Drug Authority Research Articles

Abstract B006: Qualitative research study on the use of minimal residual disease as an intermediate endpoint in multiple myeloma clinical trials in Saudi Arabia

Abstract Introduction: The U.S. Food and Drug Administration has recently considered minimal residual disease (MRD) as an acceptable accelerated approval endpoint in multiple myeloma (MM). Meta-analysis studies have shown the clinical benefit of MRD negativity in certain hematological cancers such as MM. Objectives: This qualitative research study, with a unique focus on the Saudi context, aims to assess the opinions and experiences of hematology and oncology specialists and consultants in Saudi Arabia. The study is particularly interested in their views on the use of MRD as an intermediate endpoint in early-phase clinical trials for fast-track drug approval by the Saudi Food and Drug Authority in the context of multiple myeloma. This includes assessing the use of MRD in both newly diagnosed and relapsed/refractory MM. The secondary objective is to gather information about the feasibility and availability of sensitive MRD detection methods in real-world medical practice and clinical trials in Saudi Arabia. Study Design: The study will involve interviewing 30 registered male or female physicians specialized in hematology and oncology in Saudi Arabia. The physicians will be included in the study using purposive sampling methods. The study will collect the physicians’ opinions and experiences about MRD. The interviews will be conducted through a single focus group and several face-to- face interviews or performed online, using ZOOM. Participants should have more than one year of experience post-residency or post-fellowship training. The predetermined set of semi- structured questions will cover topics such as the definition of MRD, its clinical and research significance, MRD detection thresholds, duration of MRD negativity, and its correlation with other clinical endpoints, such as progression-free survival and overall survival. The interviews will be conducted by scientific oncology and hematology evaluation experts at the Saudi Food and Drug Authority, who play a crucial role in this study. The study will consist of 5–10 semi- structured one-to-one interviews and focused group discussions of as few as four participants. Before starting any interview, participants will complete consent forms, including the study’s goals and who will conduct the study. Qualitative data will be prepared and analyzed by an expert in data analysis, ensuring the highest research standards. The results will be presented using descriptive and interpretive methods. Citation Format: Albandari A Alnasser, Tariq H Alqurayshah. Qualitative research study on the use of minimal residual disease as an intermediate endpoint in multiple myeloma clinical trials in Saudi Arabia [abstract]. In: Proceedings of the AACR Special Conference: Liquid Biopsy: From Discovery to Clinical Implementation; 2024 Nov 13-16; San Diego, CA. Philadelphia (PA): AACR; Clin Cancer Res 2024;30(21_Suppl):Abstract nr B006.

Abstract B007: A qualitative research study on hematology and oncology consultants’ experiences and opinions on using minimal residual disease (MRD) as a fast-track approval endpoint in early-phase clinical trials in multiple myeloma in Saudi Arabia

Abstract Introduction: The U.S. Food and Drug Administration recently considered the minimal residual disease (MRD) as an acceptable accelerated approval endpoint in multiple myeloma (MM). The data from the meta-analysis studies established the clinical benefit of MRD negativity in certain hematological cancers such as MM. Objectives: The primary objective of this qualitative research study is to assess hematology and oncology consultants’ opinions and experiences on the adequacy of using minimal residual disease (MRD) as an intermediate endpoint in early- phase clinical trials in multiple myeloma (MM) for fast-track approval of drugs and biological products in the Saudi Food and Drug Authority. That may include using MRD in MM in both settings: newly diagnosed and relapsed/refractory MM. The secondary objective is to gather information about the feasibility and availability of sensitive methods for detecting MRD in the context of real-world medical practice and clinical trials in Saudi Arabia. Study Design: The study design is a qualitative approach to interviewing 30 registered male, or female physicians specialized in hematology and oncology in Saudi Arabia. The interviews will be conducted in two ways: a single focus group and several face-to-face interviews. The participants should have more than 1 year of experience post-fellowship training. The participants will be invited for an interview via email or phone. A predetermined set of semi-structured questions is to be asked in the same order to each participant. The topic of questions will include the definition of MRD, clinical and research significance of MRD, MRD detection thresholds (e.g., 10^-5 vs. 10^-6), duration of MRD negativity at the complete response, correlation with other clinical endpoints such as progression-free survival (PFS) and overall survival (OS). The interviews will be conducted by scientific oncology and hematology evaluation experts at the Saudi Food and Drug Authority who have considerable experience in engaging in personal discussion. This qualitative study has about 5–10 semi-structured one-to-one interviews of hematology and oncology consultants performed at a convenient time for each doctor. Moreover, the discussions in focus groups can be as small as four participants. Qualitative data will be prepared and analyzed by an expert in data analysis. Citation Format: Tariq Hassan Alqurayshah, Albandari Alnasser, Tariq Alqurayshah. A qualitative research study on hematology and oncology consultants’ experiences and opinions on using minimal residual disease (MRD) as a fast-track approval endpoint in early-phase clinical trials in multiple myeloma in Saudi Arabia [abstract]. In: Proceedings of the AACR Special Conference: Liquid Biopsy: From Discovery to Clinical Implementation; 2024 Nov 13-16; San Diego, CA. Philadelphia (PA): AACR; Clin Cancer Res 2024;30(21_Suppl):Abstract nr B007.

