1

Welcome

2

Apologies

3

Confirmation of the minutes of the 54th meeting held on Tuesday 24 November 2015

4

Declaration of conflicts of interest

5

Matters arising

5.1

Objections to recommendations made at the 54th meeting

The deadline for intentions to object to a recommendation made at the 54^th meeting, together with a statement of the grounds on which the objection will be made, was 9 February 2016. The Committee will consider any objections raised.

5.1.1

Oral contraceptives – objection to the proposed reclassification from prescription medicine to restricted medicine (Royal New Zealand College of General Practitioners)

A valid objection (PDF 482 KB, 4 pages) was received regarding the Committee's recommendation of reclassifying selected oral contraceptives (desogestrel, ethinylestradiol, norethisterone and levonorgestrel) from prescription medicine to restricted medicine, when sold in the manufacturer's original pack containing not more than six months' supply by a registered pharmacist who has successfully completed a training programme, when indicated for oral contraception in women who have previously been prescribed an oral contraceptive within the last 3 years from the date of an original medical practitioner's prescription.

The objection was upheld on the grounds of the process the Committee undertook to make their recommendation on Green Cross Healthcare Ltd's alternative proposal (PDF 222 KB, 3 pages) for selected oral contraceptives (desogestrel, ethinylestradiol, norethisterone and levonorgestrel).

5.2

Matters arising for information

5.2.1

Updating the guidance document titled 'How to change the legal classification of a medicine in New Zealand' to include the publication of additional information submitted in objections

The 'How to change a legal classification of a medicine in New Zealand' document (PDF 426 KB, 13 pages), provides guidance on the medicine classification process for the Committee members and members of the public.

A recent objection to a recommendation made by the Committee has identified an area of the process that could be more transparent. Objections are not published on the Medsafe website and therefore there is no opportunity for stakeholders to comment on the grounds for an objection. It has been noted that objections lodged by submitters may include a modification of the original submission and there is no opportunity for stakeholders to comment on any revisions prior to the meeting.

It is proposed to update the guidance document titled 'How to change the legal classification of a medicine in New Zealand' to include the process of publication of additional information submitted in objections.

5.2.2

Updating the Medicines Classification Committee Handbook to include a Deputy Chair

The Medicines Classification Committee Handbook is a document for members to refer to regarding their responsibilities and meeting protocol.

It is proposed to update the Medicines Classification Committee Handbook to include a Deputy Chair (the second officer of the Ministry of Health) for times when the Chair is unavailable.

5.2.3

Review of tramadol and codeine reclassification

The Committee will review the outcomes of the Australian Advisory Committee on Medicines Scheduling meeting to take place 15-17 March 2016.

5.2.4

Change in classification wording of benzydamine – change in classification wording of benzydamine from general sales medicine for topical and external use to general sales medicine for oral mucosal and topical use.

Medsafe received an enquiry from an Australian company on the Committee’s recommendation at the 54^th meeting on benzydamine and the impact the recommendation had on harmonisation between Australia and New Zealand.

At the 54^th meeting, the Committee made the recommendation that the classification of benzydamine change from:

1. General sale; for dermal use.
2. Pharmacy-only; for external use except for dermal use.
3. Prescription; for internal use

to

1. General sale; for topical or external use.
2. Prescription; for internal use except for topical or external use.

The definition of external use of medicines in the Medicines Regulations 1984 is:

in relation to any medicine or related product, means for application to the anal canal, ear, eye, mucosa of the mouth, nose, skin, teeth, throat, or vagina, where local action only is required and where extensive systemic absorption will not occur; but nothing in these regulations relating to medicines or related products intended for external use shall apply to nasal drops, nasal inhalations, nasal sprays, teething applications, throat lozenges, throat pastilles, throat sprays, or throat tablets.

Medsafe has amended the wording of the classification of benzydamine to incorporate what it believes the MCC was trying to capture in its recommendation.

The classification of benzydamine has been changed to:

1. Prescription medicine; for internal use except for oral mucosal or topical use.
2. General sales medicine; for oral mucosal or topical use.

5.2.5

Classification wording of lignocaine – proposed amendment to classification wording

Medsafe has noted that the use of the term 'external use' in the general sale classification of lignocaine is unintentionally excluding lignocaine throat sprays.

Medsafe proposes amending the classification from:

1. General sales; for external use in medicines containing 2% or less; in throat lozenges containing 30 milligrams or less per dose form

to

1. General sales; for external use and in throat sprays in medicines containing 2% or less; in throat lozenges in medicines containing 30 milligrams or less per dose form

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Submissions for reclassification

6.1

Alcohol >20% – proposed extension of the general sales medicine classification of alcohol >20% to have the additional requirement of the product being wall mounted (Te Arai BioFarma Ltd)

This is a submission (PDF 149 KB, 5 pages) that proposes the extension of the general sales medicine classification of >20% alcohol in hand sanitisers to include the additional requirement of the product being in a wall mounted dispenser for the prevention of the spread of microbes.

6.2

Adapalene – proposed reclassification from prescription medicine to prescription medicine except in medicines containing not more than 1 mg/g and when supplied in a pack of not more than 30 g by a pharmacist (Green Cross Healthcare Ltd and Natalie Gauld Ltd)

This is a submission (PDF 2.54 MB, 20 pages) to reclassify adapalene from prescription medicine to prescription medicine except in medicines containing not more than 1 mg/g and when supplied in a pack of not more than 30 g by a pharmacist for the topical treatment of comedo, papular and pustular acne (acne vulgaris) of the face, chest or back.

