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Eruditio : Indonesia Journal of Food and Drug Safety

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Published by Badan Pengawas Obat dan Makanan

ISSN : 27472493 EISSN : 28076222 DOI : https://doi.org/10.54384

Core Subject : Health, Science, Agriculture,

Agriculture, Biological Sciences & Forestry Biochemistry, Genetics & Molecular Biology Chemistry Medicine & Pharmacology Public Health

Eruditio : Indonesia Journal of Food and Drug Safety adalah jurnal yang diterbitkan oleh Pusat Pengembangan Sumber Daya Manusia Pengawasan Obat dan Makanan (PPSDM POM), Indonesia. Jurnal ini memuat hasil kajian dan kajian literatur di bidang keamanan Obat dan Makanan.

Arjuna Subject : Pharmacology, Toxicology and Pharmaceutics - Ilmu Farmasi

Articles 65 Documents

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Profil Aktivitas Enzim Diastase pada Madu Produksi UMKM Lokal Berdasarkan Hasil Uji BPOM di Jambi Desmita Adriani Syamsu; Ratnawita; Ayu Pratiwi Ayu; Agung Darmawati
Eruditio : Indonesia Journal of Food and Drug Safety Vol 3 No 1 (2022): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Honey is a healthy product often sought after during the Covid-19 pandemic. This is one factor that increases the number of honeys produced by SMEs. During 2019-2021, there was an increase in the number of requests for honey sample testing by business actors at the food chemical testing laboratory at the Indonesia FDA Provincial Office in Jambi. This study aims to determine honey's quality profile by testing the diastase enzyme's activity using a UV-Vis Spectrophotometer. This research is a retrospective experimental analysis to provide an overview of test results related to honey quality by observing the diastase enzyme's activity in honey. The test data were processed using SPSS 16 to determine the percentage of samples that met the requirements (MS) and did not meet the requirements (TMS). Then the data were analyzed by quantitative descriptive using a histogram comparison between honey samples with MS and TMS in 2019-2021. According to the Indonesian National Standard (SNI)-8664:2018, good honey has a diastase enzyme activity of at least 3 Diastase numbers (DN). A total of 84 samples tested showed that 78.6% is MS with diastase enzyme activity between 3 DN to 28 DN, and 21.4% is TMS. However, based on the data, it is known that the number of TMS samples has decreased. Strengthening cooperation between Indonesia FDA Provincial Office POM in Jambi and stakeholders is important to assist local honey businesses in improving the quality of their products. It includes assisting the honey harvesting process and controlling the temperature and pH of the environment to maintain the content of enzymes, vitamins, and minerals.

Peredaran Vitamin C Injeksi Ilegal di Indonesia Dewa Gede Bayu Rastika; Neti Triwinanti; Muhammad Gafur Salaffudin
Eruditio : Indonesia Journal of Food and Drug Safety Vol 2 No 2 (2022): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Vitamin C has various benefits for both health and beauty. The high demand for vitamin C, especially the injection type, raises the crime potential where some individuals distribute illegal vitamin C injections. In Indonesia, vitamin C injection is categorized as a prescription drug used to treat vitamin C deficiency, and some countries have banned the use of it as a whitening agent. Illegal vitamin C injection distribution risks public health because its safety, efficacy, and quality aren’t guaranteed. This paper aims to identify types of illegal vitamin C injections circulating in Indonesia, map the distribution of illegal vitamin C injections, including the modus operandi used, and formulate recommendations to prevent its distribution in Indonesia. This research was conducted using a qualitative method with a narrative approach as well as primary and secondary data collection. As a result, some brands of illegal vitamin C injections circulating in Indonesia are Bionic White Skin, Neutro Skin, Vitamin C + Collagen, VC Injection, and Vitamin C Daehan New Pharm. According to the laboratory test, the level of vitamin C from 3 of 4 illegal vitamin C injections doesn’t meet the requirement, indicating low product quality and a chance of product counterfeiting. Some modus operandi by criminals found are sales through e-commerce, beauty clinics, and exhibitions. Influencers also have an important role in the decision made by society to use illegal vitamin C injections. Therefore, it is recommended to strengthen supervision, including cyber patrols, raising awareness, tracing distribution facilities, and collaboration by various stakeholders to prevent the circulation of illegal vitamin C injections in Indonesia.

