Written Answers Nos. 1270-1292
1270. Deputy Colm Burke asked the Minister for Health if he will provide details in respect of the approval process for Oxycontin and drugs containing oxycodone by the HPRA; if the guidance has changed since it was first approved on the Irish market; and if he will make a statement on the matter. [63635/22]
View answerOxycodone-containing medicines have been authorised by the HPRA since 1998. These medicines are subject to non-renewable prescription, and are controlled under the Misuse of Drugs Regulations, 2017.
The marketing authorisation holder for a medicine has a legal obligation to inform the medicines regulator (e.g. HPRA) of information which impacts on the risks and benefits of their medicinal product. They also have a responsibility to ensure that product information (Summary of Product Characteristics (SmPC) and the Package Leaflet (PL)) for each of their authorised medicines is kept up-to-date. The role of the regulator is to ensure that the marketing authorisation for a medicine, as described in the product information, reflects the available data and outlines the terms under which the balance of benefits and risks of a medicine is positive.
Oxycodone-containing medicines authorised for use in Ireland contain warnings in the approved product information detailing the risks associated with prescription opioids, including, abuse, misuse, dependence and advice to be followed by healthcare professionals and patients to mitigate against these risks. Specifically, the product information highlights the need for monitoring of patients prescribed oxycodone-containing medicines by healthcare professionals, especially for signs of drug-seeking behaviour associated with dependence. Patients are further advised to immediately speak to their doctor if they are concerned that they may become dependent or notice signs of dependency.
Additionally, the European Medicines Agency’s safety committee known as the Pharmacovigilance Risk Assessment Committee (PRAC), of which the HPRA is a member, recently concluded a routine periodic review of the risk-benefit balance of oxycodone-containing medicines based on new and emerging safety information. Following this review, PRAC recommended further measures to improve awareness and recognition about the risks of abuse and dependence [opioid use disorder (OUD)]. Additional measures include establishing a treatment strategy prior to starting oxycodone-containing medication based on the agreement of treatment goals and a discontinuation plan with patients. PRAC recommended further strengthening of the warnings in the product information highlighting that patients are informed of the risks and signs of opioid use disorder before and during treatment. Strengthening of the package leaflet will further enhance patient awareness to the signs of dependence and addiction.
The product information for oxycodone-containing medicines authorised in Ireland has been updated since authorisation and the most recent information is available on the ‘Find a medicine’ section of the HPRA website.
1271. Deputy Colm Burke asked the Minister for Health the number of opioids licensed for use in Ireland that have been dispensed as part of a public drug scheme or in a HSE hospital, psychiatric facility or primary care setting and by a private GP from 2011 to date in tabular form; and if he will make a statement on the matter. [63636/22]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly in relation to the data available in respect of the community drug schemes, as soon as possible.
1272. Deputy Colm Burke asked the Minister for Health his views on whether clinical guidance and licensing guidance should be reviewed on oxycontin in the context of litigation in other countries; and if he will make a statement on the matter. [63637/22]
View answerThe Health Products Regultory Authority (HPRA) are responsible for the regulation of medicines, medical devices and other health products and does not provide clinical guidance concerning medicines.
Guidance on the licensing of medicines is harmonised across the EU. Licensing guidance for the medicines intended for the treatment of different types of pain outlines the clinical trials that should be conducted depending on the severity of pain, the efficacy and safety requirements that need to be met, and the need for long-term safety data (12 months). Licensing guidance is reviewed, updated and agreed by EU member states, depending on clinical circumstances.
Oxycodone-containing medicines authorised in Ireland are indicated for the treatment of severe pain, that is uncontrolled by other pain medicines. The lowest effective dose for pain-relief should be used, and should only be used for duration of time when they are considered necessary. Oxycodone-containing medicines are subject to non-renewable prescription, and are controlled drugs. Such medicines cannot be promoted to the public. Therefore, the regulation of oxycodone-containing medicines in Ireland, and across the EU, is strict. The conditions of authorisation in other jurisdictions may be different.
