1

WELCOME

The Chair opened the 65^th meeting at 9.33am with a karakia and welcomed members and guests.

2

APOLOGIES

No apologies were received.

3

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

The following amendments were noted about the minutes from the 64^th meeting:

1. Dr Marcia Walker is one of the New Zealand Medical Association nominated members on the Committee.
2. Agenda item 5.3 (c) the attachment of the presentation on the medicinal cannabis scheme and CBD regulation was not attached to the minutes for signing.
3. Agenda item 6.1 the sentence regarding “poor practice” was changed for clarification purposes to “documentation system support”.
4. Agenda item 6.3 a typographical error was amended in the discussion section from evidenceis to evidence is.

4

DECLARATION OF CONFLICTS OF INTEREST

Conflict of Interest forms were returned to the secretary. The Chair concluded that there were no interests which would pose a conflict with any of the items on the agenda.

5

MATTERS ARISING

5.1

Objections to recommendations made at the 64th meeting

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

5.1.1

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

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

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

This was a Medicines Adverse Reaction Committee (MARC) recommendation (PDF, 755 KB, 54 pages) proposing the reclassification of pholcodine from a pharmacy-only medicine to a restricted medicine.

Background

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

At the 55th meeting, 3 May 2016, the Committee considered a submission to change the classification wording for iansoprazole, promethazine, sumatriptan, ibuprofen, omeprazole, pantoprazole, opium, pholcodine and ranitidine. The submission proposed to remove references to approved or manufacturer's original packs. The Committee deferred a decision due to insufficient information.

At the 61st meeting, the Committee agreed that pholcodine has limited potential for abuse. A rare but fatal association with anaphylaxis and neuromuscular blockers and pholcodine was discussed but the evidence for this was considered limited. The Committee discussed how over the counter medicines are sometimes not perceived by patients as medicines and therefore it is more difficult to identify this when taking a patient's medication history. However, the Committee concluded that there were minimal safety concerns around pholcodine and that the current classification is appropriate.

The Committee agreed that consumers can appropriately self-manage coughs and cold. There are alternative cough and cold products available over the counter.

The Committee suggested that Medsafe should review the risk-benefit profile and efficacy of pholcodine, which is a grandfathered medicine.

Medsafe’s review was referred to the Medicines Adverse Reactions Committee (MARC) at their December 2019 meeting. The MARC looked at the association between pholcodine and neuromuscular blocking agent anaphylaxis and found while efficacy studies were inferior, adverse reactions were rare but serious and there must be a pre-sensitisation. People can be sensitised from a number of sources, e.g. cosmetics and chemicals used in occupations such as hairdressing. Studies have noted that the Immunoglobulin E (IgE) response for pholcodine reduces when pholcodine is not in the market, so studies have narrowed this down to medicinal pholcodine as a major sensitizer. However, the evidence is inconclusive and causality unclear. The Medsafe report recommended a change in classification to restricted (pharmacist only) to ensure an interaction with a pharmacist.

At the 64^th meeting, 7 July 2020, the Committee considered the MARC submission that was a result of the Medsafe report and was interested in what effects the absence of pholcodine had had in countries where it has been removed from the market, such as Sweden.

Sweden had an alternative product for dry coughs, but New Zealand has few medicinal alternatives. The current amount of pholcodine purchased over the counter in New Zealand is unknown as this may have changed due to the recent classification changes for other cough suppressants, such as dextromethorphan, but is unlikely to be high volumes.

The Committee discussed that the efficacy data was weak and old, but it was unlikely that better data would be obtained as countries are moving away from using pholcodine and there is no reason to repeat efficacy studies, so the efficacy evidence is unlikely to change. However, this does not mean there is no need for the product as there is still consumer demand.

It was noted that anaphylaxis is rare and neuromuscular blocking agent anaphylaxis is rarer again. A person would have to have repeated exposure to be at risk and that exposure can come from a number of substances in the environment. The causality is unclear.

There is evidence of allergic-type reactions and it is noted there is some concern about masking a cough. It is likely that if the classification is restricted medicine then pharmacists would limit the supply to those who don’t need it and can add value by way of clinical intervention.

The change in classification may not mitigate the risk of anaphylaxis under anaesthetic, as the sensitisation may occur from exposure to a number of substances, but the interaction with the pharmacist may reduce the risk to the individual person.

It was noted that most submitters opposed the reclassification but the chance to reduce the volume used by intervention of a pharmacist may be useful. The Committee discussed reasons to retain the current classification, such as there are no other alternatives, that the connection with neuromuscular blocking agents is not clear due to other environmental factors, and mitigations such as taking a complete history pre-surgery. However, it was considered that these are not compelling reasons to retain the current classification and the allergic-type reaction risk can be best managed by moving to a restricted medicine classification where people who need it can access it from a pharmacist.

