title: ADR Reporting by the General Public: Lessons Learnt from the Dutch and Swedish Systems.
abstract: Consumer reporting of adverse drug reactions (ADRs) has existed in several countries for decades, but throughout Europe the role of consumers as a source of information on ADRs has not been fully accepted until recently. In Europe, The Netherlands and Sweden were among the first countries to implement consumer reporting well before it was mandated by law throughout the EU. Consumer reporting is an integral part of the spontaneous reporting systems in both The Netherlands and Sweden, with yearly numbers of reports constantly increasing. Consumer reporting forms and handling procedures are essentially the same as for healthcare professional reporting; the message in the reports, not the type of messenger, is what is of importance. Studies have established the significant contribution of consumer reporting to ADR signal detection. Combining all reports regardless of reporter type is recommended since it yields the largest critical mass of reports for signal detection. Examples of signals where consumer reports have been of crucial importance for signal detection are electric shock-like sensations associated with the use of duloxetine, and persistent sexual dysfunction after discontinuation of selective serotonin reuptake inhibitors. An example of consumer reporting significantly strengthening a detected signal is Pandemrix(®) (influenza H1N1 vaccine)-induced narcolepsy. Raising public awareness of ADR reporting is important, but time- and resource-consuming. The minimum effort taken should be to passively inform consumers, e.g. via stakeholders' homepages and via drug product information leaflets. Another possibility of reaching out to this target group could be through co-operation with other (non-government) organizations. Information from consumer reports may give a new perspective on ADRs via the consumers' unfiltered experiences. Consumers' views may change the way the benefit-harm balance of drugs is perceived and assessed today, and, being the ultimate users of drugs, consumers could have a relevant influence in the regulatory decision-making processes for drugs. All stakeholders in pharmacovigilance should embrace this new valuable source of information.
authors: Netherlands Pharmacovigilance Centre Lareb, WHO Collaborating Centre in Pharmacovigilance for Education and Patient Reporting, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands, l.harmark@lareb.nl.
authors: Linda
authors: L
authors: Härmark
authors: Florence
authors: F
authors: van Hunsel
authors: Birgitta
authors: B
authors: Grundmark
mesh_terms: D003256:Community Participation; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D006801:Humans; D009426:Netherlands; D060735:Pharmacovigilance; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D013548:Sweden
references: Am J Psychiatry. 1995 May;152(5):810
references: 7726327
references: Tijdschr Psychiatr. 2014;56(5):336-40
references: 24838589
references: Pharmacoepidemiol Drug Saf. 2011 Mar;20(3):286-91
references: 21351310
references: Ned Tijdschr Geneeskd. 2005 Mar 5;149(10):529-33
references: 15782689
references: Drug Saf. 2008;31(6):515-24
references: 18484785
references: Pharmacoepidemiol Drug Saf. 2015 Feb;24(2):152-8
references: 25079444
references: Drug Saf. 2006;29(5):385-96
references: 16689555
references: Ned Tijdschr Geneeskd. 2014;158:A6651
references: 24846110
references: Pharmacoepidemiol Drug Saf. 2011 Oct;20(10):1098-103
references: 21809408
references: J Clin Psychopharmacol. 2009 Apr;29(2):157-64
references: 19512977
references: Drug Saf. 2012 Oct 1;35(10):845-54
references: 22967189
references: Drug Saf. 2007;30(3):187-90
references: 17343426
references: Drug Saf. 2014 May;37(5):343-50
references: 24777653
references: Drug Saf. 2012 Jan 1;35(1):45-60
references: 22149419
references: Eur J Clin Pharmacol. 2010 Nov;66(11):1143-50
references: 20658130
references: J Thromb Haemost. 2014 Sep;12(9):1385-7
references: 24909698
references: Br J Clin Pharmacol. 2009 May;67(5):558-64
references: 19552751
references: Pharmacoepidemiol Drug Saf. 2013 Mar;22(3):302-5
references: 23280652
references: Drug Saf. 2013 Mar;36(3):199-206
references: 23444232
references: Drug Saf. 2003;26(4):211-7
references: 12608885
references: Br J Clin Pharmacol. 2007 Feb;63(2):148-56
references: 17274788
references: BMJ. 2004 Sep 4;329(7465):573
references: 15345644
references: Lakartidningen. 2002 Aug 22;99(34):3290-5
references: 12362847
references: Drug Saf. 2010 Sep 1;33(9):775-88
references: 20701410
references: Pharmacoepidemiol Drug Saf. 2010 Jan;19(1):26-32
references: 19953500
references: Br J Clin Pharmacol. 2013 Apr;75(4):1109-17
references: 22905902
references: Int J Pharm Pract. 2014 Jun;22(3):231-3
references: 23937120
references: Drug Saf. 2014 Jun;37(6):409-19
references: 24748428
references: Ann Pharmacother. 2010 May;44(5):936-7
references: 20388861
references: Drug Saf. 2012 Oct 1;35(10):807-18
references: 22928729
references: Expert Opin Drug Saf. 2014 Sep;13 Suppl 1:S21-9
references: 25171156
references: J Clin Psychiatry. 2003 Aug;64(8):969-71
references: 12927017
references: Drug Saf. 2009;32(11):1067-74
references: 19810778
references: Health Technol Assess. 2011 May;15(20):1-234, iii-iv
references: 21545758
references: Farm Hosp. 2013 Jan-Feb;37(1):65-71
references: 23461502
references: Pharmacoepidemiol Drug Saf. 2013 Oct;22(10):1134-7
references: 24092565
references: Drug Saf. 2013 Apr;36(4):267-76
references: 23475583
references: Med J Aust. 2013 Nov 18;199(10):684-6
references: 24237099
references: PLoS One. 2013 Jun 18;8(6):e66338
references: 23823902
references: Drug Saf. 2007;30(8):669-75
references: 17696579
references: BMC Complement Altern Med. 2010 Feb 25;10:8
references: 20184759
references: BMJ. 2012 Aug 07;345:e4916
references: 22872709
references: Drug Saf. 2013 Dec;36(12):1129-49
references: 24092596