Patient Group Direction (PGD) Number :

Transcription

1 Notice to all staff: The Patient Group Directions (PGDs) for the Hertfordshire and South Midlands Area Team may only be used by members of the healthcare professions named on the title page, and only if each professional has individually been listed by their manager as an authorised user meeting the competency and training requirements of that PGD. Each healthcare professional using a PGD must also have signed a copy of that PGD and have one available to refer to. Staff must not download PGDs from the internet and use them straightaway. The PGDs are only on the internet so that the appropriate GP/clinical manager can access them when they need to authorise their team members, or to check that their team is using the most recent version. The GP/clinical manager should also have signed the appropriate section of the PGD before use. Page 1 of 14

2 Patient Group Direction (PGD) Number : Administration of Hepatitis A (inactivated) and Typhoid Polysaccharide combined vaccine to provide active immunisation against hepatitis A virus infection and typhoid fever for adults and adolescents by Registered Nurses employed by GP practices within the Hertfordshire and South Midlands Area Team and signatories to the PGD Approval of Patient Group Direction This Patient Group Direction has been approved on behalf of the Hertfordshire and South Midlands Area Team by: Authorising Officer for the Name: Heather Moulder, Director of Nursing & Hertfordshire and South Midlands Quality Area Team Signature: Date: 20 th August 2013 Date of Issue September 2013 Issue Number PGD Date of Review September 2015 The Hertfordshire and South Midlands Area Team is committed to being an organisation within which diversity, equality and human rights are valued. We will not discriminate either directly or indirectly and will not tolerate harassment or victimisation in relation to gender, marital status (including civil partnerships), gender reassignment, disability, race, age, sexual orientation, religion or belief, trade union membership, status as a fixed-term or part-time worker, socio-economic status and pregnancy or maternity leave status. Equality Impact Assessment undertaken by policy author Date: July 2013 This document is available electronically, in a larger font or an alternative format on request. Page 2 of 14

3 Document History: To replace: All previous PCT PGDs for the administration of Hepatitis A (inactivated) and Typhoid Polysaccharide combined vaccine to provide active immunisation against hepatitis A virus infection and typhoid fever for adults and adolescents within the Hertfordshire and South Midlands Area Team Progress Lead Person & Contact Date Number V1 - First Draft May 2013 V2 Final Draft Including amendments from those circulated August 2013 Circulation List Barbara Hamill, Immunisation July 2013 Manager, Public Health England, Hertfordshire & South Midlands Area Team Cath Fenton, Consultant, Public Health England, Screening and Immunisation Lead, South Midlands and Hertfordshire Area Team Sarah Whiteman, Medical Director, Hertfordshire and South Midlands Area Team Heather Moulder, Director of Nursing & Quality, Hertfordshire and South Midlands Area Team Approved by the 20 th August 2013 Pharmaceutical Services Regulations Committee for the Hertfordshire and South Midlands Area Team Review Date September 2015 Date of Archiving Previous PCT PGD for the administration of Hepatitis A (inactivated) and Typhoid Polysaccharide combined vaccine to provide active immunisation against hepatitis A virus infection and typhoid fever for adults and adolescents September 2013 Table of Contents Page Front Sheet 4 1. Clinical Condition or Situation to which the Direction Applies 5 2. Description of Treatment 7 3. Adrenaline Management in the event of an anaphylactic reaction Audit Characteristics and qualification required of staff 12 Page 3 of 14

4 6. References National/Local Policies or Guidelines Management/authorisation of Patient Group Direction 14 Patient Group Direction (PGD) Number : Administration of Hepatitis A (inactivated) and Typhoid Polysaccharide combined vaccine to provide active immunisation against hepatitis A virus infection and typhoid fever for adults and adolescents by Registered Nurses employed by GP practices within the Hertfordshire and South Midlands Area Team and signatories to the PGD Valid from: 1 st September 2013 Expiry (review) date: 1 st September 2015 After this date the direction is no longer valid. (Note: a review will be carried out sooner as a result of a critical incident, new safety or clinical information, changes in legislation or change in best practice.) Supersedes: All previous PCT PGDs for the administration of Hepatitis A (inactivated) and Typhoid Polysaccharide combined vaccine to provide active immunisation against hepatitis A virus infection and typhoid fever for adults and adolescents within the Hertfordshire and South Midlands Area Team Development of Patient Group Direction This Patient Group Direction has been developed on behalf of the Hertfordshire and South Midlands Area Team by: Name Signature Date Medical Director Sarah Whiteman 19 th August 2013 Pharmacist Hertfordshire, Bedfordshire & Luton CSU Carolyn Haselden 19 th August 2013 Page 4 of 14

