Patient Group Direction (PGD) for the administration of Meningococcal Group A, C, W-135 and Y conjugate vaccine

PATIENT GROUP DIRECTIONS 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.

1. Clinical condition or situation to which the direction applies

Indication

For active immunisation against invasive meningococcal diseases caused by Neisseria

meningitidis group A, C, W-135 and Y.

Objectives of care

To reduce morbidity and mortality from Neisseria meningitidis group A, C, W-135 and

Inclusion criteria

Valid consent has been obtained from the patient/carer who does not want to consult with their GP and would prefer to access vaccination from the PGD user.
Individuals from 6 months of age and over at risk of meningococcal diseases caused by Neisseria meningitidis group A, C, W-135 and Y (N.B. product specific age indications must be followed).
This includes:
Pilgrims travelling to Saudi Arabia for Hajj or Umrah, who are required to show proof of vaccination.
Travellers visiting risk areas for meningococcal disease, whose planned activities put them at higher risk. Risk must be identified with reference to current recognised sources such as:
̵ http://www.fitfortravel.nhs.uk/home.aspx
̵ http://travelhealthpro.org.uk/country-information/
̵ http://www.travax.nhs.uk/
Patients who missed their routine school vaccination in school years 9 and 10 or the catch-up MenACWY vaccination. If these patients are going to university or college for the first time, they must be aware that up to 25 years of age they are entitled to receive

the vaccine free from an NHS service provider.

Exclusion criteria

(Refer to current and relevant SPC (Great Britain or Northern Ireland) and online Green Book guidance for additional details)

Patients for whom no valid consent has been received.
Individuals under 6 months of age (N.B. product specific age indications must be followed).
Hypersensitivity to the active substance(s) or to any of the excipients or trace residuals in Menveo®, Nimenrix® or MenQuadfi®. See section 2 and 6.1 of the relevant Summary of Product Characteristics (SPC).
Hypersensitivity to diphtheria toxoid (Menveo®) or tetanus toxoid (Nimenrix® or MenQuadfi®).
Confirmed anaphylactic reaction to a previous dose of meningococcal Group A, C, W-135 and Y vaccine.
Contacts of confirmed meningococcal group A, C, W or Y infection.
Acute febrile illness – postpone administration until completely recovered.
MenC or Hib/MenC vaccine administered in last 4 weeks – postpone administration (minimum interval between these vaccines should be 1 month).
Has an evolving neurological condition. (With an evolving neurological condition, immunisation should be deferred until the neurological condition has resolved or

stabilised).

1. Clinical condition or situation to which the direction applies – continued

Cautions

(including any relevant action to be taken)

Bleeding disorders

Vaccines should be given with caution to patients with thrombocytopenia or any coagulation disorder (including those taking anticoagulants) since bleeding may occur following intramuscular administration to these patients (1) (2) (3). It is recommended that the appropriate healthcare professional (e.g. GP) is consulted prior to injection, to determine if intramuscular injection is suitable and if vaccination should be scheduled shortly after the patient receives their medication/treatment to reduce bleeding. If the vaccine is offered, the patient/carer should be informed about the risk of bleeding from the injection.
Patients on stable anticoagulation therapy, including patients on warfarin who are up- to-date with their scheduled International Normalised Ratio (INR) testing and whose latest INR was below the upper threshold of their therapeutic range, can receive intramuscular vaccination (4). If in any doubt, the clinician responsible for prescribing or monitoring the patient’s anticoagulant therapy should be consulted prior to injection. Syncope
Syncope (fainting) can occur following, or even before, any vaccination 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
(5).
Immunosuppressed patients
Patients that are immunosuppressed due to disease or treatment, including asplenia or dysfunction of the spleen, or HIV infection (regardless of CD4 count), may not produce a sufficient protective antibody response following vaccination (6).
Specialist advice may be required - see the Green Book chapters 6 & 7:
̵ https://www.gov.uk/government/publications/contraindications-and-special- considerations-the-green-book-chapter-6
̵ https://www.gov.uk/government/publications/immunisation-of-individuals- with-underlying-medical-conditions-the-green-book-chapter-7
Pregnancy and Breast-feeding
Vaccines can be administered during pregnancy or breast-feeding where there is a high risk of infection, and the benefits of vaccination outweigh the risks (1) (2) (7) (8) (3). It is recommended that the appropriate healthcare professional (e.g. GP, midwife) is consulted prior to injection.
Protection against meningococcal disease
Meningococcal Group A, C, W135 and Y conjugate vaccines only confer protection against Neisseria meningitidis group A, C, W-135 and Y (1) (2) (7) (8) (3).
The vaccine will not protect against infection from any other Neisseria meningitidis groups. Furthermore, not all vaccine recipients will be fully protected against meningitis ACWY (1) (2) (7) (8) (3).
Other considerations
For patients with other health conditions, the risks and benefits of vaccination must be weighed on an individual basis. Refer back to appropriate healthcare professional.
Healthcare professionals must not delegate their responsibility and they have the right to refuse vaccination to eligible patients based on their own clinical judgement. Where there is doubt, vaccination should not be initiated until the patient has sought advice

