Published: 29 February 2023

Committees

Minutes for the 71st meeting  of the Medicines Classification Committee held by Videoconference on 14 November 2023 at 9:33am

Contents

  1. Welcome
  2. Apologies
  3. Confirmation of the minutes of the 70th meeting held on 25 October 2022
  4. Declaration of conflicts of interests
  5. Matters arising
  6. Submissions for reclassification
  7. New chemical entities
  8. Harmonisation of the New Zealand and Australian schedules
  9. Agenda items for next meeting
  10. General business
  11. Date of next meeting

1. WELCOME

Present

Andi Shirtcliffe (Chair)
Alison Cossar
Dr Marcia Walker
Megan Peters
Bronwen Shepherd
Jessica Crocket (Secretariat)

In attendance (from Medsafe)

Matthew Spencer (Manager, Product Regulation)
Leah Russell (Team Leader, Product Regulation)

Observing (from Medsafe)

Amy Lynch (Science Advisor, Product Regulation)
Sutharsana Yathursan (Science Advisor, Product Regulation)

1. Welcome

The Chair opened the 71st Medicines Classification Committee (the Committee) meeting at 9:33am and welcomed members and guests. The Chair began the meeting with a karakia.

The Chair introduced Alison Cossar, an officer of the Ministry of Health, who is a new member to the Committee.

The Chair opened discussion for members to bring forward topics which are front of mind. Members noted that it would be helpful to have meetings that are kanohi ki te kanohi (face to face). Members discussed current workforce and workload issues in the health system. Members also discussed the importance of public consultation on medicine classification agenda items.

2. Apologies

One apology was received from Dr Ben Hudson.

3. Confirmation of the minutes of the 70th meeting held on 25 May 2023 

The minutes of the 70th meeting were accepted as a true and accurate record. The minutes have been ratified by the Committee Chair.

4. Declaration of conflicts of interest

Committee members handed in their conflict of interest forms. No members had conflicts which precluded their participation in the 71st Medicines Classification Committee meeting.

5. Matters arising

5.1 Objections to recommendations made at the 70th meeting.

The deadline for intentions to object to a recommendation made at the 70th Medicines Classification Committee meeting, together with a statement of the grounds on which the objection would be made, was 18 July 2023.  No valid objections were received.

6. Submissions for reclassification

6.1 Phenol – proposed change to prescription classification statement to include provision by podiatrists under certain conditions (Podiatrist Board of New Zealand and Podiatry New Zealand)

Purpose

High concentration phenol has a long history of use by podiatrists for nail chemical matrixectomy. Podiatrists have been using phenol for this indication for a number of years in a swab dose form. It has recently come to light that phenol products, as medicines, currently are not approved. As well as sourcing a product that may be approved in New Zealand, down-scheduling phenol may enable use of an approved medicine by podiatrists.

Phenol is currently classified as:

Prescription: for injection

Pharmacy-only: in medicines other than for injection containing more than 3%

General sale: in medicines other than for injection containing 3% or less.

This submission by the Podiatrist Board of New Zealand and Podiatry New Zealand proposes the reclassification of phenol to allow provision by podiatrists for chemical matrixectomy under certain conditions.

Background

The Committee noted that the current use of phenol by podiatrists is for nail ablation as a treatment for ingrown toenails.

The Committee noted that in New Zealand phenol is a medicine under the Act. The Committee noted that in other jurisdictions phenol is a medical device.

The Committee noted the need to have a classification statement that enables use of phenol by podiatrists, given that phenol has a long history of safe use by podiatrists for treatment of ingrown toenails. The Committee noted the submission proposes a ‘prescription except when’ classification statement to enable use of phenol by podiatrists. 

The Committee noted that, given the recent clarification of the categorisation of phenol as a medicine in New Zealand, patients are accessing phenol through prescription by a general practitioner (under section 29 of the Act) and then taking prescribed phenol to the podiatrist. The Committee highlighted that this current mechanism of access is not a sustainable practice.

The Committee acknowledged that phenol is a hazardous chemical but noted that podiatrists were proposing reclassification to allow use of products such as a swabs, rather than bottles of phenol.

