Patient Group Direction (PGD) for the Administration of:
Intradermal Trivalent Seasonal Influenza Vaccine (Intanza)
Prescription Only Medicine (POM)
To adults aged 18 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
Adults aged 18 years and over who require immunisation against seasonal influenza in line with Department of Health guidance. Refer to inclusion criteria. VACCINES FOR STAFF SHOULD NOT BE USED AT THE EXPENSE OF VACCINE FOR THE RISK GROUPS This PGD does not include individuals considered to be at occupational risk. Responsibility for occupational influenza immunisation rests with employers and should be provided through occupational health services.
Inclusion Criteria
Informed consent has been given in accordance with current Locala Community Partnerships guidelines (Locala staff) or Department of Health guidelines (GP Practice staff) for the administration of the medicine The Department of Health updates the recommended eligible groups of patients to receive the vaccine annually. Nurses working to this PGD must have the current year’s guideline on groups and priority order available. This information is circulated to all GPs and PCTs and the letter is available from the internet at : http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/doc uments/digitalasset/dh_133963.pdf Seasonal influenza vaccine is offered annually between 1st September and 31st January to: All those aged 65 years and over on 31.3.2013 (ie born on or before 31.3.1948); All those aged 18 years and over in a clinical risk group listed in table 1. Those living in long-stay residential care homes or other long-stay care facilities where rapid spread is likely to follow introduction of infection and cause high morbidity and mortality (this does not include prisons, young offender institutions, university halls of residence etc.)
Approval date: 23.8.12
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Review date: 31.8.13
Those who are in receipt of a carer’s allowance, or those who are the main carer for an elderly or disabled person whose welfare may be at risk if the carer falls ill. This should be given on an individual basis at the GP’s discretion in the context of other clinical risk groups in their practice. Health and social care staff directly involved in patient care (but responsibility for occupational influenza immunisation rests with employers and it should be provided through occupational health services). Consideration should also be given to the vaccination of household contacts of immunocompromised individuals. Other categories as identified by the CMO through official confirmation in CMO letters – see below re pregnant women* Those requiring vaccination in the event of a flu-pandemic – further details will be forwarded from the CMO in the event of a flu-pandemic.
Inclusion Criteria Continued
* For the 2012/2013 seasonal influenza programme, DH have advised that pregnant women at any stage of pregnancy (first, second or third trimesters) should be vaccinated. Table 1 – Clinical Risk Groups 2012/13 (Please note this list is not exhaustive and clinicians are urged to refer to the Green Book Chapter 19 on Influenza, including any updates published since. Clinicians should also take into account the risk of influenza exacerbating any underlying disease that any patient may have, as well as the risk of serious illness from influenza itself. Clinical Risk Groups
Chronic respiratory disease
Chronic heart disease
Examples (list not exhaustive – decision based on clinical judgement) • Asthma that requires continuous or repeated use of inhaled or systemic steroids or with previous exacerbations requiring hospital admission. • Chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema; bronchiectasis, cystic fibrosis, interstitial lung fibrosis, pneumoconiosis and bronchopulmonary dysplasia (BPD) • Congenital heart disease • Hypertension with cardiac complications • Chronic heart failure • Individuals requiring regular medication and/or follow-up for ischaemic heart disease •
Chronic kidney disease
• Chronic kidney disease at stage 3,4 or 5, • Chronic kidney failure • Nephrotic syndrome • Kidney transplantation
Chronic liver disease
• Cirrhosis • Biliary atresia • Chronic hepatitis
Approval date: 23.8.12
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Review date: 31.8.13
• Stroke • Transient ischaemic attack (TIA) • Conditions in which respiratory function may be compromised (e.g. polio syndrome sufferers)
Inclusion Criteria Continued Chronic • neurological disease
Diabetes
Immuno suppression
Pregnant women
Clinicians should consider the need for Influenza vaccination on an individual basis considering the clinical needs of their patients, in particular, individuals with cerebral palsy, multiple sclerosis and related or similar conditions; or hereditary and degenerative diseases of the Nervous System or muscles; or severe neurological disability. • Type 1 diabetes • Type 2 diabetes requiring insulin or oral hypoglycaemic drugs • Diet controlled diabetes • Immunosupression due to disease or treatment. • Patients undergoing chemotherapy leading to immunosuppression • Asplenia or splenic dysfunction • HIV infection at all stages • Individuals treated with or likely to be treated with systemic steroids for more than a month at a dose equivalent to prednisolone at 20mg or more per day (any age). • Some immunocompromised patients may have a suboptimal immunological response to the vaccine* • Pregnant women at any stage of pregnancy (first, second or third trimesters)
* It is difficult to define at what level of immunosuppression a patient could be considered to be at a greater risk of the serious consequences of flu and should be offered flu vaccination. This decision is best made on an individual basis and left to the patient’s clinician.