from the appropriate healthcare professional.

1. Clinical condition or situation to which the direction applies – continued
Product interactions	Prior to administration and where indicated, medication that the patient is using should be checked for product interactions using the British National Formulary (BNF) and SPC. This includes checking that the patient’s medication does not suggest conditions that are excluded from vaccination under this PGD. Whenever possible, Nimenrix® and an anti-tetanus toxoid (TT) containing vaccine, such as DTaP-HBV-IPV/Hib vaccine, should be co-administered or Nimenrix® should be administered at least one month before the TT containing vaccine.
Action if patient is excluded from the service	The risk to the patient of not being vaccinated must be considered. If administration is postponed, arrange a future date for vaccination as appropriate. Discuss with patient and document the reasons for exclusion from vaccination under the PGD. If the patient has consented, refer them to their GP and/or inform their GP. Pregnant and breastfeeding women should be signposted to other appropriate healthcare professionals. Contacts of confirmed meningococcal group A, C, W or Y infection should be signposted to other NHS services such as their GP, where they may be able to receive more specialist advice and vaccination.
Action if patient declines the service	Ensure patient/carer fully understands the risks of declining vaccination. Advise the patient/carer about the protective effects of the vaccine. Explain NHS eligibility for vaccination where appropriate. Reschedule vaccination if appropriate. Document the reasons for declining vaccination and any action taken, including advice given to the patient in their medication record. Pregnant travellers to the Hajj/Umrah who refuse vaccination should be referred to their GP who may be able to issue an exemption certificate.

2. Description of vaccine

Name, strength & formulation of drug

Supplier

Name of

product

Composition

Pharmaceut

ical form

Excipients

Age

indications

GlaxoSmithKline UK

Menveo®

Meningococcal Group A, C, W- 135 and Y conjugate vaccine

Powder and solvent for solution for injection

Powder

Sucrose
Potassium dihydrogen phosphate Solution
Sodium dihydrogen phosphate monohydrate
Disodium phosphate dihydrate
Sodium chloride
Water for injections

From 2 years

Pfizer Limited

Nimenrix®

Meningococcal Group A, C, W- 135 and Y conjugate vaccine

Powder and solution for solution for injection

Powder:

Sucrose
Trometamol Solvent:
Sodium chloride
Water for injections

From 6 months

Sanofi Pasteur

MenQuadfi®

Meningococcal Group A, C, W and Y conjugate

vaccine

Solution for injection

Sodium chloride
Sodium acetate
Water for injections

From 12 months

For a full list of excipients, see section 2 and 6.1 of the relevant SPC.

Legal status

POM – Prescription Only Medicine

Dose/dose range

0.5 ml (1) (2) (7) (8) (3)

Use of PGD outside terms of SPC

This PGD covers vaccination in England, Scotland, Wales and Northern Ireland. Please note that Northern Ireland may have a separate SPC from Great Britain and guidance may differ. Please refer to the relevant SPC for more information.
Although healthcare professionals have the right to refuse vaccination even

where a patient is eligible, they cannot override PGD exclusions.

