Revised: 23 May 2013

Committees

Minutes of the 27th meeting of the Medicines Classification Committee - 23 May 2002

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

PRESENT

Dr Stewart Jessamine (Chairman)
Dr Graham Wardrope
Ms Andrea Shirtcliffe
Mr Bernard McKone
Mrs Carol Smith (Secretary)

1. Welcome

The Chairman welcomed members to the meeting.

He explained to the Committee why the Minister's Delegate had chosen not to accept the Committee's recommendation to adopt a framework for the classification of herbal medicines at that particular point in time. He said that a discussion paper on the proposed Trans-Tasman Joint Agency was currently with the Minister. If it came into effect, this agency would regulate both medicines and complementary medicines on both sides of the Tasman. While the proposed framework was recognised as having considerable merit, the time was not considered appropriate for the adoption of a new approach to regulating those herbal products which had not formerly been regulated in New Zealand. He said that the decision not to accept the Committee's recommendation was not a reflection on its expertise but rather a decision based on other events, of which the Committee could not have been expected to be aware at the time. It was therefore, recommended by the Minister's Delegate that where herbal substances were not currently on the schedule and the recommendation to classify was based on a recommendation to harmonise from the Australian National Drugs and Poisons Schedule Committee (NDPSC), that these applications should be put on hold. The Chair indicated that he believed Medsafe and the Australian Therapeutic Goods Administration would convene an expert panel at a future date to conduct a more final risk/benefit analysis. However, when there were recommendations or applications to reclassify herbal medicines which were already scheduled, these should be considered using the usual process and criteria.

The Chairman said that the discussion paper would shortly be made available to members. He went on to outline the nature of the proposed new scheduling committee. He said that it was proposed that new chemical entities should be scheduled by a committee similar to the Medicines Assessment Advisory Committee and there would be a committee similar in nature to the Medicines Classification Committee (MCC) to advise on rescheduling. This committee would be drawn from both sides of the Tasman and would be based on expertise rather than on representation. It was noted that the terms of most current members would have expired by the time the Joint Agency was due to take effect in 2004.

2. Apologies

Ms Frances Hughes
Dr T Bevin

It was noted that four members were required to form a quorum.

Ms Hughes had returned to the United States of America on a Harkness Fellowship. Although she had been back in New Zealand for a period of time it had not been possible to hold a meeting before her return to the States in early May. It was noted that she would have completed her Fellowship by the date of the next meeting.

An apology was also received from Dr John McEwen, newly-elected chairman of the NDPSC. Other commitments meant that Dr McEwen was unable to attend the meeting. However, he had expressed interest in making contact with the MCC and it was agreed that telephone contact should be made at a prearranged point in time so that Dr McEwen could be introduced to the Committee and could comment on any points which were of particular interest.

3. Confirmation of the minutes of the 26TH meeting

The minutes of the 26^th meeting were confirmed as an accurate record of that meeting and were signed by the Chairman.

4. Declaration of conflict of interests

None of the members had any interest which could be considered prejudicial to recommendations made about any of the agenda items to be considered at the meeting.

5. MATTERS ARISING from the 26th meeting

5.1 Objections to recommendations made at the 26th meeting

5.1.1 Paracetamol pack size harmonisation for general sale

GlaxoSmithKline had objected to the Committee's recommendation that packs for general sale should carry warnings of liver damage. The Committee agreed that this was not a valid basis for objection as it was not based on new safety data. Nor did the Committee agree that, because there had been a recommendation against such a warning in the Newgreen report, no such warning should be used. Members felt strongly that in recent times there had been a move away from shielding patients from risk information. They agreed that there was a move towards fully informed consumers and that consumers had a right to be informed of possible dangers as well as benefits. The recommendation was a move to inform consumers in positive terms.

The Committee also acknowledged that while it could make recommendations about pack warnings and could implement them in some cases by insisting on the use of manufacturers' packs only for some classification changes, this was not applicable in the case of general sale paracetamol. For this reason, the recommendation had conveyed the Committee's desire to see such a warning included on packs, rather than its insistence that it should be included as a condition of reclassification. Harmonisation of general sale pack sizes was dependent upon harmonisation of Australian and New Zealand guidelines for paracetamol. The Committee's recommendation had been forwarded to the Medsafe evaluation team and no further action would take place until the harmonised guidelines were returned to the Committee.

5.1.2 Paracetamol 665mg modified release tablet

GlaxoSmithKline also objected to the Committee's recommendation that paracetamol 665 milligram modified release tables should remain classified as a prescription medicine. The Committee was of the opinion that the company had approached the case from the wrong direction and that consent to market should be sought before attempting to have the product rescheduled. That way, Medsafe would evaluate the full safety data for the product first and this assessment would be available for consideration for any subsequent application for reclassification. The Committee agreed that it would be happy to reconsider the classification of the product again after it had been evaluated for consent to market.

Members agreed that this would be a useful product for the management of chronic pain. However, they also agreed that chronic pain required some kind of monitoring in the same way as for higher strengths of ibuprofen. New post-marketing data supplied by the company did not sway the earlier opinion that the product would be best used for chronic pain requiring professional oversight and management. The Committee agreed that the product did not fit with the criteria for OTC sale. Nor did it conform to the current paracetamol guidelines with regard to strength of dose form though it was recognised that this situation might alter with the new harmonised paracetamol guidelines.

Recommendation

That there be no change to the current prescription medicine classification for paracetamol 665 milligram modified release tablets.

Teleconference

At this point in the meeting contact was made with Dr McEwen, Chairman of the NDPSC. Members introduced themselves and Dr McEwen provided information about his background. It was agreed that, as there was little to comment on at this stage in the meeting, contact would be re-established later in the day in case there were matters on which Dr McEwen wished to comment. Later contact was made as agreed but there were no issues which required further discussion.

5.2.1 Belladonna

The Weleda submission had been deferred from an earlier meeting pending a final recommendation from the NDPSC on the harmonised position for solanaceous alkaloids. This item was discussed in conjunction with the harmonisation of solanaceous plants and alkaloids (see item 8.2.4, Recommendations to the MCC from the NDPSC in November 2001). The recommendation is included in the recommendations from item 8.2.4

5.2.2 Hyoscine, hyoscyamine, hyoscyamus

The Weleda submissions had been deferred from an earlier meeting pending a final recommendation from the NDPSC on the harmonised position for these medicines. This item was discussed in conjunction with the harmonisation of solanaceous plants and alkaloids (see item 8.2.4, Recommendations to the MCC from the NDPSC in November 2001). The recommendation is included in the recommendations from item 8.2.4.

5.2.3 Prochlorperazine

It had been brought to the attention of the Committee at the previous meeting that the only OTC pack of buccal prochlorperazine had been discontinued. This meant that pharmacists could no longer sell prochlorperazine for the relief of nausea associated with migraine because of the requirement in the schedule for the product to be sold only in the manufacturer's original pack appropriately labelled for that indication. The Committee wished to discuss whether this requirement should be removed from the schedule so that pharmacists could still sell prochlorperazine for nausea associated with migraine.

Members agreed that the requirement for a specific OTC pack should be removed in order to allow pharmacists to sell up to 10 prochlorperazine tablets for the relief of nausea associated with migraine. However, they did not wish to consider widening the indications to include general nausea, viewing undiagnosed nausea as a condition requiring medical intervention.

The Committee also discussed whether or not the prochlorperazine entry should be amended to allow the medicine to be sold by appropriately accredited pharmacists and nurses in conjunction with the emergency contraceptive pill.

While incidence of nausea with the levonorgestrel-only emergency contraceptive pill was relatively low, members considered that it could still be required in some cases and that nurses and pharmacists accredited to sell the emergency contraceptive pill should also be able to provide prochlorperazine if required. Whereas a buccal preparation was appropriate for nausea associated with migraine, an oral preparation was seen to be more suitable in preventing nausea associated with emergency contraception. For this reason it was agreed that the word 'buccal' should also be removed from the schedule entry.

