Medicines for an aging population: The EMA perspective and policies.

The European Medicines Agency adopted their Geriatric Medicines Strategy more than a decade ago. The strategy aims at elucidating the evidence basis for marketing authorization of new medicines which will be used in the older population, and at ensuring the appropriate communication of findings to the patient and healthcare provider. During the past decade new tools and data sources have emerged to support the strategy goals, and their use should be considered.

Inequalities in Diabetes Mortality Between Microregions in Hungary.

Regional differences in diabetes mortality are high in Hungary. In our cross-sectional study, we aim to reveal the drivers of the inequalities in diabetes mortality across the 197 microregions of Hungary. To account for the influence of changes in healthcare and social conditions, we compared two periods (2009-12 and 2013-16).

Antimicrobial Diterpenes from Rough Goldenrod ( Mill.).

is one of the goldenrod species native to North America but has sporadically naturalized as an alien plant in Europe. The investigation of the root and leaf ethanol extracts of the plant using a bioassay-guided process with an anti- assay resulted in the isolation of two antimicrobial components. Structure elucidation was performed based on high-resolution tandem mass spectrometric and one- and two-dimensional NMR spectroscopic analyses that revealed (-)-hardwickiic acid (Compound ) and (-)-abietic acid (Compound ).

Association of exogenous factors with the access to innovative pharmaceutical products in Hungary.

Introduction: Access to innovative pharmaceuticals is thought to be associated with several exogenous factors related to the local legal or financial framework of pharmaceutical reimbursement. Our aim was to describe the association between the outcome of the reimbursement procedure on innovative pharmaceutical submissions in Hungary and several potential explanatory variables related to the legal or financial framework of reimbursement procedures, such as the submission implying a need for a legal act to conclude on a positive decision; having a risk-sharing agreement (RSA) in place at the time of submission; the aim of the submission and expenditure on individual funding requests.

Methods: Publicly available administrative announcements of the Hungarian National Health Insurance Fund Manager were used to construct the analysis dataset including all concluded procedures between 1 January 2018 and 7 June 2021, complemented with information on the overall aim of the submission (new compound or new indication).

Nine-dimensional bioprofiles of Tunisian sages (Salvia officinalis, S. aegyptiaca and S. verbenaca) by high-performance thin-layer chromatography - effect-directed analyses.

Ethyl acetate extracts of Tunisian Salvia aegyptiaca and S. verbenaca aerial parts and S. officinalis leaves were examined via bioanalytical profiling using high-performance thin-layer chromatography (HPTLC) combined with nine bioactivity assays, namely antibacterial (Aliivibrio fischeri, Bacillus subtilis, and Rhodococcus fascians), antifungal (Bipolaris sorokiniana, and Fusarium avenaceum), radical scavenging (DPPH•), and enzyme inhibitory (α-glucosidase, acetylcholinesterase, and lipase) ones.

Stability Study of Constituents and Investigation of Their Membrane Permeability by ChemGPS-NP and the Parallel Artificial Membrane Permeability Assay.

Willd., greater galangal, has been used for thousands of years as a spice as well as in traditional medicine. Its central nervous system (CNS) stimulant activity and neuroprotective effects have been proved both in animal models and human trials.

Validation of the Musculoskeletal Health Questionnaire in a general population sample: a cross-sectional online survey in Hungary.

Background: The Versus Arthritis Musculoskeletal Health Questionnaire (MSK-HQ) measures symptom severity and health-related quality of life (HRQoL) of people with musculoskeletal (MSK) conditions. We aimed to test the psychometric properties of the MSK-HQ among the general adult population and identify the determinants of MSK-HQ states. In addition, we aimed to explore the relationship between MSK-HQ and standard well-being measurement tools.

Development, testing, and implementation of a new procedure to assess the clinical added benefit of pharmaceuticals.

Objectives: The reimbursement process for innovative health technologies in Hungary lacks any formalized assessment of clinical added benefit (CAB). The aim of this research is to present the development, retrospective testing, and implementation of a local assessment framework for determining the CAB of cancer treatments at the Department of Health Technology Assessment of the National Institute of Pharmacy and Nutrition in Hungary.

Methods: The assessment framework was drafted after screening existing methods and a retrospective comparison of local reimbursement dossiers to that of German and French methods.

