Revised: 23 May 2013

Committees

Minutes of the 24th meeting of the Medicines Classification Committee - 2 November 2000

Held in the Medsafe Conference Room, 18th Floor, Grand Plimmer Tower, 4-6 Gilmer Terrace, Wellington. Commencing at 9:30am.

Present

Dr S Jessamine (Chair)
Ms F Hughes
Dr T Bevin
Dr G Wardrope
Mr B McKone
Ms A Shirtcliffe
Mrs C Smith ( Secretary)

In attendance

Dr B Priestly (Australian National Drugs and Poisons Schedule Committee)
Dr N Rafter, Medsafe

The meeting opened at 9:35am

1 WELCOME

Dr Jessamine welcomed to the meeting Dr Brian Priestley from the Australian National Drugs and Poisons Schedule Committee (NDPSC). He also welcomed Ms Frances Hughes, new Ministry of Health member and Ms Andrea Shirtcliffe, new member nominated by the Pharmaceutical Society of New Zealand.

Each attendee spoke briefly about his or her background and experience by way of introduction.

2 APOLOGIES

There were no apologies

3 CONFIRMATION OF THE MINUTES OF THE TWENTY-THIRD MEETING

The minutes of the twenty-third meeting were confirmed as an accurate record of the meeting and were signed by the Chairman.

The Chairman explained for the benefit of new members that minutes of meetings had been published on the Medsafe website over the past year. He told the Committee that, in the interest of transparency, other ministerial advisory committees serviced by Medsafe were also moving towards publishing on the website. Medsafe had also requested that, from this current meeting, companies making submissions for reclassification should submit their material in both paper and electronic form. Companies had been agreeable to this and company submissions were now published on the website together with Medsafe reports as part of the consultation process. The availability of this information would enable those wishing to comment on submissions to understand the view expressed in the submission and also the view taken by Medsafe. This approach was seen as providing for all interested parties a clearer understanding of the issues to be addressed and allowing a maximum degree of transparency for the classification process.

4 DECLARATION OF CONFLICT OF INTERESTS

The Chairman briefly outlined the new Ministry of Health Conflict of Interest Protocol for Statutory Bodies and other Committees. Members had been provided with this document as part of the revised Members’ Handbook.

There was some brief discussion.

Dr Jessamine pointed out that, in the case of technical advisory committees, it was often those with the most expertise who were likely to have a conflict of interest. While he was not aware of a case where a member of one of the advisory committees serviced by Medsafe had been excluded from discussion due to a conflict of interest, he thought there could be occasions when it was inappropriate for a member to vote. He concluded that a declared conflict of interest could be regarded as being of value rather than as a disadvantage.

No member was aware of a conflict of interest which could be considered prejudicial to any of the recommendations to be made at the twenty-fourth meeting.

5 MATTERS ARISING

5.1 Objections to recommendations made at the 23rd meeting

5.1.1 Nicotine

Objections to the recommendation to reclassify nicotine in chewing gum and transdermal patches to general sale medicine had been received from Pro-Health Products Ltd, sponsor for Nicobrevin and, jointly, from the Pharmaceutical Society and the Pharmacy Guild. The objections had not met the criterion for objections in that they had not been based on new safety data not available to the Committee at the time the recommendation was made. Copies of the letters of objection and the replies were provided for the Committee but it was not considered necessary to reconsider the recommendation made at the previous meeting.

It was noted that the Health Funding Authority initiative to fund certain smoking cessation products was a separate issue from the level of access afforded by reclassification.

5.1.2 Phenazopyridine

Douglas Pharmaceuticals had requested that the reclassification of phenazopyridine from pharmacy-only to prescription medicine be postponed until the Committee had studied relevant safety data. The recommendation to harmonise with Australia at a more restrictive classification was based on there being no products containing phenazopyridine registered in either country. However, the company reported that it was in the process of preparing a product for the New Zealand over-the-counter (OTC) market. Under these circumstances, Medsafe thought it was fair for the Committee to consider whether or not the more restrictive classification was appropriate and the company was asked to supply safety data.

The Committee felt that this medicine was not particularly effective in the treatment of urinary tract infection and was not sure that it fitted the criteria for OTC sale. However, it was agreed that, in order to gain consent to market, the company would need to demonstrate both safety and efficacy. Members thought that a recommendation on the classification of phenazopyridine should be deferred until the Committee was able to consider the safety data supplied by the company with its application for consent to market.

The company had provided data comparing phenazopyridine with flavoxate. As flavoxate was classified as a restricted medicine in both Australia and New Zealand, the Committee agreed that this should be taken into consideration at the time a final recommendation was made.

As there were no products containing phenazopyridine on the Australian market, any application for consent to market would be regarded as a new chemical entity and would enter the Australian market initially as a prescription medicine. Only after this could a request be made for rescheduling.

Recommendation

• That there be no change to the current pharmacy-only classification of phenazopyridine
• That the classification of phenazopyridine should be reconsidered as part of the evaluation process of any subsequent application for consent to market a product containing this substance
• That the Medsafe Evaluation Team should be notified of this recommendation in order to flag the Douglas application for consent to market a product containing phenazopyridine and to direct the application through the MCC as part of the evaluation process
• That the NDPSC be advised of the MCC recommendation not to harmonise at this point in time.

5.2 Other matters arising

5.2.1 Alclometasone

A recommendation had been deferred from the last meeting on whether or not a 0.05% alclometasone dipropionate cream or ointment in 30 gram packs should be reclassified from prescription medicine to restricted medicine pending further information from the company and the Dermatological Society. The NDPSC had already recommended in favour of the change. A response had been received from the Dermatological Society. The company had provided only a table of the comparative potency of alclometasone as listed in Martindale ¹ in further support of its submission.

As alclometasone dipropionate 0.05% and clobetasone butyrate 0.05% were considered to be of comparable potency, members agreed that the two should be considered together. For further discussion see agenda item 6.b.

Recommendation

• That there should be no change to the current prescription medicine classification of topical alclometasone dipropionate
• That the NDPSC should be asked to reconsider its recent recommendation to make 0.05% alclometasone dipropionate available over the counter.

5.2.2 Desloratadine

This was a new chemical entity for which a classification had been deferred pending information from the Medicines Assessment Advisory Committee (MAAC) about its safety in comparison with that of loratadine. The MAAC had not found any significant problems with desloratadine. It was metabolised differently from loratadine and there were fewer potential problems for interactions with other medicines.

Members were happy that the safety profile was satisfactory for OTC sale but questioned whether there were precedents for classifying a new chemical entity as a pharmacy-only medicine without a preliminary period as a prescription medicine. It was noted that fexofenadine, a metabolite of terfenadine, had been given immediate pharmacy-only status. The Committee agreed to make a similar recommendation for desloratadine.

Recommendation

That desloratadine should be classified as a pharmacy-only medicine.

5.2.3 Salbutamol and terbutaline

The Committee was informed that although the intention had been that it should consider the possible reclassification of these substances at the current meeting, Medsafe had not had sufficient resources at its disposal to conduct the required consultation process within the time available and discussion of this agenda item had had to be postponed. It was agreed that the discussion should not be delayed further. The need for wide and comprehensive consultation was recognised. Members also recognised that there might be a need to take into account epidemiological issues which were particular to New Zealand.