Comments

Seven comments were received about the objection to the recommendation made at the 64^th meeting about the reclassification of pholcodine. All seven comments supported retaining the current classification as a pharmacy-only medicine.

Discussion

The Chair summarised the discussion that took place at the 64^th meeting for pholcodine and outlined the key themes of the valid objections. The fundamental essence of the valid objections deemed there was no new safety evidence provided by the MARC paper, but a new decision was made by the Committee.

The Committee considered the comments received during consultation and reflected upon the discussions that resulted in their decision to reclassify pholcodine from pharmacy-only to restricted (pharmacist-only).

It was noted that the 64^th meeting minutes may have been misinterpreted as the decision being weighted on the MARC paper and the inconclusive evidence rather than the benefit for a differential diagnosis provided by a pharmacist.

Additionally, the Committee noted that the discussion around “reducing volume used by intervention by a pharmacist” may have been taken out of context. The comments indicate this was interpreted as market share or sales volumes. The Committee would like to clarify the intention behind this phrase was to indicate reducing the amount of pholcodine consumed when it may not be required, through an interaction with a pharmacist supporting differential diagnosis.

The Chair took the opportunity at this time to remind the Committee of their role to consider their decision for reclassification should be based on safety criteria, efficacy and clinical parameters. The Committee also have a role in proactively identifying where health professional involvement is required in every sale or whether self-selection in a premise where a health professional is available mitigates the risk and benefit.

It is noted that the same criteria used when a submission is made should also be applied by the Committee when making recommendations to change a medicine classification.

The Committee considered the challenges and impacts on pharmacists and acknowledges the pressure this decision may add to their workload. However, the benefit provided by an interaction with a pharmacist for a differential diagnosis was considered an important step for patient safety, particularly with indications for treatment of a dry cough being limited.

The Committee discussed the issues around the implementation of the recommendation for the reclassification of pholcodine. The Committee acknowledges the impact on pharmacists as frontline healthcare workers and considered the suggestion from the objections requesting a longer lead in time prior to the implementation process. The Committee agrees that this would allow for more flexibility and time for preparation given the current pressures on pharmacists due to the pandemic. The Committee suggests following a similar implementation as with the codeine reclassification.

Conclusion

In conclusion, the Committee felt they had comprehensively considered the benefits and risks of harm of pholcodine at their 64^th meeting, as per the guidance document How to change the legal classification of a medicine in New Zealand. The Committee emphasised the importance of an interaction with a pharmacist for a differential diagnosis. This is to reduce use of pholcodine when it may not be indicated, reducing the potential risk of harm.

The Committee proposes that Medsafe liaise with the sector to plan and prepare for implementation for the reclassification of pholcodine.

Recommendation

To change the classification of pholcodine from pharmacy-only to restricted (pharmacist only).

5.2

Paracetamol – recommendation received from the coroner

Purpose

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

1. Pharmacy sales: 16 g per transaction (i.e. 32 x 500 mg tablets)
2. All other outlets 8 g per transaction (i.e. 16 x 500 mg tablets)
3. A maximum of 50 g (i.e. 100 x 500 mg tablets) by prescription.

Note that this Coroner’s recommendation relates to the Alannah Spankie case and has been reported in national media outlets.

Background

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

At the 57^th meeting, 1 November 2016, paracetamol was presented as a part of the standing agenda item Harmonisation of the New Zealand and Australian Schedules.

The Committee recommended:

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

At the 58^th meeting, 16 May 2017, an update was provided on paracetamol.

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

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

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

At the 59^th meeting, 7 November 2017, another update was provided.

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

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

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

It is noted that at the 60^th meeting of the MCC, 26 April 2018, the MARC recommended at the 172nd meeting that the MCC consider reclassifying modified release paracetamol from pharmacy-only medicines to restricted medicines, and that guidelines for the treatment of modified release paracetamol overdose be updated.

The Committee discussed classifications for paracetamol, ibuprofen, diclofenac and aspirin, and how these varied by strength and dosage form.

The Committee arrived at a consensus decision that modified release paracetamol be reclassified from a pharmacy-only medicine to a restricted medicine.

The current classification of paracetamol is:

• Prescription; except when specified elsewhere in this 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 Sales;
  • 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.

Comments

Eleven comments were received about this agenda item. Please see the published comments on the Medsafe website for more detailed information.

