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Revised: 23 May 2013

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Minutes of the 46th meeting of the Medicines Classification Committee - 15 November 2011

HELD IN THE MEDSAFE BOARDROOM, LEVEL 6, DELOITTE HOUSE, 10 BRANDON STREET, WELLINGTON. COMMENCING AT 9:30am

5.3 Clobetasone

An over-the-counter 30 g pack of Eumovate cream was launched on 1 May 2012. An over-the-counter 15 g pack will be launched later this year.

Present:

Dr Stewart Jessamine (Chair)
Dr Melissa Copland
Mr Andrew Orange
Dr Mark Peterson
Dr Enver Yousuf
Ms Andrea Kerridge (Secretary)

Part Attendance (from Medsafe):

Dr Haley Ataera (Advisor Science, Prescription Medicines)
Ms Tania Chinnaiyah (Advisor Science (Product Safety), Compliance Management)
Mrs Julie Lagan (Advisor (Product Safety), Compliance Management)
Dr Susan Martindale (Principal Advisor, Regulation)
Dr Mary-Jane McCarthy (Team Leader, Non-Prescription Medicines)
Mrs Mary Miller (Senior Advisor Science, Non-Prescription Medicines)

Observers (for specific agenda items only):

Bayer Consumer Healthcare New Zealand
Nycomed Pty Limited
Pharmacybrands Limited
Salterelo Limited
Sanofi New Zealand

Apologies:

Dr Timothy Healy

1 WELCOME

The Chair opened the 46^th meeting at 9:30am and welcomed members and guests.

2 APOLOGIES

Apologies were received from Dr Healy.

3 CONFIRMATION OF THE MINUTES OF THE 45^TH MEETING HELD ON TUESDAY 12 APRIL 2011

The minutes of the 45^th meeting were accepted as a true and accurate record. The minutes were signed and dated by the Chair.

4 DECLARATION OF CONFLICTS OF INTEREST

The Conflict of Interest forms were returned to the Secretary.

The following conflicts of interest were declared:

One member declared a potential conflict with agenda item 6.3, omeprazole 10 mg and 20 mg enteric coated tablets. Payment had been received by the member from the New Zealand College of Pharmacists, who had received sponsorship from Bayer, for providing two education sessions when omeprazole was reclassified from prescription to restricted medicine. This same conflict had been declared at the 44^th meeting on 2 November 2010 and the Committee agreed that the same rules should apply. The member could participate in discussion but not vote on the recommendation. It was also agreed that by the next meeting enough time would have passed for this to cease being a conflict.
The same member declared a potential conflict with agenda item 6.4, pantoprazole 20 mg enteric coated tablets. Because pantoprazole is similar to omeprazole, a proton pump inhibitor with the same indications, then by association the same rule could apply. The Committee agreed that, because of the member's involvement with omeprazole (described above) there was a potential for a perceived conflict. As the perceived conflict was not product specific, and no direct payment was received, the Committee determined the member could participate in discussion but not vote on the recommendation.

The Committee discussed the premise of a conflict of interest for one medicine being applicable to all medicines of a specific therapeutic group, e.g. proton pump inhibitors in this instance. It was noted that adoption of this approach could lead to members being unable to vote on a growing number of recommendations. It was therefore agreed that potential conflicts of interest should be considered on a case-by-case basis and that the decision at this meeting should not set precedence.

Mr Orange confirmed, following his declaration at the last meeting, that he now had a practising certificate from the Pharmacy Council.

It was noted that one member was also on PHARMAC's Pharmacology and Therapeutics Advisory Committee.

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

5 MATTERS ARISING

5.1 Objections to recommendations made at the 45^th meeting

No objections had been received.

5.2 Amorolfine

At the 45^th meeting the Committee considered harmonising with the Australian classification of amorolfine. In June 2010, the Australian National Drugs and Poisons Schedule Committee had agreed to reschedule amorolfine topical preparations from restricted medicine to pharmacy-only medicine, and preparations containing amorolfine for the treatment of tinea pedis remain as general sale medicines.

In Australia, amorolfine is classified as:

Schedule 4 (prescription medicine); except when included in Schedule 2; except in preparations for the treatment of tinea pedis
Schedule 2 (pharmacy-only medicine); in preparations for topical use except in preparations for the treatment of tinea pedis.

In New Zealand, amorolfine is currently classified as:

prescription; except for external use
restricted; for external use in medicines containing more than 0.25%
pharmacy-only; for external use in medicines containing 0.25% or less except in medicines for tinea pedis only
general sale; for external use in medicines for tinea pedis only.

At the 45^th meeting the Committee noted that the general sale entry for amorolfine, for the treatment of tinea pedis, was already harmonised with Australia. However the Committee requested further information on the impact of the harmonisation proposal, i.e. to reschedule amorolfine topical preparations from restricted medicine to pharmacy-only medicine.

This harmonisation proposal was reconsidered in light of Medsafe's report on the safety of amorolfine. There is only one product containing the active ingredient amorolfine currently available in New Zealand as a restricted medicine, Loceryl nail lacquer (which contains 5% amorolfine). The Loceryl datasheet states that adverse effects are rarely experienced and relatively minor. The Committee noted there had only been one adverse drug reaction reported to the Centre for Adverse Reactions Monitoring and that this report was submitted in 1999. This reaction was classified as not serious and unlikely to be related to amorolfine.

Two pre-meeting comments were received during the consultation period. One supported the reclassification of amorolfine topical preparations containing more than 0.25% from restricted the pharmacy-only medicine and stated topical amorolfine fitted the criteria for a pharmacy-only classification. The other would prefer high strength amorolfine preparations to remain restricted medicines to ensure the patient is fully informed of the correct use of the nail lacquer.

The Committee agreed that most decisions to treat using amorolfine were empirical and the risk of misdiagnosis was equal for doctors and pharmacists. The alternative to topical was use of an oral treatment associated with a number of serious adverse reactions. Treatment of fungal nail infections was usually for the purpose of appearance. Topical treatment has no obvious safety issues, a good therapeutic margin, it is hard to overdose using it and patients cannot abuse it. Reclassifying topical preparations to pharmacy-only would improve consumer convenience.

The question arose as to whether self-diagnosis and continued use of topical amorolfine would deny patients access to better treatments. The Committee considered this to be unlikely and the product information advises consumers to seek medical advice if their nail does not appear to be responding to the course of topical treatment. Concerns were also expressed over the advertising of the product, in the risk of use in diabetics and also with those who bite their fingernails that have been treated. However, appropriate labelling and advice would mitigate these risks.

The Committee concluded that amorolfine topical preparations should be reclassified from restricted to pharmacy-only medicines. However, the pack insert and labelling should be reviewed by Medsafe to ensure that the treatment advice is adequate for use as a pharmacy-only medicine.

The general sale classification of amorolfine was discussed separately during agenda item 5.9.

Recommendation

That New Zealand should harmonise with Australia and reschedule amorolfine topical preparations from restricted medicines to pharmacy-only medicines.
That Medsafe should review the labelling and pack insert to ensure there is good treatment advice for use as a pharmacy-only medicine.

5.3 Clobetasone

At the 45^th meeting it was brought to the Committee's attention that the non-availability of Becoderm-C had left consumers without an over-the-counter clobetasone butyrate 0.05% topical preparation option.

Clobetasone is currently classified as:

prescription; except when specified elsewhere in the Schedule
restricted; for dermal use in medicines containing 0.05% or less and in packs containing not more than 30 g 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.

The Committee were to discuss removing the wording, 'which have received the consent of the Minister or Director-General to their distribution as restricted medicines and are sold in the manufacturer's original pack', from the restricted medicine classification statement of clobetasone. However, since the 45^th meeting, the Committee had been made aware that, following the approval of a change in name of Becoderm-C to Eumovate the sponsor company has confirmed that over-the-counter clobetasone butyrate 0.05% topical preparation is now available.

Two pre-meeting comments were received during the consultation period. Both informed the Committee that Eumovate topical cream was expected to be introduced into the New Zealand market soon and so the Committee's original consideration was no longer relevant.

The Committee agreed that, because of the assurances received, there was no longer a need to remove the suggested wording and no recommendation required. However, it was also agreed that if Eumovate topical cream was not on the market soon, Medsafe would initiate an out-of-session consultation to ensure that consumers would not be left without an over-the-counter clobetasone butyrate 0.05% topical preparation option.

Recommendation

No recommendation was required.

5.4 Fingolimod 0.5 mg immediate release capsule
(Gilenya, Novartis New Zealand Limited)

An out-of-session consultation took place in May 2011 regarding the classification of fingolimod.

Fingolimod is a sphingosine-1-phosphate receptor modulator. Fingolimod is metabolised by sphingosine kinase to the active metabolite fingolimod-phosphate. Fingolimod-phosphate binds at low nanomolar concentrations to sphongosine-1-phosphate (S1P) receptors 1, 3, and 4 located on lymphocytes, and readily crosses the blood brain barrier to bind S1P receptors 1, 3 and 5 located on neural cells in the central nervous system. By acting as a functional antagonist of S1P receptors on lymphocytes, fingolimod-phosphate blocks the capacity of lymphocytes to egress from lymph nodes, causing a redistribution, rather than depletion, of lymphocytes. This redistribution reduces the infiltration of pathogenic lymphocyte cells into the central nervous system where they would be involved in nerve inflammation and nervous tissue damage. Fingolimod hydrochloride is a white to almost white crystalline powder which is freely soluble in water. Each Gilenya capsule contains 0.5 mg fingolimod, mannitol and magnesium stearate.

Gilenya is indicated as a disease modifying therapy for the treatment of patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

The Committee recommended that fingolimod should be classified as a prescription medicine. This classification was gazetted alongside the recommendations from the 45^th meeting on 4 August 2011.

Recommendation

No further recommendation was required.

5.5 Methenamine hippurate

Methenamine hippurate is currently available as a general sale medicine. The Committee considered whether this was an appropriate classification or whether pharmacy-only would be more appropriate given its increased marketing for the relief of urinary tract infections.

