Niamh Smyth
Question:153. Deputy Niamh Smyth asked the Minister for Health the reason a person (details supplied) is waiting on an operation in Beaumont Hospital; and if he will make a statement on the matter. [7455/23]
View answerHospital Appointments Status
Questions (153)
Written answers
Under 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.
In relation to the particular query raised, as this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
Seirbhísí agus Tacaíochtaí Gaeilge
Questions (154)
Aengus Ó Snodaigh
Question:154. D'fhiafraigh Deputy Aengus Ó Snodaigh den Aire Sláinte an dtabharfaidh an grúpa tras-Rialtais atá in mbun oibre ar thodhchaí lipéadú bia in Éirinn aird ar mholadh atá á mbrú chun cinn ag feachtas faoi láthair múnla an dátheangachais mar atá i bhfeidhm i gCeanada cheana féin a chur i bhfeidhm sa stát seo chun a chinntiú gur sa dá teanga oifigiúil atá lipéid, an Ghaeilge chomh feiceálach ar a laghad leis an mBéarla ar tháirgí, agus eolas tábhachtach curtha ar fáil don phobal labhartha Gaeilge. [7463/23]
View answerWritten answers
Tá lipéadú bia san AE á rialú ag Rialachán (AE) um Fhaisnéis Bhia do Thomhaltóirí (FIC) Uimh. 1169/2011 maidir le faisnéis bhia a chur ar fáil do thomhaltóirí.
Bunaíodh Grúpa Oibre Tras-Rialtais in 2022 chun Seasamh na hÉireann a fhorbairt maidir leis na cúig ghné atá le hathbhreithniú faoin Rialachán FIC:
1. Lipéadú comhoiriúnaithe cothaithe ar aghaidh an phacáiste a thabhairt isteach;
2. Próifílí cothaitheach a leagan síos chun srian a chur le húsáid maímh shláinte mar uirlis mhargaíochta le haghaidh bianna ard saille, siúcra agus salainn agus srian a chur le margaíocht na mbianna sin do leanaí;
3. Leathnú ar an gceanglas maidir le lipéadú tionscnaimh/bunáitíochta;
4. Na rialacha reatha maidir le marcáil dáta a athbhreithniú;
5. Ceanglas a thabhairt isteach maidir le liosta comhábhar agus dearbhú cothúcháin maidir le deochanna alcólacha.
Is iad cuspóirí an Ghrúpa Tras-Rialtais seasamh na hÉireann ar leasuithe an Choimisiúin ar Rialachán FIC a phlé, a fhorbairt agus a chomhaontú. Níl lipéadú dátheangach mar chuid de shainchúram an Ghrúpa Oibre Tras-Rialtais. Ba cheart a thabhairt ar aird, áfach, i dtrasuíomh na hÉireann ar an Rialachán FIC (Ionstraim Reachtúil 556/2014) go bhfuil rogha ann faisnéis éigeantach faoi bhia a sholáthar go dátheangach.
Dental Services
Questions (155)
Richard Bruton
Question:155. Deputy Richard Bruton asked the Minister for Health if he has reviewed the adequacy of dental services for people who hold medical cards; and if he will make a statement on the matter. [7465/23]
View answerWritten answers
The Dental Treatment Services Scheme (DTSS) provides dental care, free of charge, to medical card holders aged 16 and over. Since May 1st 2022, there has been additional prevention treatments included and a 40-60% increase in fees across most treatment items. This has led to an increase in the numbers of treatments provided and the number of patients being seen. An additional allocation of €15 million has been made in Budget 2023 to enhance the provision of oral healthcare services. This includes €5 million allocated on a one-off basis to support the HSE Public Dental Service to provide care this year, including through a HSE ‘safety-net’ service for adult medical card holders who are in need of emergency care and are still having difficulty accessing a local dentist. The Government recognises that substantive reform of the DTSS is required, as set out in the National Oral Health Policy. My Department is working closely with the HSE to ensure the establishment of focused implementation structures to drive implementation of the Policy. Resources will be provided for new clinical leadership and reform leadership posts. These implementation structures will help to substantively reform the provision of public oral healthcare services to all ages. While it will take a number of years to bring reform to complete fruition, there will be an early emphasis in implementation on addressing the current issues, including the reform of the provision of services for medical card holders.
