PHE publications gateway number:
PATIENT GROUP DIRECTION (PGD)
Supply of potassium iodide 65mg tablets to adults and children
exposed to, or at risk of exposure to radioactive iodine
For the supply of potassium iodide 65mg tablets by HEALTHCARE PROFESSIONALS
to adults and children exposed to or at risk of exposure to radioactive iodine
Reference no:
Version no:
Valid from:
Review date:
Expiry date:
PotassiumiodidePGD
02.00
1 March 2016
1 March 2018
1 March 2019
Public Health England has developed this PGD template for local authorisation
Those using this PGD must ensure that it is formally authorised and signed by a clinical
governance or patient safety lead, who has designated responsibility for signing PGDs, so
this document meets legal requirements for a PGD. THE PGD IS NOT LEGAL OR VALID
WITHOUT THIS LOCAL, FORMAL AUTHORISATION.
Authorising organisations must not alter or amend the clinical content of this document
(sections 4, 5 and 6); such action will invalidate the clinical sign-off with which it is provided.
As operation of this PGD is the responsibility of commissioners and service providers, the
authorising organisation can decide which staff groups, in keeping with relevant legislation,
can work to the PGD. Therefore sections 2, 3 and 7 can be amended.
THE PRACTITIONER MUST BE AUTHORISED BY NAME, UNDER THE CURRENT
VERSION OF THIS PGD BEFORE WORKING ACCORDING TO IT.
Practitioners and organisations must check that they are using the current version of the
PGD. Amendments may become necessary prior to the published expiry date.
PotassiumiodidePGD v02.00 Valid from: 1 March 2016 Expiry: 1 March 2019
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Change history
Version
number
Change details
Date
PGD290514
Original template developed and ratified
29th May 2014
PGD02.00
Template reviewed and the following changes made:
1st March 2016
1. Put into the new PHE template format
2. Iodate solution removed – the PGD is for tablets only
3. Additional information added for administration
4. Additional recording requirements added
5. References updated
PotassiumiodidePGD v02.00 Valid from: 1 March 2016 Expiry: 1 March 2019
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1. PGD template development
This PGD template has been developed by the following on behalf of Public Health England:
Developed by:
Name
Signature
Date
Judith Field
Pharmacist
(Lead Author)
Doctor
UK National Countermeasure Manager
Emergency Response Department
Public Health England
1st March 2016
Nick Gent
Consultant in Health Protection
Emergency Response Department
Public Health England
1st March 2016
Nicky Brown
Registered Nurse
Senior Nurse
Chief Nurse Directorate
Public Health England
1st March 2016
This PGD template has been peer reviewed by an Expert Panel in accordance with the PHE
PGD Policy. It has been agreed by the PHE Medicines Management Group and the PHE
Quality and Clinical Governance Steering Group.
Expert Panel
Name
Designation
John Simpson (Chair)
Director of Emergency Preparedness, Resilience and
Response
Public Health England
Jackie Lamberty
Pharmacist Medicines Management Adviser
Public Health England
Sally Millership
Consultant in Communicable Disease Control
Public Health England East of England
Sally Coomber
Consultant Occupational Physician
Deputy Director Staff Health and Wellbeing
Public Health England
Andrew Simpson
Consultant Medical Microbiologist
Public Health England
Duncan Cox
Specialist Radiation Protection Scientist
Public Health England
PotassiumiodidePGD v02.00 Valid from: 1 March 2016 Expiry: 1 March 2019
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2. Organisational authorisations
The PGD is not legally valid until it has had the relevant organisational authorisation.
It is the responsibility of the organisation that has legal authority to authorise the PGD, to
ensure that all legal and governance requirements are met. The authorising body accepts
governance responsibility for the appropriate use of the PGD.
SEE SEPARATE GGC AUTHORISATION AND LOCAL AUTHORISATION SHEET authorises
this PGD for use by the services or providers listed below:
Authorised for use by the following organisations and/or services
Limitations to authorisation
eg Any local limitations the authorising organisation feels they need to apply in-line with the way
services are commissioned locally. This organisation does not authorise the use of this PGD by ….
Organisational Approval (legal requirement)
Role
Name
Sign
Date
Additional signatories according to locally agreed policy
Role
Name
Sign
Date
Complete e.g. NHSE Governance Lead,
Medical Director
Organisations must add an individual practitioner authorisation sheet or list of authorised
practitioners. This varies according to local policy but this should be a signature list or an
individual agreement as included at the end of this PGD.
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3. Characteristics of staff
•
Qualifications and
professional registration
Additional requirements
Those registered health care professionals that are listed and
approved in legislation as able to operate under patient group
directions and have current registration.
•
must be authorised by name as an approved practitioner under
the current terms of this PGD before working to it
•
must have undertaken appropriate training for working under
PGDs for supply/administration of medicines
•
must be competent in the use of PGDs (see NICE Competency
framework for health professionals using patient group
directions).
•
must be familiar with the product and alert to changes in the
Summary of Product Characteristics
•
must have undertaken training appropriate to this PGD as
required by local policy
•
have access to the PGD and associated online resources.
