PATIENT GROUP DIRECTION Supply / Administration of: Pandemrix (GSK brand) Pandemic influenza vaccine (H1N1)v (Split virion, inactivated, adjuvanted) By: Nurses, Health Visitors and Pharmacists In: General Practice, Health Centres, Community Clinics, Patients Own Home, School Clinics, Care Homes, Pharmacies and other non-nhs sites where NHS care is provided It is the responsibility of the professional working under this PGD to verify that the patient fulfils the stated criteria for supply or administration of the treatment concerned It is not appropriate to have a PGD in place that is infrequently used by healthcare professionals because of progressive unfamiliarity with its contents. Any healthcare professional that works to a PGD infrequently should consider whether to cease doing so This PGD will be reviewed every 2 years, or sooner in light of new guidance Review date: October 2011 PGD Pandemrix influenza vaccine v1 20_10_09 with Pharmacy Lead signature.docpage 1 of 8
1. Reason for introducing PGD Immunisation 2. Clinical Condition or situation to which this PGD applies 2.1 Define condition/situation Protection against H1N1 (Swine) Influenza 2.2 Criteria for inclusion Patients in at risk groups which, in order of priority, are: 1. Individuals aged six months and up to 65 years in the current seasonal flu vaccine clinical at risk groups* 2. Pregnant women 3. Household contacts of immunocompromised individuals 4. People aged 65 and over in the current seasonal flu vaccine clinical at risk groups *Persons aged over 6 months at higher risk due to: Chronic respiratory disease, including asthma Chronic heart disease Chronic renal failure Chronic liver disease, including cirrhosis Diabetes mellitus Immunosuppression, including asplenia or splenic dysfunction Health and social care staff at risk of contracting H1N1 (Swine) influenza. This includes staff who have regular clinical contact with patients and who are directly involved in patient care. This includes (but is not an exclusive list) doctors, dentists, midwives and nurses, paramedics and ambulance drivers, occupational therapists, physiotherapists and radiographers. Students and trainees in these disciplines and volunteers who are working with patients must also be included. 2.3 Criteria for exclusion Children less than 6 months old History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine. Acute illness and infections with fever or systemic upset (postpone vaccination) Severe reaction to a preceding dose 2.4 Cautions Caution is needed when administering this vaccine to PGD Pandemrix influenza vaccine v1 20_10_09 with Pharmacy Lead signature.docpage 2 of 8
[to include consideration of concurrent medication] 2.5 Patient consent [verbal, written, implied] persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to residues (egg and chicken, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) Informed consent as stated in local consent policy Agreed to be seen by a healthcare professional working within a PGD 2.6 Action if patient excluded Reassure and provide practical advice Advise on the importance of being immunised Advise on when the subject can be vaccinated, and by whom, where applicable Advise on potential disease complication 2.7 Action if treatment declined by patient, parent, or guardian 3. Characteristics of Staff Advice about protective effects of the vaccine and the risks of infection and disease complications Document advice given Inform or refer to GP as appropriate 3.1 Class of healthcare professional for whom PGD is applicable & Professional qualifications required 3.2 Additional requirements/specialist qualifications required. 3.3 Continued training requirements 4. Description of treatment. Registered Nurse, RN Pharmacist, MRPharmS This PGD will only apply whilst you are employed or working at the time for Dudley PCT (NHS Dudley and Dudley Community Services) Competent to undertake immunisations Specific training in vaccine administration, the immunisation programme and having up-to-date knowledge Three-yearly update in immunisation and vaccination, and annual update in the management of anaphylaxis and CPR 4.1a Generic name of medicine Pandemic influenza vaccine (H1N1)v (split virion, and form (e.g. tablets) inactivated, adjuvanted) 4.1b Presentation One pack containing: - one pack of 50 vials of 2.5ml suspension with a stopper - two packs of 25 vials of 2.5ml emulsion with a stopper The volume after mixing 1 vial of suspension (2.5ml) with 1 vial of emulsion(2.5ml) corresponds to 10 doses of vaccine (5ml) List of excipients Suspension vial: Octoxynol 10 Thiomersal Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Magnesium chloride (MgCl2) PGD Pandemrix influenza vaccine v1 20_10_09 with Pharmacy Lead signature.docpage 3 of 8
