1

Welcome

The Chair opened the 49th meeting at 9:30 am and welcomed members and guests.

The meeting had originally been scheduled for Tuesday 30 April 2013. The meeting was postponed until Monday 17 June 2013 because Medsafe had been unable to establish a representative quorum for the original date.

The Chair informed members that the fee paid for meeting attendance had been increased recently. Fees paid to Committee members had not been reviewed in over 10 years and the increased fee would align the Committee with other Ministerial advisory committees.

2

Apologies

There were no apologies.

3

Confirmation of the minutes of the 48th meeting held on Tuesday 30 October 2012

The minutes of the 48th meeting were accepted as a true and accurate record. The minutes were signed and dated by the Chair.

4

Declaration of conflicts of interest

The Conflict of Interest forms were returned to the Secretary.

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

Objections to recommendations made at the 48th meeting

No objections had been received.

Review of the classification criteria

At the 47th meeting on 1 May 2012, a Committee member suggested that revisiting the criteria used when considering a medicine for reclassification for non-prescription sale should be added to the agenda of the next meeting.

At the 48th meeting on 30 October 2012, following discussion, the Committee recommended that:

1. the classification criteria would be considered at the next meeting
2. Medsafe should put together a paper with the outcome of the United Kingdom consultation and classification criteria options for discussion at the next meeting.

The Committee considered the paper prepared by Medsafe. The purpose of the paper was to stimulate discussion to enable the Committee to make recommendations regarding:

1. the criteria used when considering a medicine for reclassification
2. any action following the outcome of the Medicines and Healthcare products Regulatory Agency consultation regarding their procedure for moving medicines from prescription to over-the-counter.

The Committee noted that on 31 January 2013, the Minister for Health and Ageing in Australia appointed a panel to conduct a review of medicines and poisons scheduling arrangements. On the Australian Department of Health and Ageing website were links to two documents, Part A – What this review is about and Part B – Background to scheduling arrangements. The deadline for consultation submissions was 29 April 2013.

The consultation and review of the medicines and poisons scheduling arrangements in Australia was expected to be completed by 30 September 2013. The Committee considered this consultation would be a significant issue with respect to its own considerations of scheduling requirements.

Two pre-meeting comments were received during the consultation period. Both anticipated contributing to the public consultation and requested a copy of the paper put together by Medsafe. One specifically commented that the current classification criteria do not take into account the ability of members of the public to understand the medications they are purchasing, and to take those medications correctly particularly in combination.

The Committee considered the current classification criteria against the criteria used in New Zealand, Australia and the UK / Europe alongside the criteria proposed by Brass et al (2011). The classification criteria used in New Zealand generally reflects the criteria used in other countries and therefore it was felt no significant change was required.

However, Committee members made a number of suggestions for tweaking the current classification criteria. For example, consumer convenience could become patient access. The scope of the criteria should be broadened to reflect the submissions for reclassification the Committee considered (eg, submissions for reclassification are not always for the short term symptomatic relief of specified indications). The criteria are, as a whole, negative and could be written more positively.

It was suggested to include consideration of the accuracy of self-diagnosis and treatment, by a pharmacist or patient, how easy a diagnosis is to understand and the consequences of getting this wrong. Also that cost should not be a criterion considered because the information supplied in a submission for reclassification does not provide the relevant data to make a decision regarding cost. The Committee agreed that a positive statement should be included in the classification criteria to confirm that cost is not a factor.

The Committee considered the definition for suitability for non-prescription sale. The definition was adopted in 1990 by the Commission of the European Communities. Committee members were not aware of any alternative more recent definition that could be used instead. The Committee considered removing this definition and replacing it with a principle that reflects what the Committee considers as suitable for non-prescription sale (eg, the ability of a pharmacist to diagnose and manage and a consumer to self-diagnose and self-manage).

The Committee agreed that the Medsafe paper should be revised taking their discussion into account. The paper should then be approved out-of-session and added to the agenda of the next meeting to allow for public consultation. The Medsafe paper would be considered at the next meeting alongside the consultation and review of the medicines and poisons scheduling arrangements in Australia and any comments received during the consultation period.

Recommendation

That Medsafe should revise the paper as discussed.

That the Medsafe paper should be approved out-of-session by the Committee and added to the agenda of the next meeting to allow for public consultation.

That the Medsafe paper should be considered at the next meeting alongside the consultation and review of the medicines and poisons scheduling arrangements in Australia.

Further data to support the reclassification of diphtheria, tetanus and pertussis (acellular, component) vaccine (Pharmacybrands Limited)

The Committee reconsidered the submission to: reclassify diphtheria, tetanus and pertussis (acellular, component) vaccine (Tdap) in a single dose from prescription medicine to prescription medicine except when administered to a person aged 18 years or over by a pharmacist who has successfully completed the Immunisation Advisory Centre vaccinator course; and is complying with the immunisation standards of the Ministry of Health; now that further data had been submitted.

The resubmission included:

1. more evidence on the benefits of tetanus and diphtheria vaccine when used as proposed by pharmacists
2. detailed information on patient selection
3. information on how to find out if a patient had received the primary vaccination
4. an alternative, simpler treatment algorithm.

Three pre-meeting comments were received during the consultation period. A further pre-meeting comment was received after the consultation period. It was noted that, because the further data submitted was not provided with the agenda, the comments received were not on this data or its significance.

One comment supported the proposed reclassification, believing it essential to increase the number of approved vaccinators who can administer whooping cough vaccines in the community. The extended opening hours of pharmacies would allow patients greater convenience in being vaccinated. The reclassification would also lead to a reduction in the number of people who suffer from whooping cough which would in turn reduce hospital admissions.

The other three supported the proposed reclassification in principle. However, raised the following concerns:

1. the vaccines should be entered on the National Immunisation Register to ensure effective communication between providers
2. fragmentation of care – electronic notification should be received by the patient's general practice which may minimise fragmentation
3. there should be an evaluation of how the influenza vaccination by pharmacists is working in practice before there is any increase in the range of immunisations that can be offered by pharmacists
4. pharmacies should be audited, in a similar fashion to general practices, with checks on the vaccination facilities that need to be provided
5. pharmacist delivery of vaccinations will lead to distancing of patients from general practice, particularly the less frequent attenders
6. there is currently no ability to accurately record in a central repository the immunisations received because Tdap is not currently funded and is not within the National Immunisation Register
7. devolvement of the National Immunisation Register to Primary Health Organisations will have a significant impact on the way in which authorised vaccinators will record immunisation data for adults
8. the reclassification should be extended to all authorised vaccinators, and not just pharmacists.

In considering the data provided in the resubmission, the Committee agreed there was little harm in reclassifying tetanus and diphtheria as well as pertussis. The resubmission had addressed the Committee's concerns raised at the last meeting.

One concern raised was that pharmacists could advertise the vaccine focussing on the tetanus component. This concern was addressed in the algorithm by referring the patient to a doctor if they had not received a primary series of tetanus vaccinations.

Fragmentation of care was once again raised as another concern. The National Immunisation Register would need to be enabled to prevent fragmentation of care, however this may take years. The question arose as to whether the reclassification should be deferred because of this reason when it has a public health benefit. The resubmission, as did the original submission, included a form for notifying a patient's doctor that they had received the vaccination.