The Secretary had written to iNova Pharmaceuticals (Australia) Pty Limited regarding their product Hiprex, which contains 1 g methenamine hippurate, and this classification discussion. The approved indications for this product are "Hiprex has antibacterial properties that will suppress or eliminate urinary bacteria". A response was received which concluded there was no justification for the upward classification to pharmacy-only considering the number of doses sold compared to the number and minor nature of the adverse drug reports in Australia over the same period. Figures of adverse drug reports for New Zealand were not available. Methenamine hippurate is currently a general sale medicine in Australia. If the product was classified as a pharmacy-only medicine in New Zealand it would be difficult to justify the product remaining on the market when the labelling would be different from that in Australia.

One pre-meeting comment had been received during the consultation period which supported the reclassification of methenamine hippurate from general sale to a pharmacy-only medicine. The submission noted that, although initially marketed as a urinary antiseptic useful as prophylaxis of chronic or recurrent urinary infections, it was more recently being promoted as a short-term treatment of urinary tract infection. In addition, the submission commented that pharmacist advice would be required to appropriately counsel the patient, and ensure that it is not being taken in conjunction with a urinary alkaliniser (which would render the product ineffective). The submission supported the reclassification to pharmacy-only so that sales would be made with pharmacy staff oversight.

The Committee were informed that Medsafe was currently investigating a complaint regarding the promotion of Hiprex. The main concerns of the complaint were that Hiprex was allegedly being marketed for an indication of 'for effective relief from urinary tract infections', and that Medsafe had not assessed or recommended that the Minister's delegate grant consent for this indication. The complaint also provided promotional material that stated the product was suitable for use in pregnancy and in children, conditions in which safety has not been fully established.

The Committee discussed the availability of Hiprex as a general sale medicine. The product had been in use for a long time and appeared relatively safe in the average consumer who has no underlying renal condition. It was also noted that despite its availability as general sale, the company claimed that Hiprex was commonly treated as if it was a restricted medicine and was only sold with pharmacist oversight.

It was accepted that patients with chronic or recurrent urinary tract infection can self-diagnose. However, use of the product in these circumstances usually arose from clinical advice. The Committee noted that inappropriate use could delay patients from seeking more appropriate treatment for an infection.

The Committee discussed whether a prescription medicine classification would be more appropriate for the promoted indication, 'for effective relief from urinary tract infections'. The Committee considered that the legitimate use of this product is in a highly selective group of patients where clinical intervention is required. In these patients it is used as an add-on treatment and so is not suitable for self-selection. A prescription medicine classification would appear appropriate but would reduce consumer convenience.

The Committee considered there are different causes of urinary tract infection and when patients consult with a doctor there is an opportunity to ensure that any risk of serious infection or severe infections such as pyelonephritis are excluded. The Food and Drug Administration in America advise that the use of methenamine hippurate in the absence of proven infection is unlikely to provide any patient benefit. Also, its use is generally recommended in partnership with antibiotics where long term antibiotic therapy is being considered. However, despite this expert opinion the product remains a general sale medicine in America, Australia, Europe and the United Kingdom.

The Committee agreed that any rescheduling decision recommended at this meeting may have implications for the complaint procedure. A decision should not be made until the complaint was resolved. The Committee also agreed that further data would be required from the company for consideration at the next meeting, e.g. the method of sale, reports of any adverse drug reactions in New Zealand and more information on appropriate use of the product clinically i.e. for self-selection over-the-counter.

Recommendation

That Medsafe should report back on the action taken with the complaint regarding the promotion of Hiprex.
That iNova Pharmaceuticals (Australia) Pty Limited should provide the following for consideration at the next meeting:
- further data on the number of products dispensed according to prescription versus the number sold over-the-counter
- any reports of adverse drug reports in New Zealand
- more information on appropriate use of the product clinically, i.e. for self-selection over-the-counter.
That the Committee should consider at the next meeting whether a proposal to reclassify methenamine hippurate should be included on the agenda for the second meeting of the Committee in 2012.

5.6 Oseltamivir

Oseltamivir is currently classified as a prescription medicine; except when sold in a pharmacy between the months of April to November inclusive by a registered pharmacist who is satisfied that the medicine is for the treatment of a consumer who is resident in New Zealand, is 12 years of age or more, and currently has the symptoms of influenza. This classification was kept up to date by publishing a Gazette notice every six months. However, in an update to the Medicines Regulations 1984 which came into effect on 1 August 2011, this classification was added permanently to Schedule 1. The Committee considered whether adding this classification permanently to the Schedule was appropriate.

The Committee noted that currently in New Zealand there was one brand of medicine marketed that contained oseltamivir.

At the 32^nd meeting on 25 November 2004, the Committee recommended, following a proposal from a Committee member, that oseltamivir be added to the agenda of the next meeting. At the 33^rd meeting on 9 June 2005, the Committee recommended that, following a company submission, the reclassification of oseltamivir from prescription to restricted medicine should be deferred pending further information regarding resistance, monitoring of resistance, promotion, national strategy and limitation of use. At the 34^th meeting on 9 June 2006, after considering this further information, the Committee recommended that pharmacists should be able to sell oseltamivir between the months of May and September for the treatment of influenza but not for prophylaxis. At the 36^th meeting on 8 February 2007, the Committee recommended that oseltamivir should be returned to the agenda after there had been a period of market experience at the new level of access. At the 39^th meeting on 25 June 2008, the Committee recommended that, following a company submission, there be no change to the current classification of oseltamivir. At the 40^th meeting on 25 November 2008, the Committee concluded there was no new data from the 2008 influenza season which would justify a change to the current classification of oseltamivir. At the 41^st meeting on 14 May 2009, the Committee concluded there was insufficient evidence of resistance with exposure to Tamiflu (compared to resistance associated with spontaneous mutations) that would cause them to reconsider the current classification status of oseltamivir.

In response to the pandemic in 2009, on 9 July 2009 the classification of oseltamivir was gazetted as a prescription medicine; except when sold in a pharmacy between the months of May to September inclusive, or for the duration of the Influenza A (H1N1) Pandemic, by a registered pharmacist who is satisfied that the medicine is for the treatment of a consumer who is resident in New Zealand, is 12 years of age or more, and currently has symptoms of influenza; except when supplied from a Community-based Assessment Centre established and operated by a district health board in accordance with a protocol approved by the National Incident Controller for the Influenza A (H1N1) Pandemic. This notice was not renewed after six months and did not need consideration by the Committee.

Following advice from the Office of the Director of Public Health, on 1 April 2010 a Gazette notice was published to widen public access to oseltamivir to include the month of April and remove the requirement for the ill patient to be present in the pharmacy. Modelling from the northern hemisphere postulated that seasonal influenza was likely to arrive early in 2010. Oseltamivir was classified as a prescription medicine; except when sold in a pharmacy between the months of April to September inclusive by a registered pharmacist who is satisfied that the medicine is for the treatment of a consumer who is resident in New Zealand, is 12 years of age or more, and currently has the symptoms of influenza. Further advice confirmed that seasonal influenza may not have reached its peak in 2010 and so on 9 September 2010 a Gazette notice was published to widen public access to oseltamivir to include the months of October and November. Further advice confirmed that it would be reasonable to extend the Gazette notice so this classification of oseltamivir was gazetted again on 24 February 2011 and 8 August 2011. Again these classifications did not need consideration by the Committee.

Two pre-meeting comments had been received during the consultation period. One stated the Committee may want to reconsider the wording, 'for the treatment of a person who is resident in New Zealand', because it would be reasonable to supply to someone staying in New Zealand who is not necessarily a resident. The other noted that the classification of oseltamivir as a prescription medicine had already been incorporated into the Schedule.

The Committee discussed the term resident. The intent was that resident did not refer to a residency visa but rather to a consumer who was physically present in New Zealand. However, in New Zealand according to the Immigration Act 2009, resident means the holder of a resident visa. It was suggested that the term resident could be removed from the wording. The Committee considered the relevance of stating specific dates within the wording. April to November was based on flu season. However, some patients who have travelled overseas experience symptoms outside of the New Zealand flu season. Also, it was considered whether a restricted classification may be more appropriate given that the current wording states it must be sold in a pharmacy by a registered pharmacist.

The Committee agreed that the classification of oseltamivir as a restricted medicine; for the treatment of a consumer who is in New Zealand, is 12 years of age or more, and currently has the symptoms of influenza, should be added to the agenda of the next meeting to allow for further consultation.

Recommendation

That the classification of oseltamivir as a restricted medicine; for the treatment of a consumer who is in New Zealand, is 12 years of age or more, and currently has the symptoms of influenza, should be added to the agenda of the next meeting.

5.7 PDE-5 inhibitors

Phosphodiesterase type 5 (PDE-5) inhibitors are currently classified as prescription medicines; except when present as an unmodified, naturally occurring substance; except when specified elsewhere in the Schedule. This classification was recommended at the 42^ndmeeting on 3 November 2009 and initially gazetted on 11 February 2010.

At the 45^th meeting the Committee recommended that Medsafe reconsider the wording of PDE-5 inhibitors alongside the wording of lovastatin, as a prescription medicine, so that any foodstuffs would not be inadvertently captured. Medsafe noted that the current wording would permit products containing a high concentration of substances that inhibited PDE-5 to be present, even though it was generally accepted that high levels of PDE-5 inhibition were likely to be associated with significant interactions with other medicines and cause serious side effects.

Medsafe recommended that PDE-5 inhibitors should be classified as prescription medicines; except when present as an unmodified, naturally occurring substance in a food that has not been subject to a manufacturing process other than heating, freezing, drying, preserving, bottling, canning, or packaging in retort pouches; except when specified elsewhere in the Schedule.

The Committee considered this wording alongside the following four submissions received during the consultation period.

Submission 1

This submission objected to the proposed rewording and challenged it on numerous grounds. Specifically:

with the introduction of the Natural Health Products Bill for its first reading, the timing of the discussion is premature and pre-empts proposed legislation which communicates the Government's clear intentions in regulating and managing the natural products industry
if introduced the proposed changes would be unworkable and it is unreasonable to recommend to the Minister of Health something which is unworkable for the industry.

