In the last few years there have been more and more situations where specific medications approved by Medsafe are not available in New Zealand, and doctors have been forced to consider prescribing alternative, unapproved medications.

• An approved medication has been tested for quality, safety and efficacy, and has received Medsafe approval.
• An unapproved medication has not received the above approval from Medsafe.
• Unapproved use of a medication is where a prescriber prescribes an approved medication but for a use outside of the use /condition/ indication the medication has received approval for.

Medical practitioners (MCNZ registered doctors) in New Zealand have the ability to prescribe any medication, be it, approved, unapproved, or for an unapproved use. However, where, as in the above scenario, a prescriber is prescribing either an unapproved medication, or a medication for an unapproved use, there are specific obligations and risks, which prescribers need to be aware of. This Factsheet looks at prescribing unapproved medication and provides an outline of matters doctors should consider prior to prescribing.

Under s 29 of the Medicines Act (the Act), unapproved medicines may be supplied and/or administered to patients, provided the request for such is from a medical practitioner and for the treatment of a particular patient under the current care of that medical practitioner. The supplier (usually a pharmacy) has an obligation under the section to provide Medsafe with information regarding the supply of the unapproved medication.

To comply with the Code of Health and Disability Services Consumers' Rights and Privacy legislation, it is crucial doctors:

• Discuss the medication with their patient and advise the patient that the medication is unapproved;
• Obtain informed consent to prescribe – that is, a full discussion with the patient about any potential side effects and risks of the medication and why the doctor is considering prescribing it;
• Advise the patient that because it is an unapproved medication, information about the prescribing of such, including the patient’s personal details, will be provided to Medsafe by the pharmacy/supplier; and
• Where the medication could be considered experimental – where there is limited support for its use – the abovementioned consent should be obtained in writing.

Responsibility to ensure the appropriateness of a patient’s care, treatment and prescribed medication, and adherence to the Medical Council of New Zealand’s relevant guidelines (particularly Good Medical Practice and Good Prescribing Practice) rests with the doctor. When signing a prescription for an unapproved medication the doctor should ensure:

1. They are working within their area of expertise;
2. The patient named is under their care and they have a treatment plan / follow up;
3. The medicine is appropriate for the patient in all respects;
4. The patient has been given the dosage instructions in writing;
5. A thorough explanation has been provided to the patient, outlining the risks of using medicines which have not gone through the Medsafe approval process.

It is important to note that unapproved medicines are not necessarily unsafe to use – this prescribing often happens for medicines that are commonly used and approved in other countries, or when there is limited or no stock of the approved medication in New Zealand. However, it is important that the doctor considers the evidence and clinical experience of the use of the unapproved medicine; weighs up the risks and benefits; discusses this with the patient as part of the consent process; and ensures detailed medical notes are made.

If you have any specific concerns about prescribing under Section 29 of the Medicines Act, and you are a member of the Medical Protection Society, you can call our advisers to discuss your concerns on 0800 2255677, or email us on [email protected].