1.

Welcome

The Chairman declared the meeting open at 9:30am and welcomed Dr Susan Alder, Chair of the Australian National Drugs and Poisons Schedule Committee (NDPSC). Dr Alder said that she was pleased to be able to attend a meeting of the Medicines Classification Committee (MCC) and spoke briefly on the progress of the scheduling harmonisation project.

Dr Jessamine also introduced Dr Natasha Rafter from Medsafe who had been involved in writing a number of reports for the Committee, and Ms Sarita Von Afehlt who had recently joined Medsafe and was present as an observer.

2.

Apologies

There were no apologies

3.

Confirmation of the minutes of the 24^TH meeting

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

4.

Declaration of conflict of interests

One member of the Committee declared an involvement with a pharmaceutical company working party for a product which was not on the agenda of the current meeting. The Chairman felt that this was of insufficient importance to warrant withdrawal of the member from discussion or voting. He pointed out that ministerial advisory committee members who had the greatest conflict of interest were often those who also had the most knowledge about the subject concerned. For that reason, such members were often included in discussion but might be asked to abstain from voting.

The member's written declaration was noted and filed.

5.

MATTERS ARISING

5.1

Objections to recommendations made at the 24th meeting

There were no objections to recommendations made at the 24^th meeting.

5.2

Paracetamol pack sizes for general sale

The Committee had been awaiting the results of a British study to determine whether or not pack sizes should be reduced for general sale to align with the 8 gram pack sizes available for general sale in the UK or whether they should be increased from 10 grams to 12.5 grams in order to harmonise with Australian general sale pack sizes.

Members agreed that there were two separate issues to be discussed and that each should be dealt with separately.

The results of the British study were discussed first. The Committee thought that it was unfortunate that the British reduction in pack size for general sale and the move from bottles to blister packs had both been included in the study. They agreed that it was impossible to determine whether pack-size reduction alone had resulted in a reduction in the suicide rate. While impulsive overdoses appeared not to be as serious, there did not appear to be a reduction in the rate of intentional suicide. While the UK study did suggest some impact on toxicity, the research was not sufficiently detailed to allow the Committee to draw any conclusions about the reason for this impact.

The problem of intentional overdose did not appear to be as significant in New Zealand as in the UK. A two-gram difference in pack size was not perceived as being sufficient to produce a significant reduction in paracetamol poisoning rates, especially as there was no way of enforcing single-pack sales. As no restrictions were placed on the quantities of toxic substances which may be sold, it was agreed that it was not appropriate to place such restrictions on paracetamol. Members recognised that large numbers of paracetamol tablets could be obtained through pharmacies.

The New Zealand concern with paracetamol was seen as being directed more towards unintentional overdoses for children. This and other safety issues, were seen as best able to be addressed through improved labelling.

Having reviewed the data concerning the reduction of pack sizes in the UK, the Committee agreed that the data was unconvincing in that several changes had taken place at the same time. There was insufficient evidence to justify a reduction in pack size for general sale in New Zealand.

Discussion on labelling issues followed. The Committee agreed that improved labelling was preferable to reduction in pack sizes. Paracetamol was promoted as a safer analgesic than non-steroidal anti-inflammatory agents (NSAIAs) but members agreed that safety issues should be stressed.

The NDPSC Chairperson explained the progress to date with paracetamol labelling issues in Australia and the Australian position regarding paracetamol. She said that the chronic liver problems and impulsive suicides amongst teenage girls were not the same in Australia as for the UK. She felt that the introduction of blister packs in the UK would have had considerable impact in decreasing impulsive suicides. In Australia, paracetamol was pushed very heavily as a safe alternative to NSAIAs and she felt that there would be considerable resistance in Australia to any reduction in pack size. Pack size was not perceived to be a problem in Australia and there would be no safety grounds to justify any reduction. She also pointed out that companies would like to move to a harmonised position and agreed that pack warnings needed to be readdressed.

The Committee then moved on to discuss whether or not to increase paracetamol pack sizes for general sale in order to harmonise with Australia.

The Chairman pointed out that an earlier company submission for harmonisation of general sale pack sizes had been turned down pending the outcome of the British study and that this study had now proven to be unconvincing.

It was noted that the lethal dose of paracetamol was between 10 and 12.5 grams and that an extra 4 tablets in a 10 gram pack would not make an appreciable difference to an outcome. Members agreed that there were two safety issues to be considered in the case of overdose. First was the size of the dose taken and second, the delay in seeking treatment. It was agreed that it was the latter which was critical and once more than one pack had been taken, treatment was needed. Four tablets were not considered to increase the risk.

There had been no public demand for an increase in general sale pack sizes and the Committee agreed that the issue was one of harmonisation for commercial purposes. Most, if not all paracetamol products were manufactured in Australia but packaged separately for the New Zealand market.