Submission 2

This submission expressed concern in regard to the proposal to change the wording for the classification so only foods are exempt. There are a number of dietary supplements that contain unadulterated guarana or horny goat weed which have some or weak activity at the PDE-5 receptor and the proposed changes would make these products prescription medicines.

It suggested the following wording would be more appropriate, 'except when present as an unmodified, naturally occurring substance in a food that has not been subject to a manufacturing process other than heating, freezing, drying, preserving, bottling, canning, or packaging in retort pouches; except when specified elsewhere in this Schedule'. This would mean that not only foods are exempt but also other products containing unmodified ingredients.

Submission 3

A representative of the natural health products sector opposed the classification of PDE-5 inhibitors as prescription medicines for the following reasons:

PDE-5 inhibitors, including horny goat weed, guarana, and tribulus, are classified as 'natural health product' or 'complementary medicine' ingredients not prescription medicine ingredients in the countries that New Zealand considers its key international trading partners
the Committee is considering classification of ingredients that would fall under the jurisdiction of a New Zealand Natural Health Products regulator. The establishment of such a New Zealand regulator is imminent, with the Natural Health Products Bill currently in Health Select Committee
naturally occurring substances with PDE-5 inhibitor activity are internationally considered safe for use in Natural Health Products globally, and Medsafe has not provided evidence of any outstanding health concerns or risk to consumers through the consumption of products containing these PDE-5 inhibitors
classification of horny goat weed, guarana, and tribulus as prescription medicines contradicts the Committee's previous ruling - the ruling of November 2010 not to classify gingko biloba or a standardised extract of such to be a medicine as there was insufficient evidence of risk of harm, it was deemed safe for use and was already being sold within New Zealand as a dietary supplement (natural health product) with supportive claims
the classification of PDE-5 inhibitors as prescription medicines will result in a significant negative impact on the market including the loss of 25 products minimum in the domestic market, and at least five companies who will be required to move manufacturing of these products to Australia
the classification of PDE-5 inhibitors as prescription medicines in New Zealand will create a trade barrier for New Zealand companies currently serving both domestic and export markets.

There appeared to be some confusion with this submission because PDE-5 inhibitors were already classified as prescription medicines and had been since February 2010. Medsafe contacted the concerned party and explained that it was not the intent to capture the dietary supplements being referred to in the submission.

Submission 4

This submission suggested the wording had already been incorporated into the Schedule as part of the Medicines Amendment Regulations 2011, which came into effect on 1 August 2011. However, this was not the case. PDE-5 inhibitors are currently classified as prescription medicines; except when present as an unmodified, naturally occurring substance; except when specified elsewhere in the Schedule.

The Committee were reminded that under the current wording all unmodified, naturally occurring substances remain unscheduled even if they exhibit potent PDE-5 inhibitory activity. However, as there do not currently appear to be any natural substances with clinically significant activity at the PDE-5 receptor catalytic site, continuation of the current controls would pose a minimal risk of harm to the public. The Committee's concern at the last meeting was the current wording would permit a natural substance to be extracted from a plant and concentrated to levels far in excess of what naturally occurs, and potentially to levels of activity that could be associated with harm.

The Committee acknowledged that their original recommendation to classify PDE-5 inhibitors as a class as prescription medicines was on the grounds of the potential public health risk posed by clinically significant potent pharmaceutical PDE-5 inhibitors. The current wording ensures that caffeine, and other substances with very weak or clinically insignificant activity at the PDE-5 receptor are not inadvertently captured. The Committee noted that, given the low potency of these natural substances in vitro , the degree of concentration required or the amount that would need to be ingested to equate to clinically significant PDE-5 inhibition is likely to be very high and in excess of the quantities included in tablets or tinctures.

It was finally concluded that overall the submissions received supported the current wording and that no change to the scheduling was required.

Recommendation

That the current classification of PDE-5 inhibitors remained appropriate.

5.8 Tuberculin

At the 45^th meeting the Committee considered harmonising with the Australian classification of tuberculin. In December 2010 the Delegate decided to list tuberculin in Schedule 4 (prescription medicine) of the Standard for the Uniform Scheduling of Medicines and Poisons to ensure clarity in interpretation and enforcement.

This harmonisation proposal was reconsidered now that Medsafe had provided data on the potential health impact of adding tuberculin to the New Zealand Schedule as a prescription medicine. Medsafe concluded there would not be any health impact because tuberculin is already classified as a prescription medicine in New Zealand under the class entry for antigens. Tuberculin would remain a prescription medicine and there would be no new restrictions on its use, i.e. it would still be possible for tuberculin skin tests to be administered by nurses under supervision and in accordance with standing orders.

The Committee noted there were currently two medicines marketed in New Zealand containing tuberculin but these were classified as prescription medicines already. It was concluded that there should be a separate entry for tuberculin as a prescription medicine in New Zealand.

Recommendation

That New Zealand should harmonise with Australia - tuberculin should be added to the New Zealand Schedule as a prescription medicine.

5.9 Classification of medicines used by Podiatrists

Podiatry New Zealand asked that the Committee consider the pharmacy-only classification of medicines used by Podiatrists (i.e. amorolfine, ciclopirox, clotrimazole, econazole, isoconazole, ketoconazole, miconazole, nystatin, terbinafine and tioconazole). They suggested that the pharmacy-only classification of medicines used by Podiatrists should include the wording (or words of similar meaning) - 'except when sold in practice by a podiatrist registered with the Podiatrist's Board'.

The current pharmacy-only classification of these medicines limits their general sale status only to the treatment of tinea pedis:

amorolfine; for external use in medicines containing 0.25% or less except in medicines for tinea pedis only
ciclopirox; for external use in medicines containing 2% or less except in medicines for tinea pedis only
clotrimazole; for external use except in medicines for tinea pedis only
econazole; for dermal use except in medicines for tinea pedis only
isoconazole; for dermal use
ketoconazole; for dermal use except in medicines for tinea pedis only or in medicines for treatment of the scalp containing 1% or less
miconazole; for external use except in medicines for tinea pedis only
nystatin; for dermal use
terbinafine; for dermal use except in medicines for tinea pedis only
tioconazole; for dermal use except in medicines for tinea pedis only.

The Committee noted that there were 28 medicines currently marketed in New Zealand that could be affected by a reclassification to include sale by a Podiatrist.

Podiatrists provide diagnostic, preventative and rehabilitive treatment of conditions affecting the feet and the lower limbs. Overall the Committee felt that the request was sensible, specifically from a consumer convenience point of view. The Committee noted that acceptance of the proposal would still ensure that access to the medicine would occur through a health professional who could provide advice on the safe and appropriate use of the medicine. Concern was expressed that access by podiatrists could potentially lead to antifungal agents being combined with active ingredients, such as topical steroids. However, it was noted that podiatrists would not have direct access to these products.

The Committee concluded that the pharmacy-only classification of amorolfine, ciclopirox, clotrimazole, econazole, isoconazole, ketoconazole, miconazole, nystatin, terbinafine and tioconazole should include the wording 'except when supplied by a podiatrist registered with the Podiatry Board' (or words of similar meaning) so that those medicines would be available as general sale.

Recommendation

That the pharmacy-only classification of medicines used by Podiatrists should include the wording 'except when supplied by a podiatrist registered with the Podiatry Board', or words of similar meaning.

5.10 Codeine

At the 42nd meeting on 3 November 2009, the Committee recommended that the decision to allow cough and cold preparations containing codeine to continue to be available at the pharmacy-only level would be reviewed in 12-18 months' time. When the Committee recommended that analgesics containing codeine should be reclassified as restricted medicines, it did so because of increased reports of abuse and addiction. The review in 18 months' time was suggested to determine whether the reclassification had had the required impact, and more importantly whether the abuse of cough and cold medicines containing codeine had increased as consumers move from one source of codeine to another.

The reclassification of codeine was gazetted on 4 October 2010. The 47^th meeting, scheduled to take place in April 2012, represents the 18 month point. The Committee considered what the review should include for consideration at the 47th meeting.

The Committee noted that there were five medicines currently marketed in New Zealand that contained codeine and were classified as pharmacy-only.

The Chair had contacted a New Zealand specialist who had agreed, with support from Medsafe, to provide a review of the New Zealand data and feed back from the addiction treatment sector.

It was also suggested that Medsafe should ask companies and pharmacies to provide sales data in terms of pack size and dosage for the last three years. The questions that the Committee required to be answered were:

are patients presenting in pharmacies asking for codeine containing products
what products are patients taking
what conditions are codeine containing products being used to treat (pain or cough and cold relief)?

Both reviews would be considered at the next meeting.

Recommendation

That the reviews regarding codeine provided by a New Zealand Specialist and Medsafe should be considered at the next meeting.

6 SUBMISSIONS FOR RECLASSIFICATION

6.1 Cetirizine hydrochloride 10 mg tablet
(Histaclear, AFT Pharmaceuticals Limited)

Purpose

This was a company submission requesting the reclassification of cetirizine hydrochloride 10 mg tablets from pharmacy-only medicine to general sale medicine when in packs containing sufficient tablets for only five days' supply and when used for Seasonal Allergic Rhinitis.

Background

At the 8^th meeting on 6 December 1991, the Committee recommended that cetirizine be classified as a prescription medicine. At the 9^th meeting on 28 May 1992, the recommendation was for cetirizine to be classified as pharmacy-only. At the 16^th meeting on 24 April 1994, the Committee had requested that the Medicines Adverse Reactions Committee should actively seek further information about cetirizine and loratadine. However, when considering this data at the 17^th meeting on 15 May 1997, it was agreed that no further data had been produced which would cause them to reconsider the present classification of either cetirizine or loratadine and it was concluded that no further action was necessary at that point.

Cetirizine is currently classified as:

prescription; except for oral use
pharmacy-only; for oral use.