EfeEfektivitas Pengawasan Pangan Fortifikasi oleh Badan POM sebagai Intervensi Penurunan Stunting di Provinsi Lampungktivitas Pengawasan Pangan Fortifikasi Oleh Badan POM Sebagai Intervensi Penurunan Stunting Di Propinsi Lampung Yulia Rahmawati
Eruditio : Indonesia Journal of Food and Drug Safety Vol 3 No 1 (2022): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Stunting is a national development problem because stunting has an impact on the decline in the quality of Indonesian people. Efforts to accelerate stunting reduction include specific nutrition and sensitive nutrition interventions. Consumption of fortified food is part of a sensitive nutrition intervention. This paper aims to see the effectiveness of fortified food supervision carried out by the Indonesian FDA Provincial Office in Bandar Lampung. The methodology used is to analyze the data obtained from the results of the supervision of the Indonesian FDA Provincial Office in Bandar Lampung in 2018-2021 with the stages of collecting test data for samples of fortified food products in 2018-2021 for consumption of iodized salt and wheat flour and cooking palm oil; calculate the percentage comparison of the test results for fortified food product samples that meet the requirements (MS) with those that do not meet the requirements (TMS); analyze the data obtained by looking at the increase or decrease in the test results that meet the requirements (MS) with those that do not meet the requirements (TMS). The testing results for fortified food products such as iodized salt, wheat flour, and cooking oil have increased for products with MS every year. A product is said to meet the requirements if it meets the standards and requirements for safety, efficacy/benefits, and product quality. This result indicates the success of the supervision carried out by the Indonesian FDA Provincial Office in Bandar Lampung. Supervising the Indonesian FDA's fortification food as a stunting intervention in Lampung Province is effective.

Analisis Kuantitatif Tar dan Nikotin Terhadap Rokok Kretek Yang Beredar di Indonesia: Analisis Kuantitatif Tar dan Nikotin Terhadap Rokok Kretek yang Beredar di Indonesia Relita Florentika; Widiyanto Kurniawan
Eruditio : Indonesia Journal of Food and Drug Safety Vol 2 No 2 (2022): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Tar and nicotine are substances contained in cigarettes, which are harmful to health and causes addiction. Nicotine can paralyze the brain and taste, increase adrenaline hormone which affects the heart to beat faster and work harder. Nicotine in respiration system can be rapidly absorbed from the lungs into the blood. The perilous effect of nicotine and tar is stimulating the formation of cancer cells. Based on regulation, tar and nicotine content must be listed on cigarette packages, so people can easily discover it. Aim of this research was to know the tar and nicotine content of kretek cigarettes sold in Indonesia. Sample of this research using cigarettes taken from Yogyakarta, Mamuju, Pontianak, Kupang, Palembang, Manokwari, Sofifi, Jambi, Palangkaraya, Jakarta, Pekanbaru, Palu, Pangkalpinang, Jayapura, Banjarmasin, Kendari, Ambon, Batam, Padang, Mataram and Denpasar. This research is expected to provide general information to the public regarding the suitability and correctness of the nicotine and tar content of cigarettes shown on the packaging. Tar and nicotine content are determined by gas chromatography on the total particulate matter (TPM) obtained from the smoking process using a smoking machine. Result showed that nicotine content was 57,00-152,00% and two brands contained nicotine more than requirement (maximum 120,00%). The tar content ranged from 48,67-151,95% and two brands contained nicotine more than 120,00% of the packaging label.

