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Abstrak :
Penggunaan obat off-label sudah meluas di dunia klinis, namun penggunaan obat diluar indikasi klinis yang disetujui dapat menyebabkan beberapa masalah terkait obat. Obat off-label digunakan karena obat yang tersedia dan disetujui tidak memberikan efek yang diinginkan sehingga dokter mencoba obat yang belum disetujui indikasinya. Tugas khusus ini bertujuan untuk memberikan suatu ukuran mutu pelayanan farmasi mengenai pemilihan penggunaan obat off-label di Puskesmas Kecamatan Kalideres. Metode yang digunakan dalam laporan merupakan studi literatur terkait indikasi off-label obat-obatan yang tersedia di Puskesmas Kecamatan Kalideres Jakarta Barat. Obat-obat yang memiliki indikasi off-label dari daftar obat di puskesmas kecamatan Kalideres yaitu: amitriptilin, asetilsistein, aspirin, asam folat, domperidon, kalsium glukonat, kotrimoksazol, deksametason, dimenhidrinat, ibuprofen, ketokonazole, metformin, metoklopramide, metronidazol, nifedipin dan prednison. ...... The use of off-label drugs has become widespread in clinical practice worldwide, but the use of drugs outside approved clinical indications can lead to several drug-related issues. Off-label drugs are used when drugs do not produce the desired effects, prompting doctors to try drugs whose indications have not been approved. This report aims to provide a measure of the quality of pharmacy services regarding the selection of off-label drug use at the Kalideres Sub-district Community Health Center. The method used in the report is a literature study related to off-label indications of drugs available at the Kalideres Sub-district Community Health Center in West Jakarta. Drugs with off-label indications from the list of drugs at the Kalideres Sub-district Community Health Center include: amitriptyline, acetylcysteine, aspirin, folic acid, domperidone, calcium gluconate, cotrimoxazole, dexamethasone, dimenhydrinate, ibuprofen, ketoconazole, metformin, metoclopramide, metronidazole, nifedipine, and prednisone.

Abstrak :
Pendahuluan Pasien anak, termasuk di Pediatric Intensive Care Unit (PICU), tergolong rentan menerima peresepan obat off-label, yang berpotensi menimbulkan kejadian efek samping obat. Penelitian ini bertujuan mengevaluasi penggunaan obat off-label pada pasien anak di PICU RSCM, yang belum pernah diteliti. Metode Sampel merupakan peresepan yang diambil dari rekam medis secara consecutive sampling. Perhitungan jumlah sampel menggunakan proporsi tunggal dan beda dua proporsi. Kriteria inklusi adalah pasien anak <18 tahun yang dirawat di PICU RSCM tahun 2018. Kriteria eksklusi adalah pasien dengan data pengobatan yang sulit dibaca atau tidak lengkap, obat luar, elektrolit, dan suplemen. Data ditabulasi berdasarkan nama obat, jenis kelamin, usia, status off-label obat berdasarkan usia pasien, dan klasifikasi Anatomical Therapeutic Chemical (ATC). Uji Chi-Square dipakai untuk mengetahui beda proporsi penggunaan obat off-label antar kelompok. Hasil Dari 400 peresepan yang dievaluasi, 23,8% tergolong off-label kategori usia. Berdasarkan klasifikasi ATC, peresepan di PICU didominasi oleh obat kardiovaskular (25,25%). Obat muskuloskeletal paling sering diresepkan secara off-label (84,6%). Tidak ada perbedaan signifikan proporsi penggunaan obat off-label pada kelompok laki-laki (21%) dan perempuan (26,5%) (p = 0,196,). Proporsi off-label pada kelompok usia bayi (0-2 tahun) 33,8%, anak (2-12 tahun) 18,6%, dan remaja (12-18 tahun) 14,3%. Peresepan off-label pada bayi lebih tinggi secara signifikan dibandingkan anak (p = 0,002) dan