The Committee was informed that the matter had been controversial in Australia and was due for discussion again in the near future but that Australia would wait until New Zealand had considered the matter before taking further action.

5.2.4 Theophylline and aminophylline

As the oral liquid forms of these medicines were less restrictively classified in New Zealand than in Australia, it was agreed that an independent review should be undertaken by a third party in order to determine a safe level of availability at which to harmonise. It was noted that the review covered theophylline only.

The review commissioned by Medsafe had been completed and copies had been forwarded to the NDPSC for consideration at its November meeting.

Members considered the material presented in the expert report which suggested that theophylline was not suitable for OTC sale. It was noted, however, that the report did not address the possibility of sale as restricted medicine. Nor did it differentiate between theophylline in higher doses for the treatment of asthma and low-dose preparations as bronchodilators in cough medicines. Some members questioned whether the scope of the paper was sufficiently broad to address the public health and safety issues required for classification recommendations.

The Committee acknowledged the narrow therapeutic window of theophylline and the potential for adverse effects but doubted that there was sufficient evidence to justify removing products from the OTC market.

Pharmacists agreed that products containing theophylline were sold in large volumes in winter months. There was discussion around whether or not products were effective at the levels contained in cough preparations, and whether adverse effects could be expected at these levels. While the expert report stated that adverse reactions including, cardiac arrhythmias, could occur within the therapeutic range, it also stated that these were not likely to be life-threatening with standard doses. The report also pointed out that theophylline had been available OTC for several decades which presumed that it had not been recognised as an important cause of adverse effects. However, the Committee recognised the difficulty obtaining reliable adverse reaction data about OTC products.

Overall, members felt that the information contained in the report did not justify the removal of cough products containing liquid theophylline from the OTC market. Because of the narrow therapeutic index, the potential safety concerns and the need for advice on the safe and effective use of the medicine, the Committee agreed that a restricted medicine classification would be appropriate. Members were inclined towards their earlier recommendation of a cut-off point of 2% for low-dose cough preparations and a prescription classification for higher concentrations for the treatment of asthma. New Zealand would then harmonise with Australia for cough preparations. Members felt that Australia should be asked to consider classifying liquid theophylline as a prescription medicine when indicated for the treatment of asthma. Liquid aminophylline should be regarded in the same way.

It was noted that no company responses had been received during the consultation process.

Recommendation

• That liquid oral theophylline and liquid oral aminophylline should be classified as restricted medicines in preparations containing 2% or less
• That medicines containing concentrations of liquid oral theophylline or liquid oral aminophylline greater than 2% should be classified as prescription medicines
• That the NDPSC should be recommended to reclassify concentrations of liquid oral theophylline and liquid oral aminophylline greater than 2% from S3 to S4.

6 SUBMISSIONS FOR RECLASSIFICATION

6.1 Beclomethasone (Beconase Hayfever, GlaxoWellcome)

A recommendation on this company submission had been deferred from the 21^st meeting pending further information about a suitable minimum age limit for its use. The current submission was for reclassification from restricted medicine to pharmacy-only medicine for seasonal allergic rhinitis including hayfever for adults 18 years and over.

The Committee agreed that there were two aspects to this submission, firstly, whether or not the medicine should move from restricted medicine to pharmacy-only medicine and, secondly, whether the minimum age restriction of 18 years on the sale of the product was appropriate and justifiable.

The level of access was discussed first. Members felt that the medicine was safe for sale as a pharmacy-only medicine if its use was over a short duration and it was the only steroid to be taken. They noted that there was no package information about use with other steroids. However, there was considerable concern about long-term and even year-round use of products. Pharmacists observed high sales volumes, particularly in the hay-fever season and not always for adults. While tablets still appeared to be the preferred option for consumers, nasal sprays were gaining in popularity and were likely to become a first-line treatment. Dramatic price reductions of nasal corticosteroids in recent times had made OTC purchase cheaper than obtaining products on prescription and had therefore removed a further element of control and initiated a change in behavioural patterns.

The Committee also considered the age restriction of 18 years which the company had proposed for the pharmacy-only product. Members immediately saw an anomaly in that a product could be sold as a restricted medicine to children over twelve years but that an identical product could be sold without pharmacist intervention only to consumers over 18 years of age if it were labelled as a pharmacy-only medicine. Pharmacists saw this as being difficult to monitor and preferred not to have to use an age limit as a means of determining who could purchase a product at a certain level of classification, particularly if the age restriction was different from the 12-year minimum age limit specified in the currently approved data sheet. Members did not feel that the Committee could justify the use of an age limit other than that specified in the approved data sheet as a tool for a change in the level of classification.

Consideration was given to the evidence provided by the company to support the proposed over-18-years age restriction. Only one study had been provided on growth velocity and the company had acknowledged the weaknesses of that study. The FDA had concluded that the evidence provided in the study was poor and that there was little or no risk of a reduction in growth velocity. Recent studies in the New England Journal of Medicine were reported as having been conducted mostly with higher doses of beclomethasone than those available for OTC use and having taken place over a period of more than one year. While some decrease in growth was noted it was transient, occurring only over the first year.

The Committee concluded that there were issues to be clarified regarding growth and that the whole area of growth velocity with nasal corticosteroids was still under debate. They saw the company proposal of an 18-year age restriction as a safeguard in the event of possible future problems rather than as a limit which could be established from relevant data.

Most Committee members were comfortable with the current 12-year age limit as long as the product remained a restricted medicine. This would allow an element of control over the age at which the product was used and also an opportunity for advice to be provided on the duration of use and the use of the medicine with other steroids. They saw sale as restricted medicine as a better way to manage potential risks than a lower classification with a higher age restriction.

It was noted that the product was equivalent to restricted medicine in Australia and that the Australians would probably be reluctant to move it to a less restrictive level of accessibility.

The Committee agreed by majority vote that beclomethasone nasal spray should retain its current restricted medicine classification on the grounds that this level of classification would best manage any potential risks associated with the medicine.

Recommendation

That there be no change to the current classification of beclomethasone nasal sprays.

6.2 Clobetasone butyrate 0.05% cream (Eumovate, GlaxoWellcome)

This was a company submission for reclassification from prescription medicine to restricted medicine.

As alclometasone dipropionate 0.05% and clobetasone butyrate 0.05% were considered to be of comparable potency, members agreed that the two submissions should be considered together (see agenda item 5.2.1).

The Dermatological Society had responded to Medsafe’s request for advice about both medicines. It did not support OTC availability for either product.

The Pharmaceutical Society supported reclassification of both medicines but no supporting material was supplied.

The Pharmacy Guild indicated support for whatever advice the Dermatological Society provided on both medicines.

The Committee considered the company submissions in the light of the Medsafe reports and the advice provided by the Dermatological Society. The Dermatological Society had expressed a number of concerns. It took strong issue with the Committee’s view at the previous meeting that alclometasone was sufficiently safe for OTC sale claiming a range of steroid side-effects including:

• thinning of the skin and steroid atrophy and steroid-induced striae
• steroid-induced perioral dermatitis
• steroid-induced rosacea.

