The Committee will also discuss whether or not the prochlorperazine entry should be amended to allow the medicine to be sold by appropriately accredited pharmacists and nurses in conjunction with the emergency contraceptive pill.

Omitted from the February 2001 meeting of NDPSC. MCC had agreed in May 2000 to a 40% cut-off level for general sale and had been waiting for a formal recommendation from the NDPSC (see also item 6.3 above).

Change the pharmacy-only entry to:

Dextromethorphan in packs containing 600 mg or less of dextromethorphan:

1. in divided preparations containing 30 mg or less of dextromethorphan per dosage unit, with a recommended dose not exceeding 30 mg of dextromethorphan; or
2. in undivided preparations containing 0.3 per cent or less of dextromethorphan, with a recommended dose not exceeding 30 mg of dextromethorphan

The classification of dextromethorphan was changed in 2000 to in order to harmonise. The further recommendation is based on a history of substance abuse of all dose forms. The recommendation would result in a change to the classification of all products which are currently available for general sale. Companies objecting to the change need to demonstrate that the product could not be readily abused.

Make a separate prescription medicine entry. Exclude atropine methonitrate from the pharmacy-only entry for atropine.

If atropine methonitrate is listed separately as a prescription medicine there is no need to exclude it in the atropine entry in the New Zealand schedule. There are no medicines registered in New Zealand containing atropine methonitrate.

Reclassify as prescription medicine for all strengths and dose forms.

There would be no regulatory impact as New Zealand has only prescription products.

Adopt the following pharmacy-only entry:

as the only therapeutically active substance in divided preparations for oral use containing 10 mg of hyoscine butylbromide per dosage unit in a pack containing 20 or less dosage units.

To date the MCC has recommended against harmonisation for Buscopan tablets which are restricted medicine in New Zealand (see also recommendation in November 2001, agenda item 8.5.5). No other products would be affected.

Add to the schedule as a prescription medicine.

Add to the schedule as a prescription medicine.

Medsafe had earlier queried the accuracy of a recommendation for a prescription medicine entry for digoxin antibody. The NDPSC has now responded with a recommendation for a more acceptable name.

Add to the schedule as a prescription medicine

There are no products registered in New Zealand containing dextrorphan, a metabolite of dextromethorphan.

Delete the prescription medicine generic entry.

A generic entry is unnecessary as ion exchange resins should be scheduled separately by name.

Reclassify from restricted medicine to prescription medicine as colestyramine on the grounds that the primary indications for this medicine do not meet the requirements for sale as a restricted medicine.

Two Questran products would be affected by the change.

Add to the schedule as a prescription medicine.

Glatiramer acetate is included in the SUSDP but not the New Zealand schedule.

Add to the schedule as a prescription medicine.

Acepromazine is included in the SUSDP but not the New Zealand schedule

Add to the schedule as a prescription medicine.

This is an androgenic steroid. There is no reference to it in Martindale.

Add the following to the schedule as prescription medicines:

3-aminobenzoic acid ethyl ester methanesulphonate
amylocaine
butacaine
diperodon
etidocaine
orthocaine

There is no reference to the first or last of these in Martindale which suggests that they may be obsolete and should be removed from the schedules.

The scheduling of amethocaine should be as follows:

The imposition of an upper limit for dermal pharmacy-only products would have no effect on any product currently registered in New Zealand.

New Zealand would retain the exemption from prescription status allowing optometrists to use eye preparations.

Add to the New Zealand schedule as a prescription medicine on the grounds of harmonisation.

As this substance is not scheduled in New Zealand, has no reference in Martindale and there are no products in either country, it may be a suitable candidate for removal from the schedules.

The scheduling of benzocaine should be as follows:

The imposition of an upper limit for topical pharmacy-only products would affect the Sultan Topex range of oral gel products (4) which contain 20%.

Add to the schedule as a prescription medicine.

There are no medicines registered in either country containing this ingredient.

The scheduling of cinchocaine should be as follows:

Cinchocaine for external use is currently pharmacy-only in medicines containing more than 2% and general sale below that level. However, it appears that the recommended change should have no affect on products currently registered in NZ.

Add to the New Zealand schedule as prescription medicines.