Committee members made a number of suggested minor amendments to the pre-vaccination checklist and consent form included in the resubmission:

1. the first sentence on page one should refer to 'a trained pharmacist vaccinator'.
2. remove the sentence on page four 'this vaccine should be used during every pregnancy to protect each baby' – if two pregnancies are close together two vaccinations would not be necessary
3. the reference on page four should be from the Ministry of Heath rather than the Centre for Disease Control.

Patients should also be offered the Consumer Medicine Information on receiving the vaccine.

The Committee agreed that the benefits of the reclassification outweighed the risks, and that: diphtheria, tetanus and pertussis (acellular, component) vaccine (Tdap) should be reclassified from prescription medicine to prescription medicine except when administered in a single dose to a person aged 18 years or over by a 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. Subject to the minor amendments being made to the pre-vaccination checklist and consent form.

The provider requirements for the vaccinator course were reworded so they reflect the same as that required for the influenza vaccine reclassified following the 48th meeting on 30 October 2012.

The Committee went onto discuss the suggestion that the reclassification should be extended to all authorised vaccinators (ie, nurses), and not just pharmacists. This suggestion had implications for the already reclassified influenza vaccine, as well as Tdap and meningococcal vaccine (item 6.1).

Medical Officers of Health currently authorise nurses to become vaccinators. Following their training, pharmacists would have the same level of clinical training and the same level of resuscitation experience as nurses in terms of vaccination. Following discussion, the Committee considered it appropriate that the vaccine prescription medicine exemption could apply to nurses as well as pharmacists. To allow for public consultation and to observe the outcome of the proposed Tdap and meningococcal vaccine reclassifications, the Committee agreed to foreshadow this suggestion to the next meeting.

Recommendation

That diphtheria, tetanus and pertussis (acellular, component) vaccine (Tdap), should be reclassified from prescription medicine to prescription medicine except when administered in a single dose to a person aged 18 years or over by a 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. Subject to the minor amendments being made to the pre-vaccination checklist and consent form.

Foreshadow that the reclassification of influenza vaccine (from prescription medicine to prescription medicine except when administered to a person aged 18 years or over by a 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), and potentially Tdap and meningococcal vaccine, should be amended from administration by a pharmacist to include all authorised vaccinators.

Secretary’s note

A valid objection has been received regarding the discussion point: “remove the sentence on page four ‘this vaccine should be used during every pregnancy to protect each baby’ – if two pregnancies are close together two vaccinations would not be necessary”.

A valid objection has been received regarding the recommendation that diphtheria, tetanus and pertussis (acellular, component) vaccine (Tdap), should be reclassified from prescription medicine to prescription medicine except when administered in a single dose to a person aged 18 years or over by a 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. Subject to the minor amendments being made to the pre-vaccination checklist and consent form.

See the addendum to these minutes (at the top of this page) for further details.

Classification of febuxostat as a prescription medicine
(Adenuric, Te Arai Biofarma Limited)

An out-of-session consultation took place in December 2012 regarding the classification of febuxostat.

Adenuric tablet is a potent, non purine, selective inhibitor of xanthine oxidase that prevents the normal oxidation of purines to uric acid. The active ingredient in Adenuric is febuxostat, a 2-arylthiazole derivative.

Adenuric is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and / or gouty arthritis). Adenuric is indicated in adults.

The Committee recommended that febuxostat should be classified as a prescription medicine. This classification was gazetted on 7 February 2013 alongside the recommendations from the 48th meeting.

Recommendation

No further recommendation was required.

Classification of cholera vaccine as a prescription medicine
(Dukoral, Pharmacybrands Limited)

At the 46th meeting on 15 November 2011, the Committee recommended that vibrio cholera and enterotoxigenic Escherichia coli vaccine should be reclassified from prescription medicine to restricted medicine. Also that this recommendation be delayed until Medsafe was satisfied that appropriate educational material and campaign for pharmacists had been established. Medsafe subsequently received and was satisfied that appropriate educational material and campaign for pharmacists had been established.

Following the 46th meeting, the manufacturer of the vaccine requested that the reclassification to restricted medicine be deferred until a decision had been made in Australia.

In October 2012, the Delegate in Australia decided not to harmonise with New Zealand and that the current scheduling of cholera vaccine (as a prescription medicine) remained appropriate.

To ensure that there was no requirement to produce an entirely New Zealand specific product, cholera vaccine was reclassified in New Zealand as a prescription medicine; except in the form of an oral liquid containing Vibrio cholerae when sold in a pharmacy by a registered pharmacist. This reclassification allows pharmacists to gain access to the vaccine as if it was classified as a restricted medicine.

One pre-meeting comment was received during the consultation period which supported the reclassification to prescription medicine; except in the form of an oral liquid containing Vibrio cholerae when sold in a pharmacy by a registered pharmacist.

Recommendation

No further recommendation was required.

Training for pharmacist vaccinators

Following the recent submissions for specific vaccinations to be reclassified so they can be administered 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. A number of queries were raised by Committee members, regarding the training requirements of pharmacist vaccinators, which were discussed and clarified.

1. What level of resuscitation is required for pharmacist vaccinators? This question was difficult to answer because there are a number of training providers that provide resuscitation training, each with a different scoring system.
2. Are the reaccreditation requirements for pharmacist vaccinators the same for other vaccinators such as nurses? Yes. In reclassifying influenza vaccine the exemption from prescription medicine requires pharmacists to undertake the same training, accreditation and reaccreditation as other authorised vaccinators in order to be able to provide a vaccination service. The reclassification however, exempts pharmacists from the requirement of gaining approval from a Medical Officer of Health for the vaccine programme they are providing.

The statement on pharmacist vaccinators, by the Pharmacy Council of New Zealand, was tabled (http://www.pharmacycouncil.org.nz/cms_show_download.php?id=274).

The Committee noted it was not in their remit to recommend training requirements for vaccinators. However, it was suggested that the Chair write to the Pharmacy Council of New Zealand, asking them to liaise with the appropriate bodies, to define the appropriate level of training that is required for a pharmacist vaccinator to resuscitate a patient who has gone into anaphylactic shock. This would clarify the Committee's position.

Recommendation

That the Chair should write to the Pharmacy Council of New Zealand, asking them to liaise with the appropriate bodies, to define the appropriate level of training that is required for a pharmacist vaccinator to resuscitate a patient who has gone into anaphylactic shock.

Classification of canagliflozin, pertuzumab, teriflunomide and trastuzumab emtansine as prescription medicines

Because the meeting had been postponed, another out-of-session consultation took place in May 2013 regarding the classification of canagliflozin, pertuzumab, teriflunomide and trastuzumab emtansine.

1. Canagliflozin – Invocana 100 mg and 300 mg film coated tablets

   he active ingredient canagliflozin is an inhibitor of sodium-glucose co-transporter 2.

   Invocana is indicated in adults with type 2 diabetes mellitus to improve glycaemic control as:

   Monotherapy

   When diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.

   Add-on therapy

   Add-on therapy with other anti-hyperglycaemic agents including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

   Canagliflozin was considered by the Delegate in Australia in February 2013. The Delegate made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include canagliflozin in Schedule 4 (prescription medicine), with an implementation date of 1 May 2013.

