Mercury and selenium concentrations in the oysters Saccostrea palmula and Crassostrea corteziensis from four coastal lagoons of NW Mexico: health risk assessment

Mercury (Hg) and selenium (Se) concentrations in the soft tissue of the oysters Saccostrea palmula and Crassostrea corteziensis from four coastal lagoons (Altata, Macapule, Navachiste, El Colorado) of Northwest Mexico were determined. A total of 2520 specimens of S. palmula and 3780 of C. corteziensis (72.15 ± 4.95 and 73.57 ± 5.31 mm, respectively) were sampled seasonally from summer 2019 to spring 2020. The higher Hg concentration (wet weight) for S. palmula (0.13 ± 0.03–0.11 ± 0.02 µg g−1) and C. corteziensis (0.12 ± 0.02–0.11 ± 0.03 µg g−1) were obtained in summer−autumn 2019; Hg level was similar among the coastal lagoons and did not exceed the limit established by Mexican legislation and by the Food and Drug Agency. The higher Se concentration occurred in spring 2020 for both oyster species in El Colorado lagoon (4.55 ± 0.02 and 4.08 ± 0.05 µg g−1, respectively). The Se/Hg molar ratio of S. palmula and C. corteziensis ranged from 48.76–149.59 and 31.72–155.37, respectively; while the Se health benefit value was 19.23–42.28 and 17.82–35.30, respectively. The hazard quotient for Hg -estimated as methylmercury- and Se in both species of oyster was below 1. The high molar ratio obtained (Se/Hg > 1) indicates that the concentration of Se was sufficient to neutralize the possible toxicity of the Hg, therefore, the consumption of S. palmula and C. corteziensis from the four coastal lagoons studied does not represent a risk.

Barriers to the Implementation of Alcohol Policies in Jayapura City

Background: Basic Health Research (RISKESDAS) in 2018 found as many as 15 provinces out of 35 provinces had a prevalence of alcohol consumption above the national prevalence, and Papua was reportedly in the top 15 of the prevalence of high alcohol consumption (alcohol) as much as 4.6%. Objective: To describe the obstacles to the implementation of local government policies in curbing the circulation of alcohol in Jayapura City. Method: This is a descriptive study using a qualitative single instrumental case study design in Jayapura City from May to September 2020. Purposive sampling technique was employed to determine participants who consisted of an integrated team of alcohol control and supervision (n =6). Data collection was using in-depth interviews and non-participant observation. Result: Communication between the integrated team was not optimal. National Food and Drug Agency (BPOM) had not routinely conducted sample tests as the majority of traditional alcoholic beverages sold in shops such as local liquors were illegal. The division of duties and responsibilities by the integrated team was good, but the execution in the field was not as agreed upon. There were alcohol traders who have not applied for licenses to sell alcohol because the process to get license permits was too complicated. The content of Perda No.8 of 2014 weakened the police because they could not give punishment like Satpol PP, however, Satpol PP did not have an investigating team. Conclusion: The lack of commitment from the control and supervision team of alcohol circulation in carrying out their duties. The resources involved were lacking. Coordination among the integrated teams was not going well thus the division of tasks and authorities with implementation actions in the field did not work according to the policy enforce in Jayapura City. Evaluation of work programs by policy implementers could be carried out to increase the success of implementation.

DATA OF ILLEGAL SUBSTANCE USE IN ROMANIA PROVIDED BY N.A.A. COMPARED WITH THE ANALYSIS OF INDICTMENTS PREPARED BY D.I.I.C.O.T. ORADEA

Drug use and New Psychoactive Substances (NPS) use are a sensitive issue due to the consequences that those who admit having this habit may expect to suffer. Part of the scientific community recommends that quantitative descriptions on this topic be verified or possibly supplemented by data obtained from research activities that use more reliable data and methods. In Romania, the prevalence estimation of drug and NPS use is performed by the National Anti – Drug Agency by conducting two studies, one every three years and another conducted every four years, respectively. In order to analyze the accuracy of the results presented in the reports prepared by the National Anti – Drug Agency, in this article we compared these results with those resulted from the analysis of the indictments issued by the Directorate for Investigation of Organized Crime and Terrorism – Oradea Territorial Service in 2013 – 2019. As a result of this comparison, it was found that there are certain significant differences between the information contained in the two data.

