GG&C PGD ref no: 2016/1338 YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT Clinical Condition Indication: For active immunisation of individuals who are deemed to be at risk from Virus. Inclusion criteria: Travellers going to areas of high or moderate prevalence of hepatitis A virus. Long stay travellers or travellers to low to moderate risk areas of hepatitis A virus who are unable to take reasonable precautions with food and water hygiene. Parenteral drug users Individuals at high risk because of sexual practices Laboratory staff working with the virus Individuals at risk of occupational exposure e.g. workers in contact with sewage During an outbreak as defined by Health Protection Scotland Patients with chronic liver disease Close contacts of hepatitis A cases Under certain circumstances, certain groups could be at increased risk of infection or transmission and immunisation should be considered in light of local circumstances. Such groups might include child care and residential facilities. Exclusion criteria: For Epaxal 500 RIA units only Allergy to eggs or egg products Children under 1 year Anaphylactic reaction to a previous dose a hepatitis A vaccine Anaphylactic reaction or severe sensitivity to any component of the hepatitis A vaccine Evolving neurological condition, immunisation should be deferred until resolved or stabilised. History of severe reaction (i.e. anaphylactic reaction) to latex where vaccine is not latex free. Non consent Non consent Acute illness or fever, immunisation should be postponed until fully recovered. Template Version: 2011 Page 1 of 10
Cautions/Need for further advice/circumstances when further advice should be sought from the prescriber: Action if patient declines or is excluded: Referral arrangements for further advice / cautions: During pregnancy or lactation where there is high to moderate risk of hepatitis A infection (Vaccine should be used with caution). Known bleeding disorder administer subcutaneously Refer to appropriate clinician e.g. GP, Travel Health Consultant, Sexual Health, GUM or ID Consultant. If declined advise regarding protective effect of immunisation and potential disease complications. Document advice given and refer to appropriate clinician. As above Template Version: 2011 Page 2 of 10
Drug Details Name, form & strength of medicine: Route/Method of administration: vaccine Havrix Monodose (GlaxoSmithKline) 1440 ELISA units/1ml per dose, Havrix Junior Monodose (GlaxoSmithKline) 720 ELISA units/0.5ml per dose, Avaxim (Sanofi Pasteur MSD Limited) 320 antigen units/ml Vaqta Paediatric (Sanofi Pasteur MSD Limited) 50 antigen units/ml Epaxal (MASTA) 48 units/ml. Intramuscular to deltoid area Deep subcutaneous injection for individuals with a bleeding disorder (caution possibility of reduced immunogenicity with this route) Dosage (include maximum dose if appropriate): Vaccine product Havrix Monodose Ages Dose Volume 16 years or over 1440 ELISA units 1.0ml Havrix Junior Monodose One to 15 years 720 ELISA units 0.5ml Avaxim 16 years or over 160 antigen units 0.5ml Vaqta Adult 18 years or over 50 units 1.0ml Vaqta One to 17 Paediatric years 25 units 0.5ml Epaxal One year or over 500 RIA units 0.5ml Vaccines may be used interchangeably Template Version: 2011 Page 3 of 10
Frequency: Primary immunisation Primary immunisation consists of one dose of the appropriate vaccine Reinforcing Dose A reinforcing dose should optimally be administered at 6-12mths following primary immunisation. However, a reinforcing dose can be given at any time after 12 months up to several years following primary immunisation (i.e. the primary dose does not need to be repeated). Duration of treatment: Maximum or minimum treatment period: Quantity to supply/administer: Additional Monitoring:* Legal Category: Is the use outwith the SPC:** Storage requirements: Until further evidence is available on persistence of protective immunity, a further booster at 25 years is indicated for those at ongoing risk (Green Book 2015). n/a n/a 1 dose per occasion No POM No Store between 2 0 C-8 0 C in locked storage. NHS GG&C Vaccine Ordering, Storage and Handling Guidelines should be observed http://www.staffnet.ggc.scot.nhs.uk/info%20centre/policiesprocedur es/ggcclinicalguidelines/ggc%20clinical%20guidelines%20elect ronic%20resource%20direct/vaccine%20ordering%20storage%20 and%20handling%20guideline.pdf Vaccine storage history e.g. temperature charts must be checked and deemed satisfactory before administration to patient. * The black triangle symbol has now been replaced by European additional monitoring ( ) ** Summary of Product Characteristics Template Version: 2011 Page 4 of 10
Warnings including possible adverse reactions and management of these: Awareness of potential side effects as listed below: Minor Local Reactions mild transient soreness, erythema, induration at the injection site. Less Common headache, fatigue, fever, nausea, vomiting, diarrhoea, loss of appetite and rash. Very Rarely - anaphylactic reactions, arthralgia, myalgia, convulsions Please refer to current BNF, ebnf http://www.bnf.org/bnf/ or SPC at http://emc.medicines.org.uk/ for full details. Assessment of patients pre and post immunisation. Any adverse event to be recorded and highlighted within patients individual record Use the Yellow Card System to report adverse drug reactions directly to the CMS. Yellow Cards and guidance on their use are available at the back of the BNF or online at http://yellowcard.mhra.gov.uk/ Advice to patient/carer including written information provided: Explain treatment and course of action. Give patient a copy of any relevant patient information leaflet if available. PIL available at http://emc.medicines.org.uk/ Explain that to give long-lasting immunity to hepatitis A dosing requires at least two injections six months apart, hence the importance of a final dose at 12 months for the accelerated schedule Further Information available to patients at www.immunisationscotland.org.uk and www.fitfortravel.nhs.uk Monitoring (if applicable): Follow up: n/a Advise patient to contact GP etc in event of any reaction See advice to Patient/Carer Template Version: 2011 Page 5 of 10