5 Director of Nursing & Quality Heather Moulder 19 th August Clinical condition or situation to which the direction applies: Indication Criteria for inclusion To provide active immunisation against hepatitis A virus infection and typhoid fever for adults and adolescents For further information see the Hepatitis A & Typhoid chapter in the Immunisation against infectious disease (HMSO) Green Book at Only use where both protection against hepatitis A virus infection and typhoid fever are required Informed consent obtained and documented in the patient s medical notes Adults and adolescents over the age of 15 years old (Hepatyrix ) or 16 years old (ViATIM ) Criteria for inclusion for Typhoid Polysaccharide vaccine: Individuals travelling to countries where typhoid is endemic, especially if staying with or visiting the local population Travellers to endemic areas with frequent and/or prolonged exposure to conditions where sanitation & food hygiene are likely to be poor laboratory personnel who may handle S. typhi in the course of their work Criteria for inclusion for Hepatitis A (inactivated) vaccine: Individuals travelling to and living in areas of high or intermediate prevalence Patients with severe liver disease of whatever cause, including those with chronic hepatitis B or C infection Patients with haemophilia who receive plasma-derived clotting factors. Individuals who are at risk due to their lifestyle, to include parenteral drug abusers, and MSM (men who have sex with men) with multiple partners where sexual behaviour is likely to put them at risk Occupational exposure laboratory workers, those who are in direct contact with the virus and individuals who work directly in contact with raw untreated sewage, those who work with primates Page 5 of 14

6 Staff and residents of some large residential institutions for those with learning difficulties or where standards of personal hygiene among clients/patients may be poor. Individuals who are identified to be at risk during an outbreak situation, or close contacts of hepatitis A cases with onset of jaundice in the last week following advice from the local Health Protection Unit (HPU). Criteria for exclusion (For further guidance refer to local occupational health service or see current Immunisation against Infectious Disease Green Book at There are very few individuals who cannot receive the Hepatitis A (inactivated) and Typhoid Polysaccharide combined vaccine. When there is doubt, appropriate advice should be sought from the GP/ Specialist or local Health Protection Unit (HPU), rather than withholding the vaccine (see Consent refused needs to be clearly documented in the patient s medical notes Children under 15 years old (Hepatyrix ) or under 16 years old (ViATIM ) Pregnant/ suspected pregnancy Breast feeding A confirmed anaphylactic reaction to a previous dose of the combined vaccine or Hepatitis A (inactivated) or Typhoid Polysaccharide monovalent vaccines A confirmed anaphylactic reaction to any component of the vaccine (including neomycin which may be present in trace amounts) Severe / acute febrile illness / acutely unwell - postpone until they have fully recovered (Minor illnesses / infection without fever or systemic upset are not valid reasons to postpone immunisation). In individuals with an evolving neurological condition, immunisation should be deferred until the neurological condition has resolved or stabilised Previous hepatitis A infection, if confirmed by blood test For Hepatyrix - Individuals with a history of severe latex allergy (e.g. anaphylaxis). For latex allergies other than anaphylaxis, vaccines supplied in vials or syringes that contain latex can be administered. Patients with a suppressed immune system, for example due to disease or treatment with immunosuppressant medicines, including HIV Patients receiving haemodialysis Presence of any contraindication as detailed in the Page 6 of 14

