Revised: 23 May 2013

Committees

Minutes of the 43rd meeting of the Medicines Classification Committee - 13 April 2010

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

Classification of dextromethorphan, guaiphenesin, ipecacuanha and phenylephrine

As part of the briefing provided to the Minister of Health, to allow him to make a decision about the recommendations of the Committee, Medsafe suggested alternate advice with respect to several of the recommendations about the appropriate classification of cough and cold medicines.

Dextromethorphan

Medsafe did not agree that there was sufficient evidence of harm or abuse to warrant consideration of the reclassification of dextromethorphan, for the treatment of the symptoms of cough and cold in adults and children over 12 years of age, at the next meeting. While dextromethorphan is a weak opioid that can be subject to abuse, there is limited evidence that dextromethorphan abuse in New Zealand is a significant problem (Medsafe is only aware of two reports of abuse in recent years). Medsafe therefore recommended that the Minister of Health reject this recommendation. Medsafe proposes to monitor dextromethorphan and revisit the issue if the number of reports of abuse increases significantly.

Phenylephrine

Medsafe did not agree that there was sufficient evidence of harm to warrant consideration of the reclassification of phenylephrine, for the treatment of the symptoms of cough and cold in adults and children over 12 years of age, at the next meeting. The Committee, at its 30^th, 31^st and 32^nd meetings, reviewed the safety of phenylephrine and no new safety data was presented to either the Cough and Cold Working Party or the Committee that would warrant overturning the earlier Committee decision. Medsafe therefore recommended that the Minister of Health reject this recommendation.

Ipecacuanha

Medsafe did not agree that a safety review of ipecacuanha should be undertaken, and considered at the next meeting, to determine if the benefits of treatment as a cough and cold medicine outweigh the risks associated with its toxicity as there is no evidence of harm associated with use. Medsafe therefore recommended that the Minister of Health reject this recommendation.

The Minister of Health has accepted the Committee's advice that:

1. dextromethorphan, ipecacuanha and phenylephrine should be reclassified from general sale medicines to pharmacy-only medicines for the treatment of the symptoms of cough and cold in children aged 6-12 years
2. the current classification for guaiphenesin remained appropriate.

The Minister has rejected the Committee's recommendations that:

1. a proposal to reclassify dextromethorphan and phenylephrine to pharmacy-only medicines for the treatment of the symptoms of cough and cold in adults and children over 12 should be added to the agenda of the next meeting
2. Medsafe should consider a safety review of ipecacuanha to determine if the benefits of treatment as a cough and cold medicine outweigh the risks associated with its toxicity.

The current general sale classification of dextromethorphan, guaiphenesin, ipecacuanha and phenylephrine, as treatments for cough and cold in adults and children over 12 years of age, therefore remains unchanged.

---

Present:

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

In Attendance:

Ms Abby Cutfield (Advisor Pharmacovigilance, Medsafe)
Dr Susan Kenyon (Senior (Pharmacovigilance) Advisor, Medsafe)
Dr Susan Martindale (Principal Advisor Regulation, Medsafe)
Dr Enver Yousuf (Principal Clinical Advisor, Medsafe)

Apologies:

Dr David Galler

1 WELCOME

The Chair opened the 43rd meeting at 9:30am and welcomed members and guests. The Chair welcomed Mr Orange and Dr Peterson as new members of the Committee.

2 APOLOGIES

Apologies were received from Dr Galler who could not attend the meeting because he was overseas. The Chair informed the Committee that, because he was leaving employment with the Ministry of Health, Dr Galler was unable to continue as a member. The Chair acknowledged the important role Dr Galler had played on the Committee and advised that a new member from the Ministry of Health would be appointed by the Minister of Health.

Ms Cutfield and Dr Kenyon were only present for Agenda Item 6.2. Dr Copland left the meeting at 12:20pm.

3 CONFIRMATION OF THE MINUTES OF THE 42ND MEETING HELD ON TUESDAY 3 NOVEMBER 2009

The minutes of the 42nd 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:

1. One member declared owning a 50% share of a retail pharmacy and a 50% share of a non-trading pharmacy. Decisions relating to any reclassification could therefore have financial implications and become a conflict of interest. The Committee agreed that this was inherent in the nomination process of members from the Pharmaceutical Society and so could not be considered a conflict of interest.
2. Another member declared being an executive member of the Pharmaceutical Society of New Zealand. The Society could be engaged in developing and helping provide educational resources for pharmacists if, following discussion, rizatriptan 5 mg wafers were reclassified as a restricted medicine. This could be interpreted as a conflict of interest with Agenda Item 6.6. However, the Committee agreed that the member could fully participate in the discussion and vote.

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 Diclofenac

(Voltaren Rapid, Novartis Consumer Health Australasia Pty Ltd)

At the 42nd meeting on 3 November 2009 the Committee considered a submission to increase the maximum pack size for pharmacy-only sale of diclofenac in solid oral dosage forms, containing 12.5 mg or less per dose, from 20 to 40 dosage units. The indications were for the temporary relief of painful conditions such as headache, the temporary relief of symptoms of cold and flu, and the reduction of fever. The Committee felt that although the sponsor company presented a strong case for packs of 40 dosage units in terms of safety and significant risk, they would be more comfortable with 5 days' supply, i.e. 30 dosage units.

Diclofenac is currently classified as pharmacy-only medicine; in solid dose form in medicines containing 12.5 mg or less per dose form in packs containing not more than 20 tablets or capsules and with a recommended daily dose of not more than 75 mg.

The submission was reconsidered because the sponsor company had provided data to increase the maximum pack size from 20 to 30 dosage units, as requested by the Committee. The following conclusions were presented in the submission and drawn from the data submitted to the 42nd meeting:

1. the majority of patients only take sufficient medication according to the nature of the pain and the efficacy of the product and do not appear to use more medication simply because it is available
2. adverse event rates are similar between diclofenac (75 mg per day), ibuprofen (1200 mg per day) and placebo for up to seven days.

The Australian National Drugs and Poisons Schedule Committee considered a similar scheduling of diclofenac at its 57th meeting in October 2009. They generally agreed there was insufficient robust data regarding the extended use of diclofenac accessed or supplied in an unmonitored environment. They decided that the current scheduling of diclofenac remained appropriate.

The Committee's opinion from the 42nd meeting was drawn from the risk of prolonged use at higher doses and a lack of comfort that consumers would follow guidelines. The discussion regarding codeine led the Committee to accept that five days' supply was sufficient for short-term use. The Committee's previous analysis of the sponsor data indicated a level of acceptance of the safety of the proposed dose regimen; the only concern was that the larger pack represented a duration of use that lent itself to chronic usage.

One pre-meeting comment had been received during the consultation period and this was in support of increasing the maximum pack size to 30 dosage units. The comment was received from the same submitter who had not supported the change at the 42nd meeting.

It was concluded that the proposal to increase the pack size from 20 to 30 tablets was unlikely to be associated with an increased use of harm, or be seen as promoting chronic use for the product

Recommendation

That diclofenac should be classified as pharmacy-only medicine; 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.

5.2 Ginkgo biloba

Ginkgo biloba was presented to the Committee at the 42nd meeting on 3 November 2009 for information only. Medsafe had received a New Medicine Application for a medicine, namely tebonin, containing an extract from ginkgo biloba. The Committee noted that this formed the first instance of an application being made for approval under section 20 of the Medicines Act 1981, for a medicine containing a standardised extract of ginkgo biloba. Concern was expressed that any decision to classify ginkgo biloba would not only affect this product but all products containing ginkgo biloba. The Committee felt they would be able to make a more informed decision if they were provided with further data relating to the classification of ginkgo biloba. The scheduling would largely be determined by its indication which was not yet approved.

At the 42nd meeting the Committee recommended that the classification of ginkgo biloba be deferred until the next meeting so that the Committee could consider the data relating to the classification.

The classification was deferred again until the next meeting because Medsafe was in the process of collecting the following further information for the Committee:

1. review of clinical evaluation
2. safety data
3. advice on whether ginkgo biloba or tebonin (a standardised extract of ginkgo biloba) should be scheduled.

Recommendation

That the classification of ginkgo biloba be deferred until the next meeting so that the Committee can consider the additional data supplied by Medsafe relating to the classification.

5.3 Vaccines

Vaccines are currently classified as prescription medicines.

It had been brought to Medsafe's attention that the classification of vaccines needed to be reviewed to address the classification of some existing medicines.

Currently there are 19 specific vaccines listed in the Schedule. Seventeen of these are classified as prescription medicines. However inactivated haemophilus influenzae type b and pneumococcal I, II, and III in oral vaccines, for the prophylaxis of bacterial complication of colds, are classified as restricted medicines

One pre-meeting comment had been received during the consultation period and this was in support of updating the Schedule to exempt vaccines included elsewhere in the Schedule from the prescription medicines entry. They did not support the inclusion of a class entry for vaccines as prescription medicines within the Schedule. The Committee acknowledged the argument set out in this submission however understood that a generic entry for vaccines was required in the Schedule to provide for new or unapproved vaccines to be automatically scheduled at an appropriate level.

The Committee noted that the inclusion of an exemption for oral vaccines from the prescription medicines entry would make the default position for an unapproved oral vaccine to be a general sale medicine which would not be appropriate. In addition, the Committee also noted that the Schedule already included a number of oral vaccines as prescription medicines.

The Committee agreed that the current schedule entry for vaccines should be amended to classify all vaccines as prescription medicines except when specified elsewhere in the Schedule. The Committee also noted that the schedule entries for the ingredients of oral vaccines, for the prophylaxis of bacterial complication of colds, was incomplete and several of the claimed active ingredients in the product were not scheduled. The Committee asked Medsafe to amend the Schedule to resolve this issue by including all known ingredients included in the product Buccaline Berna within the Schedule as restricted medicines.

