title: Signal detection for Thai traditional medicine: examination of national pharmacovigilance data using reporting odds ratio and reported population attributable risk.
abstract: Herbal containing medicine consumption has increased while the awareness of adverse drug reaction (ADR) was less than conventional medicine. Early detection of unexpected numbers of ADRs from herbal medicines' reports which are abnormal from the whole database needs quantification. Disproportionality analysis has been performed for signal detection by using reporting odds ratio (ROR) as measurement. The impact of having medicine as exposures in each ADR should be measured by using reported population attributable risks (RPAR). This study aimed to quantify the contribution of Thai traditional medicine (TTM) to ADR reports and to assess the association between TTMs and serious adverse drug reactions. Data were retrieved from the adverse drug reaction surveillance database, Thai-Food and Drug Administration from 2002 to 2013. Crude and adjusted RORs for each drug-ADR pair and RPARs were computed. TTM contributed only 0.001% of all serious ADRs reported. Out of 4208 TTM-ADR pairs were examined, three had the statistically significant RORs, namely Andrographis paniculata and anaphylactic shock (ROR 2.32, 95% CI 1.03, 5.21); green traditional medicine and Stevens-Johnson syndrome (ROR 13.04, 95% CI 5.4-31.51) and Derris scandens Benth and angioedema (ROR 2.71, 95% CI 1.05-6.95). Their RPARs ranged from 0.05% to 0.16%. We conclude that TTMs need more intensive surveillance.
authors.affiliation: Health Product Vigilance Center, Food and Drug Administration, Ministry of Public Health, 11000, Thailand; Epidemiology Unit, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla 90110, Thailand.
authors.forename: Sareeya
authors.initials: S
authors.lastname: Wechwithan
authors.affiliation: Health Product Vigilance Center, Food and Drug Administration, Ministry of Public Health, 11000, Thailand.
authors.forename: Wimon
authors.initials: W
authors.lastname: Suwankesawong
authors.affiliation: Epidemiology Unit, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla 90110, Thailand.
authors.forename: Vorasith
authors.initials: V
authors.lastname: Sornsrivichai
authors.affiliation: Epidemiology Unit, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla 90110, Thailand.
authors.forename: Edward B
authors.initials: EB
authors.lastname: McNeil
authors.affiliation: Field Epidemiology Training Program (FETP), Bureau of Epidemiology, Department of Disease Control, Ministry of Public Health, 11000, Thailand.
authors.forename: Chuleeporn
authors.initials: C
authors.lastname: Jiraphongsa
authors.affiliation: Epidemiology Unit, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla 90110, Thailand. Electronic address: cvirasak@medicine.psu.ac.th.
authors.forename: Virasakdi
authors.initials: V
authors.lastname: Chongsuvivatwong
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000209:etiology; D006801:Humans; D008518:Medicine, East Asian Traditional / Q000009:adverse effects; D016017:Odds Ratio; D060735:Pharmacovigilance; D028321:Plant Preparations / Q000009:adverse effects*; D010946:Plants, Medicinal / Q000737:chemistry*; D013785:Thailand / Q000453:epidemiology
chemical_list: D028321:Plant Preparations
keywords: ADR; Herbal medicine; Reporting odds ratio; Serious ADR; Thai traditional medicine