PGD for PCV13 PCV PGD 2014 … · Pneumococcal Conjugated Vaccine 7 (replaced with PCV13 in 2010);...

PGD for PCV13

Reference Number: NHSE(LR)/PGD/PCV13 v1.1 Page 1 of 10 Valid from: 1st April 2014 Review date: 1st January 2016 Expiry date: 31st March 2016

Patient Group Direction for the Administration of Pneumococcal Conjugated

Vaccine (PCV13 - Prevenar 13® )

This PGD must be read in conjunction with the core PGD (Reference:

NHSE(LR)/PGD/Core PGD for Immunisations), which details information that is common to all of the immunisation PGDs.

This 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: 1.1

Expiry date: 31st March 2016 The master copy for this PGD is held N:\2.0 Medical\Clinical Adviser Medicines\Patient Group Directions\Final Signed PGDs\Immunisation PGDs 2014 Change history Version number

Change details Date

1.0 First version December 2013 1.1 Revision of content March 2014

PGD for PCV13


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

References: • SmPC References for Prevenar 13®. Latest version on eMC (accessed March

2014): http://www.medicines.org.uk/emcmobile/medicine/22689/spc

• Green Book chapter on Pneumococcal vaccines (accessed March 2014): https://www.gov.uk/government/publications/pneumococcal-the-green-book-chapter-25

PGD for PCV13


PGD for PCV13


Patient Group Direction for the Administration of Pneumococcal Conjugated Vaccine (PCV13 - Prevenar 13® )

Clinical condition or situation to which this PGD applies

Active immunisation against pneumococcal disease.

Inclusion criteria • Child aged from 2 months and up to 2 years of age as a primary course of immunisation against pneumococcal disease;

• Any child aged 2 to 5 years in a clinical risk group, in whom there is an increased risk of morbidity or mortality from pneumococcal disease. Clinical at-risk groups (see Appendix 1 for more specific details) include: o Asplenia, or dysfunction of spleen; o Immunosuppression due to disease or treatment; o Chronic respiratory disease; o Chronic heart disease; o Chronic kidney disease; o Chronic liver disease; o Diabetes mellitus; o Individuals with cochlear implants; o Individuals with cerebrospinal fluid leaks;

• Children aged 2-5 years with asplenia, splenic dysfunction, immunosuppression, or complement deficiency, who completed routine childhood vaccinations with Pneumococcal Conjugated Vaccine 7 (replaced with PCV13 in 2010);

• Children under 5 years of age who have previously had invasive pneumococcal disease (IPD);

• Severely immunocompromised (see Appendix 1 for definitions) children aged at least 5 years, and adults - irrespective of their routine childhood vaccinations.

Exclusion criteria As above in general exclusion criteria, plus: • Child under 2 months of age; • Has had a previous dose of Pneumococcal Conjugate

Vaccine (PCV) within the last 2 months; • Any individual who has had a confirmed anaphylactic

reaction to a previous dose of pneumococcal conjugate vaccine or a confirmed anaphylactic reaction to any component of the vaccine including diphtheria toxoid;

• Children in a clinical risk group, starting immunisation at 5 years of age or over;

• Children NOT in a clinical risk group, starting immunisation at aged 2 years or over.

PGD for PCV13


Action if excluded • If under 2 months of age defer until appropriate age; • If excluded due to previous dose of PCV, wait until the

recommended interval has passed; • Children in a clinical risk group starting immunisation at 5

years of age or over - give pneumococcal polysaccharide vaccine 23-valent (PPV23) only (see PGD for PPV23).

Special considerations/ additional information

• Cochlear implants: Where possible vaccination should be completed at least 2 weeks before implantation. However surgery should not be delayed if the course of immunisation has not been completed;

• For children who will later require a dose of pneumococcal polysaccharide vaccine PPV23 discuss with parent/carer/ patient and refer to GP;

• Very premature infants (born ≤ 28 weeks of gestation) who are in hospital should have respiratory monitoring for 48-72 hours when given their first immunisation, particularly those with a previous history of respiratory immaturity. If the child has apnoea, bradycardia or desaturations after the first immunisation, the second immunisation should also be given in hospital, with respiratory monitoring for 48-72 hours.

Details of the medicine

Name, form and strength of medicine

Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) suspension for injection (PCV13 - Prevenar 13®)

Dose 0.5ml

Frequency CHILDREN NOT IN A CLINICAL RISK GROUP (routine schedule) Infants aged 2 to 12 months: • 3 doses at 2, 4 and 12 months (3rd dose at 13 months of

age at the latest); • Minimum 2 month interval between doses; • Third dose should always be given after first birthday Unimmunised or partially immunised child aged 12 to 24 months: • One dose ADDITIONALLY, IF IN A CLINICAL RISK GROUP At-risk children aged 12 months to 5 years with asplenia, splenic dysfunction, or immunosuppression: • 2 doses with a 2 month interval;

PGD for PCV13


• All should also receive a dose of PPV23 vaccine after the second birthday and at least 2 months after the last dose of PCV (refer to PGD for PPV).

