Electronic Theses and Dissertation

Reaksi Obat yang Tidak Diharapkan (ROTD) merupakan tantangan penting dalam terapi jangka panjang, khususnya pasien hipertensi. Penelitian ini bertujuan untuk mengetahui angka kejadian ROTD, mengidentifikasi obat penyebab, serta menganalisis faktor risiko yang berhubungan dengan kejadian ROTD pada pasien hipertensi rawat jalan di RSUDZA Banda Aceh. Penelitian menggunakan pendekatan kuantitatif dengan desain potong lintang pada 85 pasien yang dipilih melalui purposive sampling. ROTD dievaluasi menggunakan algoritma Naranjo (kausalitas), skala Hartwig-Siegel (tingkat keparahan), serta kriteria Schumock dan Thornton (potensi pencegahan). Analisis data mencakup uji univariat, bivariat (chi-square dan point biserial), serta regresi logistik multivariat. Hasil menunjukkan bahwa sebagian besar pasien mengalami ROTD, dengan 90,3% kasus dikategorikan probable berdasarkan skala Naranjo, 80,6% berskala ringan-sedang, dan 87,3% dinilai mungkin dapat dicegah berdasarkan skala Hartwig-Siegel. Obat antihipertensi yang paling sering menyebabkan ROTD adalah amlodipin (24,2%), yang menyebabkan edema perifer, serta Sacubitril-Valsartan (9%) yang memicu batuk. Uji bivariat menunjukkan usia, durasi pengobatan, dan riwayat merokok sebagai faktor risiko signifikan, sementara pada uji multivariat, durasi pengobatan merupakan faktor risiko paling kuat. Temuan ini menjelaskan pentingnya evaluasi menyeluruh terhadap terapi obat, terutama pada pasien dengan risiko tinggi, untuk meningkatkan keselamatan dan efektivitas pengobatan hipertensi. Penelitian ini diharapkan dapat memperkuat pelaksanaan farmakovigilans serta mendorong optimalisasi pelaporan ROTD di layanan kesehatan.

Kata kunci: Antihipertensi, faktor risiko, farmakovigilans, ROTD.

Adverse Drug Reaction (ADR) remain a major challenge in long term therapy, particularly among hypertensive patients. This study aimed to determine the incidence of ADR, identify the most commonly implicated drugs, and analyze associated risk factors in outpatient hypertensive patients at dr. Zainoel Abidin General Hospital, Banda Aceh. A cross-sectional study with a quantitative approach was conducted on 85 patients selected through purposive sampling. ADR were assessed using three established tools: the Naranjo algorithm (for causality), the Hartwig and Siegel scale (for severity), and the Schumock and Thornton criteria (for preventability). Data were analyzed using univariate, bivariate (chi-square and point biserial), and multivariate (logistic regression) methods. Results showed that ADR occurred in a substantial proportion of patients, with 90.3% classified as probable according to the Naranjo scale and 80.6% rated as mild to moderate in severity based on the Hartwig scale. According to Schumock and Thornton, 87,1% of ADR were considered might be preventable. The most commonly implicated antihypertensive drugs were amlodipine (24.2%), associated with peripheral edema, and sacubitril-valsartan (9%), associated with cough. Bivariate analysis identified age, treatment duration, and smoking history as significant risk factors, while multivariate analysis indicated that treatment duration was the strongest risk factor. These findings underscore the importance of comprehensive drug therapy evaluation, particularly in high-risk patients, to improve the safety and effectiveness of antihypertensive treatment. This study is expected to support pharmacovigilance efforts and encourage more optimal ADR reporting in clinical practice. Keywords: ADR, antihypertensive drugs, hypertension, risk factors, pharmacovigilance