Level Of Public Health Protection Research Articles

Pharmaceuticals: Management Safety of Circulation of Drugs

The adoption and implementation of EU pharmaceutical directives and regulatory documents in Ukraine will significantly enhance the level of public health protection. Establishing a unified pharmaceutical market with EU countries will also improve the safety, quality, and accessibility of medications in Ukraine. To achieve these objectives, a comprehensive system for managing drug circulation safety has been proposed, with detailed functions and roles elaborated. Key components of this safety management system include robust monitoring mechanisms, stringent regulatory compliance measures, and effective communication channels among stakeholders. By implementing these measures, Ukraine can ensure that drugs are safe, effective, and of high quality, thereby fostering greater public trust in the healthcare system. Additionally, the integration of advanced technologies and best practices from EU countries can streamline drug approval processes, reduce counterfeit medications, and enhance pharmacovigilance. Efforts to improve the circulation of drugs will not only guarantee their safety and quality but also make them more readily available to the population. This will involve upgrading infrastructure, enhancing regulatory frameworks, and fostering collaboration with international pharmaceutical organizations. Overall, these initiatives are crucial for aligning Ukraine's pharmaceutical sector with European standards, ultimately leading to better health outcomes for its citizens and a more resilient healthcare system.

Food labelling

Abstract The Commission has undertaken to regulate the information provided to consumers on food. In particular, it intends to propose mandatory front-of-pack nutrition labelling (FoPNL) for food by the end of 2022. Even though nutrition labelling has been regulated by the EU since 1990, the tactics of industry, with the support of a minority of Member States, have prevented, so far, the adoption of a single, EU-wide, mandatory FoPNL scheme. Questions therefore arise regarding the extent to which the EU may secure agreement for the adoption of an EU-wide scheme which could effectively contribute to a high level of public health protection.

A quantitative risk metric to support individual sanitary measure reviews in international trade

In order for the United States Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) to make an equivalence determination for a foreign meat, poultry or egg products inspection procedure that differs from FSIS inspection procedures (an Individual Sanitary Measure or ISM), a country must demonstrate objectively that its food safety inspection system provides the same level of public health protection as the FSIS inspection system. To evaluate microbiological testing data that such countries may submit to this end, we present a possible risk metric to inform FSIS's assessment of whether products produced under an alternative inspection system in another country pose no greater consumer risk of foodborne illness than products produced under FSIS inspection. This metric requires evaluation of prevalence estimates of pathogen occurrence in products for the foreign country and the U.S. and determining what constitutes an unacceptable deviance of another country's prevalence from the U.S. prevalence, i.e., the margin of equivalence. We define the margin of equivalence as a multiple of the standard error of the U.S. prevalence estimate. Minimizing the margin of equivalence ensures the maximum public health protection for U.S. consumers, but an optimum choice must also avoid undue burden for quantitative data from alternative inspection systems in the foreign country. Across a wide range of U.S. prevalence levels and sample sizes, we determine margin of equivalence values that provide high confidence in conclusions as to whether or not the country's product poses no greater risk of foodborne illness from microbiological pathogens. These margins of equivalence can be used to inform FSIS's equivalence determination for an ISM request from a foreign country. Illustrative examples are used to support this definition of margin of equivalence.This approach is consistent with the World Trade Organization's concept of risk equivalence and is transparent and practical to apply in situations when FSIS makes an equivalence determination for an ISM requested by a foreign country.

A framework for chemical safety assessment incorporating new approach methodologies within REACH

The long-term investment in new approach methodologies (NAMs) within the EU and other parts of the world is beginning to result in an emerging consensus of how to use information from in silico, in vitro and targeted in vivo sources to assess the safety of chemicals. However, this methodology is being adopted very slowly for regulatory purposes. Here, we have developed a framework incorporating in silico, in vitro and in vivo methods designed to meet the requirements of REACH in which both hazard and exposure can be assessed using a tiered approach. The outputs from each tier are classification categories, safe doses, and risk assessments, and progress through the tiers depends on the output from previous tiers. We have exemplified the use of the framework with three examples. The outputs were the same or more conservative than parallel assessments based on conventional studies. The framework allows a transparent and phased introduction of NAMs in chemical safety assessment and enables science-based safety decisions which provide the same level of public health protection using fewer animals, taking less time, and using less financial and expert resource. Furthermore, it would also allow new methods to be incorporated as they develop through continuous selective evolution rather than periodic revolution.