At-risk children aged 12 months to 5 years: • One dose; • All should also receive a dose of PPV23 vaccine after the

second birthday and at least 2 months after the last dose of PCV13 (refer to PGD for PPV23).

Severely immunocompromised children diagnosed from five years onwards and adults: • One dose; • All should also receive a dose of PPV23 vaccine at least 2

months after the last dose of PCV13 (refer to PGD for PPV23).

Refer to Appendix 2 for pneumococcal vaccination schedule for at-risk patients (and refer to PGD for PPV23).

Quantity Depends on schedule (see above) Adverse effects As detailed in the core PGD, plus

Common: • Pyrexia; • Irritability; • Somnolence; • Poor quality sleep. • Refer to SmPC for complete list.

PGD for PCV13


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 the vaccine in accordance with this PGD;

• The training has included both the theoretical and practical aspects of the techniques required to administer vaccines by the following routes (please tick as appropriate): Intramuscular injection □ Subcutaneous injection □

• 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 this vaccine. 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.

PGD for PCV13


Appendix 1

Clinical At-Risk Groups for Pneumococcal Vaccination (Adapted from Table 25.1 Green Book, Chapter 25)

Clinical At-Risk Group Examples

Asplenia, or dysfunction of spleen

Includes sickle cell disease, and coeliac syndrome that may lead to splenic dysfunction.

Chronic respiratory disease

• Chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema; bronchiectasis, cystic fibrosis, interstitial lung fibrosis, pneumoconiosis, and bronchopulmonary dysplasia (BPD);

• Children with respiratory conditions caused by aspiration, or a neurological disease (e.g. cerebral palsy) with a risk of aspiration

• Asthma is not an indication unless is so severe that it requires continuous or frequently repeated use of systemic steroids (as defined in Immunosuppression, below).

Chronic heart disease

• Congenital heart disease; • Hypertension with cardiac complications; • Chronic heart failure; • Individuals requiring regular medication and/or

follow-up for ischaemic heart disease.

Chronic kidney disease

• Chronic kidney disease at stages 4 and 5 (see http://www.kidney.org/professionals/kdoqi/guidelines_ckd/p4_class_g1.htm for definitions);

• Kidney dialysis; • Nephrotic syndrome; • Kidney transplantation.

Chronic liver disease Includes cirrhosis, biliary atresia, and chronic hepatitis.

Diabetes mellitus

• Type 1 diabetes; • Type 2 diabetes requiring insulin or oral

hypoglycaemic medicines (does not include diet controlled diabetes).

Immunosuppression due to disease or

treatment

• Patients undergoing chemotherapy leading to immunosuppression;

• Asplenia or splenic dysfunction; • Bone marrow transplant; • HIV infection at all stages;

PGD for PCV13


• Multiple myeloma; • Genetic disorders affecting the immune system

(e.g. IRAK-4, NEMO, complement deficiency) • Individuals treated with, or likely to be treated with,

systemic steroids for more than a month at a dose equivalent to prednisolone at 20mg or more per day (any age), or for children under 20kg a dose of 1mg or more per kg per day.

Individuals with cochlear implants

It is important that immunisation does not delay the cochlear implantation.

Individuals with cerebrospinal fluid

leaks

Includes leakage of cerebrospinal fluid such as following trauma or major skull surgery, and those with CSF shunts.

PGD for PCV13


Appendix 2

Pneumococcal Vaccination Schedule for Those in a Clinical Risk Group (Adapted from Table 25.2 Green Book, Chapter 25)

Age of At-Risk Child (at presentation)

PREVENAR 13® ▼ 13-valent pneumococcal

conjugate vaccine (PCV13)

PNEUMOVAX II® 23-valent pneumococcal polysaccharide vaccine

(PPV23)

2 months to under 12 months of age (includes children who have asplenia, or splenic dysfunction, or who are immunosuppressed)

Vaccination according to the routine immunisation schedule at 2 months, 4 months and between 12 & 13 months of age (i.e. within a month of the first birthday)

One dose after the second birthday PPV23 should be given at least 2 months after final dose of PCV

12 months to under 5 years

One dose One dose after the second birthday and at least 2 months after the final dose of PCV13

12 months to under 5 years of age who have asplenia or splenic dysfunction or who are immunosuppressed

Two doses, with an interval of 2 months between doses

One dose after the second birthday and at least 2 months after the final dose of PCV13

Between 2 & 5 years of age who have been fully immunised who then develop splenic dysfunction or immunosuppression

One additional dose

At-risk children aged over 5 years and at-risk adults

PCV13 is not recommended One dose

PGD for PCV13 PCV PGD 2014 … · Pneumococcal Conjugated Vaccine 7 (replaced with PCV13 in 2010);...

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