Exclusion Criteria
Approval date: 23.8.12
Informed consent has NOT been given in accordance with current Locala Community Partnerships guidelines (Locala staff) or Department of Health guidelines (GP Practice staff) for the supply of the medicine Patients less than 18 years of age Current acute febrile illness Patients who have confirmed anaphylaxis to egg or egg products. Refer to hospital specialist. Patients with egg allergy and uncontrolled asthma (BTS SIGN step 4 or above). Refer to hospital specialist.
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Review date: 31.8.13
Exclusion Criteria Continued
Cautions/Need for Further Advice
•
• •
•
Action if Patient Declines or is Excluded
Approval date: 23.8.12
Patients with egg allergy-consider using another vaccine that is either egg free or has an ovalbumin content of <0.12µg/ml. See PGD number 17 v 7, Trivalent Seasonal Influenza Vaccine. Any individual who has had a confirmed anaphylactic/hypersensitivity reaction to: (i) A previous dose of influenza vaccine (ii) Any constituent of the vaccine. Please check with the SPC. (iii) Formaldehyde (iv) Octoxinol-9 (v) Chicken protein (vi) Antibiotics which may be used in the production process e.g. neomycin Previous severe reaction to vaccination. Refer to prescriber. Occupational risk-individuals should be referred to employer’s occupational health service. Please also see Cautions/Need for further advice section In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not required. 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 The immunogenicity of the vaccine could be reduced in immunosuppressed patients. Consult with the individual’s clinician to find out whether vaccination should be postponed until immune function has recovered. For individuals with chronic immunodeficiency, such as HIV, vaccination is recommended even if the antibody response might be limited. Some ointments and creams which are prescribed to treat eczema can affect the immune response. Seasonal influenza 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. The anticoagulant effect of Warfarin is possibly enhanced by influenza vaccine. Patients who are excluded from treatment under the contraindications identified above should be referred to an appropriate medical practitioner/prescriber. This should be documented clearly in the patient’s record. Where patients do not wish to receive treatment under this PGD, refusal and action taken should be documented in the patient’s record. Give information about risks of infection and benefits of treatment (where appropriate). Give information about how to recognise signs and symptoms of infection (where appropriate). Advise flu sufferers to avoid contact with ill, elderly or immunosuppressed individuals if possible.
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Review date: 31.8.13
DESCRIPTION OF TREATMENT Name, Form & Strength of Medicine
▼ Intanza Trivalent Seasonal Influenza Vaccine (Split virion, inactivated) suspension for injection 9 microgram/strain suspension for injection and 15 microgram/strain suspension for injection. This product does not contain latex or thiomersal Intanza Influenza Vaccine carries the black triangle symbol (▼). ALL adverse reactions MUST be reported. See side effects section.
Route/Method
VACCINES MUST NOT BE GIVEN INTRAVENOUSLY Immunisation should be carried out by the intradermal route. The recommended site of administration is the deltoid region. Intanza may be given at the same time as other vaccines. Immunisation should be carried out on separate limbs. If administered in the same limb, they should be given at least 2.5cm apart. The site at which each vaccine was given, and batch numbers of the vaccines, should be noted in the individual’s record (using the appropriate clinical code) It should be noted that the adverse reactions may be intensified.