Recommendations for public health protection against flood disaster

Flood disaster is one of the most serious natural disasters in the world, and it could pose an inestimable impact on the affected people. Based on existing laws, regulations, and emergency manuals in China, extensive literature review, epidemiological and related protection evidence, and expert consultation, this study analyzed different health risk factors of flood disaster and proposed a multi-stage, multi-population, and multi-phase comprehensive protection measures for the public in the perspective of pre-event prevention, in-event intervention and post-event rescue strategy, which could provide a scientific basis for improving the level of public health protection against the flood disaster and corresponding health outcomes.

INFLUENCE OF METEOROLOGICAL CONDITIONS ON THE LEVEL OF POLLUTION OF THE AIRALE TERRITORIES

The concept of risk assessment is currently considered in most countries of the world as the main mechanism for the development and adoption of managerial decisions at all levels of public health protection. The concept of risk assessment is based on determining the individual and collective (population) risk of a pathological condition under the influence of adverse environmental factors [1, 2]. In modern conditions, public health directly depends on the safety of the environment and the level of disease prevention. The activity of a modern person is carried out in conditions of an increase in the intensity and duration of the action of adverse environmental factors. The combination, simultaneous or sequential action of several factors leads to a mutual burdening of their influence on the human body, causing a rapid depletion of human physiological reserves. In response to the effect of a certain dose (intensity and duration) of unfavorable factors, states of extreme stress of adaptation mechanisms with reversible phenomena of maladjustment can develop [3]. Environmental safety is the levels of exposure to environmental factors that are safe for human health, that is, they violate the homeostasis of the functional systems of the body. The analysis of associative relationships between the content of metals and homeostatic indicators of the most sensitive systems of the body showed that for a safe and normal state of indicators of blood, biochemical metabolism, immunity, upper limits of the environmentally safe content of metals in human blood can be proposed.

Developing a Financing System to Support Public Health Infrastructure.

All people in the United States deserve the same level of public health protection, making it crucial that every health department across the country has a core set of foundational capabilities. Current research indicates an annual cost of $32 per person to support the foundational public health capabilities needed to promote and protect health for everyone across the nation. Yet national investment in public health capabilities is currently about $19 per person, leaving a $13-per-person gap in annual spending.To "create the conditions in which people can be as healthy as possible" and to protect national security, this gap must be filled. The Public Health Leadership Forum convened national experts in the public health, public policy, and other partner sectors to develop options for long-term, sustainable financing. The group aligned around core principles and criteria necessary to establish a sustainable financing structure.Informed by the work of the expert panel, the authors recommend a Public Health Infrastructure Fund for state, territorial, local, and tribal governmental public health, that would provide $4.5 billion of new, permanent resources needed to fully support core public health foundational capabilities.

Analysis of Foreign Matter in Foodstuffs Using the Light Filth Test: Report 2012-2013.

The European legislation set the new hygiene standards in food chain with the purpose to ensure high levels of public health protection in relation to food production. In order to guarantee excellent hygiene standards in food chain, particular attention must be paid to the presence of foreign matter, like light solid impurities of mineral, vegetable or animal origin. The light filth test is a suitable method used to detect and count light solid impurities applicable to different foodstuffs. We report the results of the analysis of 93 foodstuffs official samples investigated for the presence of foreign matter at the Institute for Experimental Veterinary Medicine of Sardinia, from 2012 to 2013. Insect fragments were found in a sample of semolina and in a sample of canned tomato; plastic fragments were found in a sample of grated bread.

Estimated human health risks from recreational exposures to stormwater runoff containing animal faecal material

Scientific evidence supporting recreational water quality benchmarks primarily stems from epidemiological studies conducted at beaches impacted by human fecal sources. Epidemiological studies conducted at locations impacted by non-human faecal sources have provided ambiguous and inconsistent estimates of risk. Quantitative Microbial Risk Assessment (QMRA) is another tool to evaluate potential human health risks from recreational exposures to non-human faecal contamination. The potential risk differential between human and selected non-human faecal sources has been characterized previously for direct deposition of animal feces to water. In this evaluation, we examine the human illness potential from a recreational exposure to freshwater impacted by rainfall-induced runoff containing agricultural animal faecal material. Risks associated with these sources would be at least an order of magnitude lower than the benchmark level of public health protection associated with current US recreational water quality criteria, which are based on contamination from human sewage sources.

