Patient Group Direction (PGD) for the administration of typhoid vaccine

1. Clinical condition or situation to which the direction applies

Indication

• Pre-exposure immunisation against typhoid fever caused by Salmonella enterica serovar

Typhi, (S. Typhi).

Objectives of care

• Reduce morbidity and mortality from typhoid fever.

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 2 years of age (N.B. product specific age exclusions must be followed –

  see description of treatment).

• Patients travelling to areas of high typhoid endemicity, especially where there is poor sanitation and food hygiene.

• Travellers visiting typhoid-endemic areas whose planned activities put them at higher

risk.

Exclusion criteria

(Refer to current and relevant

• Patients for whom no valid consent has been received.

• Hypersensitivity to the active substance(s) or to any of the excipients or trace residuals

SPC (Great Britain or

in the typhoid vaccine. See section 2 and 6.1 of the relevant Summary of Product

Northern Ireland) and online

Green Book guidance for additional details)

Characteristics (SPC).

• Individuals under 2 years of age.

• Patients with acute febrile illness.

• Has an evolving neurological condition (with an evolving neurological condition,

immunisation should be deferred until the neurological condition has resolved or

stabilised).

Additional Vivotif® exclusions

• Patients under 5 years of age.

• Patient is immunosuppressed through disease, treatment or medication.

• Patients with acute gastrointestinal illness.

• Patients who are receiving or have completed any antibiotic or antibacterial sulfonamide

treatment in the last three days.

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

Cautions

(including any relevant action to be taken)

Pregnancy and breastfeeding

• Vaccines can be administered during pregnancy or breastfeeding where there is a high risk of infection, and the benefits of vaccination outweigh the risks (1) (2). It is recommended that the appropriate healthcare professional (e.g. GP, midwife) is consulted prior to injection.

  Bleeding disorders (TYPHIM Vi®)

• TYPHIM Vi® 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). 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. If in any doubt, the clinician responsible for prescribing or monitoring the patient’s anticoagulant therapy should be consulted prior to injection (3).

• TYPHIM Vi® may alternatively be administered by the subcutaneous (SC) route to individuals with bleeding disorders (N.B. There is a lack of evidence that subcutaneous injection is any safer than intramuscular injection in individuals taking anticoagulants, and injection by this route is more likely to cause local reactions) (4). Healthcare professionals who are not professionally competent to perform SC injections should refer the individual(s) to a suitable alternative provider.

  Syncope (TYPHIM Vi®)

• 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

(1).

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

Cautions

(including any relevant action to be taken)

Immunosuppressed patients (TYPHIM Vi®)

• 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 (5).

• 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

    Protection

• These vaccines provide protection against the risk of infection related to Salmonella typhi but gives no protection against Salmonella paratyphi A or B or against non- typhoidal Salmonellae. Even after vaccination, not all recipients of will be fully protected against typhoid fever. Therefore, travellers should take all necessary precautions to avoid contact with or ingestion of potentially contaminated food or water (1) (2).

  Other considerations

• For patients with other health conditions, the risks and benefits of vaccination must be weighed on an individual basis. Refer to the appropriate healthcare professional e.g. GP. 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.

• Vivotif® may be administered concomitantly with yellow fever vaccine, CVD 103-HgR cholera vaccine and oral polio vaccine. No data are available regarding interaction between Vivotif and other live attenuated vaccines (2).

• Vaccination with Vivotif® should be postponed during and for at least three days before and after antibiotic or antibacterial sulfonamide treatment, due to possible inhibition of the growth of the vaccine organisms and potential attenuation of the immune response. A longer interval should be considered for long-acting antibiotics (e.g., azithromycin) (2).

• TYPHIM Vi® may be administered during the same vaccination session with other common vaccines (yellow fever, diphtheria, tetanus, poliomyelitis, rabies prepared on Vero cells, meningitis A+C, hepatitis A and hepatitis B) (1).