7 current Summary of Product Characteristics or Immunisation Against Infectious Disease ( Cautions/Need for further advice from a doctor The vaccine may contain traces of formaldehyde. Caution should be exercised when the vaccine is administered to subjects with hypersensitivity to formaldehyde. ViATIM contains phenylalanine, which may be harmful for people with phenylketonuria. As with all injectable vaccines, the vaccine must be administered with caution to subjects with thrombocytopenia or a bleeding disorder (see Method / Route section) Action if excluded Specialist advice must be sought on the vaccines and circumstances under which they should be given. The risk to the individual of not being immunised must be taken into account Depending on the exclusion criteria and contra-indications the patient may be able to receive the Hepatitis A (inactivated) or Typhoid Polysaccharide monovalent vaccines or the Live Oral Typhoid vaccine Inform or refer to GP as appropriate Document reason(s) for exclusion and advice given in patient s medical notes Action if patient declines treatment 2. Description of Treatment: Depending on the reason the patient declines treatment and any exclusion criteria or contra-indications the patient may be able to receive the Hepatitis A (inactivated) or Typhoid Polysaccharide monovalent vaccines or the Live Oral Typhoid vaccine Give advice about protective effects of the vaccine and the risks of infection and disease complications Inform or refer to GP as appropriate Document reason(s) for decline and advice given in patient s medical notes Name, strength and formulation of drug Hepatitis A (inactivated) and Typhoid Polysaccharide combined vaccines (Both available as pre-filled syringes): Hepatyrix, suspension for injection: Slightly opaque white suspension. 1 dose (1 ml) contains: Hepatitis A virus (HM175 strain) (inactivated) 1440 ELISA Units Vi polysaccharide of Salmonella typhi (Ty2 strain) 25 micrograms Produced in human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated 0.5 milligrams Page 7 of 14

8 Al 3+ ViATIM, Suspension and solution for suspension for injection in a prefilled syringe: The syringe contains 0.5 millilitre of purified Vi polysaccharide typhoid vaccine and 0.5 millilitre of inactivated hepatitis A vaccine. Legal status Method / Route The component Hepatitis A (inactivated, adsorbed) is a cloudy and white suspension and the component Typhoid polysaccharide is a clear and colourless solution. 1 dose (1ml) contains: Originally contained in the suspension: Hepatitis A virus, GBM strain (inactivated),160 U produced in human diploid (MRC-5) cells adsorbed on aluminium hydroxide, hydrated (0.3 milligrams Al) In the absence of an international standardised reference, the antigen content is expressed using an in-house reference Originally contained in the solution: Salmonella typhi (Ty 2 strain) capsular Vi polysaccharide 25 micrograms POM (prescription only medicine) Hepatyrix Hepatyrix is for intramuscular administration in the deltoid region Shake well before use ViATIM ViATIM should be administered by slow intramuscular injection in the deltoid region. The two vaccine components should only be mixed immediately prior to injection. Shake before mixing and again prior to injection to obtain a homogeneous suspension. The contents of the two compartments are mixed by slowly advancing the plunger. The final volume to be injected is 1 millilitre (ml). Hepatyrix and ViATIM The vaccine should not be administered in the gluteal region/ buttocks. The vaccine must not be administered either intravascularly or intradermally The deep subcutaneous route may be used only for patients with thrombocytopenia or a bleeding disorder (or individuals at risk of haemorrhage). Firm pressure should be applied to the injection site (without rubbing) for at least two minutes after the injection. The vaccine can be given at the same time as other vaccines, such as travel vaccines. Injectable vaccines Page 8 of 14

9 should be given at separate sites, preferably in different limbs. If given in the same limb, they should be given at least 2.5 cm apart The vaccine must not be mixed with other vaccines in the same syringe The vaccine should be inspected for any foreign particles and/or variation of physical aspect before use. In the event of either being observed, discard the vaccine The vaccine should be administered at least two weeks prior to risk of potential exposure (but also see Special Considerations / Additional Information section) Dose / Dose range Primary vaccination: Frequency of administration Patient advice / Follow up treatment A single dose of 1.0 ml Booster vaccination: In order to provide long term protection against infection caused by hepatitis A virus, a booster dose of an inactivated hepatitis A vaccine is recommended at any time between 6 and 12 months after the primary immunisation with the combined vaccine (Viatim may be given up to 36 months after the primary immunisation) The combined vaccine may be given as a single dose of 1.0 ml for booster vaccination between 6 and 12 months (but may be given up to 36 months later) following primary immunisation with an inactivated hepatitis A vaccine to subjects who also require protection against typhoid fever. If the initial dose of hepatitis A vaccine was given as a combined typhoid and hepatitis A vaccine, then a single dose of 1.0 ml of Viatim may be given approximately 36 months after the first dose (if a booster dose of hepatitis A vaccine and protection against typhoid fever is required) In subjects who remain at risk of typhoid fever, revaccination should be carried out with a single dose of a purified Vi polysaccharide typhoid vaccine every 3 years, unless it is also appropriate to administer a booster of hepatitis A vaccine in which case a single dose of 1.0 ml of Viatim may be used Provide suitable printed Patient Information Leaflet (PIL) Give advice about the vaccine and how it is administered Date of next immunisation if appropriate, and advice about re-immunisation regime Give advice on possible side effects and their management and when to seek medical advice sore arm is a normal reaction to the injection Give advice on the management of post-immunisation pyrexia and management of local reactions Patient should be advised to consult with a doctor if they are concerned about any reaction Give advice on the modes of transmission and importance of improving sanitation and water supplies in endemic areas and on scrupulous personal, food and water hygiene, Page 9 of 14

