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"Kendala administrasi obat secara oral masih dialami oleh sebagian besar populasi seperti populasi disfagia, geriatri, dan pediatri. Pirfenidon merupakan salah satu terapi penyakit Idiopathic Pulmonary Fibrosis (IPF) yang sebagian besar dialami oleh populasi geriati. Tablet pirfenidon yang tersedia berupa tablet dosis 267 mg dengan regimen terapi tiga tablet sebanyak tiga kali per hari. Hal tersebut mengakibatkan peningkatan frekuensi penelanan pada terapi jangka panjang pengobatan IPF dengan pirfenidon. Tujuan penelitian ini adalah memperoleh formula tablet cepat hancur (TCH) pirfenidon menggunakan metode sublimasi yang memiliki karakteristik waktu hancur kurang dari 3 menit dan keregasan kurang dari 1%. Pada penelitian ini, TCH pirfenidon diformulasikan menggunakan metode sublimasi, yaitu dengan tablet kempa langsung yang dilanjutkan dengan proses sublimasi. Untuk memfasilitasi proses sublimasi, pada formula ditambahkan eksipien amonium bikarbonat dengan tiga variasi konsentrasi yaitu 2% (F1), 5% (F2), dan 10% (F3). TCH yang dihasilkan dievaluasi meliputi waktu hancur, waktu pembasahan, kekerasan, keregasan, kadar obat, dan disolusi obat. Hasil evaluasi TCH pirfenidon menunjukkan bahwa TCH yang memenuhi persyatan adalah TCH F1 dengan waktu hancur 29,53 ± 2,55 detik; waktu pembasahan 28,73 ± 1,55 detik; kekerasan tablet 4,91 ± 0,29 kP; keregasan 0,9%; kadar 103,98 ± 1,04%; dan jumlah obat terdisolusi pada menit ke-30 adalah 93,22 ± 4,07%. Berdasarkan hasil evaluasi, dapat disimpulkan bahwa formula TCH F1 yang dibuat menggunakan metode sublimasi dapat menghasilkan sediaan TCH yang memenuhi persyaratan. Oleh karena itu, TCH pirfenidon berpotensi menjadi alternatif sediaan bagi terapi IPF untuk memfasilitasi penelanan tablet.

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Constraints of oral drug administration are still experienced the most by dysphagia, geriatric, and pediatric populations. Pirfenidone is one of the therapies for Idiopathic Pulmonary Fibrosis (IPF) which is mostly experienced by the geriatric. On the market, pirfenidone tablets are available with the dose of 267 mg, with a therapeutic regimen of three tablets three times per day. This resulted in an increase in the frequency of ingestion for long-term therapy with pirfenidone. The purpose of this study was to obtain formula for fast disintegrating tablet (FDT) of pirfenidone using sublimation method with disintegration time < 3 minutes and friability <1%. In this study, FDTs were made using sublimation method, which were compressed using direct compression method before. To facilitate the sublimation, ammonium bicarbonate was added to the formula with three various concentration which were 2%(F1), 5%(F2), and 10%(F3). The FDTs were then evaluated for disintegration and wetting time, hardness, friability, assay, and dissolution. Based on the result, FDT that met the requirements was FDT F1 with the disintegration time of 29.53 ± 2.55 seconds; wetting time of 28,73 ± 1,55 seconds; hardness of 4,91 ± 0,29 kP; friability value of 0,9%; assay result was 103,98 ± 1,04%; and the amount of drug dissolved within 30 minutes was 93,22 ± 4,07%. It was concluded that formula FDT F1 made by sublimation method could produce FDT that met the requirements. Therefore, FDT is potential to be an alternative dosage form to facilitate tablet swallowing for IPF therapy."

"Apotek merupakan sarana pelayanan kefarmasian tempat dilakukannya praktik kefarmasian oleh Apoteker (Kementerian Kesehatan Republik Indonesia, 2016). WHO menentukan sebuah standar bagi apoteker untuk dapat meningkatkan, menunjang akses, dan mendukung pelayanan di apotek yaitu Good Pharmacy Practice (GPP). PT. Kimia Farma Apotek melaksanakan penerapan GPP melalui penyediaan dan penerapan Standar Operating Procedure (SOP) yang di dalamnya telah diatur standar pelayanan kefarmasian yang perlu diterapkan oleh setiap apotek jaringan. Oleh karena itu dilakukan penilaian terhadap penerapan GPP di apotek Kimia Farma Menteng Huis berdasarkan SOP yang telah tersedia. Pelaksanaan tugas khusus Self-assesment GPP dilaksanakan berdasarkan formulir penilaian yang memuat sembilan kategori penilaian, yaitu legalitas apotek, penampilan apotek dan petugas, layanan obat dengan resep, layanan obat tanpa resep, SOP protokol new normal, morning briefing dan serah terima shift, delivery, homecare, telefarma, dan PRB community, penyimpanan obat. Penilaian dilakukan dengan pemberian poin 1 (Aspek tidak terlaksana), 2 (Aspek terlaksana Sebagian), atau 3 (aspek terlaksana sepenuhnya). Dari 9 kategori tersebur terdapat 50 aspek penilaian, sebanyak 30 aspek memperoleh poin 3, sebanyak 13 aspek memperoleh poin 2, dan sebanyak 7 aspek memperoleh poin 1.

