Written Answers Nos. 313-327
313. Deputy Louise O'Reilly asked the Minister for Health the number of home help hours provided by each of the local health offices in CHO8 in each of the years 2012 to 2017 and to date in 2018; and if he will make a statement on the matter. [8177/18]
Amharc ar fhreagraAs this is a service matter I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
314. Deputy Louise O'Reilly asked the Minister for Health the number of home help hours provided by each of the local health offices in CHO9 in each of the years 2012 to 2017 and to date in 2018; and if he will make a statement on the matter. [8178/18]
Amharc ar fhreagraAs this is a service matter I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
315. Deputy Róisín Shortall asked the Minister for Health further to Parliamentary Questions Nos. 535 of 20 September 2017 and 411 of 10 October 2017 and a recent media report (details supplied), if he will request that the HSE's medicines management programme reviews the changes made to the prescription of lidocane medicated plasters; and if he will make a statement on the matter. [8186/18]
Amharc ar fhreagraMedicines play a vital role in improving the health of Irish patients. Securing access to existing and new and innovative medicines is a key objective of the health service. However, the challenge is to do this in an affordable and sustainable manner. The medicines bill for the community drugs schemes – primarily the GMS, Long Term Illness and Drugs Payment schemes and the High Tech Arrangement – was approximately €1.8 billion in 2017.
To ensure patients receive the highest quality care, resources invested in medicines must be used efficiently and effectively. This requires an integrated approach to secure best value for money for all treatments, greater efficiencies in the supply chain and the use of the most cost-effective treatments.
Lidocaine 5% medicated plaster is licensed for the symptomatic relief of neuropathic pain associated with previous herpes zoster (shingles) infection, known as post-herpetic neuralgia (PHN), in adults. It has been reimbursed in the community drugs schemes since 2010. The projected budget impact on introduction was low due to the specific licensed indication but total expenditure trebled between 2012 and 2016, from €9.4 million to over €30 million, mainly from off-license use for pain not associated with shingles.
An HSE Medicines Management Programme (MMP) review of this product highlighted that the clinical evidence for its use in PHN is limited due to lack of comparative data, and its value is uncertain for other types of pain. The National Centre for Pharmacoeconomics estimated that, in Ireland, only 5-10% of prescribing of this product has been for the licensed indication of PHN.
Following the MMP review, the HSE introduced a new reimbursement system for the product from 1 September 2017. This process supports its appropriate use, ensuring that PHN patients continue to receive this treatment.
Under the protocol, all patients who were receiving antivirals for shingles were automatically approved for the lidocaine medicated plaster. No action was required by GPs and the patient’s pharmacy was notified of his or her approval status.
However, since 1 December 2017, non-shingles patients no longer automatically receive this item under the community drugs schemes. In August 2017 the HSE advised GPs of the changes and of treatment alternatives.
It is possible for non-shingles patients to be approved for the patch through the community drug schemes. The patient's GP should apply to the Medicines Management Programme through the online system, and the MMP will review the application and inform the GP of its decision.
I am advised that the MMP has received over 4,700 applications from GPs, of which some 14% have been approved. For many of the conditions applied for, prescribing of the patch was inappropriate, for example for conditions such as deep venous thrombosis, angina, gout and endometriosis.
Where a GP’s application is rejected, it may be appealed. The HSE advises that over 60% have been accepted on clinical grounds.
Full details of the review are available on the HSE website at http://hse.ie/eng/about/Who/clinical/natclinprog/medicinemanagementprogramme/yourmedicines/lidocaine-plaster/lidocaine-medicated-plaster.html.
This decision is a matter for the HSE. However, I fully support the objectives of the HSE Medicines Management Programme.
