Revised: 23 May 2013

Committees

Minutes of the 45th meeting of the Medicines Classification Committee - 12 April 2011

Held in the Medsafe Boardroom, Level 6, Deloitte House, 10 Brandon Street, Wellington. Commencing at 9:30am

Present:

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

In Attendance (from Medsafe):

Dr Mary-Jane McCarthy (Team Leader, Non-Prescription Medicines)
Mrs Mary Miller (Senior Advisor Science, Non-Prescription Medicines)

1 WELCOME

The Chair opened the 45^th meeting at 9:30am and welcomed members and guests.

2 APOLOGIES

There were no apologies.

3 CONFIRMATION OF THE MINUTES OF THE 44^TH MEETING HELD ON TUESDAY 2 NOVEMBER 2010

The minutes of the 44^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. All members declared they had no additional interests which would pose a conflict with any of the items on the agenda.

Mr Orange stated he had recently applied to the Pharmacy Council to move from the Practising to Non-Practising Register of Pharmacists. He queried whether this would affect his membership on the Committee and if it would be more appropriate to have a practising pharmacist instead. The Chair confirmed section 9(3) of the Medicines Act 1981 states that the Committee shall include two persons nominated by the Pharmaceutical Society of New Zealand. As examples, these persons could be practising or non-practising pharmacists, a member of another health profession, or a consumer, as long as the person continued to have the support and nomination of the Pharmaceutical Society. So from a legislative viewpoint it would not be an issue for Mr Orange to continue being on the Committee as long as he still had the support of the Pharmaceutical Society.

5 MATTERS ARISING

5.1 Objections to recommendations made at the 44^th meeting

5.1.1 Guaiphenesin 600 mg and 1200 mg modified release tablets
(Mucinex, Reckitt Benckiser (New Zealand) Limited)

An objection was received regarding the Committee's previous recommendation that the warning regarding a potential risk of developing kidney stones, labelled on products containing high doses of guaiphenesin, should remain.

At the 41^st meeting on 14 May 2009, Reckitt Benckiser (New Zealand) Limited made a submission for the reclassification of guaiphenesin from prescription to general sale medicine in 600 mg and 1200 mg modified release guaiphenesin tablets for use as an expectorant to help relieve chest congestion. The Committee supported the reclassification and recommended that a warning be placed on Mucinex packs regarding the potential risk of developing kidney stones when guaiphenesin is used at high doses for long periods of time. At the 44^th meeting a submission was received requesting removal of this warning. The Committee recommended that this warning remain.

In the objection Reckitt Benckiser (New Zealand) Limited asserted that the Committee may not have fully considered some of the information submitted at the 44^th meeting. Key points discussing the relevance and interpretation of the safety data were revisited in the documentation supporting the objection. Two issues were presented for consideration:

1. misuse abuse of combination products
2. post-marketing safety data.

One pre-meeting comment had been received during the consultation period which believed that the potential risk of developing kidney stones was not significant enough to warrant a special warning on the label of guaiphenesin-containing products. A paper by Pickens et al from Urology 54: 23-27, 1999, was also submitted which concluded guaiphenesin can cause urolithiasis if taken in excess, however an average patient who uses limited quantities for minor respiratory ailments was unlikely to be at risk.

Overall the Committee felt they had considered the information submitted at the last meeting and that little additional data had been provided. However, the reasoning in support of the objection was understood. It was unclear as to whether guaiphenesin alone causes kidney stones or whether it only occurred in combination with other medicines. The Committee agreed that the overall risk of developing renal stones when using guaiphenesin was very low.

The Committee discussed that the original basis of the warning was to discourage long-term off-label use of the product. It was felt patients should be informed of the risk of developing kidney stones if the product was taken for prolonged periods, even if the risk was small.

The Committee reviewed the current product information and expressed concern that this material currently included the statement, 'guaiphenesin is not recognised to produce side effects even at doses several times higher than those recommended'. A similar statement was also included in the Mucinex datasheet. The Committee considered that this type of statement was inappropriate and should be deleted from the pack insert and datasheet. It should be replaced with a statement regarding the relative safety of the product which did not potentially encourage consumers to take higher doses than those recommended in the prescribing information. The Committee recommended that Medsafe review the pack insert and datasheet to correct these statements and to ensure that the product information included words to the effect that prolonged use of the product at high dose has been associated with the development of renal stones.

Recommendation

• That the objection be upheld.
• That Medsafe should review the revised pack insert and datasheet to ensure they have appropriate wording regarding the increased risk of kidney stones when guaiphenesin is used at high doses for long periods of time and review the statement that 'guaiphenesin is not recognised to produce side effects even at doses several times higher than those recommended'.

5.1.2 Paracetamol

An objection was received regarding the Committee's recommendation that New Zealand should not increase the maximum pack size for sale of paracetamol as a general sale medicine from 10 g to 12.5 g in order to harmonise with the less restrictive Australian classification.

The objection contends that the Committee may not have correctly interpreted the data provided at the last meeting in relation to an increased risk arising from a larger pack size. Additional data was submitted in support of the objection and the submission concluded there was no data to suggest that a 12 g dose of paracetamol would significantly increase the risk of harm over and above that associated with a 10 g dose.

One pre-meeting comment had been received during the consultation period which supported the Committee's recommendation at the last meeting. Pack sizes of analgesics, particularly paracetamol, need to be reduced with restrictions placed on the number of packs that can be sold at any one time. It was suggested the general public were unaware of how toxic paracetamol can be if taken incorrectly.

The following documents were tabled:

1. Daly FFS, et al. Guidelines for the management of paracetamol poisoning in Australia and New Zealand - explanation and elaboration. Med J Aust2008; 188(5): 296-301.
2. Ministry of Health. 2006-2016. New Zealand Suicide Prevention Strategy.
3. Ministry of Health. 2008-2012. New Zealand Suicide Prevention Action Plan - the Evidence for Action.

The Committee considered the additional data submitted in support of the objection. The references provided supported the Committee's previous conclusion that there was a difference in risk between a 10 g and 12.5 g pack size of paracetamol. The references demonstrated that although there was no data to suggest that ingesting 12 g of paracetamol would significantly increase the risk of mortality over and above that associated with ingesting 10 g, ingestion of over 12 g increased the risk of harm and the need for intervention. There is also evidence that taking standard doses of paracetamol for even the minimally extended periods of time, that can occur with a larger pack size, can be associated with hepatic injury in some circumstances, e.g. when taken with other hepatotoxic substances.

