available from URL: http://www.bma.org.uk/ap.nsf/content/AdverseDrugRe-actions [Accessed 2007 Sep 17]
- 7.van Grootheest AC, Passier JLM, van Puijenbroek EP. Direct reporting of side effects by the patient: favourable experience in the first year. Ned Tijdschr Geneesk 2005; 149: 529–33Google Scholar
- 8.Council for International Organizations of Medical Sciences. International reporting of adverse drug reactions. CIOMS working group report. Geneva: World Health Organisation, 1987Google Scholar
- 9.The ATC/DDD system 2007 [online]. Available from URL: http://www.whocc.no/atcddd/ [Accessed 2007 Sep 17]
- 14.de Jong-van den Berg LTW. Women and drug use. Pharm Weekbl 2001; 136: 1624–8Google Scholar
- 15.Medawar C, Herxheimer A, Bell A, et al. Paroxetine, panorama and user reporting of ADRs: consumer intelligence matters in clinical practice and post-marketing drug surveillance. Int J Risk Saf Med 2002; 13: 161–9Google Scholar
- 18.Passier JLM. Lithium and hyperparathyroidism. Geneesmid-delenbulletin 2005; 39(11): 131–2Google Scholar
- 19.van Grootheest AC, de Graaf L. Pergolide en gokverslaving. Geneesmiddelenbulletin 2006; 40(8): 86–7Google Scholar
- 20.Dutch SPC. Permax® [online]. Available from URL: http://www.cbg-meb.nl/IB-teksten/h14587-h14588-h14589.pdf [Accessed 2000 Jan 2]
- 21.Dutch SPC. Sandostatin® [online]. Available from URL: http://www.cbg-meb.nl/IB-teksten/h12612-h12613-h12614-h1499-7.pdf [Accessed 2007 Oct 25]
- 22.US SPC. Sandostatin® [online]. Available from URL: http://www.fda.gov/cder/foi/label/2005/019667s050lbl.pdf [Accessed 2007 Oct 25]
- 25.Levy MJ, Goadsby PJ. Octreotide dependency: a cautionary tale [abstract]. Endocrine Abstracts 2004; 7: 110Google Scholar