Patient Group Direction (PGD) Number :

Transcription

1 Notice to all staff: The Patient Group Directions (PGDs) for the Central Midlands Area 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

2 Patient Group Direction (PGD) Number : Administration of Adsorbed Diphtheria, Tetanus, Acellular Pertussis & Inactivated Poliomyelitis Combined Vaccine (dtap/ipv - Boostrix-IPV ) to pregnant women by Registered Nurses employed by GP Practices within the Central Midlands Area and signatories to the PGD Approval of Patient Group Direction This Patient Group Direction has been approved on behalf of the Central Midlands Area by: Authorising Officer for the Central Name: Professor Aly Rashid Midlands Area Signature: Date: Date of Issue 1/7/15 Issue Number PGD 24 16/15 Date of Review 1/7/17 The Central Midlands Area 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. Page 2 of 11

3 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 Progress Lead Person & Contact Date Number V1 First Draft Jo Jenkins Senior Pharmacist June 2015 Hertfordshire Community NHS Trust jo.jenkins@hchs.nhs.uk Circulation List Barbara Hamill 15 th June 2015 Cath Fenton Review Date 1/7/17 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 Management/authorisation of Patient Group Direction 11 Page 3 of 11

4 Patient Group Direction (PGD) Number : Administration of Adsorbed Diphtheria, Tetanus, Acellular Pertussis & Inactivated Poliomyelitis Combined Vaccine (dtap/ipv - Boostrix-IPV ) to pregnant women by Registered Nurses employed by GP Practices within the Central Midlands Area and signatories to the PGD Valid from: 1/7/15 Expiry (review) date: 1/7/17 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 PGDs for the administration of Adsorbed Diphtheria, Tetanus, Acellular Pertussis & Inactivated Poliomyelitis Combined Vaccine (dtap/ipv - Repevax ) to pregnant women within the Central Midlands Area Development of Patient Group Direction This Patient Group Direction has been developed on behalf of Central Midlands Area by: Medical Director Name Signature Date Aly Rashid Senior Pharmacist NHS E incoming CDAO Lead Nurse Bhavisha Pattani Manjit Darby Page 4 of 11

5 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 weeks pregnant (inclusive) the optimal time of administration is weeks of pregnancy (inclusive). Criteria for exclusion 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 were not vaccinated against pertussis between 28 weeks of pregnancy and the onset of labour, up to when their baby receives their first vaccination (at 2 months of age). Boostrix-IPV can be given to new mothers who are breastfeeding. 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 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 Boostrix-IPV should not be given. The vaccine is suitable for those with an egg allergy. Boostrix-IPV 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); If the pregnant woman is acutely unwell and has a fever, Page 5 of 11

6 Cautions/Need for further advice from a doctor 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. An encephalopathy (brain disorder) of unknown origin within seven days of previous immunisation with pertussiscontaining vaccine-seek further medical advice. 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. Action if patient declines treatment 2. Description of Treatment: Name, strength and formulation of drug Legal status Inform or refer to GP as appropriate Document reason(s) for exclusion and advice given in patient s medical notes Reschedule immunisation if appropriate 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 Adsorbed Diphtheria, Tetanus, Acellular Pertussis & Inactivated Poliomyelitis Combined Vaccine (dtap/ipv - Boostrix-IPV ) as a pre filled 0.5ml syringe 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 The deep subcutaneous route may be used for patients with thrombocytopenia or a bleeding disorder (or individuals at risk of haemorrhage) to reduce the risk of bleeding Page 6 of 11

7 Dose / Dose range A single 0.5ml dose Frequency of administration Patient advice / Follow up treatment Adverse Reactions and their Management 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 Prior to use, the pre-filled syringe should be shaken well to obtain a turbid white suspension. 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 A single 0.5ml dose of Boostrix-IPV 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. A small painless nodule may form at the injection site; this usually disappears and is of no consequence. These symptoms are usually mild and transient - see GP if severe or serious. Very common and common adverse reactions may include: loss of appetite, nausea, vomiting, diarrhoea, fever, headache, irritability, somnolence, malaise. For a full list of adverse effects see the Boostrix-IPV Summary of Product Characteristics at 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 Reporting Initially GP and documented in the patient s medical notes Page 7 of 11

8 procedure of Report in line with local Incident Policy and Procedure Adverse Reactions 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 ) 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 Additional Facilities Special Considerations / Additional Information syringe 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 or after of pregnancy in order to give Boostrix-IPV at the same visit. Pregnant women are at risk of severe illness at any stage of pregnancy from influenza. There are no reasons why Boostrix-IPV cannot be administered at the same time as anti-d treatment. Pregnant women who have received immunisation against pertussis recently should also be offered immunisation with Boostrix-IPV, 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. 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 Boostrix-IPV 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 Boostrix-IPV at the same visit. Pregnant women are at risk of severe illness at any stage of pregnancy from influenza. There are no reasons why Boostrix-IPV cannot be administered at the same time as anti-d treatment. Pregnant women/new mothers who had confirmed or suspected pertussis infection during pregnancy should still be offered the vaccine in line with the criteria for inclusion. Boostrix-IPV can be given to women who plan to breast feed or to new mothers who are breastfeeding. There is evidence that pertussis antibodies in breast milk are increased after immunisation in pregnancy and breastfeeding may therefore help reduce the likelihood of a baby becoming ill with pertussis. However, whilst there may be some pertussis antibodies transferred to the infant in breast milk of women vaccinated at weeks gestation, this will not be enough to replace the need for the infant to complete the recommended primary immunisation schedule on time. For a comprehensive list of all warnings, cautions and potential Page 8 of 11

9 Arrangements for handling, security, storage and labelling Records adverse reactions, refer to the current British National Formulary (BNF), the current Summary of Product (SPC) and the Green Book - Immunisation against infectious disease at 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

10 5. Characteristics of Staff: Qualifications required Registered nurse with current Nursing & Midwifery Council (NMC) registration employed by GP practices within the Central Midlands Area 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). Continued training requirements Attend training dates as required and keep up to date with changes 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 Accessed 8 th June Current edition of the British National Formulary Accessed 8 th June SPC for Boostrix-IPV available at Accessed 8 th June Health Service Circular HSC 2000/026: Patient Group Directions (England only), 9 August 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. ( ) 10 CMO Letter - Temporary Programme Of Pertussis (Whooping Cough) Vaccination Of Pregnant Women 27 th September CMO Letter - Continuation of temporary programme of pertussis (whooping cough) vaccination of pregnant women. 10 May 2013 Publication Gateway Reference Number: _data/file/197839/130510_pertussis_continuation_letter_final.pdf 12. Previous PGD for the administration of Adsorbed Diphtheria, Tetanus, Acellular Pertussis & Inactivated Poliomyelitis Combined Vaccine (dtap/ipv - Repevax ) to pregnant women 13. Public Health England Vaccination against pertussis (Whooping cough) for pregnant women Information for healthcare professionals July 2014 PHE pertussis pregnancy info 2014 Page 10 of 11

11 7. Management of Patient Group Direction (PGD) Number : 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