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Abstrak :
ABSTRAK
Off-label merupakan istilah penggunaan obat yang diresepkan di luar informasi yang tertera pada izin edar. Penggunaan obat off-label memiliki risiko tinggi terkait dengan aktivitasnya pada kelompok pasien tertentu, salah satunya yaitu pasien hamil. Penelitian ini bertujuan untuk mengevaluasi pola penggunaan obat off-label pada pasien hamil di Instalasi Rawat Inap dan Gawat Darurat Kebidanan-Kandungan RSUP Fatmawati periode Maret 2015. Penelitian ini menggunakan desain studi cross-sectional dengan pengambilan data melalui resep, rekam medis, serta kardeks. Sampel penelitian adalah data pasien hamil yang menerima obat pada bulan Maret 2015. Evaluasi dilakukan terhadap 670 terapi obat dari 196 pasien yang sebagian besar berusia 20-35 tahun dengan usia kehamilan trimester ketiga dengan diagnosis persalinan kurang bulan. Terdapat sebanyak 8 obat off-label yang meliputi 5 obat off-label (62,50%) dengan 145 terapi off-label di Instalasi Rawat Inap dan 3 obat off-label (37,50%) dengan 37 terapi off-label di Instalasi Gawat Darurat Kebidanan-Kandungan. Penggunaan obat off-label dalam terapinya di kedua instalasi dengan kategori off-label indikasi sebanyak 58,65%, kategori obat off-label kontraindikasi sebanyak 27%, dan kategori obat off-label dosis sebanyak 14,35%. Berdasarkan hasil dapat diketahui bahwa penggunaan obat off-label tertinggi terdapat di Instalasi Rawat Inap dengan golongan obat sistem kardiovaskuler.

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ABSTRACT
Off-label is a term used in drug which is prescribed outside the official information of the marketing authorization. Off-label use of drug has a high risk to 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 the Inpatient Unit and Obstetric-Gynecology Emergency Unit Fatmawati Hospital March 2015. Cross-sectional study design was used for the research and the data was collected from prescriptions, medical records, as well as index card. The research sample were the data of pregnant patients who received drug on March 2015. Evaluation was conducted to 670 drugs therapy of 196 patients aged 20-35 years 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 medications were off-label in the Inpatient Unit also 3 (37,50%) drugs and 37 medications were off-label in the Obstetrics-Gynecology Emergency Unit. The medications with the off-label indication category were 58.65%, off-label contraindication category were 27%, and off-label dose category were 14,35%. Based on the results, it can be concluded that the highest use of off-label drug was at Inpatient Unit with the drug classification of cardiovascular system class.

Abstrak :
ABSTRAK Pemerintah melalui Departemen Kesehatan telah memberikan secara gratis hematinik yang mengandung 200 gram fero sulfat dan 0.25 gram asam folat sejak tahun 1970, namun prevalensi anemia pada pasien hamil di Puskesmas Kecamatan Matraman masih 30% pada tahun 2014. Penelitian ini bertujuan untuk mengetahui faktor-faktor yang dapat memengaruhi efektivitas dari hematinik yang dikonsumsi oleh pasien hamil di Puskesmas Kecamatan Matraman periode Maret-Mei 2015. Metode penelitian menggunakan rancangan studi cross-sectional dengan teknik pengambilan data purposive sampling. Data diperoleh dari hasil pemeriksaan kadar hemoglobin pasien dan hasil wawancara pasien dengan menggunakan kuesioner yang telah diuji validitas dan reliabilitasnya. Responden adalah pasien hamil yang mengonsumsi hematinik dari pemerintah dan telah melakukan pemeriksaan kadar hemoglobin minimal 2 kali. Jumlah sampel yang masuk kriteria inklusi pada penelitian sebanyak 85 pasien. Berdasarkan hasil penelitian, terdapat hubungan bermakna antara pengaruh kebiasaan konsumsi teh dengan kadar hemoglobin pasien (p=0,000) dan pengaruh keteraturan konsumsi hematinik dengan kadar hemoglobin pasien (p=0,004). Namun tidak ada hubungan yang bermakna antara pengaruh pola makan dengan kadar hemoglobin pasien (p=0,105) dan pengaruh cara mengonsumsi hematinik dengan kadar hemoglobin pasien (p=0,684). Penelitian ini menunjukkan bahwa faktor-faktor yang memengaruhi efektivitas penggunaan hematinik adalah kebiasaan konsumsi teh dan keteraturan konsumsi hematinik.

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ABSTRACT The government through Health Department has been giving hematinic that contains 200 gr of ferro sulfas and 0.25 gr of folic acid to pregnant patient since 1970, but anaemia prevalence in pregnant patient at Matraman primary health care still 30%. This research aimed to analyze factors that were influencing hematinic effectiveness that has been used by pregnant patient at Matraman primary health care in the period of March-May 2015. The method used for this research was cross-sectional study with purposive sampling technique. Data was obtained from the result of laboratory test for haemoglobin level and interview using valid and reliable questionnaire. Respondents of this research were pregnant patient who used hematinics that were given from government and their haemoglobin level had been measured at least twice during their pregnancy. Total respondent who met the inclusion criteria were 85 patients. Based on the result, there were significant association between tea consumption habits and haemoglobin level (p=0.000) and also significant association between patient compliance on hematinic consumption and haemoglobin level (p=0.004). But there were no significant association between dietary habit and haemoglobin level (p=0,105) and between how to consume hematinic and haemoglobin level (p=0,684). This study showed factors influencing hematinic effectiveness were tea consumption habits and patient compliance on hematinic consumption.