Revised: 23 May 2013

Committees

Minutes of the 30th meeting of the Medicines Classification Committee - 26 November 2003

Notes relevant to the minutes of the 30th meeting of the Medicines Classification Committee

The Minister's Delegate has accepted all but one of the MCC recommendations made at the 3Oth meeting.

Ibuprofen

The MCC has recommended that all 200 milligram solid dose oral ibuprofen should remain classified as pharmacy-only medicine.

Medsafe has submitted alternative advice to the effect that 200 milligram solid dose forms of ibuprofen should be made available as general sale medicines in packs of not more than 25 tablets when sold in the manufacturer's original pack and bearing appropriate warning statements to be specified in Section 12 to Part 1 of the New Zealand Regulatory Guidelines for Medicines.

After seeking an independent review of both sets of advice, the Minister's Delegate has accepted the recommendation to reclassify 200 milligram ibuprofen tablets to general sale when labelled and packaged in accordance with the conditions required by Medsafe.

Held in the Medsafe Meeting Room, 18th Floor, Grand Plimmer Tower, Wellington. Commencing at 9:30am.

Present

Dr S Jessamine (Chair)
Ms F Hughes
Mrs A Shirtcliffe
Dr T Bevin
Mrs C Smith (Secretary)

1. Welcome

The Chairman welcomed members to the 30th meeting and thanked those members whose term of office had expired for continuing in office until new members could be appointed. He said that nominations for new members had now been received and the appointment process was able to proceed.

2. Apologies

Apologies were received from Dr Wardrope and Mr McKone.

3. Confirmation of the minutes of the 29TH meeting

The minutes of the 29^th meeting were confirmed as an accurate record of that meeting and were signed by the Chairman.

4. Declaration of conflict of interests

There were no conflicts of interest declared which could be considered prejudicial to matters to be discussed at the meeting.

5. Matters Arising from the 29th meeting

5.1 Correspondence with Pharmac re access to antiemetics

Pharmac had responded to the Committee's request for easier access to antiemetics for use in palliative care by requesting more specific information.

The Committee did not wish to be involved in the debate about which antiemetics were appropriate for caring for the terminally ill. However, they were aware that some newer and perhaps more effective antiemetics were not funded by Pharmac. It was agreed that the secretary should respond to Pharmac asking that it consult with clinicians working in the area of palliative care to ensure that the most effective antiemetic medicines were made available.

5.2 Correspondence with Pharmaceutical Society re Buccaline

The Pharmaceutical Society had responded to the Committee's request for inclusion of Buccaline in the Self Care programme explaining that it was not feasible to proceed with the Committee's request. However, subsequent email correspondence was tabled at the meeting in which it became evident that it might be possible to incorporate warnings into the Self Care card on colds about products for the prophylaxis of colds and flu being unsuitable for vaccination against influenza.

It was agreed that the secretary should follow up on this in a letter to the Pharmaceutical Society.

6. Submissions for reclassification

6.1 Beclomethasone and fluticasone
(Beconase Hayfever Aqueous Nasal Spray, Flixonase Aqueous Nasal Spray, GlaxoSmithKline)

This was a company submission for reclassification from restricted medicine to pharmacy-only medicine when for the short-term treatment or prophylaxis of allergic rhinitis.

The Committee agreed that this item should be considered in conjunction with agenda items 8.5.5 and 8.5.6 which contained recommendations from the NDPSC for a similar change to the classification of budesonide and mometasone aqueous nasal sprays.

One aspect of the proposed reclassification which posed an element of concern was the possibility of repeated use for longer than the three-month term specified. However, it was noted that retention of the restricted medicine status would not necessarily ensure compliance with short-term use as consumers did not always shop at the same pharmacy. Members agreed that seasonal rhinitis was not perceived as a serious health issue and that prolonged use would inevitably occur. However, this issue had been covered in the package insert requirements and the level of access was unlikely to have a large impact on use patterns.

Ease of diagnosis was considered. Members agreed that this aspect had already been covered when the products had moved to restricted medicine. Pharmacist advice would still be available at pharmacy-only level if required. The three main questions which consumers needed to consider were adequately dealt with in the package instructions and did not need to be asked by a pharmacist. These related to whether or not the product had been used before, for how long the product had been used and whether there was any fever or bleeding.

