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Patient Group Direction (PGD) for the Administration of:

COMBINED INACTIVATED HEPATITIS A AND HEPATITIS B VACCINE (Twinrix Paediatric, Ambirix â–ź)

POM Prescription Only Medicine

To Children YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT

CLINICAL CONDITION OR SITUATION TO WHICH DIRECTION APPLIES Indication

Immunisation of non-immune children from age 1 year up to 16th birthday who are at risk of both Hepatitis A and Hepatitis B. Note: Where rapid protection against Hepatitis B is required Ambirix should NOT be used because protection against Hepatitis B is not complete until after the second dose. Where rapid protection against Hepatitis A is required Twinrix Paediatric should NOT be used. Use Ambirix (if using a combined vaccine). A single dose of Ambirix provides equivalent protection to a primary course of single Hepatitis A vaccine and will provide protection for at least one year. Refer to chapter 17 of the Green Book, (most up-to-date version) for further information.

Inclusion Criteria

Exclusion Criteria

This PGD does not include individuals considered to be at occupational risk. Refer to exclusion criteria. Informed consent has been given in accordance with current PCT guidelines for the administration of the vaccine. Individuals at risk of both Hepatitis A and Hepatitis B infection for life style, travel or medical reasons. See inclusion criteria on single component vaccine Hepatitis A and Hepatitis B PGDs. Informed consent has NOT been given for the administration of the vaccine. Current acute febrile illness. A confirmed anaphylactic reaction to a previous dose of a vaccine containing Hepatitis A or Hepatitis B, or to any constituent of the vaccine (refer to product leaflet). A confirmed anaphylactic reaction to any component of the vaccine. Post exposure prophylaxis e.g. needle stick injury. Patients with renal failure. Any renal failure patients requiring both PGD No 13v3 Combined Hepatitis A and B Paediatric Vaccine

Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 1


Cautions/Need for Further Advice

Action if Patient Declines or is Excluded

Hepatitis A and Hepatitis B vaccination should be vaccinated with monovalent vaccines. Occupational risk. For young people undertaking work experience refer to employer’s occupational health service. Ambirix should NOT be used when rapid protection against hepatitis B is required. Confirmed Hepatitis A infection. Confirmed Hepatitis B infection. Please also see Cautions/Need for further advice section Previous severe reaction to vaccination – clarify nature of severe reaction and seek advice from a prescriber. Pregnancy and Breast feeding mothers– whilst this is not a contraindication, individuals working under this PGD must seek further clinical advice from an appropriate medical practitioner. (e.g. patient’s GP) before the vaccine is administered. The benefits of administration should outweigh the risks. For further information see appropriate Green Book chapters. Thrombocytopenia, Haemophilia or any other problem that may stop blood from clotting properly, or patient taking anti coagulants Response to vaccines may be sub optimal if the patient is immunosuppressed e.g. because of disease such as HIV, or treatment e.g. chemotherapy, radiation treatment, steroids or other immunosuppressant drugs. Any individual, even if not immunosuppressed can have a poor response to Hepatitis B vaccine. Poor response is particularly associated with obesity, smoking, alcoholism and dialysis. Some ointments and creams which are prescribed to treat eczema can affect the immune response. Hepatitis A and B Vaccine should not be given during treatment with and for 14 days after stopping treatment with either Tacrolimus (Protopic) ointment, or Pimecrolimus (Elidel) cream, or similar preparations which may affect the immune response. Allergy to latex – Vial stoppers and syringe plunger stoppers are often made of this type of rubber and there is a risk of an allergic reaction to the vaccine because of this. However, for latex allergies other than anaphylactic allergies (e.g. a history of contact allergy to latex gloves), vaccines supplied in vials or syringes that contain latex can be administered. Refer to Green Book chapter 6. If an individual has a history of severe (i.e. anaphylactic) allergy to latex, vaccines supplied in vials or syringes that contain latex should not be administered. For these individuals contact the manufacturer to confirm whether the vaccine to be administered contains latex There are very few individuals who cannot receive Hepatitis A or Hepatitis B containing vaccines. Where there is doubt, appropriate advice should be sought from an immunisation co-ordinator or consultant in communicable disease control rather than withholding PGD No 13v3 Combined Hepatitis A and B Paediatric Vaccine

Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 2


vaccine. Consider if single component vaccine of Hepatitis A or Hepatitis B may be indicated. Refer to supervising doctor if appropriate. Refer to employer’s occupational health service where appropriate. Document findings and action taken in patient’s record. Give information about risks of the diseases Give information about when the vaccine may be given Travellers should be informed of the importance of scrupulous attention to personal, food and water hygiene

