Public Service Agreement 2010-2014 (Croke Park Agreement) - Third Annual Progress and Savings Report for the Department and its Agencies

Public Service Agreement 2010-2014 (Croke Park Agreement) – Third Annual Progress and Savings Report for the Department and its Agencies   Click here to download Integrated Progress Report on Action Plan for the Department and its Agencies PDF 242KB Click here to download Annual Savings Report for the Department’s Agencies PDF 155KB

Newry Women's Aid

Women's Aid responds to urgent need to provide vital support and accommodation to women and children experiencing domestic violence. This is their first BCPP project. It will provide a range of social and health information sessions to women, staff, volunteers and children while supporting the pharmacist to better understand the issues they are facing, developing a referral process and confidential service.

Mental Health First Aid Northern Ireland Manual

The MHFA Manual is the basis of the MHFA Northern Ireland training programme. It has been adapted from the original MHFA programme deveoped in Australia. The manual gives an overview of mental health in Northern Ireland, outlines the MHFA action plan, explores in detail the MHFA approach to major mental health problems, and provides an in-depth resource section with details of related organisations and sources of help.

Mental Health First Aid Northern Ireland wallet card

The MHFA wallet card supplements the MHFA Northern Ireland Manual and is used by MHFA trainers and instructors. It has the five actions of the MHFA action plan on the back.

Mental Health First Aid Training Programme

The Mental Health First Aid (MHFA) Training Programme for Northern Ireland has been adapted from the original MHFA programme established in Australia by Betty Kitchener and Anthony Jorm. MHFA is the help provided to a person who is developing a mental health problem or who is currently in a mental health crisis. The first aid is given until professional help is available or until the crisis resolves. More than 4,500 people have attended MHFA training in Northern Ireland since it began in 2009 following a successful pilot in 2005. The aims of MHFA are to: preserve life where a person may be a danger to themselves or others; provide help to prevent the mental health problem becoming more serious; promote the recovery of good mental health; provide comfort to a person experiencing a mental health problem. MHFA teaches participants: how to recognise the symptoms of mental health problems; how to provide initial help; how to go about guiding a person towards appropriate professional help. The training programme is available to people from all backgrounds and has proved successful with different professional groups. MHFA training involves teaching participants how to recognise the symptoms of mental health problems such as depression, anxiety and psychosis. Each course is delivered by two MHFA instructors, usually over two consecutive days and four sessions to a maximum of 20 delegates. The course can also be delivered one day a week for two weeks or in four three-hour sessions. To apply for the training programme, people should contact their local Health and Social care Trust. Each Trust runs MHFA training several times a year. Topics covered include: What is meant by mental health/mental ill health? Dealing with crisis situations such as suicidal behaviour, self-harm, panic attacks and acute psychotic behaviour. Recognising the signs and symptoms of common mental health problems including depression, anxiety disorders, psychosis and substance use disorders. Where and how to get help. Self help strategies.

Mental Health First Aid Northern Ireland wallet card

The MHFA wallet card supplements the MHFA Northern Ireland Manual and is used by MHFA trainers and instructors.It has the five actions of the MHFA action plan on the back.

The Institutional Foundations of Regulatory Capitalism: The Diffusion of Independent Regulatory Agencies in Western Europe

This article studies the diffusion of the main institutional feature of regulatory capitalism, namely, independent regulatory agencies. While only a few such authorities existed in Europe in the early 1980s, by the end of the twentieth century they had spread impressively across countries and sectors. The analysis finds that three classes of factors (bottom-up, top-down, and horizontal) explain this trend. First, the establishment of independent regulatory agencies was an attempt to improve credible commitment capacity when liberalizing and privatizing utilities and to alleviate the political uncertainty problem, namely, the risk to a government that its policies will be changed when it loses power. Second, Europeanization favored the creation of independent regulators. Third, individual decisions were interdependent, as governments were influenced by the decisions of others in an emulation process where the symbolic properties of independent regulators mattered more than the functions they performed.

