1

Welcome

The Deputy Chair opened the 58^th meeting at 9:30 am and welcomed members and guests.

The Deputy Chair welcomed Dr Burrell to the Committee. Dr Burrell is replacing Dr Baddock as one of the nominees from the New Zealand Medical Association. As it was his first meeting and Dr Baddock was still in attendance, Dr Burrell could participate in discussion but would not be able to vote on any recommendation. The Deputy Chair thanked Dr Baddock for her enormous contribution to the Committee during her two terms.

The Deputy Chair also welcomed the Acting Manager of Product Regulation, Ms Cossar, to the meeting who attended to provide advice to the Committee on regulatory issues if required. It was noted that advisors could advise on health and / or regulatory issues but did not have voting rights.

2

Apologies

Apologies were received from Dr Jessamine.

3

Confirmation of the minutes of the 57^th meeting held on 1 November 2016

Two amendments were made to the minutes of the 57 ^th meeting.

Under item '5.1 Report on agenda items from the previous meeting' the following sentence in the final paragraph of 6.5 should be amended from ‘The Committee noted the time limits for other regulatory processes, and decided that if a revised submission was not received for the 58 ^th meeting, an item will be added to the agenda of the 59^th meeting to act as a mechanism to determine whether to allow further time or consider the submission lapsed.’ to ‘The Committee noted the time limits for other regulatory processes and decided that if a revised submission was not received for the 58^th meeting, they would determine at the 58^th meeting whether to allow further time or consider the submission lapsed.’

Under item 5.3 Updating the guidance document titled 'How to change the legal classification of a medicine in New Zealand' and other MCC processes, the following sentence 'It was the recommendation of the Committee that the criteria be modified to be explicit that communal harm or benefit included wider community concerns – not just the safety of the therapeutic product under consideration.' should be added after the second sentence in the tenth paragraph.

The amended minutes were signed and dated by the Deputy Chair.

The Committee briefly confirmed the processes for confirming minutes of a previous meeting. Minutes of a meeting are published on the Medsafe website, to allow for any objections to a recommendation to be raised, months before they return to the next meeting for confirmation. Any amendments to the minutes should be dealt with when the Committee ratifies and agrees on the draft minutes before they are published on the Medsafe website. The Committee agreed that it should be a rare occurrence that any amendments are actually made to the minutes at the following meeting. If an amendment is made, the hard copy of the minutes are updated by hand by the Chair and signed at the meeting. The published minutes are updated after the meeting.

4

Declaration of conflicts of interest

The Conflict of Interest forms were returned to the Secretary.

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

5

Matters arising

5.1

Update on outstanding agenda items from the 57^th meeting

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

The reclassification was gazetted on 9 March 2017.

It was recommended that Green Cross Healthcare Ltd and Natalie Gauld Ltd should update Medsafe of the changes required to the training and monitoring procedures to reflect the Committee’s recommendations. It was also recommended that market sales should be collected and analysed to monitor the success of the scheme in improving access to oral contraceptive pills.

The Committee reiterated that it is interested in being updated on the outcomes of this recommendation. A response had not been received following the above two recommendations.

Recommendation

That Medsafe should write to Green Cross Health Ltd and Natalie Gauld Ltd requesting a timeline of milestones (eg, requested changes made to the training and monitoring procedures, selected oral contraceptives available in pharmacies, market sales data collected) that the Committee can expect to be updated on and when.

(8.1.f) Flubromazolam

The classification of flubromazolam under the Misuse of Drugs Act 1975 was considered by the Expert Advisory Committee on Drugs at a meeting on 11 April 2017. The Committee noted that the minutes were still being ratified by that Committee.

(8.2.1.b) 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.

When considering a medicine for reclassification, the Committee takes a number of criteria into account including the potential for a medicine to cause harm when used inappropriately. The Committee agreed that the Deputy Chair should respond to Retail New Zealand with the list of criteria that the Committee considers when reviewing a medicine for reclassification for non-prescription sale. Pharmacists have a code of ethics whereas retailers do not. The letter should also explain that the Committee will take into account the response of Retail New Zealand to their comments regarding paracetamol when considering any future medicine being made available for general sale. If the Committee feels there is a risk of that medicine being available for general sale, Medsafe could be requested to make a submission to upschedule that medicine.

In its letter, Retail New Zealand suggested that the new therapeutic products regulatory regime, currently being drafted, could include a tool for mitigating self-harm and to monitor online sales when medicines were made available for general sale. The Committee agreed and recommended that the comments from Retail New Zealand should be passed onto the team drafting the new therapeutic products regime.

Recommendation

That the Deputy Chair write 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 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.

That the Deputy Chair pass on the comments, regarding the sale of paracetamol products at general sale, from the Committee and Retail NZ to the team currently drafting the new therapeutic products regulatory regime.

56^th meeting

The 56th meeting for Natural Health Products, which was scheduled for late September 2016, has been postponed until the Natural Health Products Bill has had its third reading in Parliament.

Update on outstanding agenda items from the 55^th meeting

(6.5) Change in classification wording of lansoprazole, promethazine, sumatriptan, ibuprofen, omeprazole, pantoprazole, opium, phlocodine and ranitidine – proposed change in classification wording
(Pharmaceutical Society of New Zealand)

Further information had been requested on how the submitter would address information requirements and how the submitter would address keeping labels up to date as new information on adverse effects to a medicine is published internationally. Further information from the Pharmaceutical Society of New Zealand had not been received.

The request to remove the references in the classification statement that only approved or manufacturer's original packs may be supplied as restricted or pharmacy-only medicines was discussed later in the meeting under agenda item 5.6.3.

(8.2.1.a) Esomeprazole

The Committee recommended that the label statement on the manufacturer’s original pack should include the following warnings:

• Do not use if you are experiencing weight loss, persistent regurgitation of food or vomiting, difficulty swallowing or symptoms of gastro-intestinal bleeding, except on medical advice.
• This product is for temporary use only. [or] For short term use only.
• Do not use this medicine for any purpose other than that specified on the pack, except on doctor's advice.
• Do not use if you are pregnant except on the advice of a healthcare professional.
• Consult a doctor if symptoms/condition persist(s), worsens or recur.
• Consult a doctor if new or additional symptoms occur.

The Label Statements Database has not yet been updated.

(10.1) Calcium hydroxylapatite and polycaprolactone as dermal fillers

The Committee recommended that Medsafe should consult on changing the category of dermal fillers back to a medicine.

Medsafe confirmed the consultation should take place by the next meeting.

5.2

Objections to recommendations made at the 57th meeting

No valid objections had been received.

5.3

Update on the classification of nicotine and the regulation of e-cigarettes

In 2016, the Ministry of Health released a consultation document seeking feedback on proposed updates to the regulation of nicotine e-cigarettes in New Zealand (refer to www.health.govt.nz/news-media/media-releases/e-cigarette-consultation-opens).

The analysis of submissions following the consultation was published online, on 4 April 2017, at www.health.govt.nz/publication/consultation-electronic-cigarettes-analysis-submissions.

The Committee was requested to consider whether and when a reclassification of nicotine may be required to take place to align with any updated regulations.

Nicotine is currently classified as:

• prescription medicine; for nasal use except when sold from a smoking cessation clinic run under the auspices of a registered medical practitioner; in medicines other than for smoking cessation
• pharmacy-only medicine; for inhalation except when sold from a smoking cessation clinic run under the auspices of a registered medical practitioner, nurse, pharmacist or psychologist
• general sale medicine; in preparations for oromucosal or transdermal absorption.

One pre-meeting comment was received during the consultation period which supported the regulation of e-cigarettes in New Zealand and recommended:

1. a review on the classification of nicotine (the safety of e-cigarettes was yet to be demonstrated)
2. that e-cigarettes and their related equipment should only be available through smoking cessation providers, such as a community pharmacy.

