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Pharmacogenomics J. 2014 Aug;14(4):316-21. doi: 10.1038/tpj.2013.46. Epub 2014 Jan 7.

Building pharmacogenetics into a pharmacovigilance program in Singapore: using serious skin rash as a pilot study.

Author information

1
Vigilance Branch, Health Sciences Authority, Singapore.
2
Dermatology Department, National University Hospital, Singapore.
3
Dermatology Department, Singapore General Hospital, Singapore.
4
1] Neurology Department, Singapore General Hospital, Singapore [2] Duke-NUS Graduate Medical School, Singapore.
5
1] Dermatology Department, Changi General Hospital, Singapore [2] Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
6
Dermatology Department, Changi General Hospital, Singapore.
7
Rheumatology Department, Changi General Hospital, Singapore.
8
Rheumatology Department, National University Hospital, Singapore.
9
Rheumatology and Immunology Department, Singapore General Hospital, Singapore.
10
1] Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore [2] Neurology Department, National University Hospital, Singapore.
11
1] Molecular Diagnosis Centre, National University Hospital, Singapore [2] Pathology Department, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
12
Singapore Immunology Network, Agency for Science, Technology and Research, Singapore.
13
Pharmacology Department, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
14
1] Vigilance Branch, Health Sciences Authority, Singapore [2] Duke-NUS Graduate Medical School, Singapore.

Abstract

To study the possible genetic associations with adverse drug reactions (ADR), the Singapore Health Sciences Authority (HSA) has piloted a program to collect DNA and phenotype data of ADR cases as part of its pharmacovigilance program. Between 2009 and 2012, HSA screened 158 cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). To assess the association between HLA-B*1502 and carbamazepine (CBZ)-induced SJS/TEN, 13 cases and 26 drug-tolerant controls were analyzed. All 13 CBZ-SJS/TEN cases and 3/26 controls were HLA-B*1502 positive (odds ratio 181, 95% confidence interval: 8.7-3785, P=6.9 × 10(-8)). Discussions of the finding with the Ministry of Health and an expert panel led to the decision to make HLA-B*1502 testing the standard of care prior to first use of CBZ in Asians and to subsidize the genotyping test at public hospitals. This program illustrates the role of a regulatory authority in advancing the use of pharmacogenetics for drug safety.

PMID:
24394201
DOI:
10.1038/tpj.2013.46
[Indexed for MEDLINE]
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