Dataset Information

Hygiene inspections on passenger ships in Europe - an overview.

ABSTRACT:

Background

Hygiene inspections on passenger ships are important for the prevention of communicable diseases. The European Union (EU) countries conduct hygiene inspections on passenger ships in order to ensure that appropriate measures have been taken to eliminate potential sources of contamination which could lead to the spread of communicable diseases. This study was implemented within the framework of the EU SHIPSAN project and it investigates the legislation applied and practices of hygiene inspections of passenger ships in the EU Member States (MS) and European Free Trade Association countries.

Methods

Two questionnaires were composed and disseminated to 28 countries. A total of 92 questionnaires were completed by competent authorities responsible for hygiene inspections (n = 48) and the creation of legislation (n = 44); response rates were 96%, and 75.9%, respectively.

Results

Out of the 48 responding authorities responsible for hygiene inspections, a routine programme was used by 19 (39.6%) of these to conduct inspections of ships on national voyages and by 26 (54.2%) for ships on international voyages. Standardised inspection forms are used by 59.1% of the authorities. A scoring inspection system is applied by five (11.6%) of the 43 responding authorities. Environmental sampling is conducted by 84.1% of the authorities (37 out of 44). The inspection results are collected and analysed by 54.5% (24 out of 44) of the authorities, while 9 authorities (20.5%) declared that they publish the results. Inspections are conducted during outbreak investigations by 75% and 70.8% of the authorities, on ships on national and international voyages, respectively. A total of 31 (64.6%) and 39 (81.3%) authorities conducted inspections during complaint investigations on ships on international and on national voyages, respectively. Port-to-port communication between the national port authorities was reported by 35.4% (17 out of 48) of the responding authorities and 20.8% (10 out of 48) of the port authorities of other countries.

Conclusion

This study revealed a diversity of approaches and practices in the conduct of inspections, differences in the qualifications/knowledge/experience of inspectors, the legislation applied during inspections, and the lack of communication and training among many EU countries. An integrated European inspection programme involving competent expert inspectors in each EU Member States and special training for ship hygiene delivered to crew members and inspectors would help to minimize the risk of communicable diseases. Common inspection tools at a European level for hygiene inspection practices and port-to-port communication are needed.

SUBMITTER: Mouchtouri VA

PROVIDER: S-EPMC2847977 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundThe implementation of the Clinical Trials Directive 2001/20/EC and the Good Clinical Practice Directive 2005/28/EC fundamentally restructured and harmonized the conduct of clinical trials in Europe. GCP inspections - which affect study sites, laboratories, sponsors and contract research organizations (CRO) alike - make up an important part of these regulations. A common understanding of how these regulations apply in daily life is however not always ensured.MethodsA working group of the Clinical Research/Quality Assurance subcommittee of the German Association of Research-Based Pharmaceutical Companies (VFA) was established to outline the regulatory requirements, the experience gathered with inspections by means of a survey and to set up guidance on how to manage an inspection.Results and conclusionsThe survey, conducted with the help of 15 pharmaceutical companies within the VFA, included a total of 224 inspections (74 inspections in Germany, 150 from other European countries). Most frequent findings in and outside Germany were related to "documentation" (40.5% vs. 21.3%), "investigational new drugs" (16.2% vs. 14.7%), "drug safety" (13.5% vs. 8%) and "application for a clinical trial authorization" (5.4% vs. 12%). From a German perspective, key findings of this working group were the necessity for a clear differentiation of responsibilities between national and federal as well as international authorities, a harmonization of inspection procedures and topics, and a clarification of whether pre-study/on-study and pre-approval/post-approval GCP inspections of the federal higher authority are included in the "Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten" (ZLG) requirements. The survey illustrated, that inspections usually are conducted at the investigational site, and that most of the findings are well known and thus could be prevented by communicating and discussing audit results more intensely within study groups. Again, the survey illustrated, that a harmonization of inspections appears warranted. Finally a code of practice is provided that considers these findings and delivers a basis for a successful inspection whether at the sponsor or the GCP site.