Ms Stewart, from the Ministry’s Tobacco Control Programme, provided an update for the Committee’s information on progress to date. Cabinet decided in March 2017 to legalise nicotine e-cigarettes and e-liquid, and regulate all e-cigarettes and e-liquid (including those not containing nicotine) under the Smoke-free Environments Act 1990. Similar controls as those that apply to tobacco would be applied (eg, limits on promotion and advertising, prohibition of vaping in smoke-free areas). The Ministry does not consider that there is sufficient evidence to recommend e-cigarettes for smoking cessation, but supports their use as a harm minimisation tool for smokers if they switch completely. If any therapeutic claims were being made, the e-cigarette would need to be regulated under the Medicines Act 1981 and consent to distribute the product would need to be applied for.

Further information on the regulation of e-cigarettes is available on the Ministry of Health website at http://www.health.govt.nz/our-work/preventative-health-wellness/tobacco-control/e-cigarettes.

The Committee agreed that the current classification of nicotine was appropriate but could be reconsidered at a later meeting if required.

Recommendation

No recommendation was required.

5.4

Updated version of the document titled ‘How to change the legal classification of a medicine in New Zealand’

The updated version of the document titled ‘How to change the legal classification of a medicine in New Zealand’ was provided to the Committee for consideration, prior to its release for consultation following the meeting.

The Committee considered the following draft documentation:

1. How to change the legal classification of a medicine in New Zealand
2. Reclassification of a medicine for consideration by the Medicine Classification Committee template form
3. Observers at Ministerial Advisory Committees Consultation Document
4. Observers at Ministerial Advisory Committees Consultation Document – Appendix for the MAAC
5. Observers at Ministerial Advisory Committees Consultation Document – Appendix for the MCC.

A few final amendments were made to the draft document, ‘How to change the legal classification of a medicine in New Zealand’:

1. figure 1 on page 5 should include communal benefit in the (green) benefit considerations and communal harm in the (orange) risk considerations
2. point b in part b on page 7 refers to conditions or symptoms that can be diagnosed and managed by a pharmacist, this should be expanded to include pharmacist, nurse practitioners, nurses, and podiatrists
3. under 8) on page 9 the following statement should be added ‘communal harm or benefit includes wider community concerns – not just the safety of the medicine under consideration’
4. the proposed process from the Pharmacy Council (discussed under agenda item 5.5) should be included.

Following these amendments, the Committee agreed that the Medsafe consultation regarding the draft document, ‘How to change the legal classification of a medicine in New Zealand’ should proceed.

One pre-meeting comment was received during the consultation period which stated a strong opposition to the publication of reference lists, training and other supporting material. These concerns were relevant to the recent withdrawal of a submission to reclassify melatonin. Withdrawing an application and making the decision not to continue with the reclassification process would have been disappointing and costly to the applicant. The withdrawal could set a precedent and may mean that pharmaceutical companies, health professional organisations, Medsafe, the Ministry of Health or individuals who are considering applying to change the legal classification of a medicine in New Zealand could be dissuaded from making reclassification submissions in the future. This would in turn limit improved access to medicines.

The Committee emphasised that appendices, including reference lists, training and other supporting material, would be published if that information could be released under the Official Information Act 1982. If the submitter could demonstrate that the appendices could be withheld under the Official Information Act 1982, then they would not be published.

The Committee also discussed the process for observers at meetings. It was reiterated that no new information should be presented by observers at the meeting they attend as there was insufficient time for Committee members to assimilate the new information and it was not a transparent process for any interested parties. It was agreed that it was useful for observers to answer questions, however observers did not necessarily need to be present to answer questions and a teleconference could suffice.

There would be a Medsafe consultation on the process for observers at meetings towards the end of the year because the consultation document would need to be considered by the Medicines Assessment Advisory Committee and the Medicine Adverse Reactions Committee. The Committee agreed that the Medsafe consultation should proceed following the insertion of their comments into the consultation document.

Recommendation

That the Medsafe consultation regarding the draft document ‘How to change the legal classification of a medicine in New Zealand’ should proceed, following the suggested amendments being made.

That the Medsafe consultation regarding observers at Ministerial Advisory Committees should proceed, following the insertion of the comments made at this meeting and following consideration by the Medicines Assessment Advisory Committee and the Medicines Adverse Reactions Committee.

5.5

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

The Pharmacy Council (the Council) provided an amended version of their proposed additional process to the medicine reclassification process originally submitted to the Committee at its 57^th meeting on 1 November 2016.

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

Two pre-meeting comments were received during the consultation period. Both supported the proposed additional process for the following reasons:

1. it would result in a more robust reclassification process
2. it would ensure that both those applying for a reclassification, as well as pharmacists who would be affected by the outcome of any future reclassifications, would have a thorough understanding of the process involved
3. it would provide efficiencies and ensure there was no duplication of training or educational tools required as a condition of the reclassification
4. flexibility was required as not all reclassifications from prescription to restricted would require a pharmacist to undertake further training – many already sit within a pharmacists current scope of practice
5. the Council was the appropriate body to determine whether additional training for pharmacists was required because it would not benefit financially from any reclassification.

Two suggestions were also made in the pre-meeting comments. Issues of conflict of interest need to be adequately dealt with and favourable consideration of evidence should be given to those submissions who had collaborated with health professional organisations rather than just health professionals.

The Committee agreed that it was happy with the proposed additional process, following an update to point 2 on page 2. Point 2 should be expanded to ‘The Council / PSNZ framework will look for evidence of collaboration with other health professional organisations in support of the application. Inter-professional collaboration reflecting the joint Society and New Zealand Medical Association’s Integrated Practice Framework will be expected.’

The Committee recommended that the proposed additional process should be updated as discussed and added to the document ‘How to change the legal classification of medicine in New Zealand’ to allow for public consultation.

Recommendation

That the proposed additional process from the Pharmacy Council should be updated as discussed and added to the document ‘How to change the legal classification of medicine in New Zealand’ to allow for public consultation.

5.6

Amendments to classification wording

5.6.1

Articaine, lignocaine and prilocaine with or without felypressin – proposed amendment of the classification wording
(Dental Council)

Three observers representing the Dental Council were available but were not called into the meeting room as the Committee had no questions for them.

Purpose

This was a submission proposing an amendment to the classification statements of articaine, lignocaine and prilocaine with or without felypressin to include use by oral health therapists.

Background

Articaine is currently classified as:

• prescription medicine; except when used as a local anaesthetic in practice by a dental therapist registered with the Dental Council.

Felypressin is currently classified as:

• prescription medicine; except when combined with a local anaesthetic and used in practice by a dental therapist registered with the Dental Council.

Lignocaine is currently classified as:

• prescription medicine; 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 dental therapist registered with the Dental Council; for oral use; for ophthalmic use except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board; except when specified elsewhere in this schedule; except for external use and in throat sprays in medicines containing 2% or less; in throat lozenges in medicines containing 30 mg or less per dose form
• pharmacy-only medicine; for urethral use; for external use in medicines containing 10% or less and more than 2%
• general sale medicine; for external use and in throat sprays in medicines containing 2% or less; in throat lozenges in medicines containing 30 mg or less per dose form.

Prilocaine is currently classified as:

• prescription medicine; for injection except when used as a local anaesthetic in practice by a dental therapist registered with the Dental Council; except when specified elsewhere in this schedule
• pharmacy-only medicine; for dermal use in medicines containing 10% or less of local anaesthetic substances.

The Committee noted there were 19 products currently approved that could be affected by the reclassification.

Comments

Three pre-meeting comments were received during the consultation period. All three supported the amendment to the classification statements for the following reasons:

1. without the amendment, there would be restrictions in the usage of local anaesthetics by oral health therapy graduates that would potentially hinder the treatment of patients
2. it would help increase access to dental care for vulnerable populations
3. the current classification statements already accommodate dental therapists
4. administering local anaesthetics aligns with oral health therapists’ scope of practice and is an area in which they are already trained and competent
5. it would be appropriate for this extension to be made to ensure that oral health therapists can fully perform their duties and that patients are not disadvantaged in any way.

