EFSA was asked to deliver a scientific opinion on the risks to public health related to the presence of aflatoxins in food. The risk assessment was confined to aflatoxin B1 (AFB1), AFB2, AFG1, AFG2 and AFM1. More than 200,000 analytical results on the occurrence of aflatoxins were used in the evaluation. Grains and grain-based products made the largest contribution to the mean chronic dietary exposure to AFB1 in all age classes, while 'liquid milk' and 'fermented milk products' were the main contributors to the AFM1 mean exposure. Aflatoxins are genotoxic and AFB1 can cause hepatocellular carcinomas (HCCs) in humans. The CONTAM Panel selected a benchmark dose lower confidence limit (BMDL) for a benchmark response of 10% of 0.4 μg/kg body weight (bw) per day for the incidence of HCC in male rats following AFB1 exposure to be used in a margin of exposure (MOE) approach. The calculation of a BMDL from the human data was not appropriate; instead, the cancer potencies estimated by the Joint FAO/WHO Expert Committee on Food Additives in 2016 were used. For AFM1, a potency factor of 0.1 relative to AFB1 was used. For AFG1, AFB2 and AFG2, the in vivo data are not sufficient to derive potency factors and equal potency to AFB1 was assumed as in previous assessments. MOE values for AFB1 exposure ranged from 5,000 to 29 and for AFM1 from 100,000 to 508. The calculated MOEs are below 10,000 for AFB1 and also for AFM1 where some surveys, particularly for the younger age groups, have an MOE below 10,000. This raises a health concern. The estimated cancer risks in humans following exposure to AFB1 and AFM1 are in-line with the conclusion drawn from the MOEs. The conclusions also apply to the combined exposure to all five aflatoxins.

Risk assessment of aflatoxins in food

Hepatitis B virus (HBV) infection has shown an intermediate or high endemicity level in low-income countries over the last five decades. In recent years, however, the incidence of acute hepatitis B and the prevalence of hepatitis B surface antigen chronic carriers have decreased in several countries because of the HBV universal vaccination programs started in the nineties. Some countries, however, are still unable to implement these programs, particularly in their hyperendemic rural areas. The diffusion of HBV infection is still wide in several low-income countries where the prevention, management and treatment of HBV infection are a heavy burden for the governments and healthcare authorities. Of note, the information on the HBV epidemiology is scanty in numerous eastern European and Latin-American countries. The studies on molecular epidemiology performed in some countries provide an important contribution for a more comprehensive knowledge of HBV epidemiology, and phylogenetic studies provide information on the impact of recent and older migratory flows.

Hepatitis B virus burden in developing countries.

Current NHS finance mechanisms use activity-based models that do not measure individual services. Economic policies that measure profitability of different services can drive improvement and efficiency. Monitor is looking at the introduction of a requirement for foundation trusts to implement these policies, and will shortly be consulting on the processes involved.

The new economics.

Detailed, country-specific epidemiological data are needed to characterize the burden of chronic hepatitis C virus (HCV) infection around the world. With new treatment options available, policy makers and public health officials must reconsider national strategies for infection control. In this study of 15 countries, published and unpublished data on HCV prevalence, viraemia, genotype, age and gender distribution, liver transplants and diagnosis and treatment rates were gathered from the literature and validated by expert consensus in each country. Viraemic prevalence in this study ranged from 0.2% in Iran and Lebanon to 4.2% in Pakistan. The largest viraemic populations were in Pakistan (7 001 000 cases) and Indonesia (3 187 000 cases). Injection drug use (IDU) and a historically unsafe blood supply were major risk factors in most countries. Diagnosis, treatment and liver transplant rates varied widely between countries. However, comparison across countries was difficult as the number of cases changes over time. Access to reliable data on measures such as these is critical for the development of future strategies to manage the disease burden.

https://onlinelibrary.wiley.com/doi/pdf/10.1111/jvh.12350

Historical epidemiology of hepatitis C virus (HCV) in select countries - volume 3.