Overall the Committee did not have a problem with an increase to harmonise with Australian pack sizes but was concerned about labelling issues. It was agreed that there was considerable misunderstanding about use of paracetamol in multi-ingredient products though it was pointed out that such products currently carried the words 'contains paracetamol'. There was also misunderstanding about the nature of the liver failure resulting from paracetamol poisoning and the fact that overdose did not result in 'drifting off'. Members agreed that these issues needed to be addressed. The issue of alcohol warnings should also be revisited.

The Committee also discussed the matter of multiple pack sales in supermarkets. While it was agreed that supermarkets could be asked to develop codes for the sale of paracetamol, it also agreed that any lessening of availability could drive consumers to increased aspirin use. Changes to the general sale availability of aspirin were not considered feasible.

The Committee agreed that New Zealand should harmonise with Australia by increasing the pack size limits for general sale to correspond with those in Australia. However, this should not take place until new labelling guidelines had been completed in both countries. The paracetamol guidelines currently contained in the New Zealand Regulatory Guidelines for Medicines should be updated and approved by the MCC before the increase in pack size came into effect. Medsafe should approach grocery organisations to suggest that they develop codes for the sale of medicines such as paracetamol and aspirin.

Recommendation

• That New Zealand should increase the maximum pack size for sale of paracetamol as a general sale medicine from 10 grams to 12.5 grams
• That the increase should take place only after the MCC had approved revised labelling requirements
• That Medsafe should ask grocery organisations to consider developing codes for the sale of medicines such as aspirin and paracetamol.

6.

Submissions for reclassification

6.1

Emergency contraceptive pill (ECP) ( morning-after pill)

This was a Medsafe proposal to revisit the possibility of making emergency contraception more widely available. An earlier recommendation had been made by the Committee to grant wider access to the Yuzpe regimen containing both oestrogen and a progestogen. For a variety of reasons this recommendation had not been progressed. Since that time a safer and more readily-tolerated progestogen-only emergency contraceptive containing levonorgestrel had come on to the market and had already been made available over the counter in a number of other countries including France, the UK, Norway and parts of Canada.

The Chairman outlined the events which had taken place earlier including the reactions to public consultation. He said that the issues were mainly moral and the biggest concern was that the product had been considered to be an abortificient. However, he said that, by legal definition, this was not the case. Packaging had been considered to be an important issue at the time and a special pack had been planned along with a public information campaign and a consumer leaflet. He said that, at the time, access for nurses had not been intended. He pointed out that packaging requirements would now have changed and that a suitable company package might already be available. CMI had also come into effect since that time and would provide a suitable vehicle for consumer information.

It was noted that while the ECP was available only to over-16-year-olds in Britain, under-16s had access to contraceptives in New Zealand.

The Committee did not express any doubts about whether or not there should be wider access to the ECP but went on to discuss the possible options for allowing this access.

Pharmacy-only medicine was not considered to provide sufficient control and was not discussed at length.

Restricted medicine was seen as unsuitable in that recording the sale was perceived as providing a barrier to access. This had also been noted in the USA. Nor would this classification allow access to other health professionals such as nurses in schools or specialist clinics.

The Committee agreed that nurses with suitable training should have access to the ECP. This could best be done by maintaining the prescription medicine classification for levonorgestrel but exempting it from that status when used by nominated registered health professionals as had been done for a number of other prescription medicines. Members noted that this form of exemption could not be used in Australia because of differences in legislation. The NDPSC Chairperson pointed out that Australia did not have the same financial barriers to access as medical consultations were mostly free of charge in Australia. She said that the issue of emergency contraception was controversial in Australia and that the political climate was not currently in favour of a move towards wider availability. If New Zealand reclassified the ECP, Australia would choose not to harmonise because of legislative problems. There were no emergency contraceptive products available in Australia.

Although the Committee agreed that nurses should have access to the ECP there was doubt about whether this access should be available to all nurses or only to those with the relevant expertise. The implications of the proposed new nurse prescribing legislation were discussed. One of the members explained how nurses would require accreditation in certain areas before being able to prescribe from a schedule of approved medicines. Progress had already been made towards setting up the accreditation process. This method of accreditation was seen by the Committee as a good way of ensuring that the ECP was prescribed only by nurses with competency in the relevant field. Some issues around supply were still to be resolved.

The Chairman pointed out that there were two different issues to be considered and while independent prescribing rights for nurses would ensure the competency of nurses, their scopes of competency could not be recognised by the medicines legislation when it came to scheduling medicines.

The Committee also discussed the competency of pharmacists to sell the ECP. Members agreed that not all pharmacists were competent to provided the required counselling or had the facilities to do this with an appropriate degree of privacy. There was often a range of other issues such as rape and trauma associated with a need for the product. It was also acknowledged that not all pharmacists would be happy to supply this product even if they were well set up to provide the service. Approximately 30% of all pharmacies were now thought to be able to provide consulting rooms.