2. Pertuzumab – Perjeta 420 mg/14 mL concentrate for infusion

   Perjeta is supplied in a single-dose vial containing 14 mL of preservative-free concentrate solution.

   Perjeta is indicated in combination with trastuzumab and docetaxel for patients with HER2-positive metastatic (stage IV) or unresectable locally recurrent breast cancer who have not received previous treatment or whose disease has relapsed after adjuvant therapy.

   Pertuzumab is not included in the Standard for the Uniform Scheduling of Medicines and Poisons (1 January 2013) in Australia.

3. Teriflunomide – Aubagio 14 mg film coated tablet

   Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the dihydroorotate dehydrogenase (DHO-DH) enzyme.

   Aubagio is indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability.

   Teriflunomide was considered by the Delegate in Australia in February 2013. The Delegate made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include teriflunomide in Schedule 4 (prescription medicine), with an implementation date of 1 May 2013.

4. Trastuzumab emtansine – Kadcyla 100 mg and 160 mg powder for infusion

   Kadcyla is available as a single-use vial. Kadcyla, as a single agent, is indicated for the treatment of patients with HER2 positive, unresectable locally advanced or metastatic (stage IV) breast cancer who have received prior treatment with trastuzumab and a taxane.

   Trastuzumab emtansine is not included in the Standard for the Uniform Scheduling of Medicines and Poisons (1 January 2013) in Australia.

The Committee recommended that canagliflozin, pertuzumab, teriflunomide and trastuzumab emtansine should be classified as prescription medicines. These classifications were gazetted on 16 May 2013.

Recommendation

No further recommendation was required.

Melatonin 2 mg prolonged release tablet – recommendation following the 48th meeting
(Circadin, Aspen Pharma Pty Limited c/o Pharmacy Retailing (NZ) Limited trading as Health Care Logistics)

At the 48th meeting on 30 October 2012, the Committee recommended that melatonin 2 mg prolonged release tablets should not be reclassified from prescription medicine to restricted medicine, in a pack of up to 30 tablets, when used as monotherapy for the short term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 and over. More time on the market with experience in New Zealand with the proposed indication was required.

In response to a request from Aspen Pharma Pty Limited, the Committee confirmed what would be required if another submission for reclassification was made at a later meeting. The submission should address the:

1. risk of use in children
2. difficulty in diagnosing primary insomnia currently, particularly in the elderly
3. likelihood and impact of an important diagnosis being missed.

If another submission was received within a year, it was considered appropriate to address the outstanding issues only. However, if a submission for reclassification was made in five years' time, a full submission would be required.

At their request, two representatives of the company were given the opportunity to ask questions and observe the discussion. It was understood by the company that more safety data was required. The lack of safety data was the main reason for the Committee recommending not to reclassify at the last meeting. However, a number of questions were asked specifically around the risk of use in children and the screening tool. The Committee made a number of suggestions for any future submission. For example, the next submission should also try and quantify the importance of an important diagnosis of primary insomnia being missed, what the impact of this would be and how this risk could be mitigated.

The Committee agreed that it would not be possible to repeat this request for future submissions for reclassification because of time constraints on the agenda.

Recommendation

No further recommendation was required.

Meningococcal vaccine – proposed reclassification from prescription medicine to prescription medicine except when...
(Pharmacybrands Limited)

Three representatives of the company observed the discussion but left the meeting room before a final recommendation was made.

Purpose

This was a submission from Pharmacybrands Limited (the parent company for Life, Unichem, Amcal, Radius and Care Chemist pharmacies in New Zealand) for the reclassification of meningococcal vaccine from prescription medicine to prescription medicine except when administered to a person aged 16 years or over by a pharmacist who has successfully completed the Immunisation Advisory Centre vaccinator course and is complying with the immunisation standards of the Ministry of Health.

The age 16 years or older, rather than 18, was chosen to maximise coverage of those going into hostel-type accommodation for education purposes (eg, university) and those moving into new situations (eg, forestry workers, flatting).

The submission included a summary of the risks and benefits of the reclassification proposal using the value-tree tool.

The Committee noted there were two products currently marketed that would be affected by the reclassification.

Background

At the 7th meeting on 31 July and 1 August 1990, the Committee recommended that meningococcal vaccine be classified as a prescription medicine.

Comments

A total of 12 pre-meeting comments were received during the consultation period. A further pre-meeting comment was received after the consultation period.

Two supported the reclassification proposal. Comments in support of the reclassification proposal could be summarised into the following themes, the:

1. vaccination would be more accessible within the community
2. profile of the vaccine would be raised
3. pool of vaccinators would increase.

Although the other 11 supported the reclassification proposal in principle, a large number of issues were raised. The main issues could be summarised in the following themes:

1. the age should be changed from 16 to 18 years
2. patient safety needed to be considered
3. the submission proposed the reclassification of 'meningococcal vaccine' in a generic sense (the selection of a specific meningococcal vaccine is a clinically complex process)
4. the vaccine should be connected to the National Immunisation Register to ensure communication with the primary care providers
5. concerns around training of pharmacy vaccinators (the training should meet the current vaccinator training standards including two yearly updates)
6. the reclassification should be extended to all authorised vaccinators, and not just pharmacists
7. the reclassification would lead to greater inequities in terms of who can access and who can afford the vaccine
8. concerns about the overall governance of commercial pharmacies and how quality practice would be maintained
9. the reclassification of vaccines should be in the context of a national strategy and vaccination policy
10. any reclassification should address the health needs of the New Zealand population
11. misunderstanding of Medsafe's role in relation to the Committee.

Discussion

The Committee acknowledged the number of comments that had been received during the consultation period. There was some misunderstanding of what it meant for a pharmacist to become an authorised vaccinator. The reclassification would mean any pharmacist who successfully completes the training becomes an authorised vaccinator who does not need the authorisation of the Medical Officers of Heath to run a vaccination programme. Reaccreditation and training for pharmacists is exactly the same as other authorised vaccinators.

The Committee agreed that who would be receiving the vaccine and how the vaccine would be administered was well defined in the submission. However, which vaccination should be administered and what happens after the vaccination required further discussion and definition.

The Committee agreed it would be appropriate for the pre-vaccination check list and consent form included with the submission to include information on both of the vaccines currently available. Pharmacists could then have an informed discussion with a patient regarding which vaccination they would like to receive. Vaccinations differ in cost which should be highlighted. However, a patient may decide on a vaccine based on cost rather than health benefits. The Committee emphasised that a patient should be able to make an informed choice following a discussion with the pharmacist.

It was suggested that the general practitioner notification should include which brand of vaccination was administered.

Further work was required on the information given after a meningococcal vaccination. The information sheet stated that protection lasts five years or more which wasn't supported by the literature provided in the submission. The protection period is different for different vaccines. Again it would be appropriate for the information sheet to include information about both vaccines currently on the market.

The observers confirmed that the pre-vaccination checklist, general practitioner notification and patient information had been written with input from the Immunisation Advisory Centre. However, acknowledged that amendments could be made as suggested.

The Committee concluded that the data presented in the submission supported a reclassification and that the risks discussed could be mitigated in the documentation used by pharmacists. The Committee recommended that meningococcal vaccine should be reclassified and that the wording of the reclassification should include the same training provider requirements as the influenza vaccine (ie, administered 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).

