1

Welcome

2

Apologies

3

Confirmation of the Minutes of the 44th Meeting Held on Tuesday 2 Novemeber 2010

4

Declaration of conflicts of interest

5

Matters Arising

5.1

Objections to recommendations made at the 44th meeting

5.1.1

Guaiphenesin 600 mg and 1200 mg modified release tablets
(Mucinex, Reckitt Benckiser (New Zealand) Limited)

An objection has been received regarding one of the Committee's recommendations, that the labelled warning regarding a potential risk of developing kidney stones at high doses should not be removed.

Reckitt Benckiser (New Zealand) Limited felt that the Committee may not have fully considered some of the information submitted. This recommendation will be reconsidered now that further data has been provided.

5.1.2

Paracetamol

An objection has been received regarding the Committee's recommendation that New Zealand should not increase the maximum pack size for sale of paracetamol as a general sale medicine from 10 g to 12.5 g in order to harmonise with the less restrictive Australian classification.

The submission contends that the Committee may not have correctly interpreted the data provided at the last meeting in relation to increased risk arising from a larger pack size. The submission also suggests that there is no data to support the premise that maintaining the pack size as suggested will have any impact on overdosing or overdose outcomes. The Committee will reconsider this recommendation using the additional data provided in the objection submission.

5.1.3

Red Yeast Rice

An objection has been received regarding the Committee's recommendations that:

• lovastatin should be added to the New Zealand Schedule as a prescription medicine
• monacolin K should be added to the New Zealand Schedule as a prescription medicine
• Medsafe should consider the wording of monacolin K as a prescription medicine so that any foodstuffs would not be inadvertently captured.

It has also been brought to Medsafe's attention that lovastatin and monacolin K are synonyms because they have identical structures.

Medsafe has consulted the New Zealand Food Safety Authority and the following wording has been proposed. That lovastatin shold be classified as a prescription medicine, 'except when present as an unmodified, naturally occurring substance in a food that has not been subject to a manufacturing process other than heating, freezing, drying, preserving, bottling, canning, or packaging in retort pouches'. This wording reflects the Committee's intent from the last meeting. Monacolin K would also be added to Medsafe's searchable classification database with the wording 'see lovastatin'.

The Committee will reconsider their recommendations using the additional data provided with the objection and any comments received regarding the proposed wording for lovastatin as a prescription medicine.

5.2

PDE-5 inhibitors

Phosphodiesterase type 5 (PDE-5) inhibitors are currently classified as prescription medicines, 'except when present as an unmodified, naturally occurring substance; except when specified elsewhere in this schedule'.

The Committee will discuss whether this wording needs to be reconsidered following their discussion around the classification of lovastatin.

5.3

Aspirin

The labelling of all aspirin containing products with respect to international alignment has been referred to Medsafe for consideration. An update will be provided to the Committee.

5.4

Eltrombopag olamine (Revolade 25 mg and 50 mg film coated tablets)

An out-of session consultation took place in December 2010 regarding the classification of eltrombopag olamine.

The Committee recommended that eltrombopag olamine should be classified as a prescription medicine. This classification was gazetted alongside the recommendations from the previous meeting.

5.5

Paracetamol

Harmonising with Australia on the labelling of paracetamol has also been referred to Medsafe. An update on progress to date will be provided to the Committee.

6

Submissions for Reclassification

6.1

Guaiphenesin 600 mg and 1200 mg modified release tablets
(Mucinex, Reckitt Benckiser (New Zealand) Limited)

This is a company submission (Adobe pdf document 218kb) requesting an update to the general sale classification of guaiphenesin to 'for oral use in medicines containing 2% or less or 200 milligrams or less per dose form; for oral use in modified release form with a maximum recommended daily dose of not more than 2.4 grams sold in a pack containing not more than 10 days supply approved by the Minister or the Director-General for distribution as a general sale medicine'.

This follows comments from the last meeting that the Committee considered it would be prepared to support a limited change in pack size to allow a pack containing 10 days or less to be available as a general sale medicine.

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 - August 2010

The Committee will consider harmonising with the following decisions.

1. Amorolfine
   Reschedule all amorolfine topical preparations from Schedule 3 (restricted) to Schedule 2 (pharmacy-only). The exemption from scheduling for preparations containing amorolfine for treatment of tinea pedis remains appropriate.
2. C1 esterase inhibitors
   C1 esterase inhibitors should be included in the general exemption for blood products.
3. Iodine
   Exempt oral preparations of iodine for use in prophylaxis and treatment in the event of radioactive iodine exposure under an emergency plan approved by an appropriate authority.

8.2.2

Decisions by the Delegate - December 2010

To be considered under agenda item 8.1.

9

For the Next Meeting

10

General Business

10.1

Is non-prescription oseltamivir availability under strict criteria workable?
A qualitative study in New Zealand (Gauld et al)

An article from the Journal of Antimicrobial Chemotherapy Advance Access, published 3 November 2010, will be presented to the Committee for information.

10.2

Risks, benefits and issues in creating a behind-the-counter category of medications (Reid et al)

A special feature from the Journal of the American Pharmacists Association (2011; 51: 26-39), will also be presented to the Committee for information.

11

Date of Next Meeting