1

Welcome

The Chair opened the 62^nd meeting at 9:30 am with a karakia and welcomed members and guests.

The Committee offered their condolences following the loss of Dr Stewart Jessamine who was a mentor and friend to many. Dr Jessamine was previously a member and Chair of the Committee. The Committee recalled Dr Jessamine’s significant contribution to improving the practice of medicine throughout his career.

2

Apologies

Apologies were received from Professor Les Toop and Dr David Burrell.

3

Confirmation of the minutes of the 61^st meeting held on 2 November 2018

The following amendments were noted about the minutes of the 61^st meeting:

1. Agenda item 6.2. Following the Secretary’s note, the Committee discussed whether the words ‘volume of sales’ accurately reflected the discussion that had occurred. The Committee concurred that the words ‘overconsumption by individuals’ better described the discussion and to revise the sentence for clarification purposes to: ‘The Committee understood that the misuse of dextromethorphan is associated with overconsumption by individuals and therefore a restricted entry may mitigate this risk’.

The remainder of the minutes of the 61^st meeting were accepted as a true and accurate record. The minutes were signed and dated by the Chair.

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 61^st meeting

No valid objections were received.

Medsafe explained what the valid objection criteria were and outlined the themes raised from the objections received.

The Committee understood that the minutes should accurately reflect the discussion and rationale of a recommendation. The Committee suggested to include in the minutes, where relevant, that there were in-depth discussions or a range of opinions so that the minutes accurately capture the nature of the discussions. The Committee concurred that the minutes should not be a transcript because this was not considered helpful or appropriate.

The Committee was reminded of the importance of following process when making recommendations because this was considered one of the valid objection criteria. It was clarified that the Committee should make recommendations only on the classification status sought in an application, which has undergone consultation, and not recommend any alternative options. The Committee may however, indicate its willingness to consider a classification change other than that sought initially. This would require a separate submission to ensure adequate consultation.

The Committee indicated that they found this discussion helpful and that an outline of the objections received, whether valid or not, should become a regular agenda item. Medsafe agreed.

5.2

Membership of the MCC

The Minister has appointed Andi Shirtcliffe as chairperson and a new member from the Ministry, Dr Natasha White. Dr White currently holds the position of Deputy Director of Public Health at the Ministry of Health and is experienced in public health matters. The Committee congratulated Andi Shirtcliffe and Dr White on their appointments.

5.3

Gazette notice to implement recommendations made at the 61^st meeting

Medsafe outlined the process for implementing classification recommendations and drew attention to the Gazette. Medsafe reported on the challenges encountered when implementing recommendations from the 61^st meeting.

Medsafe highlighted the published time frames (both legislative and published guidance) for implementing changes to the classification of a medicine.

This agenda item was meant to help members have a line of sight as to the outcome and implementation of recommendations. The Committee indicated that they found this helpful and that it should become a regular agenda item. Medsafe agreed.

5.4

Update on outstanding agenda items from the 61^st meeting

(5.3) Referred submission from the 60th meeting - agenda item 6.4 melatonin - proposed reclassification from prescription medicine to a restricted medicine

(6.1) Melatonin prolonged release 2 mg tablets - proposed reclassification from prescription medicine to prescription except when classification

The Committee had agreed to write to the Pharmaceutical Society of New Zealand (PSNZ) and the Pharmacy Council about the points raised in the discussions on melatonin. This action will be taken once the recommendation to reclassify melatonin has been confirmed. The Minister’s Delegate had requested further advice prior to making a decision. Medsafe advised that this is currently under progress.

(6.2) Dextromethorphan, opium tincture, squill oxymel and pholcodine - proposed reclassification from general sale and pharmacy only medicines to restricted medicines

The Committee had recommended that Medsafe should review the risk-benefit profile and efficacy of pholcodine and dextromethorphan. The Committee was advised that this review is in progress.

(9.1) Reclassification of codeine

The Committee was advised that a paper on the classification of codeine was planned to be submitted for consideration at the 62^nd meeting.

Medsafe advised that this paper is on-track for submission to the 63^rd meeting and pointed out to the Committee that the timeframe for implementation will need to be reviewed. The implementation date of 30 January 2020 is not practicable and Medsafe will work with stakeholders to revise this time frame.

The Committee was concerned that if the classification of codeine was to be harmonised with Australia that there may be a potential for a gap in analgesia treatment options available without a prescription, in particular for dental pain. Other analgesia treatment options available without a prescription include paracetamol and nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, diclofenac, naproxen and mefenamic acid. Codeine is the only opioid analgesic available without a prescription.

6

Submissions for reclassification

6.1

Ropivacaine up to 7.5 mg/mL, solution for injection – proposed reclassification from prescription medicine to prescription except when classification
(Podiatrists Board of New Zealand )

Purpose

This is a submission (PDF, 197 KB, 14 pages) from the Podiatrists Board of New Zealand proposing that ropivacaine be reclassified from a prescription medicine to a ‘prescription except’ classification for podiatrists with the extended scope of practice of podiatric surgeons.