The Dermatological Society also expressed concern about the use of these steroids in inappropriate body areas and for inappropriate age groups. It stated that both children and the elderly showed more potent steroid absorption and steroid-induced side-effects. It was also of the opinion that these steroids should not be used on the face, flexural areas and groin which were prone to steroid side-effects. Such use would be beyond control if products were to become available over the counter.

A third area of concern to the Dermatological Society related to the ability of pharmacists to diagnose the conditions for which these steroids were appropriate, the possible consequential masking of more serious conditions and the resultant delay in obtaining suitable treatment. The MCC had already expressed concern in these areas and was interested to note that dermatologists had observed such problems even with hydrocortisone.

Members agreed that clobetasone butyrate 0.05% and alclometasone dipropionate 0.05% topical preparations were more potent than hydrocortisone 1%. They felt that consumers were already well-served by OTC access to 1% hydrocortisone products and they saw no strong grounds to make more potent products available. If a more potent preparation than 1% hydrocortisone was required then members were of the opinion that medical advice was also required. They agreed that they still had some concerns about the correct use of hydrocortisone and were reluctant to see more potent topical corticosteroids available over the counter.

Possible use patterns were considered. Members agreed that there would be a tendency for more potent products to be perceived as being ‘better’ than hydrocortisone thus initiating a trend away from hydrocortisone towards more potent, though not necessarily more appropriate products. One member pointed out that market forces were currently driving the prices for topical corticosteroids down and that consumers would naturally move towards less expensive products if these were available over the counter.

Sharing of OTC medicines was acknowledged as being quite common. The Committee did not see these medicines as suitable for use without prior diagnosis.

The Committee was informed that the NDPSC took a conservative view towards hydrocortisone and that no application had yet been made for reclassification of clobetasone. However it was noted that the NDPSC had recently recommended that alclometasone 0.05% topical preparations should become S3 (restricted medicine) in Australia.

Based on the advice provided by the Dermatological Society about side-effects and potential inappropriate use and on their own concerns about a change in use pattern and the relative potency in relation to OTC hydrocortisone, members agreed that both clobetasone and alclometasone should remain prescription medicines. They agreed that 1% hydrocortisone should be used as a benchmark for the OTC classification of topical corticosteroids for both potency and range of indications.

Recommendation

That there be no change to the prescription medicine classification of clobetasone butyrate 0.05% topical cream.

7 NEW MEDICINES FOR CLASSIFICATION

7.1 Nicotine 1mg lozenges (Nicotinell, Novartis)

This was a company submission for classification of a new dose form.

The Pharmaceutical Society had supported a restricted medicine classification for this dose form. It claimed that too many child poisonings had occurred with nicotine patches and gum and it was of the opinion that even more were likely to occur with lozenges which could be mistaken for confectionery. The Committee felt that the Pharmaceutical Society should be asked to provide supporting data for such claims. Members could recall only one case of child poisoning which involved a child chewing a patch.

Members discussed whether it would be more appropriate to classify nicotine lozenges as general sale medicines in the same way as nicotine gum or as restricted medicine as for the sublingual tablet. Plasma levels appeared to be fairly similar for gum, sublingual tablets and lozenges although the latter two were identified as being easier to swallow.

It was generally agreed that nicotine lozenges were unlikely to be a first-line treatment for smoking cessation as subsidised products were likely to be used first. However, they were seen as a useful alternative for those who experienced difficulty using gum or patches.

Overall, the Committee agreed that, as it was a new formulation, the lozenge should enter the market at the same level as the sublingual tablet. Very little marketing data was currently available. Members agreed that they would be happy to reconsider the classification at a later date in the light of marketing data. However, they recognised that such data might be slow to accumulate as subsidised products were more likely to be used. As with sublingual tablets, nicotine lozenges should be made available through smoking cessation clinics run under the auspices of appropriate registered health professionals.

Members noted the point made by the company that lozenges were more environmentally friendly in that, unlike gum, there was no residue to be disposed of.

Recommendation

That nicotine lozenges should be classified as restricted medicines except when sold in a smoking cessation clinic run under the auspices of a registered medical practitioner, nurse, pharmacist or psychologist.

7.2 New chemical entities in medicines which have not yet been granted consent to market

The Committee considered the list of new chemical entities in products for which application had been made for consent to market. Members agreed that, should products containing any of these ingredients be granted consent to market, they should all be classified as prescription medicines.

Recommendation

• That the following active ingredients be classified as prescription medicines:
  • Gemifloxacin
  • Lopinavir
  • Mifepristone
  • Olizumab
  • Telithromycin

8 HARMONISATION OF NZ AND AUSTRALIAN SCHEDULES

8.1 Outstanding harmonisation issues

8.1.1 Hydrocortisone - harmonisation of pack sizes

The Chairman told the Committee that Australia had relaxed the classification of dermal hydrocortisone products in order to harmonise with the less restrictive level of classification in New Zealand. However, pack sizes for OTC sale in Australia had been 30 grams or 30 millilitres rather than the 15 grams or 15 millilitres permitted for OTC sale in New Zealand. This meant that although the two countries now harmonised on their classification and their permitted cut-off points, they did not harmonise on pack size. He pointed out that the Committee had already addressed the matter of pack sizes available for OTC sale in New Zealand at an earlier meeting and had agreed that these should be increased. A recommendation was postponed pending harmonisation with Australia.

The Committee agreed that New Zealand should harmonise with Australia on pack sizes for the sale of OTC hydrocortisone.

It was thought that regulatory impact would be minimal as no product currently on the market would be forced to change classification. Companies could market larger OTC pack sizes when they chose subject to a changed medicine notification for the necessary changes to labelling.

Recommendation

That the maximum pack size limit for the sale of dermal hydrocortisone preparations as restricted medicines or pharmacy-only medicines should be increased from 15 grams or 15 millilitres to 30 grams or 30 millilitres.

8.1.2 Pseudoephedrine - harmonisation of pack sizes

Although New Zealand and Australia had already harmonised on the classification of pseudoephedrine, Australia had recently moved to counter abuse of pseudoephedrine by imposing a pack size limit of 60 on uncompounded pseudoephedrine tablets for OTC sale. The Chairman said that New Zealand was now experiencing the same abuse problems as Australia and that New Zealand should impose the same pack size limits. This would not apply to products where pseudoephedrine was compounded with other active ingredients. It was recognised that the current schedule entry might have to be expressed differently in order to implement this. The Committee agreed that the OTC sale of uncompounded pseudoephedrine tablets or capsules should be limited to 60 dose units.

Recommendation

That solid dose forms of pseudoephedrine in uncompounded preparations should have a maximum pack size limit of 60 dose units for sale as pharmacy-only medicine.

8.2 Recommendations made by the NDPSC to the MCC in February 2000

1 Staphisagria

Reclassify from:

Restricted medicine

(internal use 0.2% or more)

Pharmacy-only medicine

(external use and internal under 0.2%)

to:

Pharmacy-only medicine; except in medicines containing 0.2% or less

As there were no medicines registered in New Zealand containing staphisagria the change would have no regulatory impact.