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A pharmacy store is where the pharmacy practices were performed by the pharmacist. WHO had determined a standard for pharmacists to improve and support pharmacy practices and services in stores, which was Good Pharmacy Practice (GPP). PT. Kimia Farma Apotek implemented GPP through the provision and application of Standard Operating Procedures (SOP), which regulate the standards of pharmaceutical service and must be implemented by each Kimia Farma store. Therefore, an assessment of the implementation of GPP was carried out at the Kimia Farma Menteng Huis based on the available SOP. Implementation of this self-assessment was carried out based on an assessment form that contains nine assessment categories, namely pharmacy legality, pharmacy and staff appearance, prescription drug services, non-prescription drug services, new normal protocol SOP, morning briefing and shift handover, delivery, homecare, tele pharma, and PRB community, and medicines storage. The assessment is carried out by rate 1 point if the aspect was not implemented, 2 point if the aspect ix Universitas Indonesia was implemented partially, or 3 points if the aspect was fully implemented. From all the 9 categories there are 50 assessment aspects, Kimia Farma Menteng Huis got 30 aspects with 3 points, 13 aspects with 2 points, and 7 aspects with 1 point."

"Tuberkulosis (TB) hingga saat ini menjadi salah satu masalah kesehatan masyarakat dunia. Di Indonesia, prevalensi infeksi TB mencapai 8,5% dan merupakan angka prevalensi TB terbesar kedua di dunia pada tahun 2019. Dalam rangka mendukung keberhasilan program penanggulangan TB nasional, dilaksanakan upaya pemantauan dan evaluasi keberhasilan program penanggulangan TB di Indonesia. Sejak bulan Maret 2022 – Mei 2023, puskesmas kecamatan cengkareng telah melayani 166 pasien dewasa TB Sensitif Obat (TB-SO) dosis intermiten. Dalam rangka menilai keberhasilan program tersebut, dilakukan evaluasi hasil pengobatan periode Maret 2022 – April 2023 serta dilakukan penyusun leaflet sebagai sarana edukasi pengobatan TB-SO dosis intermiten. Evaluasi pengobatan dilaksanakan melalui pengelolahan data retrospektif menggunakan perangkat lunak Microsoft excel dari data sekunder hasil rekapitulasi pengobatan OAT 2HRZE/4H3R3 sejak bulan Maret 2022 – Mei 2023. Sedangkan, pembuatan leaflet dilakukan berdasarkan studi literatur dari pustaka tahun 2009 – 2021 dan ditulis secara ringkas dan menarik. Berdasarkan hasil evaluasi, dari 166 pasien dewasa TB-SO dosis intermiten; 48,80% pasien sembuh; 13,25% pasien dirujuk ke fasilitas kesehatan lain; 9,64% pasien Loss to Follow Up; 0,6% pasien meninggal; 21,08% pasien menjalankan terapi fase awal; dan 6,63% pasien menjalankan terapi fase lanjutan. Selain itu, telah dibuat leaflet pengobatan TB dosis 4HRZE/2H3R3 sebagai media edukasi bagi pasien TB.

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Tuberculosis (TB) has become one of the world's public health problems. In Indonesia, the prevalence of TB infection reached 8.5% and was the second highest TB prevalence in the world in 2019. To support the success of the national TB program, evaluation, and monitoring of TB programs in Indonesia were carried out. From March 2022 – May 2023, Puskesmas kecamatan cengkareng has treated 166 adult patients with drug-sensitive TB (SO-TB). To assess the success of the program, an evaluation of the treatment was carried out and the leaflet was compiled as an educational media. The evaluation was carried out retrospectively using secondary data from the recapitulation of OAT 2HRZE/4H3R3 treatment from March 2022 – May 2023, all the data were processed using Microsoft Excel software. Meanwhile, the leaflet was created based on literature studies from the 2009 – 2021 literature. Based on the evaluation results, from 166 adult patients with intermittent dose TB-SO; 48.80% of the patients recovered; 13.25% of patients were referred to other health facilities; 9.64% of patients were Loss to Follow Up; 0.6% of patients died; 21.08% of patients underwent intensive phase therapy; and 6.63% of patients underwent continuous phase therapy. In addition, the leaflet for drug-sensitive TB has been made as educational media for TB patients."