Comments

Two pre-meeting comments were received during the consultation period and neither supported the reclassification proposal for the following reasons:

the proposal underestimates the value of the important role that community pharmacists play in the primary care setting
it overestimates the ability of the public to fully understand the significance of the warnings and precautions printed on the product packaging
reclassification to general sale sends a message to the public that these medicines can be taken by everyone, without risk
four of the seven proposed warning statements stipulate that the medicine should not be taken unless under the advice of a doctor or pharmacist in specific cases
the recommendation at the 42^nd meeting on 3 November 2009, that fexofenadine (in small pack sizes) be reclassified to general sale, should not be seen as a precedent for other second-generation 'non-sedating' antihistamines
despite an indication for seasonal allergic rhinitis, the public may see it as an antihistamine available from the supermarket for other conditions
sedation is noted as an adverse effect in most datasheets for cetirizine and patients need to be advised that there is even a potential low risk with the second-generation antihistamines, which can only be done in consultation with a health professional
the submission to limit the pack size to only five days' supply is irrelevant because there is no prevention to a patient buying more than one pack and allergic rhinitis is not a condition limited to only five days
while allergic rhinitis is often a self-diagnosed condition, its management is varied and the optimal therapeutic choice for an individual patient should be made in consultation with a health professional, e.g. oral antihistamines are not first-line options for the management of allergic rhinitis.

Discussion

The Committee considered the reclassification of cetirizine hydrochloride 10 mg tablets and loratadine 10 mg tablets together.

The safety, efficacy and abuse potential of both cetirizine hydrochloride and loratadine were similar to fexofenadine. Fexofenadine had been recommended for reclassification as a general sale medicine at the 42^nd meeting on 3 November 2009. At the 42^nd meeting the Committee accepted that seasonal allergic rhinitis was self-diagnosable.

The Committee discussed the proposed labelling as there was a subtle difference between the proposed labelling for the two products. The cetirizine hydrochloride pack stated, Histaclear Once-a-Day Non-Drowsy Allergy Relief. Whereas the loratadine pack stated, Loraclear Once-a-Day Hayfever Relief - Non-drowsy antihistamine for rapid hayfever relief. It was agreed that the label for cetirizine hydrochloride pack should reflect the wording on the loratadine pack and decrease the prominence of the non-drowsy statement so that it is not in association with the product name. The pack could carry the statement 'Non-drowsy antihistamine…' in the same manner as that of loratadine.

The Committee concluded that both cetirizine hydrochloride and loratadine should be reclassified from pharmacy-only medicine to general sale medicine when in packs containing sufficient tablets for only five days' supply and when used for Seasonal Allergic Rhinitis.

Recommendation

That cetirizine hydrochloride should be reclassified from pharmacy-only medicine to general sale medicine when in packs containing sufficient tablets for only five days' supply and when used for Seasonal Allergic Rhinitis.
That Medsafe should review the labelling to ensure that the cetirizine hydrochloride pack was brought into line with the loratadine pack.

6.2 Loratadine 10 mg tablet
(Loraclear Hayfever Relief, AFT Pharmaceuticals Limited)

Purpose

This was a company submission requesting the reclassification of loratadine 10 mg tablets from pharmacy-only medicine to general sale medicine when in packs containing sufficient tablets for only five days' supply and when used for Seasonal Allergic Rhinitis.

Background

At the 5^th meeting on 11 November 1986, the classification of loratadine was considered but no recommendation was made pending further information from the Medicines Assessment Advisory Committee. At the 6^th meeting on 10 March 1987, the Committee were informed that the Medicines Assessment Advisory Committee had requested further information. At the 7^th meeting on 31 July and 1 August 1990, the Committee recommended that loratadine be classified as a part II (pharmacy-only) medicine. At the 9^th meeting on 28 May 1992, the Committee decided that loratadine should remain a pharmacy-only medicine. At the 11^th meeting on 29 June 1993, the Committee was asked by the Medicines Adverse Reactions Committee to consider classifying loratadine as a restricted medicine. However it was recommended that there be no change to the present pharmacy-only classification. At the 16^th meeting on 24 April 1994, the Committee had requested that the Medicines Adverse Reactions Committee should actively seek further information about cetirizine and loratadine. However, when considering this data at the 17^th meeting on 15 May 1997, it was agreed that no further data had been produced which would cause them to reconsider the present classification of either cetirizine or loratadine and it was concluded that no further action was necessary at that point.

Loratadine is currently classified as:

prescription; except for oral use
pharmacy-only; for oral use.

Comments

Two pre-meeting comments were received during the consultation period and neither supported the reclassification proposal for the following reasons:

the proposal underestimates the value of the important role that community pharmacists play in the primary care setting
it overestimates the ability of the public to fully understand the significance of the warnings and precautions printed on the product packaging
reclassification to general sale sends a message to the public that these medicines can be taken by everyone, without risk
four of the seven proposed warning statements stipulate that the medicine should not be taken unless under the advice of a doctor or pharmacist in specific cases
the recommendation at the 42^nd meeting on 3 November 2009, that fexofenadine (in small pack sizes) be reclassified to general sale should not be seen as a precedent for other second-generation 'non-sedating' antihistamines
despite an indication for seasonal allergic rhinitis, the public may see it as an antihistamine available from the supermarket for other conditions
the submission to limit the pack size to only five days' supply is irrelevant because there is no prevention to a patient buying more than one pack and allergic rhinitis is not a condition limited to only five days
while allergic rhinitis is often a self-diagnosed condition, its management is varied and the optimal therapeutic choice for an individual patient should be made in consultation with a health professional, e.g. oral antihistamines are not first-line options for the management of allergic rhinitis.

Discussion

The Committee considered the reclassification of cetirizine hydrochloride 10 mg tablets and loratadine 10 mg tablets together.

Recommendation

That loratadine should be reclassified from pharmacy-only medicine to general sale medicine when in packs containing sufficient tablets for only five days' supply and when used for Seasonal Allergic Rhinitis.

6.3 Omeprazole 10 mg and 20 mg enteric coated tablets
(Losec, Bayer New Zealand Limited)

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

Purpose

This was a company submission requesting that the current pharmacy-only classification of omeprazole (in divided solid dosage forms for oral use containing 20 mg or less, with a maximum daily dose of 20 mg in a pack size of up to 14 dosage units, for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over, when sold in a pack approved by the Minister or the Director-General for distribution as a pharmacy-only medicine); be amended to increase the maximum allowed pack size from 14 to 28 dosage units.

Background

Omeprazole was classified as a prescription medicine at the 6^th meeting on 10 March 1987.

Omeprazole was considered but no recommendations were made at the 7^th meeting on 31 July 1990, 26^th meeting on 11 December 2001, 28^th meeting on 19 November 2002, 33^rd meeting on 9 June 2005, 35^th meeting on 9 June 2006 and the 38^th meeting on 14 December 2007.

At the 40^th meeting on 25 November 2008, the Committee recommended that tablets or capsules containing 10 mg or less of omeprazole should be reclassified from prescription to restricted medicine when sold in packs which have received the consent of the Minister or the Director-General to their sale as restricted medicines and are sold in the manufacturer's original pack.

At the 42^nd meeting on 3 November 2009, the Committee recommended that:

tablets containing 20 mg of omeprazole or less should be classified as a restricted medicine when sold in packs approved by the Minister or the Director-General for distribution as a restricted medicine
the requirements for omeprazole to be classified as a restricted medicine should be inserted into the New Zealand Regulatory Guidelines for Medicines by Medsafe
Medsafe should be satisfied with the proposed warning labels of any product containing omeprazole seeking consent for distribution as a restricted medicine.

At the 44^th meeting on 2 November 2010, the Committee recommended that:

omeprazole, in tablets containing 20 mg or less of omeprazole, with a maximum daily dose of 20 mg of omeprazole in a pack size of up to 14 dosage units, should be reclassified from restricted medicine to pharmacy-only medicine for the short-term, symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over, when sold in a pack approved by the Minister or the Director-General for distribution as a pharmacy-only medicine.
Medsafe should update the New Zealand Regulatory Guidelines to reflect this recommendation and to ensure that the warnings statements for omeprazole read 'consult a pharmacist or doctor'.

Omeprazole is currently classified as:

prescription; except when specified elsewhere in the Schedule
restricted; in tablets or capsules containing 20 mg or less when sold in a pack approved by the Minister or the Director-General for distribution as a restricted medicine
pharmacy-only; in divided solid dosage forms for oral use containing 20 mg or less, with a maximum daily dose of 20 mg in a pack size of up to 14 dosage units, for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over, when sold in a pack approved by the Minister or the Director-General for distribution as a pharmacy-only medicine.

Comments

One pre-meeting comment was received during the consultation period and this had reservations about providing a double treatment pack of omeprazole 20 mg as a pharmacy-only medicine. The only benefit of having a double treatment pack was to offer the consumer an economical option of having another course of treatment on hand in the event of recurrence.

Discussion

It was noted by the Committee that a pack with 28 dosage units was not significantly different from a pack of 14 dosage units in terms of potency, therapeutic index, toxicity, abuse potential and currently availability. However, the following issues needed consideration:

consumer convenience - accessibility of the medicine and suitability for self-treatment
inappropriate use - consumers could take the medicine on a monthly basis with a larger pack size without consulting a doctor
the current packs and labels had been created around 14 days' treatment, e.g. the current Consumer Medicine Information insert states 'to get the best results from Losec and Losec Extra take a full course of treatment by finishing the pack'
concerns over the labelling - the advice is that a 14 day treatment duration will provide optimal results.

The main argument of the submission appeared to be consumer convenience of a two treatment pack. The Committee queried whether convenience outweighs the risk of inappropriate prolonged use or prevention of other more appropriate treatment after consultation with a doctor. The United Kingdom classification and Australian scheduling allow a maximum of 14 days treatment.

While acknowledging that consumers can purchase multiple packs in a single transaction, the Committee felt that availability of a larger pack size may be seen to endorse a longer treatment period. The Committee discussed what short-term actually means and concluded that as oesophageal reflux is not a curable condition, 28 days could be considered short-term.

The observers confirmed that the current 14 dosage unit pack size would be kept on the market. The labelling suggested in the submission was based on the label statements database on the Medsafe website. The observers also confirmed the Company would be open to making labelling adjustments if required.