Recommendation

• That vaccines should be classified as prescription medicine; except when specified elsewhere in this Schedule.
• That Medsafe should include all known ingredients included in the product Buccaline Berna within the Schedule as restricted medicines.

5.4 Fluorides

At the 40th meeting on 25 November 2008 the Committee recommended that New Zealand should harmonise with Australia on the classification of fluoride products.

At the 42nd meeting on 3 November 2009 it had been brought to Medsafe's attention that the wording of the New Zealand Schedule did not harmonise exactly with that of the Australian Standard for the Uniform Scheduling of Drugs and Poisons. Following discussion the Committee recommended that there should be no change to the wording of the prescription medicine entry for fluoride in the New Zealand Schedule.

Fluorides are currently classified as:

• prescription medicine; for internal use in medicines containing more than 0.5 mg per dose unit except in medicines containing 15 mg or less per litre or per kilogram; except in parenteral nutrition replacement preparations; for external use in medicines containing more than 5500 mg per litre or per kilogram except when used in practice by a registered dental therapist
• restricted medicine; for external use in liquid form in medicines containing 5500 milligrams or less and more than 1000 milligrams per litre or per kilogram and when sold in packs approved by the Minister or the Director-General for distribution as restricted medicines; for external use in non-liquid form in medicines containing 5500 milligrams or less and more than 1000 milligrams per litre or per kilogram, except in medicines containing 1500 milligrams or less and more than 1000 milligrams per litre or per kilogram and when sold in packs approved by the Minister or the Director-General for distribution as general sale medicines; except when used in practice by a registered dental therapist
• pharmacy-only medicine; for internal use in medicines containing 0.5 milligrams or less per dose unit; except in parenteral nutrition replacement preparations; for external use in liquid form in medicines containing 1000 milligrams or less per litre or per kilogram and when sold in packs approved by the Minister or the Director-General for distribution as pharmacy-only medicines, except in medicines containing 220 milligrams or less per litre or per kilogram and in packs containing not more than 120 milligrams of total fluoride which have been approved by the Minister or the Director-General for distribution as general sale medicines; except when used in practice by a registered dental therapist; except in medicines containing 15 milligrams or less per litre or per kilogram
• general sale; for external use in liquid form in medicines containing 220 milligrams or less per litre or per kilogram and in packs containing not more than 120 milligrams of total fluoride which have been approved by the Minister or the Director-General for distribution as general sale medicines; for external use in non-liquid form in medicines containing 1500 milligrams or less per litre or per kilogram and, when containing more than 1000 milligrams per litre or per kilogram, sold in packs approved by the Minister or the Director-General for distribution as general sale medicines; in medicines containing 15 milligrams or less per litre or per kilogram; in parenteral nutrition replacement preparations.

It had been brought to Medsafe's attention that there was still an inconsistency between the New Zealand and Australian Schedules. In Australia, high concentration fluoride products are exempt from scheduling when supplied to dental professionals and are not subject to the labelling and storage controls required by the New Zealand decision to make these products prescription medicines.

Industry had expressed a concern regarding this inconsistency. The Committee noted the inconsistency, sought advice from the Chief Dental Advisor and considered further information supplied by industry.

The Committee noted that the Chief Dental Advisor had no objection to high fluoride concentration products being supplied in a manner similar to that which occurs in Australia. Following this advice, Medsafe received clarification from industry on:

1. the "established supply channels to dental professionals" (taken from the minutes of the Australian National Drugs and Poisons Schedule Committee, June 2008) and how they worked
2. the assurances that these supply channels were used appropriately
3. the definition of dental professionals and whether they are legally identifiable groups of professionals
4. how these dental professionals would be identified as legal recipients of the fluoride products
5. how industry would ensure that only these dental professionals had access to the fluoride products in New Zealand.

Having considered this new information the Committee agreed fluorides should be unscheduled when supplied to the range of dental professionals recognised by the Dental Council of New Zealand. This approach would harmonise New Zealand with Australia. The Committee recommended that the fluoride entry in the Schedule should be updated to prescription medicine; for internal use in medicines containing more than 0.5 mg per dose unit except in medicines containing 15 mg or less per litre or per kilogram; except in parenteral nutrition replacement preparations; for external use in medicines containing more than 5500 mg per litre or per kilogram except when supplied to a dental professional recognised by the Dental Council of New Zealand.

The Committee were reassured that, following implementation of this recommendation, high concentration fluoride products would still be medicines and sponsor companies would still be required to make an application to Medsafe for consent to market.

Recommendation

That the prescription medicine fluorides entry in the Schedule should be updated to prescription medicine; for internal use in medicines containing more than 0.5 mg per dose unit except in medicines containing 15 mg or less per litre or per kilogram; except in parenteral nutrition replacement preparations; for external use in medicines containing more than 5500 mg per litre or per kilogram except when supplied to a dental professional recognised by the Dental Council of New Zealand.

5.5 Codeine

At the 42nd meeting on 3 November 2009 the Committee recommended that codeine in combination products should be reclassified as a restricted medicine when:

• each dose unit contains not more than 15 mg of codeine base
• the maximum daily dose is limited to 100 mg of codeine base
• the pack size is not more than five days' supply
• sold in packs approved by the Minister or the Director-General for distribution as a restricted medicine.

The Committee also 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.

Codeine is currently classified as:

• prescription medicine; in medicines containing more than 15 mg of codeine per dose unit in combination with one or more therapeutically active ingredients
• class C2 controlled drug; other than a preparation or mixture described in Schedule 3, Part 6
• class C6 controlled drug; (i) Compounded with one or more other pharmacologically active ingredients in such a way that the substance cannot be recovered by readily applicable means or in a yield which would constitute a risk to health; and (ii) Containing not more than 100 milligrams of the substance in each dosage unit and with a concentration of not more than 2.5 percent in undivided preparations.

Controlled drugs are classified as pharmacy-only medicines; that are medicines specified in Part 6 of Schedule 3 of the Misuse of Drugs Act 1975; except when specified elsewhere in this Schedule.

The Australian National Drugs and Poisons Schedule Committee considered post-meeting submissions regarding the June 2009 scheduling decision for over-the-counter products containing codeine at its 57th meeting in October 2009. The June 2009 resolution regarding a Schedule 3 entry (restricted medicine) for all over-the-counter combination analgesics containing codeine was confirmed. However, it was agreed to vary the June 2009 resolution regarding the Schedule 2 entry (pharmacy-only medicine) for codeine combinations for cough and colds by increasing the pack size limit to not more than six days (rather than five) of the supply at the maximum dose recommended on the label.

The Committee confirmed that their conclusion at the 42nd meeting regarding cough and cold preparations containing codeine reflected the status quo and was not a formal recommendation. A recommendation was not felt necessary at the time as there were not any packs of more than six days' supply on the market. The Committee concluded that that cough and cold preparations containing codeine could be classified as pharmacy-only medicines when:

• each dose unit contains not more than 15 mg of codeine base
• the maximum daily dose is limited to 100 mg of codeine base
• the pack size is not more than six days' supply
• sold in packs approved by the Minister or the Director-General for distribution as a pharmacy-only medicine.

The Committee agreed that this should be a recommendation.

Following the consultation period, Medsafe considered submissions asking to delay the gazettal date for the reclassification recommendations. No objections were received regarding the reclassification. The submissions did however express concerns around the timeframe allowed for industry and pharmacies to absorb the changes, specifically the repackaging. A draft letter was tabled at the meeting to display how Medsafe proposed to manage the recommendations and subsequent submissions. The purpose of the letter would be to advise the sponsor companies of medicines containing codeine that:

1. changes to the classification of analgesic medicines and cough and cold preparations containing codeine would come into effect on 4 October 2010
2. new labelling requirements would apply to codeine-containing cough and cold preparations from 1 May 2011.

The date of 4 October 2010 should give industry and pharmacies enough time to absorb the changes, as requested. The date of 1 May 2011 would coincide with the implementation of the Cough and Cold Working Group recommendations. The Committee agreed that Medsafe should send the letter to sponsor companies. The letter would also be published on Medsafe's website (www.medsafe.govt.nz/hot/alerts/CoughandCold/InfoOct2009.asp).

Recommendation

• That cough and cold preparations containing codeine should be classified as pharmacy-only medicines when:
  • each dose unit contains not more than 15 mg of codeine base
  • the maximum daily dose is limited to 100 mg of codeine base
  • the pack size is not more than six days' supply
  • sold in a pack approved by the Minister or the Director-General for distribution as a pharmacy-only medicine.
• That Medsafe should write to the sponsor companies of medicines containing codeine regarding:
  1. changes to the classification of analgesic medicines and cough and cold preparations containing codeine that would come into effect on 4 October 2010
  2. new labelling requirements that would apply to codeine-containing cough and cold preparations from 1 May 2011.

6 SUBMISSIONS FOR RECLASSIFICATION

6.1 Calcipotriol cream, ointment and scalp application
(Pharmacybrands Ltd)

Purpose

This was a submission from Pharmacybrands Ltd, the parent company for Life, Unichem, Amcal and Care Chemist Pharmacies in New Zealand. The classification requested was for calcipotriol cream, ointment and scalp application, to change from prescription medicine to prescription medicine; except when sold by a pharmacist to an adult with mild to moderate psoriasis previously diagnosed by a doctor in a maximum pack size of 30 g or 30 mL. This submission was incorrectly published in the agenda as a reclassification from prescription to restricted medicine.