1273. Deputy Colm Burke asked the Minister for Health the total number of new medications licensed in the State for dealing with depression, stress and anxiety medications since 1 January 2019 to date; and if he will make a statement on the matter. [63638/22]
View answerThe World Health Organisation (WHO) classifies medicines according to the main therapeutic use of the main active ingredient of the medicine. The classification system is known as the Anatomical Therapeutic Chemical (ATC) classification system.
Medicines for the treatment of depression, stress, anxiety and related nervous system conditions are classified by WHO ATC under the broad categories N05 (psycholeptics including antispsychotics, anxiolytics, hypnotics and sedatives) and N06 (psychoanaleptics including antidepressants, psychostimulants, psycholeptics and psychoanaleptics in combinations and anti-dementia medicines).
The ‘Find a medicine’ section of the HPRA website provides information on each authorised medicine and the ATC code. Lists of medicines authorised since 1 January 2019 under each of the ATC codes, N05 and N06, are attached.
Please note the following:
- the lists include generics of previously authorised innovator medicines
- due to the broad categories explained above, the medicines listed may be authorised for conditions other than depression, stress or anxiety
- each strength of a medicine has a separate entry on the lists
- medicines on the lists may not be marketed
- each of these medicines are subject to non-renewable prescription.
Medicines authorised since 1 January 2019 under ATC code N05 (psycholeptics including antispsychotics, anxiolytics, hypnotics and sedatives). A total of 72 medicines: Find a Medicine Results (hpra.ie)
Medicines authorised since 1 January 2019 under ATC code N06 (psychoanaleptics including antidepressants, psychostimulants, psycholeptics and psychoanaleptics in combinations and anti-dementia medicines). A total of 27 medicines: Find a Medicine Results (hpra.ie)
1274. Deputy Colm Burke asked the Minister for Health the timeframe to move the HPV programme from a two-dose programme to a single dose programme; and if he will make a statement on the matter. [63639/22]
View answerAs this PQ relates to an operational issue, it has been referred to the HSE for answer.
1275. Deputy Colm Burke asked the Minister for Health the way that it is intended to monitor the HPV programme for effectiveness in view of the intention to move the HPV programme from a two-dose programme to a single dose programme; and if he will make a statement on the matter. [63640/22]
View answer1276. Deputy Colm Burke asked the Minister for Health when the HPV programme will be reviewed for clinical effectiveness in view of the intention to move the HPV programme from a two-dose programme to a single dose programme; if it is intended to return to a two-dose programme should this prove negative; and if he will make a statement on the matter. [63641/22]
View answer1278. Deputy Colm Burke asked the Minister for Health the way that the move of the HPV programme from a two-dose programme to a single dose programme may affect the target date for the elimination of cervical cancer in Ireland; and if he will make a statement on the matter. [63643/22]
View answerI propose to take Questions Nos. 1275, 1276 and 1278 together.
The immunisation programme in Ireland is based on the advice of the National Immunisation Advisory Committee (NIAC). The committee's recommendations are based on the prevalence of the relevant disease in Ireland and international best practice in relation to immunisation.
The National Immunisation Advisory Committee (NIAC) has updated their advice about the number of HPV vaccine doses young people need to receive. The NIAC advise that people with healthy immune systems now only need one dose of HPV vaccine.
Recent scientific evidence did not show a big difference in the effectiveness of the HPV vaccine in people with healthy immune systems, aged 9 to 24 years, who received one, two or three doses of the HPV vaccine.
My Department has asked the Health Protection Surveillance Centre to consider the clinical effectiveness of moving from a two dose to a one dose regimen. It is important to note that any surveillance programme needs to be operational for some time before data can be used to assess clinical effectiveness.
Ireland is committed to the global effort to virtually eliminate cervical cancer in the decades ahead and much progress is being made. In Ireland we are in a strong position to meet the global targets set by the World Health Organisation through developments in our HPV vaccination, cervical screening and cancer treatment services.
1277. Deputy Colm Burke asked the Minister for Health the way that is it intended to reach the 90% coverage rate for the HPV vaccine given that NIAC has advised that this is essential for an effective single-dose programme; and if he will make a statement on the matter. [63642/22]
View answerThe immunisation programme in Ireland is based on the advice of the National Immunisation Advisory Committee (NIAC). The committee's recommendations are based on the prevalence of the relevant disease in Ireland and international best practice in relation to immunisation.
