The Amiodarone Passport and the Patient Handheld

The Amiodarone Passport and the Patient Handheld Information Booklet

Information for patients and healthcare professionals

Sheffield Teaching HospitalsNHS Foundation Trust

PROUD TO MAKE A DIFFERENCESHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST

Instruction to the Prescribing PhysicianPlease use this list below as a guide when you are discussing amiodarone as a treatment option with a patient. It is recommended that each point is checked. Once you have completed the list a label (which is in the back of this booklet) can be placed in the medical notes as a record of informed consent.

benefits

serious and common side effects

what to do in the event of a side effect

how and when to take the medicine

expected duration of treatment

arrangements for monitoring

GMC: Good practice in prescribing and managing medicines and devices (February 2013)

Name of Healthcare Professional: ......................................................................

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samp le

Patient given Amiodarone Passport

Date given: .....................................................

Given by

Signature: .......................................................

Print name: ....................................................

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Address: ...............................................................................

................................................................................................

................................................................................................

Postcode: .............................................................................

Home telephone: ...............................................................

Mobile telephone: .............................................................

Hospital number: ...............................................................

Name of GP: .......................................................................

Address: ...............................................................................

Postcode: .............................................................................

Telephone number: ...........................................................

Prescribing Consultant: .....................................................

Date treatment commenced: ..........................................

Reason for therapy: ...........................................................

Expected duration of treatment: ....................................

Your information

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How to use this bookletThe booklet provides you with important information about your treatment and contact information for you to obtain further advice. You should take this booklet with you to any GP or hospital appointments.

There are 3 sections to this booklet:

Section A

This includes important information about amiodarone.

Section B

In this section you will find 'Monitoring Record Sheets' to help you and your doctor to monitor your amiodarone treatment including blood tests that you will require.

Section C

Other useful information

Contents page

Introduction 6

Section A - Important information 7

What is amiodarone? 8

Side effects 13

Section B - Monitoring record sheets 17

Amiodarone shared care protocol 18

Amiodarone baseline test record sheet 19

Responsibilities of the primary care clinician 20

Amiodarone monitoring schedule sheets 21

Section C - Other useful information 33

Contact information 34

Useful information for healthcare professionals 35

Indications / patient selection 36

Dose 36

Contra-indications 37

Monitoring 38

Appendix 1 39

Appendix 2 40

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IntroductionThis booklet has been given to you because you are starting to take a medicine called amiodarone.

A doctor, nurse or pharmacist will go through this booklet with you, explain what it all means and answer any questions you may have.

Responsibilities of the patient:

• Readthisbookletcarefully

• Readthedruginformationleafletwhich comes in your box of tablets

• EnsureyourMonitoringRecordSheets are completed as advised

• ConsultyourGPifyouhaveanyconcerns about your treatment

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Section A

Important Information about Amiodarone

What is amiodarone?Amiodarone belongs to the group of medicines known as anti-arrhythmic drugs. It is used to control an irregular or rapid heart rate. It acts on the heart cells and slows the electrical signals sent through the heart.

Your doctor will arrange various tests to check for problems that could make the medicine unsuitable for you. Once these tests have been completed the results can be written in the 'Baseline Tests Record Sheet' by you or your doctor for future reference.

After treatment has started:During the time you are prescribed amiodarone and for up to six months after stopping amiodarone you will need monitoring at six monthly intervals.

Your GP or hospital doctor will review any symptoms that might occur and arrange your blood tests for you. Please take your book with you to your appointment so the results can be recorded in the booklet.

1. How should I take this medicine?

You should take your amiodarone tablets as directed on the label on the box. You usually need to take a higher dose for the first one or two weeks; this is so that the amount of amiodarone which your body needs can build up enough for the medicine to work properly and as quickly as possible. The dosage should then be reduced to a dose which keeps your heart rhythm normal (usually taken once a day).

You should try to take the tablets at the same time each day with a glass of water.

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2. What if I forget to take a tablet? If you forget to take a tablet, take one as soon as you

remember on the same day. If it is nearly time for your next tablet take that one as usual and do not take the one you missed.