Recommendation

That the current restricted medicine entry should be amended to allow sale of up to 10 tablets for the treatment of nausea associated with migraine or, when sold by nurses or pharmacists accredited to sell the emergency contraceptive pill, for the prevention of nausea associated with emergency contraception.

5.2.4 Sabadilla

This was a new submission from Weleda in response to the Committee's request at the previous meeting for further information. The Committee felt that it was now able to determine Weleda's intent. The company had applied the proposed framework to the submission and the Committee saw no reason not to apply those principles to this particular submission. It recognised that the company submission was conservative in that it was based on the LD50 for a 10 kilogram child. Members agreed to recommend that the company's submission be adopted.

Recommendation

• Sabadilla should be classified as follows:
  • Prescription medicine: except when specified elsewhere
  • Pharmacy-only medicine: in packs containing 18 milligrams or less and more than 1.8 milligrams of total alkaloids
  • General sale: in packs containing 1.8 milligrams or less of total alkaloids with a recommended daily dose of 0.6 milligrams or less of total alkaloids

6. Submissions for reclassification

6.1 Minoxidil 2% topical solution (Headway, Pacific)

This was a company submission for reclassification from restricted medicine to pharmacy-only medicine. It was noted that later in the agenda there was a recommendation from the NDPSC to reclassify both the 2% and 5% strengths of topical minoxidil from restricted medicine to pharmacy-only medicine (see agenda item 8.4.4).

The Committee noted that it had already asked the company to make a submission for this level of classification when it had refused to recommend a general sale classification at an earlier meeting. In the light of discussion provided by the NDPSC and the report prepared by Medsafe for the earlier submission, the Committee saw no reason for either strength of topical minoxidil to remain classified as restricted medicine.

Recommendation

That minoxidil topical preparations containing 5% or less should be reclassified from restricted medicine to pharmacy-only medicine.

6.2 Aciclovir cream (Zovirax, GlaxoWellcome NZ Ltd)

This was a company submission for the reclassification of aciclovir cream for the treatment of herpes labialis from pharmacy-only medicine to general sale medicine. The Chairman informed the Committee that in February 2002 the NDPSC had made a similar recommendation to the MCC for packs of up to 10 grams containing 5% or less of aciclovir. While February 2002 recommendations from the NDPSC were not on the agenda for the current meeting it had been decided that NDPSC discussion would be helpful for the Committee and the relevant papers had been included with the agenda material.

The Committee discussed the consequences of misdiagnosis if the medicine were to become available without the advice of a pharmacist and agreed that these were too small to override the benefits of general sale access.

The contagious nature of herpes labialis was considered and the risk of transferring the infection to the eye. Members queried whether this information would be conveyed through sale at pharmacy-only level and were informed that leaflets were available in pharmacies. It was noted that a large percentage of pharmacy-sales were for replacement tubes to keep on hand for those already infected and aware of the need for early treatment. When applying the criteria for OTC sale, the Committee could find no safety reasons for smaller tubes to remain in pharmacies. However, there was some doubt about the larger, 5 and 10 gram tubes. Members felt that these did not fit the criterion of short-term use in that they could not be used in 3 or 4 days. Need for a larger tube suggested chronicity and the need for other intervention. It also increased the risk that the product might be used in the genital area.

Members agreed that tubes containing 3 grams or less should be reclassified to general sale but that tubes containing more than 3 grams should remain pharmacy-only medicines. This recommendation should be referred back to the NDPSC.

Recommendation

• That topical aciclovir for the treatment of herpes labialis should be classified as general sale medicine when in packs of 5% or less and containing 3 grams or less.
• That topical aciclovir for the treatment of herpes labialis should be classified as a pharmacy-only medicine when in packs containing more than 3 grams
• That the NDPSC should be informed of this decision.

6.3 Salicylic acid

This was a submission on behalf of SSL New Zealand Ltd for a change to the upper limit for sale as general sale medicine from 12.5% to 40% in order to harmonise with Australia (see also agenda item 8.1.4 below). The NDPSC had earlier recommended that salicylic acid should be classified as a general sale medicine at all strengths. The MCC had not agreed with this recommendation and had recommended that a 40% upper limit be placed on the amount of salicylic acid permitted for general sale. The NDPSC had recently responded accepting this cut-off point.

There was some concern about use at general sale level of higher strength products. The Committee agreed that Medsafe should be asked to include package warnings in the NZ Regulatory Guidelines against use on moles, on the face or in the genital area.

Recommendation

• That salicylic acid should be classified as a restricted medicine in products containing more than 40% and as a general sale medicine in products containing 40% or less
• That Medsafe should be asked to include in the Regulatory Guidelines, a requirement for warnings on the packs against use on moles, on the face or in the genital area.

7. New Medicines for classification

The Committee agreed that all but two of the new chemical entities submitted for classification fulfilled the requirements for classification as prescription medicines. The two exceptions were gadobutrol, a contrast agent for magnetic resonance imaging, and tetrastarch, a plasma volume expander. As such products were exempt from scheduling in Australia these had been classified as general sale medicines in New Zealand in order to harmonise.

Recommendation

• That the following be classified as general sale medicines:
  • gadobutrol
  • tetrastarch
• That the following be classified as prescription medicines:
  • atomoxetine
  • choriogonodatrophin alpha
  • drotrecogin alfa
  • ezetimibe
  • levosimendan
  • lutropin alfa
  • vardenafil

8. Harmonisation of NZ and Australian schedules

8.1 Outstanding harmonisation issues

8.1.1 Insulins

New Zealand and Australia had not yet harmonised on the classification of insulins. While there did not appear to have been a formal recommendation from the NDPSC for the reclassification of insulins, Medsafe was in favour of reclassifying them from restricted medicine to prescription medicine in order to harmonise.

The Chairman explained that there appeared to have been quite high abuse of insulins in Australia in some sports prior to the Olympics. While there did not seem to be any evidence of such abuse in New Zealand, he thought that restricted medicine was an inappropriate classification for such medicines.

The Committee agreed that the current emergency supply order was more than adequate to cover emergency situations and members were happy to see insulins reclassified as prescription medicines.

It was noted that the entry for protamine sulphate would require amendment as the exemption from prescription status when used in insulins would no longer be required.

Recommendation

• That insulins be reclassified from restricted medicine to prescription medicine
• That the exemption for use in insulins be removed from the prescription medicine entry for protamine sulphate.

8.1.2 Dicyclomine and propantheline

These two medicines had been omitted from earlier NDPSC recommendations for anticholinergics to become prescription medicines. There were products registered in New Zealand which contained these medicines. However, no response had been received during the consultation process from companies marketing these products. The Committee agreed that these should become prescription medicines in line with other anticholinergics.

Recommendation

That dicyclomine and propantheline should be reclassified from pharmacy-only medicine and restricted medicine respectively to prescription medicine.

8.1.3 Ephedra

At the time that ephedrine was reclassified from pharmacy-only to prescription medicine as part of the harmonisation process, the NDPSC had recommended the removal of ephedra from the New Zealand schedule. The Committee had not agreed to this and ephedra remained classified as a pharmacy-only medicine.

Although there were no medicines registered in New Zealand which contained ephedra, Medsafe supported reclassification from pharmacy-only to prescription medicine for consistency with ephedrine and as a tool for better control over abuse. There had been evidence of abuse of ephedra for weight loss. Ephedra, also known as Ma-huang, was also contained in some Chinese medicines. Members agreed that ephedra should be reclassified.

Recommendation

That ephedra species be reclassified from pharmacy-only medicine to prescription medicine.

8.1.4 Salicylic acid

Reclassify to general sale for dermal use in medicines containing 40% or less and to restricted medicine for dermal use in medicines containing more than 40%.

The recommendation had been omitted from the February 2001 meeting of the NDPSC. The MCC had agreed in May 2000 to a 40% cut-off level for general sale and had been waiting for a formal recommendation from the NDPSC. The MCC recommendation is contained in agenda item 6.3 above.