Disability Services
Questions (156)
Seán Sherlock
Question:156. Deputy Sean Sherlock asked the Minister for Health if he will fund a community neuro-rehabilitation team to be set up in CHO4. [7466/23]
View answerWritten answers
As this question refers to service matters, I have asked the Health Service Executive (HSE) to respond to the Deputy directly, as soon as possible.
Health Services
Questions (157)
Seán Sherlock
Question:157. Deputy Sean Sherlock asked the Minister for Health his views on the over 8s referral protocol to community opticians; and whether the €22.51 paid to opticians per consultation reflects the real cost of administering the scheme for community opticians. [7467/23]
View answerWritten answers
The HSE Primary Care Eye Services Review Group Report, published in June 2017, set out current levels of service, models of service provision and the consultation process undertaken with patients, advocates, ophthalmic staff and representative bodies. It also highlighted the limitations of the current model of service delivery, including the impact on waiting lists, and set out the way forward for a significant amount of eye services to be delivered in a primary care setting.
The Report estimated that 60% of existing outpatient activity could be moved to primary care thus enabling hospital services to focus on patients who require more specialist diagnostics or treatments. This Report remains current and the HSE has advised that it will advance the transfer of care for children aged 8+ years to local optometrists, thereby reducing waiting lists and enhancing access to primary eye care services.A project team with a wide-ranging membership was established in late 2019 / early 2020 to progress this initiative. The work of the team was paused due to the requirement to focus resources on the COVID 19 pandemic. However, the project team has been reconvened and is progressing matters in relation to this initiative.
The Community Ophthalmic Services Scheme (COSS) is a national fee-per-item scheme which was introduced in 1979. Under the COSS, medical card holders aged over 16 years can be seen by ophthalmologists, community ophthalmic physicians, optometrists or dispensing opticians.
Eligible patients can receive an eye examination and be provided with prescribed optical appliances in accordance with a national schedule of approved optical appliances.
The Health Professionals (Reduction of Payments to Ophthalmologists, Optometrists and Dispensing Opticians) Regulations 2013 (SI 274 of 2013) sets the fees for optometrists and dispensing opticians under the Community Optometric Services, Community Spectacle Dispensing Services and Health Amendment Act Card Schemes.
I am committed to increasing the fees payable to contractors for a standard eye examination under the COSS. This is a priority for my Department, and work with stakeholders is ongoing to implement this change in 2023.
Question No. 158 answered with Question No. 152.
Health Service Executive
Questions (159, 160)
Catherine Murphy
Question:159. Deputy Catherine Murphy asked the Minister for Health the funding set aside on an annual basis for contingent liability for the past ten years to date by the HSE; the way in which the amount is determined by the HSE; if the HSE carries out an actuary analysis for budgeting current and future contingent liability; and if the HSE conducts a risk assessment in the context of contingent liability. [7477/23]
View answerCatherine Murphy
Question:160. Deputy Catherine Murphy asked the Minister for Health the amount of funds set aside on an annual basis for contingent liability for the past ten years to date in 2023; the way in which it is determined the amount that is forecast to be needed for contingent liability; if he carries out an actuary analysis for budgeting current and future contingent liability; if he conducts a risk assessment in the context of contingent liability; and if he will make a statement on the matter. [7478/23]
View answerWritten answers
I propose to take Questions Nos. 159 and 160 together.
Financial accounting standards require an entity to recognise a provision for a liability if, and only if, a present obligation (legal or constructive) has arisen as a result of a past event (the obligating event), payment is probable ('more likely than not'), and the amount can be estimated reliably. By contrast, contingent liabilities arise where either there is uncertainty about the transfer of economic resources in relation to the obligation or where the amount of the obligation cannot be reliably estimated (or both).
Contingent liabilities are thus not provided for in the entity's Statement of Financial Position, or charged as an expense to the Statement of Income and Expenditure but are instead disclosed by way of note to the entity's accounts.
While there have been additional disclosures made in previous years in relation to a range of contingent liabilities within the HSE's annual financial statements, the main contingent liability noted by the HSE in its 2021 Annual Financial Statements (AFS) arose in relation to the settlement of clinical and non-clinical claims under the Clinical Indemnity Scheme which are handled on the HSE's behalf by the State Claims Agency.
