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The pharmaceutical industry cannot be separated from the use of API (Active Pharmaceutical Ingredient) as an active ingredient in the production of medicines that can have an impact on the health of its workers. The purpose of this study was to evaluate the effectiveness of API exposure control in the process of making Dhasolone 5 mg drug tablets using Prednisolone as the active ingredient which belongs to OHC (Occupational Hazard Category) 4 and can cause hormonal disturbances with a decrease in corticotropin. This research is a quantitative analytical survey by taking dust exposure samples from API Prednisolone and laboratory analysis using HPLC-UV (High Performance Liquid Chromatography-Ultra-Violet) according to the BV-2012-25247 method. Another method used in this study also refers to SNI 7235:2009 for sampling of respiratory dust exposure which is analyzed gravimetrically. The population in this study were workers in the process of making Dhasolone 5 mg drug tablets, which included the stages of weighing, sifting, granulating, tablet compression and primary packaging by taking samples of initial personal exposure as many as 15 people. The results of the initial measurement showed that the exposure to Prednisolone in the weighing, sieving, and granulation section had an exposure rating of category 4 (exposure was not well controlled). Then the work process was improved through the installation of an enclosure system (dispensing booth) in the weighing process so that personal exposure measurements were carried out again with the results of this control effectively controlling the risk of exposure to workers from the geometric average (GM) of 100±1.68 g/m3 to 0 ,44±6.72 g/m3. In other processes, exposure control is carried out through administration and Personal Protective Equipment (PPE). Control through PPE is also said to be effective in controlling API exposure by using a PAPR (Powered Air Purifying Respirator) unit which has an APF (Assigned Protection Factor) value of 1,000 above the minimum required APF, which is 250. An assessment of the effectiveness of using PAPR was also carried out using data surrogate, which the measurement data of personal exposure to respirable dust carried out on workers in the sieving, granulation, and tablet compression sections. In general, from the measurement results, control through the use of PAPR is effective in controlling respiratory dust exposure (characteristics are the same as API) with the exposure result being in category 2 which indicates the exposure is well controlled and has a probability of 97.8%. While controlling administratively, there are gaps that need to be improved through the implementation of API hazard communication and socialization related to the procedure.
Metode: Pendekatan penelitian yang digunakan dalam penelitian ini adalah pendekatan kuantitatif. Metode penelitian yang digunakan adalah kombinasi metode kuantitatif dan kualitatif, dengan desain penelitian potong lintang. Teknik sampling yang digunakan dalam penelitian ini adalah proportionate stratified random sampling dengan kriteria inklusi dan eksklusi. Pengolahan data dilakukan dengan analisis univariat, bivariat, dan multivariat dengan interval kepercayaan 95%. Dalam penelitian ini juga dilakukan tes laboratorium untuk memvalidasi dan mendapatkan data kondisi stres biologis pada pekerja melalui pengujian hormon kortisol dari air liur.
Hasil: Seluruh variabel independen memiliki faktor risiko > 1 terhadap variabel dependen. Terdapat hasil yang signifikan dari variabel independen kebisingan, lama kerja, umur, riwayat keturunan hipertensi, aktivitas fisik, penggunaan APT, indeks massa tubuh, dan kadar hormon kortisol terhadap hipertensi, melalui pengujian secara statistik dengan p value < 0.05. Sedangkan, untuk variabel perilaku merokok dan konsumsi alkohol memiliki p value > 0.05. Kebisingan sebagai variabel utama memiliki OR 19.067 melalui uji multivariat, setelah dilakukan kontrol oleh variabel perancu lama kerja, riwayat keturunan hipertensi, aktivitas fisik, penggunaan APT, dan indeks massa tubuh terhadap hipertensi.
Kesimpulan: Pekerja yang terpapar kebisingan berisiko untuk mengalami hipertensi. Pekerja yang memiliki lama kerja lebih dari lima tahun, tidak melakukan aktivitas fisik, tidak menggunakan APT, dan memiliki indeks massa tubuh yang tidak normal berisiko lebih besar untuk mengalami hipertensi.
Kata kunci: Farmasi, Hipertensi, Hormon Kortisol, Industri, Kebisingan
Penyelenggaraan Fraksionasi Plasma merupakan salah satu kebijakan yang dilakukan Pemerintah Indonesia dalam rangka memenuhi akses masyarakat terhadap Produk Obat Derivat Plasma (PODP). Sebagaimana diketahui sampai saat ini kesediaan PODP di Indonesia masih 100% impor, hal tersebut menyebabkan PODP masih sulit di akses masyarakat. Permenkes No. 4 tahun 2023 tentang Penyelenggaraan Fraksionasi Plasma merupakan revisi kedua dari peraturan sebelumnya, dimana tidak adanya implementasi yang dicapai pada peraturan-peraturan sebelumnya. Pentingnya melakukan analisis kesiapan kebijakan ini diharapkan dapat memberikan informasi terkait faktor yang berdampak positif dan negatif serta mampu memberikan rekomendasi kepada para pemangku kepentingan agar pelaksanaan implementasi kebijakan penyelenggaraan fraksionasi plasma dapat berjalan dengan baik dan sesuai dengan target waktu yang ditetapkan. Faktor yang mempengaruhi dari implementasi penyelenggaraan fraksionasi plasma tersebut antara lain terkait tata kelola, sistem informasi, teknologi, pembiayaan, sumber daya manusia, layanan, dan politik yang didapati dapat memberikan dampak terhadap keberhasilan implementasi penyelenggaraan fraksionasi plasma lokal sehingga mampu menciptakan kemandirian farmasi dalam rangka mewujudkan pilar ketahanan kesehatan dalam transformasi kesehatan di Indonesia. Kata kunci: Fraksionasi plasma, obat derivat plasma, farmasi
Implementing Plasma Fractionation is one of the policies carried out by the Government of Indonesia to fulfill public access to Plasma Derivative Medicinal Products (PDMPs). As is well known now, PDMPs readiness in Indonesia is still 100% imported, which causes PDMPs to be difficult for the public to access. Permenkes No. 4/2023 concerning the Implementation of Plasma Fractionation is the second revision of the previous regulation, where implementation has yet to be achieved in the previous regulations. The importance of conducting a policy readiness analysis is expected to provide information regarding factors that have positive and negative impacts and to be able to provide recommendations to stakeholders so that the plasma fractionation implementation policy can run well and in accordance with the set time targets. Factors that influence the implementation of plasma fractionation include governance, information systems, technology, financing, human resources, services, and politics, which are found to have an impact on the successful implementation of local plasma fractionation to create pharmaceutical independence in order to realize pillar of health resilience in health transformation in Indonesia. Key words: Plasma fractionation, derivate plasma, pharmaceutical
Kata kunci : resep elektronik, e-resep, resep online, pelayanan farmasi, rumahsakit.
