Written Replies Nos. 868 to 887
868. Deputy Clare Daly asked the Minister for Health further to Parliamentary Questions Nos. 609 to 611, inclusive, of 11 April 2017, the reason he has stated that there was more vaccine produced by a company (details supplied) purchased than that of another company; and the reason 90% of the swine flu vaccinations were of the Pandemrix vaccine as distinct from Celvapan. [19460/17]
Amharc ar fhreagra869. Deputy Clare Daly asked the Minister for Health further to Parliamentary Question No. 610 of 11 April 2017, the number of doses of Pandemrix that were purchased; the number that were used; and the status of the unused vaccines. [19461/17]
Amharc ar fhreagra870. Deputy Clare Daly asked the Minister for Health further to Parliamentary Question No. 609 of 11 April 2017, the amount of money spent on the Pandemrix vaccine. [19462/17]
Amharc ar fhreagra872. Deputy Clare Daly asked the Minister for Health the cost of the swine flu vaccination programme; and the cost of the vaccines purchased, the public mass vaccination campaign, the setting up of emergency clinics around the country, the extra staff costs in hiring part-time staff and for overtime, the media campaign and other associated costs. [19464/17]
Amharc ar fhreagra873. Deputy Clare Daly asked the Minister for Health further to Parliamentary Question No. 610 of 11 April 2017, if it is correct that the HSE had contracts in place for items (details supplied). [19465/17]
Amharc ar fhreagraI propose to take Questions Nos. 868 to 870, inclusive, and 872 and 873 together.
The Health Service Executive (HSE) was guided on all aspects of the pandemic influenza vaccination campaign by the Pandemic Expert Influenza Group and the National Immunisation Advisory Committee. I have been informed by the HSE that they had contracts in place for the provision of pandemic vaccine, with Baxter for 4.25 million doses of Celvapan vaccine, and with GSK for 3.45 million doses of Pandemrix vaccine. However, Baxter had severe production difficulties and was unable to supply the amounts of vaccines as per the contract. Approximately 3 million doses of Pandemic vaccine were delivered to Ireland - 600,000 Baxter (Celvapan) and 2.4 million GSK (Pandemrix).
Of the 2.4 million Pandemrix influenza vaccines purchased, 90% were distributed. The shelf life for pandemic vaccines was 24 months. In 2011, all unused and expired vaccines were returned to the vaccine manufacturers for destruction.
The original budget for pandemic vaccine was €80 million and the actual spend was €30 million. The reduction was achieved by the purchase of less vaccines and negotiations with the vaccine manufacturers. The HSE is unable to provide the cost of each pandemic vaccine as this is commercially sensitive information.
I have been informed by the HSE that their National Immunisation Office does not have information on the other costs.
871. Deputy Clare Daly asked the Minister for Health further to Parliamentary Question No. 611 of 11 April 2017, the reason Pandemrix continued to be used after 2009 when the Irish Medicines Board was in possession of facts that showed it had a far greater likelihood of adverse reactions. [19463/17]
Amharc ar fhreagraThe first reports of a link between pandemic influenza vaccination and narcolepsy came in the second half of 2010. In August 2010, the Swedish pharmacovigilance authority reported that it was investigating six cases of narcolepsy reported by health care professionals as a possible adverse event following the use of Pandemrix vaccine, used during the H1N1 2009 pandemic. This was followed later that month by reports from the Finnish National Institute for Health and Welfare noting there had been a more than expected number of cases of narcolepsy in children and adolescents that year. On 23 September 2010, the Committee on Human Medicinal Products (CHMP) of the EMA concluded in its initial review of available data that the available evidence did not confirm a link but that more research was needed.
