5: SHARED CARE PROTOCOL
THE ADMINISTRATION OF HBVAX PRO 40μg (Recombinant Hepatitis B Vaccine)
This protocol should be read in conjunction with the leaflet ‘HBVAX PRO 40μg’ (Aventis Pasteur MSD). Further information is available from the Vaccine Information Service as advertised in the enclosed leaflet or via the contact numbers listed below.
Background
Department of Health Guidelines recommend that all patients who are on dialysis, or who are approaching the need for dialysis, should be vaccinated against the hepatitis B virus.
Hepatitis B poses a particular risk to patients with chronic renal failure who may be dialysis dependent or with an imminent requirement for dialysis. Historically, it has been difficult to effectively immunised these patients against hepatitis B because there is a high non-response rate to vaccines in patients with renal impairment and the vaccines that have been available up until now have not addressed this problem, even when double dose regimes have been administered.
Aims of Treatment
It is anticipated the HBVAX PRO 40μg vaccine will achieve a response rate of greater than 80% in our patients after a single course of vaccine (3 doses over 6 months).
Patient Selection
Patients will be selected from the following modalities
- Haemodialysis
- Peritoneal dialysis
- Pre-dialysis, including failed transplants
Clinical Responsibility
The medical and nursing staff of the Wessex Renal and Transplant Unit will be responsible for the pre-screening and post-monitoring of patients. The Department is also responsible for initiating the vaccination process by written referral to the General Practitioner (GP).
The General Practitioner (GP) will be responsible for the prescription and administration of the vaccine.
All parties, including the patient, will be responsible for maintaining the continuity of treatment and completing the shared-care documentation to ensure that the course of vaccine is successfully completed and evaluated and on-going communication is sustained.
In the case of poor/non-response to the vaccine, the Renal Department will undertake to plan the management of future dosing regimes and to communicate this to the patients and to the GP.
Contact Numbers
6: Hepatitis B Vaccination Strategy
PRE-VACCINATION SCREENING PROTOCOL
NB. Throughout the vaccination period, all patients must be screened for hepatitis B surface antigen levels according to local protocol until immunity has been established.
POST-VACCINATION MONITORING PROTOCOL
7: Letter To Patient
Dear Patient
Re: Hepatitis B vaccination
The Department of Health recommends that all patients who are on dialysis, or who are approaching the need for dialysis, should be vaccinated against hepatitis B virus and we want to make sure that you are protected as far as possible.
The enclosed leaflet explains this in more detail and why it is important for you to be vaccinated for your own protection. Please read this carefully and if you have any queries, please ask the nurses or doctors in the renal unit for further advice. It is important that you understand why you should be vaccinated.
We will write to your GP very soon to ask him to arrange a course of vaccine for you. It is then up to you to book an appointment with him in order to start the vaccinations. You should do this as soon as you have confirmed with the nurse in charge of your area that the letter has been sent to your GP.
It is absolutely vital that you receive all 3 injections at the right times and that you complete the course of vaccine in order for you to be fully protected. If you do not complete the course or do not attend for your appointments at the correct times, the vaccine will note work. We will perform a blood test 2 months after you have completed the course of vaccine when you come to clinic or attend for dialysis to check that the vaccine has been effective.
If you are unsure about any aspect of this or are having difficulty attending for your appointments, please speak to the nurses in your area so that they can help you.
Yours sincerely
Dr R Lewis
Clinical director WRTU
Consultant Nephrologist
8: Letter to General Practitioner
Dear Doctor
Re: PATIENT ID DIALYSIS UNIT:
In line with the Department of Health Guidelines, the Wessex Renal and Transplant Unit have adopted the policy to vaccinate all patients against Hepatitis B virus (HBV) who are either on dialysis or who are approaching end stage renal failure with an imminent requirement for dialysis. We would greatly appreciate your assistance with the implementation of this immunisation programme.
Our problem in the past has been a high non-response rate to available hepatitis B vaccines amongst our dialysis population. However, Aventis Pasteur MSD have produced an improved vaccine, HBVAX PRO 40μg which is 4 times the strength of the usual vaccine and has proved to be considerably more successful in achieving sero-conversion in renal patients.
We have worked closely with Aventis Pasteur MSD during the past few months to develop a successful vaccination strategy for our patients and I enclose the relevant literature. All patients have been notified about the strategy and they have all been provided with written information in addition to verbal explanation.
The vaccine is administered by intra-muscular injection, preferably into the deltoid muscle, in 3 divided doses over a 6-month period at months 0, 1 and 6.
I would be most grateful if you would undertake to vaccinate this patient, who is currently on haemodialysis/peritoneal dialysis/pre-dialysis at your earliest convenience. We have advised him/her to arrange and appointment with you for this purpose.
In future, we hope to vaccinate all patients pre-dialysis, but we must first address the large cohort of dialysis patients who are currently not immunised.
If you have any further queries, please do not hesitate to contact one of the nurses in the relevant clinical area given above, for information. Contact numbers are provided on the enclosed shared-cared protocol.
Yours sincerely
Dr R Lewis
Clinical Director WRTU
Consultant Nephrologist
9: Current Policy for Screening for Hepatitis B
- Patients admitted to a Renal Unit should be routinely tested for HbsAg unless they have been tested one month prior to admission
- All patients must have a known hepatitis B status prior to commencement on haemodialysis treatment
- Patients re-admitted following dialysis outside United Kingdom should be tested and found negative for HbsAg before being dialysed in the main unit. Individual risk assessment should be taken for patients who dialysed in countries where exposure to HBV is considered likely
- Patients on chronic haemodialysis programme are routinely tested every three months for HBsAg
10: Management of patients with Hepatitis B virus on haemodialysis
- Patients infected with HBV should ideally be dialysed in separate isolation facilities
- Separate machines should be used for patients with HBV
- Rigorous application of universal precautions is essential to prevent blood contamination and transmission of infection.
- All equipment to be cleaned and disinfected as per unit protocol.
- Disposal of waste as per infection control guidelines
11. References
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Report of Rosenheim Advisory Group Hepatitis and Treatment of Chronic renal failure. Department of Health and Social Security 1972
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Good Practice Guidelines for Renal Dialysis/Transplantation Units Prevention and Control of Blood-borne Virus Infection Department of Health 2002