4.2 Legal status Water for injections Emulsion vial: Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Water for injections POM (Prescription Only Medicine) Licensed or unlicensed use 4.3 Dose [Where a range is applicable include criteria for deciding on a dose] See under Criteria for Inclusion Child aged from 6 months to 9 years of age Individuals aged from 10 years to less than 60 years of age 1 x 0.25ml dose repeated after at least 3 weeks 1 x 0.5ml dose Individuals aged 60 years and over Immunocompromised individuals aged 10 years and over 1 x 0.5ml dose 1x 0.5ml dose repeated after at least 3 weeks It is recommended that subjects who receive a first dose of Pandemrix, complete the vaccination course with Pandemrix. 4.4a Instructions for mixing and preparing the vaccine for administration See also Dept Of Health training video available from this link: 08 October 2009: Swine flu vaccination staff training video or web address: http://www.dh.gov.uk/en/p ublichealth/flu/swineflu/in formationandguidance/ind ex.htm 1. Before mixing the two components, the emulsion and suspension should be allowed to reach room temperature, shaken and inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed, discard the vaccine. 2. The vaccine is mixed by withdrawing the contents of the vial containing the emulsion by means of a syringe and by adding it to the vial containing the suspension. 3. After the addition of the emulsion to the suspension, the mixture should be well shaken. The mixed vaccine is a whitish emulsion. In the event of other variation being observed, discard the vaccine. 4. The volume of Pandemrix (5 ml) after mixing corresponds to 10 doses of vaccine. 5. The vial should be shaken prior to each administration. 6. Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection. PGD Pandemrix influenza vaccine v1 20_10_09 with Pharmacy Lead signature.docpage 4 of 8
7. The needle used for withdrawal must be replaced by a needle suitable for intramuscular injection. 8. After mixing, use the vaccine within 24 hours and do not store above 25 C. Any unused product or waste material should be disposed of in accordance with local requirements. 4.4b Route / method of administration Intramuscular injection preferably into the deltoid muscle or anterolateral thight (depnding on muscle mass). There is no data with Pandemrix using the subcutaneous route. Therefore, heathcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with bleeding disorders e.g. haemophilia, thrombocytopaenia that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleeding the opinion of the clinician responsible for managing the haematological condition should be sort. DH advice is that these patients should given vaccine by deep subcutaneous injection (Gateway ref: 12781) 4.5 Frequency One course for current pandemic 4.6 Total dose and number of times treatment can be administered; state time frame 2 doses separated by a minimum of 3 weeks (Dosing frequency subject to review further guidance will be disseminated from Dept of Health if number of injections can be reduced to one) 4.7 Information on follow-up management 4.8 Written/verbal advice for patient/carer before/after treatment and management 4.9 Instructions on identifying, managing & reporting adverse drug reactions Advise / Advised to seek medical advice if more severe reactions to injection occur When the next dose is due, if applicable Provide patient information leaflet, if available Advise on potential side-effects and what action to take if they occur Advise on self-treatment for minor reactions Where there is a family history of febrile convulsions provide advice on prevention of fever Seek medical advice if more severe reactions occur. Treat anaphylaxis according to policy and procedure Injection site reactions Less serious reactions: fever and malaise Serious reactions: anaphylaxis very rare but potentially fatal Treat anaphylaxis according to policy and procedure Advise on self-treatment for minor reactions and to seek medical advice if more severe reactions occur Report any adverse reactions to the CSM via PGD Pandemrix influenza vaccine v1 20_10_09 with Pharmacy Lead signature.docpage 5 of 8