A critical assessment framework to identify, quantify and interpret the sources of uncertainty in cost-effectiveness analyses.

Background: Using a standardized approach to describe the sources of uncertainty in cost-effectiveness analyses might bring added value to the local critical assessment procedure of reimbursement submissions in Hungary. The aim of this research is to present a procedural framework to identify, quantify and interpret sources of uncertainty, using the reimbursement dossier of darolutamide as an illustrative example.

Methods: In the procedural framework designed for the critical assessment of cost-effectiveness analyses, the quantifiability of an identified source of uncertainty is assessed through the input parameters of the originally submitted model, which is followed by the interpretation of its impact on estimates of costs and outcomes compared to the base case cost-effectiveness conclusion.

Patient-centred care in Hungary: Contributions to foster a policy agenda.

In Hungary, the National Health Insurance Fund provides health care coverage for nearly all residents, but healthcare spending is below the EU's average (6.4% versus 9.9% of the GDP in 2019, respectively).

Type Strains of Entomopathogenic Nematode-Symbiotic Bacterium Species, (EMC) and (EMA), Are Exceptional Sources of Non-Ribosomal Templated, Large-Target-Spectral, Thermotolerant-Antimicrobial Peptides (by Both), and Iodinin (by EMC).

Antimicrobial multidrug resistance (MDR) is a global challenge, not only for public health, but also for sustainable agriculture. Antibiotics used in humans should be ruled out for use in veterinary or agricultural settings. Applying antimicrobial peptide (AMP) molecules, produced by soil-born organisms for protecting (soil-born) plants, seems a preferable alternative.

Methodology and implementation of the WHO European Childhood Obesity Surveillance Initiative (COSI).

Establishment of the WHO European Childhood Obesity Surveillance Initiative (COSI) has resulted in a surveillance system which provides regular, reliable, timely, and accurate data on children's weight status-through standardized measurement of bodyweight and height-in the WHO European Region. Additional data on dietary intake, physical activity, sedentary behavior, family background, and school environments are collected in several countries. In total, 45 countries in the European Region have participated in COSI.

Goldenrod Root Compounds Active against Crop Pathogenic Fungi.

Root extracts of three goldenrods were screened for antimicrobial compounds. 2,8- and 2,8-matricaria esters from European goldenrod () and - and -dehydromatricaria esters from grass-leaved goldenrod () and first from showy goldenrod () were identified by high-performance thin-layer chromatography combined with effect-directed analysis and high-resolution mass spectrometry or nuclear magnetic resonance spectroscopy after liquid chromatographic fractionation and isolation. Next to their antibacterial effects (against , , and pv.

Dietary Sodium and Potassium Intake in Hungarian Elderly: Results from the Cross-Sectional Biomarker2019 Survey.

High sodium intake and inadequate potassium intake are associated with high blood pressure. The elderly are more salt sensitive than other age groups, yet a reliable estimate of the dietary sodium and potassium intake of this age group in Hungary is unavailable. The study aimed to estimate the sodium and potassium intakes in the Hungarian elderly from 24 h urine sodium and potassium excretion.

Socioeconomic differences in food habits among 6- to 9-year-old children from 23 countries-WHO European Childhood Obesity Surveillance Initiative (COSI 2015/2017).

Background: Socioeconomic differences in children's food habits are a key public health concern. In order to inform policy makers, cross-country surveillance studies of dietary patterns across socioeconomic groups are required. The purpose of this study was to examine associations between socioeconomic status (SES) and children's food habits.

The grass root endophytic fungus Flavomyces fulophazii: An abundant source of tetramic acid and chlorinated azaphilone derivatives.

Fungal endophytes are remarkable sources of biologically active metabolites of ecological and pharmacological significance. In this study, fungal isolates producing yellow pigments and originating from grass roots, were identified as the recently described grass root colonizing dark septate endophyte (DSE), Flavomyces fulophazii (Periconiaceae, Pleosporales). While analyzing the metabolite composition of 17 isolates of this fungus, 11 previously undescribed compounds, including four tetramic acids (dihydroxyvermelhotin, hydroxyvermelhotin, methoxyvermelhotin, oxovermelhotin), and seven chlorinated azaphilones (flavochlorines A-G), together with the known tetramic acid vermelhotin, were tentatively identified by high performance liquid chromatography (HPLC)-tandem mass spectrometry (MS/MS).