6.3

Albendazole – proposed reclassification from prescription to pharmacy-only medicine (Te Arai BioFarma Ltd)

This is a company submission (PDF 2.39 MB, 75 pages) to reclassify albendazole from prescription medicine to pharmacy-only medicine in total doses not exceeding 400 mg for the treatment of a variety of parasitic worms.

6.4

Loratadine – proposed extension of the current general sales classification to include an increased pack size (Claratyne 10 mg tablets, Bayer Healthcare Ltd)

This is a company submission (PDF 550 KB, 38 pages) to increase the general sales medicine pack size of loratadine from five days' supply to 10 days' supply for the treatment of allergic rhinitis.

6.5

Change in classification wording of lansoprazole, promethazine, sumatriptan, ibuprofen, omeprazole, pantoprazole, opium, pholcodine and ranitidine – proposed change in classification wording (Pharmaceutical Society of New Zealand)

This is a submission (PDF 246 KB, 9 pages) that proposes a change in classification wording of lansoprazole, promethazine, sumatriptan, ibuprofen, omeprazole, pantoprazole, opium, pholcodine and ranitidine to remove the reference that only approved or manufacturer's original packs may be supplied as Section 23 of the Medicines Regulations 1984 provides exemption to certain labelling requirements.

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New medicines for classification

7.1

New chemical entities that are not yet classified in New Zealand

8

Harmonisation of the 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)

8.2.1

Decisions by the Delegate – November 2015

Decisions also included under agenda item 8.1.

a) Esomeprazole

A new pharmacy-only medicine (Schedule 2) entry should be created for esomeprazole in oral preparations containing 20 mg or less of esomeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days' supply.

The restricted medicine (Schedule 3) entry of esomeprazole, oral preparations containing 20 mg or less of esomeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply, should be down-scheduled to pharmacy-only medicine (Schedule 2).

The prescription medicine (Schedule 4) entry should be amended to except when a pharmacy-only medicine (Schedule 2) or a prescription medicine (Schedule 3).

Esomeprazole is classified as a prescription medicine in New Zealand.

b) Hydrocortisone

The pharmacy-only medicine (Schedule 2) entry for hydrocortisone and hydrocortisone acetate but excluding other salts and derivatives, in preparations for human therapeutic use should be amended to:

1. for dermal use in preparations containing 0.5 percent or less of hydrocortisone, in packs containing 30 g or less of such preparations, containing no other therapeutically active constituent other than an antifungal substance; or
2. for dermal use in preparations containing 1 percent or less of hydrocortisone, in packs containing 15 g or less of such preparations, containing an antifungal substance and no other therapeutically active constituent:
   1. for the treatment of tinea (tinea pedis, tinea cruris, tinea corporis) and other fungal skin infections; and
   2. not labelled for the treatment of children under 12 years of age; or
3. for rectal use in preparations containing 0.5 percent or less of hydrocortisone, when combined with a local anaesthetic substance but no other therapeutically active constituent except unscheduled astringents:
   1. in undivided preparations in packs of 35 g or less; or
   2. in packs containing 12 or less suppositories.

In New Zealand, hydrocortisone and hydrocortisone acetate but no other esters of hydrocortisone is classified as:

1. Restricted medicine, for dermal use in medicines containing 1% or less but more than 0.5% by weight of hydrocortisone base with no other active ingredient except an antifungal and in a quantity of 30 grams or less or 30 millilitres or less per container; in rectal medicines containing 1% or less but more than 0.5% by weight of hydrocortisone base and in combination with a local anaesthetic and in a quantity of 35 grams or less per container or up to 12 suppositories per pack
2. Pharmacy-only medicine, for dermal use in medicines containing 0.5% or less by weight of hydrocortisone base with no other active ingredient except an antifungal and in a quantity of 30 grams or less or 30 millilitres or less per container; in rectal medicines containing 0.5% or less by weight of hydrocortisone base and in combination with a local anaesthetic and in a quantity of 35 grams or less per container or 12 suppositories or fewer per pack

In all other circumstances hydrocortisone is classified as a prescription medicine.

c) Levocetirizine

A new pharmacy-only medicine (Schedule 2) entry should be created for levocetirizine in preparations for oral use except in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:

1. in a primary pack containing not more than 5 days' supply; and
2. labelled with a recommended daily dose not exceeding 5 mg of levocetirizine.

The prescription medicine (Schedule 4) entry should be amended to levocetirizine except:

1. when included in Schedule 2; or
2. in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
   1. in a primary pack containing not more than 5 days' supply; and
   2. labelled with a recommended daily dose not exceeding 5 mg of levocetirizine.

In New Zealand, levocetirizine is classified as a pharmacy-only medicine for oral use and prescription medicine except for oral use.

d) Naloxone

A new restricted medicine (Schedule 3) entry should be created for naloxone when used for the treatment of opioid overdose.

Naloxone is classified as a prescription medicine in New Zealand.

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Agenda items for the next meeting

10

General business

11

Date of the next meeting