It was also suggested that topical anaesthetic agents such as those containing benzocaine could be considered for rewording to permit use by dental therapists and / or oral health therapists because topical anaesthetic agents can be more favourable in paediatric dental procedures.

Discussion

The Committee agreed that they did not have any outstanding questions after reading the submission. The reclassification would widen the scope of use of the medicines articaine, lignocaine and prilocaine with or without felypressin.

Benzocaine could not be considered because it had not been included in the submission.

Recommendation

That the classification statements of articaine, lignocaine and prilocaine with or without felypressin should be amended to include use by oral health therapists.

A letter from the Dental Council, dated 16 May 2017, was tabled at the meeting after the committee had completed its deliberations. The letter confirmed information that was already included in the submission, that oral health therapists must hold and administer adrenaline for the management of an anaphylaxis event. The Committee made their recommendation before acknowledging this letter because it could be viewed as new information being presented at the meeting.

5.6.2

Diphtheria, tetanus and pertussis (acellular, component) vaccine – proposed amendment to the prescription medicine except classification
(Green Cross Healthcare Ltd and Natalie Gauld Ltd)

Three observers were available but were not called into the meeting room as the Committee did not have any outstanding questions for them.

Purpose

This was a submission proposing an amendment to the classification statement of diphtheria, tetanus and pertussis (acellular, component) vaccine administered by pharmacists to include pregnant women aged 13 years and over. The age limit of non-pregnant women would remain as 18 years and over.

Background

Diphtheria, tetanus and pertussis (acellular, component) vaccine is currently classified as:

• prescription medicine; except when administered in a single dose to a person 18 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health.

Comments

Five pre-meeting comments were received during the consultation period. All five supported the amendment to the classification statement for the following reasons:

1. widening access would support the National Immunisation Programme’s general immunisation priorities, direction of travel and the pertussis prevention strategies to protect those most at risk from severe disease (ie, those aged under one year)
2. although the exact figures are not available, data indicates that the majority of New Zealand women were not currently accessing the Tdap vaccination during their pregnancy and improving access would help
3. there was an urgency because the last epidemic peaked in 2012 and epidemics occur about every 2-5 years
4. it would be logical to enable pregnant women access to pharmacist provided vaccination as this would reduce access barriers, specifically for those groups who are at greater risk
5. a Committee recommendation to amend the classification statement could set the stage for Government funding to follow (pharmacists’ ability to offer funded vaccines would require a change to the eligibility criteria determined by PHARMAC)
6. lowering the age of availability from a pharmacist could remove a regulatory barrier to a health need in the community.

It was also recommended to remove the age restriction linked to pregnant women and to include an expectation on pharmacists to notify midwives involved in the woman’s care that the vaccine had been provided.

Discussion

The Committee agreed any factor that increased access to this vaccination for pregnant women should be recommended.

Most pregnant women in New Zealand are under the care of Lead Maternity Carers. The Committee also agreed that Lead Maternity Carers could give this vaccination providing they meet the same standards as other vaccinators. They already give a Vitamin K injection.

The Committee discussed a letter received from the Manager of the Immunisation Team from the Ministry of Health. The letter suggested that the age limit for pregnant women should be removed so that all pregnant women could receive the vaccination in a pharmacy. A further submission would be required in order to consider removing the age limit. The Committee could only consider the submission and the supporting data that had been consulted on which suggested age 13 years and over. The vaccine included diphtheria and tetanus as well as pertussis, so further data would be required on all three in the younger age group. The Committee also noted it would be useful to view data on what would happen if there were multiple pregnancies over a small number of years (ie, the vaccine would be given a number of times over a small number of years).

The Committee was asked who should be notified when the diphtheria, tetanus and pertussis (acellular, component) vaccination was given to a pregnant women in a pharmacy. The general practitioner, Lead Maternity Carer and the National Immunisation Register were all agreed upon. Although outside of their scope, the Committee looked forward to the time when all healthcare professional systems could link such information together. General practitioners also have access to the National Immunisation Register.

There was a brief discussion about how vaccinations by pharmacists are advertised. A comment was made that it is often unclear which pharmacies provide which vaccinations. Although outside the scope of this Committee, it could come under the issue of access and should be considered by the submitter as part of implementation.

The Committee did not have any outstanding questions after reading the submission.

Recommendation

That the classification statement of diphtheria, tetanus and pertussis (acellular, component) vaccine administered by pharmacists should be amended to include pregnant women aged 13 years and over.

5.6.3

Sildenafil – proposed amendment to the prescription medicine except classification
(Individual pharmacist submission)

Purpose

This was a submission from a pharmacist that proposed two amendments to the prescription medicine classification of sildenafil:

1. to remove the requirement that it must be supplied in a manufacturer’s original pack
2. to amend the age limit from 35-70 years to 25-70 years.

Background

At the 50^th meeting, the Committee recommended that sildenafil 25 mg, 50 mg and 100 mg film coated tablets (Silvasta) should not be reclassified from prescription medicine to restricted medicine, when supplied by a pharmacist who has successfully completed the approved training programme and is accredited to supply sildenafil, for the treatment of erectile dysfunction in males aged 35-70 years. Following publication of the minutes, an objection to the recommendation was received and the item was added to agenda of the next meeting for further consideration.

At the 51^st meeting on 8 April 2014, the Committee recommended that:

• Douglas Pharmaceuticals Limited should be offered the opportunity to proceed with the reclassification of sildenafil from a prescription medicine to a prescription medicine; except when supplied by a pharmacist who has successfully completed the approved training programme for the treatment of erectile dysfunction in males aged 35-70 years
• the screening tool should require pharmacists to contact the patient's general practitioner, with the option for the patient to opt-out
• if unhappy with the proposed amendments, Douglas Pharmaceuticals Limited should be offered the opportunity to withdraw their application.

At the 53^rd meeting on 5 May 2015, the Chair provided the Committee with an update on the reclassification of sildenafil. On 16 October 2014, sildenafil was reclassified as a prescription medicine except in medicines for oral use containing 100 mg or less per dose unit when sold in the manufacturer's original pack containing not more than 12 solid dosage units for the treatment of erectile dysfunction in males aged 35-70 years by a registered pharmacist who has successfully completed a training programme endorsed by the Pharmaceutical Society of New Zealand.

Following the reclassification, Douglas Pharmaceuticals Limited and subsequently Pfizer New Zealand Limited have had training programmes endorsed by the Pharmaceutical Society of New Zealand. The training requirements for both brands of sildenafil had been aligned.

Sildenafil and its structural analogues is currently classified as:

• prescription medicine; except sildenafil in medicines for oral use containing 100 mg or less per dose unit when sold in the manufacturer's original pack containing not more than 12 solid dosage units for the treatment of erectile dysfunction in males aged 35-70 years by a registered pharmacist who has successfully completed a training programme endorsed by the Pharmaceutical Society of New Zealand.

The Committee noted there were 15 products currently approved that could be affected by the reclassification.

Comments

Five pre-meeting comments were received during the consultation period.

In response to the amendment to remove the requirement that sildenafil must be supplied in manufacturer’s original pack, one supported the amendment because:

1. the current classification may be limiting access of this medicine to some patients because of financial constraints
2. it would allow pharmacists to supply an adequate trial quantity following the initial consultation
3. an information sheet is not available in the manufacturer’s original pack but provided by the pharmacist.

Three did not support the amendment for the following reasons:

1. packaging other than the manufacturer’s pack removes traceability of supply which would be problematic if there was a requirement for a consumer recall
2. it would increase the potential for counterfeiting
3. branding is important to businesses involved in the pharmaceutical market
4. appropriate consumer information could be included in packs to support the pharmacists verbal advice
5. cost paid by the patient is predominantly driven by pharmacy mark-up and professional consultation fee, and not the cost of the product.

