national haemophilia council 2015 annual report

National Haemophilia Council2015 Annual Report

Generated Image of Blood flowing inside Blood Vessel

NATIONAL HAEMOPHILIA COUNCIL

Mission Statement

“To advise and recommend on the optimum provision of treatment and care for persons

with haemophilia and related bleeding disorders.”

Vision

“To set the international benchmark for the provision of effective advice and inclusive

involvement in optimising the management of haemophilia.”

The establishment of a National Haemophilia Council (NHC) was approved by Governmentfollowing the recommendations of the Lindsay Tribunal in 2001. The Regulations placing theCouncil on a statutory footing were signed by the Minister for Health and Children on the 22ndJuly, 2004 and amended to include the Health Service Executive in the Health (MiscellaneousProvisions) Act 2007.

National Haemophilia Councilwww.nationalhaemophiliacouncil.ie

NATIONAL HAEMOPHILIA COUNCIL ANNUAL REPORT 2015


CONTENTS

1. Preamble• General Information .........................................................................................................1

• Overview of the National Haemophilia Council (NHC) ....................................................1

• Haemophilia Services in Ireland ......................................................................................2

• Chairman’s Statement ....................................................................................................4

• Chief Officer's Statement ................................................................................................7

• NHC Membership ..........................................................................................................10

2. Review of 2015• Annual Report ...............................................................................................................15

• Meetings of NHC ..........................................................................................................15

• Secretariat .....................................................................................................................15

• NHC Strategic Plan 2014 - 2017 ...................................................................................16

• Follow–up Audits 2015 ...................................................................................................17

• NHC meeting with St. James’s Hospital Board .............................................................18

• Research in Haemophilia ..............................................................................................19

• Finance ..........................................................................................................................25

• Ethics in Public Office Act, 1995 and 2001 ....................................................................36

• Website ..........................................................................................................................36

Appendix AList of NHC members and numbers of meetings attended in 2015 ...................................37

Appendix BStrategic Plan ....................................................................................................................38

Appendix C3 Comprehensive Care Centres .......................................................................................41

Appendix DHaemophilia Product Selection and Monitoring Advisory Board (HPSMAB) .....................47

Glossary ............................................................................................................................50

OVERVIEW OF THE NATIONAL HAEMOPHILIA COUNCIL

GENERAL INFORMATION

National Haemophilia Council Auditor: HSE Offices Office of the Comptroller and Auditor GeneralMill Lane 3A Mayor Street UpperPalmerstown Dublin 1Dublin 20 D01 WP44D20 KH63

BACKGROUND

The establishment of the National Haemophilia Council was approved by Government following therecommendations of the Lindsay Tribunal in 2001. The Regulations placing the Council on a statutoryfooting were signed by the Minister for Health and Children on the 22nd July, 2004 and amended toinclude the Health Service Executive in the Health (Miscellaneous Provisions) Act 2007.

The principal function of the Council is to advise the Minister, health service agencies and otherpersons on any matter relating to haemophilia, on its own initiative or at the request of the Ministeror a health agency.

It may provide advice in relation to:

(i) The care and treatment of persons with Haemophilia;

(ii) Protocols for the treatment of Haemophilia;

(iii) Health services (including Counselling Services) for persons with Haemophilia;

(iv) Education and training of staff who provide services for persons with Haemophilia;

(v) Education and health promotion for persons with Haemophilia and their families;

(vi) The changing needs of persons with Haemophilia in order to help ensure that health servicesrespond effectively to such changing needs;

(vii) Developments arising from research into Haemophilia;

(viii) Appropriate support services for the families of persons with Haemophilia.


1

HAEMOPHILIA SERVICES IN IRELAND

1.0 StructureThere are four levels of Haemophilia services provided in Ireland:

1. Comprehensive Care Centre’s (Level 1)• Cork University Hospital• National Centre for Hereditary Coagulation Disorders, St. James’s Hospital, Dublin• Our Lady’s Children’s Hospital Crumlin, Dublin

2. Haemophilia Treatment Centres - hospitals which treat patients with Haemophilia(Level 2)

• Galway University Hospital

3. Hospitals with a Consultant Haematologist who provides services to a largegeographical area (Level 3)

• Letterkenny General Hospital• Midland Regional Hospital, Tullamore• Our Lady of Lourdes Hospital Drogheda• Sligo Regional Hospital• University Hospital Waterford

4. All other hospitals with a 24hr Emergency Departments (Level 4)

Level 1The National Centre for Hereditary Coagulation Disorders (NCHCD) based at St. James's Hospital,Dublin, The Paediatric Haemophilia Service based at Our Lady's Children's Hospital Crumlin(OLCHC) and Cork University Hospital (CUH) all function as Comprehensive Care Centres. Adultsare treated at St. James's Hospital and Cork University Hospital, while children are treated at OurLady's Children's Hospital Crumlin and at the Comprehensive Coagulation Centre at Cork UniversityHospital. All the Comprehensive Care Centres (CCCs) provide access to a 24 hour on-call service(by phone and on site) for Haemophilia and other related bleeding disorders.

Level 1 Centres are audited on a triennial basis by an International team of auditors and are certifiedby the European Haemophilia Network (EUHANET).

Level 2University Hospital Galway functions as a Haemophilia Treatment Centre for adults and children. AHaemophilia nurse is available in the Centre. The hospital provides access to a 24hr on-call service(by phone and on site) for Haemophilia and other related bleeding disorders. Patients are treated ona shared care basis with the appropriate Comprehensive Care Centre where the patient is registered.Level 2 Haemophilia Centres are audited on a triennial basis by a national audit team from theComprehensive Care Centres

The Haemophilia Treatment Centre is certified by the European Haemophilia Network (EUHANET).


2

Level 3The following Level 3 hospitals have a Consultant Haematologist on their staff. They can provideemergency care for patients attending at the Emergency Department in co-operation with the patientsregistered Comprehensive Care Centre.

• Letterkenny General Hospital

• Midland Regional Hospital, Tullamore

• Our Lady of Lourdes Hospital, Drogheda

• Sligo Regional Hospital

• University Hospital Limerick

• University Hospital Waterford

Level 3 hospitals are audited periodically.

Level 4All other hospitals with a 24hr Emergency Departments (ED) represent sites where patients canattend in an emergency situation. These hospitals should share their treatment responsibilities as amatter of urgency with the consultant on call at the appropriate Comprehensive Care Centre, whendealing with all patients with Haemophilia and other related bleeding disorders.

Level 4 hospitals should have available an appropriate treatment dose for the management ofinherited bleeding disorders. The hospitals should be aware of the requirement for urgency ofimmediate contact with haematology services in Comprehensive Care Centres


3

CHAIRMAN’S STATEMENT

2015 started with a full schedule because we were carrying forward some work from 2014. Our firsttask was to start the arrangements for a follow-up audit of Haemophilia services in Cork UniversityHospital (CUH) and Our Lady’s Children’s Hospital Crumlin (OLCHC). The Council considered thatit is essential that the level of services that are available to patients with Haemophilia should be, asfar as possible at a similar level in all Comprehensive Care Centres.

The 2014 audit reports demonstrated that there were some notable deficiencies in the level of serviceavailable at CUH and to a lesser extent in OLCHC. The Council informed both management teamsat specifically arranged meetings in CUH and OLCHC, of these particular deficiencies. It wasdiscussed how it might be possible to improve the service. The Council expected most of thesedeficiencies to be rectified as early as possible. To that end we commissioned a follow-up Audit inthe latter part of 2015. The request for improvement of services triggered numerous meetings, lettersand phone calls to various Managers at various levels and various locations throughout the countryand the Health Service Executive (HSE) to try and achieve these objectives concerning theoutstanding issues.

The Council updated the Acute Treatment Guidelines for Adults and distributed the guidelines to allHospital Managers with a 24hr Emergency Department. The Treatment Guidelines were alsouploaded on our revised and redesigned NHC website. The modified Treatment Guidelines forchildren are expected to be circulated in 2016.

The Council spent some time on revising its 2014 – 2017 Strategic Plan. This we also finalised andpublished on our website.