DESCRIPTION OF TREATMENT Name, Form & Strength of Medicine Route/Method

Inactivated Hepatitis A and rDNA Hepatitis B vaccine Twinrix Paediatric Ambirix ▼ VACCINES MUST NOT BE GIVEN INTRAVENOUSLY Hepatitis A and B vaccines are routinely given intramuscularly in the upper arm or anterolateral thigh. The buttock must not be used because vaccine efficacy may be reduced. For individuals with a bleeding disorder, however, vaccines should be given by deep subcutaneous injection to reduce the risk of bleeding. Hepatitis A and B vaccine can be given at the same time as other vaccines such as MMR, MenC, Td/IPV and other travel vaccines. The vaccines should be given at a separate site, preferably a separate limb. If given in the same limb, they should be given at least 2.5 cm apart. The site at which each vaccine was given should be noted in the individual’s record. For primary immunisation Twinrix Paediatric and Ambirix ▼ are not interchangeable with single component vaccines or each other. Once initiated the primary course of vaccination should be completed with the same brand of vaccine.

Dosage PRIMARY IMMUNISATION Vaccine

Age

Dose

No of Doses

Interval

Twinrix Paediatric

1 to 15 years

0.5ml

THREE

Zero, one and six months

Ambirix ▼

1 to 15 years

1ml

TWO

Zero, followed by a second dose after 612 months

PGD No 13v3 Combined Hepatitis A and B Paediatric Vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 3


Frequency

Twinrix Paediatric The standard primary course of vaccination consists of a dose at zero, one and six months. (THREE doses in total). If the child reaches their 16th birthday before the course is completed, give remaining doses using the adult vaccine. (Refer to the PGD for Hepatitis A and Hepatitis B adult vaccine). Ambirix â–ź The standard primary course of vaccination consists of a dose at zero, followed by a second dose after 6 to 12 months. (TWO doses in total). It is recommended that Ambirix should only be administered where completion of the 2-dose vaccination course can be achieved before the child reaches their 16th birthday as further doses of any Hep A and Hep B vaccine will not be covered under a PGD as this use would be unlicensed. If the child has reached their 16th birthday before the course is completed, refer to a prescriber. The recommended schedules must be adhered to. Once initiated the primary course of vaccination should be completed with the same brand of vaccine. Where immunisation has been delayed beyond the recommended intervals, the vaccine course should be resumed but not repeated. Reinforcing Immunisation Twinrix Paediatric In situations where a booster dose of both hepatitis A and hepatitis B are desired, Twinrix Paediatric can be given if the child is still under 16. Alternatively, subjects primed with Twinrix Paediatric may be administered a booster dose of either of the monovalent vaccines. Refer to PGDs for the individual vaccines. Ambirix In situations where a booster dose of both hepatitis A and hepatitis B are desired, the monovalent vaccines should be used. Refer to PGDs for the individual vaccines. The use of Ambirix as a booster dose is not covered under this PGD. Refer to SPC. If the individual has passed their 16th birthday by the time a booster dose is needed refer to the PGD for Hepatitis A and Hepatitis B adult vaccine

PGD No 13v3 Combined Hepatitis A and B Paediatric Vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 4


Duration of Treatment

See Frequency above

Maximum or Minimum Treatment Period Quantity to Supply/Administer Side Effects

See Frequency above See Frequency above Reactions are usually mild and confined to first few days after immunisation. Common side effects include: Local reaction (pain, redness, swelling), fever, drowsiness, malaise, fatigue, headache, nausea, diarrhoea, irritability/fussiness and loss of appetite. This list is not exhaustive. Please refer to current BNF and product SPC/leaflet for complete list Guillain-Barre syndrome has been reported very rarely. Refer to product SPC for full list of side effects. Ambirix and Twinrix Paediatric have no or negligible influence on the ability to drive and use machines.

Anaphylactic reactions to vaccines are extremely rare but have the potential to be fatal. Onset is rapid, usually within minutes but can occur within hours of vaccine administration. It is not possible to define a particular time period in which an individual should be observed following immunisation. See Green Book Chapter 8. Report all serious suspected adverse reactions (ADRs) in adults and all serious and minor reactions in children (under 18 years), to the Medicines and Healthcare products Regulatory Agency (MHRA) using a yellow card (located at the back of the BNF) or on- line via www.yellowcard.gov.uk. Report serious suspected reactions even if they are listed above, in the BNF, or in the product SPC. Serious reactions are those that are fatal, life threatening, disabling, incapacitating or which result in or prolong hospitalisation and/or are medically significant. Ambirix carries a black triangle symbol (ď ą). This indicates an intensely monitored medicine and all adverse reactions must be reported. Yellow cards may be completed by a nurse, pharmacist, the patient or a doctor, but it is the responsibility of the health professional identifying the ADR to report it. Yellow cards and guidance on their use are also available at the back of the BNF.

