Patient Group Direction (PGD) for the administration of measles, mumps and rubella (MMR) 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	Active immunisation against measles, mumps and rubella.
Objectives of care	Active immunisation for those who are at an increased risk of measles, mumps and rubella.
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 aged 12 months and over. Individuals who have not received two doses of MMR vaccine or immunisation status is unknown. Mumps or measles outbreak (in the communal setting such as colleges, university, further education institutions, schools). Travellers to potential measles, mumps and rubella risk areas, especially if staying with friends or family and mixing with the local population.
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 12 months of age. Hypersensitivity to the active substance(s) or to any of the excipients, neomycin or trace residuals in MMRVAXPRO® and Priorix®. See section 2 and 6.1 of the relevant Summary of Product Characteristics (SmPC). Patients who have had a confirmed anaphylactic reaction to a previous dose of a measles-, mumps- or rubella-containing vaccine. Patients who have had a confirmed anaphylactic reaction to gelatine (MMRVAXPRO® only). Known or suspected pregnancy. Acute febrile illness – postpone administration until completely recovered. Active untreated tuberculosis. Patients who are receiving, or have received in the past 6 months, immunosuppressive chemotherapy or radiotherapy. Patients who are receiving or have received in the past 12 months immunosuppressive biological therapy (e.g. anti-TNF therapy such as alemtuzumab, ofatumumab and rituximab). Patient is immunosuppressed through disease, treatment or medication. Patient has taken high-dose systemic corticosteroids within the last 3 months. See Greenbook chapter 6 for further information. Patients with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g., hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion. Patients with blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems. Patients with severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage in children below 12 months: CD4+ <25%; children between 12-35 months: CD4+ < 20%; children between 36-59 months: CD4+ < 15%. Patients with a family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated. Rare hereditary problems of fructose intolerance (MMRVAXPRO® only). Patients with an evolving neurological condition. (With an evolving neurological condition, immunisation should be deferred until the neurological condition has resolved or stabilised).

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This

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

Cautions

(including any relevant action to be taken)

Bleeding disorders

MMRVAXPRO® and Priorix® should be given with caution via the intramuscular route (IM) to patients with thrombocytopenia or any coagulation disorder (including those taking anticoagulants) since bleeding may occur in these patients (1) (2) (3). It is recommended that the appropriate healthcare professional (e.g. GP) is consulted prior to injection, to determine if IM 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 IM vaccination. If in any doubt, the clinician responsible for prescribing or monitoring the patient’s anticoagulant therapy should be consulted prior to injection (4).
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).
Anaphylactic reactions (1) (2) (3)
As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Individuals with a history of allergies may potentially be at increased risk of anaphylaxis or anaphylactoid reactions. Close monitoring is recommended following vaccination for the early signs of such reactions.
Predisposition to neurological problems
Caution should be employed in administration of MMR vaccines to patients with individual or

family history of febrile convulsions, or a history of cerebral injury (6). The healthcare professional should be alert to the temperature elevation that may occur following vaccination.

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

Cautions

(including any relevant action to be taken)

Protection (1) (2) (3)

Vaccination may not result in protection in all vaccinees.
Limited protection against measles may be obtained by vaccination up to 72 hours after exposure to natural measles. However, there is no conclusive evidence that vaccination of individuals recently exposed to wild-type mumps or wild-type rubella will provide protection.
Transmission
Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7 to 28 days after vaccination. However, there is no evidence of transmission of these excreted vaccine viruses to susceptible contacts (1) (2) (3). Laboratory tests (1) (2) (3)
It has been reported that live attenuated measles, mumps, and rubella virus vaccines given individually may result in a temporary depression of tuberculin skin sensitivity. Therefore, if a tuberculin test is to be done, it should be administered either any time before, simultaneously with, or 4 to 6 weeks after vaccination.
Pregnancy
Pregnancy should be avoided for at least 1 month following vaccination (1) (2) (3).
Breast feeding
Studies have shown that breast-feeding postpartum women vaccinated with live attenuated rubella vaccines may secrete the virus in breast milk and transmit it to breast-fed infants. Therefore, the risks and benefits of vaccinating the mother should be evaluated on an individual basis (1) (2) (3). It is recommended that the appropriate healthcare professional (e.g. GP, midwife) is consulted prior to injection.
Pork gelatine
Patients/carers should be informed that the MMRVAXPRO® vaccine contains porcine gelatine. If the patient/carer does not wish for MMRVAXPRO® to be administered, the healthcare professional should offer Priorix® as an alternative if eligible, as this vaccine does not contain gelatine (2).
Other considerations
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.

