1

Welcome

2

Apologies

3

Confirmation of the minutes of the previous meeting

4

Declaration of conflicts of interest

5

Matters arising

5.1

Report on standing agenda items

5.2

Objections to recommendations made at the previous meeting

5.3

Updating the guidance document titled 'How to change the legal classification of a medicine in New Zealand' and other MCC processes.

At the recent 55th MCC meeting, the Committee made the recommendation that:

Recommendation

That the guidance document titled 'How to change the legal classification of a medicine in New Zealand' should be changed to reflect the suggestions made by the Committee and consulted on as an agenda item for the 57th meeting.

Following this recommendation, Medsafe has evaluated and reviewed the current MCC processes as well as developing a proposal for an update to the decision criteria currently used.

The relevant documentation is attached. This includes the proposal (PDF 138 KB, 9 pages) and a submission template for commenting on this proposal (Word 49 KB, 3 pages).

5.4

Medicine reclassification – proposed process when considering the reclassification of prescription medicine to restricted medicine
(Pharmacy Council)

This is a submission (PDF 412 KB, 4 pages) from the Pharmacy Council (the Council) propsing a process for consideration of submissions for medicine reclassifications. Under this process, any future submissions for medicines to be reclassified from prescription to restricted medicines would be reviewed against the Council's framework and a report will be provided to the MCC for discussion during its consideration of the application.

The process is intended to provide the MCC with information regarding pharmacist competence to safely and effectively supply a particular medicine to a patient as a restricted medicine. The framework is currently being developed in collaboration with the Pharmaceutical Society of New Zealand (PSNZ) and is designed to provide the MCC with assurance regarding Pharmacist Competence Standards, current guidelines or protocols and relevant codes (e.g. Code of Ethics). The process will also enable the Council to provide a recommendation as to whether any formal training or upskilling is required or whether it is within a pharmacist's current competence and knowledge. Advice around screening tools and documentation will also be provided in the report to the MCC.

5.5

Review of codeine reclassification

The outcomes of the Australian Committee on Medicine Scheduling (ACMS) meeting in August 2015 have been released to the Committee. The Committee will review the outcomes regarding the classification of codeine at its 57th meeting and will consider harmonising with the Australian Schedule.

If a recommenddation is made that impacts the current classification of codeine, the Secretariat will add the recommendation to the agenda of the 58th meeting to allow for a full consultation.

6

Submissions for reclassification

6.1

Bifonazole – proposed amendment to the general sale medicine classification
(Bayer Healthcare Ltd)

This is a submission (PDF 1.0 MB, 24 pages) to amend the general sale medicine classification wording of bifonazole, from

• general sale medicine for dermal use in medicines for tinea pedis only or in shampoos containing 1% or less, to
• general sale medicine for dermal use in medicines for tinea pedis only or in shampoos containing 1% or less or when sold in practice by a podiatrist registered with the Podiatrists Board.

6.2

Melatonin
(Luminarie Healthcare Ltd)

This submission has been withdrawn by the submitter.

This is a submission to reclassify melatonin as a dietary supplement.

The mechanism for this to be achieved would be to exclude melatonin from scheduling when for oral use in 1 mg or less.

6.3

Melatonin
(Natalie Gauld Ltd and Pharmacy Retailing (NZ) Ltd trading as Healthcare Logistics)

This submission has been withdrawn by the submitter.

This is a submission to reclassify melatonin from prescription medicine to one of the two proposed prescription medicine except classifications sought. The two proposed classification options are prescription medicine except when:

1. provided in a 2 mg prolonged release formulation, when sold in the manufacturer's original pack, and supplied by a pharmacist who has successfully completed a training programme on insomnia from the Goodfellow Unit or endorsed by the Pharmaceutical Society of New Zealand for the treatment of insomnia, or
2. provided in a 2 mg prolonged release formulation, when sold in the manufacturer's original pack, and supplied by a pharmacist who has successfully completed a training programme endorsed by the Pharmaceutical Society of New Zealand for the treatment of insomnia.

