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Welcome

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Apologies

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Declaration of conflicts of interest

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matters arising

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Submissions for reclassification

A company submission for the reclassification from pharmacy-only medicine to general sale for propamidine isethionate eye drops and dibromopropamidine isethionate eye ointment.

See also the recommendation from the NDPSC (agenda item 8.1.3 )

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New Medicines for classification

The NDPSC has made the following recommendations to the MCC in 2006.

Boron

The NDPSC has recommended that:

1. The MCC be asked to recommend that the NDPSC harmonise on the NZ nomenclature for boron. The New Zealand schedule classifies boron as boric acid.
2. That the MCC should harmonise with the Australian classification for boron.

In New Zealand boric acid is pharmacy-only in medicines containing more than 2% and general sale in medicines containing 2% or less.

In Australia boron is classified as a prescription/S4 medicine in:

• preparations for internal use containing more than 3mg per recommended daily dose
• glycerines and honeys of borax or boric acid
• preparations for vaginal use
• preparations for dermal paediatric use being:
  • dusting powders or
  • other preparations containing more than 0.35% of boron
• other preparations for dermal use containing more than 0.35% or boron except for antifungal preparations

Classify as a prescription medicine.

Cathine is a constituent of catha, the leaves of catha edulis. It is used as an anorectic. Cathine is not scheduled in New Zealand. However, catha edulis, the plant from which cathine is obtained, is a Class C controlled drug. Another of its constituents, cathinone, is a Class B controlled drug. Martindale does not ascribe any therapeutic use to cathinone but notes that its effects resemble those of amphetamines and that dependence and psychotic reactions have been reported.

Propamidine and dibromopropamidine (see 6.1 above)

Reclassify from prescription medicine to restricted medicine.

There is one azelastine eye drop preparation registered in New Zealand which would be affected by this change.

In both countries salicylic acid is restricted medicine in products containing more than 40% and unscheduled in products containing 40% of less. In NZ the schedule entry applies to external use whereas in Australia it applies to dermal use. The NDPSC has recommended that NZ change 'external' to 'dermal' in order to harmonise.

In NZ there are topical oral gels containing choline salicylate which would be affected if 'external' were changed to 'dermal'. In order to maintain the current classification of these products, the current terminology would need to remain. Choline salicylate may also be used in the ear.

Choline salicylate is a derivative of salicylic acid. Derivatives of substances are covered by the parent entry in the SUSDP but are not covered by the introductory statement in the NZ schedule. Choline salicylate may be given orally in doses of up to 870 mg 4-hourly.

NZ may wish to consider separate entries for choline salicylate for internal use. Choline salicylate is a rINN.

Add a prescription medicine entry for oxiconazole 'except when specified elsewhere' to the New Zealand schedule in order to harmonise fully. The NDPSC has already agreed to harmonise on the OTC classifications for external use in the New Zealand schedule. According to Martindale, oxiconazole has only external applications.

The NDPSC has recommended that the following new chemical entities should be added to the NZ schedule as prescription medicines:
Palifermin
Rasagilin
Olmesartan
Lanthanum
Pegvisoment

Adopt the indication and age restriction into the pharmacy-only schedule entries.
These are essentially harmonised in that the indications and the age restriction are already requirements in the NZ Regulatory Guidelines for pharmacy-only nasal corticosteroids. Adopting this recommendation would have no regulatory effect on any of the products currently on the NZ market.

The recommendation applies to the following medicines:
Beclomethasone
Budesonide
Fluticasone
Mometasone
Triamcinolone

Harmonise with the Australian classification. Etidronic acid is a prescription medicine in New Zealand but is unscheduled in Australia when in topical medicines containing 1% or less. No New Zealand products would be affected by the change.

Add a new pharmacy-only entry for lobeline to cover the alkaloid contained in lobelia. This is for consistency with the Australian schedule. No products would be affected. The current exemptions for smoking or burning would apply to the new entry.

Reclassifiy to restricted medicine to harmonise with Australia.
Note that this would allow all pharmacists to sell emergency contraception without the current training requirement. Provision would need to be made to allow continued access for use by accredited family planning nurses.

The NDPSC has recommended that lithium should be exempt from scheduling when in preparations containing 0.25% of lithium as an excipient and that this should apply only to dermal products.

Make new schedule entries for pyridoxamine and pyridoxal which are consistent with the entry for pyridoxine.