Pramoxine is already in the New Zealand schedule under its INN, pramocaine. It appears to be used only externally. Its classification is general sale at 2% or less and pharmacy-only above that concentration. As there are no longer any medicines available in New Zealand containing pramocaine, the recommendation would have no regulatory effect.

Dimethisoquin is the BANM and USAN for which the INN is quinisocaine. It is also a surface anaesthetic. There are no medicines containing this registered in New Zealand and it is not included in the schedule.

The scheduling of lignocaine should be as follows:

NB The New Zealand schedule would retain the current exemptions from prescription status for named health professionals. The NDPSC recognises that different legislative controls prevent harmonisation of these entries.

The scheduling of prilocaine should be as follows:

The exemption from prescription status for use by dental therapists would remain in the New Zealand schedule.

The pharmacy-only entry should be removed from the schedule on the grounds that there were safety concerns about the registration process for oral vaccines if they were moved to pharmacy-only medicine.

The recommendation overlooks the fact that oral vaccines are only pharmacy-only if they are not specified elsewhere in the schedule. It is New Zealand practice to list vaccines by ingredient. Any vaccines intended to be prescription medicines will be scheduled as such.

Adopt as a prescription medicine. There are no medicines registered in New Zealand which contain nicoumalone.

Delete the restricted medicine entry.

New Zealand has a pharmacy-only entry for internal use which is probably the entry intended in the recommendation. There are no products listed in New Zealand under terebene. There is no reference in Martindale.

Delete the pharmacy-only entries.

There are no medicines registered in New Zealand containing either of these medicines. There is no reference in Martindale to the latter. There are other pesticides preferred to monosulfiram.

Reassess the scheduling of nystatin and hexamidine in dermal products for tinea pedis.

While there are no nystatin products registered specifically for this indication there are several pharmacy-only products for dermal infections. Hexamidine is general sale for all indications. It was moved to general last year as part of the harmonisation project.

Remove from the schedule.

Mandelic acid is currently classified as pharmacy-only medicine. There are no medicines registered in New Zealand which contain mandelic acid.

• Delete the pharmacy-only entry for nux vomica and the restricted medicine entry for strychnine and reclassify both to prescription medicine under the following two entries:
  Strychnos nux vomica
  Strychnos spp
• Delete the pharmacy-only and restricted medicine entries for brucine

Note that strychnine is an Appendix G medicine in Australia which means it is exempt from scheduling below a concentration other than the standard one, in this case, 1 mg/kg. A statement to this effect would need to be added to the New Zealand schedule entry.

An entry for strychnos nux vomica appears redundant when there is already an entry covering all strychnos species. However, retention of the name nux vomica as a separate entry might help avoid confusion as this is the name by which the medicine has traditionally been known.

Brucine would presumably be covered by the prescription medicine entries for strychnos or nux vomica.

There are no medicines registered in New Zealand containing any of these substances.

Reclassify to prescription medicine as Juniperus sabine

Juniperus sabina is one of the herbals for which a delay had been requested for classification as a prescription medicine and for which Medsafe had agreed that no further action should be taken over until the outcome of the joint agency proposal was known.

However, the PDR For Herbal Medicines states that the medicinal part of Juniperus sabina or savin tops are the essential oil of the leaves and branch tips; the dried leafy branch tips; the fresh non-woody branch tips with leaves; and the branches and leaves.

Savin oil is already a prescription medicine which means that it is unavailable for use in complementary medicines. However, there may be complementary medicines derived from parts of the plant other than the essential oil. Changing the name to Juniperus sabina may increase the scope of the substance to be classified.

Delete 'except in preparations for topical use' from the prescription medicine entry on the grounds that this recommendation was obsolete.

This wording was added to the New Zealand schedule at the request of the NDPSC. New Zealand has no medicines containing this substance.

Make a new pharmacy-only entry for potassium chlorate except when in medicines containing 10% or less of potassium chlorate.

New Zealand has only one product registered and this would remain general sale.

Reclassify to prescription medicine as follow:

Ephedra spp: except in preparations containing 0.001% or less of ephedrine

See also agenda item 8.1.3 above.

Add 'for injection' to the prescription medicine entry.

