Published: 9 August 2021

Committees

Minutes of the 66th meeting of the Medicines Classification Committee held in Wellington on 11 May 2021 at 9:39 am

Present:
Andi Shirtcliffe (Chair)
Dr Natasha White
Dr David (Buzz) Boothman-Burrell
Dr Marcia Walker
Angela Renall
Kerri Miedema
Jacinta Patel (Secretary)

In attendance (from Medsafe):
Alison Cossar (Manager, Product Regulation, Medsafe)
Courtenay Kularatne (Advisor, Committee and Support Services)
Leah Russell (Team Leader, Product Regulation, Medsafe)
Alice Weil (Advisor, Product Regulation)
Outi Kolju (Advisor, Product Regulation)

For agenda item 6.2 only:
Andrea Kerridge (Senior Advisor, Pharmacovigilance)

1

Welcome

The Chair opened the 66th meeting at 9:39 am and welcomed members and guests.

2

Apologies

No apologies were received.

3

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

The minutes of the 65th meeting were accepted as a true and accurate record. The minutes were signed and dated by the Chair.

4

Declaration of conflicts of interest

The Conflict of Interest forms were returned to the Secretary. 

The following conflicts of interest were declared:

  1. Mrs Miedema declared she held shares in AFT Pharmaceuticals. It was determined this conflict would be managed by sitting out agenda items 5.1a Hyoscine Butylbromide and 6.3 Ibuprofen 300mg in powder form.

All other members declared they had no additional interests which would pose a conflict with any of the items on the agenda.

5

Matters arising

The Committee reflected on the comments received about the minutes for the 65th meeting and agreed that the minutes should accurately reflect the discussion and rationale of a recommendation. However, the Committee noted that the minutes should not be a full transcript of the meeting because this was not considered helpful or appropriate.

5.1

Objections to recommendations made at the 65th meeting

The deadline for the intention to object to a recommendation made at the 65th meeting, together with a statement of the grounds on which the objection would be made, was 15th January 2021.

5.1.a

 

 

Hyoscine butylbromide – proposed addition of oral liquids in the current classification

A valid objection on the grounds that the Committee did not consider all of the safety issues and benefits correctly was received regarding the Committee’s recommendation to not amend the classification of hyoscine butylbromide.

Comments

No comments were received on this agenda item.

Discussion

The Committee reviewed the objection and revisited the discussion that took place at the 65th meeting for hyoscine butylbromide.

The Committee reaffirmed they are satisfied with the overall safety profile of hyoscine butylbromide. The Committee then considered the benefit-risk value tree framework provided in the guidance and determined that the addition of liquid form of hyoscine butyl bromide does not improve access or clinical outcomes.

Additionally, the Committee determined that the liquid form poses more risk from unintended use, unintentional misuse with therapeutic intent or accidental ingestion, therefore the benefit-risk profile was not favourable.

Recommendation

The current classification of hyoscine butylbromide should remain unchanged.

5.1b

 

Ibuprofen 400mg – proposed reclassification from restricted medicine to pharmacy only medicine

Two valid objections on the grounds that the Committee did not consider all of the safety issues and benefits correctly and there was a breach of appropriate process were received regarding the Committee’s recommendation to not amend the classification of Ibuprofen 400mg.

Note: Ibuprofen 400mg was discussed in conjunction with agenda item 8.2.3.b.

Comments

One comment was received about this agenda item.

Discussion

The Committee reviewed the objections and revisited the discussion that took place at the 65th meeting for ibuprofen 400mg. The Committee was satisfied that they considered all of the data within the submission, and took into account their own experience and observations in clinical practice.

The Committee noted that both of the objections highlight the use of the term ‘general sales’ in the minutes. The Committee would like to clarify that the terminology was a comment to the general availability of ibuprofen rather than the committee misinterpreting the classification that was being sought.

The Committee considered that the input of a health professional was valuable when accessing the 400mg strength. In addition, the Committee noted that reserving the health professional input for the higher strength is consistent with other NSAIDs available in the market.

The Committee acknowledged that there is a risk of the 400mg Ibuprofen product being withdrawn from the New Zealand market as a result of not harmonising with the Australian scheduling decision but agree there are a number of other ibuprofen products therefore should not affect access or clinical outcomes and determined alignment with the approach for other higher strength NSAIDs with health professional input  is seen to be beneficial. within the New Zealand context was the best approach.

