Classification of Medicines

Agenda Items for the 24^th Medicines Classification Committee Meeting

Agenda items for the 24^th meeting of the Medicines Classification Committee held on 2 November 2000

Please note that company submissions are now accessible. Click on the medicine trade name to download the company submission. Click on the active ingredient name to download the Medsafe report.

Beclomethasone (Beconase Hayfever, GlaxoWellcome)

A recommendation on this company submission had been deferred from the 21^st meeting pending further information about a suitable minimum age limit for its use. The current submission is for reclassification from restricted medicine to pharmacy-only medicine for seasonal allergic rhinitis including hayfever for adults 18 years and over.
Medsafe report (Microsoft Word document 37KB)
GlaxoWellcome submission (Microsoft Word document 54KB)

Clobestasone butyrate 0.05% cream (Eumovate, GlaxoWellcome)

A company submission for reclassification from prescription medicine to restricted medicine.
Medsafe report (Microsoft Word document 37KB)
GlaxoWellcome submission (Microsoft Word document 54KB)

Nicotine 1mg lozenges (Nicotinell, Novartis)

A company submission for classification for a new dose form.
Medsafe report (Microsoft Word document 54KB)
Novartis submission (Microsoft Word document 54KB)

Harmonisation with Australia

Recommendations made by the NDPSC to the MCC in February 2000

Pharmacy-only medicines recommended for deletion
The NDPSC has recommended that the following medicines be deleted from the New Zealand schedule. This means that, if deleted, they would become general sale medicines.

Acetomenaphthone
Aloes for internal use
Aloin
Bentiromide
Biphenylacetic acid
Bisacodyl
Bromelains
Calcium hypochlorite
Calcium salicylate
Camphor, ammoniated
Capsicum oleo-resin
Chromium Oxide
Colocynth
Copper
Cyanocobalamin
Dextranomer
Dextrans
Dibromopropamidine
Fluoroscein
Formic acid
Hetastarch
Hexamidine
Hippuric acid
Hydrogen peroxide
Hydroiodic acid
Hydroxocobalamin
Ichthammol
Iodic acid
Ipomoea
Irrigation medicines
Isopropyl alcohol
Jaborandi
Jalap resin
Krameria,
Magenta
Menadiol
Monoacetin
Nitrous ether spirit
Oxerutins
Pentastarch
Phenoxyethanol
Phytomenadione
Picric acid
Piroctone
Polygeline
Pomegranate
Propamidine
Quassia
Salsalate
Scillarins
Sennosides
Sodium hydroxide
Sodium iodide
Sodium picosulphate
Sodium salicylate
Solcoseryl
Stannous chloride
Stannous oxide
Sucralfate
Tannic acid
Theobromine
Thiomersal (covered by the entries for mercury)
Thioxolone
Trichloroacetic acid

Medicines recommended for addition as prescription medicines

Abrus precatorius (Jequirity) seed or root
Acorus calamus (calamus)
Allylisopropylacetylurea
Amygdalin
Anchusa officinalis
Borago officinalis (borage) except the fixed oil derived from the seeds of borago officinalis
Broxaldine
Broxyquinoline
Buniodyl sodium
Cacalia spp
Crotalaria spp
Cynoglossum spp
Dulcin
Ethylhexanediol
Eupatorium cannabinum (hemp agrimony)
Farfugium japonicum
Heliotropium spp
Heliotropium supinum
Juniperus sabina [savin(e)]
Ligularia dentata
Petasites spp
Pteridium spp
Pulmonaria spp
Safrole for internal therapeutic use except in preparations containing 0.1% or
less of safrole
Senecio spp
Symphytum spp (comfrey) except for dermal use
1,1,1-trichloroethane in pressurised spray packs
Trichodesma africana
Triparanol
Tussilago farfara

Medicines recommended for change from pharmacy-only to prescription medicine

Bithionol
Buclosamide
Coniine
Cotarnine
Diamthazole
Phenolphthalein

Other changes recommended to the New Zealand schedule

Amidopyrine
Amend the current prescription medicine entry to read:
amidopyrine (aminophenazone) and its derivatives

Boron
Delete the pharmacy-only entries for boric acid and sodium perborate. Add the following new prescription medicine entry for boron:
in preparations for internal use
in glycerins or honeys of borax or boric acid
in preparations for vaginal use
in preparations for paediatric dermal use , being (I) dusting powders; or (II) other preparations containing more than 0.15% of boron except antifungal preparations
in preparations for dermal use containing more than 0.15% of boron except antifungal preparations

Cinchophen
Amend the prescription medicine entry to read:
Cinchophen and its derivatives for therapeutic use

Clioquinol
Amend the prescription medicine entry to read:
clioquinol and other halogenated derivatives of 8-hydroxyquinoline

Colecalciferol
Delete the prescription medicine entry from the schedule. Covered by the vitamin D entry.