Increasing the pack size would also be contrary to the spirit of The New Zealand Suicide Prevention Strategy. The Strategy states, as one broad area for action, the adoption of safer dispensing of medications and other lethal chemicals commonly used in suicide and suicide attempts should be encouraged (page 25). The New Zealand Suicide Prevention Action Plan noted that in the United Kingdom, reducing the sizes of packs of paracetamol and restricting point of sale led to significant reductions in deaths, hospital admissions and liver transplants from paracetamol overdose (page 44). The United Kingdom findings suggest consideration should be given to introducing further restrictive measures in New Zealand to reduce suicide attempts using paracetamol. One of the key areas highlighted for action in the Action Plan was to review the feasibility of tightening regulations to reduce the risks posed by paracetamol.

Increasing the maximum pack size for sale of paracetamol as a general sale medicine from 10 g to 12.5 g in order to harmonise with the less restrictive Australian classification would therefore be in direct opposition to the New Zealand Suicide Prevention Strategy and Action Plan and could not be considered to be in the public interest.

The Committee concluded, having reconsidered the data and given the compelling evidence of risk associated with doses over 12 g, Australia should harmonise with New Zealand in that the maximum pack size for sale of paracetamol as a general sale medicine should be 10 g. The objection was not upheld.

Recommendation

That Australia should harmonise with New Zealand in that the maximum pack size for sale of paracetamol as a general sale medicine should be 10 g.

5.1.3 Red Yeast Rice

An objection had been received regarding the Committee's recommendations that:

• lovastatin should be added to the New Zealand Schedule as a prescription medicine
• monacolin K should be added to the New Zealand Schedule as a prescription medicine
• Medsafe should consider the wording of monacolin K as a prescription medicine so that any foodstuffs would not be inadvertently captured.

It had also been brought to Medsafe's attention that lovastatin and monacolin K are synonyms because they have identical structures. Lovastatin is a HMG-CoA reductase inhibitor scheduled as a prescription medicine in several countries.

Medsafe consulted the New Zealand Food Safety Authority about the classification of lovastatin / monacolin K and the following wording had been proposed;
"that lovastatin should be classified as a prescription medicine, 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". Medsafe considered that this wording reflected the Committee's intent when it recommended scheduling of the substance at its last meeting. In addition, Medsafe proposed that monacolin K be added to Medsafe's searchable classification database with the wording 'see lovastatin'.

Although an objection to the scheduling recommendation had been submitted, no additional data other than simple email communication in support of the objection had been received by the Committee. The Committee noted that the comments in these emails relating to the packaging of monacolin K were not relevant to the reclassification issue.

The Committee considered the proposed rewording of the Schedule entry for lovastatin / monacolin K as part of the objection as well as other options for wording a Schedule entry, e.g. inclusion of a specific concentration cut-off so that only products above a specific concentration would become prescription medicines. The Chair explained that unless specific reference is made in the Schedule, every reference to a medicine in the Schedule applies only to a concentration of that medicine which is greater than 10 mg / l or / kg. The Committee noted that data supporting the use of a concentration cut-off had not been provided during any of its previous considerations of scheduling this substance.

The Committee also discussed the option of including an indication within the Schedule wording to differentiate between different uses of lovastatin / monacolin K. However in the absence of further data the Committee considered that this option had no utility at this point in time.

Ultimately the Committee considered red yeast rice to be a product where biological manipulation, namely deliberate cultivation of rice in a solution containing red yeast, leads to increases in the concentration of lovastatin in a foodstuff which potentially reach therapeutic levels. The Committee considered that the evidence presented did not support the contention that naturally produced lovastatin / monacolin K is safer than synthetically produced lovastatin. This is supported by evidence to suggest that red yeast rice has a side effect profile similar to that of pharmaceutically produced HMG-CoA reductase inhibitors (statins). Other statins in the Schedule are classified as prescription medicines.

The objection was therefore not upheld. The Committee confirmed that the wording suggested by the New Zealand Food Safety Authority, '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', captured the intent of their scheduling recommendation. It was agreed that Medsafe should revisit this wording to check it appropriately captures both synthetic and naturally occurring forms of lovastatin.

Recommendation

• That lovastatin should be added to the New Zealand Schedule as a prescription medicine.
• That monacolin K should be added to Medsafe's searchable classification database with the wording 'see lovastatin'.
• That Medsafe should review the wording of lovastatin, as a prescription medicine, to confirm that foodstuffs would not be inadvertently captured.

5.2 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 this Schedule'. This classification was recommended at the 42^nd meeting on 3 November 2009.

Whilst working on the classification of lovastatin and monacolin K, it became apparent to Medsafe that the wording of this Schedule entry may not adequately capture the intent of the Committee when it recommended products including these substances be scheduled. Medsafe noted that the current wording would permit products containing a high dose of a naturally occurring PDE-5 substance, to be exempt from scheduling, even though it was generally accepted that high levels of PDE-5 inhibition were likely to be associated with significant side effects.

The correspondence between Medsafe and the New Zealand Food Safety Authority regarding the wording for the classification of lovastatin had recommended different wording from that used in the PDE-5 inhibitor Schedule entry. The Committee discussed whether this wording needed to be reconsidered following their discussion around the classification of lovastatin. The Committee concluded the wording of the Schedule entries for both lovastatin and PDE-5 inhibitors should be similar in that they not inadvertently capture foodstuffs.

Recommendation

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.

5.3 Aspirin

The labelling of all aspirin containing products with respect to international alignment had been referred to Medsafe for consideration. An update was provided to the Committee by the Chair.

Medsafe considered the warning statements for aspirin in New Zealand, Australia, United Kingdom, European Union, Canada and the United States. It was noted that the statements varied significantly between the jurisdictions and there was no international consensus. Medsafe also noted different warning statements were used depending on the scheduling of the product and how it was proposed to be used.

