Revised: 23 May 2013

Committees

Minutes of the 37th meeting of the Medicines Classification Committee - 17 May 2007

Held in the Medsafe Boardroom, Level 6, Deloitte House, 10 Brandon Street, Wellington. Commencing at 9:30am.

Present

Dr S Jessamine (Chair)
Mrs A Shirtcliffe
Ms N Gauld
Dr J Peckham
Dr T Healy
Mrs C Smith (Secretary)

1. Welcome

The Chair welcomed members to the 37th meeting.

2. Apologies

There were no apologies.

3 CONFIRMATION OF THE MINUTES OF THE 36TH mEETING

The minutes of the 36th meeting were confirmed as being an accurate account of that meeting and were signed by the Chair.

4. Declaration of conflicts of interest

One of the members had declared involvement with sales force effectiveness surveys and focus groups conducted by pharmaceutical companies, some of which were represented on the current agenda. Some of the products involved were also currently under review by the Committee.

These issues were considered in the absence of the member. The Committee concluded that as the work undertaken on sales force effectiveness surveys by that member was concerned with assessments of sales representatives rather than products, there would be little if any conflict of interest in this area.

The focus group in which the member had participated and which might have been seen to pose a potential conflict, was in connection with a product which had recently been reclassified on the recommendation of the Committee. The requirements for the sale of the product in question which resulted from the reclassification were already in effect. The product was not due for consideration for a change of classification at the current meeting.

The Committee agreed that there was no significant conflict of interest for any of the products under discussion on the current agenda and agreed that the member should have full participation in the meeting.

5 matters arising

5.1 OXERUTINS (BAN)/HYDROXYETHYLRUTOSIDES

In 2000 oxerutins had been reclassified to general sale on the understanding that there were no products registered in New Zealand which contained oxerutins. However, it was subsequently noted that there was a current general sale product available containing hydroxyethylrutosides, a synonym for oxerutins. Neither name is scheduled in Australia and it was thought that no product containing these was sold in Australia. This had since proved not to be the case. The Committee noted that the product contained 250 milligrams of oxerutins and that there was an application pending for a product in the same range containing 500 milligrams. Both products were sold as unscheduled medicines in Australia.

The Committee was happy that these products should remain unscheduled. However, there was some concern about use during pregnancy. Although the product information leaflet warned against use during pregnancy unless on the advice of a doctor, there was no information on the outer pack to warn consumers not to use the product under these circumstances. The Committee felt that the indications for tired, aching, heavy, painful or swollen legs were symptoms frequently experienced during pregnancy. In the absence of access to medical advice at the point of purchase, the Committee felt that there should be some warning on the outer carton to alert women not to use the product during pregnancy without first seeking medical advice.

While the Committee was unable to enforce such a pack warning, members agreed that the sponsor company should be approached with the suggestion that a warning against use during pregnancy should be added to the outer pack of medicines containing oxerutins.

Recommendation

That the sponsor company should be asked to include a warning on the pack of products containing oxerutins against use during pregnancy without first seeking medical advice.

5.2 Boron

At the previous meeting the Committee had agreed that advice should be sought from the complementary medicines sector on the strengths and recommended doses of boron used in complementary medicines in New Zealand and for data to justify these strengths and dose levels. This information could be then be considered alongside data from Australia so as to ascertain whether or not New Zealand should harmonise on the more restrictive level of scheduling which was in force in Australia.

No such information had been received from the complementary medicines sector as a result of the normal consultation process. Members agreed that, as the consultation document on the Medsafe website had suggested that the matter would be likely to be postponed until later in the year to allow this information to be gathered, the postponement should occur at this point. Failing any response to support a different course of action, the Committee would proceed towards harmonisation with the Australian scheduling of boron at the 38th meeting.

A recommendation was not required at this point in time.

5.3 Chloramphenicol

The Committee had agreed that, in view of the recent reclassification in the United Kingdom, chloramphenicol for use in the eye would be a suitable candidate to consider for over-the-counter use in this country.

The Secretary reported that she had sought information from two sponsor companies that marketed chloramphenicol eye products, asking whether they would be interested in making a submission for reclassification. However, there had been no response to date from either company.

