Michael Healy-Rae
Ceist:239. Deputy Michael Healy-Rae asked the Minister for Health the position regarding home help for a person (details supplied) in County Kerry; and if he will make a statement on the matter. [35299/15]
Amharc ar fhreagraHome Help Service Provision
Ceisteanna (239)
Freagraí scríofa
As the Deputy's question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy. If the Deputy has not received a reply from the HSE within 15 working days, he can contact my Private Office and they will follow the matter up with the HSE.
Home Help Service Data
Ceisteanna (240, 241)
Martin Ferris
Ceist:240. Deputy Martin Ferris asked the Minister for Health the number of new applications for home help, in tabular form, that were approved for each of the past six months in County Kerry. [35316/15]
Amharc ar fhreagraMartin Ferris
Ceist:241. Deputy Martin Ferris asked the Minister for Health the number of new applications for home help, in tabular form, that were approved but not allocated due to financial constraints for each of the past six months in County Kerry [35317/15]
Amharc ar fhreagraFreagraí scríofa
I propose to take Questions Nos. 240 and 241 together.
As these are service matters they have been referred to the Health Service Executive for direct reply. If you have not received a reply from the HSE within 15 working days please contact my Private Office and they will follow up the matter with them.
Dental Services Provision
Ceisteanna (242)
Jack Wall
Ceist:242. Deputy Jack Wall asked the Minister for Health if there is support for persons (details supplied) in County Kildare with their dental issues; and if he will make a statement on the matter. [35318/15]
Amharc ar fhreagraFreagraí scríofa
As this is a service matter, it has been referred to the Health Service Executive for direct reply to the Deputy. If you have not received a reply from the HSE within 15 working days please contact my Private Office and they will follow up the matter with them.
Medicinal Products Supply
Ceisteanna (243, 244, 245, 246, 258, 261)
Michael Healy-Rae
Ceist:243. Deputy Michael Healy-Rae asked the Minister for Health further to Parliamentary Question No.472 of 29 September 2015, the reason the matter was not addressed; and if he will make a statement on the matter. [35336/15]
Amharc ar fhreagraMichael Healy-Rae
Ceist:244. Deputy Michael Healy-Rae asked the Minister for Health his plans to make it mandatory to report and publicise adverse drug reactions in relation to Roaccutane; and if he will make a statement on the matter. [35337/15]
Amharc ar fhreagraMichael Healy-Rae
Ceist:245. Deputy Michael Healy-Rae asked the Minister for Health if the original product information, all records and updates, archive, database and otherwise for Roaccutane will be provided, along with the individual reasons for each update and change since its introduction on 19 April 1983 to the present; and if he will make a statement on the matter. [35338/15]
Amharc ar fhreagraMichael Healy-Rae
Ceist:246. Deputy Michael Healy-Rae asked the Minister for Health if he will provide the physicians' guide, the physicians' checklist, for prescribing Roaccutane; the important information for patients prescribed Roaccutane on contraception; the pharmacists' guide to dispensing Roaccutane for female and male patients; the pregnancy prevention plans for Roaccutane since 1983 to the present; and if he will make a statement on the matter. [35339/15]
Amharc ar fhreagraMichael Healy-Rae
Ceist:258. Deputy Michael Healy-Rae asked the Minister for Health further to Parliamentary Question No. 790 of 22 September 2015, if he will address a matter (details supplied); and if he will make a statement on the matter. [35391/15]
Amharc ar fhreagraMichael Healy-Rae
Ceist:261. Deputy Michael Healy-Rae asked the Minister for Health his views on a matter (details supplied) regarding the drug Roaccutane; and if he will make a statement on the matter. [35399/15]
Amharc ar fhreagraFreagraí scríofa
I propose to take Questions Nos. 243 to 246, inclusive, 258 and 261 together.
Roaccutane (isotretinoin) is authorised for treating severe forms of acne which have been resistant to other standard therapies. When first authorised for use in Ireland in 1983, Roaccutane was authorised for the management of cystic or conglobate forms of acne vulgaris, or for use in cases of severe acne which have failed to respond to adequate courses of accepted therapy.
Information is not collected in relation to the clinical condition for which a drug is prescribed in individual cases. In relation to Roaccutane the only available information relates to the number of prescriptions dispensed under the GMS and Community Drugs Schemes. This information was provided to the Deputy by the HSE in response to a previous parliamentary question (Ref no. 33338/15).
