Pharmaceutical Law and Ethics

Subject Code : SFA-765

module description
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Module Name Pharmaceutical Law and Ethics
Module Level, if applicable 4th year Types of teaching and learning Teaching, Discussion
Code, if applicable SFA-765 Class size 50
Semester 7th semester Attendance time (hours per week per semester) 2 h
Person responsible for the module Apt. Yulianto, MPH Forms of active participation Discussion
Lecturer(s) Apt. Yulianto, MPH Workload Lecture: 2 (hour) x 14 (meeting) = 28

Preparation and follow up 4 (hour) x 14 (self-learning) = 56
Language English- Indonesia Total workload 84 hours
Relation to curriculum Compulsory course Credit points 2 CU
Requirements according to examination regulations Minimum attendance at lectures is 75% (according to UII regulation). Final score is evaluated based on assignment and reports (40%), mid semester exam (30%), and end semester exam (30%).
Recommended prerequisites Dispensing Pharmacy
Related course –
Study and examination requirements and forms of examination Mid-term, Final term, and Presentation

By the end of this course students should be able to:

  • Explain the laws and regulations and professional code of conduct related to pharmaceutical practices.
  • Analyze the problems of law and ethics in pharmaceutical practices based on the laws and codes of ethics of Indonesian pharmacists.
  • Accept assignments given responsibly in lectures
  • Ask questions and give answers in lecture discussions based on ethical manners

The course will cover: 

  • Introduction to laws and regulations
  • Introduction to professional ethics
  • Legislation in the field of health
  • Legislation in the field of pharmaceutical (production, distribution, service)
  • Pharmaceutical service standards (pharmacies, health centers, hospitals)
  • Indonesian pharmacist code of conduct
  • Indonesian pharmacist competency standards
  • Indonesian pharmacist oath
  • Case study of pharmaceutical etiquette

Text books, slides (power points), and video

  • Is, MH, 2015, Etika dan Hukum Kesehatan, Teori dan Aplikasinya di Indonesia, Kencana
  • Anonim, 1949, Undang-Undang Obat Keras St No. 419, Jakarta
  • Anonim, 1962, Peraturan Pemerintah No. 20 tentang Lafal Sumpah Janji Apoteker, Jakarta
  • Anonim, 1990, Keputusan Menteri Kesehatan No 347 tentang Obat Wajib Apotek, Jakarta
  • Anonim, 1993, Peraturan Menteri Kesehatan No 919 tentang Kriteria Obat yang Dapat Diserahkan Tanpa Resep, Jakarta
  • Anonim, 1997, Undang-Undang No 5 tentang Psikotropika, Jakarta
  • Anonim, 1999, Undang-Undang No 8 tentang Perlindungan Konsumen, Jakarta
  • Anonim, 2005, Peraturanan Menteri Kesehatan No 168 tentang Prekursor Farmasi, Jakarta
  • Anonim, 2008, Peraturanan Menteri Kesehatan No 1120 tentang Perubahan atas
  • Permenkes No 1010/MENKES/PER/XI/2008 tentang Registrasi Obat.
  • Anonim, 2009, Kode Etik Apoteker Indonesia, IAI
  • Anonim, 2009, Undang-Undang No 44 tentang Rumah Sakit, Jakarta
  • Anonim, 2009, Undang-Undang No 35 tentang Narkotika, Jakarta
  • Anonim, 2009, Peraturan Pemerintah No 51 tentang Pekerjaan Kefarmasian, Jakarta
  • Anonim, 2010, Peraturanan Menteri Kesehatan No 1799 tentang Industri Farmasi
  • Anonim, 2011, Peraturanan Menteri Kesehatan No 1148 tentang Pedagang Besar Farmasi, Jakarta
  • Anonim, 2014, Peraturan Menteri Kesehatan No 58 tentang Puskesmas, Jakarta
  • Anonim, 2014, Peraturan Menteri Kesehatan No 9 tentang Klinik, Jakarta
  • Anonim, 2015, Peraturan Menteri Kesehatan No 9 tentang Perubahan Penggolongan Psikotropika, Jakarta
  • Anonim, 2015, Peraturan Menteri Kesehatan No 3 tentang Penyimpanan, Pemusnahan dan Pelaporan Narkotika, Jakarta