Discussion

Foremostly, the Committee would like to offer their condolences to the whānau and friends of Alannah Spankie for their loss.

On behalf of the Committee, the Chair would like to extend their appreciation to the Coroner for putting this in front of the Committee in the interests of transparency which will allow for proper feedback.

The Chair summarised the coroner’s recommendations and noted that additional references had been provided for the Committee to review.

The Committee discussed the findings of the paper “Stocks of paracetamol products stored on urban New Zealand household: a cross sectional study” by Kumpula E-K, Noris, Pomerleu AC (2020).

The Committee noted that the findings in this paper indicate that a paracetamol product is present in the majority of people’s homes (86.6% in the study) and most was prescribed paracetamol.

The Committee expressed concern for the consumer perception around the safety of paracetamol due to the wide availability.

The Committee reviewed the comments received and note the proactive stance suggested by the Pharmaceutical Society. The Society does not support a restriction on pack size but would instead suggest all paracetamol containing products should be reclassified to pharmacy-only.

One member discussed comments raised around the suggestion that PHARMAC should review the amount of paracetamol available on prescription and dispensing restrictions while ensuring access to patients with long term conditions.

The Committee acknowledges and commends positive engagement with leading supermarkets since the 58^th meeting and the release of the coroner’s report. Progressive Enterprises Limited (Countdown) has restricted the sale of paracetamol in their supermarkets to one pack per customer. It is noted that a comment was received from FoodStuffs New Zealand who have not proposed any restrictions to the sale of paracetamol but have indicated an interest in engaging with the Committee regarding potential future review of paracetamol.

The Chair confirms receipt of the letter with the attached comment from Susan Kenyon of Medsafe and Associate Professor David Reith of the Paracetamol Overdose Prevention Working Group. The letter summarises the feedback received from healthcare professionals on the consultation for proposed changes to paracetamol warning and advisory statements by Medsafe. Some of the feedback related to large pack sizes and widespread availability as a contributing factor to public perception of paracetamol as a benign medicine.

Conclusion

The recommendation received from the coroner relates to restrictions on numbers of packs (in grams) per retail transaction, therefore is not a formal submission within the mandate of the Committee for decision. However, the Committee acknowledged that the issues surrounding paracetamol are serious and require extensive consultation.

In the interest of having a transparent and fulsome consultation, the Committee has requested that Medsafe further consider options for addressing both the issues raised by the coroner and broader issues relating to both single active ingredient paracetamol and combination products.

Recommendation

No recommendation for reclassification was required.

5.3

Update on outstanding agenda items from the 64th meeting

5.3(a) Opportunities to optimise access to vaccines (as discussed in agenda item 6.1 of the 63^rd and 64^th meetings)

At the 64^th meeting held on 9 July 2020, the Committee expressed interest in meeting with the Immunisation and Primary Care teams to discuss how classification can help achieve the goals of wider access to immunisations within a clearer, more person-centric system.

The Committee were updated on the strategic direction for improving access to vaccinations. They decided that a set meeting with the immunisation and primary care teams was no longer required and they will engage with them as needed.

5.3(b) Alkyl nitrites (as discussed in agenda item 8.2.1.a of the 63^rd and 64^th meetings)

At the 64^th meeting the Committee received feedback from the Rainbow Community, Men who have Sex with Men (MSM) and other supporting organisations regarding alkyl nitrites. The feedback received indicated that there was confusion over the practical effects of the recommendation and did not take into account alternative classification proposals for the recommendation. The Chair expressed an interest to meet with the sector while further information on impacts in Australia is sought.

The Chair, the Secretary and the Manager of Product Regulation met with sector to discuss regulations, use and misuse, risks and unintended consequences, enforcement and the affects seen in Australia. The Chair expressed this is an ongoing conversation and will continue to engage with the relevant parties.

6

SUBMISSIONS FOR RECLASSIFICATION

6.1

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

Purpose

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

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

The current classification of fexofenadine is:

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

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

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

Background

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

At the 22^nd meeting on 10 November 1999, the Committee recommended that fexofenadine should be classified as a prescription medicine except when specified elsewhere in the schedule and that the current pharmacy-only entry for fexofenadine should be amended by the addition of the words ‘for oral use’.

At the 46^th meeting on 15 November 2011, the Committee recommended that capsules containing 60 mg or less and tablets containing 120 mg or less of fexofenadine hydrochloride should be classified as general sales medicines when:

• used only for short term treatment (maximum five days of therapy) of Seasonal Allergic Rhinitis
• used in adults and children 12 years and over
• used in small (maximum 10 dosage units) oral presentations with a maximum daily dose of 120 mg
• sold in packs approved by the Minister or the Director-General for distribution as a general sales medicine.

