Patient Group Direction (PGD) Number :

Notice to all staff: The Patient Group Directions (PGDs) for the Hertfordshire and South Midlands Area Team may only be used by members of the healthcare professions named on the title page, and only if each professional has individually been listed by their manager as an authorised user meeting the competency and training requirements of that PGD. Each healthcare professional using a PGD must also have signed a copy of that PGD and have one available to refer to. Staff must not download PGDs from the internet and use them straightaway. The PGDs are only on the internet so that the appropriate GP/clinical manager can access them when they need to authorise their team members, or to check that their team is using the most recent version. The GP/clinical manager should also have signed the appropriate section of the PGD before use. Page 1 of 11

Patient Group Direction (PGD) Number 12 0913: Administration of Adsorbed Diphtheria, Tetanus, Acellular Pertussis & Inactivated Poliomyelitis Combined Vaccine (dtap/ipv - Repevax ) to pregnant women by Registered Nurses employed by GP Practices within the Hertfordshire and South Midlands Area Team and signatories to the PGD Approval of Patient Group Direction This Patient Group Direction has been approved on behalf of the Hertfordshire and South Midlands Area Team by: Authorising Officer for the Name: Heather Moulder, Director of Nursing & Hertfordshire and South Midlands Quality Area Team Signature: Date: 20 th August 2013 Date of Issue September 2013 Issue Number PGD 12 0913 Date of Review September 2015 The Hertfordshire and South Midlands Area Team is committed to being an organisation within which diversity, equality and human rights are valued. We will not discriminate either directly or indirectly and will not tolerate harassment or victimisation in relation to gender, marital status (including civil partnerships), gender reassignment, disability, race, age, sexual orientation, religion or belief, trade union membership, status as a fixed-term or part-time worker, socio-economic status and pregnancy or maternity leave status. Equality Impact Assessment undertaken by the policy author Date: July 2013 This document is available electronically, in a larger font or an alternative format on request. Page 2 of 11

Document History: To replace: All previous PCT PGDs for the administration of Adsorbed Diphtheria, Tetanus, Acellular Pertussis & Inactivated Poliomyelitis Combined Vaccine (dtap/ipv - Repevax ) to pregnant women within the Hertfordshire and South Midlands Area Team Progress Lead Person & Contact Date Number V1 First Draft July 2013 V2 Final Draft Including amendments from those circulated August 2013 Circulation List Barbara Hamill, Immunisation July 2013 Manager, Public Health England Sarah Whiteman, Medical Director, Hertfordshire & South Midlands Area Team Heather Moulder, Director of Nursing and Quality, Hertfordshire and South Midlands Area Team Approved by the 20 th August 2013 Pharmaceutical Services Regulations Committee for the Hertfordshire and South Midlands Area Team Review Date September 2015 Date of Archiving Previous PCT PGD for the administration of Adsorbed Diphtheria, Tetanus, Acellular Pertussis & Inactivated Poliomyelitis Combined Vaccine (dtap/ipv - Repevax ) to pregnant women September 2013 Table of Contents Page Front Sheet 4 1. Clinical Condition or Situation to which the Direction Applies 5 2. Description of Treatment 6 3. Adrenaline Management in the event of an anaphylactic reaction 9 4. Audit 9 5. Characteristics and qualification required of staff 9 6. References National/Local Policies or Guidelines 10 7. Management/authorisation of Patient Group Direction 11 Page 3 of 11

Patient Group Direction (PGD) Number 12 0913: Administration of Adsorbed Diphtheria, Tetanus, Acellular Pertussis & Inactivated Poliomyelitis Combined Vaccine (dtap/ipv - Repevax ) to pregnant women by Registered Nurses employed by GP Practices within the Hertfordshire and South Midlands Area Team and signatories to the PGD Valid from: 1 st September 2013 Expiry (review) date: 1 st September 2015 After this date the direction is no longer valid. (Note: a review will be carried out sooner as a result of a critical incident, new safety or clinical information, changes in legislation or change in best practice.) Supersedes all previous PCT PGDs for the administration of Adsorbed Diphtheria, Tetanus, Acellular Pertussis & Inactivated Poliomyelitis Combined Vaccine (dtap/ipv - Repevax ) to pregnant women within the Hertfordshire and South Midlands Area Team Development of Patient Group Direction This Patient Group Direction has been developed on behalf of the Hertfordshire and South Midlands Area Team by: Medical Director Pharmacist Hertfordshire, Bedfordshire & Name Sarah Whiteman Carolyn Haselden Signature Date 19 th August 2013 19 th August 2013 Page 4 of 11

