1

WELCOME

2

APOLOGIES

3

CONFIRMATION OF THE MINUTES OF THE 64^TH MEETING HELD ON 9 JULY 2020

4

DECLARATION OF CONFLICTS OF INTEREST

5

MATTERS ARISING

5.1

Objections to recommendations made at the 64th meeting

The deadline for the intentions to object to a recommendation made at the 64^th meeting, together with a statement of the grounds on which the objection would be made, was 1^st September 2020.

5.1.1

Reclassification of pholcodine – objection to the proposed recommendation that pholcodine be reclassified from a pharmacy-only medicine to a restricted medicine.

Five valid objections (PDF, 835 KB, 23 pages)  were received regarding the Committee’s recommendation to reclassify pholcodine from a pharmacy-only medicine to a restricted medicine.

These objections have been accepted as valid on the basis the that the committee did not consider all the safety issues correctly, or the benefits, and that there was a breach of the appropriate process.

This was a Medicines Adverse Reaction Committee (MARC) recommendation (PDF, 755 KB, 54 pages) proposing the reclassification of pholcodine from a pharmacy-only medicine to a restricted medicine. (See attached file: 180-3.2.1-Pholcodine MARC review.pdf)

5.2

Paracetamol – recommendation received from the coroner

Pursuant to section 57B (3) Coroners Act 2006, the Coroner has made a recommendation to the Committee proposing that the following restrictions be implemented as to the quantities of paracetamol available for purchase in New Zealand:

(a)   Pharmacy sales: 16 g per transaction (i.e. 32 x 500 mg tablets)

(b)   All other outlets 8 g per transaction (i.e. 16 x 500 mg tablets)

(c)   A maximum of 50 g (i.e. 100 x 500 mg tablets) by prescription.

Background:

At the 57^th meeting of the Committee paracetamol was presented as a part of the standing agenda item Harmonisation of the New Zealand and Australian Schedules.

The Committee recommended:

• That the pharmacy only entry should be amended to a single pack size of a maximum of 100 tablets or capsules.
• That no other change should be made to the existing classifications of paracetamol.
• That Medsafe should write to the Pharmacy Council and the Food and Grocery Council appraising them that general sale packs of paracetamol should not be sold online by grocery retailers. Pack sizes sold by online pharmacies should be restricted to 32 tablets or capsules and similar oversight should be applied as to in store shopping.

At the 58^th meeting an update was provided on paracetamol.

Medsafe had written to the Pharmacy Council of New Zealand, the Pharmaceutical Society of New Zealand, Retail New Zealand and the Grocery Council to highlight the potential purchase of general sale packs of paracetamol for deliberate self-harm and that paracetamol is not suitable for online sales. Pack sizes sold by online pharmacies should be restricted to 32 tablets or capsules and similar oversight should be applied to in-store shopping.

A response letter had been received from Retail New Zealand, dated 6 March 2017, who had discussed the issue with their grocery members. There were mixed views from the retailers about the effectiveness of limiting the sale of multiple packs and ceasing the sale of paracetamol via online channels.

The Committee discussed the response letter and were concerned that their comments regarding the sale of paracetamol products as general sale medicines had not resulted in any action.

At he 59^th meeting another update was provided.

The Deputy Chair wrote back to Retail New Zealand with the list of criteria that the Committee considers when reviewing a medicine for reclassification for non-prescription sale and a comment that the sector’s approach to the sale of paracetamol will be taken into account when considering the reclassification of future medicines and their availability for general sale.

A response was received on 27 July 2017. Retail New Zealand emphasised that in the previous letter they had clearly outlined a mix of views amongst members and that some members were willing to comply with the Committee’s requests regarding paracetamol.

The Deputy Chair passed on the comments, regarding the sale of paracetamol medicines at general sale, from the Committee and Retail New Zealand to the team currently drafting the new therapeutic products regulatory regime in an email dated 27 July 2017.