By the end of March 2011 the Irish Medicines Board (IMB), now the Health Products Regulatory Authority (HPRA) had received reports of two confirmed cases of narcolepsy following vaccination with pandemic vaccines. The Department of Health and the HSE agreed that the HSE Health Protection Surveillance Centre would work with the IMB and Irish clinical experts in narcolepsy to examine the Irish data and report back the findings. The Final Report of National Narcolepsy Study Steering Committee was published on 19 April 2012. It found a 13-fold higher risk of narcolepsy in vaccinated compared to unvaccinated individuals and the absolute increased risk associated with the vaccine was five narcolepsy cases per 100,000 vaccinated children and adolescents.
The vaccination programme in Ireland was based on the advices of the National Immunisation Advisory Committee. A number of "at risk" groups were defined and prioritised for vaccination commencing in October 2009. Over 1.1 million pandemic vaccinations were recorded, giving a 25% uptake for the total population. The vaccine uptakes among the priority groups were 50% for those medically at risk, 32% for pregnant women (it was 45% during early part of programme), 31% for health care workers, 60% for children aged 6 months to 4 years, 39% for children aged 5-14 years and 25% for those aged 65 years and older. The public pandemic vaccination campaign ended on 31 March 2010. However, following a full assessment of the situation at that time the vaccine continued to be made available free of charge to the “at risk” groups through General Practice and Maternity Units until September 2010.
Since the 2010/2011 influenza season H1N1 has been incorporated in the seasonal flu vaccine used in Ireland. Pandemrix was distributed to GPs in January 2011 with a recommendation that it be used for those in at risk groups for a three week period when there was a temporary shortage of seasonal influenza vaccine. All sites were asked to return any unused vaccine and it has not been recommended for use since then.
875. Deputy Thomas Pringle asked the Minister for Health if he will address the ongoing concern regarding access to new pump start-ups for children in County Donegal with type 1 diabetes, in view of the departure of a person (details supplied); his views on requests for a new paediatrician specialising in diabetes to be based at Letterkenny Hospital in the future; and if he will make a statement on the matter. [19472/17]
Amharc ar fhreagraIn response to the particular query raised, as this is a service matter, I have asked the HSE to respond to you directly.
876. Deputy Sean Fleming asked the Minister for Health the number of new managerial staff appointed in the HSE in 2015, 2016 and to date in 2017; the overall increase in managerial staff compared with the percentage increase in staff for hospital consultants, non-consultant hospital doctors, nursing staff and medical staff; and if he will make a statement on the matter. [19483/17]
Amharc ar fhreagraI have asked the HSE to respond to the Deputy directly on this matter.
877. Deputy Sean Fleming asked the Minister for Health the number of physiotherapists available in a location (details supplied) in each of the years 2013 to 2016 and to date in 2017; his plans to reinstate the level of services available in the location to its normal staffing levels; and if he will make a statement on the matter. [19484/17]
Amharc ar fhreagraAs this question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply.
878. Deputy Pearse Doherty asked the Minister for Health when a person (details supplied) in County Donegal can expect to be called for an operation; and if he will make a statement on the matter. [19485/17]
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 you directly.
879. Deputy Marc MacSharry asked the Minister for Health if it is now mandatory for the next-of-kin of adults with special needs resident in HSE institutions who have managed their personal finances over the years to hand over the management of these finances to the HSE service providers; and if he will make a statement on the matter. [19493/17]
Amharc ar fhreagraThe particular issue raised by the Deputy is a service matter for the Health Service Executive (HSE). Accordingly I have arranged for the Deputy's question to be referred to the HSE for direct reply to the Deputy.
880. Deputy Brendan Griffin asked the Minister for Health if the range of food products available through the reimbursement scheme will be expanded for sufferers of PKU and BH4; the status of engagements he may have had with concerned parties; and if he will make a statement on the matter. [19498/17]
Amharc ar fhreagraPhenylketonuria (PKU) is a debilitating lifelong condition, in which people must maintain an extremely low protein diet. In Ireland, a national programme, Diet for Life, is in place for lifetime management of the condition and it provides continuous individual monitoring and assessment of patients.
