Core Patient Group Direction (PGD) for the …psnc.org.uk/lsllpc/wp-content/uploads/sites/113/2015/08/...Core Patient Group Direction (PGD) for the Administration of Immunisations

Reference Number: NHSE(LR)/Core PGD v2.3 Page 1 of 24 Valid from: 1st April 2014 Review date: 1st January 2017 Expiry date: 31st March 2017

Core Patient Group Direction (PGD) for the Administration of Immunisations by Healthcare Professionals

Individual vaccine PGDs must be read in conjunction with this Core PGD

This Patient Group Direction (PGD) must only be used by registered healthcare professionals, working within NHS England (London Region), who have been named

and authorised to practice under it.

Version number: 2.3 Expiry date: 31st March 2017

The master copy for this PGD is held at: N:\2.0 Medical\Patient Group Directions\Final signed PGDs\Other\2016 Change history Version number

Change details Date

1.0 First version December 2013 2.0 Revised version to include training and

competency requirements January 2014

2.1 Inclusion of BCG vaccine February 2014 2.2 Revision of content of core PGD, and separation

of individual vaccine PGDs March 2014

2.3 Revision to update links and exclude the requirement of GP to be in the vicinity/building

August 2016

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PGD Development and Clinical Approval PGD Working Group This PGD was developed by a working group involving pharmacists from a number of Clinical Commissioning Groups across London, plus nurse representatives. Name and role Job title and organisation Jonathan Mason Pharmacist and Lead Author

Clinical Adviser (Medicines) NHS England (London Region)

Henrietta Hughes Doctor

Medical Director North Central and East London Area Team NHS England (London Region)

Eileen Bryant Nurse reviewer

Primary Care Nurse Adviser NHS England (London Region)

Nicola Pratelli Nurse Reviewer

Population Health Practitioner Manager Immunisation South NHS England (London Region)

Thara Raj Public Health Specialist

London Public Health Specialist (Immunisation) and Acting Public Health Consultant (Health in the Justice System) NHS England (London Region)

Nick Beavon Pharmacist Reviewer

Chief Pharmacist Wandsworth Clinical Commissioning Group

Raana Ali Pharmacist Reviewer

Senior Prescribing Adviser (Tower Hamlets) North and East London Commissioning Support Unit

Pauline Taylor Pharmacist Reviewer

Head of Medicines Management Haringey Clinical Commissioning Group

Helen Tsang Pharmacist Reviewer

Practice Link Pharmacist North West London Commissioning Support Unit

Dee Vadukul Pharmacist Reviewer

Senior Practice Pharmacist Richmond Clinical Commissioning Group

Seema Buckley Pharmacist Reviewer

Chief Pharmacist NHS Kingston Clinical Commissioning Group

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PGD authorisation The clinical content has been approved on behalf of NHS England (London Region) by: Name and role Job title and

organisation Signature Date

David Webb Designated Pharmacist

Regional Pharmacist (NHS England London Region)

24.8.16

Henrietta Hughes Designated Doctor

Medical Director North Central and East London Area Team NHS England (London Region)

24.8.16

Professional review and approval: Name and role Job title and


Tushar Shah Pharmacist reviewer

Pharmacy Adviser NHS England (London Region)

24/08/16

Gwen Kennedy Interim Director of Nursing (South London) NHS England London Region

24/08/16

This PGD has been approved on behalf of NHS England (London Region) by: Name Job title and


Bronagh Scott Signing on behalf of NHS England (London Region)

Deputy Chief Nurse NHS England (London Region)

24.08.2016

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Guidelines

• The Core PGD and suite of individual vaccine PGDs have been developed to

provide system-wide leadership and consistency for delivery of immunisation and vaccination programmes across London;

• The core PGD covers the authorisation of staff, documentation, audit requirements and general guidance on best practice required to safely administer vaccines;

• Not all vaccines included in the suite of individual vaccine PGDs may be commissioned;

• The inclusion criteria for individual vaccines may be broader than for current national programmes to facilitate future changes to immunisation schedules and prevent delay in administration;

• Healthcare professionals should refer to Vaccine Updates published by Public Health England to confirm changes to vaccination schedules https://www.gov.uk/government/collections/vaccine-update;

• Information provided is based on the current edition of ‘Immunisation against Infectious Diseases’ Department of Health (2006) The Green Book [and web based updates] accessed at: https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book;

• The health professional must be authorised by name, under the current version of this Core PGD, and the specific PGDs for the vaccine(s) they are administering: the healthcare professional must complete and sign the declaration at the end of this document.