Adverse Drug Reactions to acetaminophen and ibuprofen in the paediatric population: analysis of the Italian spontaneous reporting database

Background: Acetaminophen and ibuprofen are the only antipyretics drugs approved in children, and are considered safe and well tolerated. However, data regarding the adverse drug reaction (ADR) profile of these drugs in children are scattered. Aim: The aim of our study is to evaluate the ADRs of acetaminophen and ibuprofen through an observational study over a period of 15 years (January 2005-April 2020). Reports of suspected ADRs to the active substances ‘acetaminophen’ and ‘ibuprofen’ are listed and accessible through the Italian spontaneous reporting database (RAM system) by AIFA (Pharmacovigilance of the Italian Drug Agency). Methods: Acetaminophen ADRs in paediatric populations were 15% of cases, with more frequent involvement of skin and soft tissue (54.36%) and gastrointestinal apparatus (44.09%); liver dysfunction accounts for 5.67%. Results: Ibuprofen paediatric ADRs were 26%: skin and soft tissues in 63.16% of cases, gastrointestinal tract in 47.75%, hematemesis and melena in 6.38%; kidney injury in 2.25% of cases. Conclusion: Children aged 2 to 11 are more frequently affected by ADRs than infants and adolescents. The risk of gastrointestinal and renal side effects is significantly higher with ibuprofen. Hepatobiliary side effects are more frequently linked to acetaminophen. Potentially fatal ADRs have been reported sporadically for both drugs.

Identifikasi Bakteri Escherichia coli dalam Air Minum Galon pada Kantin yang ada di Universitas Andalas Padang

The National Food and Drug Agency has controlled the refill drinking water in drinking water depots and also controlled food at school canteens ranging from elementary, junior high, to high school, but the National Food and Drug Agency never do food quality controlling in canteens at universities. Objectives: To identified the contamination by coliform and E. coli bacteria in drinking water at Andalas University canteen. Methods: This research was descriptive to identify coliform bacteria on 15 drinking water at the Andalas University faculty canteens. Samples were taken directly using a sterile bottle, while data analysis using Most Probable Number (MPN) tables 5-1-1 and the presence of E. coli bacteria colonies from drinking water samples. Results: 9 of 15 water samples were contaminated by coliform bacteria with the highest MPN index of 240/100 ml that was found in 2 samples. From 9 samples containing coliform bacteria, all of them were found to contain E. coli bacteria. Conclusion: Most of the samples were contaminated by coliform and E. coli bacteria. Drinking water served using a kettle was more contaminated than drinking water served using gallons.Keywords: Coliform, Escherichia coli, MPN

A Novel Screen for Expression Regulators of the Telomeric Protein TRF2 Identified Small Molecules That Impair TRF2 Dependent Immunosuppression and Tumor Growth

Telomeric repeat-binding factor 2 (TRF2) is a subunit of the shelterin protein complex, which binds to and protects telomeres from unwanted DNA damage response (DDR) activation. TRF2 expression plays a pivotal role in aging and cancer, being downregulated during cellular senescence and overexpressed during oncogenesis. Cancers overexpressing TRF2 often exhibit a poor prognosis. In cancer cells, TRF2 plays multiple functions, including telomere protection and non-cell autonomous roles, promoting neo-angiogenesis and immunosuppression. We present here an original screening strategy, which enables identification of small molecules that decrease or increase TRF2 expression. By screening a small library of Food and Drug Agency (FDA)-approved drugs, we identified two molecules (AR-A014418 and alexidine·2HCl) that impaired tumor growth, neo-angiogenesis and immunosuppression by downregulating TRF2 expression in a mouse xenograft model. These results support the chemotherapeutic strategy of downregulating TRF2 expression to treat aggressive human tumors and validate this cell-based assay capable of screening for potential anti-cancer and anti-aging molecules by modulating TRF2 expression levels.

