HSE - LenusThe Lenus digital repository system captures, stores, indexes, preserves, and distributes digital research material.http://www.lenus.ie:802024-03-27T16:40:08Z2024-03-27T16:40:08ZReport on the Uptake of the Influenza Vaccine for Health Care Workers (HCWs) and Residents in Long-Term/Residential Care Facilities (LTCFs/RCFs) 2022-2023 SeasonHealth Protection Surveillance Centre (HPSC)http://hdl.handle.net/10147/6413192024-03-27T15:48:11Z2023-08-01T00:00:00ZReport on the Uptake of the Influenza Vaccine for Health Care Workers (HCWs) and Residents in Long-Term/Residential Care Facilities (LTCFs/RCFs) 2022-2023 Season
Health Protection Surveillance Centre (HPSC)
This HSE-HPSC report on the uptake of the influenza vaccine for the current season 2022-2023 presents results based on a number of data sources, focussing on data obtained from both hospitals and long-term/residential care facilities (LTCFs or RCFs). These capture uptake in health care workers (HCWs) based in acute hospitals and also among HCWs and residents in LTCFs.
The data presented in this report are for the influenza season 2022-2023. Nationally, the HSE target uptake of 75% remained unchanged from the previous season.
2023-08-01T00:00:00ZBrexit Guide for Stakeholders Organisations Responsible for Human Application of Tissues and Cells - HospitalsHealth Products Regulatory Authority (HPRA)http://hdl.handle.net/10147/6413182024-03-27T15:47:45Z2020-11-20T00:00:00ZBrexit Guide for Stakeholders Organisations Responsible for Human Application of Tissues and Cells - Hospitals
Health Products Regulatory Authority (HPRA)
As the UK will become a third country, following Brexit, we would like to draw your attention to the fact that import of tissues into Ireland from outside of the European Union (EU), i.e. a third country, must only take place under an authorisation by the HPRA. There is still uncertainty surrounding the content of the withdrawal agreement, but stakeholders should be prepared. It is important to consider the impact Brexit may have on your supply of tissues and cells.
The recently published Directive 2015/566 is an implementing Directive of 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells. It has been transposed into Irish legislation as S.I. No. 33 of 2019 European Communities (quality and safety of human tissues and cells) (amendment) Regulations 2019.
This legislation sets out the specific requirements in relation to an importing tissue establishment (ITE) authorisation, which is a requirement when importing tissues or cells from a supplier outside of the EU.
2020-11-20T00:00:00ZGuide to Clinical Trials Regulation-National Collaboration Project (CTR-NCP)Health Products Regulatory Authority (HPRA)National Office for Research Ethics Committeehttp://hdl.handle.net/10147/6413172024-03-27T15:47:10Z2021-03-29T00:00:00ZGuide to Clinical Trials Regulation-National Collaboration Project (CTR-NCP)
Health Products Regulatory Authority (HPRA); National Office for Research Ethics Committee
The Clinical Trials Regulation-National Collaboration Project is a joint undertaking by the HPRA and the National Office for Research Ethics Committee (the National Office) to facilitate preparation for the implementation of the new Clinical Trials Regulation (CTR) (Regulation (EU) No 536/2014). The HPRA, the National Office, and sponsors of clinical trials will participate in the Collaboration Project to gain experience that will facilitate the implementation of the CTR in Ireland.
The CTR aims to create an environment that is favourable for conducting clinical trials, with the highest standards of patient safety, across the EU. Intrinsic to this is the simplification of current rules. The CTR will impact the way that sponsors submit clinical trial documentation, and how the competent authority (the HPRA) and the NREC-CT review and approve clinical trials.
2021-03-29T00:00:00ZGuide to Good Distribution Practice of Medicinal Products for Human UseHealth Products Regulatory Authority (HPRA)http://hdl.handle.net/10147/6413162024-03-27T15:46:51Z2021-03-09T00:00:00ZGuide to Good Distribution Practice of Medicinal Products for Human Use
Health Products Regulatory Authority (HPRA)
The purpose of this document is to provide additional clarification to wholesalers and brokers located in Ireland regarding the Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01). These guidelines, published by the European Commission, became effective on 8 September 2013. Due to some typographical errors in the guidelines, an updated version was published, Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01), available on the European Commission website, (hereafter referred to as ‘the guidelines’).