The Council were concerned about the need for a robust way to identify patients with a diagnosedbleeding disorder, who had by necessity to attend as an emergency patient to any EmergencyDepartment of any Hospital who were available on a 24hr 7 days basis. To that end the “SevereBleeding Disorder Alert Cards” (SBDAC) were designed and printed with the assistance of the IrishHaemophilia Society (IHS) and distributed by the various Comprehensive Care Centres. The essenceof the SBDAC is to alert all healthcare staff (irrespective of their grade) in the ED the patientpresenting has a diagnosed Bleeding Disorder and that the appropriate “Replacement Therapy”should start within 30 minutes of arrival at the Emergency Department.

The former Minister for Health, Dr. Leo Varadkar launched the updated Severe Bleeding Alert Cardon the 4th February 2015. The Council achieved great media coverage of the launch of the cardthrough the secular press and through the HSE. The cards were distributed through the Centre’s andI hope by now that all relevant patients have them and actually carry them on their person at all times.

The Council arranged an interactive meeting with Dr. Cathal O’Donnell, Medical Director, NationalAmbulance Service (NAS) and Mr. Martin Dunne, Director of the National Ambulance Service in theoffices of the National Ambulance Service in Tallaght, Dublin. The objective of the meeting was in


4

light of the re-launch of the “Severe Bleeding Disorder Alert Cards”, that the NAS was aware of theneed for an immediate team response if a patient presents with a severe bleeding disorder in anemergency. Following the meeting the Council received a Clinical Directive from the NAS that patientswith Haemophilia, irrespective of their presenting complaint (not just haemorrhages) that are withina 60 minute transport time of a designated Haemophilia Treatment Centre should be brought directlyto the Emergency Department of that Centre, bypassing other hospitals.

The impending arrival of all such patients should be pre-alerted to the designated receiving Centre.Haemophilia Treatment Centres are based in:

• St. James’s Hospital Dublin

• Our Lady’s Children’s Hospital, Dublin

• Cork University Hospital

• University Hospital Galway

During the year we were made aware that a “National Clinical Programme for Rare Diseases” underthe Clinical Directorship of Professor Eileen Treacy was being established under the auspices of theEU and likely to be implemented on an EU phased basis. Haemophilia would technically fall withinthe remit of this new Clinical Programme.

Haemophilia Treatment is different in Ireland and as such treatment is provided under a statutorybasis, following the recommendations of the Lindsey Tribunal. The Council recognised the need forthis programme to cover other rare diseases but were not convinced that “Haemophilia” serviceswould benefit by this arrangement. The Council after much discussion, decided that Dr. Barry White,Clinical Director, NCHCD would liaise with Professor Treacy concerning the issue on an on-goingbasis.

The Council continued to exert political pressure for patients with Haemophilia, co-infected withHepatitis C so that this cohort of patients could get appropriate access to modern Hepatitis Ctreatment. After continued pressure, we were delighted to be made aware that the appropriatetreatment was being initiated by mid 2015, and we have been informed that it is expected that all ofthis cohort of patients, would be offered access to treatment by the end of 2016.

The Council carried out various activities throughout the year all with the objective of improvementof the delivery of optimum Haemophilia Services to patients throughout the country.

Dr. Barry HarringtonChairperson


5


6

Dr. Niamh O’Connell, Ms. Michele Tait, Mr. Brian O’Mahony, Mr Ger O’Reilly


7

CHIEF OFFICER’S STATEMENT

I was appointed Chief Officer of the National Haemophilia Council (NHC) on the 1st September 2014and I am based in the HSE National Hepatitis C Office, Mill Lane, Palmerstown, Dublin given theexisting synergies between both work streams.

In 2015 Dr. Barry Harrington, Chairman of the NHC and Ms. Michele Tait, (the then) National HepatitisC Co-ordinator introduced me to both patients and health professionals working in the delivery ofcare and support to persons with Haemophilia and stressed the need to continue to improve theservices for patients with Haemophilia in Ireland.

2015 was an extremely busy and successful year for the NHC. Real progress was made in theprovision of Haemophilia care and a vast amount of work was completed by the Council in 2015. TheCouncil’s work in 2015 contributed to progress being made in haemophilia services in Cork UniversityHospital (CUH) and Our Lady’s Children’s Hospital Crumlin, Dublin (OLCHC) and the continuedsuccess of the National Centre for Hereditary Coagulation Disorders in St. James’s Hospital, Dublin.

The Council ensures that we focus on the patient’s needs and what is best for them. I feel that thisis something unique about the work of the National Haemophilia Council. A statutory body, that hasrepresentation for all areas of the health system (Patient, Clinical and Management) which will leadto improvements in the Irish healthcare system in the long term.

The Council met six times in 2015. The meetings were held in the Irish Haemophilia Society's (IHS)offices with the very kind permission of the Chairperson Ms. Traci Dowling, the executive committeeand staff of the IHS based at Cathedral Court, New Street, Dublin 8. The meetings were held on the29th January, 26th March, 14th May, 9th July, 17th September and the 26th November. I attendedall meeting except the 9th July as I was on annual leave.

I attended many meetings with members of the NHC in 2015 and I was responsible for the smoothrunning of the launch of the Severe Bleeding Disorder Alert Card (SBDAC) for patients with the kindassistance and support of Ms. Debbie Greene from the IHS.

On the 4th February, 2015 the Council re-launched the Severe Bleeding Disorder Alert Card. Thecard was launched by the then Minister for Health Dr. Leo Varadkar in the offices of the IrishHaemophilia Society. The cards are designed to ensure that patients with severe Haemophilia getimmediate appropriate treatment at Hospital Emergency Departments. The launch was verysuccessful and the Council were pleased with the publicity and media coverage of this great event.

We arranged the formal presentation of the 2014 Annual Report to the Minister for Health Dr. LeoVaradkar following the launch of the SBDAC on the 4th February, 2015.

On the 6th February, 2015 the Council met with the members of the Board of St. James’s Hospitaland the management team of the hospital at their board meeting to present and discuss the auditreport of March 2014 regarding the National Centre for Hereditary Coagulation Disorders (NCHCD)at St. James’s Hospital. The report was outstanding as to the level of service and staff commitmentand this was communicated to the Board. The NCHCD is considered as a service of excellence andthe Centre delivers a service to Haemophilia patients of an excellent sustainable level.

On the 7th February, 2015 I attended the Irish Haemophilia Society’s Conference for people withHepatitis C in the Castleknock Hotel Dublin. This conference centered on the impact of Hepatitis Con the lives of patients with Haemophilia.

The Acute Treatment Guidelines for adults with Haemophilia and related bleeding disorders weredistributed to all hospitals in Ireland with an Emergency Department in February, 2015. The TreatmentGuidelines were developed in conjunction with the two Comprehensive Care Centres for adults withHaemophilia and related bleeding disorders in Ireland; The NCHCD, St. James’s Hospital, Dublinand the Comprehensive Coagulation Centre, Cork University Hospital, Wilton, Cork. The guidelinesaim to standardise and improve care for patients with bleeding disorders. I also uploaded the revisedAcute Treatment Guidelines for the treatment of patients with Haemophilia on the homepage of theNHC website.

On the 7th and 8th March, 2015 I attended my first Irish Haemophilia Society’s Annual Conferencein Athlone, Co. Westmeath where I met many members of the IHS and their families. This was agreat opportunity and I wish to thank the IHS for their invitation.

On the 20th May, 2015 I attended a meeting with members of the NHC and the Minister for HealthLeo Varadkar. The Council made a number of recommendations to Minister Varadkar and alsoupdated him on the 3 Comprehensive Care Centre’s in Ireland.

On the 30th June, 2015 I attended a meeting with members of the NHC and the National AmbulanceService (NAS) and I am delighted to report that following the meeting the council received a ClinicalDirective 08/2015 from Dr. Cathal O’Donnell, Medical Director, NAS which states that in anemergency situation, people with Haemophilia, who need an ambulance and who are within a 60minute transport time of a designated Haemophilia Treatment Centre NCHCD, OLCHC, CUH andGUH will be brought directly to the Emergency Department of that Centre, bypassing other hospitals.The NAS has agreed that a pre-alert (by radio message) will be sent to the receiving TreatmentCentre by contacting the Treatment Centre in advance, it should ensure that the appropriate treatmentis administered without delay.