Staff Characteristics Professional qualifications: Specialist competencies or qualifications: Those registered health care professionals that are listed and approved in legislation as able to operate under patient group directions and have current registration. Has undertaken appropriate training and competence to undertake immunisation including recognition and treatment of anaphylaxis Continuing education & training: Has undertaken appropriate training for working under PGDs for the supply and administration of medicines All health care professionals working under the direction will be expected to maintain their competence as specified in hospital, local and national policies e.g. Nursing & Midwifery Council guidelines. 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 in all aspects of immunisation including recognition and treatment of anaphylaxis. Referral Arrangements and Audit Trail Referral arrangements Any prolonged reaction, whether mild or severe should be reported to the appropriate clinician. Records/audit trail: Patient s name, address, date of birth and consent given Contact details of GP (if registered) Diagnosis Dose and form administered, with batch details Advice given to patient (including side effects) Signature/name of staff who administered or supplied the medication, and also, if relevant, signature/name of staff who removed/discontinued the treatment Details of any adverse drug reaction and actions taken including documentation in the patient s medical record Referral arrangements (including self-care) Template Version: 2011 Page 6 of 10
References/ Resources and comments: Notes: SPC Summary of Product Characteristics http://emc.medicines.org.uk/ BNF British National Formulary www.medicinescomplete.com TRAVAX www.travax.nhs.uk NMC (2010) Standards for Medicines Management NMC (2015) The NMC Code of Professional Conduct: standards for conduct, performance and ethics http://www.nmc-uk.org/ NHS GG&C Immunisation Best Practice Guideline http://www.staffnet.ggc.scot.nhs.uk/info%20centre/policiesproce dures/ggcclinicalguidelines/ggc%20clinical%20guidelines% 20Electronic%20Resource%20Direct/Immunisation%20Best%20 Practice%20Guideline.pdf NHS GG&C Vaccine Ordering Storage and Handling Guidelines http://www.staffnet.ggc.scot.nhs.uk/info%20centre/policiesproce dures/ggcclinicalguidelines/ggc%20clinical%20guidelines% 20Electronic%20Resource%20Direct/Vaccine%20Ordering%20S torage%20and%20handling%20guideline.pdf Immunisation against Infectious Diseases (2006). DOH (green book) always refer to on-line version NHS HealthScotland website https://www.gov.uk/government/organisations/publichealth-england/series/immunisation-against-infectious-diseasethe-green-book http://www.healthscotland.com/topics/health/immunisation/index. aspx Health Protection Scotland Immunisation and Vaccine Preventable Diseases website http://www.hps.scot.nhs.uk/immvax/guidelines.aspx Immunisation Scotland www.immunisationscotland.org.uk Template Version: 2011 Page 7 of 10
This Patient Group Direction must be agreed to and signed by all healthcare professionals involved in its use. The original signed copy will be held at PPSU, Queens Park House, Victoria Infirmary. The PGD must be easily accessible in the clinical setting. Organisation: * Lead Author Template Version: 2011 Page 8 of 10
AUTHORISATION: Antimicrobial use If the PGD relates to an antimicrobial agent, the use must be supported by the NHS GG&C Antimicrobial Management Team (AMT). A member of this team must sign the PGD on behalf of the AMT. Microbiology Name: approval Designation: Signature: Date: (on behalf of NHS GG&C AMT) Template Version: 2011 Page 9 of 10
Local Authorisation: Service Area for which PGD is applicable: I authorise the supply/administer medicines in accordance with this PGD to patients cared for in this service area. Lead Clinician for the service area (Doctor) Name: Signature: Designation: Date: E-Mail contact address: I agree that only fully competent, qualified and trained professionals are authorised to operate under the PGD. Records of nominated individuals will be kept for audit purposes. Name (Lead Professional): Signature: Designation: Date: E-Mail contact address: Description of Audit arrangements: Frequency of checks: (Generally annually) Names of auditor(s): 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. Note to Authorising Managers: authorised staff should be provided with an individual copy of the clinical content of the PGD and a photocopy of the document showing their authorisation. I have read and understood the Patient Group Direction. I acknowledge that it is a legal document and agree to supply/administer this medicine only in accordance with this PGD. Name of Professional Signature Date Template Version: 2011 Page 10 of 10