Medsafe gave some further background on this agenda item. Medsafe reiterated that under the Act, which provides definitions of a medicine and medical device, phenol when used for nail chemical matrixectomy would be considered a medicine. Medsafe advised that there are two modes that need to be put in place to enable use of medicines containing phenol by podiatrists (without need for prescription): the first being a classification which enables use of phenol by podiatrists, and the other being an approved medicine containing phenol for the proposed indication (nail chemical matrixectomy).

Comments:

The Committee discussed that there were two comments on this agenda item. Comments were largely supportive of podiatrists’ use of phenol in their practice but noted that there are currently no medicines containing phenol that are approved for the proposed indication.

Discussion

The Committee discussed the proposed classification statement for phenol by the submitter, which is as follows:

Prescription; for injection; except when specified elsewhere in this schedule; except when supplied in the manufacturer’s original pack that has received consent from the Minister or Director-General to a podiatrist registered with the Podiatrists Board of New Zealand, for chemical matrixectomy.

Pharmacy only; in medicines other than for injection containing more than 3%; other than for chemical matrixectomy.  

General sale; in medicines other than for injection containing 3% or less.

The Committee noted that a key challenge in podiatrists’ supply of phenol is that there are no approved medicines containing phenol (for the proposed indication).

The Committee discussed the requirement of the proposed classification statement, ‘manufacturer’s original pack that has received consent from the Minister or Director-General’. The Committee discussed whether this requirement could create a barrier to access; noting that although phenol is a dangerous chemical, podiatrists have appropriate knowledge on use and pharmacists have appropriate knowledge on storage. Medsafe advised that this requirement would ensure phenol would remain a prescription medicine until it is supplied to a podiatrist given that the proposed statement is ‘prescription except when’.

The Committee discussed if pharmacists could compound phenol (in compliant volumes) for supply to podiatrists under section 26 of the Act (including under a practitioner’s supply order). However, they concluded that this is not possible.

The Committee noted that only a small volume of phenol is required for nail chemical matrixectomy. The Committee noted that it would be difficult to compound a small volume of phenol for use by podiatrists for a specified patient.

The Committee noted that there are alternative methods for matrixectomy e.g. matrixectomy with electrocautery.

The Committee noted that current medicines containing phenol approved in New Zealand are in dose forms (e.g. topical gels) and at strengths that would not be suitable for nail chemical matrixectomy.

The Committee noted that the inclusion of the indication ‘chemical matrixectomy’ in the classification statement ensures that any approved product used is appropriate for the proposed indication but does not limit that product in terms of it’s strength or dose form.

The Committee noted that this is a wider issue and that there are other issues for podiatrists for some local anaesthetics (e.g. lignocaine) and some anti-fungal medicines. The Committee acknowledged that podiatrist prescribing rights are outside of their remit but signalled that it could be positive for podiatrists to have appropriate mechanisms for prescribing within their scope of practice.

The Committee noted that podiatrists are well-equipped and experienced to appropriately supply phenol for nail chemical matrixectomy. The Committee agreed that they would like to support reclassification to best enable podiatrist supply of phenol for nail chemical matrixectomy. The Committee determined that they should support the reclassification of phenol so that, should there be a product approved podiatrists can continue to supply phenol safely and appropriately.

The Committee discussed the addition of the proposed pharmacy only statement ‘other than for chemical matrixectomy’ in the submission. The Committee noted that the wording of the classification statement is important and should enable appropriate and safe use by podiatrists and not create confusion as to the intention of the reclassification of phenol. The Committee recommended that Medsafe should consider the suitability of this statement before a decision by the Minister of Health’s delegate is made.

Recommendation

The Committee recommended that the prescription classification statement of phenol should be amended to:

Prescription except when supplied in a manufacturer’s original pack that has received consent from the Minister or Director-General to a podiatrist registered with the Podiatrists Board of New Zealand (PBNZ), for chemical matrixectomy.

New medicines for classification

The following new chemical entities were submitted to the Committee for classification.

7. New chemical entities

7.1a Tezepelumab

Tezspire, solution for injection in pre-filled syringe (210 mg Tezepelumab).