In order to promote trans-Tasman harmonisation of labelling, Medsafe decided that the labelling of all aspirin products should be aligned with the warning statements used in Australia. The following statements will replace any existing statements in New Zealand and be incorporated into the database of required label statements (words of similar meaning are acceptable):

1. Unless a doctor has told you to, do not use this product for more than a few days at a time. Warning - prolonged or excessive use can be harmful.
2. Do not use this product with other medicines containing other anti-inflammatory medicines or other medicines that you are taking regularly unless advised to do so by a doctor or a pharmacist.
3. Do not use this product during the first six months of pregnancy, except on doctor's advice. Do not use at all during the last three months of pregnancy.
4. Unless a doctor has told you to, do not use this product if you have asthma. Do not use this product if you have a stomach ulcer, or are allergic to aspirin or anti-inflammatory medicines. If you get an allergic reaction stop taking and see you doctor immediately.
5. Unless a doctor has told you to, do not use this product in children under 12 years of age or teenagers with chicken pox, influenza or fever.

Medsafe will write to Medicines New Zealand, the New Zealand Self-Medication Industry and the sponsors of all aspirin products regarding the alignment of these warning statements.

Recommendation

No recommendation was required.

5.4 Eltrombopag olamine (Revolade 25 mg and 50 mg film coated tablets)

An out-of-session consultation took place in December 2010 regarding the classification of eltrombopag olamine.

Revolade film-coated tablets contain eltrombopag olamine. Eltrombopag olamine is an oral small molecule, thrombopoietin receptor agonist. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethyl-phenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. Each film coated table contains eltrombopag olamine equivalent to either 25 mg or 50 mg of eltrombopag as eltrombopag free acid.

Revolade is indicated for the treatment of adult patients with chronic immune (idiopathic) thrombocytopenic purpura who have had an inadequate response or are intolerant to corticosteroids and immunoglobulins.

The Committee recommended that eltrombopag olamine should be classified as a prescription medicine. This classification was gazetted alongside the recommendations from the previous meeting on 17 February 2011. It was noted that out-of-session consultations like this may take place more often with Medsafe's abbreviated evaluation process.

Recommendation

No recommendation was required.

5.5 Paracetamol

Harmonising with Australia on the labelling of paracetamol had also been referred to Medsafe for consideration. An update was provided to the Committee by the Chair.

Medsafe considered the warning statements in New Zealand and Australia. Overall the statements were similar in both countries. However, the Australian statements were more specific about how long a product should be used for, that a product should not be used with another product containing paracetamol, and included contact details for the Poisons Information Centre. Medsafe decided that the labelling of all paracetamol products will be harmonised with the warning statements used in Australia.

The following statements will replace any existing statements in New Zealand and be incorporated into the database of required label statements (words of similar meaning are acceptable):

1. Do not give this medicine for longer than 48 hours at a time unless advised to by a doctor or pharmacist. Warning / caution: Prolonged or excessive use can be harmful.
2. Do not take with other products containing paracetamol, unless advised to do so by a doctor or pharmacist.
3. Recommended doses:
   • 3 to 12 months old - 60 to 120 mg up to fourtimes a day
   • 5 years old - 120 to 250 mg up to four times a day
   • 12 years old - 250 to 500 mg up to four times a day
   • 12 years old and over - 500 to 1000 mg up to four times a day.
4. If an overdose is taken or suspected, ring the Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766) or go to hospital straight away even if you feel well because of the risk of delayed, serious liver damage.

Medsafe will write to Medicines New Zealand, the New Zealand Self-Medication Industry and the sponsors of all paracetamol products regarding the harmonisation of these warning statements.

Recommendation

No recommendation was required.

6 SUBMISSIONS FOR RECLASSIFICATION

6.1 Guaiphenesin 600 mg and 1200 mg modified release tablets
(Mucinex, Reckitt Benckiser (New Zealand) Limited)

Purpose

This was a company submission requesting an update to the general sale classification of guaiphenesin to 'for oral use in medicines containing 2% or less or 200 milligrams or less per dose form; for oral use in modified release form with a maximum recommended daily dose of not more than 2.4 grams sold in a pack containing not more than 10 days' supply approved by the Minister or the Director-General for distribution as a general sale medicine'.

This followed comments from the last meeting that the Committee considered it would be prepared to support a limited change in pack size to allow a pack containing 10 days or less to be available as a general sale medicine. Currently packs containing not more than 5 days' supply were available as general sale.

Background

At the 7^th meeting on 31 July 1990 and 1 August 1990, guaiphenesin was reclassified as:

• Part II pharmacy (pharmacy-only); in medicines containing more than 2% of guaiphenesin
• general sale; in medicines containing 2% or less of guaiphenesin.

At the 27^th meeting on 23 May 2002, the Committee recommended that guaiphenesin be classified as prescription medicine in liquid form containing more than 2% or solid dose form containing more than 200 mg.

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

• guaiphenesin should be reclassified from prescription medicine to general sale medicine when the pack size is limited to not more than five days' supply, in a modified release dosage form with a maximum daily dose of not more than 2400 mg, and in packs approved by the Minister or the Director-General for distribution as general sale medicines
• guaiphenesin should be reclassified from prescription medicine to restricted medicine when pack size is more than five days but not more than 30 days' supply, in a modified release dosage form, a maximum daily dose of not more than 2400 mg is recommended and in packs approved by the Minister or the Director-General for distribution as restricted medicines
• Medsafe should be satisfied with data supporting efficacy, and with the proposed label warnings, of any modified release guaiphenesin product seeking consent to be sold as an over-the-counter medicine.

At its 57^th meeting in October 2009, the Australian National Drugs and Poisons Schedule Committee confirmed that their current scheduling entries for modified release formulations of guaiphenesin remained appropriate. They did not harmonise with the recommendations made by the Committee at the 41^stmeeting.

At the 43^rd meeting on 13 April 2010, the Committee recommended that the current scheduling of guaiphenesin remained appropriate.

