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Published in: Drug Safety 3/2012

01-03-2012 | Original Research Articles

Expectations for Feedback in Adverse Drug Reporting by Healthcare Professionals in the Netherlands

Authors: Drs Ingrid Oosterhuis, PharmD, Florence P.A.M. van Hunsel, Eugène P. van Puijenbroek

Published in: Drug Safety | Issue 3/2012

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Abstract

Background: In 2010, the Netherlands Pharmacovigilance Centre Lareb received more than 4000 reports from healthcare professionals (HCPs). All HCPs received individual personal feedback containing information about the reported drug-adverse drug reaction (ADR) association. It is unclear what type of information HCPs expect in this feedback letter.
Objective: The aim of the study was to examine the expectations of the personal feedback of HCPs who reported an ADR to the Netherlands Pharmacovigilance Centre Lareb.
Methods: A questionnaire survey was conducted among a random sample of 1200 pharmacists, general practitioners (GPs) and medical specialists who reported an ADR to the Netherlands Pharmacovigilance Centre Lareb between 1 January 2009 and 27 January 2010. Responders and non-responders were compared on the basis of profession, number of reports submitted to the pharmacovigilance since 2007 and their last report being serious or not. Questions were asked about the importance of personal feedback and the type of information reporters would like to see in their personal feedback. Both linear and logistic regression analysis were performed, with correction for possible confounding factors.
Results: The response rate to the questionnaire was 34.6% (n = 399). The type of information the respondents generally would like to see in their personal feedback is information about the time course of the ADR and information about the pharmacological mechanism. However, GPs were, in general, less interested in receiving feedback than pharmacists and medical specialists.
Most of the respondents were (very) unsatisfied if they received only a confirmation letter instead of personal feedback. Personalized feedback was considered to be (very) important for reporting an ADR in the future. Most of the respondents (80.3%) stated that the personal feedback increased their knowledge. Only 0.6% of respondents had not read the personalized feedback. No differences were found between responders and non-responders, with the exception that responders had reported statistically more often to the Netherlands Pharmacovigilance Centre Lareb in the past 3 years.
Conclusions: Most of the respondents would like personal feedback instead of a standard confirmation letter. In general, pharmacists and medical specialists would like more information than GPs. The information in this study is useful in generating more customized personal feedback in the future, and could be useful for other pharmacovigilance centres that are interested in writing personalized feedback to make available to reporters.
Literature
1.
go back to reference Passier A, ten Napel M, van Grootheest K, et al. Reporting of adverse drug reactions by general practitioners: a questionnaire-based study in the Netherlands. Drug Saf 2009; 32 (10): 851–8PubMedCrossRef Passier A, ten Napel M, van Grootheest K, et al. Reporting of adverse drug reactions by general practitioners: a questionnaire-based study in the Netherlands. Drug Saf 2009; 32 (10): 851–8PubMedCrossRef
2.
go back to reference Backstrom M, Mjorndal T, Dahlqvist R, et al. Attitudes to reporting adverse drug reactions in northern Sweden. Eur J Clin Pharmacol 2000; 56 (9–10): 729–32PubMed Backstrom M, Mjorndal T, Dahlqvist R, et al. Attitudes to reporting adverse drug reactions in northern Sweden. Eur J Clin Pharmacol 2000; 56 (9–10): 729–32PubMed
3.
go back to reference Annual report Netherlands Pharmacovigilance Centre Lareb 2010 [online]. Available from URL: http://www.lareb.nl/ [Accessed 2011 May 5] Annual report Netherlands Pharmacovigilance Centre Lareb 2010 [online]. Available from URL: http://​www.​lareb.​nl/​ [Accessed 2011 May 5]
4.
