Document Title: PCT Doc Ref.: Version No.: 1/2014. Local Doc Ref.:

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1 Document Title: Patient Group Direction (PGD) for the vaccination of pregnant women (gestation week 28 onwards) and new mothers against pertussis (Whooping Cough) using Boostrix-IPV (Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content) (dtap/ipv)) PCT Doc Ref.: Local Doc Ref.: PGD Version No.: 1/2014 Owner: File Reference: Document Overseeing Group: Placement in Framework: Jayne Carter, Administrator for Public Health Direct Commissioning Team I:\AngleseyHouse\Commissioning Directorate\Primary Care & Specialised Commissioning\Public Health\Immunisation\ \PGDs\Approved Approval Level: Date of Approval: PGD Oversight and Authorisation Group June 2014 Review Date: June 2016 Amendment Dates: Page(s) Brief Description June 2014 Boostrix-IPV PGD for the vaccination of pregnant women against pertussis developed in response to national change in pertussis vaccine procurement 1. This PGD will come into effect on 1 st July and will replace Repevax PGD for the vaccination of pregnant women against pertussis. Start date: 1 July 2014; Expiry date: 30 June 2016 Page 1 of 10

2 Patient Group Direction (PGD) for the vaccination of pregnant women (gestation week 28 onwards) and new mothers against pertussis (Whooping Cough) using Boostrix-IPV (Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content) (dtap/ipv)) For use during temporary programme of pertussis (Whooping Cough) vaccination of Pregnant Women Approved By NHS England Shropshire and Staffordshire Area Team Name Signature Medical Director Dr Ken Deacon Head of Public Health and Primary Care Mrs Rebecca Woods LPN Pharmacy Chair Dr Manir Hussain Date of patient group direction approved Date this patient group direction becomes due for review 30 June June 2016 or in response to new local/national guidelines. Start date: 1 July 2014; Expiry date: 30 June 2016 Page 2 of 10

3 STAFF CHARACTERISTICS Provider of NHS services within Shropshire and Staffordshire Area Team geography Registered nurse with current NMC registration Specialist competencies or qualifications: The clinical manager/ lead GP has 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 has proof of training by the healthcare professional on the legal aspects of supply or administration of medicines under a Patient Group Direction The clinical manager/ lead GP has assessed the competency of the healthcare professional to work to this Patient Group Direction. The healthcare professional has 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 practitioner needs to reinforce and update their knowledge and skills in this area of practice with particular reference to changes and national directives The registered healthcare 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 MANAGER UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY Start date: 1 July 2014; Expiry date: 30 June 2016 Page 3 of 10

4 CLINICAL CONDITION Clinical need addressed Inclusion criteria There has been a considerable increase in pertussis activity in the UK since mid The current national outbreak is the largest seen in the UK for over a decade. The greatest number of cases is in infants under the age of 3 months 3. The purpose of the programme is to boost antibodies in the vaccinated women in late pregnancy, so that pertussis specific antibodies are passed from the mother to her baby. The aim is to protect the infant before routine immunisation can be started at 8 weeks of age 3. Boostrix-IPV vaccine (dtap/ipv) should be offered to:- Pregnant women, in the period weeks 28 to 38 (inclusive) of pregnancy; the optimal time is in the period weeks 28 to 32 (inclusive) 3,4,5. Pregnant women who are now beyond week 38 of pregnancy should be offered immunisation up to the onset of labour so that some direct protection may still be provided to the infant 4,5 New mothers who have never previously been vaccinated against pertussis, up to when their child receives their first vaccination (usually at 8 weeks of age) 4,5. NB: There is no evidence of risk from vaccinating pregnant women or those who are breast-feeding with inactivated viral or bacterial vaccines or toxoids (Plotkin and Orenstein, 2004) 6,. NB: Women who have had the pertussis infection itself should still receive the vaccination as protection gained from natural infection is not life long and wanes over time. Vaccination will provide optimal antibody levels for the pregnant women to pass to her baby Exclusion criteria (for full details of interacting medicines refer to current Summary of Product Characteristics (SPC) & BNF) Pregnant women under 28 weeks of pregnancy Non consenting pregnant women There are very few medical reasons why Boostrix-IPV should not be given, however it should not be given to pregnant women who have had:- A confirmed anaphylactic reaction to a previous dose of pertussis, diphtheria, tetanus or polio vaccines; 7 A confirmed anaphylactic reaction to any component of the vaccine or to any substances carried over from manufacture including neomycin or polymyxin. 7 Confirmed anaphylactic reaction to latex. Manufacturer (GSK) should be contacted to determine the latex content of the batch of vaccine to be used 7 An encephalopathy (brain disorder) of unknown origin within seven days of previous immunisation with pertussis-containing vaccine 7 Transient thrombocytopenia or neurological complications following an Start date: 1 July 2014; Expiry date: 30 June 2016 Page 4 of 10