Waterpipes and e-cigarettes: Impact of alternative smoking techniques on indoor air quality and health

Waterpipe (WP) smoking is growing as an alternative to cigarette smoking, especially in younger age groups. E-cigarette use has also increased in recent years. A majority of smokers mistakenly believe that WP smoking is a social entertainment practice that leads to more social behavior and relaxation and that this type of smoking is safe or less harmful and less addictive than cigarette smoking. In reality, WP smokers are exposed to hundreds of toxic substances that include known carcinogens. High exposures to carbon monoxide and nicotine are major health threats. Persons exposed to secondhand WP smoke are also at risk. There is growing evidence that WP smoke causes adverse effects on the pulmonary and cardiovascular systems and is responsible for cancer.E-cigarettes are marketed as a smokeless and safe way to inhale nicotine without being exposed to the many toxic components of tobacco cigarettes, and as an aid to smoking cessation. In fact, consumers (vapers) and secondhand vapers can be exposed to substantial amounts of VOC, PAH or other potentially harmful substances. Of major health concern is the inhalation of fine and ultrafine particles formed from supersaturated 1,2-propanediol vapor. Such particles can be deposited in the deeper parts of the lung and may harm the respiratory system or increase the risk of acquiring asthma. More research on the safety of e-cigarettes needs to be conducted to ensure a high level of public health protection in the long-term.

An Alternative Approach to Water Regulations for Public Health Protection at Bathing Beaches

New approaches should be considered as the US Environmental Protection Agency (EPA) moves rapidly to develop new beach monitoring guidelines by the end of 2012, as these guidelines serve as the basis by which states and territories with coasts along the oceans and Great Lakes can then develop and implement monitoring programs for recreational waters. We describe and illustrate one possible approach to beach regulation termed as the “Comprehensive Toolbox within an Approval Process (CTBAP).” The CTBAP consists of three components. The first is a “toolbox” consisting of an inventory of guidelines on monitoring targets, a series of measurement techniques, and guidance to improve water quality through source identification and prevention methods. The second two components are principles of implementation. These include first, “flexibility” to encourage and develop an individualized beach management plan tailored to local conditions and second, “consistency” of this management plan to ensure a consistent national level of public health protection. The results of this approach are illustrated through a case study at a well-studied South Florida recreational marine beach. This case study explores different monitoring targets based on two different health endpoints (skin versus gastrointestinal illness) and recommends a beach regulation program for the study beach that focuses predominately on source prevention.

Disinfection by-products in drinking water – a case study on Calgary, Alberta, Canada

Disinfection by-products (DBPs) have been monitored in Calgary's drinking water for approximately 15 years. The variability of the DBPs has typically exhibited similar patterns over the period of monitoring. Due to the nature of the surface waters supplying the water treatment plants, the level of DBPs was largely influenced by surface runoff events where the level of natural organic matter (NOM) increased, which was characterized by a relatively high total organic carbon (TOC) content. Principal component analysis (PCA) was utilized for this study to quickly identify the key underlying correlations present within the very large, complex multivariate data matrix. Apart from TOC, chlorine demand, chlorine residual and temperature were observed to correlate with the formation of DBPs in the finished drinking water. In addition to TOC, PCA also indicates that pH and temperature in the distribution system could have an influence on the variability of DBPs in Calgary's drinking water. It was apparent that upgrades to the water treatment systems in Calgary have resulted in an improved removal of DBP precursors such as NOM prior to chlorination, which is a key factor in reducing the DBP levels in the drinking water, thereby providing an enhanced level of public health protection.

Community Referrals — Opportunities for Improvements

The pharmaceutical regulatory environment in Europe has changed dramatically over the past two decades with the establishment of the European Economic Area Agreement and the European Union. The Community has instituted a progressive programme of harmonising medicines legislation with the objective of creating a genuine single market in the pharmaceutical sector, while ensuring a high level of public health protection. This article analyses the Community referral procedures for medicinal products for human use that are used to resolve disagreements between member states. The results are used not only to identify opportunities for improvement in the referral process but also to indicate to the applicant possible improvements in registration strategy.

