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Tanggung Jawab Hukum Administrasi Apotek Terhadap Penjualan Obat Keras Tanpa Resep Dokter Di Kabupaten Lebak Merujuk Pada Permenkes Nomor 9 Tahun 2017 Tentang Apotek

Septianingsih, Epi (2024) Tanggung Jawab Hukum Administrasi Apotek Terhadap Penjualan Obat Keras Tanpa Resep Dokter Di Kabupaten Lebak Merujuk Pada Permenkes Nomor 9 Tahun 2017 Tentang Apotek. Master thesis, UNIVERSITAS SULTAN AGENG TIRTAYASA.

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Abstract

This research aims to determine legal measures against the sale of potent drugs without a doctor's prescription in Lebak Regency referring to Minister of Health Regulation Number. 9 of 2017 concerning Pharmacies. This research was motivated by the problem that pharmacists' practices were reported negatively by several media in Indonesia. This research study aims to find out what the legal responsibilities are for pharmacies that sell hard drugs without a doctor's prescription, as well as how supervision is carried out by the Food and Drug Monitoring Agency (BPOM) for hard drugs that have a distribution permit. Through a statutory approach and a sociological approach, problems can be studied in depth. Then all the data in this research was analyzed qualitatively. Based on the results of the legal basis analysis, it can be stated that the sale of hard drugs without a doctor's prescription is a legal violation in accordance with Article 8 Paragraph (1) Letter (d) of the Consumer Protection Law Number 8 of 1999, so that consumers who are harmed are in accordance with Article 45 Consumer Protection Law Number 8 of 1999 can sue for compensation either through the court or outside the court, namely through the Consumer Dispute Resolution Agency. This is a form of repressive legal protection, while preventive legal protection can be through ICE (Information Communication and Education) and outreach to the community. Meanwhile, the punishment that pharmacies receive in accordance with article 32 of Minister of Health Regulation No. 9 of 2017 are administrative sanctions starting from written warnings, temporary suspension of activities to revocation of SIA. BPOM's supervision of pharmacies in Lebak district takes the form of monitoring, providing guidance and coaching on the management of pharmaceutical preparations in government agencies and the community. It is felt that the role and function of BPOM is not optimal, so the practice of selling hard drugs in several pharmacies still occurs frequently. Consumers should bring a doctor's prescription when buying hard drugs at the pharmacy. Pharmacists on duty should be more careful and more thorough in serving consumers who buy drugs in the hard drugs category. The Health Service should periodically check sales of hard drugs carried out by pharmacies spread across Lebak district.

Item Type: Thesis (Master)
Contributors:
ContributionContributorsNIP/NIM
Thesis advisorMuin, Fatkhul198311282009121002
Thesis advisorikomatussuniah, ikomatussuniah198002242014042001
Additional Information: Penelitian ini bertujuan untuk mengetahui upaya hukum terhadap penjualan obat keras tanpa resep dokter di Kabupaten Lebak merujuk pada Permenkes No 9 tahun 2017 tentang Apotek. Penelitian ini dilatarbelakangi oleh adanya permasalahan bahwa praktik Apoteker diberitakan negatif oleh beberapa media di Indonesia. Kajian penelitian ini bertujuan untuk mengetahui bagaimana tanggung jawab hukum administrasi bagi Apotek yang menjual obat keras tanpa resep dokter, serta bagaimana pengawasan yang dilakukan oleh Badan Pengawasan Obat-Obatan dan Makanan (BPOM) terhadap obat keras yang memiliki izin edar. Melalui pendekatan Undang-Undang (Statute Approach) dan pendekatan sosiologis (Sosiologic Approach), permasalahan dapat dikaji secara mendalam. Kemudian keseluruhan data dalam penelitian ini dianalisis secara kualitatif. Berdasarkan hasil analisa dasar hukum dapat dinyatakan bahwa penjualan obat keras tanpa resep dokter merupakan suatu pelanggaran hukum sesuai dengan Pasal 8 Ayat (1) Huruf (d) Undang-Undang Perlindungan Konsumen Nomor 8 Tahun 1999, sehingga bagi konsumen yang dirugikan, sesuai dengan Pasal 45 Undang-Undang Perlindungan Konsumen Nomor 8 Tahun 1999 dapat menggugat ganti rugi baik melalui lembaga pengadilan maupun di luar pengadilan yaitu melalui Badan Penyelesaian Sengketa Konsumen. Hal ini merupakan bentuk dari perlindungan hukum represif sedangkan perlindungan hukum preventif dapat melalui KIE (Komunikasi Informasi dan Edukasi) serta sosialisasi kepada masyarakat. Sementara sakni yang didapat Apotek sesuai Pasal 32 Permenkes No 9 tahun 2017 adalah sanksi administratif dimulai peringatan tertulis, penghentian sementara kegiatan hingga pencabutan SIA. Pengawasan yang dilakukan BPOM terhadap apotek di kabupaten Lebak berupa pemantauan, pemberian bimbingan, dan pembinaan terhadap pengelolaan sediaan farmasi di instansi pemerintah dan masyarakat. Peran dan fungsi BPOM dirasa belum maksimal, sehingga praktik penjualan obat keras di beberapa apotek masih kerap terjadi. Konsumen sebaiknya membawa resep dokter saat membeli obat keras ke apotek. Apoteker yang bertugas sebaiknya lebih berhati-hati dan lebih teliti dalam melayani konsumen yang membeli obat kategori obat keras. Dinas Kesehatan, sebaiknya melakukan pengecekan penjualan obat keras yang dilakukan apotek yang tersebar di kabupaten Lebak secara berkala.
Uncontrolled Keywords: Responsibility, Law, Pharmacy Tanggung Jawab, Hukum, Apotek
Subjects: K Law > K Law (General)
Divisions: 08-Pascasarjana > 74101-Magister Ilmu Hukum
08-Pascasarjana
Depositing User: epi septianingsih
Date Deposited: 23 Feb 2024 09:24
Last Modified: 23 Feb 2024 09:24
URI: http://eprints.untirta.ac.id/id/eprint/33340

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