6.4

Selected oral contraceptives (desogestrel, ethinylestradiol, levonorgestrel and norethisterone)
(Green Cross Health Ltd and Natalie Gauld Ltd)

This is a submission (PDF 1.1 MB, 39 pages) to reclassify selected oral contraceptives (desogestrel, ethinylestradiol, levonorgestrel and norethisterone) from prescription medicine to a prescription medicine except when supplied by a pharmacist

Desogestrel, ethinylestradiol and norethisterone are currently classified as prescription medicines.

Levonorgestrel is currently classified as:
Prescription: except when specified elsewhere in this schedule; except in medicines for use as emergency post-coital contraception when sold by nurses recognised by their professional body as having competency in the field of sexual and reproductive health

Restricted: 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

The proposed prescription medicine except classification is as follows for each substance:

1. ethinylestradiol
   • prescription medicine except when supplied at a strength of 35 μg or less in combination with levonorgestrel or norethisterone and when supplied in the manufacturer’s original pack by a pharmacist who has successfully completed a training programme endorsed by the Pharmaceutical Society of New Zealand for the supply of oral contraception
2. levonorgestrel
   • prescription medicine except when supplied in the manufacturer’s original pack by a pharmacist who has successfully completed a training programme endorsed by the Pharmaceutical Society of New Zealand for the supply of oral contraception
   • restricted medicine 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
3. norethisterone
   • prescription medicine except when supplied in the manufacturer’s original pack by a pharmacist who has successfully completed a training programme endorsed by the Pharmaceutical Society of New Zealand for the supply of oral contraception
4. desogestrel
   • prescription medicine except when not in combination and when supplied in the manufacturer's original pack by a pharmacist who has successfully completed a training programme endorsed by the Pharmaceutical Society of New Zealand for the supply of oral contraceptives.

Other requirements around the supply are as follows:

1. that there has been no break in therapy, the same formulation is continued, unless that formulation is not available in NZ
2. if there has been a gap in therapy or the formulation is not available in NZ, the therapy may change, e.g. where a woman stopped treatment, had a baby and now is post-partum and breast-feeding
3. that supply can only occur if the woman is eligible for supply in accordance with the screening tool consistent with World Health Organisation's Medical Eligibility Criteria for contraceptives, and approved by the MCC (or Pharmaceutical Society of New Zealand, as the MCC sees fit)
4. doctor referral occurs where the woman is ineligible according to the screening tool
5. a full rescreening is undertaken at first visit to a pharmacy, and annually if required
6. a maximum of 6 months’ supply can be provided
7. the woman needs to have been prescribed an oral contraceptive in the past three years by a doctor (based on prescription or first dispensing date)
8. the woman's GP is informed of the supply unless the woman opts out of this process
9. verbal and/or written information is supplied on the need for smear tests, sexually transmitted infection checks (if necessary), contraceptive options including long-acting reversible contraception, compliance, adverse effects, and what to do if a tablet is missed or diarrhoea or vomiting occur.

The Pharmacy Council Protocol for the Sale and Supply of Pharmacist Only Medicines for Chronic conditions would also apply to the pharmacist supply of oral contraceptives. See www.pharmacycouncil.org.nz/cms_show_download.php?id=212 This protocol includes:

• face-to-face consultations when possible unless due to disability or geographical isolation within New Zealand where this is impractical
• no pharmacist-supply to patients who reside outside of New Zealand unless a face-to-face consultation occurs
• a requirement to exercise professional judgement to prevent the supply of medicines that are unnecessary or in excess to the patient's needs
• electronic record-keeping of the supply of the medicine and records of the consultation
• follow-up information is collected and added to the patient’s record
• other health practitioners caring for the patient are referred to or consulted with if necessary and with the patient's permission
• privacy requirements
• the need to determine the appropriateness of the medicine
• advising the patient using verbal and appropriate written information.