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

• there should not be an additional classification of guaiphenesin, in modified release tablets containing 600 mg or 1200 mg of guaiphenesin (Mucinex) in packs containing more than five but not more than 10 days' supply, as a pharmacy-only medicine for use as an expectorant which thins and loosens mucus (phlegm) to help relieve chest congestion
• the restricted medicine classification statement should not be amended to "for oral use in modified release form with a maximum recommended daily dose of not more than 2.4 g sold in a pack containing more than 10 days' supply but not more than 30 days' supply approved by the Minister or the Director-General for distribution as a restricted medicine"
• the labelled warning statement to seek medical advice if symptoms persist should be amended from 'after three days' to 'after five days', however Medsafe would need to review the revised warning and pack insert
• the labelled warning regarding a potential risk of developing kidney stones at high doses should not be removed (a valid objection had been raised regarding this recommendation - see item 5.1.1).

The Committee considered that it would be prepared to support a limited change in pack size to allow a pack containing 10 days or less to be available as a general sale medicine, hence the current submission.

Guaiphenesin is currently classified as:

• prescription; for oral use in medicines containing more than 2% or 200 mg per dose form except when specified elsewhere in this Schedule; except for oral use in modified release form with a maximum recommended daily dose of not more than 2.4 g sold in a pack containing not more than 5 days' supply approved by the Minister or the Director-General for distribution as a general sale medicine
• restricted; for oral use in modified release form with a maximum recommended daily dose of not more than 2.4 g sold in a pack containing more than 5 days' supply but not more than 30 days' supply approved by the Minister or the Director-General for distribution as a restricted medicine
• general sale; for oral use in medicines containing 2% or less or 200 mg or less per dose form; for oral use in modified release form with a maximum recommended daily dose of not more than 2.4 g sold in a pack containing not more than 5 days' supply approved by the Minister or the Director-General for distribution as a general sale medicine.

Comments

One pre-meeting comment was received during the consultation period and this supported extending the permitted pack size to 10 days' supply for guaiphenesin in modified release preparations as a general sale medicine.

Discussion

The Committee considered at the last meeting that it would be prepared to support a limited change in pack size to allow a pack containing 10 days or less to be available as a general sale medicine. No further data was submitted for this meeting and, although concern was expressed over long term use of the product, the Committee again supported the limited change. The prescription and restricted entries of guaiphenesin in the Schedule would also need to be amended to reflect this change.

Recommendation

That the general sale classification of guaiphenesin should be amended to 'for oral use in medicines containing 2% or less or 200 mg or less per dose form; for oral use in modified release form with a maximum recommended daily dose of not more than 2.4 g sold in a pack containing not more than 10 days' supply approved by the Minister or the Director-General for distribution as a general sale medicine'.

7 NEW MEDICINES FOR CLASSIFICATION

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

7.1 Denosumab - Prolia 60 mg / mL solution for injection

Denosumab is a fully human IgG2 monoclonal antibody with high affinity and specificity for RANK ligand. Denosumab has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells.

Prolia is a sterile, preservative free, clear, colourless to slightly yellow solution for injection. The solution may contain trace amounts of translucent to white proteinaceous particles. Each 1 mL single-use pre-filled syringe contains: 60 mg denosumab, 47 mg sorbitol, 1 mg acetate, 0.1 mg polysorbate 20, sodium hydroxide for adjusting to pH 5.2, in Water for Injection. Each 1 mL single-use vial contains: 60 mg denosumab, 47 mg sorbitol, 1 mg acetate, sodium hydroxide for adjusting to pH 5.2, in Water for Injection.

Prolia is indicated for the treatment of osteoporosis in postmenopausal women. Prolia significantly reduces the risk of vertebral, non-vertebral and hip fractures.

In Australia, the Standard for the Uniform Scheduling of Medicines and Poisons classifies denosumab as a prescription medicine.

Recommendation

That denosumab should be classified as a prescription medicine.

7.2 Eculizumab - Soliris 300 mg / 30 mL solution for infusion

Soliris is a sterile solution of eculizumab, a humanized monoclonal antibody directed against the alpha chain of the C5 complement protein.

It is indicated for treatment of patients with paroxysmal nocturnal haemoglobinuria to reduce haemolysis.

Recommendation

That eculizumab should be classified as a prescription medicine.

7.3 Indacaterol (indacaterol maleate) - Onbrez Breezhaler 150 µg and 300 µg capsules

Indacaterol acts locally in the lung as a bronchodilator when inhaled. Indacaterol is a nearly full agonist at the human β₂-adrenergic receptor with nanomolar potency. In isolated human bronchus, indacaterol has a rapid onset of action and long duration of action.

Onbrez Breezhaler is a long-acting β₂-agonist indicated for long-term, once-daily, maintenance bronchodilator treatment of airflow limitation in patients with chronic obstructive pulmonary disease. Onbrez hard capsules are for oral inhalation only.

In Australia, the Standard for the Uniform Scheduling of Medicines and Poisons classifies indacaterol as a prescription medicine.

Recommendation

That indacaterol should be classified as a prescription medicine.

7.4 Prucalopride - Prucalopride 1 mg and 2 mg film coated tablets

The chemical name for prucalopride is 4-amino-5-chloro-2,3-dihydro-N-[1-(3-methoxypropyl)-4-piperidinyl]-7-benzofurancarboxamide butanedioate (1:1). Prucalopride is available as film-coated tablets containing 1 mg or 2 mg of prucalopride (as prucalopride succinate).

Prucalopride is a dihydrobenzofurancarboxamide with enterokinetic activities. Prucalopride is a selective, high affinity serotonin (5-HT₄) receptor agonist, which is likely to explain its enterokinetic effects. It is indicated for the treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.

Recommendation

That prucalopride should be classified as a prescription medicine.

7.5 Sapropterin (sapropterin dihydrochloride) - Kuvan 100 mg soluble tablet

Sapropterin dihydrochloride is an off-white to yellow crystalline powder. It melts with decomposition at 239-241 degrees centigrade. The stereochemical configuration of sapropterin dihydrochloride has been demonstrated by single-crystal x-ray analysis. Sapropterin dihydrochloride is hygroscopic.

Kuvan is supplied as immediate release soluble tablets intended to be administered orally following dissolution. The tablets are off-white to light yellow. Each tablet contains 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin), mannitol (E421), calcium hydrogen phosphate anhydrous, crospovidone type A, ascorbic acid (E300), sodium stearylfumarate and riboflavin (E101).