The possibility of misdiagnosis was also considered. This too was considered to be adequately covered in the package information requirements which contained clear instructions about what to do if the product did not work. The Committee felt that consumers were unlikely to continue using a product which did not work. Nasal blockages were likely to occur in children younger than 12 years and were usually accompanied by discharge. If the condition was caused by nasal polyps, corticosteroids were the correct treatment so harm would not ensue.

There was some concern about use with inhaled steroids. Although systemic absorption was known to be low, there was concern that absorption could be just sufficient to cause problems for those already using inhaled steroids for asthma prevention. Members thought that the packaging should be quite specific about use with other steroid products as consumers did not always know what these were and that clear wording such as "some asthma prevention inhalers" should be used. This requirement should be included in the NZ Regulatory Guidelines for the labelling of OTC nasal corticosteroids.

Possible reduction of growth velocity was considered likely to be more of a concern in children under 12 years and therefore not relevant to the products under consideration. Otherwise, the group of medicines was recognised as having a good safety profile.

The Committee noted that, while strong reliance was being placed on packaging instructions, it had been demonstrated in the ibuprofen study provided in a submission later on the agenda, that consumers do read package information. Members agreed that, in order to be approved for pharmacy-only sale, the labelling should be required to be tested against the Australian guidelines for understandability.

The Committee concluded that these medicines should be reclassified to pharmacy-only on the condition that the labelling complied with the two points identified above.

Recommendation

• That beclomethasone, fluticasone, mometasone and budesonide should each be reclassified from restricted medicine to pharmacy-only medicine when in aqueous nasal sprays for the short-term treatment or prophylaxis of allergic rhinitis when:
  • sold in the manufacturer's original pack which has received the consent of the Minister or the Director-General to its distribution as a pharmacy-only medicine
  • labelled to comply with the Australian guidelines for understandability
  • labelled with clear warnings about use with other steroids for asthma prevention.

6.2 Buccaline (Pharmabroker Sales)

This was a company submission for the reclassification of pneumococcal vaccine and haemophilus influenzae vaccine from restricted medicine to pharmacy-only medicine when in oral vaccines for the prophylaxis of bacterial complications of colds in order to allow Buccaline to be marketed as a pharmacy-only medicine.

The Committee was of the opinion that the company demonstrated little understanding of its reasons for classifying the product as a restricted medicine. The Committee's concerns were around public perception of the product as an alternative to influenza vaccination and its possible use as such by at-risk consumers. However, members felt that the company submission had failed to address these issues. Instead it had attempted to further a case for efficacy. While promising not to advertise prevention of influenza, the company provided papers in the submission to support the prevention of influenza.

The Committee agreed that, despite company claims to the contrary, advertising had given the impression that Buccaline would prevent or lessen colds and 'flu. This impression was particularly strong amongst older people. Members were of the opinion that many consumers did not distinguish between colds and 'flu or between viral and bacterial infections. Misconceptions about the product were particularly evident in general practice where older consumers who were offered influenza vaccine were refusing on the grounds that they had already used Buccaline instead.

The Committee was informed that a major airline company had contacted Medsafe earlier in the year seeking advice on whether Buccaline could be used for its annual influenza vaccine programme. It appeared that many employees had asked to use Buccaline in favour of influenza vaccine.

It was noted that sales volumes for Buccaline had increased when influenza vaccine was promoted. The Committee speculated on whether or not there might also have been an increase in sales during the SARS alert.

As at earlier meetings, members had no concerns about safety of the product though they had seen no convincing evidence that it was efficacious. Nor were they concerned with matters relating to packaging. Their concern remained with consumer confusion and potential use of the product by at-risk consumers and with the fact that the company had failed to try and address these issues.

The Committee rejected the company submission to reclassify Buccaline to pharmacy-only medicine on public safety grounds on the basis that while it promised not to promote the product for flu prophylaxis the company continued to talk about the prevention of influenza. This undermined the Committee's opinion that the company would not continue to promote the product for the implied prophylaxis of influenza.

Recommendation

That there be no change to the current restricted medicine classification of pneumococcal vaccine and haemophilus influenzae vaccine.

6.3 Ciclopirox (Stieprox Liquid, Stiefel)

This was a company submission for an increase from 1% to 2% for the pharmacy-only classification of topical ciclopirox. The product in question was a shampoo.

The Committee explored issues relating to the possible general sale classification of creams in the 1% -2% range if the change were to be implemented on the grounds that these would have longer contact with the skin than a shampoo. However, it was noted that any such product would be required to demonstrate safety at that level of classification if application were sought for consent to market.