Additional Facilities

Immediate access to Adrenaline/Epinephrine for treatment of PGD No 13v3 Combined Hepatitis A and B Paediatric Vaccine

Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 5


Anaphylaxis Access to a telephone. Vaccines must be stored and transported according to manufacturers’ guidelines and PCT Cold Chain policy.

Special Considerations/ Additional Information

Vaccine should be stored in the original packaging at a temperature of 2 to 8º C. If the vaccine has been frozen, it should be discarded. Healthcare professionals are reminded that in some circumstances the recommendations regarding vaccines given in the Green Book chapters may differ from those in the Summary Product Characteristics (SPC) for a particular vaccine. When this occurs, the recommendations in the Green Book are based on current expert advice received from the JCVI and should be followed. Green Book recommendations are reflected in this PGD which in some instances could result in an unlicensed use of a licensed product.

Advice to Patient/Carer/ Parent/Guardian

Explain procedure and further action if required. Give a copy of the manufacturer’s patient information leaflet and discuss as required. Give advice on the management of fever and other common/uncommon post-vaccination adverse effects. Management of local/general reactions. Anaphylaxis is rare but a delayed reaction can occur. Advise to seek urgent medical attention if the patient develops breathlessness, swelling or rash Give advice about avoiding exposure to Hepatitis A and Hepatitis B infection particularly if immunosuppressed. Travellers, particularly if immunosuppressed or late presenting for vaccination, should be informed of the importance of scrupulous attention to personal, food and water hygiene Advise blood test may be required 1– 4 months after third dose if at continued risk Advise that some individuals are poor responders to the Hepatitis B vaccine, give life style advice and advise care with handling sharps, body fluids etc. When explaining blood test results, advise whether the child is protected. Advise that if the child is accidentally exposed to blood or body fluids potentially infected with Hepatitis B urgent medical advice must be sought. Hepatitis B Immunoglobulin may be needed for nonresponders or individuals in high-risk situations. Those at occupational risk (those planning to carry out work experience in a high risk area) should be advised to inform the people planning their placement of their Hepatitis B status. See Green Book Chapter 18 PGD No 13v3 Combined Hepatitis A and B Paediatric Vaccine

Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 6


Follow Up

For information on follow up blood tests for Hepatitis B, refer to the Hepatitis B Child vaccine PGD.

REFERRAL ARRANGEMENTS AND AUDIT TRAIL Referral Arrangements

If patient is excluded from this PGD refer to GP or other appropriate clinician. Any health professional administering a vaccination must be able to identify and contact an appropriate clinician, e.g. GP, or the NHS Kirklees Immunisation Coordinator, as necessary, e.g. in the case of a child with an allergy to components of the vaccine.

Records/Audit trail

Self referral to GP practice or A&E department if appropriate (post immunisation). The following information must be documented in records which should be stored appropriately and can be easily retrieved where necessary. Patient’s name, address, date of birth and consent given. If consent is either refused or withdrawn, this decision should also be documented. Contact details of GP if applicable Dose administered and route. Site of injection. Batch details, expiry date, manufacturer, supplier and brand name Advice given to patient (including side effects) Date administered Signature and name of staff who administered the vaccine. For paperless practices the electronic record should identify the name of the nurse administering the vaccine and should ideally have an electronic signature. Scanned paper records are acceptable Details of any subsequent adverse drug reaction and actions taken including referral arrangements. (This MUST be documented in the patient’s medical record) For all vaccines administered to children or young people up to age 16 or still in full time education. The following records must also be completed. Computerised records and data collection held by Child Health Information Services (CHIS) The Personal Health Child Record (PHCR –red book) (manual records) should be completed if available. Failure to present this is not a reason to refuse to administer vaccination. If the red book is not available vaccination may proceed as long as there is clear information in respect of which vaccinations the child is due to receive. Every effort should be made to complete the red book at PGD No 13v3 Combined Hepatitis A and B Paediatric Vaccine

Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 7


the earliest opportunity and the importance of providing it at subsequent vaccination appointments should be communicated to the parent/guardian. If applicable to the vaccine given Travel destination Liaison with HPA

PGD No 13v3 Combined Hepatitis A and B Paediatric Vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 8