Recommendation

The current classification of ibuprofen 400mg should remain unchanged.

5.2

Update on outstanding agenda items from the 65th meeting

 

There were no outstanding agenda items.

6

Submissions for reclassification

6.1

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

Purpose

This is an individual submission (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 to prevent gout, and where the supply meets the approved criteria.

Background

Note: The background is an informative excerpt of previous minutes where the substance has been discussed

At the 7th meeting, held on 31 July and 1 August 1990, allopurinol was scheduled as a prescription medicine.

The current classification for allopurinol is Prescription medicine.

Comments

Nine comments were received about this agenda item.

Discussion

The Committee reviewed and considered all of the information provided in the submission and the various comments received. The Chair noted a late comment (104KB, 1 page) received from PHARMAC in support for the proposal.

The Committee considered the benefit-risk profile of the medicine and reflected on their own experiences with gout in their practice. They agreed that the proposal could support addressing access issues to medical practices and improve continuity of care in remote areas. The Committee noted that gout rarely presents in isolation, rather gout typically presents with comorbidities such as diabetes, hypertension and heart disease.

The Committee acknowledged there are favourable equity outcomes possible from this proposal. They also raised several concerns that are unaddressed by the current submission, including:

  • The risk of missing and/or undertreating the associated comorbidities of gout
  • duration for pharmacist follow-up with the patient before a follow-up with their doctor
  • the absence of an electronic care plan that would allow management between community pharmacies and medical practice
  • processes around training and education for pharmacists.

The Committee were supportive of this submission and agreed there is an unmet clinical need however acknowledged that a change in classification alone will have limited impact on improving health outcomes and equity.

The Committee discussed their understanding that reclassification can enable a pathway for policy changes and programmatic development, however holds reservations with the current proposal until the concerns identified are addressed.

The Committee concluded there should be engagement with the Pharmacy Council process for medicines reclassification as outlined in the guidance before a recommendation can be made.

Recommendation

The Committee is deferring the decision and referring this submission to the Pharmacy Council process.

6.2

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

Purpose

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. There is no change proposed for the ulcer formulation.

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 (e.g., in children 18 months of age and younger).

The submission proposed the following warning statements:

  1. Do not use in babies under 4 months of age
  2. Do not exceed the maximum stated dose
  3. Prolonged or excessive use can be harmful
  4. Do not use in patients known to be allergic to salicylates.
Background

Note: The background is an informative excerpt of previous minutes where the substance has been discussed

At the 7th meeting, held on 31 July and 1 August 1990, choline salicylate was scheduled as a pharmacy only medicine.

At the 9th meeting, held on 28th May 1992, the Committee agreed that choline salicylate and alcohol (Bonjela) was suitable for general sale. Choline salicylate should be reclassified as a General Sale Medicine and the Department would be left to look at a way of rewording the entry for alcohol to allow it to be used as a General Sale Medicine in this case.

At the 36th meeting, held on 8th February 2007, the Committee discussed choline salicylate within the harmonisation item for salicylic acid.

In Australia and New Zealand, salicylic acid was a restricted medicine in products containing more than 40% and unscheduled in products containing 40% or less.  In NZ the schedule entry applied to external use whereas in Australia it applied to dermal use.  The NDPSC had recommended that New Zealand should change ‘external’ to ‘dermal’ in order to harmonise.

It was noted that in New Zealand there were topical oral gels containing choline salicylate which would be affected if ‘external’ were changed to ‘dermal’ in New Zealand.  Choline salicylate could also be used in the ear and given orally in doses of up to 870 milligrams four-hourly.

It seemed sensible therefore to adopt separate schedule entries for choline salicylate in New Zealand particularly in view of the fact that choline salicylate was a recommended International Non-proprietary Name (INN) in its own right.  Choline salicylate was a derivative of salicylic acid.  Derivatives of substances are covered by the parent entry in the SUSDP but are not covered by the introductory statement in the New Zealand schedule.  With regard to the general sale choline salicylate products currently on the New Zealand market, 10% maximum concentration and pack sizes of not more than 15 grams was considered a suitable cut-off point for general sale.  Products above this cut-off point should be prescription medicines.

