1

Welcome

2

Apologies

3

Confirmation of the Minutes of the 42nd Meeting Held on Tuesday 3 November 2009

4

Declaration of Conflicts of Iinterest

5

Matters Arising

5.1

Diclofenac
(Voltaren Rapid, Novartis Consumer Health Australasia Pty Ltd)

At the 42^nd meeting the Committee considered a submission to increase the maximum pack size for pharmacy-only sale of diclofenac in solid oral dosage forms, containing 12.5 mg or less per dose, from 20 to 40 dosage units. The submission will be reconsidered now that the sponsor company has provided additional data to increase the maximum pack size to from 20 to 30 dosage units.

5.2

Ginkgo biloba

Ginkgo biloba was presented to the Committee at the 42^nd meeting for information only. Medsafe had received a New Medicine Application for a medicine containing an extract from Ginkgo biloba. The Committee recommended that the classification of ginkgo biloba be deferred until the next meeting so that the Committee can consider the data relating to the classification.

The classification will be considered if Medsafe supplies the Committee with further information on the safety and toxicity of the product.

5.3

Vaccines

Vaccines are currently classified as prescription medicines.

It has been brought to Medsafe's attention that the classification of vaccines needs to include the following conditions:

• except oral vaccines
• except when specified elsewhere in this Schedule.

There are currently 19 specific vaccines listed in the Schedule. Eighteen of these are classified as prescription medicines. However, pneumococcal vaccine is classified as a restricted medicine; in oral vaccines for the prophylaxis of bacterial complication of colds.

6

Submissions for Reclassification

6.1

Calcipotriol cream, ointment and scalp application
(Pharmacybrands Ltd)

This is a submission (Adobe pdf document 324kb) document from Pharmacybrands Ltd, the parent company for Life, Unichem, Amcal and Care Pharmacies in New Zealand. The reclassification change for calcipotriol cream, ointment and scalp application, from prescription medicine to restricted medicine, is sought only for the smaller pack sizes (30 g pack sizes from cream and ointment, and 30 mL for scalp application) for the topical treatment of psoriasis vulgaris including plaque psoriasis in adults previously diagnosed by a doctor.

6.2

Dextromethorphan, guaiphenesin, ipecacuanha and phenylephrine
(Cough and Cold medicines, Medsafe)

This is a Medsafe submission (Adobe pdf document 399kb) for the reclassification of dextromethorphan, guaiphenesin, ipecacuanha and phenylephrine when sold as general sale medicines to either restricted or pharmacy-only medicines for the treatment of the symptoms of cough and cold.

6.3

Flurbiprofen 8.75 mg lozenges
(Strepfen, Reckitt Benckiser (New Zealand) Ltd)

This is a company submission (Adobe pdf document 229kb) for the reclassification of flurbiprofen 8.75 mg lozenges from pharmacy-only medicine to general sale medicine for the relief of pain, swelling and inflammation associated with severe sore throats.

6.4

Loperamide 2 mg caplets and capsules
(Imodium, Johnson & Johnson Pacific)

This is a company submission (Adobe pdf document 230kb) for the reclassification of loperamide 2 mg caplets or capsules, when sold in packs containing not more than eight or less, from pharmacy-only medicine to general sale medicine for the symptomatic treatment of acute non specific diarrhoea.

6.5

Minoxidil 5% solution
(Regaine for men, Johnson & Johnson Pacific)

This is a company submission (Adobe pdf document 896kb)for the reclassification of minoxidil 5% solution from pharmacy-only medicine to general sale medicine for the treatment of androgenetic alopecia in healthy men and women.

6.6

Rizatriptan 5 mg wafers
(Maxalt, Merck Sharp & Dohme (New Zealand) Limited)

This is a company submission (Adobe pdf document 1600kb) for the reclassification of rizatriptan 5 mg wafers from prescription medicine to restricted medicine for the acute treatment of migraine with or without aura.

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

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

8.2.1

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 reduce cholesterol by stimulating an increase in low-density-lipoprotein-receptors (LDL) on hepatocyte membranes, thereby increasing the clearance of LDL from the circulation. The NDPSC 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 considered harmonising with the above classification at the 42^nd meeting and agreed to delay making a recommendation until further information on the indications and side effect profile of red yeast rice extract, which contains lovastatin, and a literature review of lovastatin, can be considered.
   The harmonisation will be considered now that the further information has been provided.
2. Succimer
   The NDPSC considered the scheduling of succimer. It is used in the treatment of lead poisoning as it forms water-soluble chelates with heavy metals. Succimer has also been used to treat arsenic and mercury poisoning. The NDPSC decided to include an entry for succimer 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.

8.2.2

57^th Meeting on 20-21 October 2009

The NDPSC considered the scheduling of the following substances in the SUSDP.

1. Magnesium sulfate
   Magnesium sulfate is available as Epsom salts in the heptahydrate complex. In April 2008, the Adverse Drug Reactions Advisory Committee (ADRAC) in Australia concluded that there was considerable risk to consumers from a 950 mg dried magnesium sulfate preparation, indicated for the relief of occasional constipation. The NDPSC decided to include an entry for magnesium sulfate, for human therapeutic use in divided oral preparations except when containing 1.5 g or less of magnesium sulfate per recommended daily dose, in Schedule 3 (restricted medicine).
2. Nabiximols
   Cannabidiol is a cannabinoid found in Cannabis sativa. Cannabidiol was reputed to have analgesic, anticonvulsant, muscle relaxant, anxiolytic, neuroprotective, anti-oxidant and anti-psychotic activity. Nabiximols are a specific extract of Cannabis sativa. The NDPSC decided to create a new entry for nabiximols, including a list of cannabinoids present, in the form of a buccal spray for human therapeutic use, in Schedule 8 (controlled drug).
3. Nebivolol
   Nebivolol is a long-acting cardioselective beta-blocker. The NDPSC decided to include nebivolol in Schedule 4 (prescription medicine).
4. Red yeast rice
   Red yeast rice is a reddish purple fermented rice. When produced using certain strains of Monascus purpureus it contains quantities of pharmacologically active substances, including monacolins, which can inhibit HMG-CoA reductase, especially lovastatin. Due to this activity some red yeast rice preparations have been sold in other countries as a dietary supplement for controlling cholesterol. Red yeast rice would be captured by the class entry for HMG-CoA reductase inhibitors (see agenda item 8.2.1a). The NDPSC decided to create a new entry for red yeast rice, for human therapeutic use, in Schedule 4 (prescription medicine).
5. Ustekinumab
   Ustekinumab is a human monoclonal antibody directed against the p40 protein subunit which forms part of the structure of both interleukin-12 (IL-12) and interleukin-23 (IL-23). It acts by inhibiting the binding of these two cytokines to cell surface receptors. IL-12 and IL-23 were thought to have a crucial role in the pathogenesis of psoriasis, the most common adult immune skin disease. The NDPSC decided to include ustekinumab in Schedule 4 (prescription medicine).
6. Vaccinia virus vaccine
   The vaccinia virus is the live virus used in the smallpox vaccine. It is a pox-type virus related to smallpox and when given to humans as a vaccine it helps the body to develop immunity to smallpox. The NDPSC decided to include vaccinia virus vaccine in Schedule 4 (prescription medicine).

The Committee will consider harmonising with the above classifications.

9

For the Next Meeting

10

General Business

11

Date of Next Meeting