Tezspire contains 210 mg Tezelumab and is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

Recommendation

The MCC recommended that tezepelumab be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1b Clascoterone

Winlevi, clascoterone 1% cream.

Winlevi is a cream containing 1% clascoterone and is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Recommendation

The MCC recommended that clascoterone be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1c AOH1996

Medsafe has received inquiry as to the availability of AOH1996 in Aotearoa New Zealand. Medsafe has not received any medicine applications for medicines containing AOH1996.

AOH1996 is an experimental anticancer medicine. Medsafe recommends that AOH1996 be classified as a prescription medicine.

Recommendation

The MCC recommended that AOH1996 be added to the New Zealand Medicines Schedule as a prescription medicine.

Harmonisation of the New Zealand and Australian schedules

Secretariat’s Note:

Public consultation is an important part of the Committee process, Medsafe has noted that submissions on agenda items have been low recently. In particular, comments on recent Australian classification/ reclassification decisions have been low. These are included in the Committee agenda to provide recommendations on the classification with consideration as to whether the adoption of the Australian classification would be appropriate for a New Zealand context.

Medsafe will investigate whether additional communication strategies may increase engagement, including clarification of the intent of harmonisation items. Stakeholders are encouraged to comment on any and all MCC agenda items.

For further information on the Committee process please refer to the Medsafe published guidance document ‘How to change the legal classification of a medicine in New Zealand’ or email the Committee Secretariat at committees@health.govt.nz.

8.1 New chemical entities which are not yet classified in New Zealand

3 May 2023 Scheduling Final Decisions Public Notice 

8.1a Andexanet alfa

Andexanet alfa is a coagulation factor Xa recombinant, inactivated-zhzo. Andexanet alfa is indicated for patients treated with rivaroxaban and apixaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

From 1 June 2023 andexanet alfa was classified as a prescription medicine in Australia.

Recommendation

The Committee recommended that andexanet alfa be added to the New Zealand Medicines Schedule as a prescription medicine.

8.1b Avatrombopag

Avatrombopag is indicated for treatment of thrombocytopenia in adult patients with chronic liver disease under certain conditions or for treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia under certain conditions.

From 1 June 2023 avatrombopag was classified as a prescription medicine in Australia.

Recommendation

The Committee recommended that avatrombopag be added to the New Zealand Medicines Schedule as a prescription medicine.

8.1c Difelikefalin

Difelikefalin is indicated for the treatment of moderate to severe pruritus associated with chronic kidney disease in patients undergoing haemolysis.
From 1 June 2023 difelikefalin was classified as a prescription medicine in Australia.

Recommendation

The Committee recommended that difelikefalin be added to the New Zealand Medicines Schedule as a prescription medicine.

8.1d Ivosidenib

Ivosidenib is indicated for treatment of patients with cholangiocarcinoma under certain conditions or treatment of patients with acute myeloid leukemia under certain conditions.

From 1 June 2023 ivosidenib was classified as a prescription medicine in Australia.

Recommendation

The Committee recommended that ivosidenib be added to the New Zealand Medicines Schedule as a prescription medicine.

8.1e Pralsetinib

Pralsetinib is indicated for treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer under certain conditions and treatment of patients with advanced or metastatic RET fusion-positive thyroid cancer under certain conditions.

From 1 June 2023 pralsetinib was classified as a prescription medicine in Australia.

Recommendation

The Committee recommended that pralsetinib be added to the New Zealand Medicines Schedule as a prescription medicine.

8.2 Decisions by the Secretary to Department of Health and Ageing in Australia (or the Secretary’s Delegate).

3 May 2023 Scheduling Final Decisions Public Notice

8.2.1. Paracetamol

Purpose

Paracetamol is a widely used analgesic and antipyretic. In Australia the Therapeutic Goods Administration (TGA) announced on 3 May 2023 that there would be scheduling changes for paracetamol. The proposed scheduling changes will affect the maximum size of packs of immediate release paracetamol from:

  • 20 tablets or capsules to 16 for unscheduled (general sales) products (8 grams per pack)
  • 100 tablets or capsules to 50 for schedule 2 (pharmacy-only) products (25 grams per pack)

The TGA has also announced a limit of 100 tablets/ capsules for schedule 3 (restricted/ pharmacist-only) products (50 grams per pack).

