Written Answers Nos. 252-264
252. Deputy Finian McGrath asked the Minister for Health further to Parliamentary Question No. 774 of 22 September 2015, if he will clarify a matter (details supplied); and if he will make a statement on the matter. [36854/15]
View answerAs 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.
253. Deputy Mary Lou McDonald asked the Minister for Health the reason redress for women resident in certain institutions cardholders are not given priority for counselling services; and if he will make a statement on the matter. [36870/15]
View answerEligibility for health services for the Magdalen women is provided by the Redress for Women Resident in Certain Institutions Act 2015 which sets out the primary and community health services available in Ireland, free of charge, effective from 1 July 2015. The services are as follows: GP services; prescribed drugs, medicines, aids and appliances; dental, ophthalmic and aural services; home nursing; home support; chiropody; physiotherapy; and counselling. Under the legislation, all of the primary and community health services being made available to Magdalen women are as specified by Judge Quirke.
Counselling is provided across the health service, by both the HSE and the voluntary sector including primary care, social care and within mental health. Counselling is available to a Magdalen woman relative to her admission to, and work in, any of the institutions specified in the Schedule in the Redress for Women Resident in Certain Institutions Act 2015.
We require additional information to provide an appropriate service for individual women. It is our intention to establish contact with these women to determine their individual requirements, outside those who may already be receiving counselling through existing services.
254. Deputy Gerry Adams asked the Minister for Health his plans to address persistent shortages of epinephrine injectors for anaphylaxis, given his announcement on 15 October 2015 to make these medicines more widely available. [36881/15]
View answer255. Deputy Gerry Adams asked the Minister for Health if he is aware of shortages of epinephrine injectors in any other European countries; and if he will explain the apparent ability in the North of Ireland to maintain stock at appropriate levels. [36882/15]
View answerI propose to take Questions Nos. 254 and 255 together.
My Department does not have information on shortages in other markets nor am I aware of any specific shortages relating to adrenaline supply in other European countries. In terms of the North of Ireland, it is a very different market from the Republic’s in that it shares the large UK market for pharmaceuticals.
There are currently three adrenaline auto-injectors authorised and marketed in Ireland. Brands include Anapen®, Epipen® and Jext®. I am aware that at various times one or more of these products has been in short supply.
The Health Products Regulatory Authority (HPRA) has been working with the suppliers to try to restore continuity of supply. The HPRA employs a number of procedures which help to reduce the occurrence, impact and length of medicines shortages. One such mechanism, used in the case of adrenaline auto-injectors, is to facilitate Batch Specific Requests (BSRs). BSRs enable the company to temporarily supply, essentially identical, medicines from other countries to the Irish market to alleviate shortages. BSRs are typically processed within 24 hours of submission by a company to the HPRA. I understand that the HPRA is working with the companies concerned to facilitate the provision of further stock in the coming weeks.
Adrenaline auto-injectors are complex systems due to both the characteristics of the adrenaline active substance, which is chemically unstable, and of the delivery device, which is designed to be as patient friendly as possible. The manufacture of these products is also complex. For these reasons supply shortages can occur from time to time.
The availability is also impacted by the shelf-life of these 3 auto-injector products (which ranges from 18 to 24 months). This is short compared to some other medicinal products.
I can confirm that the HPRA has recently granted a Marketing Authorisation (MA) for a fourth adrenaline auto-injector, Emerade®. This has a 3 year shelf life. It is expected that supplies of Emerade® will arrive onto the Irish market in the coming days. This will help to alleviate the supply problems that patients have been experiencing recently.
256. Deputy Gerry Adams asked the Minister for Health if he is aware that a medication manufacturer (details supplied) is currently providing EpiPens free of charge to schools in the United States of America; and if a similar arrangement might be sought for Irish schools. [36883/15]
View answerI understand that the initiative the Deputy refers to involving the supply by a medication manufacturer of adrenaline auto-injectors to schools in the United States of America is part of a marketing strategy by that company.
In relation to the Statutory Instrument which I signed on 15 October 2015, making a number of rescue medicines available for use in emergency situations by lay persons, the arrangements that it permits are voluntary. No schools or other organisations are obliged to participate unless they wish to do so. Furthermore the Statutory Instrument makes it a condition of administration of the medications concerned by lay persons that such persons must have undergone appropriate training in this regard.
I wish to stress the importance of people continuing to carry the medicines that they need to manage their own health needs, as this initiative in no way diminishes any individual's responsibility in this regard.