8.2 Recommendations made by the NDPSC to the MCC in February 2001

8.2.1. Dextromethorphan

Change the pharmacy-only entry to:

Dextromethorphan in packs containing 600 mg or less of dextromethorphan:

1. in divided preparations containing 30 mg or less of dextromethorphan per dosage unit, with a recommended dose not exceeding 30 mg of dextromethorphan; or
2. in undivided preparations containing 0.3 per cent or less of dextromethorphan, with a recommended dose not exceeding 30 mg of dextromethorphan

The classification of dextromethorphan had been changed in 2000 to in order to harmonise. The further recommendation was based on a history of substance abuse in Australia of all dose forms. The recommendation would result in a change to the classification of all products which were currently available for general sale. Companies objecting to the change were asked to demonstrate that the products could not be readily abused.

The New Zealand Self-Medication Industry Association had responded denying the claim of evidence of abuse of all dose forms. The Association also requested more time for companies to respond if the Committee were to recommend a change in the classification of dextromethorphan.

The Committee agreed that there had been no evidence of abuse of general sale products. Medsafe had been consulted and had produced evidence of abuse only of the imported raw material. Members felt that any classification other than general sale was inappropriate for those products already classified as general sale medicines.

Recommendation

• That the classification of dextromethorphan remain unchanged
• That the NDPSC be informed that the MCC had rejected the recommendation to reclassify dextromethorphan on the grounds that there was no evidence of abuse of general sale products in New Zealand.

8.2.2 Atropine methonitrate

Make a separate prescription medicine entry. Exclude atropine methonitrate from the pharmacy-only entry for atropine.

It was agreed that if atropine methonitrate were listed separately as a prescription medicine there would be no need to exclude it in the atropine entry in the New Zealand schedule. There were no medicines registered in New Zealand containing atropine methonitrate.

Recommendation

That atropine methonitrate be classified as a prescription medicine.

8.2.3. Homatropine

Reclassify as prescription medicine for all strengths and dose forms.

It was noted that there would be no regulatory impact if the recommendation were implemented as New Zealand had only prescription products registered as medicines.

Recommendation

That homatropine should be reclassified to prescription medicines for all strengths and dose forms.

8.2.4. Hysoscine butylbromide

Adopt the following pharmacy-only entry:

as the only therapeutically active substance in divided preparations for oral use containing 10 mg of hyoscine butylbromide per dosage unit in a pack containing 20 or less dosage units.

To date the MCC had recommended on a number of occasions that Buscopan tablets should not be reclassified from restricted medicine to pharmacy-only medicine in New Zealand. The Committee maintained its stance on the classification of this product.

It was noted that if the changes to the hyoscine entry as recommended in agenda item 8.5.5 were implemented they would cause hyoscine butylbromide tablets to become pharmacy-only entries. Members agreed therefore that separate entries should be made in the schedule to preserve the current status of hyoscine butylbromide tablets.

Recommendation

• That separate schedule entries should be made for hyoscine butylbromide as follows:
  • Prescription medicine;
    except when specified elsewhere
  • Restricted medicine;
    for oral use in medicines containing 10 milligrams or less per dose form and in packs containing not more than 20 dose units

8.2.5 Mandragora officinarum

Add to the schedule as a prescription medicine.

The Committee agreed that as this was a herbal medicine which had not previously been classified in New Zealand, its classification should be delayed along with a number of other herbal medicines until the outcome of the Joint Agency Project was known and a way of dealing with such herbal products was agreed upon.

Recommendation

That mandragora officinarum should not be classified as a prescription medicine at this time.

8.2.6 Digoxin-specific antibody fragment

Add to the schedule as a prescription medicine.

Medsafe had earlier queried the accuracy of a recommendation for a prescription medicine entry for digoxin antibody. The NDPSC had since responded with a recommendation for a more acceptable name. The Committee agreed that this should be added to the schedule.

Recommendation

That digoxin-specific antibody fragment should be added to the schedule as a prescription medicine.

8.2.7 Dextrorphan

Add to the schedule as a prescription medicine

It was noted that there were no products registered in New Zealand containing dextrorphan, a metabolite of dextromethorphan, and the Committee agreed that this should be added to the schedule.

Recommendation

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

8.2.8 Ion exchange resins

Delete the prescription medicine generic entry.

Members agreed that a generic entry was unnecessary as ion exchange resins should be scheduled separately by name.

Recommendation

That the generic entry for ion exchange resins be removed from the schedule.

8.2.9 Colestyramine resin

Reclassify from restricted medicine to prescription medicine as colestyramine on the grounds that the primary indications for this medicine do not meet the requirements for sale as a restricted medicine.

No response had been received from the sponsor companies of the two products which would be affected by the change. Members agreed to harmonise on the classification.

Recommendation

That colestyramine be reclassified from restricted medicine to prescription medicine.

8.2.10 Glatiramer acetate

Add to the schedule as a prescription medicine.

Glatiramer acetate was included in the Australian schedule but not the New Zealand schedule. The Committee agreed that it should be added as a prescription medicine.

Recommendation

That glatiramer acetate be added to the schedule as a prescription medicine.

8.2.11 Acepromazine

Add to the schedule as a prescription medicine.

Acepromazine was included in the Australian schedule but not the New Zealand schedule. New Zealand schedule. The Committee agreed that it should be added as a prescription medicine.

Recommendation

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

8.2.12 Thiomesterone

Add to the schedule as a prescription medicine.

This had been identified as an androgenic steroid. There was no reference to it in Martindale. However, the Committee agreed that it should become a prescription medicine.

Recommendation

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

8.2.13 Local anaesthetics

Add the following to the schedule as prescription medicines:

• 3-aminobenzoic acid ethyl ester methanesulphonate
• amylocaine
• butacaine
• diperodon
• etidocaine
• orthocaine

The Committee noted that there was no reference to the first or last of these in Martindale which suggested that they may be obsolete and should be removed from the schedules. Members thought that the NDPSC could be asked to remove these from their schedule if they were not contained in any products in Australia. The remaining local anaesthetics should be added as prescription medicines.

Recommendation

• That the following be added to the schedule as prescription medicines'
  • amylocaine
  • butacaine
  • diperodon
  • etidocaine
• That the NDPSC be recommended to delete 3-aminobenzoic acid ethyl ester methanesulphonate and orthocaine from the Australian schedule if these were not contained in any products.

8.2.14 Amethocaine

The scheduling of amethocaine should be as follows:

Prescription

except when specified below

Pharmacy-only

in dermal preparations containing 10% or less but more than 2% of total local anaesthetic substances

General sale

in dermal preparations containing 2% or less of total local anaesthetic substances

The Committee was informed that the imposition of an upper limit for dermal pharmacy-only products would have no effect on any product currently registered in New Zealand. Members agreed to the change. They noted that New Zealand would retain the exemption from prescription status allowing optometrists to use eye preparations.

Recommendation

That the pharmacy-only schedule entry for amethocaine be amended to impose an upper limit of 10% for dermal products and that the prescription entry be amended to accommodate the change.

8.2.15 Benzamine

Add to the New Zealand schedule as a prescription medicine on the grounds of harmonisation.

As this substance was not scheduled in New Zealand, had no reference in Martindale and was not contained in products in either country, members agreed that the NDPSC should be recommended to remove benzamine from the Australian schedule.

Recommendation

That the NDPSC be recommended to delete benzamine from the schedule.

8.2.16 Benzocaine

The scheduling of benzocaine should be as follows:

Prescription

except when specified below

Pharmacy-only

in topical preparations other than eye drops containing 10% or less but more than 2% of total local anaesthetic substances
in tablets or capsules containing 200mg or less except in lozenges containing 30mg or less of total local anaesthetic substances

General sale

in dermal preparations containing 2% or less of total local anaesthetic substances
in lozenges containing 30mg or less of total local anaesthetic substances

It was noted that the imposition of an upper limit for topical pharmacy-only products would affect the Sultan Topex range of oral gel products (4) which contained 20%. As there had been no comment from the sponsors of this product, the Committee agreed to the change for external products in the interest of consistency and harmonisation.