The ages at which vaccines are recommended in the immunisation schedule are chosen by the NIAC in order to give each child the best possible protection against vaccine preventable diseases. As the HPV vaccine is preventative it is intended to be administered, if possible, before a person becomes exposed to HPV infection.
Therefore, the gender-neutral HPV vaccination programme targets all girls and boys in first year of secondary school to provide maximum coverage.
The NIAC has updated their advice about the number of HPV vaccine doses young people need to receive stating that people with healthy immune systems now only need one dose of HPV vaccine.
The reason for this change is that recent scientific evidence did not show a big difference in the effectiveness of the HPV vaccine in people with healthy immune systems, aged 9 to 24 years, who received one, two or three doses of the HPV vaccine.
The HSE continue to provide communications support and vaccine opportunities to strive to reach an uptake of 90% for the HPV vaccine for those in first year of second level education.
Furthermore, in line with the NIAC's advice, I have asked the HSE to facilitate and operationalise the Laura Brennan HPV Vaccination Catch-Up Programme.
This programme offers a free HPV vaccines to all boys and girls in second level education who were previously eligible to receive the HPV vaccine and who have not yet, for whatever reason, received it.
Young women, up to the age of 25, who have now left secondary school, and who did not receive the vaccine, are also eligible to receive the vaccine as part of the catch-up programme.
Eligible young people and their parents can register their interest in receiving the vaccine on www.hpv.ie This link also contains detailed information about the HPV vaccine.
1279. Deputy Pádraig Mac Lochlainn asked the Minister for Health when a person (details supplied) in County Donegal will receive an appointment in Beaumont Hospital; and if he will make a statement on the matter. [63649/22]
View answerUnder 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.
1281. Deputy Verona Murphy asked the Minister for Health the number of dental practices in County Wexford which have ceased providing medical card services to persons with disabilities in the past 36 months; the medical card dental services that are currently available to adult persons with disabilities; the provision in place for those whose local dentist withdraws from the provision of medical card services; and if he will make a statement on the matter. [63653/22]
View answerThe Dental Treatment Services Scheme (DTSS) provides dental care, free of charge, to medical card holders aged 16 and over. Services available annually and on demand include an examination including preventative elements, two fillings, emergency extractions, and a scale and polish. Since May 1st 2022, there has been additional prevention treatments included and a 40-60% increase in fees across most treatment items. More complex care, such as dentures, is also available. Patients with additional needs can access a broader range of treatments.
The DTSS is a “choice of dentist” scheme which does not require the patient to register with a particular dentist and enables medical card holders, including those with additional needs, to attend any DTSS contractor directly without recourse to the HSE. Where access to a dentist is difficult, local HSE services assist patients who make enquires and make lists of DTSS contractors available to medical card holders. In exceptional circumstances, the HSE directly assists patients to access emergency dental treatment by contacting private contractors or arranging treatment through HSE-employed dentists.
Adults with additional needs who cannot receive care in a general dental practice setting may need special care services provided via the HSE Public Dental Services. A general dental practitioner or a GP can refer a patient to the HSE for receipt of special care services. A patient or caregiver can also make contact with the HSE directly. These patients who have additional needs are given an oral health examination and have their treatment provided using additional supports where necessary. Supports to care include Relative Analgesia, IV sedation and Dental General Anaesthetic.
I have asked the HSE to reply to the Deputy directly with the service-related information sought.
1282. Deputy Verona Murphy asked the Minister for Health the number of dental practices in County Wexford which have ceased providing medical card services in the past 36 months; the medical card dental services that are currently available to medical card users; the provision in place for those whose local dentist withdraws from the provision of medical card services; and if he will make a statement on the matter. [63654/22]
View answerThe Dental Treatment Services Scheme (DTSS) provides dental care, free of charge, to medical card holders aged 16 and over. Services available annually and on demand include an examination including preventative elements, two fillings, emergency extractions, and a scale and polish. Since May 1st 2022, there has been additional prevention treatments included and a 40-60% increase in fees across most treatment items. More complex care, such as dentures, and a broader range of treatments for patients with additional needs and high-risk patients are also available.