7

New medicines for classification

7.1

Betaine – proposed classification as a restricted medicine
(Emerge Health Pty Ltd on behalf of Healthcare Logistics)

This is a company submission (PDF 4.8 MB, 10 pages) for the classification of betaine as a restricted medicine when indicated:

1. as an adjunct in the treatment of homocystinuria
2. to decrease elevated homocysteine blood levels in patients of all age groups with:
   1. cystathionine beta-synthase (CBS deficiency) type of homocystinuria, or
   2. 5, 10-methylenetetrahydrofolate reductase deficiency (MTHFR deficiency), or
   3. Cobalamin cofactor metabolism defect (cbl defect) type of homocystinuria.
3. to increase methionine and S-adenosylmethionine blood levels in patients with 5, 10-methylenetetrahydrofolate reductase deficiency (MTHFR deficiency) and cobalamin cofactor metabolism defect (cbl defect) type of homocystinuria.

7.2

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

8.1.a

Alirocumab

Alirocumab is a fully human monoclonal antibody (IgG1 isotype) that targets PCSK9. Alirocumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture.

Alirocumab is indicated as an adjunct therapy to diet, for long-term use in adult patients with primary hypercholesterolaemia (nonfamilial and heterozygous familial) to reduce low-density lipoprotein cholesterol (LDLC). Alirocumab is indicated in combination with a statin (HMGCoA reductase inhibitor), with or without other lipid modifying therapy (LMT), in patients not appropriately controlled with a statin. Alirocumab (Praluent) is indicated as monotherapy, or as add on to other non-statin LMT, in patients who cannot tolerate statins.

Alirocumab is classified as a prescription medicine in Australia.

8.1.b

Armodafinil

Armodafinil Modafinil is a racemic mixture of the enantiomers Rmodafinil and Smodafinil with the stereogenic centre at the sulphur atom. Armodafinil is Rmodafinil only.

Modafinil/armodafinil are oral wakefulness promoting agents, but pharmacologically different from other stimulants (including sympathomimetic amines). The exact mechanism of action is unknown.

Armodafinil is indicated:

• to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy
• to treat excessive sleepiness associated with moderate to severe chronic shift work sleep disorder where non-pharmacological interventions are unsuccessful or inappropriate
• as an adjunct to continuous positive airways pressure (CPAP) in obstructive sleep apnoea/hypopnoea syndrome in order to improve wakefulness.

Armodafinil is classified as a prescription medicine in Australia.

8.1.c

Asfotase alfa

Asfotase alfa is a human recombinant tissue on specific alkaline phosphatase (TNSALP)-Fc-deca-aspartate fusion protein with enzymatic activity, produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.

Asfotase alfa is indicated for long-term enzyme replacement therapy in patients with paediatric onset hypophosphatasia.

Asfotase alfa is classified as a prescription medicine in Australia.

8.1.d

Deoxycholic acid

Deoxycholic acid is a an adipocytolytic drug, which when injected into localized subcutaneous fat, physically disrupts the cell membrane of adipocytes and causes adipocytolysis, the destruction of fat cells.

Deoxycholic acid is indicated for the improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.

Deoxycholic acid is classified as a prescription medicine in Australia.

8.1.e

Di-iodohydroxyquinoline

Di-iodohydroxyquinoline (INN) or iodoquinol (USAN) is a quinoline derivative that is used in the treatment of amoebiasis.

In Australia, Di-iodohydroxyquinoline is classified as:

• restricted medicine for vaginal use
• prescription medicine except when a restricted medicine or for human use.

8.1.f

Flubromazolam

Flubromazolam is a benzodiazepine derivative. It is a triazolo analogue of the designer benzodiazepine, flubromazepam.

Benzodiazepines enhance the activity of gammaaminobutyric acid (GABA), a major inhibitory neurotransmitter in the brain. This results in anxiolytic, sedative, hypnotic, muscle relaxant and antiepileptic effects. Molecular formula: C H BrFN CAS Number: 612526406.

IUPAC name: 8bromo6(2fluorphenyl)1methyl4H[1,2,4]triazolo[4,3a]benzodiazepine.