Background

The change was sought only for the smaller pack sizes (30 g pack sizes from cream and ointment, and 30 mL for scalp application) for the topical treatment of psoriasis vulgaris including plaque psoriasis in adults previously diagnosed by a doctor. The submission was independent from both the distributor and the manufacturer. It included an algorithm and draft pharmacist training notes. Pharmacybrands stated they would allow this training material to be available to all community pharmacies in New Zealand. Additionally, Pharmacy Today, the trade magazine read by community pharmacists, pharmacy technicians and pharmacy assistants, had indicated its interest to Pharmacybrands in publishing information about the proposed change, including continuing education material about psoriasis and appropriate treatment with topical calcipotriol.

Calcipotriol was classified as a prescription medicine in 1991. At the 33rd meeting on 9 June 2005 calcipotriol for the treatment of psoriasis was noted as another suitable candidate for possible reclassification from prescription medicine to an over-the-counter classification. It was agreed a company should be invited to make a submission for the reclassification however a company submission was not received.

Submissions

Three pre-meeting comments had been received during the consultation period. Each of the submissions referred to the reclassification of calcipotriol from prescription medicine to restricted medicine as published in the agenda, however they may still apply to the change requested.

One interested body did not support the reclassification. It was concluded that changing the classification of calcipotriol from prescription medicine represented a danger to the well-being of patients because of an increased risk of hypercalcaemia and an increased risk of all adverse events. Not only would it result in the uncontrolled use of the calcipotriol but it would also limit the medical management of the disease.

Two other interested bodies supported the reclassification. One commented that patients previously diagnosed with psoriasis vulgaris would be better able to self manage their condition through increased access to calcipotriol. In addition, pharmacists were well positioned to play a more supportive role by being readily accessible to provide professional advice and education for patients. The other commented that currently pharmacists could compound or counter-prescribe dithranol preparations (for example micanol) as a restricted medicine for the treatment of plaque-type psoriasis. The adverse event and safety profile of calcipotriol is much better than that of dithranol and it was for this reason that the Committee should favour the reclassification.

Discussion

The Committee agreed that although treatment of psoriasis should not be initiated by a pharmacist, its continuation by a pharmacist was appropriate at such small doses.

In the Committee's opinion, the algorithm proposed needed additional work, for example extra safeguards. The Committee agreed to consider the algorithm outside of the meeting and feed any ideas back to the Secretary so that the Chair could provide further feedback to the company.

In terms of safe use of the product the Committee noted that the application did not resolve the need to monitor the patient's calcium levels, as required by the data sheet. This would need to be addressed when a pharmacist sold the product. The Committee concluded that the risk of hypercalcaemia was not significant as long as the duration of treatment was short and the total area of psoriasis being treated was small. Amendment to the treatment algorithm to include advice to refer the patient back to a general practitioner was also considered a possible potential solution. It was also considered important that, where possible, the patient's usual general practitioner was advised of the provision of calcipotriol to the patient and that this should form part of the clinical practice outlined in the treatment algorithm.

The Committee agreed that the safety profile of calcipotriol when used in the manner set out in the application was sufficient to allow the medicine to be used by a pharmacist to treat an adult with mild to moderate psoriasis previously diagnosed by a doctor. However, further work was required on the algorithm.

Recommendation

• That calcipotriol should be classified as prescription medicine; except when a maximum of 30 g or 30 mL is sold by a pharmacist to an adult with mild to moderate psoriasis previously diagnosed by a doctor.
• That Medsafe should be satisfied with the treatment algorithm.

6.2 Dextromethorphan, guaiphenesin, ipecacuanha and phenylephrine
(Cough and Cold medicines, Medsafe)

Purpose

This was a Medsafe submission proposing the reclassification of dextromethorphan,

guaiphenesin, ipecacuanha and phenylephrine from general sale medicines to either restricted or pharmacy-only medicines when sold for the treatment of the symptoms of cough and cold. The submission, derived from recommendations from the Cough and Cold Review Group, assessed the safety of cough and cold medicines containing dextromethorphan, guaiphenesin, ipecacuanha and phenylephrine and recommended that parents have point of sale access to professional advice when considering purchase of these products for children aged 6-12 years.

Background

In December 2007 the Medicines Adverse Reactions Committee reviewed the use of cough and cold medicines and recommended that they be contraindicated in children under two years.

Following actions taken in Canada and the United Kingdom to restrict the use of these medicines to children six years and over, Medsafe sought further advice from the Medicines Adverse Reactions Committee. In addition the Cough and Cold Review Group was formed to provide advice to Medsafe from a wider range of clinical experts than was currently included in the Medicines Adverse Reactions Committee. The Group also included a lay representative, a representative from Plunket and a representative from the pharmaceutical industry. For further information on the Cough and Cold Review Group see www.medsafe.govt.nz/hot/alerts/CoughandCold/InfoOct2009.asp

The conclusions of the Medicines Adverse Reactions Committee and the Cough and Cold Review Group were:

1. there was no evidence that many of the medicines contained in widely available cough and cold products work in children
2. there was evidence of rare but serious adverse reactions in children using these products, predominantly in children under six years
3. there was no need to use medicines to treat the common cold as these medicines only relieve symptoms and do not make the duration of the cold shorter
4. as there were no benefits to taking these medicines and a risk of serious side effects they should not be used in children under six years and used in children aged 6-12 years after taking advice from a healthcare professional.

The Cough and Cold Review Group recommended that:

1. the packaging and labelling for medicines included in cough and cold products should:
   • restrict their use to children aged six years and over
   • advise parents to seek the advice of a healthcare professional before using in children aged 6-12 years (where applicable)
   • advise patients not to use more than one cough and cold medicine at the same time without checking with a healthcare professional
2. the Committee should be asked to consider the reclassification of these medicines when used in children to either restricted or pharmacy-only medicines.

The Committee noted that many of the medicines included in cough and cold products are already classified as pharmacy-only or restricted medicines. The submission was therefore limited to the medicines dextromethorphan, phenylephrine, guaiphenesin and ipecacuanha as they were present in cough and cold medicines and are currently classified as general sale medicines.

International assessment of cough and cold medicines

In Australia, the Medicines Evaluation Committee considered a Therapeutic Goods Administration review of the safety and efficacy of over-the-counter cold and cold medicines in the treatment of children aged 2-12 years at a meeting on 30 July 2009. The review proposed changes to the availability, labelling, packaging and scheduling of these products. With reference to scheduling, it was recommended that the Australian National Drugs and Poisons Schedule Committee should be asked to consider including substances used in cough and cold medicines in Schedule 3 (restricted medicine) when intended for use in children aged 6-12 years, and in Schedule 4 (prescription medicine) for use in children under 6 years of age. The Australian National Drugs and Poisons Schedule Committee had not yet discussed this recommendation and it was expected to be considered at the June 2010 meeting.

On 19 November 2009 the Medicines and Healthcare products Regulatory Agency in the United Kingdom released new advice that parents and carers should no longer use over-the-counter cough and cold medicines in children under six. The Medicines and Healthcare products Regulatory Agency review concluded there was no evidence that cough and cold medicines work in children and that their use is associated with side effects, including allergic reactions, effects on sleep and hallucinations. Cough and cold medicines would continue to be available for 6-12 year olds but would only be sold in pharmacies to allow parents to receive professional advice on the use of these products. The review also advised that all liquid preparations containing the specified substances should be supplied in a child resistant container.

Submissions

A total of ten pre-meeting comments were received during the consultation period. A further three submissions were received after the closing date. However, these late submissions were provided to the Committee. Most submissions (11 of 13) did not support the reclassification proposal. The following points were made in these submissions:

1. the Cough and Cold Review Group did not recommend the reclassification suggested, rather that a referral should be made to the Committee to consider the reclassification of cough and cold medicines
2. the reclassification proposal would result in additional costs (of up to 40%) if New Zealanders were required to buy products from a pharmacy instead of a supermarket
3. availability of the products would be affected in rural areas
4. the Cough and Cold Review Group considered the use of products in children under the age of 12, but Medsafe's submission to the Committee included use in adults as well
5. products are currently contraindicated in children under the age of two years
6. any conclusion on reclassification should be deferred until the results of the efficacy studies from the United States are known (in the proposed 18 months time)
7. the Committee had considered dextromethorphan, guaiphenesin, and phenylephrine at past meetings and the reclassification goes against previous recommendations
8. there was not sufficient justification or evidence for the reclassifications proposed.
9. New Zealanders have been using the products for decades with minimal adverse effects
10. each substance should have had its own submission to the Committee.

The two submissions which supported reclassification made the following points:

• it would provide the optimal mix of public safety and ease of access
• there would be a significant increase in the safety and effectiveness of treatment for patients suffering from cough and cold.

Of these two submissions one supported a change in the classification of ipecacuanha and phenylephrine only.

Discussion

The Chair confirmed that the Cough and Cold Review Group had asked the Committee to consider the reclassification of cough and cold medicines. The Chair noted however, that the only way Medsafe could ask the Committee to consider reclassification was to make a submission to the Committee seeking a change in classification of the four substances available as general sale medicines used in cough and cold products. To ensure that the submission accurately reflected the intent of the Cough and Cold Review Group, Medsafe commissioned the Chair of the Group to draft the submission on behalf of Medsafe. The expertise and experience of Chair of the Group was well known to the Committee as she had recently completed her second term as a member of the Committee. In addition, throughout her membership of the Committee, the Chair of the Group as author of the report had disclosed any potential or perceived conflicts of interest. The Committee was satisfied that her authorship of the Medsafe report did not constitute a conflict of interest.