yellow cards or online via this link: http://swineflu.mhra.gov.uk/ 4.10 Arrangements for referral for medical advice. Refer patients to the medical practitioner Contact emergency services for life-threatening reactions 4.11 Precautions, facilities & supplies. Store between 2-8 0 C Do not use if contents freeze, becomes discoloured or contains large particles Do not contaminate the vaccine with antiseptic, detergent or alcohol: allow alcohol swabs of skin or vial bung to fully evaporate before use Protect from light by storing in original container Shake well before use Immediate access to the following is essential: adrenaline 1 in 1000, telephone. Access to the following is desirable: ambu bag and mask, oxygen therapy, defibrillator, ECG machine, plastic airway 4.12 Specify method of recording supply/administration, sufficient to enable audit trail. 5. Audit Supplies will be delivered directly from Dept of Health Clients notes (Manual, Computerised, Own Held): Name, address and DoB of patient Brand, batch number and expiry date Dose, site, route Date given and by whom Patient s GP Any current or previous adverse reactions Any reason for refusing treatment Serious adverse reactions should be documented in a child s health records and on their medical records. GP should also be informed The use of this PGD to be monitored by the service in which it is used PGD Pandemrix influenza vaccine v1 20_10_09 with Pharmacy Lead signature.docpage 6 of 8
6. Management 6.1 PGD Group Noel Aslett Mary Akufo-Tetteh Julie Burford Kate Owen Others Pauline MacDonald Tony Collins Duncan Jenkins Prescribing Adviser, PGD Chair Advanced Nurse Practitioner Advanced Nurse Practitioner Nurse Prescribing Lead Nurse Consultant Communicable Disease Deputy Director of Public Health Specialist in Pharmaceutical Public Health 6.2 Authorisation This PGD has been approved on behalf Dudley PCT by: Name Signature Date Senior Pharmacist Alison Tennant 28/10/09 Clinical Governance Lead 6.3 Persons permitted to authorise staff they are responsible for to operate this PGD Clinical Governance Leads Prescribing Leads Directors of Public Health Clinical Leads in General Practice Senior Pharmacists Locality General Managers, General Managers and Clinical Service Managers Nurse Caseload Holders for Community Nurses 7. References For further information healthcare professionals are recommended to consult the following literature: CMO/CNO/CPO updates Immunisation Against Infectious Diseases (Green Book) Current edition of the British National Formulary Manufacturer s product literature and SPC available from: http://www.emea.europa.eu/influenza/vaccines/pandemrix/pandemrix_pi.html Dept of Health Guidance on pandemic influenza vaccine available from: 08 October 2009: Swine flu vaccination staff training video Dept of Health letter 15 th October 2009 (Gateway ref 12781): The H1N1 swine flu vaccination programme 2009-10 NMC Guidelines for the administration of medicines NMC Code of Professional Conduct PGD Pandemrix influenza vaccine v1 20_10_09 with Pharmacy Lead signature.docpage 7 of 8
PGD for Influenza Vaccine administration by Nurses, Health Visitors and Pharmacists within Dudley PCT It is the responsibility of the Authorising Person to keep this list up to date and in a safe place for reference. Any healthcare professionals who no longer meets the competency requirements or leave the service or practice must be removed from the list; likewise, any new healthcare professionals meeting the competency requirements have to be added to the list in order to work under the Patient Group Direction. The Authorising Person is only expected to confirm that the Healthcare Professionals meets the minimum training and competency requirements under this PGD. It is the responsibility of the Healthcare Professional themself, their Professional Body and the PCT that they are fit to practice. This Patient Group Direction is to be read, agreed to and signed by all healthcare professionals it applies to. One copy should be given to each nurse with the original signed copy being kept by the Authorised Person with responsibility for PGDs within the service or practice. I confirm that I have read and understood the content of this patient group direction and that I am willing and competent to work under it within my professional code of conduct. Healthcare Professionals permitted to supply or administer under this PGD Name of Healthcare Professional Signature Authorised Person with responsibility for PGDs Signature Date approved PGD Pandemrix influenza vaccine v1 20_10_09 with Pharmacy Lead signature.docpage 8 of 8