5.3

Update on outstanding agenda items from the 64th meeting

6

SUBMISSIONS FOR RECLASSIFICATION

6.1

Fexofenadine – proposed change to pack size limit and reclassification from pharmacy only to general sale
(Telfast, Sanofi-Aventis New Zealand Limited)

This submission (PDF, 904.62 KB, 50 pages) from Sanofi-Aventis New Zealand Limited proposes an increase to the 60mg and 120mg fexofenadine general sale pack sizes to 20 dosage units or less and not more than 10 days supply for the treatment of Seasonal Allergic Rhinitis (SAR), when used only in adults and children 12 years and over with a maximum daily dose of 120mg when sold in manufacturer’s original pack.

Additionally, this submission proposes the reclassification of fexofenadine from pharmacy only to general sale when used for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in tablets containing 180mg or less of fexofenadine hydrochloride with maximum daily dose of 180mg when sold in the manufacturer’s original pack containing 5 dosage units or less and not more than 5 days’ supply.

The current classification of fexofenadine is:

Pharmacy Only; for oral use except for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in capsules containing 60 milligrams or less of fexofenadine hydrochloride or in tablets containing 120 milligram or less of fexofenadine hydrochloride with a maximum daily dose of 120 milligram when sold in the manufacturer’s original pack containing 10 dose units or less and not more than 5 days’ supply.

General Sale; for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in capsules containing 60 milligrams or less of fexofenadine hydrochloride or in tablets containing 120 milligrams or less of fexofenadine hydrochloride with a maximum daily dose of 120 milligrams when sold in the manufacture’s original pack containing 10 dosage units or less and not more than 5 days’ supply.

Note: Fexofenadine is also listed in the agenda as a harmonisation matter under agenda item 8.2.2.b

6.2

Ibuprofen 400mg – proposed reclassification from restricted medicine to pharmacy only medicine
(Nurofen 400 Double Strength, Reckitt Benckiser (New Zealand) Pty Limited)

This submission (PDF, 2.10 MB, 41 pages) from Reckitt Benckiser (New Zealand) Pty Limited proposes the reclassification of ibuprofen 400mg, in packs containing not more than 12 dose units when sold in the manufacture’s original pack labelled for use by adults and children over 12 years of age, from a restricted medicine to pharmacy only medicine. Larger pack sizes containing 13-50 dose units are to remain as a restricted medicine and are not subject of this application.

The current classification of ibuprofen is:

Prescription; except when specified elsewhere in this schedule.

Restricted; for oral use in tablets or capsules containing up to 400 milligrams per dose form and in packs containing not more than 50 dose units and that have received the consent of the Minister or the Director-General to their distribution as restricted medicines and that are sold in the manufacturer's original pack labelled for use by adults and children over 12 years of age.

Pharmacy only; for oral use in liquid form with a recommended daily dose of not more than 1.2 grams for the relief of pain and reduction of fever or inflammation when sold in the manufacturer's original pack containing not more than 8 grams; for oral use in solid dose form containing not more than 200 milligrams per dose form and with a recommended daily dose of not more than 1.2 grams when sold in the manufacturer's original pack containing not more than 100 dose units; except in divided solid dosage forms for oral use containing 200 milligrams or less per dose form with a recommended daily dose of not more than 1.2 grams and when sold in the manufacturer's original pack containing not more than 25 dose units.

General Sale; for external use; in divided solid dosage forms for oral use containing 200 milligrams or less per dose form with a recommended daily dose of not more than 1.2 grams and when sold in the manufacturer's original pack containing not more than 25 dose units per pack.

6.3

Flurbiprofen – proposed reclassification from pharmacy only medicine to general sale medicine
(Flurbiprofen lozenge, Reckitt Benckiser (New Zealand) Pty Limited)

This submission (PDF, 2.28 MB, 37 pages) from Reckitt Benckiser (New Zealand) Pty Limited proposes the reclassification of flurbiprofen in locally oromucosal preparations containing 10 mg or less per dose unit, when sold in the manufacturer’s original pack containing not more than 16 dose units from pharmacy only to general sale.

The current classification for flurbiprofen is:

Prescription; except in locally acting oromucosal preparations containing 10 milligrams or less per dosage unit.

Pharmacy Only; in locally acting oromucosal preparations containing 10 milligrams or less per dosage unit.