Pharmaceutical Society members said that a system of accreditation could be set up so that only those pharmacists who had received accreditation from the Society would be able to sell the ECP. It was thought that a system could be in place early in the following year. As it would not be financially viable for a pharmacist to spend time on one person it was envisaged that a consultation charge would apply in addition to the cost of the product.

An immediate problem was perceived in the use only of accredited pharmacists for the sale of the ECP in that consumers would have difficulty identifying which pharmacies were able to supply the product. Pharmaceutical Society members thought that there would be ways to resolve this issue.

No additional groups of registered health professionals were considered as being appropriate for access to the ECP at this time.

Funding issues were discussed. It was recognised that while the ECP was funded in this country on prescription this was an issue separate from classification. Exempting the ECP from prescription status for nurses would not automatically result in its being funded. Provision by nurses would be on the basis of sale to the consumer. Members noted that the product did not appear to be excessively expensive.

Members discussed whether or not an antiemetic would be required with the levonorgestrel-only regimen. Some members felt that even though the need for this was considerably less than with the Yuzpe regimen, it was desirable that provision should be made for an antiemetic to be available if necessary. Steps should be taken to find out which was the most suitable product for this purpose.

There was general consensus that nurses and pharmacists should be able to dispense the ECP but that it should remain a prescription medicine. In addition, the Committee agreed that only members of those professions who had gained accreditation through their controlling bodies to dispense the ECP should be permitted to do so. While this could not be enforced with current legislation it was thought that this might be possible under the forthcoming Health Professionals Competencies Health Bill.

The Committee discussed the information that would be required to be supplied with the product. The Chairman said that the CMI contained all but one of the requirements of the earlier exercise. CMI did not contain information on how the ECP worked. The Committee felt that the companies supplying ECP products should be asked to include this in their CMIs.

Recommendation

• That there should be wider access to emergency contraception but it should remain a prescription medicine
• That the access should be extended, by means of an exemption to prescription status, to pharmacists and nurses but to no other health professionals
• That only those pharmacists and nurses who had received accreditation from their controlling bodies should be permitted access to the ECP
• That consideration should be given to the provision of a suitable antiemetic
• That companies be asked to reflect the wider usage of the ECP by adopting into CMI information on how the product works

6.2

Paracetamol 665mg modified release tablets.

This was a GlaxoSmithKline submission for reclassification from prescription medicine to pharmacy-only medicine for a new presentation. The company had withdrawn the submission the week before the meeting and no further action was required by the Committee.

6.3

Aconite

This was a Weleda submission for reclassification of alkaloids of aconite from prescription medicine to allow pharmacy-only sale at some strengths and for a change to the level for exemption from scheduling.

The Chairman pointed out that the recent reclassification of aconite and a number of other plants used in herbal medicine to prescription medicine in order to harmonise with the Australian classification, had removed legal access to these for herbalists. The Committee agreed that they wished to allow such practitioners to continue their legitimate business as was undertaken before harmonisation provided there were no relevant safety issues. Members agreed that it should be possible to adopt some kind of scientific framework for the classification of such substances.

The Committee was in favour of the demarcation of pack sizes proposed in the expert report and the expression of cut-off points as a concentration of total alkaloids. Members were also in agreement with the way the cut-off points suggested in the report were calculated on a multiple of the lowest fatal dose and thought this might be used as a basis for a framework for the classification of all herbal medicines. They agreed to apply these to the classification of aconitum species and to consult with the NDPSC and industry on the feasibility of such a framework.

Proposed framework for herbal medicines

Recommendation

• That the following levels of classification should be applied for aconitum species:

• That the NDPSC should be informed of the above recommendations for the classification of aconite
• That interested bodies, particularly those with an interest in the medicines for which exemption from prescription status had been sought (under agenda item 8.1.4) should be given an opportunity to comment on the proposed framework.

6.4

Belladonna

This was a Weleda submission for modification to the current cut-off points for restricted and pharmacy-only medicines and a change to the exemption from scheduling.

The Chairman said that the NDPSC had made a recommendation for the consistent classification of the belladonna alkaloids and that the recommendation could be expected to be considered by the MCC at the next meeting. For this reason, he thought that consideration of the Weleda submission should be postponed until it could be considered in the light of the NDPSC recommendation. The Committee agreed to this course of action. No recommendation was required at this stage.

6.5

Hydrocyanic acid

This was a Weleda submission for reclassification from prescription medicine to allow pharmacy-only sale at some strengths and for a change to the level for exemption from scheduling.

The Committee considered the expert report commissioned by Medsafe. Members agreed that the framework, as discussed under the item on aconite (see 6.3 above) should be applied. The toxic adult dose was noted as being 50mg. This would mean that, to fit with the framework, packages for sale as pharmacy-only medicines should contain no more than 5mg of hydrocyanic acid and general sale medicines should contain no more than 0.5mg of hydrocyanic acid.