Budget impact analysis of subcutaneous infliximab (CT-P13 SC) for treating inflammatory bowel disease in Saudi Arabia: Analysis from payer perspective

Background The Saudi Food and Drug Authority (SFDA) has approved the subcutaneous (SC) administration of infliximab, presenting a more convenient alternative with reduced outpatient visits and diminished expenses compared to the intravenous (IV) administration. However, the financial implications of this formulation have not been examined from the perspective of Saudi payers. Methods and materials A prevalence-based budget impact model was developed to evaluate the financial effects of introducing "environment without" versus "with infliximab SC." The model’s time horizon spanned over 2 years (2021–2023), aligning with the biennial national pharmaceutical procurement cycle. The comparison focused on infliximab SC versus all available formulations of infliximab IV in the Saudi market for two inflammatory bowel diseases (IBD): Ulcerative Colitis (UC) and Crohn’s Disease (CD). Treatment comparators’ comparability and dose escalations were substantiated by published studies, utilizing dosing information from the summary of product characteristics. Drug acquisition costs were derived from SFDA registered prices, with IV formulation administration costs included. Scenario analysis assessed the budget impact of infliximab SC introduction at uptake rates ranging from 0% to 100%. Results Introducing infliximab SC demonstrated cost-saving potential in the treatment of IBD. At 100% uptake with UC patients for 2 years, infliximab SC resulted in savings of -SAR-31.9 million (-SAR29,145 per patient). Similarly, for CD, introducing infliximab SC at 100% uptake over 2 years yielded savings of -SAR106.2 million (-SAR36,585 per patient). Conclusion This study reveals that infliximab SC is associated with cost-saving potential when compared to infliximab IV formulations available in Saudi Arabia. Future research should address uncertainties related to real-world comparative effectiveness, the convenience of administration, patient tolerability, and physician acceptance of the SC formulation of infliximab, alongside comparisons with other TNF-alpha inhibitors.

Titanium dioxide (TiO2) in herbal and health products registered by Saudi Food and Drug Authority (SFDA): a descriptive study

Titanium dioxide (TiO2) in herbal and health products registered by Saudi Food and Drug Authority (SFDA): a descriptive study

An Assessment of the Prevalence of Aflatoxin M1 Level in Milk and Milk Powder based on High Performance Liquid Chromatography and Dietary Risk Assessment

Milk is susceptible to Aflatoxin M1 (AFM1) contamination, mainly through consumption of contaminated animal's feed. The natural occurrence of aflatoxin M1 (AFB1) has been surveyed in samples of milk and milk powder. Samples collected from different regions of Saudi Arabia during the period from 2013 to 2021 were subjected to high-performance liquid chromatography analysis, and (AFB1) was quantified with detection limits of 0.5µg/kg. The Saudi Food and Drug Authority has taken strong actions to limit AFM1 contamination, increase aflatoxin control, and modify the regulations. A study analyzed 363 randomly collected milk samples (168 milk, 195 milk powder) from Saudi Arabia using LC-MS/MS. Out of the 363 samples, 20 were positive for AFM1, with 343 were within the limits. One out of the 168 milk samples and 19 out of the 195 milk powder samples exceeded the limits, with seven originating from Saudi Arabia. The highest AFM1 concentration (3.97µg/kg) was found in the Saudi samples. Saudi Arabia's mycotoxin regulations significantly reduced AFM1 contamination in milk, which is not considered a serious health hazard.

Off‑label and unapproved pediatric drug utilization: A meta‑analysis.