People with PKU in Ireland can get essential clinical nutritional products and low protein foodstuffs free of charge, under the Long Term Illness (LTI) Scheme. About €5 million worth of these products are provided annually under the LTI Scheme.
For a product to be supplied on the community drugs schemes, the supplier must apply to the HSE for reimbursement approval and the product must meet published criteria. In November 2016, the HSE published revised guidelines on applications for reimbursement of non-drug items, including clinical nutritional and other products for people with PKU.
A number of reimbursement applications have been made under the new guidelines. The HSE has assessed these applications and will notify applicants in the coming weeks and it is hoped that this process will broaden the list of products available on the LTI Scheme.
There is also a process for reimbursement of particular items for individuals, if required. The HSE has, in the past, made exceptional arrangements, on an individual basis, taking into account the price constraints outlined.
New products have come to market elsewhere in recent years and suppliers need to increase the range and availability of their products in Ireland also, so that Irish patients can have a much better choice and variety of food. The next opportunity for suppliers to seek reimbursement is expected to be later this year.
881. Deputy Sean Sherlock asked the Minister for Health his views on the clinical effectiveness of the drug Respreeza; and if he will now include respreeza for reimbursement. [19504/17]
Amharc ar fhreagra963. Deputy Mattie McGrath asked the Minister for Health if he will review all the evidence relating to alpha-1 Respreeza and enter into meaningful discussions with a company (details supplied) to find a solution to make Respreeza available for persons as soon as possible; and if he will make a statement on the matter. [19850/17]
Amharc ar fhreagra964. Deputy Mattie McGrath asked the Minister for Health if he will engage with a company (details supplied) with a view to lifting the 31 May 2017 deadline for providing alpha-1 Respreeza therapy to the 21 persons currently on Respreeza in order to allow discussions take place in a favourable environment; and if he will make a statement on the matter. [19851/17]
Amharc ar fhreagraI propose to take Questions Nos. 881, 963 and 964 together.
Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
882. Deputy Sean Sherlock asked the Minister for Health if consideration has been given to blood screening for severe and potentially fatal allergic reactions to a drug (details supplied). [19505/17]
Amharc ar fhreagraThere are no plans to introduce blood screening for severe allergic reactions to the chemotherapy drug Taxol (paclitaxel).
The Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines in Ireland. The HPRA highlights the fact that all medicines have some risks and a small number of people may develop side effects (also known as adverse reactions). The clinician treating the patient balances the risks associated with a medicine in the context of the overall benefit of the medicine to the health of the patient and the condition being treated.
Virtually all chemotherapeutic agents have the potential to initiate infusion or allergic reactions. Premedication can help to prevent and/or reduce the severity of infusion reactions, particularly infusion reactions. Generally, testing patients for allergy prior to receiving a chemotherapy is of limited value because the positive and negative predictive values are not known. Therefore, not all patients with positive results to these tests will develop reactions. Patients must be monitored closely both during and immediately after all chemotherapy infusions. Additional risk minimisation measures have been introduced to diminish the incidence and severity of infusion reactions (for example, prolonging the drug infusion, premedication, and antihistamines and glucocorticoids), and these measures have reduced the rate of severe reactions.
The packaging of all medicines placed on the market must include a Summary of Product Characteristics (SmPC) leaflet, which sets out detailed product information intended for healthcare professionals. This information is regularly updated as new data becomes available through various sources of post-marketing experience, including further studies, literature reviews, and evaluation of adverse reaction data. Section 4.2 of the Taxol SmPC provides detailed information on the premedication schedules and method and durations of administration which should be followed. It is advised in the SmPC that this chemotherapy should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents, and that appropriate supportive equipment should be available as hypersensitivity reactions are known to occur. The National Cancer Control Programme's published protocol on paclitaxel as monotherapy for breast and ovarian cancer states that facilities to treat anaphylaxis must be present when the drug is administered.