It was also noted that the term 'external use' would be retained in the schedule. By legal definition this would cover products used on the ear, throat, oral mucosa, teeth and gums as well as on the skin. Benzocaine does not appear to be used in the eye.

There was some doubt about the use of oral products containing up to 200 milligrams being available as pharmacy-only medicines. Although it was known that benzocaine had been used internally for appetite suppression, according to Martindale there was little evidence of efficacy for this indication or information about a suitable dose range. There were no such products registered in New Zealand. It was agreed that the NDPSC should be asked to supply more information on the classification of oral benzocaine.

Recommendation

• That the pharmacy-only schedule entry for benzocaine be amended to impose an upper limit of 10% for external products and that the prescription entry be amended to accommodate the change.
• That the NDPSC be asked to provide further information about the pharmacy-only classification of oral products containing up to 200 milligrams and details of products available in Australia.

8.2.17 Butyl aminobenzoate

Add to the schedule as a prescription medicine.

There were no medicines registered in either country containing this ingredient. However, the Committee agreed that it should be added to the schedule.

Recommendation

That butyl aminobenzoate be added to the schedule as a prescription medicine.

8.2.18 Cinchocaine

The scheduling of cinchocaine should be as follows:

Prescription

except when specified below

Pharmacy-only

for topical use other than eye drops in preparations containing 0.5% or less of total local anaesthetic substances

Cinchocaine for external use was currently a pharmacy-only medicine in New Zealand in products containing more than 2% and general sale below that level. Therefore, adopting the NDPSC recommendation would be adopting a more restrictive classification. However, it appeared that the recommended change would have no affect on products currently registered in New Zealand and members therefore agreed to accept the recommendation.

Recommendation

That cinchocaine should be classified as a pharmacy-only medicine when for external use but not ophthalmic use in medicines containing 0.5% and that all other uses should be prescription medicines.

8.2.19 Dimethisoquin and pramoxine

Add to the New Zealand schedule as prescription medicines.

Pramoxine was already included in the New Zealand schedule under its International Non-proprietary Name, (INN), pramocaine. It appeared to be used only externally. Its classification was general sale at 2% or less and pharmacy-only above that concentration. However, as there were no longer any medicines available in New Zealand containing pramocaine, the recommendation would have no regulatory impact and the Committee agreed that it should be put into effect.

It was noted that the INN for dimethisoquin was quinisocaine. It was also a surface anaesthetic. There were no medicines containing this registered in New Zealand. Members agreed that it should be added using the INN.

Recommendation

• That pramocaine and quinisocaine should be classified as prescription medicines
• That the NDPSC should be notified of the New Zealand use of the INN in both cases.

8.2.20 Lignocaine

The scheduling of lignocaine should be as follows:

Prescription

except when specified below

Pharmacy-only

in preparations for topical use other than eye drops: containing 10% or less but more than 2% of total local anaesthetic substances;
in divided preparations containing 200 mg or less of total local anaesthetic substances per dosage unit except in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit

General sale

in dermal preparations containing 2% or less of total local anaesthetic substances
in lozenges containing 30 mg or less of total local anaesthetic substances

As for benzocaine, this recommendation included a pharmacy-only classification for internal use in tablets or capsules containing up to 200 milligrams. Any such products would be prescription medicines in New Zealand. Martindale made no reference to an oral use for lignocaine and there was no reference to its use as an appetite suppressant. It was agreed that further information should be sought from the NDPSC.

The only other change recommended appeared to be the imposition of an upper limit on the amount of lignocaine permitted in pharmacy-only external products. It was agreed that, for clarity, the current wording in the schedule would be largely retained.

The Secretary pointed that urethral products would be considered to be for topical application in Australia whereas these would be internal products in New Zealand. As oral and injectable products were the only internal products captured in the New Zealand schedule, urethral products were currently unscheduled. It was agreed that this had probably occurred by default. Pharmacia had brought this matter to the Committee's attention and had stated that it would be happy to harmonise on a pharmacy-only classification. In order to harmonise with Australia on the use of urethral products it was agreed that urethral use should be added to the pharmacy-only entry in the schedule.

It was also noted that the New Zealand schedule would retain the current exemptions from prescription status for named health professionals. The NDPSC had recognised that different legislative controls prevented harmonisation of these entries.

Recommendation

• That the pharmacy-only schedule entry for lignocaine be amended to impose an upper limit of 10% for external products and that the prescription entry be amended to accommodate the change
• That urethral use should be included as a pharmacy-only medicine
• That the NDPSC be asked to provide further information about the pharmacy-only classification of oral products containing up to 200 milligrams of lignocaine and details of products available in Australia.

8.2.21 Prilocaine

The scheduling of prilocaine should be as follows:

Prescription

except when specified below

Pharmacy-only

for topical use other than eye drops in preparations containing 10% or less of total local anaesthetic substances

Although New Zealand had applied a general sale classification for medicines containing less than 2%, there were no medicines registered in this category. None of the products currently on the market would be affected by adopting the recommendation. Prilocaine did not appear to be used in the eye. Reference to eye drops in the pharmacy-only entry could be avoided by substituting 'dermal' for 'topical'. Any eye product would then be caught in the prescription entry as intended. Apart from injection, Martindale referred to skin application as the only other use.

The exemption from prescription status for use by dental therapists would remain in the New Zealand schedule.

Recommendation

That the pharmacy-only medicine entry for prilocaine should be amended to impose an upper limit of 10% on dermal medicines.

8.2.22 Oral vaccines

The pharmacy-only entry should be removed from the schedule on the grounds that there were safety concerns about the registration process for oral vaccines if they were moved to pharmacy-only medicine.

The recommendation overlooked the fact that oral vaccines were only pharmacy-only if they are not specified elsewhere in the schedule. New Zealand listed vaccines in the schedule according to their ingredients. Any vaccines intended to be prescription medicines would be scheduled as such.

The Committee was not aware of any products which fell under this classification category. All oral vaccines were known to be prescription medicines because of the classification of the active ingredients. The only product to which members thought the oral vaccine entry might apply was Buccaline Berna. It was noted that this product contained haemophilus influenzae and pneumoccocus I,II and III. Both types of bacteria were classified as prescription medicines when contained in vaccines. If the product was considered to have vaccine activity, then it should be classified as a prescription medicine. If it did not have a vaccine-type activity, there was nothing other than the oral vaccines entry to hold the product in the pharmacy-only medicine classification. It was agreed that this was an evaluation issue and that Medsafe should be asked to review the status of the product in order to determine its proper classification. Meanwhile, it was agreed that the oral vaccines entry should be removed from the schedule.

Recommendation

• That the pharmacy-only entry for oral vaccines should be removed from the schedule
• That Medsafe should be asked to review the status of Buccaline Berna to determine whether or not its active ingredients were of vaccine strength so that it might be appropriately classified as either a prescription medicine or a general sale medicine.

8.2.23 Nicoumalone

Adopt as a prescription medicine.

It was noted that there were no medicines registered in New Zealand which contained nicoumalone but members agreed it should be added to the schedule.

Recommendation

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

8.2.24 Terebene

Delete the restricted medicine entry.

The Committee noted that New Zealand had a pharmacy-only entry for internal use and that this was is probably the entry intended in the recommendation. There were no products registered in New Zealand containing terebene and there was no reference to it in Martindale.

Recommendation

That terebene be deleted from the schedule.

8.2.25 Monosulfiram and dichlofenthion

Delete the pharmacy-only entries.

There were no medicines registered in New Zealand containing either of these medicines. Nor was there any reference in Martindale to the latter. There were other pesticides preferred to monosulfiram. Members agreed that these should be deleted.

Recommendation

That monosulfiram and dichlofenthion be deleted from the schedule.

8.2.25 Nystatin and hexamidine

Reassess the scheduling of nystatin and hexamidine in dermal products for tinea pedis.

Hexamidine had already been reclassified to general sale for all indications as part of the harmonisation project.