I arranged the follow-up audits of Cork University Hospital and Our Lady’s Children’s Hospital, Crumlinin 2015. The follow-up audit team from the UK came to Ireland on the 12th November and carriedout the follow-up audit of CUH on that day. On the 13th November the auditors visited OLCHC tocarry out the follow-up audit of OLCHC. The outcomes for the follow-up audit reports was verypositive for the two Comprehensive Care Centre’s.

I will continue to ensure that the work of the NHC together with the Health Service Executive (HSE)and the Minister for Health receive recommendations that will not only continue to provide high qualityHaemophilia care in Ireland but also identify further efficiencies that can be made in the provision ofcare.

The members of the NHC together with the HSE and the Department of Health (DOH) continue toimprove Haemophilia care in Ireland. I acknowledge the great work of all the dedicated members ofthe NHC and it is my pleasure to work with such dedicated people. I look forward to continuingworking with the members of the Council who provide a world class health service for people withHaemophilia in Ireland.


8


9

Finally, I would like to thank Dr. Barry Harrington, Chairman of the National Haemophilia Council forhis support and guidance since I commenced my position as Chief Officer in September, 2014. Dr.Harrington and the Council are dedicated and committed to ensuring that all persons withHaemophilia in Ireland have optimum Haemophilia care nationally. Dr. Harrington and the membersof the Council continue to promote the principal functions of the NHC in advising the Minister forHealth, Health Service Agencies and other persons on all matters relating to Haemophilia care inIreland.

I am very pleased to present the 2015 National Haemophilia Council Annual Report.

Ms. Gráinne LeachChief Officer

COUNCIL MEMBERSHIP

Statutory Instrument No. 451 of 2004 provides for the appointment to the Council by the Minister forHealth of up to eleven members, two of whom are appointed on the nomination of the IrishHaemophilia Society. The Irish Haemophilia Society's two nominees are Mr. Brian O'Mahony, (ChiefExecutive Officer of the Irish Haemophilia Society) and Ms. Debbie Greene (Administrator of the IrishHaemophilia Society).

The Council members at the end of 2015 are listed below and their attendances at Council meetingsare listed in the Appendices.

Dr. Barry Harrington (Chairperson)

Dr. Barry Harrington was born in Dublin, qualified as a Dentist in 1964 at the Royal College ofSurgeons in Ireland. Dr. Harrington worked in private dental practice in Northern Ireland and Dublin(1964 - 1985).

In September 1985 he was appointed a Consultant. In 1986 he was appointed as Consultant DentalSurgeon to the National Centre Hereditary Coagulation Disorders attached to St. James's Hospital.Dr. Harrington was a member of the Executive Committee of the Irish Haemophilia Society in 1988 -2002.

Dr. Harrington is a member of the Irish Dental Association (1964 – to present date) and was Presidentfrom 1998 - 1999. After his official retirement in 2004, he continued as a part-time teacher at theDDUH until 2010. Dr. Harrington was appointed as Chairperson of the National Haemophilia Councilby Dr. James Reilly, Minister for Health in July 2011 and reappointed by Dr. Leo Varadkar in July2014 for a further term.


10


11

Professor Colm J Bergin MD, FRCPI, FRCP(Ed)

Professor Colm Bergin is a Consultant Physician in Infectious Diseases, St James's Hospital, Dublinand Clinical Professor of Medicine at Trinity College Dublin. He is the Associate Director of theWellcome-Health Research Board (HRB) Clinical Research Facility, St. James's Hospital Dublin, andthe Dean of Postgraduate Medical Training and Dun's Tutor, RCPI.

Prior appointments have included Clinical Director of the Surgical and Medical SubspecialtiesDirectorate at St. James's Hospital, Dublin (2006-2012), President of the Infectious Diseases Societyof Ireland (IDSI) (2009-2012) and National Programme Lead for OPAT, Health Services Executive,Ireland (2010-2012).

Professor Bergin is the co-director of the Department of GU Medicine and Infectious Diseases ClinicalStudies Unit, the department has an active national and international research reputation. ProfessorBergin has secured funding from national and international funds including FP-7 funding in 2012. Heis the supervisor for a number of MD and PhD degrees covering research topics in medical education,cost effectiveness of medical care (HIV and HCV) molecular and clinical epidemiology, immunologyof host response to infections (TB and HCV), neurocognitive disease in HIV infection and innovativeinterventions to affect social behaviours in disease modelling.

Mr. Michael Conroy, Principal Officer, Cancer, Blood & Organ Policy Unit, DOH

Mr. Michael Conroy is Head of the Cancer, Blood & Organs Policy Unit of the Department of Health.He has worked across a range of Government Ministries in both policy and programme roles. Apartfrom his current role, the main focus of Michael's policy work has been in the heritage, industry andillicit drugs areas.


12

Dr. Ruth Gilmore

Dr. Ruth Gilmore qualified in 1998 from National University of Ireland, Galway. Subsequently, shedid her postgraduate Haematology training in Ireland and did a Masters in Medical Informatics aswell as an MD on Thrombin Generation in Trinity College Dublin whilst working at the National CentreHereditary Coagulation Disorders in St James's Hospital. Dr. Gilmore was appointed a Consultant inHaematology to Galway University Hospital in 2011. Her research interests include rare bleedingdisorders, thrombin generation and the use of computers in Health Care. Her areas of specialresponsibility are Haemostasis and Thrombosis, Obstetric Haematology and Paediatric Haematology.Dr. Gilmore was appointed to the Council in July 2013.

Ms. Debbie Greene

Ms. Debbie Greene joined the Irish Haemophilia Society in 2003. Ms. Greene is the Administrator ofthe Society having taken up the role in May 2009. Ms. Greene oversees the day to day running ofthe office including the organization of Information Days, Regional Meetings and Conferences,Staffing, Event Management, the Website and is the Editor of all Irish Haemophilia SocietyPublications. Ms. Greene is a member of the Irish Haemostasis Research Foundation and is alsoinvolved with the World Federation of Hemophilia Twinning Program. Ms. Greene represents theSociety at various Comprehensive Care Centre Team Meetings.

Ms. Ruth Hunter Nolan

Ms. Ruth Hunter Nolan gained a Diploma in Adult Nursing in 1999 in Middlesex University, U.K. andcompleted a degree in Nursing in Trinity College in 2002. She was appointed as the Quality AssuranceOfficer in the National Centre for Hereditary Coagulation Disorders in 2010. She also provides anational service to the Comprehensive Care centres in Ireland by supporting the multidisciplinaryteam in developing methods of improving the quality of their service. Previous to this she has heldother nurse management posts in practice development and cardiology nursing in St James'sHospital. Ruth is the Quality Assurance Officer, St. James's Hospital.


13

Dr. William Murphy

Dr. William Murphy was appointed Medical and Scientific Director of the Irish Blood TransfusionService in 1996. He received his training in Edinburgh and at McMaster University in Ontario inCanada. He was Senior Lecturer in Medicine at the University of Edinburgh and ConsultantHaematologist to the Scottish National Blood Transfusion Service 1991 - 1996. He has madenumerous publications to the medical literature and has an active research project related to clinicalgrade red cells.

Dr. Beatrice Nolan

Dr. Beatrice Nolan was appointed as a Consultant Haematologist to St James's Hospital in 2001 witha commitment to Our Lady’s Children's Hospital Crumlin (OLCHC) in 2008. Dr. Nolan was appointedfull-time Lead Consultant Haematologist in relation to paediatric haemophilia and allied bleedingdisorders at the Children's Hospital in Crumlin with a national remit.

Mr. Brian O’Mahony

Mr. Brian O'Mahony is Chief Executive of the Irish Haemophilia Society. He represents the societyas Vice Chair of the Haemophilia Product Selection and Monitoring Advisory Board established bythe Minister in 2002. He previously served as Chairperson of the Irish Haemophilia Society for 17years and as President of the World Federation of Hemophilia (WFH) for 10 years. He continues towork as a volunteer with WFH. Among his activities are writing, advocating, facilitating training onstrategic planning, national procurement systems, and lobbying. He is a Fellow of the Institute ofBiomedical Sciences and of the Academy of Clinical Science and Laboratory Medicine. He also hasprofessional qualifications in occupational health and safety and in management and he holds anassistant adjunct Professors post in Trinity College. Brian O'Mahony has severe Haemophilia B.


