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Patient Group Direction (PGD) for the Administration of:

HEPATITIS A AND TYPHOID VACCINE (Hepatyrix, ViATIM)

POM Prescription Only Medicine

To Adults and Children of 15 years and Over 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

Inclusion Criteria

Exclusion Criteria

Cautions/Need for Further Advice

Adults and adolescents of 15 years and over needing immunisation against Hepatitis A and Typhoid. Please Note The licensed age range for each brand of Hepatitis A and Typhoid vaccine is different: Use Hepatyrix for adults and adolescents aged 15 years and over. Use ViATIM for adults and adolescents aged 16 years and over. Adults and adolescents travelling to areas of high prevalence of both diseases. (If the patient is considered to be at risk of only one of the diseases, the appropriate monovalent vaccine should be used). Informed consent has been given in accordance with current PCT guidelines for the administration of the vaccine.

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 Vi antigen-containing Typhoid or to any constituent of the vaccine (check the product leaflet). A confirmed anaphylactic reaction to any component of the vaccine. Confirmed Hepatitis A infection. Contacts of confirmed cases of Hepatitis A when longer than 7 days after onset of the disease in the primary case. 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 necessarily 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 because of disease such as HIV, or treatment e.g. chemotherapy, radiation treatment, steroids or other immunosuppressant drugs. Some ointments and creams which are prescribed to treat eczema can affect the immune response. Hepatitis A and Typhoid Vaccine PGD No 14 v3 Hepatitis A and Typhoid vaccine

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


Action if Patient Declines or is Excluded

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. Refer to supervising doctor if 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 Consider whether single component vaccines for Hepatitis A or Typhoid could 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

Combined Hepatitis A and Typhoid vaccines: Brand Names Hepatyrix From 15th birthday onwards ViATIM

From 16th birthday onwards

Combined Hepatitis A and Typhoid vaccines do not contain thiomersal.

Route/Method

VACCINES MUST NOT BE GIVEN INTRAVENOUSLY

Vaccines are routinely given by intramuscular injection into 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. Firm pressure should be applied to the injection site (without rubbing) for at least 2 minutes after the injection. Hepatitis A and Typhoid vaccine can be given at the same time as other vaccines such as travel vaccines. The vaccines should be given at separate sites, preferably in different limbs. If given in the same limb, they should be given at least 2.5cm apart. The site at which each vaccine was given should be noted in the individual’s record. Manufacturers do not recommend simultaneous administration with Immunoglobulin, as data is not available.

PGD No 14 v3 Hepatitis A and Typhoid vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence)


Dosage Dosage of Combined Hepatitis A (HAV) and Typhoid Vaccines (Vi P Ty)

Frequency

Dose

Vaccine Product

Age

Dose HAV

Hepatyrix

15 years or over

1440 ELISA units

25Âľg

1ml

ViATIM

16 years or over

160 antigen units

25Âľg

1ml

Vi P Ty

Volume

Primary Vaccination The course consists of a SINGLE dose of 1ml for both adults and adolescents. The vaccine should preferably be given at least two weeks prior to risk of exposure to Hepatitis A and Typhoid, but can be given up to the day of departure. Protection from a primary course lasts for at least one year. Booster Vaccination: When Hepatitis A and Typhoid Vaccine Given as First Dose: Give a booster dose of Hepatitis A vaccine to provide long term protection against Hepatitis A. This is recommended to be given between 6 and 12 months after the dose of Hepatitis A and Typhoid vaccine, but can be given later if delayed. Manufacturers of ViATIM state that it can be given up to 36 months later if not given at recommended time. Revaccinate with Typhoid Vaccine 3 years after the initial dose for individuals at continued risk. Hepatitis A and Typhoid Vaccine can be used to provide this booster dose if the 2nd dose of Hepatitis A vaccine was not given earlier. When Hepatitis A Single Component Vaccine Given as First Dose:A dose of combined Hepatitis A and Typhoid Vaccine can be given in place of the 2nd dose of Hepatitis A vaccine, if protection against typhoid is also required. This dose is recommended to be given between 6 and 12 months after the initial dose of Hepatitis A vaccine, and will give long term protection against Hepatitis A and 3 years protection against typhoid.

Duration of Treatment

See Frequency

Maximum or Minimum Treatment Period Quantity to Supply/Administer

See Frequency See Frequency

PGD No 14 v3 Hepatitis A and Typhoid vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence)


Side Effects

Reactions are usually mild and confined to first few days after immunisation. Common side effects include: Local reaction (pain, swelling, induration, erythema), itching, malaise, headache, general aches, fever, nausea, diarrhoea, myalgia, arthralgia. 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 with the monovalent Hepatitis A vaccine. No studies on the effects on the ability to drive and use machines have been performed. Rarely, some side effects listed in the product SPC may affect the ability to drive or operate machinery. 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. 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

Special Considerations / Additional Information

Immediate access to Adrenaline/Epinephrine for treatment of Anaphylaxis Access to a telephone. Vaccines must be stored and transported according to manufacturers’ guidelines and PCT Cold Chain policy. 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

Explain procedure and further action if required. PGD No 14 v3 Hepatitis A and Typhoid vaccine

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


Patient/Carer/ Parent/Guardian

Follow Up

Give a copy of the manufacturer’s patient information leaflet and discuss as required. Advice on the management of fever and other common/uncommon post-vaccination adverse effects. Management of local/general reactions. May cause dizziness or fainting. If affected advise patient not to drive or operate machinery. Anaphylaxis is rare but a delayed reaction can occur. Advise to seek urgent medical attention if the patient develops breathlessness, swelling or rash Travellers, particularly if immunosuppressed or late presenting for vaccination, should be informed of the importance of scrupulous attention to personal, food and water hygiene See Frequency.

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 PGD No 14 v3 Hepatitis A and Typhoid vaccine

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


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 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

STAFF CHARACTERISTICS Qualifications Specialist Training or Qualifications

Continuing Training & Education

References/Resources and Comments

Registered nurse with current registration working in 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 and is competent 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, current green book chapters and to updated DH advice where appropriate. SPC from Electronic Medicines Compendium http://www.medicines.org.uk/ BNF chapter 14.4 Immunological products and vaccines http://www.bnf.org/bnf/ DH Immunisation Against Infectious disease (The Green Book) 2006, chapters 17 and 33 (updated Feb and March 2011 respectively). These can be accessed at:http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/Public ationsPolicyAndGuidance/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 14 v3 Hepatitis A and Typhoid vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence)


This PGD is an updated version of the Kirklees PCT PGD No 14v2, ‘Hepatitis A and Typhoid Vaccine’ 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

12th April 2011

Deputy Director Infection Control

12th April 2011

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

12th April 2011

Immunisation Nurse Team Leader

12th April 2011

Specialist Technician – Community and Support Services

12th April 2011

PGD No 14 v3 Hepatitis A and Typhoid vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 7

12th April 2011

12th April 2011


Individual Authorisation for the Administration of Hepatitis A and Typhoid 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 14 v3 Hepatitis A and Typhoid vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 8


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 14 v3 Hepatitis A and Typhoid vaccine Approval Date: 31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 9

Date:

PGD_No_14v3_Hep_A_and_Typhoid  

http://www.kirklees.nhs.uk/fileadmin/documents/New/Public_Information/med_mgt/PGDs/Updated_July_11/PGD_No_14v3_Hep_A_and_Typhoid.pdf

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