Although there were several pharmacy-only products for dermal infections, there were no nystatin products registered specifically for this indication. The Committee agreed that nystatin was not effective against the infections which caused tinea pedis.

Recommendation

That the pharmacy-only entry for nystatin for dermal use be amended to remove the exception for use for tinea pedis.

8.2.26 Mandelic acid

Remove from the schedule.

Mandelic acid was noted as being classified as a pharmacy-only medicine. However, there were no medicines registered in New Zealand which contained mandelic acid and members agreed that it should be deleted.

Recommendation

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

8.2.27 Strychnine and brucine

• Delete the pharmacy-only entry for nux vomica and the restricted medicine entry for strychnine and reclassify both to prescription medicine under the following two entries:
  Strychnos nux vomica
  Strychnos spp
• Delete the pharmacy-only and restricted medicine entries for brucine

Comments from Weleda were tabled at the meeting.

It was noted that strychnine was an Appendix G medicine in Australia which meant it was exempt from scheduling below a concentration other than the standard one, in this case, 1 milligram per litre or per kilogram. It was agreed that this cut-off point was not appropriate for application to the entry for strychnos species and that the general exemption should be allowed to apply. Nux vomica was also contained in Appendix G but its cut-off point was the same as for the general exemption.

The Committee agreed that an entry for strychnos nux vomica was redundant as there was already an entry covering all strychnos species. However, they were in favour of retaining an entry for nux vomica as this was the name by which the substance had traditionally been known and that which would be most likely to be used if anyone were seeking its classification.

Brucine would presumably be covered by the prescription medicine entries for strychnos or nux vomica and it was agreed that this could be removed.

There were no medicines registered in New Zealand containing nux vomica, strychnine or brucine.

Recommendation

• That the entries for strychnine and brucine be deleted from the schedule
• That new prescription medicine entries should be made for strychnos species and for nux vomica and that the general exemption should apply to these medicines.

8.2.28 Savin oil

Reclassify to prescription medicine as Juniperus sabine

Juniperus sabina was one of the herbals for which a delay had been requested for classification as a prescription medicine and for which it had been agreed that no further action should be taken until the outcome of the joint agency proposal was known.

The PDR For Herbal Medicines stated that the medicinal part of Juniperus sabina or savin tops were the essential oil of the leaves and branch tips; the dried leafy branch tips; the fresh non-woody branch tips with leaves; and the branches and leaves.

Savin oil was already classified as a prescription medicine which meant that it was unavailable for use in complementary medicines. However, it was thought that there might be complementary medicines on the New Zealand market which were derived from parts of the plant other than the essential oil. It was agreed that changing the name to Juniperus sabina could increase the scope of the substance to be classified and deny access to products to which the Committee did not wish to restrict at this point in time. It was therefore agreed that the entry for savin oil should remain unchanged in the schedule.

Recommendation

That the prescription medicine schedule entry for savin oil should remain unchanged.

8.2.29 Pregnenolone

Delete 'except in preparations for topical use' from the prescription medicine entry on the grounds that this recommendation was obsolete.

This wording was added to the New Zealand schedule at the request of the NDPSC. New Zealand had no medicines containing this substance. Members agreed that the exception for topical use should be removed.

Recommendation

That pregnenolone should be a prescription medicine for all uses.

8.2.30 Potassium chlorate

Make a new pharmacy-only entry for potassium chlorate except when in medicines containing 10% or less of potassium chlorate.

As New Zealand had only one product registered and this would remain general sale, the Committee agreed to the new schedule entry.

Recommendation

That potassium chlorate should be classified as a pharmacy-only medicine except in medicines containing 10% or less.

8.2.31 Ephedra

Reclassify to prescription medicine as follows:

Ephedra spp: except in preparations containing 0.001% or less of ephedrine

This was discussed in agenda item 8.1.3 above. As the amount specified in the exception was equivalent to the general exemption, the addition of the extra wording was seen as unnecessary. No further recommendation was required.

8.2.32 Adenosine

Add 'for injection' to the prescription medicine entry.

Medsafe had previously queried this recommendation on the grounds that any other route of administration would automatically become general sale. It appeared that there was a complementary medicine in Australia in tablet form and which was not scheduled. There was no such product registered in New Zealand. Members agreed that the schedule entry should be amended so that there could be harmonisation for complementary products.

Recommendation

That the prescription medicine entry for adenosine entry should be amended to limit its prescription use to injectable forms only.

8.2.33 Benzyl benzoate

Delete the pharmacy-only entry from the schedule.

This would result in products containing more than 2.5% moving from pharmacy-only to general sale. The highest strength currently registered in New Zealand was a 25% topical solution. Members agreed to accept the recommendation.

Recommendation

That benzyl benzoate be removed from the schedule.

8.2.34 Benorylate

Reclassify from pharmacy-only medicine to prescription medicine.

As New Zealand had no registered medicines containing benorylate, it was agreed that the recommendation should be accepted as there would be no regulatory impact.

Recommendation

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

8.2.35 Benzydamine

Reclassify as prescription medicine except for topical use.

As there were only external products registered in New Zealand, there would be no regulatory impact if the recommendation were implemented. Benzydamine had been used orally and by injection and members agreed that such products should be prescription medicines.

Recommendation

That benzydamine should be classified as a prescription medicine except for external use and that the pharmacy-only entry should be modified accordingly.

8.2.36 Ibuprofen

New Zealand should adopt the revised wording of the SUSDP 15 (2) amendment for ibuprofen that:

• sets an upper daily dose for divided and undivided preparations for ibuprofen (1200mg)
• relaxes the concentration requirements for ibuprofen liquid preparations but retains a 4 gram total content of ibuprofen in these packs (no concentration specified).

The Committee found the upper limit of 1200 milligrams per daily dose acceptable for both liquid and solid dose forms of OTC ibuprofen. These were the doses already in effect for products registered in New Zealand. This was seen as a good opportunity to include requirements for solid dose forms in the New Zealand Regulatory Guidelines along with those for liquid forms. This would allow for simplification of the currently rather complex schedule entry by transferring some of the requirements which were included in the schedule to a more appropriate location.

With regard to liquid forms, the Committee agreed that the intention to reclassify liquid ibuprofen to pharmacy-only medicine had been for paediatric doses only. Liquid ibuprofen had not been intended to be available at this level for chronic use. Members agreed that the recommendation would allow the same paediatric doses to be available but would also allow smaller volumes of more concentrated products. While wishing to retain the proposal to limit the total pack content to 4 grams, the Committee also wished to place limits on the concentration permitted for pharmacy-only sale which would maintain consistency with pharmacy-only solid dose forms. It agreed that concentrations only of 100 milligrams in 5 millilitres and 200 milligrams in 5 millilitres should be available as pharmacy-only medicines. . The NDPSC should be recommended to accept the same concentration limits for S2 liquid ibuprofen.

These concentration limits should be implemented in the next Gazette notice. However, once the requirements had been included in the Guidelines the requirement to be sold in an approved pack would ensure compliance with these concentrations and with any other specific requirements currently stated in the schedule entry. These requirements could then be omitted from subsequent updates to the First Schedule

Recommendation

• That the maximum daily dose for pharmacy-only solid dose and liquid ibuprofen should not exceed 1200 milligrams
• That the maximum pack size for pharmacy-only liquid preparations should not exceed 4 grams of total ibuprofen content
• That packs for pharmacy-only sale should be in concentrations only of 100 milligrams in 5 millilitres or 200 milligrams in 5 millilitres of ibuprofen
• That the changes should be notified in the Gazette but Medsafe should be asked to include these changes and other requirements in the Regulatory Guidelines so that they would no longer be required to be listed in amendments to the First Schedule to the Medicines Regulations 1984.
• That the NDPSC be asked to adopt the MCC recommendation limiting the concentrations of liquid ibuprofen permitted in pharmacy-only (S2) medicines.