The consultation document had stated that this agenda item was likely to be carried over until the 38th meeting later in the year to allow adequate time for the sponsor company or companies to prepare a submission. The Committee agreed therefore that the item should be carried over to the 38th meeting in order to allow time for the companies to respond. The UK public consultation document on the reclassification of chloramphenicol eye drops would be provided for consideration at the 38th meeting.

A recommendation was not required at this point in time.

5.4 Mefenamic acid and naproxen

At the 36th meeting the Committee had agreed to harmonise with the Australian recommendation to include a maximum recommended daily dose for pharmacy-only products containing ibuprofen.

The Committee had noted that although there was a maximum daily dose in the medicines schedule for pharmacy-only diclofenac there was no such requirement for pharmacy-only mefenamic acid or naproxen. Members had agreed that, for consistency, a maximum recommended daily dose should apply to all pharmacy-only analgesics. They had requested that advice should be sought from sponsor companies about suitable maximum recommended daily doses for over-the-counter products containing these medicines.

The Secretary reported that the only response to date had been from a sponsor of a naproxen product which had recommended 1250 milligrams as a suitable maximum daily dose for dysmenorrhoea to accommodate the doses on its current pharmacy-only naproxen pack.

There had been no response from sponsors of products containing mefenamic acid. It was noted that the current dose instructions for pharmacy-only capsules containing mefenamic acid was 6 X 250 milligram capsules per day for a maximum of seven days. As this medicine was used for a single indication for a limited duration the dosage was likely to be the same for any OTC product containing mefenamic acid. However, further consultation would be necessary for naproxen as it was indicated for other types of analgesia as well as for dysmenorrhoea.

The Committee decided that information should be requested from the Centre for Adverse Reactions Monitoring about any adverse reactions to either of these medicines. Safety data should also be sought from other sources and the matter should be reconsidered at the 38th meeting.

No recommendation would be made at this time.

5.5 Nicotinic acid and nicotinamide

The Committee had deferred making a recommendation about the harmonisation of nicotinamide and nicotinic acid at the previous meeting pending the outcome of the February 2007 meeting of the Australian National Drugs and Poisons Schedule Committee (NDPSC).

The NDPSC had previously recommended that nicotinamide should be deleted from the New Zealand schedule and that the nicotinic acid entry in the New Zealand schedule should be reworded to harmonise with that in the Australian schedule.

In New Zealand both nicotinic acid and nicotinamide were scheduled as restricted medicines (S3) when in medicines containing more than 100 milligrams per dose and general sale medicines when in products containing 100 milligrams or less.

In Australia nicotinic acid was harmonised with New Zealand but the S3 (restricted medicine) entry specifically exempted nicotinamide from scheduling.
Subsequent discussion at the February meeting of the NDPSC had resulted in no change to the earlier recommendation.

The Committee noted that there were a number of scheduled nicotinamide products registered in New Zealand which would be affected by such a change.

Members noted that nicotinamide did not appear to cause the same degree of vaso-dilation as nicotinic acid. There did not appear to be any evidence of misuse or abuse. While there was some concern about use in diabetes, they concluded that there were no major public safety issues to justify not harmonising on the less restrictive classification. The Committee agreed therefore to harmonise with Australia on the classification of nicotinamide.

Recommendation

That nicotinamide should be exempt from scheduling.

Secretary's note
It appears that since the original recommendation to harmonise on the exemption from scheduling for nicotinamide was made, it has been noted that the cut-off point between general sale and S3 (restricted medicine) nicotinic acid has been changed in Australia from 100 milligrams per dose form to 250 milligrams per dose form. This means that nicotinic acid is no longer harmonised and will need to be returned to the agenda of the next meeting. In the interim nicotinamide will be exempted from the current, unharmonised nicotinic acid entry. If the current classification of nicotinic acid changes at the next meeting, the exemption for nicotinamide will be carried over. Possible future changes to the cut-off level between general sale nicotinic acid and restricted medicine nicotinic acid will have no effect on the unclassified status of nicotinamide.

5.6 Antihistamines in children under 2 years of age

At the previous meeting the members had indicated that they would welcome further discussion about the use of sedating antihistamines for children in this age group.