That the requirements for fexofenadine hydrochloride to be classified as a general sales medicine should be inserted into the New Zealand Regulatory Guidelines for Medicines by Medsafe.

That Medsafe should be satisfied with the proposed warning labels of any product containing fexofenadine hydrochloride seeking consent for distribution as a general sale medicine.

At the 58th meeting, 16 May 2020, it was noted that the Australian Delegate recommended that the unscheduled (general sale) entry of fexofenadine should be amended to when in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when labelled with a recommended daily dose not exceeding 120 mg of fexofenadine from not more than five days' supply to not more than 10 days' supply.

The Australian delegate received advice that the proposal to down-schedule was appropriate for the following reasons.

1. Lack of sedative effects. Low abuse potential. Ease of accessibility, consumer preference. Increase in pack size will support sufferers of seasonal allergic rhinitis requiring more accessible, flexible and convenient pack size to self-manage their condition.
2. Non-use of alternative treatments, misdiagnosis, potential use for other allergic disorders.
3. Seasonal allergic rhinitis can last up to 10 days.
4. Fexofenadine has a wide therapeutic index and well-established toxicity profile. Has been shown to be safe at dosages of 800 mg/day, which is six times the dose recommended for treatment of seasonal allergic rhinitis.
5. Current dosage, formulation, labelling and packaging for unscheduled fexofenadine remains unchanged except for the increase in pack size.
6. The proposed increase pack size of fexofenadine would retain the statement to seek medical advice if symptoms persist after five days to ensure any consumers who may not be experienced users or who have not previously used it to mitigate the potential for misdiagnosis of any underlying serious symptoms.
7. Seasonal allergic rhinitis is a common, easily identified condition that is appropriate for self-management. Non treatment of seasonal allergic can affect a sufferer's quality of life.
8. The number of adverse events recorded on the TGA's Database of Adverse Event Notifications for the period before and after the availability of unscheduled fexofenadine show an unchanged safety profile.

The Committee considered the Scheduling delegate’s final decisions, July 2016 (made in a meeting on 27 October 2016) published on the Therapeutic Goods Administration website and discussed harmonising with the above classification.

The submission increased the pack size available at general sale from five to 10. The Committee stated again it was difficult to harmonise without seeing the full submission and data set considered in Australia.

The Committee recommended that New Zealand should not harmonise with Australia and that the general sale entry of fexofenadine should not be amended to when in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when labelled with a recommended daily dose not exceeding 120 mg of fexofenadine from not more than five days' supply to not more than 10 days' supply.

Comments

One comment was received about this agenda item. The comment opposed the proposal.

Discussion

This item was discussed in conjunction with the harmonisation agenda item 8.2.2.b fexofenadine. Aspects of this discussion may also be applicable to agenda item 8.2.2.b.

The Committee briefly discussed the pack size extension at general sale for the 60mg and 120mg strengths and were satisfied with the overall safety profile supporting fexofenadine. The Committee noted that the proposed classification would be consistent with the classifications of other non-sedating antihistamines.

The Committee discussed the second part of this proposal relating to the introduction of a 180mg strength pack to general sale when used for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in tablets containing 180mg or less of fexofenadine hydrochloride with maximum daily dose of 180mg when sold in the manufacturer’s original pack containing 5 dosage units or less and not more than 5 days’ supply.

The Committee raised concerns relating to the ability for a consumer to make a selection if all three strengths were available under general sale and the risk of double dosing. It was determined that due to the pack size the risk of overdose was minimal. One Committee member suggested that mitigation measures are put in place such as clear labelling on all strengths.

Recommendation

That the general sale classification of fexofenadine should be amended to increase the 60mg and 120mg fexofenadine general sale pack sizes to 20 dosage units or less and not more than 10 days supply for the treatment of Seasonal Allergic Rhinitis (SAR), when used only in adults and children 12 years and over with a maximum daily dose of 120mg when sold in manufacturer’s original pack.

That the general sale classification of fexofenadine should be amended to include general sale when used for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in tablets containing 180mg or less of fexofenadine hydrochloride with maximum daily dose of 180mg when sold in the manufacturer’s original pack containing 5 dosage units or less and not more than 5 days’ supply.

6.2

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

(Nurofen 400 Double Strength, Reckitt Benckiser (New Zealand) Pty Limited)

Purpose

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

The current classification of ibuprofen is:

Prescription; except when specified elsewhere in this schedule.

