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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 Pharmaceutrical Schedule) are independent of the conditions imposed under the Medicines Act or Misuse of Drugs Regulations.

Clozapine
Codalax & Codalax Forte
Dexamphetamine sulphate
Methylphenidate hydrochloride
Riluzole
Tasmar
Vesanoid

Clozapine (updated Aug 2007)
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, and
• Medical practitioners employed as registrars in the branch of psychiatry who are under the supervision of persons of the kind 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.

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.

Codalax & Codalax Forte

Danthron 25mg + poloxamer 188 200mg per 5ml oral suspension; danthron 75mg + poloxamer 1888 1000mg per 5ml oral suspension
Douglas Pharmaceuticals Ltd
Restriction:
Codalax and Codalax Forte may only be used for the prevention or treatment of constipation in the terminally ill

Dexamphetamine sulphate

Restrictions:
Only medical practitioners vocationally registered under the Medical Practitioners Act 1995 in internal medicine, paediatrics, psychological medicine or psychiatry, or any medical practitioner acting on the recommendation of one of the above, can prescribe dexamphetamine sulphate for a patient under his or her care.
Any other medical practitioner has to apply for Ministerial approval to prescribe dexamphetamine (applications should be sent to Medsafe).
Dexamphetamine can be dispensed at any community or hospital pharmacy.
Any person responsible for the care of a patient on dexamphetamine can administer it in accordance with the prescriber’s directions.

Methylphenidate hydrochloride

Restrictions:
Only medical practitioners vocationally registered under the Medical Practitioners Act 1995 in internal medicine, paediatrics, psychological medicine or psychiatry, or any medical practitioner acting on the recommendation of one of the above, may prescribe methylphenidate for a patient under his or her care.
Any medical practitioner employed by a hospice may prescribe methylphenidate for a patient under hospice care.
Any other medical practitioner will have to apply for Ministerial approval to prescribe methylphenidate (applications should be sent to Medsafe).
Methylphenidate can be dispensed at any community or hospital pharmacy.
Any person responsible for the care of a patient on methylphenidate, including a patient under hospice care, can administer it in accordance with the prescriber’s directions.

Riluzole
Rilutek 50mg tablet
sanofi-aventis new zealand limited
Restriction:
This consent is given subject to the following conditions:
Rilutek can only be prescribed by specialist physicians who care for patients with Motor Neurone Disease, neurologists and palliative care physicians

Tasmar

Tolcapone 100mg film coated tablets
Roche Products NZ Ltd
Restrictions:
Only medical practitioners vocationally registered under the Medical Practitioners Act 1995 in the branch of internal medicine may prescribe Tasmar
Patients receiving Tasmar undergo baseline liver function tests, followed by fortnightly tests for the first 3 months of treatment and 4-weekly tests thereafter
Patients are prescribed Tasmar only after informed consent has been obtained.

Vesanoid

Tretinoin 10mg capsules
Roche Products NZ Ltd
Restriction:
This medicine may only be prescribed by:

1. medical practitioners who are vocationally registered under the Medical Practitioners Act 1995 in the branch of internal medicine and/or pathology; and
2. medical practitioners employed as registrars in internal medicine and/or pathology who are under the supervision of persons of the kind referred to in paragraph (a) above.