Despite legislative enforcement on authorized drugs, off-label and unapproved pediatric drug use is prevalent. The present study aimed to assess the global prevalence of off-label and unlicensed prescriptions among hospitalized children via meta-analysis. A comprehensive examination of articles published between 1990 and 2023 from the PubMed, Scopus, Excerpta Medica Database, Web of Science and Google Scholar databases was conducted. Key word-based advanced searches were executed using the aforementioned databases. A total of 45 studies that reported the prescriptions of off-label and unlicensed drugs to pediatric patients were included. The global prevalence of off-label and unlicensed drug prescriptions to children in pediatrics or neonatal departments was 56%. Patient sample sizes varied from 40-13,426, with a range of 240-8,891 total prescriptions issued. Of the 45 studies examined, 22 studies originated from Europe, 13 from Asia, 3 from South America, 3 from Africa, and 2 each from North America and Australia. Africa had the highest prevalence rate at 66%, followed by Asia, South America, North America, Australia and Europe. The present meta-analysis demonstrated that the prevalence of off-label and unlicensed drug prescriptions given to pediatric patients was notably high and geographically diverse. Therefore, drug authorities should standardize pediatric prescription practices in future.

Implementation of the Indonesian Food and Drug Authority Agency's (BPOM) Health Service Policy on the Sale of Non- Prescribed Prescription Drugs at Pharmacies in Makassar

Implementation of the Indonesian Food and Drug Authority Agency's (BPOM) Health Service Policy on the Sale of Non- Prescribed Prescription Drugs at Pharmacies in Makassar

Effect of fasting-induced headache on calcitonin gene related peptide (CGRP) and other clinical biomarkers on the first day of Ramadan: Sub-analysis from a randomized open label clinical trial

BackgroundFasting-induced headaches (FIHs) have been shown to occur on the first day of Ramadan and clearly decline thereafter. Despite the wealth of knowledge about different types of headaches (e.g., migraine-, cluster-, and tension-type headaches), research on the mechanism underlying FIHs, as well as their treatment, remains scarce. Our study aimed to investigate any association between FIHs during the first day of Ramadan and potential headache-related biomarkers, including fasting blood glucose (FBG), C-reactive protein (CRP), magnesium, vitamin B9, vitamin B12, homocysteine, and calcitonin gene related peptide (CGRP), and to assess whether a prophylactic use of paracetamol may influence these biomarkers.MethodsAs part of a randomized, open-label clinical trial that evaluated the effect of paracetamol as a prophylactic therapy for FIH, blood samples from stratified subjects in the prophylaxis and control groups were withdrawn while fasting after the 1st dose of paracetamol (in the prophylaxis group) and prior to reporting headache occurrence.ResultsPlasma and serum were separated for 61 subjects; 31 and 30 subjects from the prophylaxis and control groups, respectively. Overall, no significant differences were found in the levels of FBG, CRP, magnesium, vitamin B9, and vitamin B12 in headache-suffering subjects compared to those without headache despite the use of paracetamol for prophylaxis. Homocysteine, however, was significantly reduced in all subjects who experienced FIH compared to those without headache (median 6.9 [1.6] vs. 7.7 [2.7] umol/L; p = 0.041). On the contrary, when the CGRP was measured using immunoassay, it was found to be significantly elevated in all headache-suffering subjects compared to those without headache (median 126.1 [17.7] vs. 105.8 [19.6] pg/mL; p ≤ 0.0001). This difference was maintained upon comparing the headache to non-headache subjects in both the prophylaxis (median 121.5 [15.4] vs. 105.8 [9.4] pg/mL; p < 0.01) and control groups (median 128.5 [28.3] vs. 105.8 [23.8] pg/mL; p < 0.01). Additionally, an elevated CGRP level was found to increase the odds of having a FIH [OR = 1.32; 95%CI 1.06–1.22].ConclusionsOur findings revealed the role of CGRP in FIHs for the first time and suggest further investigation in signaling pathways downstream CGRP receptors. Furthermore, the modulation CGRP or CGRP receptors could have a clinical application in the prevention of FIHs.Trial registrationThis study was registered with the Saudi Food and Drug Authority in the Saudi Clinical Trials Registry (SCTR; No. 22122102).

Strengthening regulation for medical products in Tanzania: An assessment of regulatory capacity development, 1978-2020.