High sugar content of European commercial baby foods and proposed updates to existing recommendations.

The aim was to determine whether commercial baby foods marketed within Europe (up to 36 months of age) have inappropriate formulation and high sugar content and to provide suggestions to update European regulations and recommendations as part of a nutrient profile model developed for this age group. The latter was produced following recommended World Health Organization (WHO) steps, including undertaking a rapid literature review. Packaging information from countries across the WHO European region was used to determine mean energy from total sugar by food category.

Liquid chromatographic method for the simultaneous determination of achiral and chiral impurities of dapoxetine in approved and counterfeit products.

A reversed-phase high performance liquid chromatographic method was developed and validated for the simultaneous determination of the related substances of S-dapoxetine, including R-dapoxetine, (3S)-3-(dimethylamino-3-phenyl-1-propanol), S-3-amino-3-phenyl-1-propanol, 1-naphtol, 4-phenyl-2H,3H,4H-naphtho[1,2-b]pyran and 1-(2E)-Cinnamyloxynaphthalene. During the screening experiments seven different polysaccharide-type chiral stationary phases (amylose-based Lux-Amylose-1, Lux-i-Amylose-1 and Lux-Amylose-2, as well as cellulose-based Lux-Cellulose-1, Lux-Cellulose-2, Lux-Cellulose-3 and Lux-Cellulose-4) were tested in polar organic mode using a mobile phase consisting of 0.1% diethylamine in methanol, ethanol, 2-propanol and acetonitrile with 0.

Traditional Eastern European diet and mortality: prospective evidence from the HAPIEE study.

Purpose: Cardiovascular disease (CVD) and cancer mortality rates in Eastern Europe are among the highest in the world. Although diet is an important risk factor, traditional eating habits in this region have not yet been explored. This analysis assessed the relationship between traditional dietary pattern and mortality from all-causes, CVD and cancer in Eastern European cohorts.

Inequalities in education and national income are associated with poorer diet: Pooled analysis of individual participant data across 12 European countries.

Background: Malnutrition linked to noncommunicable diseases presents major health problems across Europe. The World Health Organisation encourages countries to conduct national dietary surveys to obtain data to inform public health policies designed to prevent noncommunicable diseases.

Methods: Data on 27334 participants aged 19-64y were harmonised and pooled across national dietary survey datasets from 12 countries across the WHO European Region.

Fast, Spectroscopy-Based Prediction of In Vitro Dissolution Profile of Extended Release Tablets Using Artificial Neural Networks.

The pharmaceutical industry has never seen such a vast development in process analytical methods as in the last decade. The application of near-infrared (NIR) and Raman spectroscopy in monitoring production lines has also become widespread. This work aims to utilize the large amount of information collected by these methods by building an artificial neural network (ANN) model that can predict the dissolution profile of the scanned tablets.

Prevalence of Severe Obesity among Primary School Children in 21 European Countries.

Background: The World Health Organization (WHO) European Childhood Obesity Surveillance Initiative (COSI) was established more than 10 years ago to estimate prevalence and monitor changes in overweight and obesity in children aged 6-9 years. Since then, there have been five rounds of data collection in more than 40 countries involving more than half a million children. To date, no comparative studies with data on severe childhood obesity from European countries have been published.

Enhancing Pharmacovigilance Capabilities in the EU Regulatory Network: The SCOPE Joint Action.

In November 2013, a team of European regulators initiated the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. Funded by the Health Programme of the European Union, and with contributions from the involved Member States, SCOPE gathered information and expertise on how regulators in Member States run their national pharmacovigilance systems to meet the requirements of the pharmacovigilance legislation that came into effect in June 2012. The SCOPE project evaluated then-current practices and developed tools to further improve the skills and capability in the pharmacovigilance network.

Good practice criteria for childhood obesity prevention in kindergartens and schools-elaboration, content and use.

Background: In accordance with the policy actions that address childhood overweight and obesity at European level and as a contribution to the EU Action Plan on Childhood Obesity 2014-20, a Joint Action on Nutrition and Physical Activity (JANPA) was established. As part of JANPA work package 6, an evaluation framework to identify good practices, targeting childhood obesity prevention in kindergartens and schools, was developed. This article describes the WP 6 JANPA framework of good practice criteria and its development, compares it to other frameworks and discusses its potential for future use.