Luton CSU Director of Nursing and Quality Heather Moulder 19 th August 2013 1. Clinical condition or situation to which the direction applies: Indication To provide indirect protection against pertussis to infants by offering immunisation to their pregnant mothers to boost antibody levels such that they pass more pertussis specific antibodies to their babies through their placenta. Criteria for inclusion Informed consent obtained and documented in the patient s medical notes. Pregnant women who are 28-38 weeks pregnant (inclusive) the optimal time of administration is 28-32 weeks of pregnancy (inclusive). Pregnant women over 38 weeks of pregnancy to the time of onset of labour who have not received the vaccine between 28 and 38 weeks of pregnancy. New mothers who have never previously been vaccinated against pertussis, up to when their child receives their first vaccination (at 2 months of age) Criteria for exclusion There are very few individuals who cannot receive the vaccine. When there is doubt, appropriate advice should be sought from an Immunisation Co-ordinator or Consultant in Communicable Disease Control or Health Protection rather than withholding the vaccine (see www.dh.gov.uk/greenbook). Consent refused and documented in the patient s medical notes Under 28 weeks of pregnancy A new mother whose newborn has received their first immunisations at 2 months of age There are very few medical reasons why Repevax should not be given. The vaccine is suitable for those with an egg allergy. Repevax 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; a confirmed anaphylactic reaction to any component of the vaccine or to any substances carried over from manufacture (formaldehyde, glutaraldehyde, neomycin, streptomycin, polymyxin B or bovine serum albumin); an encephalopathy (brain disorder) of unknown origin Page 5 of 11

Cautions/Need for further advice from a doctor within seven days of previous immunisation with pertussis-containing vaccine. 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. As with all injectable vaccines, the vaccine must be administered with caution to subjects with thrombocytopenia or a bleeding disorder (or individuals at risk of haemorrhage). (see Method / Route section) Individuals with immunosuppression or with HIV infection (regardless of CD4 counts) should be considered for vaccination in the absence of exclusions or contraindications (the vaccination should be postponed until the end of the disease or treatment where possible). However, these individuals may not develop a full antibody response if they are immunosuppressed, and vaccine protective efficacy has not been studied. Re-immunisation should be considered after treatment is finished and recovery has occurred. Specialist advice may be required. Action if excluded Specialist advice must be sought on the vaccines and circumstances under which they could be given. The risk to the individual of not being immunised must be taken into account. Inform or refer to GP as appropriate Document reason(s) for exclusion and advice given in patient s medical notes Reschedule immunisation if appropriate Action if patient declines treatment 2. Description of Treatment: Give advice about protective effects of the vaccine and the risks of infection and disease complications Inform or refer to GP as appropriate Document reason(s) for decline and advice given in Patient s medical notes Name, strength and formulation of drug Legal status Adsorbed Diphtheria, Tetanus, Acellular Pertussis & Inactivated Poliomyelitis Combined Vaccine (dtap/ipv - Repevax ) POM (prescription only medicine) Note: The use of this vaccine in pregnant women is not included in the product licence. However, its administration to this patient group follows the advice of the JCVI. Method / Route Vaccines are routinely given intramuscularly into the deltoid area of the upper arm or anterolateral thigh The deep subcutaneous route may be used for patients with Page 6 of 11