Although the Committee were initially uncomfortable with a pack containing 28 dosage units, when considered objectively there was no concern. The product is effective and little harm has been associated with its use. Any risk could be handled by appropriate labelling and the labelling proposed in the submission was appropriate. The Committee agreed that the benefits of consumer convenience of a two treatment pack outweighed the risk. The pack would need to clearly state it was a two treatment pack, which it does.

The Committee therefore recommended, with one member abstaining from voting due to a declared conflict, that the current pharmacy-only classification of omeprazole should be amended to increase the maximum allowed pack size from 14 to 28 dosage units. However, because of the concerns discussed around the label requirements, Medsafe should look at the labelling of all omeprazole products and harmonise with Australia where possible.

Recommendation

That the current pharmacy-only classification of omeprazole should be amended to increase the maximum allowed pack size from 14 to 28 dosage units.
That Medsafe should look at the labelling of all omeprazole products and harmonise with Australia where possible.

6.4 Pantoprazole 20 mg enteric coated tablet
(SOMAC Heartburn Relief, Nycomed Pty Limited)

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

Purpose

This was a company submission requesting the reclassification of pantoprazole, in tablets containing 20 mg or less of pantoprazole, from restricted medicine to pharmacy-only medicine for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over.

Background

At the 14^th meeting on 2 November 1994, the Committee recommended that pantoprazole should be classified as a prescription medicine.

At the 41^st meeting on 14 May 2009, the Committee recommended that:

tablets or capsules containing 20 mg or less of pantoprazole should be reclassified from prescription medicine to restricted medicine when sold in packs approved by the Minister or the Director-General for distribution as restricted medicines
Medsafe should be satisfied with proposed pregnancy statements and the terminology used on the labels of any pantoprazole product seeking consent to be sold as an over-the-counter medicine.

Pantoprazole is currently classified as:

prescription; except when specified elsewhere in the Schedule
restricted; in tablets or capsules containing 20 mg or less of pantoprazole when sold in a pack approved by the Minister or the Director-General for distribution as a restricted medicine.

Comments

One pre-meeting comment was received during the consultation period that supported the reclassification proposal in light of the past years' experience with omeprazole as a pharmacy-only medicine.

Discussion

Overall the Committee felt that, because the safety profile of pantoprazole was similar to and arguably better than omeprazole, the scheduling of both should be similar. The submission provided evidence that 20 mg a day for 14 days is safe and effective. Overseas approval at the proposed level supported a reclassification change. The Periodic Safety Update Report provided revealed no significant new safety issues since the change in classification in international markets and confirmed the safety profile. The labels and Consumer Medicine Information were acceptable. The supporting data supported efficacy at this dose.

The observer confirmed that in Australia, when pantoprazole was reclassified from a restricted to a pharmacy-only medicine, there was a significant delay from the recommendation to the gazettal date due to the requirement for educational material to be developed. This educational material would be adopted for the New Zealand environment.

The Committee discussed the merits of classifying all proton-pump inhibitors to the same classification. In the past the Committee had reclassified therapeutic groups, e.g. sedating antihistamines at one meeting. However, the Committee noted that therapeutic group reclassifications could lead to a novel member of the therapeutic group that has a significantly different risk-benefit profile being reclassified without any supporting data.

The Committee went on to consider whether the wording of the Schedule entries of pantoprazole should be exactly the same as those for omeprazole. After discussion it was agreed, with one member abstaining from voting due to a declared conflict, that the Committee should make a recommendation only on the classification sought. However, in this instance it would be appropriate to use similar wording to that of omeprazole for pantoprazole in the Schedule.

The Committee were comfortable with a 28 day pack, and recommended that the scheduling and the labelling requirements should be the same as omeprazole.

Recommendation

That pantoprazole, in tablets containing 20 mg or less of pantoprazole, should be reclassified from restricted medicine to pharmacy-only medicine for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over.
That the scheduling and labelling requirements of pantoprazole should be the same as omeprazole.

6.5 Vibrio cholera and enterotoxigenic Escherichia coli vaccine
(Dukoral, Pharmacybrands Limited)

Three representatives of the sponsor 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 and Care Pharmacies in New Zealand) for the reclassification of Vibrio cholera and enterotoxigenic Escherichia coli vaccine from prescription medicine to restricted medicine. The reclassification was sought for the 3 mL oral liquid vaccine.

Background

All vaccines are currently classified as prescription, except when specified elsewhere in the Schedule.

Comments

Two pre-meeting comments were received during the consultation period. One interested party supported the reclassification in part, but with the following conditions:

the reclassification is for the prevention of traveller's diarrhoea only
all pharmacists have access to adequate training and that appropriate written information on the self-management of traveller's diarrhoea is able to be given to all consumers purchasing the vaccine
pharmacies have an appropriate place available to observe those consumers who may be at risk of an allergic reaction for 15 minutes after taking the vaccine.

The other submission supported the reclassification but again only for the prevention of traveller's diarrhoea, not for the prevention of cholera.

Discussion

The Committee considered that the main argument for the submission appeared to be consumer convenience and cost. The vaccine came in two doses, with the second dose taken at home within a week of the first. The main questions considered were:

are pharmacists best placed to provide adequate advice on travel vaccinations
was the vaccine appropriate for both indications, i.e. active immunisation from cholera and enterotoxigenic Escherichia coli
can the second dose be stored appropriately at home
does the packaging and proposed treatment algorithm provide sufficient consumer education about risks and benefits, the need for continued hand and food hygiene, and advice that travellers may need other vaccines?

Some of the concerns raised were applicable irrespective of whether the vaccine was bought from a doctor, travel medicine specialist or a pharmacist.

The Committee noted that there was uncertainty as to how effective the vaccine was in vivo although it was recommended by the World Health Organisation for both indications in specific circumstances. One member commented that people travelling to an area where cholera was an issue would need a comprehensive assessment of other vaccinations that may be required and therefore consideration of the submission may be premature as it should depend on whether other traveller vaccinations also move into pharmacies.

The Committee were concerned that using such a vaccine may give a patient a sense of security and so avoid other practices e.g. good hand hygiene. The Committee noted that consumer information accompanying the vaccine included specific advice on hand and food hygiene which may mitigate some of the risk.

The risk of inappropriate use was difficult to assess. The Committee questioned the observers for any information they may have on this issue and on the potential risk of allergic reaction to the vaccine occurring, especially as this risk may be more common with the second dose which was taken at home.

The observers confirmed that:

reclassification for both indications would be preferred
education was a key component
not all pharmacists would offer the vaccine
pharmacists would be well placed to advise a consumer to consult a doctor if appropriate
stability data had shown that the vaccine may be stored at 37 degrees centigrade for up to a month
the risk of allergic reaction was very low and existed irrespective of who sold the vaccine, as the normal medical practice was to advise consumers to take the second dose at home.

The Committee agreed that the application could be considered separately from other discussions on pharmacy vaccination and that, on review of the material provided, there was no evidence that use of this vaccine risk was likely to be associated with abuse or communal harm. The Committee recommended that Vibrio cholera and enterotoxigenic Escherichia coli vaccine, as a 3 mL oral vaccine, should be reclassified from prescription medicine to restricted medicine. However, before this reclassification was gazetted, appropriate educational material for pharmacists should be developed.

The Committee suggested that the education pack should:

be endorsed by the Pharmaceutical Society of New Zealand
be accompanied by an education campaign
provide up to date advice regarding both indications
include information on how to store the vaccine
be aligned and continually kept up to date with current travel advice
state that other vaccines are available and may be more appropriate
have similar recommendations to those in Canada (for example)
include the need for additional precautions whilst travelling, e.g. hand hygiene
be accessible
be maintained so that the pharmacists were kept up to date
provide website addresses for travel advice on other vaccines that may be required.

Recommendation

That Vibrio cholera and enterotoxigenic Escherichia coli vaccine should be reclassified from prescription medicine to restricted medicine.
That this recommendation be delayed until Medsafe is satisfied that appropriate educational material and campaign for pharmacists has been established.

7 NEW MEDICINES FOR CLASSIFICATION

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

7.1 Boceprevir - Victrelis

Boceprevir (SCH503034) is a structurally novel, ketoamide protease inhibitor, for the treatment of Chronic Hepatitis C in treatment-naïve as well as treatment-experienced patients.

The use of boceprevir in combination with the current treatment therapy of peginterferon and ribavirin has resulted in significant improvements in the efficacy in the treatment of Hepatitis C patients and offers a significant advance in the treatment of this disease.

Recommendation

That boceprevir should be classified as a prescription medicine.

7.2 Dapagliflozin propanediol - Empliciti 5 mg and 10 mg film coated tablets

The active ingredient in Empliciti is dapagliflozin propanediol monohydrate, a potent, highly selective and orally-active inhibitor of the human renal sodium-glucose co-transporter 2 (SGLT2), the main transporter responsible for renal glucose reabsorption.

Monotherapy

It is proposed that Empliciti is indicated as an adjunct to diet and exercise in patients for whom metformin is inappropriate due to intolerance.

Initial Combination

It is proposed that Empliciti is indicated for use as an initial combination therapy with metformin, as an adjunct to diet and exercise, and to improve glycaemic control in patients with type 2 diabetes mellitus when dual dapagliflozin and metformin therapy is appropriate.

Add-on Combination

It is proposed that Empliciti is indicated in patients with type 2 diabetes mellitus to improve glycaemic control:

in combination with metformin, when metformin alone with diet and exercise does not provide adequate glycaemic control
in combination with a sulphonylurea, when a sulphonylurea alone with diet and exercise does not provide adequate glycaemic control
in combination with a thiazolidinedione, when a thiazolidinedione alone with diet and exercise does not provide adequate glycaemic control
in combination with insulin (alone or with up to two oral anti-diabetic medications) when the existing therapy, along with diet and exercise, does not provide adequate glycaemic control.

Recommendation

That dapagliflozin propanediol should be classified as a prescription medicine.

