1.

Welcome

2.

Apologies

3

Confirmation of the Minutes of the 36th Meeting

4.

Declaration of conflicts of interest

5

matters arising

5.1

Oxerutins (Ban)/Hydroxyethylrutosides

In 2002 oxerutins were reclassified to general sale on the understanding that there were no products registered in New Zealand which contained oxerutins. However, it has since been discovered that there is a current product containing hydroxyethylrutosides. Hydroxyethylrutosides is a synonym for oxerutins. This was not picked up at the time. Neither is scheduled in Australia and no product containing these is sold in Australia. The Committee will discuss the appropriate nomenclature and level of access for the product containing this medicine.

5.2

Boron

The Committee is seeking advice from the complementary medicines sector on the strengths and recommended doses of boron used in complementary medicine in New Zealand and for data to justify these strengths and dose levels.

This item is likely to be carried over until the 38th meeting later in the year to allow adequate time for the information to be submitted.

5.3

Chloramphenicol

The Committee has agreed that chloramphenicol for use in the eye would be a suitable candidate to consider for over-the-counter use.

This item is likely to be carried over until the 38th meeting later in the year to allow adequate time for the sponsor company or companies to prepare a submission.

5.4

Mefanamic acid and naproxen

The Committee is seeking advice from sponsor companies about suitable maximum recommended daily doses for over-the-counter products containing these medicines.

5.5

Nicotinic acid and nicotinamide

A recommendation about the harmonisation of nicotinamide and nicotinc acid was deferred from the last meeting pending the outcome of the February 2007 meeting of the Australian National Drugs and Poisons Schedule Committee (NDPSC).

The recommendation was to delete nicotinamide from the New Zealand schedule and reword the nicotinic acid entry to harmonise with that in the Australian schedule. The recommendation remains unchanged.

In New Zealand both nicotinic acid and nicotinamide are restricted medicines (S3) when containing more than 100 milligrams per dose and general sale below this cut-off.

In Australia nicotinic acid is harmonised with New Zealand but the S3 (restricted medicine) entry specifically exempts nicotinamide from scheduling. The S3 entry in the Australian schedule is:

Nicotinic acid: except

1. in preparations containing 100 mg or less per dose form
2. nicotinamide

Adoption of this recommendation would mean that nicotinamide would become a general sale medicine in New Zealand.

5.6

Antihistamines in children under 2 years of age

Further discussion about the use of sedating antihistamines for children in this age group.

6.

Submissions for reclassification

6.1

Eye preparations for use by optometrists

The New Zealand Association of Optometrists (NZAO) has made a submission for an exemption from classification for a number of pharmacy-only products to allow them to be sold or used in an optometry practice. The medicines are:

Antazoline
Levocabastine
Lodoxamide
Naphazoline
Oxymetazoline
Pheniramine
Propamidine and dibromopropamidine.
Sodium cromoglicate
Tetrahydrazoline
Xylometazoline

Note that the submission applies only to pharmacy-only products.

6.2

Clotrimazole (Canesten range of vaginal products, Bayer)

A further submission for the reclassification of the Canesten range of products containing one course of treatment of vaginal thrush from restricted medicine to pharmacy-only medicine.

6.3

Ranitidine (Zantac Relief, GlaxoSmithKline)

A company submission for the reclassification from pharmacy-only medicine to general sale medicine when in packs containing no more that 7 day's supply of 150 mg tablets.

7.

New Medicines for Classification

8.

Harmonisation of New Zealand and Australian schedules

Recommendations made by the NDPSC to the MCC.

8.1

Aspirin in compound products

Aspirin based products should be classified as prescription medicines when combined with caffeine, paracetamol, salicylamide or any derivative of these substances.

8.2

Iron

New Zealand should harmonise on the pack size limit of unscheduled iron to minimise the risk of poisoning in children. The maximum pack size for unscheduled medicines containing iron in Australia is 750 milligrams. New Zealand currently has no upper pack size limit for general sale products containing iron.

8.3

Selenium

Selenium should be classified as a prescription medicine in oral preparations containing more than 300 micrograms.

Selenium should be a pharmacy-only medicine except when in oral preparations containing a maximum recommended daily dose of 150 micrograms or in topical preparations containing 3.5% or less of selenium sulphide. These exceptions should be general sale medicines.

In New Zealand selenium is currently a general sale medicine in external products containing 2.5% or less and in oral preparations containing 150 micrograms or less.

The proposed change should have no effect on products on the New Zealand market.

8.4

Vitamin A

Allow topical preparations containing 1% or less to be available as general sale medicines. Topical preparations containing more than 1% are prescription medicines in Australia. The New Zealand schedule does not currently make provision for topical products.

8.5

Benzydamine

Benzydamine for dermal use should be exempt from scheduling.

Note that this recommendation does not apply to mouth and throat application. These would remain pharmacy-only.

Benzydamine is currently a pharmacy-only medicine for external use in New Zealand. A number of dermal products would be affected by the change.

8.6

Potassium Chloride

Make a new prescription medicine entry for potassium chloride except when in products:

• containing less than 600 milligrams per dose unit
• for oral rehydration
• for oral bowel cleansing prior to diagnostic, medical and surgical procedures
• for enteral feeding

Potassium chloride is currently covered by the potassium entry in the New Zealand schedule.