1. Introduction

The preferred way for patients to receive medicines is for prescribers to provide care for individual patients on a one-to-one basis. However, in some cases, it may be necessary or convenient for a patient to receive a medicine directly from another healthcare professional. Unless already covered by exemptions to the Medicines Act, there are two ways of achieving this, by PGD, or by Patient Specific Direction (PSD). Information and guidance on PGDs can be found on the NICE website (http://www.nice.org.uk/mpc/goodpracticeguidance/GPG2.jsp). The NHS Constitution states that patients have the right to receive the vaccinations that the Joint Committee on Vaccination and Immunisation (JCVI) recommends should be provided through national immunisation programmes http://www.nhs.uk/choiceintheNHS/Rightsandpledges/NHSConstitution/Documents/2013/the-nhs-constitution-for-england-2013.pdf

2. Definition

A PGD is a specific written instruction for the supply, or administration, of a named medicine in an identified clinical situation. It applies to groups of patients who may not

https://www.gov.uk/government/collections/vaccine-update

https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book


http://www.nice.org.uk/mpc/goodpracticeguidance/GPG2.jsp

http://www.nhs.uk/choiceintheNHS/Rightsandpledges/NHSConstitution/Documents/2013/the-nhs-constitution-for-england-2013.pdf


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be individually identified before presentation for treatment. PGDs must be signed by a senior doctor, and a senior pharmacist, both of whom must have been involved in their development. PGDs must also be signed by an appropriate person who has designated responsibility for signing PGDs on behalf of the authorising body, in line with legislation. PGDs may only be used by certain groups of healthcare professionals, in line with legislation. Nurses and pharmacists are among the qualified health professionals who may work under PGDs.

3. Staff Groups and Authorisation

These PGDs apply to nurses and pharmacists. Healthcare professionals operating under these PGDs must be registered with their regulatory body:

• Nurses must be registered with the NMC; • Pharmacists must be registered with either the GPhC, or PSNI.

Healthcare professionals operating under the core and specific vaccine PGDs must be individually named on the declaration form at the end of each document. The named professional must read the core PGD and specific vaccine PGDs that are relevant to their service, and then sign that they understand each PGD, and are competent to administer the vaccine(s). All named professionals can, once authorised, administer vaccines covered by the PGDs included in this document.

4. Specialist Competencies or Qualifications

It is the responsibility of the individual professional to ensure that:

• They have been trained and are competent to administer the vaccines named in these PGDs (see below);

• They have had Basic Life Support training (including how to recognise and deal with suspected anaphylaxis) within the last 3 years, and have updated their Basic Life Support training every 12 months (this can be face to face, or via e-learning);

• They are fully conversant with the details of the core PGD and the individual vaccine PGDs prior to the administration of any vaccines.

The healthcare professional must have undertaken appropriate training for PGDs, and the ability to work under these for the supply and/or administration of medicines, and must be competent in all aspects of immunisation, in line with the National Minimum Standards for Immunisation Training (2005), available online from http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1196942164323, including:

• The pharmacology of immunisation and vaccines; • The diseases for which the vaccines are recommended; • Epidemiology, and the role of vaccines in preventing communicable diseases; • Local and national immunisation programmes and guidelines • Contraindications/specific considerations/possible side effects; • Assessing individuals’ fitness for immunisation;

http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1196942164323

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• Advising parents (or people with parental responsibility) on immunisation issues in children;

• Handling and storage of vaccines, and the ‘cold chain’; • Requirements for records of vaccines given; • The recognition and treatment of anaphylaxis The individual professional’s competence with regards to their practice will be assessed during their training. The professional should ensure they are aware of any changes to the recommendations for these vaccines. It is the responsibility of the professional to keep up-to-date with continuing professional development and take part in audit on a regular basis. Appendix 1 provides an assessment tool for healthcare professionals and their mentors/managers to assess competency with regard to supply/administration of medicines under PGD.

5. Continuing education and training

• It is the responsibility of the practitioner, to keep up-to-date with their continued professional development, in line with NMC, or GPhC requirements;

• The practitioner should be aware of general recommendations for vaccines, and the schedule for childhood immunisation in the UK, as directed by the Chief Medical Officer, Public Health England, or Department of Health;

• Health professionals working to these PGDs must have attended appropriate training sessions incorporating the core knowledge as indicated under qualifications above, including basic life support;

• The practitioner must be alert to changes in Summaries of Product Characteristics, the Green Book chapters for individual vaccines, and national and local immunisation programmes.

6. Review

The Core PGD, individual vaccine PGDs, and related guidelines will be reviewed every two years, or sooner, if: • There is a change in the status or name of the authorising organisation; • There is a change in the licensed indications of the product(s), or a change in

evidence-based clinical guidelines; • Further guidance is issued by the Department of Health, or other appropriate

organisation; • There is a change in legislation.