No new information had become available since the previous meeting. It appeared that no good efficacy data was available for use of sedating antihistamines in this age group. Paediatricians consulted by one of the members confirmed that there had been no studies in children under two years of age but that data from two studies in older children had been extrapolated to younger children. These studies cited by one of the members included a sedating antihistamine together with phenylephrine. While the studies showed some efficacy for adults and older children, there appeared to be little improvement in runny noses or coughs in preschool children. In view of the low efficacy in this age group the Committee considered that the risks appeared to outweigh the benefits for children under two years of age. Until further information became available, members wished to classify all sedating antihistamines in the same way. However, they would be happy to consider making sedating antihistamines other than promethazine less restrictively classified for this age group if it could be shown that the respiratory depression associated with promethazine was not a class effect.

It was noted that cold and cough remedies were high on the list of poisonings in young children.

The Committee looked at the various uses for antihistamines. It was agreed that sedating antihistamines should not be used to treat allergies in young children as there were safer alternatives in the non-sedating antihistamines.
Sedation was seen as inappropriate in this age group. It was noted that paradoxical reactions were possible in younger children who might be stimulated rather than sedated. This had been confirmed by paediatricians consulted by one of the members.

Members considered the options available for treating colds and coughs in infants under two years of age and noted that there appeared to be few options other than saline nasal drops for children in this age group.

The Committee agreed that it would be helpful for pharmacists if some material could be provided on the management of coughs and colds in children under two years of age. Publications such as Pharmacy Today and The New Zealand Pharmaceutical Journal should be approached with a view to publishing such information. Paediatricians should be consulted to see if they would be prepared to provide advice about the management of coughs and colds in children under two years of age.

After considerable discussion, the Committee agreed that it wished to stand by its earlier decision that sedating antihistamines should be prescription medicines when used for children under two years of age on the grounds that:

• this was a vulnerable group of the population
• there was insufficient evidence of efficacy in this age group
• there was suspicion of harm in this age group
• use for sedation was considered inappropriate in this age group.

No further recommendation was required.

5.7 Levonorgestrel

Classification of single-dose 1.5 milligram emergency contraceptive

The Secretary informed the Committee that the Gazette notice effecting the reclassification of levonorgestrel for post-coital emergency contraception had been worded in such a way as to allow access for pharmacists and suitably accredited nurses to both the two-tablet pack containing two tablets of 0.75 milligrams each and the single dose pack containing one 1.5 milligram tablet. Although the newer single-dose pack had not been specifically considered by the Committee at the time the recommendation was made, Medsafe had noted that a single-dose pack was now available, that it offered consumer choice and the safety issues were the same as for the two-dose regimen. The Committee agreed with this course of action.

Product promotion

The sponsor company had written to the Committee expressing concern at the comment recorded in the minutes of the 36th meeting which stated that the company had not so far chosen to advertise the product. The company asked that it be made known that the emergency contraceptive pill had been advertised extensively since it became available without a prescription in 2001. The advertising had been targeted at the 18 -35 age group with emphasis on the younger demographic. Advertising had been in the format of magazine advertisements in women's magazines, BIG Day Out Publications, bill boards in university, bar and nightclub bathrooms as well as high traffic areas such as popular beaches and shopping/nightlife areas. There had also been weekly advertisements in the Chinese Times to try and raise the awareness amongst the Chinese Student population.

Over the past two years radio advertising had also been utilised to great effect. These advertising campaigns had generally been run from October through to March of the following year as the company had found that this was the time when sales had traditionally increased due to summer weather causing young people to be out and about more and to schools and universities being on vacation.

Members applauded this publicity. However, they noted that there was still considerable public unawareness of the availability of the product. Neither of the general practitioners was aware of promotional material in doctors' surgeries and agreed that the company should be asked to promote the OTC availability of the emergency contraceptive in surgery waiting rooms and to general practitioners.

It was suggested that the secretary should advise those responsible for the Ministry's Sexual Health Strategy of this lack of awareness of the over-the-counter availability of the post-coital emergency contraceptive.

5.8 Salicylic acid/choline salicylate and ibuprofen

There had been several comments received on the outcome from the last meeting in which respondents queried the need for a separate schedule entry for choline salicylate and the rationale for the 15 gram pack size and 10% concentration limits for general sale choline salicylate.