Improving medicines regulation can lead to better population health, but how this process works in low- and middle-income countries remains underexplored. Tanzania's pharmaceutical sector is often cited as a successful example of a well-functioning regulatory system in a developing country, attributed to the work of the Tanzania Food and Drugs Authority (TFDA), now the Tanzania Medicines and Medical Devices Authority (TMDA). This raises the question: how was this regulatory capacity developed, and what lessons can other countries learn from Tanzania's experience? This paper analyzes changes in Tanzania's pharmaceutical regulation over three periods of significant sectoral reform. A desk review was conducted of Tanzania's policies, laws, regulations, guidelines, procedures, and institutional reports. The study reveals that Tanzania's regulatory capacity improved significantly through targeted reforms that addressed challenges in key regulatory areas. The three key periods examined are: 1) The separation of medicines regulation from food safety (1978-2003), 2) The expansion of regulatory domains and the establishment of a semi-autonomous regulatory agency (2003-2011), and 3) The expanded role of the Pharmacy Council to include premises regulation (2011-2020). The development of a well-functioning regulatory system in Tanzania resulted from advancements in four key areas: 1) The evolution of a legal regulatory framework, 2) Strong stakeholder engagement, 3) Continuous capacity building, and 4) Effective organizational leadership. Tanzania's regulatory system has evolved from being relatively ineffective to leading regional harmonization efforts in East Africa. This progress was not linear, requiring sustained effort, collaboration, and support from key development partners such as the Global Fund, WHO, and UNDP. Future efforts to enhance regulatory effectiveness should focus on creating adaptive systems that respond to changing needs, rather than solely prescriptive functions.

Adverse Event Profile of First-line Drugs for Treating Patent Ductus Arteriosus in Neonates: A Disproportionality Analysis Study of USFDA Adverse Event Reporting System.

Acetaminophen, ibuprofen, and indomethacin are widely used as first-line drugs for patent ductus arteriosus (PDA) closure in preterm neonates. However, their relative safety profiles remain unclear. Adverse event reports related to the first-line drugs used in PDA and neonates in general were retrieved from the US Food and Drug Authority (FDA) Adverse Event Reporting System. Deduplicated reports were analyzed using proportional reporting ratios and reporting odds ratios to identify disproportionality safety signals between drugs. A total of 969 unique reports related to the first-line drugs used in PDA and 499 reports in the neonatal period were included. Acetaminophen signals primarily involved the liver, while ibuprofen and indomethacin signals pertained to gastrointestinal, renal, vascular, and mortality outcomes. Higher occurrences of death were reported with indomethacin and ibuprofen compared with acetaminophen. This first comparison of PDA drug safety profiles from spontaneous reports highlights some differences, with acetaminophen potentially conferring a safer adverse effect profile overall. While limitations include missing data and reporting biases, the signals warrant further validation. Given its comparable efficacy to ibuprofen, as demonstrated in other studies, acetaminophen has the potential to be preferred as an initial medical therapy for PDA.

Titanium dioxide (TIO2) in herbal and health products registered by Saudi food and drug authority (SFDA): A descriptive study

Titanium dioxide (TIO2) in herbal and health products registered by Saudi food and drug authority (SFDA): A descriptive study

A Disturbing Emerging Trend of Alcohol-Based Hand Sanitizer Burns in Northern Ghana: A Case Series

Introduction: During the COVID-19 pandemic and in the aftermath of it, there was a surge in the use of alcohol-based hand sanitizer (ABHS). This was because the Center for Disease Control and Prevention and the World Health Organization recommended it as an essential commodity for hand hygiene and the reduction of infection transmission. However, alcohol is flammable and has the potential to cause burns if ignited. There are few reports of ABHS-related burns in literature. We aim to report 8 cases of ABHS burns in Northern Ghana and sound a clarion call to stakeholders on a disturbing emerging trend. Case Presentation: About 62.5% of the victims were children and 75% were female with a male-to-female ratio of 1:3. The mean age of victims was 13.25 years while the mean total burn surface area was 29.8%. All victims in this study sustained their injuries because of an attempt by either them or their collaborators to use ABHS as fuel to light a fire for domestic purposes. Most of the burns sustained were second-degree (75%). The case fatality rate of ABHS burns was 25%. Conclusion: Alcohol-based hand sanitizer, though effective for hand hygiene, is flammable and can cause burns when used injudiciously. ABHS burn is an emerging public health problem. There is a need for public education to curb this emerging trend and forestall future incidents. The Food and Drugs Authority (FDA) should consider the addition of warning labels for flammability on the containers and instruction manuals of sanitizers.