Croton oil
Reclassify from restricted medicine to prescription medicine as croton tiglium

Etofenamate
Adopt a prescription medicine entry for use other than external and amend the pharmacy-only entry to external use only.

Felbinac
Adopt a prescription medicine entry for use other than external and amend the pharmacy-only entry to external use only. (It is only used topically). Delete biphenylacetic acid, its chemical name.

Iron
Delete the current pharmacy-only entry and replace with:
Iron compounds (excluding iron oxides when present as an excipient up to one per cent in undivided preparations or up to 10mg per dosage unit in the casing or coating of divided preparations) for human internal use except:
when a prescription medicine
in divided preparations containing 5mg or less of iron per dosage unit
in oral undivided preparations containing 0.1% or less of iron
Make a new prescription medicine entry for iron in preparations for injection.

Isopropamide
Adopt the following pharmacy-only entry:
in preparations for dermal use containing 2% or less.

Loperamide
Make a new schedule entry for loperamide as a prescription medicine when for injection. Amend the pharmacy-only entry accordingly.

Methlyene blue
Delete the pharmacy-only entry and make a new prescription medicine entry for methylene blue for injection.

Oxiconazole
Make a new prescription medicine entry ‘except for dermal or vaginal use’.
Make a new restricted medicine entry ‘for vaginal use’.

Pilocarpine
Modify the prescription medicine entry for pilocarpine to read:
in medicines containing more than 0.025% of pilocarpine

Retinol
Delete the prescription medicine entry. Amend the entry for vitamin A to:
in preparations containing more than 3000mcg retinol equivalents per recommended daily dose.

Ribonuclease, deoxyribonuclease (for external use)
Delete the pharmacy-only entries from the schedule.
Make a new prescription medicine entry for deoxyribonuclease ‘except for external use and except when specified elsewhere in the schedule’.

Staphisagria
Reclassify from:
Restricted medicine (internal use 0.2% or more)
Pharmacy-only medicine (external use and internal under 0.2%)
to:
Pharmacy-only medicine; except in medicines containing 0.2% or less

Vitamin D
Amend the prescription medicine entry to read:
in medicines for internal use containing more than 25 mcg per
recommended daily dose.

Zinc chloride
Amend the pharmacy-only entry to:
for dermal use in medicines containing more than 5%

Recommendations made by the NDPSC to the MCC in May 2000

Formaldehyde, paraformaldehyde

Amend the current pharmacy-only entries to read:

(excluding its derivatives) except in medicines containing 5% or less

Phenolphthalein

Reclassify from pharmacy-only to prescription medicine.

Macrogol 3350

Adopt as a restricted medicine for oral bowel cleansing purposes.

Harmonisation of Low-Concentration and Banned Medicines

Exemptions from scheduling for low-concentration medicines

The project to harmonise the New Zealand and Australian schedules has resulted in New Zealand moving a number of mainly plant-derived medicines into the prescription medicine category.   This puts even very low concentrations of such substances outside the legal use of complementary health practitioners such as homoeopaths.   It is not the intention that complementary practitioners be deprived of access to these substances at appropriate concentrations.   Australia allows access by means of a general exemption in the cover statement to the Uniform Scheduling of Drugs and Poisons (SUSDP).   New Zealand is seeking a way to harmonise with Australia while allowing reasonable access for complementary health practitioners.

One solution may be for New Zealand to add the following statement or words of similar effect to the current preamble to the update to the First Schedule to the Medicines Regulations:

Unless specific reference is made otherwise, a reference to a medicine in the Schedule does not include any concentration of 10 milligrams or less per litre or per kilogram of that medicine or of total plant alkaloids or glycosides in the Schedule.

