Penyakit tidak menular merupakan penyakit yang insidensinya semakin meningkat setiap tahunnya dan memiliki angka morbiditas dan mortalitas yang tinggi, terutama pada lansia. Lansia dan pra-lansia di Desa Banyurejo, Kecamatan Tempel, Kabupaten Sleman diketahui banyak yang menderita hipertensi. Sebagian besar penderita sudah mengetahui mereka memiliki hipertensi namun kesadaran untuk mengontrol tekanan darah dengan mengubah pola hidup yang lebih sehat dan konsumsi obat antihipertensi secara teratur belum dioptimalkan. Maka dari itu, tim abdimas FK-KMK UGM Dr. dr. Rul Afiyah Syarif, M.Kes., dr. Mia Munawaroh Yuniyanti, M.Biomed., dan Dr. Rio Jati Kusuma, S.Gz.,MS. menyelenggarakan kegiatan pembentukan kelompok hipertensi di Dusun Senoboyo, Desa Banyurejo, Tempel, Sleman. Kegiatan disertai dengan memberikan penyuluhan dan pelatihan agar para penderita hipertensi dapat lebih baik dalam mengontrol tekanan darahnya.

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LATAR BELAKANG

Obat merupakan salah satu komponen utama upaya pelayanan kesehatan. Hal ini berlaku di fasilitas kesehatan tingkat pertama (FKTP) dan juga di fasilitas pelayanan kesehatan rujukan tingkat lanjut (FKRTL). Tersedianya akses obat secara luas dan murah bagi sebagian besar masyarakat merupakan salah satu indikator penting upaya pelayanan kesehatan. Obat perlu dikelola secara efektif dan efisien agar dapat mencapai sasaran seperti yang diharapkan. Bagian pengadaan dan instalasi farmasi fasilitas kesehatan sering dihadapkan pada tantangan seperti obat apa saja yang harus disediakan, berapa banyak yang dibutuhkan, bagaimana memperkirakan kebutuhan obat di berbagai populasi, dan bagaimana menjamin mutu dan keamanan obat bagi setiap individu penggunanya.

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Background

Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Real-World Evidence (RWE) is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWD can be analyzed to produce RWE on the usage and/or benefits and risks of a medication or a medical product. RWD and RWE offer the possibility to bring about novel insights on patients’ clinical care, regulatory decision-making, and health technology assessment. Detailed information on data sources, data standards, data reliability, how to generate evidence, and regulatory considerations can be found on FDA’s document titled Framework for FDA’s Real-World Evidence Program (U.S. FDA, 2018). RWE has the potential to supplement information derived from clinical trials, providing accessible data in a shorter time and at lower costs. This is especially relevant to pediatrics, where the evidence base to guide medication use in children may be insufficient. Studies using RWD offer the opportunity to assess long-term effects and the safety of medications that are used to treat pediatrics population (Lasky et al., 2020).

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Background

Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Real-World Evidence (RWE) is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWD can be analyzed to produce RWE on the usage and/or benefits and risks of a medication or a medical product. RWD and RWE offer the possibility to bring about novel insights on patients’ clinical care, regulatory decision-making, and health technology assessment. Detailed information on data sources, data standards, data reliability, how to generate evidence, and regulatory considerations can be found on FDA’s document titled Framework for FDA’s Real-World Evidence Program (U.S. FDA, 2018). Randomized Controlled Trials have limited external validity since the results from a study conducted in a specially selected homogeneous patient subpopulation, and carried out under ideal circumstances, may not necessarily extend well to the general (heterogeneous) patient population with complex care needs, multiple comorbidities, or concomitant medications (Katkade et al, 2018).

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Background

Data related to patient health status and/or the delivery of health care routinely collected from a variety of sources have been defined as Real-World Data (RWD) by the FDA. On the other hand, Real-World Evidence (RWE) is described as clinical evidence about the usage and potential benefits or risks of a medical product derived from an analysis of RWD. RWD and RWE offer the possibility to bring about novel insights on patients’ clinical care, regulatory decision-making, and health technology assessment. Detailed information on data sources, data standards, data reliability, how to generate evidence, and regulatory considerations can be found on FDA’s document titled Framework for FDA’s Real-World Evidence Program (U.S. FDA, 2018). In oncology, RWE refers to evidence derived from the use and analysis of real-world data, which are data obtained outside the context of conventional randomized controlled trials (Khozin et al., 2017).

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