Iron Infusion Consent - Queensland Health

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URN:

Family name:

Given name(s):

Address:

Date of birth: Sex: M F I

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Iron Infusion Consent

Adult (18 years and over) OR

Child/Young Person (under 18 years)

IRON INFUSION CONSENT

v1.00

Clinical content review: 2021

Clinical check: 08/2021

Published: 09/2021

SW9511

C. Patient OR substitute decision-maker OR parent/

legal guardian/other person* requests the following

procedure(s)

Iron infusion

Ferric Carboxymaltose (Ferinject

)

Ferric Derisomaltose (Monofer

)

Iron Polymaltose (Ferrosig

)

Iron Sucrose (Venofer

)

Is this off-label use? Yes No

D. Risks specic to the patient in having an iron

infusion

(Doctor/clinician to document additional risks not included in

the patient information sheet):

E. Risks specic to the patient in not having an iron

infusion

(Doctor/clinician to document specic risks in not having an

iron infusion):

F. Alternative treatment options

(Doctor/clinician to document alternative treatment not

included in the patient information sheet):

G. Information for the doctor/clinician

The information in this consent form is not intended to be

a substitute for direct communication between the doctor/

clinician and the patient OR substitute decision-maker OR

parent/legal guardian/other person*.

I have explained to the patient OR substitute decision-maker

OR parent/legal guardian/other person* the contents of this

form and am of the opinion that the information has been

understood.

Name of doctor/clinician:

Designation:

Signature: Date:

A. Does the patient have capacity?

Complete for ADULT patient only

Yes è GO TO section B

No è COMPLETE section A

You must adhere to the Advance Health Directive (AHD),

or if there is no AHD, the consent obtained from a substitute

decision-maker in the following order: Category 1. Tribunal-

appointed guardian; 2. Enduring Power of Attorney; or

3. Statutory Health Attorney.

Name of substitute decision-maker:

Category of substitute decision-maker:

Complete for CHILD/YOUNG PERSON patient only

Yes

Although the patient is a child/young person, the patient may

be capable of giving informed consent and having sufcient

maturity, understanding and intelligence to enable them to

fully understand the nature, consequences and risks of the

proposed procedure/treatment/investigation/examination and

the consequences of non-treatment – ‘Gillick competence’

(Gillick v West Norfolk and Wisbech Area Health Authority

[1986] AC 112)

è GO TO section B

Parent/legal guardian/other person* with parental rights and

responsibilities to provide consent and complete this form

è COMPLETE section A

* Formal arrangements, such as parenting/custody orders, adoption, or

other formally recognised carer/guardianship arrangements. Refer to the

Queensland Health ‘Guide to Informed Decision-making in Health Care’

and local policy and procedures. Complete the source of decision-making

authority as applicable below.

If applicable, source of decision-making authority (tick one):

Court order è Court order veried

Legal guardian è Documentation veried

Other person* è Documentation veried

Name of parent/legal guardian/other person*:

Relationship to child/young person:

B. Is an interpreter required?

If yes, the interpreter has:

provided a sight translation of the informed consent form

in person

translated the informed consent form over the telephone

Name of interpreter:

Interpreter code: Language:

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(Afx identication label here)

URN:

Family name:

Given name(s):

Address:

Date of birth: Sex: M F I

DO NOT WRITE IN THIS BINDING MARGIN

Except as permitted under the Copyright Act 1968, no part of this work may be

reproduced communicated or adapted without permission from Queensland Health

To request permission email: ip_of[email protected].au

Iron Infusion Consent

Adult (18 years and over) OR

Child/Young Person (under 18 years)

H. Patient OR substitute decision-maker OR parent/

legal guardian/other person* consent

I acknowledge that the doctor/clinician has explained:

• the “Iron infusion” patient information sheet

• the medical condition and proposed treatment, including the

possibility of additional treatment

• the general and specic risks and benets of the procedure

• the prognosis, and risks of not having the procedure

• alternative treatment options

• that there is no guarantee the procedure will improve the

medical condition

• that if a life-threatening event occurs during the procedure:

- an adult/young person will be treated based on

documented discussions (e.g. AHD or ARP [Acute

Resuscitation Plan])

- a child’s health care will be provided in accordance with

good clinical practice and in the best interests of the patient

• that a doctor/clinician other than the consultant/specialist

may assist with/conduct the clinically appropriate treatment;

this may include a doctor/clinician undergoing further training

under supervision

• that if the doctor/clinician wishes to record video, audio or

images during the procedure where the recording is not

required as part of the treatment (e.g. for training or research

purposes), I will be asked to sign a separate consent form.