Kuvan is indicated for the treatment of hyperphenyllalaninemia in sapropterin-responsive adult and paediatric patients with phenylketonuria or tetrahydrobiopterin deficiency.

In Australia, the Standard for the Uniform Scheduling of Medicines and Poisons classifies sapropterin as a prescription medicine.

Recommendation

That sapropterin should be classified as a prescription medicine.

7.6 Telaprevir - Incivo 375 mg film coated tablet

Telaprevir is an inhibitor of the Hepatitis C Virus (HCV) NS3 4A protease, an enzyme that is essential for HCV replication. Telaprevir drug substance is a white to off-white powder with a solubility in water of 0.0047 mg/mL.

Incivo is available as yellow, caplet-shaped, film-coated tablets of approximately 20 mm in length. Incivo, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genoptype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis):

1. who are treatment-naïve
2. who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.

In previously treated patients, when available, the use of peginterferon alfa-2a in combination with Incivo and ribavirin should be considered due to the limited data with peginterferon alfa-2b.

Recommendation

That telaprevir should be classified as a prescription medicine.

7.7 Ticagrelor - Brilinta 90 mg film coated tablets

Ticagrelor is primarily a CYP3A4 substrate and a mild inhibitor of CYP3A4. Ticagrelor is a member of the chemical class cyclopentyltriazolopyrimidines, which is a selective adenosine diphosphate receptor antagonist acting on the P2Y₁₂ ADP-receptor that can prevent ADP-mediated platelet activation and aggregation.

Brilinta, co-administered with acetylsalicylic acid, is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (unstable angina, non ST elevation myocardial infarction or ST elevation myocardial infarction); including patients managed medically, and those who are managed with percutaneous coronary intervention or coronary artery by-pass grafting.

Recommendation

That ticagrelor 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 Afamelanotide

Melanocyte stimulating hormone (MSH) is a polypeptide isolated from the pars intermedia of the pituitary of fish and amphibia which causes dispersal of melanin granules in the skin of fish and amphibia and allows adaptation to the environment. In adult humans, the pituitary gland lacks a distinct intermediate lobe, and the pituitary is not thought to secrete melanocyte stimulating hormone directly. However, the precursor molecule, pro-opiomelanocortin, is cleaved in the pituitary into corticotrophin, the glycoprotein β-lipotrophin and an amino-terminal peptide. Subsequent processing in other tissues (i.e. the brain and gastrointestinal tract) may yield three forms of melanocyte stimulating hormone: α-MSH, β-MSH, and γ-MSH.

Afamelanotide (4-L-norleucine-7-D-phenylalanine-α-MSH, also known as Melanotan-1) is a synthetic analog of the naturally occurring melanocortin peptide hormone α-MSH. Afamelanotide should not be confused with a similar substance commonly known as Melanotan-II, which is a cyclic lactam synthetic analog of α-MSH.

In December 2010 the Delegate decided to list afamelanotide in Schedule 4 (prescription medicine), with a cross-reference to melanocyte stimulating hormone, in the Standard for the Uniform Scheduling of Medicines and Poisons.

Recommendation

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

8.1.2 Asenapine

Asenapine is a novel atypical antipsychotic medication. It has been shown to have activity on dopamine (D)-2 and serotonin (5-HT)-2A receptors as well as on 5-HT_1A, 5-HT_1B, 5-HT_2C, 5-HT₆, 5-HT₇, D₃ and alpha-2 adrenergic receptors. It has highest affinity for blocking serotonin receptors, followed by dopamine and alpha-adrenergic receptors with minimal affinity for muscarinic receptors. Its proposed indications are for the treatment of schizophrenia, including prevention of relapse and maintenance of clinical improvement during continuation therapy, and acute mania or mixed episodes associated with bipolar disorder.

In December 2010 the Delegate decided to list asenapine in Schedule 4 (prescription medicine) in the Standard for the Uniform Scheduling of Medicines and Poisons.

Recommendation

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

8.1.3 Belimumab

Belimumab is a humanised monoclonal antibody that inhibits B-lymphocyte stimulator (a naturally occurring protein required for B lymphocyte development). It is under investigation in Australia for the treatment of auto-immune diseases.

Belimumab is captured in Australia and New Zealand under the prescription medicine class entry for monoclonal antibodies.

In December 2010 the Delegate decided to list belimumab in Schedule 4 (prescription medicine) in the Standard for the Uniform Scheduling of Medicines and Poisons.

Recommendation

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

8.1.4 Degarelix

Degarelix is a gonadotrophin releasing hormone which acts through binding to pituitary gonadotrophin releasing hormone receptors. This results in reduced release of gonadotrophins (luteinising hormone and follicle-stimulating hormone) and consequently a reduction in testosterone secretion in males. It is indicated for the treatment of patients with prostate cancer in whom androgen deprivation therapy is warranted.

Degarelix is captured in Australia and New Zealand under the prescription medicine class entry for gonadotrophic hormones.

In August 2010 the Delegate decided to list degarelix in Schedule 4 (prescription medicine) in the Standard for the Uniform Scheduling of Medicines and Poisons.

Recommendation

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

8.1.5 Dronedarone

Dronedarone is an antiarrhythmic drug that is structurally related to amiodarone, but has a shorter half-life because it is less lipophilic. It is indicated to reduce the risk of cardiovascular hospitalisation in patients with paroxysmal or persistent atrial fibrillation or atrial flutter, with a recent episode of atrial fibrillation / atrial flutter and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted, in addition to standard therapy.

In August 2010 the Delegate decided to list dronedarone in Schedule 4 (prescription medicine) in the Standard for the Uniform Scheduling of Medicines and Poisons.

Recommendation

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

8.1.6 Icatibant

Icatibant acetate is a selective bradykinin B2 antagonist used in the symptomatic treatment of acute attacks of hereditary angioedema in adults with complement C1 esterase inhibitor deficiency. Icatibant acetate is given by subcutaneous injection, preferably into the abdomen. It is indicated for the symptomatic treatment of acute attacks of hereditary angioedema in adults with C1 esterase inhibitor deficiency.

In August 2010 the Delegate decided to list icatibant in Schedule 4 (prescription medicine) in the Standard for the Uniform Scheduling of Medicines and Poisons.