Freedom of Commercial Expression and Public Health Protection in Europe

Abstract This chapter focuses on the extent to which public health has been relied upon by the EU legislature or by Member States of the European Union to limit the freedom of commercial operators to promote their goods and services. First, it discusses why courts in the United States and in Europe have ruled that the freedom of commercial operators to advertise their goods and services should be protected, in light of the fundamental role advertising plays in a liberal market economy. It shows that freedom of commercial expression has been made conditional upon the disclosure of sufficient and reliable information to consumers, thus reflecting a model of consumer protection based on the well-informed and reasonably circumspect consumer. Secondly, it addresses the more controversial question of the extent to which public health may be invoked as an overriding requirement of public interest to curtail the right of commercial operators to promote their goods and services. The approach of the Court of Justice is compared with that taken by the US Supreme Court. This comparative approach highlights the differences between the two: the former is very reluctant to exercise its review powers, while the latter has made it excessively difficult for public authorities to impose any meaningful advertising restrictions. It is argued that neither court has been able to strike a suitable balance between, one the one hand, the need to review the validity of restrictions imposed by public authorities on commercial speech to ensure a high level of public health protection and, one the other hand, the need to ensure that courts do not substitute their assessment to that of the legislature in exercising their judicial review powers. A more balanced approach is required to ensure the adequate protection of consumer health.

Freedom of Commercial Expression and Public Health Protection in Europe

AbstractThis chapter focuses on the extent to which public health has been relied upon by the EU legislature or by Member States of the European Union to limit the freedom of commercial operators to promote their goods and services. First, it discusses why courts in the United States and in Europe have ruled that the freedom of commercial operators to advertise their goods and services should be protected, in light of the fundamental role advertising plays in a liberal market economy. It shows that freedom of commercial expression has been made conditional upon the disclosure of sufficient and reliable information to consumers, thus reflecting a model of consumer protection based on the well-informed and reasonably circumspect consumer. Secondly, it addresses the more controversial question of the extent to which public health may be invoked as an overriding requirement of public interest to curtail the right of commercial operators to promote their goods and services. The approach of the Court of Justice is compared with that taken by the US Supreme Court. This comparative approach highlights the differences between the two: the former is very reluctant to exercise its review powers, while the latter has made it excessively difficult for public authorities to impose any meaningful advertising restrictions. It is argued that neither court has been able to strike a suitable balance between, one the one hand, the need to review the validity of restrictions imposed by public authorities on commercial speech to ensure a high level of public health protection and, one the other hand, the need to ensure that courts do not substitute their assessment to that of the legislature in exercising their judicial review powers. A more balanced approach is required to ensure the adequate protection of consumer health.

Evaluation of Fecal Pollution Indicators in an Oyster Quality Assurance Program: Application of Epidemiological Methods

Shellfish Quality Assurance programs rely on the use of bacteriological fecal pollution indicators as a routine monitoring tool for risk assessment and management in shellfish growing areas. Internationally, shellfish programs vary in detail but are typically based on either the United States model, as in Australia, which relies on the enumeration of indicator bacteria in water as a measure of fecal pollution, or the European Union model, which assesses the exposure of production sites to fecal pollution by determining indicator bacteria present in shellfish flesh. The equivalency of these approaches for delivering the same level of public health protection is not immediately apparent Both indicator tests are used in combination in a very conservative approach adopted in the Australian state of New South Wales (NSW) by the Shellfish Program for the oyster (predominately Sydney rock oyster) fishery, the country's oldest and the state's most productive fishery. This study reports on the analysis of a large data set of these two indicators taken at multiple sites within three NSW estuaries between 2000 and 2005. We report on performance measures used routinely in epidemiological studies to compare the two tests. These measures demonstrate poor agreement between the two tests. When the harvest area is deemed closed by the water test the odds of a negative test based on shellfish flesh is approximately one in four. Conversely, the odds of a positive test based on shellfish flesh occurring during extended periods of dry weather when the water test is clear exceed one in five and are seemingly random in occurrence. We are able to demonstrate a highly significant statistical relationship between the water test and environmental covariates of rainfall, salinity, and water temperature. We use k-fold cross validation methods to develop predictive models using these environmental covariates that can account for over 90% of the variation in water test readings. In contrast we are unable to demonstrate a valid predictive model for the oyster flesh test using these covariate. We discuss the results of these analyses and suggest that there are significant issues with the efficacy of the shellfish flesh test and, in particular, the unexplained systematic error that occurs at a high rate in the current program. The dual use of these tests in harvest management results in routine uncertainty that must create significant unpredictability and costs in trade. In turn, this uncertainty and the costs of testing result in levels of commercial risk that could prove unsustainable. The study highlights the need for the performance of tests to be rigorously appraised in shellfish quality assurance programs. In so doing it may be possible to maintain public health standards while minimizing unnecessary disruptions and costs in the trade of fresh oysters.