8.2.37 Silver

Modify the pharmacy-only entry so that the following are general sale medicines

• oral solutions containing 0.3% or less
• other medicines containing 1% or less

Shift the wording of the current pharmacy-only exemption for silver sulfadiazine from the 'silver' to the 'silver sulfadiazine' entry.

Adopt the SUSDP warning statement 'overuse may stain skin or mouth' for silver solutions for oral use or in chewing gums.

New Zealand did not appear to have any registered products which would be affected by the classification change and it was agreed that this part of the recommendation could be put into effect. As there were no products which would justify the inclusion of the above warning statement into the New Zealand Regulatory Guidelines, this part of the recommendation was seen as requiring no action. Silver sulfadiazine was discussed later on the agenda (see item 8.5.1).

Recommendation

That silver should be classified as a pharmacy-only medicine except in oral solutions containing 0.3% or less or in other medicines containing 1% or less.

8.2.38 Selenium

Change the classification of products for external use containing more than 2.5% from pharmacy-only to prescription medicine.

This was seen as being inconsistent in that it would make external products more restrictively classified than internal products. All internal products containing more than 150 micrograms per recommended daily dose would remain pharmacy-only. It was agreed that, for consistency, external products containing more that 2.5% should remain pharmacy-only medicines and that the NDPSC should be recommended to harmonise on this classification.

Recommendation

• That the classification of selenium for external use remain unchanged
• That the NDPSC be recommended to harmonise on the New Zealand classification for selenium

8.2.39 Pyrithione zinc

Classify as pharmacy-only except when in shampoos containing 2% or less.

This was currently general sale in New Zealand and was covered under the entry for zinc for external use. The secretary reported that there were a large number of shampoos marketed, most of which contain 1% or less. However, one shampoo containing 2.08% would become a pharmacy-only medicine. The Committee thought that Medsafe should be asked to check the content of this product in order to ensure that the product concerned did contain more than 2% of pyrithione zinc.

Recommendation

• That pyrithione zinc should be classified as a pharmacy-only medicine for external use in medicines containing more than 2%
• That Medsafe be asked to verify the content of any products containing more than 2% of pyrithione zinc.

8.2.40 Guaiphenesin

Reclassify to prescription medicine except for oral liquids containing 2% or less or solid dose forms containing 200 mg or less which should become general sale medicines.

The change was thought not to affect any of the products currently on the market and the Committee agreed to implement the recommendation.

Recommendation

That guaiphenesin should be classified as a prescription medicine in liquid form containing more than 2% or solid dose form containing more than 200 milligrams

8.2.41 Mannityl hexanitrate, erythryl tetranitrate

Reclassify from pharmacy-only to restricted medicine for consistency with isosorbide dinitrate and glyceryl trinitrate.

New Zealand had no products containing either medicine. The Committee agreed to accept the recommendation. However, it was noted that harmonisation had not been achieved for all medicines in this group and the Committee agreed that the matter should be rectified at the next meeting.

Recommendation

That mannityl hexanitrate and erythryl tetranitrate should be reclassified from restricted medicine to prescription medicine.

8.3 Recommendations made by the NDPSC to the MCC in May 2001

8.3.1 Folic acid and folinic acid

Reclassify to:

prescription medicine

for injection

pharmacy-only

medicines containing more than 500 micrograms per recommended daily dose

general sale

medicines containing 500 micrograms or less per recommended daily dose

It was noted that the MCC has already reclassified folinic acid from prescription medicine to restricted medicine at the request of the NDPSC. It was also noted that calcium folinate (leucovorin) tablets came in strengths of 10 and 15 milligrams only and that there were no tablets which corresponded with the range recommended for general sale or pharmacy-only. Martindale did not suggest that folinic acid was used as a dietary supplement in the same way as folic acid, giving the only indications for oral use as methotrexate rescue and folate-deficient megaloblastic anaemia, and recommended doses which were consistent with the range available in New Zealand. The 10 and 15 milligram tablets had recently moved from prescription medicine to restricted medicine at the recommendation of the NDPSC and would now move again to pharmacy-only. Folinic acid injections would move back to prescription medicine. There would be no change to the current classification of folic acid tablets but injections would move to prescription medicine. The Committee noted that an exemption from prescription status would be required for folic acid to allow use at general sale level in parenteral nutrition replacement preparations. Folinic acid did not appear to be used in this way. Members agreed to adopt the recommendation.

Recommendation

That folic acid and folinic acid be classified as follows:

prescription medicine

for injection

pharmacy-only

medicines containing more than 500 micrograms per recommended daily dose

general sale

medicines containing 500 micrograms or less per recommended daily dose

8.3.2 Polysulphated glycosamino glycans

Add to the list of prescription medicines.

In the New Zealand schedules these medicines would be listed according to their individual names. It was unclear as to which medicines the recommended entry would apply. The Committee agreed that such an entry was unnecessary in the New Zealand schedule.

Recommendation

That a new prescription medicine entry for polyslphated glycosamino glycans was not required.

8.3.3 Hypromellose

Schedule as a prescription medicine when contained in injections.

The Committee agreed that hypromellose should be included in the schedule. As it was not contained as an excipient in any injectable medicines which were not already prescription medicines by virtue of their active ingredients, a cut-off point or exemption statement to avoid catching medicines which should be less restrictively classified would be unnecessary. Members noted that one product would move from pharmacy-only to prescription medicine.

Recommendation

That hypromellose be classified as a prescription medicine when contained in injections.

8.3.4 Levetiracetam

Add to the schedule as a prescription medicine.

This was a new chemical entity for use in epileptic patients for the treatment of partial onset seizures. New Zealand had not received an application for consent to market a medicine containing levetiracetam.

Recommendation

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

8.4 Recommendations made by the NDPSC to the MCC in August 2001 8.4.1 Nizatidine

Reclassify from restricted medicine to pharmacy-only medicine when for the relief of symptoms of oesophageal reflux and when in packs containing not more than 14 days' supply.

While members saw that this would bring the OTC classification of nizatidine into line with that of ranitidine and famotidine, they acknowledged that there were no longer any nizatidine products marketed in New Zealand and that nizatidine had never been available over the counter. They agreed that if there were no OTC products available in Australia, the OTC entry should be removed from the schedule and nizatidine should remain a prescription medicine.

Recommendation

That the NDPSC should be asked whether or not there were OTC products containing nizatidine marketed in Australia and if there were no such products the OTC classification should be removed from both schedules.

8.4.2 Bexarotene

Add to the schedule as a prescription medicine.

The Committee was informed that bexarotene was a new chemical entity not registered for consent to market in Australia or New Zealand but available in Australia through the Special Access Scheme when used for the treatment of T-cell lymphoma. Members agreed that it should be added to the schedule.

Recommendation

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

8.4.3 Bifonazole

Amend the pharmacy-only entry to allow scalp preparations containing 1% or less to become general sale medicines as for ketoconazole.

It was noted that there was one product in New Zealand which would be affected by this change. Members agreed to adopt the recommendation.

Recommendation

That bifonazole should be a general sale medicine when in scalp preparations containing 1% or less.

8.4.4 Minoxidil

Reclassify topical preparations containing 5% or less from restricted medicine to pharmacy-only medicine.

This matter was discussed earlier on the agenda and the recommendation was adopted. (See agenda item 6.1)

8.4.5 Darbepoetin alpha

Add to the schedule as a prescription medicine.

Recommendation

That darbepoetin alpha be added to the schedule as a prescription medicine.

8.5 Recommendations made by the NDPSC to the MCC in November 2001 Recommendations of the Joint Expert Advisory Committee on Antibiotic Resistance (jetacar)

8.5.1 Silver sulfadiazine

Silver sulfadiazine should be classified as a prescription medicine at all strengths. Silver sulfadiazine was permitted as a pharmacy-only medicine in New Zealand in packs containing 50 grams or less. There was only one OTC pack available, Silvazine Topical Cream. The Committee discussed the NDPSC report on ophthalmic sulfacetamide which had been written after the Jetacar recommendation. This report was relevant to all medicines in the sulfonamide group including silver sulfadiazine. The report showed that there were no significant antibiotic resistance issues for sulfonamides and that restricting access would not increase resistance. Restricted access could, in fact, worsen resistance problems by causing other antibiotics to be used instead. Members agreed that OTC use of silver sulfadiazine was appropriate for the treatment of minor burns and that the 50 gram pack size should retain its current pharmacy-only status. The NDPSC should recommended to harmonise with the New Zealand classification of silver sulfadiazine. It was noted that in agenda item 8.2.37 the NDPSC had recommended that the silver sulfadiazine schedule entry should be removed from the silver entry. The Committee was happy for silver sulfadiazine to be scheduled separately.