7. Guidance and Information Sources

The healthcare professional should have access to all relevant advice and guidance including: • The current, up to date chapters of ‘Immunisation against Infectious Diseases

Handbook (Green Book: last updated Sept 2014)’, available online at https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book;



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• Current signed copies of relevant PGDs; • Summaries of Product Characteristics for the vaccines, available from the

Electronic Medicines Compendium website www.medicines.co.uk; • NICE Good Practice Guidance on PGDs:

https://www.nice.org.uk/guidance/mpg2 and relevant NICE guidance; • MHRA guidance: ‘Patient Group Directions in the

NHS’ http://www.mhra.gov.uk/Howweregulate/Medicines/Availabilityprescribingsellingandsupplyingofmedicines/ExemptionsfromMedicinesActrestrictions/PatientGroupDirectionsintheNHS/index.htm

• Current edition of British National Formulary (BNF), and BNF for Children www.bnf.org;

• Nursing and Midwifery Council (NMC) ‘Standards for Medicines Management’ and ‘The Code’ http://www.nmc-uk.org;

• General Pharmaceutical Council ‘The Performance Standards and Guidance’ http://www.pharmacyregulation.org/standards

• Health Protection Agency (2005) National Minimum Standards for Immunisation Training: http://www.hpa.org.uk/EventsProfessionalTraining/HealthProtectionAcademy/AdditionalOpportunitiesAndInformation/ImmunisationTrainingResources/

• Royal College of Nursing Immunisation Guidance (2013): Supporting the delivery of immunisation education http://www.rcn.org.uk/__data/assets/pdf_file/0005/553748/004479.pdf

• For Health Protection/Public Health advice contact Public Health England: https://www.gov.uk/government/organisations/public-health-england

8. Patient Consent

The NHS Constitution states that patients have the right to accept or refuse treatment that is offered, and not to be given any physical examination or treatment unless they have given valid consent. If patients do not have the capacity to give consent, then consent must be obtained from a person legally able to act on the patient’s behalf, or the treatment must be in their best interests (http://www.nhs.uk/choiceintheNHS/Rightsandpledges/NHSConstitution/Documents/2013/the-nhs-constitution-for-england-2013.pdf) Consent must be obtained and documented for all patients for whom vaccination is proposed. See Department of Health guidance at https://www.gov.uk/government/publications/reference-guide-to-consent-for-examination-or-treatment-second-edition Guidance about consent, including the provision of verbal and written information; translation; interpretation; data protection and competency of adults to consent may also be found in The Green Book, chapter 2, current online version. Written information on the proposed immunisations should be given to the patient (or to the person with parental responsibility where the patient is a child), before obtaining consent to treatment. Consent is required at the time of each immunisation, once the patient's fitness and suitability have been established. Written consent is not essential, but is considered good practice by many people, since it serves to record the decision and the discussions that have taken place with the patient or the person giving consent. With

http://beta.medicines.org.uk/emc/

http://www.mhra.gov.uk/Howweregulate/Medicines/Availabilityprescribingsellingandsupplyingofmedicines/ExemptionsfromMedicinesActrestrictions/PatientGroupDirectionsintheNHS/index.htm



http://www.bnf.org/

http://www.nmc-uk.org/

http://www.pharmacyregulation.org/standards

http://www.hpa.org.uk/EventsProfessionalTraining/HealthProtectionAcademy/AdditionalOpportunitiesAndInformation/ImmunisationTrainingResources/

http://www.hpa.org.uk/EventsProfessionalTraining/HealthProtectionAcademy/AdditionalOpportunitiesAndInformation/ImmunisationTrainingResources/

http://www.rcn.org.uk/__data/assets/pdf_file/0005/553748/004479.pdf

https://www.gov.uk/government/organisations/public-health-england



https://www.gov.uk/government/publications/reference-guide-to-consent-for-examination-or-treatment-second-edition

https://www.gov.uk/government/publications/reference-guide-to-consent-for-examination-or-treatment-second-edition

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respect to these PGDs, a written record that consent has been given should always be made. This may take the form of a signature on a consent form, or a note made by the immuniser that valid consent has been obtained. Children under 16 may give or refuse consent themselves provided they can demonstrate competence under Fraser guidelines. If a young person lacks capacity to consent, then consent can be given on their behalf by a person with parental responsibility, or by a Court. Care should be taken to ensure that patients or those with parental responsibility feel their questions have been adequately answered and that their concerns about immunisation have been sensitively considered.