Recommendations:

  • That salicylic acid should be a general sale medicine in preparations for dermal use containing 40% or less
  • That salicylic acid should remain a restricted medicine in preparations other than dermal preparations containing 40% or less
  • That choline salicylate should be a general sale medicine in preparations containing 10% or less and in packs containing 15 grams or less
  • That choline salicylate should be a prescription medicine except in preparations containing 10% or less and in packs containing 15 grams or less
  • That the NDPSC should be recommended to consider similar entries for choline salicylate.

At the 37th meeting held on 17th May 2007, the Committee responded to the comments received at the 36th meeting. The Committee stood by its earlier recommendation that there should be a separate entry in the schedule for choline salicylate as it had its own recommended INN.  As a derivative of salicylic acid it was not covered by the introductory statement to the New Zealand schedule as it was in Australia.  Unlike salicylic acid, choline salicylate could also be used internally and the Committee was of the opinion that possible internal use should be covered in the schedule.  Members agreed that the recommendation for this schedule addition made to the NDPSC at the 36th meeting should be reiterated.

The Committee also stood by the 15 gram/10% upper limits as the cut-off for general sale choline salicylate as this accommodated general packs currently on the market.  Companies wishing to change this level could make a submission for reclassification in the normal way.

There had also been comment on the recommendation that the wording for the general sale scheduling of salicylic acid entry restricting products containing 40% or less to dermal use only.  It was agreed that the inclusion of the choline salicylate entry now covered those products currently on the market which were other than for dermal use.  However, the removal of “dermal” would have no regulatory impact on products on the market and would harmonise with the Australian wording.  Members agreed therefore that the word “dermal” could be removed from the relevant schedule entry.

Comments

Three comments were received about this agenda item.

Discussion

The Committee reviewed and considered all of the information provided in the submission and the comments received. It was noted that all of the comments supported the reclassification and attention was drawn to the letter of support from Reckitt Benckiser.

The Committee discussed reclassifying both indications, for the treatment of infant teething and mouth ulcers, to pharmacy-only. The Committee expressed a concern that due to how well known this product is, parents could still access the product in a supermarket, even if it was indicated for mouth ulcers only. However, the evidence supporting the reclassification only suggested an issue when used for infant teething.

The Committee discussed the risk of the product leaving the market as a result of up-scheduling but determined this was unlikely to be an issue as Reckitt Benckiser has indicated support of this reclassification in their comment.

The Committee noted that the term ‘infant’ is not defined by the first schedule and that the age restriction of the teething product needs to be defined by age in years instead. The Committee agreed that the suggested defined age statement ‘use in children under 18 months of age’ is appropriate.

Recommendation

That the classification of choline salicylate should be amended to include pharmacy only; in medicines containing 10% or less and in packs sizes of 15 grams or less for the treatment of teething in children under 18 months of age.

Secretary’s note:

In addition to the reclassification, the submission proposed warning and advisory statements to be required on the packs of products containing choline salicylate. The Committee did not specifically discuss this aspect of the submission at the meeting therefore a recommendation will be made out of session. however, this

The submission proposed the following warning statements:

  1. Do not use in babies under 4 months of age
  2. Do not exceed the maximum stated dose
  3. Prolonged or excessive use can be harmful
  4. Do not use in patients known to be allergic to salicylates.

Note that the above proposed warning statements a, b and c are already included on the current labels for Bonjela.

These statements will be reviewed out of session and followed up at the next meeting.

6.3

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

Purpose

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.

Background

Note: The background is an informative excerpt of previous minutes where the substance has been discussed

Ibuprofen is currently classified as follows:

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.

Comments

Three comments were received about this agenda item.

Discussion

The Committee reviewed and considered all of the information provided in the submission and the comments received. The Chair noted a late comment (120KB, 2 pages) received from AFT Pharmaceuticals addressing the comments against their proposal.   

The Committee discussed the different ibuprofen/paracetamol combination products currently available on the market. Medsafe advised the Committee that there are no currently approved products in this strength and dosage combination. Medsafe also noted that one current application would be affected by this classification change, Maxigesic Cold & Flu Hot Drink Double Strength, combination paracetamol 1000 mg and ibuprofen 300 mg, powder for oral solution.

The Committee then discussed the classification statements for ibuprofen and compared the variation of the different dosage forms defined within the statements. The Committee noted that the restricted statement captures ibuprofen 400mg strength in tablets and capsules and that the pharmacy only statement captures ibuprofen 200mg strength in both solid dosage forms and divided solid dosage forms. 