3. How long should I continue to take the amiodarone tablets?

You should continue taking the tablets for as long as they are prescribed by your doctor. You should make sure that your medication is reviewed by your doctor at least once every six months.

4. How should I store my medicine?

Store your medicine in a cool dry place.

Keep this medicine out of the sight and reach of children.

5. Where do I get more tablets when these are finished?

You should be able to get more tablets from your GP.

Make sure you get a new supply before the tablets run out.

6. Is there any food or drink that I should avoid?

Do not drink or eat anything containing grapefruit juice whilst taking amiodarone.

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7. Are there any medicines which I should not take with amiodarone?

Some medicines may not be suitable to take with amiodarone. Please inform your doctor or pharmacist if you are taking any of the following:

Antibiotics e.g. erythromycin, moxifloxacin, levofloxacin, sulfamethoxazole, co-trimoxazole

Anticoagulants Antimalarials e.g. chloroquine Antipsychotics e.g. amisulpiride, haloperidol Antivirals Beta-blockers Calcium channel inhibitor e.g. diltiazem, verapamil Cholesterol lowering (maximum dose reductions for

atorvastatin and simvastatin) Other cardiac drugs e.g. flecainide, disopyramide,

procainamide, quinidine, Cimetidine Ciclosporin Diuretics e.g. frusemide, etc Digoxin Ivabradine Levothyroxine Lithium Orlistat Pentamidine Phenytoin Simvastatin (maximum dose should be reduced to 20mg) Tricyclic Antidepressants e.g. amitriptyline

There may be other medicines (including over the counter medicines and oral herbal supplements e.g St John’s Wort) that may not be suitable to take with amiodarone so it is always best to check with your doctor or pharmacist if you are started on a new medicine.

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8. What should I do if I am already prescribed warfarin or another anticoagulant drug?

Important notice You may need to change the dose of warfarin when you start taking amiodarone and also if you stop amiodarone.

Prescribers note for warfarin

For patients taking warfarin prior to starting amiodarone the warfarin dose should be reduced by approximately one-quarter when amiodarone is started. INR should then be checked weekly for 4 - 6 weeks and until INR is stable. If amiodarone is stopped the effect may persist for up 6 weeks or more, so again INR should be checked weekly until it is stable. Note that amiodarone-induced hyperthyroidism will increase warfarin dose requirements.

9. What if I have more questions about amiodarone?

If you need more advice or information, ask your doctor or pharmacist. There are more contact details at the back of this booklet.

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10. Are there any side effects of this medicine?

Please read the drug information leaflet which comes in the box with your tablets.

If side effects occur, do not stop taking the tablets but tell your doctor as soon as possible.

Important notice Amiodarone can cause serious and life-threatening side effects involving the thyroid gland, liver or lungs.

• Ifyoufeelsick(nauseous)forafewweeksorarephysicallysick (vomit), lose or gain weight or have itchy skin please see your GP.

• PleaseseeyourGPimmediatelyifyoudevelopshortnessofbreath or a persistent cough whilst taking amiodarone.

• Youwillneedtohavebloodtestsbeforestartingamiodaroneand then every 6 months, to check for any liver or thyroid problems.

The following pages of this booklet describe some of the possible side effects of amiodarone and the likelihood of experiencing problems.

Please note it takes a long time for amiodarone to be removed from the body so problems can occur several weeks or even months after treatment has stopped.

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Very common side effects:

These affect more than 1 in 10 people who take amiodarone

• Abnormal blood test results.

Action: Your GP will advise you

•Eye problems. You may get small deposits in the eye caused by the amiodarone. These are not harmful and usually go away after stopping it. You may notice a blue halo effect when looking at bright lights at night time. If you regularly have your eyes tested, tell the optician that you are taking amiodarone as the deposits will show up on the eye test.

Action: If you are worried that you have developed these symptoms please speak to your GP

•Gastrointestinal problems including nausea and changes in your sense of taste.

Action: If you are worried that you have developed these symptoms please speak to your GP.

•Photosensitivity skin reactions with redness, tingling, burning or blistering.