316. Deputy Marc MacSharry asked the Minister for Health if his Department's decision to restrict the Versatis pain management patches on medical cards or the drug payment scheme for medical problems other than shingles will be reviewed; if his attention has been drawn to the large number of persons with back conditions such as scoliosis that are suffering since the patches were withdrawn; and if he will make a statement on the matter. [8187/18]
Amharc ar fhreagraMedicines play a vital role in improving the health of Irish patients. Securing access to existing and new and innovative medicines is a key objective of the health service. However, the challenge is to do this in an affordable and sustainable manner. The medicines bill for the community drugs schemes – primarily the GMS, Long Term Illness and Drugs Payment schemes and the High Tech Arrangement – was approximately €1.8 billion in 2017.
To ensure patients receive the highest quality care, resources invested in medicines must be used efficiently and effectively. This requires an integrated approach to secure best value for money for all treatments, greater efficiencies in the supply chain and the use of the most cost-effective treatments.
Lidocaine 5% medicated plaster is licensed for the symptomatic relief of neuropathic pain associated with previous herpes zoster (shingles) infection, known as post-herpetic neuralgia (PHN), in adults. It has been reimbursed in the community drugs schemes since 2010. The projected budget impact on introduction was low due to the specific licensed indication but total expenditure trebled between 2012 and 2016, from €9.4 million to over €30 million, mainly from off-license use for pain not associated with shingles.
An HSE Medicines Management Programme (MMP) review of this product highlighted that the clinical evidence for its use in PHN is limited due to lack of comparative data, and its value is uncertain for other types of pain. The National Centre for Pharmacoeconomics estimated that, in Ireland, only 5-10% of prescribing of this product has been for the licensed indication of PHN.
Following the MMP review, the HSE introduced a new reimbursement system for the product from 1 September 2017. This process supports its appropriate use, ensuring that PHN patients continue to receive this treatment.
Under the protocol, all patients who were receiving antivirals for shingles were automatically approved for the lidocaine medicated plaster. No action was required by GPs and the patient’s pharmacy was notified of his or her approval status.
However, since 1 December 2017, non-shingles patients no longer automatically receive this item under the community drugs schemes. In August 2017 the HSE advised GPs of the changes and of treatment alternatives.
It is possible for non-shingles patients to be approved for the patch through the community drug schemes. The patient's GP should apply to the Medicines Management Programme through the online system, and the MMP will review the application and inform the GP of its decision. I am advised that the MMP has received over 4,700 applications from GPs, of which some 14% have been approved. For many of the conditions applied for, prescribing of the patch was inappropriate, for example for conditions such as deep venous thrombosis, angina, gout and endometriosis.
Where a GP’s application is rejected, it may be appealed. The HSE advises that over 60% have been accepted on clinical grounds.
Full details of the review are available on the HSE website at http://hse.ie/eng/about/Who/clinical/natclinprog/medicinemanagementprogramme/yourmedicines/lidocaine-plaster/lidocaine-medicated-plaster.html.
This decision is a matter for the HSE. However, I fully support the objectives of the HSE Medicines Management Programme.
317. Deputy Niamh Smyth asked the Minister for Health if he will request the HSE to expedite an appointment for a person (details supplied); and if he will make a statement on the matter. [8193/18]
Amharc ar fhreagraUnder the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.
The National Waiting List Management Policy, A standardised approach to managing scheduled care treatment for in-patient, day case and planned procedures, January 2014, has been developed to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care. This policy, which has been adopted by the HSE, sets out the processes that hospitals are to implement to manage waiting lists.
In relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to the Deputy directly.
318. Deputy Jack Chambers asked the Minister for Health the details of the new day centre opening in Dublin 15 (details supplied); when it will be open; the location of the centre; the contact details for the service provider; and if he will make a statement on the matter. [8203/18]
Amharc ar fhreagraThe Government is committed to providing services and supports for people with disabilities which will empower them to live independent lives, provide greater independence in accessing the services they choose, and enhance their ability to tailor the supports required to meet their needs and plan their lives. This commitment is outlined in the Programme for Partnership Government, which is guided by two principles: equality of opportunity and improving the quality of life for people with disabilities.