The Committee noted that the cut-off levels for the proposed framework were 1 milligram higher for pharmacy-only medicine than that requested by Weleda and recommended in the expert report but that the general sale cut off point was only half of the amount recommended in both documents.

Recommendation

• That hydrocyanic acid should have the following classification:
  
  Prescription medicine except when specified below
  Pharmacy-only medicine for oral use in packs containing not more than 5mg of hydrocyanic acid
  General sale medicine for oral use in packs containing not more than 0.5mg of hydrocyanic acid
  
  
• That the NDPSC should adopt the above classification of hydrocyanic acid.

6.6

Hyoscine, hyoscyamine, hyoscyamus

This was a Weleda submission for amendments to the schedule entries for hyoscine and hyoscyamine and to their proposed exemption limit and for additional, consistent entries for hyoscyamus.

The Committee agreed that, as these medicines would be included in the NDPSC recommendation covering belladonna alkaloids, a recommendation should be postponed until the NDPSC recommendation could be considered. No recommendation was required at this stage.

6.7

Sabadilla

This was a Weleda submission for reclassification from prescription medicine to allow pharmacy-only sale at some strengths and for a change to the level for exemption from scheduling.

Medsafe had commissioned an expert report for this medicine. However, the report had not been available in time for the meeting and it was agreed that the matter should be postponed until the next meeting. The chairman said that the Committee could also expect a further recommendation on sabadilla from the NDPSC and that the Weleda submission would best be considered along with this recommendation.

The Committee agreed to postpone this item until the next meeting.

7.

New Medicines for classification

The Committee considered the information provided by the Medicines Assessment Advisory Committee secretariat for the classification of the following new chemical entities:

Acamprosate
Agalsidase alfa
Anakinra
Caspofungin acetate
Dienogest
Drospirenone
Eflornithine HCl
Ertapenem sodium
Lanreotide
Modafinil
Piracetam
Rifapentine
Tiotropium
Verteporfin
Voriconazole
Zoledronic acid

Members agreed that, in view of their indications and as these were new chemical entities, most should be classified as prescription medicines.

However, the Committee considered that there was insufficient information available to classify eflornithine hydrochloride as a prescription medicine. While it was noted that the company making the application had not appeared to request an OTC classification, the Committee wanted further information about whether or not the medicine had been available in other countries for any period of time and whether or not safety data would justify an OTC classification.

Recommendation

• That the following be classified as prescription medicines:
  Acamprosate
  Agalsidase alfa
  Anakinra
  Caspofungin acetate
  Dienogest
  Drospirenone
  Ertapenem sodium
  Lanreotide
  Modafinil
  Piracetam
  Rifapentine
  Tiotropium
  Verteporfin
  Voriconazole
  Zoledronic acid
• That further information should be sought about whether or not eflornithine hydrochloride was suitable for classification as an over-the-counter medicine.

8.

Harmonisation of NZ and Australian schedules

8.1

Outstanding harmonisation issues

8.1.1

Prescription medicines in Australia which should be added to the New Zealand schedule

The following medicines had been recommended for inclusion in the New Zealand schedule as prescription medicines but had not yet been considered by the Committee:

ambucetamide
octatropine
phenthimentonium bromide
pipenzolate
piperidolate
tigloidine

It was noted that there were no medicines registered in New Zealand containing any of these substances. The Committee recommended that, in accordance with the agreed principles of harmonisation, these medicines should be added to the New Zealand schedule.

Recommendation

That the following medicines should be added to the New Zealand schedule as prescription medicines:

ambucetamide
octatropine
phenthimentonium bromide
pipenzolate
piperidolate
tigloidine

8.1.2

Anticholinergics recommended for change from restricted medicine to prescription medicine

The following anticholinergics were classified as restricted medicines:

adiphenine
ambutonium bromide
benzilonium bromide
hexocyclium methylsulphate
mepenzolate
methanthelinium bromide
oxybutinin
oxyphencyclimine
oxyphenonium bromide
penthienate
tiemonium iodide
tricyclamol
tridihexethyl

However, the Committee noted that oxybutinin tablets and syrup would be the only products registered in New Zealand to be affected by a classification change. No company comment had been received about the proposed change of classification for these products. Members agreed that the indications for these medicines would be more appropriately dealt with under medical supervision.

It was noted that a mechanism should be set in place for notifying those responsible for maintaining the nurse prescribing schedules of changes in classification as access for nurse prescribing could be affected by changes between prescription and OTC status.

Recommendation

That the following anticholinergics should be reclassified from restricted medicines to prescription medicines:

adiphenine
ambutonium bromide
benzilonium bromide
hexocyclium methylsulphate
mepenzolate
methanthelinium bromide
oxybutinin
oxyphencyclimine
oxyphenonium bromide
penthienate
tiemonium iodide
tricyclamol
tridihexethyl

8.1.3

Clidinium bromide

The NDPSC had recommended that New Zealand change from pharmacy-only to prescription medicine. The Committee noted that there would be no regulatory impact from such a change as the only product registered in New Zealand also contained a controlled drug which determined its classification.