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

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

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

Background

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

At the 35^th meeting, 9 June 2006, the Committee recommended:

• That 400 milligram ibuprofen tablets should be reclassified from prescription medicine to restricted medicine when in packs approved by the Minister or the Director-General to their sale as restricted medicines
• That Medsafe should be asked to update the relevant section of the New Zealand Regulatory Guidelines for Medicines to reflect the Committee’s requirements for the sale of 400 milligram ibuprofen tablets as restricted medicines.

The Secretary noted that in order to carry out the Committee’s recommendation the restricted medicine schedule entry for 400 milligram ibuprofen tablets should follow the format used for pharmacy-only and general sale ibuprofen in that the product should be sold only when in packs approved for sale at this level. Medsafe could then be asked to add the requirements for restricted medicine ibuprofen to the current ibuprofen guidelines in the New Zealand Regulatory Guidelines for Medicines.

At the 37^th meeting on 17 May 2007, as a part of the harmonisation, it was recommended that the restricted medicine entry for ibuprofen 400 milligram tablets should be amended to show that the product is not indicated for children under 12 years of age.

Comments

Two comments were received for about this agenda item. Both comments do not support the proposal.

Discussion

The Committee notes that this proposal is not supported by the Pharmaceutical Society of New Zealand and the Pharmacy Guild of New Zealand and briefly discussed the concerns raised by the comments.

The Committee discussed the safety and dosing of ibuprofen and highlighted concerns for consumers that may have otherwise used a codeine containing product then replacing these with a non-steroidal medicine, particularly around the elderly.

There were concerns around the justification presented by the submission to widening access to non-steroidal anti-inflammatory medicines. The Committee noted this could lead to issues such as an increased risk for upper gastrointestinal (GI) bleeding and acute kidney injury.

The Committee considered the comment raised relating to the risks associated with the availability of the 400mg strength ibuprofen at general sale versus the consumer benefit. The Committee agrees that the risks outweigh the consumer access benefit as the usual prescribed adult dose of ibuprofen is two tablets of the 200mg strength. Additionally, the Committee considered that the 400mg ibuprofen single tablet dose is a relatively new presentation to the market at restricted level so it is unlikely that consumers are familiar with it; Therefore the consumer benefit is minimal when compared to the significant potential for harm if a consumer accidentally takes twice the recommended dose of ibuprofen.

The Committee signalled that if there is a clinical advantage for an individual consumer to be recommended the ibuprofen 400mg tablet dose form, then the supply should always be accompanied by the oversight and advice of a pharmacist.

The Committee concluded there were no clear benefits for introducing a 400mg strength ibuprofen at pharmacy only level.

Recommendation

The current classification of ibuprofen 400mg should remain unchanged.

6.3

Flurbiprofen – proposed reclassification from pharmacy only medicine to general sale medicine

(Flurbiprofen lozenge, Reckitt Benckiser (New Zealand) Pty Limited)

Purpose

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

The current classification for flurbiprofen is:

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

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

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

Background

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

The Committee noted that a submission for the reclassification of flurbiprofen lozenges had also been made to the Australian National Drugs and Poisons Schedule Committee for consideration at their 58th meeting on 16-18 February 2010.

At the 43^rd meeting on 13 April 2010, the Committee considered a submission for the reclassification of flurbiprofen 8.75 mg lozenges from pharmacy-only medicine to general sale medicine, for the relief of pain, swelling and inflammation associated with severe sore throats. The Committee recommended that the submission would be reconsidered if Reckitt Benckiser provided data confirming that consumers could clearly differentiate and understand the differences between Strepfen and cough and cold unmedicated preparations such as Strepsils.

Two pre-meeting comments had been received during the consultation period and neither supported the reclassification proposed. Concern was emphasised about the potential for consumer confusion between Strepfen and unmedicated preparations such as Strepsils, with consequent adverse impacts on consumer safety. In addition, the submissions noted the proposed warning statements on the label of Strepfen lozenges (e.g. check with your pharmacist or doctor if you are receiving regular treatment with other medications) were not what was expected on a general sale product. A pharmacy-only classification was the least restrictive for a medicine whilst retaining its display and sale within the environment of a pharmacy.

One Committee member had bought examples of both Strepfen and Strepsils and it was agreed that the packets looked similar.

Reckitt Benckiser had contacted the Secretary and stated that further data would be provided at a later unspecified date. However, the Committee agreed that, because of the comments received and that the same submission was being discussed as a harmonisation issue during Agenda Item 8.2.2a, the reclassification of flurbiprofen 8.75 mg lozenges would not be carried forward to the next agenda as a matter arising. However, additional data could be submitted by Reckitt Benckiser in a new submission to the Committee.