The Committee noted the amount of ibuprofen products already on the market and determined there is no clear clinical need for this product. The Committee  considered the impact of the dose form on adverse effects, particularly gastroduodenal injury (GDI) and briefly discussed the reconstituted strength of the 300 mg sachet product against currently available ready to use liquid ibuprofen.

The Committee noted that there is currently no market experience with ibuprofen presented in a sachet for reconstitution as a hot drink, either in the lower strength format captured under current general sale and pharmacy only entries, or the higher strength presentation containing 300 mg ibuprofen. The known risk of GDI associated with ibuprofen and evidence that dissolution characteristics may influence the rate of GDI both support a cautious approach to down-scheduling the higher strength. The Committee therefore determined a pharmacy-only classification was not appropriate. 

The Committee concluded that the risk-benefit profile was unfavourable, so was not in support of the current proposal for reclassification. The paper demonstrates there are differences in the adverse effects because of the dose forms and supports a cautious approach. The Committee also noted that there is no market experience with combination products presented in sachets for reconstitution as a hot drink, but this situation would change if AFTs lower strength product was approved and marketed in future.

Additionally, the Committee agreed that an interaction with a pharmacist would allow a consumer to receive advice and understand the risks associated with this dosage form.

The Committee has indicated a willingness to consider restricted medicine as an alternative classification however, this would require a revised submission to progress through the consultation process.

Recommendation

That the classification of ibuprofen should remain unchanged. 

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)

Purpose

This is a submission (PDF, 336.89KB, 25 pages) from the Dental Council of New Zealand proposing to extend 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 of New Zealand to use them in their practice.

Background

Note: The background is an informative excerpt of previous minutes where the substance has been discussed

Benzocaine is currently classified as follows:

Prescription; except when specified elsewhere in this schedule;
except in dermal preparations containing 2% or less of total anaesthetic substances;
except in lozenges containing 30 milligrams or less of total anaesthetic substances per dosage unit.

Pharmacy only; in preparations for topical use, other than eye drops, containing 10% or less of total anaesthetic substances except in dermal preparations containing 2% or less of total anaesthetic substances;
in divided preparations containing 200 milligrams or less of total anaesthetic substances per dosage unit except in lozenges containing 30 milligrams or less of total anaesthetic substances per dosage unit.

General Sale in dermal preparations containing 2% or less of total anaesthetic substances; in lozenges containing 30 milligrams or less of total anaesthetic substances per dosage unit.

Amethocaine is currently classified as follows:

Prescription: for internal use;
for external use in medicines containing more than 10%;
for ophthalmic use except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board.

Pharmacy only for external use in medicines containing 10% or less and more than 2%.

General sale for external use in medicines containing 2% or less.

Lignocaine is currently classified as follows:

Prescription; for injection except when used as a local anaesthetic in practice by a nurse whose scope of practice permits the performance of general nursing functions or by a podiatrist registered with the Podiatry Board or by a dental therapist or oral health therapist registered with the Dental Council;
for ophthalmic use except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board;
for oral use except in throat lozenges in medicines containing 30 milligrams or less per dose form;
for external use in medicines containing more than 10%;
except in throat sprays in medicines containing 2% or less;
except when specified elsewhere in this schedule.

Pharmacy only for urethral use;
for external use in medicines containing 10% or less and more than 2%.

General Sale in throat lozenges in medicines containing 30 milligrams or less per dose form;
for external use in medicines containing 2% or less;
in throat sprays in medicines containing 2% or less.

Prilocaine is classified as follows:

Prescription for injection except when used as a local anaesthetic in practice by a dental therapist or oral health therapist registered with the Dental Council;
except when specified elsewhere in this schedule.

Pharmacy only for dermal use in medicines containing 10% or less of local anaesthetic substances.

Comments

Three comments were received about this agenda item.

Discussion

The Committee reviewed and considered all of the information provided in the submission and the comments received. The Committee was satisfied with the overall safety and scope of the reclassification proposal for topical oral benzocaine, tetracaine hydrochloride (amethocaine), lidocaine (lignocaine) and prilocaine. The Committee noted that oral health therapists have been able to administer local anaesthetics by injection without needing standing orders or a dentist on site since 2017.

The Committee agrees that changing the classification statement to widen access to include oral health therapists and dental therapists registered with the Dental Council of New Zealand allows dental professionals to work to their competencies within their scope of practice and benefits patients.