9. Inclusion of Black Triangle () Vaccines and Use of Vaccines Outside the Terms of the Summary of Product Characteristics (SmPC)

• The black triangle symbol () identifies medicines that are monitored intensively by the MHRA. These are usually, but not always, newly licensed medicines. There is no standard time for which products retain a black triangle; safety data is usually reviewed after 2 years;

• The MHRA guidance “Patient Group Directions in the NHS” makes it clear that it is acceptable to include black triangle vaccines used in immunisation programmes in a PGD, provided they are used in accordance with the schedules recommended by the Joint Committee on Vaccination and Immunisation (JCVI);

• Medicines used outside the terms of the SmPC may be included provided such use is justified by current best clinical practice. In this case the guidance for recommendations is from the JCVI and stated in The Green Book, and is to ensure people are not denied immunisation unnecessarily;

• The Green Book states that in some circumstances the recommendations regarding vaccines may differ from those in the SmPC for a particular vaccine. Where this is the case, the recommendations given are based on current expert advice received from the JCVI and should be followed.

10. Facilities To Be Available When Vaccines Are Administered

All health professionals administering vaccines must be familiar with techniques for resuscitation of an individual including recognition and treatment of anaphylaxis, in line with the Resuscitation Guidelines produced by the UK Resuscitation Council, which are available online at https://www.resus.org.uk/pages/guide.htm A working telephone must be available prior to administration of an injection. In date Adrenaline (Epinephrine) 1/1000 (1mg/1ml) injection must be available for use, but not drawn up in advance. Administration in healthcare settings: • GP practice: administration must take place in a confidential consultation area. • Pharmacy: administration must take place in a confidential consultation area.

https://www.resus.org.uk/pages/guide.htm

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Administration in domiciliary settings: Vaccines can be administered in a domiciliary setting (e.g. patient’s home, or residential home). The healthcare professional should ensure that the cold chain is maintained (see below) when transporting vaccines. The healthcare professional should ensure that they have a working mobile phone.

11. Storage and Handling

Healthcare professionals are expected to follow good practice guidance for care, storage and transport of the vaccine within the cold chain:

• Unless otherwise stated for a specific product, vaccines should be stored in an appropriate refrigerator, between +2oC and +8oC, and protected from light (keep the vaccine in the original outer container until it is due to be administered);

• Have a system in place to ensure that the cold chain has been maintained; • The refrigerator temperature must be recorded every working day and the records

retained for 25 years; • Ensure that the vaccine has not been frozen; • A vaccine must NEVER be used beyond its expiry date; • Allow to warm to room temperature prior to administration; • Unless otherwise stated, vaccines should be used as supplied: in many cases, no

dilution or reconstitution is necessary. If the vaccine requires reconstitution, always ensure it is mixed according to the manufacturer’s guidelines, using the diluent supplied;

• Visually inspect the vaccine for any foreign particulate matter before administration. Check with the SmPC on the appearance of the vaccine before administering (e.g. clear solution, or uniform suspension], and discard if otherwise;

• Any unused product, or waste material should be disposed of in accordance with local requirements.

• Refer to the Green Book: https://www.gov.uk/government/publications/storage-distribution-and-disposal-of-vaccines-the-green-book-chapter-3

12. Incident Reporting

Any drug errors, or other significant incidents should be reported in accordance with local Adverse Incident/Near Miss/SUI Reporting & Management Policies through the formal reporting process. Serious incidents should be reported to NHS England.

13. Documentation and Audit

Standards of records, record keeping, and audit must comply with those laid down by professional regulators.

• The use of these PGDs must be audited on an annual basis; • Clear audit trails must be organised for each patient and the vaccine administered; • The professional must be able to identify patients who have received vaccines

under these PGDs for audit purposes. This can be via either a computerised, or

https://www.gov.uk/government/publications/storage-distribution-and-disposal-of-vaccines-the-green-book-chapter-3

https://www.gov.uk/government/publications/storage-distribution-and-disposal-of-vaccines-the-green-book-chapter-3

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paper record; • Monitoring and auditing the use of these PGDs is important and necessary for their

review. The authorising organisation will ask for results of local audits to inform review of these PGDs.

Appendix 2 provides guidance on audit requirements.

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Core Patient Group Direction for the Administration of Immunisations by Healthcare Professionals

This Patient Group Direction (PGD) provides advice and information that is relevant for all vaccines included in the suit of NHS England (London Region) immunisation PGDs, including general exclusion criteria, advice to be given to patients/parents/person with parental responsibility, common adverse effects, record-keeping etc. The individual PGDs specify any additional information that is specific to the individual vaccine. The individual PGDs must be read in conjunction with this section.

Legal Category All vaccines are Prescription Only Medicines (POMs).