As the Deputy's question relates to an individual case, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy.
319. Deputy Brendan Howlin asked the Minister for Health when Parts 2 and 3 of the Children and Family Relationships Act 2015 will be commenced; the timeframe for same; the progress made in this regard; the reason for the delay; and if he will make a statement on the matter. [8206/18]
Amharc ar fhreagraOfficials in my Department are undertaking the work necessary to facilitate the commencement of Parts 2 & 3 of the Children and Family Relationships Act 2015. We are working to resolve a small number of technical issues in order to ensure that the processes associated with Parts 2 & 3 of the Act can be commenced. I hope to be in a position to lay the Regulations before the Houses of the Oireachtas as early as possible in 2018.
320. Deputy Louise O'Reilly asked the Minister for Health if his attention has been drawn to the procedure necessary for the removal of transvaginal mesh devices; if his attention has been further drawn to the number and locations of the surgeons qualified to carry out these procedures; and if he will make a statement on the matter. [8209/18]
Amharc ar fhreagraI am aware of the safety concerns that have been raised surrounding the use of Transvaginal mesh procedures. I am also aware of the significant challenges which may be associated with mesh removal where this is necessary, which I am informed by the Health Service Executive may require gynaecological, general surgical or urological expertise, depending on the tissues involved. As Minister for Health, I want to ensure that both the current use of mesh implants in uro-gynaecological procedures in Ireland, and the on-going clinical management of women who have had these procedures in the past, are in line with international best practice and emerging evidence. At my request, the Chief Medical Officer is preparing a report on the many clinical and technical issues involved. I am informed that this work involves engagement with national and international bodies, the professional colleges and others. This work is underway and will take a number of months to complete and I would ask the Deputy to await the outcome of that work.
321. Deputy Niamh Smyth asked the Minister for Health the status of an appointment for a person (details supplied); and if he will make a statement on the matter. [8215/18]
Amharc ar fhreagraUnder the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.
The National Waiting List Management Policy, A standardised approach to managing scheduled care treatment for in-patient, day case and planned procedures, January 2014, has been developed to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care. This policy, which has been adopted by the HSE, sets out the processes that hospitals are to implement to manage waiting lists.
In relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to the Deputy directly.
322. Deputy Shane Cassells asked the Minister for Health if a person with a medical card that is on farm assist can retain their medical card for three years after they enter full-time employment (details supplied); and if he will make a statement on the matter. [8218/18]
Amharc ar fhreagra323. Deputy Shane Cassells asked the Minister for Health if a person ##with a medical card that is a dependant on a farm assist payment can retain their medical card for three years after they enter or return to full-time employment (details supplied); and if he will make a statement on the matter. [8219/18]
Amharc ar fhreagraI propose to take Questions Nos. 322 and 323 together.
As these questions relate to service matters, I have arranged for the question to be referred to the Health Service Executive for direct reply.
324. Deputy Darragh O'Brien asked the Minister for Health the status of the reimbursement of the drug Ocrevus; and if he will make a statement on the matter. [8223/18]
Amharc ar fhreagraThe HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013; therefore, the matter has been referred to the HSE for reply to the Deputy.