257. Deputy Gerry Adams asked the Minister for Health if he will explain the decision to inform the media regarding the administration of life saving medication by trained persons without a prescription, in advance of informing the Members of the Houses of the Oireachtas, despite consistent questioning on this matter. [36884/15]
View answerI had previously indicated to this House that new provisions in relation to supply of emergency medicines would be forthcoming. There was considerable public interest in this matter and when I signed the new regulations into law last week, I considered an early public announcement was appropriate to ensure that organisations and individuals were aware of this important initiative as soon as possible.
258. Deputy Clare Daly asked the Minister for Health when he plans to introduce a duty of candour on a statutory basis for Irish health care professionals and administrators. [36889/15]
View answer259. Deputy Clare Daly asked the Minister for Health his plans to introduce sanctions for non-compliance with the Health Service Executive's open disclosure policy; and the monitoring systems that are in place to ensure that the open disclosure system is properly functioning. [36890/15]
View answer260. Deputy Clare Daly asked the Minister for Health the avenues for appeal or redress that are open to patients who feel that a health professional or administrator has not fulfilled the obligations under the Health Service Executive's open disclosure policy. [36891/15]
View answerI propose to take Questions Nos. 258 to 260, inclusive, together.
A National Policy on Open Disclosure was developed by the HSE and the State Claims Agency and launched in 2013. The Policy is designed to ensure an open, consistent approach to communicating with patients and their families when things go wrong in the provision of healthcare. It is important that patients and their families are kept informed and that feedback is forthcoming on investigations. It is also vital that the steps that need to be taken to prevent a recurrence of adverse events are established. The HSE has now begun implementing the Policy across all health and social care services.
I intend to bring legislative proposals to Government very shortly which will facilitate open disclosure of adverse events to patients. The purpose of such legislation is to provide certain legal protections for healthcare providers for open disclosure undertaken in good faith and in compliance with national standards. This will provide further support to healthcare providers in their communications with patients and family members if an adverse event occurs. This will help to foster a culture of openness and transparency, which encourages reporting. The Ethical Code of Practice set out by the Medical Council also makes clear the responsibilities of doctors in relation to open disclosure.
A new National Incident Management System (NIMS) was introduced by the State Claims Agency (SCA) in 2014 and since June 2015 all incidents in the healthcare sector are now being reported directly on to NIMS. It facilitates more detailed and consistent reporting of incidents. The SCA and the HSE are continuing to work towards more comprehensive and consistent reporting. The NIMS is the national recording management system to be utilised by all facilities covered by the Clinical Indemnity Scheme to capture adverse events that occur throughout the public healthcare system. As part of this reporting process data is collected on whether the incident was the subject of open disclosure. It will, therefore, be possible to monitor compliance with the HSE's Open Disclosure policy by using the NIMS database and non-compliance issues can be addressed by the HSE.
From a patient safety perspective the key focus of open disclosure is on learning so that systems and processes can be improved in order to reduce potential future harms to patients. If a person is not satisfied that a health professional or administrator has fulfilled their obligations regarding open disclosure then that person has recourse to the HSE's complaints procedures. It is also open to a person to raise a complaint with the appropriate professional regulatory body or with the Ombudsman.
261. Deputy Clare Daly asked the Minister for Health given the seriousness of some of the adverse reactions to Gardasil, reported to his Department and to the Health Product Regulatory Authority, and given that these adverse reactions are chronic and enduring, the systems he will put in place to monitor and support those experiencing such adverse reactions on an ongoing basis. [36902/15]
View answer262. Deputy Clare Daly asked the Minister for Health when he will commission and-or fund an Irish clinical review of reports of serious adverse reactions to the drug Gardasil. [36903/15]
View answerI propose to take Questions Nos. 261 and 262 together.
The HPV vaccine protects girls from developing cervical cancer when they are adults. The vaccine is available free of charge from the HSE for all girls in 1st year of secondary school. This is in accordance with the recommendation received from the NIAC which indicated that the HPV vaccine should be offered on an annual basis to all girls aged 12. The advice, based on public health considerations and supported by the cost-effectiveness analysis, is that HPV vaccines confer maximum benefit both individually and on a population basis if administered prior to HPV exposure. The vaccine protects against two high risk types of HPV (16 & 18) that cause 73% of all cervical cancers. Vaccinated women and girls will still be at risk from other high risk types of HPV that can cause cervical cancer and will therefore need to continue to have regular cervical smear tests.
In Ireland, the Health Products Regulatory Authority (HPRA) is the regulatory authority for medicines in Ireland. There are 2 licensed HPV vaccines available in Ireland (Gardasil® and Cervarix®). Gardasil® is the vaccine used by the HSE in the School Immunisation Programme. Gardasil® is a medicinal product which has been authorised for use across the European Union since September 2006 following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA).