The DTSS is a “choice of dentist” scheme which does not require the patient to register with a particular dentist and enables medical card holders to attend any DTSS contractor directly without recourse to the HSE. Where access to a dentist is difficult, local HSE services assist patients who make enquires and make lists of DTSS contractors available to medical card holders. In exceptional circumstances the HSE directly assists patients to access emergency dental treatment by contacting private contractors or arranging treatment through HSE-employed dentists.
I am aware that there are some towns with no or very few DTSS dentists that have sufficient capacity to accept new patients. For this reason, €5 million of additional funding has been allocated through Budget 2023 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 struggling to access a local dentist.
I have asked the HSE to reply to the Deputy directly with the service-related information sought.
1283. Deputy Verona Murphy asked the Minister for Health the average number of sessions that are currently operating at Wexford General Hospital for dental services under anaesthesia per week; and if he will make a statement on the matter. [63655/22]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
1284. Deputy Verona Murphy asked the Minister for Health the number of children with special needs who are currently waiting for dental treatment under anaesthesia at Wexford General Hospital; the number of children with special needs who are waiting 24, 36 and 48 months and longer, respectively; and if he will make a statement on the matter. [63656/22]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
1285. Deputy Verona Murphy asked the Minister for Health the number of adults with special needs who are currently waiting for dental treatment under anaesthesia at Wexford General Hospital; the number of adults with special needs who are waiting 24, 36 and 48 months and longer, respectively; and if he will make a statement on the matter. [63657/22]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
1286. Deputy Verona Murphy asked the Minister for Health the number of dentists by local electoral area in County Wexford at present who are contracted to provide dental services under the dental treatment services scheme; and if he will make a statement on the matter. [63658/22]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
1288. Deputy Matt Shanahan asked the Minister for Health the number of dental practices in Waterford city and county which have ceased providing medical card services to persons with disabilities in the past three years; the medical card dental services that are currently available to adult persons with disabilities; the provision in place for those whose local dentist withdraws from the provision of medical card services; and if he will make a statement on the matter. [63660/22]
View answerThe Dental Treatment Services Scheme (DTSS) provides dental care, free of charge, to medical card holders aged 16 and over. Services available annually and on demand include an examination including preventative elements, two fillings, emergency extractions, and a scale and polish. Since May 1st 2022, there has been additional prevention treatments included and a 40-60% increase in fees across most treatment items. More complex care, such as dentures, is also available. Patients with additional needs can access a broader range of treatments.
The DTSS is a “choice of dentist” scheme which does not require the patient to register with a particular dentist and enables medical card holders, including those with additional needs, to attend any DTSS contractor directly without recourse to the HSE. Where access to a dentist is difficult, local HSE services assist patients who make enquires and make lists of DTSS contractors available to medical card holders. In exceptional circumstances, the HSE directly assists patients to access emergency dental treatment by contacting private contractors or arranging treatment through HSE-employed dentists.
Adults with additional needs who cannot receive care in a general dental practice setting may need special care services provided via the HSE Public Dental Services. A general dental practitioner or a GP can refer a patient to the HSE for receipt of special care services. A patient or caregiver can also make contact with the HSE directly. These patients who have additional needs are given an oral health examination and have their treatment provided using additional supports where necessary. Supports to care include Relative Analgesia, IV sedation and Dental General Anaesthetic.
I have asked the HSE to reply to the Deputy directly with the service-related information sought.
1289. Deputy Matt Shanahan asked the Minister for Health the number of dental practices in Waterford city and county which have ceased providing medical card services in the past three years; the medical card dental services that are currently available to medical card users; the provision in place for those whose local dentist withdraws from the provision of medical card services; and if he will make a statement on the matter. [63661/22]
View answerThe Dental Treatment Services Scheme (DTSS) provides dental care, free of charge, to medical card holders aged 16 and over. Services available annually and on demand include an examination including preventative elements, two fillings, emergency extractions, and a scale and polish. Since May 1st 2022, there has been additional prevention treatments included and a 40-60% increase in fees across most treatment items. More complex care, such as dentures, and a broader range of treatments for patients with additional needs and high-risk patients are also available.