Issues relating to resistance were also discussed and it was noted that, while very little research had been done in this area, there was thought to be a certain degree of resistance. However, it was considered to be insufficient to justify a recommendation not to implement the requested change.

Use for treatment of the wrong condition was dismissed as consumers would be unlikely to continue using a product which did not work.

The degree of anti-inflammatory activity associated with the product was considered as being of possible value in the treatment of dandruff.

The Committee agreed to the change.

Recommendation

That the classification of ciclopirox for external use should be changed to allow products containing 2% or less to be sold as pharmacy-only medicines.

6.4 Ibuprofen 200 milligram tablet (Boots Healthcare)

This was a company submission for reclassification from pharmacy-only to general sale in packs containing not more than 25 tablets.

It was noted that the NDPSC had recently adopted the above classification change.

Most members were not in favour of the proposed change in classification. They saw the availability of aspirin as insufficient justification for moving other anti-inflammatory medicines to general sale and felt that a precedent would be set for other medicines in this class.

The Committee felt that there was already a good selection of aspirin and paracetamol products available at supermarket level and did not perceive a need for an alternative analgesic product. Nor were members happy about the possibility of promotional specials through supermarket outlets.

Without the availability of pharmacist advice at the point of sale, members expressed concern about use by the elderly. They felt that there was potential for interactions with other medicines, in particular warfarin, and that certain interactions could lead to renal problems. Although relevant warnings were included in the package information, the Committee was not convinced that the warning statements were adequate for the proposed level of classification.

They were also concerned about gastro-intestinal side-effects, particularly in the elderly. One member commented that these were often misperceived to be a normal result of the use of anti-inflammatory medicines and were therefore under-reported.

Adverse reaction reporting was considered not to be a good indicator for ibuprofen. Although there was comprehensive adverse reaction reporting for newer medicines, this was not the case for older medicines. Nor was adverse reactions reporting considered to be a good vehicle for monitoring OTC use.

The Committee had earlier agreed that, in order to become general sale medicines, any submissions for new analgesics should be accompanied by a 'real world' study of OTC use on a self-selected basis. It was noted that the company had attempted to address this. While adverse reaction reports indicated no great change, there had been no actual implementation studies done in either USA or the UK where ibuprofen was available on general sale.

Members also thought that, at the dose and duration recommended for general sale, the anti-inflammatory effects of ibuprofen would be minimal and they were not convinced that the benefits associated with ibuprofen outweighed its risks as an analgesic at general sale level. They concluded that while general sale classification was not associated with a significant increase in adverse reactions, they would require a 'real world' study based on consumer self-selection without professional intervention or oversight before recommending a change to a lower level of classification. In addition, they were not satisfied that issues relating to interactions and increased risk in the elderly could be addresses by labelling alone and that access to professional advice was essential.

Recommendation

That there be no change to the current classification of ibuprofen.

Note that the Minister's Delegate did not accept the above recommendation.

6.5 Ketotifen eye drops 0.025% (Zaditen, Novartis)

This was a company submission for reclassification from prescription medicine to pharmacy-only medicine for ophthalmic use.

The Committee took into account the fact that the product was not yet available over the counter elsewhere though application had been sought for sale at this level in some Nordic countries. Members also noted that, apart from Japan, the product appeared to have received consent to market relatively recently in most of the countries in which it was currently marketed. It was noted that Japan did not have a good record of adverse reactions reporting.

Members felt that to date there did not appear to be sufficient in-use data to ensure that ketotifen was of comparable safety to other pharmacy-only antihistamines used in the eye. With this in mind they were reluctant to recommend a pharmacy-only classification. However, they agreed that the safety profile was sufficient for them to give favourable consideration to a period of sale with pharmacist monitoring if the company wished to make a submission for sale as a restricted medicine.

Recommendation

That there be no change to the current prescription medicine classification of ketotifen.

6.6 Phenylephrine (Wyeth Consumer Healthcare)

This was a company submission for the reclassification of phenylephrine to accommodate solid dose forms. The current schedule entry was intended to apply to liquid dose forms. The submission proposed a cut-off point of 10 milligrams or less per dose form for general sale and a pharmacy-only classification for solid dose forms containing more than 10 milligrams. There was no change proposed for the current liquid dose forms or for nasal or ophthalmic use.

Members agreed that as the half-life of phenylephrine was shorter than pseudoephedrine it was likely to be not as effective as a decongestant as pseudoephedrine. Despite differences in their pharmacology both medications had similar: side effect and safety profiles, contra-indications for use and interactions with other medicines.