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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. Live vaccine intervals Where a patient has received a live vaccine in the last 4 weeks or another live vaccine is planned within 4 weeks of the administration of an MMR vaccine, Green Book recommendations should be followed: https://www.gov.uk/government/publications/immunisation-schedule-the-green-book- chapter-11 Immune globulin (IG) is not to be given concomitantly with MMR vaccines (2). Due to an increased risk of fever, tenderness at the injection site, change in eating habits and irritability when Bexsero® was co-administered with a combined measles-mumps-rubella- varicella (MMR-V) vaccine, separate vaccination with Priorix® can be considered when possible.
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. Signpost to other services if appropriate. Pregnant individuals should be signposted to other appropriate healthcare professionals. Patients in risk categories not covered by this PGD (see exclusions) should be signposted to other services where they may be able to receive more specialist advice/vaccination or refer to the GP if appropriate. Explain patient eligibility for immunisation as part of the routine immunisation schedule (see the Green Book chapter 11) if appropriate.
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.

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2. Description of vaccine
Name, strength & formulation of drug
Supplier	Name of product	Composition	Pharmaceutical form	Excipients	Age indications
GlaxoSmithKline UK	Priorix®	Measles, Mumps and Rubella vaccine (live)	Powder and solvent for solution for injection in a pre-filled syringe	Powder: Amino acids Lactose (anhydrous) Mannitol Sorbitol Solvent: Water for injections	From 12 months
Merck Sharp & Dohme (UK) Ltd	MMRVAXPRO®	Measles, Mumps and Rubella vaccine (live)	Powder and solvent for solution for injection in a pre-filled syringe	*14.5 milligrams of sorbitol per dose	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		0.5ml (1) (2) (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.

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2. Description of vaccine – continued
Route/method of administration	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) (3). For patients with bleeding disorders, a fine needle (equal to 23 gauge or finer calibre) should be used for IM injection, followed by firm pressure applied to the site (without rubbing) for at least 2 minutes. Alternatively, vaccination can be given by subcutaneous injection to reduce risk of bleeding (see cautions) (4). 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 (7). The vaccine must be reconstituted in accordance with the manufacturer’s instructions prior to administration. For information on specific instructions on vaccine reconstitution and preparation, see section 6.6 of the product SPC. Alcohol and other disinfecting agents must be allowed to evaporate from the skin before injection of the vaccine since they can inactivate the attenuated viruses in the vaccine (1). Vaccines should under no circumstances be administered intravascularly (1) (2) (3). In children 12 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 (7). Priorix® (1) Given by subcutaneous injection, although it can also be given by IM injection, in the deltoid region. MMRVAXPRO® (2) (3) Given by IM injection into the deltoid area of the upper arm. Can also be administered by subcutaneous injection.
Frequency of administration	Individuals 12 months or older should receive one dose at an elected date. A second dose should be administered at least 1 month after the first dose (2) (3). If the patient has previously received a single dose of MMR vaccine, a second dose may be administered to complete the schedule (7).
Follow up / minimum or maximum period	Booster doses should be considered based on official recommendations (refer to product SPC and official guidelines).