The Committee noted that the submission draws on public comment for use in paediatric dental procedures. Medsafe advised that neither of the currently approved products on the market (Zap gel or Oraqix) are approved for  paediatric use therefore a change of classification provides limited benefits to the intention of the proposal.

The Committee agreed to the reclassification but emphasised that the proposed change in classification can only be applied to approved uses of products.

Recommendation

That the topical oral benzocaine, tetracaine hydrochloride, lidocaine and prilocaine should be amended to include the following statements:

Benzocaine:
Prescription; except when containing 20% or less and used topically as a local
anaesthetic in practice by a dental therapist or oral health therapist registered with the Dental Council.

Prilocaine:
Prescription; except when containing 2.5% or less and used topically as
a local anaesthetic in practice by a dental therapist or oral health therapist registered with the Dental Council.

Lidocaine (Lignocaine):
Prescription; except when containing 2.5% or less and used topically as a local
anaesthetic in practice by a dental therapist or oral health therapist registered with the Dental Council.

Tetracaine (Amethocaine)
Prescription; except when containing 2% or less and used topically as a local
anaesthetic in practice by a dental therapist or oral health therapist registered with the Dental Council.

6.5

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

Purpose

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.

Background

Note: The background is an informative excerpt of previous minutes where the substance has been discussed

At the 7th meeting, held on 31 July and 1 August 1990, hyaluronidase was scheduled as a general sale medicine.

Comments

Three comments were received about this agenda item.

Discussion

The Committee reviewed and considered all of the information provided in the submission and acknowledged all of the comments of support received.

The Committee discussed the use of hyaluronidase and commented that it is used by the cosmetics industry to reverse the unwanted effects of dermal fillers. The Committee note that under current legislation (The Medicines Act 1981 and The Medicines Regulation 1984), dermal fillers are considered medical devices in New Zealand.

The Committee noted that hyaluronidase is classified as a prescription medicine in a number of other countries and that the change in classification would align with the classifications in other jurisdictions.

The Committee discussed the safety issues around the potential for arterial injury and consumers acquiring and using hyaluronidase improperly.

The Committee acknowledged that up-scheduling hyaluronidase poses potential risk to the general public as it places a prescription requirement on the ability to reverse undesirable effects of dermal fillers. However, it was agreed that it is inappropriate for a non-health professional to administer hyaluronidase themselves.

The Committee concluded that up-scheduling hyaluronidase to a prescription medicine improves clinical outcomes by reducing potential harm to the general public and the risk of worsened outcomes.

The Committee support this proposal and agreed that the classification of hyaluronidase should be reclassified to a prescription medicine.

Recommendation

That hyaluronidase should be reclassified as a prescription medicine.

7

New medicines for classification

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

7.1a

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

Risdiplam is a survival of motor neuron 2-directed RNA splicing modifier.

Risdiplam addresses the underlying cause of SMA: a reduced amount of survival motor neuron (SMN) protein. The protein is encoded by the SMN1 and SMN2 genes. SMA is caused by mutations in SMN1 that code for inactive forms of the protein. The activity of the SMN2 gene, which produces much smaller quantities of SMN, tends to determine the severity of disease.

Risdiplam is indicated for the treatment of spinal muscular atrophy (SMA).

Secretary’s note

This item was not discussed at the meeting and will be followed up out of session.

7.1b

Cemiplimab

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

Cemiplimab is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. Cemiplimab belongs to a class of drugs that binds to the programmed death receptor-1 (PD-1), blocking the PD-1/PD-L1 pathway.

Cemiplimab is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation

Secretary’s note

This item was not discussed at the meeting and will be followed up out of session.

7.2

New chemical entities identified by Medsafe

7.2a

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.

Background

Medsafe Investigation and Enforcement team (IET) have notified the Secretary of an unscheduled higher risk substance that is seen at the border and have provided an introductory background with a view toward potential scheduling.

The IET and the border pharmacist continue to see importation of higher risk newer generation Performance and Image Enhancing Drugs (PIEDS) that include several selective androgen receptor modulators (SARMs), often packaged alongside other products subject to potential abuse, such as those scheduled as human growth hormone secretagogues or anabolic steroids.

Discussion

The Committee noted the concerns raised by the Medsafe Investigation and Enforcement team about cardarine and peroxisome proliferator-activated receptor δ (PPAR) agonists (SARM-like substances). The Committee requested that Medsafe provide further information that explores safety concerns and whether a class entry is required to capture these types of substances.  

