Thursday, 9 Feb 2023

Written Answers Nos. 280-299

Mental Health Services

Ceisteanna (280)

Michael Healy-Rae

Ceist:

280. Deputy Michael Healy-Rae asked the Minister for Health if he will provide an update on north Kerry CAMHS (details supplied); and if he will make a statement on the matter. [6313/23]

Freagraí scríofa

Minister of State at the Department of Health

As this is a service matter, I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.

Disability Services

Ceisteanna (281)

Cormac Devlin

Ceist:

281. Deputy Cormac Devlin asked the Minister for Health if his attention has been drawn to the case of a person (details supplied); and if he will make a statement on the matter. [6317/23]

Freagraí scríofa

Minister for Health

As the question relates to a service matter, I am forwarding the PQ to the HSE for a direct reply to the Deputy.

Medicinal Products

Ceisteanna (282, 283, 302, 305)

Michael Healy-Rae

Ceist:

282. Deputy Michael Healy-Rae asked the Minister for Health if his Department will provide persons with access to a drug (details supplied); and if he will make a statement on the matter. [6319/23]

Brendan Griffin

Ceist:

283. Deputy Brendan Griffin asked the Minister for Health if his Department will provide a person (details supplied) with access to a medication; and if he will make a statement on the matter. [6333/23]

Bríd Smith

Ceist:

302. Deputy Bríd Smith asked the Minister for Health if he will clarify the reason exactly a GP cannot prescribe cariban on the drugs payment scheme; if he will acknowledge that the majority of women do not see a consultant until after 12 weeks of pregnancy and it is the case that a GP would be qualified to prescribe the drug and be automatically covered on the DPS; if he will clarify the reason that a GP would not be qualified to do so if this is not permissible; if he will clarify the standard practice of the prescription of the drug that exists in other EU member states; if he will further outline his Department’s recommendations to help with extreme nausea and vomiting for the first 12 weeks of pregnancy or until the drug can be accessed; and if he will make a statement on the matter. [6375/23]

Paul Kehoe

Ceist:

305. Deputy Paul Kehoe asked the Minister for Health the reason the drug cariban cannot be prescribed by a GP on the drugs payment scheme, given that the majority of women do not see a consultant until after 12 weeks; if this is the current standard practice in other EU member states; his Department’s recommendations, in the meantime, to help with the extreme nausea and vomiting for the first 12 weeks, or until the drug can be accessed; and if he will make a statement on the matter. [6383/23]

Freagraí scríofa

Minister for Health

I propose to take Questions Nos. 282, 283, 302 and 305 together.

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 morning sickness, 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 schemes eligibility – either the General Medical Services (GMS) Scheme or the Drugs Payment Scheme (DPS) – and submits the claim using the relevant administrative code in their monthly submission to PCRS.

Since 1st January 2023, reimbursement support for Cariban® (doxylamine/pyridoxine) has been available under an exceptional arrangement on an individual patient basis where consultant initiated. The number of applications received by the Primary Care Reimbursement Service (PCRS), as of 8th February 2023, are 357.

Finally, the HSE provides general advice on treatments for hyperemesis gravidarum at:

www2.hse.ie/conditions/hyperemesis-gravidarum/treatment/

Question No. 283 answered with Question No. 282.

Medicinal Products

Ceisteanna (284, 289, 294, 299, 301)

Mairéad Farrell

Ceist:

284. Deputy Mairéad Farrell asked the Minister for Health the process in writing through which pregnant women experiencing extreme nausea and vomiting can obtain the drug cariban; and if he will make a statement on the matter. [6334/23]

Ged Nash

Ceist:

289. Deputy Ged Nash asked the Minister for Health the process, in detail, through which pregnant women in Ireland experiencing extreme nausea can access the drug cariban; the reason that women are having trouble obtaining the drug; and if he will make a statement on the matter. [6362/23]

Michael McNamara

Ceist:

294. Deputy Michael McNamara asked the Minister for Health if he will outline the process for obtaining the cariban drug for pregnant women experiencing extreme nausea and vomiting; and if he will make a statement on the matter. [6367/23]

Catherine Connolly

Ceist:

299. Deputy Catherine Connolly asked the Minister for Health the process whereby pregnant women experiencing extreme nausea can obtain access to cariban; and if he will make a statement on the matter. [6372/23]

Bríd Smith

Ceist:

301. Deputy Bríd Smith asked the Minister for Health if he will clearly outline the process through which pregnant women experiencing extreme nausea and vomiting can obtain cariban under the drugs payment scheme; and if he will make a statement on the matter. [6374/23]

Freagraí scríofa

Minister for Health

I propose to take Questions Nos. 284, 289, 294, 299 and 301 together.