5 earlier immunisation against diphtheria and/or tetanus. 7 Temporary Exclusion If the pregnant woman is acutely unwell and has a fever, immunisation should be postponed until she has recovered. This is to avoid wrongly associating any cause of fever, or its progression, with the vaccine and to avoid increasing any pre-existing fever. Having a minor illness without a fever (e.g. a cold) is not a reason to delay immunisation. 6 Caution/need for further advice NB: The use of Boostrix-IPV is NOT contraindicated for breast feeding mothers. 7 Egg allergy is NOT a contraindication A history or a family history of convulsions and a family history of an adverse event following DTP vaccination DO NOT constitute contraindications 7 If any of the following events are known to have occurred around the time of receipt of a previous pertussis-containing vaccine, the decision to give pertussis-containing vaccines should be carefully considered 7 : - Temperature of 40.0 C within 48 hours of vaccination, not due to another identifiable cause. - Collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination. - Convulsions with or without fever, occurring within 3 days of vaccination. Vaccination should be deferred for individuals with evidence of current neurological deterioration including poorly controlled epilepsy 6,. Boostrix-IPV should be administered with caution to patients with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration 7 (see Route/Method section below) Interaction with other medicinal products Concomitant administration of Boostrix-IPV and other vaccines or with immunoglobulins has not been studied. It is unlikely that co-administration will result in interference with the immune responses 7. As with other vaccines, patients receiving immunosuppressive therapy may not achieve an adequate response 7. Boostrix-IPV may be administered concomitantly with human papilloma virus vaccine with no clinically relevant interference with antibody response to any of the components of either vaccine 7. According to generally accepted vaccine practices and recommendations, if concomitant administration of Boostrix-IPV with other vaccines or immunoglobulins is considered necessary, they should be given at separate sites preferably in a different limb. If given in the same limb they should be at least 2.5cm apart 6,7 There are no reasons why Boostrix-IPV cannot be administered at the same time as influenza vaccine. However, influenza immunisation should not be delayed until week 28 of the pregnancy, or after, in order to give Boostrix- Start date: 1 July 2014; Expiry date: 30 June 2016 Page 5 of 10

6 Management of excluded patients Action for patients not wishing to receive care under this PGD IPV at the same visit. Pregnant women are at risk of severe illness at any stage of pregnancy from influenza. 8 Document in the individual s notes, advise and counsel accordingly. Specialist advice must be sought on the vaccines and circumstances under which they should be given. The risk to the individual of not being immunised must be taken into account For individuals temporarily excluded due to acute or febrile illness advise when the vaccine may be given and arrange another appointment. Give advice about protective effects of the vaccine and the risks of infection and disease complications. Document advice given. Inform or refer to GP as appropriate. TREATMENT AND DRUG DETAILS Name form and strength of medicine Boostrix-IPV (Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content) (dtap/ipv)) Legal classification Boostrix-IPV is a sterile turbid white suspension supplied in a single dose (0.5 ml) pre-filled syringe. POM Prescription Only Medicine Black triangle warning Suspected adverse reactions. Should be reported using the Yellow Card reporting scheme ( Method of obtaining supply Site for treatment Route/method Dose Not applicable GP practices will be able to order Boostrix-IPV through ImmForm as part of this programme. GP surgeries Boostrix-IPV should be administered by deep intramuscular injection preferably into the deltoid muscle. 7 Intramuscular injections should be given with care in patients on anticoagulant therapy or suffering from coagulation disorders because of the risk of haemorrhage. In these situations and following official recommendations the administration of Boostrix-IPV by deep subcutaneous injection may be considered, although there is a risk of increased local reactions ml maximum dose 0.5 ml A single 0.5ml dose of Boostrix-IPV should be given irrespective of the number of foetuses in the pregnancy 3 Number of times treatment may be administered N.B. Shake vaccine gently immediately before administration to obtain a homogeneous turbid white suspension. Prior to administration, the vaccine should be visually inspected for any foreign particulate matter and/or variation of physical aspect. In the event of either being observed, discard the vaccine. Women who become pregnant again while the programme is in place should be offered immunisation during each pregnancy to maximise transplacental transfer of antibody. Pregnant women who have received Start date: 1 July 2014; Expiry date: 30 June 2016 Page 6 of 10