If I choose not to consent, it will not adversely affect my

access, outcome or rights to medical treatment in any way.

I was able to ask questions and raise concerns with the

doctor/clinician.

I understand I have the right to change my mind regarding

consent at any time, including after signing this form (this

should be in consultation with the doctor/clinician).

I/substitute decision-maker/parent/legal guardian/other

person* have received the following consent and patient

information sheet(s):

“Iron infusion”

On the basis of the above statements,

I/substitute decision-maker/parent/legal guardian/other

person* consent to having an iron infusion.

Name of patient/substitute decision-maker/parent/legal

guardian/other person*:

Signature: Date:

If the patient is a young person:

I am not aware of any legal or other reason that prevents

me from providing unrestricted consent for this young

person for this treatment (not applicable if the young

person is Gillick competent and signs this form).

DO NOT WRITE IN THIS BINDING MARGIN

Except as permitted under the Copyright Act 1968, no part of this work may be

reproduced communicated or adapted without permission from Queensland Health

To request permission email: ip_of[email protected].au

Adult and Child/Young Person | Informed consent: patient information

A copy of this form should be given to the

patient/substitute decision-maker/parent/legal guardian/

other person*

to read carefully and allow time to ask any questions about the procedure. The

consent form and patient information sheet should be included in the patient’s medical record.

Iron infusion patient information

SW9511 v1.00 Clinical content review: 2021 Clinical check: 08/2021 Published: 09/2021 Page 3 of 6

Iron use in children

The product information for each of the following products state they are not indicated for use in

children; however, iron infusions are commonly used in children. This is called off-label use and

is common in paediatric medical practice. If you have any questions about off-label use, please

discuss these with your doctor/nurse/midwife. For further information on off-label use in children

go to section 6 “Where can I nd support or more information?”. The information in these guides

refers to the best available evidence and best practice protocols that support the safety and

benet of these products for paediatric use.

1. What is an iron infusion and how will it help me/the patient?

Our bodies need iron. Iron is used to make haemoglobin, this is the part of the red blood cell

that transports oxygen around the body. Iron is also important for muscle strength, energy

and mental function. If your iron levels are low you may feel tired and not be able to perform

your normal daily activities. As the iron levels drop lower, the haemoglobin levels drop below

normal. This is known as iron deciency anaemia.

The most common way to treat iron deciency is

to take iron by mouth as a tablet or liquid. This

works for most people and is usually tried rst.

You might need an iron infusion if you:

• are not able to take iron tablets/liquids

• are not responding to iron tablets/liquids

• need to increase your iron levels quickly

(e.g. before major surgery, late in pregnancy

or to avoid a blood transfusion)

• if you have chronic kidney disease, chronic

heart failure, or inammatory bowel disease.

Sometimes more than one iron infusion is

required to fully elevate your iron levels.

An intravenous (IV) iron infusion is an infusion made up of iron, not blood, that is infused

directly into your bloodstream. A plastic cannula is placed into one of your veins and is

attached to a pump that infuses the iron into your body. Iron infusions work faster to replace

iron than tablets or liquids taken by mouth.

Staining of the skin from intravenous iron is uncommon, but when it occurs the stain can be

long lasting or permanent (see image above). The leakage occurs in the area around the

cannula (drip site) into the surrounding tissues.

Iron infusion

Image: Iron staining.

Source: Canning, M & Grannell, L. 2020, ‘A Stain on iron

therapy,’ Australian Prescriber, vol. 43, no. 5, pp.160-3,

retrieved 29/08/2021 (www.nps.org.au/assets/p160-Canning-

Grannell.pdf). Image used under CC BY-NC-ND 4.0 licence.

Iron infusion patient information

SW9511 v1.00 Clinical content review: 2021 Clinical check: 08/2021 Published: 09/2021 Page 4 of 6

Preparing for the treatment

Before you have an iron infusion, you must

tell your doctor/nurse/midwife and the nurses

performing the infusion if you:

• are pregnant/trying to get pregnant, as an

IV iron infusion should be avoided in the

rst trimester

• have a history of asthma, eczema or other

allergies

• have had a reaction to any type of iron

injection or infusion in the past

• have a history of high iron levels

(haemochromatosis) or liver problems

• have (or may have) an infection at the

moment.

