PGD Version No.: 3/

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1 Document Title: Patient Group Direction for Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) - Prevenar 13 ( ) Area Team Doc Ref.: PGD Version No.: 3/2014 NHS Doc Ref.: Author: Owner: File Reference: Document Overseeing Group: Jacqui Seaton, Head of Medicines Management Rebecca Woods, Head of Public Health Commissioning I:\NHS_ENGLAND\AngleseyHouse\Commissioning Directorate\Primary Care & Specialised Commissioning\Public Health\Immunisation\ \10) PGDs\Approved PGD Working Group Placement in Framework: Approval Level: Medicines Management Committee Date of Approval: November 2014 Review Date: November 2016 Amendment Dates: Page(s) Brief Description October 2014 Updated to new PGD format 1

2 Patient Group Direction for administration of Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) - Prevenar 13 ( ) Please note: There are 2 pneumococcal vaccines, this PGD applies to the Pneumococcal polysaccharide Conjugate Vaccine (PCV) - Prevenar 13 ( ) only. There is a separate PGD relating to 23-valent pneumococcal polysaccharide vaccine (PPV). Approved By NHS England and Staffordshire Area Team Medical Director Name Dr Ken Deacon Signature LPN Pharmacy Chair Dr Manir Hussain Head of Public Health Commissioning Rebecca Woods Date of patient group direction approved November 2014 Date this patient group direction becomes due for review November 2016 or in response to new local/national guidelines. 2

3 STAFF CHARACTERISTICS Provider of NHS services within NHS England (Shropshire & Staffordshire Area Team) Registered nurse with current NMC registration Specialist competencies or qualifications: The health care professional must have a good understanding of the NICE Good Practice Guidance on Patient Group Directions. The NICE competency framework: For health professionals using Patient Group Directions should be used by health care professionals planning to work under this PGD to identify any gaps in their knowledge. The gaps should be addressed before the healthcare professional is authorised to work under this PGD. The clinical manager/ lead GP/commissioner must have evidence that the health care professional has undertaken training to carry out clinical assessment of patient leading to confirmation that the patient requires treatment according to the indications listed in the PGD. The healthcare professional must provide evidence of training, appropriate annual updates and continued professional development undertaken to support their competence for administration of this treatment. The clinical manager/ lead GP must have assessed the competency of the healthcare professional to work to this Patient Group Direction. The NICE competency framework: For health professionals using Patient Group Directions should be used to support this assessment. The health care professional must have undertaken training and annual updates in the recognition and treatment of anaphylaxis, including practical in Basic Life Support and has immediate access to an in-date supply of adrenaline 1mg in 1ml (1:1000) at the time of the consultation. (The practitioner must be deemed competent in basic life support and in emergency administration of adrenaline) The health care professional must have access to all relevant sources of information e.g. information issued by the Department of Health (Green Book), British National Formulary (BNF), Summary of Product Characteristics (SPC), and the clinical guideline concerning medicine(s) within this Patient Group Direction (PGD). The practitioner must be competent and knowledgeable in vaccine cold chain standards. The registered health care practitioner is professionally accountable for supply or administration under the PGD as defined in their own profession s Code of Professional Conduct and Ethics. YOU MUST BE AUTHORISED BY NAME BY YOUR CLINICAL LEAD UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY 3

