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"ABSTRAK Off-label merupakan istilah penggunaan obat yang diresepkan di luarinformasi yang tertera pada izin edar. Penggunaan obat off-label memiliki risikotinggi terkait dengan aktivitasnya pada kelompok pasien tertentu, salah satunyayaitu pasien hamil. Penelitian ini bertujuan untuk mengevaluasi pola penggunaanobat off-label pada pasien hamil di Instalasi Rawat Inap dan Gawat DaruratKebidanan-Kandungan RSUP Fatmawati periode Maret 2015. Penelitian inimenggunakan desain studi cross-sectional dengan pengambilan data melaluiresep, rekam medis, serta kardeks. Sampel penelitian adalah data pasien hamilyang menerima obat pada bulan Maret 2015. Evaluasi dilakukan terhadap 670terapi obat dari 196 pasien yang sebagian besar berusia 20-35 tahun dengan usiakehamilan trimester ketiga dengan diagnosis persalinan kurang bulan. Terdapatsebanyak 8 obat off-label yang meliputi 5 obat off-label (62,50%) dengan 145terapi off-label di Instalasi Rawat Inap dan 3 obat off-label (37,50%) dengan 37terapi off-label di Instalasi Gawat Darurat Kebidanan-Kandungan. Penggunaanobat off-label dalam terapinya di kedua instalasi dengan kategori off-label indikasisebanyak 58,65%, kategori obat off-label kontraindikasi sebanyak 27%, dankategori obat off-label dosis sebanyak 14,35%. Berdasarkan hasil dapat diketahuibahwa penggunaan obat off-label tertinggi terdapat di Instalasi Rawat Inap dengangolongan obat sistem kardiovaskuler.

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ABSTRACT Off-label is a term used in drug which is prescribed outside the officialinformation of the marketing authorization. Off-label use of drug has a high riskto certain group of patient regarding to its activity, especially pregnant patient.This study aimed to evaluate the pattern of off-label use in pregnant patients in theInpatient Unit and Obstetric-Gynecology Emergency Unit Fatmawati HospitalMarch 2015. Cross-sectional study design was used for the research and the datawas collected from prescriptions, medical records, as well as index card. Theresearch sample were the data of pregnant patients who received drug on March2015. Evaluation was conducted to 670 drugs therapy of 196 patients aged 20-35years old with third trimester of pregnancy and preterm labour diagnosed mostly.There were 8 off-label drugs use including 5 (62,50%) drugs and 145 medicationswere off-label in the Inpatient Unit also 3 (37,50%) drugs and 37 medicationswere off-label in the Obstetrics-Gynecology Emergency Unit. The medicationswith the off-label indication category were 58.65%, off-label contraindicationcategory were 27%, and off-label dose category were 14,35%. Based on theresults, it can be concluded that the highest use of off-label drug was at InpatientUnit with the drug classification of cardiovascular system class."

"Tingginya kebutuhan akan obat dalam dunia kesehatan mendukung Industri Farmasi menjadi salah satu industri yang dikendalikan dan diawasi secara ketat oleh pemerintah baik dari segi produksi, perizinan, peredaran, maupun kualitas obat yang diedarkan. Salah satu upaya yang dilakukan industri farmasi dalam rangka mempertahankan kualitas obat yang diproduksinya tetap memenuhi standar mutu yaitu dengan menerapkan Cara Pembuatan Obat yang Baik (CPOB). Apoteker dituntut untuk memiliki pengetahuan dan pengalaman praktis untuk dapat mengatasi permasalahan yang ada di Industri Farmasi. Praktek Kerja Profesi Apoteker (PKPA) dilakukan pada bulan Februari-Maret 2016 di PT. Glaxo Wellcome Indonesia agar calon Apoteker memiliki bekal pengetahuan dan pemahaman tentang tugas dan tanggung jawab Apoteker di Industri Farmasi. Melalui PKPA tersebut, diharapkan calon Apoteker dapat mengembangkan kompetensi dan wawasan untuk dapat melaksanakan pekerjaan kefarmasian dan menerapkan CPOB di Industri Farmasi.

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The high demand of drugs in the field of health supports Pharmaceutical Industry became one of the industries that controlled and monitored by government in terms of production, licensing, distribution and quality of drugs in circulation. One of the efforts made by Pharmaceutical Industry in order to maintain drugs quality that were produced still meet quality standards by implementing Good Manufacturing Practice (GMP). Pharmacists are required to have knowledge and experience to be able to overcome problems that occur in Pharmaceutical Industry. Pharmacist Internship Program (PKPA) conducted on February-March 2016 at Glaxo Wellcome Indonesia for prospective pharmacist to have the knowledge and understanding of the duties and responsibilities of pharmacists in the Pharmaceutical Industry. Through this PKPA, prospective pharmacist is expected to develop their competency and insight to be able to carry out the work of pharmacy and implement GMP in Pharmaceutical Industry."