Written Answers Nos. 364-380
364. Deputy Billy Kelleher asked the Minister for Health if a person (details supplied) with type 1 diabetes will be provided with access to CREON under the long-term illness scheme; and if he will make a statement on the matter. [16237/19]
Amharc ar fhreagraAs the particular issue raised relates to an individual case, I have arranged for the question to be referred to the HSE for direct reply to the Deputy.
365. Deputy Jack Chambers asked the Minister for Health the waiting times for persons with dyspraxia for occupational therapy services in Dublin 15, in tabular form; and if he will make a statement on the matter. [16243/19]
Amharc ar fhreagraThe Government is committed to providing services and supports for people with disabilities which will empower them to live independent lives, provide greater independence in accessing the services they choose, and enhance their ability to tailor the supports required to meet their needs and plan their lives. This commitment is outlined in the Programme for Partnership Government, which is guided by two principles: equality of opportunity and improving the quality of life for people with disabilities.
As the Deputy's question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy.
366. Deputy Jack Chambers asked the Minister for Health the status of the development of Roselawn health centre, Dublin 15; and if he will make a statement on the matter. [16244/19]
Amharc ar fhreagraAs the HSE has responsibility for the provision, along with the maintenance and operation of Primary Care Centres and other Primary Care facilities, the Executive has been asked to reply directly to the Deputy.
367. Deputy Fiona O'Loughlin asked the Minister for Health if a person (details supplied) can be considered for a psychiatric unit nursing home; and if he will make a statement on the matter. [16259/19]
Amharc ar fhreagraAs this is a service matter I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
368. Deputy Fiona O'Loughlin asked the Minister for Health if a person (details supplied) can be considered for the fair deal scheme; and if he will make a statement on the matter. [16260/19]
Amharc ar fhreagraThe Nursing Homes Support Scheme (NHSS), commonly referred to as Fair Deal, is a system of financial support for people who require long-term residential care. Participants contribute to the cost of their care according to their means while the State pays the balance of the cost. The Scheme aims to ensure that long-term nursing home care is accessible and affordable for everyone and that people are cared for in the most appropriate settings.
Participants in the Scheme contribute up to 80% of their assessable income and a maximum of 7.5% per annum of the value of assets held. In the case of a couple, the applicant’s means are assessed as 50% of the couple’s combined income and assets. The first €36,000 of an individual’s assets, or €72,000 in the case of a couple, is not counted at all in the financial assessment. The capital value of an individual’s principal private residence is only included in the financial assessment for the first three years of their time in care. This is known as the three year cap.
In order to determine how much an applicant will contribute to the cost of their care, a financial assessment is carried out by the HSE which takes account of a person's income and assets.
Where a resident under the NHSS has assets including land or property, they may defer their contribution to care based on such assets under Ancillary State Support (also known as Nursing Home Loan). This contribution becomes payable on their death. However, where the asset concerned is the principal residence of the surviving partner of the person who has died, the surviving partner may request that repayment of the loan is further deferred for their lifetime. A person wishing to apply for a further deferral, or a representative acting on their behalf, must apply for such a deferral not later than 3 months after the death of the applicant. In compelling circumstances, an application may be made up until 6 months after the death of the applicant. The application should be made on the form specified by the HSE.
The person in question should contact their local HSE Nursing Homes Support Scheme Office who can assist them on an individual basis to understand the factors that they need to consider.
369. Deputy Fiona O'Loughlin asked the Minister for Health further to Parliamentary Question No. 364 of 5 February 2019, when a response will issue. [16268/19]
Amharc ar fhreagraI regret that due to an error in processing your PQ No. 364 of 5 February 2019 was not referred to the HSE as indicated in the reply. It has now been referred to the HSE for direct reply to the Deputy.
370. Deputy James Browne asked the Minister for Health further to Parliamentary Question No. 374 of 12 March 2019, when the projects (details supplied) will move to advanced planning stage; and if he will make a statement on the matter. [16270/19]
Amharc ar fhreagraAs the Health Service Executive is responsible for the management of the healthcare property estate, I have asked the HSE to respond directly to you in relation to this matter.
371. Deputy Ruth Coppinger asked the Minister for Health the number of termination of pregnancies here in the first quarter of 2019. [16271/19]
Amharc ar fhreagraUnder section 20 of the Health (Regulation of Termination of Pregnancy) Act 2018, a notification of each termination of pregnancy carried out under the legislation must be notified to the Minister for Health within 28 days of it being carried out.
The Minister must prepare a report on the notifications received in a given year not later than 30 June the following year, and lay it before the Houses of the Oireachtas. This report may then be published.
Therefore, no information on notifications received under the Act will be released until after the annual report for 2019 has been laid before the Houses of the Oireachtas on or before 30 June 2020.