4 CLINICAL CONDITION Clinical need addressed Inclusion criteria For active immunisation against invasive disease (including sepsis, meningitis, bacteraemic pneumonia, bacteraemia) caused by streptococcus pneumoniae serotype 1, 3, 4, 5, 6A, 6B, 7F,9V, 14, 18C, 19A, 19F and 23F as recommended in the childhood immunisation schedule. ( All children from eight weeks of age to under two years of age as part of the routine childhood immunisation programme. Children aged 1 to 2 years with unknown or incomplete vaccination history Clinically at-risk children aged over 12 months and under 5 years, presenting late for immunisation, or who have incomplete vaccination history. Children over one year and under 5 years of age in a clinical risk group as identified within the Green Book Pneumococcal chapter 25 (appendix 1). (Patients not covered within the risk groups should be assessed on an individual basis and administration if necessary should be done by patient specific direction) Exclusion criteria (for full details of interacting medicines refer to current Summary of Product Characteristics (SPC) & BNF) Caution/need for further advice /Interactions Declined consent (parent/guardian) Acute febrile illness A confirmed hypersensitivity reaction to a previous dose of the Prevenar 13 ( ) vaccine. A confirmed hypersensitivity reaction to any component of the vaccine. A confirmed hypersensitivity reaction to diphtheria toxoid Prevenar 13 ( ) is not intended for use in adults. Prevenar 13 ( ) should not be given to children under 6 weeks or over 5 years of age. Check past medical history and allergies prior to administration of vaccine Minor illnesses without fever or systemic upset (e.g. a cold) are not valid reasons to postpone immunisation. If an individual is acutely unwell, immunisation may be postponed until they have fully recovered. Prevenar 13 ( ) does not contain any latex or thiomersal. Immunocompromised children (from disease or treatment) may not develop a full antibody response. Re-immunisation should be considered after treatment is finished and recovery has occurred. Specialist advice may be required (see current Green Book). Inhaled and topical steroids do not cause immunosuppression. Very premature infants (born 28 weeks of gestation) who are in hospital should have Prevenar 13 ( ) PGD respiratory monitoring for hrs 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 hrs. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed. 4

5 Pneumococcal vaccines can be given at the same time as other vaccines such as DTaP/IPV/Hib, MMR, MenC, Hib/MenC and influenza. The vaccines should be given at separate sites, preferably in different limbs. If given in the same limb, they should be given at least 2.5cm apart. The site at which each vaccine was given should be noted in the individual s records. Management of excluded patients Action for patients not wishing to receive care under this PGD Document in the individual s notes, advise and counsel accordingly. Refer to medical practitioner or seek appropriate advice from a Consultant in Health Protection if necessary For individuals temporarily excluded due to acute or febrile illness advise when the vaccine may be given and arrange another appointment. Advise the individual about the protective effects of the vaccine, the risks of infection, including potential complications. Document action and advice given (record declined vaccine in the individuals clinical record). Refer to doctor or independent prescriber. Treatment and Drug details Name form and strength of medicine Legal classification Black triangle warning Suspected adverse reactions. Should be reported using the Yellow Card reporting scheme ( Method of obtaining supply Site for treatment Route/method Prevenar 13 ( )suspension for injection (PCV) Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) POM Prescription only medicine. Yes Order through the ImmForm website ( GP surgeries Health Centres Prevenar 13 ( )is routinely administered by intramuscular injection (preferably into anterolateral aspect of thigh in infants or deltoid muscle of the upper arm in young children) Vaccination by deep subcutaneous route should be reserved only for individuals with a bleeding disorder. NB. Shake the vaccine well immediately before administration (Storage can cause the vaccine to separate into a white deposit and clear supernatant. The vaccine should be shaken well to obtain a white homogeneous suspension and should not be used if there is any residual particulate matter after shaking.) Dose Number of times treatment may be administered 0.5ml Single dose Primary Immunisation and Reinforcing Immunisation The primary course of Prevenar 13 ( ) vaccination consists of two doses with an interval of two months between each dose. The recommended schedule for vaccination is two and four months of age. If the primary course is interrupted, it should be resumed but not repeated, allowing an interval of two months between doses. 5