Dosage & Frequency
Adults aged 18 years to 59 years – 9µg, a single injection of 0.1ml Adults aged 60 years and older – 15µg, a single injection of 0.1ml
Ovalbumin content
Intanza 9µg ≤ 0.24 µg/ml (≤0.024µg/0.1ml dose) Intanza 15µg ≤ 0.24µg/ml (≤ 0.024µg/0.1ml dose)
Duration of Treatment
See Dosage
Maximum or Minimum Treatment Period
See Dosage
Quantity to
See Dosage
Supply/Administer Licensing Information
This product is licensed for the listed indication
Approval date: 23.8.12
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Review date: 31.8.13
Side Effects
Reactions are usually mild and confined to the first few days after immunisation occurs. They usually resolve spontaneously within 1 to 3 days after onset. Common side effects include: Local reactions (redness*, swelling, pain and induration-a small painless nodule at the injection site) itching, headache, fever, shivering, bruising, malaise, myalgia and arthralgia. * In some cases local redness lasted up to 7 days. Please refer to product SPC for a full list of side effects Guillaine-barre syndrome has been reported very rarely after immunisation with influenza vaccine (one case per million people vaccinated in one US study, Lasky et al., 1998). However a causal relationship has not been established. 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-Vaccine safety and the management of adverse events following immunisation. This list is not exhaustive. Please refer to current BNF, product SPC and Green Book for full details. The trivalent influenza vaccine Intanza carries the black triangle symbol (ď ą) Report all suspected adverse reactions, however minor, to the Medicines and Healthcare products Regulatory Agency (MHRA), Commission on Human Medicines using a Yellow Card or on-line via www.yellowcard.gov.uk. Report all suspected reactions even if they are listed above, in the BNF or in the Summary of Product Characteristics (product data sheet). Yellow cards may be completed by any healthcare professional or the patient, but it is the responsibility of the healthcare professional identifying the suspected ADR to report it.
Special Considerations/ Additional Information
Approval date: 23.8.12
Immediate access to adrenaline/epinephrine for treatment of anaphylaxis. Access to a telephone Vaccines must be stored and transported according to manufacturersâ&#x20AC;&#x2122; guidelines and the Locala Cold Chain Policy. The vaccines should be stored in original packaging at a temperature of 20C to 80C. If the vaccine has been frozen it MUST be discarded.
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Review date: 31.8.13
Explain the treatment/procedure, why it is needed, and further action where required. Provide the product patient information leaflet and advise the patient to read it. The patient should be warned to discontinue treatment immediately and seek medical advice if hypersensitivity reactions occur. If severe drug reaction occurs advise to attend Accident and Emergency. Advise on the management of fever and other common/uncommon postvaccination 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.
Advice to Patient/Carer
Follow Up
Advise patient to seek further medical advice if they experience any hypersensitivity reaction
Approval date: 23.8.12
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Review date: 31.8.13
REFERRAL ARRANGEMENTS AND AUDIT TRAIL If patient is excluded from this PGD refer to GP where appropriate. 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. Self referral to GP practice / A & E department if appropriate (post immunisation)
Referral Arrangements
Records/Audit Trail
The following information must be documented in records which should be stored appropriately and can be easily retrieved where necessary: Patientâ&#x20AC;&#x2122;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 Indication that the patient was treated under PGD (including PGD number if practicable). Batch number, expiry date, manufacturer 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. Where applicable, details of any subsequent adverse drug reaction and actions taken including referral arrangements. This MUST be documented in the patientâ&#x20AC;&#x2122;s medical record. Current medication (if not already available in the clinical record) Known allergies Referral arrangements (including self-care) .
Approval date: 23.8.12
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Review date: 31.8.13
STAFF CHARACTERISTICS Qualifications
Specialist Competencies or Qualifications
Continuing Training & Education
All nurses with valid Nursing and Midwifery Council (NMC) registration working within Locala CP or at a GP practice within NHS Kirklees. Has undertaken appropriate training and successfully completed the competencies to undertake the clinical assessment of patients leading to a diagnosis that requires treatment 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 â&#x20AC;&#x201C; e.g. annual updates in Immunisation and Vaccination Has undertaken training and is competent in resuscitation skills. Has undertaken training and is competent in the recognition and treatment of anaphylaxis Accepts personal responsibility for working within the PGD, understands the legal implications of doing so and works within the scope of the PGD. 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. Attends updates in administration of medicines through the use of Patient Group Directives at recommended intervals including mandatory annual updates on Anaphylaxis and Resuscitation. Keeps updated via departmental updates and meetings. Practitioner should have access to current BNF, Green Book chapters and updated DH advice where appropriate.
