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- Title
Building pharmacogenetics into a pharmacovigilance program in Singapore: using serious skin rash as a pilot study.
- Authors
Toh, D S L; Tan, L L; Aw, D C W; Pang, S M; Lim, S H; Thirumoorthy, T; Lee, H Y; Tay, Y K; Tan, S K; Vasudevan, A; Lateef, A; Chong, Y Y; Chan, Y C; Loke, C; Chan, C L; Koay, E S C; Ren, E C; Lee, E J D; Sung, C
- 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.
- Subjects
SINGAPORE; PHARMACOGENOMICS; PILOT projects; DRUG side effects; CARBAMAZEPINE; DECISION making; MEDICATION safety
- Publication
Pharmacogenomics Journal, 2014, Vol 14, Issue 4, p316
- ISSN
1470-269X
- Publication type
Article
- DOI
10.1038/tpj.2013.46