Recommendation

That clidinium bromide be reclassified from pharmacy-only medicine to prescription medicine.

8.1.4

Herbal medicines for which exemption from prescription status had been requested

Various members of the complementary medicines sector had requested a delay in implementing the earlier recommendation to classify the medicines listed below as prescription medicines. Those who requested a delay and any other interested bodies were asked to submit safety data to support a concentration at which these medicines would be safe for general sale. The medicines were:

acorus calamus
amygdalin
borago officinalis
eupatorium cannabium
juniperus sabina
senecio
symphytum
tussilago farfara
petastes
pteridium

Although some responses had been received, a further delay had been sought from some parties.

Having formulated a basis for a framework for the classification of herbal medicines during the discussion on aconite, the Committee felt that that framework could now be applied to the above medicines. It was agreed that interested parties should be asked to make proposals for cut-off levels within the proposed framework. The matter should be resolved at the next meeting and no further delays should be incurred. The NDPSC should be informed of the proposal to set up a framework for the classification of herbal medicines and notified about the further delay in harmonising on the classification of these medicines.

Copies of two near-identical letters requesting a review of the way in which herbal medicines were regulated, were tabled during the meeting together with a response from Medsafe. The Committee was informed that although the form letters were addressed to the MCC the requests made in these letters and another already included in members' agenda papers, were not within the terms of reference of the Committee. However, Medsafe had responded and the response had been included for the Committee's information.

Recommendation

• That bodies with an interest in the sale of the following medicines should make proposals for appropriate cut-off levels for these medicines within the proposed framework:

acorus calamus
amygdalin
borago officinalis
eupatorium cannabium
juniperus sabina
senecio
symphytum
tussilago farfara
petastes
pteridium

Proposals should be submitted to the Committee secretary by 31 July 2001 which is the closing date for the next meeting

• That the NDPSC should be informed about the proposed framework for the classification of herbal medicines and should be asked to comment.

8.1.5

Injectable medicines and related changes

The Committee had agreed early in the harmonisation process to harmonise with Australia on the classification of injectable medicines which were prescription medicines in Australia but which were classified differently in New Zealand. This was now considered to be almost complete in that such differences had mostly been identified and addressed through NDPSC recommendations about individual medicines.

Medsafe had undertaken a project to identify those injectables which were not harmonised and to seek ways of harmonising. The results of this project had been presented to the Committee and were summarised in 4 categories. These were:

1. Changes already implemented.
   These included contrast media and plasma volume expanders which were exempt from scheduling in Australia. All active ingredients had been identified and reclassified as general sale medicines in order produce an end-result similar to exemption from scheduling. In addition, an exemption from pharmacy-only status had been added to the pharmacy-only entry for injectables in the schedule in order to allow these medicines to become general sales items. While it was agreed that the generic entry for injectable medicines would need to be removed from the schedule by the end of the process it was necessary for it to remain in order to maintain the current classification of those medicines which were still to be considered.
2. Changes to be considered at the current meeting.
   These were changes identified in the Medsafe project which were still to be made which had already undergone consultation through the normal process.
3. Changes to be considered at a later date.
   These were for vitamin and mineral injections. Although the NDPSC had recommended that these change to general sale medicines, some of the issues raised during the harmonisation process had caused the NDPSC to wish to reconsider the classification of these injections. It was agreed that the current New Zealand classifications should be maintained meanwhile.
4. Injectable medicines which may remain unharmonised.
   These were blood products except for factor VIII which were prescription medicines in New Zealand but were exempt from scheduling in Australia.

Changes to be considered at the 25^th meeting

Acetylcysteine
The NDPSC had recommended that this should become a prescription medicine. Medsafe had noted that acetycysteine was present as an excipient in some contact lens preparations and that a general sale category would be necessary for external use. The Committee agreed to this proposal.

Alcohol
During the course of the injectable project, Medsafe had identified injections containing 96% and 100% alcohol. Other injectable products were infusions containing not more that 10%. The high concentration injections were not considered suitable for general sale. The Committee agreed that high-concentration alcohol injections should be prescription medicines. They agreed that the cut-off point of 20%, as proposed by Medsafe, would allow sufficient leeway for other infusion which might be introduced.

Cyclizine
The NDPSC had recommended that cyclizine for injection should become a prescription medicine. The Committee agreed that this was a more appropriate classification for the injectable dose form.

Factor VIII
This had been classified less restrictively than other blood products for ease of access. As blood products were exempt from scheduling in Australia, the Committee saw no reason why Factor VIII should not be reclassified as a general sale medicine in order to achieve a level of access similar to that in Australia. It was recognised that an exemption statement would need to be added to the pharmacy-only injectable medicine entry in the schedule until such time as that entry could be removed from the schedule.