The DTSS is a “choice of dentist” scheme which does not require the patient to register with a particular dentist and enables medical card holders to attend any DTSS contractor directly without recourse to the HSE. Where access to a dentist is difficult, local HSE services assist patients who make enquires and make lists of DTSS contractors available to medical card holders. In exceptional circumstances the HSE directly assists patients to access emergency dental treatment by contacting private contractors or arranging treatment through HSE-employed dentists.
I am aware that there are some towns with no or very few DTSS dentists that have sufficient capacity to accept new patients. For this reason, €5 million of additional funding has been allocated through Budget 2023 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 struggling to access a local dentist.
I have asked the HSE to reply to the Deputy directly with the service-related information sought.
1291. Deputy Noel Grealish asked the Minister for Health the number of dental practices in Galway city and the rest of County Galway which have ceased providing medical card services to persons with disabilities in the past ten years; the medical card dental services that are currently available to adult persons with disabilities; the provision in place for those whose local dentist withdraws from the provision of medical card services; and if he will make a statement on the matter. [63665/22]
View answerThe Dental Treatment Services Scheme (DTSS) provides dental care, free of charge, to medical card holders aged 16 and over. Services available annually and on demand include an examination including preventative elements, two fillings, emergency extractions, and a scale and polish. Since May 1st 2022, there has been additional prevention treatments included and a 40-60% increase in fees across most treatment items. More complex care, such as dentures, is also available. Patients with additional needs can access a broader range of treatments.
The DTSS is a “choice of dentist” scheme which does not require the patient to register with a particular dentist and enables medical card holders, including those with additional needs, to attend any DTSS contractor directly without recourse to the HSE. Where access to a dentist is difficult, local HSE services assist patients who make enquires and make lists of DTSS contractors available to medical card holders. In exceptional circumstances, the HSE directly assists patients to access emergency dental treatment by contacting private contractors or arranging treatment through HSE-employed dentists.
Adults with additional needs who cannot receive care in a general dental practice setting may need special care services provided via the HSE Public Dental Services. A general dental practitioner or a GP can refer a patient to the HSE for receipt of special care services. A patient or caregiver can also make contact with the HSE directly. These patients who have additional needs are given an oral health examination and have their treatment provided using additional supports where necessary. Supports to care include Relative Analgesia, IV sedation and Dental General Anaesthetic.
I have asked the HSE to reply to the Deputy directly with the service-related information sought.
1292. Deputy Noel Grealish asked the Minister for Health the number of dental practices in Galway city and the rest of County Galway which have ceased providing medical card services in the past ten years; the medical card dental services that are currently available to medical card users; the provision in place for those whose local dentist withdraws from the provision of medical card services; and if he will make a statement on the matter. [63666/22]
View answerThe Dental Treatment Services Scheme (DTSS) provides dental care, free of charge, to medical card holders aged 16 and over. Services available annually and on demand include an examination including preventative elements, two fillings, emergency extractions, and a scale and polish. Since May 1st 2022, there has been additional prevention treatments included and a 40-60% increase in fees across most treatment items. More complex care, such as dentures, and a broader range of treatments for patients with additional needs and high-risk patients are also available.
The DTSS is a “choice of dentist” scheme which does not require the patient to register with a particular dentist and enables medical card holders to attend any DTSS contractor directly without recourse to the HSE. Where access to a dentist is difficult, local HSE services assist patients who make enquires and make lists of DTSS contractors available to medical card holders. In exceptional circumstances the HSE directly assists patients to access emergency dental treatment by contacting private contractors or arranging treatment through HSE-employed dentists.
I am aware that there are some towns with no or very few DTSS dentists that have sufficient capacity to accept new patients. For this reason, €5 million of additional funding has been allocated through Budget 2023 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 struggling to access a local dentist.
I have asked the HSE to reply to the Deputy directly with the service-related information sought.