325. Deputy Thomas Pringle asked the Minister for Health if hospitals within the Saolta hospital group have been affected in view of the recent safety call-back of foetal monitoring devices; if all compromised foetal monitoring devices have been fully retired from all use; and if he will make a statement on the matter. [8233/18]
Amharc ar fhreagra348. Deputy Clare Daly asked the Minister for Health if each of the 11 hospitals signed and returned a letter to a company (details supplied) guaranteeing that all staff had been trained in specific use of these monitors in view of the recent report that foetal monitoring in the maternity services may have had deficiencies since 2009; if each hospital had regular audits of training in same for all new and locum staff since 2009; if there are audits of same; the length of time from appointment that new and locum staff were trained in the use of these monitors in each hospital; if the company wrote to either the HSE, his Department or another Government funded body since 2009 regarding the monitors; and if so, the action taken in view of the severity of the notice. [8371/18]
Amharc ar fhreagra349. Deputy Clare Daly asked the Minister for Health if a company (details supplied) wrote to the HSE or his Department since 2009 to identify that some units had not returned a signed letter saying that all staff that use the monitors had received appropriate training; if so, the action the HSE took with respect to these specific units; and the length of time it took to ensure compliance. [8372/18]
Amharc ar fhreagra350. Deputy Clare Daly asked the Minister for Health if the risk assessment committee is only carrying out current risk assessments and is not historically investigating or reviewing cases which would be better assessed by a review committee or HIQA. [8373/18]
Amharc ar fhreagra351. Deputy Clare Daly asked the Minister for Health if the risk assessment team will include a service user and not include healthcare professionals that had direct contact with a company (details supplied) or other responsibilities for ensuring that practice standards with respect to foetal monitors in a particular unit were achieved, audited or maintained. [8374/18]
Amharc ar fhreagra352. Deputy Clare Daly asked the Minister for Health if only 11 units are involved in the report into foetal monitoring; and if so, the name of each. [8375/18]
Amharc ar fhreagraI propose to take Questions Nos. 325 and 348 to 352, inclusive, together.
As this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to each Deputy. However, the Department is in a position to provide some information ahead of this direct reply, as follows.
Actions taken
The Department of Health was made aware of the matter relating to the monitoring of fetal heart rates in late January 2018 and immediately asked the HSE to examine the issue as a matter of urgency.
In 2009 a Field Safety Notice (FSN) was issued with new advice and guidance in relation to using these monitors and the known risks in relation to reading the fetal heartrate. The Health Products Regulatory Authority advise that it was confirmed to the manufactor that all relevant hospitals had received this notice in 2009, and that in 2011 a software upgrade had been applied to the machines.
In addition, there was a software revision applied to all these devices in Ireland and Philips Healthcare confirmed to the HPRA in November 2011 that the software revision had been completed in all Irish centres. The HPRA monitored the completion and effectiveness of these communications and the software revision.
The HPRA confirmed that all hospitals acknowledged receipt of the FSN, and that by 2011 all Avalon fetal monitors in Irish hospital had the software updates installed. The National Women and Infant’s Health Programme has requested updates from the hospitals that were affected by the FSN 2009.
Avalon Fetal monitors are CE marked medical devices on the market in Europe. [A medical device that has been approved will bear a CE mark. This indicates it meets the basic requirements for safety and effectiveness under European law].
These medical devices were not recalled in Europe or USA as a result of this issue. The use of the word ’recall’ is US Food and Drug Administration [FDA] terminology used in communications for either a device correction or a removal, depending on the action being taken in the United States.
The HPRA has monitored the incident and complaint rates nationally, on a European level and internationally and at no time identified the need for additional regulatory action.
Hospitals Impacted
The HSE advises that hospitals where the monitors were located are as follows, Coombe Women and Infants University Hospital, Portlaoise Hospital, Regional Hospital Mullingar, University Hospital Limerick, National Maternity Hospital, Sligo University Hospital, Rotunda Hospital, South Tipperary General Hospital, St Luke's General Hospital Kilkenny, Cork University Maternity Hospital and Wexford General Hospital.
Risk Assessment Team
Due to the nature and complexity of this issue and the level of assurance currently available in relation to actions taken to date, a Risk Assessment Team has been established will be responsible for assessing the nature of any potential risk to patient safety and to determine the appropriateness of actions taken by the manufacturer and the health service to date. If deficits are identified, the Risk Assessment Team will advise on any actions required to safeguard the safety of patients. These actions will include but may not be limited to;
1. Understanding the nature of any patient safety risks identified in the FSN.
2. Undertaking an assessment of the actions taken following the issue of the FSN in 2009 and since then. This will include consideration of the technological and human factors issues that may have impacted on CTG interpretation.