Equivalent and proportionate changes will also apply to preparations of wrapped powders and sachets of granules that contain paracetamol. The date of implementation for scheduling changes for paracetamol in Australia is 1 February 2025.

In Aotearoa New Zealand the maximum pack sizes of immediate release paracetamol in solid dose form available over the counter are currently as follows:

  • 10 grams for general sales medicines (equivalent 20 x 500 mg tablets)
  • 50 grams for pharmacy-only medicines (equivalent 100 x 500 mg tablets)

There is a limit of three months’ supply for prescription medicines (which could consist of 720 x 500 mg tablets, if prescribed at the maximum daily dose).

Background

The Committee noted that this item is a harmonisation item with Australia.

The Committee noted that paracetamol has been considered for classification a number of times over recent years. The Committee noted that there is wide-spread use of paracetamol as an over-the-counter (OTC) analgesic in New Zealand.

The Committee noted that changing the pack size limit for general sales from 20 tablets (10 grams paracetamol) to 16 tablets (8 grams paracetamol) and pharmacy only from 100 tablets (50 grams paracetamol) to 50 tablets (25 grams paracetamol) is related to toxicity and overdose risk and treatment strategies. The MCC noted that the toxic dose of paracetamol is 10 grams and that a heightened management plan is required at a dose of 25-30 grams or more.

Secretariat’s Note:

Given that paracetamol is widely used as an over-the-counter analgesic and antipyretic, it is acknowledged that there could be large implications for the New Zealand public should paracetamol be reclassified. Medsafe prepared a background document to aid in the MCC’s consideration of paracetamol. This background document can be found here. (PDF 13 pages, 336KB)


The Committee noted that one of the key issues associated with paracetamol overdose is home stockpiling of paracetamol dispensed on prescription. The Committee noted that reducing pack sizes may not affect paracetamol home stockpiling. The Committee also noted that the availability at general sales and the options of self-checkout mean that paracetamol is easily accessible.

Comments

The Committee noted that six comments were submitted on the paracetamol agenda item in New Zealand. The Committee noted that the comments were varied. Some comments suggested it would be beneficial to have a limit of the number of packs sold per sale. Some comments also noted differences between the Australian and New Zealand context and highlighted that the Committee should consider the New Zealand context for their recommendation including cost barriers.

Discussion

The Committee noted that intentional overdose of paracetamol can be seen in all age groups, and although is prominent in young people can also be seen in the elderly population.

The Committee noted that, given the toxic dose of paracetamol is shown to be 10 grams, having pack sizes change at general sales to 8 grams (16 tablets) could be positive. The Committee noted that other presentations e.g. sachets of powders are also available and would not be affected should the Committee reclassify only solid oral dose forms e.g. tablets/capsules. The Committee noted the risk of individuals purchasing paracetamol in multiple dose forms and products.

The Committee considered that should there be a reduction in pack sizes available at general sale there could be increased pressure on pharmacists and prescribers to supply bigger pack sizes.

The Committee noted that they have previously asked Retail New Zealand and the Food and Grocery Council (see MCC 58th meeting) to limit the number of paracetamol packs sold. The Committee acknowledged that the number of paracetamol packs sold is one part of the overall problem of paracetamol toxicity.

The Committee noted that the Medicines Act 1981 does not allow provision to enforce limits on the number of packs of paracetamol sold. The MCC considered that, given the increased use of self-checkouts and the demonstrated ability of supermarkets to effectively restrict the number of an item in a sale during the COVID-19 pandemic, it may be beneficial (in consideration of public safety) to contact these groups, and other retailers, again regarding restricting the number of paracetamol packs sold (per sale).

The Committee noted that there is evidence that a large proportion of paracetamol home stockpiles comes from prescribed routes.

The Committee noted the importance of all members in the health sector e.g. pharmacists, pharmacy assistants or technicians and kaiāwhina contributing to safe supply of paracetamol. The Committee suggested that it would be beneficial for the pharmacy sector to structure a ‘best-practice’ scenario regarding paracetamol supply.