The HSE reports its financial performance and position in line with the Financial Reporting Standard (FRS) 102, subject to a number of exceptions to the FRS102 standard which have been directed by the Minister for Health including an exception in relation to the reporting of clinical and non clinical claims by the State Claims Agency. The costs of clinical and non clinical claims being handled by the State Claims Agency on the HSE's behalf is met annually (by Ministerial direction) on a pay-as-you-go basis, and is accounted for as an expense as costs are incurred in the HSE's financial statements and under Subhead K.4 in the Department's appropriation account. As note 1 on Accounting Policies to the HSE's AFS details, the accounting treatment in relation to the claims being handled by the State Claims Agency is divergent from the FRS102 standard.
In relation to the potential future costs of claims, the State Claims Agency provides regular actuarial forecasts to the Department, projecting potential future costs of claims in the medium term. These forecasts are based on the State Claims Agency’s best current estimate of the ultimate cost of resolving each claim, including all foreseeable costs such as settlement amounts, plaintiff legal costs and defence costs such as fees payable to counsel, consultants, etc. Based on current actuarial estimates, the cost of such claims is expected to increase significantly in future years.
Addressing the incidence of claims under the Clinical Indemnity Scheme is a high priority for my Department, first and foremost from a patient safety and harm reduction perspective, with the secondary benefit of reducing the costs of such claims to the exchequer. The Patient Safety (Notifiable Patient Safety Incidents) Bill 2019 currently proceeding through the legislative process in the Oireachtas is one measure which, when enacted, is expected to improve patient safety and therefore reduce the costs of claims.
Additionally, on 31st January the Government approved the establishment of an Interdepartmental Working Group to examine the rising cost of health-related claims, with a particular focus on high value claims, to consider mechanisms to reduce costs. The Group’s considerations will include developing a plan to implement risk management and other initiatives to reduce the occurrence of adverse incidents and to recommend measures to address patient concerns following the occurrence of adverse incidents, taking into account measures suggested by Dr Scally in his final implementation review report. The Group will be chaired independently by an expert healthcare professional, Dr Rhona Mahony and will be comprised of membership from across key government departments and agencies. This is an important piece of work for patients and for the whole health service, and I look forward to engaging with the Working Group and working to implement the group’s findings and recommendations in due course.
Question No. 160 answered with Question No. 159.
Health Service Executive
Questions (161)
Catherine Murphy
Question:161. Deputy Catherine Murphy asked the Minister for Health if he will correct the record of Dáil Éireann in respect of the Parliamentary responses that issued from his Department on 8 May 2018 (details supplied); if his attention has been drawn to comments made by his Secretary General and the Comptroller and Auditor General in relation to contingent liabilities and recognition of same at an Oireachtas Public Accounts Committee meeting on 9 February 2023.; and if he will make a statement on the matter. [7479/23]
View answerWritten answers
The HSE reports its financial performance in line with Financial Reporting Standard 102 (FRS102) issued by the Financial Reporting Council, subject to certain exceptions to Generally Accepted Accounting Principles (GAAP) directed by the Minister for Health in relation a number of areas where the HSE has been directed to diverge from GAAP in how it accounts for depreciation, pensions, capital grants, clinical claims. Costs of contingent liabilities are not provided for or funded in the HSE’s determination until such time as the cost is incurred- for example in relation to clinical and non-clinical claims dealt with by the State Claims Agency on the HSE’s behalf, the liability only crystallises each year when the claims are actually settled. These costs are detailed in note 11 to the HSE’s 2021 annual financial statements which sets out the current year costs incurred together with the estimated overall liability associated with the Clinical Indemnity Scheme.
I am grateful to the Deputy for highlighting this matter and I am happy to clarify that one aspect of the response to the Parliamentary Question response detailed on 8 May 2018 that ‘There has been no crystallisation of a contingent liability for the Department in the last ten years’ should be amended to note as follows:
‘The costs of contingent liabilities are not provided for or funded in advance but are instead funded on a ‘pay as you go’ basis when the costs of the liabilities are settled. In the case of clinical and non-clinical claims dealt with on the HSE’s behalf by the State Claims Agency, the crystallisation of such liabilities occurs when the claims are settled and appropriate levels of funding are provided within the HSE’s determination each year to meet the costs of claims settled within the year.’