General Exclusion Criteria

• All vaccines are contraindicated in those who have had: o A confirmed anaphylactic reaction to a previous

dose of a vaccine containing the same antigens, or o A confirmed anaphylactic reaction to another

component contained in the relevant vaccine, e.g. neomycin, streptomycin or polymyxin B (which may be present in trace amounts in some vaccines): check the SmPC for the individual vaccine to confirm excipients;

• In individuals with an evolving neurological condition, immunisation should be deferred until the neurological condition has resolved or stabilised;

• Confirmed history of infection with the causative agent(s) included in the specific vaccine;

• Patient/parent/person with parental responsibility does not consent to immunisation;

• *Vaccination should be delayed in subjects with an acute severe febrile illness (see below: Action to be taken if patient excluded or vaccine is declined). However, minor illnesses without fever or systemic upset (e.g. a cold) are not valid reasons to postpone immunisation;

• Valid consent is not given; • Mental Capacity Act (MCA): should the healthcare

professional feel that the patient or patient’s parent/legal guardian who is giving consent, is unable to deliberate sufficiently with regard to the information they have been given, then the Mental Capacity Act should be followed.

Live vaccines may be temporarily contraindicated in individuals who are: • Immunosuppressed (see the Green Book, Chapter 6); • Pregnant.

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Cautions Including Any Relevant Action to be Taken

• For individuals with bleeding disorders; especially those on anticoagulant treatment, the intramuscular administration route should NOT be used: the subcutaneous route should be used;

• Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs, such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints;

• If patients are taking other medicines, the SmPC and individual PGD should be read to alert the practitioner to potential interactions;

• Thiomersal: In the UK, none of the routine childhood vaccines contain thiomersal. A small number of other vaccines use thiomersal in the manufacturing process and may therefore contain trace levels of the compound. Regulatory authorities and scientific committees have reviewed the safety of thiomersal in vaccines. These reviews have consistently concluded that there is no evidence of an association between thiomersal-containing vaccines and neurodevelopmental disorders, including autism;

• The practitioner may refer at any time to a medical practitioner, or other expert if necessary;

• For any child protection concerns, adhere to Local Child Protection Guidelines and Safeguarding Children Policy.

Vaccination of Patients With Complex or Uncertain Vaccine Histories

When patients present for immunisation there is an opportunity to confirm their immunisation status. For patients with incomplete immunisation status refer to the Public Health England algorithm: ‘Vaccination of Individuals with Uncertain or Incomplete Immunisation Status’: http://www.hpa.org.uk/webc/hpawebfile/hpaweb_c/1194947406156 If in doubt refer for advice.

Concomitant Administration of Different Vaccines

• Most vaccines can be given at the same time as other vaccines – check the individual PGDs and SmPCs for details;

• Concomitant administration of 2 or more vaccines does not require the presence of 2 healthcare professionals;

• If live vaccines are given simultaneously, then each vaccine virus will begin to replicate and an appropriate immune response is made to each vaccine. After a live vaccine is given, natural interferon is produced in response to that vaccine. If a second live vaccine is given

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during this response, the interferon may prevent replication of the second vaccine virus. This may attenuate the response to the second vaccine. Based on evidence that MMR vaccine can lead to an attenuation of the varicella vaccine response, the recommended interval between live vaccines is currently four weeks. For this reason, if live vaccines cannot be administered simultaneously, a four-week interval is recommended (refer to the Green Book);

• Different injectable vaccines should always be administered at different injection sites – preferably in different limbs. If given in the same limb, the sites should be at least 2.5cm apart. The site at which each vaccine was given should be noted in the individual’s records;

• BCG Vaccination: no further immunisation should be given in the arm used for BCG immunisation for at least three months because of the risk of regional lymphadenitis.

Patients With Impaired Immune Response

• People with impaired immune response, e.g. those with HIV infection, splenectomy, or taking long-term immunosuppressive therapy, must be vaccinated according to the recommended schedules, though vaccines may not produce a sufficient protective antibody response;

• For patients with temporary immunosuppression, re-immunisation should be considered after treatment is finished and recovery has occurred: specialist advice may be required.

Patients With Severe Latex Allergy

• See information in the Green Book, chapter 6; • As a precaution, if an individual has a history of severe

(i.e. anaphylactic) allergy to latex, vaccines supplied in vials or syringes that contain latex should not be administered under these PGDs;

• For latex allergies other than anaphylactic allergies (e.g. a history of contact allergy to latex gloves), vaccines supplied in vials or syringes that contain latex can be administered;

• If a patient has a history of severe latex allergy the healthcare professional must check with the manufacturer(s) of the vaccine(s) as to whether they contain latex before immunisation;

• If the vaccine(s) to be administered contain(s) latex then an alternative latex free vaccine(s) should be given if available. If this is not possible then the patient should be referred for specialist advice.

Patients With Severe Egg Allergy

• Individuals with a confirmed anaphylactic reaction to egg, or egg protein, should not receive certain vaccines. This

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will be specified in the exclusion criteria in the individual vaccine PGD;

• Non-anaphylactic allergy and dietary sensitivity to eggs is not a contra-indication to vaccination.

