Written Answers Nos. 459-477
459. Deputy Thomas P. Broughan asked the Minister for Health the position regarding possible sanctions or fines on so-called non-performing hospitals; the benchmarks upon which such performance measurements rest; and if he will make a statement on the matter. [33300/15]
View answerIn relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to you directly. If you have not received a reply from the HSE within 15 working days please contact my Private Office and my officials will follow the matter up.
460. Deputy Anthony Lawlor asked the Minister for Health the Health Service Executive estates that are delaying the tendering process for the new endoscopy unit at Naas General Hospital in County Kildare; if this matter can be expedited without delay; and if he will make a statement on the matter. [33313/15]
View answerI want to advise the Deputy that the HSE is not intentionally delaying the tendering process. The project to be delivered at Naas General Hospital is more extensive than the endoscopy services department referred to. In addition it includes accommodation and ancillary services to support the new physical medicine, physical therapy, oncology services and day procedures departments. All stages of capital projects, including the design and tendering processes, are subject to review to ensure that the projects deliver value for money. This includes, where possible, 'future proofing' to ensure that capital developments meet not just current standards but that provision is made for additional capacity and/or improved equipping and that these are addressed appropriately. In this regard the strategic upgrade to the specification which the project's design and tender documents will reflect are - a duplex (rather than simplex) reverse osmosis filtration system and two lifts. Currently, HSE Estates is in consultation with the hospital's clinical leads to ensure that the project's specification and building tender documents are fully defined as soon as is possible. The HSE must also ensure that its tendering documents are comprehensive and comply with national guidelines and EU directives.
461. Deputy Denis Naughten asked the Minister for Health when the national ambulance service will have satellite navigation systems installed in its vehicles; his views that such a system is not a prerequisite of dynamic deployment; and if he will make a statement on the matter. [33321/15]
View answerAs this is a service matter, I have asked the HSE to respond to you directly. If you have not received a reply from the HSE within 15 working days please contact my Private Office and my officials will follow the matter up.
462. Deputy Michael Healy-Rae asked the Minister for Health if he will supply the original product information for Roaccutane and each of the 27 updates; the reason for each individual update since 1983; and if he will make a statement on the matter. [33335/15]
View answer464. Deputy Michael Healy-Rae asked the Minister for Health if he will provide all the supplementary information which is distributed to prescribing doctors, pharmacists, other health care professionals and patients, in association with Roaccutane since 1983; and if he will make a statement on the matter. [33337/15]
View answerI propose to take Questions Nos. 462 and 464 together.
The currently available product information (i.e. Summary of Product Characteristics and Package Leaflet) for Roaccutane has been the subject of a number of changes since 1998. As with all medicines, any change to this information requires approval by the Health Products Regulatory Authority (HPRA) or another EU Member States Medicines Agency on foot of a formal application to vary the authorisation and the submission of relevant supporting data. In practice, product information is very frequently updated as new data become available through various sources of post-marketing experience, including further studies, literature reviews, and evaluation of adverse reaction data. In this context there have been numerous updates and changes to the product information for Roaccutane from January 1998 until now.
The current product information was supplied to the Deputy on 26 May 2015 in response to a previous parliamentary question. Information on the various changes over the years would require a detailed and time-consuming search by the HPRA through archived material and various databases used over the time. As stated in my response on 22nd September 2015 (Composite reply 30562/15) I am happy to facilitate a meeting between the Deputy and the HPRA to discuss the Deputy's information requests.
Details of supplementary information, other than information contained in the Summary of Product Characteristics and Package Leaflet were provided to the Deputy on 13 May 2015 (Composite reply 18761/15).
463. Deputy Michael Healy-Rae asked the Minister for Health if he will outline the well known documented risks related to the use of Roaccutane in women of child bearing potential; and what the Health Products Regulatory Authority and the company (details supplied) are doing to eliminate risks; and if he will make a statement on the matter. [33336/15]
View answerSince it was first authorised for use in Ireland, Roaccutane (isotretinoin) has been contraindicated in women who are pregnant or breastfeeding. Use of isotretinoin has also been consistently contraindicated in women of childbearing potential since the product was first authorised, unless all of the conditions specified in the product information are met.
An EU wide Pregnancy Prevention Plan (PPP) was introduced in October 2003 to further reduce the potential risk of pregnancy in women by expanding the available information and highlighting the well-known and documented risks related to use in women of child-bearing potential. These measures include supplementary information distributed to prescribing doctors, pharmacists, other relevant healthcare professionals and patients, including the following:
- Physician’s guide to prescribing Roaccutane to female patients;
- Physician’s checklist for prescribing to female patients;
- Patient information brochure;
- Important information for patients prescribed Roaccutane on contraception; and
- Pharmacist’s guide to dispensing Roaccutane.