remaja (p = 0,001) Kesimpulan Sebanyak 23,8% peresepan pada pasien PICU diberikan secara off-label berdasarkan usia, dan yang tersering adalah obat muskuloskeletal. Perbedaan proporsi obat off-label antar jenis kelamin tidak signifikan, sedangkan antar kelompok usia signifikan. ......Introduction Pediatric patients, including Pediatric Intensive Care Unit (PICU) patients, are prone to off-label drug prescriptions, which potentially lead to adverse drug reactions. This study aimed to assess the use of off-label drugs on PICU patients at RSCM, which has never been studied before. Methods Samples were prescriptions taken from medical records connsecutively. Sample size were calculated using single proportion and difference between two proportions. The inclusion criteria were <18 years old PICU patients at RSCM admitted in 2018. The exclusion criteria were patients with unclear or incomplete data, external drugs, electrolytes, and supplements. Data were tabulated by drug name, sex, age, off-label drug status based on patient age, and Anatomical Therapeutic Chemical (ATC) classification. Difference in proportions between groups were tested using Chi-Square. Results Of the 400 prescriptions evaluated, 23.8% were off-label by age. Based on the ATC classification, PICU prescription was dominated by cardiovascular drugs (25.25%). Musculoskeletal drugs were most often prescribed off-label (84.6%). There was no significant difference in off-label prescription between males (21%) and females (26.5%) (p = 0.196). The proportion of off-label in the infant age group (0-2 years) was 33.8%, in children (2-12 years) 18.6%, and in adolescents (12-18 years) 14.3%. Infants were given off-label drugs significantly higher than children (p = 0.002) and adolescents (p = 0.001) Conclusion Off-label prescription in PICU patients is 23.8%. Musculoskeletal drugs are most often prescribed off-label. The difference in the proportion of off-label drugs between sexes was not significant, whereas between age groups was significant

Abstrak :
ABSTRAK Reaksi obat tidak dikehendaki (ROTD) adalah salah satu masalah kesehatan di masyarakat yang terjadi terutama pada populasi anak.  ROTD pada anak dapat memiliki efek yang relatif lebih parah bila dibandingkan dengan orang dewasa. Penggunaan obat off-label merupakan faktor risiko terjadinya ROTD pada anak. Penelitian tentang penggunaan obat off-label sudah dilakukan di beberapa tempat di Indonesia tetapi sebagian besar hanya sebatas persentase penggunaan obat off-label tetapi tidak diketahui lebih lanjut tentang pengaruhnya terhadap munculnya ROTD. Tujuan dari penelitian ini adalah mengevaluasi penggunaan obat off-label dan on-label sebagai faktor risiko terjadinya reaksi obat tidak dikehendaki pada pasien pediatri di ruang rawat Rumah Sakit Umum Pusat Fatmawati.  Penelitian ini merupakan penelitian studi kohor yang membandingkan reaksi obat tidak dikehendaki antara peresepan secara ­on-label  dan off-label selama masa rawat pasien. Studi ini meneliti 130 pasien dengan jumlah penggunaan obat sebanyak 549 obat selama 4 bulan masa penelitian. Sebanyak 141 obat digunakan secara off-label dan 408 obat digunakan secara on-label. Pemberian obat off-label memiliki risiko untuk terjadinya ROTD 5,787 (Relative Risk=5,787; 95% Confidence Interval 1,072- 31,256) atau 5 kali lebih besar dibandingkan dengan pemberian obat on label. Peneitian ini mengindikasikan bahwa pemberian obat off-label merupakan faktor risiko terjadinya reaksi obat tidak dikehendaki. Variabel perancu yang berhubungan bermakna dengan kejadian ROTD adalah variabel umur (p< 0,05).