The practitioner must be authorised by name, under the current
version of this PGD before working according to it.
Continued training
requirements
•
All health care professionals working under the direction will be
expected to maintain their competence as specified in hospital,
local and national policies e.g. Nursing & Midwifery Council
guidelines
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4. Clinical condition or situation to which this PGD applies.
Clinical condition or
situation to which this
PGD applies
Known or suspected exposure to radioactive iodine or at risk of
exposure.
Criteria for inclusion
All age groups ie adults, including pregnant and lactating women,
children, babies and neonates:
1. With known or suspected exposure to radioactive iodine or at risk
of exposure
2. As a precautionary countermeasure as declared by PHE
Note: Pregnant and lactating women, neonates, infants and children
are a priority for treatment. Prophylactic administration of potassium
iodate to the pregnant mother is also effective in protecting the
thyroid of the foetus
Criteria for exclusion1
Those with known:
• anaphylaxis, severe allergy or sensitivity to any iodine containing
medicines
• renal failure
Pregnancy and hyperthyroidism are not exclusion criteria2.
Cautions including any
relevant action to be
taken
None
Action to be taken if the
patient is excluded
Explain why they have been excluded and refer the individual to the
supervising doctor.
Action to be taken if the
patient or carer declines
treatment
Advise the individual or their carer of the possible consequences of
refusing treatment and about its protective effects.
Refer the individual to the supervising doctor.
1
Exclusion under this Patient Group Direction does not necessarily mean the medication is contraindicated, but
it would be outside its remit and another form of authorisation will be required
2
If pregnant women with active hyperthyroidism take potassium iodate there is a risk of foetal thyroid blockage.
However this contraindication has not been included because hypothyroidism is screened post-natally in the
UK.
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5. Description of treatment
Name, strength &
formulation of drug
Potassium iodide 65mg tablets equivalent to 50mg of iodine
Legal category
Pharmacy only (P) medicine
Black triangle
No
Off-label use
Yes
Although the Summary of Product Characteristics (SPC) states that
treatment should be initiated within one hour of exposure, treatment
should nevertheless be considered after this time period as the likely
benefits of treatment outweigh the likely risks of non-treatment.
Timeframe to be decided according to local advice at the time of an
incident.
Route / method of
administration
Oral
Dose and frequency of
administration
Where possible, the dose
should be administered
before exposure, or as
soon as possible after an
exposure has occurred.
Tablets
Iodine equivalent
Adults, elderly and
adolescents (over 12
years)
2 tablets
100mg
Children (3-12 years)
1 tablet
50mg
Children (1 month – 3
years)
½ tablet
25mg
The dose may be crushed and mixed with milk, water or fruit juice,
honey, jam or yoghurt before administration
Neonates (birth – 1 month) ¼ tablet
12.5mg
Duration of treatment
A single dose to be administered. This will protect against exposure
lasting up to 24 hours.
Quantity to be supplied
As above
Storage
Store in original container below 25 oC
Store out of reach and sight of children
Disposal
Any unused product or waste material should be disposed of in
accordance with local requirements.
Drug interactions
The following interactions may occur, but are not contraindications to
giving potassium iodide. Where advice is given by the appropriate
public health authority that potassium iodide should be taken then the
benefit of taking this medicine outweighs the risk of the interactions
given below.
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• Medicines such as captopril and enalapril can cause hyperkalaemia.
This effect may be enhanced with the use of potassium iodide
• The effect of quinidine on the heart is increased by increased
plasma concentration of potassium
• Hyperkalaemia results from the interaction between potassium salts
and potassium-sparing diuretics such as amiloride or triamterene or
aldosterone antagonists
Identification &
management of adverse
reactions3
The risk of adverse reactions, particularly to a single dose, is remote.
Where advice is given by the appropriate public health authority that
potassium iodide should be taken, then the benefit of taking this
medicine outweighs the risk of undesirable effects.
A detailed list of adverse reactions is available in the Summary of
Product Characteristics, which is available from the electronic
Medicines Compendium website: www.medicines.org.uk
Reporting procedure of
adverse reactions
All suspected adverse reactions in children and severe adverse
reactions in adults should be reported using the Yellow card system on
http://yellowcard.mhra.gov.uk
Any serious adverse reaction to the drug should be documented in the
individual’s record.
Medical staff should also be informed.
Additional warnings
The risk of health problems occurring, particularly to a single dose, is
remote. Where advice is given by the appropriate public health
authority that potassium iodide should be taken then the benefit of
taking this medicine outweighs the risks.
Additional information
Throughout pregnancy the number of doses of potassium iodide
should be kept to a minimum and in iodine deficiency prolonged
dosage could lead to maternal or foetal thyroid blockage with possible
consequences for foetal development, but this PGD is for
administration of a single dose.
If potassium iodide is administered late in pregnancy, the thyroid
function of the new-born should be monitored. This is generally met by
routine screening in the neonatal period; great care should be taken to
ensure that this screening is performed and reported promptly as soon
as possible after birth.