The Committee stood by its earlier recommendation that there should be a separate entry in the schedule for choline salicylate as it had its own recommended International Non-proprietary Name. As a derivative of salicylic acid it was not covered by the introductory statement to the New Zealand schedule as it was in Australia. Unlike salicylic acid, choline salicylate could also be used internally and the Committee was of the opinion that possible internal use should be covered in the schedule. Members agreed that the recommendation for this schedule addition made to the NDPSC at the 36th meeting should be reiterated.

The Committee also stood by the 15 gram/10% upper limits as the cut-off for general sale choline salicylate as this accommodated general packs currently on the market. Companies wishing to change this level could make a submission for reclassification in the normal way.

There had also been comment on the recommendation that the wording for the general sale scheduling of salicylic acid entry restricting products containing 40% or less to dermal use only. It was agreed that the inclusion of the choline salicylate entry now covered those products currently on the market which were other than for dermal use. However, the removal of "dermal" would have no regulatory impact on products on the market and would harmonise with the Australian wording. Members agreed therefore that the word "dermal" could be removed from the relevant schedule entry.

There had also been comments about the differences in definitions and terminology between Australia and New Zealand. These were in connection with schedule entries for ibuprofen as well as salicylic acid/choline salicylate. These were not within the terms of reference of the MCC and would be dealt with in legislation under the Australia New Zealand Therapeutic Products Agency.

The Secretary had already responded to the above matters.

Recommendation

• That the word "dermal" be removed from the schedule entry permitting salicylic acid products containing 40% or less to be sold as general sale medicines.
• That the recommendation for the NDPSC to harmonise on the scheduling of choline salicylate should be reiterated.
  

5.9 Pipradrol

At the previous meeting the Committee had recommended that, in the interest of harmonisation, pipradrol should be added to the schedule as a prescription medicine. The Secretary reported that she had subsequently discovered that pipradrol was already scheduled under the Misuse of Drugs Act. It had not therefore been included in the Gazette notice implementing the changes from the 36th meeting and the NDPSC had been notified that pipradrol was one of the medicines for which harmonisation was not currently possible.

6. Submissions for reclassification

6.1 Eye preparations for use by optometrists

The New Zealand Association of Optometrists (NZAO) had made a submission for an exemption from classification status for a number of pharmacy-only products to allow them to be sold by retail or supplied in circumstances corresponding to retail from an optometry practice.

The medicines were:

• Antazoline
• Levocabastine
• Lodoxamide
• Naphazoline
• Oxymetazoline
• Pheniramine
• Propamidine and dibromopropamidine.
• Sodium cromoglicate
• Tetrahydrazoline
• Xylometazoline

The Committee had no safety concerns with the use of these medicines by registered optometrists in the course of their practice or as a result of consultation with individual customers. Optometrists were qualified to deal with the conditions that these medicines were used for. In addition, there were few concerns about toxicity, abuse or inappropriate use of these medicines.

The mechanism sought in the submission for exemption from classification status was already in use in some circumstances. This exemption applied only to a registered member of a professional body. It did not apply to a practice in general. This meant that an optometrist could use, recommend or sell a product as a result of diagnosis. However, an optometry assistant would be able to make sales only when under the supervision of a registered optometrist. This was seen as unlikely to be practical in an optometry practice and extremely difficult to monitor.

There was considerable concern about how the safe sale of medicines could be managed from an optometry practice by optometry assistants. Whereas a registered pharmacist was required to be on the premises at all times during opening hours, there was no such requirement for an optometry practice to have a registered optometrist in attendance. Registered pharmacists were normally in or close to the retail area and able to keep an eye on situations where intervention for advice could be required. However, optometrists spent much of their time behind closed doors in consulting rooms and were unable to oversee customers.

Pharmacy assistants required specific training in the sale of eye products including knowing when to seek advice from the pharmacist. There were no such procedures in place for assistants in optometry practices. The Committee was concerned that there were safety issues around diagnosis and around conditions which might be missed by a staff member untrained in dealing with eye conditions.

Issues around the handling and storage of medicines in an optometry practice would also need to be addressed.