Objectives Hospital-acquired infections (HAIs) are significant problems as public health issues which need attention. Such infections are significant problems for society and healthcare organizations. This study aimed to carry out a systematic review and a meta-analysis to analyze the prevalence of HAIs globally. Methods We conducted a comprehensive search of electronic databases including EMBASE, Scopus, PubMed and Web of Science between 2000 and June 2021. We found 7031 articles. After removing the duplicates, 5430 studies were screened based on the titles/ abstracts. Then, we systematically evaluated the full texts of the 1909 remaining studies and selected 400 records with 29,159,630 participants for meta-analysis. Random-effects model was used for the analysis, and heterogeneity analysis and publication bias test were conducted. Results The rate of universal HAIs was 0.14 percent. The rate of HAIs is increasing by 0.06 percent annually. The highest rate of HAIs was in the AFR, while the lowest prevalence were in AMR and WPR. Besides, AFR prevalence in central Africa is higher than in other parts of the world by 0.27 (95% CI, 0.22–0.34). Besides, E. coli infected patients more than other micro-organisms such as Coagulase-negative staphylococci, Staphylococcus spp. and Pseudomonas aeruginosa. In hospital wards, Transplant, and Neonatal wards and ICU had the highest rates. The prevalence of HAIs was higher in men than in women. Conclusion We identified several essential details about the rate of HAIs in various parts of the world. The HAIs rate and the most common micro-organism were different in various contexts. However, several essential gaps were also identified. The study findings can help hospital managers and health policy makers identify the reason for HAIs and apply effective control programs to implement different plans to reduce the HAIs rate and the financial costs of such infections and save resources.

/pdf/global-prevalence-of-nosocomial-infection-a-systematic-2e87jawy.pdf

Global prevalence of nosocomial infection: A systematic review and meta-analysis

Viral hepatitis, particularly hepatitis B and C, are diseases with worldwide distribution that present a significant public health problem. Seroprevalence studies allow assessment of the extent of the disease burden, the identification of populations at risk and the monitoring trends over time. A multi-center seroprevalence study, carried out in Bulgaria (covering the five largest cities – Sofia, Plovdiv, Varna, Pleven, and Stara Zagora) in 1999–2000 estimated a crude seroprevalence rate of 3.9% for HBsAg and 1.3% for anti-HCV. A decade later, comparable rates were observed in a study including 865 outpatients consulting a clinical laboratory in Plovdiv, the second largest administrative region in Bulgaria. The crude seroprevalence rate measured for hepatitis B (HBsAg) was 3.9%. The HBsAg prevalence rate in individuals ≤19 years of age (targeted by vaccination) was significantly lower compared to the rate in adults ≥20 years of age –1% versus 4.8%. The lack of dynamics in the overall level of HBsAg carriers is likely related to the excessively low hepatitis B vaccine coverage in individuals, born before the introduction of the universal vaccination of newborns in August 1991. Anti-HCV antibodies were detected in 0.7% of the subjects. J. Med. Virol. 87:401–406, 2015. © 2014 Wiley Periodicals, Inc.

Prevalence of HBV and HCV among outpatients in the plovdiv region of Bulgaria, 2010–2011

OBJECTIVE: This article’s objective is to critically assess the Bulgarian legislation on health technology assessment (HTA). It analyses how innovative therapies and orphan drugs in particular would respond to the regulators’ decision-making criteria for reimbursement. MATERIALS AND МETHODS: The study features critical analysis of current decision-making criteria for drug reimbursement in Bulgaria, as well as hypothetical scenario planning for orphan medicinal products. RESULTS: The approval for inclusion into the Positive Drug List (PDL) (which is a must for reimbursement) has been reorganised into an assessment scoring system with decisionmaking criteria (presence of therapeutic alternative, clinical effectiveness, safety, pharmacoeconomics and societal value) divided into weighted indicators. An explicit threshold has been set – a medicinal product must score 60 points at least to be included in PDL. Under the currently defi ned reimbursement decision-making criteria a hypothetical middle-of-the-road scenario planning shows that an orphan drug would score 20 points for therapeutic alternative, 28 for clinical effectiveness and 12 for safety. It would take no points for pharmacoeconomics and societal value. This leaves the orphan drugs with a total score of 60 points, making the fi nal outcome of real-life assessment and decision-making heavily dependent on small fl uctuations. CONCLUSIONS: The current reimbursement decision-making framework in Bulgaria seems to be generalised and not suffi ciently transparent. It is unable to precisely assess innovative health technologies. The availability of a therapeutic alternative emerges as a key reimbursement decision-making criterion for orphan drugs, as these innovative products nominally provide the fi rst medicinal therapy alternative to rare diseases.