PL/CMO/2012/1,PL/DN/2012/1,PL/CPHO/2012/1: The seasonal flu immunisation References & programme 2012/13. Accessed at: Resources http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/d ocuments/digitalasset/dh_133963.pdf Chapter 19, Influenza, Green Book. Available at http://immunisation.dh.gov.uk/category/the-green-book/ SPCs for Intanza accessed at http://www.medicines.org.uk/emc
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 DOH guidance.
Approval date: 23.8.12
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Review date: 31.8.13
PATIENT GROUP DIRECTION Number 116 FOR THE ADMINISTRATION OF INTANZA (INTRADERMAL) TRIVALENT SEASONAL INFLUENZA VACCINE Created August 2012 This PGD has been developed for use by the individuals listed below:
NAME Lucianne Ricketts Dawn Toothill
POSITION Head of Medicines Management, Locala Community Partnerships (LCP) Specialist Pharmacy Technician, Community Services (LCP)
DATE September 2012 September 2012
Linda Fox
Community Services Pharmacy Manager September 2012 (LCP)
Jane Oâ&#x20AC;&#x2122;Donnell
Deputy Director of Infection Prevention and September 2012 Control-NHS Kirklees
Approval date: 23.8.12
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Individual Authorisation for the Administration of Intanza Intradermal Trivalent Seasonal Influenza Vaccine by nurses employed either by Locala Community Partnerships or GP Practices within NHS Kirklees.
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 healthcare professional is willing to be professionally accountable for this work as defined in their Code of Professional Conduct.
Name of Professional
Signature
Authorising Manager
Date
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. Authorised staff working at a fixed base should have access to the signed PGD held at the base. Authorised staff who may administer medicines away from the base should have an individual copy of the relevant signed PGD with them when administering the medicine. Approval date: 23.8.12
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CONSULTATION PROCESS ADOPTED IN DEVELOPING THIS PATIENT GROUP DIRECTION TITLE OF DOCUMENT: NUMBER: New Document (Y/N) Review of Document (Y/N) Revised Document (Y/N) If revised – what revisions were required? Director Lead
Author
List of persons involved in developing/updating PGD
PGD for Intanza Intradermal Seasonal Influenza Vaccine 116 Yes No No
Christina Quinn Director of Clinical and Operational services Dawn Toothill Community Services Specialist Pharmacy Technician Lucianne Ricketts, Head of Medicines Management Linda Fox, Community Services Pharmacy Manager Jane O’Donnell – Deputy Director of Infection Prevention and Control - NHS Kirklees
List of persons/groups involved in consultation process
Dr Ebere Okereke – Consultant in Communicable Disease Control - West Yorkshire HPU Deborah Mitchell – Practice Nurse - Lindley Group Practice Locala Community Partnerships Medicines Management Committee NHS Kirklees Medicines Management Committee Dr Damian Riley-Medical Director-ABL & CKW Clusters NHS Kirklees Vaccinations & Immunisations Group
Approval date: 23.8.12
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Review date: 31.8.13
This patient group direction must be agreed to and signed by all health care professionals involved in its use. Locala Community partnerships will hold the original signed copy. The PGD must be easily accessible in the clinical setting. Locala Community Partnerships
ORGANISATION Director of Clinical Operational Services
and Name: Christina Quinn
Signature:
Head of Management
Date:
Medicines Name: Lucianne Ricketts
Signature:
Medical Lead
Name: Dr Stephen Warner
Signature:
Approval date: 23.8.12
Date:
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Date:
Review date: 31.8.13
PCT Authorisation ORGANISATION
NHS Kirklees
Governance Lead
Name: Sue Cannon
Signature:
Date:
Senior Medicines Name: Eric Power Management Adviser
Signature:
Medical Director
Name: Dr Damian Riley
Signature:
Approval date: 23.8.12
Date:
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Date:
Review date: 31.8.13