1

Welcome

2

Apologies

3

Confirmation of the Minutes ot the 46th Meeting Held on Tuesday 15 November 2011

4

Declaration of conflicts of interest

5

Matters Arising

5.1

Objections to recommendations made at the 46th meeting

5.1.1

No objections have been received.

5.2

Codeine

At the 42nd meeting on 3 November 2009, the Committee recommended that the decision to allow cough and cold preparations containing codeine to continue to be available at the pharmacy-only level would be reviewed in 12-18 months' time. This meeting represents the 18 month point.

The Committee will consider reviews, provided by Medsafe and a New Zealand Specialist, to determine whether the reclassification has had the required impact, and more importantly whether abuse of cough and cold medicines containing codeine has emerged as a problem following reclassification.

5.3

Methenamine hippurate

Methenamine hippurate is currently available as a general sale medicine. The Committee will consider the following information, recommended at the 46th meeting, and decide whether a proposal to classify methenamine hippurate should be included on the agenda of the 48th meeting:

1. A report from Medsafe on the action taken with the complaint regarding the promotion of Hiprex
2. Documentation from iNova Pharmaceuticals (Australia) Pty Limited - further data on the number of products dispensed according to prescription versus the number sold over-the-counter, any reports of adverse drug reports in New Zealand and more information on appropriate use of the product clinically, i.e. for self-selection over-the-counter.

5.4

Oseltamivir

Oseltamivir is currently classified as a prescription medicine; except when sold in a pharmacy between the months of April to November inclusive by a registered pharmacist who is satisfied that the medicine is for the treatment of a consumer who is resident in New Zealand, is 12 years of age or more, and currently has the symptoms of influenza.

As suggested at the 46th meeting, the Committee will consider the reclassification of oseltamivir as a restricted medicine; for the treatment of a consumer who is in New Zealand, is 12 years of age or more, and currently has the symptoms of influenza.

6

Submissions for Reclassification

6.1

Influenza vaccine
(Pharmacybrands Limited)

This is a submission (Adobe pdf document 705 KB) from Pharmacybrands Limited (the parent company for Life, Unichem, Amcal, Radius and Care Pharmacies in New Zealand) for the reclassification of influenza vaccine from prescription medicine to prescription medicine except when administered to an adult by a pharmacist who has successfully completed the NZQA approved vaccinator's course and is complying with the immunisation standards of the Ministry of Health.

6.2

Melatonin 2 mg prolonged release tablet
(Circadin, Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics

This is a company submission (Adobe pdf document 613 KB) for the reclassification of melatonin 2 mg prolonged release tablets from prescription medicine to restricted medicine, in a pack of up to 30 tablets, when used as monotherapy for the short term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 and over.

6.3

Trimethoprim 300 mg tablet
(TMP, Pharmacybrands Limited)

This is a submission (Adobe pdf document 543 KB) from Pharmacybrands Limited (the parent company for Life, Unichem, Amcal, Radius and Care Pharmacies in New Zealand) for the reclassification of trimethoprim from prescription medicine to prescription medicine except when supplied in packs of three tablets to women aged 16 to 70 years for uncomplicated urinary tract infection by a pharmacist who has successfully completed the New Zealand College of Pharmacists' training in the treatment of urinary tract infections.

6.4

Vitamin D (colecalciferol)
(Medsafe)

This is a Medsafe submission (Adobe pdf document 336 KB) considering the reclassification of vitamin D, in tablets containing 1.25 mg of colecalciferol, from prescription medicine to restricted medicine for the prevention and treatment of vitamin D deficiency states in adults.

7

New Medicines for Classification

8

Harmonisation of New Zealand and Australian Schedules

8.1

New chemical entities which are not yet classified in New Zealand

8.2

Decisions by the Secretary to the Department of Health and Aging in Australia, or the Secretary's Delegate

8.2.1

Decisions by the Delegate - September 2011

To be considered under agenda item 8.1

8.2.2

Decisions by the Delegate - February 2012

As follows and to be considered under agenda item 8.1.

1. Azelastine
   Azelastine, when in topical eye preparations containing 0.05% or less, should be rescheduled from Schedule 3 (restricted medicine) to Schedule 2 (pharmacy-only medicine).
2. Diclofenac
   Dermal preparations containing more than 1% and up to 4% or less of diclofenac, except when for the treatment of solar keratosis, should be rescheduled to Schedule 2 (pharmacy-only medicine). The Delegate also confirmed that Schedule 4 (prescription medicine) remains appropriate for preparations containing more than 4% of diclofenac and for use in the treatment of solar keratosis, and preparations containing 1% or less remain unscheduled.

9

For the Next Meeting

10

General Business

10.1

Presentations

The following presentations will be given:

• Classification Switches and Access to Medicines by Tim Roper, Executive Director of the New Zealand Self-Medication Industry Association Inc.
• Reclassification of Medicines - How New Zealand compares with other Countries by Khay Ooi, Senior Analyst, Regulatory Analysis and Delivery, Medsafe.

11

Date of Next Meeting