Action to be Taken if Patient Excluded or Vaccine is Declined

• *If excluded due to current febrile, or acute illness provide advice regarding making a future appointment to have the vaccine when the illness has resolved;

• Signpost/refer to an appropriate health service provider with information about further options;

• If excluded for clinical reasons, specialist advice should be sought on the vaccines, and circumstances under which they could be given. The risk to the individual of not being immunised must be taken into account;

• If immunisation is declined, provide advice about the protective effects of the vaccine and the risks of infection and disease complications, including risk to others;

• Refer to GP if appropriate; • Document reason for exclusion and advice given.

Written and Additional Advice to be Provided to the Patient/Parent/ Person With Parental Responsibility Prior to Administration of Vaccine(s)

• Informed consent must be obtained prior to administration of the vaccine(s);

• Patients/parents/person with parental responsibility must be given access to the manufacturer’s Patient Information Leaflet for them to read. If sufficient leaflets are supplied with the vaccine being administered, a copy should be provided;

• Patient/parent/person with parental responsibility should receive verbal and written (where available) information about the vaccines, expected side effects and management of adverse reactions prior to receiving the vaccine in a form that is appropriate, e.g. taking into consideration language and literacy.

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Route of administration

• In general, vaccines are routinely given by deep intramuscular injection, in either the deltoid muscle (upper arm), or the vastus lateralis muscle (anterolateral aspect of the thigh) as follows:

o Under 1 year of age use the anterolateral aspect of the thigh;

o Over 1 year of age use either the anterolateral aspect of the thigh, or the deltoid muscle (larger/older children);

• Vaccination by deep subcutaneous route should be reserved only for individuals with a bleeding disorder (see above under Cautions);

• Use the needle supplied with the vaccine or: o Blue (23G x 25mm) or orange (25G x 25mm)

needle for intra-muscular injection; o Orange needle (25G x16 mm) for sub-cutaneous

injection; o Refer to the Green Book chapter on Immunisation

Procedures: https://www.gov.uk/government/publications/immunisation-procedures-the-green-book-chapter-4

Adverse reactions The most common reactions to vaccines administered by parenteral routes are: • Local reactions at the injection site, including pain,

swelling or redness. Injection site reactions usually occur within 48 hours of injection, and last for 1 to 2 days;

• Local adverse reactions that generally start within a few hours of the injection and are usually mild and self-limiting. Although these are often referred to as ‘hypersensitivity reactions’, they are not allergic in origin, but may be either due to high titres of antibody or a direct effect of the vaccine product, e.g. endotoxin in whole-cell bacterial vaccines. The occurrence or severity of such local reactions does not contraindicate further doses of immunisation with the same vaccine, or vaccines containing the same antigens;

• Systemic adverse reactions which include fever, malaise, myalgia, irritability, headache and loss of appetite

Anaphylaxis is very rare – approximately 1 per million doses. Management of adverse effects: • Paracetamol or ibuprofen should only be recommended to

treat pain, headache or fever if they occur after immunisation. Whilst paracetamol and ibuprofen can lower the duration of fever and reduce distress, there is no evidence that they prevent febrile convulsions. These

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drugs should not be used routinely to prevent fever following vaccination, as there is some evidence that prophylactic administration of antipyretic drugs around the time of vaccination may lower antibody responses to some vaccines;

• If effects are severe, or the patient develops a fever above 39°C, they should be advised to contact a doctor;

• Adrenaline (Epinephrine) 1/1000 (1mg/1ml) injection must be available for use in the event of anaphylaxis.

Adverse Drug Reaction Reporting

• Reactions must be documented and reported to the patient’s GP;

• All significant reactions/incidents should be recorded in the patient’s clinical record as detailed below:

o Nature of the reaction and site; o Time of onset of symptoms; o Action taken, e.g. dialling 999; o Vaccine/brand/manufacturer; o Batch number/expiry date; o Dose/route of administration; o Other medication currently taken, including over the

counter and/or herbal medicines; o Advice given on future management, e.g.

vaccine(s) to avoid, what the patient should tell their GP/health professional;

• Report to the Commission on Human Medicines (CHM) via the Yellow Card Scheme (at the back of a BNF), or online from www.yellowcard.mhra.gov.uk:

o All serious adverse effects to established medicines in adults;

o All serious and minor adverse reactions to established medicines in children (under 18 years);

o All suspected reactions to medicines showing the black triangle symbol (▼), in adults and children.

Follow-Up If applicable, the patient/parent/person with parental responsibility should be informed when the next dose is due

Written and/or Additional Advice to be Given to the Patient/Parent/ Person With Parental Responsibility After Administration of Vaccine(s)

• Advice should be given regarding fever control and management of reactions;

• Report any adverse reactions to the vaccination that are severe or prolonged to the GP or nurse;

• Seek urgent medical attention if the symptoms of anaphylaxis, e.g. breathlessness and/or swelling, develop.