The Committee was asked for clarification of interpreting the statement manufacturer’s original pack. One view from the sector was that so long as the tablets are supplied in the original packaging, any quantity of sildenafil tablets up to the maximum permitted 12 may be supplied within that packaging.

In response to the amendment to amend the age limit to 25-70 years, four supported the amendment for the following reasons:

1. there appears to have been no significant increase in sildenafil adverse events in New Zealand since the reclassification
2. the approved screening tool used by pharmacists appears to be successful in picking up conditions that require referral to a doctor
3. use of sildenafil in men from the age of 18 would have no additional risk than in men over the age of 35 – however pharmacists should refer these men for a medical assessment initially with ongoing supply being managed safely and appropriately by a pharmacist.

One pre-meeting comment did not support the amendment because:

1. studies regarding erectile dysfunction tend to be carried out among middle-aged and elderly men
2. among the organic conditions contributing to the onset of erectile dysfunction, metabolic and cardiovascular risk factors are of particular relevance to the 20-29 year age group
3. lowering the age limit may also exacerbate potential recreational misuse
4. there needs to be convincing evidence of clinical need for sildenafil in younger males.

Discussion

The Committee discussed the two proposed amendments in turn.

First, the Committee considered the suggestion to remove the requirement that sildenafil must be supplied in a manufacturer’s original pack.

This was the same suggestion to the one made by the Pharmaceutical Society of New Zealand at the 55^th meeting on 3 May 2016. A submission was made to change the classification statements of lansoprazole, promethazine, sumatriptan, ibuprofen, omeprazole, pantoprazole, opium, phlocodine and ranitidine to remove the references that only approved or manufacturer's original packs may be supplied as restricted or pharmacy-only medicines. Further information had been requested on how the submitter would address information requirements and how the submitter would address keeping labels up to date as new information on adverse effects to a medicine is published internationally. Further information from the Pharmaceutical Society of New Zealand had not been received.

The Committee considered whether the reason for the Committee’s original recommendation for the requirement that sildenafil must be supplied in the manufacturer’s original pack was still valid. The Committee also queried whether the requirements of the manufacturer’s original pack were covered by the pharmacy Code of Ethics and the Health Practitioners Competence Assurance Act 2003.

The Committee agreed that the Deputy Chair should write to the Pharmaceutical Society of New Zealand for further information on what the sector would do to ensure that patients are fully informed and so that they can make an informed choice if they are buying a medicine that is not in the manufacturer’s original pack. The Deputy Chair should also request the further information not yet received following their submission to the 55^th meeting.

The Committee noted there were currently 35 classification statements in Schedule 1 of the Medicines Regulations 1984 that referred to the manufacturer’s original pack. The Committee requested that Medsafe should write a paper summarising these medicines and the Committee deliberations behind each reference to the manufacturer’s original pack.

It was acknowledged by the Committee that there was variation between pharmacies regarding what information is given to patients when purchasing a medicine.

The Committee was asked for clarification of interpreting the statement ‘manufacturer’s original pack’. One view was that so long as the tablets are supplied in the original packaging, any quantity of sildenafil tablets up to the maximum permitted 12 may be supplied within that packaging. It was confirmed that breaking the original pack and removing tablets would create a medicine that isn’t approved.

Secondly, the Committee considered the suggestion to amend the age limit from 35-70 years to 25-70 years.

The Committee considered whether there was evidence of clinical need in the younger age group, if there was a risk of psychological dependence and what the harm would be. The Committee agreed with the suggestion that the younger males should go to their general practitioner first before getting any subsequent supply from a pharmacy. There was the risk of off label use in this age group.

The Committee recommended that there should be no change to the age limit for the supply of sildenafil in a pharmacy because further data was required on its safety, evidence of clinical need and the potential for communal harm in this age group.

Recommendation

That there should be no change to the current classification statement of sildenafil.

That the Deputy Chair write to the Pharmaceutical Society of New Zealand for further information on what the sector would do to ensure that patients are fully informed if they are buying a medicine that is not in the manufacturer’s original pack. Further information following their submission to change the classification statements of lansoprazole, promethazine, sumatriptan, ibuprofen, omeprazole, pantoprazole, opium, phlocodine and ranitidine should also be requested.

That Medsafe write a paper summarising all medicines in Schedule 1 of the Medicine Regulations 1984 that reference the manufacturer’s original pack and the Committee deliberations behind each reference.

5.7

Submission for the reclassification of melatonin
Aspen Pharmacare Australia Pty Ltd and Natalie Gauld Ltd

A submission for the reclassification of melatonin, received 26 January 2017, was withdrawn prior to the meeting. This was the second time the submission had been withdrawn.

The submitters wanted to withhold entire appendices and certain publications from the reference list, which did not align with current Committee policy. The current policy is that any documentation in a submission that would be made available under the Official Information Act 1982 should be published.

6

Submissions for reclassification

6.1

Codeine – proposed reclassification of the pharmacy-only medicine entry to a more restricted medicine classification
(Medsafe)

Purpose

This was a Medsafe submission proposing the reclassification of codeine from pharmacy-only and restricted medicines to a more restrictive classification.

The submission was made following the recommendation made at the 57^th meeting, that;

• an item to consider the reclassification of codeine should be added to the agenda for the 58th meeting for the possible harmonisation with Australia of all pharmacy-only entries of codeine to be amended to restricted medicine
• Medsafe should review the relationships between the Australian and New Zealand markets, the role of codeine in cough and cold products and whether the benefit of its use outweighs the risk of harm.

Background

A summary of the Committee’s discussions on codeine at previous meetings can be found in Table 1 of the Medsafe submission.

Codeine is currently classified as:

• prescription medicine; except when specified elsewhere in the Schedule
• restricted medicine; in medicines for oral use containing not more than 15 mg of codeine per solid dosage unit or per dose of liquid with a maximum daily dose not exceeding 100 mg of codeine, when combined with one or more active ingredients in such a way that the substance cannot be recovered by readily applicable means or in a yield that would constitute a risk to health, for use as an analgesic and when sold in a pack of not more than five days' supply, approved by the Minister or the Director-General for distribution as a restricted medicine
• pharmacy-only medicine; in medicines for oral use, containing not more than 15 mg of codeine per solid dosage unit or per dose of liquid with a maximum daily dose not exceeding 100 mg of codeine, when combined with one or more active ingredients in such a way that the substance cannot be recovered by readily applicable means or in a yield that would constitute a risk to health, for the treatment of the symptoms of cough and cold and when sold in a pack of not more than six days' supply, approved by the Minister or the Director-General for distribution as a pharmacy-only medicine.

The Committee noted there were 26 products currently approved that could be affected by the reclassification.

Comments

Eight pre-meeting comments were received during the consultation period.

Two comments supported harmonisation with Australia and the reclassification of all codeine-containing medicines to prescription medicine for the following reasons:

1. combined codeine products are potentially harmful
2. there are few regulations governing over-the-counter access to codeine
3. dispensing data of over-the-counter codeine-containing products was not readily available and not linked to client data so the scope of the problem was not fully known
4. there are no pharmacological advantages in combination products
5. up-scheduling would help protect consumers from the harm that these drugs can and have caused over many years, enable safer and more effective analgesic treatments for acute pain to be promoted to consumers and ensure that the need for any form of treatment with codeine-based products was appropriately assessed by a medical practitioner on an individual basis.

It was also suggested that a well-developed and targeted public health strategy should be implemented to educate the public about the harm associated with codeine-based products and the reasons behind the reclassification to prescription only access.

Three comments did not support the reclassification of codeine-containing cough and cold medicines from pharmacy-only medicine to a more restrictive classification for the following reasons:

1. codeine in cough and cold medicines should remain a pharmacy-only medicine because there is no evidence that neither misuse nor harm is problematic in New Zealand
2. there was limited evidence in New Zealand to suggest any transferred abuse has occurred from codeine-containing analgesics to cold and flu preparations and any recommendation by the Committee needed to be evidence-based
3. other risk mitigating measures would be more appropriate than a reclassification, such as improvement in the monitoring system currently used by pharmacists to record purchasing and sales data from patients and a public education initiative.