The Chair noted from the comments received during the consultation period that the Medsafe submission had been interpreted in a number of different ways. The Committee acknowledged that the submission was open to interpretation and noted that it had generated a great deal of media attention. While public submissions improve the decision-making process of committees, the Committee was concerned that many of the submissions received were derived from misunderstanding the Medsafe application. Many submissions argued for instance, that the Medsafe proposal misrepresented the position in the United Kingdom. This was despite the submission clearly stating that the United Kingdom's decision to reclassify was limited to use in children and its acknowledgment that products to treat cough and cold would continue in the United Kingdom in adults and children over 12 years.

The Committee was also disturbed that many of the submissions considered cough and cold medicines as items of ordinary commerce that would be part of consumer goods purchased on a weekly basis. In the Committee's opinion, all medicines have both risks and benefits and they should never be considered as being an item of ordinary commerce. Before a medicine can be sold in a supermarket, Medsafe and the Committee undertake an assessment of the risk the medicine poses to health, how that risk can be managed by appropriate labelling and packaging, and what benefits may fall to the consumer by having access to the product from a general sale outlet. Nevertheless these medicines should be treated with respect and the instructions on the labelling followed.

Following considerable deliberation the Committee agreed that the best way to examine the submission would be to consider each substance separately against the key risk and benefits sections of the classification criteria set out in Medsafe's classification guidelines. The Committee also agreed that consideration of the classification of these four medicines should be limited to the scope of the data supporting the submission, i.e. use in children aged 6-12 years for the treatment of the symptoms of cough and cold.

The Committee noted that Medsafe was in the process of contraindicating the use of dextromethorphan, guaiphenesin, ipecacuanha and phenylephrine in children less than six years of age when used to treat the symptoms of cough and cold. Changes to package labelling had already been approved by Medsafe for some products.

When discussing each substance the Committee considered:

1. efficacy data
2. safety data
3. abuse potential
4. the need for specialist advice from a healthcare practitioner
5. whether it could be considered a concern in adults and children over 12 years of age, even though there was no data regarding this within the submission.

Dextromethorphan

Dextromethorphan - recent history of scheduling decisions

At the 27th meeting on 23 May 2002 the Committee recommended that the classification of dextromethorphan remain unchanged because there was no evidence of abuse of general sale products in New Zealand. At the 30th meeting on 26 November 2003 the Committee recommended that over-the-counter packs of dextromethorphan should be limited to packs containing 600 mg or less and with a recommended daily dose of not more than 120 mg. At the 37th meeting on 17 May 2007 the Committee recommended that, on the grounds of harmonisation at the less restrictive level, the Australian National Drugs and Poisons Schedule Committee should be recommended to harmonise with New Zealand on the classification of dextromethorphan.

Dextromethorphan is currently classified as:

• prescription medicine; except when specified elsewhere in this Schedule
• pharmacy-only medicine; in liquid form containing more than 0.25% or in solid dose form containing more than 15 mg per dose form when in packs containing not more than 600 mg and with a recommended daily dose of not more than 120 mg
• general sale medicine; in liquid form containing 0.25% or less or in solid dose form containing 15 mg or less per dose form when in packs containing not more than 600 mg and with a recommended daily dose of not more than 120 mg.

Committee consideration of dextromethorphan against scheduling criteria

Consumer convenience

The Committee considered that there was a case for allowing some cough and cold medicines intended for use in children 6-12 years of age to be available from a general sale outlet. It was noted that the appropriate level of consumer convenience however should be determined by the overall risk-benefit of the medicine. Also, whether a reduction in consumer convenience (by limiting sale of a product to a pharmacy) was necessary in order to enable consumers to access information needed to guide the safe use of the product.

Potency

Dextromethorphan is a weak opiod agonist and its use is associated with a number of adverse effects. It was noted from the submission that there was very little data on the efficacy of dextromethorphan in children and noted reference to several studies which demonstrated that products containing dextromethorphan were ineffective in children.

Current availability

Products containing dextromethorphan in New Zealand are currently available in a range of general sale outlets. Cough and cold medicines containing other opiod substances are available only from pharmacy. In Australia, and other jurisdictions, dextromethorphan is only available from a pharmacy.

Therapeutic index

It was considered that, other than dose extrapolation from adult doses, the method which has been used for currently approved products and the available data indicates that the dose regimen currently used for children aged 6-12 years is ineffective. There are no contemporary studies that Medsafe is aware of that have explored the minimum effective dose of dextromethorphan in children (or in adults). The Committee noted that many of the known side effects of dextromethorphan are dose related and it would appear that the increment between efficacy and increased risk of side effects in children may be small, (based on the assumption that the minimum effective dose is likely to be larger than the current dose regimen and the current regimen can produce toxicity in some children).

Toxicity

It was noted that the side effect profile for dextromethorphan is relatively well defined and includes events such as drowsiness, respiratory depression, vomiting, constipation, confusion and hallucinations / disorientation. The Committee also noted that there is a clinically significant interaction between dextromethorphan and the selective serotonin receptor inhibitor antidepressants, and serotonin and noradrenalin reuptake inhibitors, that can lead to serotonin syndrome which can be a life threatening event. While selective serotonin receptor inhibitor antidepressants are used infrequently in children, they are prescribed in this population and general sale availability may pose a significant risk.

Abuse potential

Internationally dextromethorphan has been identified as a drug of abuse. In New Zealand, at the Centre for Adverse Reactions Monitoring, there have recently been two reports of abuse of dextromethorphan in cough and cold medicines. The Committee considered that tightening up of the controls on access to codeine as a result of concerns about its abuse may lead to increased abuse of dextromethorphan.

Inappropriate use

It was noted that, in addition to the potential for abuse, there was also scope for inappropriate use of products to unnecessarily sedate children. The issue of inappropriate sedation of children was previously considered to be one of the reasons why anti-histamines were reclassified to restricted medicines.

Precautions

The Committee considered that there are a number of possible risks associated with use of dextromethorphan (as set out above) that would be difficult to manage through labelling and sale outside a pharmacy. The inability of a general sale outlet, such as a supermarket, to manage the purchase of multiple bottles of medication was a particular issue with a medicine which has a known abuse potential.

Communal harm

It was considered that dextromethorphan abuse by adults and the risk of inappropriate use as a child sedative meant that access to this medicine at a general sale level had the potential to cause communal harm.

Dextromethorphan - conclusions

The Committee's overall risk-benefit assessment of dextromethorphan was that the safe and quality use of the medicine in children aged 6-12 years could be improved by providing parents with point of sale information and advice about its use to treat the symptoms of cough and cold.

The Committee also considered that, given increasing concerns about abuse of over-the-counter opioid medicines in the community, it was inappropriate for dextromethorphan to be available as a general sale medicine.

Given the evidence of abuse of dextromethorphan and the presence of a clinically significant interaction with a commonly prescribed group of antidepressant medicines, the Committee also expressed concern about continued general sale access to this medicine for use in adults.

Dextromethorphan - recommendations

• That dextromethorphan should be reclassified from general sale medicine to pharmacy-only medicine for the treatment of the symptoms of cough and cold in children aged 6-12 years.
• That a proposal to reclassify dextromethorphan to a pharmacy-only medicine for the treatment of the symptoms of cough and cold in adults and children over 12 should be added to the agenda of the next meeting.

Guaiphenesin

Guaiphenesin - recent history of scheduling decisions

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

At the 41st meeting on 14 May 2009 the Committee reconsidered the scheduling of guaiphenesin and recommended:

That guaiphenesin should be reclassified from prescription medicine to general sale medicine when:

• pack size is limited to not more than 5 days' supply
• in a modified release dosage form
• a maximum daily dose of not more than 2400 mg is recommended
• sold in packs approved by the Minister or the Director-General for distribution as general sale medicines.

That guaiphenesin should be reclassified from prescription medicine to restricted medicine when:

• pack size is more than 5 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
• sold in packs approved by the Minister or the Director-General for distribution as restricted medicines.

The Committee noted that use of modified release guaiphenesin dose forms was contraindicated in children aged less than 12 years.

Guaiphenesin is currently classified as:

• prescription medicine; 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 grams 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 medicine; 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 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 medicine; 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 grams 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.

Committee consideration of guaiphenesin against scheduling criteria

Consumer convenience

The Committee considered that there was a case for allowing some cough and cold medicines intended for use in children 6-12 years of age to be available from general sale outlets. It was noted that the appropriate level of consumer convenience however was determined by the overall risk-benefit of the medicine. Limiting sale of a product to a pharmacy on safety grounds would allow a consumer access to information and advice, and was a legitimate reason for marginally reducing access.

Potency

Guaiphenesin is an expectorant thought to act by increasing the volume and reducing the viscosity of secretions in the trachea and bronchi, thereby increasing the efficiency of the cough reflex and facilitating the removal of secretions. Evidence for the proposed mechanism is lacking. A Cochrane collaboration meta-analysis found some evidence for the effectiveness of guaiphenesin in children, however the evidence was weak.

Current availability

Products containing guaiphenesin New Zealand are currently available as general sale medicines.

Therapeutic index

As with many of the medicines used in the management of cough and cold, there seems to be no evidence available to support the minimum dose of guaiphenesin that is effective in children.

Toxicity

It was noted that the side effect profile of guaiphenesin was well established. Most side effects are mild and include nausea and vomiting. Consumption of large doses of guaiphenesin has been rarely reported to lead to the formation of renal stones.

Abuse potential

There is no evidence that guaiphenesin is abused.