You may want to ask your doctor/nurse/

midwife about the following:

• Why do I need an IV iron infusion?

• What are the other options?

• How many infusions will I need to get

enough iron?

• (If you are currently taking iron tablets/

liquids) When do I stop taking the iron

tablets/liquids and will I need to use them

again?

• How long will it take for my iron levels to

improve?

• Any questions about side effects that may

worry you.

The day of the treatment

There is preparation needed for an iron

infusion. Here are some useful tips:

• It is helpful if you are well hydrated prior

to your iron infusion so that putting in a

cannula may be easier.

• Have your regular breakfast/lunch – you do

not need to fast.

• Take all your regular medications.

• Tell your nurse/midwife administering the

iron infusion if you are pregnant or not.

• If you experience any side effects, inform

your nurse/midwife immediately.

• Adults can drive home after the iron

infusion and all patients can resume

usual activities (unless you experienced

an unexpected reaction and medical staff

inform you otherwise).

• Very little iron crosses into breast milk

so breast feeding mothers may safely

breastfeed.

All the iron products listed on this consent

form have Australian marketing approval

from the Therapeutic Goods Administration

(TGA). The Australian approved product

information lists the approved indications

(uses) and any age restrictions. Off-label use

occurs when an iron infusion is prescribed

outside the approved product information

(either the indication or the age restriction)

and is common in paediatric medical practice.

A doctor/nurse/midwife will discuss the

suitable treatment options for your child.

The indications and age restrictions for iron

infusion are as follows:

• Ferric Carboxymaltose (Ferinject

)

– Treatment of iron deciency when

oral iron preparations are ineffective or

cannot be used. The diagnosis must be

based on laboratory tests. Precaution:

The product information states that Ferric

Carboxymaltose is not recommended in

children under 14 years.

• Ferric Derisomaltose (Monofer

) –

Product information states that Ferric

Derisomaltose Iron Supplement is for

Adults 18 years and older, for use in iron

deciency when oral preparations are

ineffective, inappropriate or when rapid iron

delivery is necessary.

• Iron Polymaltose (Ferrosig

) –

Product information states that there

is no age restriction. Treatment of iron

deciency anaemia when oral therapy

is contraindicated, gastrointestinal

absorption of iron is defective or when

patient noncompliance or persistent

gastrointestinal intolerance makes oral

therapy impractical. Iron supplement

for Iron deciency anaemia where oral

treatment not appropriate or gastrointestinal

absorption is defective.

• Iron Sucrose (Venofer

) – Treatment

of iron deciency anaemia in patients

undergoing long-term haemodialysis

and who are receiving supplemental

erythropoietin therapy (a drug used to

stimulate red blood cell production in bone

marrow for anaemia). The diagnosis of iron

deciency must be based on appropriate

laboratory tests. Precaution: The product

information states that the safety and

efcacy of Iron Sucrose in children has not

been established.

Iron infusion patient information

SW9511 v1.00 Clinical content review: 2021 Clinical check: 08/2021 Published: 09/2021 Page 5 of 6

Rare risks and complications

• anaphylaxis – rare and usually occurs in

the rst few minutes of the iron infusion and

is characterised by breathing difculties,

which may be life threatening. You will be

closely monitored whilst the iron infusion is

given and for at least 30 minutes

• rapid heart beat (tachycardia) and low

blood pressure

• skin staining (brown discoloration) may

occur due to leakage of iron into the tissue

around the cannula (drip) site. This is not

common, but the stain can be long lasting

or permanent (see image)

• inform the nurse straight away of any pain,

discomfort, burning, prickling, redness,

staining or swelling at the cannula (drip) site

• death as a result of this procedure is

possible. You will be closely monitored

whilst the iron infusion is given and for at

least 30 minutes following completion.

This treatment does not require an

anaesthetic.

What are the risks of not having an

iron infusion?

There may be health consequences if you

choose not to have the proposed treatment.

Please discuss these with the doctor/nurse/

midwife.

If you choose not to have the treatment, you

will not be required to sign a consent form.

If you have signed a consent form, you have

the right to change your mind at any time

prior to the treatment. Please contact the

doctor/nurse/midwife to discuss.

