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For the supply of potassium iodate 85mg tablets byINSERT HEALTHCARE PROFESSIONAL GROUPS WHICH CAN SUPPLY UNDER THE PGDto adults and children exposed to or at risk of exposure to radioactive iodine

Reference no:PotassiumiodatePGD

Version no:02.00

Valid from:1 March 2016

Review date:1 March 2018

Expiry date: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.

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:
  1. Put into the new PHE template format
  2. Iodate solution removed – thePGD is for tablets only
  3. Additional information added for administration
  4. Additional recording requirements added
  5. References updated
/ 1st March 2016
  1. PGD template development

This PGD template has been developedby the following on behalf of Public Health England:

Developed by: / Name / Signature / Date
Pharmacist(Lead Author) / Judith Field
UK National Countermeasure Manager
Emergency Response Department
Public Health England / / 1st March 2016
Doctor
/ Nick Gent
Consultant in Health Protection
Emergency Response Department
Public Health England / / 1st March 2016
Registered Nurse
/ Nicky Brown
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 PHEQuality 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
  1. Organisational authorisations

The PGD is not legally valid until it has had the relevant organisational authorisation.

It is the responsibility of theorganisation thathas legal authority toauthorise 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.

INSERT AUTHORISING BODY NAME 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
egAny 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
Complete e.g. NHSE Governance Lead, Medical Director
Additional signatories according to locally agreed policy
Role / Name / Sign / Date

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.

3.Characteristics of staff
Qualifications and professional registration / To be completed by the organisation authorising the PGDeg: registered professional with one of the following bodies:
  • nursescurrently registered with the Nursing and Midwifery Council (NMC).
  • pharmacists currently registered with the General Pharmaceutical Council (GPhC).
  • additional registered healthcare professionals to be added by organisation authorising the PGD

Additional requirements /
  • 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 frameworkfor 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 PDG and associated online resources.
  • should fulfil any additional requirements defined by local policy
  • authorising body to insert any additional requirements
The practitioner must be authorised by name, under the current version of this PGD before working according to it.
Continued training requirements /
  • training in the management of emergency situations following the release of, or the potential release of radioactive iodine.
  • authorising body to insert any additional training requirements

  1. Clinical condition or situation to which this PGD applies.

Clinical condition or situation to which this PGD applies / Known or suspected exposure to radioactive iodineor 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 exclusion[1] / Those with known:
  • anaphylaxis, severe allergy or sensitivity to any iodine containing medicines
  • renal failure
Pregnancy and hyperthyroidism are not exclusion criteria[2].
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. Description of treatment

Name, strength & formulation of drug / Potassium iodate85mg 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
The dose may be crushed and mixed with milk, water or fruit juice, honey, jam or yoghurt before administration
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
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 iodate. Where advice is given by the appropriate public health authority that potassium iodate should be taken then the benefit of taking this medicine outweighs the risk of the interactions given below.
  • Medicines such as captopril and enalapril can cause hyperkalaemia. This effect may be enhanced with the use of potassium iodate
  • 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 reactions[3] / 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.
Adetailedlist ofadversereactionsisavailableintheSummaryof Product Characteristics, which is available from the electronic Medicines Compendium website:
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
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 iodate 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 iodate 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.
Written information to be given to patient or carer / Supply marketing authorisation holder's patient information leaflet (PIL).
A special Public Health Englandleaflet, “Potassium iodate tablets”, in addition to the PIL, has been developed for giving to all individuals at the time of treatment.
Patient advice /follow up treatment / Explain why the treatment is necessary.
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 iodate 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 iodate treatment.
Records / Record:
  • whether valid informed consent was given
  • name of individual, address, date of birth and GPwith 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 the individual is 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 shouldbe 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.
6.Key references
Key references /
  • Potassium iodate85mg tabletsSummary of Product Characteristics
  • WHO guidance
  • NRPB guidance
  • NICE Medicines Practice Guideline 2 (MPG2): Patient Group Directions
  • NICE MPG2 Patient group directions: competency framework for health professionals using patient group directions
  • Health Technical Memorandum 07-01: Safe Management of Healthcare Waste. Department of Health 20th March 2013

  1. 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 amwilling 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 ofINSERT NAME OF ORGANISATIONfor 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

PotassiumiodatePGD v02.00 Valid from: 1 March 2016Expiry: 1 March 2019

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[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.

[3]Refer to British National Formulary (BNF) and Summary of Product Characteristics (SPC) for complete list