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ABSTRACT Adverse drug reaction (ADR) is  one of the health problems in the community that occurs mainly in the pediatric population. ADR in children can have a relatively more severe effect compared to adults. The use of off-label drugs is a risk factor for ADR in children. Research on off-label drug use has been carried out in several places in Indonesia, but most are only limited to the percentage of off-label drug use, but it is not known more about its effect on the emergence of ROTD. The purpose of this study was to evaluate the use of off-label and on-label drugs as risk factors for adverse drug reactions in pediatric patients in the ward room at the RSUP Fatmawati. This study is a cohort study that compares adverse drug reactions between on-label and off-label prescriptions during the patient's care period. The study examined 130 patients with a total drug use of 549 during the 4 months of the study, 141 drugs are used off-label and 408 drugs are used on-label. Patients who received an off-label drug has a risk for ADR 5,787 (Relative Risk = 5,787; 95% Confidence Interval 1,072-31,256) or 5 times higher than patients who received the drug on label. This research indicates that giving off-label drugs is a risk factor for adverse drug reactions. Confounding variables that are significantly related to the incidence of ADR are age variables (p <0.05).

 

Abstrak :
Pendahuluan: Penelitian di beberapa negara menunjukkan tingkat penggunaan obat off-label yang tinggi pada pasien pediatrik. Penggunaan obat off-label sendiri berpotensi meningkatkan kejadian efek samping obat. Penelitian ini bertujuan untuk mengevaluasi penggunaan obat off-label kategori usia pada pasien bangsal anak RSUPN Dr. Cipto Mangunkusumo (RSCM) yang belum pernah diteliti sebelumnya. Metode: Desain penelitian adalah observasional analitik cross sectional. Sampel merupakan data sekunder dari rekam medis pasien pediatrik yang dirawat di Bangsal Anak RSCM yang dipilih secara consecutive sampling. Kriteria inklusi adalah rekam medik pasien anak 0-18 tahun yang dirawat di Bangsal Anak RSCM periode Januari – Desember 2018, dan kriteria eksklusi berupa data pengobatan yang sulit dibaca, tidak lengkap, serta peresepan elektrolit, suplemen, dan obat luar. Obat yang diberikan dicatat dan ditabulasi. Status peresepan off-label ditentukan berdasarkan usia ketika obat diresepkan dan dicocokkan dengan ketentuan yang tertera pada label atau referensi yang relevan. Beda proporsi penggunaan obat off-label antar kelompok dianalisis menggunakan uji Chi-Square. Hasil: Dari 456 sampel peresepan, 12,5% (CI95 = [9,46%; 15,54%]) di antaranya diberikan secara off-label kategori usia. Berdasarkan klasifikasi ATC, golongan obat terbanyak yang diberikan secara off-label adalah agen antineoplastik dan imunomodulasi (61,2%) dan sistem muskuloskeletal (20,0%). Tidak didapatkan hubungan bermakna antara jenis kelamin dengan penggunaan obat off-label (p = 0,571; PR= 1,19; CI95 = [0,732; 1,942]) serta antara kategori usia bayi, anak, dan remaja dengan penggunaan off-label (p = 0,392). Kesimpulan: Tingkat penggunaan obat off-label kategori usia di bangsal anak 12,5%. Dalam penelitian ini, jenis kelamin dan kelompok usia tidak berpengaruh terhadap prevalensi penggunaan obat off-label. ......Introduction: Various studies conducted in many countries showed high level of off-label drug use in pediatric patients. Off-label drug use may increase the occurrence of adverse drug reactions. This study aims to evaluate off-label drug use in Dr. Cipto Mangunkusumo National Central General Hospital (RSCM) which has never been conducted. Methods: Samples were secondary data from medical records of pediatric patients admitted to RSCM Pediatric Ward and collected using consecutive sampling method. Inclusion criteria were medical records of patient of 0-18 years old admitted in the period of January-December 2018, and exclusion criteria were unreadable or incomplete medication record, and electrolyte, supplement, or external medicine. Collected data were recorded and tabulated. Off-label status was determined based on patients’ age when the drug was prescribed and then was matched with the information on the label of the drug or relevant references. Results: Of 456 evaluated prescriptions, 12,5% (CI95 = [9,46%; 15,54%]) were administered off-label according to age category. Based on Anatomical Therapeutic Chemical (ATC) classification, the most frequent drugs prescribed off-label were anti-neoplastic and immunomodulating (61,2%) and musculoskeletal system drugs (20,0%). There was no association between gender and off-label drug use (p = 0,571; PR= 1,19; CI95 = [0.732; 1.942]), and also between infant, children, and adolescent age categories and off-label drug use (p = 0,392). Conclusion: The prevalence of off-label drug use according to age category in the pediatric ward was 12.5%. In this study, gender and also infant, children, and adolescent age categories had no effect on the prevalence of off-label drug use.