These exemptions would be general sale or unscheduled medicines. Note that a number of oral products which are currently pharmacy only would become general sale medicines.

Note also that New Zealand would need to include medicines for dialysis to the above exceptions from prescription status.

8.7

Ibuprofen 400 milligram tablets

The NDPSC has recommended that these should carry package warnings against use for children under 12 years of age.

8.8

Clotrimazole for use on nails

The recommendation is to amend the pharmacy-only entry to accommodate use for fungal infections of the nails.

This could be effected either by specifying use on the nail or changing “dermal” to “external” as for other topical antifungals.

New Zealand does not have a nail preparation containing clotrimazole. Martindale does not include the treatment of nail infections as one of the uses of clotrimazole.

8.9

Azacitidine

Add to the schedule as a prescription medicine.

Azacitidine is an antimetabolite antineoplastic with general properties similar to those of cytarabine.

8.10

Guanidine

Add to the schedule as a prescription medicine.

Guanidine was previously unscheduled in Australia and listed in the New Zealand schedule as a restricted medicine. It was removed from the New Zealand schedule on the recommendation of the MCC in May 2000 on the grounds that it had proven not to be very effective and was now obsolete. At the same time the MCC recommended that the NDPSC did not add this substance to the SUSDP. Guanidine is now a prescription medicine in Australia.

8.11

Ivabradine

Add to the schedule as a prescription medicine.

Ivabradine is a new medicine for the treatment of chronic stable angina due to atherosclerotic coronary artery disease in patients with normal sinus rhythm who are unable to tolerate or who have a contraindication to the use of beta blockers.

8.12

Butoconazole for vaginal use

Make a new schedule entry to allow butoconazole to be sold as a restricted medicine when in products for vaginal use.

This is in line with the classification of other antifungal medicines.

8.13

Prochlorperazine for oral use

Amend the restricted medicine entry from '10 tablets' to '10 oral dose units' to allow for capsules or other possible oral dose forms.

8.14

Tiprinavir

Add to the schedule as a prescription medicine.

Tiprinavir is a non-peptide HIV-protease inhibitor with antiviral activity against HIV.

8.15

Methyl salicylate

Add a prescription medicine entry for internal use.

Methyl salicylate is unscheduled in New Zealand. There is one internal product, a general sale antacid, in which methyl salicylate is used as an excipient. An exemption for excipients would be required to accommodate this product.

8.16

Rifampicin/rifamycin

Medsafe had acted on an earlier recommendation to remove one of these from the schedule on the grounds that they were synonyms and that one should be deleted.

Medsafe had later observed that these two rINNs did not appear to be synonymous and suggested that both should be retained in the schedule. Rifampicin applies only to rifamycin AMP. Rifamycin applies to the sodium salt. This has since been recognised in Australia and the recommendation has been amended to retain both entries.

8.17

Sodium nitrite

Exempt from scheduling when present as an excipient.

Sodium nitrite is not used as an excipient in any product registered in New Zealand.

8.18

Methoxamine

Harmonise with the Australian classification for prescription medicine when for injection.

In New Zealand methoxamine is a prescription medicine except for external use, a pharmacy-only medicine when in external medicines containing more than 1% and general sale in medicine containing 1% or less. These are already harmonised. There are no products registered in New Zealand which contain methoxamine.

8.19

Datura/Stramonium

Replace the entry for Datura spp with entries for Datura stramonium and Datura tatula and delete the restricted medicine entry for stramonium.

8.20

Diamthazole

Add to the schedule as a prescription medicine. There is no reference in Martindale to diamthazole.

8.21

Di-isopropylamine dichloroacetate

Add to the schedule as a prescription medicine.

Di-isopropylamine dichloroacetate is a vasodilator that has been given in peripheral and cerebral vascular disorders.

8.22

Felbinac

Delete the pharmacy-only entry for external use and make a new schedule entry for felbinac as a prescription medicine.

There is one external product in New Zealand which contains felbinac.

8.23

Polysulfated glycosaminoglycans

Add to the schedule as prescription medicines. These are likely to be listed by individual names in both schedules.

8.24

Picric acid

Reclassify as a prescription medicine. Add a separate entry for trinitrophenol which is a synonym. There is no rINN.

Picric acid is currently a general sale medicine in New Zealand. There are no registered medicines containing picric acid.

8.25

Ketoprofen

Amend the general sale availability from external use to dermal use. This would have no regulatory impact on products on the New Zealand market.

8.26

Pyrithione zinc

Amend the wording of schedule entries from ‘external use’ to ‘treatment of the scalp’.

Implementation of this recommendation would have no regulatory effect on any of the general sale products currently on the New Zealand market.

8.27

Vitamin D

Harmonise on the wording of the Australian prescription medicine entry for vitamin D by making the recommended maximum daily dose of 25 micrograms applicable only to products for internal use in order to avoid any inadvertent capture of external products.

8.28

Viprynium

The NDPSC has recommended that viprynium should be cross-referenced to pyrvinium.

The New Zealand schedule does not use cross referencing. The rINNM is pyrvinium. There are no medicines containing this substance so a change in nomenclature is unlikely to cause confusion.

9.

For the Next Meeting

10.

General Business