Medsafe had previously queried this recommendation on the grounds that any other route of administration would automatically become general sale. It appears that there is a complementary medicine in Australia which is in tablet form and which is not scheduled. There is no such product registered in New Zealand.

Delete from the schedule.

This would result in products containing more than 2.5% moving from pharmacy-only to general sale. The highest strength currently registered is a 25% topical solution.

Reclassify from pharmacy-only medicine to prescription medicine.

New Zealand has no registered medicines containing benorylate

Reclassify as prescription medicine except for topical use.

New Zealand has only topical (ie external products). However, benzydamine has been used orally and by injection.

New Zealand should adopt the revised wording of the SUSDP 15 (2) amendment for ibuprofen that:

sets an upper daily dose for divided and undivided preparations for ibuprofen (1200mg) relaxes the concentration requirements for ibuprofen liquid preparations but retains a 4 gram total content of ibuprofen in these packs (no concentration specified).

Modify the pharmacy-only entry so that the following are general sale medicines

oral solutions containing 0.3% or less

other medicines containing 1% or less

Shift the wording of the current pharmacy-only exemption for silver sulfadiazine from the 'silver' to the 'silver sulfadiazine' entry*.

Adopt the SUSDP warning statement 'overuse may stain skin or mouth' for silver solutions for oral use or in chewing gums.

New Zealand does not appear to have any registered products which would be affected by the classification change. There are no products which would justify the inclusion of the above warning statement into the New Zealand Regulatory Guidelines. *For silver sulfadiazine, see later recommendation made in November 2001 to reclassify to prescription medicine for all strengths (agenda item 8.5.1).

Change the classification of products for external use containing more than 2.5% from pharmacy-only to prescription medicine.

This is inconsistent in that it would make external products more restrictively classified than internal products. All internal products containing more than 150 mcg per recommended daily dose would remain pharmacy-only.

Two shampoos registered in New Zealand would remain general sale.

Classify as pharmacy-only except when in shampoos containing 2% or less.

This is currently general sale in New Zealand and is covered under the entry for zinc for external use. There are a large number of shampoos marketed, most of which contain 1% or less. However, there is one shampoo containing 2.08% which would become a pharmacy-only medicine.

Reclassify to prescription medicine except for oral liquids containing 2% or less or solid dose forms containing 200 mg or less which should become general sale medicines.

The change should not affect any of the general sale products currently on the market.

Reclassify from pharmacy-only to restricted medicine for consistency with isosorbide dinitrate and glyceryl trinitrate.

New Zealand has no products containing either medicine.

prescription medicine	for injection
pharmacy-only	in medicines containing more than 500 micrograms per recommended daily dose
general sale	in medicines containing 500 micrograms or less per recommended daily dose

Note that the MCC has already reclassified folinic acid from prescription medicine to restricted medicine at the request of the NDPSC.

Calcium folinate (leucovorin) tablets come in strengths of 10 mg and 15 mg only. There are no tablets containing less than 10 mg. These recently moved from PM to RM at the recommendation of the NDPSC and would now move again to PO.

There would be no change to the current classification of folic acid tablets (max 5mg) but injections would move to PM.

An exemption from PM would be required for folic acid to allow use at general sale level in parenteral nutrition replacement preparations. Folinic acid does not appear to be used in this way.

In the New Zealand schedules, these medicines would be listed according to their individual names. It is not know which medicines would be covered by this entry.

Hypromellose is not contained as an excipient in any injectable medicines which are not already prescription medicines by virtue of their active ingredients. Therefore a cut-off point or exemption statement to avoid catching medicines which should be less restrictively classified would unnecessary.

One product would move from pharmacy-only to prescription.

This is a new chemical entity for use in epileptic patients for the treatment of partial onset seizures. New Zealand has not received an application for consent to market a medicine containing levetiracetam.

This would bring the OTC classification of nizatidine into line with that of ranitidine and famotidine. There are no longer any nizatidine products marketed in New Zealand.

Bexarotene is a new chemical entity not registered for consent to market in Australia or New Zealand but available in Australia through the Special Access Scheme when used for the treatment of T-cell lymphoma.
 

There is one product in New Zealand which would be affected by this change.