Recommendation

• That silver sulfadiazine in packs containing up to 50 grams should retain its current pharmacy-only classification
• That the NDPSC should be recommended to adopt a similar classification
• That silver sulfadiazine should be listed separately in the schedule.

8.5.2 Nitrofurazone

Reclassify to prescription medicine.

Nitrofurazone was currently classified as a pharmacy-only medicine. There were no longer medicines registered in New Zealand containing nitrofurazone.

Recommendation

That nitrofurazone should be reclassified to prescription medicine.

8.5.3 Clindamycin

Clindamycin for topical use should be reclassified from restricted medicine to prescription medicine. Increasing rates of resistance to clindamycin had been noted in New Zealand against a background of more widespread availability for the treatment of acne.

The Committee expressed surprise at the lack of response from companies or other interested bodies to the recommendation to move clindamycin back to prescription medicine. The products were recognised as being widely used and it was agreed that removing them from the OTC market would create a gap which would need to be managed by public re-education.

Several members acknowledged that they had been very much against the recommendation before reading the NDPSC report but were now convinced by the seriousness of the resistance problems. Oral and parenteral clindamycin, a lincosamide antibacterial active against a wide range of bacteria, was regarded as an important antibiotic for use in infections for which other treatment options were limited. Its use was restricted due to attempts to delay the emergence of resistance to this important antibacterial. Resistance to clindamycin was also shown to be linked to cross-resistance to erythromycin and other macrolides and to the beta streptogramin antibacterials. These new agents such as quinupristin and dalfopristin were hoped to be the solution to treating multi-resistant bacteria. The Committee agreed that access to topical clindamycin should be limited in an attempt to limit the increasing rates of clindamycin resistance and the development of cross-resistance.

Recommendation

That topical clindamycin should be reclassified from restricted medicine to prescription medicine.

Other recommendations made in November 2001

8.5.4 Butyl aminobenzoate

Amend the current prescription medicine classification to allow dermal preparations containing 2% or less to be general sale medicines in line with other local anaesthetics.

New Zealand no longer had products containing butyl aminobenzoate. The Committee agreed to adopt the recommendation.

Recommendation

That butyl aminobenzoate should be a prescription medicine except in dermal products containing 2% or less which should be general sale medicines.

8.5.5 Solanaceous plants and alkaloids

The proposed amendments applied only to pharmacy-only entries. The more restrictive classifications in Australia were prescription medicines whereas the higher oral doses were restricted medicines in New Zealand with only injectable and ophthalmic products being classified as prescription medicines. It was implied that medicines containing more than the cut-off points recommended below should become prescription medicines as they were in Australia. The following pharmacy-only entries have been recommended

• Atropa belladonna
  1. for external use in preparations containing 0.03% or less of the alkaloids of belladonna; or
  2. for oral use:
     1. in undivided preparations containing 0.03% or less of the alkaloids of belladonna when labelled with a dose of 0.3mg or less of the alkaloids of belladonna and a recommended daily dose of 1 mg or less of the alkaloids of belladonna: or
     2. in divided preparations containing 0.3 mg or less of the alkaloids of belladonna per dosage unit, when labelled with a recommended daily dose of 1 mg or less of the alkaloids of belladonna.
• Atropine
  1. for oral use:
     1. in undivided preparations containing 0.03% or of atropine when labelled with a dose of 0.3mg or less of atropine and a recommended daily dose of 1 mg or less of atropine: or
     2. in divided preparations containing 0.3 mg or less of atropine per dosage unit when labelled with a recommended daily dose of 1 mg or less of the atropine
  2. in preparations containing atropine sulfate when packed and labelled for treatment of organophosphorous poisoning:
     1. in tablets each containing 0.6 mg or less of atropine sulfate in packs of 20 tablets; or
     2. in preparations for injection each containing 0.6 mg per ml or less of atropine sulfate in packs of 5
• Datura spp
  1. for oral use except when separately specified in these Schedules:
     1. in undivided preparations containing 0.03% or less of the alkaloids of datura when labelled with a dose of 0.3mg or less of the alkaloids of datura and a recommended daily dose of 1 mg or less of the alkaloids of datura; or
     2. in divided preparations containing 0.3 mg or less of the alkaloids of belladonna per dosage unit, when labelled with a recommended daily dose of 1 mg or less of the alkaloids of datura.
• Datura stramonium
  1. for oral use when:
     1. in undivided preparations containing 0.03% or less of the alkaloids of stramonium when labelled with a dose of 0.3mg or less of the alkaloids of stramonium and a recommended daily dose of 1 mg or less of the alkaloids of stramonium; or
     2. in divided preparations containing 0.3 mg or less of the alkaloids of stramonium per dosage unit, when labelled with a recommended daily dose of 1 mg or less of the alkaloids of stramonium
     except for smoking or burning.
• Datura tatula
  1. for oral use when:
     1. in undivided preparations containing 0.03% or less of the alkaloids of stramonium when labelled with a dose of 0.3mg or less of the alkaloids of stramonium and a recommended daily dose of 1 mg or less of the alkaloids of stramonium; or
     2. in divided preparations containing 0.3 mg or less of the alkaloids of stramonium per dosage unit, when labelled with a recommended daily dose of 1 mg or less of the alkaloids of stramonium
     except for smoking or burning.
• Duboisia leichhardtii
  1. for oral use:
     1. in undivided preparations containing 0.03% or less of the alkaloids of duboisia calculated as hyoscyamine when labelled with a dose of 0.3mg or less of the alkaloids of duboisia calculated as hyoscyamine and a recommended daily dose of 1 mg or less of the alkaloids of duboisia calculated as hyoscyamine; or
     2. in divided preparations containing 0.3 mg or less of the alkaloids of duboisia calculated as hyoscyamine per dosage unit, when labelled with a recommended daily dose of 1 mg or less of the alkaloids of duboisia calculated as hyoscyamine
• Duboisia myoporides
  1. for oral use:
     1. in undivided preparations containing 0.03% or less of the alkaloids of duboisia calculated as hyoscyamine when labelled with a dose of 0.3mg or less of the alkaloids of duboisia calculated as hyoscyamine and a recommended daily dose of 1 mg or less of the alkaloids of duboisia calculated as hyoscyamine; or
     2. in divided preparations containing 0.3 mg or less of the alkaloids of duboisia calculated as hyoscyamine per dosage unit, when labelled with a recommended daily dose of 1 mg or less of the alkaloids of duboisia calculated as hyoscyamine
• Hyoscine (excluding hyoscine butyl bromide)
  1. for transdermal use in preparations containing 2mg or less of hyoscine per dosage unit; or
  2. for oral use:
     1. in undivided preparations containing 0.03% or less of hyoscine when labelled with a dose of 0.3mg or less of hyoscine and a recommended daily dose of 1 mg or less of hyoscine; or
     2. in divided preparations containing 0.3 mg or less of hyoscine per dosage unit, when labelled with a recommended daily dose of 1 mg or less of hyoscine
• Hyoscyamine
  1. for external use in preparations containing 0.03% or less of hyoscyamine; or
  2. for oral use:
     1. (i) in undivided preparations containing 0.03% or less of hyoscyamine when labelled with a dose of 0.3mg or less of hyoscyamine and a recommended daily dose of 1 mg or less of hyoscyamine; or
     2. (ii) in divided preparations containing 0.3 mg or less of hyoscyamine per dosage unit, when labelled with a recommended daily dose of 1 mg or less of hyoscyamine
• Hyoscyamus niger
  1. for oral use:
     1. in undivided preparations containing 0.03% or less of the alkaloids of hyoscyamus when labelled with a dose of 0.3mg or less of the alkaloids of hyoscyamus and a recommended daily dose of 1 mg or less of the alkaloids of hyoscyamus; or
     2. in divided preparations containing 0.3 mg or less of the alkaloids of
        hyoscyamus per dosage unit, when labelled with a recommended daily dose of 1 mg or less of the alkaloids of hyoscyamus

The Committee agreed to harmonise with Australia for all of these medicines except hyoscine butylbromide. They thought that there were few restricted medicines in which would be affected if the New Zealand harmonised with Australia on the prescription classification for higher strength products. Since the November 2001 recommendation the NDPSC had made a further recommendation in February 2002 changing the cut-off points of some entries to accommodate products already on the Australian market. Details of this were tabled at the meeting and the Committee agreed to accept the new levels.