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3. Further aspects of vaccination

Adverse reactions and their management

Follow local SOP on adverse reactions and their management.
Very common side effects include (≥1/10): Redness at the injection site and fever (1) (2) (3).
Common side effects include (≥1/100 to <1/10): Upper respiratory tract infection, rash, pain and swelling at the injection site (1) (2) (3).
Uncommon side effects include (≥1/1,000 to <1/100): Otitis media, lymphadenopathy, anorexia, nervousness, abnormal crying, insomnia, conjunctivitis, bronchitis, cough, parotid gland enlargement, diarrhoea and vomiting (1) (2) (3).
Rare side effects include (≥1/10,000 to <1/1,000): Allergic reactions and febrile convulsions
(1).
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.
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/

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3. Further aspects of vaccination – continued
Advice to patient / carer	Vaccine protection 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 (1) (2) (3). Also, if the person who is to be vaccinated has already been exposed to the measles, mumps, or rubella virus but is not yet ill, vaccination may not be able to prevent the illness from appearing (1) (2) (3). Patient information Provide a patient information leaflet and discuss as required. Provide advice on and explain potential warnings. 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. Pregnancy should be avoided for at least 1 month following vaccination (1) (2) (3). Vaccine record Provide patient with a record of vaccination.
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.
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).

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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.

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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.

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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; Priorix powder and solvent for solution for injection in a pre-filled syringe. emc (Great Britain).
[Online] 20 May 2020. [Cited: 06 May 2022.] https://www.medicines.org.uk/emc/product/1159.
Summary of Product Characteristics; MMRVAXPRO. emc (Great Britain). [Online] 02 November 2021. [Cited: 06 May 2022.] https://www.medicines.org.uk/emc/product/6307.
Summary of Product Characteristics; MMRVAXPRO. emc (Northern Ireland). [Online] 13 April 2022. [Cited: 06 May 2022.] https://www.emcmedicines.com/en-gb/northernireland/medicine?id=1f96d8ba-be03-4593-ab5f-2ea87705cf1e&type=smpc.
Chapter 14a; COVID-19 - SARS-CoV-2. The Green Book. [Online] 28 February 2022. [Cited: 06 May 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: 06 May 2022.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/147868/Green-Book-Chapter-8- v4_0.pdf.
Measles, Mumps and Rubella Vaccine, Live. BNF; The National Institute for Health and Care Excellence. [Online] [Cited: 06 May 2022.] https://bnf.nice.org.uk/drug/measles-mumps-and-rubella-vaccine-live.html.
Chapter 4; Immunisation procedures. The Green Book. [Online] June 2021. [Cited: 06 May 2022.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/147915/Green-Book-Chapter- 4.pdf.
Chapter 21; Measles. The Green Book. [Online] December 2019. [Cited: 06 May 2022.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/855154/Greenbook_chapter_21_ Measles_December_2019.pdf.

Additional resources

Measles. NHS. [Online] February 21, 2022. [Cited: May 06, 2022.] https://www.nhs.uk/conditions/measles/.
MMR catchup programme: diagnosis, case management, and advice. GOV.UK. [Online] May 02, 2013. [Cited: May 06, 2022.] https://www.gov.uk/guidance/mmr-catchup-programme-diagnosis-case-management-and-advice.
Chapter 23; Mumps. The Green Book. [Online] April 04, 2013. [Cited: May 06, 2022.] https://www.gov.uk/government/publications/mumps-the-green-book-chapter-23.
Chapter 28; Rubella. The Green Book. [Online] April 04, 2013. [Cited: May 06, 2022.] https://www.gov.uk/government/publications/rubella-the-green-book-chapter-28.
Chapter 6; Contraindications and special considerations. The Green Book. [Online] October 26, 2017. [Cited: May 06, 2022.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/655225/Greenbook_chapter_6.pd f.
Vaccines and porcine gelatine. GOV.UK. [Online] November 10, 2020. [Cited: May 06, 2022.] https://www.gov.uk/government/publications/vaccines-and-porcine-gelatine.
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.