In Appendix G to the SUSDP Australia lists medicines which, because of their toxicity, require different cut-off points for general sale availability from those in the above cover statement.   These cut-off points could be included in the New Zealand schedule against the respective medicine entries. The following medicines would be affected:

Prescription medicines

Acetylcholine; except in medicines containing 1 milligram or less per litre or per kilogram

Aldosterone; except in medicines containing 10 micrograms or less per litre or per kilogram

Antimony; except in medicines containing 1 milligram or less per litre or per kilogram

Apomorphine; except in medicines containing 1 milligram or less per litre or per kilogram

Arsenic; except in medicines containing 1 milligram or less per litre or per kilogram

Atropine; except in medicines containing 100 micrograms or less per litre or per kilogram

Croton oil; except in medicines containing 1 milligram or less per litre or per kilogram

Erysimum; except in medicines containing 1 milligram or less per litre or per kilogram

Follicle stimulating hormone; except in medicines containing 100 micrograms or less per litre or per kilogram

Haloperidol; except in medicines containing 1 milligram or less per litre or per kilogram

Hydrocyanic acid; except in medicines containing 1 microgram or less per litre or per kilogram

Indomethacin; except for external use in medicines containing 1% ore less; except in medicines containing 1 milligram or less per litre or per kilogram

Oestradiol; except in medicines containing 10 micrograms or less per litre or per kilogram

Oestrone; except in medicines containing 1 milligram or less per litre or per kilogram

Oxytocin; except in medicines containing 1 microgram or less per litre or per kilogram

Podophyllum; except in medicines containing 1 milligram or less per litre or per kilogram

Progesterone; except in medicines containing 1 milligram or less per litre or per kilogram

Propranolol; except in medicines containing 1 milligram or less per litre or per kilogram

Testosterone; except in medicines containing 1 milligram or less per litre or per kilogram

Thyroxine; except in medicines containing 10 micrograms or less per litre or per kilogram

Restricted medicines

Glucagon; except in medicines containing 100 micrograms or less per litre or per kilogram

Strychnine; except in medicines containing 1 milligram or less per litre or per kilogram

Pharmacy-only medicines

Gelsemium; except in medicines containing 1 milligram or less per litre or per kilogram

Glyceryl trinitrate; except for injection; except in medicines containing 100 micrograms or less per litre or per kilogram

Harmonisation of medicines banned from human therapeutic use in Australia

There are some substances which are considered too toxic for human therapeutic use even at minimal concentrations.   Australia lists these in Appendix C to the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP).   In New Zealand they are scheduled so that the regulatory process will prevent their being granted consent to market.   In order to harmonise with Australia and to prevent their use in even very low concentrations, the New Zealand schedule would need to include the words:

at all strengths

to those medicines which are prescription medicines in New Zealand and are included in Appendix C of the SUSDP.   This would apply to the following medicines:

Clioquinol
Croton oil
Oxyphenisatin
Silicones; for injection at all strengths

A number of Appendix C medicines are currently pharmacy-only in New Zealand or are not scheduled at all.   Most of the balance of the SUSDP Appendix C medicines are included in the current set of recommendations being considered at the next MCC meeting for inclusion as prescription medicines.   These medicines would have ‘at all strengths’ added at the time they are added as prescription medicines if the proposal is accepted by the MCC.   The medicines are:

Abrus precatorius (Jequirity) seed or root
Acorus calamus (calamus)
Allylisopropylacetylurea
Amygdalin
Anchusa officinalis
Borago officinalis (borage) except the fixed oil derived from the seeds of Borago officinalis
Buniodyl sodium
Cacalia spp
Crotalaria spp
Cynoglossum spp
Dulcin
Ethylhexanediol
Eupatorium cannabinum (hemp agrimony)
Farfugium japonicum
Heliotropium spp
Heliotropium supinum
Juniperus sabina [savin(e)]
Ligularia dentata
Petasites spp
Pteridium spp
Pulmonaria spp
Safrole for internal therapeutic use except in preparations containing 0.1% or less of safrole
Senecio spp
Symphytum spp (comfrey) except for dermal use
1,1,1-trichloroethane in pressurised spray packs
Trichodesma africana
Triparanol
Tussilago farfara

Aristolochia, which is already a prescription medicine in New Zealand except for homoeopathic use, would also fall into this category of banned medicines.

Comments would be welcome from interested bodies before the end of September.   Please note the extended deadline for comments on low-concentration and banned medicines.