Flubromazolam has high potency, and can cause strong sedation and amnesia at oral doses as low as 500 micrograms. Flubromazolam has an onset of effect of 30 minutes, and duration of effect of 12-18 hours. After effects are experienced for ≥ 24 hours. There is a risk of fatal overdose if benzodiazepines such as flubromazolam are combined with other central nervous system depressants such as opioid analgesics, alcohol and 4hydroxybutanoic acid (GHB).

There is a risk of unintended overdosing. People who use flubromazolam for its psychoactive properties reported compulsive redosing. Abrupt discontinuation of flubromazolam following regular dosing over several days can result in a withdrawal phase that includes rebound symptoms such as increased anxiety and insomnia.

Flubromazolam has recently become available online (products available for sale online include the pure substance and 250 microgram pellets).

Flubromazolam has no currently established therapeutic use and is likely to present a high risk of dependency, abuse, misuse or illicit use. The dangers associated with flubromazolam are such as to warrant limiting use to strictly controlled medical and scientific research. On this basis, flubromazolam meets two of the factors for inclusion in Schedule 9 of the Poisons Standard.

Flubromazepam has a much longer time to onset of effect (4 hours) and much longer duration of effect (3 days) than flubromazolam.

Flubromazolam is classified as a prescription medicine under the group of benzodiazepines classification.

The classification of flubromazolam is dependent on the approach taken to classify benzodiazepine derivatives (agenda item 8.2.1.a).

8.1.g

Follitropin delta

Follitropin delta is a novel human recombinant folliclestimulating hormone (rhFSH) intended for controlled ovarian stimulation (COS) in women undergoing assisted reproductive technology (ART) therapy such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).

Follitropin delta is indicated for controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.

Follitropin delta is classified as a prescription medicine in Australia.

8.1.h

Hexyl Aminolevulinate

Hexyl aminolevulinate (as hydrochloride) is a hexyl ester of 5aminolevulinic acid (5ALA or ALA), which is the first specific intermediate of heme biosynthesis.

Hexyl aminolevulinate is indicated as adjunct to standard white light cystoscopy to contribute to the diagnosis and management of bladder cancer in patients with known or high suspicion of bladder cancer.

Hexyl aminolevulinate is classified as a prescription medicine in Australia.

8.1.i

Ixekizumab

Ixekizumab is a humanised monoclonal antibody against the proinflammatory cytokine interleukin17A (IL17A).

Ixekizumab is indicated for the treatment of adult patients with moderate to severe plaque psoriasis.

Ixekizumab is classified as a prescription medicine in Australia.

8.1.j

Phleum pratense extract

Phleum pratense extract is a standardised allergen extract of grass pollen from Timothy-grass (Phleum pratense).

Phleum pratense extract is indicated for:

• allergy immunotherapy indicated for the treatment of grass pollen induced allergic rhinitis with or without conjunctivitis;
• disease modifying treatment of grass pollen induced rhinitis and conjunctivitis;

and use in persons aged 5 years or older.

Phleum pratense pollen extract (Timothy-grass pollen extract) is classified as a prescription medicine in Australia.

8.1.k

Tofacitinib

Tofacitinib is a JAK1, 2 and 3 kinase inhibitor with some limited inhibitory activity against tyrosine kinase 2 (TyK2).

Tofacitinib is indicated for the treatment of the signs and symptoms of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or are intolerant to methotrexate. Tofacitinib can be used alone or in combination with nonbiological DMARDs, including methotrexate.

Therapy with tofacitinib should be initiated and monitored by a rheumatologist or specialist physician with expertise in the management of rheumatoid arthritis.

Tofacitinib is classified as a prescription medicine in Australia.

8.1.l

Velpatasvir

Velpatasvir is a novel pangenotypic HCV non-structural protein 5A (NS5A) inhibitor for use in combination with sofosbuvir for the treatment of HCV infection.

Velpatasvir, in a fixed combination with sofosbuvir, is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults.