Recommendation

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

8.1.7 Linagliptin

Linagliptin is a DPP-4 inhibitor similar to saxagliptin, sitagliptin and vildagliptin. It is under investigation in Australia for treatment of adult patients with type 2 diabetes mellitus to improve glycaemic control in conjunction with diet and exercise, as monotherapy or as an add on to metformin, sulphonylureas, thiazolidinediones or metformin plus sulphonylureas.

In December 2010 the Delegate decided to list linagliptin in Schedule 4 (prescription medicine) in the Standard for the Uniform Scheduling of Medicines and Poisons.

Recommendation

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

8.1.8 Nitisinone

Nitisinone is a 4-hydroxyphenylpyruvate dioxygenase inhibitor. It is indicated for the treatment of patients with hereditary tyrosinaemia type 1, in combination with dietary restriction of tyrosine and phenylalanine.

In December 2010 the Delegate decided to list nitisinone in Schedule 4 (prescription medicine) in the Standard for the Uniform Scheduling of Medicines and Poisons.

Recommendation

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

8.1.9 Nomegestrol

Nomegestrol is a progestogen structurally related to progesterone used in the treatment of menstrual disorders and as the progestogen component of menopausal Hormone Replacement Therapy. It is indicated as an oral contraception in fertile women including post-menarcheal adolescents from the age of 12 years.

In December 2010 the Delegate decided to list nomegestrol in Schedule 4 (prescription medicine) in the Standard for the Uniform Scheduling of Medicines and Poisons.

Recommendation

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

8.1.10 Omega-3 acid ethyl esters

Omega-3 acid ethyl esters are made up of a mixture of the ethyl esters of alpha-linolenic acid, moroctic acid, eicosatetraenoic acid, eicosapentaenoic acid (EPA EE), heneicosapentaenoic acid, clupanodonic acid, and docosahexaenoic acid (DHA EE). Omega-3 acid ethyl esters are obtained by transesterification of the body oil of fish species coming from families such as Engraulidae, Carangidae, Clupeidae, Osmeridae, Salmonidae, and Scombridae. Omega-3 acid ethyl esters 90 is a concentrate consisting of no less than 90 per cent omega-3 acid ethyl esters, where the total of EPA EE and DHA EE together is 80 per cent. In these preparations, the content of EPA EE is not less than 40 per cent and DHA EE is not less than 34 per cent.

Omega-3 acid ethyl esters are indicated for:

1. Post myocardial infarction - adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy (e.g. statins, antiplatelet medicinal products, beta-blockers, ACE inhibitors).
2. Hypertriglyceridaemia - endogenous hypertriglyceridaemia as a supplement to diet when dietary measures alone are insufficient to produce an adequate response. Treatment is indicated for the following types of dyslipidaemia (Fredrickson classification) only:
   • Types IV and V as monotherapy and with close monitoring of LDL-C levels; and
   • Type IIb as add-on therapy to statins, when control of triglycerides with statins has been shown to be insufficient.

They are not indicated in exogenous hypertriglyceridaemia (Type I hyperchylomicronaemia) or in patients with secondary endogenous hypertriglyceridaemia including patients with diabetes mellitus.

To ensure that omega-3 fatty acids would not be inadvertently captured, the omega-3 acid ethyl esters Australian schedule entry specifically excluded salts and derivatives. The indications were also included to ensure that only omega-3 acid ethyl ester products manufactured indicated for the treatment of post-myocardial infarction and / or hypertriglyceridaemia would be captured.

In August 2010 the Delegate decided to list omega-3 acid ethyl esters in Schedule 4 (prescription medicine) in the Standard for the Uniform Scheduling of Medicines and Poisons as 'OMEGA-3-ACID ETHYL ESTERS (excluding salts and derivatives) for human therapeutic use, for the treatment of post-myocardial infarction and / or hypertriglyceridaemia'.

The Committee noted that currently in New Zealand there were no medicines that contained omega-3 acid ethyl esters. To schedule omega-3 acid ethyl esters in New Zealand may inadvertently capture foodstuffs or food supplements on the New Zealand market. The Committee considered that there was insufficient data to consider a classification decision. The case for a safety issue related to side effects was not convincing in the extract of the minutes that the Committee had considered.

Recommendation

That New Zealand should not harmonise with Australia regarding the classification of omega-3 acid ethyl esters.

8.1.11 Plerixafor

Plerixafor is a CXCR4 chemokine receptor antagonist that blocks the binding of stromal cell-derived factor 1 α. It inhibits the retention of haematopoietic stem cells in bone marrow, and increases their number in peripheral blood. It is indicated, in combination with granulocyte colony stimulating factor, to mobilise hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma or multiple myeloma.

In August 2010 the Delegate decided to list plerixafor in Schedule 4 (prescription medicine) in the Standard for the Uniform Scheduling of Medicines and Poisons.

Recommendation

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

8.1.12 Rupatadine

Rupatadine is an antihistamine with platelet-activating factor antagonist activity. It is under investigation in Australia for the symptomatic treatment of seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria in adults and adolescents (over 12 years of age).

Rupatadine is captured in Australia and New Zealand under the prescription medicine class entry for antihistamines.

In December 2010 the Delegate decided to list rupatadine in Schedule 4 (prescription medicine) in the Standard for the Uniform Scheduling of Medicines and Poisons.

Recommendation

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

8.1.13 Tafluprost

Tafluprost is a synthetic analogue of dinoprost (a prostaglandin F2α). It is indicated for the reduction of elevated intraocular pressure in open-angle glaucoma or ocular hypertension.

As a prostaglandins analogue, tafluprost is captured in Australia and New Zealand under the prescription medicine class entry for prostaglandins.

In December 2010 the Delegate decided to list tafluprost in Schedule 4 (prescription medicine) in the Standard for the Uniform Scheduling of Medicines and Poisons.

Recommendation

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

8.1.14 Tuberculin

Tuberculin skin tests are used to detect tuberculoprotein hypersensitivity when Bacillus Calmette-Guerin vaccination is being considered or as an aid to diagnosis of tuberculosis. Tuberculin for sensitivity testing is given by intradermal injection as in the Mantoux test.

