√ 13 Jenis Regulasi Obat di Indonesia

Regulasi obat di Indonesia – proses perjalanan obat selalu diawasi dengan teliti mulai dari proses perencanaan, produksi, distribusi, penyimpanan, konsumsi sampai ke monitoring efek samping  obat. Regulasi obat di Indonesia ini diterapkan seperti negara-negara maju di luar negeri yang menerapkan regulasi obat bertujuan untuk mengendalikan peredaran jenis obat di pasaran sehingga meminalisir terjadinya kesalahan pengobatan atau medication error.
Regulasi obat di Indonesia
Regulasi obat di Indonesia
Regulasi obat di Indonesia dibagi menjadi beberapa 3 tipe disesuaikan berdasarkan kriteria masing-masing. Regulasi obat yang pertama dibagi berdasarkan tanda yang ada di kemasan obat, kedua regulasi obat dibagi berdasarkan keamanan penggunaan pada kehamilan dan ketiga regulasi obat berdasarkan golongan kelas terapi. Maka dari itu bagi anda yang diiming-imingi dengan bayaran yang besar untuk mengantarkan obat ilegal atau sebagai kurir nya sebaiknya anda tolak karena jika sampai tertangkap polisi maka anda akan dimasukkan ke dalam penjara. Nah untuk lebih lengkapnya silahkan simak penjelasan tentang macam regulasi obat di Indonesia yang perlu kamu ketahui di bawah ini.
A. Regulasi obat di Indonesia mengatur beredarnya obat dalam 5 kelompok, yaitu :
1. Obat daftar “G” atau dalam bahasa Belanda ‘Gevaarlijk’ yang artinya berbahaya, ditandai dengan dot atau bulatan berwarna merah dengan huruf K di tengahnya.
2. Obat daftar “O” dari kata Opium yaitu golongan opiat yang sangat diawasi oleh pemerintah peredarannya.
3. Obat daftar “W” atau dalam bahasa Belanda ‘Waarcshuwing’ yang artinya peringatan, yaitu obat bebas terbatas, penjualannya dibatasi hanya di Apotek dan toko obat berijin, ditandai dnegan bulatan berwarna biru.
4. Obat daftar “B” atau obat Bebas yang boleh dijual di mana saja, di tandai dengan bulatan berwarna hijau.
5. Obat tradisional di bagi dalam 3 kategori, yaitu :
– Jamu,herbal dalam bentuk simplisia
– Herbal terstandar, bahan bakunya mempunyai standar tertentu
– Fitofarmaka, herbal berstandar yang sudah mengalami uji klinik
Badan POM juga meregulasi bahan lainnya antara lain suplemen makanan seperti vitamin dan mineral, serta pangan fungsional yaitu makanan yang dianggap berfungsi menjaga kesehatan seperti serat, omega 3 dan omega 6. Juga dikenal obat wajib apotek atau disingkat OWA, yaitu obat daftar G yang boleh diberikan oleh Apoteker kepada pasien yang sebelumnya telah mendapatkan obatnya dari Dokter, biasanya untuk penggunaan jangka panjang atau kondisi tertentu.
B. Berdasarkan keamanan penggunaan pada kehamilan, obat dibagi menjadi 5 kategori, yaitu :
6. Kategori A, yaitu studi berpembanding menunjukkan tidak ada resiko yang ditimbulkan.
7.  Kategori B, yaitu studi tidak ada resiko yang terjadi pada manusia.
8. Kategori C, yaitu studi risiko yang tidak dapat disingkirkan.
9. Kategori D, yaitu studi bukti menunjukkan risikonya positif.
10. Kategori X, yaitu studi kontradiksi pada kehamilan.
C. Obat dalam farmasi merupakan obat yang digunakan pada terapi dapat dibagi dalam 3 golongan besar, sebagai berikut :
11. Obat Farmakodinamis, yang bekerja terhadap fungsi organ dengan jalan mempercepat atau memperlambat proses fisiologi atau fungsi biokimia dalam tubuh, misalnya hormon, diuretika, hipnotika, dan obat otonom.
12. Obat Kemoterapeutis, tidak bekerja pada organ tubuh tetapi membunuh parasit dan kuman di dalam tubuh tuan rumahnya. Hendaknya obat ini memiliki kegiatan farmakodinamika yang sekecil-kecilnya terhadap organisme tuan rumah berkhasiat membunuh sebesar – besarnya terhadap sebanyak mungkin parasit (cacing, protozoa) dan mikroorganisme (bakteri dan virus). Obat – obat neoplasma (onkolitika, sitostatika, obat kanker) juga dianggap termasuk golongan ini.
13. Obat Diagnostik, merupakan obat pembantu untuk melakukan diagnosis (pengenalan penyakit), misalnya untuk mengenal penyakit pada saluran lambung – usus digunakan barium sulfat dan untuk saluran empedu digunakan natrium propanoat dan asam iod organik lainnya.
Demikianlah ulasan lengkap pada postingan kali ini mengenai bagaimana regulasi obat di Indonesia, semoga ulasan diatas dapat menambah wawasan anda tentang regulasi obat di Indonesia. Semoga setelah membaca artikel diatas dapat menambah ilmu yang bermanfaat. Jangan lupa share dan nantikan artikel menarik selanjutnya hanya di blog inFarmasi.com.

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