Recommendation

That staphisagria be reclassifed to pharmacy-only except in medicines containing 0.2% or less

2 Amidopyrine

Amend the current prescription medicine entry to read:

amidopyrine (aminophenazone) and its derivatives

Aminophenazone was the rINN. Therefore the New Zealand schedule entry should be changed. There were no products registered in New Zealand so the change would have no regulatory impact. As derivates were listed separately in the schedule, there was no need for the additional wording.

Recommendation

That the amdopyrine entry be changed to aminophenazone.

3 Adopt the following as prescription medicines:

• Abrus precatorius (Jequiry) seed or root
• Acorus calamus (calamus)
• Allylisopropylacetylurea
• Amygdalin
• Anchusa offininalis
• Borago officinalis (borage) except the fixed oil derived from the seeds of Borago officinalis
• Buniodyl sodium
• Cacalia spp
• Crotalaria spp
• Cynglossum spp
• Dilcin
• Ethylhexandediol
• Farfugium japonicum
• Heliotropium spp
• Heliotropium supinum
•        Juniperus sabina [savin(e)]
• Ligularia dentata
• Petasites spp
• Pteridium spp
• Pulmonaria spp
• Safrole for internal therapeutic use except in preparations containing 0.1% or less of safrole
• Senecio spp
• 1,1,1-trichloroethane in pressurised spray packs
• Trichosesma africana
• Triparanol
• Tussilago farfara

The chairman pointed out that these were all Appendix C medicines which were banned in Australia at all strengths. They would be dealt with later on the agenda under the proposal to harmonise the use of low concentration and banned medicines (see agenda item 8.4).

4 Clioquinol

Amend the prescription medicine entry to read:
ciloquinol and other halogenated derivatives of 8-hydroxyquinoline

The amendment was considered unnecessary as any other derivatives would be specified separately in the schedule.

Recommendation

That the clioquinol entry remain unchanged

5 Cinchophen

Amend the prescription medicine entry to read:
Cinchophen and its derivatives for therapeutic use

The comments concerning the scheduling of derivatives were as for clioquinol. ‘For therapeutic use’ was considered unnecessary.

Recommendation

That the cinchophen entry remain unchanged

6 Croton oil

Reclassify from restricted medicine to prescription medicine as croton tiglium

Croton oil was already classified as a prescription medicine. There were no registered products.

Recommendation

That the croton oil entry be changed to croton tiglium.

7 Reclassify the following from pharmacy-only to prescription medicine:

• Bithionol
• Buclosamide
• Coniine
• Cotarnine

These were noted as being Appendix C medicines in Australia. None were contained in registered medicines in New Zealand. The Committee thought they should become prescription medicines in view of their toxicity. They should be dealt with in the same manner as other Appendix C medicines when the harmonisation of low concentration and banned medicines was considered (see agenda item 8.4). It was also noted that these were not included with the medicines listed in item 8.4).

Recommendation

• That the following medicines be reclassified from pharmacy-only to prescription medicine:
  • Bithionol
  • Buclosamide
  • Coniine
  • Cotarnine
• That these medicines be scheduled in the same way as other Australian Appendix C medicines by the addition of a statement to their schedule entries disallowing their use at any concentration.

8 Symphytum

Adopt symphytum spp (comfrey) for dermal use as a general sale medicine
Adopt symphytum spp (comfrey) except for dermal use as a prescription medicine.

This was also an Appendix C medicine but was unscheduled in New Zealand. There had been considerable response from the complementary medicines sector over this recommendation. Medsafe had agreed that a recommendation should not be made with regard to a classification status for this medicine until there had been further consultation to establish whether there was a level at which internal use of symphytum was safe for general sale. It was agreed that the matter should be returned to the agenda for the next meeting when consideration could be given to information provided by interested bodies.

9 Eupatorium

Adopt eupatorium cannabinum (hemp agrimony) as a prescription medicine.

There had also been response from the complementary medicines sector over this recommendation. The Committee agreed that further information should be sought as for symphytum.

10 Phenolphthalein

Reclassify from pharmacy-only to prescription medicine.

Although most products had been discontinued, there were still 4 pharmacy-only products on the New Zealand market which would be forced from the market if they were to become prescription medicines. Three of these appeared to be laxatives and one to be for bowel cleansing. In view of the evidence that phenolphthalein was a carcinogen, the Committee agreed to the recommended reclassification (A further recommendation was received from the NDPSC in May 2000. See 8.c.2)

Recommendation

That phenolphthalein be reclassified from pharmacy-only medicine to prescription medicine.

11 Reclassify from pharmacy-only to general sale:

Aloes for internal use

• Aloin
• Bisacodyl
• Ipomoea
• Jalap resin
• Sennosides
• Sodium picosulphate
• Pomegranate
• Quassia

The following points were noted:

• There were no products registered in New Zealand containing:
  • ipomoea
  • jalap resin
  • pomegranate
  • quassia
• Aloin was contained only in Ford Pills which also contained phenolphthalein so the product would become a prescription medicine if it were to remain on the market. (see 10 above).
• Aloes for internal use were contained in one product, Slendretts Tablet. All the other ingredients were general sale. The recommendation was not supported by the Pharmaceutical Society.
• Bisacodyl was contained in approximately 6 products. The recommendation was supported by Baxter but not by the Pharmaceutical Society or the Pharmacy-Guild
• Sennosides; The MCC had declined submissions to move sennosides to general sale on two previous occasions on the grounds that the use of bulk laxatives should be encouraged and that stimulant laxatives should have pharmacist advice available at the point of sale. Sennosides were known to be abused by anorexics. The Pharmaceutical Society and the Pharmacy-Guild did not support a relaxation of classification.

There was strong feeling amongst members against a move to general sale for stimulant laxatives. Laxative abuse was well-known. Since the matter had last been considered by the Committee a case had occurred in New Zealand of a pharmacist having been taken to court and subsequently struck from the register for selling laxatives when abuse was obvious. One member questioned the difference between sale in a supermarket and sale in a pharmacy. Pharmacists on the Committee responded that pharmacy assistants were mostly women who tended to be sensitive towards anorexia and laxative abuse. They were often quite vigilant and proactive in their intervention. Pharmacists did intervene for cases of known abuse particularly in the wake of the recent court case. Also, although bulk laxatives were unpopular, their use was generally encouraged in pharmacies.

The Committee was informed that, when the NDPSC Working Party had made the recommendation to harmonise at the least restrictive level unless there was a public health issue, it had not been aware of this sort of evidence for harm.

Members wished to retain the New Zealand situation where stimulant laxatives were classified more restrictively than bulk laxatives. They considered that a freeing up of classification could only lead to further harm. They recommended that the NDPSC be asked to consider adopting the New Zealand position on the classification of laxatives.

Recommendation

• That stimulant laxatives should continue to be classified as pharmacy-only medicines
• That the NDPSC should be asked to consider adopting the New Zealand position for classifying stimulant laxatives in a more restrictive manner than bulk laxatives.

12 Cyanocobalamin, hydroxocobalamin

Delete the pharmacy-only entries from the schedule.

These were currently pharmacy-only in medicines containing more than 50mcg per recommended daily dose. This level had been set to be consistent with the Dietary Supplement Regulations. These regulations were currently under revision and the Ministry Food Section had indicated support for the removal of these from the schedule.