14

Dr. Susan O'Shea

Dr. Susan O'Shea was appointed lead Haemophilia Consultant in Cork University Hospital in 2009.Dr. O'Shea is Director of the Coagulation Centre in Cork University Hospital. Dr. O'Shea hasundergone specialty training in disorders of Haemostasis and Thrombosis in Duke University MedicalCentre in the United States, before she returned to Ireland. Dr. O'Shea has been involved in clinicalresearch in many areas of coagulation.

Dr. Barry White

Dr. Barry White is a Consultant Haematologist and Director of the National Centre for HereditaryCoagulation Disorders (NCHCD) at St. James's Hospital since 2001.He undertook his training as acoagulation specialist at St. James's Hospital and the Royal Free Hospital London and hasundertaken extensive research in the area of coagulation disorders. Dr. White is also NationalDirector, Quality and Clinical Care, Health Service Executive (HSE).


15

2. REVIEW OF 2015

ANNUAL REPORT

This is the twelfth Annual Report of the National Haemophilia Council (NHC) to be submitted to theMinister for Health under the provisions of Statutory Instrument (S.I.) No. 451 of 2004. It covers theperiod from 1st January 2015 to 31st December 2015. This report endeavors to inform the Ministeron all aspects of Haemophilia that have come to the Councils attention.

MEETINGS OF THE NATIONAL HAEMOPHILIA COUNCIL

The National Haemophilia Council met six times during 2015. The attendance at the meetings islisted in Appendix A. The dates of the meetings are:

• 29.01.15

• 26.03.15

• 14.05.15

• 09.07.15

• 17.09.15

• 26.11.15

SECRETARIAT

The administrative and secretarial support to the NHC is provided by the Chief Officer Ms. GráinneLeach. The office of the administrative support to the council is housed at:

National Haemophilia CouncilHealth Service ExecutiveMill LanePalmerstownDublin 20D20 KH63

Tel: 6201708E-mail: [email protected]

STRATEGIC PLAN 2014 - 2017

The Chairperson Dr. Barry Harrington in collaboration with Mr. Brian O'Mahony and Ms. DebbieGreene from the Irish Haemophilia Society produced the Strategic Plan for the NHC for the years

2014 - 2017.

A special meeting of the Council was devoted to developing the Strategic Plan for 2014 - 2017. Mr.Brian O'Mahony acted as rapporteur for the meeting. Following the meeting a new plan was draftedwith inputs from Dr. Harrington and Ms. Debbie Greene. The Strategic Plan was approved by allmembers of the Council.

The Strategic Plan is vital for the future success of the Council as it identifies clear directions andgoals. The strategic plan will be reviewed on an on-going basis by the Council. The strategic planconsists of four broad goals and 35 objectives. (See Appendix B)


16


17

3 COMPREHENSIVE CARE CENTRES (3CCC’S)

Follow-up Audits of 2 CCsThe International Follow-up Audits of the two CC’s in Ireland were carried out on the 12th November,2015 in Cork University Hospital, Wilton, Cork and on the 13th November, 2015 in Our Lady’s'Children's Hospital Crumlin, Dublin 12.

The two members of the follow-up audit team were:

Dr. David J Perry, MD PhD FRCPEdin. FRCPLond. FRCPathConsultant HaematologistCambridge Haemophilia & Thrombophilia Centre,Box 217 Cambridge University Hospital NHS Foundation TrustAddenbrooke's HospitalCambridge Biomedical CampusHills RoadCambridge CB2 0QQEngland

Ms. Chris HarringtonNurse Consultant in Haemophilia5 Sarsden BuildingsSt Christophers PlaceLondon W1U 1NBEngland


18

Follow-up Audits 2015The International Follow-up audit reports for the two Comprehensive Care Centers were issued tothe Consultants in both of the Comprehensive Care Centres regarding the accuracy of the reports.Once they were checked, the reports were returned to Dr. David Perry for any alterations (if needed)to be included and then issued formally to the Council.

The consensus from the reports was to maintain the concept of "a one stop shop" approach for theprovision of services. This concept of the "One Stop Treatment Centre" has been put together by theexcellent dedicated Haematology staff over the years, in line with best international practice, for theprovision of excellence in care for patients with Haemophilia. These services should all be locatedas convenient to one another as physically possible for the comfort and convenience of patients andstaff.

The Council acknowledged and thanked all the staff at the 2 CCC for their hard work and in thepreparation of the documentation, necessary for the audits.

Dr. Barry Harrington, Chairperson of the NHC will write in early 2016 to the Chief Executive’s of bothCork University Hospital and Our Lady’s' Children's Hospital Crumlin seeking a meeting regardingthe outcomes of the follow-up audits.

National Centre for Hereditary Coagulation Disorders (NCHCD) St. James's HospitalJames's Street Dublin 8D08 FT5D

The Council requested a meeting with the Board of St. James’s Hospital. The meeting took place inSt. James's Hospital on the 6th February, 2015. The Council presented the International Audit Reportof the NCHCD which was held in March 2014 to the members of the board. The Council thankedand informed the board that in the opinion of the Auditors the Haemophilia services at St. James’sHospital was considered a World Class Service. The Council also informed the board that all thestaff in the NCHCD should be congratulated for providing a great service to their patients and forachieving the objective of providing a world class service.


19

RESEARCH IN HAEMOPHILIA

PUBLICATIONS 2015

Below is a list of research papers on Haemophilia and related bleeding disorders publishedin peer review journals

Cork University Hospital

Management of Pregnancy and delivery in carriers of Haemophilia in a multidisciplinary clinic.E Molloy, MI Khan, C Ryan, C Duggan, S O’Shea

Designing patient-specific factor VIII treatment regimens for Haemophilia A based upon individualpharmacokinetic profiles.Maeve Crowley, S O Shea, James O Donnel

Irish Haemophilia Society (I.H.S) Publications 2015

The Irish Haemophilia Society (I.H.S) published the following in 2015

• Spring Magazine

• Summer Magazine

• Autumn Magazine

• Winter Magazine

• Annual Report 2015

• Summer Positive News

• Winter Positive News

• December Junior Magazine

• December Youth Magazine


20

I H S Peer Reviewed Publications

In 2015 the Society published the following peer reviewed publications:

• Guide to National Tenders for Purchase of Clotting Factor Concentrates. 2nd edition. Brian O’Mahony. World Federation of Hemophilia. Available on www.wfh.org

• Coagulation factor Concentrates (CFCs) Tender and Procurement Procedures in 38 EuropeanCountries. European Haemophilia Consortium Monograph. Brian O Mahony, Declan Nooneand Lucia Prihodova. October 2015. Available at www.ehc.eu

• Survey of Coagulation Factor Concentrates Tender and Procurement Procedures in 38European Countries. Haemophilia (2015), 1-8 DOI: 10.1111/hae.12720 B O’Mahony, D Nooneand L Prihodova.

• Improving Haemophilia Patient Care through Sharing Best Practice. European Journal ofHaematology 2015 95 Suppl. 79 (1-8) Philippe de Moerloose, Daniel Arnberg, Brian O’Mahony,Brian Colvin

• Issues in Assessing Products for the Treatment of Haemophilia - The Intersection BetweenEfficacy, Economics and Ethics. Journal of Blood Medicine. Albert Farrugia, Declan Noone,Uwe Schlenkrich, Steffen Schlenkrich, Brian O’Mahony, Josephine Cassar. 2015;6 185-195

• Managing Haemophilia for life: 5th Haemophilia Global Summit. European Journal ofHaematology 2015 95 Suppl. 79 (1-23) Cedric Hermans, Gerry Dolan, Ian Jennings, JerzyWindyga, Sebastien Lobet, Carlos Rodriguez- merchant, Matteo Dario Di Minno, Victor Jiminez-Yuste, Brian O’Mahony.