The Committee noted the claim that it was technically difficult to convert phenylephrine to methamphetamine and that there was no record of methamphetamine being manufactured illicitly from phenylephrine in Australia. However, no data was presented demonstrating conclusively that conversion to methamphetamine was not possible. The Committee considered that a number of factors such as the availability of pseudoephedrine and other precursors, would determine whether phenylephrine would become a possible starting material for illicit methamphetamine manufacture. Members were reassured that the steps taken by pharmacists to limit access to pseudoephedrine within pharmacies had been effective in reducing diversion of pseudoephedrine to manufacture of methamphetamine. Most methamphetamine in New Zealand was now manufactured from ephedrine and pseudoephedrine imported illegally from overseas.

Because the indications, risks and benefits of use for phenylephrine were similar to those for pseudoephedrine, and also because the case for lack of utility of phenylephrine as a precursor for methamphetamine manufacture remained uncertain, the Committee did not support general sale status for solid dose forms of phenylephrine. While there was agreement that 10 milligrams was an appropriate therapeutic dose, the Committee felt that this should apply as a maximum cut-off point for all over-the-counter oral dose forms of phenylephrine and that all oral dose forms below this cut-off point should be classified as pharmacy-only medicines.

For that reason members agreed that a classification change should not be made at his point but that the matter should be returned to the agenda of the next meeting following consultation on the Medsafe website. The proposal would be for all OTC oral dose forms of phenylephrine containing 10 milligrams or less per recommended dose, in both liquid and solid dose presentations to be classified as pharmacy-only medicines.

Recommendation

• That there be no change to the current classification of phenylephrine
• That a proposal should be included on the agenda of the next meeting to classify all oral dose forms of phenylephrine to pharmacy-only medicine when in preparations containing 10 milligrams or less per recommended dose.

6.7 Sodium picosulfate (Dulcopearls, Boehringer Ingelheim)

This was a company submission for reclassification from prescription medicine to pharmacy-only when for laxative use. This item was discussed in conjunction with the NDPSC recommendation to reclassify sodium picosulfate and macrogols (see agenda item 8.3.1).

The product had moved from pharmacy-only to prescription medicine in response to a similar classification change for sodium phosphate following adverse reactions associated with oral laxative products, in particular those used for oral bowel cleansing prior to diagnostic, surgical or medical procedures.

The Committee felt that the company submission justified a return to pharmacy-only classification for laxative use for sodium picosulfate when compared to the safety profile of other laxatives in that class. It was agreed that any issues relating to abuse and eating disorders were no different from those associated with other laxatives and there had been no evidence of problems relating specifically to sodium picosulfate. Nor had there been evidence of side-effects over a number of years of use. It was pointed out that, even in chronic use, the dose remained effective and did not require an increase over long-term use.

Members wished to uphold their earlier policy to keep stimulant laxatives classified at a higher level than bulk laxatives in order to encourage use of the former as second-line treatment. They were therefore not willing to adopt the NDPSC recommendation to reclassify sodium picosulfate to general sale for laxative use. The classification would therefore not be harmonised for laxative use. Sodium picosulfate for oral bowel cleansing would remain a restricted medicine in both countries due to the risks associated with use at the higher doses required for that indication.

Recommendation

That sodium picosulfate for laxative use should be reclassified from prescription medicine to pharmacy-only medicine.

6.8 Ephedra species

This was a submission from Health & Herbs International for reclassification from prescription medicine to general sale medicine for ephedra species which do not contain ephedrine, in particular, ephedra navadensis.

The applicant had provided evidence that the product in question did not contain any ephedrine or pseudoephedrine. The Committee agreed that the intention of the scheduling of ephedra species was to control access to ephedrine and that it was reasonable that ephedra products which did not contain ephedrine or pseuduoephedrine should be not caught by the schedule entry. It was agreed that ephedra species containing 10 milligrams or less of ephedrine or pseudoephedrine per litre or per kilogram should be exempt from scheduling. This approach was noted as being consistent with the way in which some other plants and their alkaloids had been scheduled.