While no medicine (including vaccines) is entirely without risk, the safety profile of Gardasil® has been continuously monitored since it was first authorised both nationally and at EU level. This is done by both monitoring of individual adverse reaction reports received by competent authorities across Europe (including the HPRA) and Periodic Safety Update Reports (PSURs) submitted by the Marketing Authorisation Holder (i.e. license holder) for the vaccine on a regular basis.
As part of its monitoring of the safety of medicines, the HPRA operates an adverse reaction reporting system, where healthcare professionals and patients are encouraged to report adverse reactions they consider may be associated with their treatment, through the range of options in place for reporting (https://www.hpra.ie/homepage/about-us/report-an-issue). All reports received are evaluated and considered in the context of the safety profile of the product concerned, with reports followed up as necessary for further information, that may assist in the assessment of the case.
As of the 9 October 2015, the Health Products Regulatory Authority (HPRA) has received 921 reports of suspected adverse reactions/events notified in association with the use of HPV vaccines (Gardasil® 918 and Cervarix® 3). The vast majority of reports received by the HPRA regarding both Gardasil® and Cervarix vaccines to date have been consistent with the expected pattern of adverse effects for the vaccines, as described in the product information.
The EMA has commenced a review of the human papilloma virus (HPV) vaccine "to further clarify aspects of their safety profile," although the agency points out that this review "does not question that the benefits of HPV vaccines outweigh their risks".
The HPRA is participating in the Pharmacovigilance and Risk Assessment Committee's (PRAC) review of HPV vaccines to clarify aspects of their safety profile. As for all licensed medicines, the safety of these vaccines is monitored by the PRAC (an EU level drug safety committee) where the HPRA is actively represented and contributes.
The current review will look at available data with a focus on rare reports of two conditions: complex regional pain syndrome (CRPS, a chronic pain condition affecting the limbs) and postural orthostatic tachycardia syndrome (POTS, a condition where the heart rate increases abnormally after sitting or standing up, causing symptoms such as dizziness and fainting, as well as headache, chest pain and weakness). Reports of these conditions in young women who have received a HPV vaccine have been previously considered during routine safety monitoring by the PRAC but a causal link between them and the vaccines was not established. Both conditions can occur in non-vaccinated individuals and it is considered important to further review if the number of cases reported with HPV vaccine is greater than would be expected. The outcome of the PRAC review is anticipated before the end of this year.
In addition the EMA is currently evaluating data from a new epidemiological study on the safety of human papilloma virus (HPV) vaccines, Gardasil® and Cervarix®. The study conducted jointly by the French medicines agency (ANSM) and the French national health insurance fund (CNAMTS) compared the incidence of autoimmune conditions in girls given HPV vaccines with the incidence in girls not given the vaccines.
The EMA have advised healthcare professionals that available data does not warrant any change to the use of these vaccines. Healthcare professionals should therefore continue using Gardasil® and Cervarix® in accordance with the current product information.
263. Deputy Éamon Ó Cuív asked the Minister for Health the reason medical cards which are under review have been cancelled in respect of persons (details supplied) in County Galway, despite the fact that a request for an extension on these cards was sent to the medical card section by this Deputy's office on 25 September 2015, before the cards were due to expire on 30 September 2015, and also despite the fact that information requested by the Health Service Executive in respect of a review of these medical cards was forwarded by the applicants within the required timeframe; if any policy directive has been issued by him to the Health Service Executive not to cancel existing medical cards where they are still under consideration; if he has not issued such a directive, his plans to do so to ensure that medical card holders retain their medical cards while under periodic review; and if he will make a statement on the matter. [36904/15]
View answerUnder the Health Act, 1970, as amended, it is the function of the HSE to decide on the entitlement to a medical card and a GP visit card. I am aware that the HSE has a very structured protocol in place for the medical card application and review process and every effort is made for on-going engagement between the HSE and applicants during this process.
Neither I, nor Minister Varadkar, has given - or will give - any instruction to the HSE as referenced by the Deputy. Under the legislation, it is very clear that there is no role for the Minister for Health in assessing an individual’s medical card eligibility. You will appreciate that it is contrary to the HSE Governance Act of 2013 for the Minister for Health to give a direction to the HSE relating to a decision concerning the eligibility of an individual.
I have asked the HSE to examine this matter and to reply to the Deputy as soon as possible. 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.
264. Deputy Dara Calleary asked the Minister for Health if he is aware that a community health service (details supplied) in County Mayo is threatened with closure; if he will provide funding for the service; and if he will make a statement on the matter. [36906/15]
View answerAs 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.