2. Description of vaccine
Route/method of administration	Meningococcal group A, C, W-135 and Y conjugate vaccines should under no circumstances be administered intravascularly, subcutaneously or intradermally (1) (2) (7) (8) (3). Immunisation should be carried out by intramuscular injection (IM) into the deltoid region of the upper arm (1) (2) (7) (8) (3). In children 6 months through to 35 months, the preferred sites for IM injection are the anterolateral aspect of the thigh (if suitably trained), or the deltoid muscle if muscle mass is adequate (9). Vaccines should be prepared and reconstituted as per manufacturers' instructions. The vaccine should be inspected for any foreign particulate matter and /or for any variation of physical aspect prior to administration. If either is observed the vaccine should not be administered (1) (2) (7) (8) (3). Where two or more injections need to be administered at the same time, they should be given at separate sites, preferably in different limbs. If more than one injection is to be given in the same limb, they should be administered at least 2.5cm apart (6). For patients with bleeding disorders, a fine needle (equal to 23 gauge or finer calibre) should be used for the vaccination, followed by firm pressure applied to the site (without rubbing) for at least 2 minutes (see cautions) (4).
Frequency of administration	A single dose of 0.5mL (1) (2) (7) (8) (3).
Follow up / minimum or maximum period	Follow available official recommendations regarding the need for boosters or further doses (6). See the Green Book Chapter 22 or the official recommendations from The Ministry of Health – Kingdom of Saudi Arabia on their requirements for Hajj and Umrah pilgrims to obtain a visa for entry into KSA: http://www.moh.gov.sa/en/Hajj/Pages/HealthRegulations.aspx

3. Further aspects of vaccination

Adverse reactions and their management

Follow local SOP on adverse reactions and management.
Very common side effects include (≥1/10): Headache, sleepiness, irritability, malaise, drowsiness, fatigue, loss of appetite, fever (≥38°C), injection site pain, injection site
erythema (≤50 mm), injection site induration (≤50 mm), nausea and myalgia (1) (2) (7) (8).
Common side effects include (≥1/100 to <1/10): Diarrhoea, vomiting, rash, arthralgia, injection site erythema (>50 mm), injection site induration (>50 mm) and chills (1) (2) (7) (8).
Uncommon side effects include: Dizziness and injection site pruritus (1) (2) (7) (8).
Rare side effects include (≥1/10,000 to <1/1,000): Lymphadenopathy, stomach pain, urticaria, pain in extremity and axillary pain (3).
Frequency of MenQuadfi® side effects may differ, please check relevant SPC.
Emergency equipment must be available including immediate access to epinephrine (adrenaline) 1:1000 for IM injection. Please refer to resuscitation council guidelines.
Healthcare professionals should confirm with patients that they are fit to leave the premises after a period of observation. Patients should not leave if they are feeling at all unwell without speaking to the healthcare professional.
The onset of anaphylaxis is rapid, typically within minutes, and its clinical course is unpredictable with variable severity and clinical features. Due to the unpredictable nature of anaphylactic reactions, it is not possible to define a particular time period over which all patients should be observed following immunisation to ensure they do not develop anaphylaxis.
In the event that the patient exhibits signs of anaphylaxis after injection, healthcare professionals must seek urgent medical attention.
Advise the patient to consult their GP if there is a severe local reaction at the injection site, if they have a fever or if any other serious symptoms develop.
For a comprehensive list of all warnings, cautions and potential adverse reactions, refer to the current BNF, current and relevant SPCs (Great Britain or Northern Ireland) and the

Green Book - Immunisation against infectious disease.

Reporting procedure of adverse reactions

Report to GP if appropriate & document in patient’s medication records.
Follow local SOP for reporting of adverse events.
MenQuadfi® is a black triangle product and is subject to additional monitoring.
All suspected adverse reactions must be reported via the Yellow Card scheme to the MHRA or on the website at https://yellowcard.mhra.gov.uk/
An adverse reaction should be reported even if it is not certain that the medicine has caused it, if it is well recognised, or if other drugs were given at the same time.
Further information is available online from https://yellowcard.mhra.gov.uk/

3. Further aspects of vaccination – continued

Advice to patient / carer

Explain protection level expected from vaccine. Advise patients that not all those who receive the vaccine will be fully protected, and the vaccine only protects against infections for which it has been developed.
Provide a patient information leaflet and discuss as required.
Provide advice on and explain potential warnings.
Provide patient with a record of vaccination.
Advise on possible side effects and their management. If the symptoms do not resolve and/or the patient experiences other severe symptoms, they should be advised to contact their GP, NHS 111 or visit A&E.
Advise patients on the activities that may put them at higher risk, such as overcrowded/confined spaces or activities that promote exchange of respiratory

secretions.