Secretary's note
Subsequent to the meeting it became evident that the above approach could not be used to implement the Committee's intentions. Both ephedrine and pseudoephedrine were in the process of being incorporated into the schedules of the Misuse of Drugs Act 1975. Consequently they would be removed from the First Schedule to the Medicines Regulations 1984. Ephedra species would also need to be removed from the schedule as any species containing ephedrine would become controlled drugs. Any ephedra species containing no ephedrine would become general sale medicines. As there was no general sale component to the medicines schedule, there was no tool for indicating the legal status of any ephedra species which did not contain ephedrine. However, ephedra navadensis could be added to the alphabetical list of medicines on the Medsafe website so that there would be some reference point for those seeking its classification. The onus would be on sponsors wishing to market products containing other ephedra species to prove that the species in question did not contain ephedrine or pseudoephedrine. Until the change to a controlled drug took effect, ephedra navadensis should be exempted from the prescription medicine schedule entry for ephedra species.

Recommendation

• That ephedra navadensis be added to the general sale list on the Medsafe website.
• That until such time as ephedra and ephedrine were removed from the schedule, the entry for ephedra species should carry an exemption for ephedra navadensis.

7. New Medicines for classification

The Committee considered the list of new chemical entities requiring classification.

Epinastine, an H1-receptor antagonist with other anti-allergic properties and indicated for the treatment or prevention of the symptoms of seasonal allergic conjunctivitis was seen as a potential pharmacy-only medicine in line with other similar medicines. However, as a new chemical entity it was agreed that this should initially be sold as a prescription medicine until more information became available as a result of its use.

All other medicines for consideration were new chemical entities which fitted the criteria for prescription medicine classification.

Recommendation

• That the following new chemical entites should be classified as prescription medicines:
  • Adefovir dipivoxil
  • Cinacalcet
  • Duloxetine hydrochloride
  • Efalizumab
  • Emtricitabine
  • Enfuvirtide
  • Epinastine hydrochloride
  • Everolimus

8. Harmonisation of NZ and Australian schedules

8.1 Harmonisation matters arising or outstanding

8.1.1 Fluorides

The Committee noted that although the schedules were now harmonised, regulatory differences appeared to affect the level of access for some mouthwash products. These differences allowed some products to be sold on general sale in Australia even though they contained scheduled quantities of fluoride. The Chairman said that Medsafe had commenced discussions with the TGA and the it was hope that the differences would be resolved. Discussion was also under way as to whether or not toothpastes should be treated differently from mouthwashes. No further input was required by the Committee at this stage.

8.2 NDPSC response to MCC recommendations

8.2.1 Benzamine, orthocaine, 3-aminobezoic acid ethyl ester methanesulphonante

The Committee noted that the NDPSC had accepted its recommendation to remove these from the Australian schedule.

8.2.2 Silver sulfadiazine

The Committee noted that the NDPSC had opted not to harmonise with New Zealand on the OTC availability of silver sulfadiazine and that the matter would be revisited after two years.

8.2.3 Selenium

The NDPSC had reported that selenium was now harmonised. The Committee noted that this was, in fact, the case only for external products. However, the two committees had agreed to differ on the classification of oral products due to low levels of selenium in New Zealand. The Chairman said that the matter would eventually be reviewed.

8.2.4 Solanaceous alkaloids

The Committee was informed that the NDPSC had agreed to harmonise on its recommendation of a 300 microgram exemption from scheduling for atropine but remained unharmonised for hyoscine and hyoscyamine with cut off points of 150 micrograms on the grounds that these were twice as potent as atropine.

8.3 Recommendations made by the NDPSC to the MCC in October 2002

8.3.1 Sodium picosulfate and macrogols

These should remain unscheduled for laxative use.

Macrogols for other than bowel cleansing were unscheduled in New Zealand and the classification was therefore harmonised. No recommendation was required.

Prior to reclassification to prescription medicine for laxative use, sodium picosulfate had been classified as a pharmacy-only medicine along with other stimulant laxatives. MCC policy to date had been to keep stimulant laxatives as pharmacy-only medicines to encourage the use of bulk laxatives as a first line of treatment.

For the discussion and recommendation see agenda item 6.7 above.

8.3.2 Acetylcysteine

Preparations for oral use containing 1 gram or less per recommended daily dose should become general sale medicines.

The recommendation was thought to be based around sports supplement products available in Australia. A toxicology report showed that the LD50 was 6 grams per kilogram in rats and 1 gram per kilogram in dogs. It was therefore considered safe for general sale at doses of up to 1 gram per day.

Recommendation

That acetylcysteine should be available as a general sale medicine for oral use in medicines containing 1 gram or less per recommended daily dose.

