ADR Reporting by the General Public: Lessons Learnt from the Dutch and Swedish Systems

Drug Safety

Volumn 38, Issue 4, 2015, Pages 337-347

  Härmark, Linda ^a   van Hunsel, Florence ^a   Grundmark, Birgitta ^b,c  

^a Netherlands Pharmacovigilance Centre Lareb   (Netherlands)

^b MEDICAL PRODUCTS AGENCY   (Sweden)

^c UPPSALA UNIVERSITY   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

CONSUMER; DRUG SURVEILLANCE PROGRAM; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMAN; NETHERLANDS; POSTMARKETING SURVEILLANCE; PROCEDURES; SWEDEN;

CONSUMER PARTICIPATION; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; NETHERLANDS; PHARMACOVIGILANCE; PRODUCT SURVEILLANCE, POSTMARKETING; SWEDEN;

EID: 84939946284     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.1007/s40264-015-0264-1     Document Type: Review

References (67)

1. CIOMS Working Group VIII. Practical aspects of signal detection in pharmacovigilance: report of CIOMS Working Group VIII. Geneva: CIOMS; 2010.
2. Raine J. Risk management: a European Regulatory view. In: Mann RM, Andrews EB, editors. Pharmacovigilance. 2nd ed. NewYork:Wiley; 2007:553–558.
3. Lester J, Neyarapally GA, Lipowski E, Graham CF, Hall M, Dal Pan G. Evaluation of FDA safety-related drug label changes in 2010. Pharmacoepidemiol Drug Saf. 2013;22(3):302–5.
4. The Erice Manifesto. for global reform of the safety of medicines in patient care. Drug Saf. 2007;30(3):187–90.
5. World Health Organization. Safety monitoring of medicinal products: reporting system for the general public. 2012. http://www.who.int/medicines/areas/quality_safety/safety_efficacy/qas_safetymonitoringmp/en/.
6. van Hunsel F, Harmark L, Pal S, Olsson S, van Grootheest K. Experiences with adverse drug reaction reporting by patients: an 11-country survey. Drug Saf. 2012;35(1):45–60.
7. van Grootheest K, de Graaf L, de Jong-van den Berg L. Consumer adverse drug reaction reporting: a new step in pharmacovigilance? Drug Saf. 2003;26(4):211–217.
8. van Hunsel FPAM. The contribution of direct patient reporting to pharmacovigilance [thesis]. Groningen: Rijsuniversiteit Groningen; 2011.
9. Avery AJ, Anderson C, Bond CM, et al. Evaluation of patient reporting of adverse drug reactions to the UK ‘Yellow Card Scheme’: literature review, descriptive and qualitative analyses, and questionnaire surveys. Health Technol Assess. 2011;15(20):1–iv.
10. Aagaard L, Nielsen LH, Hansen EH. Consumer reporting of adverse drug reactions: a retrospective analysis of the Danish adverse drug reaction database from 2004 to 2006. Drug Saf. 2009;32(11):1067–74.
11. Durrieu G, Palmaro A, Pourcel L, et al. First French experience of ADR reporting by patients after a mass immunization campaign with influenza A (H1N1) pandemic vaccines: a comparison of reports submitted by patients and healthcare professionals. Drug Saf. 2012;35(10):845–54.
12. Leone R, Moretti U, D’Incau P, et al. Effect of pharmacist involvement on patient reporting of adverse drug reactions: first Italian study. Drug Saf. 2013;36(4):267–76.
13. Parretta E, Rafaniello C, Magro L, et al. Improvement of patient adverse drug reaction reporting through a community pharmacist-based intervention in the Campania region of Italy. Expert Opin Drug Saf. 2014;13(Suppl 1):21–9.
14. Vilhelmsson A. A pill for the ill? Depression, medicalization and public health [thesis]. Lund University; 2014.
15. Margraff F, Bertram D. Adverse drug reaction reporting by patients: an overview of fifty countries. Drug Saf. 2014;37(6):409–19.
16. Esther SM, Jimeno FJ, Aguirre C, Garcia M, Ordonez L, Manso G. Direct reporting by patients of adverse drug reactions in Spain [in Spanish]. Farm Hosp. 2013;37(1):65–71.
17. Kubota K, Okazaki M, Dobashi A, et al. Temporal relationship between multiple drugs and multiple events in patient reports on adverse drug reactions: findings in a pilot study in Japan. Pharmacoepidemiol Drug Saf. 2013;22(10):1134–7.
18. Herxheimer A, Crombag R, Alves TL. Direct patient reporting of adverse drug reactions; a fifteen-country survey and literature review. Health Action International Europe; 2010.
19. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP). 2013. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/06/WC500144009.pdf. Accessed 15 Oct 2014.
20. Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385–96.
