V02.00 HepA/B vaccine (Temp) PGD amended to: include additional healthcare practitioners in Section 3 refer to vaccine incident guidelines in off-label and storage sections amended to reflect temporary recommendation updates and change in supply situation include minor rewording, layout and formatting changes for clarity and consistency with other PHE PGD templates 28 September 2018 PGD development This PGD has been developed by the following health professionals on behalf of Public Health England: Developed by: Name Signature Date Pharmacist (Lead Author) Elizabeth Graham Lead Pharmacist - Immunisation and Countermeasures, PHE 28/09/2018 Doctor Sema Mandal Consultant Epidemiologist, Immunisation and Countermeasures, PHE 28/09/2018 Registered (Chair of Expert Panel) David Green Nurse Consultant – Immunisation and Countermeasures, PHE 28/09/2018 This PGD has been peer reviewed by the PHE Immunisations PGD Expert in accordance with PHE PGD Policy. It has been ratified by the PHE Medicines Management Group and the PHE Quality and Clinical Governance Delivery Board. Expert Panel Name Designation Ed Gardner Advanced Paramedic Practitioner/Emergency Care Practitioner, Medicines Manager, Proactive Care Lead Jacqueline Lamberty Lead Pharmacist Medicines Management Services, Public Health England Vanessa MacGregor Consultant in Communicable Disease Control, Public Health England, East Midlands Health Protection Team Alison Mackenzie Consultant in Public Health Medicine / Screening and Immunisation Lead, Public Health England / NHS England South (South West) Sema Mandal Consultant Epidemiologist, Immunisation and Countermeasures, Public Health England Gill Marsh Senior Screening and Immunisation Manager, Public Health England / NHS England Lancashire and South Cumbria Lesley McFarlane Screening and Immunisation Co-ordinator, NHS England / Public Health England Leicestershire, Lincolnshire and Northamptonshire
Local enquiries regarding the use of this PGD may be directed to……………. Section 7 provides a practitioner authorisation sheet. Individual practitioners must be authorised by name to work to this PGD. Alternative practitioner authorisation sheets may be used where appropriate in accordance with local policy but this should be an individual agreement or a multiple practitioner authorisation sheet as included at the end of this PGD. Characteristics of staff Qualifications and professional registration Registered professional with one of the following bodies: nurses and midwives currently registered with the Nursing and Midwifery Council (NMC) pharmacists currently registered with the General Pharmaceutical Council (GPhC) (Note: This PGD is not relevant to privately provided community pharmacy services) paramedics and physiotherapists currently registered with the Health and Care Professions Council (HCPC) The practitioners must also fulfil the detailed below. to confirm whether all practitioners listed above have organisational authorisation to work under this PGD. Additional requirements Additionally practitioners: must be authorised by name as an approved practitioner under the current terms of this PGD before working to it must have undertaken appropriate training for working PGDs for supply/administration of medicines must be competent in the use of PGDs (see for health professionals using PGDs) must be familiar with the vaccine product and alert to changes in the Summary of Product Characteristics (SPC), Immunisation Against Infectious Disease (“”), and national and local immunisation programmes must have undertaken training appropriate to this PGD as required by local policy and in line with the must be competent to undertake immunisation and to discuss issues related to immunisation must be competent in the handling and storage of vaccines, and management of the “cold chain” must be competent in the recognition and management of anaphylaxis must have access to the PGD and associated online resources should fulfil any additional requirements defined by policy THE INDIVIDUAL PRACTITIONER MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE WORKING ACCORDING TO IT. Continued training requirements Practitioners must ensure they are up to date with relevant issues and clinical skills relating to immunisation and management of
quantity administered batch number and expiry date anatomical site of vaccination advice given, including advice given if excluded or declines immunisation details of any adverse drug reactions and actions taken supplied via Patient Group Direction (PGD) Records should be signed and dated (or a password controlled immunisers record on e-records). All records should be clear, legible and contemporaneous. The local Child Health Information Services team (Child Health Records Department) must be notified using the appropriate documentation/pathway as required by any local or contractual arrangement. A record of all individuals receiving treatment this PGD should also be kept for audit purposes in accordance with local policy. Key references Key references Product Immunisation Against Infectious Disease: The Green Book , last updated June 2012, , last updated October 2016, , last updated December 2013 and , last updated June 2017. Summary of Product Characteristic for Twinrix® GlaxoSmithKline UK. Last updated 24 November 2016. Summary of Product Characteristic for Twinrix® Paediatric, GlaxoSmithKline UK. Last updated 24 November 2016. Summary of Product Characteristic for Ambirix®, GlaxoSmithKline UK. Last updated 23 November 2016. resources. Accessed 10 August 2017. Hepatitis A infection: prevention and control guidance including and guidance. Public Health England. Last updated 19 July 2018. Hepatitis B: vaccine recommendations during supply constraints including , last updated February 2018, , last updated 21 August 2017 and , last updated 7 August 2017. Landing page last updated 12 July 2018. General Health Technical Memorandum 07-01: Safe Management of Healthcare Waste. Department of Health 20 March 2013 National Minimum Standards and Core Curriculum for Immunisation Training. Published February 2018. NICE Medicines Practice Guideline 2 (MPG2): Patient Group Directions. Published March 2017. NICE MPG2 Patient group directions: competency framework for health professionals using patient group directions. January 2014. PHE Immunisation Collection PHE Vaccine Incident Guidance