Members agreed that they were not happy for the medicines in question to be sold from optometry practices at this point in time. However, they would be happy to revisit the matter should the NZAO come back to the Committee with a code of ethics and a training protocol for staff members who were not optometrists. This would allow staff members other than optometrists to sell medicines more safely once they had gained accreditation having undergone an approved course of training. The Committee suggested that the NZAO should consult with the Pharmaceutical Society of New Zealand on legal or other requirements relating to the handling and storage of medicines.

As an interim measure, the Committee agreed that it would consider a further application for the medicines in question to be exempt from scheduling when sold by an optometrist. However, such sales could be made only by a registered practitioner. Sales by staff other than registered optometrists would be in breech of medicines legislation.

Recommendation

That the current submission from the New Zealand Association of Optometrists to allow a number of pharmacy-only eye preparations to be sold through optometry practices should be declined.

6.2 Clotrimazole (Canesten range of vaginal products, Bayer)

This was a further submission for the reclassification of the Canesten range of products containing one course of treatment of vaginal thrush from restricted medicine to pharmacy-only medicine. At the 34th meeting the Committee had declined the submission on the grounds that there were a number of problems associated with misdiagnosis or the presence of underlying conditions or infections. The company had since responded with a further submission in which it addressed the Committee's concerns.

There was considerable discussion around the need for professional intervention in the sale of these products. The Chair pointed out that the company had responded to all the questions previously posed by the Committee and that, provided pharmacy assistants followed the protocol, there should be no problems.

One of the members reported that a specialist spoken to in this area had pointed out that delayed treatment of lichen sclerosis could result in malignancy. Lichen sclerosis could sometimes be confused with thrush and repeated thrush treatments used thus delaying diagnosis.

It was generally agreed that the Committee's current concerns were now largely related to how the sale of products should be made rather than to safety of the product or the possibility of misdiagnosis.

While problems relating to misdiagnosis had not been completely resolved, there was good consumer information supplied with the products. Members agreed that it would be useful to have some follow-up about consumers who had used the products but had still found it necessary to consult a doctor at a later date.

With regard to convenience to the consumer, members felt that there would be little change. The current requirements for pharmacists in the sale of these products would largely be transferred to pharmacy assistants. However, the process might be quicker in that there would be no need to wait for a pharmacist to become available in order to make a sale.

On the other hand, advice from a pharmacist could provide greater consumer convenience in selecting a suitable product. It was thought that the wide range of products available might be confusing for consumers if self-selection were required. In particular a pharmacist could ensure patients were appropriately referred.

Members agreed that the overall convenience of a change to pharmacy-only would probably be greater for the pharmacist than for the consumer. Pharmacies were generally busy places and sale of these products took time. In addition there were some very good pharmacy assistants. However, most pharmacists in a range of pharmacies canvassed by committee members wished that the sale of vaginal thrush products should remain with pharmacists.

Members felt that it would be useful to see data which would show that referral to a medical practitioner was not particularly important.

Cultural issues were also a matter for consideration. It was thought that a pharmacist might be better equipped to persist in asking the appropriate questions of reticent or reluctant consumers.

It was noted that the NDPSC recommendation to retain the status quo and keep these products at S3 (restricted medicine) level was based largely on the fact that a reasonable number of referrals to general practitioners were made. The NDPSC was more confident that these levels of referral would remain constant if products for the treatment of vaginal thrush were to retain their current status. In New Zealand there was also a significant number of referrals made to general practitioners.

In conclusion the Committee agreed that although the company submission had largely answered its previous concerns members still thought that a certain degree of professional judgement was required in the sale of these medicines. Members were in favour for the development at some future date of a programme of accreditation for pharmacy assistants in the sale of medicines for vaginal candidiasis. However, they agreed that the supply of a protocol alone was not sufficient for the sale of the products to be made by pharmacy assistants.

Recommendation

That the Canesten range of products for the treatment of vaginal thrush should remain restricted medicines.

6.3 Ranitidine (Zantac Relief, GlaxoSmithKline)

This was a company submission for the reclassification from pharmacy-only medicine to general sale medicine of ranitidine when in packs containing no more that 7 days' supply of 150 mg tablets.