The information breakdown held by the HPRA that the Deputy refers to is the breakdown of reported adverse reactions notified to the HPRA and I understand that the HPRA has provided this breakdown directly to the Deputy. Of the five cases where Roaccutane was used for an unknown indication, the HPRA made efforts to obtain this information from the person reporting the adverse reaction but such information was not forthcoming.
European and Irish legislation provides for ongoing monitoring of the benefits and risks of medicines through a system known as pharmacovigilance. This monitoring includes review and evaluation of suspected adverse reaction reports at National and EU level. The national regulatory medicines authorities (in Ireland the HPRA) in each EU Member State are responsible for gathering and evaluating national adverse reaction reports and in turn submitting these reports to the European Medicines Agency, which is responsible for the overall co-ordination of pharmacovigilance activities across the EU.
In accordance with European and national legislation, marketing authorisation holders (manufacturers) are legally obliged to notify all suspected serious adverse reactions in Ireland (reported either by a healthcare professional or a patient) to the HPRA within 15 days of first notification of the company. Reporting of suspected adverse reactions by health professionals and patients is undertaken on a voluntary basis across the EU with all health professionals strongly encouraged to report any suspected adverse reaction. International data indicates that Ireland has a high rate of reporting and the HPRA regularly reminds health care professionals about reporting in its Drugs Safety Newsletter.
In previous replies to the Deputy I have provided detailed information on the authorisation process for a medicine and the safety monitoring process once the medicine is placed on the market. Before it can be made available to patients a medicine must meet predefined standards of quality, safety and efficacy and approval is given on the basis of a favourable benefit versus risk balance for a specific indication.
There is in addition extensive pharmacovigilance legislation which monitors the medicine’s safety once it is in use to ensure that risks can be promptly identified and managed so that harm is prevented. Reporting of suspected adverse reactions is only one of a number of ways of identifying new adverse reactions. However individual reports of suspected adverse reactions alone are rarely sufficient to confirm that a certain reaction is caused by the medicine in question. Other factors such as the extent and conditions of use of the medicine, the nature of the reaction, the condition being treated, any new conditions arising and other medicines taken by the patient have all to be taken into account. Further data is usually required, including worldwide spontaneous case reports, clinical trials and epidemiological studies, to confirm the reactions and help determine their significance.
A review of Roacccutane across the EU took place in 2011 when further warnings regarding skin reactions were added to the product information for patients and their doctors. The risk of depression associated with Roaccutane was also reviewed at that time. However it was concluded on the basis of all the available evidence that the existing monitoring requirements provided on the product information is sufficient.
In conclusion therefore no medicine is without risk but the extensive authorisation and monitoring process in place across the EU ensures that risks are identified and managed.
The Deputy will have previously received from the HPRA a copy of the current product information. I am arranging to forward the Deputy a copy of the original product authorisation from 1983. Following authorisation any change (e.g. new indications, updated safety information, product changes) require approval on foot of a formal application to vary the authorisation and the submission of relevant supporting data. In practice product information changes frequently. Information relating to all these the changes is not readily available in the HPRA and will entail detailed searches through archived material.
However the HPRA is happy to meet the Deputy to discuss his information requirements further and will be communicating directly with the Deputy in coming days to arrange a meeting.
Since it was first authorised for use in Ireland, Roaccutane has been contraindicated in women who are pregnant or breastfeeding. An EU wide Pregnancy Prevention Plan (PPP) was introduced in October 2003 to further reduce the potential risk of pregnancy in women. The Plan consists of key educational information on the risks of treatment and specific criteria for managing therapy in women of child-bearing potential. I am arranging to send the Deputy copies of material distributed by the marketing authorisation holder for use by prescribing doctors, pharmacists, other relevant healthcare professionals and patients, including a checklist for prescribing to female patients.
In addition the Medicinal Products (Prescription and Control of Supply) Regulations 2003 were amended in 2005 to introduce restrictions on certain medicines containing Isotretinoin. Regulation 7(9) of the Regulations provides that the prescription of a medicine containing Isotretinoin which is intended for the treatment of a woman of childbearing potential, shall not be dispensed later than seven days after the date on the prescription and the treatment shall not exceed a period of thirty days.
While the legislation does not restrict the type of medical practitioner that can prescribe Isotretinoin, the product’s product information (SmPC) requires that the product should only be prescribed by or under the supervision of physicians with expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of isotretinoin therapy and monitoring requirements.