Records to be kept

In all cases manual records including any risk assessment forms or computerised records should include:
̵ Patient’s name, address and date of birth;
̵ Name of immuniser;
̵ Dose, site and route of injection;
̵ Date of administration;
̵ Brand name, batch number & expiry date of vaccine;
̵ Confirmation that there are no contraindications; that side effects have been discussed; support literature given (if applicable) and any other advice given;
̵ That valid informed consent was given prior to administration;
̵ Details of any adverse reactions and actions taken;
̵ Signature and printed name and designation (in black ink) for paper records. For computer records, ensure data authentication of practitioner delivering care.
GP may be notified, if the patient has consented for personalised information to be shared.
Pharmacy/clinic records should be stored in line with relevant legislation and local policies. Generally, records should be kept for 8 years in adults and until 25 years of age

in children

3. Further aspects of vaccination– continued

Additional facilities / requirements

Policies and procedures must be in place for providing a private vaccination service including cold chain management, sharps disposal, needlestick injury, consent, record keeping and training requirements.
Pharmaceutical refrigerator (or validated cool box for storing vaccines if running an
“offsite” clinic).
Resuscitation kit, including immediate access to 1:1000 epinephrine (adrenaline).
Access to medical support (this may be via telephone).
Disposal - equipment used for vaccination, including used vials or ampoules, should be disposed of at the end of a session by sealing in a proper, appropriately sized puncture- resistant ‘sharps’ box (UN-approved, BS 320).
If vaccinating children, healthcare professionals must be appropriately trained on vaccination techniques in these patients. Furthermore, SOP’s must be followed with procedures and policies in place for vaccinating these patients.
All PGD users must be familiar with and have online access to the latest edition of the

Green Book, noting that clinical guidance may change and that the Green Book is frequently updated.

3. Further aspects of vaccination – continued

Additional facilities / requirements

PGD users must:

Be familiar with and have online access to the latest edition of the Green Book, noting that clinical guidance may change and that the Green Book is frequently updated.
Be aware of current clinical recommendations and be able to undertake administration (where applicable) and discuss any issues that may arise.
Have been trained and assessed as being competent in the delivery of this medicine covered by this PGD.
Maintain their skills, knowledge and professional level of competence in this area according to their individual code of professional conduct.
Possess appropriate professional indemnity.
Agree to work within the terms of the implementing PGD.
Be aware of medicine handling, storage and administration guidelines.
Regularly check BNF/BNFC / Green Book for contraindications, cautions and interactions. The superintendent/clinical lead of the implementing pharmacy/clinic will be responsible for:
Providing adequate up-to-date clinical resources.
Ensuring that staff using the PGD, have access to up-to-date resources.
Ensuring that staff have received adequate training in all areas relevant to this PGD.
Requirements for Continuing Professional Development (CPD)
All staff involved in the implementation of this PGD should participate in adequate and appropriate Continual Professional Development to ensure procedures follow the most up to date clinical guidance.
Facilities and supplies to be available
Consultations carried out under the authorisation of this PGD should be completed in a private space, physically closed off from interruption such as a pharmacy consultation room, in order to ensure patient confidentiality.
The following should be available:
1. Safe storage areas for medicines and equipment
2. Clean and tidy clinical rooms that allow confidentiality and patient privacy
3. Copies of the current PGD
4. Access to a current BNF and Green Book
  Audit
All health risk assessment, advice and medicine supply record forms should be stored in the pharmacy/clinic and will be audited by the implementing pharmacy/clinic in order to analyse service delivery. If the service is deemed insufficient, management staff, the superintendent/clinical lead and implementing healthcare professional will be informed

and an action plan drawn up to remedy the service.

3. Further aspects of vaccination – continued

Consent

Prior to the administration and/or supply of a medicine, consent must be obtained, preferably written, from the patient, and documented either in the patient’s medical records/notes or on an administration form.
The key points include:
If a patient’s fitness and suitability cannot be established, supply should be deferred.
There is no legal requirement for consent to be in writing but written consent serves to record the decision and the discussions that have taken place.
Consent - either written or verbal - is required at the time of each supply.
Consent remains valid unless the patient who gave it withdraws it. If there is new information between the time consent was given and when the supply is offered, including new evidence of risk, new medicines becoming available or where there is a significant change in the patient’s condition, it may be necessary for the patient to reconfirm their consent.
Written and verbal information should be available in a form that can be easily understood by the person who will be giving the consent. Where English is not easily understood, translations and properly recognised interpreters should be used in order that they can make informed consent.
The attendance of a patient for the supply/administration of treatment after an invitation to attend for this purpose may be viewed as acceptance that the patient may have the treatment/administration.
Patients should also be informed about how data on the supply will be stored, who will be able to access that information and how that data may be used.
Where consent is either refused or withdrawn, this decision must be documented.
Consent obtained before the occasion upon which a patient attends for the

supply/administration is only an agreement for the patient to be included in this instance and does not mean that consent is in place for each future supply/administration.