Note: Flurbiprofen is also listed in the agenda as a harmonisation matter under agenda item 8.2.2.c

6.4

Hyoscine butylbromide – proposed addition of oral liquids in the current classification
(Gastrosoothe, AFT Pharmaceuticals Limited)

This submission (PDF, 1.21 MB, 18 pages) from AFT Pharmaceuticals Limited proposing the reclassification of hyoscine butylbromide for oral use in medicines containing not more than 20 milligrams per dose as an addition of oral liquids in the current restricted medicine classification.

The current classification of hyoscine butylbromide is:

Prescription; except when specified elsewhere in this schedule.

Restricted; for oral use in medicines containing not more than 10 milligrams per dose form and in packs containing not more than 20 tablets or capsules;

for oral use in medicines containing not more than 20 milligrams per dose form and in packs containing not more than 10 tablets or capsules for the relief of muscle spasm of the gastrointestinal tract.

Note: Hyoscine butylbromide is also listed in the agenda as a harmonisation matter under agenda item 8.2.1.e.

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

Brolucizumab

Beovu solution for injection 120 milligram / millilitre (TT50-10769)

7.1b

Indocyanine Green

Spy Agent Green powder for injection, 25 milligram (TT50-10762)

7.1c

Acalabrutinib

Calquence capsule, 100 milligram (TT50-10756)

Note: From 1 February 2020, Acalabrutinib is classified as a prescription medicine in Australia.

7.1d

Siponimod

Mayzent film coated tablet, 0.25 milligram and 2 milligram (TT50-10743)

Note: From 1 February 2020, Siponimod is classified as a prescription medicine in Australia.

7.1e

Fremanezumab

Ajovy solution for injection, 225 milligram / 1.5 millilitre (TT50-10814)

7.1f

Isatuximab

Sarclisa concentrated injection for infusion, 20 milligram / millilitre (TT50-10813)

7.1g

Alitretinoin

Zematane capsule, 10 milligram and 30 milligram (TT50-10822)

8

HARMONISATION OF THE NEW ZEALAND AND AUSTRALIAN SCHEDULES

Background:

 At the 64th meeting, the Committee has asked for changes to the process for the Harmonisation with Australia agenda items to ensure adequate consultation with affected stakeholders. The Australian changes can be considered for discussion and further information in the first instance without the requirement for a recommendation the first time they are brought to the attention of the Committee.

8.1

New chemical entities which are not yet classified in New Zealand

8.1.1

Acalabrutinib

Acalabrutinib is indicated for: the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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

8.1.2

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.

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

8.1.3

Enasidenib

Enasidenib is indicated for: the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 (IDH2) mutation in the blood or bone marrow as detected by a US Food and Drug Administration-approved test.

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

8.1.4

Gilteritinib

Gilteritinib is indicated for: the treatment of adults who have relapsed or refractory acute myeloid leukemia with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test for the detection of a FLT3 mutation in the blood or bone marrow.

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

8.1.5

Siponimod

Siponimod is indicated for: the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

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

8.1.6

Sodium glycerophosphate hydrate

Sodium glycerophosphate hydrate is indicated for: use in adult and paediatric patients as a supplement to parenteral nutrition to meet the daily requirements of phosphate.

From 1 February 2020, Sodium glycerophosphate hydrate is classified as a prescription medicine in Australia.

8.1.7

Voretigene neparvovec

Voretigene neparvovec is indicated for: the treatment of patients with viable retinal cells and confirmed biallelic RPE65 mutation-associated retinal dystrophy.

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

Final decisions for new chemical entities and medicines (29 May 2020)

8.1.8

Cabotegravir

Cabotegravir is an investigational new drug under development for the treatment of HIV infection. It is an integrase inhibitor, with a carbamoyl pyridone structure similar to dolutegravir.

From 1 June 2020, cabotegravir is classified as a prescription medicine in Australia.

8.1.9

Cedazuridine

Cedazuridine is part of a fixed-dose combination medicine with decitabine is indicated for treatment of myelodysplastic syndromes (MDS)

From 1 June 2020, Cezauridine is classified as a prescription medicine in Australia.

8.1.10

Decitabine

Decitabine is indicated for: treatment of myelodysplastic syndromes

From 1 June 2020, Decitabine is classified as a prescription medicine in Australia

8.1.11

Fosnetupitant

Fosnetupitant is part of a fixed-dose combination medication with palonosetron indicated for prevention of acute and delayed chemotherapy-induced nausea and vomiting.

