1.

Welcome

2.

Apologies

3

Confirmation of the Minutes of the 37^th Meeting

4.

Declaration of Conflicts of Interest

5.

Matters Arising

5.1

Objections to recommendations made at the 37^th meeting

5.1.1

Polysulfated glycosaminoglycans

An objection from Alcon indicating inadvertent capture of intraocular viscoelastic products with the recommended generic schedule entry for polysulfated glycosaminoglycans as prescription medicines. Intraocular viscoelastic products are exempt from scheduling under Appendix A in the Australian schedule. They are general sale medicines in New Zealand in order to harmonise with the Australian exemption.

5.1.2

Antihistamines in children under 2 years of age.

An objection from Schering Plough to the recommendation for all sedating antihistamines to be prescription medicines for children under 2 years of age. As no recommendation was made at the 37^th meeting, the objection per se is not valid. However, the MCC is interested in considering any new safety data on this subject. - Please Click here for Medsafe's Report (PDF 530 KB, 14 pages).

5.2

Other matters arising from the 37^th meeting

5.2.1

Exemption to allow optometrists to sell certain pharmacy-only medicines

The New Zealand Association of Optometrist has indicated that it wishes for sales of these products to be made only by registered optometrists during the course of a consultation. There was no intention for these to be sold by other staff.

5.2.2

Nicotinic acid

The recommendation is for New Zealand to harmonise with the 250 mg cut-off point between restricted medicine and prescription medicine.

The current classification of nicotinic acid in New Zealand is restricted medicine in medicines containing more than 100 mg per dose form and general sale in medicines containing 100 mg or less per dose form.

The current classification of nicotinic acid in Australia is:

• Prescription: in medicines containing more than 250 mg per dose form
• Restricted: in medicines containing 250 mg or less and more than 100 mg
• General sale: in medicines containing 100 mg or less per dose form

The recent New Zealand exemption for nicotinamide is to remain in effect.

The proposed change would cause one restricted medicine containing 500 mg of nicotinic acid to become a prescription medicine.

5.2.3

Aspirin in compound products

Further consideration of whether or not New Zealand should harmonise with the Australian prescription medicine scheduling of aspirin when compounded with caffeine, paracetamol or salicylamide.

5.2.4

Potassium in glucosamine sulphate complexed products

The Committee is seeking information about the potassium content of glucosamine sulfate complexed products in order to avoid classifying glucosamine under the schedule entries for potassium.

5.2.5

Mefenamic acid and naproxen

Further consideration of suitable maximum recommended daily dose statements for pharmacy-only packs.

5.2.6

Iron pack size limits

Further consideration of the NDPSC recommendation that there should be an upper pack size limit of 750 milligrams and a maximum recommended daily dose of 24 milligrams for general sale iron products which are in undivided dose forms or in solid dose forms containing more than 5 milligrams per dose form.

Oral products exceeding these limits should be pharmacy-only medicines.

5.2.7

Ranitidine labelling

Consideration of revised pack warning statements for proposed general sale ranitidine products arising from the last meeting.

5.2.8

Boron

Consideration of information submitted by the complementary medicines and dietary supplements sector to inform the Committee about the current doses and strengths of boron in complementary medicines and dietary supplements in New Zealand. This will be considered alongside the NDPSC recommendation to harmonise with the Australian scheduling. (See 37^th MCC agenda for the Australian scheduling.)

5.2.9

Chloramphenicol eye preparations

Consideration of chloramphenicol eye drops for reclassification from prescription medicine to an over-the-counter classification. The Committee wishes to discuss this in view of the recent reclassification in Britain.

6.

Submissions for Reclassification

6.1

Company Submissions

6.1.1

Fusidic acid 1% eye drops (Fucithalmic, CSL)

A company submission for the reclassification from prescription medicine to restricted medicine of 10 milligrams per gram fusidic acid in 5 gram tubes for the treatment of eye bacterial infections.