"Industri farmasi memiliki kewajiban untuk menghasilkan obat yang memenuhi persyaratan mutu, keamanan, dan efektivitas. Pada penerapan Change Request, PT Mahakam Beta Farma (MBF) melaksanakan seluruh proses menggunakan dokumen fisik. Dalam rangka meningkatkan efektivitas dan efisiensi proses serta penyimpanan dokumen, PT. MBF melakukan perubahan menjadi sistem yang terkomputerisasi. Berdasarkan CPOB 2018, penggantian operasi manual menjadi sistem komputerisasi tidak boleh mengakibatkan penurunan kualitas produk, kendali proses, atau pemastian mutu, dan tidak meningkatkan risiko terhadap proses. Oleh karena itu dilakukan validasi sistem komputer Change Request PT. MBF. Validasi dilakukan berdasarkan protokol validasi yang telah disetujui berdasarkan User Requirement Specification dan dilaksanakan melalui dua tahap yaitu kualifikasi Intalasi software dan hardware serta kualifikasi operasional software. Pada kualifikasi instalasi terdapat 82 uji yang harus dilaksanakan, terdiri dari 74 uji software, 4 uji hardware, dan 4 uji terkait instruksi kerja. Seluruh uji hardware lolos uji, 3 aspek instruksi kerja lolos uji dan 1 aspek belum terlaksana tetapi pelaksanaannya telah dijadwalkan, 67 aspek software lolos uji sedangkan 7 aspek lainnya lolos dengan catatan dan perbaikan. Pada kualifikasi operasional terdapat 62 tahap uji terkait alur kerja software dan seluruh aspek telah lolos uji. Hal tersebut menunjukan bahwa sistem CR PT. MBF telah memenuhi kualifikasi instalasi dan operasional sehingga dapat dilanjutkan dengan kualifikasi performa.

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The pharmaceutical industry has an obligation to produce drugs that meet the quality, safety, and effectiveness requirements. In implementing the Change Request, PT Mahakam Beta Farma (MBF) performed the entire process using physical documents. To increase the effectiveness and efficiency of the processes and storage management, PT. MBF changed the system to a computerized system. Based on CPOB 2018, replacing manual operations with computerized systems may not decrease product quality, process control, or quality assurance, and doesn’t increase the process risk. Therefore, validation for the computer system was performed. The validation is carried out based on the validation protocol that was written based on the User Requirements Specification and carried out in two stages, there are installation qualification and operational qualification. In the installation qualification, there are 82 tests consisting of 74 software tests, 4 hardware tests, and 4 tests related to work instructions. All hardware tests passed the test, 3 aspects of work instructions passed the test and 1 aspect had not been performed but had been scheduled, 67 aspects of the software passed the test while 7 other aspects passed with notes and improvements needed. In operational qualification, there are 62 test stages related to software workflow and all aspects have passed the test. It could be concluded that the CR system of PT. MBF has passed the installation and operational qualifications and can be continued with performance qualification."

"Acute Kidney Injury (AKI) merupakan komplikasi serius yang umum terjadi pada pasien rawat inap. Berdasarkan penelitian tahun 2005, terjadi peningkatan insiden dan keparahan AKI hingga 50% akibat penggunaan obat selama rawat inap. Salah satu tugas apoteker di RS adalah melakukan pemantauan terapi obat, terdapat beberapa obat di RSUI yang dinilai mampu menginduksi terjadinya AKI. Oleh karena itu, dilakukan pembuatan daftar obat yang dapat menginduksi terjadinya AKI serta studi kasus terjadinya AKI pada pasien rawat inap akibat penggunaan obat di RSUI pada bulan Maret 2023. Daftar obat penginduksi AKI dibuat berdasarkan studi literatur dari pustaka tahun 2005 – 2023 kemudian obat dikategorikan berdasarkan kelas terapi obat. Sedangkan, studi kasus dilaksanakan secara retrospektif menggunakan data sekunder pasien rawat inap RSUI pada bulan Maret 2023 yaitu rekam medis salah satu pasien yang memenuhi kriteria inklusi dan eksklusi. Terdapat 26 obat yang mampu menginduksi AKI di RSUI. Berdasarkan studi kasus, terapi ramipril diduga mampu meningkatkan risiko terjadinya AKI pada salah satu pasien RSUI yang dinilai berdasarkan peningkatan nilai serum kreatinin dan penurunan nilai GFR. Ramipril diduga menjadi penyebab peningkatan risiko terjadinya AKI berdasarkan angka prevalensinya sebesar 28%, adanya riwayat perbaikan fungsi ginjal saat penghentian obat, serta fungsi ginjal yang kembali memburuk ketika terapi ramipril kembali dilanjutkan. Penilaian kondisi pasien menggunakan instrumen naranjo dibutuhkan untuk mengonfirmasi insiden terjadinya AKI akibat ramipril.