Medical Records
Questions (162, 163, 164)
John Lahart
Question:162. Deputy John Lahart asked the Minister for Health if there is a particular protocol followed by the HSE and Medical Council in relation to the retention of patient files when a general practitioner has ceased their practice; and if he will make a statement on the matter. [7482/23]
View answerJohn Lahart
Question:163. Deputy John Lahart asked the Minister for Health if patients can access their medical file and records when a general practitioner ceases their practice; and if he will make a statement on the matter. [7483/23]
View answerJohn Lahart
Question:164. Deputy John Lahart asked the Minister for Health if there is a particular protocol for the retention of patient files when a general practitioner has been removed from the Medical Council register; and if he will make a statement on the matter. [7484/23]
View answerWritten answers
I propose to take Questions Nos. 162 to 164, inclusive, together.
GPs are private contractors, most of whom hold a General Medical Services (GMS) Scheme contract with the HSE for the provision of medical services without charge to patients who hold a medical card or GP visit card. As private practitioners, the responsibility for the management of practice medical records rests with the GP concerned. GPs are required to ensure all personal data is processed in line with the General Data Protection Regulation principles and best practices, and patients can request a copy of their medical records directly from their GP surgery. The Irish College of General Practitioners' Processing of Patient Personal Data: A Guideline for General Practitioners publication provides guidance to GPs to comply with their data protection obligations including retention periods for medical records and the transfer of records to another practice. When there is a sudden closure of a GP practice the HSE endeavour to allocate a locum GP to take over the panel of GMS patients and advertise the list for a permanent replacement. When a GP retires or otherwise leaves the GMS scheme the HSE can facilitate the transfer of the records of GMS patients to the new doctor providing services for these patients. In such cases, the patient is notified that if they do not agree to the transfer of their records they can indicate this to the HSE. The HSE has no role in relation to medical records held by GPs of patients who do not hold a medical or GP visit card. In its role as regulator for registered medical practitioners in Ireland, the Medical Council does not have a statutory function in relation to the location or transfer of patient records in circumstances where a medical practice has ceased to operate and/or a medical practitioner has withdrawn from the Register or retired from practice.
However, in its Guide to Professional Conduct and Ethics for Registered Medical Practitioners, the Medical Council sets out a comprehensive range of professional principles that all doctors registered with the Council are expected to follow. This includes principles in respect of the management of medical records, and includes, for example, guidance in relation to retirement or transfer of patient care:
"If you are planning to retire or to reduce your patient list, you should make arrangements for the transfer of your patients to another doctor. You should let your patients know before these arrangements take effect. With the patient’s consent, all relevant medical records should be sent to the doctor taking over the care of the patient ".
Question No. 163 answered with Question No. 162.
Question No. 164 answered with Question No. 162.
Period Poverty
Questions (165)
Bríd Smith
Question:165. Deputy Bríd Smith asked the Minister for Health if he can clarify Government policy in relation to tackling period poverty; if they are supporting the passing of the legislation currently at Seanad Committee stage; if they intend to provide free products at secondary levels as well as third levels; and if he will make a statement on the matter. [7486/23]
View answerWritten answers
Period poverty is a priority for this Government, which has supported the roll-out of period dignity measures in Budgets 2022 and 2023.
The Department of Health and HSE were allocated €714,000 in 2022 and €814,000 in 2023, to support Local Authorities, NGOs, charities and other locally based organisations to place products in public buildings and facilities and to provide supports to those most at risk; minorities including Travellers and Roma, and those living with addiction, homelessness and/or disadvantage.
The Department of Health also chairs an inter-Departmental Period Poverty Implementation Group, with representation from most Government Departments, to co-ordinate implementation of period dignity measures across Government. The most recent meeting of the Group was in December, 2022.
The funding of period poverty measures in each sector is a matter for the relevant Government Department. Provision in the education sector is therefore a matter for the Department of Education and the Department of Further and Higher Education, Research, Innovation and Science, respectively. Both are represented on the Period Poverty Implementation Group.