Tuberculin is captured in Australia and New Zealand under the prescription medicine class entry for antigens.

In December 2010 the Delegate decided to list tuberculin in Schedule 4 (prescription medicine) in the Standard for the Uniform Scheduling of Medicines and Poisons.

In New Zealand, tuberculin skins tests are given by nurses under supervision and standing orders. The Committee felt that more data would be required on the potential impact of adding tuberculin to the New Zealand Schedule as a prescription medicine before making a recommendation. It was agreed to add this to the agenda of the next meeting so that Medsafe could provide such data for discussion.

Recommendation

• That the classification of tuberculin as a prescription medicine should be added to the agenda of the next meeting.
• That Medsafe should provide data to the Committee on the potential health impact of adding tuberculin to the New Zealand Schedule as a prescription medicine.

8.1.15 Vorinostat

Vorinostat is a member of a class of anti-neoplastic agents called histone deacetylase inhibitors, used for the treatment of cutaneous T-cell lymphoma. Vorinostat is also under investigation for the treatment of multiple myeloma and mesothelioma. Vorinostat is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease subsequent to prior systemic therapies. The recommended dose is 400 mg orally once daily with food.

In August 2010 the Delegate decided to list vorinostat in Schedule 4 (prescription medicine) in the Standard for the Uniform Scheduling of Medicines and Poisons.

Recommendation

That vorinostat 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 August 2010

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

1. leptospermum scoparium oil(manuka oil) - new entry in Schedule 6 (poison)
2. 4-methylmethcathinone (mephodrone) - new entry in Schedule 9 (prohibited substance)
3. clofarabine - new entry in Schedule 4 (already classified as a prescription medicine in New Zealand)
4. saxagliptin - new entry in Schedule 4 (already classified as a prescription medicine in New Zealand)
5. eltrombopag - new entry in Schedule 4 (already classified as a prescription medicine in New Zealand).

Australia did not harmonise with New Zealand on the scheduling of beta-carotene. In Australia, beta-carotene remained unscheduled.

a. Amorolfine

Amorolfine is a morpholine derivative with antifungal activity. It acts by interfering with the synthesis of sterols essential for the functioning of fungal cell membranes. It is active in vitro against a wide variety of pathogenic and opportunistic fungi including dermatophytes, Blastomyces dermatitidis, Candida spp.,Histoplasma capsulatum, and Sporothrix schenckii. Amorolfine also has variable activity against Aspergillus spp. Despite its in vitro activity, amorolfine is inactive when given systemically which has limited its use to topical applications for superficial infections.

Following a submission, the National Drugs and Poisons Schedule Committee agreed to reschedule amorolfine topical preparations from Schedule 3 (restricted) to Schedule 2 (pharmacy-only), and that the exemption from scheduling for preparations containing amorolfine for treatment of tinea pedis remained appropriate. Amorolfine was now classified in Australia as:

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

At the 11^th meeting on 29 June 1993, the Committee recommended that amorolfine be classified as a prescription medicine. At the 19^th meeting on 20 May 1998, the Committee recommended that topical medicines containing 0.25% or less of amorolfine be classified as pharmacy-only medicines and those containing more than 0.25% be classified as restricted medicines.

In New Zealand, amorolfine is currently scheduled 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
• general sale; for external use in medicines for tinea pedis only.

The Committee considered harmonising with the Australian classification of amorolfine. It was noted that harmonising with Australia would affect one product currently being marketed in New Zealand.

One pre-meeting comment had been received during the consultation period which would prefer high strength (5%) amorolfine external preparations to remain restricted medicines.

The Committee noted that the general sale classification of amorolfine was already harmonised. However, the Committee required data on the safety of amorolfine as a restricted medicine before it could consider its reclassification to pharmacy-only in order to harmonise with Australia.

Recommendation

That Medsafe should provide data on the safety of amorolfine as a restricted medicine for consideration at the next meeting.

b. C1 esterase inhibitors

C1 esterase inhibitors (C1-INH) are serine protease inhibitors affecting complement components C1r and C1s. They are also inhibitors of other serine esterases involved in the coagulation (factor XI and thrombin), fibrinolysis (plasminogen activator) and contact (factor XII and kallikrein) systems. They are prepared from human plasma and given as replacement therapy in hereditary angioedema. Hereditary angioedema is an autosomal dominant disorder caused by deficiency or abnormal function of the C1-INH. C1-INH are administered for both short-term prophylaxis and treatment of acute life-threatening attacks by slow intravenous injection or infusion.

The National Drugs and Poisons Schedule Committee agreed to include C1 esterase inhibitors in the general exemption for blood products. In Australia there is a general exemption (appendix A of the Standard for the Uniform Scheduling of Medicines and Poisons) for human blood products including:

• whole blood
• blood components including red cells, white cells, platelets and plasma (including cryoprecipitate)
• the following plasma-derived therapeutic proteins and their equivalent recombinant alternatives; albumin, anticoagulation complex, C1 esterase inhibitors, clotting factors, fibrinogen, protein C, prothrombin complex concentrate and thrombin.

The Committee considered a similar exemption for C1 esterase inhibitors in New Zealand. At the 39^th meeting on 25 June 2008, the Committee recommended that fractionated and recombinant blood products should be reclassified from prescription to general sale medicines. At the 40^th meeting on 25 November 2008, the Committee recommended that New Zealand should harmonise with Australia on the exemption from classification for blood and blood products. In New Zealand, human albumin, antithrombin III, blood clotting factors, blood corpuscles, whole blood, factor VIII inhibitor bypassing fraction, fibrinogen, plasma, plasma protein fraction, plasmin, plasminogen activator, platelets and thrombin are currently classified as general sale.

The Committee noted that harmonising with Australia on an exemption of C1 esterase inhibitors would not affect any products currently on the market in New Zealand. The Committee felt exempting C1 esterase inhibitors from classification as a blood product was appropriate.

Recommendation

That New Zealand should harmonise with Australia and classify C1 esterase inhibitors as general sale medicines.

c. Iodine

Potassium iodide or potassium iodate may be taken by mouth for radiation protection to saturate the thyroid when uptake of radio-iodine by the gland is not desired. Therapeutically, potassium iodide may also be used as an antifungal, an expectorant and in veterinary medicine as a treatment of actinobacillosis, actinomycosis and simple goiter. Non-therapeutic uses include the manufacture of photographic emulsions, as well as in animal and poultry feeds.