6.1.2

Diclofenac (Voltaren Rapid 12.5mg, Novartis)

A company submission (please note this is a zipped word document and will require winzip or a smilar programme to unzip) for an increase in the permitted pack size for pharmacy-only sale from 20 dose units to 40 dose units per pack.

6.1.3

Octocog alpha (Advate, Baxter)

A company submission (comparative data) for the reclassification of octocog alpha injections for reclassification from prescription medicine to general sale medicine.
All other Factor VIII products including those which are recombinant, are general sale medicines in New Zealand.

6.1.4

Omeprazole 10 mg capsules (Omezol Relief, Pacific)

A company submission for the reclassification of omeprazole 10 milligram capsules from prescription medicine to restricted medicine when in packs of 14 capsules for the short-term symptomatic relief of reflux-like symptoms in sufferers aged 18 years and over.

6.2

Matters referred by Medsafe

6.2.1

Codeine with paracetamol in C VI controlled drugs

Controlled drugs that fulfill the criteria for medicines in Part VI of the Third Schedule to The Misuse of Drugs Act 1975 are classified under a general entry as pharmacy-only medicines in the medicines schedule. Part VI allows up to 100 milligrams of codeine to be contained in each dose unit of any product in which the codeine is compounded with another ingredient in such a way that the substance cannot be recovered by readily applicable means or in a yield which would constitute a risk to health. There is no restriction on pack size.

Medsafe has noted that codeine levels in pharmacy-only combination products are rising. Previously approved products contained around 8 milligrams of codeine. This has gradually increased to 15 milligrams. An application has now been received for a product containing 30 milligrams together with 500 milligrams of paracetamol and in packs of 12 and 96 tablets.

Medsafe has asked that the Committee consider whether it is appropriate for combination products containing 30 milligrams or more of codeine and in unlimited pack sizes to be available as pharmacy-only medicines.

6.2.2

Zinc

The New Zealand schedule and the Australian SUSDP are harmonised on the classification of zinc as a general sale medicine in oral preparations containing 25 milligrams or less per recommended daily dose and a prescription medicine in oral preparations containing more than 25 milligrams per recommended daily dose. However, the SUSDP makes provision for oral products containing up to 50 milligrams per recommended dose to be unscheduled as long as they bear appropriate warning statements. This means that it is possible for products containing more than 25 milligrams and up to 50 milligrams per recommended daily dose to be unscheduled products in Australia but prescription medicines in New Zealand.

The proposal is for New Zealand to harmonise on the less restrictive classification.

6.2.3

Frusemide/ Furosemide

The recommended International Non-Proprietary Name for frusemide is furosemide. Furosemide is also the BAN and the USAN. Some of the newer products are using furosemide on the label. The proposal is for the schedule entry to be amended from frusemide to furosemide.

Note that the SUSDP also lists the medicine as frusemide.

7.

New Medicines for Classification

8.

Harmonisation of New Zealand and Australian Schedules

8.1

Update on harmonisation matters

8.2

Recommendations made by the NDPSC to the MCC in February and June 2007

8.2.1

Pyrethrins

At the time this recommendation was made pyrethrins were not scheduled in New Zealand and were included in Schedule 5 in Australia. Schedule 5 medicines are substances with a low potential for causing harm, the extent of which can be reduced through the use of appropriate packaging with simple warnings and safety directions on the label. In effect, pyrethrins were therefore harmonised.

The NDPSC recommendation was to make a S2 (pharmacy-only) entry for medicines containing more than 10% and to ask New Zealand to harmonise on this.

There are no current pyrethrin products on the New Zealand market. Previous products contained less than 2% of pyrethrins.

8.2.2

New medicines scheduled in Australia but not in New Zealand

8.2.3

Stimulant laxatives to general sale

The NDPSC has recommended that the following stimulant laxatives should be reclassified from pharmacy-only medicines to general sale medicines:
aloin
aloes
bisacodyl
colocynth
jalap resin
sennocides
sodium picosulfate

9.

For the Next Meeting

10.

General Business