Medsafe suggested that, particularly considering the limited number of comments on the agenda item, that the MCC should consider not making a recommendation until a wider public consultation had been undertaken. This would be by utilising the Ministry of Health’s consultation tool.

Recommendation

The Committee recommended that this item be deferred to a future Medicines Classification Committee meeting and that further public consultation be made before the Committee provide recommendation on whether New Zealand should harmonise with Australia on the classification of paracetamol.

8.2.2. Brimonidine

Purpose

Brimonidine is a medicine which may be used to lower intraocular pressure in patients under certain conditions or may be used to relieve redness of the eye due to minor eye irritations. In Australia the TGA has re-scheduled brimonidine to:

  • Schedule 4 (prescription); except when included in schedule 2.
  • Schedule 2 (pharmacy-only); in ophthalmic preparations for adult use containing not more than 0.025% brimonidine.

The implementation date was the 1 June 2023.

In Aotearoa New Zealand brimonidine is currently classified as a prescription medicine.

Background

The Committee noted that the consideration of the reclassification of brimonidine is a harmonisation item with Australia. The Committee noted that Australia has recently reclassified brimonidine to allow for a lower strength (0.025%) ophthalmic preparation to be available at Schedule 2 (equivalent New Zealand pharmacy-only) under certain conditions.

The Committee noted that in New Zealand approved products are only available at strengths of 0.15% or 0.2%. The Committee noted that approved products are currently largely used for open-angle glaucoma or ocular hypertension.

The Committee noted that there are currently no approved products that would be captured under the pharmacy-only classification (e.g. strength not more than 0.025%) should they recommend harmonisation with Australia. However, the Committee did indicate that there were products available globally that, if approved, may meet the proposed pharmacy-only classification conditions, including products manufactured by Bausch + Lomb who commented on this agenda item in support of reclassification.

The Committee noted that brimonidine is a highly selective and potent α2-adrenegic receptor agonist. The Committee noted that brimonidine has a slightly different mechanism of action, due to its potent selectivity, when compared with other ocular decongestants (e.g. naphazoline and tetrahydrozoline).

The Committee noted that a lower strength (not more than 0.025%) brimonidine would be indicated for symptoms such as eye-redness, eye-dryness, eye-irritations and eye-fatigue e.g. due to external allergens.

The Committee noted that in Australia the Schedule 2 classification for brimonidine is for adults 18 years and over. The Committee noted that this is aligned with Canada where the OTC brimonidine preparations are only indicated for those 18 years and over. The Committee noted that in the United States of America (USA) the OTC brimonidine preparations are indicated for those aged five years and older.

The Committee discussed the benefit of having a new ocular decongestant product on the market (containing an alternate active ingredient to those currently available). The Committee also noted that brimonidine has reduced rebound congestion/ redness and minimal loss of effectiveness over time.

The Committee noted that the reclassification proposal is of low risk. The Committee noted that there is some risk of allergic reactions (although low). The Committee noted that as this is a proposal for self-selection there is some risk that patients may use OTC brimonidine for ocular conditions that would require medical attention. However, the Committee noted the Therapeutic Goods Administration of Australia (TGA) had indicated that this risk could be mitigated through appropriate labelling. The Committee considered brimonidine to be of low risk of toxicity at the lower strength and with no risk of abuse.

The Committee noted that brimonidine is categorised as pregnancy B3. The Committee noted side effects could include pain/stinging on administration or headache (although this would be more unusual).

Comments

The Committee noted that two comments were submitted on the brimonidine agenda item in New Zealand.

Discussion

The Committee found the benefits and risks of the proposed pharmacy-only classification for brimonidine to be aligned with eye drops of the same indication. The Committee found that the associated indications with lower strength brimonidine could be self-managed and self-diagnosed.

The Committee noted that they would benefit from greater public consultation, and that it would have been helpful to have submissions from ophthalmologist and optometrist professional bodies. The Committee noted that should they have pharmacy-only brimonidine classification, this would not allow optometrists to stock this medicine. The Committee noted it may be useful to consider whether there should be a prescription except when to allow optometrist supply of brimonidine.