thrombocytopenia or a bleeding disorder (or individuals at risk of haemorrhage) to reduce the risk of bleeding The vaccine should not be administered into the gluteal area The vaccine must not be administered either intravascularly or intradermally Injectable vaccines should be given at separate sites, preferably in different limbs. If given in the same limb, they should be given at least 2.5 cm apart The vaccine must not be mixed with other vaccines in the same syringe Shake well before use The vaccine should be inspected for any foreign particles and/or variation of physical aspect before use. In the event of either being observed, discard the vaccine Dose / Dose range A single 0.5ml dose Frequency of administration Patient advice / Follow up treatment Adverse Reactions and their Management A single 0.5ml dose of Repevax should be given irrespective of the number of foetuses in the pregnancy. A single injection Women who become pregnant again while the programme is in place should be offered immunisation during each pregnancy to maximise transplacental transfer of antibody. Provide suitable printed patient Information leaflet (PIL) Give advice on possible side effects and their management and when to seek medical advice sore arm is a normal reaction to the injection Give advice on the management of post-immunisation pyrexia and management of local reactions Patient should be advised to consult with the doctor if they are concerned about any reaction Local reactions (pain, swelling, erythema and induration) at the injection site within 48 hours following vaccination are the most commonly reported symptoms and may occur more frequently following subsequent doses. These symptoms are usually mild and transient - see GP if severe or serious. A small, painless nodule may form at the injection site; this usually disappears and is of no consequence Very common and common adverse reactions may include: loss of appetite, nausea, vomiting, diarrhoea, fever, chills, headache, irritability, restlessness, somnolence, malaise, asthenia, fatigue, body ache and aching or swollen joints, myalgia, pruritis, rash, injection site bruising and skin changes Other adverse reactions may include: Convulsions and episodes of pallor, cyanosis and limpness (HHE) Side effects with an unknown incidence include: Extensive limb swelling which may extend from the injection site beyond one or both joints and is frequently associated with erythema, and sometimes with blisters. The majority of these reactions appeared within 48 hours of vaccination and spontaneously resolved over an average of 4 days without sequelae; Page 7 of 11

Reporting procedure of Adverse Reactions lymphadenopathy; urticaria; face oedema; dyspnoea; pharyngitis ; insomnia ; eye pain; earache; rhinitis; coughing; abdominal pain; back pain; urinary incontinence; brachial neuritis and Guillain- Barré syndrome Confirmed anaphylaxis occurs extremely rarely following administration of the vaccine. Appropriate medical equipment and drugs for the treatment of an anaphylactic event to be available (see local anaphylaxis guidelines or the current edition of the British National Formulary (BNF)). Other allergic conditions may occur more commonly and are not contra-indications to further immunisation. Consult doctor if fever > 39.5 C, or other serious symptoms Initially GP and documented in the patient s medical notes Report in line with local Incident Policy and Procedure All suspected reactions should be reported to the Commission on Human Medicines via the Yellow Card system (copies of the yellow card are available at the back of the BNF or via www.yellowcard.gov.uk ) by the Nurse or the Doctor. State brand and batch number Drug Interactions The vaccine must not be mixed with other vaccines in the same syringe There are no reasons why Repevax cannot be administered at the same time as influenza vaccine. However, influenza immunisation should not be delayed until week 28 or after of pregnancy in order to give Repevax at the same visit. Pregnant women are at risk of severe illness at any stage of pregnancy from influenza. There are no reasons why Repevax cannot be administered at the same time as anti-d treatment. Pregnant women who have received 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. Additional Facilities Special Considerations / Additional Information Appropriate medical equipment and drugs for the treatment of an anaphylactic event to be available (see local anaphylaxis guidelines or BNF) Immediate access to epinephrine (adrenaline) 1 in 1000 injection There are no reasons why Repevax cannot be administered at the same time as the seasonal influenza vaccine. However, influenza immunisation should not be delayed until week 28 or after of pregnancy in order to give Repevax at the same visit. Pregnant women are at risk of severe illness at any stage of pregnancy from influenza. There are no reasons why Repevax cannot be administered at the same time as anti-d treatment. For a comprehensive list of all warnings, cautions and potential adverse reactions, refer to the current British National Page 8 of 11

Arrangements for handling, security, storage and labelling Records Formulary (BNF), the current Summary of Product (SPC) and the Green Book - Immunisation against infectious disease at www.dh.gov.uk/greenbook) All medicines supplied to a patient under a PGD must comply with the European Commission (EC) labelling and leaflet directive i.e. must be fully labelled and an appropriate Patient Information Leaflet (PIL) supplied. Before use, nurses should satisfy themselves that the vaccine has been properly stored and that the cold chain has not been broken. Store in a refrigerator (2 C - 8 C). Do not freeze. Vaccines which have been frozen must not be used. Keep the container in the outer carton in order to protect from light. 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, puncture-resistant sharps box (UN-approved, BS 7320).. In all cases manual records and computerised records should be completed immediately, be clear, accurate, legible and include: Patient s name, NHS number, address, date of birth, consent given and GP (if registered) Dose, site and route of injection Brand, Manufacturer, batch number and/or expiry date of vaccine Date and time given and by whom Advice given to the patient Detail of any adverse reaction and action taken 3. Adrenaline (Epinephrine) Management in the Event of an Anaphylactic Reaction: Adrenaline (epinephrine) 1:1000 (1mg/ml) Intramuscular injection Subcutaneous route (not generally recommended) Age of Patient Volume of adrenaline (epinephrine) 1:1000 (1mg/1ml) Adults and adolescents over 12 years 0.5ml (500 micrograms) (0.3ml (300 micrograms) if the child is small or pre-pubertal) These doses may be repeated if necessary at 5 minute intervals according to blood pressure, pulse and respiratory function with urgency of hospital transfer * Use suitable syringe for measuring small volumes 4. Audit: Stock Reconciliation Stock Storage Stock balances should be reconcilable with receipts, administration records and disposals on an individual patient basis. Product should be stored in accordance with the specifications of the PGD and Summary of Product Characteristics relating to the vaccine Page 9 of 11