Recommendation

That the pharmacy-only entries for cyanocobalamin, hydroxocobalamin be deleted from the schedule.

13 Acetomenaphthone, menadiol, phytomenadione

Delete the pharmacy-only entries from the schedule.

These were all noted as types of Vitamin K. The Committee was informed that nutritional replacement preparations for parenteral administration were exempt from scheduling in Australia.

As most of the products registered in New Zealand were for either injection or infusion, the Secretary explained that their removal from the schedule would not result in harmonisation until the matter of how New Zealand scheduled injectables had been resolved.

The following course of action was agreed upon:

Recommendation

• That acetomenaphthone, menadiol and phytomenadione be removed from the schedule
• That the NDPSC be informed that the matter of how New Zealand was to schedule injectables would need to be resolved before the classification of the injectable products would be effected
• That Medsafe should attempt to resolved this matter in time to be included in the Gazette notice giving effect to the changes from the 24th meeting.

14 Plasma volume expanders

Delete the following from the schedule:

• dextrans
• hetastarch
• pentastarch  
• polygelene

The Committee was informed that, as for parenteral nutritional replacement preparations, plasma volume expanders were also exempt from scheduling in Australia. Members agreed that Medsafe should harmonise these in the same way as for parenteral nutritional replacement preparations by removing them from the schedule and by resolving the problem related to the scheduling of injectable medicines in New Zealand.

Recommendation

That plasma volume expanders should be classified as general sale medicines and their reclassification should be implemented in the same way as for parenteral nutritional replacement preparations.

15 Acids and caustic poisons

Delete the following from the schedule:

• formic acid
• sodium hydroxide
• trichloracetic acid
• hippuric acid

These were all classified as pharmacy-only medicines. Sodium hydroxide had long been a problem in maintaining a higher-than-necessary classification for a wide range of medicines in which it was not an active ingredient. Medsafe foresaw no potential problems for those products in which sodium hydroxide was the active ingredient to be available as general sale medicines.

New Zealand had no registered products containing formic acid, hippuric acid or trichloroacetic acid.

The Pharmaceutical Society did not support the removal of trichloroacetic acid from the schedule.

Although there were no approved products containing trichloroactic acid, it was thought that the raw chemical was used for therapeutic purposes such as skin peeling and the removal of tattoos. Members felt that more information was necessary and that the matter should be revisited at the next meeting. The Pharmaceutical Society should be requested to provide evidence to support it’s opinion, not only for this case but also on all future occasions.

Recommendation

• That formic acid, sodium hydroxide and hippuric acid should be removed from the schedule
• That further information should be sought for consideration at the next meeting about the uses of trichloroacetic acid
• That the Pharmaceutical Society be asked to provide information to support its view that trichloroacetic acid should remain a pharmacy-only medicine.

16 Topical drugs used for scalp disorders

Delete jaborandi as a pharmacy-only medicine
Modify the prescription medicine entry for pilocarpine to read:

in medicines containing more than 0.025% of pilocarpine

The New Zealand prescription medicine entry for pilocarpine was noted as being already harmonised. New Zealand had only eye products. None of these contained less than 0.5%. Members noted that Martindale did not refer to a topical use of pilocarpine for scalp disorders.

The Committee noted that there was no reference to jaborandi in Martindale and that there were no products registered in New Zealand containing jaborandi.

Recommendation

That the pharmacy-only entry for jaborandi be removed from the schedule.

17 Piroctone

Delete the pharmacy-only entry from the schedule.

Piroctone was noted as being a pharmacy-only medicine in products containing more than 1%. All products on the New Zealand market contained less than this. Therefore there would be no regulatory impact in deleting the entry.

Recommendation

That the pharmacy-only entry for piroctone be deleted from the schedule.

18 Thioxolone

Delete the pharmacy-only entry from the schedule.

It was noted that New Zealand had no registered products containing thioxolone.

Recommendation

That the pharmacy-only entry for thioxolone be deleted from the schedule.

19 Isopropyl alcohol

Delete the pharmacy-only entry from the schedule.

Isopropyl alcohol was classified as a pharmacy-only medicine when in uncompounded medicines for external use.

It was noted as being contained as an active ingredient in only 4 products all of which were general sale. There was one pending application for consent to market for an ear drop which would move from pharmacy-only to general sale if it received consent to market.

The Pharmaceutical Society did not support the NDPSC recommendation on the grounds that isopropyl alcohol was used to prepare illicit controlled drugs. However, this was not a therapeutic use as defined in the medicines legislation and was therefore not within the terms of reference of the Committee.

Recommendation

That the pharmacy-only entry for isopropyl alcohol be deleted from the schedule.

20 Phenoxyethanol

Delete the pharmacy-only entry from the schedule.

Phenoxyethanol was currently classified as pharmacy-only in medicines containing more than 2%. There were no products registered in New Zealand in this category.

Recommendation

That the pharmacy-only entry for phenoxyethanol be deleted from the schedule.

21 Broxaldine, Broxyquinoline

Add to the schedule as prescription medicines.

These were both noted as having pharmacy-only entries. There were no longer any products registered in New Zealand containing these ingredients. Nor was there any reference to either in Martindale. They were not scheduled in Australia. Members saw no need for their entries to be maintained in the schedule.

Recommendation

• That broxaldine and broxyquinoline should be deleted from the schedule
• That the NDPSC should be recommended not to schedule these medicines.

22 Fluorescein

Delete the pharmacy-only entry from the schedule.

The Committee noted that there were two eye drop solutions and a sterile impregnated eye strip which would go to general sale if the recommendation were implemented. Members were happy for these to change. However, there were also two solutions for injection into the eye which would move to general sale if the entry for injectables was moved from the schedule. This was not considered to be appropriate. Even though the injections were currently pharmacy-only, the Committee felt there should be a prescription medicine entry for fluorescein for injection. Members felt that in the interest of the harmonisation of most injectable products as prescription medicines, the NDPSC should be asked to make a similar prescription medicine entry for fluorescein.

As such a recommendation would result in an outcome other than that contained in the initial proposal, it would be necessary to add the matter to the agenda of the following meeting so that the normal consultation process could be undertaken. It would also be necessary to delay the removal of the pharmacy-only entry for fluorescein until the classification of the eye injections was finalised.

Recommendation

• That fluorescein should be considered at the next meeting for reclassification as a prescription medicine for injection
• That fluorescein should become a general sale medicine for uses other than for injection.
• That the NDPSC be asked to consider making a similar entry in the SUSDP for fluorescein for injection.

23 Magenta

Delete the pharmacy-only entry from the schedule.

There were no products registered in New Zealand containing magenta.

Recommendation

That the pharmacy-only entry for magenta be deleted from the schedule.

24 Methylene blue

Delete the pharmacy-only entry and make a new prescription medicine entry for methylene blue for injection.

Baxter, the only supplier of an injectable form, had indicated its support for the change to prescription medicine. It was noted that two tablet presentations would move to general sale.

Recommendation

That the pharmacy-only entry be removed from the schedule and new prescription medicine entry be made for methylene blue for injection.

25 Krameria, tannic acid

Delete the pharmacy-only entry from the schedule.

