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"Drug efficacy, safety, and biologics discovery : emerging technologies and tools covers key emerging technologies in pharmaceutical R & D and how they have substantially impacted (or are currently impacting) drug discovery. The cross-disciplinary collaborations implicit in integrating these technologies with drug discovery operations will fuel the engine for future innovations. This book cuts across the multiple areas of drug discovery, each chapter authored by pioneers in that field, making for a broad appeal to the chemical and biological scientists and technologists involved in drug discovery and development."

"Industri farmasi merupakan badan usaha yang memiliki izin dari Menteri Kesehatan untuk melakukan kegiatan pembuatan obat atau bahan obat. Dalam Peraturan BPOM Nomor 23 Tahun 2022 Pasal 4 ayat (2), disebutkan bahwa dalam hal standar dan/atau persyaratan mutu obat dan bahan obat terdapat lebih dari satu farmakope yang diterapkan di negara lain atau pedoman/ketentuan yang berlaku secara internasional, suatu industri obat memilih standar dan/atau persyaratan mutu yang memiliki parameter uji yang lebih lengkap, serta menggunakan metode yang lebih unggul dalam ketepatan, kepekaan, presisi, selektivitas/spesifitas, dan/atau otomatisasi. Maka dari itu, perlu dilakukan analisis perbandingan metode analisis pada Farmakope Indonesia edisi VI (FI VI) dan United States Pharmacopeia 2022 (USP NF 2022) yang merupakan farmakope/kompendial dari negara lain yang berlaku secara internasional untuk menentukan metode analisis yang lebih unggul untuk digunakan di PT Kalbe Farma Tbk. Penyusunan tugas khusus dilakukan dengan cara membandingkan monografi bahan baku obat atau obat yang terdapat di kompendial FI VI dan USP NF 2022, yaitu Propilparaben (Nipasol), Klorobutanol, dan Pektin. Berdasarkan penelitian yang telah dilakukan, metode yang lebih unggul dalam penetapan kadar Propilparaben (Nipasol) adalah dengan menggunakan High Performance Liquid Chromatography (HPLC) berdasarkan metode analisis USP NF 2022, metode yang lebih unggul dalam penetapan kadar Klorobutanol adalah dengan menggunakan Kromatografi Gas (GC) berdasarkan metode analisis USP NF 2022, dan metode yang lebih unggul dalam identifikasi Pektin adalah dengan menggunakan Spektrofotometri UV-Vis berdasarkan metode analisis USP NF 2022.

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The pharmaceutical industry is a business entity that has a permit from the Minister of Health to carry out activities to manufacture drugs or medicinal ingredients. In BPOM Regulation Number 23 of 2022 Article 4 paragraph (2), it is stated that in terms of standards and/or requirements for the quality of drugs and medicinal substances there is more than one pharmacopeia that is applied in other countries or guidelines/provisions that apply internationally, a drug industry choosing standards and/or quality requirements that have more complete test parameters, as well as using methods that are superior in accuracy, sensitivity, precision, selectivity/specificity, and/or automation. Therefore, it is necessary to carry out a comparative analysis of analytical methods in the Indonesian Pharmacopeia VI edition (FI VI) and the United States Pharmacopeia 2022 (USP NF 2022) which are pharmacopeias/compendials from other countries that apply internationally to determine which analytical method is superior to use. at PT Kalbe Farma Tbk. The preparation this assignment is carried out by comparing the monographs of medicinal raw materials or drugs contained in compendial FI VI and USP NF 2022, namely Propylparaben (Nipasol), Chlorobutanol, and Pectin. Based on the research that has been done, the method that is superior in determining Propylparaben (Nipasol) levels is to use High Performance Liquid Chromatography (HPLC) based on the USP NF 2022 analysis method, the method that is superior in determining Chlorobutanol content is to use Gas Chromatography (GC) based on the USP NF 2022 analysis method, and a superior method in identifying pectin is to use UV-Vis Spectrophotometry based on the USP NF 2022 analysis method."

