1

Welcome

2

Apologies

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Confirmation of the Minutes of the 41^ST Meeting Held on Thursday 14^th May 2009

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Declaration of Conflicts of Interest

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Matters Arising

5.1

Amyl Nitrite

Amyl nitrite is currently classified as a prescription medicine, except when sold from outlets licensed to sell cyanide paste for the purpose of vertebrate pest control.

It has been brought to Medsafe's attention that the wording of the exception needs updating to more clearly reflect the requirements of the Agricultural Compounds and Veterinary Medicines Act 1997. Following external advice, Medsafe proposes that the amyl nitrite schedule entry be amended to prescription medicine, except when sold in circumstances complying with any regulations or conditions imposed under the Agricultural Compounds and Veterinary Medicines Act 1997 in respect of the sale of cyanide paste.

The revised wording does not alter the level of access currently allowed for amyl nitrite.

5.2

Codeine

Codeine is currently classified as prescription medicine when in combination products containing more than 15 mg of codeine per dose unit. Otherwise, codeine in combination products is pharmacy-only.

As indicated at the 41^st meeting, the Committee will consider suitable codeine cut-off points and pack sizes for over-the-counter (OTC) sale. The proposal is to reclassify codeine in combination products to either a restricted medicine or a pharmacy-only medicine when:

• Each dose unit contains not more than 15 mg of codeine base.
• The maximum daily dose is limited to 100 mg of codeine base.
• The pack size is not more than 5 days' supply.

5.3

Famciclovir 500 mg tablet
(Famvir, Novartis New Zealand Ltd)

At the 41^st meeting the Committee considered a submission for the reclassification of famciclovir 500 mg tablets from prescription medicine to restricted medicine when sold in packs of three tablets for the treatment of recurrent Herpes labialis (cold sores). The Committee recommended that there should be no change to the current prescription medicine classification.

The reclassification will be reconsidered if the sponsor company provides additional information in support of the classification change.

5.4

Heparin

At the 40^th meeting blood and blood products had been recommended for reclassification as general sales medicines. An unintended consequence of this had recently been identified; some products containing blood clotting factors also contained small amounts of heparin as an excipient. Heparin remains classified as a prescription medicine, thereby preventing these products from being reclassified to general sale as had been the intention.

Medsafe proposes that the Committee discuss exempting heparin from classification as a prescription medicine to general sale medicine when present as an excipient.

5.5

Lansoprazole 15 mg capsule
(Solox, Douglas Pharmaceuticals Ltd)

At the 40^th meeting the Committee recommended that there should be no change to the current classification of lansoprazole 15 mg capsules as prescription medicine. The submission will be reconsidered now that the sponsor company has provided additional information in support of the classification change from prescription medicine to restricted medicine.

5.6

PDE-5 Inhibitors

At the 41^st meeting the Committee agreed, in principle, with a proposal to classify phosphodiesterase type 5 (PDE-5) inhibitors as prescription medicines. However, the Committee requested that Medsafe identify appropriate wording for the Schedule entry to ensure that caffeine and other substances with very weak, clinically insignificant activity at the PDE-5 receptor are not inadvertently covered.

The Committee will consider the following wording proposed by Medsafe; PDE-5 inhibitors should be classified as prescription medicines except:

• when specified elsewhere in the Schedule, or
• when present as an unmodified, naturally occurring substance.

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Submissions for reclassification

6.1

Omeprazole 20 mg tablet
(Losec MUPS tablets, Bayer New Zealand Ltd)

This is a company submission (Adobe PDF document 192 KB) for the reclassification of omeprazole 20 mg tablets from prescription medicine to restricted medicine for the short term relief of reflux-like symptoms.

6.2

Fexofenadine hydrochloride 60 mg capsule, 120 mg film coated tablet and 60 mg film coated tablet
(Telfast, Sanofi-Aventis Australia Pty Ltd)

This is a company submission (Adobe PDF document 178 KB) for the reclassification of fexofenadine hydrochloride 60 mg capsules, 120 mg film coated tablets and 60 mg film coated tablets from pharmacy-only medicine to general sales medicine for the treatment of Seasonal Allergic Rhinitis (SAR).

6.3

Diclofenac 12.5 mg film coated tablet
(Voltaren Rapid, Novartis Consumer Health Australasia Pty Ltd)

This is a company submission (Adobe PDF document 167 KB) to increase the maximum pack size for pharmacy-only sale of diclofenac 12.5 mg film coated tablets from 20 to 40 dosage units. The indications are for the temporary relief of painful conditions, the temporary relief of symptoms of cold and flu, and the reduction of fever.

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New Medicines for Classification

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Harmonisation of New Zealand and Australian schedules

8.1

New chemical entities which are not yet classified in New Zealand

8.2

Recommendations made by the National Drugs and Poisons Schedule Committee (NDPSC) to the MCC

8.2.1

55^th Meeting on 17-18 February 2009

No unresolved recommendations.

8.2.2

56^th Meeting on 16-17 June 2009

1. HMG-CoA Reductase Inhibitors (Statins)
   The NDPSC considered scheduling HMG-CoA reductase inhibitors ('statins') as a class entry. They agreed to include an entry for all HMG-CoA reductase inhibitors in Schedule 4 (prescription medicine) of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP).
   The Committee will consider harmonising with the above classification.
2. Loperamide
   The NDPSC decided to amend the entry for loperamide in the SUSDP to clarify that liquid preparations of loperamide are classified as prescription medicines.
   Medsafe proposes to clarify the classification status of loperamide liquid preparations in New Zealand by amending the wording for the prescription medicine Schedule entry to read "except when specified elsewhere in this Schedule".
   Loperamide will remain pharmacy-only when in packs containing not more than 20 tablets or capsules.

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For the Next Meeting

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General Business

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Date of Next Meeting