It was also agreed that the reclassification should be subject to Medsafe reviewing and being satisfied with the documentation used by pharmacists. The documentation should:

1. be more consumer friendly in the language used
2. include information on all the different types of meningococcal vaccine currently available so that a pharmacist can discuss these with a patient and then the patient can make an informed choice on what vaccine they would like
3. patient material (ie, pre-vaccination checklist, general practitioner notification and patient information) should be regularly kept up to date
4. the Consumer Medicine Information should be available for the patient, depending on the vaccine administered
5. patient information provided should be product specific (eg, duration of protection of the vaccine).

Recommendation

That meningococcal vaccine should be reclassified from prescription medicine to prescription medicine except when administered to a person 16 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.

That the reclassification should be subject to Medsafe reviewing and being satisfied with the documentation used by pharmacists.

Secretary’s note

Two valid objections have been received regarding the recommendation that meningococcal vaccine should be reclassified from prescription medicine to prescription medicine except when administered to a person 16 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.

See the addendum to these minutes (at the top of this page) for further details.

Naproxen – proposed reclassification from pharmacy-only medicine to general sale medicine
(Naprogesic, Bayer New Zealand Limited)

One representative of the company observed the discussion but left the meeting room before a final recommendation was made.

Purpose

This was a company submission from Bayer New Zealand Limited for the reclassification of naproxen, in solid dose form for oral use containing 250 mg or less (or 275 mg of naproxen sodium) per dose form with a recommended daily dose of not more than 1.25 g and in a pack containing not more than 25 tablets or capsules, from pharmacy-only medicine to general sale medicine.

The indications proposed for naproxen as a general sale medicine were the temporary relief of pain and / or inflammation associated with headache, migraine headache, tension headache, muscular pain, period pain, dental pain, back pain, arthritic pain, pain associated with sprains and strains, aches and pains associated with cold and flu, joint pain, tendonitis, and the reduction of fever.

The fundamental premise of the reclassification proposal was that naproxen 250 mg is sufficiently similar to ibuprofen 200 mg, in terms of efficacy and safety, that the same classifications can be applied to both. Ibuprofen is currently classified as a general sale medicine; for external use; in divided solid dosage forms for oral use containing 200 milligrams or less per dose form with a recommended daily dose of not more than 1.2 grams and when sold in the manufacturer's original pack containing not more than 25 dose units per pack.

The submission proposed the following warning statements for naproxen as a general sale medicine:

1. Do not use in children under 6 years old except on doctor's advice.
2. Do not use this product if you are aged 65 years or over except on doctor's advice.
3. Do not use if you have a stomach ulcer.
4. Do not use if you have heart failure.
5. Do not use if you have kidney problems or impaired renal function.
6. Do not use if you have asthma except on doctor's advice.
7. Do not use if you are allergic to naproxen or other anti-inflammatory medicines.
8. If you get an allergic reaction, stop taking and see your doctor.
9. Do not use for more than a few days at a time except on doctor's advice.
10. Do not exceed the recommended dose. Excessive use can be harmful.
11. Do not use this product with other medicines containing naproxen, aspirin or other anti-inflammatory medicines or with other medicines you are taking regularly except on doctor's advice.
12. Do not use at all during the last 3 months of pregnancy.
13. Do not use [this product/insert name of the product] during the first 6 months of pregnancy, except on doctor's advice.

An article from the June 2013 edition of Prescriber Update was tabled at the meeting, 'Non-steroidal anti-inflammatory drugs and acute kidney injury'. All non-steroidal anti-inflammatory drugs, including naproxen, have been associated with the development of acute kidney injury.

The Committee noted there were two products currently marketed that would be affected by the reclassification.

Background

At the 4th meeting on 11 March 1986, the Committee recommended that naproxen and its salts be reclassified to pharmacy-only when in solid dose forms of 250 mg or less and with a pack size limit of 15 tablets or capsules for the treatment of dysmenorrhoea.

At the 7th meeting on 31 July and 1 August 1990, the Committee confirmed that naproxen and its salts be classified as prescription; except when specified elsewhere in the Schedule, and pharmacy-only; in solid dose forms of 250 mg or less of naproxen when in a pack containing not more than 15 tablets of capsules and sold only for the treatment of dysmenorrhoea.

At the 8th meeting on 6 December 1991, the Committee recommended that naproxen up to and including 250 mg with a pack size of not more than 30 tablets or capsules should be restricted medicines. This would mean a reversal of the decision at the 7th meeting.

At the 9th meeting on 28 May 1992, the Committee recommended there should be a pharmacy-only pack for dysmenorrhoea in strengths of up to 250 mg of naproxen per dose form and containing not more than 20 dose forms per pack.

At the 16th meeting on 24 April 1996, in response to a submission for the reclassification of a naproxen sodium 220 mg tablet as either a general sale or a pharmacy-only medicine with unrestricted indications, the Committee recommended there be no change to the current classification of naproxen.

At the 17th meeting on 15 May 1997, the Committee recommended that the Ministry prepare a draft document setting out a framework for the consistent classification of all non-steroidal anti-inflammatory medicines. Also that there be no change to the classification of naproxen until this framework had been established.

At the 18th meeting on 15 October 1997, the Committee recommended that there be no change to the recommendation made at the 16th meeting.

At the 22nd meeting on 10 November 1999, the Committee recommended that naproxen should be reclassified as a pharmacy-only medicine when in packs containing 250 mg or less per dose form and in a pack of not more than 30 tablets or capsules.

At the 38th meeting on 14 December 2007, in view of the Australian conclusion not to require maximum recommended daily dose limits for naproxen and mefenamic acid to ensure consistency with other pharmacy-only non-steroidal anti-inflammatory drugs the Committee agreed it would not pursue this matter any further.

Naproxen is currently classified as:

• prescription; except when specified elsewhere in the Schedule
• pharmacy-only; in solid dose form containing 250 milligrams or less per dose form in packs of not more than 30 tablets or capsules.

Comments

Four pre-meeting comments were received during the consultation period. Three strongly opposed the reclassification proposal for the following reasons:

1. non-steroidal anti-inflammatory drugs are not equivalent, they are similar but differ in strengths, dosing and toxicity
2. toxicity of naproxen may not be comparable to placebo at over-the-counter doses
3. patients would be unfamiliar with naproxen as an over-the-counter medicine because use of non-prescription naproxen is uncommon in New Zealand
4. toxicity needs to be considered
5. there may be an increased risk of adverse events
6. concerns around increased gastrointestinal risk compared to ibuprofen, increased cardiovascular risk over placebo and the risk of inappropriate dosing
7. complacency may occur with supermarket availability
8. although the packaging states not to use in asthma, there is the potential for this to be missed or ignored
9. arthritic pain, a condition that should be managed by a health professional, is one proposed indication
10. the dosage of two tablets followed by one is unique amongst other non-prescription analgesics
11. the product information seems to exclude aspirin allergy which is of significant concern
12. the classification status of naproxen in most countries is restricted to pharmacy
13. the proposed dose for reclassification to general sale appears to be prescription-level dosage for naproxen sodium
14. without professional advice, the risks associated with overuse or incorrect use may increase
15. there would be a risk to patients who self-select multiple products for multiple conditions
16. there are no control mechanisms in place to prevent patients purchasing large amounts through multiple packs
17. community pharmacists play an important role in managing and triaging minor ailments, they can provide alternative treatments where appropriate and know when to refer the patient to a doctor for further investigation

The other suggested caution should be exercised in a reclassification to general sale. If patients were not getting adequate relief from those non-steroidal anti-inflammatory drugs already available as general sale medicines it would appropriate for them to see a health practitioner.