"Obat yang disalurkan oleh Pedagang Besar Farmasi (PBF) harus memenuhi standar dan persyaratan keamanan, khasiat, mutu, dan label. Apabila obat yang telah disalurkan tidak memenuhi standar dan persyaratan tersebut, maka obat terebut harus ditarik dari peredarannya. Pelaksanaan penarikan obat yang dilakukan oleh PBF perlu menerapkan prinsip Cara Distribusi Obat yang Baik (CDOB). Tujuan dari tugas khusus ini adalah untuk mengevaluasi kesesuaian pelaksanaan penarikan obat (recall) di PT Kimia Farma Trading and Distribution Cabang Jakarta 3 berdasarkan aspek Cara Distribusi Obat yang Baik (CDOB) 2020. Pengumpulan data terkait pelaksanaan penarikan obat di lapangan dilakukan dengan cara observasi langsung, wawancara dengan narasumber, serta penelusuran SOP terkait penarikan obat. Data tersebut kemudian dibandingkan dengan kriteria yang terdapat pada CDOB 2020. Hasil memperlihatkan bahwa kriteria penarikan obat yang terdapat pada CDOB 2020 seperti prosedur tertulis penarikan obat, proses penyimpanan obat, serta pendokumentasian penarikan obat secara umum telah dilaksanakan oleh PT KFTD Jakarta 3 secara baik. Kesimpulannya adalah pelaksanaan penarikan obat di PT KFTD Jakarta 3 secara umum telah sesuai dengan persyaratan dan ketentuan yang terdapat pada CDOB 2020.

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Drugs distributed by pharmaceutical distributors must meet safety, efficacy, quality, and label standards and requirements. If the drug that has been distributed does not meet these standards and requirements, then the drug must be recalled from circulation. The implementation of drug recalls carried out by pharmaceutical distributors needs to apply the principles of Good Distribution Practice (GDP). The purpose of this special assignment was to evaluate the suitability of carrying out drug recalls at PT Kimia Farma Trading and Distribution Jakarta 3 based on aspects of Good Distribution Practice (GDP) 2020. Data collection related to the implementation of drug recalls in the field was carried out through direct observation, interviews with sources, and tracing SOPs related to drug recall. The data was then compared with the criteria contained in GDP 2020. The results showed that the drug recall criteria contained in GDP 2020, such as written drug recall procedures, drug storage processes, and documentation of drug recall in general, have been carried out properly by PT KFTD Jakarta 3. The conclusion is that the implementation of drug recalls at PT KFTD Jakarta 3 is in general in accordance with the terms and conditions contained in GDP 2020."

"Drug-drug interactions in pharmaceutical development comprehensively reviews the relevant science, industrial practice, and regulatory agency positions on drug-drug interactions. It focuses on the evaluation of potential drug-drug interactions, allowing researchers to address risk factors before a drug is put to market. The book covers both clinical and nonclinical aspects for understanding drug-drug interactions as well as in vitro and in vivo studies for use in studying interactions at the drug discovery stage."

"Pengelolaan obat di puskesmas masih memiliki kendala dalam ketersediaan obat, penyimpanan, maupun pengendalian obat. Penelitian ini bertujuan untuk menganalisis kesesuaian pengelolaan obat di Puskesmas Margamulya tahun 2021 terhadap standar indikator pengelolaan obat. Metode yang digunakan adalah penelitian deskriptif observasional. Pengumpulan data secara concurrent dengan observasi langsung dan retrospective dengan penelusuran data sekunder, serta dilakukan wawancara. Hasil pengumpulan data kemudian dilakukan analisis dengan indikator pengelolaan obat yang terdiri dari 26 indikator diantaranya kesesuaian item obat dengan FORNAS (72,22%), kesesuaian item dengan pola penyakit (78,48%), ketepatan jumlah perencanaan (170,01%), kesesuaian jumlah permintaan (74,64%), kesesuaian jumlah penerimaan (67,95%), penyimpanan narkotika dan psikotropika (71,43%), penyimpanan obat high-alert di apotek (0%) dan gudang (33,33%), penyimpanan obat LASA di apotek (31,71%) dan gudang (37,14%), nilai ITOR (2,73 kali/tahun), tingkat ketersediaan obat (17,44 bulan), item stok aman (46,98%), item stok berlebih (53,02%), obat yang tidak diresepkan (37,58%), nilai obat kedaluwarsa (3,29%). Hasil analisis menunjukkan bahwa pengelolaan obat di Puskesmas Margamulya memenuhi 9 indikator sesuai dengan standar, 15 indikator tidak memenuhi standar dan 2 indikator tidak dapat dianalisis dikarenakan kurangnya data. Oleh karena itu, diperlukan peninjauan kembali aspek pengendalian obat, perlu meningkatkan jumlah, soft skill dan pengetahuan petugas farmasi dalam pelayanan kefarmasian, menerapkan sistem informasi manajemen puskesmas.