The Free Provision of Period Products Bill 2021 is at Committee Stage in Seanad Éireann. The Government has committed to supporting the Bill and the recommendations of the Period Poverty in Ireland Discussion Paper. Progression of the Bill is subject to further information arising from the current supports that have been rolled out in 2022. Firstly, more accurate estimates of the cost in each sector are needed and data from initial rollout of supports in each sector will inform this, once available. Secondly, engagement with the Office of Government Procurement (OGP) is ongoing regarding the development of a Government procurement framework that includes period products and dispensers by the OGP. The Framework is expected be in place by the summer of 2023. Thirdly, once the data from 2022 reporting is available and analysed in order to inform costs, these will need to be submitted to Government through the annual Estimates process leading to Budget 2024.
Medicinal Products
Questions (166)
Duncan Smith
Question:166. Deputy Duncan Smith asked the Minister for Health the reason the drug cariban cannot beprescribed by a GP on the drug payment scheme; and if he will make a statement on the matter. [7492/23]
View answerWritten answers
As part of Budget 2023, funding of €32.2 million was announced for Women’s Health Initiatives in 2023.
This included dedicated funding of €1.3m for Cariban® (doxylamine/pyridoxine) to help women who experience hyperemesis gravidarum, a severe form of nausea and vomiting, during pregnancy. Hyperemesis gravidarum is expected to affect about 1% of the pregnant population.
The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Good s) Act 2013. Only licenced indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA) can be added to the formal reimbursement list.
Within the European Union (EU), the pricing and reimbursement of medicines is a national competence. As Member States operate different pharmaceutical reimbursement systems across the EU, a direct comparison of the reimbursement of products is not possible. The competent authority for pricing and reimbursement in Ireland is the HSE.
Cariban® is an Exempt Medicinal Product (EMP), i.e., it is not licensed in Ireland and, therefore, cannot be added to the formal reimbursement list.
However, following the recommendations of the HSE Medicines Management Programme, and to address the unmet need of patients with hyperemesis gravidarum, reimbursement support for Cariban® (doxylamine/pyridoxine), an unlicensed Exempt Medicinal Product, has now been made available on an individual patient basis for those patients who meet the criteria and where Consultant Obstetrician initiated.
Under the community drug schemes, Exempt Medicinal Products must be Consultant initiated. However, whilst the original prescriber of Cariban® must be a consultant and specialist in the relevant field, the HSE will accept a GP prescription subsequent to the initial hospital prescription for approved patients.
The relevant HSE circular regarding the exceptional arrangement for Cariban® is available at:
www.hse.ie/eng/staff/pcrs/circulars/pharmacy/pharmacy-circular-001-23-cariban.pdf.
In order to obtain reimbursement support for Cariban® under this exceptional arrangement, the prescribing consultant must confirm whether the following apply:
- The individual has nausea and vomiting of pregnancy (NVP) which requires systemic treatment.
- The individual has been assessed using the pregnancy unique quantification of emesis and nausea (PUQE) assessment tool and the appropriate treatment algorithm has been followed.
- The individual has not responded to conservative management.
The consultant must also make an Unlicensed Product Declaration and submit the completed application form by email to the Primary Care Reimbursement Service (PCRS).
Once reviewed by the PCRS, the prescriber and dispensing pharmacy are emailed (via secure email) with the reimbursement decision. The community pharmacy then dispenses the product under the specific patient’s community drug schemes eligibility and submits the claim using the relevant administrative code in their monthly submission to PCRS.
While reimbursement support is offered on the basis of the patient’s eligibility under the General Medical Services (GMS) Scheme or the Drugs Payment Scheme (DPS), Cariban® is not on the formal reimbursement list.
This exceptional arrangement has been put in place to ensure that those patients suffering from hyperemesis gravidarum have access to Cariban®. The dedicated funding that has been allocated is based on 1% of the pregnant population requiring treatment for hyperemesis gravidarum. The number of approved applications to date is in line with expectations and indicates that the budget allocated will be used in 2023. As of 10th February 2023, the number of applications received by the Primary Care Reimbursement Service (PCRS) stands at 384.
There are three other products containing doxylamine/pyridoxine, which are licensed in Ireland:
- Xonvea® gastro-resistant tablets.
- Navalem® modified-release hard capsules.