Discussion

It was acknowledged that the fundamental premise of the reclassification proposal was that naproxen 250 mg is sufficiently similar to ibuprofen 200 mg, in terms of efficacy and safety. The data supplied in the submission had demonstrated this premise.

An issue was raised in the difference in dose. Whilst the submission was to reclassify 250 mg of naproxen, most of the literature supplied with the submission referred to 220 mg of naproxen. The Committee also agreed that any recommendation should only be to reclassify a dose of 220 mg naproxen with the proposed dosing regimen. No data was provided to support a reclassification of 250 mg naproxen.

One member noted that the suggested naproxen dosage for general sale was the maximum dose. Whereas the ibuprofen dose available at general sale was low.

One member suggested that the warning statement, 'Do not use in children under 6 years old except on doctor's advice', should be changed to 12 years old. Twelve was the age supported by the literature provided with the submission.

Naproxen is generally given with gastric protection because of its potential to cause gastrointestinal bleeds. A concern was also raised in that naproxen is one of the more risky non-steroidal anti-inflammatory drugs in terms of renal function. Neither of these concerns had been fully addressed in the data provided with the submission. It was agreed that a low dose regime, restricted to three times a day, could mitigate these risks.

The observer confirmed that the company would be willing to revise their submission to accommodate the requests and concerns highlighted by the Committee.

The Committee concluded that a revised submission to reclassify naproxen, in solid dose form for oral use containing 220 mg or less per dose form with a recommended daily dose of not more than 660 mg and in a pack containing not more than 15 tablets or capsules (ie, 5 days' supply), from pharmacy-only medicine to general sale medicine would be considered at the next meeting.

The revised submission should include a comparative study with ibuprofen and any evidence of the renal and gastric side effects at that dose (ie, 220 mg naproxen).

Recommendation

That a revised submission to reclassify naproxen, in solid dose form for oral use containing 220 mg or less per dose form with a recommended daily dose of not more than 660 mg and in a pack containing not more than 15 tablets or capsules, from pharmacy-only medicine to general sale medicine would be considered at the next meeting.

7

New medicines for classification

The following new chemical entity was submitted to the Committee for classification.

Vismodegib – Erivedge 150 mg capsule

Erivedge is available as a pink / grey hard capsule containing 150 mg of vismodegib.

Vismodegib is a low molecular weight, orally available inhibitor of the Hedgehog pathway. Hedgehog pathway signalling through the smoothened transmembrane protein leads to the activation and nuclear localisation of GLI transcription factors and induction of Hedgehog target genes. Many of these genes are involved in proliferation, survival and differentiation. Vismodegib binds to and inhibits smoothened transmembrane protein thereby preventing Hedgehog signal transduction.

Erivedge is indicated for the treatment of adult patients with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma where surgery and / or radiation therapy are not appropriate.

Vismodegib is not included in the Standard for the Uniform Scheduling of Medicines and Poisons (1 May 2013) in Australia.

Recommendation

That vismodegib should be classified as prescription medicine.

Alogliptin

Alogliptin is an inhibitor of dipeptidylpeptidase-4 and is proposed for use in the treatment of Type 2 diabetes mellitus.

In Australia in February 2013, the Delegate decided to include alogliptin in Schedule 4 (prescription medicine) with an implementation date of 1 May 2013.

Recommendation

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

Crofelemer

Crofelemer is a proanthocyanidin from the bark latex of the tree Croton lechleri that acts locally on the intestinal lumen to normalise flow of chloride ions and water into the gastrointestinal tract. Crofelemer is indicated for the control and symptomatic relief of diarrhoea in patients with HIV / AIDS.

In Australia in February 2013, the Delegate decided to include crofelemer in Schedule 4 (prescription medicine) with an implementation date of 1 May 2013.

Recommendation

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

Dimethyl fumarate

Dimethyl fumarate is indicated for patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

In Australia in February 2013, the Delegate decided to include dimethyl fumarate in Schedule 4 (prescription medicine) with an implementation date of 1 May 2013.

Recommendation

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

Fidaxomicin

Fidaxomicin is an antibacterial agent indicated for the treatment of Clostridium difficile-associated diarrhoea. Fidaxomicin is to be used for a condition that requires diagnosis, management and prescription by a medical professional.

In Australia in November 2012, the Delegate decided to include fidaxomicin in Schedule 4 (prescription medicine) with an implementation date of 1 January 2013.

Recommendation

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

Ivacaftor

Ivacaftor is a respiratory agent. It potentiates the cystic fibrosis transmembrane conductance protein, specifically G551D-CFTR, resulting in increased chloride transport on the surface of epithelial cells in multiple organs. Ivacaftor is proposed for the treatment of cystic fibrosis in patients six years of age and older who have a G551D mutation in the cystic fibrosis transmembrane conductance protein gene.

In Australia in February 2013, the Delegate decided to include ivacaftor in Schedule 4 (prescription medicine) with an implementation date of 1 May 2013.

Recommendation

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

Micafungin

Micafungin is an echinocandin class of antifungal agents. It is indicated for the treatment of invasive candidiasis, oesophageal candidiasis for whom intravenous therapy is inappropriate, prophylaxis of candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia for 10 or more days.

In Australia in February 2013, the Delegate decided to include micafungin in Schedule 4 (prescription medicine) with an implementation date of 1 May 2013.

Recommendation

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

Olodaterol

Olodaterol is a long-acting beta2-agonist and is proposed for use in the treatment of chronic obstructive pulmonary disease.

In Australia in February 2013, the Delegate decided to include olodaterol in Schedule 4 (prescription medicine) with an implementation date of 1 May 2013.

Recommendation

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

Pasireotide diaspartate

Pasireotide diaspartate is proposed for the treatment of patients with Cushing's disease for whom medical therapy is appropriate. It is a somatostatin analogue that binds to four of the five human somatostatin receptors, especially human somatostatin receptor-5 which is expressed at high levels in corticotropin (ACTH)-producing adenomas. The resulting inhibition of ACTH secretion is used in the treatment of Cushing's disease, particularly when surgery is not an option or has failed. It is given as the diaspartate, but doses are expressed in terms of the base; 125 micrograms of pasireotide diaspartate is equivalent to about 100 micrograms of pasireotide.

In Australia in February 2013, the Delegate decided to include pasireotide and pasireotide diaspartate in Schedule 4 (prescription medicines) with an implementation date of 1 May 2013.

Recommendation

That pasireotide and pasireotide diaspartate should be added to the New Zealand Schedule as prescription medicines.

Retapamulin

Retapamulin is an antibiotic, indicated for the topical treatment of the following bacterial skin and skin structure infections:

1. primary impetigo
2. secondary infected traumatic lesions (eg, small lacerations, abrasions, sutured wounds)
3. secondary infected dermatoses including infected psoriasis, infected atopic dermatitis and infected contact dermatitis.