Avoid: direct sunlight on your skin or use of sunbeds/sunlamps

You must: keep your arms and legs covered, wear a hat and use a total sun block cream whilst in sunlight.

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Common side effects:These affect more than 1 in 100 people who take amiodarone

•Liver problems including jaundice (yellow skin colouring). Some of the liver problems may cause death.

Action: Seek immediate medical advice.

•Lung problems including breathing difficulties, cough, weight loss, fever or tiredness. Some of the lung problems may cuase death.

Action: Seek immediate medical advice

If you think that you have developed any of the following symptoms then you should consult your GP:

•Thyroid problems. You may feel weak, restless, inactive or notice weight changes. Some types of thyroid problems may be fatal.

•Nightmare and sleeping problems

•Extrapyramidal movements. These are abnormal and involuntary movements.

•Grey skin colour changes may occur if amiodarone is taken at a high dose for long period of time.

•Slower heart rate

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Uncommon side effects:These affect more than 1 in 1000 people who take amiodarone


•Heart problems or worsening of symptoms with some types of heart problems. You may experience fatigue, breathlessness or swelling of the feet and legs.

•Muscle problems with weakness or trouble walking

•Nerve problems affecting the limbs, hands or feet. You may develop "pins and needles" or numbness in the hands, legs, or feet, muscle weakness or trouble walking

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Very rare side effectsThese affect fewer than 1 in 10,000 people who take amiodarone


• balanceorcoordinationproblems

• metabolicproblemswithabnormalbloodtests

• impotence

• painfulswellingofthetesticles

• bronchospasmorrespiratorydistress1

• headaches

• intracranialhypertension2

• skinproblemsincludingskinrashes

• hairloss

• vasculitis3

1 Characterised by shortness of breath, wheeze, blue lips 2 Characterised by headaches and blurred vision3 Inflammation involving the blood vessels which can affect many organs of the body including the skin presenting with red or purple spots, or blistering

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Section B

Monitoring Record Sheets

i. To initiate amiodarone in appropriate patients (see indications)

ii. To discuss benefits and side effects of treatment with the patient/carer and obtain informed consent.

iii. To issue the patient hand held book

iv. To ensure patients are commenced on an appropriate loading and then maintenance dose prior to shared care

v. To prescribe the first month's supply or a sufficient prescription until the maintenance dose is reached by the patient

vi. To contact patient's GP to request prescribing under shared care using the amiodarone Transfer of Care (ToC) form and send a link to or copy of the SCP

vii. To make the baseline test results available to the GP continuing care

viii. To advise the GP regarding the duration of treatment

ix. To address any concerns with the GP regarding the patient's treatment.

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Amiodarone Shared Care Protocol (SCP)

Statement of PurposeThis Shared Care Protocol has been written to enable the safe and appropriate continuation of care for patients initiated on amiodarone in hospital. Every patient prescribed amiodarone should be given a handheld record, to promote understanding and ensure adequate monitoring.

The SCP acknowledges that amiodarone is a useful medication but has potentially serious side effects and also that some patients are already prescribed amiodarone in primary care after initial specialist prescription.

Responsibilities of secondary care doctor

Amiodarone baseline test record sheetYour hospital doctor should arrange for these tests when you start amiodarone. The record sheet can be completed when the test results are available.

Tests Date Result Signature

Liver ALT function

Thyroid TSH function T4

Chest x-ray

Pulmonary function tests

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Responsibilities of the primary care doctor

i. To refer appropriate patients to secondary care for assessment

ii. If appropriate, to agree to prescribe in accordance with the SCP by returning the amiodarone ToC form to the referring consultant

iii. In the event that the GP is not able to prescribe, or where the SCP is agreed but the consultant is still prescribing certain items e.g. hospital only product, the GP will provide the consultant with full details of existing therapy promptly by fax on request

iv. Where the GP does not prescribe, amiodarone will be added to the practice prescribing system as a hospital only drug

v. To report any adverse reaction to the Commission on Human Medicines (CHM) and the referring consultant

vi. To continue to prescribe for the patient as advised by the consultant

vii. To undertake monitoring as per SCP

viii. To inform the consultant if the patient discontinues treatment for any reason

ix. To seek the advice of the consultant if any concerns with the patient's treatment

x. To conduct a six monthly face to face medication review or more frequent if required

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Amiodarone monitoring scheduleThese monitoring sheets should be completed at six monthly intervals in accordance with the Sheffield Amiodarone Shared Care Protocol

Symptoms and Date Comment Signature signs of side effects Cough, breathlessness or fever

Visual disturbance



Liver function ALT

Section C of this booklet includes advice for patients and doctors about what to do in the event of abnormal findings.