8.4 Recommendations made by the NDPSC to the MCC in February 2003

8.4.1 Collagen, hyaluronic acid

The recommendation was to amend the prescription medicine entry for injectable products containing collagen or hyaluronic acid to include only those injectable products used for implantation or tissue augmentation when for cosmetic use. This would allow for viscoelastic ocular preparations and synovial fluid replacement injections to be unscheduled so that they harmonise with Australia but would capture inappropriate cosmetic use. This change would be consistent with the entries for polylactic acid and polyacrilamide .

The Committee agreed that there was considerable margin for severe problems related to use of cosmetic injections by those without appropriate expertise and that use should be limited to those with competencies in this area. Although it was believed that nurses were gaining access to injectable prescription cosmetic products under Standing Orders, this was seen as inappropriate practice and not within the scope intended by Standing Orders.

Limiting the prescription medicine entries to injections or implantations for cosmetic use would allow other types of injections to remain unscheduled. Intraocular viscoelastic preparations had already been exempted from classification to allow this. The Committee noted that there were still harmonisation problems for synovial fluid preparations which remained prescription medicines in New Zealand under the current wording in the schedule. These were unscheduled in Australia as they were regarded as medical devices rather than medicines. Although the Committee was not altogether happy with this level of scheduling, it was agreed that, in the face of regulatory differences, a move to general sale was the only tool available to achieve harmonisation of classification for products already marketed.

Recommendation

That the prescription medicine entries in the schedule for collagen and hyaluronic acid should be amended to read:
In injections or implantations for tissue augmentation or cosmetic use

8.4.2 Oxedrine (synephrine)

The recommendation was to classify oxedrine as a prescription medicine except in preparations containing 30 milligrams or less per recommended daily dose.

It was noted that although New Zealand had no registered medicines containing oxedrine, there were thought to be a number of complementary products and thermogenic weight-loss products which contained this substance.

While natural oxedrine was found in plant extracts including some citrus species, it was noted to be a sympathomimetic agent with a potential similar to that of other sympathomimetic agents to cause cardiovascular toxicity. The Australian committee had done a full assessment of the safety of oxedrine and the Committee was satisfied with the NDPSC recommendation of 30 milligrams as a safe cut-off point for general sale. The proposed cut-off point would allow complementary products to continue to be marketed at a safe level.

The Committee noted that there had been no response to the recommendation from the complementary medicines area and it was assumed that there had been no problems with the proposed cut-off level.

Recommendation

That oxedrine should be classified as a prescription medicine in medicines containing more that 30 milligrams per recommended daily dose and should be available as a general sale medicine in products containing 30 milligrams or less per recommended daily dose.

8.4.3 Pegfilgrastim

Add to the schedule as a prescription medicine.

There were currently no products registered in New Zealand containing pegfilgrastim. It was agreed, that, according to the principles of harmonisation, pegfilgrastim should be added to the schedule as a prescription medicine.

Recommendation

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

8.5 Recommendations made by the NDPSC to the MCC in June 2003

8.5.1 Hydroquinone

Reclassify from pharmacy-only medicine to prescription medicine for products containing concentrations greater than 2%.

The subsequent recommendation made at the October meeting of the NDPSC revealed that the above recommendation did not reflect the full intention of the NDPSC. The NDPSC's intention was that New Zealand should adopt the more restrictive Australian classification for products containing 2% or less and that these should become pharmacy-only medicines in New Zealand. The only general sale hydroquinone products permitted in Australia were hair preparations containing 1% or less.

In view of the fact that the recommendation had changed from that advertised as an agenda item for the current meeting, the Committee agreed that further consultation would be necessary before a change could be implemented and that a recommendation could not be made at the present time.

It was agreed that skin whitening was widely practiced in Asia. Although the extent of use was not known in New Zealand, members agreed that there could be products which were sold outside pharmacies and that there should be consultation with the cosmetic industry.

The matter would be revisited at the next meeting.

8.5.2 Injectable medicines

The pharmacy-only entry for injectable medicines should be removed from the schedule. Injectable medicines should be classified according to the classification level of their active ingredients.

The Committee agreed that there had been a gradual increase in the number of medicines exempted from the injectable entry to allow harmonisation with Australia. Prior to the current meeting there had been mainly minerals and vitamins which had been captured by the pharmacy-only entry for injectable medicines. While these were already unscheduled in Australia, they had recently been reviewed and the NDPSC was happy that their unscheduled status be maintained. There appeared to be few problems associated with their use and those that did occur were mainly related to misreading of labels in hospitals.

The MCC agreed therefore that the injectable medicines entry should be removed from the schedule so that injectable medicines would be classified according to their active ingredients as for medicines administered by all other routes of administration. Members agreed that products could be reclassified reasonably quickly if a problem emerged.