STAFF CHARACTERISTICS Qualifications Specialist Training or Qualifications

Continuing Training & Education

References/Resources and Comments

Registered nurse with current registration working within Kirklees PCT Has undertaken appropriate training and is competent to undertake the clinical assessment of patients according to the indications listed in this PGD. Has undertaken appropriate training and is competent for working under PGDs for the supply and administration of medicines. Has undertaken training appropriate to this PGD – e.g. annual updates in Immunisation and Vaccination. Has undertaken training in all aspects of immunisation including contraindications and the recognition and treatment of anaphylaxis. Has undertaken training and is competent in resuscitation skills. The practitioner should be aware of any change to the recommendations for the medicine listed. It is the responsibility of the individual to keep up-to-date with continued professional development and to work within the limitations of their scope of practice. Attends compulsory annual updates in Immunisation and Vaccination. Undertakes mandatory annual updates on Anaphylaxis and Resuscitation. Practitioner should have access to product leaflet, current BNF, Green Book chapters and updated DH advice where appropriate SPC from Electronic Medicines Compendium http://www.medicines.org.uk/ BNF chapter 14 http://www.bnf.org/bnf/ DH Immunisation Against Infectious disease (The Green Book) chapter 18 (updated 19th November 2009) and chapter 17 (updated February 2011). These can be accessed at:http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/Publicati onsPolicyAndGuidance/DH_079917 National Travel Health Network and Centre (NaTHNaC): http://www.nathnac.org/

Advice contained in the individual Summary of Product Characteristics (SPC) may have been overridden in accordance with guidance issued by the relevant Dept of Health Green Book Chapter. This will result in an unlicensed use of a licensed product following current DH guidance

PGD No 13v3 Combined Hepatitis A and B Paediatric Vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 9


This PGD is an updated version of the Kirklees PCT PGD No 13v2 ‘Combined Hepatitis A and B Paediatric Vaccine – Twinrix Paediatric & Ambirix’, April 2009. It was updated for use in Kirklees Primary Care Trust by the individuals listed below: Name Dr Ebere Okereke Julie Bulmer Jane O’Donnell Lucianne Ricketts Deborah Mitchell Sally Wright Lisa Meeks

Position

Date

Consultant in Communicable Disease Control (West Yorkshire Health Protection Agency) School Nurse Team Leader

30th March 2011

Deputy Director Infection Control

30th March 2011

Senior Medicines Management Adviser - Strategy and Operational Development. GP Practice Nurse

30th March 2011

Immunisation Nurse Team Leader

30th March 2011

Specialist Technician – Community and Support Services

30th March 2011

.

PGD No 13v3 Combined Hepatitis A and B Paediatric Vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 10

30th March 2011

30th March 2011


Individual Authorisation for the Administration of Combined Hepatitis A and B Paediatric Vaccine by Nurses Employed either by the PCT/KCHS or GP Practices within Kirklees PCT. THE PCT DOES NOT ACCEPT LIABILITY IN RESPECT OF GP EMPLOYED STAFF. PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own Code of Professional Conduct I have read and understood the Patient Group Direction and agree to administer this medicine only in accordance with this PGD. In signing this declaration the nurse is willing to be professionally accountable for this work as defined in the NMC Code of Professional Conduct 2008. Name of Professional Signature Authorising Manager and Date Signature

Staff who are no longer required to administer under this PGD should be removed from it. This can be done by crossing through the relevant name, adding date and initials. Authorising Managers For Practice Staff this will be the GP. For PCT staff this will be the team leader, or relevant clinical manager (see PGD policy) Note to Authorising Managers: Authorised staff working at a fixed base should have access to the signed PGD held at the base. Authorised staff who may give vaccinations away from the base should have an individual copy of the relevant signed PGD with them when administering the vaccine. PGD No 13v3 Combined Hepatitis A and B Paediatric Vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 11


AUTHORISATION This patient group direction must be agreed to and signed by all health care professionals involved in its use. The NHS Trust should hold the original signed copy. The PGD must be easily accessible in the clinical setting.

ORGANISATION

KIRKLEES PRIMARY CARE TRUST

Director of Patient Care & Professions

Name: Sheila Dilks

Signature: Assistant Director of Medicines Management & Prescribing

Name: Neill McDonald

Signature: Medical Director

Date:

Name: Dr Judith Hooper

Signature: CEC Chair

Date:

Date:

Name: Dr David Anderson

Signature:

PGD No 13v3 Combined Hepatitis A and B Paediatric Vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 12

Date:

PGD_No_13_Combined_Hep_A_and_Hep_B_Paed  

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