If the recommendation to reclassify proceeded, a two year implementation timeframe was requested.

Three comments supported a reclassification to restricted medicine for the following reasons:

1. maintaining over-the-counter pharmacy access would enable the population to self-manage conditions with the support of pharmacists who are readily accessible in the community
2. a prescription only classification would restrict access
3. the evidence from Australia cannot be generalised to New Zealand
4. up-scheduling these products would increase the burden on general practitioners to manage misuse and dependence
5. a clearer understanding of the magnitude of the problem of dependence, misuse and harm was needed.

The Committee was also provided with the joint statement, by the Pharmacy Council of New Zealand and the Pharmaceutical Society of New Zealand, regarding the sale of codeine-containing analgesics.

Discussion

An error was acknowledged in the agenda title for this item. The agenda referred to a proposed reclassification of the pharmacy-only medicine entry to a more restricted medicine classification, whereas the Medsafe submission considered both the pharmacy-only and restricted medicine classification of codeine. Because of this error, a lot of the comments received focussed on only the pharmacy-only classification of codeine.

The Committee noted there was a lack of data in New Zealand regarding over-the-counter use of codeine.

Some Committee members preferred risk mitigating factors rather than reclassification (eg, a real time database or tracking system to monitor codeine use). A data tracking system could subsequently be used to gather the lacking data to help the Committee make a recommendation at a later date.

Other Committee members strongly agreed with harmonising with Australia in that all codeine-containing products should be reclassified to prescription only. Codeine is also a controlled drug regulated under the Misuse of Drugs Act 1975 and the Committee questioned whether it should be available in an over-the-counter category at all. Other opioids were the most tracked medicines in New Zealand yet there was no existing tracking system for codeine. Patients were essentially taking an opioid without supervision.

Reclassifying codeine to prescription would send a message to prescribers. General practitioners could reconsider their current approaches to prescribing codeine and aim to reduce the prescription rates of codeine given its limited effectiveness in the majority of the population compared with other analgesics. When general practitioners prescribe a medicine that is available over-the-counter, they tend to assume it is a safe product and prescribe it more liberally.

It was noted that pharmacy-only medicines do not require data sheets so specific safety information cannot always be provided to a patient, although some product sponsors may opt to produce one. As outlined in the Medsafe submission, there have been a number of safety concerns relating to codeine use in the last few years. Upscheduling to a restricted or prescription medicine would require data sheets for these medicines to be produced by the sponsors.

The efficacy of the small dose of codeine in the non-prescription combination products was discussed. The existing evidence does not show that they are any better than paracetamol or ibuprofen, when taken on their own. In addition, codeine is a pro-drug which is metabolised to morphine. There is considerable variation in this metabolism with up to 10% of the population being considered rapid metabolisers, and up to 10% being slow metabolisers. There is no way to know before taking codeine if someone is a rapid or slow metaboliser. Rapid metabolisers are at greater risk of side effects such as respiratory depression whereas slow metabolisers get no benefit from taking codeine.

The Committee questioned whether the experience in Australia provided enough evidence to harmonise the classification of codeine in New Zealand.

The Committee also noted that there was another opioid available as a pharmacy medicine used to treat coughs (Gee’s Linctus).

After considerable deliberation and discussion, the Committee agreed that they required more information before making a recommendation on the reclassification of codeine. The Committee considered that the following questions would need to be answered to allow codeine to continue to be available without prescription:

1. what education and continuing professional development would be provided to health professionals regarding the sale and prescription of codeine to minimise the risk of misuse and addiction in consumers?
2. how will the sector fill the data gap with respect to over-the-counter codeine use?
3. how will the sector track the sale of codeine in pharmacy in order to better identify consumers with additional needs for pain management and / or addiction problems?

Without a sufficient answer to any of the above questions, the Committee would have to consider a more restrictive classification of codeine as had been done in Australia.

The reclassification of codeine would be added to the agenda of the next meeting. The Committee considered that further information would be required to enable a decision on whether a reclassification is warranted.

Recommendation

That the reclassification of codeine be added to the agenda of the next meeting.

That the sector would need to answer the following questions to allow codeine to continue to be available without prescription:

1. what education and continuing professional development would be provided to health professionals regarding the sale and prescription of codeine to minimise the risk of misuse and addiction in consumers?
2. how will the sector fill the data gap with respect to over-the-counter codeine use?
3. how will the sector track the sale of codeine in pharmacy in order to better identify consumers with additional needs for pain management and / or addiction problems?

6.2

Sedating antihistamines – proposed amendment and reclassification of non-prescription medicine entries to prescription medicine
(Medsafe)

Purpose

This was a Medsafe submission to amend and reclassify the non-prescription medicine entries of the following sedating antihistamines to prescription medicine when used in children under six years of age for the treatment of nausea and vomiting and travel sickness:

• brompheniramine
• chlorpheniramine
• cyclizine
• dexchlorpheniramine
• diphenhydramine
• doxylamine
• meclozine
• promethazine
• trimeprazine.

Background

At their 166th meeting, the Medicines Adverse Reactions Committee recommended that the Committee should consider reclassifying all sedating antihistamines when used in children under six years of age for the treatment of nausea and vomiting and travel sickness to prescription medicines. This would not change the classification for use in allergic conditions (ie, they would still be available as a restricted medicine for the treatment of allergic conditions in children aged two years of age and older).

The purpose of the Medsafe submission was to provide the Committee with information about the safety of sedating antihistamines and the reasons for the Medicines Adverse Reactions Committee recommendations for the reclassification consideration.

Although overall there would still be different age categories for use, dependent upon the indication, the reclassification would apply to all oral sedating antihistamines to reduce confusion.

The Committee noted there were 54 products currently approved that could be affected by the reclassification.

Comments

Two pre-meeting comments were received during the consultation period.

One supported the proposed amendment and reclassification of non-prescription medicine entries to prescription medicine for sedating antihistamines because the safety concerns raised by Medsafe were significant.

The other supported greater clarity in aligning the classification statements of the various sedating antihistamines in accordance with age-related risk and approved indications. However, strongly opposed making all sedating antihistamines prescription medicines for all indications in children under six years of age. Retaining a restricted medicine classification was recommended with clear dosing guidelines that are indicated for nausea and vomiting and travel sickness from the age of two years.

Discussion

The Committee felt that the proposed reclassification was not practical and that sedating anti-histamines were well managed at pharmacy level.

It was noted that reclassifying the proposed sedating antihistamines would simplify their use because there is currently a wide range of medicines and indications which adds to their complexity. It may have been more useful to consider the reclassification of each sedating antihistamine separately, rather than the one submission.

There was efficacy data for sedating anti-histamine use for allergy but there was a lack of evidence of the benefit when used in nausea and vomiting and travel sickness. Anecdotal pharmacy experience suggests that these medicines are useful for the treatment of child travel sickness.

The Committee agreed to retain the status quo regarding the reclassification of the stated sedating antihistamines to prescription medicine when used in children under six years of age for the treatment of nausea and vomiting and travel sickness.

Recommendation

That the sedating antihistamines, brompheniramine, chlorpheniramine, cyclizine, dexchlorpheniramine, diphenhydramine, doxylamine, meclozine, promethazine and trimeprazine should not be amended and reclassified from non-prescription to prescription medicines when used in children under six years of age for the treatment of nausea and vomiting and travel sickness.

7

New medicines for classification

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

7.1

Daratumumab – Darzalex concentrate for infusion 100 mg/5 mL and 400 mg/20 mL (TT50-10110, a)

Daratumumab is a human monoclonal IgG1κ antibody against CD38 antigen, produced in a mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology.

