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: PotassiumiodidePGD Version no: 02.00 Valid from: 1 March 2016 Review date: 1 March 2018 Expiry date: 1 March 2019 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. Page 1 of 11
Change history Version number Change details Date PGD290514 Original template developed and ratified 29 th May 2014 PGD02.00 Template reviewed and the following changes made: 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 1 st March 2016 Page 2 of 11
1. PGD template development This PGD template has been developed by the following on behalf of : Developed by: Name Signature Date Pharmacist (Lead Author) Doctor Registered Nurse Judith Field UK National Countermeasure Manager Emergency Response Department Nick Gent Consultant in Health Protection Emergency Response Department Nicky Brown Senior Nurse Chief Nurse Directorate 1 st March 2016 1 st March 2016 1 st 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 John Simpson (Chair) Jackie Lamberty Sally Millership Sally Coomber Andrew Simpson Duncan Cox Designation Director of Emergency Preparedness, Resilience and Response Pharmacist Medicines Management Adviser Consultant in Communicable Disease Control East of England Consultant Occupational Physician Deputy Director Staff Health and Wellbeing Consultant Medical Microbiologist Specialist Radiation Protection Scientist Page 3 of 11
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 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. Page 4 of 11
3. Characteristics of staff Qualifications and professional registration Additional requirements Continued training 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. 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 Page 5 of 11
4. Clinical condition or situation to which this PGD applies. Clinical condition or situation to which this PGD applies Criteria for inclusion Criteria for exclusion 1 Cautions including any relevant action to be taken Action to be taken if the patient is excluded Action to be taken if the patient or carer declines treatment Known or suspected exposure to radioactive iodine or at risk of exposure. 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 Those with known: anaphylaxis, severe allergy or sensitivity to any iodine containing medicines renal failure Pregnancy and hyperthyroidism are not exclusion criteria 2. None Explain why they have been excluded and refer the individual to the supervising doctor. 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. Page 6 of 11
5. Description of treatment Name, strength & formulation of drug Potassium iodide 65mg tablets equivalent to 50mg of iodine Legal category Black triangle Off-label use Route / method of administration Pharmacy only (P) medicine No 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. 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 Quantity to be supplied Storage Disposal Drug interactions A single dose to be administered. This will protect against exposure lasting up to 24 hours. As above Store in original container below 25 o C Store out of reach and sight of children Any unused product or waste material should be disposed of in accordance with local requirements. 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. Page 7 of 11
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 reactions 3 Reporting procedure of adverse reactions Additional warnings Additional information 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 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. 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. 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 Page 8 of 11
Written information to be given to patient or carer Patient advice /follow up treatment Supply marketing authorisation holder's patient information leaflet (PIL). A special leaflet, Potassium iodide tablets, in addition to the PIL, has been developed for giving to all individuals at the time of 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 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. Page 9 of 11
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 20 th March 2013 https://www.gov.uk/government/publications/guidance-on-the-safemanagement-of-healthcare-waste Page 10 of 11
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. Page 11 of 11