Antimicrobial activity, toxicity and retrospective clinical effectiveness of Kantinka BA and Kantinka Herbaltics, two multi-component-herbal products used in the management of infectious diseases in Ghana

There is an upsurge in the incidence of persons living with infectious diseases and their associated symptoms. Also, there is increased resistance and high cost of available synthetic antimicrobial therapeutic agents. This calls for screening candidate herbal products to examine the risk-to-benefit ratio for users. Moreover, there are inadequate proven scientific studies to assess the quality, effectiveness, and toxicity of herbal products that traditional medicine practitioners in Ghana commonly use for the management of infectious diseases such as those caused by Neisseria gonorrhoeae, Candida albicans and the symptomatic management of symptoms associated with infections like cough, skin infections among others and gastritis. Kantinka BA and Kantinka Herbaltics, two multicomponent herbal products, have been used to manage the above-mentioned disease conditions. The study aims to evaluate the in vitro antibacterial activity, assess the retrospective clinical effectiveness (clinical responses; the disappearance of presenting signs and symptoms associated with infections, gastritis), and the quality and toxicity of Kantinka BA and Kantinka Herbaltics. The products are registered by the Food and Drugs Authority (FDA). Data on 200 patients who were diagnosed with infectious diseases such as Human Immunodeficiency Virus (HIV) / Acquired Immunodeficiency Syndrome (AIDS) and associated symptoms from January 2018 to June 2018 was obtained from the Adom Herbal Clinic, and the Tafo Government Herbal Medicine Records Unit was assessed. The antibacterial activity of the products was evaluated using the HT-SPOTi method. Phytochemical screening, microbial load, and pH were carried out according to standard procedures. Acute toxicity was carried out according to the Organization for Economic Cooperation and Development (OECD) guideline 425. Phytochemical screening, pH, and microbial load have been established for both products. Binding toxicity studies revealed that the products are non-toxic at a 2000 mg/kg dose. The two products exhibited antimicrobial activities against the test organisms with Minimum Inhibitory Concentration (MIC) and Minimum Lethal Concentration (MLC) determined for Kantinka BA and Kantinka Herbaltics as 5% and 10% and &lt;80, respectively, against C. albicans and N. gonorrhoeae - the signs and symptoms associated with infections disappeared during the management period. The products are safe and may effectively manage some infectious diseases and associated symptoms.

The Perception of Contraceptive Practice Among Female Patients Treated With Isotretinoin in Saudi Arabia.

Background Practicing and following a Pregnancy Prevention Program (PPP) is crucial to prevent isotretinoin-induced teratogenicity. Our study aims to assess the current practice of dermatologists about PPP when prescribing oral isotretinoin and the compliance of the patients toward contraceptive methods. Methods The research used a cross-sectional design and utilized a probability sampling method in Saudi Arabia. An online self-administered questionnaire was used to collect data that included female participants who were previously treated/being treated with isotretinoin for acne. Data was analyzed using SPSS (IBM Inc., Armonk, New York). Results Our study examined 359 female patients receiving isotretinoin treatment. Isotretinoin was primarily used for severe nodular forms of acne resistant to regular treatment 229 (63.8%). Regarding awareness, 326 (90.8%) were familiar with isotretinoin's teratogenic effects, and 112 (31.2%) were familiar with the Saudi Food and Drug Authority's Pregnancy Prevention Program. Physicians were among the most prevalent information sources 254 (71%). In terms of isotretinoin usage, 227 (63.2%) had one course. Regarding contraceptive practice, 167 (46.5%) were informed about the necessity of a negative pregnancy test before starting treatment, and 29 (50.9%) of those who received more than two courses had good awareness. Conclusion The study identified a notable awareness gap among the participants, as over two-thirds demonstrated a poor awareness level regarding isotretinoin. A significant proportion of participants were informed about the importance of contraceptive practices, including the necessity of a negative pregnancy test before, during, and after treatment.

