To ask the Minister for Health if he will provide the detail of the information held by his department after November 2009 regarding the safety profile of the pandemrix vaccine compared to other vaccines for swine flu; and if his department was briefed by the Irish Medicines Board as to the heightened risk of serious adverse drug reactions associated with the drug.
Clare Daly T.D.
As you are aware this matter is the subject of litigation in which plaintiffs allege personal injury in which they claim the development of narcolepsy (cataplexy) resulted from the administration of the H1N1 pandemic vaccine. An Order requiring the defendants to make Discovery was made in the High Court on 28 November 2016 in the most advanced case. Discovery is a legal process which must be carried out in accordance with Orders made by the Courts and both the Department of Health and the HSE are working to comply with the Order made in this case. However, the size and complexity of the Discovery means that this is not a trivial or quick process and, to date, the HSE has identified 300, 000 records and the Department over 465,000 records, all which must be examined and scheduled by Counsel. Consequently, I am currently not in a position to provide the detailed information requested in this question.
Nevertheless, it is important to remember the context in which vaccination against influenza type A (H1N1) was introduced. On 11 June 2009, following consideration by its Emergency Committee, the WHO raised the Influenza type A (H1N1) alert to Pandemic level 6 which officially declares a pandemic. My Department activated the National Plan for pandemic influenza and, based on the advices of the National Immunisation Advisory Committee, ‘at risk’ groups were prioritised for vaccination. Vaccination of children was prioritised as the rates of influenza were highest in those groups at that time. The public pandemic vaccination campaign ended on 31 March 2010.
The first reports of a link between pandemic influenza vaccination and narcolepsy came in the second half of 2010. In August 2010, the Swedish pharmacovigilance authority reported that it was investigating six cases of narcolepsy reported by health care professionals as a possible adverse event following the use of Pandemrix vaccine during the pandemic. This was followed later that month by reports from the Finnish National Institute for Health and Welfare noting there had been a more than expected number of cases of narcolepsy in children and adolescents that year. On 23 September 2010, the Committee on Human Medicinal Products of the European Medicines Agency concluded in its initial review of available data that the available evidence did not confirm a link but that more research was needed. By the end of March 2011 the Irish Medicines Board, now the Health Products Regulatory Authority, had received reports of two confirmed cases of narcolepsy following vaccination with pandemic vaccines. My Department and the HSE agreed that the Health Protection Surveillance Centre would work with the Irish Medicines Board and Irish clinical experts in narcolepsy to examine the Irish data and report back the findings. The Final Report of National Narcolepsy Study Steering Committee was published on 19 April 2012. It found a 13-fold higher risk of narcolepsy in vaccinated compared to unvaccinated individuals and the absolute increased risk associated with the vaccine was five narcolepsy cases per 100,000 vaccinated children and adolescents.
To ask the Minister for Health his views on the failure of Portiuncula Hospital to inform the parents of a baby that died in the maternity unit there (details supplied) of either the existence of a review into the care given to the mother and baby in the hospital or the conclusions of that review.
– Clare Daly T.D.
Details Supplied: Lorraine and Warren Reilly, parents of Amber Reilly, who died in Portiuncula Hospital in 2010.
In November 2014 a quality and risk management process highlighted a potential problem in maternity services in Portiuncula Hospital, on the basis of a higher than expected rate of newborn babies requiring head cooling. In early 2015 an Expert Review Team chaired by Professor Jimmy Walker, Professor of Obstetrics and Gynaecology, University of Leeds was established. After the review was made public further examination of cases and contact from further families, 18 cases (that is, 16 families) met the Terms of Reference for the review.
The family, to which you refer in your question, were unaware of the 2011 review that had taken place in to the death of their daughter. They should have been previously informed and given an opportunity to be involved in the review. My Department notes that both Portiuncula Hospital and the Saolta Hospital Group have apologised unreservedly and fully to the family for the failures of care delivered that contributed to the likely preventable deaths of their two daughters.
Safeguards are now in place in Portiuncula Hospital with regular and on-going audits in the maternity unit and Saolta Hospital Group have advised that there are no continuing patient safety concerns. I am advised that the Final Report of the Review Group is due to be published in the next few weeks.
My Department is continuing to progress an ambitious programme of patient safety reforms. The new National Patient Safety Office, located in my Department, was launched by me in December 2016. I have directed this office to work on a range of initiatives, including new legislation, the establishment of a national patient advocacy service, the measurement of patient experience, the introduction of a patient safety surveillance system and extending the clinical effectiveness agenda. Within the programme of legislation, it is intended to progress the licensing of our public and private hospitals.
As the Deputy will be aware provision to support Open Disclosure which is included in the Department of Justice and Equality’s Civil Liabilities (Amendment) Bill 2017 was recently accepted at Report Stage by Seanad Eireann. The provision which is designed to give legal protection/privilege for the information and apology made to a patient is in line with the legislation. This is intended to create a positive voluntary climate for open disclosure and will support the National Policy on Open Disclosure which was developed jointly by the HSE and the State Claims Agency.
The main provisions of the Open Disclosure legislation are to:
– ensure patients are informed when adverse events happen as soon as is practicable;
– assist in supporting appropriate patient care;
– increase trust between patients and their clinicians;
– create a safe space for staff to conduct open disclosure;
– support staff in managing adverse events; and
– improve patient safety and quality of care through organisational learning. •
Open Disclosure and a strong culture of reporting of adverse events provide opportunities to learn, improve, address errors that have happened and apply the lessons to make the service safer for all patients.
The Health Information and Patient Safety Bill will include a provision that public and private health care providers must notify serious patient incidents (Serious Reportable Events (SREs)) occurring in their services to their relevant regulatory body i.e. the State Claims Agency, HIQA, the Mental Health Commission or the Chief Inspector of Social Services as appropriate. The provisions intended for patient safety incident reporting and clinical audit in the Bill will provide a comprehensive patient-centred approach to preventing, managing and learning from incidents. HIQA and the Mental Health Commission are at an advanced stage of development of Standards on the Conduct of reviews of Patient Safety Incidentswhich expand on the National Standards for Safer Better Healthcare. The Health Information and Patient Safety Bill is currently the subject of Pre-Legislative Scrutiny by the Oireachtas Committee on Health and I understand that they, following a public consultation exercise, may report in May.
My Department is committed to introducing a national licensing system in hospitals which will provide a mandatory system of licensing for public and private healthcare providers. The Patient Safety Licensing Bill is focused on governance and accountability and will ensure that providers do not operate below core standards. Licensing is part of a phased approach to better regulation in the health service.
The Government is committed to the progressive development of our maternity services. Key building blocks are now in place to facilitate the provision of a consistently safe and high quality service; these include:
– The National Maternity Strategy;
– HSE National Standards for Bereavement Care following Pregnancy Loss and Perinatal Death;
– HIQA National Standards for Safer, Better Maternity Services. •
In 2016, Ireland’s first National Maternity Strategy was published along with the HSE’s National Standards for Bereavement Care following Pregnancy Loss and Perinatal Death and HIQA’s National Standards for Safer Better Maternity Services. Since December 2015, each maternity unit has published a monthly Maternity Patient Safety Statement as recommended by the Chief Medical Officer.
These developments represent key building blocks to facilitate the provision of a consistently safe and high quality service. In addition, the newly established National Women & Infants Health Programme will lead the management, organisation and delivery of maternity, gynaecology and neonatal services, strengthening such services by bringing together work that is currently undertaken across primary, community and acute care. The Programme will also drive implementation of the Strategy and oversee the establishment of maternity networks in each hospital group.