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Visual disturbance



Liver function ALT


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Visual disturbance



Liver function ALT




Visual disturbance



Liver function ALT


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Visual disturbance



Liver function ALT


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Visual disturbance



Liver function ALT


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Visual disturbance



Liver function ALT


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Visual disturbance



Liver function ALT


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Visual disturbance



Liver function ALT


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Visual disturbance



Liver function ALT


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Visual disturbance



Liver function ALT


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Section C

Other useful information

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Contact Information for Patients

For more information call Sheffield Teachings Hospitals Medicines Advice Line at:

Northern General Hospital 0114 271 4371

Royal Hallamshire Hospital 0114 271 3296

or

Arrhythmia Nurse Specialists 0114 226 9064

If you have Atrial Flutter/Fibrillation you may find information at:

www.atrialfibrillation.org.uk

Useful Information for Healthcare Professionals

http://www.intranet.sheffieldccg.nhs.uk/medicines-prescribing/shared-care-protocols.htm

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Amiodarone Shared Care ProtocolIndications / patient selectionTreatment should be initiated by specialists only. Monitoring should take place by the specialist or as part of the SCP.

Oral amiodarone is indicated only for the treatment of severe rhythm disorders not responding to other therapies or when other treatments cannot be used:

• Asanadjunctiveshort-termtreatmentpriortoDCcardioversion of atrial flutter/fibrillation (unlicensed indication)

• TachyarrhythmiasassociatedwithWolff-Parkinson-WhiteSyndrome

• Atrialflutterandfibrillationwhenotherdrugscannotbeused

• Alltypesoftachyarrhythmiasofparoxysmalnatureincluding supraventricular, nodal and ventricular tachycardias, ventricular fibrillation, when other drugs cannot be used

Other indications fall outside this shared care protocol and the patient should be referred back to the original prescriber.

DoseA specialist should initiate loading with amiodarone and an oral or intravenous route may be used, according to the clinical situation and indication.The loading dose by mouth is: 200mg 3 times daily for 1 week reduced to 200mg twice daily for a further week. The loading dose should be prescribed by secondary care and GPs only asked to prescribe amiodarone at the maintenance dose.Maintenance usually 200mg daily or the minimum required to control the arrhythmia. Maintenance doses above 200mg daily should be managed by secondary care and are not part of the SCP.

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Adverse effect Frequency Investigation Treatment % and diagnosisPulmonary toxicity (suggested by new or worsening cough and/or shortness of breath)

HyperthyroidismHypothyroidismLiver toxicityOptic neuropathy

Pro-arrhythmiaTremor

Peripheral Neuropathy MyopathyBradycardia

Nausea, anorexia

Corneal micro-depositsPhotosensitivity

Blue discolouration of skin

2 to 17

2610.13

<1<10

<1

2-4

30

>90

4-9

<9

CXR and ECG to exclude alternative diagnoses

Free T4, TSHFree T4, TSHLFTOphthalmologic examination

ECGHistory and clinical examination

Examination, ECG

History + examinationSlit-lamp examinationHistory, examinationExamination

If pulmonary toxicity is suspected: refer urgently to initiating cardiologist or respiratory physician.