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Acute Kidney Injury (AKI) was a serious complication that commonly occurs in inpatients. Based on a study in 2005, there was an increase in the incidence and severity of AKI up to 50% due to drug induce during hospitalization. One of the responsibilities of the pharmacist in the hospital was to perform drug therapy monitor and several drugs in RSUI were considered likely to induce AKI. Therefore, a list of drugs induced AKI was created, and a case study of drug-induced AKI in hospitalized patients at RSUI in March 2023 was performed. The list of drugs induced AKI was made based on a literature study from 2005 – 2023, then the drugs were categorized based on the drug therapy class. Meanwhile, the case study was carried out retrospectively using secondary data from hospitalized patients at RSUI in March 2023, which was the medical records from one of the patients who met the inclusion and exclusion criteria. There are 26 drugs-induced AKI in RSUI. Based on the case study, ramipril therapy was thought to be likely to increase the risk of developing AKI in one of the RSUI patients as assessed by the increase of creatinine serum and the decrease GFR values. Ramipril is thought to be the cause of the increased risk of AKI based on its prevalence rate which was 28%, history of improvement in kidney function when stopping the drug, and worsened kidney function when ramipril therapy is resumed. Assessment of the patient's condition using the Naranjo instrument is needed to confirm the incidence of AKI due to ramipril."

"Pedagang Besar Farmasi (PBF) merupakan perusahaan berbentuk badan hukum yang memiliki izin melaksanakan kegiatan pengadaan, penyimpanan, penyaluran obat dan/atau bahan obat sesuai perundang-undangan. PBF memiliki kewajiban memenuhi kondisi penyimpanan obat sesuai dengan rekomendasi industri farmasi yang memproduksi produk tersebut. PBF harus menjamin ruang penyimpanana telah memenuhi persyaratan suhu yang telah ditentukan, Dalam rangka mengidentifikasi area yang mengalami fluktuasi suhu, dilakukan pemetaan suhu/ mapping suhu. Pemetaan suhu di PT. Enseval Putera Megatrading dilakukan setiap 3 tahun sekali atau jika terdapat perubahan yang mampu mempengaruhi kontrol suhu. Oleh karena terdapat perubahan mesin pendingin ruangan yang digunakan maka dilaksanakan Mapping suhu pada gudang penyimpanan coolroom di PT. Enseval Putera Megatrading Jakarta 1. Mapping dilaksanakan dengan menempatkan 30 data logger sesuai dengan denah di Gudang coolroom pada 9 rak penyimpanan. Pengukuran suhu dilakukan selama 3 hari sejak tanggal 13 – 16 Februari 2023 dengan interval pengukuran suhu setiap 10 menit. data diolah menggunakan aplikasi Microsoft Excel untuk diketahui suhu tertinggi, terendah, rata-rata, dan rata-rata MKT. Berdasarkan hasil pengukuran telah terjadi penyimpangan suhu pada ruang penyimpanan gudang coolroom yaitu melebihi suhu 25°C sebanyak 6 lokasi pengukuran yang kemungkinan disebabkan karena terdapat perubahan pengaturan pada mesin pendingin ruangan.

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procurement, and storage of medicines and/or medicinal substances by law. PBF was required to fulfill drug storage requirements by the recommendations of the pharmaceutical industry. PBF must guarantee that the storage area meets the specified temperature requirements. To identify specific areas which develop fluctuations in temperature, temperature mapping was carried out. Temperature mapping at PT. Enseval Putera Megatrading was held once every 3 years or if any changes occurred that could affect temperature control. Mapping of there was a change of the air conditioner in the cool room storage warehouse at PT. Enseval Putera Megatrading Jakarta 1, temperature mapping must be carried out. Temperature mapping was carried out by placing 30 data loggers according to the plan in the cool room warehouse on 9 storage shelves. Temperature measurements were carried out for 3 days from 13 – 16 February 2023 with temperature measurement intervals every 10 minutes. All the data was processed using Microsoft Excel to find out the highest, lowest, average, and MKT average temperatures. Based on the measurement results, there has been a temperature deviation in the cool room warehouse storage room, the temperatures were exceeding 25°C in 6 measurement locations which may be due to a change in the settings on the air conditioner."