Good distribution practice (GDP) requirements clearly outlined in the guidelines are not repeated within this guidance document as the requirements are deemed to be self-explanatory and do not need additional clarification within this document. Wholesalers should ensure that they comply in full with all requirements of both the guidelines and this HPRA guidance document. Wholesalers should ensure that documentation is made available to the HPRA to verify compliance with GDP requirements, when requested.
The licensing authority for the wholesaling of medicinal products for veterinary use is the Department of Agriculture, Food and the Marine; this guide does not relate to the wholesale of veterinary medicinal products.
For companies wishing to apply for a wholesale distribution authorisation (WDA) or to register as a broker, please refer to ‘Guide to Wholesaling and Brokering of Medicinal Products for Human Use in Ireland’ available in the ‘Publications and Forms’ section at www.hpra.ie.
2021-03-09T00:00:00ZMetagenomic assembled plasmids of the human microbiome vary across disease cohorts.Harrington, R SKhokhlova, E VDaly, K MMcDonnell, S AO'Reagan, ONolan, J ASheehan, DLavelle, ADraper, L ARoss, R PStockdale, StephenHill, ColinShanahan, FergusShkoporov, Andreyhttp://hdl.handle.net/10147/6413152024-03-27T15:45:02Z2022-06-02T00:00:00ZMetagenomic assembled plasmids of the human microbiome vary across disease cohorts.
Harrington, R S; Khokhlova, E V; Daly, K M; McDonnell, S A; O'Reagan, O; Nolan, J A; Sheehan, D; Lavelle, A; Draper, L A; Ross, R P; Stockdale, Stephen; Hill, Colin; Shanahan, Fergus; Shkoporov, Andrey
We compiled a human metagenome assembled plasmid (MAP) database and interrogated differences across multiple studies that were originally designed to investigate the composition of the human microbiome across various lifestyles, life stages and events. This was performed as plasmids enable bacteria to rapidly expand their functional capacity through mobilisation, yet their contribution to human health and disease is poorly understood. We observed that inter-sample β-diversity differences of plasmid content (plasmidome) could distinguish cohorts across a multitude of conditions. We also show that reduced intra-sample plasmidome α-diversity is consistent amongst patients with inflammatory bowel disease (IBD) and Clostridioides difficile infections. We also show that faecal microbiota transplants can restore plasmidome diversity. Overall plasmidome diversity, specific plasmids, and plasmid-encoded functions can all potentially act as biomarkers of IBD or its severity. The human plasmidome is an overlooked facet of the microbiome and should be integrated into investigations regarding the role of the microbiome in promoting health or disease. Including MAP databases in analyses will enable a greater understanding of the roles of plasmid-encoded functions within the gut microbiome and will inform future human metagenome analyses.
2022-06-02T00:00:00ZHSE Your Service Your Say: Anonymised Complaints Casebook Q3 2019http://hdl.handle.net/10147/6413142024-03-27T15:44:10Z2019-11-28T00:00:00ZHSE Your Service Your Say: Anonymised Complaints Casebook Q3 2019
This casebook sets outs a selection of complaints, nine from Hospital Groups and six from Community Healthcare Organisations, which were investigated and/or reviewed along with their outcomes. The casebook is part of the HSE’s commitment
to use complaints as a tool for learning and to facilitate the sharing of that learning.
The cases included in this edition, although each unique, have an underlying theme regarding
communication and the provision of information. The findings suggest that some of these complaints
could have been avoided if full information had been provided to the service user/patient. The cases
below also highlight issues regarding the proper application of the HSE’s complaints management process
which resulted in unnecessary investigations and reviews as well as poor complainant experience.
2019-11-28T00:00:00ZImmunisation uptake (%) at 24 months of age in 2009 (i.e. cohort born 01/01/2007-31/12/2007), based on available dataHealth Protection Surveillance Centre (HPSC)http://hdl.handle.net/10147/6413132024-03-27T15:39:02Z2010-11-23T00:00:00ZImmunisation uptake (%) at 24 months of age in 2009 (i.e. cohort born 01/01/2007-31/12/2007), based on available data
Health Protection Surveillance Centre (HPSC)
Statistical report for 2007.