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Drug management at Primary Health Center has problem with drug availability, storage, and drug control. This study aims to analyze the suitability of drug management at the Margamulya Primary Health Center in 2021 to the standard indicators of drug management. This study used observational descriptive research methods. Concurrent data collection was carried out by direct observation and retrospective with secondary data tracing, as well as interviews. The results of data collection were then analyzed with drug management indicators consisting of 26 indicators including the suitability of drug items with FORNAS (72.22%), conformity of items with disease patterns (78.48%), accuracy of the number of planning (170.01%), suitability of the number of requests (74.64%), suitability of the number of receipts (67.95%), storage of narcotics and psychotropics (71.43%), storage of high-alert drugs in pharmacies (0%) and warehouses (33.33%), storage of LASA drugs in pharmacies (31.71%)) and warehouses (37.14%), ITOR (2.73 times/year), the availability of drugs (17.44 months), safe stock items (46.98%), excess stock items (53.02%), non-prescribed drugs (37.58%), expired drug values (7.43%). The results of the analysis showed that drug management at the Margamulya Primary Health Center met 9 indicators in accordance with the standards, while 15 indicators did not meet the standards and 2 indicators could not be analyzed because of lack of data. It is necessary to review aspects of drug control, to increase the number, soft skills and knowledge of pharmacist in pharmaceutical services, and implementing a primary health center management information system."

"Pengelolaan obat secara tidak langsung berkaitan dengan kualitas kesehatan masyarakat, khususnya pada produk rantai dingin farmasi yang cenderung sensitif terhadap perubahan selama proses penyimpanan dan pendistribusian. Sebagai fasilitas pelayanan kesehatan yang dekat dengan masyarakat, Apotek Roxy Cabang Sawangan harus memperhatikan proses pengelolaan tersebut. Oleh karena itu, diperlukan penelitian yang bertujuan untuk menganalisa implementasi sistem pengelolaan produk, data persentasi penjualan, serta peranan apoteker dalam penanganan produk rantai dingin farmasi di Apotek Roxy Cabang Sawangan. Penelitian dilakukan secara observasional melalui pendekatan kualitatif. Adapun observasi dilakukan melalui studi literatur berdasarkan referensi ilmiah, regulasi nasional, dan dokumen operasional di Apotek Roxy Cabang Sawangan. Selain itu dilakukan penarikan data penjualan produk rantai dingin farmasi selama satu tahun. Analisa data yang diperoleh dilakukan dengan melakukan wawancara lanjutan, pencatatan, dan pengamatan secara langsung. Penelitian menemukan bahwa pengelolaan produk rantai dingin farmasi di Apotek Roxy Cabang Sawangan telah sesuai dengan Cara Distribusi Obat yang Baik (CDOB). Selain itu, diketahui juga bahwa penjualan produk rantai dingin farmasi selama satu tahun didominasi oleh produk insulin. Apoteker memiliki tanggung jawab penuh untuk memastikan seluruh aspek pengelolaan obat di Apotek berjalan dengan benar.