- Exeltis® gastro-resistant tablets.
The market authorisation holder of Xonvea® has not progressed the pricing and reimbursement application further with the HSE at this stage. The market authorisation holders for Exeltis® and Navalem® have not submitted pricing and reimbursement applications to the HSE.
The HSE therefore encourages clinicians, along with the Institute of Obstetricians and Gynaecologists and the National Clinical Programme for Obstetrics and Gynaecology, other healthcare professionals, and relevant representative bodies to encourage the market authorisation holders of the licensed medicinal products (Xonvea®, Exeltis® and Navalem®) to progress with the formal pricing and reimbursement process in Ireland.
Finally, the HSE provides general advice on treatments for hyperemesis gravidarum at:
www2.hse.ie/conditions/hyperemesis-gravidarum/treatment/.
Medicinal Products
Questions (167, 172)
Duncan Smith
Question:167. Deputy Duncan Smith asked the Minister for Health the number of cariban prescriptions which have been processed through the drug payment scheme to date; and if he will make a statement on the matter. [7493/23]
View answer
Marian Harkin
Question:172. Deputy Marian Harkin asked the Minister for Health to release the number of cariban prescriptions that have been processed through the drugs payment scheme for the years 2019, 2020, 2021 and 2022, in tabular form. [7564/23]
View answerWritten answers
I propose to take Questions Nos. 167 and 172 together.
Following the recommendations of the HSE Medicines Management Programme, and to help women who experience hyperemesis gravidarum (a severe form of nausea and vomiting during pregnancy), since 1st January 2023, reimbursement support for Cariban® (doxylamine/pyridoxine) has been made available under an exceptional arrangement on an individual patient basis where consultant initiated. Hyperemesis gravidarum is expected to affect about 1% of the pregnant population.
There were no applications under this arrangement for the years 2019, 2020, 2021 or 2022.
As of 10th February 2023, the number of applications received by the HSE Primary Care Reimbursement Service (PCRS) stands at 384. The number of applications to date is in line with expectations.
Hospital Appointments Status
Questions (168)
Niamh Smyth
Question:168. Deputy Niamh Smyth asked the Minister for Health the reason a person (details supplied) is waiting so long on an appointment in Monaghan Hospital. [7495/23]
View answerWritten answers
Under 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.
In relation to the particular query raised, as this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
General Practitioner Services
Questions (169)
Fergus O'Dowd
Question:169. Deputy Fergus O'Dowd asked the Minister for Health if a review can be undertaken to examine the viability of the out of hours GP north east contract (details supplied); and if he will make a statement on the matter. [7500/23]
View answerWritten answers
A strategic review of GP services is to commence shortly and will be completed this year. The review, with input from key stakeholders, will examine the broad range of issues affecting general practice and will set out the measures necessary to deliver a sustainable general practice into the future. The provision of Out of Hours GP services will be examined as part of this review.
Regarding the provision and availability of Out of Hours GPs services for the North East of the country, as this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly on this issue as soon as possible.
Ambulance Service
Questions (170)
Cian O'Callaghan
Question:170. Deputy Cian O'Callaghan asked the Minister for Health his plans to tackle the delays experienced by those in need of the National Ambulance Service; the average wait time for an ambulance; what additional staffing is required to shorten these delays; and if he will make a statement on the matter. [7501/23]
View answerWritten answers
As the Deputy may be aware, the National Ambulance Service (NAS) is in the process of transforming from a conventional emergency medical service to an agile and responsive mobile medical service, to enable patients to be treated at the lowest appropriate level of acuity, resulting in a better experience for the patient and a more efficient use of resources.
The NAS continues to experience significant service demands with a record 389,764 emergency calls received from the public in 2022, a 6% increase on the total calls received in 2021.
The Government is committed to the strategic reform of the NAS including increases in both frontline ambulance capacity and the expansion of alternative care pathways to direct patients away from emergency departments where there is no clinical need.
Significant initial progress has been made in this regard under the previous NAS Strategy ‘Vision 2020’ including:
- Expanded clinical and overall capacity in the NEOC Clinical Hub which advises emergency callers of alternative care pathways to that of conveyance by ambulance to a Hospital ED;
- Several alternative care pathways developed including the “Hear and Treat” Clinical Hub at the National Emergency Operations Centre (NEOC) and the “See and Treat” Pathfinder models.