Darzalex is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Daratumumab is not currently classified in Australia (in the Standard for the Uniform Scheduling of Medicines and Poisons, No.16, February 2017).

The Committee considered the unapproved data sheet for Darzalex.

Recommendation

That daratumumab should be classified as a prescription medicine.

7.2

Eluxadoline – Viberzi film coated tablet 75 mg, and 100 mg (TT50-10066, a)

Eluxadoline is a locally acting, mixed mu opioid receptor agonist and delta opioid receptor antagonist. Eluxadoline is also an agonist at the kappa opioid receptor, and is presented as a white to off-white crystalline powder.

Viberzi is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea.

Eluxadoline is classified as a prescription medicine in Australia (in the Standard for the Uniform Scheduling of Medicines and Poisons, No.16, February 2017).

The Committee considered the unapproved data sheet for Viberzi.

Recommendation

That eluxadoline should be classified as a prescription medicine.

7.3

Glecaprevir / pibrentasvir – Glecaprevir / Pibrentasvir film coated tablet 100 mg/ 40 mg (TT50-10126)

Glecaprevir is a pangenotypic inhibitor of the HCV NS3/4A protease, which is necessary for the proteolytic cleavage of the HCV-encoded polyprotein and is essential for viral replication.

Pibrentasvir is a pangenotypic inhibitor of HCV NS5A, which is essential for viral RNA replication and virion assembly.

Glecaprevir and pibrentasvir in combination are indicated for the treatment of adults with chronic hepatitis C virus.

Glecaprevir and pibrentasvir are not classified in Australia (in the Standard for the Uniform Scheduling of Medicines and Poisons, No.16, February 2017).

The Committee considered the unapproved data sheet for Glecaprevir / Pibrentasvir film coated tablets.

Recommendation

That glecaprevir and pibrentasvir should be classified as prescription medicines.

7.4

Palbociclib – Ibrance capsule 75 mg, 100 mg, 125 mg (TT50-10068, a, b)

Palbociclib is a highly selective, reversible inhibitor of CDK 4 and 6. Cyclin D1 and CDK4/6 are downstream of multiple signalling pathways that lead to cellular proliferation.

Ibrance is indicated for the treatment of hormone receptor positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with:

• an aromatase inhibitor
• fulvestrant in women who have received prior endocrine therapy.

In pre- or peri-menopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone agonist.

Palbociclib is not classified in Australia (in the Standard for the Uniform Scheduling of Medicines and Poisons, No.16, February 2017).

The Committee considered the unapproved data sheet for Ibrance.

Recommendation

That palbociclib should be classified as a prescription medicine.

7.5

Pegaspargase – Oncaspar solution for injection 3750 U/5 mL (TT50-10095)

Pegaspargase is a modified version of the enzyme asparaginase. The active substance is a covalent conjugate of Escherichia coli (E. coli) derived asparaginase and monomethoxypolyethylene glycol using a succinimidyl-succinate linker. The mechanism of action of asparaginase is the enzymatic cleavage of the amino acid asparagine into aspartic acid and ammonia. Depletion of asparagine in blood serum results in inhibition of protein synthesis, DNA synthesis and RNA synthesis, especially in leukaemic blasts, which are not able to synthesize asparagine, and thus undergo apoptosis.

Oncaspar is indicated as a component of antineoplastic combination therapy in patients with Acute Lymphoblastic Leukaemia.

Pegaspargase is not classified in Australia (in the Standard for the Uniform Scheduling of Medicines and Poisons, No.16, February 2017).

The Committee considered the unapproved data sheet for Oncaspar.

Recommendation

That pegaspargase should be classified as a prescription medicine.

7.6

Venetoclax – Venclexta film coated tablet 10 mg, 50 mg, and 100 mg (TT50-10122, a, b)

Venetoclax is an orally bioavailable small-molecule inhibitor of BCL-2, an anti-apoptotic protein. Overexpression of BCL-2 has been demonstrated in chronic lymphocytic leukaemia cells and has been implicated in resistance to certain therapeutic agents. Venetoclax helps restore the process of apoptosis by binding directly to the BCL-2 protein, displacing pro-apoptotic proteins like BIM, and triggering mitochondrial outer membrane permeabilisation, the release of cytochrome c from mitochondria and the activation of caspases. In nonclinical studies, venetoclax demonstrated cytotoxic activity in tumour cells that overexpress BCL-2.

Venclexta is indicated for the treatment of patients with relapsed or refractory chronic lymphocytic leukaemia:

• with 17p deletion, or
• for whom there are no other suitable treatment options.

Venetoclax is not classified in Australia (in the Standard for the Uniform Scheduling of Medicines and Poisons, No.16, February 2017).

The Committee considered the unapproved data sheet for Venclexta.

Recommendation

That venetoclax 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

a) Carfilzomib

Carfilzomib is indicated for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Carfilzomib is classified as a prescription medicine in Australia (in the Standard for the Uniform Scheduling of Medicines and Poisons, No.16, February 2017).

The Committee considered the Scheduling delegate’s final decisions, January 2017 (made in a meeting on 16 January 2017) published on the Therapeutic Goods Administration website.

Recommendation

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

b) Dermatophagoides pteronyssinus and Dermatophagoides farinae extract

Dermatophagoides pteronyssinus and Dermatophagoides farinae extract (American & European HDM extract) is a standardised allergen extract (50%) of the American HDM and the European HDM species, Dermatophagoides pteronyssinus and Dermatophagoides farinae.

In patients with a positive test of house dust mite sensitisation (skin prick test and/or specific IgE), Dermatophagoides pteronyssinus and Dermatophagoides farinae extract is indicated for the treatment of moderate to severe DM-allergic rhinitis despite use of symptom-relieving medication, and HDM-allergic asthma not responsive to inhaled corticosteroids in adults.

Dermatophagoides pteronyssinus and Dermatophagoides farinae extract are classified as prescription medicines in Australia (in the Standard for the Uniform Scheduling of Medicines and Poisons, No.16, February 2017).

The Committee considered the Scheduling delegate’s final decisions, January 2017 (made in a meeting on 16 January 2017) published on the Therapeutic Goods Administration website.

Recommendation

That Dermatophagoides pteronyssinus and Dermatophagoides farinae should be added to the New Zealand Schedule as prescription medicines.

c) Elotuzumab

Elotuzumab is indicated as a combination therapy for the treatment of multiple myeloma in adult patients who have received one or more prior therapies.

Elotuzumab is classified as a prescription medicine in Australia (in the Standard for the Uniform Scheduling of Medicines and Poisons, No.16, February 2017).

The Committee considered the Scheduling delegate’s final decisions, January 2017 (made in a meeting on 16 January 2017) published on the Therapeutic Goods Administration website.

Recommendation

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

d) Ixazomib

Ixazomib is indicated for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Ixazomib is classified as a prescription medicine in Australia (in the Standard for the Uniform Scheduling of Medicines and Poisons, No.16, February 2017).

The Committee considered the Scheduling delegate’s final decisions, January 2017 (made in a meeting on 16 January 2017) published on the Therapeutic Goods Administration website.

Recommendation

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

e) Lenvatinib

Lenvatinib is indicated for the treatment of patients with progressive, locally advanced or metastatic, radioactive iodine refractory differentiated thyroid cancer.

Lenvatinib is classified as a prescription medicine in Australia (in the Standard for the Uniform Scheduling of Medicines and Poisons, No.16, February 2017).

The Committee considered the Scheduling delegate’s final decisions, January 2017 (made in a meeting on 16 January 2017) published on the Therapeutic Goods Administration website.

Recommendation

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

f) Lipegfilgrastim

Lipegfilgrastim is indicated for the treatment of cancer patients following chemotherapy to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.

Lipegfilgrastim is classified as a prescription medicine in Australia (in the Standard for the Uniform Scheduling of Medicines and Poisons, No.16, February 2017).