Background

Ropivacaine

At the 15^th meeting on 30 November 1995, the Committee recommended that ropivacaine should be classified as a prescription medicine.

Ropivacaine is currently classified as a prescription medicine.

Comments

Two comments were received about this agenda item.

Discussion

This item was discussed in conjunction with agenda item 6.2 bupivacaine and adrenaline. Aspects of this discussion may also be applicable to agenda item 6.2 and vice versa.

The Committee noted the comments received from the PSNZ and the College of Podiatric Surgeons. The Committee noted the range of opinions by the applicant, the Podiatrists Board, and the College of Podiatric Surgeons.

Extensive discussion took place regarding the role of podiatrists and podiatric surgeons. The Committee acknowledged that they had limited knowledge about the practice of podiatry. However the Committee emphasised that podiatry is a recognised and regulated health profession and that podiatric surgeons are a recognised scope of practice for podiatrists.

The Committee questioned whether the issue of achieving access to these medicines for podiatric surgeons was better solved by reclassification or by the prescribing rights pathway.

The Committee concluded that the rationale for reclassification should be weighted on the risk-profile of the drug product and its administration, rather than the practice of podiatric surgeons who have already been deemed competent by their Responsible Authority.

The Committee was reminded that there are already classification statements that provide an exemption for podiatrists and the Committee discussed the example of lidocaine. The use of lidocaine by podiatrists is well-established and the exemption for podiatrists has been in place as early as 1993. The Committee questioned whether lidocaine is currently already used with adrenaline, as it was understood to prolong the duration of anaesthesia.

The Committee understood that there is only a small group of podiatric surgeons registered in New Zealand. The Committee discussed how the benefits of reclassifying additional options for local anaesthetics for podiatric surgeons was likely to be small (because of the limited number of practising podiatric surgeons). The Committee also commented on the possibility of challenges in equity and illustrated this with the scenario if all podiatric surgeons were located in one city.

Currently lidocaine is the only local anaesthetic available to podiatrists. The Committee commented on how the additional options for local anaesthesia (bupivacaine and ropivacaine) could benefit the practice of podiatric surgery.

The Committee discussed the additional risk associated with the dosage form of ropivacaine and bupivacaine solutions for injection. Due to their route of administration by injection, parenteral dosage forms have an additional risk (compared to oral dosage forms).

It was agreed that further information on this submission would be required and that further discussion should be deferred until additional information had been received. The Committee also pointed out that the published agenda had stated the incorrect strength (10 mg/mL instead of 7.5 mg/mL).

Recommendation

The Committee could not make a recommendation to reclassify ropivacaine based on the information provided in the submission.

The Committee has requested further information from the applicant, the Podiatrists Board of New Zealand, for consideration at a future meeting. The Committee requested the following information:

• a risk-benefit analysis as per the risk tree (Figure 1) in the guidance document 'How to change the classification of a medicine in New Zealand'
• a comparison of the risk and benefit profiles of ropivacaine and bupivacaine, compared to lignocaine
• a discussion on who the submission may affect by indicating the number of surgeries that are performed per year and if the submission may allow for more complex surgeries.

6.2

Bupivacaine up to 0.5% w/v in combination with adrenaline – proposed reclassification from prescription medicine to prescription except classification
(Podiatrists Board of New Zealand)

Purpose

This is a submission (PDF, 247 KB, 14 pages) from the Podiatrists Board of New Zealand proposing that Marcain Plain and Marcain with adrenaline, which contain the active ingredients bupivacaine and adrenaline, be reclassified from prescription medicines to ‘prescription except’ classification for podiatrists with the extended scope of practice of podiatric surgeons.

Background

Bupivacaine

Bupivacaine is currently classified as a prescription medicine.

Adrenaline

At the 22^nd meeting on 10 November 1999, in order to harmonise with Australia the Committee recommended that adrenaline be classified as:
Prescription; in medicines containing more than 1%
Restricted; in medicines containing 1% or less and more than 0.02%
General sale; in medicines containing 0.02%.

At the 48^th meeting on 30 October 2012, the Committee recommended to harmonise with Australia. The Committee recommended that preparations for injection containing 1% or less of adrenaline should be reclassified as restricted medicines and preparations above 1% should be reclassified as prescription medicines.

Adrenaline is currently classified as the following:
Prescription; in medicines containing more than 1%Restricted; in medicines containing 1% or less except in medicines for injection containing 0.02% or less
Adrenaline may be sold as general sales when in medicines in injection containing 0.02% or less.

Comments

One comment from the PSNZ was received regarding this agenda item.

Discussion

This item was discussed in conjunction with agenda item 6.1 bupivacaine and adrenaline. Aspects of this discussion may also be applicable to agenda item 6.1 and vice versa

The Committee discussed the potential complications following the use of adrenaline, particularly in peripheral areas such as the foot. The Committee also raised a question about how podiatric surgeons would be expected to manage complications relating to local anaesthetics and adrenaline. The Committee was uncertain if the scopes of practice required competency in advanced life support and management of acute hypotension.

Recommendation

The Committee could not make a recommendation to reclassify bupivacaine and adrenaline based on the information provided in the submission.

