IMPLEMENTASI PENGAWASAN OBAT YANG MENGANDUNG ZAT BERBAHAYA OLEH BADAN PENGAWAS OBAT DAN MAKANAN BAGI PERLINDUNGAN KONSUMEN (ANALISIS KASUS GAGAL GINJAL AKUT PADA ANAK)

Alfian Ramdhan Muta’ally, NIM.: 19103040117 (2023) IMPLEMENTASI PENGAWASAN OBAT YANG MENGANDUNG ZAT BERBAHAYA OLEH BADAN PENGAWAS OBAT DAN MAKANAN BAGI PERLINDUNGAN KONSUMEN (ANALISIS KASUS GAGAL GINJAL AKUT PADA ANAK). Skripsi thesis, UIN SUNAN KALIJAGA YOGYAKARTA.

Preview	Text (IMPLEMENTASI PENGAWASAN OBAT YANG MENGANDUNG ZAT BERBAHAYA OLEH BADAN PENGAWAS OBAT DAN MAKANAN BAGI PERLINDUNGAN KONSUMEN (ANALISIS KASUS GAGAL GINJAL AKUT PADA ANAK)) 19103040117_BAB-I_IV-atau-V_DAFTAR-PUSTAKA.pdf - Published Version Download (3MB) | Preview
	Text (IMPLEMENTASI PENGAWASAN OBAT YANG MENGANDUNG ZAT BERBAHAYA OLEH BADAN PENGAWAS OBAT DAN MAKANAN BAGI PERLINDUNGAN KONSUMEN (ANALISIS KASUS GAGAL GINJAL AKUT PADA ANAK)) 19103040117_BAB-II_sampai_SEBELUM-BAB-TERAKHIR.pdf - Published Version Restricted to Registered users only Download (4MB) | Request a copy

Abstract

In 2022, Indonesia was shocked by cases of acute kidney failure in children. One of the suspected causes of this is because the syrup drugs taken by patients contain contamination of Etylen Glycol and Diethylene Glycol (ED/DEG). The Minister of Health stated that until November cases of Atypical Progressive Acute Kidney Disorder in Children (GGAPA) reached 325 cases, dominated by children aged1-5 years. The implementation of supervision carried out by the Food and Drug Supervisory Agency (BPOM) on medicinal products containing hazardous substances often occurs negligence. Often supervision is not carried out strictly at all times. This case became unrest in the community. Thus, this study will examine the implementation of supervision of drugs containing hazardous substances by BPOM for consumer protection (analysis of cases of acute kidney failure in children). This research is a field research supported by literature studies with a juridical-empirical approach. This research is descriptive analysis, which describes and analyzes the implementation of drug supervision containing hazardous substances by BPOM for consumer protection. Data collection method using interview method with BPOM, observation and documentation in the field. Data processing in the form of interviews is processed through word forms to produce answers and conclusions to this study. The results of this study show that the implementation of drug supervision that causes cases of acute kidney failure in children juridically has not optimally carried out the function of pre-market and post-market drug supervision. This is evidenced by the existence of legal loopholes exploited by the pharmaceutical industry in market supervision of the supply of imported raw materials from abroad, quality control of drug production carried out by the pharmaceutical industry, and lack of coordination with health personnel in post market supervision related to reporting drug side effects . However, the law enforcement carried out by BPOM in an effort to protect consumers is in accordance with applicable laws and regulations. BPOM has cracked down on as many as 6 (six) pharmaceutical industries that produce syrup drugs containing ED/DEG contamination, so that these six industries are given administrative sanctions, in the form of stopping production, distribution, recall) and product destruction and revocation of CPOB Certificate for non-betalactam oral liquid production facilities. Then if it is proven that there are criminal acts from these 6 (six) industries, they can be threatened with crime in accordance with the provisions of applicable laws and regulations.

Share this knowledge with your friends :

Actions (login required)

View Item