7.3 Ferric carboxymaltose - Ferinject solution for injection 50 mg/mL

Ferinject solution for injection / infusion contains iron in a stable ferric state as a complex with a carbohydrate polymer designed to provide iron for the iron transport and storage proteins in the body (transferrin and ferritin). Ferric carboxymaltose was effective in increasing Hb and serum ferritin concentrations in patients with mild to moderate iron-deficiency anaemia.

Ferinject is indicated for treatment of iron deficiency when oral preparations are ineffective or cannot be used. The diagnosis must be based on laboratory tests.

Recommendation

That ferric carboxymaltose should be classified as a prescription medicine.

7.4 Ipilimumab - Winglore Concentrate for injection 5 mg/mL and Yervoy concentrate for injection 5 mg/mL

Winglore / Yervoy (ipilimumab (rch)) is a recombinant, fully human monoclonal antibody that binds to the cytotoxic T lymphocyte-associated antigen 4. Ipilimumab is an IgG1 kappa immunoglobulin with an approximate molecular weight of 148 kDa. Ipilimumab is produced in mammalian (Chinese hamster ovary) cell culture.

Winglore / Yervoy is a sterile, preservative free liquid for intravenous administration, which may contain a small amount of visible translucent-to-white, amorphous ipilimumab particulates. Winglore / Yervoy has a pH of 7.0 and an osmolarity of 260-300m Osm/kg. It is supplied at a nominal concentration of 5 mg/mL ipilimumab in 50-mg and 200-mg single-use vials. Each 1 millilitre contains 5 mg of ipilimumab and 0.1 mmol sodium (or 2.30 mg sodium).

Winglore / Yervoy, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma who have failed or are intolerant to prior therapy.

In Australia in September 2011, the Delegate decided to list ipilimumab in Schedule 4 (prescription medicine) with an implementation date of 1 January 2012.

Recommendation

That ipilimumab should be classified as a prescription medicine.

7.5 Remestemcel-L - Prochymal 100 million cells in 15 mL solution for injection

Prochymal is a formulation of ex-vivo cultured adult human mesenchymal stem cells (hMSCs) intended for intravenous infusion. Prochymal is provided as a frozen cell suspension in a cryogenic bag containing 100 x 10⁶ viable hMSCs per 15 mL. The cells should be thawed and diluted to 2.5 x 10⁶MSCs per mL prior to infusion.

The mesenchymal stem cells are derived from the bone marrow of unrelated and human leukocyte antigen (HLA)-unmatched healthy adult donors. Patient-specific blood type or HLA matching is not required for the administration of hMSCs due to the product's low immunogenic profile. The hMSCs are undifferentiated stem cells of mesodermal origin. They are primary cells that have not been genetically manipulated or immortalised during the manufacturing process. The hMSCs are manufactured under aseptic conditions in a process of isolation and culture expansion.

The Committee initially considered whether it would be appropriate to recommend remestemcel-L to be available as general sale. This would keep it in line with other blood derived cellular products. However, its use requires specialist intervention so it was concluded that a prescription medicine classification would be more appropriate.

Recommendation

That remestemcel-L should be classified as prescription medicine.

7.6 Vemurafenib - Zelboraf 240 mg film coated tablet

Vemurafenib is a low molecular weight, oral inhibitor of the activated form of the BRAF serine-threonine kinase enzyme. Mutations in the BRAF gene result in constitutive activation of the BRAF protein, which may promote overactive signalling and cell proliferation in the absence of typical growth factors. As a potent and selective inhibitor of oncogenic BRAF, vemurafenib suppresses downstream signalling through the motigen-activated protein kinase pathway. The best characterised substrate of BRAF is MEK. Phosphorylation of MEK by BRAF results in activation of pMEK. pMEK in turn phosphorylates ERK to pERK, which translocates into the nucleus where it activates transcriptional factors that are responsible for stimulating cell proliferation and cell survival.

Zelboraf is indicated for the treatment of unresectable stage IIIC or stage IV metastatic melanoma positive for the BRAF V600 mutation.

Recommendation

That vemurafenib should be classified as a prescription medicine.

8 HARMONISATION OF NEW ZEALAND AND AUSTRALIAN SCHEDULES

8.1 New chemical entities which are not yet classified in New Zealand

8.1.1 5-aminolevulinic acid

Methylaminolevulinate is used in photodynamic therapy to treat cancerous and pre-cancerous cells. Methylaminolevulinate is currently listed in Schedule 4 (prescription medicine) in Australia and is classified as a prescription medicine in New Zealand, with no specified cut-offs or use limits. Methylaminolevulinate is the methyl ester of 5-aminolevulinic acid.

In February 2010 the Cosmetic Physicians Society of Australia raised the following concerns with the Therapeutic Goods Administration about the scheduling status of 5-aminolevulinic acid and its current use by beauty therapists for photodynamic therapy:

photodynamic therapy was promoted for treatment of sun-damaged skin within the beauty profession without the relevant medical and clinical guidelines
because 5-aminolevulinic acid was unscheduled, non-medical personnel can provide skin cancer treatment to the general public without the appropriate training, diagnostic skills, follow-up or monitoring.

In Australia in March 2011, the Delegate decided to list 5-aminolevulinic acid in Schedule 4 (prescription medicine) with an implementation date of 1 January 2012.

The Committee were unsure if the product was being used in New Zealand by the beauty profession. However, given the indication for use of the product and the prevalence of skin cancer in New Zealand, felt that it would be appropriate to classify it as a prescription medicine.

Recommendation

That 5-aminolevulinic acid should be added to the New Zealand Schedule as a prescription medicine.

8.1.2 Apixaban

Apixaban is an anticoagulant substance being investigated in the prevention of venous thromboembolic events in patients undergoing elective total hip or knee replacement surgery. It is a Factor Xa inhibitor in the same class as rivaroxaban which is classified as a prescription medicine in Australia and New Zealand.

In Australia in June 2011, the Delegate decided to list apixaban in Schedule 4 (prescription medicine) effective 1 September 2011.

Recommendation

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

8.1.3 Ofatumumab

Ofatumumab is a human monoclonal antibody which appears to inhibit early stage B lymphocyte activation. Ofatumumab is being investigated for the treatment of patients with chronic lymphocytic leukaemia who have received prior therapy. It is also under investigation for the treatment of non-Hodgkin's lymphoma, rheumatoid arthritis, and multiple sclerosis.

In Australia in March 2011, the Delegate decided to list ofatumumab in Schedule 4 (prescription medicine) effective 1 June 2011.

Recommendation

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

8.1.4 Rilpivirine

Rilpivirine is a non-nucleoside reverse transcriptase inhibitor of the diarylpyrimidine class indicated for the treatment of HIV-1 infection.

In Australia in March 2011, the Delegate decided to list rilpivirine in Schedule 4 (prescription medicine) effective 1 June 2011.

Recommendation

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

8.1.5 Tolvaptan

Tolvaptan is a selective, competitive arginine vasopressin receptor 2 antagonist used to treat hyponatremia (low blood sodium levels) associated with congestive heart failure, cirrhosis, and the syndrome of inappropriate antidiuretic hormone.

In Australia in March 2011, the Delegate decided to list tolvaptan in Schedule 4 (prescription medicine) effective 1 June 2011.

Recommendation

That tolvaptan 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

8.2.1 Decisions by the Delegate - March 2011

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

vinflunine - new entry in Schedule 4 (already classified as a prescription medicine in New Zealand).

a. Diclofenac

Dermal preparations containing more than 1% of diclofenac or preparations for the treatment of solar keratosis should be included in Schedule 4 (prescription medicine) with an implementation date of 1 June 2011. The Committee considered harmonising with this classification.

The Committee noted there is currently one medicine marketed in New Zealand, that contains more than 1% of diclofenac, that could be affected by harmonising.

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

Diclofenac is currently classified in New Zealand as:

prescription; except when specified elsewhere in the Schedule; except for external use
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; for external use.

Two pre-meeting comments were received during the consultation period. One stated that if there were no topical preparations with an indication to treat solar keratosis then no action should be taken to harmonise with Australia.

The other submission alerted the Committee to an anomaly with the Delegate's decision. The original proposal from the Advisory Committee on Medicines Scheduling was that diclofenac dermal preparations containing more than 1% of diclofenac or preparations for the treatment of solar keratosis be included in Schedule 4 (prescription medicine). However, the original agenda item only related to products for solar keratosis and so during the consultation period the interested party had not made a submission in Australia in response to the agenda item. The interested party subsequently submitted a rescheduling application for dermal diclofenac between 1% and 4% to remain unscheduled, or to move to Schedule 2 (pharmacy-only medicine). However, in the Standard for the Uniform Scheduling of Medicines and Poisons, effective August 2011, diclofenac is included in Schedule 4 (prescription medicine) in dermal preparations containing more than 1% of diclofenac or preparations for the treatment of solar keratosis. Diclofenac was not considered by the Delegate in June 2011 or September 2011.

In Australia, diclofenac is classified as:

Schedule 4 (prescription medicine); except when included in Schedule 2 or 3; in preparations for dermal use unless for the treatment of solar keratosis or containing more than 1% of diclofenac
Schedule 3 (restricted medicine); in divided preparations for oral use containing 25 mg or less of diclofenac per dosage unit in a pack containing 30 or less dosage units except when included in Schedule 2
Schedule 2 (pharmacy-only medicine); in divided preparations for oral use containing 12.5 mg or less of diclofenac per dosage unit in a pack containing 20 or less dosage units and labelled with a recommended daily dose or 75 mg or less of diclofenac.

Diclofenac in New Zealand does not have a concentration cut off point for external use. The Committee acknowledged that diagnosis of solar keratosis would require a medical professional and on this basis diclofenac for this treatment should be reclassified as a prescription medicine. However, Medsafe should develop suitable wording for the New Zealand Schedule so that topical treatment for other indications was not captured.

