ประสิทธิภาพของระบบการเฝ้าระวังผื่นแพ้ยาชนิดรุนแรงแบบสตีเวนส์-จอห์นสันซินโดรมและท็อกซิก-อีพิเดอร์มัลเนโครไลซิส จากยากันชักที่มีโครงสร้างทางเคมีแบบวงแหวนอย่างใกล้ชิด ในโรงพยาบาลอุดรธานี

Parinya  Khonyang; Danklai Purimart

Authors

Parinya Khonyang Department of Pharmacy, Udon Thani Hospital, Udon Thani, Thailand
Danklai Purimart กลุ่มงานเภสัชกรรม โรงพยาบาลอุดรธานี จังหวัดอุดรธานี ประเทศไทย

Keywords:

Intensive adverse drug reaction monitoring, Stevens-Johnson Syndrome, Toxic epidermal necrolysis, Aromatic antiepileptic drugs

Abstract

Context: Aromatic antiepileptic drugs (AEDs) may cause severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), necessitating a close pharmacovigilance surveillance system.

Objective: To evaluate the effectiveness of a pharmacovigilance surveillance system for SJS and TEN in patients newly initiated on aromatic AEDs.

Methodology: This was a quasi-experimental study conducted at Udon Thani Hospital. The sample was divided into two groups: a Control Group and an Experimental Group. The Control Group’s data was collected from the hospital medical records of 502 patients treated between November 2022 and September 2023. This group received standard pharmaceutical care and medication counseling from pharmacists. The Experimental Group’s data was collected from 482 patients treated between November 2023 and September 2024. These patients received counseling and were monitored under a developed surveillance system for severe cutaneous adverse reactions (SJS and TEN), specifically designed for patients receiving aromatic AEDs for the first time. Data were analyzed using descriptive statistics. The differences between the Experimental and Control Groups were compared using the Mann-Whitney U test and the Independent t-test.

Results: Of the Control Group, 3 patients (0.60%) out of 502 developed severe cutaneous adverse reactions (SJS/TEN). From the Experimental Group 0 patients (0%) out of 482 developed SJS/TEN. The difference between the two groups was found to be not statistically significant (likely due to the overall low incidence rate or sample size). In the Experimental Group, a total of 20 adverse drug reactions (ADRs) were reported, with 15 patients experiencing non-severe reactions (mild ADRs) related to the aromatic AEDs. The remaining 5 patients experienced symptoms that were determined not to be related to the aromatic AEDs (non-drug related).

Conclusion: The surveillance system is effective in enabling an early detection of SJS/TEN, reducing the severity of the reactions. Consequently, this system should be implemented for all patients receiving aromatic AEDs for the first time.

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