6 A reinforcing (booster) dose of Prevenar 13 ( ) is recommended at 12 months of age for children who have received a complete primary course of two PCVs. Schedule First dose of 0.5ml of Prevenar 13 ( ) at two months of age. Second dose of 0.5ml at four months of age (at least two months after the first dose). A third dose of 0.5ml should be given at 12 months (at least 2 months after the last Prevenar 13 ( ) dose) Children with unknown/incomplete vaccination status Children under 1 year of age 2 doses given at least two months apart, with third dose to be given in second year of life at least one month after the second dose. Clinical Risk Groups See appendix 1 for clinical risk groups who should receive the pneumococcal immunisation. Children at increased risk of/from pneumococcal disease presenting late for vaccination If aged under 12 months 2 doses given before the age of 12 months (one month apart if necessary to ensure that 2 doses are given before a dose at 13 months) and a further dose at 13 months. If aged 12 months to 5 years single dose. NB children in this age group who have asplenia or splenic dysfunction or who are immunocompromised and may have a sub-optimal immunological response to the first dose of vaccine, a second dose should be given two months after the first dose. Children under 5 years who have had invasive pneumococcal disease Single dose irrespective of previous vaccination history. Children under 13 months with unknown or incomplete vaccination status should complete PCV schedule as above. NB: All children identified as being at increased risk of pneumococcal disease should also receive a single dose of pneumococcal polysaccharide vaccine after their 2 nd birthday, at least 2 months after the final dose of pneumococcal conjugate vaccine (please see separate PGD for pneumococcal polysaccharide vaccine PPV). See table below for summary of vaccination of children in clinical risk groups Age at presentation At-risk children 2 months to under 12 months of age Vaccine given and when to immunise 13-valent PCV 23-valent PPV (See PPV PGD) Vaccination according One dose after the to the routine second birthday immunisation schedule at 2, 4 and between 12 and 13 months of age (i.e. within a month of the first birthday) 6

7 At-risk children 2 months to under 12 months of age who have asplenia or splenic dysfunction or who are immunosuppressed At risk children 12 months to under 5 years of age At-risk children 12 months to under 5 years of age who have asplenia or splenic dysfunction or who are immunosuppressed At-risk children aged over 5 years and at-risk adults Vaccination according to the routine immunisation schedule at 2, 4 and between 12 and 13 months of age (i.e within a month of the first birthday) One dose Two doses with an interval of 2 months between doses PCV is not recommended One dose after the second birthday One dose after the second birthday and at least 2 months after the final dose of PCV One dose after the second birthday and at least 2 months after the final dose of PCV One dose Quantity to be supplied or administered Side effects Full details of side effects are available in the SPC. Suspected adverse reactions to drugs including vaccines should be reported on the yellow card available at the back of the BNF. Also at One dose(0.5ml) as per immunisation schedule Gastrointestinal disorders: Very common: Decreased appetite Common: Vomiting; diarrhoea Skin and subcutaneous tissue disorders: Common: Rash General disorders and administration site conditions: Very common: Pyrexia; irritability; any vaccination-site erythema, induration/swelling or pain/tenderness; somnolence; poor quality sleep Vaccination-site erythema or induration/swelling 2.5 cm-7.0 cm (after the booster dose and in older children [age 2 to 5 years]) Common: Pyrexia > 39 C; vaccination-site movement impairment (due to pain); vaccination-site erythema or induration/swelling 2.5 cm-7.0 cm Additional Information (including storage and disposal) Store in a refrigerator (+2 0 C to C) Do not freeze Store in original packaging Protect from light Equipment used for vaccination should be disposed of by placing in a proper, puncture-resistant sharps box according to local authority regulations and guidance in Health Technical Memorandum 07-01: Safe management of healthcare waste (Department of Health, 2013) 7

8 Advice to patient/carer Follow up BEFORE TREATMENT: Advise parent/guardian of possible side effects. For full details see product s summary of product characteristics. Advise action to be taken if side effects are experienced AFTER TREATMENT: Provide patient information leaflet Advise parent/guardian about next scheduled vaccination Inform of possible side effects and their management. Any serious adverse reaction to the vaccine should be documented in a child s health records and on their medical records. GP should also be informed. Suspected adverse reactions Patient presenting with suspected adverse drug reaction should be referred to a doctor for further investigations. All serious suspected reactions following vaccination should be documented in the patient s medical record and reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card scheme at Error reporting Any incidents or near-miss issues must be reported via the organisation s internal reporting system RECORD KEEPING Documentation needed/treatment records to be kept for audit purposes A computer or manual record of all individuals receiving treatment under this Patient Group Direction should also be kept for audit purposes. Patient s name, address, date of birth and registered GP Record of informed consent Manufacturer, vaccine name, product name, batch number, expiry date Dose administered Date of administration Anatomical site of vaccination Route of administration Advice given to patient (including advice given if vaccination is declined) Details of staff who administered (sign and print name) Details of any adverse drug reactions, and action taken including informing GP Record as supplied via Patient Group Direction (PGD) in patient s clinical record All records should be clear, legible and contemporaneous. This information should be recorded as appropriate in the patient s General Practitioner record or other patient record, depending on location AND the personal Child Health record (PCHR) the Red Book. A computerised or manual record of all individuals receiving treatment under this Patient Group Direction should also be kept for audit purposes. If vaccination has been completed by a provider other than the GP practice, timely communication to the GP practice to enable the patient s record to be updated must be completed. Any noted adverse effects following vaccination must also be reported be to the GP practice. 8