The Committee agreed that New Zealand should harmonise with Australia and discussed the terminology that would allow harmonisation because undivided preparations had been included in their Schedule 2 (pharmacy-only) entry. Harmonising would align flurbiprofen with other non-steroidal anti-inflammatory medicines.

Safety issues were not well defined for sprays and mouthwashes as they had been with other oral liquid dose forms. However, it was noted that the risk of anaphylaxis existed for all dose forms.

Following discussion, it was agreed that ‘locally acting oromucosal preparations’ would include lozenges as well as liquids and other methods of oral administration.

Comments

Two comments were received for this agenda item. Both comments do not support the proposal.

Discussion

This item was discussed in conjunction with the harmonisation agenda item 8.2.2.c flurbiprofen. Aspects of this discussion may also be applicable to agenda item 8.2.2.c.

The Committee acknowledges that flurbiprofen has come before the Committee at the 43^rd meeting, held on 13 April 2010, where the Committee at the time requested data from consumer testing indicating that consumers could clearly differentiate and understand the differences between Strepfen and Strepsils before the Committee would be comfortable considering reclassification of flurbiprofen in this product.

The Committee noted that although the submission addresses the issues raised by the Committee in 2010, the submission is deficient in New Zealand specific data and does not take into consideration the New Zealand context particularly noting that there is now a more substantive body of evidence around the prevalence of acute rheumatic fever in New Zealand.

Following a discussion of comments raised, the Committee discussed that increasing the availability of a medicine which masks the symptoms of sore throats, and without the advice of a health professional will significantly impact our current incidence of untreated streptococcal throat infections, through delayed detection and diagnosis.

The Committee agrees that given the specific New Zealand context with acute rheumatic fever, it would be inappropriate to reclassify flurbiprofen to general sale.

Recommendation

The current classification for flurbiprofen should remain unchanged.

6.4

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

Purpose

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

The current classification of hyoscine butylbromide is:

Prescription; except when specified elsewhere in this schedule.

Restricted;

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

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

Background

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

At the 21^st meeting on 25 March 1999, in response to a submission for the reclassification of 10 mg hyoscine butylbromide tablets from restricted medicine to pharmacy-only medicine, the Committee agreed that there be no change to the classification.

At the 22^nd meeting on 10 November 1999, following an objection from the company to the recommendation made by the Committee at the 21st meeting, the Committee agreed that there would still be no change to the current restricted medicine classification of 10 mg hyoscine butylbromide tablets.

At the 27^th meeting on 23 May 2002 and the 29th meeting on 22 May 2003, the Committee maintained its stance that hyoscine butylbromide remain a restricted medicine in 10 mg tablets in packs containing not more than 200 mg.

At the 33^rd meeting on 9 June 2005, in response to the submission for the reclassification of hyoscine butylbromide to pharmacy-only medicine in medicines containing 20 mg or less and in packs containing not more than 200 mg of hyoscine butylbromide, the Committee recommended that there should be no change to the current classification.

At the 55^th meeting on 12 November 2013 the Committee recommended that hyoscine butylbromide 20 mg tablets, in a pack containing not more than 10 tablets or capsules, should be reclassified from prescription medicine to restricted medicine for the relief of muscle spasm of the gastrointestinal tract.

That the company should consult with Medsafe regarding the appropriateness of halving the tablet to achieve doses for children less than 12 years of age.

That the company review its labels so that the 10 mg and 20 mg tablet packs are clearly distinguishable

Comments

One comment was received for this agenda item. The comment supported the proposal.

Discussion

This item was discussed in conjunction with the harmonisation agenda item 8.2.1.e hyoscine butylbromide. Aspects of this discussion may also be applicable to agenda item 8.2.1.e.

The Committee briefly discussed the proposal and were satisfied with the overall safety profile of hyoscine butyl bromide. However, concerns were raised over the undesirable effects such as hallucination and induced delirium.

The Committee note there is a potential for unintended misuse of liquid form hyoscine butylbromide in paediatric patients and an increased risk to elderly patients with reduced renal function.

The Committee concluded the potential harm outweighs the suggested benefit a liquid dose form would provide. The Committee noted that the available tablets are very small and do not perceive swallowing as an issue, therefore a liquid dose form has few advantages over the tablet.

Recommendation

The current classification for hyoscine butylbromide should remain unchanged.