In Australia in February 2013, the Delegate decided to include retapamulin in Schedule 4 (prescription medicine) with an implementation date of 1 May 2013.

Recommendation

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

Retigabine

Retigabine is an anticonvulsant used as a treatment for partial epilepsies.

In Australia in February 2013, the Delegate decided to include retigabine in Schedule 4 (prescription medicine) with an implementation date of 1 May 2013.

Recommendation

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

Ridaforolimus

Ridaforolimus is a small molecule and non-producing analogue of rapamycin. It is an antineoplastic agent and inhibits the mammalian target of rapamycin, interfering with the cell cycle. It is indicated for the treatment of patients with metastatic soft tissue or bone carcinoma.

In Australia in November 2012, the Delegate decided to include ridaforolimus in Schedule 4 (prescription medicine) with an implementation date of 1 January 2013.

Recommendation

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

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:

1. cetirizine and loratadine – should be reclassified from Schedule 2 (pharmacy-only medicine) to unscheduled (general sale medicine) when in divided forms for oral use containing 10 mg or less of cetirizine hydrochloride or loratadine per dose in packs containing no more than 5 days' supply for the treatment of seasonal allergic rhinitis (which harmonised with New Zealand)
2. ferric carboxymaltose – should not be included in Schedule 4 (prescription medicine) (which did not harmonise with New Zealand)
3. omeprazole – the current Schedule 3 (restricted medicine) entry should not be amended so that the maximum allowed pack size is increased from 14 to 28 dosage units (which did not harmonise with New Zealand)
4. vibrio cholera and enterotoxigenic escherichia coli vaccine – cholera vaccine should not be reclassified from Schedule 4 (prescription medicine) to Schedule 3 (restricted medicine) (which did not harmonise with New Zealand – refer to item 5.5)

Decisions by the Delegate – September 2012

No harmonisation decisions relevant to the Committee were made by the Delegate.

Decisions by the Delegate – October 2012

1. Tranexamic acid

   The Schedule 4 (prescription medicine) entry for tranexamic acid should be amended to include the wording 'except in preparations containing 3% or less of cetyl tranexamate hydrochloride for dermal cosmetic use'.

   The Committee considered harmonising with the above classification.

   The Committee noted there were no products currently marketed in New Zealand that would be affected by the proposed reclassification.

   At the 34th meeting on 9 June 2006, the Committee recommended there be no change to the current prescription medicine classification of tranexamic acid. Tranexamic acid is currently classified as a prescription medicine in New Zealand.

   The Committee concluded that there was no need to harmonise with Australia because the reclassification was for cosmetic use. The Schedule in New Zealand only includes medicines for therapeutic use, not cosmetics.

   Recommendation

   No recommendation was required.

Decisions by the Delegate – November 2012

1. Ibuprofen in combination with phenylephrine

   Ibuprofen should be reclassified from Schedule 2 (pharmacy-only medicine) to unclassified (general sale medicine) when in divided preparations containing 200 mg or less of ibuprofen in fixed dose combinations with phenylephrine in packs containing not more than 25 tablets. This included restricting the entry for the treatment of adults and children aged 12 years of age and over.

   The Committee considered harmonising with the above classification.

   The Committee noted there were no products currently marketed in New Zealand that would be affected by the proposed reclassification.

   In New Zealand, ibuprofen is currently classified as:

   • prescription; except when specified elsewhere in the Schedule
   • restricted; for oral use in tablets or capsules containing up to 400 mg per dose form and in packs containing not more than 50 dose units and that have received the consent of the Minister or the Director-General to their distribution as restricted medicines and that are sold in the manufacturer's original pack labelled for use by adults and children over 12 years of age
   • pharmacy-only; for oral use in liquid form with a recommended daily dose of not more than 1.2 g for the relief of pain and reduction of fever or inflammation when sold in the manufacturer's original pack containing not more than 8 g; for oral use in solid dose form containing not more than 200 mg per dose form and with a recommended daily dose of not more than 1.2 g when sold in the manufacturer's original pack containing not more than 100 dose units; except in divided solid dosage forms for oral use containing 200 mg or less per dose form with a recommended daily dose of not more than 1.2 g and when sold in the manufacturer's original pack containing not more than 25 dose units
   • general sale; for external use; in divided solid dosage forms for oral use containing 200 mg or less per dose form with a recommended daily dose of not more than 1.2 g and when sold in the manufacturer's original pack containing not more than 25 dose units per pack.

   One pre-meeting comment was received during the consultation period which strongly opposed the reclassification of ibuprofen in combination with phenylephrine. The lack of restriction on the quantity able to be brought under a general sale classification would present a risk to public safety, especially when the medicines are contraindicated (eg, phenylephrine should not be used in patients with severe hypertension).

   In New Zealand classification is based on the individual active ingredients, with the most restrictive classification dictating the classification of the medicine. As Ibuprofen and phenylephrine are already classified as general sale medicines, no recommendation was required.

   Recommendation

   No recommendation was required.

Decisions by the Delegate – February 2013

1. Diclofenac

   The Schedule 2 (pharmacy-only medicine) entry for diclofenac should be amended to include transdermal preparations for topical use containing 140 mg or less of diclofenac.

   The Committee considered harmonising with the above classification.

   The Committee noted there were no products, when presented in a transdermal drug delivery system for topical use, currently marketed in New Zealand that would be affected by the proposed reclassification.

   The Committee initially considered a reclassification of topical preparations at the 3rd meeting on 17 September 1985. On receiving further information on the reclassification proposal, at the 4th meeting on 11 March 1986, the Committee recommended diclofenac in preparations for dermatological use be reclassified as pharmacy-only medicines. At the 18th meeting on 15 October 1997, the Committee recommended that diclofenac for topical use should become a general sale medicine. At the 46th meeting on 15 November 2011, the Committee recommended that diclofenac for the treatment of solar keratosis should be reclassified as a prescription medicine.

   In New Zealand, diclofenac is currently classified as:

   • prescription; in preparations for the treatment of solar keratosis; except when specified elsewhere in the Schedule; except in preparations for external use other than for the treatment of solar keratosis
   • restricted; in solid dose form in medicines containing 25 mg or less and more than 12.5 mg per dose form in packs containing not more than 30 tablets or capsules
   • pharmacy-only; in solid dose form in medicines containing 12.5 mg or less per dose form in packs containing not more than 30 tablets or capsules and with a recommended daily dose of not more than 75 mg
   • general sale; in preparations for external use other than for the treatment of solar keratosis.

   One pre-meeting comment was received during the consultation period which supported the reclassification. The proposed reclassification would offer patients a different form of delivery and provide an alternative to those who may be unable to tolerate oral anti-inflammatories.

   The Committee decided not to harmonise because in New Zealand diclofenac, in preparations for external use other than for the treatment of solar keratosis, is already classified as a general sale medicine. Harmonising would result in a more restrictive classification with a more controlled dose than other products which would be left at general sale.

   Recommendation

   That the pharmacy-only medicine entry for diclofenac should not be amended to include transdermal preparations for topical use containing 140 mg or less of diclofenac.