Karakterisasi dan Uji Kemurnian Klobazam secara Kromatografi Cair Kinerja Tinggi Sebagai Baku Pembanding Farmakope Indonesia Endah Kristiana; Widya Sagita Br. Tampubolon; Atiek Supardiati E. S
Eruditio : Indonesia Journal of Food and Drug Safety Vol 2 No 2 (2022): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Clobazam is a drug with the chemical name 7‐chloro‐1‐methyl‐5‐phenyl‐1,5‐benzodiazepine, which is used to treat various types of epilepsy. Clobazam works on the brain and central nervous system to provide a calming effect. To maximize the therapeutic effect and reduce the drug's toxic effect, it is necessary to test to determine the levels in the sample of clobazam that fulfilled requirements. One way to control drugs is to strengthen the capacity and capability of testing by developing reference standards. The more reference standards developed, the more drug samples can be tested. The development of reference standards is aimed at producing the “Baku Pembanding Farmakope Indonesia (BPFI)” which can be used for qualitative and quantitative testing of clobazam samples. This test aims to produce the clobazam “Baku Pembanding Farmakope Indonesia (BPFI)” which fulfilled the characterization and purity requirements as a reference standard. Characterization was achieved by infrared spectroscopy with the wave number results showed aromatic C=C functional groups (1490.97 cm-1), C=O cyclic ketones (1670.35 and 1691.57 cm-1), and C-N amines (1330.88 and 1375.25 cm-1), UV-Vis spectroscopy results showed a wavelength of 230.5 nm, gas chromatography-mass spectroscopy results showed the main ion (m/z) of clobazam was 207 (C13H4NO2); 255.1 (C15H11ClN2); 257.1 (C14H9ClN2O); 258.1 (C14H10ClN2O); and 300 (C15H7ClN2O2), and 1HNMR, 13CNMR, HMQC, and HMBC spectroscopy which showed that the raw material was clobazam. The purity of clobazam was measured using HPLC-DAD and obtained a purity index of 1.0000 and a purity of 99.73% (n=20, SD= 0.01%, RSD=0.01%), and by DSC obtained a purity of 99, 33% and a melting point of 180.55oC. All validation parameters of the HPLC analysis method were specificity/selectivity, system-appropriate test (RSD = 0.05%), linearity (R = 0.9997) with a range of 0.015% to 0.045%, accuracy 0.19%, and precision 0, 01% have fulfilled the requirements. The characterization results of clobazam and determination of purity value can be used as “Baku Pembanding Farmakope Indonesia (BPFI)” and used in qualitative and quantitative tests by all Indonesia FDA provincial offices and stakeholder ABG (Academic, Business, government).

New Public Service Sebagai Paradigma Administrasi Publik Pengawasan Obat dan Makanan Alexander Arie Sanata Dharma
Eruditio : Indonesia Journal of Food and Drug Safety Vol 3 No 1 (2022): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Indonesia's administration experienced big-bang decentralization during the reform period, with its major milestone being Regional Autonomy. One of the follow-ups to the Law is establishing several Non-Departmental Government Agencies in 2001, one of which is the Indonesian Food and Drug Authority (BPOM). BPOM is a central agency with apparatuses in 33 provincial capitals and 40 districts/cities. Road Map of Bureaucratic Reform 2020-2024 mentions that Indonesia manages three paradigms of public administration in parallel, ranging from Weberian to New Public Service. NPS comes as a criticism of the Old Public Administration and New Public Management, whose primary focus is citizens. This research uses a qualitative approach to place NPS in drug and food surveillance in Indonesia, whose function is run by BPOM. NPS consists of 7 main principles, and each has conformity with the implementation of drug and food supervision in Indonesia. The circulation of commodities such as Drugs cannot be viewed as limited to NPM considering that in addition to BPOM as a service provider and the pharmaceutical industry as a service recipient, there are also people who will directly impact drugs and food circulating in Indonesia. Based on this conformity, it is recommended that BPOM emphasize the significance of the NPS paradigm as a public administration perspective embraced by the organization and contain it on organizational documents so that stakeholders understand BPOM's performing patterns and the concurrent public administration paradigm.