Recommendation

That this proposed change should be noted and be placed on the 67th meeting agenda for recommendation.

The Committee requests that Medsafe write an information paper for the Committee on cardarine and other SARM-like substances.

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

a. 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.

Recommendation

That Elexacaftor should be added to the New Zealand Schedule as a prescription medicine.

b. 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.

Recommendation

That Onasemnogene abeparvovec should be added to the New Zealand Schedule as a prescription medicine.

c. Opicapone

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

Recommendation

That Opicapone should be added to the New Zealand Schedule as a prescription medicine.

d. 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.

Recommendation

That Trifarotene should be added to the New Zealand Schedule as a prescription medicine.

e. 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.

Recommendation

That Cariprazine should be added to the New Zealand Schedule as a prescription medicine.

f. 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.

Recommendation

That Filgotinib should be added to the New Zealand Schedule as a prescription medicine.

8.2

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

The Committee noted that the Delegate had also made the following amendments to the Standard for the Uniform Scheduling of Medicines and Poisons.

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 with respect to 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.

Discussion

The Committee noted that under the current legislation (Section 44 of the Medicines Act 1981) a pharmacist can provide an emergency supply of a medicine however this is limited to New Zealand citizens and residents that have previously had the medicine before. The Committee notes there is variable use of the emergency supply function under the Medicines Act and therefore that there would be benefit in the Pharmacy Council  communicating guidance of the interpretation of emergency supply. Additionally, the Committee note that the reclassification does not align with current asthma guidelines.

Recommendation

That this scheduling change should be noted and be placed on the 67th  meeting agenda for recommendation.

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.

The current classification of melatonin in New Zealand:

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.

Discussion

The committee agreed that clarity on the rationale behind the scheduling change made in Australia would be helpful to inform the NZ recommendation.

Recommendation

That this scheduling change should be noted and be placed on the 67th meeting agenda for recommendation, supported by information on the rationale behind the change made in Australia.

8.2.3

Decisions by the Delegate – 25 November 2020

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.

Discussion

The Committee noted there are currently no products on the market that contain eletriptan therefore determined there is no reason to change the current New Zealand classification.

Recommendation

That the current classification of eletriptan should remain unchanged.

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.

Note: Ibuprofen 400mg has been discussed in conjunction with agenda item 5.1.b.

Recommendation

This item was discussed with agenda item 5.1.b. The current classification for ibuprofen should remain unchanged.

8.3

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

The Committee noted that the Delegate had also made the following amendments to the Standard for the Uniform Scheduling of Medicines and Poisons.

8.3.1

New chemical entities which are not yet classified in New Zealand

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.

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

Discussion

The Committee agreed to harmonise with the Australian scheduling decision.

Recommendation

That alanylglutamine should be classified as a prescription medicine.

8.3.2

Decisions by the Delegate – 7 May 2020

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.

The current classification of zolmitriptan in New Zealand is:

Prescription; except when specified elsewhere in this schedule.

Restricted; in a pre-filled nasal spray device containing not more than 5 milligrams of zolmitriptan, for the acute relief of migraine attacks with or without aura in patients who have a stable, well-established pattern of symptoms and when sold in a pack of not more than 2 devices approved by the Minister or the Director-General for distribution as a restricted medicine.

Discussion

The Committee noted there are currently no products on the market that contain zolmitriptan therefore determined there is no reason to change the current New Zealand classification.

Recommendation

That the classification for zolmitriptan should remain unchanged.

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.

The current classification of mometasone in New Zealand is:

Prescription; except when specified elsewhere in the schedule.

Restricted; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age in aqueous nasal sprays delivering up to 50  micrograms per actuation when the maximum recommended daily dose is no greater than 200 micrograms (as a single dose) in a pack containing 200 actuations or less.

Discussion

The Committee noted there are products on the market that contain mometasone for dermal use however the Committee do not see the need to change the current New Zealand classification.

Recommendation

That the classification for mometasone should remain unchanged.

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.

Recommendation

That this scheduling change should be noted and be placed on the 67th meeting agenda for recommendation. The Committee has requested Medsafe provide more information regarding the use of this substance in nutritional supplements.

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.