Inappropriate use

It was noted there was scope for inappropriate use of guaiphenesin to treat other medical conditions, notably fibromyalgia, however this was likely to induce emesis.

Precautions

The Committee considered that the contraindications for use of guaiphenesin, and its known side effects, are addressed in the product labelling.

Communal harm

It was considered there was no potential for guaiphenesin to cause communal harm.

Guaiphenesin - conclusions

The Committee noted that although the evidence for the effectiveness of guaiphenesin for the treatment of cough in children was limited, there was no evidence of a safety concern. Overall the Committee felt that the risk-benefit assessment supported the current classification of guaiphenesin.

Guaiphenesin - recommendations

That the current classification for guaiphenesin remained appropriate.

Ipecacuanha

Ipecacuanha - recent history of scheduling decisions

At the 7th meeting on 31 July 1990 the Committee recommended that ipecacuanha be classified as a part II pharmacy medicine. At the 16th meeting on 24 April 1996 the Committee recommended that ipecacuanha be classified as a pharmacy-only medicine in medicines containing 0.05% or more of emetine and a general sale medicine in medicines containing less that 0.05% of emetine.

Ipecacuanha is currently classified as:

• prescription medicine; in medicines containing more than 0.2% of emetine
• general sale medicine; in medicines containing 0.2% or less of emetine.

Committee consideration of ipecacuanha against scheduling criteria

Consumer convenience

The Committee considered that there was a case for allowing some cough and cold medicines intended for use in children 6-12 years of age to be available from general sale outlets. It was noted that the appropriate level of consumer convenience however was determined by the overall risk-benefit of the medicine and considered that limiting sale of a product to a pharmacy on safety grounds to allow a consumer access to information and advice was a legitimate reason for marginally reducing access.

Potency

Ipecacuanha is an emetic medicine that has been traditionally used as an expectorant by encouraging the cough reflex. At higher doses ipecacuanha produces vomiting. It was noted that there did not seem to be any contemporary data supporting the efficacy of ipecacuanha as a treatment for cough and cold in either adults or children. In several submissions, the opinion was expressed that ipecacuanha was a medicine whose time had passed and that there was no role for this substance in modern day treatment of cough and cold.

Current availability

The number of ipecacuanha products on the New Zealand market for the treatment of cough and colds is small.

Therapeutic index

It was noted that, in the absence of evidence for an effective dose, it was impossible to determine the therapeutic index of ipecacuanha. The current recommended dose of ipecacuanha when used as an expectorant is up to 1.4 mg of total alkaloids per day. When ipecacuanha is used to induce vomiting in children the recommended dose is 7-14 mg. Based on current use the therapeutic index for ipecacuanha is therefore moderate.

Toxicity

It was noted that the side effect profile for ipecacuanha was well known and side effects were largely dose related (due to the amount of emetine absorbed by the patient). Nausea, vomiting, gastro-intestinal irritation and erosion leading to bloody vomiting and diarrhoea are well recognised side effects of ipecacuanha. Exposure to high doses of emetine have been associated with cardio-toxicity including heart rhythm problems and myocardial infarction. Due to the toxicity of emetine, products containing doses of emetine that are high enough to induce vomiting are classified as prescription medicines.

Abuse potential

Abuse of ipecacuanha is well recognised though rare. There have been several reports in the medical literature of chronic abuse of ipecacuanha to induce vomiting in eating disorders; cardiotoxicity and myopathy have occurred and may be a result of accumulation of emetine. The Committee noted the absence of New Zealand data on abuse of ipecacuanha.

Inappropriate use

It was noted there was scope for inappropriate use of ipecacuanha in patients with eating disorders.

Precautions

The Committee considered that the evidence supporting the continued use of this medicine was deficient. The side effect profile, especially its ability to cause vomiting (which may occur in children as a consequence of cough anyway), was such that labelling information needed to be supplemented by professional advice available at point of sale.

Communal harm

It was considered that there was very limited potential for ipecacuanha to cause communal harm.

Ipecacuanha - conclusions

The Committee raised significant concerns about the risk-benefit profile of ipecacuanha given its recognised toxicity and the absence of evidence of benefit in either adults or children.

The Committee considered that a review of the safety and efficacy of ipecacuanha should be undertaken to determine if the medicine continued to have a place in the management of cough and cold in children and adults.

In the interim, given the known side effects of ipecacuanha, and the risk of significant harm in overdose, the Committee considered that despite its long history of use at a general sale level, the safe use of the product required access to professional advice in excess of that which could be delivered by a product label.

Ipecacuanha - recommendations

• That ipecacuanha should be reclassified from general sale medicine to pharmacy-only medicine for the treatment of the symptoms of cough and cold in children aged 6-12 years.
• That Medsafe should consider a safety review of ipecacuanha to determine if the benefits of treatment as a cough and cold medicine outweigh the risks associated with its toxicity.

Phenylephrine

Phenylephrine - recent history of scheduling decisions

At the 30th meeting on 26 November 2003 the Committee recommended that there be no change to the current classification of phenylephrine. At the 32nd meeting 25 November 2004 the Committee recommended that phenylephrine for oral use should be a general sale medicine in products containing 50 mg or less per recommended daily dose for consumers less than 65 years of age. Products recommending higher doses for use by the elderly should be pharmacy-only medicines.

Phenylephrine is currently classified as:

• prescription medicine; except when specified elsewhere in this schedule
• pharmacy only medicine; for nasal use in medicines containing more than 1%; for ophthalmic use in medicines containing 5% or less and more than 1%; for oral use in medicines containing more than 50 mg per recommended daily dose or in packs containing more than 250 mg of phenylephrine per pack
• general sale medicine; for nasal or ophthalmic use in medicines containing 1% or less; for oral use in medicines containing 50 mg or less per recommended daily dose and in packs containing 250 mg or less of phenylephrine per pack.

Committee consideration of phenylephrine against scheduling criteria

Consumer convenience

The Committee considered that there was a case for allowing some cough and cold medicines intended for use in children 6-12 years of age to be available from general sale outlets. It was noted that the appropriate level of consumer convenience however was determined by the overall risk-benefit of the medicine. Limiting the sale of a product to a pharmacy on safety grounds would allow a consumer access to information and advice, and this was a legitimate reason for marginally reducing access. It was noted that other decongestant medicines, including topical agents (nose drops), were currently classified as pharmacy-only medicines in New Zealand and several other jurisdictions.

Potency

Phenylephrine is a sympathomimetic agent which has mainly direct alpha-agonist properties. It produces its therapeutic effect by interacting with the same receptors as pseudopehedrine and oxymetazoline, other decongestant medicines that are scheduled as pharmacy-only or restricted medicines. It is absorbed orally and through mucosal surfaces.

In bench test studies, phenylephrine is a less potent sympathomimetic than pseudoephedrine and its effects are shorter acting. While debate continues as to whether these differences are clinically significant, as there are few contemporary head-to head studies of the two agents when used over a period of time, it is generally accepted that phenylephrine is a clinically effective decongestant.

As phenylephrine has been available for a long period of time, there are no contemporary studies examining its safety or efficacy in children of any age.

Current availability

Phenylephrine has been substituted for pseudoephedrine in a large number of cough and cold medicines due to concerns about use of pseudoephedrine to manufacture methamphetamine. Phenylephrine cannot be converted into methamphetamine. As phenylephrine is often included in combination products containing other cough and cold medications, products containing phenylephrine are available across several schedules from general sale to restricted medicine.

Therapeutic index

As with many of the medicines used in the treatment of cough and cold, there is no evidence available to support the minimum dose of phenylephrine that is effective in children. However, although many of the side effects of phenylephrine are dose related, there is evidence in adults that the dose of phenylephrine required to increase blood pressure is significantly greater than that contained in other decongestant medicines.

Toxicity

It was noted that the side effect profile of phenylephrine was well described in the literature. Use of phenylephrine is contraindicated in patients:

1. who have taken a monoamine oxidase inhibitor in the last two weeks
2. with severe hypertension or coronary artery disease
3. with narrow-angle glaucoma
4. with stenosing peptic ulcer
5. with symptomatic prostatic hypertrophy
6. with bladder neck obstruction
7. with pyloroduodenal obstruction
8. under six years of age
9. who are lactating
10. who are pregnant
11. with severe hyperthyroidism.

Use of phenylephrine can produce a number of side effects the most serious being effects on the cardiovascular system including hypertension, pulmonary oedema and arrhythmias in both adults and children. There are also case reports of phenylephrine interacting with some older antihypertensive medications leading to raised blood pressure.

Abuse potential

There is no evidence that phenylephrine has any potential for abuse, however it is well recognised that rebound nasal congestion can occur following stopping use of phenylephrine. These phenomena can sometimes lead to unnecessary chronic use of the medicine.

Inappropriate use

It was noted there was scope for inappropriate use of phenylephrine to treat other medical conditions e.g. abuse as a weight loss product.

Precautions

The Committee considered that the contraindications for use of phenylephrine, and the known side effects of the medicine, would be best addressed through a consumer having access to professional advice.

Communal harm

It was considered there was limited potential for phenylephrine to cause communal harm.

Phenylephrine - conclusions

The Committee's overall risk-benefit assessment of phenylephrine was that the safe and quality use of the medicine in children aged 6-12 years could be improved by providing parents with point of sale access to information and advice about the use of phenylephrine to treat cough and cold. The lack of evidence of benefit in this age group and the known contraindications were key to the Committee reaching this conclusion.

It was considered that the risk-benefit assessment of phenylephrine was not significantly different from that of any of the other decongestant sympathomimetic medicines available in New Zealand. The Committee therefore did not support treating phenylephrine differently from these other medicines.