There were no products registered in New Zealand containing either of these.

Recommendation

That the pharmacy-only entries for krameria and tannic acid be deleted from the schedule

26 Bentiromide

Delete the pharmacy-only entry from the schedule.

There were no products registered in New Zealand containing bentiromide.

Recommendation

That the pharmacy-only entry for bentiromide be deleted from the schedule.

27 Thiomersal

Delete the pharmacy-only entry from the schedule as thiomersal was covered by the entries for mercury.

It was noted that thiomersal was used only as a preservative.

Recommendation

That the pharmacy-only entry for thiomersal be deleted from the schedule.

28 Propamidine, dibromopropamidine

Delete the pharmacy-only entry from the schedule.

Dibromopropamidine was general sale except for eye preparations. It was noted that two eye preparations and a topical cream would move to general sale. Propamidine was also contained in eye preparations.

It was noted that the Pharmaceutical Society did not support the NDPSC recommendation where eye preparations were concerned on the grounds that, as these were anti-infective agents, a diagnosis was required before treatment was commenced. The Committee recalled that management of red-eye had been discussed on other occasions and members had agreed that access to professional advice was necessary. This opinion was upheld.

Recommendation

• That the pharmacy-only entries for propamidine and dibromopropamidine be retained for eye preparations
• That the NDPSC be asked to consider adopting the New Zealand classification of propamidine and dibromopropamidine.

29 Ichthammol

Delete the pharmacy-only entry from the schedule.

The Committee noted that ichthammol was currently pharmacy-only in medicines containing more than 10%. As there were no products registered in New Zealand containing more than 10%, the change would have no regulatory impact.

Recommendation

That the pharmacy-only entry for ichthammol be deleted from the schedule.

30 Theobromine, calcium salicylate

Delete the pharmacy-only entry from the schedule.

There were no products registered in New Zealand containing either of these medicines.

Recommendation

That the pharmacy-only entries for theobromine and calcium salicylate be deleted from the schedule.

31 Camphor, ammoniated

Delete the pharmacy-only entry from the schedule.

There were no products registered in New Zealand containing ammoniated camphor and no reference to it in Martindale.

Recommendation

That the pharmacy-only entry for ammoniated camphor be deleted from the schedule.

32 Capsicum oleo-resin

Delete the pharmacy-only entry from the schedule.

This is was noted as being a pharmacy-only medicine when for external use in products containing more than 1%. There were no such products registered in New Zealand.

Recommendation

That the pharmacy-only entry for capsicum oleo-resin be deleted from the schedule.

33 Chromium oxide, Stannous chloride, Stannous oxide

Delete the pharmacy-only entries from the schedule.

The Committee noted that the only product containing one of these was Aci Gel vaginal gel containing stannous chloride. As this product had already been wrongly classified as a general sale medicine there would be no regulatory impact.

Recommendation

That the pharmacy-only entries for chromium oxide, stannous chloride and stannous oxide be deleted from the schedule.

34 Loperamide

Make a new schedule entry for loperamide as a prescription medicine when for injection. Amend the pharmacy-only entry accordingly.

The Committee noted that loperamide was only used orally and they saw no need for a classification for a route of administration which was not used.

Recommendation

That a prescription medicine entry should not be made for loperamide for injection.

35 Irrigation medicines

Delete the pharmacy-only entry from the schedule.

The Committee could see no safety reason to keep this generic entry. Members agreed that the ingredients of these products should ensure their appropriate classification.

The recommendation had been supported by Baxter.

Recommendation

That the pharmacy-only entry for irrigation medicines should be deleted from the schedule.

36 Monoacetin

Delete the pharmacy-only entry from the schedule.

It was noted that there were no products registered in New Zealand which contained this medicine.

Recommendation

That the pharmacy-only entry for monacetin be deleted from the schedule.

37 Nitrous ether spirit

Delete the pharmacy-only entry from the schedule.

It was noted that there were no products registered in New Zealand which contained this medicine.

The Pharmaceutical Society did not support the NDPSC recommendation on the grounds that the substance was used to produce homebake. However, the Committee agreed that this was not a therapeutic purpose and was therefore not relevant to its recommendation.

Recommendation

That the pharmacy-only entry for nitrous ether spirit be deleted from the schedule.

38 Oxerutins

Delete the pharmacy-only entry from the schedule.

It was noted that there were no products registered in New Zealand which contained oxerutins.

Recommendation

That the pharmacy-only entry for oxerutins be deleted from the schedule.

39 Sucralfate

Delete the pharmacy-only entry from the schedule.

It was noted that the Alsucral range of products would move to general sale.

Recommendation

That the pharmacy-only entry for sucralfate be deleted from the schedule.

40 Hydroiodic acid, iodic acid

Delete the pharmacy-only entry from the schedule.

It was noted that there were no products registered in New Zealand which contained these medicines.

Recommendation

That the pharmacy-only entries for hydroiodic acid and iodic acid be deleted from the schedule.

41 Scillarins

Delete the pharmacy-only entry for scillarins.

It was noted that there were no products registered in New Zealand which contained scillarins.

Recommendation

That the pharmacy-only entry for scillarins be deleted from the schedule.

42 Sodium iodide

Delete the pharmacy-only entry from the schedule as it was covered by the iodine entry.

Recommendation

That the pharmacy-only entry for sodium iodide be deleted from the schedule.

43 Felbinac

Adopt a prescription medicine entry for use other than external and amend the pharmacy-only entry to external use only.
Delete biphenylacetic acid, its chemical name.

As felbinac was used only in topical preparations, the Committee saw no need for a prescription entry.

Recommendation

• That a new prescription medicine entry for felbinac for other than external use should not be made in the schedule
• That biphenylacetic acid should be deleted from the schedule

44 Etofenamate

Adopt a prescription medicine entry for use other than external and amend the pharmacy-only entry to external use only.

Members noted that etofenemate had been used in injectable form though not in New Zealand.

Recommendation

That a new prescription medicine entry for etofenemate except for external use be made in the schedule and that the pharmacy-only entry be amended accordingly.

45 Salsalate

Delete the pharmacy-only entry from the schedule.

It was noted that Disalcid 500mg capsules would become general sale medicines.

Recommendation

That the pharmacy-only entry for salsalate be deleted from the schedule.

46 Sodium salicylate

Delete the pharmacy-only entry from the schedule.

It was noted that one shampoo product would move to general sale.

Recommendation

That the pharmacy-only entry for sodium salicylate be deleted from the schedule.

47 Hexamidine

Delete the pharmacy-only entry from the schedule

It was noted that three products would move to general sale.

Recommendation

That the pharmacy-only entry for hexamidine should be deleted from the schedule.

48 Boron

Delete the pharmacy-only entries for boric acid and sodium perborate.
Add the following new prescription medicine entry for boron:

• in preparations for internal use
• in glycerins or honeys of borax or boric acid
• in preparations for vaginal use
• in preparations for paediatric dermal use , being (1) dusting powders; or (II) other preparations containing more than 0.15% of boron except antifungal preparations
• in preparations for dermal use containing more than 0.15% of boron except antifungal preparations

The Committee noted that the current New Zealand cut-off point for general sale was 2% for both boric acid and sodium perborate. There was no New Zealand schedule entry for boron.