There is a submission requesting the reclassification of 2% topical minoxidil to pharmacy-only on the current agenda.
 

Silver sulfadiazine is permitted as a pharmacy-only medicine in New Zealand in packs containing 50 grams or less. There is only one OTC pack available, Silvazine Topical Cream.

Nitrofurazone is currently classified as a pharmacy-only medicine. There are no longer medicines registered in New Zealand containing nitrofurazone.

Note that local anaesthetics which are general sale in New Zealand at 2% or less are usually pharmacy-only medicine rather than prescription medicine at strengths greater than 2%.

Atropa belladonna

1. for external use in preparations containing 0.03% or less of the alkaloids of belladonna; or
2. for oral use:

1. in undivided preparations containing 0.03% or less of the alkaloids of belladonna when labelled with a dose of 0.3mg or less of the alkaloids of belladonna and a recommended daily dose of 1 mg or less of the alkaloids of belladonna: or
2. in divided preparations containing 0.3 mg or less of the alkaloids of
   belladonna per dosage unit, when labelled with a recommended daily dose of 1 mg or less of the alkaloids of belladonna.

Atropine

1. for oral use:

1. in undivided preparations containing 0.03% or of atropine when labelled with a dose of 0.3mg or less of atropine and a recommended daily dose of 1 mg or less of atropine: or
2. in divided preparations containing 0.3 mg or less of atropine per dosage unit when labelled with a recommended daily dose of 1 mg or less of the atropine

2. in preparations containing atropine sulfate when packed and labelled for treatment of organophosphorous poisoning:

1. in tablets each containing 0.6 mg or less of atropine sulfate in packs of 20 tablets; or
2. in preparations for injection each containing 0.6 mg per ml or less of atropine sulfate in packs of 5

Datura spp for oral use except when separately specified in these Schedules:

1. in undivided preparations containing 0.03% or less of the alkaloids of datura when labelled with a dose of 0.3mg or less of the alkaloids of datura and a recommended daily dose of 1 mg or less of the alkaloids of datura; or
2. in divided preparations containing 0.3 mg or less of the alkaloids of belladonna per dosage unit, when labelled with a recommended daily dose of 1 mg or less of the alkaloids of belladonna.

Datura stramonium for oral use when:

1. in undivided preparations containing 0.03% or less of the alkaloids of stramonium when labelled with a dose of 0.3mg or less of the alkaloids of stramonium and a recommended daily dose of 1 mg or less of the alkaloids of stramonium; or
2. in divided preparations containing 0.3 mg or less of the alkaloids of stramonium per dosage unit, when labelled with a recommended daily dose of 1 mg or less of the alkaloids of stramonium

except for smoking or burning.

Datura tatula for oral use when:

1. in undivided preparations containing 0.03% or less of the alkaloids of stramonium when labelled with a dose of 0.3mg or less of the alkaloids of stramonium and a recommended daily dose of 1 mg or less of the alkaloids of stramonium; or
2. in divided preparations containing 0.3 mg or less of the alkaloids of stramonium per dosage unit, when labelled with a recommended daily dose of 1 mg or less of the alkaloids of stramonium

except for smoking or burning.

 Duboisia leichhardtii for oral use:

1. in undivided preparations containing 0.03% or less of the alkaloids of duboisia calculated as hyoscyamine when labelled with a dose of 0.3mg or less of the alkaloids of duboisia calculated as hyoscyamine and a recommended daily dose of 1 mg or less of the alkaloids of duboisia calculated as hyoscyamine; or
2. in divided preparations containing 0.3 mg or less of the alkaloids of duboisia calculated as hyoscyamine per dosage unit, when labelled with a recommended daily dose of 1 mg or less of the alkaloids of duboisia calculated as hyoscyamine

Duboisia myoporides for oral use:

1. in undivided preparations containing 0.03% or less of the alkaloids of duboisia calculated as hyoscyamine when labelled with a dose of 0.3mg or less of the alkaloids of duboisia calculated as hyoscyamine and a recommended daily dose of 1 mg or less of the alkaloids of duboisia calculated as hyoscyamine; or
2. in divided preparations containing 0.3 mg or less of the alkaloids of duboisia calculated as hyoscyamine per dosage unit, when labelled with a recommended daily dose of 1 mg or less of the alkaloids of duboisia calculated as hyoscyamine

