Advances in Pharmacoepidemiology and Drug Safety

Drug induced Stevens Johnson syndrome in Malaysia from 2011until 2015

11^th International Conference on Pharmacoepidemiology and Clinical Research

October 02-03, 2017 Kuala Lumpur, Malaysia

Noorizan Abd. Aziz, Rosda Ayu Mohamad and Yahaya Hassan

Universiti Teknologi MARA (UiTM) ITM, Selangor, Malaysia

Scientific Tracks Abstracts: Adv Pharmacoepidemiol Drug Saf

Abstract:

Introduction: Cutaneous skin reaction it the most reported cases based on the spontaneous adverse drug reactions (ADRs) reported in Malaysia 2015. Stevens-Johnson Syndrome (SJS) is the rare cutaneous skin reaction but fatal, involving skin and mucous membrane following consumption of certain drugs. SJS is defined as skin detachment of less than 10% of the total body surface area. Objective: This study was aimed to determine the SJS induced by the drug in Malaysia (2011-2015) in terms of incidence, age, race, gender and extent of disease severity, common drug�??induced SJS and the associating factors. This is a retrospective study and data was collected at Pharmacovigilance Section, National Pharmaceutical Regulatory Agency (NPRA). The total of 2011 cases of ADRs reports retrieved from Quest 2 database. After the application of the exclusion and inclusion criteria, 661 SJS cases were found out of 48,306 ADR cases reported Result: The mean incidence is 4.25 % (ranged from 3.05-5.05), female patients had slightly higher incidence of SJS (n=387, 50.5%), Malay Patients the highest (58.5%) and the highest age range is between 31 to 45 years old (24. 1%).About half of SJS cases, 49.2% (n=325) cases were classified as having severe SJS. The extent or degree of SJS severity was no association with gender (n=483, r�?? = -0.040, p = 0.370), race (n=468, r�?? = 0.058, p = 0.175) and groups of age (n=484, r�?? = -0.033, p = 0.400) using a Kendall Tau-b analysis. The first 3 frequent drugs associated with SJS is Allopurinol with 131 cases (19.8%), followed by carbamazepine (n=107, 14.80%) and phenytoin (n=73, 10.10%). Conclusions: Allopurinol and epileptic drugs are the frequent drugs caused SJS. Social demographic data that been studied has no association with the extent of SJS severity.

Biography :

Noorizan is a Professor in Clinical Pharmacy, Faculty of Pharmacy, Universiti Teknologi MARA(UiTM), Malaysia. Graduated in Master of Science, Radiopharmacy, from University of Southern California,1983 and PharmD, from University of Minnesota, USA,1985. She has been teaching Pharmacy more than 30 years at University Sains Malaysia(USM),Universiti Teknologi MARA(UiTM) and Management and Science University (MSU). Her current research interest focus on clinical pharmacy, pharmacoepidemiology, pharmaceutical outcome study, pharmacy practice and halal pharmaceuticals. Involved She also National Committee of Halal Pharmaceutical Products and Assessor Panel for National Research Grant. She is a preceptor for Critical Care, infectious Disease and Nephrology Pharmacy for undergraduate and clinical pharmacy post-graduate students.