21. Golomb BA, McGraw JJ, Evans MA, Dimsdale JE. Physician response to patient reports of adverse drug effects: implications for patient-targeted adverse effect surveillance. Drug Saf. 2007;30(8):669–75.
22. The Medical Products Agency. Inrapporterade biverkningar. 2012. http://www.lakemedelsverketse/upload/nyheter/2013/arsrapport_2012_biverkningar_2013-04-17pdf. Accessed 15 Oct 2014.
23. van Hunsel F, Passier A, van Grootheest AC. Comparing patients’ and healthcare professionals’ ADR reports after media attention: the broadcast of a Dutch television programme about the benefits and risks of statins as an example. Br J Clin Pharmacol. 2009;67(5):558–64.
24. Medawar C, Herxheimer A, Bell A, Jofre S. Paroxetine, Panorama and user reporting of ADRs: consumer intelligence matters in clinical practice and post-marketing drug surveillance. Int J Risk Saf Med. 2002;15(3–4):161–9.
25. Medawar C, Herxheimer A. A comparison of adverse drug reaction reports from professionals and users, relating to risk of dependence and suicidal behaviour with paroxetine. Int J Risk Saf Med. 2004;16:5–19.
26. Ekins-Daukes S, Irvine D, Wise L, Fiddes S. The Yellow Card Scheme: evaluation of patient reporting of suspected adverse drug reactions [abstract]. Pharmacoepidemiol Drug Saf. 2006;15:S1–316.
27. Blenkinsopp A, Wilkie P, Wang M, Routledge PA. Patient reporting of suspected adverse drug reactions: a review of published literature and international experience. Br J Clin Pharmacol. 2007;63(2):148–56.
28. van Hunsel FP, ten Berge EA, Borgsteede SD, van Grootheest K. What motivates patients to report an adverse drug reaction? Ann Pharmacother. 2010;44(5):936–7.
29. van Hunsel F, van der Welle C, Passier A, van Puijenbroek E, van Grootheest K. Motives for reporting adverse drug reactions by patient-reporters in the Netherlands. Eur J Clin Pharmacol. 2010;66(11):1143–50.
30. Frankenfeld C. “Serious” and “severe” adverse drug reactions need defining. BMJ. 2004;329(7465):573.
31. de Langen J, van Hunsel F, Passier A, de Jong-van den Berg L, van Grootheest K. Adverse drug reaction reporting by patients in the Netherlands: three years of experience. Drug Saf. 2008;31(6):515–524.
32. The Netherlands Pharmacovigilance Centre Lareb. Gokverslaving en antiparkinsonmiddelen. Geneesmiddelenbulletin. 2006;40(8):86–7.
33. McLernon DJ, Bond CM, Hannaford PC, et al. Adverse drug reaction reporting in the UK: a retrospective observational comparison of yellow card reports submitted by patients and healthcare professionals. Drug Saf. 2010;33(9):775–88.
34. Inch J, Watson MC, Anakwe-Umeh S. Patient versus healthcare professional spontaneous adverse drug reaction reporting: a systematic review. Drug Saf. 2012;35(10):807–18.
35. Rolfes L, van Hunsel F, Wilkes S, van Grootheest K, van Puijenbroek E. Adverse drug reaction reports of patients and healthcare professionals-differences in reported information. Pharmacoepidemiol Drug Saf (Epub 31 Jul 2014). doi:10.1002/pds.3687.
36. Walji R, Boon H, Barnes J, Austin Z, Welsh S, Baker GR. Consumers of natural health products: natural-born pharmacovigilantes? BMC Complement Altern Med. 2010;10:8.
37. The Uppsala Monitoring Centre (WHO Collaborating Centre for International Drug Monitoring). Monitoring medicines project. 2010. http://www.monitoringmedicines.org. Accessed 25 Sep 2014.
38. Raine JM. Drug safety: reporting systems for the general public. BMJ. 2012;345:e4916.
39. Krska J, Jones L, McKinney J, Wilson C. Medicine safety: experiences and perceptions of the general public in Liverpool. Pharmacoepidemiol Drug Saf. 2011;20(10):1098–103.
40. Arnott J, Hesselgreaves H, Nunn AJ, et al. What can we learn from parents about enhancing participation in pharmacovigilance? Br J Clin Pharmacol. 2013;75(4):1109–17.
41. van Grootheest AC, Passier JL, van Puijenbroek EP. Direct reporting of side effects by the patient: favourable experience in the first year [in Dutch]. Ned Tijdschr Geneeskd. 2005;149(10):529–33.
42. Vilhelmsson A, Svensson T, Meeuwisse A. A pill for the ill? Patients’ reports of their experience of the medical encounter in the treatment of depression. PLoS One. 2013;8(6):e66338.
43. Ekbom Y, Hedenmalm K, Dalin L, Lonnroth K, Persson I. Reporting of side-effects–a system in need of improvement. Reporting of a physician questionnaire [in Swedish]. Lakartidningen. 2002;99(34):3290–5.