Project description:Cars have a high share of global transport-related CO2 emissions. To model the market diffusion of new energy carriers and powertrains like electric vehicles, fleet turnover models are commonly used. A decisive influence factor for the substitution dynamics of such transformations is the survival rate of the national car fleet of a country. It represents the likelihood of a car reaching a certain lifespan. Due to a lack of data, current methods to estimate such survival probabilities neglect the imports and exports of used cars. Existing studies are limited to countries with a predominant market of new cars, compared to low numbers of imported and exported used cars. In this study, we resolve this marked simplification and propose a new method to estimate survival probabilities for countries with a high number of imported and exported used cars. Empirical data on the car stock, on inflows of new and used cars, and on outflows of exported and scrapped cars are gathered from 71 national statistics offices. Survival rates of the car fleets of 31 European countries are derived, for which we find a pronounced regional variability. Average lifespans of cars vary from 8.0 to 35.1 years, with a mean of 18.1 years in Western and 28.4 years in Eastern European countries, revealing the high impact of cross-border flows of cars. The study also shows that survival rate estimates can be improved significantly even in the absence of reliable data if a combination of a Weibull and a Gaussian distribution is used. It is likely that the predictive power of existing models (regarding the future environmental impact of car fleets) could be improved significantly if these findings were considered accordingly. The findings of this study can directly be included in fleet turnover and policy assessment models. They also enable the analysis of economic and environmental spillover effects from the imports and exports of used cars between countries. Supplementary Information The online version contains supplementary material available at (10.1186/s12544-020-00464-0).

Project description:Background and objectivesExternal reference pricing (ERP) is a price regulation tool widely used by policy makers in the European Union (EU) Member States (MS) to contain drug cost, although in theory, it may contribute to modulate prices up and down. The objective of this article was to summarise and discuss the main findings of part of a large project conducted for the European Commission ('External reference pricing of medicinal products: simulation-based considerations for cross-country coordination'; see www.ec.europa.eu/health/healthcare/docs/erp_reimbursement_medicinal_products_en.pdf) that aimed to provide an overview of ERP systems, both on processes and potential issues in 31 European countries (28 EU MS, Iceland, Norway, and Switzerland).MethodsA systematic structured literature review was conducted to identify and characterise the use of ERP in the selected countries, to describe its impact on the prices of pharmaceuticals, and to discuss the possible cross-country coordination issues in EU MS. This research was complemented with a consultation of competent authorities' and international organisations' representatives to address the main issues or uncertainties identified through the literature review.ResultsAll selected countries applied ERP, except the United Kingdom and Sweden. Twenty-three countries used ERP as the main systematic criterion for pricing. In the majority of European countries, ERP was based on legislated pricing rules with different levels of accuracy. ERP was applied either for all marketed drugs or for specific categories of medicines; it was mainly used for publicly reimbursed medicines. The number of reference countries included in the basket varied from 1 to 31. There was a great variation in the calculation methods used to compute the price; 15 countries used the average price, 7 countries used the lowest price, and 7 countries used other calculation methods. Reported limitations of ERP application included the lack of reliable sources of price information, price heterogeneity, exchange rate volatility, and hidden discounts. Spill-over effect and downward price convergence have often been mentioned as ERP's consequences leading to pricing strategies from pharmaceutical companies.ConclusionWhile ERP is widely used in Europe, processes and availability of price information vary from one country to another, thus limiting ERP implementation. Furthermore, ERP spill-over effect is a major concern of pharmaceutical firms leading to implementation of the so-called 'launch sequence strategies'.