2010-11-23T00:00:00ZClostridium difficile Infection: Annual Epidemiological Report 2014Health Protection Surveillance Centre (HPSC)http://hdl.handle.net/10147/6413122024-03-27T15:38:41Z2015-09-11T00:00:00ZClostridium difficile Infection: Annual Epidemiological Report 2014
Health Protection Surveillance Centre (HPSC)
In 2014, 1,802 cases of Clostridium difficile infection (CDI) were notified. Of those, 1,613 (89.5%) were classified as new cases, 155 (8.5%) as recurrent, with 34 (2%) of unknown case type. This represents a national crude incidence rate of 38.5 cases per 100,000 population, which represents a small decrease compared to the rate reported in 2013 (41.3)
Of the 1,802 CDI cases, 1,202 (67%) were reported from patients aged 65 years or older
The voluntary enhanced CDI surveillance scheme received information on 1,780 CDI cases from 53 hospitals, covering 94% of all cases notified to Public Health Departments. Of those, 928 were healthcare-associated, representing a national CDI incidence rate of 2.3 cases per 10,000 bed days used for 2014, a decrease from 2.4 in 2013
Data collected on patient location at symptom onset highlights that CDI is not confined to acute healthcare facilities. It is commonly encountered in long term care facilities (7% of all CDI) and in the community (34% of all CDI)
Of 290 C. difficile isolates with available ribotyping data (16% of all cases) reported from 20 hospitals, the most frequent ribotypes reported in 2014 were: 078 and 014 (both n=31; 11%), 015 (n=27, 9%) and 005 (n=18, 6%).
2015-09-11T00:00:00ZNational polio preparedness and response plan [v2.0]Polio Working Group, National Health Protection Servicehttp://hdl.handle.net/10147/6413112024-03-27T15:38:25Z2023-06-12T00:00:00ZNational polio preparedness and response plan [v2.0]
Polio Working Group, National Health Protection Service
Poliomyelitis is a highly infectious disease that largely affects children under 5 years of age, causing permanent paralysis (1 in 200 infections) or death (2-10% of those paralysed) (WHO, 2022a). In 1988, the World Health Assembly adopted a resolution for the worldwide eradication of polio, launching the Global Polio Eradication Initiative (World Health Assembly, 1988).
The last recorded case of polio in Ireland was in 1984 (HPSC, 2023a). In 2022, the number of poliovirus cases reported worldwide increased. Whilst Europe has been free from indigenous polio since 2002, cases were reported in Germany, Poland, Ukraine and the United Kingdom. Additionally, poliovirus was detected in Israel and the United States. The cases in Ukraine, UK and Israel were classified as outbreaks by the World Health Organization (WHO). A European Regional Certification Commission for Poliomyelitis Eradication report of September 2021 suggested 11 European Union/European Economic Area (EU/EEA) countries are now at an intermediate risk of sustained polio outbreaks (WHO, 2021a).
Any case of polio virus in Ireland is considered a public health emergency and requires immediate response. This response plan has been prepared for use should one or more cases of wild type (WPV) or vaccine-derived poliovirus (VDPV) infection occur in Ireland.
Building on earlier work led by the Department of Health, this document (2023) reflects amendments made to reflect WHO guidance, changing epidemiology worldwide, the role of environmental surveillance and the need to continue to strengthen vaccination uptake across the population and, in particular, among vulnerable groups. It presents the response plan for Ireland, with strengthened clinical surveillance, establishment of wastewater surveillance, and pathways for response including containment, contact tracing and consideration of wider population investigation and measures for any detection.
2023-06-12T00:00:00ZGuide to Performance Studies Conducted in IrelandHealth Products Regulatory Authority (HPRA)http://hdl.handle.net/10147/6413102024-03-27T15:38:04Z2022-06-15T00:00:00ZGuide to Performance Studies Conducted in Ireland
Health Products Regulatory Authority (HPRA)
The purpose of this guide is to provide an overview of legislation and key concepts relevant to performance studies (PS) involving in vitro diagnostic medical devices (IVDs). In addition, information is provided on how to submit applications or notifications to the Health Products Regulatory Authority (HPRA).
This guide is targeted at PS sponsors (e.g. manufacturers, academic groups, clinical research organisations) who wish to conduct PS involving IVDs in Ireland. The information may also prove useful for ethics committees and other stakeholders.
This guidance does not purport to be the definite interpretation of the law and/or regulations and is for guidance purposes only. Relevant legislation relating to in vitro diagnostic medical devices should be consulted in addition to this guide.
2022-06-15T00:00:00Z