1.

Welcome

2.

Apologies

3.

Confirmation of the minutes of the 33^rd meeting

4.

Declaration of conflict of interests

5.

Matters Arising from the 33^rd Meeting

5.1

Amphotericin objection to recommendation to reclassify

The Pharmaceutical Society has objected to the recommendation to reclassify amphotericin from restricted medicine to prescription medicine when in lozenges for the treatment of oral candidiasis. The objection was made on the grounds that due process had not been observed in the consultation process. Consultation is now open on this matter. The company concerned has reiterated its support of the reclassification to harmonise with the Australian scheduling.

5.2

Zanamivir (Relenza)

The sponsor company has expressed its intention not to proceed with a submission for the reclassification of zanamivir.

5.3

Oseltamivir (Tamiflu 75mg capsules, Roche)

Ongoing consideration of the company submission for reclassification from prescription medicine to restricted medicine for the treatment and prophylaxis of influenza in adults and adolescents.

5.4

Simvastatin (10 milligram tablets, GlaxoSmithKline)

Ongoing consideration of the company submission for the reclassification of 10 milligram tablets from prescription medicine to restricted medicine in the light of the company response to the Committee's concerns at the 33^rd meeting about issues relating to training and protocols for OTC sale.

6.

Submissions for Reclassification

6.1

Domperidone (Motilium, 10mg tablets, Janssen-Cilag)

A new company submission for reclassification from prescription medicine to restricted medicine with amendments to indications, pack size and labelling to address Committee concerns with the earlier submission. The latest submission is for the reclassification of 10 milligram tablets in packs containing 20 tablets for the symptomatic treatment of nausea and for the treatment of the symptoms of dysmotility-like dyspepsia: sense of fullness, feeling of abdominal distension, eructation, flatulence and heartburn.
Janssen-Cilag submission (PDF document 390KB)

6.2

Hydrocortisone 0.5% with cinchocaine (Proctosedyl, Sanofi Aventis)

A company submission for the reclassification of proctosedyl suppositories and tablets from restricted medicine to pharmacy-only medicine. Please note that any change to the classification of hydrocortisone in combination with a local anaesthetic may affect the classification of other products currently on the market.
Sanofi Aventis submission (PDF document 301KB)

7.

New Medicines for Classification

8.

Harmonisation of New Zealand and Australian Schedules

8.2

Harmonisation matters arising or outstanding

8.1.1

Antihistamines
Use in children under two years of age

The Committee was concerned that some sedating antihistamine products had dose instructions for children under two years of age. This was considered inappropriate for OTC sale. Use in children under two should be addressed with a view to possible reclassification to prescription medicine.

8.1.2

Icodextrin

A recommendation to reclassify from pharmacy-only medicine to general sale medicine on the grounds that:

• the intention is that medicines for dialysis should be general sales medicines in New Zealand
• icodextrin is an unscheduled medicine in Australia

8.1.3

Kava

At the previous meeting the Committee had agreed that kava should be considered with a view to harmonising with Australia. The NDPSC had recently reclassified kava as a prescription medicine except when it conformed to the conditions below and was exempt from scheduling.

Piper methysticum (kava):

1. in preparations for oral use containing dried whole or peeled rhizome or containing aqueous dispersions or aqueous extracts of whole or peeled rhizome when labelled with a recommended daily dose of 250 milligrams or less of kavalactones:
   1. containing more than 25 milligrams of kavalactones per dose, labelled with the statement:
      WARNING : Not for prolonged use. Not recommended for use by pregnant or lactating women. May harm the liver;
   2. in tablet or capsule form containing 125 milligrams or less of kavalactones per tablet or capsule or:
   3. in the form of a teabag when the amount of dried whole or peeled rhizome does not exceed 3 grams
2. in topical preparations for use on the rectum, vagina or throat containing dried whole or peeled rhizome or containing aqueous dispersions or aqueous extracts of whole or peeled rhizome; or
3. in dermal preparations.

8.1.4

Paracetamol 665 milligram tablets

Review of the current prescription medicine classification of paracetamol in tablets containing more than 500 milligrams to allow 665 milligram tablets to be sold as pharmacy-only medicines. Tablets containing 665 milligrams of paracetamol are pharmacy-only (S2) medicines in Australia.

8.1.5

Quinine

The restricted medicine entry for quinine for the prevention of cramp should be removed from the schedule and quinine should be reclassified as a prescription medicine except in medicines containing 50 milligrams or less per recommended daily dose. No change is recommended to the current general sale classification of quinine.

8.1.6

Tranexamic acid

Tranexamic acid should be reclassified from prescription medicine to restricted medicine when for the treatment of menorrhagia.

8.1.7

Mepyramine

The MCC recommended at the 33^rd meeting that mepyramine for dermal use should remain a pharmacy-only medicine as there had been no reported problems in NZ relating to sensitization. The Committee recommendation to the NDPSC had crossed with a recommendation from the NDPSC to the MCC for mepyramine for dermal use to be reclassified to prescription medicine because of concerns with topical use of sensitizing antihistamines.

8.1.8

Quassia

Remove from the schedule. Quassia is currently a pharmacy-only medicine in New Zealand. There are no products registered which contain quassia.

8.2

Recommendations made by the NDPSC to the MCC in July 2005

8.2.1

Darifenacin

Add to the schedule as a prescription medicine.

8.2.2

Cetuximab

Add to the schedule as a prescription medicine.

9.

For the Next Meeting

10.

General Business