Revised: 23 May 2013

Committees

Minutes of the 29th meeting of the Medicines Classification Committee - 22 May 2003

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
Mr B McKone
Dr T Bevin
Mrs C Smith (Secretary)

1. Welcome

The chairman welcomed members to the twenty-ninth meeting.

2. Apologies

An apology was received from Dr G Wardrope.

3. Confirmation of the minutes of the 28TH meeting

The minutes of the twenty-eighth 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 28th meeting

5.1 Buccaline (Berna)

This was a submission from Pharmabroker Sales for the reclassification of pneumococcus I, II and III vaccine and haemophilus influenzae vaccine from prescription medicine to pharmacy-only medicine when contained in oral vaccines. The product had earlier been identified as having been incorrectly classified as a pharmacy-only medicine in that it contained two ingredients which were classified as prescription medicines. Due to the long period over which the product had been available as a pharmacy-only medicine and the lack of immediate safety concerns, Medsafe had agreed that the product should be allowed to continue to be marketed as a pharmacy-only medicine until the matter of its classification had been resolved. The Committee had requested a submission from the sponsor company to justify the continued sale of Buccaline as a pharmacy-only medicine. The Committee had also requested efficacy data. As this product was a grandfathered product already on the market prior to current legislation, very little data were available on file. It was noted that the product had recently been sold and that "Berna" had been dropped from the product name.

The Committee observed that the efficacy data produced in the submission were not of a standard acceptable to a modern regulatory environment. The studies were either very small or were large, non-controlled and not double-blind. It was not possible to establish the basis of selection of subjects. Some of the data were for combined treatments though no reason for this was evident. It was agreed that efficacy data of this standard would not be accepted if a comparable product were to seek consent to market. However, members acknowledged that lack of efficacy was not a valid reason to withdraw a product from the market and that this could be done only if the product were demonstrated to be dangerous.

As at the previous meeting, the Committee was not concerned with the safety of the ingredients of Buccaline per se. These ingredients were seen as reasonably non-toxic and there appeared to have been little or no evidence of adverse reactions.

However, members agreed that there was a major safety issue in that the product could be mistaken for an alternative to influenza vaccine by at-risk consumers. Although Buccaline was not indicated for prevention of influenza, the inclusion of haemophilus influenzae bacteria as an ingredient gave credence to the general perception that the product prevented or mitigated the symptoms of influenza or colds, neither of which was an approved indication for the product. Advertising was also seen as enhancing this perception. The Committee agreed that there was an increasing demand for alternative products and for self-medication. There was also a strong element of the population who was not in favour of vaccination. Members were concerned that consumers who were at risk from influenza could select the product as an ineffective substitute for vaccination in the belief that they were afforded protection from influenza.

Members agreed that the product had been available for too long to be made into a prescription medicine. They also felt that the more restrictive the classification, the more credibility would be given to the product. It was agreed that Buccaline should not be classified as a prescription medicine.

The Committee agreed that there would always be consumers who opted for alternative choices. It felt therefore that there should be safeguards in place to ensure that this choice should be made on a properly informed basis. Pharmacists could refer consumers to their doctors for 'flu injections. However, sales of pharmacy-only medicines were not necessarily made by pharmacists. The Committee felt that Buccaline would be a suitable candidate for a Self Care card and it was agreed that the Secretary should write to the Pharmaceutical Society suggesting this. It was thought that use of the product might also be considered in an overall approach to vaccination.

There was still a strong element of concern that the correct information should be available at the point of sale. The Committee felt that if the product were to be classified as a restricted medicine, sales would need to be made by pharmacists. In addition, products would not be available for self-selection. Provision of an approved data sheet would then be a requirement and CMI (Consumer Medicines Information) could be requested from the sponsor company.

It was agreed that, to ensure pharmacist intervention in the sale and to require a data sheet and CMI for Buccaline, haemophilus influenzae vaccine and pneumococcus vaccine should be classified as restricted medicines when in oral vaccines for the prophylaxis of bacterial complications of colds. The grounds for this level of classification were based on the Committee's concern that in the case of Buccaline, lack of efficacy presented a safety issue. There was little evidence to support the perceived indication for the product. Other than that it was used as an alternative to vaccination, the Committee saw little harm in the product. It was agreed that Medsafe should be asked to ensure that the data sheet should contain warnings that the product would not prevent influenza and would not prevent the development of coughs or colds. CMI containing these warnings should also be provided for the product along with advice on influenza vaccination. The Pharmaceutical Society should be asked to provide similar information with a Self Care card.