It was noted that a number of other adjustments would be necessary to the schedule as a consequence of removing the entry for injectables and that Medsafe should make these adjustments.

Recommendation

That the pharmacy-only entry for injectable medicines should be removed from the schedule.

8.5.3 Antihistamines

As a result of the recently-commissioned New Zealand Ministry of Health Review of Antihistamines a number of risks had been identified which warranted differentiation of the sedating antihistamines from the non-sedating antihistamines.

The NDPSC had adopted the broad principles adopted by the Trans-Tasman Harmonisation Working Party and had recommended a number of changes.

The Committee agreed that the two major areas of concern associated with antihistamines appeared to be over-sedation of children and use as sedatives. The latter issue had already been addressed by the Committee at an earlier date.

It was also acknowledged that there was greater risk associated with use of sedating antihistamines when driving or operating machinery and that for this reason sedating antihistamines should be used more sparingly and non-sedating antihistamines should be encouraged as first access for allergies. The current scheduling did not make this distinction between the two types of antihistamines. The Committee agreed that scheduling should be used to effect this.

Members then went on to discuss combination products containing sedating antihistamines. While no studies had been done on these, there was no evidence to justify putting such products into a more restrictive level of classification. Part of the argument for this was that sedating effects were countered by the inclusion of stimulants and the lower level of classification was therefore justified. They agreed that they had no problems with specifically packaged night and day formulations remaining at pharmacy-only level provided that it was clear which were the night formulations.

While the NDPSC had made a number of recommendations for classification changes to specific medicines, the Committee felt that a number of issues relating to combination products still needed to be resolved and issues related to travel sickness and use for sedation were still to be addressed by the NDPSC. Nor did the NDPSC recommendation take into account combination products containing paracetamol or other analgesics of which there were a large number in both countries marketed as pharmacy-only medicines.

It was agreed that the Committee would adopt the broad principles of the Trans-Tasman Harmonisation Working Party at this point in time. These were that sedating antihistamines should be classified more restrictively than non-sedating antihistamines and that certain combination sedating antihistamine products should continue to be classified as pharmacy-only medicines. However, the Committee would refrain from making recommendations about specific medicines until such time as the outcome of the recent NDPSC meeting became available and further consideration had been given to combination products and those used for sedation and travel sickness. Further consultation would take place following the results of the NDPSC meeting and the matter would be considered again at the next meeting.

8.5.4 Dextromethorphan

Amend the pharmacy-only entry for dextromethorphan to the following:

When supplied in a pack containing 600 milligrams or less and with a recommended daily dose of 120 milligrams or less.

The above recommendation was supported by a letter from Pfizer requesting reclassification from prescription medicine to pharmacy-only medicine for sustained release liquid preparations containing 0.6% or less with a recommended dose not exceeding 60 milligrams.

The Committee agreed that the imposition of upper dose limits and limits on pack size provided a safer option than the current scheduling and that the proposed word change should be incorporated into the pharmacy-only entry in the schedule. Members agreed that the pack size limits and dose limits should also be applied to the general sale entries. This could be done immediately if the change would not affect any products already on the market but would require consultation if it would result in a change of classification for any currently marketed product.

Recommendation

That over-the counter packs of dextromethorphan should be limited to packs containing 600 milligrams or less and with recommended daily doses of not more than 120 milligrams.

8.5.5 Budesonide aqueous nasal sprays

Reclassify from restricted medicine to pharmacy-only medicine. Similar conditions should apply. The indication had been changed from seasonal rhinitis to allergic rhinitis.

For discussion and recommendation see agenda item 6.1

8.5.6 Mometasone aqueous nasal sprays

Reclassify from restricted medicine to pharmacy-only medicine. Similar conditions should apply. The indication had been changed from seasonal rhinitis to allergic rhinitis.

It was noted that there was currently no OTC mometasone product marketed in New Zealand.

For discussion and recommendation see agenda item 6.1

8.5.7 Deferiprone

Add to the schedule as a prescription medicine.

The Committee noted that deferiprone was an oral chelating agent for the second-line treatment of thalassaemia major. Consent had not yet been sought to market this medicine in New Zealand. The Committee agreed that, according to the principles of harmonisation, this medicine should be added to the schedule.

Recommendation

That deferiprone should be classified as a prescription medicine.

8.5.8 Nicotine

Reclassify nicotine lozenges from restricted medicine to pharmacy-only medicine.

