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Welcome

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Apologies

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CONFIRMATION OF THE MINUTES OF THE 43RD mEETING HELD ON tuesday 13 april 2010

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Declaration of conflicts of interest

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matters arising

5.1

Objections to recommendations made at the 43rd meeting

5.1.1

Ipecacuanha
(Cough and Cold medicines, Medsafe)

Weleda (New Zealand) Limited have proposed an amendment be made to the Committee's recommendation that ipecacuanha should be reclassified from general sale medicine to pharmacy-only medicine for the treatment of the symptoms of cough and cold in children aged 6-12 years. The amendment proposed is that a dosage limit should be included in the reclassification so products with an alkaloid content of less than 40 mcg per dose are excluded and remain general sale medicines.

The reason for the proposal is that there are no known safety issues with ipecacuanha at this level.

5.2

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

At the 43rd meeting the Committee considered a submission 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.

The submission will be reconsidered if the company provides data confirming that consumers can clearly differentiate and understand the differences between Strepfen, and cough and cold un-medicated preparations such as Strepsils.

5.3

Ginkgo biloba

Ginkgo biloba was presented to the Committee at the 42nd 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 so that the Committee could consider data relating to the classification.

The classification of ginkgo biloba will be considered now that additional data on the safety and toxicity of the product has been supplied by Medsafe.

5.4

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

At the 43rd meeting the Committee considered a submission for the reclassification of minoxidil 5% solution from pharmacy-only medicine to general sale medicine for the treatment of androgenetic alopecia (common baldness) in healthy men and women.

The submission will be reconsidered if the company provides improved labelling appropriate for general sale.

5.5

Sedating antihistamines

It has been brought to Medsafe's attention that potential confusion could arise between the pharmacy-only classification statement for sedating antihistamines and the recent requirement for labels in oral cough and cold medicines to include a contraindication for use in children under six years of age.

The sedating antihistamines affected are brompheniramine, chlorpheniramine, dexchlorpheniramine, diphenhydramine, doxylamine, pheniramine, promethazine, trimeprazine and triprolidine.

Sedating antihistamines are currently classified as pharmacy-only medicines 'for oral use in medicines for adults and children over two years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose of a day/night pack containing <sedating antihistamine substance> or when at least one of the other therapeutically active ingredients is a sympathomimetic decongestant'.

The Committee will consider whether the following actions together could resolve the issue:

• remove the words 'for adults and children over two years of age' from the pharmacy-only classification statement
• add to the New Zealand Regulatory Guidelines for Medicines the requirement for the statement 'must not be used in children under six years of age' to be added to the label when the sedating antihistamine is used for the treatment of the symptoms of cough and cold.

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Submissions for reclassification

6.1

Aspirin
(Pharmacybrands Limited)

This is a submission (Adobe pdf document 340kb) from Pharmacybrands Limited (the parent company for Life, Unichem, Amcal and Care Pharmacies in New Zealand) for the reclassification of aspirin, in solid dose preparations containing 150 mg or less of aspirin, from general sale medicine to pharmacy-only medicine for the inhibition of blood clotting and to reduce the risk of heart attack and stroke.

6.2

Guaiphenesin 600 mg and 1200 mg modified release tablets
(Mucinex, Reckitt Benckiser (New Zealand) Limited)

This is a company submission (Microsoft Word document 90kb) requesting an additional classification of guaiphenesin, in modified release tablets containing 600 mg or 1200 mg of guaiphenesin (Mucinex) in packs containing more than five but not more than 10 days supply, as a pharmacy-only medicine for use as an expectorant which thins and loosens mucus (phlegm) to help relieve chest congestion.

The submission also proposes that the:

• restricted medicine classification statement should be amended to 'for oral use in modified release form with a maximum recommended daily dose of not more than 2.4 g sold in a pack containing more than 10 days supply but not more than 30 days supply approved by the Minister or the Director-General for distribution as a restricted medicine'
• labelled warning statement to seek medical advice if symptoms persist should be amended from 'after three days' to 'after five days'
• labelled warning regarding a potential risk of developing kidney stones at high doses should be removed.

6.3

Nicotine 1 mg and 15 mg volatile liquid and 1 mg spray
(Nicorette Inhaler and Nicorette QuickMist Mouth Spray, Johnson and Johnson (New Zealand) Limited)

This is a company submission (Adobe pdf document 80kb) requesting the general sale classification of nicotine be amended from 'for transdermal use in chewing gum, lozenges or sublingual tablets' to 'for preparations for oromucosal or transdermal absorption'.

This amendment would result in the Nicorette Inhaler (containing 10 mg and 15 mg of nicotine) to be reclassified from pharmacy-only medicine to general sale medicine, and the Nicorette QuickMist Mouth Spray (containing 1 mg of nicotine) to be classified as a general sale medicine.

6.4

Omeprazole 10 mg tablet
(Losec, Bayer New Zealand Limited)

This is a company submission (Microsoft Word document 263kb) requesting the reclassification of omeprazole, in tablets containing 10 mg or less of omeprazole, 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

Salicylic acid 40%
(The Podiatrists' Board)

This is a submission (Microsoft Word document 40kb) requesting the reclassification of salicylic acid, in packs of medicated plasters or pads containing salicylic acid 40% w/w, from pharmacy-only medicine to restricted medicine for the removal of hard corns.