Recommendation

That diclofenac for the treatment of solar keratosis should be reclassified as a prescription medicine.
That Medsafe should come up with suitable wording for the Schedule to ensure that topical treatments for other indications were not captured by this prescription medicine entry.

b. Mercury / mercurochrome

With an implementation date of 1 June 2011, a Schedule 2 (pharmacy-only medicine) entry should be created for mercurochrome preparations containing 2% or less of mercurochrome for external use. A new Schedule 4 (prescription medicine) mercurochrome entry should be created for all other preparations of mercurochrome, excluding those listed in Schedules 2 (pharmacy-only medicine) and 6 (poison). The Committee considered harmonising with this classification.

The Committee noted there are currently no medicines marketed in New Zealand containing mercury or mercurochrome that could be affected by harmonising.

At the 7^th meeting on 31 July and 1 August 1990, the following classifications were recommended:

mercurochrome; part II pharmacy (pharmacy-only medicine)
mercury oxides; part I pharmacy (restricted medicine)
mercury, ammoniated; part I pharmacy (restricted medicine)
mercury; part I pharmacy (restricted medicine).

At the 21^st meeting on 25 March 1999, in the interests of harmonisation with Australia, the Committee recommended that mercury be reclassified as a pharmacy-only medicine in topical preparations containing 0.5% or less and prescription medicine in all other preparations, and that mercurochrome be deleted from the Schedule. At the 32^nd meeting on 25 November 2004, the Committee recommended that the prescription entry for mercury be amended by the addition of the words 'except in medicines containing 1 mg of mercury per litre or per kilogram' and that a prescription medicine entry should be made for methyl mercury with an exemption of 300 mcg of methyl mercury per litre or per kilogram. At the 33^rd meeting on 9 June 2005, the Committee stood by its earlier recommendation that mercury should be a prescription medicine; except in medicines containing 1 mg of mercury per litre or per kilogram.

Mercury is currently classified in New Zealand as:

prescription; except when specified elsewhere in the Schedule; except in medicines containing 1 mg or less per litre or per kilogram
pharmacy-only; for external use in medicines containing 0.5% or less.

There is no entry in the Schedule for mercurochrome.

One pre-meeting comment had been received during the consultation period that queried how the recommendation from Australia would match with the current New Zealand pharmacy-only classification of mercury.

Members commented that they were surprised mercurochrome antiseptics were still marketed as more efficacious, less toxic and safer options were available. The Committee were reminded of the underlying principle of trans-Tasman scheduling harmonisation, to harmonise on the less restrictive schedule while giving due consideration to public health and safety issues and / or specific jurisdictional needs. Given that there were no obvious public health issues, the Committee agreed to harmonise with Australia on the classification of mercurochrome.

Recommendation

That New Zealand should harmonise with Australia regarding the classification of mercurochrome.

8.2.2 Decisions by the Delegate - June 2011

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

canakinumab - new entry in Schedule 4 (already classified as a prescription medicine in New Zealand)
eculizumab - new entry in Schedule 4 (already classified as a prescription medicine in New Zealand)
fexofenadine - for the short-term symptomatic relief of seasonal allergic rhinitis in adults and children 12 years of age and over when sold in small packs of 10 dosage units or less (i.e. not more than 5 days' supply at the current maximum recommended dose) with a maximum daily dose of 120 mg should be exempt from scheduling
fingolimod - new entry in Schedule 4 (already classified as a prescription medicine in New Zealand)
ticagrelor - new entry in Schedule 4 (already classified as a prescription medicine in New Zealand)
vernakalant - new entry in Schedule 4 (already classified as a prescription medicine in New Zealand).

a. Ibuprofen

The maximum allowable amount of ibuprofen in liquid preparations in Schedule 2 (pharmacy-only medicine) should be increased from 4 g to 8 g with an implementation date of 1 September 2011. The Committee considered harmonising with this classification.

The Committee noted there are currently no medicines marketed in New Zealand containing more than 4 g and less than 8 g of ibuprofen that could be affected by harmonising.

At the 7^th meeting on 31 July and 1 August 1990, the Committee decided that a recommendation to change the classification of liquid ibuprofen could not be made on the basis of the limited information available. At the 13^th meeting on 26 May 1994, the Committee recommended that ibuprofen syrup be available as a restricted medicine when for children over 12 months of age. Also, in addition to the warnings suggested by the company, the labels should include warnings against use in children with dehydration, diarrhoea or any known gastric problem. Following the 13^th meeting Committee members were consulted by telephone and agreed that a wider overview should be taken of liquid ibuprofen. At the 14^th meeting on 2 November 1994, the Committee recommended that ibuprofen in liquid form be classified as a restricted medicine when:

sold in the manufacturer's original pack which has the consent of the Minister for sale as a restricted medicine
in pack sizes of not more than 200 ml
in strengths of 100 mg or less per 5 ml
contraindicated for use for children under 12 months of age
contraindicated for use in children with a temperature higher than 37.7 degrees C
contraindicated for use in children suffering dehydration through diarrhoea and / or vomiting
juvenile rheumatoid arthritis is not included as an indication.

In a postal consultation conducted in May 1995, the Committee recommended that the temperature contraindication be removed for the sale of liquid ibuprofen as a restricted medicine. At the 19^th meeting on 19 May 1998, the Committee recommended that ibuprofen should be a pharmacy-only medicine when in liquid form for oral use in medicines sold in the manufacturer's original pack containing 200 ml or less in volume and in strengths of 100 mg or less per 5 ml and when bearing the package information required in the New Zealand Regulatory Guidelines for the medicines to be sold over-the-counter.

At the 27^th meeting on 23 May 2002, the Committee recommended that:

the maximum daily dose for pharmacy-only solid dose and liquid ibuprofen should not exceed 1200 mg
the maximum pack size for pharmacy-only liquid preparations should not exceed 4 g of total ibuprofen content
packs for pharmacy-only sale should be in concentrations only of 100 mg in 5 ml or 200 mg in 5 ml of ibuprofen
the changes should be notified in the Gazette but Medsafe should be asked to include these changes and other requirements in the Regulatory Guidelines so that they would no longer be required to be listed in amendments to the First Schedule to the Medicines Regulations 1984
the Australian National Drugs and Poisons Schedule Committee be asked to adopt the Committee's recommendation limiting the concentrations of liquid ibuprofen permitted in pharmacy-only (schedule 2) medicines.

At the 29^th meeting on 22 May 2003, the Committee noted that the Australian National Drugs and Poisons Schedule Committee had opted not to adopt their recommendation. There were no restrictions on the concentration for over-the-counter sale in Australia.

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 in packs containing not more than 4 g in medicines that have received the consent of the Minister or the Director-General to their distribution as pharmacy-only medicines and that are sold in the manufacturer's original pack; 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 and in packs containing not more than 100 dose units and when in medicines that have received the consent of the Minister or the Director-General to their distribution as pharmacy-only medicines and that are sold in the manufacturer's original pack; except in packs containing 200 mg or less per oral solid dose form and not more than 25 dose units per pack in medicines that have received the consent of the Minister or the Director-General to their distribution as general sale medicines and that are sold in the manufacturer's original pack
general sale; for external use; in packs containing 200 mg or less per oral solid dose form and not more than 25 dose units per pack in medicines that have received the consent of the Minister or the Director-General to their distribution as general sale medicines and that are sold in the manufacturer's original pack.

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

One interested party did not support the harmonisation proposal. A pack of paediatric strength ibuprofen would be 400 ml and this was considered excessive. It was also noted there is no restriction on the pack size of liquid paracetamol preparations sold as pharmacy medicines.

The other submission supported the harmonisation proposal and encouraged the Committee to consider increasing the pack size from 4 g to 8 g. A number of points, with supporting data, were made that the Committee considered:

risks and benefits on the use
purposes for which the substance is to be used and the extent of the use
toxicity
the potential for abuse.

The submission asserted that the risk-benefit profile for ibuprofen was comparable to that of paracetamol if used in accordance with the recommended dose.

The Committee discussed the public health issue around a larger pack size, specifically accidental indigestion. It was agreed that the risk could be managed by appropriate labelling and packaging:

clear dosing instructions on the label
a child resistant top
an appropriate measuring device to ensure the correct dose is given.

With the inclusion of the above factors the Committee agreed that it would be appropriate to harmonise with Australia and increase the maximum allowable amount of ibuprofen in liquid preparations as a pharmacy-only medicine from 4 g to 8 g.

Recommendation

That New Zealand should harmonise with Australia and increase the maximum allowable amount of ibuprofen in liquid preparations as a pharmacy-only medicine from 4 g to 8 g.
That Medsafe should review the labelling and pack insert to ensure there are clear dosing instructions, and ensure there is a child resistant top and an appropriate measuring device.

b. Ibuprofen combined with paracetamol

Combination ibuprofen and paracetamol preparations currently captured by Schedule 2 (pharmacy-only medicine) (up to 200 mg ibuprofen and 500 mg paracetamol) should be rescheduled to Schedule 3 (restricted medicine) when in packs of 30 dosage units or less. Combination ibuprofen and paracetamol preparations in packs of more than 30 dosage units should be captured by Schedule 4 (prescription medicine). The Delegate decided on an implementation date of 1 September 2011. The Committee considered harmonising with this classification.

The Committee noted there are currently four medicines marketed in New Zealand containing ibuprofen and paracetamol that could be affected by harmonising.

Paracetamol is currently classified as:

prescription; except when specified elsewhere in the Schedule
pharmacy-only; in liquid form; in suppositories; in tablets or capsules containing 500 mg or less and in packs containing more than 10 g; in slow-release forms containing 665 mg or less and more than 500 mg; in powder form containing not more than 1 g per sachet and more than 10 g per pack
general sale; in tablets or capsules containing 500 mg or less and in packs containing not more than 10 g; in powder form in sachets containing 1 g or less and not more than 10 g.

In New Zealand classification is based on the individual active ingredients, with the most restrictive classification dictating the classification of the medicine.

