1

Welcome

2

Apologies

3

Confirmation of the minutes of the 65^th meeting held on 27 October 2020

4

Declaration of conflicts of interest

5

Matters arising

5.1

Objections to recommendations made at the 65th meeting

5.1a

5.1b

5.2

Recommendations implemented from the 65th meeting

5.3

Update on outstanding agenda items from the 65th meeting

6

Submissions for reclassification

6.1

Allopurinol – proposed change to the prescription classification statement
(Individual submission)

This is an individual submission (PDF, 322.58KB, 9 pages) proposing an amendment to the Prescription classification statement for allopurinol to Prescription medicine except when provided by a pharmacist who has completed gout training with the Pharmaceutical Society of New Zealand and is providing the medication to a person who has previously been prescribed allopurinol tablets to prevent gout, and where the supply meets the approved criteria.

The current classification for allopurinol is Prescription medicine.

6.2

Choline Salicylate – proposed reclassification from general sale medicine to pharmacy only medicine
(Medsafe)

This is a submission (PDF, 295.63KB, 15 pages) from Medsafe proposing the reclassification of choline salicylate when used for infant teething, from general sale to pharmacy-only medicine.

The submission proposes the following classification:

Prescription medicine; except when specified elsewhere in this schedule; except in medicines containing 10% or less and in pack sizes of 15 grams or less

Pharmacy-only; in medicines containing 10% or less and in packs sizes of 15 grams or less for the treatment of infant teething.

General sale; in medicines containing 10% or less and in pack sizes of 15 grams or less.

Note that infant is not a term currently used in the First Schedule to the Medicines Regulations 1984. It may be more appropriate to define an age in years instead (in children 18 months of age and younger).

6.3

Ibuprofen 300mg in powder form – proposed reclassification from prescription medicine to pharmacy only medicine
(AFT Pharmaceuticals Ltd)

This is a submission (PDF, 1.94MB, 30 pages) from AFT Pharmaceuticals Ltd proposing the reclassification of ibuprofen 300mg to Pharmacy-only, for oral use in powder form containing up to 300 milligrams per dose form with a recommended daily dose of not more than 1.2 grams, and sold in the manufacturers original packs containing not more than 12 dose units, and labelled for use by adults and children over 12 years of age.

6.4

Topical Oral Benzocaine, Tetracaine Hydrochloride (Amethocaine), Lidocaine (lignocaine) and Prilocaine – proposed reclassification from prescription medicine to prescription except when classification
(Dental Council - New Zealand)

This is a submission (PDF, 336.89KB, 25 pages) from the Dental Council New Zealand proposing to extend the classification for the classification for topical oral benzocaine, tetracaine Hydrochloride, lidocaine and prilocaine to allow access without a prescription for oral health therapists and dental therapists registered with the Dental Council to use them in their practice.

6.5

Hyaluronidase – proposed reclassification from general sale medicine to prescription medicine
(New Zealand Society of Cosmetic Medicine)

This is a submission (PDF, 175.08KB, 8 pages) from the New Zealand Society of Cosmetic Medicine proposing the reclassification of hyaluronidase from general sale to prescription medicine.

7

New medicines for classification

7.1

New chemical entities

New medicine applications have been received for the following new chemical entities that require classification.

7.1a

Risdiplam

Evrysdi, powder for oral solution, 750 microgram / millilitre (TT50-10851)

7.1b

Cemiplimab

LIBTAYO, concentrate for solution for infusion, 350 milligram (TT50-10841)

7.2

New chemical entities identified by Medsafe

7.2.a

Cardarine

Cardarine (GW501516) is a metabolic activator that selectively targets the peroxisome proliferator-activated receptor δ (PPARδ) with high affinity and potency thereby rendering it as a PPARδ agonist. Other marketed drugs in that class include the thiazolidinediones for treatment of type 2 diabetes mellitus, some of which have had post-marketing safety problems.

8

Harmonisation of the New Zealand and Australian schedules

8.1

New chemical entities which are not yet classified in New Zealand

29 September 2020

8.1a

Elexacaftor

Elexacaftor, in combination with tezacaftor and ivacaftor, is indicated for the treatment of cystic fibrosis in patients 12 years or older with at least 1 F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

From 1 October 2020, Elexacaftor is classified as a prescription medicine in Australia.

8.1b

Onasemnogene abeparvovec

Onasemnogene abeparvovec is an adeno-associated virus vector-based gene therapy indicated for the treatment of spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.

From 1 October 2020, Onasemnogene abeparvovec is classified as a prescription medicine in Australia.

8.1c

Opicapone

Opicapone is indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson disease experiencing "off" episodes.

From 1 October 2020, Opicapone is classified as a prescription medicine in Australia.

8.1d

Trifarotene

Trifarotene cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years or older.

From 1 February 2020, Trifarotene is classified as a prescription medicine in Australia.

8.1e

Cariprazine

Cariprazine is an atypical antipsychotic which is used in the treatment of schizophrenia, bipolar mania, and bipolar depression.

From 1 February 2020, Cariprazine is classified as a prescription medicine in Australia.

8.1f

Filgotinib

Filgotinib is a medication used for the treatment of rheumatoid arthritis.

From 1 February 2020, Filgotinib is classified as a prescription medicine in Australia.

8.2

Decisions by the Secretary to the Department of Health and Aging in Australia (or the Secretary’s Delegate) for noting

29 September 2020

8.2.1

Salbutamol

Amendment to the schedule 3 (pharmacist only) entry for salbutamol revised to allow pharmacists to dispense salbutamol inhalers to persons presenting with bronchospasm associated with asthma or chronic obstructive pulmonary disease, exercise-induced asthma and other stimuli known to induce bronchospasm. As well, there is a change to the wording re previous supply to clarify that previous supply can have been from any pharmacy.