Die Trinkwasserverordnung 2001 – bewährt oder revisionsbedürftig?

The current regulatory approach in Germany combines regulations defined in the Drinking Water Ordinance with a comprehensive catalogue of technical rules as well as with guidelines and recommendations by the Federal Environment Agency and the Drinking Water Commission. This approach has proven successful in practice. Some parts would benefit from revision. The regulator is currently contemplating some revision in order to take experience of federal, state and local authorities as well as of water suppliers with implementation of the current Ordinance into account. The intention is improvement particularly towards reducing bureaucracy without compromising the current high level of public health protection through drinking water hygiene in Germany.

Setting microbiological water quality standards for sea bathing - a critical evaluation

The World Health Organization (WHO) recently produced draft guidelines for safe recreational water environments. The microbiological standards proposed in the guidelines are expected to overestimate the degree of water quality required to provide given levels of public health protection. The WHO standards were obtained by means of a risk assessment which featured a dose-response model derived from a series of randomised controlled trials. The trials have many strengths but biases and problems with statistical analysis are likely to have led to over-estimation of the risks from bathing in the dose-response model. In addition, the WHO risk assessment failed to consider the effects of uncertainty and variability in risk estimates and sensitivity to model assumptions. Improved standards could be obtained by extending the risk assessment to examine these effects and by incorporating a suitably revised dose-response model.

Monitoring the marine environment for small round structured viruses (SRSVS): a new approach to combating the transmission of these viruses by molluscan shellfish

This study investigates human enteric virus contamination of a shellfish harvesting area. Samples were analysed over a 14-month period for Small Round Structured Viruses (SRSVs) using a previously developed nested RT-PCR. A clear seasonal difference was observed with the largest numbers of positive samples obtained during the winter period (October to March). This data concurs with the known winter association of gastroenteric illness due to oyster consumption in the UK and also with the majority of the outbreaks associated with shellfish harvested from this area during the study period. RT-PCR positive amplicons were further characterised by cloning and sequencing. Sequence analysis of the positive samples identified eleven SRSV strains, of both Genogroup I and Genogroup II, occurring throughout the study period. Many shellfish samples contained a mixture of strains with a few samples containing up to three different strains with both Genogroups represented. The observed common occurrence of strain mixtures may have implications for the role of shellfish as a vector for dissemination of SRSV strains. These results show that nested RT-PCR can identify SRSV contamination in shellfish harvesting areas. Virus monitoring of shellfish harvesting areas by specialist laboratories using RT-PCR is a possible approach to combating the transmission of SRSVs by molluscan shellfish and could potentially offer significantly enhanced levels of public health protection.

Monitoring the marine environment for Small Round Structured Viruses (SRSVS): A new approach to combating the transmission of these viruses by molluscan shellfish

This study investigates human enteric virus contamination of a shellfish harvesting area. Samples were analysed over a 14-month period for Small Round Structured Viruses (SRSVs) using a previously developed nested RT-PCR. A clear seasonal difference was observed with the largest numbers of positive samples obtained during the winter period (October to March). This data concurs with the known winter association of gastroenteric illness due to oyster consumption in the UK and also with the majority of the outbreaks associated with shellfish harvested from this area during the study period. RT-PCR positive amplicons were further characterised by cloning and sequencing. Sequence analysis of the positive samples identified eleven SRSV strains, of both Genogroup I and Genogroup II, occurring throughout the study period. Many shellfish samples contained a mixture of strains with a few samples containing up to three different strains with both Genogroups represented. The observed common occurrence of strain mixtures may have implications for the role of shellfish as a vector for dissemination of SRSV strains. These results show that nested RT-PCR can identify SRSV contamination in shellfish harvesting areas. Virus monitoring of shellfish harvesting areas by specialist laboratories using RT-PCR is a possible approach to combating the transmission of SRSVs by molluscan shellfish and could potentially offer significantly enhanced levels of public health protection.