10 especially for HIV-positive/immunosuppressed persons travelling to endemic areas. General travel health advice if travelling The vaccine will not prevent infection caused by other hepatitis-causing agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus or other pathogens known to infect the liver The vaccine protects only against typhoid fever caused by Salmonella enterica serotype Typhi. Protection is not conferred against paratyphoid fever or infections with any other serotypes of S. enterica Ty21a vaccine should not be commenced within three days of completing any antibacterial agents, and similarly, antibacterial therapy should not commence within three days after the last dose of vaccine. If malaria prophylaxis is also required, the fixed combination of atovaquone and proguanil can be given concomitantly with Ty21a. Doses of mefloquine and Ty21a should be separated by at least 12 hours. For other anti-malarials, there should be an interval of at least three days between the last dose of Ty21a and the first dose of malaria Adverse Reactions and their Management Reporting procedure of Adverse Reactions prophylaxis. Local reactions (pain, swelling, erythema and induration at injection site) are the most commonly reported symptoms following vaccination. These symptoms are usually mild and transient - see GP if severe (see Product s SPC) Common adverse reactions include: headache, fever, nausea, diarrhoea, itching, malaise, general aches, myalgia, arthralgia, asthenia There have been very rare reports of anaphylaxis following administration of the vaccine. Appropriate medical equipment and drugs for the treatment of an anaphylactic event to be available (see local anaphylaxis guidelines or the current edition of the British National Formulary (BNF)) Consult doctor if fever > 39.5 C, or other serious symptoms Some adverse reactions that may affect the ability to drive or operate machinery have been reported after receiving this vaccine so patients must take extra care when driving or using machines. If patients are affected they should not drive or use machines. For a comprehensive list of all warnings, cautions and potential adverse reactions, refer to the current British National Formulary (BNF), the current Summary of Product (SPC) and the Green Book - Immunisation against infectious disease Initially GP and documented in the patient s medical notes Report in line with local Incident Policy and Procedure All suspected reactions should be reported to the Page 10 of 14

11 Commission on Human Medicines via the Yellow Card system (copies of the yellow card are available at the back of the BNF or via ) by the Nurse or the Doctor. State brand and batch number Drug Interactions The effect of concomitant administration of immunoglobulins on the immunogenicity of the vaccine has not been assessed. Therefore, interference with the immune response of the vaccine cannot be ruled out The vaccine must not be mixed with other vaccines in the same syringe Additional Facilities Appropriate medical equipment and drugs for the treatment of an anaphylactic event to be available (see local anaphylaxis guidelines or BNF) Immediate access to epinephrine (adrenaline) 1 in 1000 Special Considerations / Additional Information Arrangements for handling, security, storage and labelling injection Administer vaccine at least 2 weeks prior to the risk of exposure. However, if a patient presents for travel advice less than two weeks before travel they should still be offered vaccination. The importance of good personal, water and food hygiene must be emphasised to this group of patients as their response may not be maximal prior to departure For a comprehensive list of all warnings, cautions and potential adverse reactions, refer to the current British National Formulary (BNF), the current Summary of Product (SPC) and the Green Book - Immunisation against infectious disease Store in a refrigerator between 2 o C and 8 o C in original packaging Before use, nurses should satisfy themselves that the vaccine has been properly stored and that the cold chain has not been broken. Do not freeze (if the vaccine has been frozen the vaccine must be discarded) Protect from light The vaccine should be inspected for any foreign particles and/or variation of physical aspect before use. In the event of either being observed, discard the vaccine Shake well before use All medicines supplied to a patient under a PGD must comply with the European Commission (EC) labelling and leaflet directive i.e. must be fully labelled and an appropriate Patient Information Leaflet (PIL) supplied. For administration of vaccines a PIL should be offered or made available to the patient to read. Disposal - Equipment used for vaccination, including used vials or ampoules, should be disposed of at the end of a session by sealing in a proper, puncture-resistant sharps box (UN-approved, BS 7320). Page 11 of 14

