Implanon Consent Form

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Overview of the IMPLANON NXT®


checklist and consent form

This document, comprising a doctor checklist and patient consent form for the
insertion of IMPLANON NXT®, has been developed by the RACGP’s National
Standing Committee – GP Advocacy & Support and National Standing Committee –
Quality Care to assist General Practitioners maintain a high level of quality and
safety in the insertion of IMPLANON NXT®. This document:

(a) does not imply a recommendation of the product itself; and

(b) The information set out in this document is current at the date of first
publication and is intended for use as a guide of a general nature only and
may or may not be relevant to particular patients or circumstances. Nor is this
publication exhaustive of the subject matter. Persons implementing any
recommendations contained in this publication must exercise their own
independent skill or judgement or seek appropriate professional advice
relevant to their own particular circumstances when so doing. Compliance
with any recommendations cannot of itself guarantee discharge of the duty of
care owed to patients and others coming into contact with the health
professional and the premises from which the health professional operates.
Whilst the text is directed to health professionals possessing appropriate
qualifications and skills in ascertaining and discharging their professional
(including legal) duties, it is not to be regarded as clinical advice and, in
particular, is no substitute for a full examination and consideration of medical
history in reaching a diagnosis and treatment based on accepted clinical
practices. Accordingly The Royal Australian College of General Practitioners
and its employees and agents shall have no liability (including without
limitation liability by reason of negligence) to any users of the information
contained in this publication for any loss or damage (consequential or
otherwise), cost or expense incurred or arising by reason of any person using
or relying on the information contained in this publication and whether caused
by reason of any error, negligent act, omission or misrepresentation in the
information.

The forms are designed for use in a three-stage process – an initial consultation
followed by the insertion and removal of the implant.

Medical Indemnity Insurers (MIIs) may have requirements regarding IMPLANON


NXT®. It is important to be aware of these and complete appropriate training that
meets the educational requirements prior to inserting IMPLANON NXT®.

This checklist and consent form is not a substitute for reading the approved Product
Information and for being familiar with the insertion and removal technique.

© RACGP - IMPLANON NXT® CHECKLIST&CONSENT FORM MAY 2011


Stage 1 – Initial Consultation

Doctor
• Tick and date the Pre-insertion Section
• Explain the Pre-insertion Section in the ‘Patient Consent Form’
• Ask Patient to tick, date and sign the Pre-insertion Section in the ‘Patient
Consent Form’ and return it prior to insertion.

Stage 2 – Insertion

Doctor
• Sight and record the Patient’s completed Pre-insertion Section of the
‘Patient Consent Form’
• Tick off and date the Insertion Section in the ‘Doctors’ Checklist’
• Sign and date the Post-insertion Section of the ‘Patient Consent Form’
• Ask Patient to sign and date the Post-insertion Section of the ‘Patient
Consent Form’.

Stage 3 – Removal

Doctor
• Tick and date the Removal Section of the ‘Doctors’ Checklist’.

Consider:

o having a reminder system as a service for regular patients


o scanning the Patient Consent form if you require an electronic record.

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© RACGP – IMPLANON NXT® CHECKLIST&CONSENT FORM MAY 2011
Med Rec No. _______________
Doctors’ Checklist
Patient name _______________
for the Insertion of IMPLANON NXT®
DOB _______________
Pre insertion Section
No contraindication according to the Manufacturer’s product information, particularly
medications which can decrease the effectiveness of IMPLANON NXT®

Confirmation that there are no known allergies to local anaesthetics, sex hormones,
plastics, metals, latex or any of the active or inactive ingredients or excipients contained in
IMPLANON NXT®

Implant planned for day 1-5 in cycle, or as per Manufacturer’s instructions

If previously using another method of contraception, I have discussed the importance of


using effective contraception prior to insertion of IMPLANON NXT®

I have discussed the benefits, risks and side effects of IMPLANON NXT®®

I have discussed the insertion and removal process of IMPLANON NXT®

Doctor’s signature: Date:

Insertion Section

Pre-insertion Section of Patient Consent Form completed and returned

Implant present in cannula pre-insertion

Implant inserted between day 1-5 in cycle, or as per Manufacturer’s instructions

If inserted later than day 5, I have advised of the importance of using additional
contraceptive cover for 7 days

I have adequately excluded pregnancy / I am satisfied that the woman is not pregnant

I have followed the Manufacturer’s instructions on the correct method of insertion

Needle fully retracted into the body of the applicator

Implant is palpable after insertion, or

The implant is not palpable (see manufacturer’s notes on management plan)

Procedure completed, batch number ‘sticker’ affixed to consent form and date of insertion
/ removal of implant recorded on appropriate credit card slip for patient.