A104 PREVALENCE OF GHOST-AUTHORSHIP IN INDUSTRY-SPONSORED CLINICAL TRIALS

Background Ghost-authorship involves the exclusion of individuals who have made substantial contributions to the article from the author byline. Previous studies have found that ghost-authorship is highly prevalent in industry-sponsored clinical trials. Its prevalence, however, has yet to be investigated in trials of biologics in the management of inflammatory bowel disease (IBD). Aims To determine the prevalence of ghost-authorship in IBD biologic industry-sponsored clinical randomized controlled trials (RCTs). Methods Biologic medications indicated for ulcerative colitis (UC) or for Crohn’s disease (CD) were identified using the Food and Drug Agency (FDA) database. We identified the clinical trials on clinicaltrials.gov corresponding to the data presented at the time of FDA approval. Specifically, we included the first publication for each trial to report study results for our analysis. Two authors independently identified the presence of ghost-authorship, which we defined as the exclusion on the author byline of the included RCT publication of any individuals who assisted in the writing of the trial manuscript and/or performed the data analyses. Results We identified a total of 28 relevant RCTs on biologic medications (10 for UC and 18 for CD), which were matched to 20 publications. We found ghost-authorship in 70% of publications (n=14); 40% (n=8) involved manuscript and protocol writing assistance from sponsor staff; 35% (n=7) involved medical writers from external companies; 15% (n=3) involved both sponsor staff and medical writers assisting in manuscript writing; and 20% (n=4) involved individuals performing data analysis or interpretation. Conclusions We found that ghost-authorship in industry-sponsored IBD biologic clinical trials has a moderately high prevalence, with the most common being manuscript or protocol writing assistance. A lack of transparency regarding sponsor-affiliated and/or external contributors may negatively affect the trust placed in medical research. One limitation is that data was only extracted from publications. Further evidence on ghost-authorship may be found in study protocols and registrations, which will be investigated in the future. Funding Agencies None

Intravenous Artesunate for the Treatment of Severe Imported Malaria: Implementation, Efficacy, and Safety in 1391 Patients

Background Intravenous artesunate is the World Health Organization–recommended first-line treatment for severe malaria worldwide, but it is still not fully licensed in Europe. Observational studies documenting its safety and efficacy in imported malaria are thus essential. Methods We prospectively collected clinical and epidemiological features of 1391 artesunate-treated patients among 110 participant centers during the first 7 years (2011–2017) of a national program implemented by the French Drug Agency. Results Artesunate became the most frequent treatment for severe malaria in France, rising from 9.9% in 2011 to 71.4% in 2017. Mortality was estimated at 4.1%. Treatment failure was recorded in 27 patients, but mutations in the Kelch-13 gene were not observed. Main reported adverse events (AEs) were anemia (136 cases), cardiac events (24, including 20 episodes of conduction disorders and/or arrhythmia), and liver enzyme elevation (23). Mortality and AEs were similar in the general population and in people with human immunodeficiency virus, who were overweight, or were pregnant, but the only pregnant woman treated in the first trimester experimented a hemorrhagic miscarriage. The incidence of post-artesunate–delayed hemolysis (PADH) was 42.8% when specifically assessed in a 98-patient subgroup, but was not associated with fatal outcomes or sequelae. PADH was twice as frequent in patients of European compared with African origin. Conclusions Artesunate was rapidly deployed and displayed a robust clinical benefit in patients with severe imported malaria, despite a high frequency of mild to moderate PADH. Further explorations in the context of importation should assess outcomes during the first trimester of pregnancy and collect rare but potentially severe cardiac AEs.

Pharmacovigilance: procedures for uniform assessment of periodic safety update reports and their implementation in national settings. Focus on analgesics

Pharmacovigilance activities are of vital importance for ensuring effective and safe medicinal products. In order to clarify to which extent marketing authorisation holders (MAHs) meet the requirements of the Law and the Directives related to this activities, we conducted a systematic search among the procedures submitted to the Bulgarian Drug Agency (BDA) related to the implementation of the decisions of the Pharmacovigilance Committee and the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for a period of 6 years. The results of the study showed significant discrepancies between regulatory requirements and the behavior of the MAH at the national level. This could be a serious problem, as inadequate or late implementations of the PRAC (Pharmacovigilance Risk Assessment Committee)/CMDh/EC recommendations can lead to untimely informing of healthcare professionals and patients about potential safety concerns and risks related to the use of medicinal products.

Compassionate Drug Use – Time Arising for a New Law in Bulgaria in the Era of COVID-19

Nowadays the health care systems over the world are in a critical period trying to take control over the pandemic of COVID-19. The Bulgarian the Government introduced rapidly (8-to March 2020), restrictive control measures including general lockdown and social distancing. Despite several clinical trials, there are still no specific therapies or any vaccine against COVID-19. The only option available is using investigational drugs for compassionate use (CU). The global pandemic mandates Bulgarian Drug Agency (BDA) for a reasonable update of the existing national regulation concerning CU and off-label therapies. The update of the existing national regulation regarding CU is vital to ensure the effective and sustainable development of health policies and technologies over the COVID-19 pandemic and beyond.