1

Welcome

2

Apologies

3

Confirmation of the Minutes of the 45th Meeting Held on Tuesday 12 April 2011

4

Declaration of Conflicts of Interest

5

Matters Arising

5.1

Objections to recommendations made at the 45th meeting

No objections have been received.

5.2

Amorolfine

At the 45th meeting the Committee considered harmonising with the Australian classification of amorolfine. The National Drugs and Poisons Schedule Committee had agreed to reschedule amorolfine topical preparations from restricted medicine to pharmacy-only medicine, and preparations containing amorolfine for the treatment of tinea pedis remain as general sale medicines.

At the 45th meeting the Committee noted that the general sale entry for amorolfine, for the treatment of tinea pedis, was already harmonised. However the Committee requested further information on the impact of the harmonisation proposal, i.e. to reschedule amorolfine topical preparations from restricted medicine to pharmacy-only medicine.

This harmonisation will be reconsidered now that Medsafe has provided a report (Adobe PDF document 132KB) on the safety of amorolfine.

5.3

Clobetasone

At the 45th meeting it was brought to the Committee's attention that the discontinuation of Becoderm-C has left consumers without an over-the-counter clobetasone butyrate 0.05% topical preparation option.

The Committee will discuss removing the wording, 'which have received the consent of the Minister or Director-General to their distribution as restricted medicines and are sold in the manufacturer's original pack', from the restricted medicine classification statement of clobetasone.

5.4

Fingolimod 0.5 mg immediate release capsule
(Gilenya, Novartis New Zealand Limited)

An out-of-session consultation took place in May 2011 regarding the classification of fingolimod.

The Committee recommended that fingolimod should be classified as a prescription medicine. This classification was gazetted alongside the recommendations from the 45th meeting.

5.5

Methenamine hippurate

Methenamine hippurate is currently classified as a general sale medicine. The Committee will discuss whether this is an appropriate classification or whether pharmacy-only would be more appropriate given its indication, for the relief of urinary tract infections, and increased marketing.

5.6

Oseltamivir

Oseltamivir is currently classified as prescription; except when sold in a pharmacy between the months of April to November inclusive by a registered pharmacist who is satisfied that the medicine is for the treatment of a consumer who is resident in New Zealand, is 12 years of age or more, and currently has the symptoms of influenza. This classification is kept up to date by publishing a Gazette notice every six months, rather than adding it permanently to the Schedule.

The Committee will consider adding this classification permanently to the Schedule.

5.7

PDE-5 inhibitors

At the 45th meeting the Committee recommended that Medsafe reconsider the wording of PDE-5 inhibitors alongside the wording of lovastatin, as a prescription medicine, so that any foodstuffs would not be inadvertently captured.

Medsafe recommends that PDE-5 inhibitors should be classified as prescription medicines, 'except when present as an unmodified, naturally occurring substance in a food that has not been subject to a manufacturing process other than heating, freezing, drying, preserving, bottling, canning, or packaging in retort pouches; except when specified elsewhere in this Schedule'.

The Committee will consider this wording alongside any submissions regarding the potential impact this classification would have on the market.

5.8

Tuberculin

At the 45th meeting the Committee considered harmonising with the Australian classification of tuberculin. In December 2010 the Delegate decided to list tuberculin in Schedule 4 (prescription medicine) in the Standard for the Uniform Scheduling of Medicines and Poisons.

This harmonisation will be reconsidered now that Medsafe has provided data (Adobe PDF document 7KB) on the potential health impact of adding tuberculin to the New Zealand Schedule as a prescription medicine.

6

Submissions for Reclassification

6.1

Cetirizine hydrochloride 10 mg tablet
(Histaclear, AFT Pharmaceuticals Limited)

This is a company submission (Adobe PDF document 389KB) requesting the reclassification of cetirizine hydrochloride 10 mg tablets from pharmacy-only medicine to general sale medicine when in packs containing sufficient tablets for only five days' supply and when used for Seasonal Allergic Rhinitis.