For neonates who have been administered potassium iodide in the first
few weeks of life thyroid-stimulating hormone (TSH) levels and, if
necessary, T4 levels should be monitored and appropriate
replacement therapy given.
Iodine is actively transported in breast milk; however, the dosage in
breast milk is insufficient on its own to protect babies. Therefore,
breast feeding mothers should continue to breast feed their babies,
and these babies should also receive potassium iodide in the normal
dose by age given above.
The special precautions listed in the SPC have been considered but
PHE has determined that the benefit outweighs the risk.
3
Refer to British National Formulary (BNF) and Summary of Product Characteristics (SPC) for complete list
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Written information to
be given to patient or
carer
Supply marketing authorisation holder's patient information leaflet
(PIL).
Patient advice /follow up
treatment
Explain why the treatment is necessary.
A special Public Health England leaflet, “Potassium iodide tablets”, in
addition to the PIL, has been developed for giving to all individuals at
the time of treatment.
Advise that the dose may be crushed and mixed with milk or water,
juice, jam, honey or yogurt before administration if appropriate.
Inform the individual or their carer of possible side effects and their
management. Ensure that the individual is aware that medical advice
should be sought if side effects or any other unexplained effects on
health are experienced.
All pregnant women in their third trimester and those with babies aged
under 1 month should advise their GP and midwife so that umbilical
cord blood/blood samples can be tested, after birth, for TSH hormone
levels, and, if raised, T4 levels in the baby.
If stable iodine is given to neonates close follow up of thyroid function
is essential. For neonates who have been administered potassium
iodide in the first few weeks of life TSH levels and, if necessary, T4
levels should be monitored and appropriate replacement therapy
given.
Adults with previously treated or active thyroid disease should consult
their GP if they notice any change in their condition.
Other individuals do not need to consult their GP unless they notice
any change in their condition. If they consult their GP for any reason,
they should mention that they have received potassium iodide
treatment.
Records
Record:
• whether valid informed consent was given
• name of individual, address, date of birth and GP with whom the
individual is registered
• name of member of staff who supplied the product
• name and brand of product
• date of supply
• dose, form and route of administration of product
• quantity supplied
• batch number and expiry date
• advice given; including advice given if excluded or declines
treatment
• where practical, details of any adverse drug reactions and actions
taken
• record the medicine was supplied via PGD
• records should be signed and dated
• ideally contact details for the individual to be recorded
• if possible, record the whereabouts of the individual during 6 hours
prior to treatment (for better estimation of exposure).
All records should be clear, legible and contemporaneous.
A record of all individuals receiving treatment under this PGD should
also be kept for audit purposes in accordance with local policy.
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6. Key references
Key references
• Potassium iodide 65mg tablets Summary of Product Characteristics
www.medicines.org.uk/emc/
• WHO guidance
http://www.who.int/ionizing_radiation/pub_meet/Iodine_Prophylaxis_
guide.pdf
• NRPB guidance
https://www.gov.uk/government/uploads/system/uploads/attachment
_data/file/425072/Documents_of_the_NRPB_Volume_12_Number_
3.pdf
• NICE Medicines Practice Guideline 2 (MPG2): Patient Group
Directions https://www.nice.org.uk/guidance/mpg2
• NICE MPG2 Patient group directions: competency framework for
health professionals using patient group directions
https://www.nice.org.uk/guidance/mpg2/resources
• Health Technical Memorandum 07-01: Safe Management of
Healthcare Waste. Department of Health 20th March 2013
https://www.gov.uk/government/publications/guidance-on-the-safemanagement-of-healthcare-waste
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7. Individual practitioner authorisation sheet
BY SIGNING THIS PATIENT GROUP DIRECTION YOU ARE INDICATING THAT YOU AGREE TO
ITS CONTENTS AND THAT YOU WILL WORK WITHIN IT
PATIENT GROUP DIRECTIONS DO NOT REMOVE INHERENT PROFESSIONAL
OBLIGATIONS OR ACCOUNTABILITY
IT IS THE RESPONSIBILITY OF EACH PROFESSIONAL TO PRACTISE ONLY WITHIN THE
BOUNDS OF THEIR OWN COMPETENCE
Practitioner
I confirm that I have read and understood the content of this Patient Group Direction and
that I am willing and competent to work to it within my professional code of conduct
Signed……………………………….………………………….…..Date……….….…………..............
Name (Print)…………….…………..………….………………………………………….…….............
Designation……………………………………………………………….…..………………................
Authorising manager
Manager to give authorisation on behalf of INSERT NAME OF ORGANISATION for the named
healthcare professional who has signed the PGD
Signed…………………………………….………………………. Date………………………..........
Name (Print)………………………..…………………………………….……………..………..........
Designation………………………………………………………………..…………….…….............
Note to authorising manager
By signing above you are confirming that you have assessed the staff member as competent to
work under this PGD and that they have the organisational approval to do so.
You must give this signed PGD to each authorised practitioner as it shows their authorisation to
use the PGD.
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