The Committee supported a reclassification to allow harmonisation with Australia.

Medsafe suggested that we reach out to ophthalmologist and optometrists for comment or objection following minutes publication.

The Committee noted that in Australia OTC lower strength brimonidine is for adults 18 years and over. The Committee notes that in New Zealand age restrictions for OTC products are often included as a label statement rather than included in the classification. The Committee recommended that brimonidine have an age restriction label statement that is consistent with comparable ophthalmic products. The Committee noted that lower strength brimonidine demonstrates at least comparable safety to current comparable products. Medsafe confirmed that naphazoline has a label statement requirement ‘do not use in children under 12 years of age’. The Committee recommended that label statements reflect consistency across the OTC decongestant eye drops.

The Committee did also note that if companies choose to harmonise labelling between Australia and New Zealand OTC brimonidine products may be submitted for ’18 years and over’, as this is part of the Australian classification.

Secretariat’s Note:

Following the meeting Medsafe confirmed that in New Zealand tetrahydrozoline has a label statement requirement ‘do not use in children under 6 years of age’.

Recommendation

The Committee recommended that the classification for brimonidine be amended to:

Prescription; except when specified elsewhere in this schedule.

Pharmacy-only; in ophthalmic preparations containing not more than 0.025% brimonidine.

8.2.3 Fexofenadine

Purpose

Fexofenadine is a non-sedating antihistamine. The TGA has rescheduled fexofenadine to increase the pack size available for general sale from five dosage units to 10 dosage units under certain conditions. The conditions are as follows:

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

The implementation date was the 1 June 2023.

In Aotearoa New Zealand the pack size limit for fexofenadine for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in tablets containing 180 mg or less of fexofenadine hydrochloride with a maximum daily dose of 180 mg when sold in the manufacturer’s original pack available general sale is five dosage units or less and not more than five days’ supply.

The MCC last considered the classification of fexofenadine at the 65th MCC meeting (27 October 2020) following a submission from Sanofi-Aventis New Zealand Limited which led to a number of recommendations including that tablets containing 180 mg or less of fexofenadine hydrochloride be available general sales under the aforementioned conditions.

Background

The Committee noted that the consideration of the reclassification of fexofenadine is a harmonisation agenda item with Australia. The Committee noted that the aforementioned Australia reclassification of fexofenadine allows for larger pack sizes (up to 10 dosage units and up to 10 days’ supply) of 180 mg strength fexofenadine to be available general sale when for the treatment of seasonal allergic rhinitis and when in children 12 years of age and over.

The Committee noted their previous consideration of the classification of fexofenadine at the 65th MCC meeting.

The Committee noted that OTC medicines should be for self-limiting conditions. The Committee noted that they sought outside advice from the Te Whatu Ora Pharmacy Minor Aliments work program on how that program defined a self-limiting condition. The Committee noted that the standards and guidance of the National Health Services (NHS) of the United Kingdom (UK) defined acute to be less than two weeks.

Comments

The Committee noted the comment that was received for this agenda item. The Committee noted that the Pharmacy Guild did not support harmonisation of the proposed fexofenadine classification with Australia. The Committee noted that the Pharmacy Guild had highlighted concerns related to use of fexofenadine in pregnancy.

Discussion

The Committee considered the classification of other non-sedating antihistamines available general sales. The Committee considered it important for those experiencing related self-limiting conditions to have access to non-sedating antihistamines at general sales.

The Committee noted that many individuals experience allergic rhinitis (hay fever). The Committee noted that hay fever is commonly mis-diagnosed by individuals experiencing symptoms, with patients self-diagnosing symptoms as hay fever when they are experiencing something else. The Committee noted risks associated with misdiagnosis are mitigated given this reclassification only allows short duration of use. The Committee also noted that access is important for those who are correctly self-diagnosing.

The Committee noted that it would have been helpful to have more public consultation on this agenda item.

The Committee questioned whether there was a need to expand the availability at general sale. The Committee questioned, given fexofenadine availability at general sale is for self-limiting conditions, whether there would be a benefit in increasing supply from five to 10 days. The Committee also noted that individuals could purchase multiple packs at general sales.