Specialist to request PFTs including DLCO* and HRCT** chest scan (see also advice under monitoring on page 4)See algorithm Appendix 1 See algorithm Appendix 1See algorithm Appendix 2If optic neuropathy/neuritis is suspected, refer urgently to ophthalmology and discuss the possibility of stopping amiodarone & alternative antiarrhythmic therapy with patient's cardiologistStop amiodaroneReduce dosage or withdraw if possible

Usually reversible on withdrawal of the drug

If severe, discuss with cardiologist whether to stop amiodarone or insert pacemakerReduce dosage

None

Use sunblock

Reduce dosage if possible

* DCLO is Diffusing Capacity of Lung for carbon monOxide. ** HCRT is High Resolution Computed Tomography

Contra-indications / side effects / interactionsFor full details on contraindications, side effects and interactions see SPC available at http://www.medicines.org.uk/emc/ and the British National Formulary available at http://www.bnf.org/bnf/index.htm

Common side effects

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Patients taking warfarinFor patients taking warfarin prior to starting amiodarone the warfarin dose should be reduced by approximately one-third when amiodarone is started. INRs should then be checked weekly for 4-6 weeks and until INR stable. If / when amiodarone is stopped the interacting effect may persist for up 6 weeks or more, so again INR should be checked weekly until stable. Note that amiodarone-induced hyperthyroidism will increase warfarin dose requirements.

MonitoringMonitoring should take place during the loading of amiodarone, and then every 6 months whilst treatment continues. See table below. Please ensure that "Patient on Amiodarone" is marked on every lab test form.

Monitoring at baseline and during loading is the responsibility of secondary care. Further monitoring is the responsibility of primary care.

Baseline Loading

History & examination (H&E)

H&E relating to adverse effects***

Heart rate and ECG

TFTs

U & Es

LFTs (ALT)

Digoxin level (if on digoxin)

INR (if on warfarin)

CXR

PFTs inc DLCO

Eye examination

If suspected pulmonary toxicity

If suspected pulmonary toxicity

Assess if new or worsening visual symptoms occur

6 months and every 6 months thereafter unless otherwise stated

Assess serum digoxin levels if dose increased or toxicity is suspected

Monitor INR levels. Adjust warfarin dose accordingly

Continue annually

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Appendix 1

Thyroid function: TFTs every 6 months

Check TFTs every 6 months or if patient presents with clinical features suggestive of thyroid disease

Inform initiating consultant of results and managment.Refer for endocrine opinion if situation is uncertain or

patient is unstable.

Clinicallyeuthyroid

RecheckTFTs in

4 weeks

Results suggest hypothyroid - increased TSH/ decreased

T3 or T4

Considerstarting

thyroxine

Clinicalhypothroidism

weight gain

fatigue

bradycardia

Clinicallyeuthyroid

Routineendocrine

referral

Results suggest thyrotoxic -

decreased TSH/ increased T3 or T4

Clinicalthyrotoxicosis

weight loss

asthenia

restlessness

increased heart rate

worseningarrhythmia,

CFF or angina

Refer urgentlyto

endocrinologist

Normalresults

Continue treatment, reassess in 6 months

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Appendix 2

Liver function tests

Check LFTs every 6 months

If ALT 61-250iu/L and patient is not

jaundiced, continue amiodarone and repeat

LFTs in 2 weeks

Normal results (with ALT <60iu/L)

If ALT >251iu/L or jaundiced

If still raised, refer to initiating hospital specialist urgently

Continue treatmentand reassess in

6 months

Stop amiodarone and refer to initiating specialist urgently

Patients taking amiodarone may have co-morbidities that affect LFTs; these should be considered when interpreting LFTs.

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Developed by the Amiodarone Safer Prescribing Group chaired by Dr Paul Sheridan, Consultant Cardiologist, Sheffield Teaching Hospitals Foundation Trust

This record can be ordered from Xerox at Northern General Hospital (via supplies) by quoting reference number PD7572.

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PD7572-PIL3105 v4 Issue date: October 2019. Review date: October 2022

© Sheffield Teaching Hospitals NHS Foundation Trust 2019. Re-use of all or any part of this document is governed by copyright and the “Re-use of Public Sector Information Regulations 2005” SI 2005 No.1515. Information on re-use can be obtained from the Information Governance Department, Sheffield Teaching Hospitals. Email: [email protected]

Alternative formats may be available on request. Please email: [email protected]

Documents

The Amiodarone Passport and the Patient Handheld