Quality assessment of common anti-malarial medicines marketed in Gambella, National Regional State, South Western-Ethiopia

BackgroundOver the past years, there has been a growing concern that a considerable amount of anti-malarial supply in the underdeveloped world particularly in the private sector, is of poor quality. The World Health Organization (WHO) has received about 1500 reports that mentions instances of substandard and falsified products since 2013. The majority of the reports concerned antibiotics and anti-malarials. The majority of reports (42%) originate from the WHO African region.ObjectiveThis study intends to assess the quality of the most widely used anti-malarial medications [artemether-lumefantrine tablets, chloroquine phosphate tablets, primaquine phosphate tablets, artesunate, and artemether injections] in Gambella, South-West, Ethiopia.MethodsA total of 52 samples were collected on June 2022 from Gambella National Regional State, Ethiopia. Half of the districts (six) located in the four zones of the region were chosen using simple random sampling technique. All drug retail outlets available in the selected districts (locally known as woredas) were included. The samples were subjected to visual inspection with a tool adopted from the joint WHO/FIP/ USP checklist. The pharmacopeial tests for identification, uniformity of dosage forms, assay, thickness, diameter, hardness, friability, disintegration test, dissolution, and sterility tests were carried out according to the USP 44-NF 39 and International Pharmacopoeia 11th edition, 2022 monographs.Results and DiscussionOnly 25% of the samples were registered on the Ethiopian Food and Drug Authority (EFDA’s) electronic regulatory/ registration system (ERIS). Besides, 88.8% of artemether injection products were presented in clear glass ampoules. This might expose the products to photochemical degradation that leads to in loss of anti-plasmodial activity. In addition, 50% of the artemether products assessed were not bioequivalent with the comparator product in the in vitro dissolution comparison tests. Overall, the study findings reveal a high prevalence (58.3%) of substandard anti-malarial drugs in the region. The stated percent of the samples had failed in one or more of the quality test parameters assessed in this study.ConclusionThe study findings reveal a high prevalence (58.3%) of substandard anti-malarial drugs in the region. Only a quarter were registered and 38% of the unregistered products failed the quality tests. Hence, the national, regional medicine regulatory bodies and other stake holders should perform the required roles to circumvent presence of Substandard and Falsified (SF) anti-malarial drugs in the study sites.

Assessing consumers’ perception on hot foods served in plastics and earthenware bowls at selected food joints within Sekondi-Takoradi metropolis, Ghana

The study sought to find out consumers’ perceptions regarding the use of earthenware bowls and plastic bowls to serve hot foods in two most patronized food joints within the Sekondi-Takoradi Metropolis. The study adopted a descriptive survey design to gather data from consumers and operators of the selected food joints to assess knowledge of the chemical composition and potential health effects of plastic bowls used in serving foods and to determine the consumer preference to plastic or earthenware bowl. A non-probability sampling technique was purposefully used to select the respondents. A sample of thirty-two (32) respondents comprising thirty (30) consumers and two (2) operators were used for the study. The main data-gathering instruments used were interviews and observation. Data gathered had been analyzed to draw conclusions. The study revealed among others, that most of the customers had inadequate information about the potential health effects on eating from plastic bowls and the health benefits of using earthenware bowls. Based on these findings, it was recommended among others, that responsible authorities like Food and Drug Authority (FDA) should help the consumers to have a more profound knowledge concerning likely health implications of incessantly eating of hot foods in plastic bowls.

Assessment of GMP Compliance in Tempe Production on Sepande Village

Food safety is an essential aspect of sanitation science. Food safety is an essential characteristic of life, both for food producers and consumers. Therefore, food processing enterprises must prioritize hygiene standards for the common good and maintain consumer confidence by improving food security assurances. The consumption of tempe by Indonesian people is relatively high because there is an advantage that tempe has in terms of nutritional value over other foods. The regulations of the Minister of Industry were issued by the Drug and Food Supervisory Authority (BPOM) 14 years ago, and the artisans should have already carried out the production process following the requirements of the regulations. The study aims to evaluate compliance with good manufacturing practices in Tempe production and analyze the correlation between compliance with good manufacturing practices and profits. The study was conducted in May 2024 in the village of Sepande. The number of respondents in this study is 50 tempe artisans, with the probability sampling techniques taking into account that Sepande Village is the area that has the most tempe industry homes and the highest tempe producer in the Candi district. The analysis method used in the first instance is the GMP assessment checklist form, then analyzed using the GAP Analysis method to analyze the gaps that occur, and in the second instance to analyze the costs and profits, then provide a list of questions with the Likert scale method, then correlated using the help of SPSS software with the Spearman Rank Test. The results show that based on the assessment of the aspects of Good Processed Food Production in Tempe products in the village of Sepande, the level of compliance has been applied following the regulations of the ministry as well as the benefits that influence the way good processed food is produced.