From 1 June 2020, Fosnetupitant is classified as a prescription medicine in Australia.

8.1.12

Larotrectinib

Larotrectinib is indicated for: treatment of solid tumours in adults and pediatric patients that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or have progressed following treatment.

From 1 June 2020, Larotrectinib is classified as a prescription medicine in Australia.

8.1.13

Ozanimod

Ozanimod is indicated for: treatment of adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

From 1 June 2020, Ozanimod is classified as a prescription medicine in Australia.

8.1.14

Ripretinib

Ripretinib is indicated for: for the treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

From 1 June 2020, Ripretinib is classified as a prescription medicine in Australia.

8.1.15

Tafamidis

Tafamidis is indicated for: treatment of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.

From 1 June 2020, Tafamidis is classified as a prescription medicine in Australia.

8.1.16

Tucatinib

Tucatinib is indicated for: treatment of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.

From 1 June 2020, Tucatinib 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)

8.2.1

Decisions by the Delegate – 7 May 2020

8.2.1.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.

8.2.1.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.

8.2.1.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.

8.2.1.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.

8.2.1.e

Hyoscine Butylbromide

Hyoscine butylbromide was removed from the schedule 2 (pharmacy-only) entry for hyoscine and a new entry has been created.

Hyoscine butylbromide as a new entry at schedule 4 (prescription) except when included in schedule 3 (restricted) or schedule 2 (pharmacy-only)

Hyoscine butylbromide is schedule 3 (restricted) when in undivided preparations for oral use with a recommended single dose not exceeding 20 mg of hyoscine butylbromide in a pack containing 100 mg or less of hyoscine butylbromide when labelled for adults and children 6 years and over.

Hyoscine butylbromide is schedule 2 (pharmacy-only) as the only therapeutically active substance, in divided preparations for oral use, containing 20 mg or less of hyoscine butylbromide per dosage unit in a pack containing 200 mg or less of hyoscine butylbromide.

This decision has been implemented since 1 June 2020.

8.2.1.f

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.

8.2.1.g

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.

8.2.1.h

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.

8.2.2

Decisions by the Delegate – 24 August 2020

8.2.2.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

8.2.2.b

Fexofenadine

Schedule 4 (prescription) entry for fexofenadine should be amended to include:

1. the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
   1. in a primary pack containing 5 dosage units or less and not more than 5 days’ supply; and
   2. labelled with a recommended daily dose not exceeding 180 mg of fexofenadine; or
2. for the treatment of seasonal allergic rhinitis and children 6 years of age and over when:
   1. in a primary pack containing 20 dosage units or less and not more than 10 days’ supply; and
   2. labelled with a recommended daily dose not exceeding 60 mg of fexofenadine.

Schedule 2 (pharmacy-only) entry for fexofenadine should be amended to in preparations for oral use except in divided preparations:

1. for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
   1. in a primary pack containing 20 dosage units or less and not more than 10 days’ supply; and
   2. labelled with a recommended daily dose not exceeding 120 mg of fexofenadine;
2. for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
   1. in a primary pack containing 5 dosage units or less and not more than 5 days’ supply; and
   2. labelled with a recommended daily dose not exceeding 180 mg of fexofenadine; or
3. for the treatment of seasonal allergic rhinitis and children 6 years of age and over when:
   1. in a primary pack containing 20 dosage units or less and not more than 10 days’ supply; and
   2. labelled with a recommended daily dose not exceeding 60 mg of fexofenadine.

The date of implementation is 1 October 2020.

8.2.2.c

Flurbiprofen

Schedule 4 (prescription) entry for fluriprofen should be amended to except when included in or expressly excluded from Schedule 2 (pharmacy-only).

Schedule 2 (pharmacy-only) entry for flurbiprofen should be amended to include in preparations for topical oral use when:

1. in divided preparations containing 10 mg or less of flurbiprofen per dosage unit except when:
   1.  in a primary pack containing not more than 16 dosage units; and
   2. labelled only for the treatment of adults and children over 12 years.
2. in undivided preparations containing 0.25 percent or less or 10 mg or less per dose of flurbiprofen.

The date of implementation is 1 October 2020.

8.2.2.d

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

8.2.2.e

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 THE NEXT MEETING