Abstrak :
Pendahuluan Berbagai studi menunjukkan obat off-label banyak diberikan pada pasien anak. Pemberian obat off-label dapat menimngkatkan risiko efek samping obat. Penelitian ini bertujuan mengevaluasi peresepan obat off-label pada pasien anak di Instalasi Gawat Darurat RSUPN dr. Cipto Mangunkusumo (IGD-RSCM) yang selama ini belum pernah diteliti. Metode Desain penelitian ini potong lintnag. Sampel peresepan, diambil dari rekam medis pasien anak di IGD-RSCM secara consecutive sampling. Kriteria inklusi adalah peresepan untuk pasien anak usia 0-18 tahun di IGD RSCM pada periode Januari- Desember 2018. Kriteria eksklusi berupa data tidak terbaca atau tidak lengkap, peresepan elektrolit, suplemen, vitamin, dan obat luar. Data jenis kelamin, usia, dan jenis kelompok obat berdasarkan klasifikasi The Anatomical Therapeutic Chemical (ATC) dicatat. Status peresepan off-label ditentukan berdasarkan usia pasien saat obat diresepkan. Proporsi peresepan off-label pada kelompok gender dan usia anak dianalisis dengan uji Chi-Square. Hasil Dari 446 sampel peresepan yang diuji, 24,7% sampel merupakan peresepan off- label berdasarkan kategori usia.Berdasarkan kelompok ATC, kelompok obat yang paling sering diresepkan adalah obat sistem saraf dengan proposi off-label paling tinggi ditemukan pada kelompok agen antineoplastik dan imunomodulasi (88,2%). Tidak ada perbedaan proporsi peroff-label yang signifikan antara pasien anak laki- laki (21,9%) dan perempuan (27,4%) (p = 0,169, PR= 0,662 IK= 0,593 – 1,005). Tidak ada hubungan signfikan antara kelompok usia (bayi, anak, dan remaja) terhadap proporsi peresepan off-label (p = 0,086). Kesimpulan Proporsi peresepan obat off-label pasien anak di Instalasi Gawat Darurat RSCM adalah 24,7%. Jenis kelamin dan perbedaan kelompok usia antara bayi, anak, dan remaja tidak berhubungan dengan besar proporsi peresepan off-label. ......Introduction Various studies showed that pediatric patients often received off-label drugs. Off- label drug administration can increase the risk of adverse drug reactions. This study aims to evaluate the off-label prescriptions in pediatric patients at the Emergency Department of dr. Cipto Mangunkusumo Hospital (IGD-RSCM) which has never been studied. Methods This is a cross sectional study. Prescription samples were taken from the medical records at IGD-RSCM by consecutive sampling. The inclusion criteria were prescriptions for children aged 0-18 years treated at IGD-RSCM during January- December 2018. The exclusion criteria were unreadable, incomplete prescribing data, electrolytes, supplements, vitamins, and external medications. Data of gender, age, and drug class based on The Anatomical Therapeutic Chemical (ATC) classification were recorded. Off-label prescribing status was determined based on the patient's age at the time of prescription. Proportions of Off-label prescriptions in each gender and pediatric age groups were analyzed using the Chi-Square test. Results Of the 446 prescriptions analyzed , 24.7% were prescribed off-labelly by age category. Based on the ATC, nervous system drugs was the most frequently prescribed medication. The highest proportion of off-label drugs prescription was the antineoplastic and immunomodulating agent (88.2%). There was no significant difference in the off-label prescription proportion between boys (21.9%) and girls (27.4%) (p=0.169, PR=0.662 CI=0.593-1.005). There was no significant association between age groups (infants, children and adolescents) and the proportion of off-label prescriptions (p= 0.086). Conclusion The proportion of pediatric off-label prescription at the IGD-RSCM was 24.7%. Gender and pediatric age group differences were not associated with the level of off-label prescriptions proportions.