372. Deputy Clare Daly asked the Minister for Health the way in which it is planned to establish the number of children affected by anti-convulsant syndrome as a result of sodium valproate being given to their mothers during pregnancy. [16280/19]
Amharc ar fhreagra373. Deputy Clare Daly asked the Minister for Health the pathways available for parents to have their children diagnosed with anti-convulsant syndrome as a consequence of sodium valproate; and the pathways for needs assessment and treatment that will be provided for them. [16281/19]
Amharc ar fhreagra374. Deputy Clare Daly asked the Minister for Health his plans for a fully resourced public information campaign on to the risks of taking sodium valproate during pregnancy. [16282/19]
Amharc ar fhreagra375. Deputy Clare Daly asked the Minister for Health if the HPRA has imposed a requirement that warnings on the risks of sodium valproate must be displayed on the external packaging of the drug and that the medication should not be dispensed without original packaging. [16283/19]
Amharc ar fhreagraI propose to take Questions Nos. 372 to 375, inclusive, together.
This Department continues to liaise with the HSE and the Health Products Regulatory Authority (HPRA), as well as other stakeholders, to help address concerns raised over the use of sodium valproate, also known as Epilim.
As part of its Valproate Response Project, the HSE undertook a communication programme in 2018 to provide information to support the safe prescribing of valproate treatment in women with epilepsy, bipolar disorder and other conditions, to help prevent current and future harm to women of childbearing age who are pregnant or who could become pregnant while taking valproate medicines. To date, the communications plan has included:
1. Issuing letters to all prescribers and pharmacists in relation to new European Medicines Agency (EMA) and HPRA guidelines on the use of sodium valproate;
2. Issuing patient-specific letters to GPs;
3. Issuing 2500+ letters to patients who were dispensed sodium valproate;
4. Issuing letters to pharmacies advising them of the patient support service and requesting that they include a patient information leaflet every time they dispense sodium valproate;
5. Developing an information web page regarding sodium valproate; and
6. Using social media to provide regular updates to patients and stakeholders.
In addition to this HSE programme, the HPRA has collaborated with national stakeholders, including patient representatives and healthcare professionals, to implement the EMA’s new risk minimisation measures in Ireland.
These measures have included changes to the product information for patients and healthcare professionals; a visual warning on the packaging of valproate medicines; updated educational materials to reflect the new measures and provide age-appropriate advice; and a patient alert card to be attached to the packaging so that pharmacists can go through it with the patient when valproate is dispensed.
In tandem with the actions taken by the HPRA, the Pharmaceutical Society of Ireland (PSI), as pharmacy regulator, has directed pharmacists that they must inform women of child-bearing age of the potential risk of abnormal pregnancy outcomes when supplying medicines containing valproate. This includes providing a patient leaflet and Alert Card with each supply of these medicines.
On 22 March, the HSE, together with Epilepsy Ireland and the Organisation for Anti-Convulsant Syndrome (OACS) Ireland, held a public conference on sodium valproate with the aim of creating awareness for patients who were not included in the communications issued in 2018. Over 300 members of the public registered for this event, which focused on the response to this issue to date by the HSE and the HPRA.
With regard to diagnostic pathways, the HSE has advised that it has allocated funding for a dedicated Genetics Clinic to be situated in the National Children's Hospital Group. A consultant paediatrician has been appointed, and all paediatric patients referred to date with suspected foetal valproate syndrome (FVS) have been reviewed. The HSE has established a working group to identify the support service needs of patients diagnosed with FVS.
The approved product information and Package Leaflet for sodium valproate now includes detailed warnings and recommendations for healthcare professionals and patients regarding use of the drug, including the need for treatment to be initiated and supervised by a specialist experienced in the management of epilepsy or bipolar disorder. New packaging for Epilim products now includes a boxed warning and a pictogram indicating that use of sodium valproate can seriously harm an unborn baby. The PSI regularly reminds pharmacists that they must provide counselling and include a package leaflet and patient alert card with each supply of valproate medicines, whether or not the supply is made to the patient in the manufacturer’s original packaging.
376. Deputy Tony McLoughlin asked the Minister for Health his plans to ensure that the lack of regulations within the medical aesthetic and cosmetic surgery sector is addressed in order to protect public health; if his attention has been drawn to the dangers posed by botched procedures and unskilled and untrained persons conducting medical aesthetics; his further plans to combat this growing trend; and if he will make a statement on the matter. [16285/19]
Amharc ar fhreagraCosmetic surgery is currently controlled through the regulation of cosmetic surgeons in accordance with the Medical Practitioners Act 2007. Under that Act, medical practitioners, including cosmetic surgeons, who practise medicine in Ireland must be registered with the Medical Council, which has responsibility for the registration of medical practitioners and the regulation of their activities.
Certain medical devices used in cosmetic and aesthetic treatments are captured under medicines legislation and must have a product authorisation from the Health Products Regulatory Authority (HPRA) or the European Medicines Agency (EMA) before being placed on the market. There are also restrictions on who can prescribe and administer such devices as some such products are subject to prescription requirements and may only be administered by registered medical doctors or registered dentists.