The Committee considered the Scheduling delegate’s final decisions, January 2017 (made in a meeting on 16 January 2017) published on the Therapeutic Goods Administration website.

Recommendation

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

g) Lumacaftor

Lumacaftor is a component of the FDC product ORKAMBI (lumacaftor / ivacaftor), which is indicated for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the CFTR gene.

Lumacaftor is classified as prescription medicine in Australia (in the Standard for the Uniform Scheduling of Medicines and Poisons, No.16, February 2017).

The Committee considered the Scheduling delegate’s final decisions, January 2017 (made in a meeting on 16 January 2017) published on the Therapeutic Goods Administration website.

Recommendation

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

h) Sarilumab

Sarilumab, in combination with non-biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs), is indicated for the treatment of moderate to severe Rheumatoid Arthritis in adult patients who have had an inadequate response or intolerance to one or more DMARDs.

Sarilumab is classified as a prescription medicine in Australia (in the Standard for the Uniform Scheduling of Medicines and Poisons, No.16, February 2017).

The Committee considered the Scheduling delegate’s final decisions, January 2017 (made in a meeting on 16 January 2017) published on the Therapeutic Goods Administration website.

Recommendation

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

i) Sodium zirconium cyclosilicate

Sodium zirconium cyclosilicate is indicated for the treatment of hyperkalaemia in adult patients.

Sodium zirconium cyclosilicate is classified as a prescription medicine in Australia (in the Standard for the Uniform Scheduling of Medicines and Poisons, No.16, February 2017).

The Committee considered the Scheduling delegate’s final decisions, January 2017 (made in a meeting on 16 January 2017) published on the Therapeutic Goods Administration website.

Recommendation

That sodium zirconium cyclosilicate should be added to the New Zealand Schedule as a prescription medicine.

j) Sonidegib

Sonidegib diphosphate is indicated for the treatment of adult patients with:

• locally advanced basal cell carcinoma who are not amenable to curative surgery or radiation therapy.
• metastatic basal cell carcinoma.

Sonidegib is classified as a prescription medicine in Australia (in the Standard for the Uniform Scheduling of Medicines and Poisons, No.16, February 2017).

The Committee considered the Scheduling delegate’s final decisions, January 2017 (made in a meeting on 16 January 2017) published on the Therapeutic Goods Administration website.

Recommendation

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

k) Talimogene laherparepvec

Talimogene laherparepvec is indicated for the treatment of melanoma that is regionally or distantly metastatic.

Talimogene laherparepvec is classified as a prescription medicine in Australia (in the Standard for the Uniform Scheduling of Medicines and Poisons, No.16, February 2017).

The Committee considered the Scheduling delegate’s final decisions, January 2017 (made in a meeting on 16 January 2017) published on the Therapeutic Goods Administration website.

Recommendation

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

l) Venetoclax

Venetoclax is indicated for patients with relapsed/refractory chronic lymphocytic leukaemia with 17p deletion and for patients without 17p deletion who have no other suitable treatment options.

Venetoclax is classified as a prescription medicine in Australia (in the Standard for the Uniform Scheduling of Medicines and Poisons, No.16, February 2017).

The Committee considered the Scheduling delegate’s final decisions, January 2017 (made in a meeting on 16 January 2017) published on the Therapeutic Goods Administration website.

Recommendation

That venetoclax 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)

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

8.2.1

Decisions by the Delegate – March 2016

a) Performance and image enhancing drugs

The Australian Delegate recommended that new Schedule 4 (prescription medicine) entries should be created for Thymosin Beta 4, TB-500 and fibroblast growth factors.

The reasons for the recommendation comprised the following.

1. There is limited research regarding the harms and possible therapeutic benefits of these substances.
2. No form of Thymosin Beta 4 is yet approved for human therapeutic use anywhere in the world.
3. The medications are considered experimental in humans, with potential side effects including carcinogenicity and cardiovascular problems.
4. The substances are used as a performance or image enhancing agent.
5. Toxicity is unknown due to the experimental nature of the medications.
6. Misuse / abuse of Fibroblast Growth Factors have the potential to cause adverse health effects like cancer, cardiovascular problems and endocrinological health outcomes.
7. The products have not been approved for use in Australia, and as such this section is unregulated.
8. There is potential for abuse given that the substances are used as a performance or image enhancing agent.

The Committee considered the Scheduling delegate’s final decisions, March 2016 (made in a meeting on 17 March 2016) published on the Therapeutic Goods Administration website and discussed harmonising with the above classification. The Committee agreed to harmonise.

Recommendation

That New Zealand should harmonise with Australia and prescription medicine entries should be created for Thymosin Beta 4, TB-500 and fibroblast growth factors.

b) Proton pump inhibitors

The Australian Delegate recommended that the Schedule 3 (restricted medicine) entry of lansoprazole, omeprazole and rabeprazole should be down-scheduled to Schedule 2 (pharmacy-only medicine) as follows:

• lansoprazole in oral preparations containing 15 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days' supply, be down-scheduled from Schedule 3 (restricted medicine) to Schedule 2 (pharmacy-only medicine)
• omeprazole in oral preparations containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days' supply, be down-scheduled from Schedule 3 (restricted medicine) to Schedule 2 (pharmacy-only medicine)
• rabeprazole in oral preparations containing 10 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days' supply, be down-scheduled from Schedule 3 (restricted medicine) to Schedule 2 (pharmacy-only medicine).

The reasons for the recommendation comprised the following.

1. The proton pump inhibitors are safe and effective first line treatment for consumers with frequent symptoms of gastro-oesophageal reflux disease.
2. Esomeprazole and pantoprazole are already recommended for Schedule 2 (pharmacy-only medicine). The other Schedule 3 (restricted medicine) proton pump inhibitors have similar safety and efficacy profiles. Limiting the seven day availability pack size and lowest effective dose minimises the opportunity for long term adverse effects.
3. Very low toxicity with short-term use.
4. The proposed Schedule 2 (pharmacy-only medicine) seven day supply, labelling (including warning statements) and provision of Consumer Medicines Information will promote appropriate use and health education as Schedule 2 (pharmacy-only medicine).

The Committee considered the Scheduling delegate’s final decisions, March 2016 (made in a meeting on 17 March 2016) published on the Therapeutic Goods Administration website and discussed harmonising with the above classification.

Lansoprazole is currently classified in New Zealand as:

• prescription medicine; except when specified elsewhere in the Schedule
• restricted medicine; in divided solid dosage forms for oral use containing 15 mg or less with a maximum daily dose of 15 mg for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over or the relief of heartburn when sold in the manufacturer's original pack containing not more than 14 dosage units.

Omeprazole is currently classified in New Zealand as:

• prescription medicine; except when specified elsewhere in the Schedule
• pharmacy-only medicine; in divided solid dosage forms for oral use containing 20 mg or less with a maximum daily dose of 20 mg for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over when sold in the manufacturer's original pack containing not more than 28 dosage units.

Rabeprazole is currently classified in New Zealand as:

• prescription medicine.

The Committee noted there were 28 products currently approved that could be affected by the reclassification.

The Committee agreed that it was difficult to harmonise without seeing the full submission and data set considered in Australia. However, the Committee encouraged submissions from the sector to reclassify lansoprazole and rabeprazole to pharmacy-only medicine. Omeprazole is already classified as a pharmacy-only medicine in New Zealand.

Recommendation

That New Zealand should not harmonise with Australia and the restricted medicine entries of lansoprazole and rabeprazole should not be reclassified to pharmacy-only medicine.

8.2.2

Decisions by the Delegate – July 2016

a) Fexofenadine

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.