It was noted that the risk of phenylephrine associated adverse effects and interaction with other medications is greater in the adult population than in children. The Committee therefore had concerns about phenylephrine for adult use being available from general sale outlets.

Phenylephrine - recommendations

• That phenylephrine should be reclassified from general sale medicine to pharmacy-only medicine for the treatment of the symptoms of cough and cold in children aged 6-12 years.
• That a proposal to reclassify phenylephrine to a pharmacy-only medicine for the treatment of the symptoms of cough and cold in adults and children over 12 should be added to the agenda of the next meeting.

Secretary's note
As part of the briefing provided to the Minister of Health, to allow him to make a decision about the recommendations of the Committee, Medsafe suggested alternate advice with respect to several of the recommendations about the appropriate classification of cough and cold medicines.

The Minister of Health has accepted the Committee's advice that:

1. dextromethorphan, ipecacuanha and phenylephrine should be reclassified from general sale medicines to pharmacy-only medicines for the treatment of the symptoms of cough and cold in children aged 6-12 years
2. the current classification for guaiphenesin remained appropriate.

The Minister has rejected the Committee's recommendations that:

1. a proposal to reclassify dextromethorphan and phenylephrine to pharmacy-only medicines for the treatment of the symptoms of cough and cold in adults and children over 12 should be added to the agenda of the next meeting
2. Medsafe should consider a safety review of ipecacuanha to determine if the benefits of treatment as a cough and cold medicine outweigh the risks associated with its toxicity.

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

6.3 Flurbiprofen 8.75 mg lozenges
(Strepfen, Reckitt Benckiser (New Zealand) Ltd)

Purpose

This was a company submission for the reclassification of flurbiprofen 8.75 mg lozenges from pharmacy-only medicine to general sale medicine for the relief of pain, swelling and inflammation associated with severe sore throats.

Background

Flurbiprofen was classified as a prescription medicine in 1997. At the 19th meeting on 20 May 1998 the Committee recommended that flurbiprofen should be reclassified from prescription medicine to restricted medicine when contained in throat lozenges containing 10 mg or less of flurbiprofen per lozenge. At the 28th meeting on 19 November 2004 the Committee recommended that flurbiprofen should be reclassified from restricted medicine to pharmacy-only medicine when in throat lozenges containing 10 mg or less per lozenge.

Flurbiprofen is currently classified as:

• prescription medicine;except in throat lozenges containing 10 mg or less per lozenge
• pharmacy-only medicine; in throat lozenges containing 10 mg or less per lozenge.

The Committee noted that a submission for the reclassification of flurbiprofen lozenges had also been made to the Australian National Drugs and Poisons Schedule Committee for consideration at their 58th meeting on 16-18 February 2010.

Submissions

Two pre-meeting comments had been received during the consultation period and neither supported the proposal. One interested body commented that the proposed reclassification posed a risk to patients who self select multiple products for multiple conditions, for example patients with a history of peptic ulcers who self select multiple products containing non-steroidal, anti-inflammatory components. The other commented that pharmacy staff should be involved in the consultation and recommendation to sell the product. Pharmacy-only medicine is the least restrictive classification for a medicine while retaining the display and sale within the environment of a pharmacy.

Discussion

The Committee expressed concern about the reclassification of flurbiprofen lozenges to general sale medicines as the product dose form looked more like a lolly than a non-steroidal medicine. The Committee were concerned that the dose form, presentation and packaging proposed for this product (Strepfen) would make it difficult for consumers to differentiate it from the Strepsils product which contains simple sugars and flavouring agents. Such confusion could lead to consumers with contraindications to the consumption of a non-steroidal medicines inadvertently taking flurbiprofen.

The Committee considered that it could be possible to manage the risk of inappropriate use through labelling of the product. The Committee therefore reviewed in detail the current label. The Committee noted from the proposed packaging that the font size for the flavour of the lozenge, honey and lemon, was bigger than that for the active ingredient (flurbiprofen). In addition, the picture of the lozenge on the pack and the packaging in general looked very similar to the packaging of Strepsils. The Committee considered that the current packaging did not adequately address the risk of inadvertent use.

It was considered that the applicant would need to provide data from consumer testing indicating that consumers could clearly differentiate and understand the differences between Strepfen and Strepsils before it would be comfortable considering reclassification of flurbiprofen in this product.

Recommendation

• That the current classification of flurbiprofen remained appropriate.
• That the reclassification of flurbiprofen 8.75 mg lozenges from pharmacy-only medicine to general sale medicine for the relief of pain, swelling and inflammation associated with severe sore throats would be reconsidered if the company provided:
  • data confirming that consumers clearly differentiated and understood the differences between Strepfen and cough and cold un-medicated preparations such as Strepsils.

6.4 Loperamide 2 mg caplets and capsules
(Imodium, Johnson & Johnson Pacific)

Purpose

This was a company submission for the reclassification of loperamide 2 mg caplets or capsules, when sold in packs containing not more than eight, from pharmacy-only medicine to general sale medicine for the symptomatic treatment of acute non-specific diarrhoea.

Background

At the 1st meeting on 13 November 1984 the Committee supported an application to change the classification of loperamide and its salts from restricted medicine to pharmacy-only medicine.

Loperamide is currently classified as:

• prescription medicine; except when specified elsewhere in this Schedule
• pharmacy-only medicine; in packs containing not more than 20 tablets or capsules.

Submissions

Two pre-meeting comments had been received during the consultation period and neither supported the proposal. One interested body commented that although diarrhoea is a common ailment it can escalate to a potentially serious condition if not managed appropriately, i.e. by determining the actual cause. In addition, there was no control to prevent patients purchasing large amounts through multiple packs; requests for multiple packs would be questioned in a pharmacy. The other commented that consumers needed to be reminded of a medical referral where appropriate.

Discussion

It was noted that the safety of the product was derived to some extent from the proposed limited pack size of eight caplets or capsules. The Committee noted that if reclassified to general sale medicine, there were no restrictions at the retail level, other than cost, preventing a consumer from purchasing multiple packs.

The Committee had some concern that retail sale could lead to inappropriate long-term use of loperamide. However, it was noted the Periodic Safety Update Reports submitted showed loperamide was widely available and used overseas at the general sale level. Also that its use was not associated with reports of significant harm.

The Committee suggested that the safe use of the product could be further enhanced by adding warning statements on the label, for example do not take for over 24 hours without seeking advice from a healthcare practitioner and if symptoms persist for more than 48 hours see a Doctor, or words of similar meaning.

The Committee also discussed the concern that reclassification of loperamide could lead to inappropriate use of the product in occupations where individuals with a diarrhoeal illness should be temporarily excluded e.g. food handling. The Committee considered that this issue could be addressed by inclusion of general advice about hydration and hygiene if suffering from diarrhoea.

The Committee concluded that with appropriate labelling the safety profile of loperamide supported its reclassification to general sale medicine for the symptomatic treatment of acute non-specific diarrhoea.

Recommendation

• That loperamide should be reclassified from pharmacy-only medicine to general sale medicine in divided solid dosage forms for oral use containing 2 mg or less of loperamide when sold in a pack containing not more than eight approved by the Minister or the Director-General for distribution as a general sale medicine, for the symptomatic treatment of acute non specific diarrhoea.
• That the label should include the following warning statements, or words of similar meaning:
  1. do not take for over 24 hours without seeking advice from a healthcare practitioner
  2. if symptoms persist for more than 48 hours see a Doctor.
• That the product information to be inserted into the pack should include advice on:
  1. checking with an employer if diarrhoea may put others in the workplace at risk
  2. hand washing and hygiene
  3. hydration (in addition to what is already provided)
  4. recognising dehydration.

6.5 Minoxidil 5% solution
(Regaine for men, Johnson & Johnson Pacific)

Purpose

This was a company submission for the reclassification of minoxidil 5% solution from pharmacy-only medicine to general sale medicine for the treatment of androgenetic alopecia (common baldness) in healthy men and women. Regaine was previously known as Rogaine.

Background

At the 7th meeting on 1 August 1990 the Committee recommended that minoxidil, in medicines for external use, should be classified as a Part I pharmacy medicine. At the 11th meeting on 29 June 1993 and 20th meeting on 19 November 1998 the Committee recommended that there should be no change to the restricted medicine classification of minoxidil for topical use. At the 22nd meeting on 10 November 1999 the Committee recommended that 2% minoxidil should not be reclassified from restricted medicine to general sale medicine and that the company should be invited to make concurrent submissions to the Committee for reclassification to pharmacy-only medicine. An objection was received regarding this recommendation and at the 23rd meeting on 25 May 2000 the Committee recommended that there be no change to the restricted medicine classification of topical products containing 2% minoxidil. At the 27th meeting on 23 May 2002 the Committee recommended that minoxidil topical preparations containing 5% or less should be reclassified from restricted medicine to pharmacy-only medicine.

The concerns raised by the Committee at the 22nd meeting on 10 November 1999 were addressed in the submission.

Minoxidil is currently classified as:

• prescription medicine; except for dermal use in medicines containing 5% or less
• pharmacy-only medicine; for dermal use in medicines containing 5% or less.

Submissions

Two pre-meeting comments had been received during the consultation period and neither supported the reclassification change. One suggested that there would be an increased risk of patients self-selecting and self-treating their condition without the professional advice that the product requires. In addition, that without professional advice the risks associated with over use or incorrect use may increase considerably especially in those patients who are hypersensitive to minoxidil. The other commented that restricting its sale to pharmacies ensures necessary intervention with the patient in the purchase process.

