Literature DB >> 19338383

Spontaneous ADR reports as a trigger for pharmacogenetic research: a prospective observational study in the Netherlands.

Eugène van Puijenbroek1, Jean Conemans, Kees van Grootheest.   

Abstract

BACKGROUND: Information on genetic polymorphisms in drug-metabolizing enzymes is valuable when analysing the causal relationship between drug intake and an adverse drug reaction (ADR). Patients who have experienced an ADR should be informed about the possible existence of genetic polymorphisms that may contribute to the occurrence of ADRs, since this will allow adequate dosing of future medication.In collaboration with the regional hospital pharmacy Ziekenhuisapotheek Noord-Oost-Brabant (ZANOB), the Netherlands Pharmacovigilance Centre Lareb developed a method for informing physicians or pharmacists and their patients about a possible pharmacogenetic involvement in the pathogenesis of the reported ADR and for offering easy access to genotyping if requested by the treating physician. An anonymized copy of the test results could be used for the interpretation of possible signals at the pharmacovigilance centre.
OBJECTIVES: The aim of this study was to gain insight into the feasibility of informing the reporting physician or pharmacist about possible involvement of a genetic polymorphism and subsequent genotyping of patients based on ADR reports received by the Netherlands Pharmacovigilance Centre.
RESULTS: A total of 38 reports were selected in which genotyping was considered useful. In 15 of 38 cases (39.5%), the reporting health professionals actually initiated genotyping. The majority of the drugs implicated in causing ADRs were selective serotonin reuptake inhibitors, followed by other antidepressants and antipsychotic drugs. No logistical problems were encountered during this study.
CONCLUSION: The level of participating health professionals in genotyping their patients was relatively high. Apparently, reporting health professionals share the vision that information on pharmacogenetic characteristics of their individual patients is important. The use of an existing infrastructure for DNA sampling that is familiar to the patients and health professionals may have contributed to the high response rate.Pharmacovigilance centres may suggest pharmacogenetic investigation and subsequent individualized pharmacogenetic counselling after a reported ADR. These centres can also be a valuable starting point for pharmacogenetic studies, since data from different sources can be combined in the assessment of the causal relationship between drug intake and an ADR. This study shows that genotyping initiated by pharmacovigilance centres is indeed feasible, when using the standard laboratory testing infrastructure.

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Year:  2009        PMID: 19338383     DOI: 10.2165/00002018-200932030-00008

Source DB:  PubMed          Journal:  Drug Saf        ISSN: 0114-5916            Impact factor:   5.606


  13 in total

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Authors:  K A Phillips; D L Veenstra; E Oren; J K Lee; W Sadee
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Review 2.  Therapeutic drug monitoring and pharmacogenetic tests as tools in pharmacovigilance.

Authors:  Eveline Jaquenoud Sirot; Jan Willem van der Velden; Katharina Rentsch; Chin B Eap; Pierre Baumann
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3.  Pharmacogenetics of drug-induced arrhythmias: a feasibility study using spontaneous adverse drug reactions reporting data.

Authors:  Marie L De Bruin; Eugene P van Puijenbroek; Madelon Bracke; Arno W Hoes; Hubert G M Leufkens
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4.  Pharmacogenetics: from bench to byte.

Authors:  J J Swen; I Wilting; A L de Goede; L Grandia; H Mulder; D J Touw; A de Boer; J M H Conemans; T C G Egberts; O H Klungel; R Koopmans; J van der Weide; B Wilffert; H-J Guchelaar; V H M Deneer
Journal:  Clin Pharmacol Ther       Date:  2008-02-06       Impact factor: 6.875

5.  Drug metabolism genotypes and their association with adverse drug reactions in selected populations: a pilot study of methodology.

Authors:  D Clark; A Morgan; L Hananeia; D Coulter; R Olds
Journal:  Pharmacoepidemiol Drug Saf       Date:  2000-09       Impact factor: 2.890

6.  The role of the CYP2C9-Leu359 allelic variant in the tolbutamide polymorphism.

Authors:  T H Sullivan-Klose; B I Ghanayem; D A Bell; Z Y Zhang; L S Kaminsky; G M Shenfield; J O Miners; D J Birkett; J A Goldstein
Journal:  Pharmacogenetics       Date:  1996-08

7.  Genetic association between sensitivity to warfarin and expression of CYP2C9*3.

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8.  Linking pharmacovigilance with pharmacogenetics.

Authors:  David W J Clark; Emma Donnelly; David M Coulter; Rebecca L Roberts; Martin A Kennedy
Journal:  Drug Saf       Date:  2004       Impact factor: 5.606

9.  Detection of the poor metabolizer-associated CYP2D6(D) gene deletion allele by long-PCR technology.

Authors:  V M Steen; O A Andreassen; A K Daly; T Tefre; A L Børresen; J R Idle; A K Gulbrandsen
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10.  Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients.

Authors:  Munir Pirmohamed; Sally James; Shaun Meakin; Chris Green; Andrew K Scott; Thomas J Walley; Keith Farrar; B Kevin Park; Alasdair M Breckenridge
Journal:  BMJ       Date:  2004-07-03
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  6 in total

1.  Spontaneous reports and pharmacogenetics: the role of the pharmacovigilance centre.

Authors:  Eugène van Puijenbroek; Jean Conemans; Kees van Grootheest
Journal:  Drug Saf       Date:  2009       Impact factor: 5.606

2.  Pharmacogenetics and pharmacovigilance.

Authors:  Robert H Howland
Journal:  Drug Saf       Date:  2009       Impact factor: 5.606

Review 3.  Comparison of delivery strategies for pharmacogenetic testing services.

Authors:  Susanne B Haga; Jivan Moaddeb
Journal:  Pharmacogenet Genomics       Date:  2014-03       Impact factor: 2.089

4.  Clinical delivery of pharmacogenetic testing services: a proposed partnership between genetic counselors and pharmacists.

Authors:  Rachel Mills; Susanne B Haga
Journal:  Pharmacogenomics       Date:  2013-06       Impact factor: 2.533

5.  Feasibility of pharmacy-initiated pharmacogenetic screening for CYP2D6 and CYP2C19.

Authors:  J J Swen; T van der Straaten; J A M Wessels; M L Bouvy; E E W Vlassak; W J J Assendelft; H-J Guchelaar
Journal:  Eur J Clin Pharmacol       Date:  2011-10-08       Impact factor: 2.953

6.  Cytochrome P450 2C19 enzyme, Cytochrome P450 2C9 enzyme, and Cytochrome P450 2D6 enzyme allelic variants and its possible effect on drug metabolism: A retrospective study.

Authors:  Domas Naujokaitis; Virginija Asmoniene; Edmundas Kadusevicius
Journal:  Medicine (Baltimore)       Date:  2021-03-19       Impact factor: 1.817

  6 in total

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