A System Dynamics Model to Enhance the Indonesian Food and Drug Authority's Approach to Reduce Unauthorized Drug Sales in West Sumatra Province Putra Gusrianto; Yos Sunitiyoso
Eruditio : Indonesia Journal of Food and Drug Safety Vol 3 No 1 (2022): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Indonesia has a high rate of violation of prescription drug sales by unauthorized facilities such as drug stores, retail stores, as well as by doctors and other health professionals. Based on Government Regulation No. 51 of 2009 on Pharmacy Profession, prescription drugs, psychotropics, and narcotics cannot be obtained freely. These drugs can only be obtained with a doctor's prescription and are administered by a pharmacist. Inappropriate prescription drug sales result in drug misuse and irrational use, reducing the quality of drug therapy, increasing morbidity and mortality, wasting resources, reducing drug availability, increasing costs, increasing the risk of side effects, and accelerating the emergence of antimicrobial drug resistance. Between 2018 and 2020, the number of criminal cases handled by the Indonesian FDA (BPOM) related to this issue increased from 8.94% to 14.48%, and the number of violations increased from 39.85% to 68.35% in the Province of West Sumatra. Prescription drug sales violations are complicated, as it involves many factors/variables and parties. This study intends to produce recommendations for reducing violations associated with the sale of prescription drug in West Sumatra Province. This study applied a system dynamic approach to analyze and simulate the variables affecting the sale of prescription drugs at unauthorized facilities. As a result, 31 factors were discovered and 10 scenarios were simulated, showing that the pharmacist's role has a significant impact on the system. Increased public perception and understanding, pharmacists’ and other health workers' responsibilities, and legal enforcement are variables that must be intervened to reduce these violations.

Determinan Efektivitas Program Komunikasi, Informasi, Edukasi Obat dan Makanan Saat Pandemi Covid-19 Nurvika Widyaningrum; Made Widdi Ellinda Patra
Eruditio : Indonesia Journal of Food and Drug Safety Vol 2 No 2 (2022): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Consumption of medicines, health supplements, and traditional medicines has increased during the Covid-19 pandemic. People with health complaints prefer self-medication rather than outpatient treatment. The risk of self-medication needs to be balanced with the knowledge and people’s ability to choose safe medicinal products, health supplements, and traditional medicines. FDA (BPOM) increases public awareness related to the safety of drugs and food through an effective Communication, Information, and Education (CIE) program. Demographic factors can influence the awareness level, including knowledge, attitudes, and behavior. This study aims to determine the association between demographic factors and the effectiveness of CIE during the Covid-19 pandemic. The research uses quantitative methods—data collection through online questionnaires. As many as 39,398 respondents were selected through purposive sampling from the CIE audience population throughout Indonesia from June 2020 to June 2021. Data were analyzed using the ANOVA test with SPSS 16 at a significance level of 0.05. The results showed that the CIE effectiveness index was 92.61 (very effective). Demographic factors, namely occupation and education, influence the CIE effectiveness index, but gender and age had no influence. Demographic factors also influence the index of the indicator. Occupation, education, and age are also related to the media variety index. Occupation and education are also associated with the understanding index, age-related to the benefit index, and work, education, and age affect the interest index. The effectiveness of CIE during the Covid-19 pandemic is influenced by demographic factors, namely work, and education. BPOM needs to plan the CIE program by considering demographic characteristics, including education, occupation, and age of the CIE target audience so that the CIE program can be effective.