Discussion

The Committee discussed the current liquid paracetamol product pack sizes available on the New Zealand and has suggested a maximum limit of 5 mg of paracetamol per container to reflect currently available products on the New Zealand market.

Recommendation

That this scheduling change should be noted and be placed on the 67th meeting agenda for recommendation.

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.

The current classification of lidocaine (lignocaine) in New Zealand is:

Prescription; for injection except when used as a local anaesthetic in practice by a nurse whose scope of practice permits the performance of general nursing functions or by a podiatrist registered with the Podiatry Board or by a dental therapist or oral health therapist registered with the Dental Council;
for ophthalmic use except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board;
for oral use except in throat lozenges in medicines containing 30 milligrams or less per dose form;
for external use in medicines containing more than 10%;
except in throat sprays in medicines containing 2% or less;
except when specified elsewhere in this schedule.

Pharmacy only; for urethral use;
for external use in medicines containing 10% or less and more than 2%

General sale; in throat lozenges in medicines containing 30 milligrams or less per dose form;
for external use in medicines containing 2% or less;
in throat sprays in medicines containing 2% or less.

Discussion

The Committee noted that the Australian schedule is more restrictive than the current New Zealand classification and agreed no change is needed to the New Zealand schedule.

Recommendation

That the classification of lidocaine should remain unchanged.

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.

Discussion:

The Committee was advised that Medsafe are in discussion with Ministry for Primary Industries (MPI) to consider the potential implications for caffeine as a food or supplement.  MPI is the lead on food safety in New Zealand therefore it is important to liaise to ensure a decision is made relevant to the New Zealand context.

Recommendation

This item is to be referred to a future meeting once information becomes available.

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.

The current classification of paracetamol in New Zealand is:

Prescription; except when specified elsewhere in the schedule.

Restricted; in modified-release forms containing 665 milligrams or less.

Pharmacy only; in liquid form;
in suppositories;
in tablets or capsules containing 500 milligrams or less and in packs containing more than 10 grams and not more than 50 grams;
in powder form containing not more than 1 gram per sachet and more than 10 grams per pack;
except in tablets or capsules containing 500 milligrams or less and in packs containing not more than 10 grams;
except in powder form in sachets containing 1 gram or less and in packs of not more than 10 grams.

General sale; in tablets or capsules containing 500 milligrams or less and in packs containing not more than 10 grams;
in powder form in sachets containing 1 gram or less and not more than 10 grams.

Discussion

The Committee noted that modified release paracetamol was reviewed at the 60th meeting and agreed no further change to classification was required.

Recommendation

That the classification for modified release paracetamol should remain unchanged.

8.3.3

Decisions by the Delegate – 24 August 2020

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.

The current classification of adapalene in New Zealand is:

Prescription; except in medicines containing 1 milligram or less per millilitre or gram and when supplied by a pharmacist in a pack containing not more than 30 grams for the treatment of comedo, papular and pustular acne (acne vulgaris) of the face, chest or back.

Discussion

The Committee noted there are products on the market that contain adapalene and the change to the Australian statement is similar to the current New Zealand scheduling. The Committee determined there is no need to change the current New Zealand classification.

Recommendation

That the current classification for adapalene should remain unchanged.

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.

Arbutin is currently unclassified in the New Zealand schedule.

Discussion

The Committee noted that this substance is found in topical cosmetics for reduction of the appearance of spots and hyper-pigmentation. They requested the rationale behind the change made in Australia.

Recommendation

That this scheduling change should be noted and be placed on the 67th meeting agenda for recommendation, supported by information on the rationale behind the change made in Australia.

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.

Tigilanol tiglate is not currently classified in New Zealand.

Discussion

The Committee note there are no products on the market that contain tigilanol tiglate and determined there is no need to change the current New Zealand classification.

Recommendation

That the classification for tigilanol tiglate should remain unchanged.

9

Agenda items for the next meeting

The following items will be added to the agenda of the next meeting:

  1. Allopurinol for review (6.1)
  2. Salbutamol (8.2.1)
  3. Melatonin (8.2.2)
  4.  Calcifediol (8.3.2.c)
  5.  Arbutin (8.3.3.b)

10

General business

11

Date of next meeting

A date in October 2021 will be confirmed.

There being no further business, the Chair thanked members and guests for their attendance and closed the meeting at 3:25 pm.

This document was prepared and written by
Jacinta Patel
the Medicines Classification Committee Secretary

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