The National Drugs and Poisons Schedule Committee agreed to exempt oral preparations of iodine for use in prophylaxis and treatment in the event of radioactive iodine exposure under an emergency plan approved by an appropriate authority. In Australia, iodine is currently classified as a Schedule 2 (pharmacy-only) medicine:

• in preparations for human internal therapeutic use containing 300 micrograms or more of iodine per recommended daily dose; or
• in preparations for human external therapeutic use containing more than 2.5 per cent of available iodine (excluding salts, derivatives or iodophors),
  except in oral preparations for use in prophylaxis and treatment in the event of radioactive iodine exposure under an emergency plan approved by an appropriate authority.

The Committee considered a similar exemption for iodine. In New Zealand, iodine is currently classified as:

• pharmacy-only; for external use in medicines containing more than 2.5%; for internal use in medicines containing 300 micrograms or more per recommended daily dose
• general sale; for external use in medicines containing 2.5% or less; for internal use in medicines containing less than 300 micrograms per recommended daily dose.

The Committee noted that the exemption would not affect any products currently on the market in New Zealand. One pre-meeting comment had been received during the consultation period and this supported the exemption.

However, the Committee felt that this exemption was specific to Australia because they had nuclear power plants and allowed nuclear powered vessels to enter Australian ports. New Zealand does not have nuclear plants or allow nuclear powered vessels to visit so exempting iodine would not be appropriate. Emergency powers could be used in New Zealand to supply iodine in the event of an emergency.

Recommendation

That New Zealand should not harmonise with Australia in exempting iodine from scheduling when in oral preparations for use in prophylaxis and treatment in the event of radioactive iodine exposure under an emergency plan approved by an appropriate authority.

8.2.2 Decisions by the Delegate December 2010

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

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

Australia did not harmonise with New Zealand on the scheduling of tapentadol. In Australia a new Schedule 8 (controlled drug) entry had been created. In New Zealand, tapentadol had been classified as a prescription medicine.

9 FOR THE NEXT MEETING

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

1. The Committee will reconsider harmonising with the Australian classification of amorolfine using data on its safety as a restricted medicine.
2. Clobetasone - the discontinuation of Becoderm-C has left consumers without an over-the-counter clobetasone butyrate 0.05% topical preparation option. The Committee will 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.
3. Methenamine hippurate is currently classified as a general sale medicine. The Committee will discuss whether this is an appropriate classification and whether pharmacy-only would be more appropriate given its indication, for the relief of urinary tract infections, and increased marketing. Medsafe will write to iNova Pharmaceuticals (New Zealand) Limited regarding their product Hiprex and this classification discussion.
4. The Committee will discuss the classification of tuberculin with the data Medsafe provides on the potential health impact of adding tuberculin to the New Zealand Schedule as a prescription medicine.
5. The Committee will consider Medsafe's submission proposing the reclassification of vitamin D, in tablets containing 1.25 mg of colecalciferol, from prescription medicine to restricted medicine for the prevention and treatment of vitamin D deficiency states in adults.

10 GENERAL BUSINESS

10.1 Is non-prescription oseltamivir availability under strict criteria workable? A qualitative study in New Zealand (Gauld et al)

This article from the Journal of Antimicrobial Chemotherapy Advance Access, published 3 November 2010, was presented to the Committee for information. The article demonstrated the responsible attitudes within pharmacy when supplying oseltamivir under specific guidelines. The Committee noted there was now evidence of resistance associated with exposure to Tamiflu, which was the original concern.

Oseltamivir is currently classified as prescription; 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 is kept up to date by publishing a Gazette notice every six months, rather than adding it permanently to the Schedule.

The Committee felt it may now be appropriate to put this classification permanently in the Schedule and agreed to add it to the agenda of the next meeting to allow for public consultation.

Recommendation

That the classification of oseltamivir as prescription; 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, should be added to the agenda of the next meeting.

10.2 Risks, benefits and issues in creating a behind-the-counter category of medications (Reid et al)

This special feature from the Journal of the American Pharmacists Association (2011; 51: 26-39), was also presented to the Committee for information.

10.3 Observer at meetings

The New Zealand Self-Medication Industry Association had formally raised the matter of having an industry representative as an observer at meetings.

The Committee considered the following options:

1. a member of the New Zealand Self-Medication Industry Association could observe meetings
2. applicants who make a submission for reclassification could observe
3. retain the status quo.

The Chair explained that membership of the Committee was defined in legislation. There was nothing in the legislation regarding observers at meetings.

The Committee discussed the options, and also whether it would be appropriate to have an observer throughout the whole meeting or just specific items. It was felt that having an observer at meetings would increase transparency, make the classification process more understandable to industry and provide the opportunity for questions and answers. The latter would be specifically useful in submissions for reclassification. The Committee could resolve any issues at the meeting rather than the item being carried forward to the next meeting with further data requested.

Concern was expressed over the number of observers at a meeting. If the New Zealand Self-Medication Industry Association was represented, then other groups such as Medicines New Zealand and consumer groups might also ask to be observers at meetings.

Rather than appoint a single observer to oversee the process for all applicants, the Committee was most comfortable with the applicant seeking reclassification being permitted to attend as an observer.

The Committee noted it is an advisory committee to the Minister of Health's delegate so there are confidentiality issues that need to be resolved as the final decision on reclassification is not made by the Committee.

The suggestion to pilot having observers for submissions for reclassification attend over the next four meetings was supported by the Committee. Medsafe should be asked to develop a draft proposal including terms of reference, confidentiality agreements, which items of the agenda would be observed and who would observe before the pilot programme is started. These documents to be agreed by the Committee in an out-of-session consultation before being sent to the Minister's delegate to seek agreement.

Recommendation

• That having an observer for submissions of reclassification at meetings should be piloted over the next four meetings.
• That Medsafe should develop a draft proposal out-of-session with the Committee and seek agreement from the Minister's delegate before that pilot.

11 Date of Next Meeting

To take place on a Tuesday in October or November 2011. The Secretary would email members for their availability.