1.

Welcome

2.

Apologies

3.

Confirmation of the Minutes of the 29^th Meeting

4.

Declaration of conflict of interests

5.

Matters Arising from the 29^th Meeting

6.

Submissions for reclassification

6.1

Beclomethasone and fluticasone
(Beconase Hayfever Aqueous Nasal Spray, Flixonase Aqueous Nasal Spray, GlaxoSmithKline)

A company submission for reclassification from restricted medicine to pharmacy-only medicine when for the short-term treatment or prophylaxis of allergic rhinitis.
GlaxoSmithKline submission (PDF document 793KB)

6.2

Buccaline (Pharmabroker Sales)

A company submission for the reclassification of pneumococcal vaccine and Haemophilus influenzae vaccine from restricted medicine to pharmacy-only medicine when in oral vaccines for the prophylaxis of bacterial complications of colds in order to allow Buccaline to be marketed as a pharmacy-only medicine.
Pharmabroker Sales submission (PDF document 204KB)

6.3

Ciclopirox (Stieprox Liquid, Stiefel)

A company submission for an increase from 1% to 2% for the pharmacy-only classification of topical ciclopirox.
Stiefel submission (PDF document 284KB)

6.4

Ibuprofen 200 milligram tablet (Boots Healthcare)

A company submission for reclassification from pharmacy-only to general sale in packs containing not more than 25 tablets.
Boots submission (PDF document 249KB)

6.5

Ketotifen eye drops 0.025% (Zaditen, Novartis)

A company submission for reclassification from prescription medicine to pharmacy-only medicine for ophthalmic use.
Novartis submission (PDF document 300KB)

6.6

Phenylephrine (Wyeth Consumer Healthcare)

A company submission for the reclassification of phenylephrine to accommodate solid dose forms. The submission proposes a cut-off point of 10 milligrams or less per dose form for general sale and a pharmacy-only classification for solid dose forms containing more than 10 milligrams. There is no change proposed for the current liquid dose forms or for nasal or ophthalmic use.
Wyeth submission (PDF document 442KB)

6.7

Sodium picosulfate (Dulcopearls, Boehringer Ingelheim)

A company submission for reclassification from prescription medicine to pharmacy-only when for laxative use. See also agenda item 8.3.1
Boehringer Ingelheim submission (PDF document 160KB)

6.8

Ephedra species

A submission from Health & Herbs International for reclassification from prescription medicine to general sale medicine for ephedra species which do not contain ephedrine, in particular, ephedra navadensis.

7.

New Medicines for Classification

8.

Harmonisation of New Zealand and Australian Schedules

8.1

Harmonisation matters arising or outstanding

8.1.1

Fluorides

The schedules are now harmonised. Regulatory differences appear to affect the level of access for some mouthwash products.

8.2

NDPSC response to MCC recommendations

8.2.1

Benzamine, orthocaine, 3-aminobezoic acid ethyl ester methanesulphonante

The NDPSC has accepted the MCC recommendation to remove these from the Australian schedule.

8.2.2

Silver sulfadiazine

The NDPSC has opted not to harmonise with New Zealand on the OTC availability of silver sulfadiazine.

8.2.3

Selenium

Now harmonised

8.2.4

Solanaceous alkaloids

The NDPSC has agreed to harmonise on the 300 microgram exemption from scheduling for atropine but remains unharmonised for hyoscine and hyoscyamine with cut off points of 150 micrograms.

8.3

Recommendations made by the NDPSC to the MCC in October 2002

8.3.1

Sodium picosulfate and macrogols

These should remain unscheduled for laxative use.

Macrogols for other than bowel cleansing are unscheduled in New Zealand.

Prior to reclassification to prescription medicine for laxative use, sodium picolsulfate was classified as a pharmacy-only medicine along with other stimulant laxatives. MCC policy to date has been to keep stimulant laxatives as pharmacy-only medicines to encourage the use of bulk laxatives as a first line of treatment. See also agenda item 6.7 above.

8.3.2

Acetylcysteine

Preparations for oral use containing 1 gram or less per recommended daily dose should become general sale medicines.

8.4

Recommendations made by the NDPSC to the MCC in February 2003

8.4.1

Collagen, hyaluronic acid

Extend the prescription medicine entry for injectable products to include products for implantation and when used for tissue augmentation or cosmetic use. This would ensure consistency with the entries for polylactic acid and polyacrilamide.

8.4.2

Oxedrine (synephrine)

Classify as a prescription medicine except in preparations containing 30 milligrams or less per recommended daily dose.

New Zealand has no registered medicines containing oxedrine. However, there are thought to be a number of complementary products and weight-loss products which contain this substance.

While natural oxedrine is found in plant extracts including some citrus species, it is a sympathomimetic agent with a potential to cause cardiovascular toxicity. The proposed cut-off point would allow complementary products to continue to be marketed at a safe level.

8.4.3

Pegfilgrastim

Add to the schedule as a prescription medicine.

8.5

Recommendations made by the NDPSC to the MCC in June 2003

8.5.1

Hydroquinone

Reclassify from pharmacy-only medicine to prescription medicine for products containing concentrations greater than 2%.

8.5.2

Injectable medicines

The pharmacy-only entry for injectable medicines should be removed from the schedule. Injectable medicines should be classified according to the classification level of their active ingredients.

8.5.3

Antihistamines

As a result of the recently-commissioned NZ Ministry of Health Review of Antihistamines a number of risks have been identified which warrant differentiation of the sedating antihistamines from the non-sedating antihistamines.

The NDPSC has adopted the broad principles adopted by the Trans-Tasman Harmonisation Working Party and has recommended a number of changes.

The proposed changes to the classification of antihistamines have been summarised in a Medsafe document. Sponsor companies for all products containing an antihistamine are urged to check whether or not a classification change is proposed by clicking on the above link.

8.5.4

Dextromethorphan

Amend the pharmacy-only entry for dextromethorphan to the following: When supplied in a pack containing 600 milligrams or less and with a recommended daily dose of 120 milligrams or less.

The above recommendation is supported by a letter from Pfizer requesting reclassification from prescription medicine to pharmacy-only medicine for sustained release liquid preparations containing 0.6% or less with a recommended dose not exceeding 60 milligrams. Note that although Australia does not have provision for any unscheduled dextromethorphan products and the NDPSC has opted not to harmonise with NZ with regard to general sale products, the MCC will consider the above recommendation relating to pack size limits for pharmacy-only classification. The MCC will not consider changes to the classification of general sale dextromethorphan products at this time. However, the NDPSC will revisit the possibility of harmonisation with the NZ general sale classification after two years.

8.5.5

Budesonide

Reclassify from restricted medicine to pharmacy-only medicine. Similar conditions are to apply. The indication has been changed from seasonal rhinitis to allergic rhinitis.

8.5.6

Mometasone

Reclassify from restricted medicine to pharmacy-only medicine. Similar conditions are to apply. The indication has been changed from seasonal rhinitis to allergic rhinitis. There is currently no OTC mometasone product marketed in New Zealand.

8.5.7

Deferiprone

Add to the schedule as a prescription medicine.

8.5.8

Nicotine

Reclassify nicotine lozenges from restricted medicine to pharmacy-only medicine.

Nicotine sublingual tablets are also restricted medicine and should also be considered. As they are not available in Australia they were not included in the recommendation.

8.5.9

Fluconazole

Reclassify from prescription medicine to restricted medicine for single-dose oral preparations containing 150 milligrams or less for the treatment of vaginal candidiasis.

9.

For the next meeting

10.

General business