Kajian Pencantuman Keterangan Kedaluwarsa pada Label Pangan Olahan Dyah Setyowati; Lies Sugiarti
Eruditio : Indonesia Journal of Food and Drug Safety Vol 3 No 1 (2022): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Expiration date is one of the information that is mandatory to be included on the processed food label. Indonesia regulates the inclusion of expiration dates with the term "best before". One of the current world topics is food waste due to differences in understanding and inclusion of expiration date. This research aims to obtain information regarding the provisions for the inclusion of expiration date in various countries and the level of public understanding of the expiration date term. The method carried out in this research are literature study by comparing the provisions on expiration date in different countries and survey with a questionnaire. The respondents in this study were 231 respondents consisting of 78 men (33.8%) and 153 women (66.2%). Expiration date provisions or regulations still vary in various countries. Europe and Australia have separated provisions for expiration date information based on safety (use by date) and quality (best before date), while Singapore and the United States of America have not separated provisions for the inclusion of expiration date. Based on the results of a random survey using a questionnaire (google form) within 1 week, 115 respondents (49.8%) were unable to distinguish the various expiration date terms. Respondents who understood the expiration date mostly came from respondents with education levels of S1, S2 and S3 i.e. 57%, 64.7%, and 60% respectively while other education levels were less than 40%. This shows that education level correlates with the level of understanding of the respondent.

Identifikasi dan Karakterisasi Tanaman Kratom melalui Pendekatan Profil Kandungan Senyawa Penanda secara LC-HRMS QToF dan Penetapan Nilai Retention Index secara GCMS Farida Kurniawati; Dona Fitria; Aan Risma Uli Nainggolan; Puspita Ayu Wardani
Eruditio : Indonesia Journal of Food and Drug Safety Vol 3 No 1 (2022): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Kratom is illegally used in traditional medicine and health supplement products. Thus, the analytical method development is needed to identify its presence in final products. Currently, the availability of its markers is limited due to it belongs to restricted substance in Indonesia. The research was conducted to produce alternative analytical method without the use of reference standard. In addition, the research was developed by biomarker profiling approach using mass spectrometer. Mass spectrometry was performed using either gas chromatography or liquid chromatography-high resolution mass spectrometry (LC-HRMS). Both systems were developed to confirm the presence of kratom. A mass spectrometry test was carried out after the marker compounds were extracted from the leaves. The gas chromatography test was carried out using selected ion monitoring (SIM) mode at m/z 214, 397, 383, and 269. The LC-HRMS chromatography system used 0.1 % formic acid as an ion modifier. The analysis was carried out using a quadrupole time of flight (QToF) mass spectrometer as a mass analyzer with electrospray ionization (ESI) in positive mode, running in scan mode analysis. Qualitative analysis was carried out using retention time (Rt) data and ionic fragments of kratom marker compounds. There were three marker compounds obtained, namely speciociliatine, speciogynine, and mitragynine. Specificity test was carried out by identifying their retention time, followed by the determination of their Retention Index (RI) value by GCMS. In addition, m/z value of the marker compounds were confirmed by LC-HRMS QToF. The results showed that three main marker compounds can be used in the identification of kratom adulteration in traditional medicines. This method can be applied as a confirmation test of kratom adulteration in traditional medicine where the LC-HRMS QToF method is more sensitive than GCMS and TLC with LOD values of 149.2 µg/g and 67.6 mg/g respectively after extracted and isolated by TLC.

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Home Page

OAI Link

Editorial Team

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Reviewer

Google Scholar

Contact Name Listia Ningsih

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Phone +6281395105898

Journal Mail Official eruditi@pom.go.id

Editorial Address Gedung Batik Lt.5 - Badan POM Jl. Percetakan Negara No. 23 Kel. Johar Baru, Kec. Johar Baru, Jakarta Pusat 10560

Location Kota adm. jakarta pusat, Dki jakarta INDONESIA

Abstract

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Abstract

Contact Name
Listia Ningsih

Contact Email
listia.n@pom.go.id

Phone
+6281395105898

Journal Mail Official
eruditi@pom.go.id

Editorial Address
Gedung Batik Lt.5 - Badan POM Jl. Percetakan Negara No. 23 Kel. Johar Baru, Kec. Johar Baru, Jakarta Pusat 10560

Location
Kota adm. jakarta pusat,

Dki jakarta

INDONESIA