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All Journal JURNAL MANAJEMEN DAN PELAYANAN FARMASI (Journal of Management and Pharmacy Practice)
Ernawati, Hafifah
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Health Professions Medicine & Pharmacology Public Health

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Evaluation of Adverse Drug Reaction Reporting on the Badan POM Website in Yogyakarta Special Region Ernawati, Hafifah; Ikawati, Zullies; Puspitasari, Ika; Abdoellah, Siti Asfijah; Kurniawati, Fivy
JURNAL MANAJEMEN DAN PELAYANAN FARMASI (Journal of Management and Pharmacy Practice) Vol 15, No 3
Publisher : Faculty of Pharmacy, Universitas Gadjah Mada

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.22146/jmpf.105134

Abstract

Background: Adverse Drug Reaction (ADR) is defined as a harmful and unintended response to a drug, as a part of the pharmacovigilance system to identify drug safety-related issues. As a regulatory, the Indonesian Food and Drug Authority (BPOM) has facilitated an online reporting platform for healthcare professionals via the website www.e-meso.pom.go.id.Objectives: The objective of this study is to characterize Adverse Drug Reaction (ADR) reporting within the Special Region of Yogyakarta, serving as an early detection mechanism for potential drug safety hazards.Methods: This observational cross-sectional survey study utilized ADR reporting data obtained from the MESO website of the Indonesian Food and Drug Authority in the Special Region of Yogyakarta (DIY). The collected data were subjected to descriptive analysis. A total of 169 reports were analyzed, encompassing 255 suspected drugs and 255 ADR events.Results: The report identifies three predominant groups of patient disease characteristics: diseases of the circulatory system (15.38%), certain infectious and parasitic diseases (11.24%), and diseases of the respiratory system (9.47%). Regarding the type of ADR based on its Sub Organ Class (SOC), Skin and subcutaneous tissue disorders is most frequently involved (21.57%). The antibiotic group is the most commonly suspected type of drug (34.90%), with Levofloxacin and Ceftriaxone being the most implicated in causing ADR (11.24%). Oral administration is the most common route associated with ADR, followed by intravenous administration.Conclusion: In 2023, the monitoring of ADR in the Special Region of Yogyakarta revealed that antibiotics were the most frequently suspected drug class in relation to ADR. The dermatological organ system was also identified as the predominant organ affected by these reactions.
Agreement Between WHO-UMC Causality scale and the Naranjo Algorithm for Causality Assessment of Adverse Drug Reactions at Health Care Services in Yogyakarta Hafifah Ernawati; Zullies Ikawati; Ika Puspita Sari; Siti Asfijah Abdoellah; Fivy Kurniawati
JURNAL MANAJEMEN DAN PELAYANAN FARMASI (Journal of Management and Pharmacy Practice) Vol 16, No 3
Publisher : Faculty of Pharmacy, Universitas Gadjah Mada

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.22146/jmpf.110131

Abstract

Background: The WHO-UMC system and Naranjo algorithm are the most widely used tools for evaluating the causality of adverse drug reactions (ADRs) reports. Despite their wide application, a direct comparison of these methods in the context of Indonesia's ADR reporting has not yet been explored.Objectives: This study aimed to compare the agreement of causality assessment and correlation between the two methods of the WHO-UMC system and the Naranjo algorithm.Methods: In this study, 255 suspected adverse drug reactions (ADR) from 169 safety reports were analyzed in 2023, reported at healthcare services in Yogyakarta. Two independent raters performed causality assessments using the WHO-UMC criteria and Naranjo algorithm. The raters were blinded to each other's assessment results, and the assessments were conducted at different locations and times. The agreement between the two ADR causality scales was assessed using Cohen's kappa. Spearman’s correlation was also used to find the correlation between the two scales.Results: ADRs were most frequently reported by pharmacists, with the most commonly suspected drug class being antibiotics. The agreement between the two methods for all ADR cases was a Cohen's Kappa coefficient value of 0.384, indicating minimal agreement. The correlation between the two methods was 0.501, indicating a moderately positive relationship.Conclusion: A minimal moderate level of agreement was observed between the WHO-UMC and Naranjo scales. The level of agreement for serious ADR cases was classified as weak, whereas for non-serious ADR cases, it was classified as minimal. The correlation between the two methods was moderately positive.
Co-Authors Abdoellah, Siti Asfijah Fivy Kurniawati Ika Puspita Sari Ika Puspitasari Kurniawati, Fivy Siti Asfijah Abdoellah Zullies Ikawati