Discussion

A number of safety concerns were raised by the Committee including the issue of the need to monitor blood pressure during treatment. The Committee noted that the patient information supplied with the application continued to refer to the need for pharmacists or medical practitioner advice prior to and following commencement of treatment with minoxidil. The Committee also noted that the product information for minoxidil in the United Kingdom and in New Zealand stated that the cardiovascular side effects of minoxidil occurred more commonly in patients with pre-existing cardiovascular disease, and that patients should be specifically advised of these risks before commencing use of the medicine. However the material provided in the application did not include this advice.

The Committee recognised that the list of side effects of minoxidil was large and included a number of serious and significant conditions such as heart rhythm disturbance, fluid retention, worsening of angina and hypotension.

Despite these known side effects, the Committee were satisfied that the side effect profile of topical minoxidil was acceptable for a product available for general sale.

However, the Committee concluded they could not support the application for reclassification of minoxidil as they were not satisfied that the product packaging and labelling provided the appropriate information to allow a consumer to manage the risks of minoxidil at the general sale level.

Recommendation

• That there be no change to the current classification of minoxidil as a pharmacy-only medicine; for dermal use in medicines containing 5% or less.
• That the reclassification of minoxidil 5% solution from pharmacy-only medicine to general sale medicine for the treatment of androgenetic alopecia (common baldness) in healthy men and women would be reconsidered if the company provided improved labelling appropriate for a general sale classification.

6.6 Rizatriptan 5 mg wafers
(Maxalt, Merck Sharp & Dohme (New Zealand) Limited)

Purpose

This was a company submission for the reclassification of rizatriptan 5 mg wafers from prescription medicine to restricted medicine for the acute treatment of migraine with or without aura. Forty references were provided in support of the reclassification change.

Background

Rizatriptan is currently classified as prescription medicine.

Submissions

Two pre-meeting comments had been received during the consultation period and both were in support of the reclassification change. One stated it was important that patients experiencing migraines have quick convenient access to the medicine, where as presenting at a doctor's delays this. It was also commented that pharmacists are readily accessible and have the skills to manage, treat or refer patients where appropriate. The other highlighted that the reclassification would bring rizatriptan in line with two other triptans - sumatriptan and zolmitriptan.

Discussion

The Committee considered that the safety profile of rizatriptan was not significantly different from that of the other triptan medicines it had recently considered and recommended for reclassification. It was noted that as nausea and vomiting often accompany migraine, the availability of a medicine as a wafer offers advantages to patients over tablets or capsules. The Committee agreed that consumer convenience was enhanced if a range of similar medicines were available at the same classification.

The Committee had some concern that the product information did not provide clear advice on the maximum dose that can be taken to treat a single headache, and considered that the triptan family of medicines should all include advice that chronic use can result in rebound headache.

Recommendation

• That rizatriptan 5 mg wafers should be reclassified from prescription medicine to restricted medicine for the acute treatment of migraine with or without aura.
• That Medsafe should be satisfied the concerns raised by the Committee during discussion have been dealt with in the educational material developed by the company.

7 NEW MEDICINES FOR CLASSIFICATION

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

7.1 Roflumilast (Daxas film coated tablet, 500 μg)

Roflumilast is a phosphodiesterase-4 inhibitor, a non-steroid, anti-inflammatory agent designed to target both the systemic and pulmonary inflammation associated with chronic obstructive pulmonary disease.

Daxas is presented as an immediate-release film-coated tablet intended for once-daily oral administration. It is indicated for the maintenance treatment of chronic obstructive pulmonary disease associated with chronic bronchitis in patients at risk of exacerbations.

Recommendation

That roflumilast should be classified as a prescription medicine.

7.2 Saxagliptin (Onglyza film coated tablet 2.5 mg)

Saxagliptin is an oral hypoglycaemic of the dipeptidyl peptidase-4 inhibitor class of drugs.

Onglyza is used with diet and exercise to control hyperglycaemia in adults with type 2 diabetes. It lowers blood sugar by helping the body increase the level of insulin after meals.

Recommendation

That saxagliptin should be classified as a prescription medicine.

7.3 Tapentadol hydrochloride (Palexia PR, 50 mg, 100 mg, 150 mg, 200 mg and 250 mg modified release tablets and Palexia IR, 50 mg 75 mg and 100 mg film coated tablets)

Tapentadol hydrochloride is a centrally acting analgesic agent. It has been pharmacologically characterised as both a mu-opioid receptor agonist and an inhibitor of norepinephrine reuptake. A tapentadol immediate-release tablet formulation has been developed for the relief of acute pain and a tapentadol prolonged-release tablet formulation has been developed for the relief of chronic pain.

The applicant company submitted an Assessment of Abuse Potential, January 2010. In the submission to the Committee it was suggested the appropriate schedule for tapentadol would be Controlled Drug B3.

The Secretary had forwarded the Assessment of Abuse Potential to the Expert Advisory Committee on Drugs for their consideration. The Expert Advisory Committee on Drugs conducts reviews of controlled drugs and other narcotic or psychotropic substances, and recommends to the Minister of Health whether and how such substances should be classified. The Committee agreed that because tapentadol had yet to be classified by the Expert Advisory Committee on Drugs it should be classified as a prescription medicine.

Recommendation

That tapentadol should be classified as a prescription medicine.

7.4 Vernakalant hydrochloride (Vernakalant concentrate for infusion,20 mg/mL)

Vernakalant hydrochloride is a crystalline, white to beige powder with a relative molecular mass of 385.93 g/mol. It is soluble (276 - 496 mg/mL) in aqueous solutions throughout the pH range of 1.0 to 13.0. Vernakalant is supplied as concentrate for solution for infusion (sterile concentrate). It is a clear and colourless to pale yellow solution with a pH of approximately 5.5. Each mL of concentrate contains 20 mg of vernakalant hydrochloride, which is equivalent to 18.1 mg of vernakalant free base.

Vernakalant is an anti-arrhythmic medicine with relative atrial selectivity. It is indicated for the rapid conversion of recent onset atrial fibrillation (≤7 day's duration) to sinus rhythm.

Recommendation

That vernakalant should be classified as a prescription medicine.

7.5 Vinflunine (Javlor concentrate for injection, 25 mg/mL)

Vinflunine is an antineoplastic drug and a representative compound of the family of vinca alkaloids. It is a novel microtubule inhibitor which binds to tubulin at or near to the vinca binding sites inhibiting its polymerisation into microtubules which results in treadmilling suppression, disruption of microtubule dynamics, mitotic arrest and apoptotic cell death.

Javlor is a sterile aqueous solution intended for dilution with a suitable parenteral fluid (sodium chloride 0.9% solution or glucose 5% solution) and is administered as an intravenous infusion. The proposed indication for Javlor is as monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen.

Recommendation

That vinflunine 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 Magnesium sulfate

Magnesium sulfate is available as Epsom salts in the heptahydrate complex. In April 2008, the Adverse Drug Reactions Advisory Committee in Australia concluded that there was considerable risk to consumers from a 950 mg dried magnesium sulfate preparation, indicated for the relief of occasional constipation. The Australian National Drugs and Poisons Schedule Committee decided to include an entry for magnesium sulfate, for human therapeutic use in divided oral preparations except when containing 1.5 g or less of magnesium sulfate per recommended daily dose, in Schedule 3 (restricted medicine).

It was recognised that this agenda item had the potential to affect dietary supplements in New Zealand that included magnesium sulphate.

The Committee were concerned that Medsafe had not received any submissions about this agenda item as it could indicate that the Dietary Supplement sector in New Zealand was unaware of this proposal. The Committee was not prepared to discuss the proposal further until it was satisfied that the non-pharmaceutical sector had been given the opportunity to make submissions. To allow further consultation to occur the Committee supported foreshadowing the classification of magnesium sulfate as a restricted medicine as a separate agenda item for the next meeting of the Committee. It was agreed that this classification would be added to the agenda of the next meeting to allow the sector time to submit data on whether there is a significant risk of harm.

Recommendation

• That the discussion of whether magnesium sulfate in divided oral preparations except when containing 1.5 g or less of magnesium sulfate per recommended daily dose should be added to the New Zealand Schedule as a restricted medicine be included in the agenda of the next meeting.
• That Medsafe should write to the peak body of the sector (Natural Products NZ) asking them to inform their members of the Committees' interest in magnesium sulphate.

8.1.2 Nabiximols

Cannabidiol is a cannabinoid found in Cannabis sativa. Cannabidiol was reputed to have analgesic, anticonvulsant, muscle relaxant, anxiolytic, neuroprotective, anti-oxidant and anti-psychotic activity. Nabiximols are a specific extract of Cannabis sativa. The Australian National Drugs and Poisons Schedule Committee decided to create a new entry for nabiximols, including a list of cannabinoids present, in the form of a buccal spray for human therapeutic use, in Schedule 8 (controlled drug).

One pre-meeting comment had been received during the consultation period. It highlighted that nabiximols may already be scheduled under the Misuse of Drugs Act 1975 within the cannabis entries as a Schedule 2 controlled drug. Medsafe confirmed that the main chemical constituent of nabiximols is the cannabinoid, delta-9-tetrahydrocannabinol. These are scheduled under Schedule 2, Class B controlled drugs:

Tetrahydrocannabonols; except when contained in a Class C controlled drug.

A recommendation was therefore not required regarding nabiximols because it is already classified under the Misuse of Drugs Act 1975.

Recommendation

No recommendation was required.

8.1.3 Nebivolol

Nebivolol is a long-acting cardioselective beta-blocker. The Australian National Drugs and Poisons Schedule Committee decided to include nebivolol in Schedule 4 (prescription medicine).