6.2

Loratadine 10 mg tablet
(Loraclear Hayfever Relief, AFT Pharmaceuticals Limited)

This is a company submission (Adobe PDF document 474KB) requesting the reclassification of loratadine 10 mg tablets from pharmacy-only medicine to general sale medicine when in packs containing sufficient tablets for only five days' supply and when used for Seasonal Allergic Rhinitis.

6.3

Omeprazole 10 mg and 20 mg enteric coated tablets
(Losec, Bayer New Zealand Limited)

This is a company submission (Adobe PDF document 419KB) requesting that the current pharmacy-only classification of omeprazole (in divided solid dosage forms for oral use containing 20 milligrams or less, with a maximum daily dose of 20 milligrams in a pack size of up to 14 dosage units, for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over, when sold in a pack approved by the Minister or the Director-General for distribution as a pharmacy-only medicine) be amended to increase the maximum allowed pack size from 14 to 28 dosage units.

6.4

Pantoprazole 20 mg enteric coated tablet
(SOMAC Heartburn Relief, Nycomed Pty Limited)

This is a company submission (Adobe PDF document 678KB) requesting the reclassification of pantoprazole, in tablets containing 20 mg or less of pantoprazole, from restricted medicine to pharmacy-only medicine for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over.

6.5

Vibrio cholera and enterotoxigenic Escherichia coli vaccine
(Dukoral, Pharmacybrands Limited)

This is a submission (Adobe PDF document 429KB) from Pharmacybrands Limited (the parent company for Life, Unichem, Amcal and Care Pharmacies in New Zealand) for the reclassification of Vibrio cholera and enterotoxigenic Escherichia coli vaccine from prescription medicine to restricted medicine. The reclassification is sought for the 3 mL oral liquid vaccine.

7

New Medicines for Classification

8

Harmonisation of New Zealand and Australian Schedules

8.1

New chemical entities which are not yet classified in New Zealand

8.2

Decisions by the Secretary to the Department of Health and Aging in Australia, or the Secretary's Delegate

The Committee will consider harmonising with the following decisions.

8.2.1

Decisions by the Delegate - March 2011

1. Diclofenac
   Dermal preparations containing more than 1% of diclofenac or preparations for the treatment of solar keratosis should be included in Schedule 4 (prescription medicine).
2. Mercury / mercurochrome
   A Schedule 2 (pharmacy-only medicine) entry should be created for mercurochrome preparations containing 2% or less of mercurochrome for external use. A new Schedule 4 (prescription medicine) mercurochrome entry should be created for all other preparations of mercurochrome, excluding those listed in Schedules 2 (pharmacy-only medicine) and 6 (poison).

8.2.2

Decisions by the Delegate - June 2011

1. Ibuprofen
   The maximum allowable amount of ibuprofen in liquid preparations in Schedule 2 (pharmacy-only medicine) should be increased from 4g to 8g.
2. Ibuprofen combined with paracetamol
   Combination ibuprofen and paracetamol preparations currently captured by Schedule 2 (pharmacy-only medicine) (up to 200 mg ibuprofen and 500 mg paracetamol) should be rescheduled to Schedule 3 (restricted medicine) when in packs of 30 dosage units or less. Combination ibuprofen and paracetamol preparations in packs of more than 30 dosage units should be captured by Schedule 4 (prescription medicine).
3. Dimethyl sulfoxide
   Dimethyl sulfoxide's Schedule 4 (prescription medicine) entry should be amended to specifically exclude dimethyl sulfone. There should also be a cross reference from methylsulfonylmethane to dimethyl sulfone.

9

For the Next Meeting

10

General Business

10.1

Non-Prescription Medicines and Australian Community Pharmacy Interventions:  Rates and Clinical Significance (Williams et al)

A research paper from the International Journal of Pharmacy Practice (April 2011) will be presented to the Committee for information.

10.2

Australia New Zealand Therapeutic Products Agency (ANZTPA)

A summary of the announcement on 20 June 2011, that the Australian and New Zealand Governments have agreed to proceed with a joint scheme for regulation of therapeutic products, will be provided.

11

Date of Next Meeting