Recommendation
  • That haemophilus influenzae vaccine and pneumococcus vaccine should be classified as restricted medicines when in oral vaccines for the prophylaxis of bacterial complications of colds

  • That Medsafe should be asked to ensure that a data sheet and CMI be prepared containing warnings that the product will not prevent influenza or coughs or colds and that the patient leaflet should also contain advice on influenza vaccination

  • That the Pharmaceutical Society should be asked to incorporate the above warnings and advice in its written consumer information to be supplied with the product

5.2 Moderately potent topical corticosteroids

The Chairman reported progress to date regarding information sought by the Committee at the previous meeting relevant to safety for OTC sale with particular reference to clobetasone and alclometasone 0.05% topical preparations. It was understood that the University of Otago was considering assigning a review of the safety of topical corticosteroids to a post-graduate student. In addition, a recent conversation with GlaxoSmithKline indicated that the company intended to approach the School of Pharmacy to see if it could commission research from them on corticosteroids. The Committee was happy with this arrangement and the Chairman agreed to confirm the arrangement with the School of Pharmacy and the pharmaceutical company.

6. Submissions for reclassification

6.1 Hyoscyamus niger

This was a submission from Weleda for reclassification of hyoscyamus niger from pharmacy-only medicine to general sale medicine when in packs containing 30 micrograms or less of total solanaceous alkaloids. This further submission resulted from the previous meeting when the exemption from scheduling was increased from 100 micrograms to 300 micrograms per litre or per kilogram for all solanaceous alkaloids. This increase did not allow general sale status for one of the hyoscyamus niger products included in the earlier submission.

As the pack size requested by Weleda in the most recent submission was within the general principles of the herbal framework in that a general sale pack would contain not more than one hundredth of the lowest fatal dose, the Committee agreed to the change. However, members stressed that they wished it to be understood that the recommendation was made in order to accommodate the status quo prior to harmonisation with Australia and that it should not be regarded as setting a precedent.

Recommendation

That the pharmacy-only entry for oral liquid dose forms of hyoscyamus niger be amended by the addition of the words "except in packs containing 30 micrograms or less of total solanaceous alkaloids".

6.2 Ibuprofen (Nurofen gel)

This was a submission from Boots Healthcare for reclassification of topical ibuprofen from pharmacy-only medicine to general sale medicine. A similar submission had recently resulted in a classification change in Australia.

The Committee had no real safety concerns about the change. It was noted that other topical non-steroidal anti-inflammatory agents had already moved to general sale and that there appeared to have been no problems arising from this change. It was also noted that supermarkets appeared to have opted not to stock such products.

Members noted that the product pack carried a warning about sensitivity to aspirin and other non-steroidal anti-inflammatory agents. They thought that this should be included as a requirement for topical ibuprofen in the NZ Regulatory Guidelines for Medicines.

Recommendation
  • That ibuprofen for external use should be reclassified from pharmacy-only medicine to general sale medicine
  • That Medsafe should be asked to include in the ibuprofen guidelines in the NZ Regulatory Guidelines for Medicines, a requirement for a caution about sensitivity to aspirin and other non-steroidal anti-inflammatory agents on packs for external use.

6.3 Ketoprofen (Oruvail gel)

This was a submission from Aventis Pharma for reclassification of 2.5% topical ketoprofen gel from pharmacy-only medicine to general sale medicine.

As for ibuprofen, topical ketoprofen had also been changed recently to general sale medicine in Australia. The Committee agreed that the change should be implemented in New Zealand.

Recommendation

That ketoprofen for external use should be reclassified from pharmacy-only medicine to general sale medicine.

7. New Medicines for classification

7.1 Arising from the previous meeting

Polycosanol

At the previous meeting the Committee had requested more information about this medicine. Members were informed that the Medicines Assessment Advisory Committee (MAAC) had declined the application on the grounds of lack of evidence of efficacy. It was therefore unnecessary to make a classification recommendation at that point in time. It was noted that products containing polycosanol were able to be sold as listed products in Australia. However, the New Zealand application was claiming indications which would require the product to be regarded as a medicine.

7.2 New chemical entities referred by the MAAC

There was unanimous agreement that all these new chemical entities should be classified as prescription medicines.