4. References & Resources

For a comprehensive list of all warnings, cautions and potential adverse reactions, refer to the current BNF and SPCs.

References

Summary of Product Characteristics; Nimenrix powder and solvent for solution for injection in pre-filled syringe. emc (Great Britain).
[Online] March 16, 2022. [Cited: March 24, 2022.] https://www.medicines.org.uk/emc/product/4118/smpc#INTERACTIONS.
Summary of Product Characteristics; Nimenrix powder and solvent for solution for injection in pre-filled syringe. emc (Northern Ireland). [Online] February 16, 2017. [Cited: March 24, 2022.] https://www.emcmedicines.com/en- gb/northernireland/medicine?id=a46c13fc-4eda-4a46-ac2c-af0ffd4cb031&type=smpc.
Summary of Product Characteristics; MenQuadfi solution for injection. emc (Great Britain) . [Online] March 21, 2022. [Cited: April 14, 2022.] https://www.medicines.org.uk/emc/product/12818.
Chapter 14a; COVID-19 - SARS-CoV-2. The Green Book. [Online] February 28, 2022. [Cited: March 24, 2022.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1057798/Greenbook-chapter-14a- 28Feb22.pdf.
Chapter 8: Vaccine safety and the management of adverse events following immunisation. The Green Book. [Online] August 2012. [Cited: March 24, 2033.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/147868/Green-Book-Chapter-8- v4_0.pdf.
Chapter 22; Meningococcal. The Green Book. [Online] September 2016. [Cited: March 24, 2022.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/554011/Green_Book_Chapter_22. pdf.
Summary of Product Characteristics; Menveo Group A,C,W135 and Y conjugate vaccine. emc (Great Britain). [Online] December 17, 2021. [Cited: March 24, 2022.] https://www.medicines.org.uk/emc/product/2939.
Summary of Product Characteristics; Menveo Group A,C,W135 and Y conjugate vaccine. emc (Northern Ireland). [Online] December 4, 2014. [Cited: March 24, 2022.] https://www.emcmedicines.com/en-gb/northernireland/medicine?id=aafdbaf2-6d41-44f3-baad- 3cc210f8a275&type=smpc.
Chapter 4; Immunisation procedures. The Green Book. [Online] June 2021. [Cited: December 19, 2022.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/147915/Green-Book-Chapter- 4.pdf.

Additional resources

Chapter 4; Immunisation procedures. The Green Book. [Online] June 2021. [Cited: March 24, 2022.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/147915/Green-Book-Chapter- 4.pdf.
Chapter 6; Contraindications and special considerations. The Green Book. [Online] August 2017. [Cited: March 24, 2022.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/655225/Greenbook_chapter_6.pd f.
Chapter 7; Immunisation of individuals with underlying medical conditions. The Green Book. [Online] January 2020. [Cited: March 24, 2022.]
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/857279/Greenbook_chapter_7_I mmunsing_immunosupressed.pdf.
Meningococcal ACWY (MenACWY) vaccination programme. GOV.UK. [Online] January 21, 2022. [Cited: March 24, 2022.] https://www.gov.uk/government/collections/meningococcal-acwy-menacwy-vaccination-programme.
HAJJ AND UMRAH. Travel Health Pro. [Online] November 9, 2021. [Cited: March 24, 2022.] https://travelhealthpro.org.uk/factsheet/19/hajj-and-umra.
What country are you looking for? Fit For Travel. [Online] [Cited: March 24, 2022.] https://www.fitfortravel.nhs.uk/destinations.aspx.
Patient Group Direction; Medicines practice guideline [MPG2]. National Institute for Health and Care Excellence. [Online] March 27, 2017. [Cited: February 11, 2022.] https://www.nice.org.uk/Guidance/MPG2.
Competency framework for health professionals using Patient Group Directions. National Institute for Health and Care Excellence. [Online] January 4, 2018. [Cited: February 11, 2022.] https://www.nice.org.uk/guidance/mpg2/resources.