44. Consumentenbond. Ziek van de pillen. Consumentengids 2014;(5):16–19.
45. Robertson J, Newby DA. Low awareness of adverse drug reaction reporting systems: a consumer survey. Med J Aust. 2013;199(10):684–6.
46. van Hunsel FP, Kant AC, van Puijenbroek EP. Thrombosis and embolism during Diane-35 use: analysis of reports made to the Netherlands Pharmacovigilance Centre Lareb [in Dutch]. Ned Tijdschr Geneeskd. 2014;158:A6651.
47. Kant A, van Puijenbroek E, van Hunsel F. Reflections after the Diane affair. J Thromb Haemost. 2014;12(9):1385–7.
48. van Hunsel F, van Puijenbroek E, de Jong-van den Berg L, van Grootheest K. Media attention and the influence on the reporting odds ratio in disproportionality analysis: an example of patient reporting of statins. Pharmacoepidemiol Drug Saf. 2010;19(1):26–32.
49. van Hunsel F, Talsma A, van Puijenbroek E, de Jong-van den Berg L, van Grootheest K. The proportion of patient reports of suspected ADRs to signal detection in the Netherlands: case-control study. Pharmacoepidemiol Drug Saf. 2011;20(3):286–291.
50. Hazell L, Cornelius V, Hannaford P, Shakir S, Avery AJ. How do patients contribute to signal detection? A retrospective analysis of spontaneous reporting of adverse drug reactions in the UK’s Yellow Card Scheme. Drug Saf. 2013;36(3):199–206.
51. de Graaf L, van Puijenbroek EP. Serotonin reuptake inhibitors and shocklike paresthesia. J Clin Psychiatry. 2003;64(8):969–71.
52. Frost L, Lal S. Shock-like sensations after discontinuation of selective serotonin reuptake inhibitors. Am J Psychiatry. 1995;152(5):810.
53. European Medicines Agency (EMA). SmPC Cymbalta. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000572/WC500036781pdf. Accessed 24 Sep 2014.
54. Netherlands Pharmacovigilance Centre Lareb. Lareb quarterly report 2011_2: duloxetine and electric shock-like sensations. 2011. http://www.larebnl/Signalen/kwb_2011_2_dulox. Accessed 24 Sep 2014.
55. Netherlands Pharmacovigilance Centre Lareb. Lareb quarterly report 2002_2: serotonin re-uptake inhibitors (SSRIs) and shocklike paraesthesia. 2002. http://www.lareb.nl/Signalen/kwb_2002_2_ssris. Accessed 24 Sep 2014.
56. Netherlands Pharmacovigilance Centre Lareb. Lareb quarterly report 2008_4: serotonin re-uptake inhibitors (SSRIs) and shock-like paraesthasias: an update. 2008. http://www.lareb.nl/Signalen/kwb_2008_4_ssris. Accessed 24 Sep 2014.
57. Kennedy SH, Rizvi S. Sexual dysfunction, depression, and the impact of antidepressants. J Clin Psychopharmacol. 2009;29(2):157–64.
58. Ekhart CG, van Puijenbroek EP. Does sexual dysfunction persist upon discontinuation of selective serotonin reuptake inhibitors? Tijdschr Psychiatr. 2014;56(5):336–40.
59. The Medical Products Agency. A Swedish registry based cohort study provides strengthened evidence of an association between vaccination with Pandemrix and narcolepsy in children and adolescents. 2011. Available at: http://www.lakemedelsverketse/english/All-news/NYHETER-2011/A-Swedish-registry-based-cohort-study-provides-strengthened-evidence-of-an-association-between-vaccination-with-Pandemrix-and-narcolepsy-in-children-and-adolescents-/. Accessed 15 Oct 2014.
60. Rolfes L, Wilkes S, van Hunsel F, van Puijenbroek E, van Grootheest K. Important information regarding reporting of adverse drug reactions: a qualitative study. Int J Pharm Pract. 2014;22(3):231–3.
61. SCOPE Joint Action. 2014. http://www.scopejointaction.eu/. Accessed 25 Sep 2014.
62. Innovative Medicine Initiative. 2014. Available at: http://www.imieuropa.eu/. Accessed 25 Sep 2014.
63. Freifeld CC, Brownstein JS, Menone CM, et al. Digital drug safety surveillance: monitoring pharmaceutical products in twitter. Drug Saf. 2014;37(5):343–50.
64. Banerjee AK, Okun S, Edwards IR, et al. Patient-reported outcome measures in safety event reporting: PROSPER Consortium guidance. Drug Saf. 2013;36(12):1129–49.
65. Härmark L. Web-based intensive monitoring; a patient based pharmacovigilance tool [thesis]. Groningen: Rijksuniversiteit Groningen; 2012.
66. World Health Organization. WHO Collaborating Centres. 2013. http://apps.who.int/whocc/Detail.aspx?cc_ref=NET-83&designation_date1=1/5/2013&designation_date2=3/6/2013&. Accessed 25 Sep 2014.
67. The Netherlands Pharmacovigilance Centre Lareb. WHO Collaborating Centre for Pharmacovigilance in Education and Patient Reporting. 2014. http://www.larebnl/whocc?lang=en-GB. Accessed 28 Oct 2014.