Side effects explained and Patient advised to attend for review if she has any concerns

Post-insertion Section of Patient Consent Form completed and copy provided to patient
and record

Insertion adequately documented in record

Doctor’s signature: Date:


Removal Section

Removal documented in record

Doctor’s signature: Date:


For further information on the insertion and localisation of IMPLANON NXT®, contact: MSD (Schering-Plough Pty Limited)L4 / 66 Waterloo Road North Ryde NSW 2113
Tel 1800 818 553 Website http://msdonline.com.au/products/Pages/IMPLANON.aspx
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© RACGP – IMPLANON NXT® CHECKLIST&CONSENT FORM MAY 2011
Med Rec No. _______________
Patient Consent Form
Patient name _______________
for the Insertion of IMPLANON NXT® DOB _______________
Overview of treatment
The insertion of IMPLANON NXT® involves a small plastic implant containing the hormone progestogen being inserted
underneath the skin of the upper inner arm to act as a contraceptive against pregnancy for up to three years.

Patient to tick boxes


Pre Insertion Section
I have discussed the benefits, risks and side effects of using IMPLANON NXT® with my
doctor. Side effects may include:

• irregular bleeding, no bleeding, headaches, weight gain and breast symptoms

Benefits and risks • bruising and discomfort for up to one week after insertion

• the possibility of allergic reactions

• the implant moving from its original position, which could make removal more
difficult.

I am aware of the effectiveness of IMPLANON NXT® as well as its relative effectiveness


Effectiveness of
compared with other birth control methods. I am aware no birth control method is
contraception completely reliable so I could have a small chance of becoming pregnant

I understand that the IMPLANON NXT® implant must be removed by three years since
Removal after
leaving it in place for longer may increase the chances of an ectopic pregnancy
three years (pregnancy in the tube). I am aware it is my responsibility to arrange removal

The insertion and removal of the Implant may leave a small scar on the skin. I am aware
Scarring that some people are predisposed to develop a thickened scar. A larger scar is likely if the
IMPLANON NXT® implant is difficult to remove

Insertion and I understand that to reduce discomfort, my doctor will use a local anaesthetic when
removal inserting and removing the IMPLANON NXT® implant

I have advised my doctor of any known allergies, especially allergies to a local


Allergic reactions anaesthetic, sex hormones, plastics, metals, latex or any of the active or inactive
ingredients or excipients contained in IMPLANON NXT®

I have understood the information concerning IMPLANON NXT®. I will contact my doctor
Acknowledgement should I require further advice

I understand that I must advise my doctor of any medication I am taking, as well as advise
Interactions any other doctors I see, that I have an IMPLANON NXT® implant, as these can reduce
the effectiveness of IMPLANON NXT®

Based on the information above, I ______________________________________ willingly consent for my doctor to


insert an IMPLANON NXT® implant for use as a contraceptive in my Left/ Right arm. By ticking off each of the items
above, I acknowledge that these are understood by me and have been discussed with my doctor.

Signed by patient _____________________________ Date ___/___/______

Post Insertion Section


Outcome

1. I can feel the inserted implant. ___________________Date ___/___/______


2. I have a copy of the Consumer Medicine Information and the post
insertion care instructions Signed by Patient
3. I should return to see my doctor if I have any concerns or questions
4. I should have an annual check up while the implant is inserted. ___________________Date ___/___/______
5. I need to have the implant removed in 3 years time.
Signed by Doctor

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© RACGP – IMPLANON NXT® CHECKLIST&CONSENT FORM MAY 2011

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