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Enabling appropriate use of antibiotics: review of European Union procedures of harmonising product information, 2007 to 2020.

ABSTRACT: IntroductionAntimicrobial resistance (AMR) is one of the most important challenges in modern clinical practice. The European regulatory network has a strategy to support prevention of AMR by applying specific referral procedures.AimThe aim of this study was to evaluate post-authorisation changes made in the product information of key antibiotics that underwent referral procedures between 2007 and 2020.MethodIn a comprehensive analysis of the changes made for antibiotics, we extracted information on changes from the European Commission community register of medicinal products and the European Medicines Agency's database for antibiotics that went through referrals. Changes made in the specific sections of the summary of product characteristics of each referral procedure were scrutinised.ResultsWe identified 15 antibiotics from seven classes of antibiotics during the study period. The outcome of all referrals included the restriction of antibiotic use. Therapeutic indications were revised for all antibiotics, with septicaemia and gonorrhoea most common diseases removed. Posology and/or method of administration was updated for all; the majority of referrals included adjustment of dosage for specific populations. Information on contraindication (most regarding hypersensitivity) and information on warnings was amended for all referrals.ConclusionOur findings highlight the importance of the regulatory actions. The changes made in the product information aim to ensure appropriate use. Ongoing harmonisation activities are likely to lead to further refinements and restrictions on individual antibiotics in support of rational use. However, further research is required to examine the impact of post-referral label changes on the clinical practice.

SUBMITTER: Opalska A

PROVIDER: S-EPMC7667629 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Enabling appropriate use of antibiotics: review of European Union procedures of harmonising product information, 2007 to 2020.

Opalska Aleksandra A Kwa Marcel M Leufkens Hubert H Gardarsdottir Helga H

Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin 20201101 45

IntroductionAntimicrobial resistance (AMR) is one of the most important challenges in modern clinical practice. The European regulatory network has a strategy to support prevention of AMR by applying specific referral procedures.AimThe aim of this study was to evaluate post-authorisation changes made in the product information of key antibiotics that underwent referral procedures between 2007 and 2020.MethodIn a comprehensive analysis of the changes made for antibiotics, we extracted information ...[more]

PMID: 33183406

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Project description:This report of the EFSA and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring activities carried out in 2020 in 27 EU Member States (MS) and nine non-MS. Key statistics on zoonoses and zoonotic agents in humans, food, animals and feed are provided and interpreted historically. Two events impacted 2020 MS data collection and related statistics: the Coronavirus Disease 2019 (COVID-19) pandemic and the withdrawal of the United Kingdom from the EU. In 2020, the first and second most reported zoonoses in humans were campylobacteriosis and salmonellosis, respectively. The EU trend for confirmed human cases of these two diseases was stable (flat) from 2016 to 2020. Fourteen of the 26 MS reporting data on Salmonella control programmes in poultry met the reduction targets for all poultry categories. Salmonella results for carcases of various species performed by competent authorities were more frequently positive than own-checks conducted by food business operators. This was also the case for Campylobacter quantification results from broiler carcases for the MS group that submitted data from both samplers, whereas overall at EU level, those percentages were comparable. Yersiniosis was the third most reported zoonosis in humans, with 10-fold less cases reported than salmonellosis, followed by Shiga toxin-producing Escherichia coli (STEC) and Listeria monocytogenes infections. Illnesses caused by L. monocytogenes and West Nile virus infections were the most severe zoonotic diseases with the highest case fatality. In 2020, 27 MS reported 3,086 foodborne outbreaks (a 47.0% decrease from 2019) and 20,017 human cases (a 61.3% decrease). Salmonella remained the most frequently reported causative agent for foodborne outbreaks. Salmonella in 'eggs and egg products', norovirus in 'crustaceans, shellfish, molluscs and products containing them' and L. monocytogenes in 'fish and fish products' were the agent/food pairs of most concern. This report also provides updates on tuberculosis due to Mycobacterium bovis or Mycobacterium caprae, Brucella, Trichinella, Echinococcus, Toxoplasma, rabies, Coxiella burnetii (Q fever) and tularaemia.

Project description:This report provides a descriptive analysis of the African swine fever (ASF) Genotype II epidemic in the affected Member States in the EU and two neighbouring countries for the period from 1 September 2020 to 31 August 2021. ASF continued to spread in wild boar in the EU, it entered Germany in September 2020, while Belgium became free from ASF in October 2020. No ASF outbreaks in domestic pigs nor cases in wild boar have been reported in Greece since February 2020. In the Baltic States, overall, there has been a declining trend in proportions of polymerase chain reaction (PCR)-positive samples from wild boar carcasses in the last few years. In the other countries, the proportions of PCR-positive wild boar carcasses remained high, indicating continuing spread of the disease. A systematic literature review revealed that the risk factors most frequently significantly associated with ASF in domestic pigs were pig density, low levels of biosecurity and socio-economic factors. For wild boar, most significant risk factors were related to habitat, socio-economic factors and wild boar management. The effectiveness of different control options in the so-named white zones, areas where wild boar densities have been drastically reduced to avoid further spread of ASF after a new introduction, was assessed with a stochastic model. Important findings were that establishing a white zone is much more challenging when the area of ASF incursion is adjacent to an area where limited control measures are in place. Very stringent wild boar population reduction measures in the white zone are key to success. The white zone needs to be far enough away from the affected core area so that the population can be reduced in time before the disease arrives and the timing of this will depend on the wild boar density and the required population reduction target in the white zone. Finally, establishing a proactive white zone along the demarcation line of an affected area requires higher culling efforts, but has a higher chance of success to stop the spread of the disease than establishing reactive white zones after the disease has already entered in the area.

Project description:An update on the African swine fever (ASF) situation in the 10 affected Member States (MS) in the EU and in two neighbouring countries from the 1 September 2019 until the 31 August 2020 is provided. The dynamics of the proportions of PCR- and ELISA-positive samples since the first ASF detection in the country were provided and seasonal patterns were investigated. The impact of the ASF epidemic on the annual numbers of hunted wild boar in each affected MS was investigated. To evaluate differences in the extent of spread of ASF in the wild boar populations, the number of notifications that could be classified as secondary cases to a single source was calculated for each affected MS and compared for the earliest and latest year of the epidemic in the country. To evaluate possible risk factors for the occurrence of ASFV in wild boar or domestic pigs, a literature review was performed. Risk factors for the occurrence of ASF in wild boar in Romanian hunting grounds in 2019 were identified with a generalised linear model. The probability to find at least one PCR-confirmed ASF case in wild boar in a hunting ground in Romania was driven by environmental factors, wild boar abundance and the density of backyard pigs in the hunting ground area, while hunting-related variables were not retained in the final model. Finally, measures implemented in white zones (ASF-free zones that are geographically adjacent to an area where ASF is present in wild boar) to prevent further spread of ASF were analysed with a spatially, explicit stochastic individual-based model. To be effective, the wild boar population in the white zone would need to be drastically reduced before ASF arrives at the zone and it must be wide enough. To achieve the necessary pre-emptive culling targets of wild boar in the white zone, at the start of the establishment, the white zone should be placed sufficiently far from the affected area, considering the speed of the natural spread of the disease. This spread is faster in denser wild boar populations. After a focal ASF introduction, the white zone is always close to the infection hence pre-emptive culling measures in the white zone must be completed in short term, i.e. in a few months.

Dataset Information

Enabling appropriate use of antibiotics: review of European Union procedures of harmonising product information, 2007 to 2020.

Publications

Enabling appropriate use of antibiotics: review of European Union procedures of harmonising product information, 2007 to 2020.

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