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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

57th Meeting on 20-21 October 2009

The Committee will consider whether magnesium sulfate, in divided oral preparations except when containing 1.5 g or less of magnesium sulfate per recommended daily dose, should be added to the New Zealand Schedule as a restricted medicine. Any responses received from the dietary supplement sector will be included in the Committee's deliberations.

The classification of red yeast rice, which contains 10 mg/kg or more of lovastatin (monacolin K), as a prescription medicine will be considered now that the natural healthcare products sector has been given the opportunity to submit information on the effect of the proposal on products containing red yeast rice.

8.2.2

58th Meeting on 16-17 February 2010

Flurbiprofen products currently available in Australia include lozenges for the treatment of sore throats (Schedule 2 / pharmacy-only medicines) and eye drops for the treatment of intraoperative miosis (Schedule 4 / prescription medicines). The NDPSC considered an application that requested an exemption from scheduling when for topical oral use.

The NDPSC decided:

• that divided preparations for topical oral use containing 10 mg or less per dosage unit remained appropriately scheduled in Schedule 2 (pharmacy-only medicine)
• to broaden the Schedule 2 (pharmacy-only) flurbiprofen entry to include undivided preparations containing 0.25% or less or 10 mg or less per dose of flurbiprofen.

The Committee will consider this harmonisation alongside agenda item 5.2.

The first-line pharmacological intervention for nicotine dependence from cigarette smoking is nicotine replacement therapy for reducing the cravings associated with smoking cessation - available as chewing gum, transdermal patches, inhalers, nasal sprays, sublingual tablets, and lozenges.

The NDPSC decided to amend the scheduling of nicotine to exempt oromucosal spray use, as an aid in withdrawal from tobacco smoking, from scheduling.

The Committee will consider this harmonisation alongside agenda item 6.3.

The NDPSC decided to extend their current exemption for certain paracetamol plus phenylephrine combination products to also include combinations containing guaiphenesin. In summary, in Australia, paracetamol is exempt from scheduling under the following conditions:

• in individually wrapped powders or sachets of granules each containing 1000 mg or less of paracetamol as the only therapeutically active constituent (other than phenylephrine and / or guaiphenesin or when combined with effervescent agents) when enclosed in a pack that contains not more than 12 such powders or sachets
• in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent (other than phenylephrine and / or guaiphenesin or when combined with effervescent agents) when packed in a blister or strip packaging or in a container with a child resistant case and when in a pack containing not more than 25 tablets or capsules.

There are also labelling requirements attached to these conditions.

New Zealand already allows for combinations of paracetamol as general sale medicines with other active ingredients classified as general sale. As paracetamol has a higher maximum pack size cut off for general sale medicines in Australia, this could result in differences in a product's classification between the two countries.

The Committee will consider harmonising with Australia on the maximum pack size for paracetamol as a general sale medicine (which would also have the effect of increasing the maximum pack size for any general sales paracetamol combination product) or continue to require smaller pack sizes of paracetamol as general sale in New Zealand.

8.3

Other harmonisation issues

8.3.1

Benzocaine

In Australia, benzocaine is classified as a:

• Prescription medicine, except:

1. when listed in Schedule 2 (pharmacy-only medicine)
2. in dermal preparations containing 2% or less of total anaesthetic substances, or
3. in lozenges containing 30 mg or less of total anaesthetic substances per dosage unit.

• Pharmacy-only medicine in preparations for topical use other than eye drops:

1. containing 10% or less of total anaesthetic substances, except in dermal preparations containing 2% or less of total local anaesthetic substances, or
2. in divided preparations containing 200 mg or less of total local anaesthetic substances per dose unit, except in lozenges containing 30 mg or less of local anaesthetic substances per dosage unit.

The Committee will consider harmonising with the classification of benzocaine now that further information has been provided confirming that there are approved products in Australia using benzocaine as an appetite control.

8.3.2

Paracetamol

At the 26th meeting the Committee recommended that:

• New Zealand should increase the maximum pack size for sale of paracetamol as a general sale medicine from 10g to 12.5g in order to harmonise with the less restrictive Australian classification
• the increase should take place only after the MCC had approved revised labelling requirements which were acceptable to both New Zealand and Australia
• labels should include a warning with specific reference to liver failure
• Medsafe should persevere with its intention to encourage grocery organisations to consider developing codes for the sale of medicines such as aspirin and paracetamol.

It had been brought to Medsafe's attention that these recommendations had not been progressed because the joint agency between New Zealand and Australia had not been established. The Committee will reconsider the maximum pack size for paracetamol as a general sale medicine.

The Committee will consider this harmonisation alongside agenda item 8.2.2c.

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For the next meeting

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General business

10.1

Scheduling of medicines in Australia

From 1 July 2010, the National Drugs and Poisons Schedule Committee has been replaced by the Secretary of the Department of Health and Ageing, or her delegate, as the decision maker for the scheduling of medicines and chemicals in Australia. Two new expert advisory committees, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling, have been established to provide advice and to make recommendations to the Secretary (or her delegate) on medicines and chemicals scheduling decisions.

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DATE OF NEXT MEETING