Why Public Health Agencies Cannot Depend on Good Laboratory Practices as a Criterion for Selecting Data: The Case of Bisphenol A

In their safety evaluations of bisphenol A (BPA), the U.S. Food and Drug Administration (FDA) and a counterpart in Europe, the European Food Safety Authority (EFSA), have given special prominence to two industry-funded studies that adhered to standards defined by Good Laboratory Practices (GLP). These same agencies have given much less weight in risk assessments to a large number of independently replicated non-GLP studies conducted with government funding by the leading experts in various fields of science from around the world. OBJECTIVES: We reviewed differences between industry-funded GLP studies of BPA conducted by commercial laboratories for regulatory purposes and non-GLP studies conducted in academic and government laboratories to identify hazards and molecular mechanisms mediating adverse effects. We examined the methods and results in the GLP studies that were pivotal in the draft decision of the U.S. FDA declaring BPA safe in relation to findings from studies that were competitive for U.S. National Institutes of Health (NIH) funding, peer-reviewed for publication in leading journals, subject to independent replication, but rejected by the U.S. FDA for regulatory purposes. DISCUSSION: Although the U.S. FDA and EFSA have deemed two industry-funded GLP studies of BPA to be superior to hundreds of studies funded by the U.S. NIH and NIH counterparts in other countries, the GLP studies on which the agencies based their decisions have serious conceptual and methodologic flaws. In addition, the U.S. FDA and EFSA have mistakenly assumed that GLP yields valid and reliable scientific findings (i.e., "good science"). Their rationale for favoring GLP studies over hundreds of publically funded studies ignores the central factor in determining the reliability and validity of scientific findings, namely, independent replication, and use of the most appropriate and sensitive state-of-the-art assays, neither of which is an expectation of industry-funded GLP research. CONCLUSIONS: Public health decisions should be based on studies using appropriate protocols with appropriate controls and the most sensitive assays, not GLP. Relevant NIH-funded research using state-of-the-art techniques should play a prominent role in safety evaluations of chemicals.

Drugs Associated with Hepatotoxicity and their Reporting Frequency of Liver Adverse Events in VigiBase (TM) Unified List Based on International Collaborative Work

BACKGROUND Challenges exist in the clinical diagnosis of drug-induced liver injury (DILI) and in obtaining information on hepatotoxicity in humans. OBJECTIVE (i) To develop a unified list that combines drugs incriminated in well vetted or adjudicated DILI cases from many recognized sources and drugs that have been subjected to serious regulatory actions due to hepatotoxicity; and (ii) to supplement the drug list with data on reporting frequencies of liver events in the WHO individual case safety report database (VigiBase). DATA SOURCES AND EXTRACTION (i) Drugs identified as causes of DILI at three major DILI registries; (ii) drugs identified as causes of drug-induced acute liver failure (ALF) in six different data sources, including major ALF registries and previously published ALF studies; and (iii) drugs identified as being subjected to serious governmental regulatory actions due to their hepatotoxicity in Europe or the US were collected. The reporting frequency of adverse events was determined using VigiBase, computed as Empirical Bayes Geometric Mean (EBGM) with 90% confidence interval for two customized terms, 'overall liver injury' and 'ALF'. EBGM of >or=2 was considered a disproportional increase in reporting frequency. The identified drugs were then characterized in terms of regional divergence, published case reports, serious regulatory actions, and reporting frequency of 'overall liver injury' and 'ALF' calculated from VigiBase. DATA SYNTHESIS After excluding herbs, supplements and alternative medicines, a total of 385 individual drugs were identified; 319 drugs were identified in the three DILI registries, 107 from the six ALF registries (or studies) and 47 drugs that were subjected to suspension or withdrawal in the US or Europe due to their hepatotoxicity. The identified drugs varied significantly between Spain, the US and Sweden. Of the 319 drugs identified in the DILI registries of adjudicated cases, 93.4% were found in published case reports, 1.9% were suspended or withdrawn due to hepatotoxicity and 25.7% were also identified in the ALF registries/studies. In VigiBase, 30.4% of the 319 drugs were associated with disproportionally higher reporting frequency of 'overall liver injury' and 83.1% were associated with at least one reported case of ALF. CONCLUSIONS This newly developed list of drugs associated with hepatotoxicity and the multifaceted analysis on hepatotoxicity will aid in causality assessment and clinical diagnosis of DILI and will provide a basis for further characterization of hepatotoxicity.