3. Determining whether the actions taken were appropriate in order to address potential risk.
4. Determining if there are any current safety risks and the status of risk in the period from November 2009 to the present and if there are, to advise on further actions required in order to ensure patient safety.
The membership of the Risk Assessment Team, which is Chaired by the Director of the National Women and Infants Health Programme, includes both the Clinical Director and the Director of Midwifery for the Programme, a representative of the Health Products Regulatory Authority [HPRA], the HSE’s National Medical Device Equipment Advisor and the National Director for Quality Assurance and Verification.
326. Deputy Danny Healy-Rae asked the Minister for Health when a resident general practitioner will be provided in an area (details supplied) in County Kerry; and if he will make a statement on the matter. [8234/18]
Amharc ar fhreagraAs this question relates to a service matter, I have arranged for the question to be referred to the Health Service Executive for direct reply to the Deputy.
327. Deputy James Lawless asked the Minister for Health if the recent decision to remove the Versatis 5% patch from the drugs payment scheme and medical card schemes will be reconsidered; and if he will make a statement on the matter. [8235/18]
Amharc ar fhreagraMedicines play a vital role in improving the health of Irish patients. Securing access to existing and new and innovative medicines is a key objective of the health service. However, the challenge is to do this in an affordable and sustainable manner. The medicines bill for the community drugs schemes – primarily the GMS, Long Term Illness and Drugs Payment schemes and the High Tech Arrangement – was approximately €1.8 billion in 2017.
To ensure patients receive the highest quality care, resources invested in medicines must be used efficiently and effectively. This requires an integrated approach to secure best value for money for all treatments, greater efficiencies in the supply chain and the use of the most cost-effective treatments.
Lidocaine 5% medicated plaster is licensed for the symptomatic relief of neuropathic pain associated with previous herpes zoster (shingles) infection, known as post-herpetic neuralgia (PHN), in adults. It has been reimbursed in the community drugs schemes since 2010. The projected budget impact on introduction was low due to the specific licensed indication but total expenditure trebled between 2012 and 2016, from €9.4 million to over €30 million, mainly from off-license use for pain not associated with shingles.
An HSE Medicines Management Programme (MMP) review of this product highlighted that the clinical evidence for its use in PHN is limited due to lack of comparative data, and its value is uncertain for other types of pain. The National Centre for Pharmacoeconomics estimated that, in Ireland, only 5-10% of prescribing of this product has been for the licensed indication of PHN.
Following the MMP review, the HSE introduced a new reimbursement system for the product from 1 September 2017. This process supports its appropriate use, ensuring that PHN patients continue to receive this treatment.
Under the protocol, all patients who were receiving antivirals for shingles were automatically approved for the lidocaine medicated plaster. No action was required by GPs and the patient’s pharmacy was notified of his or her approval status.
However, since 1 December 2017, non-shingles patients no longer automatically receive this item under the community drugs schemes. In August 2017 the HSE advised GPs of the changes and of treatment alternatives.
It is possible for non-shingles patients to be approved for the patch through the community drug schemes. The patient's GP should apply to the Medicines Management Programme through the online system, and the MMP will review the application and inform the GP of its decision.
I am advised that the MMP has received over 4,700 applications from GPs, of which some 14% have been approved. For many of the conditions applied for, prescribing of the patch was inappropriate, for example for conditions such as deep venous thrombosis, angina, gout and endometriosis.
Where a GP’s application is rejected, it may be appealed. The HSE advises that over 60% have been accepted on clinical grounds.
Full details of the review are available on the HSE website at http://hse.ie/eng/about/Who/clinical/natclinprog/medicinemanagementprogramme/yourmedicines/lidocaine-plaster/lidocaine-medicated-plaster.html.
This decision is a matter for the HSE. However, I fully support the objectives of the HSE Medicines Management Programme.