Under legislation medical devices must also be CE marked before being placed on the market. The CE mark follows assessment of conformity to the relevant legislative requirements relating to benefit, risk, composition, safety and labelling and also of the manufacturer’s production standards. It does not regulate who can use the medical device or practice relating to the use of the device. The new EU Medical Devices Regulation (EU 2017/745), due to be commenced in May 2020, formally includes dermal fillers in Annex XVI within the scope of medical device regulation as devices without a medical purpose (cosmetic).
The HPRA's regulatory role involves monitoring the safety of medical devices in Ireland after they are placed on the market. The HPRA also operates a national reporting system for medical devices where users of devices are encouraged to report incidents or problems associated with their use to the HPRA.
Where a significant safety or quality concern is identified with the actual device, there are a range of regulatory actions the HPRA can take to protect public health. These include changes to labelling, information and safety notices to users and recalling the product from the market. They can also request changes or modifications to the device itself.
Further regulation in this area will be seen following the introduction of The Patient Safety Licensing Bill. The General Scheme of the Bill was approved by Government on 12 December 2017, has completed pre legislative scrutiny, and is currently with the Attorney Generals Office for drafting. The aim of this Bill is to improve patient safety by ensuring that providers of health services do not operate below core standards, which are applied in a consistent and systematic way. Public and private hospitals and providers of high risk healthcare activities taking place outside a hospital setting will require a license to operate. HIQA will be the licensing authority. The non-hospital high risk designated activities will be prescribed by the Minister and the Department is currently working to identify those activities which should be so designated.
The Department of Health has previously recommended that anyone seeking to have a cosmetic surgery procedure should seek advice from their General Practitioner (GP) to ensure that they are a suitable candidate for the procedure in question. GP’s can then recommend a reputable specialist practitioner in this area.
The Department further recommended a consultation with an appropriately registered plastic surgeon. In Ireland, such surgeons can be found by examining the online register of medical practitioners found at the website of the Medical Council. A patient can also establish if a surgeon is a full member of the Irish Association of Plastic Surgeons at the website of that organisation; all of its members have had full specialist training and are on the Specialist Register in Plastic And Reconstructive Surgery of the Medical Council. Specific advice, which has been prepared by the Chief Medical Officer and the Irish Association of Plastic Surgeons, is also available on the website of my Department.
377. Deputy Michael McGrath asked the Minister for Health when a child (details supplied) in County Cork will have an assessment of need under the Disability Act 2005; and if he will make a statement on the matter. [16286/19]
Amharc ar fhreagraThe Government is committed to providing services and supports for people with disabilities which will empower them to live independent lives, provide greater independence in accessing the services they choose, and enhance their ability to tailor the supports required to meet their needs and plan their lives. This commitment is outlined in the Programme for Partnership Government, which is guided by two principles: equality of opportunity and improving the quality of life for people with disabilities.
As the Deputy's question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy.
378. Deputy Robert Troy asked the Minister for Health if an appointment for an MRI scan will be expedited for a person (details supplied). [16296/19]
Amharc ar fhreagraUnder the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.
The National Waiting List Management Policy, a standardised approach to managing scheduled care treatment for in-patient, day case and planned procedures, since January 2014, has been developed to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care. This policy, which has been adopted by the HSE, sets out the processes that hospitals are to implement to manage waiting lists.
In relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to the Deputy directly.
379. Deputy James Browne asked the Minister for Health the number of children awaiting occupational therapy as part of the assessment of need first-time assessment, by county in tabular form; and if he will make a statement on the matter. [16298/19]
Amharc ar fhreagraThe Government is committed to providing services and supports for people with disabilities which will empower them to live independent lives, provide greater independence in accessing the services they choose, and enhance their ability to tailor the supports required to meet their needs and plan their lives. This commitment is outlined in the Programme for Partnership Government, which is guided by two principles: equality of opportunity and improving the quality of life for people with disabilities.
As the Deputy's question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy.
380. Deputy Alan Kelly asked the Minister for Health when a report by a company (details supplied) on the cost overruns in the national children’s hospital will be published; the reason the report has been delayed; and if he will make a statement on the matter. [16304/19]
Amharc ar fhreagra431. Deputy Mick Wallace asked the Minister for Health when he expects a report (details supplied) on the national children's hospital overspend will be published; and if he will make a statement on the matter. [16544/19]
Amharc ar fhreagraI propose to take Questions Nos. 380 and 431 together.
The independent review of escalation in costs in the New Children's Hospital undertaken by PwC has been completed, and was published today, following discussion by Government.
The report confirms that the Government decision in December 2018 to continue with this project, based on the advice available at the time, was the correct decision – any alternative course of action would have resulted in significant delay, increased costs and the possibility that the hospital would not be built. The report also points out areas of weakness that need to be addressed and strengthened to support the project to successful completion.
I will consider the report findings and recommendations in detail with the Minister for Public Expenditure & Reform, our respective Departments, the HSE and the Chair of the NPHDB and we will revert to Government next month setting out our considered response to the report.
