8 DECEMBER 2011 NEW ZEALAND GAZETTE, No. 189 5465

Product: Prograf-XL
Active Ingredient: Tacrolimus 5mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Astellas Ireland Co. Limited, County Kerry, Ireland

Dated this 5th day of December 2011.

DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

go8506

Misuse of Drugs Regulations 1977

Restriction on Supply of Methylphenidate—Approval to Prescribe, Supply and Administer (No. 2011/Meth/2)

Pursuant to Regulation 22 of the Misuse of Drugs Regulations 1977, I, Stewart Jessamine, Group Manager, Medsafe, Ministry of Health, acting under delegated authority from the Minister of Health, hereby make the following approval:

That methylphenidate (a controlled drug described in Part 2 of Schedule 2 of the Misuse of Drugs Act 1975) may be prescribed or supplied or administered by the classes of persons described, and in the circumstances set out in the following Schedule.

I hereby revoke the approval to prescribe, supply and administer methylphenidate (No. 2011/Meth/1) that was issued on 10 August 2011 and which took effect from 31 August 2011.

Schedule

Prescribing

From 1 December 2011:

The following class of persons (“vocational medical practitioners”) may prescribe methylphenidate products for a patient under his or her care for the corresponding conditions:

• Medical practitioners with a vocational scope of practice of paediatrics or 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 the 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.

Supply

From 1 December 2011:

The following class of persons may supply methylphenidate products in the following circumstances:

• 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 products 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.

Administration

From 1 December 2011:

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.

Dated at Wellington this 25th day of November 2011.

DR STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health.

go8541