The Committee agreed to harmonise and concluded that nebivolol should be classified as a prescription medicine.

Recommendation

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

8.1.4 Red yeast rice

Red yeast rice is a reddish purple fermented rice. When produced using certain strains of Monascus purpureus it contains quantities of pharmacologically active substances, including monacolins, which can inhibit HMG-CoA reductase. Lovastatin (also known as monacolin K) is one of the more potent monacolins found in red yeast rice, and it has been developed as a pharmaceutical medicine. The United States Food and Drug Administration, and several other regulators, have approved products containing lovastatin to treat hypercholesterolaemia. Lovastatin is classified as a prescription medicine in these countries. In view of the known pharmacological activity of lovastatin, the Australian National Drugs and Poisons Schedule Committee recently created an entry for red yeast rice, for human therapeutic use, in Schedule 4 (prescription medicine).

The Committee considered harmonising with the above classification at the 42nd meeting and agreed to delay making a recommendation until further information on the indications and side effect profile of red yeast rice extract, which contains lovastatin, and a literature review of lovastatin, could be considered.

The harmonisation was considered now that the following further information had been provided by Medsafe:

1. prescribing information for mevacor, an approved medicine in the United States which contains lovastatin as the active ingredient, which provided an overview of the safety profile and pharmacology of lovastatin
2. an evaluation of a red yeast rice containing complementary medicine (cholesen) conducted by the Australian Therapeutic Goods Administration in 2008 which contained an overview of the posology of red yeast rice products, and the safety profile of red yeast rice and lovastatin
3. a report regarding choleson clinical studies, dated February 2008
4. a memorandum providing a review of lovastatin for the period from 1 February 2008 to 30 January 2010.

The side effect profile and literature review of lovastatin, covering the period 1 February 2008 to 30 January 2010, supported scheduling all HMG-CoA reductase inhibitors as a class entry in harmony with the Australian Schedule 4 (prescription medicine). The World Health Organisation side effect profile suggested that lovastatin should be classified as a prescription medicine (as in the United States) in the same way as other statins in New Zealand. The literature review confirmed that foods and dietary supplement products sold on the basis of their lovastatin content, such as red yeast rice and oyster mushrooms, may contain sufficient lovastatin to warrant coverage by such a class entry.

A previous Committee member had passed on a paper, dated 28 October 2009, entitled "Red yeast rice and hyperlipidemia; how strong is the evidence?" from the Medscape Family Medicine, Best Evidence Review. The review made a number of conclusions:

1. treatment with statins is associated with a reduction in cardiovascular risk, even among low-risk patients
2. there are variable estimates with regard to the prevalence of myopathy among statin users, and there is no consensus about the best means to treat statin-associated myopathy
3. previous research found that red yeast rice is significantly superior to placebo in the treatment of hyperlipidemia
4. in the current study which focused on patients with a history of statin-induced myopathy, red yeast rice was effective in reducing total and LDL cholesterol values effectively and safety.

The level of lovastatin (also known as monacolin K), present in red yeast rice products is known to be in excess of 10 mg/kg (the New Zealand cut-off for exemption from scheduling). The Committee noted that there had been no submissions from the Dietary Supplements sector on this reclassification proposal despite several products being sold in New Zealand. Once again the Committee were concerned that the agenda item had not been identified by the relevant sector of the industry and that a decision to reclassify could have unexpected consequences.

The Committee therefore discussed foreshadowing the classification of red yeast rice which contained 10 mg/kg or more of lovastatin as a prescription medicine. While the Committee agreed there was sufficient data to schedule lovastatin as a prescription medicine, the Committee encouraged the sector to submit information to allow it to consider whether the normal 10 mg/kg exemption from scheduling should be applied or whether there is evidence to support the safe use of lovastatin at a concentration above this point.

Recommendation

• That a proposal to classify red yeast rice, which contains 10 mg/kg or more of lovastatin (monacolin K), as a prescription medicine, be added to the agenda of the next meeting.
• That Medsafe request the peak body of the natural health care products sector (Natural Products NZ) to inform its members of this proposal and ask that they submit information on the effect of the proposal on products containing red yeast rice.

8.1.5 Ustekinumab

Ustekinumab is a human monoclonal antibody directed against the p40 protein subunit which forms part of the structure of both interleukin-12 (IL-12) and interleukin-23 (IL-23). It acts by inhibiting the binding of these two cytokines to cell surface receptors. IL-12 and IL-23 were thought to have a crucial role in the pathogenesis of psoriasis, the most common adult immune skin disease. The Australian National Drugs and Poisons Schedule Committee decided to include Ustekinumab in Schedule 4 (prescription medicine).

The Committee agreed to harmonise and concluded that ustekinumab should be classified as a prescription medicine.

Recommendation

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

8.1.6 Vaccinia virus vaccine

The vaccinia virus is the live virus used in the smallpox vaccine. It is a pox-type virus related to smallpox and when given to humans as a vaccine it helps the body to develop immunity to smallpox. The Australian National Drugs and Poisons Schedule Committee decided to include vaccinia virus vaccine in Schedule 4 (prescription medicine).

The Committee noted that by default, as it was a vaccine, vaccinia virus vaccine would be classified as a prescription medicine. However, it was agreed to harmonise and that a specific entry would be included in the Schedule for vaccinia virus vaccine. This would also align with the Committee's previous recommendations regarding vaccines in Agenda Item 5.3.

Recommendation

That vaccinia virus vaccine should be added to the New Zealand Schedule as a prescription medicine.

8.2 Recommendations made by the National Drugs and Poisons Schedule Committee to the Medicines Classification Committee

8.2.1 56th Meeting on 16-17 June 2009

a. HMG-CoA Reductase Inhibitors (Statins)

The Australian National Drugs and Poisons Schedule Committee considered scheduling HMG-CoA reductase inhibitors (statins) as a class entry. They reduce cholesterol by stimulating an increase in low-density-lipoprotein-receptors (LDL) on hepatocyte membranes, thereby increasing the clearance of LDL from the circulation. The Australian National Drugs and Poisons Schedule Committee agreed to include an entry for all HMG-CoA reductase inhibitors in Schedule 4 (prescription medicine) of the Australian Standard for the Uniform Scheduling of Drugs and Poisons.

At the 57th meeting in October 2009 the Australian National Drugs and Poisons Schedule Committee considered post-meeting submissions following the June 2009 resolution to include a class entry. It was decided to vary the June 2009 resolution to clarify that the class entry applied to all HMG-CoA reductase inhibitors which included, but was not limited to, statins.

One pre-meeting comment had been received during the consultation period. The same comment had been received at the 42nd meeting on 3 November 2009 which was not in support of a class entry in the Schedule.

The Committee noted that the safety profile of the statins is largely dose dependant and varies from statin to statin. The Committee were also concerned that introducing a class entry for an effect on a receptor could lead to food stuffs, as well as medicines, being classified. The Committee decided it should take its previous experience, with respect to its management of classification of PDE-5 inhibitors, into consideration of the proposal to harmonise with Australia. At the end of this process the Committee concluded it could not recommend inclusion of a class entry for HMG-CoA reductase inhibitors in the Schedule.

Recommendation

That New Zealand should not include a class entry for HMG-CoA reductase inhibitors as a prescription medicine.

b. Succimer

The Australian National Drugs and Poisons Schedule Committee considered the scheduling of succimer. It is used in the treatment of lead poisoning as it forms water-soluble chelates with heavy metals. Succimer has also been used to treat arsenic and mercury poisoning. The Australian National Drugs and Poisons Schedule Committee decided to include an entry for succimer in Schedule 4 (prescription medicine) of the Australian Standard for the Uniform Scheduling of Drugs and Poisons.

The Committee considered and agreed in harmonising with the above classification. As a prescription medicine a doctor would take responsibility for prescribing.

It was noted that Medsafe was not aware of any products currently marketed in New Zealand that contained succimer.

Recommendation

That succimer should be added to the New Zealand schedule as a prescription medicine.

8.2.2 57th Meeting on 20-21 October 2009

The Australian National Drugs and Poisons Schedule Committee considered the scheduling of the substances listed in Agenda Item 8.1 in the Australian Standard for the Uniform Scheduling of Drugs and Poisons.

The Committee noted that, following the 57th Meeting, the Australian National Drugs and Poisons Schedule Committee did not harmonise with New Zealand regarding:

1. guaiphenesin - remained a Schedule 4 (prescription medicine) entry
2. zolmitriptan - remained a Schedule 4 (prescription medicine) entry
3. benzocaine - the item was withdrawn prior to the meeting.

9 FOR THE NEXT MEETING

Items from this meeting that may be considered at the next meeting were:

1. ginkgo biloba (agenda item 5.2)
2. dextromethorphan and phenylephrine when sold as general sale medicines to either restricted or pharmacy-only medicines for the treatment of the symptoms of cough and cold in adults and children over 12 years of age (agenda item 6.2)
3. a safety review of ipecacuanha to determine if the benefits of treatment as a cough and cold medicine outweigh the risks associated with its toxicity (agenda item 6.2)
4. flurbiprofen 8.75 mg lozenges (agenda item 6.3)
5. minoxidil 5% solution (agenda item 6.5)
6. magnesium sulfate (agenda item 8.1.1)
7. red yeast rice (agenda item 8.1.4).

10 GENERAL BUSINESS

There were no items of general business.

11 DATE OF NEXT MEETING

To take place on a Tuesday in October 2010. The Committee agreed to email their availability to the Secretary.

There being no further business, the Chair thanked members and guests for their attendance and closed the meeting at 2:30pm.