21

National Centre for Hereditary Coagulation Disorders

• Rawley O, O’Sullivan JM, Chion A, Keyes S, Lavin M, van Rooijen N, Brophy TM, Fallon P,Preston RJ, O’Donnell JS. von Willebrand factor arginine 1205 substitution results inaccelerated macrophage-dependent clearance in vivo. Journal of Thrombosis andHaemostasis, 2015: 13(5): 821-826. PMID: 25690668.

• Lavin M, Kavanagh J, Beddy P, O'Connell NM, O'Donnell JS. Recurrent lower limb venousthrombosis associated with a congenitally absent infrarenal inferior vena cava. QJM. 2015 Jun24. pii: hcv123. [Epub ahead of print] PubMed PMID: 26109595.

• Lavin M, Jenkins PV, Healy ML, Byrne M, O'Connell NM, O'Donnell JS. Age-related factor IXcorrection in symptomatic female carriers with haemophilia

• B Leyden. Haemophilia. 2015 Jul 24. doi: 10.1111/hae.12761. [Epub ahead of print] PubMedPMID: 26207849.

• Gleason E, Dichiara M, Salicio A, Quinn L, Drakeford C, Russell S, Walsh P, Hermida J, SmithO, O’Donnell JS, Montes R, Preston RJ. Activated protein C β-glycoform promotes enhancednon-canonical PAR1 proteolysis and superior resistance to ischaemic injury. Blood, 2015: Aug13;126(7):915-9. PMID: 26084674.

• Lavin M, Jenkins PV, Keenan C, White B, Betts DR, O'Donnell JS, O'Connell NM. X-linkedmoyamoya syndrome associated with severe haemophilia A. Haemophilia. 2015 Sep 30. doi:10.1111/hae.12806. [Epub ahead of print] PubMed PMID: 26422091.

• Lavin M, Jenkins PV, Healy ML, Byrne M, O’Connell NM, O’Donnell JS. Age-related factor IXcorrection in symptomatic female carriers with haemophilia B Leyden. Haemophilia, 2015:Nov;21(6):e498-500. PMID: 26207849.

• Quinn LM, Drakeford C, O’Donnell JS, Preston RJ. Engineering activated protein C to maximizetherapeutic efficacy. Biochemical Society Transactions, 2015; Aug;43(4):691-5. PMID:26551714.

• Fischer K, Iorio A, Lassila R, Peyvandi F, Calizzani G, Gatt A, Lambert T, Windyga J, GilmanEA, Makris M on behalf of the EUHASS Participants. Inhibitor development in non-severehaemophilia across Europe. Thromb Haemost. 2015 Oct;114(4):670-5. PMID: 26293381

Our Lady’s Children’s Hospital Crumlin

• Recombinant factor VIII Fc fusion protein for the prevention and treatment of bleeding in childrenwith severe hemophilia A Young G, Mahlangu J, Kulkarni R, Nolan B, Liesner R, Pasi J, BarnesC, Neelakantan S, Gambino G, Cristiano L, Pierce G, Allen G Journal of Thrombosis andHaemostasis. 2015 Jun; 13 ( 6) 967-77

• How to achieve full prophylaxis in young boys with severe haemophilia A: different regimensand their effect on early bleeding and venous access A. Nidjam, K. Kurnik, R. Liesner, R. Ljung,B. Nolan, P. Petrini and K. Fischer ON BEHALF OF THE PEDNET STUDY GROUPHaemophilia (2015), 21, 444–450

Congress Deliverables

Kulkarni R, Nolan B,Bennett C, Fischer K,Perry D, Barnes C, YuanH, Ramirez-Santiago A,Pierce G, Mei B

Kerlin B, Kulkarni R, NolanB, Wang M, Pasi J, LiesnerR, Brown S, Hanabusa H,Pabinger I, Tsao E, Allen G

Nolan B, Young G,Mahlangu J, Liesner R,Pasi J, Cristiano L, Li X,Pierce G, Allen G

Young G, Mahlangu J,Kulkarni R, Nolan B,Liesner R, Pasi J, BarnesC, Neelakantan S,Gambino G, Cristiano L,Pierce G, Allen G, onbehalf of the Kids A-LONGinvestigators

Barnes C, Fischer K,Kulkarni R, Nolan B,Mahlangu J, RangarajanS, Gambino G, Diao L,Cristiano LM, Pierce GF,Allen G

Fischer K, Kulkarni R,Nolan B, Mahlangu J,Rangarajan S, Gambino G,Diao L, Cristiano LM,Pierce GF, Allen G

Konkle B, Nolan B,Mahlangu J, Perry D,Young G, Liesner R,Rangarajan S, Brown S,Hanabusa H, Pasi J,Pabinger-Fasching I,Jackson S, Cristiano L, LiX, Pierce G, Allen G

Young G, Mahlangu J,Kulkarni R, Nolan B,Liesner R, Pasi J, BarnesC, Neelakantan S,Gambino G, Cristiano L,Barnowski C, Pierce G,Allen G, on behalf of theKids A-LONG investigators

Clinical Outcomes in Children withHemophilia B Treated Long Termwith rFIXFc: Interim Results of theB-Yond Extension Study

Long-term Efficacy of rFVIIIFcProphylaxis in Pediatric,Adolescent, and Adult Subjectswith Target Joints and SevereHemophilia A

Interim analysis of the ASPIREstudy evaluating long-term safetyand efficacy of recombinant factorVIII Fc (rFVIIIFc) in children withsevere haemophilia A

Safety, Efficacy, andPharmacokinetics of RecombinantFactor VIII Fc Fusion Protein(rFVIIIFc) in Previously TreatedPaediatric Subjects with SevereHaemophilia A (Kids A-LONG)

Safety, Efficacy andPharmacokinetics of RecombinantFactor IX Fc Fusion Protein inChildren With Haemophilia B (KidsB-LONG)

Safety, Efficacy andPharmacokinetics of RecombinantFactor IX Fc Fusion Protein inChildren With Haemophilia B (KidsB-LONG)

Long-term safety and efficacy ofrecombinant factor VIII Fc(rFVIIIFc) for the treatment ofsevere haemophilia A: an interimanalysis of the ASPIRE study

Safety, Efficacy andPharmacokinetics of RecombinantFVIII Fc Fusion Protein (rFVIIIFc)in Previously Treated Childrenwith Hemophilia A (Kids A-LONG)

Abstract

Abstract

Abstract

Abstract

Abstract

Poster

Abstract

Abstract

ASH (2015)American Societyof Hematology -57th AnnualMeeting

ASH (2015)American Societyof Hematology -57th AnnualMeeting

EAHAD (2015)EuropeanAssociation forHaemophilia andAllied Disorders - 8thAnnual Congress

EAHAD (2015)EuropeanAssociation forHaemophilia andAllied Disorders -8th AnnualCongress

HAA (2015) HAA2015 - CombinedAnnual ScientificMeeting of HSANZ,ANZSBT and ASTH

HAA (2015) HAA2015 - CombinedAnnual ScientificMeeting of HSANZ,ANZSBT and ASTH

HTRS (2015)Hemophilia &ThrombosisResearch Society -2015 ScientificSymposium

HTRS (2015)Hemophilia &ThrombosisResearch Society -2015 ScientificSymposium

Published

Published

Published

Published

Published

Presented

Published

Published


22


23

Fischer K, Kulkarni R,Nolan B, Mahlangu J,Rangarajan S, Gambino G,Diao L, Cristiano LM,Pierce GF, Allen G

Fischer K, Kulkarni R,Nolan B, Mahlangu J,Rangarajan S, Gambino G,Diao L, Ramirez-SantiagoA, Pierce GF, Allen G

Nolan B, Young G,Rangarajan S, Wang M,Kerlin B, Leung A, Tsao E,Glazebrook D, Pierce G,Allen G

Hanabusa H, Konkle B,Nolan B, Mahlangu J,Perry D, Young G, LiesnerR, Rangarajan S, Brown S,Pasi J, Pabinger-FaschingI, Cristiano L, Li X, PierceG, Allen G

Bennett C, Nolan B,Kulkarni R, Fischer K,Perry D, Barnes C, YuanH, Ramirez-Santiago A,Pierce G, Mei B