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Drug management is indirectly related to the quality of public health, especially for pharmaceutical cold chain products, which tend to be sensitive to changes during the storage and distribution process. As the closest health service facility to the community, the Roxy Pharmacy Sawangan Branch must consider this management process. Therefore, research is needed to analyze the implementation of product management systems, sales percentage data, and the role of pharmacists in handling pharmaceutical cold chain products at the Roxy Pharmacy, Sawangan Branch.

The research was conducted observationally through a qualitative approach. Observations were made through literature studies based on scientific references, national regulations, and operational documents at the Roxy Pharmacy, Sawangan Branch. In addition, sales data for pharmaceutical cold chain products in the Roxy Pharmacy Sawangan Branch were collected for one year. Analysis of the data obtained was carried out by conducting follow-up interviews, recording, and direct observation. The study found that managing pharmaceutical cold chain products at the Roxy Pharmacy, Sawangan Branch followed Good Drug Distribution Methods (CDOB). In addition, the research found that insulin products dominate sales of pharmaceutical cold chain products for one year. Pharmacists are responsible for ensuring that all aspects of drug management in pharmacies run correctly."

"Pedagang Besar Farmasi (PBF) sangat berperan penting dalam proses pengadaan karena jika di dalam proses pengadaan di PBF tidak berjalan dengan baik maka akan berpengaruh kepada proses distribusi ke tempat pelayanan kefarmasian lainnya sehingga dapat menyebabkan ketersediaan obat di tempat pelayanan kefarmasian sedikit. Pedagang Besar Farmasi merupakan perusahaan yang berbentuk badan hukum yang mimiliki izin pengadaan, penyimpanan, penyaluran obat atau bahan obat dalam jumlah besar sesuai dengan ketentuan perundang-undangan. PBF hanya dapat melaksanakan pengadaan obat dari industri farmasi atau sesama PBF. Namun, tidak semua PBF yang dapat melakukan pengadaan obat secara langsung di industri farmasi. PBF cabang hanya dapat melaksanakan pengadaan obat atau bahan obat dari PBF Pusat saja. Berdasarkan hasil Praktik Kerja Profesi Apoteker di KFTD cabang Bogor yang telah dilakukan oleh peneliti dapat disimpulkan bahwa KFTD cabang Bogor dalam melakukan perencanaan pengadaan didasarkan pada tiga metode antara lain purchase order (PO) atau stock transfer order (STO) kalkulator, forecast (marketing), dan PO outlet atau ID paket. KFTD cabang Bogor membuat surat pesanan berupa purchase order (PO) untuk produk kimia farma dan semua narkotika serta stock transfer order (STO) diperuntukkan produk non-Kimia farma serta pesanan relokasi antar cabang. KFTD cabang Bogor melakukan pengadaan kepada Unit Logistik Sentral (ULS) dan Unit Kerja Logistik (UKL) harus melalui KFTD pusat.

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Pharmaceutical Wholesalers (PBF) play an important role in the procurement process because if the procurement process at PBF does not go well, it will affect the distribution process to other pharmaceutical service locations so that the availability of drugs in pharmaceutical service locations is low. Pharmaceutical Wholesalers are companies in the form of legal entities that have permits to procure, store, distribute drugs or medicinal substances in large quantities in accordance with statutory provisions. PBF can only procure drugs from the pharmaceutical industry or fellow PBFs. However, not all PBFs can procure drugs directly in the pharmaceutical industry. PBF branches can only procure drugs or medicinal ingredients from the central PBF. Based on the results of the Pharmacist Professional Work Practice at the KFTD Bogor branch which has been carried out by researchers, it can be concluded that the KFTD Bogor branch in carrying out procurement planning is based on three methods including purchase orders (PO) or stock transfer orders (STO) calculators, forecasts (marketing), and outlet PO or package ID. KFTD Bogor branch issues orders in the form of purchase orders (PO) for pharmaceutical chemical products and all narcotics as well as stock transfer orders (STO) for non-chemical pharmaceutical products as well as orders for relocation between branches. The KFTD Bogor branch procures to the Central Logistics Unit (ULS) and the Logistics Work Unit (UKL) must go through the central KFTD."