Integrating Traditional Medicine with Modern Healthcare: Addressing Maternal and Mental Health in Uganda

Traditional medicine in Uganda, deeply rooted in cultural and historical practices, plays a significant role in addressing maternal and mental health challenges. This review explores the integration of traditional medicine with modern healthcare systems, aiming to enhance maternal and mental health outcomes while preserving cultural heritage. Traditional practices, including herbal remedies, spiritual healing, and the role of traditional birth attendants (TBAs), provide crucial support, particularly in rural areas with limited access to modern medical facilities. The review examines the contributions of traditional medicine to maternal health, including prenatal, labor, and postnatal care, and its role in mental health through spiritual and community-based practices. Despite the valuable contributions, integrating traditional and modern healthcare presents challenges such as cultural barriers, regulatory issues, and the need for standardization. Efforts to integrate these approaches include policy development, educational initiatives, and collaborative health programs. The National Drug Authority (NDA) plays a pivotal role in regulating and standardizing traditional medicine practices, ensuring safety and efficacy through research and quality control measures. Economic impacts of traditional medicine include income generation, local trade, and affordable healthcare options, although practitioners face challenges like lack of formal recognition and regulatory issues. Public perception is influenced by cultural beliefs and trust in traditional practices, with increasing acceptance of integrated approaches in urban areas. In conclusion, integrating traditional medicine with modern healthcare in Uganda offers a promising path towards a more inclusive and culturally sensitive healthcare system. By addressing challenges through mutual respect, collaboration, and evidence-based practices, Uganda can enhance maternal and mental health outcomes and build a more comprehensive healthcare system. Keywords: Traditional Medicine, Modern Healthcare, Maternal, Mental Health in Uganda

Post-marketing quality surveillance of selected antibacterial agents marketed in porous borders; the case of Ethiopia-Sudan-Eritrea border.

The presence of poor-quality medicines is becoming a public health threat in many parts of the world, particularly in developing countries. Antibiotics are among the most common anti-infective medicines that are highly prone to this problem. The purpose of this study was to assess the quality of selected antibacterials that are marketed in Setit Humera and West Gondar Zones, North West Ethiopia, which are located on the Ethiopian side of the Ethiopia-Sudan-Eritrea border. Seventy-one samples of the four antibacterial medicines (Ciprofloxacin, Norfloxacin, Amoxycillin, and Amoxycillin clavullanate combination) were collected from six sites in Setit Humera and West Gondar Zones, North West Ethiopia. A mystery shopping system was used for sample collection. Visual inspections and confirmation of the registration status were carried out using the joint WHO/FIP/USP checklist and the Ethiopian Food and Drug Authority's (EFDA's) Electronic Regulatory Information System (eRIS), respectively. Then Pharmacopeial methods (USP, BP) were employed to assess the physicochemical quality parameters. During the period of our data collection, the application status for registration in the eRIS system was checked. From 71 samples, 25.35% (18/71) were not registered, and 15.49% (11/71) were registered, but the license period had expired. Some samples (12.06% (17/71)) did not meet the visual inspection criteria. The physicochemical evaluation showed that all the samples studied met the quality specifications for the identification and hardness tests. However, concerning assay, dissolution, uniformity of dosage units, disintegration, and friability test parameters, 27.49% (23/71), 16.9% (12/71), and 14.08% (10/71), 2.82% (2/71) and 8.57% (3/35) of samples were found to be substandard, respectively. Overall, 56.33% (40/71) of the samples tested were of poor quality, failing to meet any one or more of the assessed parameters in this study. The study indicated that poor-quality antibacterial medicines are circulating in the study sites. Therefore, even if the area was affected by conflict at the time of the study, the regulatory bodies should focus on enforcing the necessary measures by collaborating with the regional and national regulatory medicine agencies to ensure that the antibacterial medicines available meet the required mandatory minimum standards.

Safety of high-dose amikacin in the first week of all-oral rifampicin-resistant tuberculosis treatment for the prevention of acquired resistance (STAKE): protocol for a single-arm clinical trial

IntroductionAn effective rifampicin-resistant tuberculosis (RR-TB) treatment regimen should include prevention of resistance amplification. While bedaquiline (BDQ) has been recommended in all-oral RR-TB treatment regimen since 2019, resistance is rising at...