12 Records In all cases manual records including the Personal Child Health Record (PCHR- red book) and computerised records should be completed immediately, be clear, accurate, legible and include: Patient s name, NHS number, address, date of birth, consent given and GP (if registered) Dose, site and route of injection Brand, Manufacturer, batch number and/or expiry date of vaccine Date of when given and by whom Advice given to the patient Detail of any adverse reaction and action taken 3. Adrenaline (Epinephrine) Management in the Event of an Anaphylactic Reaction: Adrenaline (epinephrine) 1:1000 (1mg/ml) Intramuscular injection Subcutaneous route (not generally recommended) Age of Patient Volume of adrenaline (epinephrine) 1:1000 (1mg/1ml) Adults and adolescents over 12 years 0.5ml (500 micrograms) (0.3ml (300 micrograms) if the child is small or pre-pubertal) These doses may be repeated if necessary at 5 minute intervals according to blood pressure, pulse and respiratory function with urgency of hospital transfer * Use suitable syringe for measuring small volumes 4. Audit: Stock Reconciliation Stock Storage Stock balances should be reconcilable with receipts, administration records and disposals on an individual patient basis. Product should be stored in accordance with the specifications of the PGD and Summary of Product Characteristics relating to the vaccine 5. Characteristics of Staff: Qualifications required Registered nurse with current Nursing & Midwifery Council (NMC) registration employed by GP Practices within the Hertfordshire and South Midlands Area Team Additional requirements Has undertaken appropriate training for working under PGDs for supply and administration of medicines Evidenced competency to undertake immunisations Evidenced competency to undertake immunisations Evidenced up to date training in Cardiopulmonary Resuscitation skills (annually) and management of anaphylaxis (annually). Continued training Attend training dates as required and keep up to date with Page 12 of 14

13 requirements changes The nurse is expected to ensure that he/she is up to date with the most current information and guidance relating to the vaccine in the PGD in the British National Formulary (BNF), Summary of Product Characteristics (SPC) and the Green Book - Immunisation against infectious disease The Registered Nurse must act at all times in accordance with the Nursing and Midwifery Council (NMC) code of professional conduct and Standards for the medicines management, and must at all times acknowledge any limitations in their knowledge or competence. 6. References - National / Local Policies or Guidelines: 1. Current edition of the British National Formulary Accessed May Department of Health (2006) Immunisation against infectious disease (HMSO). Updated at Accessed May Most recent version of the Manufacturers Summary of Product Characteristics (SPC) for each product available at Accessed May Health Service Circular HSC 2000/026: Patient Group Directions (England only), 9 August Department of Health, CMO letters NMC - The Code: Standards of conduct, performance and ethics for nurses and midwives (May 2008) 6. NMC- Standards for medicines management (Feb 2008) 7. Resuscitation Council (UK) Emergency Medical treatment of Anaphylactic Reactions by first medical responders and Community Nurses (updated January 2008) 8. Department of Health (6 th April 2001) Reference Guide to Consent for Examination or Treatment. Crown copyright. ( ) 9. Previous PCT PGD for the administration of Hepatitis A (inactivated) and Typhoid Polysaccharide combined vaccine to provide active immunisation against hepatitis A virus infection and typhoid fever for adults and adolescents Page 13 of 14

14 7. Management of Patient Group Direction (PGD) Number : Authorisation of GP(on behalf of the practice) for the administration of this vaccine without a prescription by the named nurse(s) below I,. (name and designation), confirm that the named nurse(s) who has/have signed this Patient Group Direction to administer the above named vaccine is/are competent to operate under the PGD and fulfil the criteria set out in the Characteristics of Staff section. I give authorisation for the named nurse(s) who has/have signed this Patient Group Direction to administer the above named vaccine as described in this direction and in accordance with this PGD and the current Department of Health Guidelines (HMSO immunisation against Infectious Diseases). Signed Date Practice Address: This Patient Group Direction is to be read, agreed to and signed by all registered nurses it applies to. One copy should be given to each nurse with the original signed copy being easily accessible within the practice setting. Once fully signed a copy of this page only to be kept by the GP Practice. By completing the section below I confirm that I have read and understood the content of this Patient Group Direction and that I fulfil the criteria set out in the Characteristics of Staff section and I am willing, competent and authorised to work under it within my professional code of conduct. Name and designation of Authorised Nurse Signature of Authorised Nurse Date Page 14 of 14