Three pre-meeting comments were received during the consultation period, none of which supported the proposed rescheduling of ibuprofen combined with paracetamol. The Committee considered the following comments:

The proposal is not in line with item two of the General Principles of Trans-Tasman Scheduling Harmonisation (www.medsafe.govt.nz/profs/class/harmon.asp). Where differences in scheduling of a drug or poison currently exist between New Zealand and Australia, the following principles should apply - the classification should be reassessed using the common set of definitions and scheduling criteria with a view to achieving a common outcome and the underlying principle is to harmonise on the less restrictive schedule while giving due consideration to public health and safety issues and/or specific jurisdictional needs. There are no concerns for the public health and safety if the combination in New Zealand remains as it is currently scheduled.
A combination of paracetamol and ibuprofen is not available in Australia at this point in time. New Zealand already has considerable experience with this combination.
Both individual ingredients are available as general sales medicines. The availability of a combination in limited pack sizes as general sales medicine is also appropriate, otherwise patients would attempt co-administration themselves without the advantage of a correctly labelled pack.
If the harmonisation is recommended, patients may still purchase and self-medicate the individual ingredients themselves. Patients would not have the advantage of a combination product, decreased dose confusion and the lack of consolidated warnings and precautions. Such a change would increase patient risk unless paracetamol and ibuprofen were also rescheduled at the same time.
The proposed rescheduling is excessive and not justified on the basis of the evidence available, e.g. toxicity of paracetamol, toxicity of ibuprofen and extent of use of the combination product in New Zealand.
Both ibuprofen and paracetamol have well-documented safety profiles. There is a low and well-characterised incidence of adverse effects for both substances and this is shared by the combination at the proposed dose.
The combination of paracetamol and ibuprofen is not intended for treatment of a chronic condition.
To date, there is no evidence that either paracetamol or ibuprofen is associated with dependency, abuse or illicit use.

The Committee acknowledged that the scheduling in Australia and New Zealand was different. Whereas Australia sometimes combined medicines in a classification statement, the classification in New Zealand was based on the individual active ingredients, with the most restrictive classification dictating the classification of the medicine. There were no safety concerns with products in New Zealand and there was no evidence of harm. If the quantity in the pack was the same for a pharmacy-only classification then the classification should be the same. The primary safety concern was with paracetamol and this was adequately managed in New Zealand by the current scheduling of paracetamol. The Committee therefore concluded that there was no need to harmonise.

Recommendation

No recommendation was required.

c. Dimethyl sulfoxide

Dimethyl sulfoxide's Schedule 4 (prescription medicine) entry should be amended to specifically exclude dimethyl sulfone. There should also be a cross-reference from methylsulfonylmethane to dimethyl sulfone. The Delegate confirmed an implementation date of September 2011. The Committee considered harmonising with this classification.

The Committee noted there are currently no medicines marketed in New Zealand containing dimethyl sulfoxide or dimethyl sulfone that could be affected by harmonising.

At the 7^th meeting on 31 July and 1 August 1990, the Committee confirmed that dimethyl sulphoxide should be classified as a prescription medicine. Dimethyl sulphoxide is currently classified as a prescription medicine. Dimethyl sulfone or methylsulfonylmethane are not currently scheduled.

The Committee concluded that again there was no need for a recommendation because of the differences between the Australian and New Zealand schedules. In Australia, derivatives of a medicine are captured under a scheduling entry, whereas, in New Zealand, only salts and esters are included.

Recommendation

No recommendation was required.

9FOR THE NEXT MEETING

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

codeine - the Committee will consider the reviews regarding codeine provided by a New Zealand Specialist and Medsafe
methenamine hippurate - the Committee will note the outcome of the complaint and consider any further information supplied by iNova Pharmaceuticals (Australia) Pty Limited regarding their product Hiprex
oseltamivir - the Committee will consider the classification of oseltamivir as a restricted medicine; for the treatment of a consumer who is in New Zealand, is 12 years of age or more, and currently has the symptoms of influenza
vitamin D - submission for reclassification.

Other items were suggested that would be considered if submissions were received from sponsor companies or other interested bodies:

influenza vaccine - could be supplied without a prescription and by a pharmacist in a similar way to Dukoral (discussed during item 6.5)
tranexamic acid - reclassification to prescription medicine except for use in heavy menstrual bleeding after diagnosis by a doctor
antibiotics that could be supplied without a prescription and by a pharmacist in specific circumstances - e.g. for the treatment of simple urinary tract infections in adult women, confirmed Chlamydia, cellulitis, and strep throat. Specifically trimethoprim - an antibiotic that could be supplied without prescription and by a pharmacist (its use in extended Paramedic care under standing orders to prevent patients going to hospital would need to be considered).

The Committee agreed that Medsafe should explore the reclassification of trimethoprim first, and develop a proposal as to whether a submission should be made.

10 GENERAL BUSINESS

10.1 Non-prescription medicines and Australian community pharmacy interventions: rates and clinical significance (Williams et al)

A research paper from the International Journal of Pharmacy Practice (April 2011) was presented to the Committee for information. The study demonstrated the way in which community pharmacy encourages appropriate non-prescription medicine use and prevents harm through intervening at the point of supply.

10.2 Australia New Zealand Therapeutic Products Agency (ANZTPA)

A summary of the announcement on 20 June 2011, that the Australian and New Zealand Governments have agreed to proceed with a joint scheme for regulation of therapeutic products, was provided to the Committee for information.

10.3 Improving the decision-making process for non-prescription drugs: A framework for benefit-risk assessment (Brass, Lofstedt and Renn)

This article from Clinical Pharmacology & Therapeutics (advanced online publication 2 November 2011) was also presented to the Committee for information. The article discusses the benefit and risk domains associated with non-prescription drugs and proposes a value-tree tool for identifying relevant benefit-risk attributes for such drugs.

10.4 Observers at meetings

This meeting represented the first pilot for having observers at meetings. The purpose for having observers at meetings was that context would be given to statements in the minutes of what was discussed by the Committee, thereby giving greater clarity and transparency.

Medsafe had developed the following proposal, which was agreed out-of-session by the Committee and signed off by the Minister's delegate:

only those who have made a submission for reclassification may observe a meeting
a maximum of three individuals involved in a specific submission may observe
observers may only observe the discussion around their submission.
discussion around a submission will only start after each observer has handed a completed and signed Statement of Confidentiality to the Secretary
observers cannot participate in the reclassification discussion unless invited by the Committee to provide explanations or additional information during the meeting
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 - a final recommendation will be made autonomously and in private to avoid any conflict of interests or interferences.

The observers attending a specific agenda item would need to be confirmed at least two weeks before a meeting date.

11 DATE OF NEXT MEETING

To take place on a Tuesday in April 2012. The Secretary would email members for their availability.

There being no further business, the Chair thanked members and guests for their attendance and closed the meeting at 3:30pm.

Committees

Minutes of the 46th meeting of the Medicines Classification Committee - 15 November 2011

Present:

Part Attendance (from Medsafe):

Observers (for specific agenda items only):

Apologies:

1 WELCOME

2 APOLOGIES

3 CONFIRMATION OF THE MINUTES OF THE 45TH MEETING HELD ON TUESDAY 12 APRIL 2011

4 DECLARATION OF CONFLICTS OF INTEREST

5 MATTERS ARISING

5.1 Objections to recommendations made at the 45th meeting

5.2 Amorolfine

Recommendation

5.3 Clobetasone

Recommendation

5.4 Fingolimod 0.5 mg immediate release capsule (Gilenya, Novartis New Zealand Limited)

Recommendation

5.5 Methenamine hippurate

Recommendation

5.6 Oseltamivir

Recommendation

5.7 PDE-5 inhibitors

Submission 1

Submission 2

Submission 3

Submission 4

Recommendation

5.8 Tuberculin

Recommendation

5.9 Classification of medicines used by Podiatrists

Recommendation

5.10 Codeine

Recommendation

6 SUBMISSIONS FOR RECLASSIFICATION

6.1 Cetirizine hydrochloride 10 mg tablet (Histaclear, AFT Pharmaceuticals Limited)

Purpose

Background

Comments

Discussion

Recommendation

6.2 Loratadine 10 mg tablet (Loraclear Hayfever Relief, AFT Pharmaceuticals Limited)

Purpose

Background

Comments

Discussion

Recommendation

6.3 Omeprazole 10 mg and 20 mg enteric coated tablets (Losec, Bayer New Zealand Limited)

Purpose

Background

Comments

Discussion

Recommendation

6.4 Pantoprazole 20 mg enteric coated tablet (SOMAC Heartburn Relief, Nycomed Pty Limited)

Purpose

Background

Comments

Discussion

Recommendation

6.5 Vibrio cholera and enterotoxigenic Escherichia coli vaccine (Dukoral, Pharmacybrands Limited)

Purpose

Background

Comments

Discussion

Recommendation

7 NEW MEDICINES FOR CLASSIFICATION

7.1 Boceprevir - Victrelis

Recommendation

7.2 Dapagliflozin propanediol - Empliciti 5 mg and 10 mg film coated tablets

Monotherapy

Initial Combination

Add-on Combination

Recommendation

7.3 Ferric carboxymaltose - Ferinject solution for injection 50 mg/mL

Recommendation

7.4 Ipilimumab - Winglore Concentrate for injection 5 mg/mL and Yervoy concentrate for injection 5 mg/mL

Recommendation

7.5 Remestemcel-L - Prochymal 100 million cells in 15 mL solution for injection

Recommendation

7.6 Vemurafenib - Zelboraf 240 mg film coated tablet

3 CONFIRMATION OF THE MINUTES OF THE 45^TH MEETING HELD ON TUESDAY 12 APRIL 2011

5.1 Objections to recommendations made at the 45^th meeting

5.4 Fingolimod 0.5 mg immediate release capsule
(Gilenya, Novartis New Zealand Limited)

6.1 Cetirizine hydrochloride 10 mg tablet
(Histaclear, AFT Pharmaceuticals Limited)

6.2 Loratadine 10 mg tablet
(Loraclear Hayfever Relief, AFT Pharmaceuticals Limited)

6.3 Omeprazole 10 mg and 20 mg enteric coated tablets
(Losec, Bayer New Zealand Limited)

6.4 Pantoprazole 20 mg enteric coated tablet
(SOMAC Heartburn Relief, Nycomed Pty Limited)

6.5 Vibrio cholera and enterotoxigenic Escherichia coli vaccine
(Dukoral, Pharmacybrands Limited)