Velpatasvir is classified as a prescription medicine in Australia.

8.1.m

Vorapaxar

Vorapaxar is an inhibitor of the PAR1 receptors on platelets that are activated by thrombin.

Vorapaxar is indicated for the reduction of atherothrombotic events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD).

Vorapaxar 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 – March 2016

8.2.1.a

Benzodiazepine derivatives

The Australian Delegate has tidied up the listing of benzodiazepines under Schedules 2 and 9 (prescription medicine and prohibited substances) of the Therapeutics Good Administration Act 1989.

The Australian Delegate decided that:

• dicyclazepam, pyrazolam, clonazolam, deschloroetizolam, flubromazepam, nifoxipam and meclonazepam, not previously scheduled, be separately specified as prohibited substances (Schedule 9); and
• the current scheduling of other benzodiazepines remains appropriate.

Currently in New Zealand, benzodiazepines are classified as a group under the Medicines Act 1981 and are individually listed as a class 5 controlled drug under the Misuse of Drugs Act.

It is proposed to keep the group listing but also individually list benzodiazepines that are prescription medicines under the Medicines Act.

8.2.1.b

Paracetamol

The Australian Delegate considered a proposal to amend its pharmacy-only (Schedule 2) entry of paracetamol to:

• restrict the pack size requirements to no more than 100 tablets or capsules per pack and no more than 50 wrapped powders or sachets of granules per pack for domestic supply, and
• specifically limit bulk pack sizes of paracetamol for supply only to hospital, nursing homes and pharmacies for dispensing purposes.

Paracetamol is classified as a pharmacy-only medicine (Schedules 2), restricted medicine (Schedule 3) and a prescription medicine (Schedule 4) in Australia.

Pharmacy-only medicine (Schedule 2)

Paracetamol for therapeutic use:

1. when combined with ibuprofen in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided doses in a primary pack containing no more than 12 dosage units per pack; or
2. in tablets or capsules enclosed in a primary pack containing not more than 100 tablets or capsules; or
3. in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules intended only as a bulk medicine pack and labelled 'For dispensing only' and 'This pack is not to be supplied to a patient'; or
4. in individually wrapped powders or sachets of granules enclosed in a primary pack containing not more than 50 wrapped powders or sachets of granules; or
5. in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules intended only as a bulk medicine pack and labelled 'For dispensing only' and 'This pack is not to be supplied to a patient'; or
6. in other preparations

except:

1. when included in Schedule 3 or 4; or
2. 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:
   1. enclosed in a primary pack that contains not more than 10 such powders or sachets of granules.
   2. compliant with the requirements of the RASML.
   3. not labelled for the treatment of children 6 years of age or less.
   4. not labelled for the treatment of children under 12 years of age when combined with phenylephrine and/or guaiphenesin; or
3. 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:
   1. packed in blister or strip packaging or in a container with a child resistant closure.
   2. in a primary pack that contains not more than 20 tablets or capsules.
   3. compliant with the requirements of the RASML.
   4. not labelled for the treatment of children 6 years of age or less.
   5. not labelled for the treatment of children under 12 years of age when combined with phenylephrine and/or guaiphenesin.

Restricted medicine (Schedule 3)

Paracetamol when combined with ibuprofen in a primary pack containing 30 dosage units or less except when included in Schedule 2.

Prescription medicine (Schedule 4)

Paracetamol:

1. when combined with aspirin or salicylamide or any derivative of these substances except when separately specified in the Schedules;
2. when combined with ibuprofen in a primary pack containing more than 30 dosage units;
3. in slow release tablets or capsules containing more than 665 mg paracetamol;
4. in non-slow release tablets or capsules containing more than 500 mg paracetamol;
5. in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules except when included in Schedule 2; or
6. for injection.

It is proposed to amend the classification of paracetamol in New Zealand to align with the Australian scheduling of paracetamol.

9

Agenda items for the next meeting

10

General business

11

Date of next meeting