During the discussion on aprepitant (Emend) capsules, one member expressed concern that although a number of anti-emetics had consent to market, these were very difficult to access for patients in terminal care. The Committee agreed that a letter should be sent to Pharmac expressing its concern about this.

Recommendation
  • That the following be classified as prescription medicines
    • Atazanavir
    • Aprepitant
    • Carbetocin
    • Human protein C
    • Laronidase-rch
    • Lumiracoxib
    • Melagatran
    • Ximelagatran
  • That a letter be written to Pharmac expressing the Committee's concern with regard to the difficulty gaining access to anti-emetics experienced by patients in terminal care.

8. Harmonisation of NZ and Australian schedules

8.1 Harmonisation matters arising or outstanding

8.1.1 Paracetamol 665 milligram tablets

The Chairman reported that the Australian National Drugs and Poisons Schedule Committee (NDPSC) had opted not to harmonise with New Zealand by accepting the MCC recommendation to make this product a prescription medicine. The classification of paracetamol 665 milligram tablets would be reviewed in two years' time.

8.1.2 Fluorides

There were still differences between Australia and New Zealand in the scheduling of products containing fluorides. It was agreed that the New Zealand schedule should be adjusted to harmonise with that of Australia in order to implement the recommendation from the Trans-Tasman Harmonisation Working Party.

Cut-off points and levels of classification were harmonised for internal use. However, it was noted that tablets in S2 in the Australian schedule were expressed as sodium fluoride rather than as elemental fluorine. As all fluoride tablets on the New Zealand market appeared to contain 2.2 milligrams or less of sodium fluoride, it was agreed that this part of the schedule should be amended to harmonise.

In terms of products on the market, the differences appeared to affect mainly higher strength dentifrices and oral rinses. In New Zealand dentifrices containing more than 2.5% were classified as prescription medicines whereas, in Australia, the highest classification for dentifrices was S3 (restricted medicine) and this classification applied to dentifrices containing more than 1000mg per kilogram (0.1%). To date there were no dentifrices marketed in New Zealand which fell into the higher classification bracket. However, harmonisation would enable marketing of one product currently not marketed in New Zealand due to the need for a different classification statement for a product with a small potential market.

Oral rinses containing less than 0.1% were general sale in New Zealand. There were several products which had consent to market. Some of these were not marketed due to the need for different labelling in New Zealand. Australia did not have a lower cut-off point for external use other than in dentifrices and all other external products, including mouth washes were the equivalent of pharmacy-only medicine. The Committee agreed that the 0.1% lower cut-off for pharmacy-only medicine should be removed so that all New Zealand external products, other than dentifrices and other oral hygiene products, containing 2.5% or less should become pharmacy-only medicines.

It was noted that "dentifrice" in the Australian schedule appeared to refer only to toothpastes whereas there was a specific definition in the Medicines Act which described dentifrices as "any substance or mixture of substances used or represented for use for the purpose of cleansing the mouths or teeth (natural of artificial) of human beings: and includes any denture fixative". The Committee agreed that it would be necessary to separate toothpastes from other dental hygiene products in order to harmonise. Avoidance of the term "dentifrice" was considered preferable in view of its specific designation in New Zealand legislation. It was agreed that Medsafe should investigate the definition of "dentifrice" in Australia and find suitable wording to harmonise the New Zealand scheduling of fluorides with that of Australia.

The Committee agreed that the classification of fluorides should be as follows but that Medsafe should finalise suitable wording to allow these levels of classification to be implemented

Prescription:
For internal use except in medicines containing 2.2 milligrams or less per dose form of sodium fluoride
For external use in medicines other than toothpastes containing more than 2.5%
Except in medicines containing 15 milligrams or less per litre or per kilogram
Except in oral hygiene products other than toothpastes containing 0.01% or less
Restricted:
In toothpastes containing more than 0.1%
Pharmacy-only:
For internal use in medicines containing 2.2mg or less per dose form of sodium fluoride
For external use in medicines other than toothpastes containing 2.5% or less
General sale:
In toothpastes containing 0.1% or less
In oral hygiene products other than toothpastes containing 0.01% or less In medicines containing 15 mg or less per litre or per kilogram

Access by dentists and dental therapists to fluoride-containing products was also discussed. Although the proposed changes to the schedule would result in a change to the classification of only a small number of oral rinses currently on the market, the Committee was concerned that access be maintained for dentists and dental therapists at all levels of classification. It was agreed that consultation should be undertaken with the Ministry's Chief Advisor, Oral Health. If necessary, an exemption from classification status should be added in order to allow access to products required by registered dentists and dental therapists.