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;

- nThe 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 schemes eligibility – either the General Medical Services (GMS) Scheme or the Drugs Payment Scheme (DPS) – and submits the claim using the relevant administrative code in their monthly submission to PCRS.

Medicinal Products

Ceisteanna (285, 290, 295)

Mairéad Farrell

Ceist:

285. Deputy Mairéad Farrell asked the Minister for Health the reason that the drug cariban cannot be prescribed by a GP on the drugs payment scheme (details supplied); and if he will make a statement on the matter. [6335/23]

Ged Nash

Ceist:

290. Deputy Ged Nash asked the Minister for Health if he will consider allowing GPs to prescribe cariban, a drug for pregnant women experiencing extreme nausea that currently is only prescribed by consultants; and if he will make a statement on the matter. [6363/23]

Michael McNamara

Ceist:

295. Deputy Michael McNamara asked the Minister for Health the reason the cariban drug is not prescribed by GPs through the drugs payment scheme (details supplied); and if he will make a statement on the matter. [6368/23]

Freagraí scríofa

Minister for Health

I propose to take Questions Nos. 285, 290 and 295 together.

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 morning sickness, during pregnancy.

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 Goods) 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, 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, Cariban® has now been made available on an individual patient basis for those patients who meet the criteria and where Consultant Obstetrician initiated.

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.

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.

Finally, 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).

Medicinal Products

Ceisteanna (286, 291, 296, 300, 303, 306)

Mairéad Farrell

Ceist:

286. Deputy Mairéad Farrell asked the Minister for Health the number of cariban prescriptions that have been processed through the drugs payment scheme to date, in tabular form; and if he will make a statement on the matter. [6336/23]

Ged Nash

Ceist:

291. Deputy Ged Nash asked the Minister for Health the number of cariban prescriptions processed in Ireland since the drug was added to the DPS in tabular form; and if he will make a statement on the matter. [6364/23]

Michael McNamara

Ceist:

296. Deputy Michael McNamara asked the Minister for Health the number of cariban prescriptions that have been processed through to drugs payment scheme to date, in tabular form; and if he will make a statement on the matter. [6369/23]

Catherine Connolly

Ceist:

300. Deputy Catherine Connolly asked the Minister for Health the number of cariban prescriptions processed to date under the drug payment scheme; and if he will make a statement on the matter. [6373/23]

Bríd Smith

Ceist:

303. Deputy Bríd Smith asked the Minister for Health if he will provide details of the number of cariban prescriptions that have been processed through the drugs payment scheme to date, in tabular form; and if he will make a statement on the matter. [6376/23]

Paul Kehoe

Ceist:

306. Deputy Paul Kehoe asked the Minister for Health the number of cariban prescriptions that have been processed through the drugs payment scheme to date, in tabular form; and if he will make a statement on the matter. [6384/23]

Freagraí scríofa

Minister for Health

I propose to take Questions Nos. 286, 291, 296, 300, 303 and 306 together.

Since 1 January 2023, reimbursement support for Cariban® (doxylamine/pyridoxine) has been available under an exceptional arrangement on an individual patient basis where consultant initiated.

The number of applications received by the Primary Care Reimbursement Service (PCRS), as of 8th February 2023, are 357.

Rights of the Child

Ceisteanna (287)

Mark Ward

Ceist:

287. Deputy Mark Ward asked the Minister for Health his views on his recent contributions to the United Nations Committee on the Rights of the Child; and if he will make a statement on the matter. [6135/23]

Freagraí scríofa

Minister of State at the Department of Health

The United Nation’s Convention on the Rights of the Child (UNCRC) is a major international human rights treaty that sets out the specific rights of children. The UNCRC was adopted by the UN General Assembly in 1989 and Ireland ratified it in 1992.

The Minister for Children, Equality, Disability, Integration and Youth, Roderic O’Gorman, led a delegation at Ireland’s appearance before the United Nations Committee on the Rights of the Child (CRC), in Geneva earlier this year, with hearings taking places over the 24th and 25th of January. The delegation comprised senior officials from a wide range of government departments, with two officials representing the Department of Health.

A wide range of areas were examined by the committee including around education, inclusivity, justice, and social protection. Representatives from the Department of Health responded to questions raised around mental health, social inclusion, hospital waiting times, health assessments, and infant health. A key theme of all responses was the rights of the child under the UNCRC and steps being taken by Ireland to ensure the rights of children are promoted and protected.