go back to reference Herdeiro MT, Figueiras A, Polonia J, et al. Influence of pharmacists’ attitudes on adverse drug reaction reporting: a case-control study in Portugal. Drug Saf 2006; 29 (4): 331–40PubMedCrossRef Herdeiro MT, Figueiras A, Polonia J, et al. Influence of pharmacists’ attitudes on adverse drug reaction reporting: a case-control study in Portugal. Drug Saf 2006; 29 (4): 331–40PubMedCrossRef
5.
go back to reference Herdeiro MT, Figueiras A, Polonia J, et al. Physicians’ attitudes and adverse drug reaction reporting: a case-control study in Portugal. Drug Saf 2005; 28 (9): 825–33PubMedCrossRef Herdeiro MT, Figueiras A, Polonia J, et al. Physicians’ attitudes and adverse drug reaction reporting: a case-control study in Portugal. Drug Saf 2005; 28 (9): 825–33PubMedCrossRef
6.
go back to reference Hasford J, Goettler M, Munter KH, et al. Physicians’ knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J Clin Epidemiol 2002; 55 (9): 945–50PubMedCrossRef Hasford J, Goettler M, Munter KH, et al. Physicians’ knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J Clin Epidemiol 2002; 55 (9): 945–50PubMedCrossRef
7.
go back to reference Eland IA, Belton KJ, van Grootheest AC, et al. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 1999; 48 (4): 623–7PubMedCrossRef Eland IA, Belton KJ, van Grootheest AC, et al. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 1999; 48 (4): 623–7PubMedCrossRef
8.
go back to reference Biriell C, Edwards IR. Reasons for reporting adverse drug reactions: some thoughts based on an international review. Pharmacoepidemiol Drug Saf 1997; 6 (1): 21–6PubMedCrossRef Biriell C, Edwards IR. Reasons for reporting adverse drug reactions: some thoughts based on an international review. Pharmacoepidemiol Drug Saf 1997; 6 (1): 21–6PubMedCrossRef
9.
go back to reference Belton KJ. Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. The European Pharmacovigilance Research Group. Eur J Clin Pharmacol 1997; 52 (6): 423–7CrossRef Belton KJ. Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. The European Pharmacovigilance Research Group. Eur J Clin Pharmacol 1997; 52 (6): 423–7CrossRef
10.
go back to reference Ekman E, Backstrom M. Attitudes among hospital physicians to the reporting of adverse drug reactions in Sweden. Eur J Clin Pharmacol 2009; 65 (1): 43–6PubMedCrossRef Ekman E, Backstrom M. Attitudes among hospital physicians to the reporting of adverse drug reactions in Sweden. Eur J Clin Pharmacol 2009; 65 (1): 43–6PubMedCrossRef
11.
go back to reference Figueiras A, Tato F, Fontainas J, et al. Influence of physicians’ attitudes on reporting adverse drug events: a casecontrol study. Med Care 1999; 37 (8): 809–14PubMedCrossRef Figueiras A, Tato F, Fontainas J, et al. Influence of physicians’ attitudes on reporting adverse drug events: a casecontrol study. Med Care 1999; 37 (8): 809–14PubMedCrossRef
12.
go back to reference van Grootheest AC. Improving pharmacovigilance and the role of the pharmacist [thesis]. Groningen: University of Groningen, 2003 van Grootheest AC. Improving pharmacovigilance and the role of the pharmacist [thesis]. Groningen: University of Groningen, 2003
13.
go back to reference Wallerstedt SM, Brunlof G, Johansson ML, et al. Reporting of adverse drug reactions may be influenced by feedback to the reporting doctor. Eur J Clin Pharmacol 2007; 63 (5): 505–8PubMedCrossRef Wallerstedt SM, Brunlof G, Johansson ML, et al. Reporting of adverse drug reactions may be influenced by feedback to the reporting doctor. Eur J Clin Pharmacol 2007; 63 (5): 505–8PubMedCrossRef
14.
go back to reference Kunac DL, Harrison-Woolrych M, Tatley MW. Pharmacovigilance in New Zealand: the role of the New Zealand Pharmacovigilance Centre in facilitating safer medicines use. N Z Med J 2008; 121 (1283): 76–89PubMed Kunac DL, Harrison-Woolrych M, Tatley MW. Pharmacovigilance in New Zealand: the role of the New Zealand Pharmacovigilance Centre in facilitating safer medicines use. N Z Med J 2008; 121 (1283): 76–89PubMed
15.
go back to reference Anton C, Cox AR, Ferner RE. Improving follow-up rates in spontaneous adverse drug reaction reporting: effectiveness of a targeted letter used by a regional centre in the UK. Drug Saf 2009; 32 (12): 1135–40PubMedCrossRef Anton C, Cox AR, Ferner RE. Improving follow-up rates in spontaneous adverse drug reaction reporting: effectiveness of a targeted letter used by a regional centre in the UK. Drug Saf 2009; 32 (12): 1135–40PubMedCrossRef