Recommendation
  • That New Zealand should harmonise with Australia on the classification of fluorides
  • That consultation should be undertaken with the Chief Advisor, Oral Health with regard to the need for exemptions from classification for use by registered dentists and dental therapists and that Medsafe should take appropriate action if necessary to facilitate such access by means of exemption from scheduling.

Secretary's note
Further investigation has established that there is no legal impediment for dentists to access medicines directly from warehouses at any level of classification. Dental therapists may order medicines at all levels other than prescription medicine. Therefore an exemption in the schedule from prescription status is necessary only to enable dental therapists to have access to fluorides for external use in medicines other than toothpastes containing more than 2.5%. It should be noted that scheduled medicines may be administered by dentists and dental therapists in the course of their practice. However, such medicines may not be offered for retail sale from a practice.

8.1.3 Other harmonisation matters

The Chairman provided an update for members on the NDPSC response to a number of recommendations made by the MCC. These were mainly acceptance of recommendations to remove obsolete medicines from the schedule or notice that substances were now harmonised. Some MCC recommendations were ongoing in that further consideration was still required. An update would be provided when these were finalised.

Medicines to remain unharmonised at this time

The NDPSC had opted not to adopt the MCC recommendation on the following medicines and to review their classification in two years' time:

Aciclovir

Upper pack size limit for general sale to remain 10 grams in Australia, 3 grams in New Zealand.

Dextromethorphan

No products available in Australia at general sale and a maximum pack size limit of 600 milligrams for all OTC products. New Zealand classification to remain unchanged.

Liquid ibuprofen

No restrictions on concentration for OTC sale in Australia. New Zealand to retain the current concentrations only.

Silver sulfadiazine

To remain prescription medicine in Australia for all packs sizes. New Zealand OTC pack to remain.

Clobetasone

Dermal packs containing 0.05% to remain OTC in Australia and prescription medicine in New Zealand.

Sodium picosulfate

Owing to timing of meetings the MCC had acted upon a foreshadowed recommendation from NDPSC which had been changed at a subsequent meeting. The NDPSC has now recommended that the MCC reconsider its recommendation for sodium picosulfate to become a prescription medicine when used as a laxative and that it should retain its earlier unscheduled status for this use. The Committee noted that stimulant laxatives were normally pharmacy-only medicines in New Zealand and that a return to the status quo would not result in harmonisation. The matter would be discussed at the next meeting.

Nizatidine

The MCC had requested that the scheduling of nizatidine be returned to prescription medicine in both schedules if there were no products containing nizatidine marketed in Australia. The NDPSC had responded that there were OTC nizatidine products on the Australian market. The Committee agreed therefore that the change to pharmacy-only should be made in the New Zealand schedule in the interest of harmonisation. As no products were marketed in New Zealand consultation was not necessary and the change could be put into effect immediately.

Recommendation

That nizatidine should be reclassified from restricted medicine to pharmacy-only medicine when in medicines which have received the consent of the Minister or the Director-General to their sale as pharmacy-only medicines and which are sold in the manufacturer's original pack containing not more than 14 days' supply.

8.2 Recommendations made by the NDPSC to the MCC in June 2002

8.2.1 Pseudoephedrine

Due to increasing illicit pseudoephedrine use, the NDPSC had recently reclassified pseudoephedrine from pharmacy-only to restricted medicine when in single-ingredient tablets or capsules of not more that 60 milligrams each and in packs containing not more than 30. The change did not apply to slow-release or combination products which would remain pharmacy-only as before. The NDPSC recognised that the change had resulted in an unharmonised position with New Zealand and had recommended that the MCC be advised of the outcome for consideration.

The Committee agreed that there was also considerable cause for concern in New Zealand with regard to crime relating to pseudoephedrine abuse. The Ministry of Health paper of January 2003 and the Pharmaceutical Society Report of February 2003 were noted. A Pharmaceutical Society nominee provided an update on the Society's position. There had been further increase in the number of raids on pharmacies and warehouses. These raids had become well-researched and perpetrators were aware of storage locations, quantities ordered and delivery times. There had also been an increase in diversions of products between warehouses and pharmacies. In response, pharmacists had been encouraged to hold minimal stocks and bulk discounts were no longer available.