Fluorescein
The NDPSC had recommended that fluorescein be deleted from the New Zealand schedule. However, Medsafe had identified two injectable eye products which it did not consider appropriate for general sale. The Committee agreed that injectable fluorescein should be classified as a prescription medicine but they were happy for all other dose forms to be general sale medicines in accordance with the NDPSC recommendation considered at the 24^th meeting.

Hyaluronic acid
During the course of the Medsafe injectables project, this was identified as a medicine which would need to be reclassified from pharmacy-only to prescription medicine when for injection. The Committee was happy for other dose forms to become general sale medicines in order to harmonise with Australia.

Nutrition replacement preparations for parenteral administration
This was another group of medicines which was exempt from scheduling in Australia and which would require reclassification to general sale in New Zealand in order to harmonise on the level of access. Medsafe had already identified any classified medicines which were contained in these preparations and had exempted them from their classification status when used in this way. However, it was necessary to add an exemption to the pharmacy-only entry for injectables while it remained in the schedule in order to put the change into effect. The Committee noted that large volume parenterals were already exempt in New Zealand from carrying a classification statement and that the change should have no effect on the labelling of these products. Members agreed to proceed with the change.

It was also noted that the only injectable medicines which would now be covered by the pharmacy-only generic entry were vitamins and mineral injections which were not nutrition replacement preparations. The NDPSC was to consider these injections in the near future. The MCC agreed to wait for a recommendation about these before giving further consideration to these medicines.

Promethazine
The Committee agreed that, as for cyclizine, promethazine was more appropriately classified as a prescription medicine when for injection.

Trometamol
The NDPSC had recommended that trometamol be reclassified as a prescription medicine when for injection. However, Medsafe had recognised that trometamol was contained as an excipient in a number of injectable medicines which had recently moved to general sale, particularly contrast media. The matter had been deferred at the 24^th meeting while an appropriate cut-off point was found below which trometamol could become a general sale medicine. Medsafe had now proposed a cut-off point of 3% and above which was well clear of the highest excipient level of 1.2% and which would allow trometamol injections at 3.5% to be classified as prescription medicines. The Committee agreed to this cut-off point.

Recommendations

• That acetylcysteine should be reclassified from pharmacy-only medicine to prescription medicine except for external use which should become general sale medicine.
• That alcohol should be come a general sale medicine except when in injections containing more than 20% which should become prescription medicines.
• That cyclizine should become a prescription medicine when for injection.
• That Factor VIII should be removed from the schedule as a pharmacy-only medicine and a statement should be added to the pharmacy-only entry for injectable medicines in order to allow Factor VIII to be sold as a general sale medicine.
• That fluorescein should be reclassified to prescription medicine when for injection and all other dose forms should be general sale medicines
• That hyaluronic acid should become a prescription medicine when for injection but other dose forms should move from pharmacy-only to general sale.
• That an exemption should be added to the pharmacy-only injectable medicines entry in the schedule to allow nutrition replacement preparations for parenteral administration to be sold as general sale medicines.
• That promethazine should become a prescription medicine when for injection.
• That trometamol should become a prescription medicine when in injections containing 3% or more. All other strengths and dose forms should be general sale medicines.

8.1.6

Pseudoephedrine harmonisation of pack sizes.

The Australian upper pack size limit for uncompounded tablets was noted as being 30 dose units of 60mg or less each rather than 60 dose units as considered at the previous meeting. There were known to be a large number of tablets and capsules containing pseudoephedrine currently on the market. However, it was not known how many of these contained more than 30 dose units. No comments had been received from companies who might be affected by a limit of 30 dose units. The Committee agreed to harmonise over pack size with Australia.

Recommendation

That pseudoephedrine be classified as a pharmacy-only medicine when in solid dose form with no other active ingredient, containing 60 milligrams or less per dose and in packs containing not more than 30 tablets or capsules.

8.1.7

Salbutamol and terbutaline Harmonisation of inhaled and oral dose forms

The NDPSC had recommended a harmonised position for the classification of salbutamol and terbutaline. The recommendation included moving the oral dose forms from restricted medicine in New Zealand to prescription medicine to harmonise with the Australian position. The recommendation also included moving inhaled forms of salbutamol and terbutaline from prescription medicine to restricted medicine.

During the consultation process there had been little opposition to moving oral forms to prescription medicine. The Committee was mostly in agreement given the concerns about the toxicity of high doses and Australian experience of abuse of oral dose forms. It was noted that no evidence of such abuse had become apparent in New Zealand. One member expressed the view that there was a case for allowing pharmacists to sell salbutamol elixir for short-term emergency situations. However, the member agreed for consensus with the rest of the Committee on making oral forms of both medicines available only on prescription.