Members also agreed that most of the entries recommended by the NDPSC would need to be modified to suit the requirements of New Zealand schedule. They were happy for Medsafe to undertake this rewording.

It was noted that the exemption for sale by licencees under the Toxic Substances Regulations would need to be retained in the pharmacy-only entry for atropine.

Comments from Weleda were discussed and members agreed that a number of products would be covered by the general exemption. Others would be accessible in homoeopathic products as pharmacy-only medicines.

It was agreed that Buscopan tablets should remain a restricted medicine in line with the Committee's earlier recommendations (see agenda item 8.2.4). Separate prescription medicine and restricted medicine entries would be required in the schedule to maintain this classification.

Recommendation

• That New Zealand should harmonise with Australia on the nomenclature and classification levels for solanaceous plants and alkaloids except for hyoscine butylbromide
• That over-the-counter hyoscine butylbromide tablets should retain their current restricted medicine classification as in the recommendation made for agenda item 8.2.4.

8.5.6 Aristolochic acid

Make a new prescription medicine entry in for aristolochic acid at all strengths in addition to the entry for aristolochia spp in order to harmonise with changes to the wording in Appendix C of the SUSDP and to cover aristolochic acids obtained from other species. The Committee agreed to adopt this recommendation.

Recommendation

That a new prescription medicine entry be made for aristolochic acid at all strengths.

8.5.7 Podophyllum and podophyllotoxin

Schedule as follows:

Prescription medicine

• Podophyllum emodi
  1. (a) in preparations for internal use
  2. (b) in preparations for the treatment of anogenital warts
  3. (c) in other preparations except when specified elsewhere
• Podophyllum pelatum
  1. in preparations for internal use
  2. in preparations for the treatment of anogenital warts
  3. in other preparations except when specified elsewhere
• Podophyllotoxin
  1. in preparations for internal use
  2. in preparations for the treatment of anogenital warts
  3. in other preparations except when specified elsewhere

Restricted Medicine

• Podophyllum emodi
  • in preparations containing 20% or less of podophyllin for the treatment of warts other than anogenital warts except when specified elsewhere
• Podophyllum pelatum
  • in preparations containing 20% or less of podophyllin for the treatment of warts other than anogenital warts except when specified elsewhere
• Podophyllotoxin
  • in preparations containing 1% or less of podophyllotoxin for the treatment of warts other than anogenital warts except when specified elsewhere

Pharmacy-only medicine

• Podophyllum emodi
  • in preparations containing 10% or less of podophyllin for the treatment of warts other than anogenital warts
• Podophyllum pelatum
  • in preparations containing 10% or less of podophyllin for the treatment of warts other than anogenital
• Podophyllotoxin
  • in preparations containing 0.5% or less of podophyllotoxin for the treatment of warts other than anogenital warts

The Committee agreed to accept the uses and levels proposed in the NDPSC recommendation for the classification of podophyllum and podophyllotoxin. However, they agreed that modification of the wording used in the SUSDP would be necessary to fit the New Zealand schedule and Medsafe should reword the entries to capture the intent of the NDPSC recommendation.

Recommendation

That podophyllum and podophyllotoxin should be classified as follows using suitable wording to be determined by Medsafe:

Prescription medicine

• Podophyllum emodi
  1. a. in preparations for internal use
  2. b. in preparations for the treatment of anogenital warts
  3. c. in other preparations except when specified elsewhere
• Podophyllum pelatum
  1. a. in preparations for internal use
  2. b. in preparations for the treatment of anogenital warts
  3. c. in other preparations except when specified elsewhere
• Podophyllotoxin
  1. in preparations for internal use
  2. in preparations for the treatment of anogenital warts
  3. in other preparations except when specified elsewhere

Restricted Medicine

• Podophyllum emodi
  • in preparations containing 20% or less of podophyllin for the treatment of warts other than anogenital warts except when specified elsewhere
• Podophyllum pelatum
  • in preparations containing 20% or less of podophyllin for the treatment of warts other than anogenital warts except when specified elsewhere
• Podophyllotoxin
  • in preparations containing 1% or less of podophyllotoxin for the treatment of warts other than anogenital warts except when specified elsewhere

Pharmacy-only medicine

• Podophyllum emodi
  • in preparations containing 10% or less of podophyllin for the treatment of warts other than anogenital warts
• Podophyllum pelatum
  • preparations containing 10% or less of podophyllin for the treatment of warts other than anogenital
• Podophyllotoxin
  • in preparations containing 0.5% or less of podophyllotoxin for the treatment of warts other than anogenital warts

8.5.8 Beclomethasone and fluticasone

Amend the schedule entries to allow beclomethasone and fluticasone to be sold as restricted medicines for both seasonal and perennial allergic rhinitis. The term 'allergic rhinitis' to be used to cover both conditions. The Committee noted that New Zealand did not schedule nasal corticosteroids according to indications. A change would be required to the labelling requirements for OTC nasal corticosteroids in the New Zealand Regulatory Guidelines. However, members agreed that Medsafe should be asked to amend the Guidelines to allow beclomethasone and fluticasone to be sold as restricted medicines for perennial as well as seasonal allergic rhinitis.

It was noted that the NDPSC had also requested a company submission in support of a similar change for budesonide. It was also noted that New Zealand allows OTC sale of mometasone and triamcinalone for the same indications as beclomethasone, budesonide and fluticasone but that no recommendation had been received for widening the OTC indications for these two medicines.

Recommendation

That the indications for OTC sale of beclomethasone and fluticasone be broadened to include both seasonal and perennial rhinitis and that Medsafe be asked to amend the relevant section of the New Zealand Regulatory Guidelines accordingly.

9 For the next meeting

It was brought to the Committee's attention that, although the Committee had acted to implement all the recommendations to harmonise on glyceryl trinitrate and other medicines in this category, the NDPSC appeared to have taken further action. Consequently complete harmonisation had not been achieved for these medicines. The Committee agreed that Medsafe should identify the areas off difference and should advertise these on the website for discussion and resolution at the next meeting.

10 General business

The Secretary brought to the attention of the Committee several inconsistencies which had occurred in the schedule during recent harmonisation changes.

Reproterol

The classification had not been amended when salbutamol and other medicines in that group had been assessed for harmonisation. As there were no medicines registered in New Zealand containing reproterol and it was not included in the Australian schedule, members agreed that it should be deleted from the schedule.

Bamifylline and diprofylline

As for reproterol, there were no medicines registered in New Zealand containing these medicines and neither was listed in the Australian schedule. It was agreed that these should also be deleted from the schedule.

Recommendation

That reproterol, bamyfylline and diprophylline be deleted from the schedule.

Alcolomethasone 0.05% dermal preparations

The Secretary reported that the NDPSC had responded to the MCC recommendation not to allow steroids more potent than 1% hydrocortisone to be available over the counter. The NDPSC did not adopt the MCC recommendation and will allow these products to continue to be sold as S3 (restricted) medicines. The MCC should review its position in 2 years.

The meeting ended at 3:30pm