All medicines are also supplied with a packaging leaflet intended for the information of the patient/consumer. Product labels and package leaflets play an essential part in the safe and effective use of the medicine by both patient and healthcare professionals.
The HPRA, in conjunction with European counterparts, continues to review the safety of authorised medicines and takes appropriate regulatory action when necessary.
883. Deputy Michael McGrath asked the Minister for Health the status of an assessment of need for a person (details supplied); the services which can be provided to the person in the intervening period; and if he will make a statement on the matter. [19506/17]
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.
884. Deputy Lisa Chambers asked the Minister for Health the status of a medical card application by a person (details supplied). [19513/17]
Amharc ar fhreagraThe Health Service Executive has been asked to examine this matter and to reply to the Deputy as soon as possible. The Health Service Executive operates the General Medical Services scheme, which includes medical cards and GP visit cards, under the Health Act 1970, as amended. It has established a dedicated contact service for members of the Oireachtas specifically for queries relating to medical cards and GP visit cards, which the Deputy may wish to use for an earlier response. Contact information was issued to Oireachtas members.
885. Deputy Kevin O'Keeffe asked the Minister for Health if he will review the criteria laid down for registration with a body in view of the costs to persons who have studied overseas, at enormous costs to their families, and who wish to return here to work, with a view to reducing the costs involved for such students (details supplied). [19514/17]
Amharc ar fhreagraThe fee of €410 referred to by the Deputy is the application fee for recognition of non-Irish professional qualifications. Applications are assessed under Directive 2005/36/EC which applies to all EEA nationals wishing to practise a regulated profession in an EEA Member State other than that in which they obtained their professional qualifications. Its intention is to make it easier for certain professionals to practise their professions in European countries other than the one in which the qualification was obtained.
In the case of the health and social care professions falling under the remit of CORU, the Directive provides for an assessment on a case-by-case basis of the qualifications/professional training/post-qualification professional experience of an applicant against the qualifications required to practise in the host Member State (i.e. Ireland). Due to the case-by-case nature of the assessment and the need to examine an applicant’s individual professional experience, it is a time-consuming and administratively burdensome process.
Regulation 89 of S.I. No. 8 of 2017 which transposes the Directive into Irish law, provides for the charging of fees by a competent authority for the application process once, interalia, such fees do not exceed the real cost of the service provided. As each Registration Board at CORU has been designated competent authority for its profession under S.I. No. 8 of 2017, it is a matter for CORU to set its own fee for qualification recognition having regard to Regulation 89. I am advised by CORU that the fee, which is in line with that charged by other competent authorities, has been set at €410 since the opening of its first register - the register for Social Workers - on 31 May 2011.
The detailed assessment process provided for under the Directive necessitates the submission of documents verifying the applicant’s identity, formal training, qualifications awarded, eligibility to practise and post-qualification professional experience. As these are important documents, CORU does not accept originals; it asks applicants to provide photocopies which have been certified by a solicitor/lawyer to be true copies of the originals. The submission of certified copies of documents is provided for in the Directive. While it is appreciated that this imposes additional costs on applicants, CORU must be confident that decisions on applications are based on appropriately certified documentation.
886. Deputy Niamh Smyth asked the Minister for Health if he will review the issues regarding services as raised in correspondence (details supplied); his plans to enhance these particular services; and if he will make a statement on the matter. [19516/17]
Amharc ar fhreagraAs this question relates to service matters, I have arranged for the question to be referred to the Health Service Executive for direct reply.
887. Deputy Niamh Smyth asked the Minister for Health if an urgent appointment can be arranged for a person (details supplied); and if he will make a statement on the matter. [19517/17]
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 scheduling of appointments for patients is a matter for the hospital to which the patient has been referred. Should a patient's general practitioner consider that the patient's condition warrants an earlier appointment, he or she should take the matter up with the consultant and the hospital involved. In relation to the specific case raised, I have asked the HSE to respond to you directly.