  Malaria Prophylaxis (Vivotif®)

• Atovaquone/proguanil can be given concurrently (6).

• There should be at least a 12-hour interval between a dose of mefloquine and a dose of oral typhoid vaccine (6).

• If other malaria prophylaxis is needed, it is recommended to complete the vaccination with Vivotif® prior to malaria prophylaxis. In this case, an interval of at least three days

should be kept between the last dose of Vivotif® and the start of malaria prophylaxis (6).

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.

• Give appropriate advice about food, water, personal hygiene and other preventative measures if travelling.

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.

• Use leaflet/information sheets produced by manufacturer, Public Health England and/or NaTHNaC if appropriate.

• Give appropriate advice about food, water, personal hygiene and other preventative

measures if travelling.

2. Description of vaccine

Name, strength & formulation of drug

Supplier

Name of

product

Composition

Pharmaceutical form

Excipients

Age

indications

Emergent BioSolutions UK

Vivotif®

Salmonella enterica serovar Typhi (abbr. S. Typhi) Ty21a

Gastro-resistant capsules, hard

-Lactose

- Sucrose

For the full list of excipients, see section 6.1.

From 5 years

Sanofi Pasteur

TYPHIM Vi®

Purified Vi capsular polysaccharide

of Salmonella typhi (Ty2 strain)

Solution for injection

• Phenol (preservative)

• Isotonic buffer solution*

  *Composition of the isotonic buffer solution:

• Sodium Chloride

• Disodium phosphate dihydrate

• Sodium dihydrogen phosphate dihydrate

• Water for Injections

From 2 years

• For a full list of excipients, refer to section 6.1 and 2 of the relevant SPC.

Legal status

• POM – Prescription Only Medicine

Dose/dose range

• TYPHIM Vi®: 0.5 mL (1)

• Vivotif®: Three capsules are to be taken on alternate days (see frequency of administration) (2)

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 - continued

Route/method of administration

TYPHIM Vi®

• Single dose of 0.5 mL by intramuscular injection (IM) into the deltoid region of the upper arm (1).

• 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).

• Shake well immediately before use (1).

• For intramuscular injection. The vaccine must not be injected intravenously or intradermally and must not be mixed with other vaccines in the same syringe (1). 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) (3). Alternatively, vaccination can be given by subcutaneous injection to reduce risk of bleeding (see cautions).

• 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).

• If two needles of different lengths are provided in the pack, choose the appropriate needle to ensure an intramuscular administration. For children of all ages and adults a 23G (blue) 25mm long needle is recommended (7).

  Vivotif®

• Gastro-resistant capsules for oral administration (2).

• A capsule is to be taken 1 hour before a meal (2).

• Capsules should be swallowed as soon as possible after placing in the mouth, with a cold or lukewarm drink (2).

• Vaccine capsules should not be chewed (2).

Frequency of administration

Vivotif®:

• One capsule is to be taken on day 0. The second capsule should be taken on day 2 and the third capsule on day 4 (2).

• The 1st dose should be administered face to face with the healthcare professional. Following administration of the 1st dose, the 2nd and 3rd doses can be supplied to the patient/carer for administration at home on days 2 and 4.

  TYPHIM Vi®:

• Single dose of 0.5 mL (1).

Follow up / minimum or maximum period

Vivotif®

• In the case of travel from a non-endemic area to an area where typhoid fever is endemic, a booster consisting of three doses may be given every three years (8).

  TYPHIM Vi®

• A single dose of vaccine should be administered at three-year intervals in adults and children over two years of age who remain at risk from typhoid fever (8).

• Follow available official recommendations regarding the need for boosters or further doses (see the Green Book Chapter 33). https://www.gov.uk/government/publications/typhoid-

the-green-book-chapter-33

3. Further aspects of vaccination

Adverse reactions and their management

• Follow local SOP on adverse reactions and their management.