However, there had been overwhelming objections raised during the consultation process from asthma experts and other interested bodies to the proposal to make inhaled dose forms of salbutamol and terbutaline available over the counter. Even the Thoracic Society of Australia and New Zealand had supported maintaining prescription status in New Zealand for these medicines.

While the Chairman pointed out that New Zealand had agreed to harmonise to the least restrictive classification and that no evidence of harm had become evident over a long period of OTC sale in Australia, the Committee felt that the New Zealand situation was different from that in Australia in a number of aspects. Most importantly, it was agreed that disease rates were different in the two countries. Members noted that Australia had not experienced the problems that New Zealand had experienced with fenoterol.

The NDPSC Chair was asked about rates of OTC sale in Australia. She replied that these varied and outlined the Australian system where OTC usage was linked to a number of issues, some of which related to cost.

It was noted that medical consultations were free of charge in Australia so that cost did not provide a barrier to correct asthma management. It was widely felt that OTC availability in New Zealand could lead to bad asthma management in that asthma suffers might be tempted to rely solely on salbutamol or terbutaline rather than incur the cost of a medical consultation required to obtain a steroid. It was also noted that the medicines could not be purchased in small amounts as would normally be considered appropriate for OTC sale but were available as 200 doses.

Another member pointed out that a restricted medicine classification would not provide access for specialist nurses in asthma clinics although it would allow pharmacists with no particular expertise in that area to sell products. Retention of the prescription classification would allow access to these medicines for suitably accredited nurses under the nurse prescribing scheme.

The Committee noted that most of the studies quoted in support of OTC availability had been conducted in the 1980s and that views had since changed on the use of steroids for asthma management. One member suggested that it might be more appropriate for beclomethasone to be made available OTC for asthma management. Members felt that, rather than demonstrate safe and appropriate use of OTC salbutamol, the papers quoted in support of the use of salbutamol alone tended to demonstrate rather that patients who used OTC salbutamol tended to undertreat their asthma.

Members agreed to harmonise with Australia by reclassifying oral forms of salbutamol and terbutaline from restricted medicine to prescription medicine. However, they were strongly of the opinion that New Zealand should not harmonise on the OTC availability of inhaled dose forms of salbutamol and terbutaline and that these should remain prescription medicines in this country.

Recommendation

• That oral dose forms of salbutamol and terbutaline should be reclassified from restricted medicines prescription medicines
• That inhaled dose forms of salbutamol and terbutaline should remain classified as prescription medicines
• That the NDPSC should be informed that the MCC had opted not to harmonise with Australia on the classification of inhaled salbutamol and terbutaline because of differing disease rates and means of access to treatment between the two countries.

8.1.8

Trichloroacetic acid

The Pharmaceutical Society had not supported the NDPSC recommendation made at the previous meeting to remove trichloroacetic acid from the schedule on the grounds that the raw chemical was thought to be used for therapeutic purposes such as skin peeling and the removal of tattoos.

The secretary had written to the Pharmaceutical Society as agreed at the previous meeting, requesting evidence in support of the Society's view. The society had not produced evidence to support a retention of the pharmacy-only classification Reference to Martindale confirmed that adverse effects were as for hydrochloric acid which was unscheduled.

Recommendation

That trichloroacetic acid should be removed from the schedule.

8.2

Recommendations made by the NDPSC to the MCC in August 2000

8.2.1

Loperamide

The NDPSC recommended that the pharmacy-only entry be amended to limit pack sizes to a maximum of 20 dosage units.

The Committee noted that there were 6 products on the market, some in several pack sizes, so that there were 19 different presentations. Approximately 50% of these pack presentations contained more that 20 tablets and would become prescription medicines. Members agreed that this was an appropriate classification for larger pack sizes.

Recommendation

That the pharmacy-only schedule entry be amended to limit pack sizes to a maximum or 20 dose units.

8.2.2

Triamcinolone acetonide nasal sprays

The NDPSC recommended that these should be moved from prescription medicine to restricted medicine when for the short-term treatment or prophylaxis of seasonal allergic rhinitis in adults and children 12 years and over when in aqueous nasal sprays delivering 55 micrograms or less per actuation when the maximum recommended daily dose was 220 micrograms and the pack contained a maximum of 120 actuations.

The Committee agreed that this would bring triamcinalone acetonide into line with other corticosteroid nasal sprays. It noted that, although there was a product registered in New Zealand, the company had made no comment on the recommendation.

Recommendation

That triamcinolone should be classified as a restricted medicine when for the short-term treatment or prophylaxis of seasonal allergic rhinitis in adults and children 12 years and over when in aqueous nasal sprays delivering 55 micrograms or less per actuation when the maximum recommended daily dose was 220 micrograms and the pack contained a maximum of 120 actuations

8.3

Recommendations made by the NDPSC to the MCC in November 2000

8.3.1

Lithium

The NDPSC recommended that the pharmacy-only entry be amended to allow preparations containing 0.01% or less to become unscheduled medicines.