16.
go back to reference van Puijenbroek E, Diemont W, van Grootheest K. Application of quantitative signal detection in the Dutch spontaneous reporting system for adverse drug reactions. Drug Saf 2003; 26 (5): 293–301PubMedCrossRef van Puijenbroek E, Diemont W, van Grootheest K. Application of quantitative signal detection in the Dutch spontaneous reporting system for adverse drug reactions. Drug Saf 2003; 26 (5): 293–301PubMedCrossRef
17.
go back to reference Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30 (2): 239–45PubMedCrossRef Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30 (2): 239–45PubMedCrossRef
18.
go back to reference Cornelissen L, van Puijenbroek EP, Van Grootheest K. Expectations of general practitioners and specialist doctors regarding the feedback received after reporting an adverse drug reaction. Pharmacoepidemiol Drug Saf 2008; 17 (1): 76–81PubMedCrossRef Cornelissen L, van Puijenbroek EP, Van Grootheest K. Expectations of general practitioners and specialist doctors regarding the feedback received after reporting an adverse drug reaction. Pharmacoepidemiol Drug Saf 2008; 17 (1): 76–81PubMedCrossRef
19.
go back to reference Harmark L, van Hunsel F, Hak E, et al. Monitoring the safety of influenza A (H1N1) vaccine using web-based intensive monitoring. Vaccine 2011; 29 (10): 1941–7PubMedCrossRef Harmark L, van Hunsel F, Hak E, et al. Monitoring the safety of influenza A (H1N1) vaccine using web-based intensive monitoring. Vaccine 2011; 29 (10): 1941–7PubMedCrossRef
20.
go back to reference SurveyMonkey [online]. Available from URL: www.surveymonkey.com [Accessed 2010 Jul 15] SurveyMonkey [online]. Available from URL: www.surveymonkey.com [Accessed 2010 Jul 15]
21.
go back to reference Streiner DL, Norman GR. Health measurement scales: a practical guide to their development and use. 3 rd ed. Oxford: Oxford University Press, 2003 Streiner DL, Norman GR. Health measurement scales: a practical guide to their development and use. 3 rd ed. Oxford: Oxford University Press, 2003
22.
go back to reference Micromedex® healthcare series 1.0 [online]. Available from URL: http://www.thomsonhc.com [Accessed 2011 May 5] Micromedex® healthcare series 1.0 [online]. Available from URL: http://​www.​thomsonhc.​com [Accessed 2011 May 5]
23.
go back to reference CIOMS Working Group IV. Benefit-risk balance for marketed drugs: evaluating safety signals. Geneva: CIOMS, 1998 [online]. Available from URL: http://www.cioms.ch/publications/g4-benefit-risk.pdf [Accessed 2011 Nov 17] CIOMS Working Group IV. Benefit-risk balance for marketed drugs: evaluating safety signals. Geneva: CIOMS, 1998 [online]. Available from URL: http://​www.​cioms.​ch/​publications/​g4-benefit-risk.​pdf [Accessed 2011 Nov 17]
24.
go back to reference Terwee CB, Bot SD, de Boer MR, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol 2007; 60 (1): 34–42PubMedCrossRef Terwee CB, Bot SD, de Boer MR, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol 2007; 60 (1): 34–42PubMedCrossRef
25.
go back to reference Edwards PJ, Roberts I, Clarke MJ, et al. Methods to increase response to postal and electronic questionnaires. Cochrane Database Syst Rev 2009; (3): MR000008 Edwards PJ, Roberts I, Clarke MJ, et al. Methods to increase response to postal and electronic questionnaires. Cochrane Database Syst Rev 2009; (3): MR000008
26.
go back to reference Kim J-O. Multivariate analysis of ordinal variables. Am J Soc 1975; 81 (2): 261–98CrossRef Kim J-O. Multivariate analysis of ordinal variables. Am J Soc 1975; 81 (2): 261–98CrossRef
Metadata
Title
Expectations for Feedback in Adverse Drug Reporting by Healthcare Professionals in the Netherlands
Authors
Drs Ingrid Oosterhuis, PharmD
Florence P.A.M. van Hunsel
Eugène P. van Puijenbroek
Publication date
01-03-2012
Publisher
Springer International Publishing
Published in
Drug Safety / Issue 3/2012
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI
https://doi.org/10.2165/11594910-000000000-00000

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