Off-label Medication Use Consent Form

The Use of Non-registered and Off Label Medications

Non-registered/off label medications shall only be used when:

• Their use is clearly justified

• Their clinical/pharmaceutical benefits outweigh the risks involved

Practitioners must be fully aware of their responsibilities when using non-registered or off-label medications and must have sufficient knowledge, information or experience to show that they are acting reasonably and in the best interests of their patients.

1. Where possible, registered products shall be used to treat patients 

2. It is recognized that the use of a non-registered/off label medication is sometimes necessary in order to provide optimum treatment for a patient

3. Any liability associated with the use of non-registered/off label medications shall be accepted provided that best practice was used

4. Adverse medication reactions and medication incidents involving non-registered/off label medications shall be reported in the same manner as for registered medications

5. Prescriber intending to use these medications on a patient shall inform and receive patient’s consent prior initiation of treatment

6. Prescriber shall provide treatment outcome report to the Director / Deputy Director (Clinical) within 3-6 months of the notification of use of unregistered/off label medication

Doctors are required to use this form to officially acquire Patient / Caregiver consent

BEFORE using a medication outside of its registered indications to treat the patient.

The completed form MUST be inserted into Patient Case Notes for record purposes.

The form is available in both Bahasa Malaysia and English language.

Reviewed 15 November 2024