Wang M, Nolan B, YoungG, Rangarajan S, Kerlin B,Kulkarni R, Ragni MV,Baker RI, Pasi J, Tsao E,Glazebrook D, Pierce G,Allen G

Kulkarni R, Fischer K,Nolan B, Mahlangu J,Rangarajan S, Gambino G,Diao L, Ramirez-SantiagoA, Pierce GF, Allen G

Baghaei F, Nolan B, PerryD, Innes A, Allen G,Siltberg H

Safety, Efficacy andPharmacokinetics of RecombinantFactor IX FC Fusion Protein inChildren with Haemophilia B(KIDS B-LONG)

Safety, Efficacy andPharmacokinetics of RecombinantFactor IX FC Fusion Protein inChildren with Haemophilia B(KIDS B-LONG)

Analysis of Bleeding Rates inPediatric Subjects With TargetJoints and Severe Hemophilia AReceiving Prophylaxis WithRecombinant Factor VIII FcFusion Protein (rFVIIIFc) in KidsA-LONG

Long-term Safety and Efficacy ofRecombinant Factor VIII Fc(rFVIIIFc) in Severe Hemophilia A

Interim results of the B-YONDstudy evaluating long-term safetyand efficacy of recombinant factorIX Fc (rFIXFc) in children withsevere hemophilia B

Low Annualized Bleeding Rates inPhase 3 Studies of RecombinantFactor VIII Fc Fusion Protein(rFVIIIFc) in Subjects with TargetJoints at Baseline

Kids B-LONG: Safety, Efficacy,and Pharmacokinetics of Long-Acting Recombinant Factor IX FcFusion Protein (rFIXFc) inPreviously Treated Children withHemophilia B

Bleeding rates reported withprophylactic treatment of adults,adolescents and children in phase3 studies of recombinant factorVIII Fc (rFVIIIFc)

Abstract

PlatformPresentation

Abstract

Abstract

Abstract

Abstract

Abstract

Abstract

ISTH (2015)InternationalSociety onThrombosis andHaemostasis - 25thCongress



JSH (2015)Japanese Societyof Hematology -77th AnnualMeeting

NHF (2015)NationalHemophiliaFoundation - 67thAnnual Meeting



NordCoag (2015)Nordic CoagulationMeeting - 48th

Published

Presented

Published

Published

Published

Published

Published

Published


24

Clinical trials at Our Lady's Children's Hospital Crumlin 2015

An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein(Known as rFVIIIFc) in Untreated Males With Severe Hemophilia ASponsor: BiogenClinicalTrials.gov Identifier:NCT02234323EudraCT Number: 2013-005512-10

Study to Determine the Safety and Efficacy of rFIXFc in Untreated Males With SevereHemophilia BSponsor: BiogenClinicalTrials.gov Identifier:NCT02234310EudraCT number:2013-003629-27

Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein(r FVIII Fc) in the Prevention and Treatment of Bleeding Episodes in Previously TreatedSubjects with Hemophilia ASponsor: Biogen IdecClinicalTrials.gov identifier: NCT 01454739EudraCT number: 2011-003072-37

Long- Term Safety and Efficacy of Recombinant Human Coagulation Factor IX Fusion Protein(r FIX Fc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjectswith Hemophilia B (B-YOND)Sponsor: Biogen IdecClinicalTrials.gov identifier: NCT 01425723EudraCT number: 2011-003075-11

A multi-centre phase III uncontrolled open- label trial to evaluate safety and efficacy of BAY81-8973 in children with severe haemophilia A under prophylaxis therapy. Sponsor: BayerClinical Trials.gov identifier: NCT 01311648EudraCT number: 2010-021781-29

Study of Voncento in subjects with von Willebrand diseaseSponsor: CSL BehringClinicalTrials.gov Identifier:NCT02552576EudraCT Number: 2013-003305-25

An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With SevereHemophilia ASponsor: CSL BehringClinicalTrials.gov Identifier:NCT02172950EudraCT Number: 2012-001336-65


25

Finance

The costs of meetings and other administrative costs were provided by the Health Service Executivein 2015. The funding of the National Haemophilia Council by the Health Service Executive was placedon a statutory basis in the Health (Miscellaneous Provisions) Act 2007. The Council is audited by theOffice of the Comptroller and Auditor General.

Below is the National Haemophilia Council Accounts for year ending 31st December 2015

NATIONAL HAEMOPHILIA COUNCIL

Accounts

FORYEAR ENDED 31st DECEMBER 2015


26


27


28


29


30


31


32


33


34


35


36

Ethics in Public Office Act, 1995 & 2001

Details on the implications of the Act were circulated to Council members and a statement of interestsform was signed by all members in 2015.

Website

The website is a key tool for the Council to promote its work and inform persons with Haemophiliaabout the services currently being provided in Ireland. The website was reactivated in November,2014 and is updated regularly.

The NHC website address is: www.nationalhaemophiliacouncil.ie

Note

1. The S.I. has been amended under the Health (Miscellaneous) Provisions act, 2007. This Act canbe viewed on the NHC website.

2. Statement of Adoption and Compliance with the Code of Practice for the Governance of StateBodies - The National Haemophilia Council is compliant.

APPENDIX A

National Haemophilia Council Attendance at Meetings in 2014

The National Haemophilia Council met six times during 2015. The dates of the meetings were:• 29.01.15• 26.03.15• 14.05.15• 09.07.15• 17.09.15• 26.11.15

Attended

Dr. Barry Harrington, Chairperson 6Appointed 07/2014

Prof. Colm Bergin 0Appointed 07/2013

Mr. Michael Conroy, Blood Organ & Cancer Policy Unit, DOH 4Appointed 08/2014

Dr. Ruth Gilmore, Consultant Haematologist, University Hospital, Galway 3Appointed 07/2013

Ms. Debbie Greene, Irish Haemophilia Society 6Reappointed 07/2013

Ms. Ruth Hunter Nolan, Clinical Nurse Manager, St. James's Hospital 3Appointed 08/2014

Dr. William Murphy, Medical Director, Irish Blood Transfusion Services 3Appointed 07/2013

Mr. Brian O'Mahony, Irish Haemophilia Society 6Reappointed 07/2013

Dr. Beatrice Nolan, Consultant Haematologist, OLCHC 4Reappointed 07/2012

Dr. Susan O'Shea Consultant Haematologist, CUH 5Reappointed 07/2013

Dr. Barry White, Medical Director NCHCD 5Reappointed 07/2013


37


38

APPENDIX B

National Haemophilia Council Strategic Plan 2014 - 2017

Background / Raison D’être• The Council was formally established on a statutory basis by Statutory Instrument (SI).

• The Council has a formal role in making recommendations to the Minister for Health and theHealth Service Executive (HSE).

• The need to learn from the tragic history of the past.

• Patients / Clinicians / Health Service Management and Department of Health to collaborativelywork together on a unique basis under the SI.

• Agreement on model for centralization of Haemophilia care.

• Formal audits undertaken under the auspices of the NHC with international expertise includingpatient involvement.

• Ability to respond publicly and co-operatively to a crisis in a timely manner.

GOALS1. Advocate for the Provision of Optimum Haemophilia Care Nationally2. Provision of Appropriate Information, Education and Research3. Ensure Viability and Effectiveness By Measuring Performance And Outcomes4. Optimise Development and Function of the National Haemophilia Council (NHC)

Goal 1:Advocate for the provision of optimum Haemophilia Care Nationally Objectives:1. Organise external peer reviewed audits of Comprehensive Care Centre's every 3 years.

2. Organise external peer reviewed audits of EHTCs by an Irish based team every 3 years.

3. Advise on the setting of clear priorities (Level 1 - EHCCC) following the audits every 2/3 years.

4. Advise on the setting of clear priorities for the development of Haemophilia care in theHaemophilia Treatment Centre’s (Level 2 - EHTC) and hospitals with a Haematologist (Level 3).

5. Advise on the prioritisation for allocation of additional funding to meet priorities identified byaudits.

6. Publication, dissemination, utilisation of National Haemophilia Treatment Guidelines for all levelsof Haemophilia care.