Limit on supply will remain at one primary pack of salbutamol with the amendment that the one pack restriction will now apply to per person being treated.

8.2.2

Decisions by the Delegate – 28 September 2020

Melatonin

The Schedule 4 (prescription) was amended to except when included in Schedule 3 (restricted).

A new entry melatonin was created in Schedule 3 (restricted) for melatonin in modified released tablets containing 2 mg or less of melatonin for monotherapy for the short term treatment of primary insomnia characterised by poor quality of sleep for adults aged 55 or over, in packs containing not more than 30 tablets.

8.2.3

Decisions by the Delegate – 25 November 2020

8.2.3.a

Eletriptan

The Schedule 4 (prescription) was amended to except when included in Schedule 3 (restricted).

A new entry for eletriptan was created in Schedule 3 (restricted) for oral use in tablets containing 40 mg or less per tablet and when in a pack containing not more than 2 dosage units for the acute relief of migraine in patients who have stable, well-established pattern of symptoms

The date of implementation is 1 February 2021.

8.2.3.b

Ibuprofen

The Schedule 2 (pharmacy only) entry should be amended to include:

in divided immediate release preparations, each containing 400 mg or less of ibuprofen in a primary pack containing not more than 12 dosage units, when labelled:

1. not for the treatment of children under 12 years of age.

8.3

Decisions by the Secretary to the Department of Health and Aging in Australia (or the Secretary’s Delegate) for recommendation

8.3.1

New chemical entities which are not yet classified in New Zealand

8.3.1.a

Alanylglutamine

Alanylglutamine is a water-soluble dipeptide comprised of amino acids L-glutamine and L-alanine. Alanylglutamine works locally in the gastrointestinal tract to both protect the integrity of the intestinal mucosa and maintain intestinal barrier functions. This his reduces bacterial translocation, the risk of infection, infection-induced inflammatory damage and infection-associated symptoms, such as diarrhoea, dehydration, malabsorption and electrolyte imbalances. Upon absorption, alanylglutamine may also help inhibit muscle protein catabolism.

Decision by the Delegate – 7 May 2020

8.3.2.a

Zolmitriptan

Schedule 4 (prescription) entry for Zolmitriptan was down-scheduled to Schedule 3 (restricted) when in divided oral preparations containing 2.5 milligrams or less per dosage unit and when sold in a pack containing not more than 2 dosage units for the acute relief of migraine in patients who have a stable, well-established pattern of symptoms.

The date of implementation is 1 February 2021.

8.3.2.b

Mometasone

Schedule 4 (prescription) entry for mometasone was down-scheduled to Schedule 3 (restricted) as the only therapeutically active substance in preparations for dermal use containing 0.1 percent or less of mometasone in packs containing 15 g or less.

This decision has been implemented since 1 June 2020.

8.3.2.c

Calcifediol

Calcifediol Anhydrous is the anhydrous form of calcifediol, an orally available synthetic form of the calcitriol prohormone calcifediol (25-hydroxyvitamin D), which can be used for vitamin D supplementation, and with potential immunomodulating activity.

From 1 June 2020, calcifediol has been classified as prescription medicine in Australia.

8.3.2.d

Paracetamol (liquid formulations)

The Schedule 3 (restricted) entry for paracetamol should be amended to include liquid preparations for oral use except when in Schedule 2 (pharmacy-only).

The Schedule 2 entry for paracetamol should be amended to include liquid preparations for oral use containing a maximum of 10 g of paracetamol per container.

This decision has been implemented since 1 June 2020.

8.3.2.e

Lidocaine

Schedule 2 (pharmacy-only) entry for lidocaine should be amended to include aqueous sprays for oromucosal use containing 0.6 per cent or less total anaesthetic substances.

This decision has been implemented since 1 June 2020.

8.3.2.f

Caffeine

Schedule 4 (prescription) entry for caffeine for internal human therapeutic use except:

1.  in divided preparations when labelled with a maximum recommended daily dose of no greater than 600 milligrams of total caffeine; or
2. in undivided preparations with a concentration of less than 5 per cent of caffeine and when labelled with a maximum recommended daily dose of no greater than 600 milligrams of total caffeine.

This decision has been implemented since 1 June 2020.

8.3.2.g

Paracetamol (modified release)

Schedule 3 (restricted) entry for paracetamol should be amended to include:

1. In modified release tablets or caplets containing 665mg or less paracetamol enclosed in a primary pack containing not more than 100 tablets or capsules; or
2. In modified release tablets or capsules containing 665 mg or less paracetamol enclosed in a primary pack containing more than 100 tablets or capsules intended only as bulk medicine and labelled “For dispensing only” and “This pack is not to be supplied to a patient”.

This decision has been implemented since 1 June 2020.

Decisions by the Delegate – 24 August 2020

8.3.3.a

Adapalene

Schedule 4 (prescription) entry for adapalene was down-scheduled to Schedule 3 (restricted) in topical preparations containing 0.1 per cent or less of adapalene for the treatment of acne vulgaris in adults and in children over 12 years of age.

The date of implementation is 1 June 2021

8.3.3.b

Arbutin

Schedule 4 (prescription) entry for Arbutin (beta) in oral preparations except herbal preparations containing 500 mg or less beta-arbutin per recommended daily dose.

The date of implementation is 1 October 2020

8.3.3.c

Tigilanol Tiglate

Tigilanol tiglate is a phorbol ester which, along with other related compounds, acts as a protein kinase C regulator. Tigilanol tiglate is an extract from blushwood berries of Queensland, Australia.

From 1 October 2020, Tigilanol Tiglate has been classified as prescription medicine in Australia.

9

Agenda items for the next meeting

10

General business

11

Date of next meeting