The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis

Drug Safety

Volumn 40, Issue 7, 2017, Pages 607-614

  Rolfes, Leàn ^a,b   van Hunsel, Florence ^a,b   van der Linden, Laura ^c   Taxis, Katja ^b   van Puijenbroek, Eugène ^a,b  

^a NETHERLANDS PHARMACOVIGILANCE CENTRE LAREB   (Netherlands)

^b UNIVERSITY OF GRONINGEN   (Netherlands)

^c UTRECHT UNIVERSITY   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ADVERSE DRUG REACTION; AGED; ARTICLE; COMPARATIVE STUDY; DRUG SURVEILLANCE PROGRAM; FEMALE; HEALTH CARE PERSONNEL; HEALTH CARE QUALITY; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL INFORMATION; PATIENT-REPORTED OUTCOME; PRIORITY JOURNAL; RETROSPECTIVE STUDY; ATTITUDE TO HEALTH; DRUG MONITORING; FACTUAL DATABASE; PATIENT; QUALITY OF LIFE; STANDARDS;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DATABASES, FACTUAL; DRUG MONITORING; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HEALTH PERSONNEL; HUMANS; MALE; PATIENTS; PHARMACOVIGILANCE; QUALITY OF LIFE; RETROSPECTIVE STUDIES;

EID: 85017478813     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.1007/s40264-017-0530-5     Document Type: Article

References (38)

1. World Health Organization. The importance of pharmacovigilance: safety monitoring of medicinal products. 2002 [cited 2016 Dec 1]. http://apps.who.int/medicinedocs/en/d/Js4893e/.
2. US Food and Drug Administration. FDA adverse events reporting system (FAERS). 2016. [cited 2016 Feb 25]. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/UCM082196.
3. Ishiguro C, Hall M, Neyarapally GA, Dal PG. Post-market drug safety evidence sources: an analysis of FDA drug safety communications. Pharmacoepidemiol Drug Saf. 2012;21(10):1134–6.
4. van Hunsel F, Härmark 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.
5. The EU pharmacovigilance system. 2012 [cited 2016 Feb 17]. http://ec.europa.eu/health/human-use/pharmacovigilance/index_en.htm.
6. 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.
7. Harmark L, van HF, Grundmark B. ADR reporting by the general public: lessons learnt from the Dutch and Swedish systems. Drug Saf. 2015;38(4):337–47.
8. 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.
9. van Hunsel F. The contribution of direct patient reporting to pharmacovigilance. Thesis, University of Groningen, The Netherlands; 2011.
10. Inacio P, Cavaco A, Airaksinen M. The value of patient reporting to the pharmacovigilance system: a systematic review. Br J Clin Pharmacol. 2016;83(2):227–46.
11. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255–9.
12. Aagaard L, Hansen E. Consumers’ reports of suspected adverse drug reactions volunteered to a consumer magazine. Br J Clin Pharmacol. 2010;69(3):317–8.
13. Chebane L, Abadie D, Bagheri H, Durrie G, Montastruc JL. Patient reporting of adverse drug reactions: experience of Toulouse Regional Pharmacovigilance Center (abstract ISoP 2012). Drug Saf. 2012;35(942):942.
14. Clothier H, Selvaraj G, Easton M, Lewis G, Crawford N, Buttery J. Consumer reporting of adverse events following immunization. Hum Vaccin Immunother. 2014;10(12):3726–30.
15. de Langen J, van Hunsel F, Passier A, de Jong-van den Berg LTW, van Grootheest AC. Adverse drug reaction reporting by patients in the Netherlands, three years of experience. Drug Saf. 2008;31(6):515–24.
16. Durrieu G, Palmaro A, Pourcel L, Caillet C, Faucher A, Jacquet A, 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.
17. Jansson K, Ekbom Y, Sjölin-Forsberg G. Basic conditions for consumer reporting of adverse drug reactions in Sweden—a pilot study (abstract 28). Drug Saf. 2006;29(10):938.
18. Leone R, Moretti U, D’Incau P, Conforti A, Magro L, Lora R, et al. Effect of pharmacist involvement on patient reporting of adverse drug reactions: first Italian study. Drug Saf. 2013;36(4):267–76.
19. McLernon DJ, Bond CM, Hannaford PC, Watson MC, Lee AJ, Hazell L, 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.
20. 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. 2003;16:5–19.
21. 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. 2015;24(2):152–8.
22. van Grootheest A, Passier J, van Puijenbroek E. Direct reporting of side effects by the patient: favourable experience in the first year (article in Dutch). Ned Tijdschr Geneeskd. 2005;149(10):529–33.
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. Vilhelmsson A, Svensson T, Meeuwisse A, Carlsten A. What can we learn from consumer reports on psychiatric adverse drug reactions with antidepressant medication? Experiences from reports to a consumer association. BMC Clin Pharmacol. 2011;11:16.
25. Netherlands Pharmacovigilance Centre Lareb. Highlights. 2015 [cited 2016 Sep 2]. http://www.lareb.nl/getmedia/412dcc1d-13fb-4b9d-83a9-a5844b6e1b79/highlights-bcl-2015-NL_1.pdf.
26. ®. Medical dictionary for regulatory activities. 2016. http://www.meddra.org.
27. Oosterhuis I, Rolfes L, Ekhart C, Muller-Hansma A, Härmark L. Development and validity testing of a clinical documentation-tool to assess individual case safety reports in an international setting (abstract 716). PDS. 2016;25(Suppl. 3):417.
28. WEB-RADR: recognising adverse drug reactions. 2016 [cited 2015 Aug 1]. http://www.web-radr.eu.
29. Counsel for International Organizations of Medical Sciences (CIOMS). Reporting adverse drug reactions; definitions of terms and criteria for their use. 1999. http://www.cioms.ch/publications/reporting_adverse_drug.pdf.
30. 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.
31. Rolfes L, van Hunsel F, van Grootheest K, van Puijenbroek E. Feedback for patients reporting adverse drug reactions; satisfaction and expectations. Expert Opin Drug Saf. 2015;14(5):625–32.
32. 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.
33. Manso G, Salgueiro M, Jimeno F, Aguirre C, Garcia M, Etxebarria A, et al. Preliminary results for reporting of problems associated with medications in Spain. The yo notifico (I notify) project. (abstract ISP3541-41). Drug Saf. 2013;36(793):951.
34. Parretta E, Rafaniello C, Magro L, Coggiola PA, Sportiello L, Ferrajolo C, 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):S21–9.
35. Povlsen K, Michan L, Frederiksen M, Kornholt J, Harder H. Characteristics and contribution of consumer reports of adverse drug reactions: experience from Denmark during the last decade (abstract P082). Drug Saf. 2012;35(10):877–970.
36. Netherlands Pharmacovigilance Centre Lareb. Annual statistics Lareb database (personal communication). 2016.
37. Rolfes L, van Hunsel F, Taxis K, van Puijenbroek E. The impact of experiencing adverse drug reaction on the patient’s quality of life: a retrospective cross-sectional study in the Netherlands. Drug Saf. 2016. (Epub ahead of print).
38. Vilhelmsson A, Svensson T, Meeuwisse A, Carlsten A. Experiences from consumer reports on psychiatric adverse drug reactions with antidepressant medication: a qualitative study of reports to a consumer association. BMC Pharmacol Toxicol. 2012;13:19.