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Regulatory Issues

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

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
Influenza Vaccine
Riluzole
Thalidomide

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

Ephedrine and Pseudoephedrine
Dexamphetamine
Methylphenidate

Clozapine
The conditions of section 23 approval for all clozapine products are:

1. The medicine may only be prescribed by:

• Registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are certified by the Medical Council of New Zealand as competent in the scope of practice of psychiatry.
• Medical practitioners employed as registrars in the branch of psychiatry who are under the supervision of the persons referred to above.
• Medical officers of special scale who:

	work solely in the field of psychiatry;
	are in the employment of a district health board; and
	are under the supervision of persons who are registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are certified by the Medical Council of New Zealand as competent in the scope of practice of psychiatry.

• Registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are registered with the Medical Council of New Zealand within the vocational scope of practice of general practice. The general practitioner must be continuing the prescribing of clozapine for a specific patient whose illness is well-controlled in collaboration, 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; and
• the sponsor creates or participates in a central "red flag" database identifying patients who have previously been prescribed clozapine and who developed adverse drug reactions, which mean further use is contraindicated.

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.

Influenza Vaccine
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, distributed or supplied in accordance with the directives contained in the New Zealand National Health Emergency Plan; 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 restrictions:

1. The vaccine may only be marketed, distributed or supplied in accordance with the directives contained in the New Zealand National Health Emergency Plan; New Zealand Influenza Pandemic Action Plan.
2. In an official declared influenza pandemic situation, CSL is to provide updated evidence of the surrogate markers used to estimate efficacy of the pandemic vaccine formulation and is committed to provide Periodic Safety Update Reports as outlined in the Risk Management Plan.

Riluzole
Rilutek, 50mg tablet
Sanofi-Aventis New Zealand Limited
Consent is given subject to the following restriction:
Rilutek can only be prescribed by specialist physicians who care for patients with Motor Neurone Disease, neurologists and palliative care physicians.

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

Ephedrine and Pseudoephedrine

The following restrictions apply to all ephedrine and pseudoephedrine products from 8 September 2011:

1. Ephedrine and Pseudoephedrine may only be prescribed by:

• Medical practitioners registered with the Medical Council of New Zealand under the Health Practitioners Competence Assurance Act 2003.

2. Ephedrine and Pseudoephedrine can be dispensed at any community or hospital pharmacy.
3. Any person responsible for the care of a patient on ephedrine or pseudoephedrine may administer it in accordance with the prescriber’s directions.

Dexamphetamine

The following restrictions apply to all dexamphetamine products:

1. Dexamphetamine may only be prescribed by:

• Registered medical practitioners, as defined in the Health Practitioners Competence Assurance Act 2003, who are certified by the Medical Council of New Zealand as competent in the scope of practice of paediatrics or psychiatry, or
• Registered medical practitioners, as defined in the Health Practitioners Competence Assurance Act 2003, who are certified by the Medical Council of New Zealand as competent in the scope of practice of internal medicine, only for the treatment of narcolepsy.
• Any other medical practitioner registered with the Medical Council of New Zealand may only prescribe dexamphetamine products when acting on the written recommendation of one of the vocational medical practitioners described above.

2. Prescriptions, written by a medical practitioner other than the vocational medical practitioner, require the name of the appropriate vocational medical practitioner to be endorsed on the prescription.
3. Any other medical practitioner has to apply for Ministerial approval to prescribe dexamphetamine (applications should be sent to Medicines Control).
4. Dexamphetamine can be dispensed at any community or hospital pharmacy.
5. Any person responsible for the care of a patient on dexamphetamine may administer it in accordance with the prescriber's directions.

Methylphenidate

The following restrictions apply to all methylphenidate products:

1. Methylphenidate may only be prescribed by

Medical practitioners with a vocational scope of practice of Paediatrics of Psychiatry, registered with the Medical Council of New Zealand under the Health Practitioners Competence Assurance Act 2003, for the treatment of Attention Deficit and Hyperactivity Disorder (ADHD), or

Medical practitioners with a vocational scope of practice of internal medicine, registered with the Medical Council of New Zealand under the Health Practitioners Competence Assurance Act 2003, for the treatment of narcolepsy, or

Medical practitioners with a vocational scope of Palliative Medicine registered with medical Council of New Zealand under the Health Practitioners Competence Assurance Act 2003, for use in palliative care treatment.

Any other medical practitioner registered with the Medical Council of New Zealand (registered medical practitioner) may only prescribe methylphenidate products when acting on the written recommendation of one of the vocational medical practitioners described above, for the conditions specified.

2. Methylphenidate may only be supplied by:

Any pharmacist, registered with the Pharmacy Council of New Zealand under the Health Practitioners Competence Assurance Act 2003, in the course of his or her employment as a pharmacist, may supply methylphenidate pursuant to a prescription issued by:

A registered medical practitioner with a vocational scope of practice of Paediatrics, Psychiatry, Internal Medicine or Palliative Medicine, when prescribing for the conditions specified in this Schedule, or

Any other registered medical practitioner when acting on the written recommendation of one of the vocational medical practitioners specified in this Schedule, with the recommendation endorsed on the prescription.

3. Methylphenidate may be administered by any person who is caring for a patient, for whom a methylphenidate product has been prescribed by any of the medical practitioners described in this Schedule, may administer the product to that patient in accordance with the prescribed directions for use.