Insight into reimbursement decision-making criteria in Bulgaria: implications for orphan drugs.

The critical problem of medical errors and the associated costs has recently been increasingly in the focus of attention of a number of world renowned experts. In the present article we review in detail and analyse the economic aspects of this problem. A methodology to assess the cost of medical errors and an algorithm for their prevention are presented. The cost of a medical error and the expenses required to avoid and prevent it are compared using graphical analysis of the prevention cost curve and the medical error compensation damages cost curve.

Economic aspects of medical errors

Introduction Nosocomial infections (NI) are frequent complications in neonatal intensive care units (NICU) which result in high morbidity and mortality. Aim To determine and analyze the incidence, risk factors and etiologic agents of NI in newborns admitted in the NICU to help plan-ning future surveillance and prevention strategies. Materials and methods A prospective cohort study was carried out at the NICU of St George University Hospital, Plovdiv, Bul-garia from January 1, 2017 to June 31, 2018. The number of neonates included in the study was 507. Descriptive statistics such as count, percent, mean and standard deviation was used. Chi-square test was performed to prove associations. Odds ratios, with 95% confidence intervals, were computed from the results of the binominal logistic regression analyses. Results Of the 507 hospitalized newborns in NICU, 48 presented with 54 NI. The incidence and the density incidence rates were 9.5% and 7.67 per 1,000 patient-days, respectively. Nosocomial infections were detected in neonates from all birth weight (BW) classes, but it was low BW and premature neonates that were at major risk to acquire them. The most common infection sites were ventilator-asso-ciated pneumonia (VAP) (67.27%), bloodstream infection (23.64%) and conjunctivitis (9.09%). Major pathogens were Gram-negative such as Klebsiella pneumoniae, E. coli, Pseudomonas aeruginosa and Acinetobacter baumannii. In the multivariate logistic regression analysis NIs were strongly associated with intubation, presence of a venous catheter, the duration of antibiotic treatment and increased CRP> 10 mg/l. Conclusions This report highlights the burden of NIs, identifies the major focus for future NI control and prevention programs.

Surveillance of Nosocomial Infections in a Bulgarian Neonatal Intensive Care Unit.

Introduction A current non-pharmacological mean for attaining painless local anaesthesia (LA) is presented by vibrotactile devices. Their concept is to reduce injection pain due to distraction by applying physical stimuli which interfere with pain signals. The aim of this study is to determine the efficacy of the DentalVibe (DV) device in reducing pain and anxiety associated with LA in paediatric patients. Methods and analysis The proposed study is a randomised controlled clinical trial with split-mouth design. Included are positive patients aged 8–12 years, requiring buccal infiltration for extraction of two bilateral primary maxillary molars. After dental fear measurement, eligible patients undergo two single-visit treatments with DV device allocated to either first or second LA via computer-generated randomisation sequence. Outcome measures will be self-reported pain felt during LA on Visual Analogue Scale; self-reported anxiety on Facial Image Scale; pain-related behaviour according to Faces, Legs, Activity, Cry, Consolability Scale; heart rate; patient preference to LA technique. Data will be analysed with intention-to-treat concept by Student’s t-test for paired samples, Wilcoxon signed-rank test, p Ethics and dissemination This study protocol has been approved by the Committee for Scientific Research Ethics, Medical University - Plovdiv, Bulgaria (Reference number P-8604, Protocol of approval No. 6/23.11.2017) and registered on a publicly accessible database. This research received institutional funding from the Medical University - Plovdiv, Bulgaria, under project SPD-03/2017. Findings will be reported in scientific publications and at research conferences, and in project summary papers for participants. Trial registration number NCT03445182; Pre-results.

https://bmjopen.bmj.com/content/bmjopen/9/7/e029460.full.pdf

Efficacy of vibrotactile device DentalVibe in reducing injection pain and anxiety during local anaesthesia in paediatric dental patients: a study protocol for a randomised controlled clinical trial

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