1.

Welcome

2.

Apologies

3.

Confirmation of the Minutes of the 27th Meeting

4.

Declaration of Conflicts of Interest

5.

Matters Arising from the 27th Meeting

5.1

Reconsideration of the recommendation to classify Ephedra as a prescription medicine.

6.

Submissions for Reclassification

6.1

Intraocular viscoelastic products

Intraocular viscoelastic products are exempt from scheduling in Australia. Until recently they have been pharmacy-only medicines in New Zealand because of the pharmacy-only injectable entry in the schedule for any injectable not more restrictively classified because of its active ingredient. Recent recommendations from Australia to move hypromellose and hyaluronic acid, formerly unscheduled in New Zealand, to prescription medicine when contained in injections has caused an even wider classification discrepancy for a number of products. Pacific Pharmaceuticals has requested harmonisation for this group of products.

6.2

Sodium picosulfate (Picoprep Powder, Baxter)

A company submission for reclassification from pharmacy-only medicine to prescription medicine when used as a laxative and to restricted medicine when used for bowel cleansing prior to diagnostic, medical or surgical procedures.
This would bring the classification of sodium picolsulfate into line with that of sodium phosphate and those macrogols which are used for similar indications. See also agenda item 8.2.5 below.
Baxter submission (PDF document 182KB)

6.3

Flurbiprofen 10 milligram lozenges (Strepfen, Boots)

A company submission for reclassification from restricted medicine to pharmacy-only medicine.
Boots submission (PDF document 470KB)

6.4

Diclofenac 12.5 milligram tablets

A submission from Pharmaceutical Solutions Ltd for reclassification from restricted medicine to pharmacy-only medicine for 12.5 milligram tablets or capsules in packs of not more than 20.
Pharmaceutical Solutions submission (PDF document 240KB)

6.5

Solanaceous plants and alkaloids

A Weleda submission for a change to the level for exemption from scheduling for atropa belladonna, atropine, hyoscine, hyoscyamine and hyoscyamus niger.
Weleda submission (PDF document 217KB)

6.6

Omeprazole 20 milligram tablets (Losec MUPS, AstraZeneca)

A company resubmission for classification from prescription medicine to restricted medicine for 20 milligram tablets. The indication is now for the 24-hour prevention of frequent heartburn and indigestion.
AstraZeneca submission (PDF document 352KB)

7.

New Medicines for classification

8.

Harmonisation of New Zealand and Australian schedules

8.1

Outstanding harmonisation issues

8.1.1

Glyceryl trinitrate and isosorbide dinitrate

These two medicines are not harmonised. The respective classification is as follows:

*topical ointment has been treated in the same way as the transdermal patch in NZ and is registered as a prescription medicine. However, according to the schedule, anything other than a patch or injection should be pharmacy-only.Presumably a topical ointment would also be a pharmacy-only medicine in Australia.

The wording in the schedules may need to be more specific to make sure different doses forms are covered at appropriate levels of classification. Currently both countries specify injections and patches as prescription medicines.

In NZ all other forms are pharmacy-only.

In Australia oral forms are restricted medicines and anything not prescription or restricted is pharmacy-only.

8.2

Recommendations made by the NDPSC to the MCC in February 2002

8.2.1

Nicotine for inhalation

The NDPSC has recommended that inhaled nicotine be classified in the same way as nicotine for dermal use and in gum. It has recommended that New Zealand adopt a similar scheduling outcome. The recommendation arose from a company submission for reclassification from S3 (restricted medicine) to S2 (pharmacy-only medicine).

Note that nicotine in gum and transdermal patches is general sale in New Zealand. Moving inhaled nicotine to the same level of classification in New Zealand would not harmonise.

8.2.2

Clobetasone

Reclassify to restricted medicine in preparations for dermal use containing 0.05% or less in packs containing 30 grams or less.

The MCC has recently agreed not to harmonise on a similar recommendation to make alclomethasone available over the counter. It had made a previous policy decision not to allow steroids more potent than 1% hydrocortisone to be available in this way.

8.2.3

Epoetin alfa

Add to the schedule for clarity. Make a similar entry for epoetin beta.

These are synthetic analogues of erythropoietin and are therefore already covered in both schedules. As Martindale also makes reference to epoetin gamma, a single entry for epoetins would cover all without loss of clarity.

8.2.4

Sodium picosulfate

Reclassify to restricted medicine when used in oral preparations for bowel cleansing prior to diagnostic, medical or surgical procedures.

Sodium picosulfate is currently a pharmacy-only medicine along with other stimulant laxatives. The classification change for bowel cleansing would bring it into line with sodium phosphate and the macrogols which are used in this way.

9.

For the Next Meeting

10.

General business