The PPP applies across all EU member states and is monitored and reviewed at EU level. The company submits the information gathered through the PPP on a yearly basis to the competent authority for each EU member state (i.e. HPRA in Ireland). The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC), (at which Ireland is represented by the HPRA) assesses the data provided to consider any need to strengthen/amend the PPP as part of the regular review of the effectiveness of these risk minimisation measures.
In addition, the Medicinal Products (Prescription and Control of Supply) Regulations 2003 were amended in 2005 to introduce restrictions on certain medicines containing Isotretinoin. Regulation 7(9) of the Regulations provides that the prescription of a medicine containing Isotretinoin (not being for external use) which is intended for the treatment of a woman of childbearing potential, shall not be dispensed later than seven days after the date on the prescription and the treatment shall not exceed a period of thirty days.
465. Deputy Michael Healy-Rae asked the Minister for Health the number of doctors currently prescribing Roaccutane; and if he will make a statement on the matter. [33338/15]
View answer472. Deputy Michael Healy-Rae asked the Minister for Health if his Department will identify, by age, gender, year, and Health Products Regulatory Authority case identification number, the instances where Roaccutane was used for its original intended purpose; and if he will make a statement on the matter. [33380/15]
View answerI propose to take Questions Nos. 465 and 472 together.
Prescriptions do not state the indication for which the medicine in question is being prescribed.
Under the Health (Pricing and Supply of Medical Goods) Act 2013, the Health Service Executive (HSE) has statutory responsibility for the administration of the GMS and Community Drugs Schemes. Only data on the number of prescriptions dispensed for Roaccutane under the GMS and Community Drugs Schemes can be provided by the HSE.
This matter has been referred to the HSE for attention and direct reply to you. If you have not received a reply from the HSE within 15 working days, please contact my Private Office and they will follow up the matter with them.
466. Deputy Peadar Tóibín asked the Minister for Health if he will provide the first-year and full-year cost of increasing funding to Healthy Ireland by 20%, 25%, 30%, 40% and 50%. [33350/15]
View answerHealthy Ireland is the National Framework for Improved Health and Wellbeing 2013-2025. The Framework is based on evidence and experience from around the world which clearly shows that to create positive changes in health and wellbeing takes the involvement of the whole of Government and all of society working in unison. On that basis, it is not possible to identify in totality how much funding is currently spent on improving health and wellbeing across all Government Departments and agencies and in wider society.
Since Healthy Ireland was launched in March 2013, expenditure on its implementation from within the budget of the Department of Health has amounted to the following:
2013 - €89,315.07
2014 - €586,470.90
2015 - €252,292.02 (to date)
In addition to the expenditure noted above, other expenditure arising within the Department could also be described as "Healthy Ireland" depending on classification.
The Deputy may also wish to note that expenditure arising in the HSE, particularly in the Health and Wellbeing Division, could also be described as implementation of Healthy Ireland. However, it is not possible to disaggregate expenditure on promoting and improving health and wellbeing generally from overall HSE expenditure. Again, for example, within overall HSE expenditure, and in addition to work which is an integral part of the Health and Wellbeing Division, a large component of health promotion and improvement work takes place across the acute and primary care services as part of normal day to day activity. There is also expenditure arising in relation to communications campaigns by the HSE.
467. Deputy Peadar Tóibín asked the Minister for Health if he will provide, in tabular form, the first-year and full-year cost of extending the Be Active After-School activity programme to each of the Health Service Executive regions. [33351/15]
View answerAs this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy. If you have not received a reply from the HSE within 15 working days please contact my Private Office and they will follow up the matter with them.
468. Deputy Pearse Doherty asked the Minister for Health if a discretionary medical card will be approved for a person (details supplied) in County Donegal; and if he will make a statement on the matter. [33354/15]
View answerThe Health Service Executive has been asked to examine this matter and to reply to the Deputy as soon as possible. The Health Service Executive operates the General Medical Services scheme, which includes medical cards and GP visit cards, under the Health Act 1970, as amended. It has established a dedicated contact service for members of the Oireachtas specifically for queries relating to medical cards and GP visit cards, which the Deputy may wish to use for an earlier response. Contact information has issued to Oireachtas members. If the Deputy has not received a reply from the HSE within 15 working days, please contact my Private Office who will follow up the matter with them.
469. Deputy Michael Healy-Rae asked the Minister for Health if the Health Products Regulatory Authority has sought third-party consent in relation to releasing information requested, as submitted by a company (details supplied), health care professionals and patients with regard to Roaccutane since 1983; and if he will make a statement on the matter. [33360/15]
View answer473. Deputy Michael Healy-Rae asked the Minister for Health if he is satisfied that a company (details supplied) is operating to the highest standard of accountability, transparency, legality, and otherwise, with regard to Roaccutane since 1983; and if he will make a statement on the matter. [33383/15]
View answerI propose to take Questions Nos. 469 and 473 together.