The Committee highlighted importance of label statements which direct patients to go to see a health professional should symptoms persist.

The Committee noted that fexofenadine does generally have greater potential side effects than other general sales anthistamines such as cetirizine and loratadine. The Committee noted the Pharmacy Guild comment around fexofenadine and risk of torsades des pointes. The Committee also noted that the fexofenadine data sheet does note risk of arrhythmias but also states that ‘no notable dose effects on QTc were found’. The Committee noted that the New Zealand Formulary lists rare side effects to include, hypotension, palpitation, arrhythmias, extrapyramidal effects. The Committee noted that often risks such as QTc prolongation and torsades des pointes are clinically relevant where multiple causative medicines and taken concurrently.

Medsafe advised that the label statements database requires that labels for general sale supply ‘do not use for more than five days at a time’. Medsafe also advised that the current classification statement for fexofenadine at general sales allows for 10 days’ supply of fexofenadine for 60 g and 120 mg or less strength tablets. The Committee noted that the classification allows for strengths other than the 180 mg to be available at general sales for 10 days’ supply. The Committee noted the discrepancy between the label statement being for use for not more than five days at a time and the classification being for pack sizes up to 10 days supply. Medsafe advised that for other medicines e.g. ibuprofen there are label statements that limit the number of days you should take the medicine which is different to the number of dosage units in the pack.

The general sales classification statement for fexofenadine in the Medsafe classification database is currently as follows:

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 manufacturer’s original pack containing 20 dosage units or less and not more than 10 days’ supply;
for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in tablets containing 180 milligrams or less of fexofenadine hydrochloride with maximum daily dose of 180 milligrams when sold in the manufacturer’s original pack containing five dosage units or less and not more than five days’ supply.

Medsafe also noted that the label statement database requires the following - ‘Do not use if you are pregnant except on the advice of a healthcare professional’ or ‘Do not use if you are breastfeeding except on the advice of a healthcare professional’.

The Committee did query whether consumers may perceive fexofenadine strength to correlate with product efficacy.

Recommendation

The Committee recommended that the classification statement for fexofenadine be amended as follows:

Prescription; except for oral use.

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 milligrams or less of fexofenadine hydrochloride with a maximum daily dose of 120 milligrams when sold in the manufacturer’s original pack containing 20 dosage units or less and not more than 10 days’ supply;
for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in tablets containing 180 milligrams or less of fexofenadine hydrochloride with a maximum daily dose of 180 milligrams when sold in the manufacturer’s original pack containing 5 10 dosage units or less and not more than 5 10 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 manufacturer’s original pack containing 20 dosage units or less and not more than 10 days’ supply;
for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in tablets containing 180 milligrams or less of fexofenadine hydrochloride with maximum daily dose of 180 milligrams when sold in the manufacturer’s original pack containing five 10 dosage units or less and not more than five 10 days’ supply

8.2.4 Melatonin

Purpose

The TGA has rescheduled immediate release melatonin to allow for pharmacist only provision when containing 5 mg or less of melatonin for the treatment of jet lag in adults aged 18 or over, in a primary pack containing no more than 10 dosage units.

The implementation date was 1 June 2023.

In Aotearoa New Zealand melatonin is currently classified as:

  • Prescription except when supplied in medicines for oral use containing 3mg or less per immediate release dose unit, or 2mg or less per modified release dose unit, when sold in the manufacturers original pack that has received consent from the Minister of Health or the Director General for the treatment of primary insomnia for adults aged 55 years or older for up to 13 weeks by a registered pharmacist.
Background

The Committee noted that there is a long history of their consideration of the classification of melatonin.

The Committee noted that Australia has recently reclassified melatonin to the include the following Schedule 3 (equivalent New Zealand pharmacist-only) statement: for immediate release preparations containing 5 mg or less of melatonin for the treatment of jet lag in adults aged 18 years and over, in a primary pack containing no more than 10 dosage units.

The Committee noted that a key consideration of the Australian harmonisation item for melatonin is whether New Zealand should reclassify melatonin for the indication of jet lag. The Committee noted that a recommended melatonin dosing schedule for jet lag is for a person to take a dose at the ‘bedtime’ of the destination country, and continue to do this for a few days, whilst you are in the destination country.