Hyoscine (excluding hyoscine butyl bromide)*

1. for transdermal use in preparations containing 2mg or less of hyoscine per
2. dosage unit; or for oral use:

1. in undivided preparations containing 0.03% or less of hyoscine when labelled with a dose of 0.3mg or less of hyoscine and a recommended daily dose of 1 mg or less of hyoscine; or
2. in divided preparations containing 0.3 mg or less of hyoscine per dosage unit, when labelled with a recommended daily dose of 1 mg or less of hyoscine

Hyoscyamine

1. for external use in preparations containing 0.03% or less of hyoscyamine;
2. or for oral use:

1. in undivided preparations containing 0.03% or less of hyoscyamine when labelled with a dose of 0.3mg or less of hyoscyamine and a recommended daily dose of 1 mg or less of hyoscyamine; or
2. in divided preparations containing 0.3 mg or less of hyoscyamine per dosage unit, when labelled with a recommended daily dose of 1 mg or less of hyoscyamine

Hyoscyamus niger for oral use:

1. in undivided preparations containing 0.03% or less of the alkaloids of hyoscyamus when labelled with a dose of 0.3mg or less of the alkaloids of hyoscyamus and a recommended daily dose of 1 mg or less of the alkaloids of hyoscyamus; or
2. in divided preparations containing 0.3 mg or less of the alkaloids of hyoscyamus per dosage unit, when labelled with a recommended daily dose of 1 mg or less of the alkaloids of hyoscyamus

 *Note: Any change to the hyoscine entry in the New Zealand schedule would have an effect on the classification of hyoscine butylbromide which is not scheduled separately. The SUSDP also has the following separate pharmacy-only entry:

hyoscine butylbromide as the only therapeutically active substance in divided preparations for oral use containing 10 mg or less of hyoscine butylbromide per dosage unit in a pack containing 20 or less dosage units.

New Zealand does not have separate entries for hyoscine butylbromide. There is no prescription medicine entry for hysoscine butylbromide in the SUSDP to cover strengths or pack sizes greater than those permitted for pharmacy-only. Buscopan 10mg tablets are restricted medicine in New Zealand. They would become pharmacy-only if the above entry for hyoscine were amended in the New Zealand schedule. The Committee has considered company submissions for reclassification of Buscopan tablets to pharmacy-only medicine on two previous occasions but has so far maintained its position that these should remain classified as restricted medicine.

Schedule as follows:

Prescription medicine

Podophyllum emodi

1. in preparations for internal use
2. in preparations for the treatment of anogenital warts
3. in other preparations except when specified elsewhere

Podophyllum pelatum

1. in preparations for internal use
2. in preparations for the treatment of anogenital warts
3. in other preparations except when specified elsewhere

Podophyllotoxin

1. in preparations for internal use
2. in preparations for the treatment of anogenital warts
3. in other preparations except when specified elsewhere

Restricted Medicine

Podophyllum emodi in preparations containing 20% or less of podophyllin for the treatment of warts other than anogenital warts except when specified elsewhere

Podophyllum pelatum in preparations containing 20% or less of podophyllin for the treatment of warts other than anogenital warts except when specified elsewhere

Podopyllotoxin in preparations containing 1% or less of podophyllotoxin for the treatment of warts other than anogenital warts except when specified elsewhere

Pharmacy-only medicine

Podophyllum emodi in preparations containing 10% or less of podophyllin for the treatment of warts other than anogenital warts

Podophyllum pelatum in preparations containing 10% or less of podophyllin for the treatment of warts other than anogenital

Podopyllotoxin in preparations containing 0.5% or less of podophyllotoxin for the treatment of warts other than anogenital warts

New Zealand does not schedule these according to indications. A change would be required to the labelling requirements for OTC nasal corticosteroids in the New Zealand Regulatory Guidelines.

The NDPSC has also requested a company submission in support for a similar change for budesonide. New Zealand also markets OTC mometasone and triamcinalone with the same indications for OTC sale as beclomethasone, budesonide and fluticasone.