9 Clinical records must be kept for at least 8 years following completion of treatment. In patients who are aged under 17 years, clinical records must be kept until the patient s 25th birthday, or for 8 years following a child s death. Data must be stored in accordance with Caldicott guidance and the Data Protection Act. Reconciliation stock balances should be reconcilable with receipts, administration records and disposal. 9

10 Register of practitioners qualified to administer and/or supply Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) - Prevenar 13 ( ) (PCV) under this Patient Group Direction Name of clinical manager/gp Lead/Commissioner Signature of clinical manager/gp Lead / Date: commissioner A copy of this page should be retained by the authorising manager for 2 years for audit purposes Please state clinical area where this PGD is in use Healthcare professional individual declaration I have read and understood the Patient Group Direction and agree to supply this medicine only in accordance with this PGD PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. It is the responsibility of each professional to practice only within the bounds of their own competence. All practitioners operating in accordance with this PGD should have a current, signed copy of it readily available for reference. If a practitioner is asked to supply, or administer a medicine not covered by this or any other PGD then a patient specific direction is required from a doctor, dentist or independent prescriber. Name of professional (please print) Signature Authorising Manager (Must sign against each entry) Date of authorisation The clinical lead should review competency of authorised practitioners annually. Authorisation to use this PGD does not remove inherent professional responsibility and accountability. References DH Immunisation against infectious disease Green Book Chapter 25 Pneumococcal Summary of Product Characteristics. Prevenar 13 suspension for injection. Available from: Acknowledgement: Medicines Management Team, Telford & Wrekin CCG for developing the PGD. 10

11 Appendix 1 Pneumococcal Clinical Risk Groups for Children (see dosage guide for immunisation requirements) Clinical Risk Group Asplenia or dysfunction of the spleen Chronic respiratory disease Chronic heart disease Examples (decision based on clinical judgement) This also includes conditions such as homozygous sickle cell disease and coeliac syndrome that may lead to splenic dysfunction.. This includes chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema; and such conditions as bronchiectasis, cystic fibrosis, interstitial lung fibrosis, pneumoconiosis and bronchopulmonary dysplasia (BPD). Children with respiratory conditions caused by aspiration, or a neuromuscular disease (e.g. cerebral palsy) with a risk of aspiration. Asthma is not an indication, unless so severe as to require continuous or frequently repeated use of systemic steroids (as defined in immunosuppression below). This includes those requiring regular medication and/or follow-up for ischaemic heart disease, congenital heart disease, hypertension with cardiac complications, and chronic heart failure. Chronic renal disease Chronic liver disease Diabetes Immunosuppression This includes nephrotic syndrome, chronic renal failure, renal transplantation. This includes cirrhosis, biliary atresia, chronic hepatitis. Diabetes mellitus requiring insulin or oral hypoglycaemic drugs. This does not include diabetes that is diet controlled. Due to disease or treatment, including asplenia or splenic dysfunction and HIV infection at all stages. Patients undergoing chemotherapy leading to immunosuppression. Individuals on or likely to be on 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. However, some immunocompromised patients may have a suboptimal immunological response to the vaccine. Individuals with cochlear implants It is important that immunisation does not delay the cochlear implantation. Where possible, pneumococcal vaccination should be completed at least 2 weeks prior to surgery to allow a protective immune response to develop. In some cases it will not be possible to complete the course prior to surgery. In this instance, the course should be started at any time prior to or following surgery and completed according to the immunisation schedule. Individuals with cerebrospinal fluid leaks This includes leakage of cerebrospinal fluid such as following trauma or major skull surgery. 11