The Health Products Regulatory Authority (HPRA) has not requested the information referred to by the Deputy from the pharmaceutical company referred to by the Deputy.
In terms of the accountability of such a company I refer the Deputy to my composite reply of 19166/15 of 19 May, in relation to the pre- and post- marketing activities that are undertaken in order to ensure the quality, safety, and efficacy of medicinal products and to monitor on an on-going basis their benefits and risks.
470. Deputy Michael Healy-Rae asked the Minister for Health if the Health Products Regulatory Authority's duty of protection extends to protecting the patients who have been prescribed Roaccutane; and if he will make a statement on the matter. [33361/15]
View answer471. Deputy Michael Healy-Rae asked the Minister for Health the position in relation to safeguards to protect the general public with regard to concerns expressed about Roaccutane; and if he will make a statement on the matter. [33374/15]
View answerI propose to take Questions Nos. 470 and 471 together.
I refer the Deputy to my composite reply 19166/15 of 19 May and composite reply 26767/15 of 2 July both which provide a detailed reply to the questions asked by the Deputy.
474. Deputy Sandra McLellan asked the Minister for Health if a personal assistant will be allocated to two preschool children (details supplied) in County Cork; and if he will make a statement on the matter. [33387/15]
View answerThe Early Childhood Care and Education (ECCE) Programme, which is the responsibility of my colleague, the Minister for Children and Youth Affairs, provides for a free pre-school year to eligible children in the year before they commence primary school. The objective of this scheme is to support early learning in a formal setting in advance of starting school. I understand that certain flexibilities are built into the scheme in an effort to accommodate children with special needs, such as an overage exemption, or waiver, for children with special needs who do not meet the age criteria and the option to avail of the free pre-school year over two years.
The Health Service Executive has no statutory obligation to provide assistant supports for children with special needs wishing to avail of the free pre-school year. However, the HSE does work at local level and in partnership with the relevant disability service providers to address individual needs as they arise. This is done, for example, by funding special pre-schools that cater specifically for children with disabilities. In some limited cases at local level, disability services have also facilitated children with a disability to attend mainstream pre-schools by providing assistant supports where possible and where resources are available. The provision of such pre-school assistant supports should not be confused with Special Needs Assistants who are funded by the Department of Education and Skills to support children with special educational needs in primary and post-primary school settings.
The Better Outcomes, Brighter Futures children and young people's policy framework that has been developed by the Department of Children and Youth Affairs contains a commitment to develop a plan for the inclusion of children with a disability in mainstream pre-school and early years settings. The Department of Children and Youth Affairs has lead responsibility for the implementation of this commitment and has recently concluded an intensive process of deliberation and consultation on the matter in conjunction with my Department and the Department of Education and Skills. Work is ongoing to develop an appropriate model of supports to facilitate the full participation of children with special needs in the ECCE Programme.
Within this context, I have asked the HSE to respond directly to the Deputy in relation to the individual cases he has highlighted. If you have not received a reply from the HSE within 15 working days please contact my Private Office and they will follow up the matter with them.
475. Deputy Gerry Adams asked the Minister for Health the number of nursing homes that were re-registered, having been deemed Health Information and Quality Authority compliant since July 2015. [33399/15]
View answer477. Deputy Gerry Adams asked the Minister for Health the position regarding nursing homes deemed non-compliant with the Health Information Quality Authority directive from July 2015; if he will provide a list of these homes; the implications for any non-compliance; and if he will make a statement on the matter. [33401/15]
View answerI propose to take Questions Nos. 475 and 477 together.
The Health Information and Quality Authority is an independent authority established under the Health Act 2007. Since 2009 all nursing homes - public, voluntary and private have been registered and inspected by HIQA. Under Section 49 of the Act the Chief Inspector must establish and maintain a register of designated centres. Details entered into the register include the name of the centre, address and date of registration. This information is published and available on the Authority’s website www.hiqa.ie.
Discussions are ongoing between the HSE and HIQA regarding the conditions that will apply to public facilities across the country. Funding available for capital investment in Community Nursing Units will be allocated on the basis of careful prioritisation across all such facilities, with the welfare of residents always being the primary concern.
It is worth noting that although many public facilities are old, and are therefore not in line with how modern facilities are designed and configured, the standard of care delivered to residents is generally of a very high standard, and residents and their families frequently express their appreciation of the care that they receive.
476. Deputy Gerry Adams asked the Minister for Health if he has secured emergency funding for accommodation upgrades in public nursing homes which failed to meet Health Information and Quality Authority accommodation standards; and the number of such homes deemed non-compliant at present. [33400/15]
View answerCompliance with standards must be a continuous process of improvement if accommodation standards are to be enhanced and maintained. Therefore all community nursing homes will require capital funding - ranging from a few hundred euro to total replacement costs. The case for funding community nursing homes has been presented as effectively as possible and we will work with the HSE to prioritise the additional funding becoming available over the multi-annual period 2016-2021.