5. Characteristics of Staff: Qualifications required Registered nurse with current Nursing & Midwifery Council (NMC) registration employed by GP practices within the Hertfordshire and South Midlands Area Team Additional requirements Has undertaken appropriate training for working under PGDs for supply and administration of medicines Evidenced competency to undertake immunisations Evidenced up to date training in Cardiopulmonary Resuscitation skills (annually) and management of anaphylaxis (annually). Attend training dates as required and keep up to date with changes Continued training requirements The Registered Nurse must act at all times in accordance with the Nursing and Midwifery Council (NMC) code of professional conduct and Standards for the medicines management, and must at all times acknowledge any limitations in their knowledge or competence. 6. References - National / Local Policies or Guidelines: 1. Department of Health (2006) Immunisation against infectious disease (HMSO). Updated at www.dh.gov.uk/greenbook Accessed 24/07/13 2. Current edition of the British National Formulary www.bnf.org Accessed 24/07/13 3 SPC for Repevax, Sanofi Pasteur available at www.medicines.org.uk Accessed 24/07/13 4 Health Service Circular HSC 2000/026: Patient Group Directions (England only), 9 August 2000 5 Department of Health, CMO letters 6 NMC - The Code: Standards of conduct, performance and ethics for nurses and midwives (May 2008) 7 NMC - Standards for medicines management (Feb 2008) 8 Resuscitation Council (UK) Emergency Medical treatment of Anaphylactic Reactions by first medical responders and Community Nurses (updated January 2008) 9 Department of Health (6 th April 2001) Reference Guide to Consent for Examination or Treatment. Crown copyright. (www.dh.gov.uk ) 10 CMO Letter - Temporary Programme Of Pertussis (Whooping Cough) Vaccination Of Pregnant Women 27 th September 2012 11. CMO Letter - Continuation of temporary programme of pertussis (whooping cough) vaccination of pregnant women. 10 May 2013 Publication Gateway Reference Number: 00077 https://www.gov.uk/government/uploads/system/uploads/attachment _data/file/197839/130510_pertussis_continuation_letter_final.pdf 12. Previous PCT PGD for the administration of Adsorbed Diphtheria, Tetanus, Acellular Pertussis & Inactivated Poliomyelitis Combined Vaccine (dtap/ipv - Repevax ) to pregnant women Page 10 of 11

7. Management of Patient Group Direction (PGD) Number 12 0913: Authorisation of GP(on behalf of the practice) for the administration of this vaccine without a prescription by the named nurse(s) below I,. (name and designation), confirm that the named nurse(s) who has/have signed this Patient Group Direction to administer the above named vaccine is/are competent to operate under the PGD and fulfil the criteria set out in the Characteristics of Staff section. I give authorisation for the named nurse(s) who has/have signed this Patient Group Direction to administer the above named vaccine as described in this direction and in accordance with this PGD and the current Department of Health Guidelines (HMSO immunisation against Infectious Diseases). Signed Date Practice Address: This Patient Group Direction is to be read, agreed to and signed by all registered nurses it applies to. One copy should be given to each nurse with the original signed copy being easily accessible within the practice/clinical setting. A fully signed copy of this page to be kept by the Clinical Service Manager for the team By completing the section below I confirm that I have read and understood the content of this Patient Group Direction and that I fulfil the criteria set out in the Characteristics of Staff section and I am willing, competent and authorised to work under it within my professional code of conduct. Name and designation of Authorised Nurse Signature of Authorised Nurse Date Page 11 of 11