3. Are there alternatives?

Making the decision to have a procedure

requires the patient/substitute decision-

maker/parent/legal guardian/other person*

to understand the options available. Please

discuss any alternative treatment options

with your doctor/nurse/midwife before signing

the consent form.

During the treatment

The duration of the iron infusion varies

depending on the product used. Your

iron infusion may take 15 to 30 minutes,

1 to 2 hours or 4 to 6 hours.

You will also need to allow time for the IV

cannula to be inserted and removed, and for

clinical observation before and after the iron

infusion (30 to 60 minutes).

2. What are the risks?

There are risks and complications with this

procedure. There may also be risks specic

to each person’s individual condition and

circumstances. Please discuss these with

the doctor/nurse/midwife and ensure they

are written on the consent form before you

sign it. Risks include but are not limited to the

following:

Common risks and complications

• low blood pressure

• palpitations

• facial ushing

• dizziness

• vomiting and nausea

• headache

• injection site reactions (see also below skin

staining in rare risks)

• joint and/or muscle pain

• changes in taste (e.g. metallic)

• (Ferric carboxymaltose [Ferinject

] only)

hypophosphataemia (low blood phosphate

level). This can cause muscle weakness,

respiratory failure, heart failure and in

rare circumstances osteomalacia (bone

softening), fractures, seizures and/or coma.

You may require oral medication to raise

your blood phosphate level.

Uncommon risks and complications

• dizziness and feeling faint

• chest and/or back pain

• chills and fever

• skin irritation and rash

• swelling of the face, mouth and limbs

• generalised lymphadenopathy (swollen

lymph nodes)

• difcult breathing.

from Queensland Health. To request permission email: ip_of[email protected]

Iron infusion patient information

SW9511 v1.00 Clinical content review: 2021 Clinical check: 08/2021 Published: 09/2021 Page 6 of 6

More information on off-label use can be

found at:

www.blood.gov.au/system/les/Corrected-

Paed-and-Neonatal-IDA-Guide-dosing-for-

iron-polymaltose.pdf

www.mja.com.au/journal/2006/185/10/

label-use-medicines-consensus-

recommendations-evaluating-

appropriateness

Staff are available to support patients’

cultural and spiritual needs. If you would like

cultural or spiritual support, please discuss

with your doctor/nurse/midwife.

Queensland Health recognises that

Aboriginal and Torres Strait Islander patients

will experience the best clinical care when

their culture is included during shared

decision-making.

7. Questions

Please ask the doctor/nurse/midwife if

you do not understand any aspect of this

patient information sheet or if you have any

questions about your/the patient’s medical

condition, treatment options and proposed

treatment.

If you require additional information about

the intravenous iron preparation prescribed

for you, please speak to the clinician/doctor/

nurse/pharmacist who can arrange to provide

you with a Consumer Medicines Information

(CMI) leaet.

8. Contact us

In an emergency, call Triple Zero (000).

If it is not an emergency, but you have

concerns, contact 13 HEALTH (13 43 25 84),

24 hours a day, 7 days a week.

4. What should I expect

after the treatment?

In some cases, iron tablets/liquids are

recommended after the infusion. If oral iron

therapy is recommended it should not start

until at least one week after your IV iron

infusion as the iron within the tablets/liquids

will not be absorbed.

Tell your doctor/nurse/midwife or

seek urgent medical attention/call an

ambulance (000) if you have:

• chest pain

• trouble breathing

• dizziness

• neck/mouth swelling.

5. Who will be performing

the treatment?

A doctor/nurse/midwife other than the

consultant/specialist may assist with/conduct

the clinically appropriate treatment. This

could be a doctor/nurse/midwife undergoing

further training, all trainees are supervised

according to relevant professional guidelines.

If you have any concerns about which

doctor/nurse/midwife will be performing the

treatment, please discuss with the doctor/

nurse/midwife.

6. Where can I nd support

or more information?

Hospital care: before, during and after is

available on the Queensland Health website

www.qld.gov.au/health/services/hospital-

care/before-after where you can read about

your healthcare rights.

More information on iron infusions can be

found on the TGA website:

www.tga.gov.au/sites/default/les/auspar-

ferric-carboxymaltose-191001.pdf

www.tga.gov.au/sites/default/les/auspar-

ferric_derisomaltose-181105.pdf