It appeared that the NDPSC recommendation was for boron to become a prescription medicine except for antifungal preparations and dermal preparations containing 0.15% or less. There did not appear to be a limit set on the concentration permitted in antifungal products for general sale even though these could be dermal products for which a concentration of 0.15% seemed to apply.

It was thought that the Australian recommendation was rather confusing. It could be expressed more clearly by making boron a prescription medicine and specifying any exceptions rather than by listing all inclusions.

There had been strong response from the complementary health sector about this recommendation which would prevent the continued use of elemental boron in dietary supplements.

The Committee thought that the information provided in the TGA review of boron was not recent and dealt with the more toxic boron salts, boric acid and borax rather than with elemental boron.

On the other hand, members felt that the National Nutritional Foods Association had made a good case for use of boron as a dietary supplement by providing a draft of a UK Review of Boron conducted in 1999 by the Expert Group on Vitamins and Minerals.

The Committee agreed that no recommendation should be made to change the New Zealand schedule entries for boric acid and sodium perborate at this time. The NDPSC should be asked to review its recommendation in the light of information contained in the UK draft Review of Boron.

Recommendation

• That there be no change to the current classification of boric acid and sodium perborate
• That the NDPSC be asked to review its current position on the classification of boron in the light of the 1999 UK draft Review of Boron.

49 Picric acid

Delete the pharmacy-only entry from the schedule.

It was noted that there were no products registered in New Zealand which contained this medicine.

The Pharmaceutical Society did not support the NDPSC recommendation because of the explosive nature of this product should it dry out. The Committee agreed that control of this aspect of a chemical should be dealt with under other legislation.

Recommendation

That the pharmacy-only entry for picric acid should be deleted from the schedule.

50 Oxiconazole

Make a new prescription medicine entry ‘except for dermal or vaginal use’.
Make a new restricted medicine entry ‘for vaginal use’.

The Committee agreed that, as there were only dermal and vaginal uses for oxiconazole, a prescription entry was unnecessary. They noted that there were no vaginal products registered in New Zealand.

Recommendation

• That a new restricted medicine entry for vaginal use be made in the schedule
• That the NDPSC be recommended to delete the S4 (prescription medicine) entry and to harmonise on the New Zealand pharmacy-only entry.

51 Diamthazole

Reclassify from pharmacy-only to prescription medicine.

As there were no products registered in either country, the change would have no regulatory impact. There was no longer a reference in Martindale as diamthazole had been superseded by safer antifungals. The Committee questioned the justification to accept a more restrictive classification and the continued need for schedule entries.

Recommendation

• That the pharmacy-only entry for diamthazole should be deleted from the schedule
• That the NDPSC should remove diamthazole from the SUSDP.

52 Bromelains

Delete the pharmacy-only entry from the schedule.

It was noted that there were no products registered in New Zealand which contained bromelains.

Recommendation

That the pharmacy-only entry for bromelains be deleted from the schedule.

53 Calcium hypochlorite

Delete the pharmacy-only entry from the schedule.

It was noted that there were no products registered in New Zealand which contained this medicine.

Recommendation

That the pharmacy-only entry for calcium hypochlorite be deleted from the schedule.

54 Ribonuclease, deoxyribonuclease (for external use)

Delete the pharmacy-only entries from the schedule.
Make a new prescription medicine entry for deoxyribonuclease ‘except for external use and except when specified elsewhere in the schedule’.

The prescription medicine entry for deoxyribonuclease had already been harmonised. Members noted that ribonuclease was not an active ingredient and did not need to be scheduled.

Recommendation

That the pharmacy-only entries for ribonuclease and deoxyribonuclease be deleted from the schedule.

55 Dextranomer

Delete the pharmacy-only entry from the schedule.

It was noted that there were no longer any products registered in New Zealand which contained this medicine.

Recommendation

That the pharmacy-only entry for dextranomer be deleted from the schedule.

56 Solcosceryl

Delete the pharmacy-only entry from the schedule.

It was noted that there were no products registered in New Zealand which contained this medicine.

Recommendation

That the pharmacy-only entry for solcoscerol be deleted from the schedule.

57 Vitamin D

Amend the prescription medicine entry to read:

in medicines for internal use containing more than 25 mcg per recommended daily dose.

The Committee noted that the current entry did not specify internal use though it was implied by the use of the words ‘daily dose’.

Recommendation

That the prescription medicine entry for vitamin D be amended to read:
for internal use in medicines containing more than 25 micrograms per recommended daily dose.

58 Colecalciferol

Delete the prescription medicine entry from the schedule. It is covered by the vitamin D entry.

The Committee agreed that the same argument could be applied to all the other vitamin D substances named individually in the schedule. However, it was not appropriate for some of these, such as alphacalcidiol and calcitriol to be classified as other than prescription medicines. Members thought a more logical approach would be to remove the vitamin D entry from the schedule so as not to catch those forms which are not intended for general sale at 25 micrograms or less per recommended daily dose. However, they saw this as a possible source of confusion and felt that both the colecalciferol and vitamin D entries should remain. The entry for ergocalciferol currently harmonised with that for colecalciferol and it was agreed that this should continue. Members agreed that Australia should be asked to harmonise on the New Zealand position for the classification of vitamin D substances.

Recommendation

• That the colecalciferol entry should remain in the schedule to show that colecalciferol was classified differently from some other forms of vitamin D.
• That Australia be asked to harmonise on the New Zealand classification of vitamin D substances.

59 Retinol

Delete the prescription medicine entry.
Amend the entry for vitamin A to:

in preparations containing more than 3000mcg retinol equivalents per recommended daily dose.

Recommendation

• That the prescription medicine entry for retinol be deleted from the schedule
• That the prescription medicine entry for vitamin A be amended to:
  in preparations containing more than 3000mcg retinol equivalents per recommended daily dose.

60 Iron

Delete the current pharmacy-only entry and replace with:

Make a new prescription medicine entry for iron in preparations for injection.

There had been considerable response to this recommendation from both industry and the complementary health sector. The Committee agreed that these responses supported their view that the New Zealand classification was in line with international trends regarding a maximum recommended daily dose for iron. There appeared to be no substantial safety reasons to justify limiting doses to 5 milligrams or 0.1% for general sale. A number of other countries regulated iron by using a maximum recommended daily dose as a cut-off point for general sale. The New Zealand limit fell well with the international range. Members felt that the NDPSC should be asked to harmonise with New Zealand on this matter.

The Committee agreed, that, in the interest of harmonising injectable medicines, iron for injection would be more appropriately classified as a prescription medicine.

Recommendation

• That the NDPSC should be asked to adopt the New Zealand level of a maximum of 24 milligrams per recommended daily dose as the cut-off point for the general sale of iron.
• That iron for injection should be classified as a prescription medicine

61 Copper

Delete the pharmacy-only entry from the schedule.

The Committee noted that all products containing copper which were registered in New Zealand were general sale medicines.

Recommendation

That the pharmacy-only entry for copper be deleted from the schedule.

62 Hydrogen peroxide

Delete the pharmacy-only entry from the schedule.

Recommendation

That the pharmacy-only entry for hydrogen peroxide should be deleted from the schedule.

