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Impact of vCJD on Haemophilia Practice Dr Gerry Dolan Nottingham Comprehensive Care Centre UK.

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Presentation on theme: "Impact of vCJD on Haemophilia Practice Dr Gerry Dolan Nottingham Comprehensive Care Centre UK."— Presentation transcript:

1 Impact of vCJD on Haemophilia Practice Dr Gerry Dolan Nottingham Comprehensive Care Centre UK

2 The UK issue – late 1990s vCJD may be transmitted by blood products. There may be a large number of infectious, asymptomatic individuals in the UK donor population. Haemophiliacs in the UK treated with plasma- derived concentrates may have been exposed and continue to be exposed to transfusion transmitted vCJD.

3 The UK issue – 1990s What can be done to minimise the risk to patients from this new TTI risk?

4 The UK issue – 1990s History in haemophilia care of devastation caused by transfusion transmitted infection – HIV. Difficulties caused by delayed acceptance of the risk of TTI and of delayed actions. Potential to improve safety for patients.

5 The UK issue – 1990s Incomplete knowledge

6 Meeting of UKHCDO in 1997 Spongiform Encephalopathy Advisory Committee (SEAC) Centre for Surveillance of CJD

7 Meeting of UKHCDO in 1997 New Disease British Disease Long incubation period  may be many infected blood donors Experimental evidence for TTI Large number of UK haemophilic population had received and were still treated with plasma products derived from UK donors.

8 Reducing risk - 1 As soon as possible – stop using UK plasma- derived products. Recombinant products treatment of choice. Plasma-derived products – use non-European plasma  USA plasma sourced products preferred.

9 Consequences BPL and SNBTS  stop production of FVIII/FIX Source and import USA plasma Long delay and interruption of supply of other productsFVII FXI

10 Patient Response Alarm among patients (1 st wave) Confidence undermined. Increased pressure for recombinant products.

11 Impact UKHCDO/Haemophilia Society – had for many years argued for the introduction of recombinant products – based on safety. ‘Failure of pathogen inactivation steps to deal with all infective agents and new/emerging pathogens’ vCJD

12 Impact Department(s) of Health – accepted the case for recombinant FVIII/IX for all children. Children  recombinant products. Adults  USA plasma-derived FVIII/IX.

13 The inevitable! 2000BPL notified UKHDCO of batches of factor concentrate prepared in 1996/7 and used before 1998 – donor subsequently diagnosed with vCJD. Many patients treated with these batches ? response

14 No clear evidence of vCJD transmitted by blood products but some experimental evidence. No test for donor or recipient infection. Long incubation period. No treatment.

15 Not tell patients v Tell them everything Write to all patients irrespective of whether they had received implicated batches or not and ask if they wanted to know:- 1. Yes and discuss in person 2. Yes and inform by letter 3. No – don’t want to know.

16 Impact on patients Considerable concern may be infected with vCJD recombinant products not available

17 Recombinant for all Undoubtedly increased political pressure to fund recombinant coagulation factor concentrates in the UK. From April 1 st 2005 – all patients with haemophilia A and B will be treated with recombinant products.

18 Unresolved issue If these recipients of UK pooled plasma products have been exposed to vCJD – what risk do they pose to others?

19 ‘Guidance’ Department of Health Advisory Committee on Dangerous Pathogens Spongiform Encephalopathy Advisory Committee Risk assessment conducted by Det Norske Veritas Consulting.

20 ‘Guidance’ Patient 1 receiving blood during an operation in 1997 –died of VCJD 6 years later. Patient 2 – received blood from donor who subsequently developed vCJD. Patient died of other causes but at autopsy PrP sc in spleen.

21 Categorisation of patients at risk 1. Symptomatic patients 2. Asymptomatic patients at risk from familial forms of CJD linked to genetic mutations. 3.Asymptomatic patients potentially at risk from iatrogenic exposure.

22 Precautions Single use instruments where possible. All procedures performed in operating theatre. Procedures should be performed at the end of list. Minimum healthcare personnel involved. Liquid repellent operating gown over a plastic apron. Mask,goggles or full-face visor.

23 Precautions Surgical instruments High and medium risk proceduresCNS, posterior eye lymphoid olfactory epith DESTROY instruments

24 Precautions Endoscopy CNS GI and olfactory if biopsy performed Quarantine/destroy

25 Other initiatives Research/surveillance Autopsy Recipients of potentially contaminated products.

26 Impact of vCJD in Haemophilia care in UK Caused great anxiety and distress to patients in the UK. Potential to severely reduce the quality of medical and surgical care to all patients.

27 Impact of vCJD in Haemophilia care in UK Massive increase in extra clinics, administration and record keeping for haemophilia centre staff. Potential to stigmatise the haemophilic population (again)

28 Impact of vCJD in Haemophilia care in UK The Recombinant for all programme should ensure that this will not happen again.

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