7. Ensure optimum two way communication between hospitals and Comprehensive Care Centre’s.

8. Take into account international developments in Haemophilia care.

9. Regular engagement with key stakeholders by the NHC Administrator and Council andsystematic reporting back to Council.

10. Define and review designation of Treatment Centre’s.

11. Ensure that the national budget for the provision of factor concentrates is maintained at anappropriate level.

12. Ensure appropriate monitoring of factor concentrate utilisation nationally.

13. Advise on implementation of new developments in Haemophilia care, including longer actingfactor, gene therapy, PK tailored therapy and self-management.

14. Advise and review any proposals on any reconfiguration or funding of health services, whichmay impact on Haemophilia care. (This may include the development of hospital groups, theintroduction of universal health insurance, and the re-development of the adult and pediatricHaemophilia facilities)

15. Promote the implementation of a quality improvement Programme 24/7.

16. Develop the roles of Haemophilia nurse specialists to allow enhancement of the service.

Goal 2: Provision of Appropriate Information, Education and Research Objectives:1. Review and formal dissemination of treatment guidelines every 3 years.

2. Identify priorities for communication from the NHC to people with Haemophilia, health careworkers and other stakeholders.

3. Update and maintain the website on a regular basis.

4. Document and process implementing guidelines changes.

5. Examine the feasibility of organising a specifically focused international meeting in Ireland.

6. Encourage research from the HTC’s and the Irish Haemophilia Society.

7. Optimise the value in the information day meeting for healthcare workers / patients.

8. Allocate the responsibility to update the webpage link to research/information on the NHCwebsite.

9. Work on publications/education with the Irish Haemophilia Society.

10. CPD of nursing staff – training pack. Implement and evaluate.

11. Facilitate and co-operate with the development of recognised accredited Nursing Programs.

Goal 3: Ensure Viability and Effectiveness by Measuring Performance and OutcomesObjectives: 1. Ensure that the Haemophilia services (Level 1, 2 & 3) carry out regular internal audits of

compliance with the guidelines and standards set by the National Haemophilia Council & thatthe Centre’s hold continual internal audits including patients’ participation.

2. Ensure there are regular progress reports.

3. Provide formal/informal feedback mechanisms.


39


40

Goal 4: Optimise Development and Function of National Haemophilia Council Objectives:1. Advise the Minister for Health and Health Service Executive on any matter relating to

Haemophilia.

2. Hold an annual meeting with the Health Service Executive and the Minister for Health.

3. Benchmark our work against best international practice/trends in managing Haemophilia.

4. Hold an annual meeting with the CEO’s of the Comprehensive Care Centre’s. (St. JamesHospital, OLCHC, CUH)

5. Hold an annual meeting with the Haemophilia teams at the Comprehensive Care Centre’s.

6. Members to have basic grounding in all aspects of Haemophilia.

7. Have a formal update from the Haemophilia Product Selection and Monitoring Advisory Board.

APPENDIX C

3 Comprehensive Care Centres

National Centre for Hereditary Coagulation Disorders (NCHCD) & H & H Ward St. James's HospitalJames's StreetDublin 8D08 FT5D

Tel: (01)4162141 Tel: H & H Assessment Unit (01)410 3129Tel Out of Hours Service: (01) 410 3132 (After 5pm Mon-Fri & weekends and Bank Holidays)

The NCHCD offers a service to patients with a wide range of bleeding and clotting disorders on anin-patient and outpatient basis, from investigation and diagnosis, to long-term management of severecoagulation disorders. The centre provides comprehensive care with a multidisciplinary approach toinclude; nursing, physiotherapy, social work, counselling and dentistry.

The H & H Ward in St. James's Hospital contains an Assessment Unit with cubicles for assessingand treating patients with haemophilia, and other bleeding or thrombotic conditions. The H & HAssessment Unit is open Monday- Friday, 8.30am- 5pm.

Patients who need emergency assessment or advice after 5pm should phone the H & H Wardor alternatively contact St. James's Hospital via the main switch board on (01) 4103000 andask for the Haematology SHO on call.

Medical Director, Consultant HaematologistDr. Barry White

Consultant HaematologistDr. Niamh O'Connell Prof. James O'Donnell Dr. Kevin Ryan

Haemophilia Nurses & contact detailsMs. Ruth Hunter Nolan, Quality Assurance Officer (01) 428 4651 Ms. Evelyn Singleton, Haemovigilance Officer (01) 410 3518

Haemophilia secretaryMs. Valerine Magill (01) 428 4348


41


42

Our Lady's Children's Hospital Crumlin Dublin 12 D12 N512

Tel: (01) 4096100 (9.00am - 5.00pm Monday-Friday) Email: [email protected]

The Haemophilia department in Our Lady's Childrens Hospital Crumlin offers a service to patientswith a wide range of bleeding and clotting disorders on an in-patient and outpatient basis, frominvestigation and diagnosis, to long-term management of severe coagulation disorders. The centreprovides comprehensive care with a multidisciplinary approach to include; nursing, physiotherapy,social work, counselling and dentistry.

Consultant HaematologistDr. Beatrice Nolan

Clinical Nurse SpecialistsMs. Bridin Brady Bleep 8734 Ms. Imelda Kelly Bleep 733Ms. Mary Kavanagh Bleep 8732Ms. Eibhlin McLaughlin Bleep 8731 Tel: 01 4096939

In case of emergency:Please attend the Emergency Department in the hospital or contact the Haematology registrar oncall through hospital switchboard on 01 4096100 for further advice.

Out of hours contact details:If you have a Haemophilia concern and it is after 5pm Monday - Friday or at the weekend / bankholidays, or if you are unable to contact the Haemophilia nurse specialist, please phone the hospitalswitchboard on (01) 4096100 and ask to speak to the Haematology Registrar on call.Contact details Monday - Friday 08.00 - 17.00 remain unchanged

Haemophilia secretary:Ms. Emma Murphy: Direct Line: (01) 4096913


43

Cork University HospitalWilton Cork

Tel: 021 4922545

Consultant HaematologistDr. Susan O'Shea Dr. Cleona DugganDr. Clodagh Ryan

Haemophilia Nurses & contact detailsMs. Brid Booth Fleming Ms. Annmarie Ryan Hall Ms. Norma Collins

SecretaryMs. Mary Dineen

Data ManagerMs. Emily Lynch

Emergency Service (Outside of opening hours)Contact the Haematology Registrar on call through the switchboard at the Cork University Hospitalat 021 4546400. Patients will be reviewed by the Haematology Registrar in the EmergencyDepartment.


44

Galway University HospitalNewcastle Road, GalwayH91 YR71

Tel: 091-524222 Email: [email protected]

Galway University hospital is a Haemophilia Treatment centre and offers a service to patients with awide range of bleeding and clotting disorders in conjunction with the Comprehensive Care Centreswhere necessary.

Consultant HaematologistDr. Ruth Gilmore

Haemophilia Clinical Nurse Specialist Ms. Maura Sweeney CNS in Haemophilia ServicesTel: (091) 52422 bleep 673E-mail: [email protected]

SecretaryMs. Tina Deane Tel: (091) 893821 E-mail: [email protected] working hours

Please contact Maura Sweeney CNS on (091) 524222 from 8.00am-4.00pm Monday-Friday onbleep 673 or contact the haematology registrar on call through switch.

Out of hours contact detailsIf you have a haemophilia concern/issue and it is after 4pm Monday - Friday or at the weekend/bankholidays, please phone the hospital switchboard on (091) 524222 and ask to speak to theHaematology Registrar on call.


45

Irish Haemophilia Society Ltd.First FloorCathedral Court New StreetDublin 8D08 VH64

Tel: 01 6579900 Fax: 01 6579901

The Irish Haemophilia Society (IHS) was founded in 1968 by members of the medical profession,people with Haemophilia, their families and friends who felt the need to provide support and advicefor members and to improve the quality of life for people with Haemophilia. The Society has grownfrom an informal and voluntary group of parents of people with Haemophilia who wanted a betterdeal for their children, to a confident and professional charity with a committed board and professionalstaff to deal with the challenges ahead.