2. Enobosarm, Selective Androgen Receptor Modulators and the Medsafe submission regarding the classification of peptide-based performance and image enhancing drugs

   A new entry should be created for enobosarm and a new class entry should be created for selective androgen receptor modulators in Schedule 4 (prescription medicine). Enobosarm was being imported into Australia and used by body builders seeking its anabolic effects on muscle. These selective androgen receptor modulators are not captured by the anabolic steroids group entry. Although they appear to have an anabolic effect on bone and muscle, they are not steroids.

   In parallel to this harmonisation consideration, Sports New Zealand had contacted the Ministry of Health to bring attention to their concerns over the risks posed to individuals consuming a range of performance and image enhancing drugs that are based on peptides and hormones. The substances have limited safety information and / or are prohibited by the World Anti-Doping Agency for use by people participating in professional sport. Although some of the substances are already classified as prescription medicines, there remain a number that are not or that require clarification regarding whether they fall under an existing classification group entry (eg, hypothalamic releasing factors, anabolic steroids).

   Based on a variety of literature reports, clinical assessor comments and information from the Australian Crime Commission, Medsafe recommended:

   1. scheduling selective androgen receptor modulators to harmonise with Australia
   2. harmonising with Australia by creating the following prescription medicine entry; 'insulin-like growth factors, except when specified elsewhere in the Schedule'
   3. scheduling growth hormone releasing peptides under the term 'human growth hormone secretagogues' (if the Committee considers these substances not to be included under the current scheduled term 'hypothalamic releasing factors')
   4. creating a class entry for 'melanocyte stimulating peptides / hormones / substances' or 'melanotropic peptides / hormones / substances' in the Schedule to capture unscheduled analogues such as bremelanotide. (otherwise these substances may be scheduled individually under their substance names).

   The submission (Microsoft Word document, 1.25MB, 35 pages) from Medsafe was published on the Medsafe website on 5 June 2013 to allow for public consultation. Four pre-meeting comments were received during this consultation period. Whilst it was noted that there was limited clinical data for most of the identified substances listed, all four generally supported Medsafe's recommendations and noted that:

   1. class entries would allow for 'new' substances to fall within current scheduling as they are created
   2. it would be useful to have individual substances listed under their commercial names
   3. such classifications would mean access to these substances could be better controlled and would allow appropriate regulatory action to be taken when necessary
   4. although on a smaller scale, New Zealand's performance and image enhancing drugs border inception data shows similar trends to that in Australia whose market has expanded rapidly in recent years
   5. classification would enable importation of these substances to be regulated and therefore reduce the risk of supply to New Zealand athletes
   6. classification would reduce risks and consequent damage to New Zealand sport's integrity.

   Comments that did not support some of Medsafe's recommendations included:

   1. growth hormone variants and other substances should not remain unclassified, even though there is a lack of data, because of the risk to public health.

   The Committee noted that only a two week period had been available for comments on the submission before the meeting took place. The Committee therefore decided that they would foreshadow their classification recommendations for the peptide-based performance and image enhancing drugs. The recommendations would then be finalised out-of-session following a further two month consultation period after publication of the minutes. This two month consultation period would also allow for any objections to be raised regarding the proposed classifications, and for submitters to indicate whether any qualifying conditions (eg, concentration limits) might be required.

   The Committee discussed using class entries but, where possible, also scheduling individual substances in order to provide greater clarity to anyone searching for ingredients scheduled under the Medicines Regulations 1984.

   Scheduling selective androgen receptor modulators to harmonise with Australia

   The Committee agreed with the concept of harmonising with Australia on this matter and, therefore, foreshadowed that a class entry should be created for selective androgen receptor modulators as prescription medicines. Also, a new entry should be created for enobosarm (otherwise known as ostarine) as a prescription medicine. Enobosarm has already been scheduled in Australia, and it is one of the most commonly cited substances falling under the selective androgen receptor modulator class entry.

   Harmonising with Australia by creating the following prescription medicine entry; 'insulin-like growth factors, except when specified elsewhere in the Schedule'

   IGF-1 is currently classified as a prescription medicine under the name 'mecasermin' but its synthetic analogues do not appear to be. The Committee foreshadowed that a class entry should be created for insulin-like growth factors as prescription medicines, except when specified elsewhere in the Schedule. This harmonises with the Australian Standard for the Uniform Scheduling of Medicines and Poisons and allows for scheduling the synthetic analogues and splice variants of IGF-1. These include:

   1. IGF-1 LR3
   2. IGF DES (1-3)
   3. MGF.

   No discussion regarding classification of the analogues under their individual names occurred as there are no INN or 'official' names for these analogues.

   The relevance of this classification to deer velvet was specifically discussed. Deer velvet, a natural product, is reported to contain insulin-like growth factors. One of these, IGF-1, has been scheduled for a long time as a prescription medicine under the name mecasermin, with no impact on the deer velvet industry. The Committee expected levels of any other insulin-like growth factors to be low, but did not know exact concentrations, so would welcome comments from the deer velvet industry on the potential impact of this group classification.

   Scheduling growth hormone releasing peptides under the term 'human growth hormone secretagogues'

   The Committee foreshadowed that a class entry should be created for human growth hormone secretagogues as prescription medicines. While these substances may already be covered under the current class entry of hypothalamic releasing factors, there is a sufficient lack of clarity that it was deemed useful to create a new and clearer entry specifically for this class.

   To further enhance clarity, the Committee also discussed adding individual substances to the Schedule. Sermorelin is already scheduled as a prescription medicine. It was foreshadowed that other synthetic growth hormone releasing peptides listed in the submission with recognised names should also be individually scheduled as prescription medicines. These substances are:

   1. ipamorelin
   2. hexarelin
   3. tesamorelin.

   Individually scheduling a naturally occurring stimulator of growth hormone secretion, ghrelin, was also discussed. Committee members had no significant objections to this, but were open to receiving comments during the consultation period.

   The Committee agreed with Medsafe in that it was not appropriate to classify the growth hormone variants mentioned in the submission because they were too ill defined to capture with any clarity. However, any comments received during the consultation would be accepted if additional information did become available in the meantime.

   Creating a class entry for 'melanocyte stimulating peptides / hormones / substances' or 'melanotropic peptides / hormones / substances' in the Schedule to capture unscheduled analogues such as bremelanotide

   The Committee discussed the classification of melanotan I, II, and any potential analogues. Melanotan I is already scheduled under the name 'afamelanotide'. Melanotan II / bremelanotide is not currently scheduled.

   The Committee foreshadowed that a class entry should be created for melanocyte stimulating compounds, rather than scheduling the substances individually under their substance names. The term 'compound' was chosen so that both peptides and hormones would be included in the class entry while omitting naturally occurring melanotropic effects such as sunshine.

   There are a large number of human growth hormone secretagogues and other performance and image enhancing drug type substances currently in supply, many with little to no data regarding their use. Due to this, the Committee agreed that Sports New Zealand should be encouraged to make submissions to the Committee to classify peptide-based performance enhancing drugs as they become aware of them in the future.

   Recommendations

   Foreshadow that New Zealand should harmonise with Australia, and a class entry should be created to classify selective androgen receptor modulators as prescription medicines.

