Off-label Medication Use Consent Form
Reviewed 13th Aug 2020
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.
Where possible, registered products shall be used to treat patients
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
Any liability associated with the use of non-registered/off label medications shall be accepted provided that best practice was used
Adverse medication reactions and medication incidents involving non-registered/off label medications shall be reported in the same manner as for registered medications
Prescriber intending to use these medications on a patient shall inform and receive patient’s consent prior initiation of treatment
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.