The I.H.S. organises conferences, offers support and outreach to members and producespublications. The office team for 2015 was:

Mr. Brian O’Mahony, Chief Executive [email protected]

Ms. Debbie Greene Administrator & Office Manager [email protected]

Ms. Anne Duffy Outreach Co-ordinator & Counsellor [email protected]

Ms. Nina Storey (Financial & Fundraising Co-ordinator [email protected]

Mr. Declan Noone (Data & Public Policy Specialist) [email protected]

Ms. Fiona Brennan Family Programme Co-ordinator [email protected]

Ms. Leah Cawley, Administrative Assistant [email protected]

Ms. Aoife Ní Fhógartaigh, Admin Assistant [email protected]

The Governing Body of the Irish Haemophilia Society consists of nine volunteers who are membersof the Society. The Governing Body is elected on an annual basis by the members at the AnnualGeneral Meeting and Conference. The board meet on a monthly basis in the Society headquarterswith the Chief Executive and Administrator to set the policy and oversee the operation of the Society.


46

H & H Ward St. James’s Hospital

Persons from left to rightMs. Carol Finn, Ms. Marie Hughes, Ms. Eadaoin O’ Shea, Ms. Victoria Graham,

Mr. Declan Noone (IHS), Ms. Debbie Greene (IHS), Ms. Evelyn Singleton, Ms. Rachel Bird


47

APPENDIX D

Haemophilia Product Selection Monitoring and Advisory Board (HPSMAB)

The HPSMA was established in 2002 to advise the contract holder in relation to the CoagulationFactor Concentrates (CFCs) which should be purchased for the treatment of Haemophilia, vonWillebrand disease and rare bleeding disorders. The contract holder in 2002 was the Irish BloodTransfusion Service (IBTS). The contract holder was changed by statutory instrument in 2011 (ClottingFactor Concentrates and other Biological [products Bill 2012 to St. James’s Hospital.

The HPSMAB in 2015 included the following members:Dr. Barry White National Haemophilia Director, St James’s Hospital (Chairman)

Mr. Brian O’Mahony CEO, Irish Haemophilia Society (Vice Chair)

Mr. Declan Noone Irish Haemophilia Society

Mr. Seamus Priest Procurement Dept., St. James’s Hospital

Ms. Evelyn Singleton Haemophilia Haemovigilance Nurse, St. James’s Hospital

Dr. Beatrice Nolan Consultant Haematologist, Our Lady’s Children’s Hospital, Crumlin

Mr. Michael Conroy Blood Policy Division, Department of Health and Children

Dr. William Murphy HSE – Clinical Lead, Blood Programme

Mr. Jeff Connell Assistant Director National Virus Reference Laboratory, UCD

Dr. Susan O’Shea Consultant Haematologist, Cork University Hospital

Ms. Betty Murphy Procurement Department, St James’s Hospital (who replaced Mr. SeamusPriest during the course of 2015)

The HPSMAB decide on which CFCs require to be purchased each year, establish selection criteria,issue the call for tender, and decide on the outcome of the tenders. Selection criteria have alwaysincluded safety, efficacy, quality, availability of supply and cost. During the course of 2015 theHPSMAB carried out 3 tender processes - for recombinant FVIII, recombinant FIX and plasma derivedFX.

The HPSMAB has been a very effective body which has resulted in the purchase of the safest andmost effective CFCs and has also resulted in very significant savings to the Exchequer. Majoradvances have occurred in Haemophilia care in Ireland since the establishment of the HPSMAB.This has included an increase in the number of adults on prophylaxis from <10% to >70%. The usageof factor concentrate per capita correlates with clinical outcomes. In 2002, Ireland was utilising 4 IUper capita of FVIII and just over 2 IU per capita of FIX. By 2015, FVIII per capita use had increasedto 8.7 and FIX to 2.31. All children with severe haemophilia are offered prophylaxis and the majorityof adults are now on prophylaxis. It would be reasonable to expect that this would have resulted in asignificant increase in cost. This has not been the case due to the work of the HPSMAB.


48

In 2002, the cost of recombinant FVIII (the product purchased in the largest quantity) in Ireland was26% above the EU average price. Cost was further added to by a handling fee of 20% imposed bythe then contract holder. The HPSMAB have organised very open, competitive tender processessince its inception which have resulted in a steady decrease in the unit price for FVIII concentrate.By 2015, the cost per unit of recombinant FVIII was 55% below the EU average cost and the handlingfees had been eliminated. Availability of treatment for Haemophilia A has more than doubled between2002 and 2015 with no increase in the budget.

The Irish Haemophilia Society commissioned a detailed analysis of the outcome of the work of theHPSMAB from 2002 to 2015. We extrapolated the 2002 pre HPSMAB tender system to 2015 andassumed our price for FVIII, FIX and factor for von Willebrand disease had remained at 26% abovethe EU average price. We also assumed the handling fee remained. We then tracked the EU averageprice for these products. We then looked at the actual prices achieved by the HPSMAB. The resultof the work of the HPSMAB was a saving of € 132,160,000 compared to what the cost would havebeen if we remained at 2002 cost level comparators. This included savings from contract to contract,savings on handling fees, savings on VAT due to the lower cost (VAT is levied on recombinantproducts) and a saving of € 4.97 million due to free product being sourced for clinical trials.

It is salutary to compare the Irish situation with Belgium, who do not have a national tender systemwhich involves the haemophilia clinicians and the patient organisation. In 2002, Ireland and Belgiumused equivalent amounts per capita of FVIII with Belgium using slightly more (Ireland purchasedsome of their 2003 supply in 2002 due to a shortage. Our actual use was 4 IU per capita but wepurchased 5.05 compared to Belgium’s 5.2). At that time, we paid 33% more than Belgium. By 2014,Ireland was using 22% more FVIII then Belgium yet we were paying 56% less than Belgium.


49

Ireland is now seen as an international leader in the field of procurement of CFCs for HaemophiliaThe Irish Haemophilia Society has published extensively in this field and has provided training coursesto haemophilia society representatives, doctors or health officials in 18 countries globally.


50

GLOSSARY

Clintech: Electronic Patient Record System

CCC: Comprehensive Care Centre’s

CUH Cork University Hospital

DoH: Department of Health

HPSMAB: Haemophilia Product Selection and Monitoring Advisory BoardThe Haemophilia Product Selection and Monitoring Advisory Board is a body setup to advice and make recommendations to the Minister for Health and Childrenon the selection of products for the treatment of Haemophilia and von Willebrand'sDisease and related bleeding disorders. The HPSMAB formally advises the Ministerfor Health & Children and recommends the products used by conducting NationalProcurement Tender processes.

HSE: Health Service Executive

IHS: Irish Haemophilia Society

NHC: National Haemophilia Council

NPHC: National Paediatric Haemophilia Centre

NCHCD: National Centre for Hereditary Coagulation Disorders, St. James's HospitalThe NCHCD offers a service to patients with a wide range of bleeding and clottingdisorders on an in-patient and outpatient basis, from investigation and diagnosis,to long-term management of severe coagulation disorders. The centre providescomprehensive care with a multidisciplinary approach to include; nursing,physiotherapy, social work, counselling and dentistry.

NCHDs: Non Consultant Hospital Doctors

OLCHC: Our Lady's Children's Hospital, Crumlin

UHG: University Hospital Galway

Mr. Brian O’Mahony, Minister for Health Dr. Leo Varadkar, Dr. Barry Harrington

Launch of Severe Bleeding Disorder Alert Card


51


52

Dr. Barry White, Dr. Beatrice Nolan, Professor Colm Bergin, Dr. Susan O’Shea, Ms. Anne Grogan, Mr. Brian O’Mahony, Ms. Debbie Greene,

Minister for Health Dr. Leo Varadkar, Ms. Gráinne Leach & Dr. Barry Harrington


53

Ms. Eadaoin O’Shea and Ms. Evelyn Singleton H & H Ward St. James’s Hospital

H & H Ward St. James’s Hospital Dublin


54

Dr. Barry White, Mr. Brian O’Mahony, Mr. Michael Conroy, Dr. Beatrice Nolan, Dr. Ruth Gilmore, Dr. Susan O’Shea and Dr. Barry Harrington

national haemophilia council 2015 annual report

Documents