A similar submission had been considered by the NDPSC at its February 2007 meeting. The NDPSC had agreed that ranitidine should be exempt from scheduling when sold in the manufacturer's original pack in divided preparations for oral use containing 150 milligrams or less per dose unit and in packs containing not more than 7 days' supply.

MCC members agreed that there appeared to be no significant problems associated with masking of more serious conditions. Studies on history of use at OTC level had shown that there appeared to have been no marked increase in the delayed diagnosis of more serious problems due to OTC use of ranitidine. One study from the United States found some consumers taking ranitidine to have warning symptoms. It was noted that patients in New Zealand can see a doctor for a relatively low cost, in contrast to the United States, but that prominence of appropriate warnings was desirable.

The Committee was happy with the safety of the product for general sale when in the pack size proposed in the submission. It was thought that the safety of the product was likely to be similar to that of antacids although antacids needed to be taken more frequently. Members agreed that the product was more effective than antacids.

Ranitidine was thought to have no harmful outcomes when taken during pregnancy. However, it was agreed that it was best avoided during pregnancy. The Committee was concerned that a warning against use during pregnancy was not included on the outer package. Although the warning appeared in the consumer information leaflet inside the pack, the Committee was concerned that pregnant women would not be aware of the warning until after the purchase had been made.

Members considered the increased possibility of death from the use of ranitidine and concluded that this risk was probably less than for non-steroidal anti-inflammatory medicines. As such occurrences were idiosyncratic, the risk would be the same at any level of access.

There was discussion about use of ranitidine at the proposed level for the treatment of dyspepsia. Such doses did not provide protection for the gastric lining. However, in view of the fact that the product was for short-term use only, this was not seen to be of sufficient significance to rule out a change from pharmacy-only to general sale.

One of the members had consulted with a number of specialists and reported that the specialists consulted had had difficulty making a case either for or against the change to general sale medicine when in the pack sizes proposed in the submission.

Discussion followed on pack warnings. Members confirmed that they would like to see a warning on the outer pack to inform pregnant women before a purchase was made. They noted that there were not many warnings on the pack. Although the box was not very large they would like to see more warnings on the outer pack. In a pharmacy there was a reasonable chance that a customer would be asked about prior use of the product and use with other medicines, particularly proton pump inhibitors or other dyspepsia medicines. There was no chance at all of this happening in a supermarket or other general sale outlet. Therefore, it was felt that as many warnings as possible should be shown on the outer pack in order to inform customers at the point of sale.

There was considerable debate as to which of the key risk warnings should be included on the pack. Ideally, the Committee thought that as many as possible of the red flag warnings in the package insert should be included on the outer pack. However, given the size of the current packet, this would probably not be possible. Options such as extending the size of the pack and removing some of the unnecessary words on the currently proposed pack were explored. Eventually the Committee concluded that recommendation for a change to general sale medicine should be deferred. Meanwhile, the company should be asked to suggest a way of modifying the outer pack to see if some, if not all, of the key warnings could be added. These included warnings about:

• use in pregnancy
• unexplained weight loss
• vomiting and/or diarrhoea
• black stools
• ulcer
• use if over 40 years of age
• recent change in symptoms

The company should also be asked to provide information about which warning statements were included on packs retailing at a similar general sale status in other countries, particularly the United States of America and the United Kingdom. The matter would be considered again at the next meeting.

Recommendation

That there be no change to the current pharmacy-only classification of ranitidine 150 milligram packs.

7. New Medicines for classification

Only one new chemical entity had been referred by the Medicines Assessment Advisory Committee for classification.

Dabigatran etexilate

The proposed indication for dabigatran etexilate was the prevention of venous thromboembolic events in patients who have undergone major orthopaedic surgery.

The Committee agreed that dabigatran etexilate should be classified as a prescription medicine.

Recommendation

That dabigatran etexilate should be classified as a prescription medicine.

8. Harmonisation of New Zealand and Australian schedules

Recommendations made by the NDPSC to the MCC.

8.1 Aspirin in compound products

The NDPSC had recommended that New Zealand should harmonise on the scheduling in the SUSDP of aspirin-based products when combined with caffeine, paracetamol, salicylamide or any derivative of these substances. These medicines were scheduled as S4 medicines in Australia.