Records to be Kept • Records must be made following vaccination/exclusion,

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they must not be made prior to the patient’s attendance for vaccination;

• Standards of records and record-keeping must comply with those laid down by the professional’s regulatory body;

• Records should be kept on computer record systems, and, where relevant, the personal child health record (PHCR). There is a duty on healthcare professionals to transfer information from handheld records to the Child Health Information System (CHIS), and Immform;

• Details of the vaccines administered must be recorded in the patient’s records. The following details must be recorded:

o Patient name, address, ID number, date of birth, and ethnicity;

o The brand of vaccine administered, batch number, expiry date, dose, route and site of administration;

o Date of administration, and date of next dose (if applicable);

• Consent must be documented; • When more than one vaccine is given simultaneously,

details of the sites of administration must be recorded to allow any reactions to specific vaccines to be noted, including differentiating between different sites on the same limb;

• The name of the professional who administered the vaccine, and their signature (or e-password) should also be recorded;

• If a vaccine is declined this must be documented as well as action taken/advice given;

• If a patient is excluded from receiving a vaccine under the PGD the reason for the exclusion must be documented in addition to action taken/advice given;

• Advice given to the patient (including side effects) should be documented;

• Details of any adverse drug reaction and actions taken including documentation, should be recorded in the patient’s medical record;

• All records must be kept for 10 years after last attendance, or up to patient’s 26th birthday, if longer than 10 years away. The version of the PGD in use at the time of vaccination should be kept for the same period;

• Procedures for entry onto patient records and/or computer records should be standardised within the practice to avoid data being held in different places.

Core PGD


Healthcare Professional’s Agreement to Practise and Practice/Pharmacy/Local Organisation Authorisation

PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR

ACCOUNTABILITY. IT IS THE RESPONSIBILITY OF EACH PROFESSIONAL TO PRACTISE ONLY WITHIN THE BOUNDS OF THEIR OWN COMPETENCE AND IN

ACCORDANCE WITH THEIR OWN CODE OF PROFESSIONAL CONDUCT. DECLARATION by healthcare professional: • I have read and understand this PGD; • I have been appropriately trained to understand the criteria listed, and the

techniques and record-keeping required to administer vaccines in accordance with this PGD;

• I confirm that I have been assessed for my knowledge and clinical competency, and EITHER am experienced in administering vaccines in the past 12 months, OR I have been observed administering vaccines in practice;

• I confirm that I am competent to undertake administration of this vaccine; • I confirm that I will ensure that I remain up to date in all aspects of the

administration of vaccines. Healthcare Professional’s Name:……………………………. Registration Number:………………………. Expiry Date: ………………………. Signature: …..………………….. Date: ………………………. Declaration by Authorising Manager*: Managers should only authorise staff who have received the required training and are competent to work to this PGD. Each authorised member of staff should be provided with an individual copy of the PGD, which they should also sign to declare themselves competent. A copy of the signed document should be kept by the individual staff member. The authorising manager should retain a copy of the signed individual authorisation page. I have read and understood the PGD and authorise the staff member named above to operate in accordance with this PGD. Authorising Manager’s Name:…………………………….. Signature: …..………………….. Date: ……………………….

*The term manager refers to the person taking responsibility for authorising healthcare professionals to operate under the terms of this PGD, and includes lead GPs, nurse managers, pharmacy managers etc.

Core PGD

Reference Number: NHSE(LR)/Competency assessment Valid from: 1st April 2014 Review date: 1st January 2017 Expiry date: 31st March 2017

Appendix 1 COMPETENCY ASSESSMENT TOOL FOR IMMUNISATION This document can be used as a self-assessment tool for practitioners who administer immunisations. To complete it, review the competency areas below and the clinical skills, techniques and procedures outlined for each of them. Score yourself in the Self-Assessment column. If you tick Need to Improve you indicate further study, practice or change is needed. When you tick Meets or Exceeds you indicate you believe you are performing at the expected level of competence, or higher. Mentors/Managers: This checklist can be used to clarify responsibilities and expectations for those who administer vaccines. Next observe their performance as they provide immunisations to several patients and provide a score in the Mentor Review columns. If improvement is needed, support the immuniser to develop a Plan of Action that will help them achieve the level of competence you expect; circle desired actions or write in others. When all competency areas meet expectations, mentors can take a copy of this document for their records; immunisers should keep this document within their PREP/CPD folder.

Self-Assessment Mentor Review Competency Clinical Skills,

Techniques and Procedures

Need to Improve

Meets or Exceeds

Need to Improve

Meets or Exceeds

Plan of Action

A. Patient/Parent Education

1. Welcome patient/family, establish rapport

2. Check patient’s records, confirming with patient/parent to ascertain previous immunisation history. Verify appropriate point on the childhood schedule, if appropriate.