Following the hearing, the Committee will make observations and recommendations to Ireland on the implementation of the Convention. My colleague Minister O'Gorman is awaiting this report and I am certain that all Government Departments will seek to engage constructively with the recommendations once received.

Rights of the Child

Ceisteanna (288)

Mark Ward

Ceist:

288. Deputy Mark Ward asked the Minister for Health if he will elaborate on his views expressed at the United Nations Committee on the Rights of the Child, where according to an article (details supplied), an official from his Department stated that it may not be the case that Ireland will reach a point where there are absolutely no children or adolescents being admitted to adult inpatient mental health facilities; if this is the Government’s official position; and if he will make a statement on the matter. [6136/23]

Freagraí scríofa

Minister of State at the Department of Health

HSE mental health services are committed to age appropriate inpatient mental health treatment and to the minimization of the number of admissions of children to adult units, while acknowledging that, in exceptional circumstances, it will continue to be necessary, where there is a clear clinical imperative, to admit a small number of children to adult units, for the shortest time possible.

Children are admitted to adult units only after efforts to place them in Child and Adolescent In-Patient Units are unsuccessful due to capacity or clinical needs. All admissions of young people under the age of 18 years are notified to the Mental Health Commission in accordance with regulations. All such admissions are also notified to a National CAMHS Lead Manager within Mental Health.

A decision to admit to an adult unit is made only if a CAMHS admission is not feasible. The majority of child admissions to adult units are for children in the 16-17 age bracket. Admission to an adult unit may often be more appropriate for the individual and to avoid any impact on younger children in CAMHS inpatient units. As such, and with respect to taking due consideration of the clinical need of the child and the services they require, it may not be the case that Ireland will reach a point there are absolutely no children using adult facilities.

Children admitted to adult units are provided with special supports by the HSE. The HSE Service Plan allows for some operational flexibility surrounding emergency placements in Adult Units, particularly where very short-term placements take place. Full account is taken of all relevant factors such as the preferences of all those involved, and geographical factors relating to access or visiting. Admission of children to adult units is for short time periods, usually resulting in transfer to a CAMHS unit or discharge with CAMHS Community team follow up.

Question No. 289 answered with Question No. 284.

Question No. 290 answered with Question No. 285.

Question No. 291 answered with Question No. 286.

Legislative Reviews

Ceisteanna (292)

Catherine Connolly

Ceist:

292. Deputy Catherine Connolly asked the Minister for Health the status of the review of the Health (Regulation of Termination of Pregnancy) Act 2018; when the completed review will be published; and if he will make a statement on the matter. [6365/23]

Freagraí scríofa

Minister for Health

The current expectation is that the Report will be submitted to the Minister in the coming days. The Report will then be considered by the Minister and published as soon as possible thereafter.

Health Services Staff

Ceisteanna (293)

Robert Troy

Ceist:

293. Deputy Robert Troy asked the Minister for Health if he will provide up-to-date information on a number of speech and language therapy vacancies in CHO 8 (details supplied). [6366/23]

Freagraí scríofa

Minister of State at the Department of Health

As this question concerns service matters, I have asked the Health Service Executive (HSE) to respond to the Deputy directly, as soon as possible.

Question No. 294 answered with Question No. 284.

Question No. 295 answered with Question No. 285.

Question No. 296 answered with Question No. 286.

Health Services Waiting Lists

Ceisteanna (297)

Robert Troy

Ceist:

297. Deputy Robert Troy asked the Minister for Health if a person (details supplied) can be placed on the May 2022 review list instead of the October 2022 review list. [6370/23]

Freagraí scríofa

Minister for Health

As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Medicinal Products

Ceisteanna (298)

Catherine Connolly

Ceist:

298. Deputy Catherine Connolly asked the Minister for Health with regard to the drug payment scheme, the analysis that his Department or the HSE has carried out into removing the requirement for the original prescriber of cariban to be a consultant, in order that GPs would have the authority to be the original prescriber for this medication; and if he will make a statement on the matter. [6371/23]

Freagraí scríofa

Minister for Health

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 morning sickness, 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.

However, following the recommendations of the HSE Medicines Management Programme, and to address the unmet need of those patients with hyperemesis gravidarum, reimbursement support for Cariban® has now been made available on an individual patient basis for those patients who meet the criteria and where Consultant Obstetrician initiated.

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.

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. 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).

This 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. 299 answered with Question No. 284.