1

Welcome

2

Apologies

3

Confirmation of the minutes of the 50th meeting held on Tuesday 12 November and Wednesday 13 November 2013

4

Declaration of conflicts of interest

5

Matters arising

5.1

Objections to recommendations made at the 50th meeting

The deadline for intentions to object to a recommendation made at the 50th meeting, together with a statement of the grounds on which the objection will be made, was 20 January 2014. The Committee will consider any objections raised.

5.1.1

Sildenafil – proposed reclassification from prescription medicine to restricted medicine (Silvasta, Douglas Pharmaceuticals Limited)

An objection has been received regarding the Committee's recommendation that sildenafil should not be reclassified as a restricted medicine when supplied by a pharmacist who has successfully completed the approved training programme and is accredited to supply sildenafil, for the treatment of erectile dysfunction in males aged 35-70 years.

Douglas Pharmaceuticals Limited felt that some of the submission was not fully portrayed to the Committee and some of the safety features may have been overlooked. The company will provide an updated original submission to include additional information that specifically addresses the concerns raised by the Committee. This recommendation will be reconsidered now that further data has been provided.

5.2

Review of the classification criteria

The Committee will be notified of final adjustments to the Medsafe paper, How to change the legal classification of a medicine in New Zealand (Adobe Acrobat document, 595 KB, 13 pages), which includes the change to publish comments (Microsoft Word document, 34 KB, 1 page) received on agenda items on the Medsafe website.

5.3

Reclassification of articaine from prescription medicine to prescription medicine except when…

An out-of-session consultation took place in January 2014 regarding the classification of articaine.

Articaine was previously classified as a prescription medicine.

The Committee recommended that articaine should be reclassified as a prescription medicine, except when used as a local anaesthetic in practice by a dental therapist registered with the Dental Council. This classification was gazetted alongside the recommendations from the 50th meeting.

5.4

Classification of nitrous oxide as prescription only when supplied for inhalation

Nitrous oxide is currently classified as a prescription medicine. At the 50th meeting on 12 and 13 November 2013, following a suggestion from Medsafe, the Committee foreshadowed the reclassification of nitrous oxide as a prescription medicine 'only when supplied for inhalation'.

5.5

Oxymetazoline - proposed reclassification from pharmacy-only medicine to general sale medicine
(Pharmaceutical Solutions in consultation with the New Zealand Retailers Association)

The Committee will reconsider the submission to reclassify oxymetazoline for nasal use, when labelled for use in adults and children over 6 years of age, from pharmacy-only medicine to general sale medicine now that further data had been submitted.

5.6

Zoster (shingles) vaccine - proposed reclassification from prescription medicine to prescription medicine except when…
(Pharmacybrands Limited and Pharma Projects Limited)

At the 50th meeting on 12 and 13 November 2013, the Committee recommended that:

1. zoster (shingles) vaccine should be classified as prescription medicine except when administered to a person 50 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health
2. the reclassification is subject to the amendments being made to the checklist and information sheets, as raised by the Committee.

The Committee will consider the amended documents provided by Pharmacybrands.

6

Submissions for reclassification

6.1

Oral Contraceptives

6.1.1

Desogestrel - proposed reclassification from prescription medicine to restricted medicine (Pharmacybrands Limited and Pharma Projects Limited)

This is a submission (Adobe Acrobat document, 783 KB, 40 pages) for the reclassification of desogestrel from prescription medicine to restricted medicine; when not in combination and when supplied for oral contraception by a pharmacist accredited to supply oral contraception, in accordance with the approved protocol for supply.

6.1.2

Ethinylestradiol - proposed reclassification from prescription medicine to restricted medicine (Pharmacybrands Limited and Pharma Projects Limited)

This is a submission (Adobe Acrobat document, 783 KB, 40 pages) for the reclassification of ethinylestradiol from prescription medicine to restricted medicine; when supplied at a strength of 35 µg or less in combination with levonorgestrel or norethisterone for oral contraception by a pharmacist accredited to supply oral contraception, in accordance with the approved protocol for supply.

6.1.3

Levenorgestrel - proposed changes to restricted medicine classification conditions
(Pharmacybrands Limited and Pharma Projects Limited)

This is a submission (Adobe Acrobat document, 783 KB, 40 pages) for the reclassification of levonorgestrel from:

• restricted medicine; in medicines for use as emergency post-coital contraception when in packs containing not more than 1.5 milligrams except when sold by nurses recognised by their professional body as having competency in the field of sexual and reproductive health

to

• restricted medicine; when supplied for oral contraception by a pharmacist accredited to supply oral contraception, in accordance with the approved protocol for supply, or in medicines for as emergency post-coital contraception when in packs containing not more than 1.5 milligrams except when sold by nurses recognised by their professional body as having competency in the field of sexual and reproductive health.

6.1.4

Norethisterone - proposed reclassification from prescription medicine to restricted medicine
(Pharmacybrands Limited and Pharma Projects Limited)

This is a submission (Adobe Acrobat document, 783 KB, 40 pages) for the reclassification of norethisterone from prescription medicine to restricted medicine; when supplied for oral contraception by a pharmacist accredited to supply oral contraception, in accordance with the approved protocol for supply.

6.2

Diclofenac – proposed reclassification from general sale medicine to pharmacy-only medicine (Novartis Consumer Health Australasia Pty Ltd)

This is a company submission for the reclassification of diclofenac in transdermal preparations for topical use containing 140 mg or less of diclofenac from general sales to pharmacy-only medicine. Confidential information has been redacted by the applicant.

7

New medicines for classification

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 2013

1. Hydroquinone and monobenzone
   The Schedules 2 and 4 hydroquinone and Schedule 4 monobenzone entries be amended to exclude cosmetic nail preparations containing 0.02 per cent or less from scheduling.
2. Tylosin
   The Schedule 5 entry for tylosin be deleted along with all exemptions in the Schedule 4 entry.
3. Besifloxacine hydrochloride, loteprednol etabonate, pasireotide diaspartate, and vilanterol trifenatate
   Schedule 4 entries be added for besifloxacine, loteprednol, pasireotide, and vilanterol as parent compounds of besifloxacine hydrochloride, loteprednol etabonate, pasireotide diaspartate, and vilanterol trifenatate, to avoid the necessity to reconsider the scheduling entries should another salt or ester appear.

8.2.2

Decisions by the Delegate - November 2013

To be considered under agenda item 8.1

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Agenda items for the next meeting

10

General business

11

Date of next meeting