   Foreshadow that New Zealand should harmonise with Australia, and classify enobosarm as a prescription medicine.

   Foreshadow that a class entry should be created to classify insulin-like growth factors as prescription medicines; except when specified elsewhere in the Schedule.

   Foreshadow that a class entry should be created to classify human growth hormone secretagogues as prescription medicines.

   Foreshadow that ipamorelin, hexarelin, tesamorelin and ghrelin should be classified as prescription medicines.

   Foreshadow that a class entry should be created to classify melanocyte stimulating compounds as prescription medicines.

   That the classification recommendations for the peptide-based performance and image enhancing drugs discussed should be finalised out-of-session following a further two month consultation period after publication of the minutes. Consideration will be given as to whether qualifying wording is required, based on the submissions received.

   That Sports New Zealand should be encouraged to make submissions to classify peptide-based performance and image enhancing drugs as they become aware of such drugs in the future.

3. Vitamin D

   A new Schedule 3 (restricted medicine) entry should be created to allow a weekly dose of vitamin D up to 175 mcg per recommended dose.

   The Committee considered harmonising with the above classification.

   The Committee noted there were no products currently marketed in New Zealand that would be affected by the proposed reclassification.

   The term 'vitamin D' encompasses ergocalciferol (vitamin D2) and colecalciferol (vitamin D3).

   At the 7th meeting on 31 July and 1 August 1990 ergocalciferol was classified as a prescription medicine (except in medicines containing 25 mcg or less of ergocalciferol per daily dose) and vitamin D, its metabolites and derivatives, as prescription medicines (if the recommended daily dose exceeded 25 mcg of vitamin D).

   At the 37th meeting on 17 May 2007 it was recommended that the prescription medicine schedule entry for vitamin D should be amended to read 'for internal use in medicines containing more than 25 mcg per recommended daily dose except in parenteral nutrition replacement preparations'.

   At the 44th meeting on 2 November 2010, following the suggestion by a Committee member, it was recommended that Medsafe should make a submission proposing the reclassification of vitamin D, in tablets containing 1.25 mg or colecalciferol, from prescription medicine to restricted medicine for the prevention and treatment of vitamin D deficiency states in adults.

   At the 47th meeting on 1 May 2012, the Committee recommended that vitamin D, in tablets containing 1.25 mg of colecalciferol, should not be reclassified from prescription medicine to restricted medicine for the prevention and treatment of vitamin D deficiency states in adults.

   Vitamin D, ergocalciferol (vitamin D2) and colecalciferol (vitamin D3) are currently classified as:

   • prescription; in medicines containing more than 25 mcg per recommended daily dose except in parenteral nutrition replacement preparations
   • general sale; in medicines containing 25 mcg or less per recommended daily dose; in parenteral nutrition replacement preparations.

   One pre-meeting comment was received during the consultation period which supported the reclassification. The reclassification could result in more vitamin D treatment, leading to reduced musculoskeletal pain and weakness, reduced fractures and therefore reduced hospitalisations due to falls and fractures. Appropriate advice and a limited number of tablets should minimise inaccurate usage and it would be more convenient for patients to obtain it from a pharmacist.

   The Committee agreed that, on the basis of recent discussions at previous meetings and the data presented, there was not enough benefit data to outweigh the risk of reclassifying vitamin D at this dose. The Committee therefore decided not to harmonise.

   Recommendation

   That a new restricted medicine entry should not be created to allow a weekly dose of vitamin D up to 175 mcg per recommended dose.

9

Agenda items for the next meeting

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

1. the Committee will discuss the revised Medsafe paper regarding the factors when considering a medicine for reclassification for non-prescription sale, alongside any comments received during the consultation period and the consultation and review of the medicines and poisons scheduling arrangements in Australia
2. the Committee will consider whether the reclassification of influenza vaccine (from prescription medicine to prescription medicine except when administered to a person aged 18 years or over by a 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), and potentially Tdap and meningococcal vaccine, should be amended from administration by a pharmacist to include all authorised vaccinators
3. a revised submission to reclassify naproxen, in solid dose form for oral use containing 220 mg or less per dose form with a recommended daily dose of not more than 660 mg and in a pack containing not more than 15 tablets or capsules, from pharmacy-only medicine to general sale medicine will be considered
4. the classifications of the peptide-based performance and image enhancing drugs, following further consultation and finalised out-of-session, will be added as a matter arising for information.

Review of the pilot for having observers during reclassification submissions

This meeting was the fourth and last meeting that would pilot having observers during reclassification submissions.

The Committee reviewed the pilot using the feedback from the companies involved. A survey was sent to those who had observed a meeting and also those who were invited but did not attend. A total of 13 out of 16 recipients responded to the survey. The survey results were published as a link from the agenda to encourage comments from interested parties during the consultation period.

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

One stated it would be interested in hearing the feedback from the observers. This information was already publicly available as a link from the agenda on the Medsafe website (www.medsafe.govt.nz/profs/class/Agen49Feedback.pdf).

The other expressed concern that only those who submit a proposal can be observers. Companies who could be affected by a reclassification proposal would like the opportunity to observe, or present a verbal submission, so that questions concerning an objection can be asked by Committee members. The benefit being the Committee would be able to hear and clarify any objections to a proposal before a recommendation is made.

In reviewing the pilot and discussing whether observing should continue, the Committee made the following comments:

1. members became more confident in the process with experience
2. it was useful to be able to ask the observers questions and get immediate feedback to clarify parts of a submission that were unclear
3. an industry representative, or companies that could be affected by a reclassification proposal, would not be able to answer questions on the data presented in the submission
4. there was not enough time for verbal presentations at a meeting – all of the data should be included in the submission with the observers only present to clarify and answer any questions
5. constructive discussion by the Committee was not restricted because observers left before a final recommendation was made

The Committee agreed that observers may continue to attend meetings under the following guidelines:

1. only those who have made a submission for reclassification may observe a meeting
2. a maximum of three individuals involved in a specific submission may observe a meeting
3. observers may only observe the initial discussion around their submission (ie, when considered under agenda item six)
4. discussion around a submission will only start after each observer has handed a completed and signed Statement of Confidentiality form to the Secretary
5. observers cannot participate in the reclassification discussion unless invited by the Committee to provide explanations or additional information during the meeting
6. observers will be asked to leave the meeting room after the submission has been discussed, but before the Committee makes the final recommendation on the reclassification submission (the Committee will make the final recommendation autonomously and in private to avoid any conflict of interests or interferences).

Recommendation

That observers may continue to attend meetings under the guidelines described.

Reclassification of medicines in Denmark

The Committee were presented with an email that described a new automatic process in Denmark which transforms products from being sold in a pharmacy to general sale after two years on the market. To date, very few products had been transformed into general sale products using this automatic procedure.

One pre-meeting comment was received during the consultation period which expressed an interest in further information on the process used in Denmark.

The Committee noted the Danish process. The Committee also noted that, in comparing the medicines released for general sale in Denmark with the current classification in New Zealand, the medicines were already similar in both jurisdictions in terms of their over-the-counter availability.

Factors contributing to international variation in reclassification

Presentation by Natalie Gauld, Director, Pharma Projects Limited.

11

Date of next meeting

To take place on a Tuesday in October or November 2013. The Secretary would email members for their availability.