The Committee noted that the current classification was pharmacy-only for medicines for dermal use containing 1% or less. New Zealand did not have any medicines registered with a concentration of 0.01% or less but members agreed to amend the entry so that it harmonised with Australia.

Recommendation

That the pharmacy-only entry be amended to allow preparations containing 0.01% or less to become unscheduled medicines.

8.3.2

Acetylcysteine

The NDPSC had recommended that acetylcysteine be classified as a prescription medicine except for oral use which should be pharmacy-only. This had been partly dealt with under the item on injectable medicines. New Zealand had no products for oral use but the Committee agreed that this use should remain pharmacy-only in the interest of harmonisation. Members had also noted during the item on injectable medicines, that an exemption from scheduling for external use would be required to allow acetylcysteine to be used as an excipient in a number of contact lens products.

Recommendation

That acetylcysteine should be classified as a prescription medicine when for injection or inhalation, a pharmacy-only medicine when for oral use and should become a general sale medicine when for external use.

8.3.3

Glyceryl trinitrate, isosorbide dinitrate

Glyceryl trinitrate
The NDPSC recommended that transdermal patches should be moved to prescription medicine along with injections while oral, dermal and rectal preparations retained their pharmacy-only classification. There had been support for this from one of the sponsor companies.

The Committee agreed to accept the recommendations of the NDPSC.

Isosorbide mononitrate
The Chairman explained to the Committee that it had been the intention for the NDPSC to recommend that isosorbide mononitrate should become a prescription medicine at all strengths but that the recommendation had somehow been omitted and had not been received in New Zealand. He said that the company with sole marketing rights in New Zealand had since been contacted and was happy for a change to prescription medicine to occur. The Committee agreed that the indications for which this medicine was used were not suitable for OTC treatment.

Recommendations

• That glyceryl trinitrate in injections and transdermal patches should become prescription medicines
• That glyceryl trinitrate in oral and rectal preparations should remain pharmacy-only medicines
• That isosorbide dinitrate should become a prescription medicine except in oral preparations containing 10mg or less per dose unit
• That isosorbide dinitrate should remain pharmacy-only medicine in oral preparations containing 10 mg or less per dose unit
• That isosorbide mononitrate should become a prescription medicine

8.3.4

Isoetharine

The NDPSC recommended that New Zealand adopt the INN, isoetarine and delete the restricted medicine entry so that all dose forms become prescription medicines. The Committee noted that there were no longer any products registered in New Zealand containing isoetharine and agreed to the recommendation.

Recommendation

• That the entry for isoetharine be amended to isoetarine
• That the restricted medicine entry be deleted so that all dose forms become prescription medicines

8.3.5

Rimiterol

The NDPSC recommended that the restricted medicine entry be deleted from the New Zealand schedule so that all dose forms became prescription medicines. The Committee noted that there were no rimiterol products in New Zealand which were restricted medicines and agreed to the deletion.

Recommendation

That the restricted medicine entry for rimiterol be deleted from the schedule and that the prescription medicine entry be amended accordingly.

8.3.6

Isoprenaline

The NDPSC recommended that the pharmacy-only entry be deleted from the New Zealand schedule so that all dose forms became prescription medicines. The Committee noted that there were no isoprenaline products which were registered as pharmacy-only medicines in New Zealand and agreed to the deletion.

Recommendation

That the pharmacy-only medicine entry for isoprenaline be deleted from the schedule and that the prescription medicine entry be amended accordingly.

8.3.7

Salcatonin

The NDPSC recommended that salcatonin be add to the schedule as a prescription medicine.

The Committee noted that Medsafe had previously considered the calcitonin entry to provide adequate cover for all types of calcitonin. It also noted that salcatonin was a BAN but not an INN If specific names for different kinds of calcitonin were to be added to the schedule it was considered consistent to add all such names. However, to date elcatonin (eel calcitonin) appeared to be the only calcitonin to have been allocated an INN. In the interest of harmonisation the Committee agreed that salcatonin should be added to the schedule.

Recommendation

That salcatonin be added to the schedule as a prescription medicine.

8.3.8

Tasonermin

The NDPSC recommended that tasonermin should be added to the New Zealand schedule as a prescription medicine. Tasonermin was a new chemical entity for which new medicine application had been withdrawn in New Zealand. The Committee agreed that it should be returned to the schedule as a prescription medicine.

Recommendation

That tasonermin should be added to the schedule as a prescription medicine.

9.

For the next meeting

No new medicines for possible classification changes were suggested at this point.

One member proposed that consideration be given to the matter of access to restricted medicines by specialist-type nurses in clinic settings for the treatment of such conditions as asthma and diabetes.

10.

General business

There were no items of general business.