3. Explain which vaccines are to be given today, inform of any expected adverse effects, answer any questions referring to DH leaflets to aid explanations/discussion as appropriate.

4. Use language appropriate leaflets/interpreter as appropriate to ensure patient/parent informed.

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5. Ensure you are conforming to applicable PGD and be aware of scope and limitations of PGDs. Immuniser must have their own individual signed authorisation.

6. For infants, ensure 8 week check has been performed.

7 Ensure informed consent is obtained prior to vaccination and be aware of issues applicable to competence and age of patient.

8 Screen for contraindications referring to Green Book as appropriate. Use on-line version only.

9 Know who to contact for advice if unsure about vaccination schedules, spacing or compatibility of vaccines.

B. Medical Protocols

1. Ensure anaphylaxis equipment is readily available.

2. Be aware of appropriate dosage, how to administer and when to use it.

3. Maintain up to date basic life support skills (mandatory yearly).

4. Be aware of protocol to follow in case of needlestick injury.

5. In case of an adverse incident during vaccination procedure (e.g. cold chain error, needlestick injury), be aware of incident reporting procedure as per local protocol.

6. Anaphylaxis awareness & training/update completed

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C. Vaccine Preparation

1. Demonstrate an understanding of the rationale for maintaining the cold chain of a vaccine; state the correct temperature range for vaccine storage and explain the system you are using to monitor the vaccine fridge.

2. Be familiar with local protocols for cold chain audit and action to be taken in case of cold chain failure.

3. Demonstrate knowledge of proper vaccine handling, e.g. protection of vaccine from light.

4. Prior to reconstitution of vaccine, check vaccine and expiry dates, including any diluents

5. Wash hands and correctly reconstitute vaccine as appropriate, ensuring vaccine diluent and lyophilized powder are fully mixed in vial.

6. Ensure informed consent is obtained prior to vaccination.

7. Select correct needle size according to the evidence base.

D. Administration of vaccine(s)

1. Recheck vaccine(s) and peel off batch number stickers (if appropriate) for record book/notes.

2. Be aware of appropriate anatomical sites for vaccination, how to locate landmarks and required route of injection (e.g.intramuscular)

3. Correctly position patient prior to vaccinating. For children instruct parent on appropriate holding of child during procedure, discuss distraction techniques and parental comforting

Core PGD


measures. 4. Demonstrate correct injection technique.

5. Demonstrate awareness of best practice regarding multiple injections, aspiration and application of gentle pressure to injection site with dry cotton wool ball.

6. Properly dispose of needle, syringe and vaccine vial(s) in sharps container.

7. Reassure patient/reassure parent and encourage comforting of child by parent.

E. Documentation

1. Document name of vaccine, batch number, expiry, date given, injection site and name of vaccinator in clinic notes. (When two injections are given to infants in one leg, record positioning e.g. DTaP/Hib/IPV –right leg upper, Men C – right leg lower, Prevenar -left leg etc.)

2. Record vaccine and date in patient/parent held record. Use ad hoc form if no red book; do not turn parent away if they do not have the red book.

3.i Complete documentation in child health record “Red Book”. 3.ii Complete information in GP record system

F. Post Vaccination Advice

1. Repeat advice to patient/parent on expected post vaccination reactions as appropriate (e.g. rash, pyrexia) and management of these. 2. Advise patient/parent who to contact in case of severe adverse

Core PGD


reaction. 2.Ensure patient/parent

is aware of contact details should further advice be required (e.g. contact number of NHS Direct). *Where the word ‘parent’ appears, please read guardian etc as appropriate.

Core PGD

Reference Number: NHSE(LR)/Audit Valid from: 1st April 2014 Review date: 1st January 2017 Expiry date: 31st March 2017

Appendix 2

Recommended Requirements for Auditing Use of Patient Group Directions It is recommended that an annual audit of administration of vaccines under PGD should be carried out as follows: At an agreed time, within 1 year of approval of the PGD, a sample of notes of patients (via the Rio records system, pharmacy record system, or other) receiving vaccines under PGD will be audited. Each practitioner should have 5 sets of notes audited. If a practitioner has been absent for long periods of the year, or has not had the opportunity to administer vaccines under PGD then the service lead/manager will undertake a separate audit appropriate to the practitioner’s clinical activity. The service lead/manager will conduct the audit and discuss the findings with the practitioner. The following areas should be audited for documented evidence of:

• Consent obtained prior to vaccination; • Reason for administering/not administering a vaccine; • Site of vaccination, batch number and expiry date of vaccine; • Asking the patient/parent/person with parental responsibility about allergies,

and other exclusion criteria; • Information given to patient/parent/person with parental responsibility; • Follow up

Service leads/managers will conduct a detailed audit of an individual’s practice within one month if there are any concerns or issues about their knowledge or competence.