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.:
Version No.: 1/2014
Local Doc Ref.:
PGD
Owner:
Jayne Carter, Administrator for Public Health Direct Commissioning Team
File Reference:
I:\AngleseyHouse\Commissioning Directorate\Primary Care & Specialised
Commissioning\Public Health\Immunisation\2013-14\PGDs\Approved
Document
Overseeing
Group:
Placement in
Framework:
Approval Level: PGD Oversight and Authorisation Group
Date of
Approval:
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
stJuly 2014
2and will replace
Repevax® PGD for the vaccination of pregnant women against
pertussis.
__________________________________________________________________________________________________
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
30 June 2014
Date this patient group direction becomes due for review
01 June 2016 or in response to new local/national guidelines.
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))
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
__________________________________________________________________________________________________
CLINICAL CONDITION
Clinical need
addressed
There has been a considerable increase in pertussis activity in the UK since mid-2011. 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 months3.
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 age3.
Inclusion criteria
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.
http://www.hpa.org.uk/webw/HPAweb&HPAwebStandard/HPAweb_C/1
317136400742
Exclusion criteria
(for full details of interacting medicines refer to current Summary of Product Characteristics (SPC)
www.medicines.org.uk & 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 used7
• An encephalopathy (brain disorder) of unknown origin within seven days of previous immunisation with pertussis-containing vaccine 7
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
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 contra-indications7
Caution/need for
further advice
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 administration7 (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 responses7.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-__________________________________________________________________________________________________ IPV® at the same visit. Pregnant women are at risk of severe illness at any stage of pregnancy from influenza.8
Management of
excluded patients
•
•
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 beingimmunised 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.Action for patients not
wishing to receive
care under this PGD
•
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))
Boostrix-IPV® is a sterile turbid white suspension supplied in a single dose
(0.5 ml) pre-filled syringe.
Legal classification
POM – Prescription Only MedicineBlack triangle warning
Suspected adverse reactions. Should be reported using the Yellow Card reporting scheme (http://yellowcard.mhra.gov.uk).
Not applicable
Method of obtaining
supply
GP practices will be able to order Boostrix-IPV® through ImmForm as part of this programme.
Site for treatment
•
GP surgeriesRoute/method
•
Boostrix-IPV® should be administered by deep intramuscular injection preferably into the deltoid muscle.7•
Intramuscular injections should be given with care in patients onanticoagulant 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.6
Dose
0.5ml – maximum dose 0.5 mlA single 0.5ml dose of Boostrix-IPV® should be given irrespective of the number of foetuses in the pregnancy 3
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.
Number of times
treatment may be
administered
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
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
Quantity to be supplied
or administered
Single dose to be administered (0.5ml)7
Side effects
Full details of side effects are available in the SPC.
www.medicines.org.uk
Suspected adverse reactions to drugs including vaccines should be reported on the yellow card available at the back of the BNF. Also at www.yellowcard.gov.uk
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
General Disorders and Administration Site Conditions
Very common Injection site reactions (such as redness and/or swelling), fatigue, injection site pain Common 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
www.medicines.org.uk
Additional Information
(including storage and
disposal)
•
Store in a refrigerator (20C – 80C)•
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 210C•
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 07-01 (Department of Health, 2006).i•
Boostrix-IPV® is thiomersal freeAdvice to patient/carer
Before Treatment:__________________________________________________________________________________________________ summary of product characteristics. Advise action to be taken if side effects are experienced
After Treatment:
•
Provide patient information leafletAny 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
No routine follow up requiredSuspected adverse
reactions
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: http://yellowcard.mhra.gov.ukAny serious adverse reaction to the vaccine should be documented in the patient’s medical record.
Error reporting
Any incidents or near-miss issues must be reported to the Area Team immunisations query line: [email protected]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•
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 recordAll 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.
•
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
Lead
Date:
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
1Public Health England. Vaccine update issue 213 March 2014
2Public Health England Vaccine update issue 215 May 2014
__________________________________________________________________________________________________
4Deputy NHS Chief Executive Letter 28th September 2012. Gateway reference number: 18193
5Public Health England Letter 10th May 2013. Continuation of temporary programme of pertussis (whooping cough) vaccination of
pregnant women.
6Green Book DOH (2006) Immunisation against Infectious Disease: London: HMSO (Chapter 24 Pertussis)
7 Boostrix-IPV® Product SPC www.medicines.org.uk
8Health Protection Scotland. NHS National Services Scotland, NHS Education for Scotland Vaccination against pertussis