- The Pathfinder "See and Treat” model of care was expanded at the end of October 2022 to three new sites in Tallaght, Limerick and Waterford.
- A Helicopter Emergency Medical Service, manned by a NAS Advanced Paramedic and EMT, established in Munster to serve patients in the South-West which commenced services in February 2023.
Government investment in 2022 saw a record funding allocation of over €200 million for the NAS which represents an increase of some €30 million from the 2019 allocation and a new record allocation is envisaged in 2023 once the NAS allocation is finalised. 2022 funding included €8.23 million for new service developments to provide for an additional 128 staff including additional frontline paramedics and strengthened clinical capacity in the NEOC Clinical Hub.In regard to the specific service matters outlined by the Deputy, I have asked the Health Service Executive (HSE) to respond to the Deputy directly with any further information it may have on the matter.
Medicinal Products
Questions (171)
Marian Harkin
Question:171. Deputy Marian Harkin asked the Minister for Health what is the process in writing by which pregnant women experiencing extreme nausea and vomiting can obtain the drug cariban (details supplied). [7563/23]
View answerWritten answers
As part of Budget 2023, funding of €32.2 million was announced for Women’s Health Initiatives in 2023.
This included dedicated funding for Cariban® (doxylamine/pyridoxine) to help women who experience hyperemesis gravidarum, a severe form of nausea and vomiting, during pregnancy. Hyperemesis gravidarum is expected to affect about 1% of the pregnant population.
The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Good s) Act 2013. Only licenced indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA) can be added to the formal reimbursement list.
Cariban® is an Exempt Medicinal Product (EMP), i.e., it is not licensed in Ireland and, therefore, cannot be added to the formal reimbursement list.
The pricing and reimbursement of medicines is a national competence. Different pharmaceutical reimbursement systems are currently in place across the EU. As Member States operate different systems, a direct comparison of the reimbursement of products is not possible. The competent authority for pricing and reimbursement in Ireland is the HSE.
However, following the recommendations of the HSE Medicines Management Programme, and to address the unmet need of patients with hyperemesis gravidarum, reimbursement support for Cariban® (doxylamine/pyridoxine), an unlicensed Exempt Medicinal Product, has now been made available on an individual patient basis for those patients who meet the criteria and where Consultant Obstetrician initiated.
Under the community drug schemes, Exempt Medicinal Products must be Consultant initiated. However, whilst the original prescriber of Cariban® must be a consultant and specialist in the relevant field, the HSE will accept a GP prescription subsequent to the initial hospital prescription for approved patients.
The relevant HSE circular regarding the exceptional arrangement for Cariban® is available at:
www.hse.ie/eng/staff/pcrs/circulars/pharmacy/pharmacy-circular-001-23-cariban.pdf.
In order to obtain reimbursement support for Cariban® under this exceptional arrangement, the prescribing consultant must confirm whether the following apply:
- The individual has nausea and vomiting of pregnancy (NVP) which requires systemic treatment;
- The individual has been assessed using the pregnancy unique quantification of emesis and nausea (PUQE) assessment tool and the appropriate treatment algorithm has been followed;
- The individual has not responded to conservative management.
The consultant must also make an Unlicensed Product Declaration and submit the completed application form by email to the Primary Care Reimbursement Service (PCRS).
Once reviewed by the PCRS, the prescriber and dispensing pharmacy are emailed (via secure email) with the reimbursement decision. The community pharmacy then dispenses the product under the specific patient’s community drug schemes eligibility and submits the claim using the relevant administrative code in their monthly submission to PCRS.
While reimbursement support is offered on the basis of the patient’s eligibility under the General Medical Services (GMS) Scheme or the Drugs Payment Scheme (DPS), Cariban® is not on the formal reimbursement list.
This exceptional arrangement has been put in place to ensure that those patients suffering from hyperemesis gravidarum have access to Cariban®. The dedicated funding that has been allocated is based on 1% of the pregnant population requiring treatment for hyperemesis gravidarum. The number of approved applications to date indicate that the budget allocated will be used in 2023.
Question No. 172 answered with Question No. 167.