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ABSTRAK
Kaptopril diketahui memiliki efek menurunkan kadar glukosa darah dengan meningkatkan sensitivitas insulin. Penelitian ini bertujuan untuk mengetahui pengaruh kaptopril pada tikus diabetes yang diinduksi diet tinggi lemak dan streptozotocin dosis rendah. Penelitian ini menggunakan 42 ekor tikus Sprague-Dawley jantan yang dikelompokkan menjadi enam kelompok (n = 7). Satu kelompok normal tidak diobati dan lima kelompok (negatif, positif, dan tiga kelompok variasi dosis kaptopril) diinduksi dengan diet tinggi lemak dan streptozotocin dosis rendah. Kelompok negatif diberi CMC 0,5%, kelompok positif diberi dosis Metformin 90 mg / 200g / hari secara oral, dan tiga kelompok kaptopril dosis bervariasi 25 mg / kg BB / hari tikus / hari secara oral; 50 mg / kg berat badan tikus / hari secara oral; 100 mg / kg BB secara oral. Tikus diinduksi dengan diet tinggi lemak (diet standar: kuning telur puyuh: mentega: sirup jagung fruktosa tinggi, 50%: 30%: 10%: 10%) selama 28 hari, dan kemudian disuntik dengan streptozotocin dosis rendah ( 30 mg / kg BB ip), kemudian dievaluasi pada hari ke 35, dilanjutkan dengan pemberian oral bahan uji dan standar selama 14 hari, dan dievaluasi setiap 7 hari. Semua dosis kaptopril menurunkan kadar glukosa secara signifikan (p <0,05). Kekuatan kaptopril mirip dengan metformin untuk menurunkan kadar glukosa, kaptopril dan metformin dapat menurunkan kadar glukosa darah kembali normal. Berdasarkan hasil tersebut, kaptopril memiliki efek potensial sebagai agen anti hiperglikemik.
ABSTRACT
Captopril is known to have the effect of lowering blood glucose levels by increasing insulin sensitivity. This study aims to determine the effect of captopril on diabetic rats induced by a diet high in fat and low dose of streptozotocin. This study used 42 male Sprague-Dawley rats which were divided into six groups (n = 7). One untreated normal group and five groups (negative, positive, and three groups of captopril dose variation) were induced with a high-fat diet and low-dose streptozotocin. The negative group was given 0.5% CMC, the positive group was given a dose of Metformin 90 mg / 200g / day orally, and the three groups of captopril had varied doses of 25 mg / kg BW / day rats / day orally; 50 mg / kg body weight of rats / day orally; 100 mg / kg BW orally. Rats were induced on a high-fat diet (standard diet: quail egg yolk: butter: high fructose corn syrup, 50%: 30%: 10%: 10%) for 28 days, and then injected with a low dose of streptozotocin (30 mg / kg BW ip), then evaluated on day 35, followed by oral administration of the test material and standard for 14 days, and evaluated every 7 days. All captopril doses decreased glucose levels significantly (p <0.05). Captopril strength is similar to metformin to lower glucose levels, captopril and metformin can lower blood glucose levels back to normal. Based on these results, captopril has a potential effect as an anti-hyperglycemic agent.