Speech by Micheál Martin, T.D. Minister for Health and Children on the launch of the pilot project on complete electronic tracing of haemophilia clotting factor concentrate into the Republic of Ireland

I am delighted to be here today to launch a major quality initiative in the delivery of haemophilia care. This will provide a new international standard to ensure excellence in the storage, delivery, prescription and administration of haemophilia products. This meeting which was organised by Dr White is the first official event of the National Haemophilia Council which was established earlier this year. This meeting provides a timely and important platform to consider just one of the wide range of issues associated with haemophilia and I hope you have found today´s discussions both interesting and informative.

As many of you are aware, the management of patients with haemophilia and related disorders involves the administration of factor concentrate which corrects the deficient clotting factor. Approximately 40,000 vials of factor concentrate are administered to this patient group every year. These products are administered both in hospital and also in the home by the patient or their caregivers. For patients with haemophilia home treatment with clotting factor concentrate is fundamental to independence and also the prompt treatment of bleeding episodes and prevention of complications.

The accurate tracing and administration of haemophilia factor concentrates is a critical component in the safe delivery of haemophilia care. It ensures that rapid and comprehensive recall mechanisms can be activated and also that the right product is administered to the right patient.

Currently a combination of manual and electronic methods are used to trace factor concentrates. In addition the prescriptions for factor concentrates are written and checked manually. The volume of haemophilia product administered per year and the need to deliver both home and hospital based care mandates the development of more sophisticated systems to monitor and validate treatment.

The key objectives of the project are:

  • Eliminate medication errors by using comprehensive electronic controls.
  • Real time identification of the location of all clotting factor concentrates to facilitate rapid and accurate recall if required.
  • Real time tracking of patient treatment history to identify unusual bleeding patterns in the home which would require hospital rather than home treatment
  • Decision support system to analyse the impact on stocks, the cost of prescribing actions and future budgetary and stock requirements

This project represents the first of its kind internationally and, as a result, has generated considerable interest from the regulatory authorities such as the FDA as well as from the European Commission who are attending this meeting today. This project will represent a new international standard in the area of haemophilia care and consequently the global consultation group of the World Federation for Haemophilia has agreed to externally review this process. This group includes representatives from the regulatory authorities (the FDA and EMEA) international clinicians, patients, the World Health Organisation, industry and governmental agencies.

Today´s meeting is also noteworthy as it represents the first official function of the National Haemophilia Council. The Council is comprised of patients, haemophilia treaters and health care administrators and its role is to advise on the national provision of haemophilia care. Work on the establishment of the National Haemophilia Council on a statutory basis is at an advanced stage. The Council has been established on an ad hoc basis pending enactment of the Statutory Instrument and has already met on a number of occasions. We are very fortunate in that Prof. John Bonnar has kindly agreed to Chair this group. Professor Bonnar is highly respected in the medical community and I am confident that he will play an invaluable role in the establishment and development of the Council. This group has already proved itself to be effective and dynamic in that there are a number of initiatives underway despite the fact that it has only recently been established. These initiatives include the development of the national haemophilia database which is another key recommendation of the Lindsay Report.

The Government agreed to accept in full the recommendations contained in Ms. Justice Lindsay´s report on the Tribunal of Inquiry into the infection with HIV and Hepatitis C of persons with haemophilia, and related matters. Officials meet regularly with the Irish Haemophilia Society and with treating consultants to progress the implementation of those recommendations.

One of the major developments in the treatment and care of persons with Haemophilia in recent years has been the manufacture of recombinant products. These products are genetically prepared and do not rely on human plasma as a source material. I am glad to say that treatment services in Ireland were among the first to develop a strategy to replace plasma derived products with recombinant clotting factor concentrates.

The first recommendation made by Judge Lindsay in her Report refers to the need that persons with haemophilia must have continued access to blood products which are of the highest standard and of the safest nature available. I established the Product Selection and Monitoring Advisory Group in 2001, membership of this group includes the Irish Haemophilia Society, Irish Blood Transfusion Service, Irish Medicines Board and a number of Consultant Haematologists including Dr White and Professor Owen Smith who played a key role in the development of the National Centre. In 2003 priority was given to the work of the Product Selection and Monitoring Advisory Group. Considerable time and effort has been dedicated to fine-tuning the Group’s Terms of Reference and to ensuring that the views of the stakeholders were given due consideration. The expiry of the contracts for clotting factor products in June 2003 gave added impetus to the work of this Group. As a result, the Group has been in a position to advise the Irish Blood Transfusion Service on the safest and most efficacious products for the treatment of haemophilia for the next two years. This represents a major achievement for the collaborative process undertaken by all concerned.

The Report of the Lindsay Tribunal acknowledged that much has been done in recent years to improve services for persons with haemophilia, particularly at the National Centre for Hereditary Coagulation Disorders. This state-of-the-art facility was opened by myself in November 2001. It provides multi-disciplinary care for patients with haemophilia and related disorders. It is accessible to all patients within the country. The Centre provides a shining example of how the objectives of both the Quality and Fairness document and the Hanly Report can improve patient outcome.

The four goals of the National Health Strategy are:

  • Better Health for Everyone
  • Fair Access
  • Responsive and Appropriate Care Delivery
  • High Performance

The Centre has worked with senior management at St James’s hospital to successfully implement the objectives of the Quality and Fairness document. The Centre has recently been externally reviewed by Professor Christine Lee, an international expert in the field of haemophilia care. She not only concluded that the Centre complied with best practice in haemophilia care but also confirmed that the Centre’s achieved the objectives outlined in the Quality and Fairness document. The health strategy identified quality, equity, accountability and patient centeredness as the key components of the delivery of a health service. In terms of quality the Centre achieves its objective of ensuring that it delivers a standard of care to patients with haemophilia which is consistent with best international practice. The Centre provides a patient-centred service. Multi-disciplinary care is delivered in a way to maximise patient convenience. This is illustrated by the provision of walk in services and the scheduling of combined clinics with other essential services such as dentistry and orthopaedic surgery.

Patients are involved in the decision making process of the centre through representation at meetings by the Irish Haemophilia Society with the Centre management. Patients are empowered to be more involved in their care through the provision of a home treatment programme, educational meetings, seminars and quality written information that is provided to the patient group. The Centre also provides an example of the benefits of the model of care outlined in the Hanly report. The service is comprehensive, multidisciplinary, high quality, safe, and consultant-provided. It is highly commended by the external review and has an extremely high rate patient satisfaction (98% in external review).

I would like to congratulate the management and the staff at the National Centre for Hereditary Coagulation Disorders and senior management of the hospital for not alone developing this major international initiative for haemophilia care but also for the innovative and progressive implementation of the recommendations of recent reports on the health service and for demonstrating the significant improvements in clinical care that can be achieved with the implementation of these reports.

It is therefore with the greatest of pleasure that I lend my support to this initiative, which will help ensure that the care provided to persons with haemophilia will be of a consistent world class standard regardless of where people live. My Department is pleased to offer the financial support, which is routed through the Eastern Regional Health Authority to the programme. With the help of the Irish Haemophilia Society, I’m sure that during the pilot phase of the programme it may be refined to ensure that the patient centred emphasis is paramount and that every aspect of the system will be geared to optimizing care. In this context I wish to congratulate Brian O´Mahony and Michael Davenport from the Society for their leadership and dedication in working with statutory agencies to develop optimum services for persons with haemophilia.

I wish you every success with the implementation of this very worthwhile project.