7 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 immunisation against pertussis, tetanus, diphtheria and/or polio relatively recently should also be offered immunisation, but with a gap of at least one month between immunisations. Although cumulative doses may increase the likelihood of injection site reactions or fever, this is outweighed by the expected benefit to the infant. 3 Single dose to be administered (0.5ml) 7 Inform the patient about possible side effects and their management. Give advice on temperature control Adverse Effects 7 Very common ( 1/10) Common ( 1/100 to <1/10) (in subjects aged 10 to 93 years) System Organ Class Frequency Adolescents and Adults Nervous System Disorders Very common Headache Gastrointestinal Disorders Common Vomiting, abdominal pain, nausea Additional Information (including storage and disposal) General Disorders and Administration Site Conditions Very common Common Injection site reactions (such as redness and/or swelling), fatigue, injection site pain Pyrexia (fever 37.5 C), injection site reactions (such as haematoma, pruritus, induration and warmth numbness) For further details about adverse effects see product SPC Store in a refrigerator (2 0 C 8 0 C) Do not freeze (If the vaccine has been frozen, the vaccine should be discarded) Protect from light (store in original packaging) Upon removal from refrigerator the vaccine is stable for 8 hours at 21 0 C Equipment used for vaccination, including used vials, ampoules, nasal applicator or partially discharged vaccines should be disposed of at the end of a session by sealing in a proper, puncture-resistant sharps box according to local authority regulations and guidance in the technical memorandum (Department of Health, 2006). i Boostrix-IPV is thiomersal free Advice to patient/carer Before Treatment: Advise patient of possible side effects. For full details see product s Start date: 1 July 2014; Expiry date: 30 June 2016 Page 7 of 10

8 summary of product characteristics. Advise action to be taken if side effects are experienced After Treatment: Provide patient information leaflet Any serious adverse reaction to the vaccine should be documented in the patient s GP medical records and the MHRA should be informed using the yellow card scheme. GP should also be informed. Follow up Suspected adverse reactions No routine follow up required Patient presenting with suspected adverse drug reaction should be referred to a doctor for further investigations. As with all vaccines, healthcare professionals and parents/carers are encouraged to report suspected adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card reporting scheme on: Error reporting 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. Any serious adverse reaction to the vaccine should be documented in the patient s medical record. Any incidents or near-miss issues must be reported to the Area Team immunisations query line: [email protected] Patient s name, address, date of birth and registered GP Manufacturer/brand of product, batch number, expiry date Record of informed consent 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. A computerised or manual record of all individuals receiving treatment under this Patient Group Direction should also be kept for audit purposes. 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. Data must be stored in accordance with Caldicott guidance and the Data Protection Act. Start date: 1 July 2014; Expiry date: 30 June 2016 Page 8 of 10

9 Reconciliation stock balances should be reconcilable with receipts, administration records and disposal. Register of practitioners qualified to administer and/or supply Boostrix-IPV (Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content) (dtap/ipv)) under this Patient Group Direction Name of clinical manager/gp Lead Signature of clinical manager/gp Date: Lead 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 1 Public Health England. Vaccine update issue 213 March Public Health England Vaccine update issue 215 May CMO letter 27 th September Gateway reference: Start date: 1 July 2014; Expiry date: 30 June 2016 Page 9 of 10

10 4 Deputy NHS Chief Executive Letter 28 th September Gateway reference number: Public Health England Letter 10 th May Continuation of temporary programme of pertussis (whooping cough) vaccination of pregnant women. 6 Green Book DOH (2006) Immunisation against Infectious Disease: London: HMSO (Chapter 24 Pertussis) 7 Boostrix-IPV Product SPC 8 Health Protection Scotland. NHS National Services Scotland, NHS Education for Scotland Vaccination against pertussis (whooping cough) the replacement of Repevax with Boostrix-IPV An update for registered healthcare practitioners May 2014 Start date: 1 July 2014; Expiry date: 30 June 2016 Page 10 of 10