The Committee has requested further information from the applicant, the Podiatrists Board of New Zealand, for consideration at the next meeting. In addition to the points already raised in agenda item 6.1, the applicant is requested to clarify if they had intended to include adrenaline in their submission because it was not clear why it was included for the submission for bupivacaine but not in the submission for rupivacaine (agenda item 6.1).

7

New medicines for classification

7.1

Tivozanib

Fotivda capsule, 890 and 1,340 micrograms (TT50-10460, a)

Recommendation

That tivozanib should be classified as a prescription medicine.

8

Harmonisation of the New Zealand and Australian schedules

8.1

New chemical entities which are not yet classified in New Zealand

December 2018 Scheduling Final Decisions Public Notice

8.1.1

Crisaborole

Crisaborole is a phosphodiesterase-4 (PDE-4) inhibitor and is developed for topical treatment of mild to moderate atopic dermatitis.

From 1 February 2019, crisaborole is classified as a prescription medicine in Australia.

Recommendation

That crisaborole should be classified as a prescription medicine.

8.1.2

Brigatinib

Brigatinib is an orphan drug used for the treatment of anaplastic lymphoma kinase-positive, r-cos 1 oncogene positive, or epidermal growth factor receptor positive non-small cell lung cancer.

From 1 February 2019, brigatinib is classified as prescription medicine in Australia.

Recommendation

That brigatinib should be classified as a prescription medicine.

8.1.3

Lanadelumab

Lanadelumab is indicated for the prophylaxis of hereditary angioedema.

From 1 February 2019, lanadelumab is classified as prescription medicine in Australia.

Lanadelumab is not specifically scheduled in the Medicines Regulations, but as a monoclonal antibody, it is captured by the entry for monoclonal antibodies as a prescription medicine.

Recommendation

That lanadelumab should be classified as a prescription medicine.

8.1.4

Romosozumab

Romosozumab is indicated for the treatment of osteoporosis.

From 1 February 2019, romosozumab is classified as prescription medicine in Australia.

Romosozumab is not specifically scheduled in the Medicines Regulations, but as a monoclonal antibody, it is captured by the entry for monoclonal antibodies as a prescription medicine.

Recommendation

That romosozumab should be classified as a prescription medicine.

28 September 2018 Scheduling Final Decisions

8.1.5

Safinamide

Safinamide is indicated for the treatment of adult patients with idiopathic Parkinson’s disease.

From 1 October 2018, safinamide has been classified as prescription medicine in Australia.

Recommendation

That safinamide should be classified as a prescription medicine.

8.1.6

Tilmanocept

Tilmanocept is a diagnostic, receptor-targeted, radiopharmaceutical developed for the detection of sentinel lymph nodes. It is indicated for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous carcinoma of the oral cavity.

From 1 October 2018, tilmanocept has been classified as prescription medicine in Australia.

Recommendation

That tilmanocept should be classified as a prescription medicine.

8.2

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

8.2.1

Decisions by the Delegate – 29 November 2018

8.2.1.a

Budesonide

The Schedule 2 entry (pharmacy-only) for budesonide should be amended to increase the dose per actuation from 50 to 64 micrograms and to remove the limit of 200 actuations per primary pack.

The implementation date for the delegate’s decision is 1 February 2019.

Budesonide is currently classified as the following:

Prescription; except when specified elsewhere in this Schedule

Pharmacy-only; 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 and when the maximum recommended daily dose is no greater than 400 micrograms (200 micrograms per nostril) in a pack containing 200 actuations or less.

Recommendation

That New Zealand should harmonise with Australia and that the pharmacy-only classification for budesonide should increase the dose per actuation to 64 micrograms and to remove the limit of 200 actuations per primary pack.

8.2.1.b

Fluticasone

The Schedule 2 entry (pharmacy-only) for fluticasone should be amended to remove the limit of 200 actuations per primary pack.

This decision has been implemented in Australia since 1 October 2018.

Fluticasone is currently classified as the following:

Prescription; except when specified elsewhere in this Schedule

Pharmacy-only; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age when in aqueous nasal sprays delivering up to 50 micrograms per actuation with a maximum recommended daily dose of 200 micrograms (as a single dose) in a pack containing 200 actuations or less.

Recommendation

That New Zealand should harmonise with Australia and that the pharmacy-only entry classification of fluticasone should remove the limit of 200 actuations per primary pack.

9

Agenda items for the next meeting

10

General business

10.1

Guidance document ‘How to change the legal classification of a medicine’ updated (March 2019)

Medsafe advised the Committee that the outcome for observers had been formalised in the guidance document. Observers are now asked to be available by teleconference or video conference on the day of the meeting, rather than attending in-person. The Committee noted that observers may be invited to attend in-person at the request of the Chair.

10.2

Update on the Therapeutic Products Bill

The Committee was reminded that the consultation on the Therapeutic Products Bill will be closing soon. The Committee discussed aspects of the Bill such as Category 3 and future memberships to committees. The Committee concurred that they wished to provide feedback on the Bill.

11

Date of next meeting

To be confirmed.