Project description:BackgroundAcross European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe.ObjectivesThe aim of this article is to provide an overview of different initiatives and policies that may influence the uptake of biosimilars in different European countries. Recommendations will be formulated on how to create sustainable uptake.MethodsAn overview of policies on biosimilars was obtained via a questionnaire, supplemented with relevant articles. Topics were organized in five themes: availability, pricing, reimbursement, demand-side policies, and recommendations to enhance uptake.ResultsIn all countries studied, biological medicines are available. Restrictions are mainly dependent on local organization of the healthcare system. Countries are willing to include biosimilars for reimbursement, but for commercial reasons they are not always marketed. In two thirds of countries, originator and biosimilar products may be subjected to internal reference pricing systems. Few countries have implemented specific incentives targeting physicians. Several countries are implementing pharmacist substitution; however, the scope and rules governing such substitution tend to vary between these countries. Reported educational policies tend to target primarily physicians, whereas fewer initiatives were reported for patients. Recommendations as proposed by the different country experts ranged from the need for information and communication on biosimilars to competitive pricing, more support for switching and guidance on substitution.ConclusionsMost countries have put in place specific supply-side policies for promoting access to biosimilars. To supplement these measures, we propose that investments should be made to clearly communicate on biosimilars and educate stakeholders. Especially physicians need to be informed on the entry and use of biosimilars in order to create trust. When physicians are well-informed on the treatment options, further incentives should be offered to prescribe biosimilars. Gainsharing can be used as an incentive to prescribe, dispense or use biosimilars. This approach, in combination with binding quota, may support a sustainable biosimilar market.

Project description:BackgroundSeafarers play an important role in the transmission of communicable diseases. The aim of the present study is to draw information and identify possible gaps on occupational health practices related to seafarers sailing on ships within the European Union Member States (EU MS) with focus on communicable diseases.MethodsA structured questionnaire was sent to competent authorities from 21 EU MS. The questionnaire included questions about occupational health policies, medical certification of seafarers, communicable diseases reporting and relevant legislation. Descriptive analysis of the data was conducted by the use of Epi Info software: EU MS were categorized in four priority groups (A, B, C, D) based on: number of passenger ships visits, volume of passengers, and number of ports in each country. Moreover, EU MS were categorized to old and new, based on the date of entry in the EU.ResultsAll 21 countries with relevant competent authorities responded to the questionnaire. The existence of specific national legislation/regulation/guidelines related to vaccination of seafarers was reported by three out of the 21 (14%) responding authorities. Surveillance data of communicable diseases related to seafarers are collected and analyzed by 4 (19%) authorities. Five out of 21 of the responding countries (24%) reported that tuberculin test result is required for the issuance of seafarer's medical certificate while a great variety of medical examination is required for the issuance of this certificate among countries.Gaps on occupational health services focused on communicable diseases related to maritime occupation have been reported by 33% of the responding countries.Responding authorities from Group A and B had the highest percentage of reported gaps followed by groups C and D. Old MS reported a higher frequency regarding gaps on occupational health services in comparison to new MS.ConclusionOur results revealed heterogeneity regarding occupational health of maritime employees in EU MS. This work provides some evidence that further work at international and European level could be considered, in order to explore the potential for harmonized initiatives regarding occupational health of seafarers.

Project description:ObjectivesThe Network on the Coordination and Harmonisation of European Occupational Cohorts (OMEGA-NET) was set up to enable optimization of the use of industrial and general population cohorts across Europe to advance aetiological research. High-quality harmonized exposure assessment is crucial to derive comparable results and to enable pooled analyses. To facilitate a harmonized research strategy, a concerted effort is needed to catalogue available occupational exposure information. We here aim to provide a first comprehensive overview of exposure assessment tools that could be used for occupational epidemiological studies.MethodsAn online inventory was set up to collect meta-data on exposure assessment tools. Occupational health researchers were invited via newsletters, editorials, and individual e-mails to provide details of job-exposure matrices (JEMs), exposure databases, and occupational coding systems and their associated crosswalks to translate codes between different systems, with a focus on Europe.ResultsMeta-data on 36 general population JEMs, 11 exposure databases, and 29 occupational coding systems from more than 10 countries have been collected up to August 2021. A wide variety of exposures were covered in the JEMs on which data were entered, with dusts and fibres (in 14 JEMs) being the most common types. Fewer JEMs covered organization of work (5) and biological factors (4). Dusts and fibres were also the most common exposures included in the databases (7 out of 11), followed by solvents and pesticides (both in 6 databases).ConclusionsThis inventory forms the basis for a searchable web-based database of meta-data on existing occupational exposure information, to support researchers in finding the available tools for assessing occupational exposures in their cohorts, and future efforts for harmonization of exposure assessment. This inventory remains open for further additions, to enlarge its coverage and include newly developed tools.