Hospital Waiting Lists
Ceisteanna (247)
Pearse Doherty
Ceist:247. Deputy Pearse Doherty asked the Minister for Health when a person (details supplied) in County Donegal will receive an appointment for an operation; and if he will make a statement on the matter. [35342/15]
Amharc ar fhreagraFreagraí scríofa
Under the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.
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 Health Service Executive, 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. If you have not received a reply from the HSE within 15 working days please contact my Private Office and my officials will follow the matter up.
Medical Card Applications
Ceisteanna (248)
Brian Walsh
Ceist:248. Deputy Brian Walsh asked the Minister for Health if an application for a medical card will be reviewed for a person (details supplied) in County Galway; and if he will make a statement on the matter. [35349/15]
Amharc ar fhreagraFreagraí scríofa
The 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 has issued to Oireachtas members.
If the Deputy has not received a reply from the HSE within 15 working days, please contact my Private Office who will follow up the matter with them.
Question No. 249 answered with Question No. 234.
Respite Care Services Availability
Ceisteanna (250)
Barry Cowen
Ceist:250. Deputy Barry Cowen asked the Minister for Health if he will provide an update on the case of a person (details supplied) in County Offaly; when the person can expect to receive respite services from the Health Service Executive, considering that the person's family submitted an application on the person's behalf over two years ago and have received no reply to date. [35365/15]
Amharc ar fhreagraFreagraí scríofa
As the Deputy's question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy. If the Deputy has not received a reply from the HSE within 15 working days, he can contact my Private Office and they will follow the matter up with the HSE.
Long-Term Illness Scheme
Ceisteanna (251)
Terence Flanagan
Ceist:251. Deputy Terence Flanagan asked the Minister for Health if a drug (details supplied) will be covered under the long-term illness scheme; and if he will make a statement on the matter. [35367/15]
Amharc ar fhreagraFreagraí scríofa
As this is a service matter, it has been referred to the Health Service Executive for direct reply to the Deputy. If you have not received a reply from the HSE within 15 working days please contact my Private Office and they will follow up the matter with them.
Medical Card Reviews
Ceisteanna (252)
James Bannon
Ceist:252. Deputy James Bannon asked the Minister for Health if he will arrange to have an application for a medical card by a person (details supplied) in County Longford reviewed; and if he will make a statement on the matter. [35374/15]
Amharc ar fhreagraFreagraí scríofa
The 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 has issued to Oireachtas members.
If the Deputy has not received a reply from the HSE within 15 working days, please contact my Private Office who will follow up the matter with them.
Home Help Service Provision
Ceisteanna (253)
Brendan Griffin
Ceist:253. Deputy Brendan Griffin asked the Minister for Health if home help hours will be reinstated for a person (details supplied) in County Kerry; and if he will make a statement on the matter. [35378/15]
Amharc ar fhreagraFreagraí scríofa
As this is a service matter it has been referred to the Health Service Executive for direct reply. If you have not received a reply from the HSE within 15 working days please contact my Private Office and they will follow up the matter with them.
Accident and Emergency Departments Waiting Times
Ceisteanna (254)
Pearse Doherty
Ceist:254. Deputy Pearse Doherty asked the Minister for Health the average waiting times at the accident and emergency department at Letterkenny General Hospital in County Donegal, in tabular form by month, from January 2015 to September 2015; and if he will make a statement on the matter. [35382/15]
Amharc ar fhreagraFreagraí scríofa
With regard to the specific information sought by the Deputy, as this is a service matter, I have asked the HSE to respond to you directly. If you have not received a reply from the HSE within 15 working days please contact my Private Office and my officials will follow the matter up.
Medical Card Applications
Ceisteanna (255)
John Perry
Ceist:255. Deputy John Perry asked the Minister for Health the position regarding an application for a medical card by a person (details supplied) in County Sligo; and if he will make a statement on the matter. [35385/15]
Amharc ar fhreagraFreagraí scríofa
The 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 has issued to Oireachtas members.
If the Deputy has not received a reply from the HSE within 15 working days, please contact my Private Office who will follow up the matter with them.
Hospital Appointments Delays
Ceisteanna (256)
James Bannon
Ceist:256. Deputy James Bannon asked the Minister for Health if he will expedite a hospital appointment for a person (details supplied) in County Longford; and if he will make a statement on the matter. [35388/15]
Amharc ar fhreagraFreagraí scríofa
Under the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.
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. If you have not received a reply from the HSE within 15 working days please contact my Private Office and my officials will follow the matter up.