  TYPHIM Vi® (1)

• Very common side effects include (≥1/10): Headache, myalgia, injection site pain, injection site erythema and injection site swelling/oedema/ induration.

• Common side effects include (≥1/100 to <1/10): Malaise, fever and fatigue.

• Frequency not known: Asthma, nausea, vomiting, diarrhoea, abdominal pain, allergic type reactions such as pruritus, rash, urticaria and arthralgia.

  Vivotif® (2)

• Common side effects include (≥1/100 to <1/10): Headache, abdominal pain, nausea, vomiting and diarrhoea.

• Emergency equipment must be available including immediate access to epinephrine (adrenaline) 1:1000 for intramuscular (IM) injection. Please refer to resuscitation council guidelines (9).

• 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/

• Follow local SOPs for adverse event management and reporting.

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.

• TYPHIM Vi®: Vaccination should occur at least 2 weeks prior to potential exposure to infection with Salmonella typhi

• Vivotif®: Protection against typhoid fever commences approximately seven to ten days after ingesting the third dose of vaccine. The entire vaccination schedule should be completed at least one week prior to travel to an endemic area.

  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.

• Give appropriate food, water and personal hygiene advice if travelling.

  Vaccine record

• Provide patient with a record of vaccination.

• Paracetamol or ibuprofen should only be recommended to treat pain, headache or fever if they occur after a dose.

  Vivotif® supply

• If the 2nd and 3rd doses are supplied for self-administration, the patient/carer should be made aware of the importance of using the capsules as recommended. Instructions on how to use and store the capsules can be found on the patient information leaflet or the

carton box.

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).

• Vivotif® capsules and TYPHIM Vi® should be stored at 2-8 °C and protected from light.

• Vivotif® supplied using this PGD must be affixed with a label as per dispensing SOP.

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

1. Summary of Product Characteristics; TYPHIM Vi Solution for Injection. emc (Great Britain). [Online] 11 January 2021. [Cited: 19 December 2022.] https://www.medicines.org.uk/emc/product/1393.

1. Summary of Product Characteristics; Vivotif Gastro-resistant capsules, hard. emc (Great Britain). [Online] 7 December 2018. [Cited: 19 December 2022.] https://www.medicines.org.uk/emc/product/1912.

2. Chapter 14a; COVID-19-SARS-CoV-2. The Green Book. [Online] 05 September 2022. [Cited: 19 December 2022.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1057798/Greenbook-chapter-14a- 28Feb22.pdf.

3. Chapter 19; Influenza. The Green Book. [Online] 21 September 2022. [Cited: 19 December 2022.] https://www.gov.uk/government/publications/influenza-the-green-book-chapter-19.

4. Chapter 7; Immunisation of individuals with underlying medical conditions. The Green Book. [Online] January 2020. [Cited: 19 December 2022.]

   https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/857279/Greenbook_chapter_7_Imm unsing_immunosupressed.pdf.

5. Typhoid vaccine. BNF; The National Institute for Health and Care Excellence. [Online] [Cited: 19 December 2022.] https://bnf.nice.org.uk/drug/typhoid-vaccine.html.

6. Chapter 4; Immunisation procedures. The Green Book. [Online] June 2012. [Cited: 19 December 2022.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/147915/Green-Book-Chapter-4.pdf.

7. Chapter 33; Typhoid. The Green Book. [Online] 4 February 2022. [Cited: 19 December 2022.] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1052907/Greenbook-chapter-33- 4Feb22.pdf.

8. Guidance: Anaphylaxis. Resuscitation Council UK. [Online] [Cited: 04 April 2022.] https://www.resus.org.uk/library/additional- guidance/guidance-anaphylaxis.

Additional resources

1. Typhoid and paratyphoid. travel Health Pro. [Online] January 27, 2022. [Cited: April 04, 2022.] https://travelhealthpro.org.uk/factsheet/49/typhoid-and-paratyphoid.

   
   

2. 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.

3. 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.