Revised: 31 October 2023

Medicines

Restrictions on the Supply, Prescribing or Administration of Medicines under the Medicines Act 1981 and Misuse of Drugs Regulations 1977

See also: Sativex Oromucosal Spray - Requirements for Prescribers

Pursuant to section 23 of the Medicines Act 1981, and regulation 22 of the Misuse of Drugs Regulations 1977, a medicine may be given consent to distribution, supply or use provided certain conditions are met. Conditions may relate to who can prescribe the medicine, or for what indication. The medicines listed below currently have conditions on supply and/or usage.

Note: the restrictions PHARMAC places on medicine subsidies (as listed in the Pharmaceutical Schedule) are independent of the conditions imposed under the Medicines Act or Misuse of Drugs Regulations.

Medicines consented under section 23 of the Medicines Act 1981 with restrictions:

• Clozapine
• Dantron and Poloxamer 188
• Pandemic & Pre-Pandemic Influenza Vaccines
• Riluzole
• Thalidomide

Medicines (controlled drugs) with prescribing restrictions under regulation 22 of the Misuse of Drugs Regulations 1977:

• Controlled drugs

Clozapine

Clopine, 25 mg, 50 mg, 100 mg and 200 mg tablet and 50 mg/mL oral solution
Douglas Pharmaceuticals Limited
Clozaril, 25 mg and 100 mg tablet
Novartis New Zealand Limited
Consent is given subject to the following restrictions:

1. The medicine may only be prescribed by:
   • A medical practitioner who is vocationally registered by the Medical Council of New Zealand in the scope of practice of psychiatry (hereinafter referred to as a Psychiatrist)
   • A medical practitioner or nurse practitioner who is prescribing under the supervision of a Psychiatrist
   • A medical practitioner who is registered by the Medical Council of New Zealand in a general scope of practice provided the medical practitioner is prescribing clozapine for a patient whose illness is being well controlled by clozapine and the prescribing decision is taken in collaboration with, or following consultation with, a Community Mental Health Team
2. Persons prescribing the medicine must comply with appropriate local treatment guidelines.
3. The medicine must be dispensed in accordance with appropriate local dispensing guidelines
4. Sale or marketing of this medicine may only occur if the sponsor has an appropriate blood monitoring and patient record database in place

Dantron and Poloxamer 188

Pinorax, 5mg dantron + 40 mg poloxamer 188 per mL oral suspension and 15mg dantron + 200 mg poloxamer 188 per mL oral suspension
AFT Pharmaceuticals Limited
Consent is given subject to the following restriction:
Pinorax may only be used for the prevention or treatment of constipation in the terminally ill.

Pandemic and Pre-pandemic Influenza Vaccines

Pandemic Influenza Vaccine H5N1 Baxter, suspension for injection
Baxter Healthcare Limited
Consent is given subject to the following restriction:
The vaccine may only be marketed, or distributed in accordance with the directives contained in the current version of the New Zealand Influenza Pandemic Action Plan.

Vepacel, suspension for injection
Baxter Healthcare Limited
Consent is given subject to the following restriction:
The vaccine may only be marketed, or distributed in accordance with the directives contained in the current version of the New Zealand Influenza Pandemic Action Plan.

Panvax Vaccine (Pandemic Influenza Vaccine), suspension for injection
CSL Biotherapies (NZ) Limited
Consent is given subject to the following restriction:
The vaccine may only be marketed, or distributed in accordance with the directives contained in the current version of the New Zealand Influenza Pandemic Action Plan.

Pandemrix (Pandemic Influenza Vaccine), suspension for injection
GlaxoSmithKline (NZ) Ltd
Consent is given subject to the following restriction:
The vaccine may only be marketed, or distributed in accordance with the directives contained in the current version of the New Zealand Influenza Pandemic Action Plan.

Riluzole

Rilutek, 50mg tablet
Sanofi-Aventis New Zealand Limited
Apo-Riluzole, 50mg tablet
Apotex New Zealand Limited
Consent is given subject to the following restriction:
Rilutek Tablets can only be prescribed by authorised prescribers where the prescribing decision is taken in collaboration with, or following consultation with, physicians who care for patients with Motor Neuron Disease, neurologists and palliative care physicians.
Rilutek Tablets can only be used by patients with vital capacity greater than 60%.

Thalidomide

Thalomid, 50mg, 100mg, 150mg and 200mg capsule
Celgene Limited
Consent is given subject to the following restrictions:

1. Thalidomide may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope and practice of internal medicine.
2. Celgene Limited will manage the risk management programme relating to the distribution and use of Thalomid.

Medicines (controlled drugs) with restrictions under regulation 22 of the Misuse of Drugs Regulations 1977

There are restrictions on the supply, prescribing, and administration of certain controlled drugs specified by regulation 22 of the Misuse of Drugs Regulations 1977.

Approval has been granted for supply, prescribing, and administration of the following controlled drugs in defined circumstances, as described in the corresponding approval notice published in the New Zealand Gazette.

Controlled Drug	Gazette Notice
Dexamfetamine	https://gazette.govt.nz/notice/id/2015-go761
Ephedrine	https://gazette.govt.nz/notice/id/2011-go6291
Lisdexamfetamine	https://gazette.govt.nz/notice/id/2022-go5683
Methylphenidate	https://gazette.govt.nz/notice/id/2015-go760
Pseudoephedrine	https://gazette.govt.nz/notice/id/2011-go6291

Applications for approval to supply, prescribe and administer controlled drugs specified by regulation 22, outside of these defined circumstances, can be made to the Medicines Control Branch (medicinescontrol@health.govt.nz).