Fexofenadine is currently classified in New Zealand as:

• prescription medicine; except for oral use
• pharmacy-only medicine; 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 mg or less of fexofenadine hydrochloride or in tablets containing 120 mg or less of fexofenadine hydrochloride with a maximum daily dose of 120 mg when sold in the manufacturer's original pack containing 10 dosage units or less and not more than 5 days' supply
• general sale medicine; for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in capsules containing 60 mg or less of fexofenadine hydrochloride or in tablets containing 120 mg or less of fexofenadine hydrochloride with a maximum daily dose of 120 mg when sold in the manufacturer's original pack containing 10 dosage units or less and not more than 5 days' supply.

The Committee noted there were 18 products currently approved that could be affected by the reclassification.

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 agreed not to harmonise.

Recommendation

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.

b) Ulipristal

The Australian Delegate recommended that a new Schedule 3 (restricted medicine) entry should be created for ulipristal for emergency post-coital contraception.

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

1. There was substantial benefit in providing another emergency contraception option for women with the ability to be used up to five days after unprotected sexual intercourse.
2. Benefit outweighs risk for ulipristal's proposed use.
3. Access to emergency contraception via a Schedule 3 (restricted medicine) listing has been established in Australia for over ten years. There is no evidence of use outside of the intended or increased extent of use of emergency as a result of a Schedule 3 (restricted medicine) listing.
4. Consistent with overseas use and Schedule 4 (prescription medicine) use in Australia. Existing Schedule 3 (restricted medicine) alternative medicines are available, but they are less efficacious.
5. The safety and toxicity profile of ulipristal is similar to levonorgestrel.
6. The Product Information states that breastfeeding mothers need to cease to feed for one week post-exposure; this would need to be managed via the packaging, labelling and education of pharmacists.
7. Toxicity is minimal in recommended dose (one tablet).
8. Single dose packaging and labelling are appropriate for Schedule 3 (restricted medicine)
9. There is no evidence of potential for abuse.
10. There is minimal risk of use as an abortifacient with current doses.

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.

Ulipristal is currently classified as a prescription medicine in New Zealand.

Ulipristal was recommended for classification as a prescription medicine at the 54^th meeting on 24 November 2015. At that meeting the Committee also encouraged healthcare professionals to put forward a submission for reclassification once there is useful information suggesting it should be reclassified.

The Committee noted there was one product currently under assessment that could be affected by the reclassification.

Five pre-meeting comments were received during the consultation period. Four supported the reclassification of ulipristal for the following reasons:

1. ulipristal has been used effectively as emergency contraception in other countries for some years
2. it has been found to be more effective than the current levonorgestrel emergency contraceptive pill
3. the ulipristal emergency contraceptive pill can delay ovulation closer to ovulation than the levonorgestrel contraceptive pill, so it is recommended for use when a woman is seen very close to ovulation
4. ulipristal contraceptive pill can be used up to 120 hours after unprotected sexual intercourse to prevent an unintended pregnancy, where levonorgestrel can only be used for 72 hours after unprotected sexual intercourse
5. ulipristal contraceptive pill does not appear to be less effective for women with a high BMI as levonorgestrel may be
6. levonorgestrel supply as an emergency contraceptive pill requires pharmacists to successfully complete mandatory training and has become an extremely beneficial service for women since 2002.

A number of disadvantages were also provided. The use of progesterone before or after ulipristal may interfere with the effectiveness of other emergency contraception or subsequent hormonal contraceptive use. Breastfeeding women are advised not to breastfeed a baby one week after ulipristal emergency contraceptive pill use. Other emergency contraception methods cannot be used within the same menstrual cycle because of the effect of progestogen on the effectiveness of ulipristal emergency contraceptive pill.

The other commented that the provisions that relate to pharmacist supply of other emergency contraceptive pills (eg, special training) should also be applied to ulipristal should it become available in New Zealand.

The Committee stated again it was difficult to harmonise without seeing the full submission and data set considered in Australia. It was agreed that ulipristal was more efficacious for larger women compared to levonorgestrel. A separate education programme would be required for pharmacists to enable them to sell ulipristal. It was suggested that this could be a good example to use the Pharmacy Council’s proposed additional process (discussed under agenda item 5.5).

The Committee agreed not to harmonise however encouraged the sector to make a reclassification submission using the Pharmacy Council’s proposed additional process. A reclassification submission for ulipristal would be a good test for the Pharmacy Council’s proposed additional process.

The Committee acknowledged it was difficult to harmonise with Australia when only the minutes of their deliberations were considered. It was agreed to add the principles of harmonisation to the agenda of the next meeting.

Recommendation

That New Zealand should not harmonise with Australia and that a new restricted medicine entry should not be created for ulipristal for emergency post-coital contraception.

That the principles of harmonisation be added to the agenda of the next meeting.

9

Agenda items for the next meeting

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

1. reclassification of codeine (refer to agenda item 6.1)
2. principles of harmonisation (refer to agenda item 8.2.2b).

10

General Business

10.1

Update to the Members’ Handbook

The Deputy Chair highlighted a number of amendments that had been made to the Handbook:

1. responsibility for the Committee, from the Minister and subsequently the Director-General of Health, has been delegated to the Group Manager, Medsafe
2. reasonable expenses for Committee members to claim were defined
3. members were assigned agenda items to lead during a meeting and the expectations of being a lead were described.

The Committee discussed the expected amount of preparation time. The suggested 4-8 hours was not realistic, especially for new members. It was felt that 6-12 hours preparation time was more reasonable.

The Chair should keep in touch with new members on the Committee to give them advice on committee processes (eg, how to prepare for a meeting and provide guidance on time commitment).

10.2

Codeine cough and cold review

At the 169^th meeting on 9 March 2017, the Medicines Adverse Reasons Committee considered the concomitant use of opioids, benzodiazepines and other central nervous system depressants and the risk of serious side effects. The full minutes can be found at http://www.medsafe.govt.nz/profs/adverse/Minutes169.htm (refer to item 3.2.1).

The Medicines Adverse Reactions Committee made eight recommendations, one of which was that the Committee considers strengthening the classification of codeine when contained in cough and cold products and to revisit the classification of other opioids contained in cough and cold products. This had been discussed under agenda item 6.1.

10.3

Bovine whey Ig-rich fraction

Bovine whey Ig-rich fraction is one of the substances requested to be added to the Permitted Substances List for the natural health products regulatory scheme.

Whey is a by-product of cheese making, so from the safety perspective, it can be regarded as being sufficiently safe to add to the permitted substances list. However, it was pointed out by one of the members of the Permitted Substances List subcommittee that the immunoglobulin-rich fraction is not the same thing as just whey.

Immunoglobulins are currently classified as prescription medicines. However, bovine whey Ig-rich fraction is not the same thing as immunoglobulins either. Rather, it is somewhat more than whey but less than immunoglobulins.

The Ig-rich fraction of whey comes from the colostrum (or foremilk), which is from the first few days of lactation. This contains about 40 g/L (or 4%) of immunoglobulins. After that the Ig fraction drops to about 0.7 g/L (or 0.07%) in normal bovine milk. 75% of the immunoglobulins is IgG1. The rest are IgM, IgA and IgG2.

Feeding calves and pregnant cows with foremilk is a common technique in animal husbandry to try to increase levels of antibodies and reduce susceptibility to disease. Colostrum is also regarded as a human food (a ‘functional food’). There are cheeses made from colostrum (eg, the Ukrainian sweet cheese Molozyvo).

The Committee was asked whether it had any objection to bovine whey Ig-rich fraction being added to the permitted substances list despite the scheduling of immunoglobulins as a prescription medicine. And if so, what would the objections be.

The Committee had no objection.

10.4

Classification of Yohimbe Bark

Yohimbine is classified as a prescription medicine in New Zealand. A query had been received from the sector regarding the classification of yohimbine bark.

Although yohimbe bark contains yohimbine, the bark itself is considered an unscheduled substance in New Zealand.

10.5

Natural Health Products Bill

Ms Cossar provided an update of the progress of the Bill. It is unlikely that further progress will be made until after the general election later this year.

11

Date of next meeting

The next meeting will be held in October / November 2017.