In both Australia and New Zealand pyridoxine is a general sale medicine in products containing 200 milligrams per recommended daily dose and is a prescription medicine in products above 200 milligrams per recommended daily dose.

New evidence presented to the NDPSC by Weleda and considered alongside the MCC recommendation for Australia to harmonise with New Zealand, indicated that the general exemption of 10 milligrams per litre or per kilogram provided adequate coverage for Weleda products to be sold as general sale medicines.

It is proposed that the pharmacy-only and general sale entries be deleted from the New Zealand schedule. Previous pack-size and daily dose limits are considered to be no longer necessary in the New Zealand schedule. A single prescription medicine schedule entry should have no impact on homoeopathic products already on the market.

The NDPSC has also recommended the inclusion of the botanical name, Schoenocoulon officinale in the schedule. Retention of the sabidilla entry would help avoid confusion.

Schedule entries for diclofenac are harmonised in all but one aspect. In Australia, pharmacy-only oral diclofenac is required to have a maximum recommended daily dose of 75 milligrams. The NDPSC has recommended that the MCC harmonise on this recommended daily dose limit. It is not known if the change would affect products on the New Zealand market.

The NDPSC has recommended that NZ harmonise with Australia on the requirements for pharmacy-only solid dose ibuprofen products to be limited to 100 units per pack and a maximum daily dose of 1200 milligrams.

NZ and Australia are already harmonised on these requirements. In NZ these requirements are currently included in the NZ Regulatory Guidelines rather than the classification schedule. They were originally omitted from the schedule entry for ibuprofen in order to simplify an already lengthy entry. However, in the interest of closer alignment of the wording of both schedules in readiness for the commencement of the Australia New Zealand Therapeutic Products Authority, NZ has been asked to include the pack limit and daily recommended dose in the schedule entry.

Rewording the schedule entry for pharmacy-only ibuprofen to include these two requirements will have no impact on the classification of products containing ibuprofen.

This item has been included on the agenda to explain the anticipated change to the pharmacy-only schedule entry for ibuprofen.

The NDPSC has recommended that deglycyrrhizinised liquorice, should be removed from the NZ schedule.

Deglycyrrhizinised liquorice is exempt from scheduling in Australia. It was classified as a prescription medicine in New Zealand because it was formerly indicated for the treatment of peptic ulcer.

The NDPSC has recommended that the provision for chlorquinaldol for external use to be available as general sale medicine be removed from the schedule on the basis that there are no general sale items registered in either country. Chlorquinaldol is currently general sale for external use and prescription medicine for external use.

Add to the schedule as a prescription medicine. Deslorelin is an analogue of gonadorelin. It is not scheduled in NZ.

Add to the schedule as a prescription medicine. Dimethoxanate is a cough suppressant scheduled as S4 in Australia.

Add to the schedule as a prescription medicine. Fomivirsen is an antiviral used in the treatment of cytomegalovirus retinitus.

Add to the schedule as a prescription medicine. Lefetamide hydrochloride has analgesic properties and has been administered by intramuscular or subcutaneous injection.

Add to the schedule as a prescription medicine. Ipriflavone is a synthetic isoflavinoid that inhibits resorption of bone.

Add a prescription medicine entry for lodoxamide for uses other than in the eye to harmonise with Australia. Both countries classify lodoxamide as a pharmacy-only medicine when for ophthalmic use. Lodoxamide is used only in the eye.

Add to the schedule as a prescription medicine. Pipradol is a CNS stimulant which is administered orally.

Add to the schedule as a prescription medicine. Riluzole is a glutamate agonist used in the management of amyotrophic lateral sclerosis.

Add to the schedule as a prescription medicine. Scopolia carniolica contains tropane alkaloids.

Add to the schedule as a prescription medicine. Tipepide is a cough suppressant which is claimed also to have an expectorant action.

Add to the schedule as a prescription medicine. Tolpropamine is an antihistamine which has been used topically for skin disorders.

Reclassify as a prescription medicine. Mercuric oxide is a pharmacy-only medicine in both countries when for ophthalmic use. However, there are no longer any products registered in either country. If the schedule entry were removed, mercuric oxide would be covered by the entry for mercury.

Delete nicotinamide from the NZ schedule and reword the nicotinic acid entry to harmonise with that in the SUSDP

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

In Australia nicotinic acid is harmonised with NZ but the S3 entry exempts nicotinamide. The S3 entry in the SUSDP 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 be a general sale medicine in New Zealand.

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For the next meeting

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General business