Boostrix - NHS England

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)
June 2014
Brief Description
Boostrix-IPV PGD for the vaccination of pregnant women against
pertussis developed in response to national change in pertussis
vaccine procurement1.
This PGD will come into effect on 1st July 20142 and will replace
Repevax® PGD for the vaccination of pregnant women against
pertussis.
__________________________________________________________________________________________________
Drug name: vaccination of pregnant women against pertussis using Boostrix-IPV. Version-1
Start date: 1 July 2014; Expiry date: 30 June 2016
Page 1 of 10
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
Medical Director
Dr Ken Deacon
Head of Public Health and
Primary Care
Mrs Rebecca Woods
LPN Pharmacy Chair
Dr Manir Hussain
Signature
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.
__________________________________________________________________________________________________
Drug name: vaccination of pregnant women against pertussis using Boostrix-IPV. Version-1
Start date: 1 July 2014; Expiry date: 30 June 2016
Page 2 of 10
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
__________________________________________________________________________________________________
Drug name: vaccination of pregnant women against pertussis using Boostrix-IPV. Version-1
Start date: 1 July 2014; Expiry date: 30 June 2016
Page 3 of 10
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
Transient thrombocytopenia or neurological complications following an
__________________________________________________________________________________________________
Drug name: vaccination of pregnant women against pertussis using Boostrix-IPV. Version-1
Start date: 1 July 2014; Expiry date: 30 June 2016
Page 4 of 10
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 contraindications7
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:
•
Caution/need for
further advice
- 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 response7.
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 vaccine7.
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__________________________________________________________________________________________________
Drug name: vaccination of pregnant women against pertussis using Boostrix-IPV. Version-1
Start date: 1 July 2014; Expiry date: 30 June 2016
Page 5 of 10
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
Action for patients not
wishing to receive
care under this PGD
• 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
Not applicable
Suspected adverse
reactions. Should be
reported using the Yellow
Card reporting scheme
(http://yellowcard.mhra.gov.uk).
Method of obtaining
supply
Site for treatment
GP practices will be able to order Boostrix-IPV® through ImmForm as part
of this programme.
Route/method
• Boostrix-IPV® should be administered by deep intramuscular injection
Dose
• GP surgeries
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.6
0.5ml – 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
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
__________________________________________________________________________________________________
Drug name: vaccination of pregnant women against pertussis using Boostrix-IPV. Version-1
Start date: 1 July 2014; Expiry date: 30 June 2016
Page 6 of 10
Quantity to be supplied
or administered
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
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
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)
•
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
•
•
•
•
Advice to patient/carer
For further details about adverse effects see product SPC
www.medicines.org.uk
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 free
Before Treatment:
• Advise patient of possible side effects. For full details see product’s
__________________________________________________________________________________________________
Drug name: vaccination of pregnant women against pertussis using Boostrix-IPV. Version-1
Start date: 1 July 2014; Expiry date: 30 June 2016
Page 7 of 10
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
No routine follow up required
Suspected 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.uk
Error reporting
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]
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
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.
__________________________________________________________________________________________________
Drug name: vaccination of pregnant women against pertussis using Boostrix-IPV. Version-1
Start date: 1 July 2014; Expiry date: 30 June 2016
Page 8 of 10
• 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
Signature
Authorising Manager
Date of
(please print)
(Must sign against
authorisation
each entry)
•
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 2014
Public Health England Vaccine update issue 215 May 2014
3
th
CMO letter 27 September 2012. Gateway reference: 18174
2
__________________________________________________________________________________________________
Drug name: vaccination of pregnant women against pertussis using Boostrix-IPV. Version-1
Start date: 1 July 2014; Expiry date: 30 June 2016
Page 9 of 10
4
th
Deputy NHS Chief Executive Letter 28 September 2012. Gateway reference number: 18193
th
Public Health England Letter 10 May 2013. 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 www.medicines.org.uk
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
5
__________________________________________________________________________________________________
Drug name: vaccination of pregnant women against pertussis using Boostrix-IPV. Version-1
Start date: 1 July 2014; Expiry date: 30 June 2016
Page 10 of 10

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