63 Isopropamide

Adopt the following pharmacy-only entry:

in preparations for dermal use containing 2% or less.

It was noted that there were no longer any products registered in New Zealand which contained isopropamide. It was also noted that the prescription medicine entry would need to be amended accordingly.

Recommendation

• That the pharmacy-only entry for isopropamide be amended to:
  • ‘for dermal use in medicines containing 2% or less’
• that the prescription medicine entry for isopropamide be amended to:
  • ‘except for dermal use in medicines containing 2% or less’

8.3 Recommendations made by the NDPSC to the MCC May 2000

1 Formaldehyde, paraformaldehyde

Amend the current pharmacy-only entries to:

(excluding its derivatives) except in medicines containing 5% or less

The Committee noted that there were no products registered in New Zealand which contained paraformaldehyde. Formaldehyde was only recorded as being an active ingredient in one product, a Rawleigh's mouthwash, which would move to general sale. Most other products were excpients in injections, the classification of which was controlled by the active ingredient.

The bracketed reference to derivatives was considered unnecessary as derivatives were scheduled separately in the New Zealand schedule and were not covered by the introductory statement.

Recommendation

That the pharmacy-only entries for formaldehyde and paraformaldeyde be amended to apply only to products containing more than 5%.

2 Phenolphthalein

Reclassify from pharmacy-only to prescription medicine.

This recommendation had been discussed earlier on the agenda (see agenda item 8.2.10) The Committee noted that the FDA had produced evidence that phenolphthalein was carcinogenic. Four products registered in New Zealand would be affected by the change.

Recommendation

That phenolphthalein be reclassified from pharmacy-only to prescription medicine.

3 Macrogol 3350

Adopt as a restricted medicine for oral bowel cleansing purposes.

The Committee noted that macrogols was the rINN for polyethylene glycols. These were not scheduled in New Zealand. As macrogol 4000 was also used for bowel cleansing, members felt it should be included in the entry. The wording should be as for sodium phosphate.

Recommendation

That the following restricted medicine entry should be added to the schedule:
Macrogols; in oral preparations for bowel cleansing prior to diagnostic, medical or surgical procedures.

8.4 Low concentration and banned medicines

The Committee discussed the Medsafe proposal to harmonise with Australia by allowing a general exemption from scheduling in the cover statement to the schedule for all medicines containing 10 milligrams or less per litre or per kilogram. To harmonise totally with Australia it would be necessary to include specific entries in the New Zealand schedule for all medicines that were scheduled as Appendix G medicines in Australia, that is, for all medicines for which Australia required a different cut-off point from that in the general exemption. Also in order to harmonise, members saw that it would be necessary for banned, or Appendix C medicines in Australia to be annotated in the New Zealand schedule to the effect that they were classified as prescription medicines at all strengths.

The Committee agreed in principle to harmonise with Australia on a general exemption for low-concentration medicines and with the scheduling of Appendix G and C medicines but felt that Medsafe should work out the details of how this should best be implemented. Members thought that there needed to be clarity and uniformity about whether medicines derived from plants should be scheduled according to individual plant names or according to the active ingredient derived from the relevant plant or plants. A preference was expressed for use of the active ingredient.

It was agreed that any Appendix G or C medicines which had been subject to comment during the consultation process should be withheld from inclusion into the schedule until further information had been obtained about safe levels for general sale use. The medicines in question were: symphytum, tussilago eupatorium cannabium, farfara, acorus calamus, borago officinalis, amygdalin, juniperus sabina, petastes, pteridium and senecio. These were all banned (Appendix C) medicines. Complementary medicines bodies should be given a specific date by which to respond with details of the maximum concentrations they wished to use for these medicines and safety data to support this.

No comments had been received about Australian Appendix G medicines for which a lower concentration had been set than the normal exemption of 10 milligrams per litre or per kilogram.

The Committee also agreed that it would be open to reviewing the restrictions placed on any of the Australian Appendix G or C medicines if safety data were provided to justify a change to their level of classification.

Recommendation

• That New Zealand harmonise with Australia by allowing a general exemption for classification status for all medicines except those listed in Appendix C or Appendix G of the Australian Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP)
• that New Zealand should ensure that medicines banned for use in Australia should not be included in the general exemption in New Zealand
• that medicines banned in Australia but used in complementary health products in New Zealand and for which submissions had been received prior to the 24th meeting of the MCC should not be excluded from use in this way until further consultation had taken place and safety data had been considered
• that medicines listed in Appendix G of the SUSDP should be similarly annotated in the New Zealand schedule
• that clarity should be sought regarding the terminology of plant-derived medicines.

9 FOR THE NEXT MEETING

Agenda items for 2001

• Inhaled salbutamol and terbutaline
  As discussed earlier in the meeting, Medsafe would conduct the necessary consultation process so that the question of whether or not to harmonise with Australia on the classification of these medicines could be considered at the next meeting.
• Emergency contraceptive pill
  Several years earlier the Committee had recommended that the Yuzpe regimen for emergency contraception was sufficiently safe to be made more widely available. Consultation had been undertaken and a large number of submissions had been received. A number of factors had prevented wider access from being implemented at the time. The Chairman told the Committee that an even safer form of emergency contraception had since become available with the single ingredient levonorgestrel regimen and it was felt that the time was now right to progress this issue. The Committee agreed that the matter should be placed on the agenda of the next meeting.
• Trichloroacetic acid to determine whether there are grounds for it to remain a pharmacy-only medicine.
  See agenda item 8.2.15
• Fluorescein for reclassification to prescription medicine for injection
  See agenda item 8.2.22
• Medicines Banned in Australia but used in complementary health products in New Zealand
  A delay has been requested in the scheduling of these medicines until further information can be obtained about possible safe levels for use in complementary medicines:
  • acorus calamus
  • amygdalin
  • borago officinalis     
  • eupatorium cannabium
  • juniperus sabina
  • senecio
  • symphytum
  • tussilago farfara
  • petastes
  • pteridium
• Paracetamol: possible pack size reduction for general sale.
  See agenda item 10 below.

10 GENERAL BUSINESS

10.1 Paracetamol

UK pack size reduction

On several earlier occasions the Committee had discussed the effect that a reduction on pack sizes might have on paracetamol poisonings. There had been general agreement that intentional poisonings usually involved between one and two packs and that a reduction in poisonings could follow if pack sizes were reduced for general sale presentations. The Committee had been aware of a British study under way to investigate this and had decided to await the results of that study. Results had since been published in the Lancet in June 2000 ².

The Committee agreed that the matter of whether or not New Zealand general sale pack sizes should be reduced should be opened to consultation and should be considered at the next meeting.

10.2 Consultation paper for the Joint Agency Project with Australia

This paper had been provided to members of all ministerial advisory committees for their information. The Chairman gave a brief update on progress since the publication of the paper.

10.3 Contracts for services

The Secretary asked that these be signed and returned as soon as possible so that members could be reimbursed for services to the Committee.

The meeting ended at 4:10pm

References

1. Martindale The Complete Drug Reference 32^nd edition p1016
2. Reduction in the Incidence of Paracetamol Poisoning, The Lancet, Vol 355, June 2000