Nicotine sublingual tablets were also considered by the Committee. These were also restricted medicines but were not included in the NDPSC recommendation, possibly because they were not available in Australia

Lozenges and sublingual tablets had initially been classified as restricted medicines as there had been insufficient data on usage experience available at the time to warrant a less restrictive level of classification. There had been concerns that their safety profile might differ from that of nicotine in patches and gum because of their different release characteristics. There had also been concern about consumption by children.

However, the Committee was now satisfied that the safety concerns for this route of administration differed little from those for nicotine in patches and gum. They were of the opinion that the more options readily available for smoking cessation, the better and were comfortable to see these products moved to pharmacy-only medicine.

The Committee stressed its ongoing support for counselling as an important aspect of smoking cessation.

Recommendation

That nicotine in lozenges and sublingual tablets be reclassified from restricted medicine to pharmacy-only medicine.

8.5.9 Fluconazole

Reclassify from prescription medicine to restricted medicine for single-dose oral preparations containing 150 milligrams or less for the treatment of vaginal candidiasis.

The Committee discussed the issues recorded in the minutes of the 38^th meeting of the NDPSC at which the recommendation was made to reclassify single dose oral fluconazole for vaginal candidiasis. It was noted that the company making the submission in Australia had proposed that the product be used as second-line treatment after topical treatment had failed to resolve the infection.

Issues discussed included:

• the possible development of resistance
• interactions with other medicines
• side effects
• ease of self-diagnosis
• ability of pharmacists to provide suitable advice
• problems associated with sexually transmitted diseases

While the Committee agreed that most of these issues were no different from those associated with the topical forms of treatment, they were not happy about the proposed use as a second-line treatment. It was felt that overwhelming consumer preference would overturn this.

Overall, the Committee felt, that the product should be sold as first-line treatment but, in order to properly handle the sale appropriately, some form of accreditation should be required for pharmacists. It was also acknowledged that the product would be useful for nurses in clinic situations and that a similar form of accreditation should apply. The accreditation process could be similar to that used for the emergency contraceptive pill.

The Committee decided to defer a recommendation at this point and to take the following action:

• seek information from the company on how the product would be presented
• approach the Pharmaceutical Society to discuss the possibility of accreditation for pharmacists
• approach the Pharmacy Guild to discuss appropriate practice in the sale of products

approach the Nursing Council to discuss including oral fluconazole in a Scope of Practice for nurses accredited in the area of sexual health.

9. For the next meeting

Other than those items deferred from the current meeting, there were no new topics suggested for inclusion on the agenda of the next meeting.

10. General business

10.1 Isosorbide dinitrate

One of the Committee members raised the issue of the OTC sale of isosorbide dinitrate for prophylactic use. While its classification had been altered to harmonise with that of Australia, it was noted that isosorbide dinitrate had been classified to be consistent with glyceryl trinitrate as a restricted medicine for acute treatment. However, the member pointed out that the only product now approved for use in New Zealand was indicated only for prophylactic use and that isosorbide dinitrate no longer appeared to be used for acute treatment.

The Committee agreed that the secretary should investigate whether or not isosorbide dinitrate was used in Australia for acute treatment at the dose levels permitted for OTC sale. The matter would be revisited at the next meeting.

10.2 Amygdalin

It was considered possible that amygdalin (laetrile) might not be covered by the schedule entry for hydrocyanic acid. In Australia amygdalin is listed in Appendix. C as a substance not permitted for human use. The Committee agreed that a new entry should be made to ensure classification of this substance as a prescription medicine at all strengths in order to prevent use in small quantities under the general exemption.

Recommendation

That amygdalin be classified as a prescription medicine at all strengths.

10.3 Approaches from pharmaceutical companies

Several members stated that they had been approached by Boots Healthcare in relation to its submission for the reclassification of ibuprofen.

It was generally agreed that it was both ineffective and inappropriate in New Zealand for pharmaceutical companies to lobby Committee members. Members were appointed to the Committee for their personal expertise, not as representatives of their nominating bodies.

Members agreed that the secretary should write to Boots to express the Committee's view about the approaches made to if.

It was agreed that the minutes of the meeting should record this as a signal to other companies who might consider similar action.

It was also agreed that a note should be added to the appropriate section of the Regulatory Guidelines and to the instructions on the Medsafe website on making submissions, stating that MCC members should not be approached by pharmaceutical companies about meeting agenda items.

The meeting closed at 3:15pm