The Committee noted that Australia considered jet lag to be a self-diagnosed, self-treated and self-limiting condition.

The Committee noted that there was a positive benefit and safety profile for the use of melatonin in the proposed reclassification conditions. The Committee noted that the side effects are well defined and identifiable.

The Committee noted that melatonin is metabolised by CYP1A2 and therefore there are potential drug-drug interactions such as with warfarin and ciprofloxacin.

The Committee noted the following review article which assesses the toxicities of short-term and longer-term melatonin treatment: Besag, Frank MC, et al. "Adverse events associated with melatonin for the treatment of primary or secondary sleep disorders: a systematic review." CNS drugs 33 (2019): 1167-1186.

The Committee noted that there is also evidence in the literature suggesting that there may be benefit in taking doses between 0.5-5 mg melatonin for jet lag.

The Committee noted that there is already a training programme through the Pharmaceutical Society New Zealand (PSNZ) for the provision of melatonin by pharmacists. The Committee questioned whether there would be a need for any new training for pharmacists for the indication of jet lag.

The Committee noted that having melatonin products for indications of jet lag may provide benefit by decreasing use of benzodiazepines and sedating antihistamines for indications of jetlag.

Medsafe advised that a large quantity of melatonin is supplied as unapproved medicines in New Zealand, and that down scheduling may encourage applications for approval of products with wider indications.

Discussion

The Committee noted that the proposed reclassification for melatonin was sensible, given that it was restricted to short-term use and for the specified indication of jet lag.

The Committee noted that melatonin is regularly available in some places overseas at a general sales level and is used for inappropriate indications e.g. cancer.

The Committee noted that this could be a good solution for international tourists who would otherwise use a less appropriate product.

The Committee discussed current use for melatonin in New Zealand including in those with Autism Spectrum Disorder (ASD) and those with menopause.

The Committee noted that melatonin is widely absorbed by bodily tissues.

The Committee recommended support for the reclassification of melatonin in jet lag.

Medsafe queried whether the Committee would recommend support for reclassification of melatonin with the addition of a pharmacist only category or with a prescription except when category to enable supply by pharmacists. Medsafe advised labelling differences between prescription except when and restricted medicine packs.

Recommendation

The Committee recommended that New Zealand align with the intentions of the classification statements with Australia. The Committee recommended that Medsafe determine whether provision of melatonin by pharmacists for jet lag would more pragmatic under a restricted classification or prescription except when classification.

20 January 2023 Scheduling Final Decisions Public Notice

8.2.5 Cetirizine

Purpose

Cetirizine is a non-sedating antihistamine. The TGA has rescheduled cetirizine to allow general sale supply for oral use for the treatment of seasonal allergic rhinitis in adults and children 6 years of age and over when: in a primary pack containing not more than 10 days’ supply; and labelled with a recommended daily dose not exceeding 10 mg of cetirizine.

Discussion

Secretariat’s Note:

This has been deferred to a future MCC meeting.

9. Agenda items for the next meeting

The Committee has referred the consideration of harmonisation of the paracetamol classification with Australia to a future MCC 72nd meeting.

10. General business (put links to other pages)

Medsafe provided the Committee with background on the Minister’s delegate’s decisions for the classification of paracetamol (liquid formulations) and low-dose cannabidiol and the implementation of the classification of methenamine hippurate.

Medsafe noted that the current government has signalled the intention to enable sale of medicines containing pseudoephedrine as pharmacist or pharmacy-only classification (54th Parliament New Zealand National Party & Act New Zealand Coalition Agreement).

Andi Shirtcliffe, as the Chair, thanked all members for their contribution to the Committee and noted that this would be her last meeting as a member of the committee. Andi also acknowledged all those who had previously been on the Committee and contributed to the classification of medicines in New Zealand.

Medsafe and Committee members thanked the Andi for her service to the MCC over many years, particularly noting the knowledge, skills, and attitude she has contributed.

11. Date of the next meeting

The Chair closed the meeting at 12:51pm with a karakia.

This document was prepared and written by Jessica Crockett as the Medicines Classification Committee Secretariat.

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