Consideration was given to whether or not there was a need for pseudoephedrine in cold and cough preparations. It was agreed that these products were effective for many consumers and there was a legitimate use for such products. Members felt that that legitimate users should not be denied access to these. However, it was generally felt that there were far too many combination products on the market containing pseudoephedrine.

Members considered the merits of classifying to a higher level. This was not thought to be a viable solution. More restrictive classification would serve only to shift the risk rather than minimise danger to pharmacists or reduce abuse. A restricted medicine classification could, in fact, increase the risk to pharmacy staff. Retail assistants would prefer to make a quick sale in order to get an agitated person out of a pharmacy before notifying the police rather than to ask that person remain in order to consult with a pharmacist. Reclassification would also result in considerable inconvenience and expense, to pharmaceutical companies, pharmacists and legitimate consumers for little amelioration of the current situation.

The Committee concluded that this was not really a classification issue and that better control would be achieved if pseudoephedrine were to be classed as a Class C Part VI controlled drug in a similar way to codeine. It was proposed that a letter be sent to those stakeholders involved in the Ministry discussion paper, notifying them of the Committee's support for pseudoephedrine to be controlled under the Misuse of Drugs Act.

Secretary's note
Since the above discussion took place a date had been set for the next meeting of the Expert Advisory Committee on Controlled Drugs. The proposal to control pseudoephedrine under the Misuse of Drugs Act was to be discussed at this meeting. As the Expert Advisory Committee on Controlled Drugs would be representing the views of the stakeholders in the Ministry paper, and the MCC Chairman was also a member of the Expert Advisory Committee on Controlled Drugs, it was suggested that the recommendation to write to all stakeholders advising them of the MCC view should be amended to a recommendation for the MCC Chairman to present the MCC view to the Expert Advisory Committee on Controlled Drugs.

Recommendation

That the Chairman should present the support of the Medicines Classification Committee for control of pseudoephedrine under the Misuse of Drugs Act to the Expert Advisory Committee on Controlled Drugs at its forthcoming meeting.

8.2.2 Hyoscine butylbromide

The NDPSC recommended an increase the amount of hyoscine butylbromide permitted for sale as a pharmacy-only medicine from 10 milligrams per tablet to 20 milligrams per tablet. The maximum pack size remained unchanged at 200 milligrams.

To date the MCC had recommended that 10 milligram tablets in packs of 20 should remain restricted medicine. The Committee stood by that position. Member felt that, as Australia and New Zealand had already agreed to differ on the classification of hyoscine butylbromide and as no request had been made in New Zealand to alter the current classification, no change should be considered at that point in time.

Recommendation

That there be no change to the classification of hyoscine butylbromide.

8.2.3 Polyacrilamide and polylactic acid

The NDPSC had recommended that these should be added to the schedule as prescription medicines when in injections or implantations for tissue augmentation or cosmetic use. The Committee agreed that medical expertise was necessary for safe execution of these procedures and the classification would be consistent with that of other substances used for such purposes.

Recommendation

That polyacrilamide and polylactic acid be added to the schedule as a prescription medicines when in injections or implantations for tissue augmentation or cosmetic use.

9. For the next meeting

Water for injection and sodium chloride for injection

These were noted as still being classified under the pharmacy-only entry for injectable medicines, thus creating a lack of harmonisation with Australia for these products. Until harmonisation of the classification of injectable vitamins and minerals was finalised it was necessary for the injectable entry to remain in the schedule. The Committee agreed that an exemption from scheduling for injectable water and sodium chloride should be discussed at the next meeting.

10. General business

Withholding tax on mileage allowances paid to Committee members.

The Secretary informed the Committee that as of 15 May, withholding tax would be deducted from mileage claims for vehicle allowance. The directive had come from the Ministry after consultation with Inland Revenue. The Secretary explained that the expenses claims form had already been modified to accommodate the change.

Briefing for new Committee members

The Secretary asked for suggestions as to the sort of information that members thought would be beneficial to new members. She explained that, in addition to the information already provided in the Members' Handbook, it was intended to provide an oral briefing on the way medicines were regulated and how the classification process worked.

Members agreed that oral reinforcement of information contained in the Member's Handbook would be valuable. It was suggested that information on the harmonisation process should be provided. Information on any frameworks, benchmarks and policies used by the Committee would also be useful.

Farewell to outgoing members

The Chairman farewelled the three members who had served their maximum term of six years on the Committee. He thanked them for their services and spoke briefly on the achievements of the Committee over the past six years.

The meeting closed at 12:40pm

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