7

NEW MEDICINES FOR CLASSIFICATION

7.1

New chemical entities

7.1a

Brolucizumab

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

Brolucizumab is a monoclonal antibody which binds to VEGF-A. By preventing VEGF-A from binding to its receptor, brolucizumab should reduce neovascularisation. Only a small volume (0.05 mL) of solution is injected into the vitreous. Very little enters the systemic circulation. Brolucizumab has a systemic half-life of 4.4 days and is eliminated like other proteins. Its pharmacokinetics are unlikely to be affected by liver or kidney disease, or other drugs.

Recommendation

That brolucizumab should be classified as a prescription medicine.

7.1b

Indocyanine Green

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

Indocyanine Green is a water soluble, tricarbocyanine dye with a peak spectral absorption at 800 nm.

Recommendation

That indocyanine green should be classified as a prescription medicine.

7.1c

Acalabrutinib

Calquence capsule, 100 milligram (TT50-10756)

Acalabrutinib is a small-molecule inhibitor of BTK. Acalabrutinib and its active metabolite, ACP-5862, form a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity.

Recommendation

That acalabrutinib should be classified as a prescription medicine.

7.1d

Siponimod

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

Siponimod is an immunomodulator with actions similar to those of fingolimod (Fingolimod Hydrochloride). Siponimod binds selectively to some of the sphingosine-1-phosphate receptor forms—including sphingosine-1-phosphate receptor 1 (found on lymphocytes and other cell types). This binding inhibits the migration of the lymphocytes to the location of the inflammation

Recommendation

That siponimod should be classified as a prescription medicine.

7.1e

Fremanezumab

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

Fremanezumab is a fully humanised monoclonal antibody produced in Chinese Hamster Ovary (CHO)cells by recombinant DNA technology.

Recommendation

That fremanezumab should be classified as a prescription medicine.

7.1f

Isatuximab

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

Isatuximab is an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds to a specific extracellular epitope of cluster of differentiation 38 (CD38) receptor and triggers several mechanisms leading to the death of CD38 expressing tumor cells.

Recommendation

That isatuximab should be classified as a prescription medicine.

7.1g

Alitretinoin

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

Alitretinoin, or 9-cis-retinoic acid, is a form of vitamin A.

Alitretinoin binds to retinoid receptors on the cell nucleus and activates the receptors. Activated receptors regulate the expression of genes that control cell differentiation and growth in both normal and abnormal cells.

In this way, alitretinoin is able to inhibit the growth of Kaposi sarcoma cells.

Recommendation

That alitretinoin should be classified as a prescription medicine.

8

HARMONISATION OF THE NEW ZEALAND AND AUSTRALIAN SCHEDULES FOR NOTING

Purpose

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

8.1

New chemical entities which are not yet classified in New Zealand

Final decisions for new chemical entities and medicines (14 January 2020)

8.1.1

Acalabrutinib

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

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

Recommendation

That acalabrutinib should be added to the New Zealand Schedule as a prescription medicine as per agenda item 7.1c.

8.1.2

Alanylglutamine

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

It is noted that this substance is found in sports supplements available on the New Zealand market.

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

Recommendation

That alanylglutamine should be noted for a change in classification and be placed on the 66^th meeting agenda to allow for consultation with sports supplement suppliers.

8.1.3

Enasidenib

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

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

Recommendation

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

8.1.4

Gilteritinib

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

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

Recommendation

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

8.1.5

Siponimod

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

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

Recommendation

That siponimod should be added to the New Zealand Schedule as a prescription medicine as per agenda item 7.1d.

8.1.6

Sodium glycerophosphate hydrate

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

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

Potential impact on products in the New Zealand Market:

• SmofKabiven NTense, emulsion for infusion, General sale (TT50-9045/2)
• SmofKabiven Low Osmo, emulsion for infusion, General sale (TT50-9045/3)
• Glycerophate pentahydrate, concentrate for infusion, General sale (TT50-7097)

Background

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

At the 25^th meeting, 17 May 2001, the Committee noted that nutrition replacement preparations for parenteral administration is a group of medicines which are exempt from scheduling in Australia and which would require reclassification to general sale in New Zealand in order to harmonise on the level of access. Medsafe identifies any classified medicines which were contained in these preparations and exempts them from their classification status when used in this way.

Recommendation

That there should be no change in classification to sodium glycerophosphate hydrate. The Committee considered the current classification conditions to be satisfactory, as it is based on a long-standing classification policy where the products are not freely available.

8.1.7

Voretigene neparvovec

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

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

Reccomendation

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

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

8.1.8

Cabotegravir

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

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

Recommendation

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

8.1.9

Cedazuridine

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

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

Recommendation

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

8.1.10

Decitabine

Decitabine is indicated for the treatment of myelodysplastic syndromes

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

Recommendation

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

8.1.11

Fosnetupitant

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

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

Recommendation

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

8.1.12

Larotrectinib

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

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

Recommendation

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

8.1.13

Ozanimod

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

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

Recommendation

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

8.1.14

Ripretinib

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

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

Recommendation

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

8.1.15

Tafamidis

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

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

Recommendation

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

8.1.16

Tucatinib

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

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

Recommendation

That tucatinib 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)

Purpose

The Committee has clarified that Decisions by the Secretary to the Department of Health and Aging in Australia are for noting the first time they are presented to the Committee. The medicines are then placed on the agenda for the following meeting to allow for consultation.

8.2.1

Decisions by the Delegate – 7 May 2020

8.2.1.a

Zolmitriptan

The 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.

Comment

One comment was received about this agenda item. The comment opposed the proposal.

Recommendation

That this scheduling change should be noted and be placed on the 66^th meeting agenda for recommendation.

8.2.1.b

Mometasone

The 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.

Comment

One comment was received about this agenda item. The comment opposed the proposal.

Recommendation

That this scheduling change should be noted and be placed on the 66^th meeting agenda for recommendation.

8.2.1.c

Calcifediol

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

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

Recommendation

That this scheduling change should be noted and be placed on the 66^th meeting agenda for recommendation.

8.2.1.d

Paracetamol (liquid formulations)

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

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

This decision has been implemented since 1 June 2020.

Recommendation

That this scheduling change should be noted and be placed on the 66^th meeting agenda for recommendation.

8.2.1.e

Hyoscine Butylbromide

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

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

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

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

This decision has been implemented since 1 June 2020.

Recommendation

Note: Hyoscine butylbromide was discussed in agenda item 6.4. The Committee recommended that the classification for hyoscine butylbromide should remain unchanged.

8.2.1.f

Lidocaine

The 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.

Recommendation

That this scheduling change should be noted and be placed on the 66^th meeting agenda for recommendation.

8.2.1.g

Caffeine

The 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.

Recommendation

That this scheduling change should be noted and be placed on the 66^th meeting agenda for recommendation.

8.2.1.h

Paracetamol (modified release)

The 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.

Recommendation

That this scheduling change should be noted and be placed on the 66^th meeting agenda for recommendation.

8.2.2

Decisions by the Delegate – 24 August 2020

8.2.2.a

Adapalene

The 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

Recommendation

That this scheduling change should be noted and be placed on the 66^th meeting agenda for recommendation.

8.2.2.b

Fexofenadine

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

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

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

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

The date of implementation is 1 October 2020.

Recommendation

Note: Fexofenadine was discussed in agenda item 6.1. The Committee recommended that the general sale classification of fexofenadine should be amended to increase the 60mg and 120mg fexofenadine general sale pack sizes to 20 dosage units or less and not more than 10 days supply for the treatment of Seasonal Allergic Rhinitis (SAR), when used only in adults and children 12 years and over with a maximum daily dose of 120mg when sold in manufacturer’s original pack.

That the general sale classification of fexofenadine should be amended to include general sale when used for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in tablets containing 180mg or less of fexofenadine hydrochloride with maximum daily dose of 180mg when sold in the manufacturer’s original pack containing 5 dosage units or less and not more than 5 days’ supply.

8.2.2.c

Flurbiprofen

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

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

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

The date of implementation is 1 October 2020.

Recommendation

Note: Flurbiprofen was discussed in agenda item 6.3. The Committee recommended that the classification for flurbiprofen should remain unchanged.

8.2.2.d

Arbutin

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

The date of implementation is 1 October 2020

Recommendation

That this scheduling change should be noted and be placed on the 66^th meeting agenda for recommendation.

8.2.2.e

Tigilanol tiglate

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

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

Recommendation

That this scheduling change should be noted and be placed on the 66^th meeting agenda for recommendation.

9

AGENDA ITEMS FOR THE NEXT MEETING

9.1. noted agenda items to be placed for recommendation from the Decisions by the Secretary to the Department of Health and Aging in Australia

10

GENERAL BUSINESS

10.1

Codeine implementation

Following on from the recommendations of the 59th meeting and the 63rd meeting, the implementation of the change to the classification of codeine-containing products is 5 November 2020. From this date, all codeine only and codeine-containing products will only be able to be supplied pursuant to a prescription. Medsafe has worked with the pharmaceutical industry sector to identify a date for this change that is practicable. All labelling should be transitioned by May 2021. Advice to healthcare professionals on managing the clinical aspects of change will be provided by bpac^nz.

11

DATE OF THE NEXT MEETING

A date in April 2021 will be confirmed.