The Committee noted that there was only one such product currently registered in New Zealand. This product contained 325 milligrams each of aspirin and paracetamol and 10 milligrams of codeine phosphate per tablet. It was classified as a pharmacy-only medicine due to the codeine content.

There did not appear to be any evidence to suggest that aspirin in combination with caffeine had resulted in an increase in renal problems in New Zealand. It appeared, however, that this was not the case in Australia where there had been a marked decrease in analgesic nephropathy following the removal of aspirin and caffeine products from the market. While there was good evidence to suggest that aspirin was more likely to be associated with analgesic nephropathy when in combination with caffeine, this effect appeared to occur only over a period of 3 to 4 years' of use so that the risk seemed largely theoretical. In addition, the problem seemed to be more evident in some countries than others.

The Committee suggested that the sponsor company should be consulted to see if it was aware of any evidence relating to the safety of the combination product and to ask what impact reclassification would be likely to have on the product.

The matter would be considered again at the 38th meeting. No recommendation would be made at this time.

8.2 Iron

The NDPSC recommended that New Zealand should harmonise on the pack size limit of unscheduled iron to minimise the risk of poisoning in children. The maximum pack size for unscheduled medicines containing iron in Australia was 750 milligrams. New Zealand currently had no upper pack size limit for general sale products containing iron. There were several medicines registered in New Zealand which would be affected by such a change. However, the Committee recognised that there could also be a number of dietary supplements which would become scheduled medicines. There was currently no way to identify such products. Although the Dietary Supplements Regulations specified the same maximum daily dose as the cut-off for general sale in the Medicines Schedule, there was no maximum pack size for dietary supplements containing iron. Some of these would probably cease to qualify as dietary supplements if an upper pack size limit were imposed and would need to be registered as medicines if they were to remain on the market.

The Committee was surprised that there had been no response received from the complementary medicines sector as a result of the consultation process, with regard to the proposed upper pack size limit for general sale products containing iron.

It was noted that the requirement for an upper pack size limit for unscheduled iron products applied only to those products containing more than 5 milligrams per dose unit. General sale products containing 5 milligrams or less of iron per dose unit were not required to adhere to the upper pack size limit of 750 grams. This information had been omitted from the recommendation which the NDPSC had made to the MCC.

Whilst the Committee agreed that action should be taken to minimise the possibility of iron poisoning in children, members felt that there was insufficient evidence available at this point in time for them to proceed. They agreed that information should be sought on which products were implicated in childhood poisonings and whether they were products which had been purchased over the counter or obtained on prescription.

In addition, the Committee wanted input from the complementary medicines sector on the nature of the products available as dietary supplements, particularly the pack sizes and the amount of iron contained in their respective dose units. Members agreed that the item should be placed on the website for a further round of consultation in the hope of receiving some response.

The matter would be returned to the agenda of the 38th meeting. A recommendation would not be made at this point in time.

8.3 Selenium

The NDPSC recommended that selenium should be classified as a prescription medicine in oral preparations containing more than 300 micrograms and a pharmacy-only medicine except when in oral preparations containing a maximum recommended daily dose of 150 micrograms or in topical preparations containing 3.5% or less of selenium sulphide. These exceptions should be general sale medicines.

The Committee noted that the NDPSC had adopted the New Zealand cut-off point for general sale oral selenium products. The NDPSC had also recommended that oral products containing 300 micrograms or less but more than 150 micrograms per recommended daily dose should become pharmacy-only medicines. Although selenium preparations containing more than 150 micrograms per recommended daily dose were currently pharmacy-only medicines there were no oral pharmacy-only selenium products registered in New Zealand. Therefore, adopting a prescription medicine classification for oral selenium products containing over 300 micrograms but more than 150 micrograms per recommended daily dose would have no regulatory impact on products currently on the New Zealand market. It was also noted that there were no registered general sale medicines in New Zealand which contained selenium. Therefore any available products were dietary supplements. As such, these products were limited in the Dietary Supplements Regulations to 150 micrograms per recommended daily dose.

Members also noted that, as the NDPSC recommendation for topical products at 3.5% or less for unscheduled medicines was less restrictive than the New Zealand cut-off point of 2.5% or less, the proposed change should have no effect on topical products. There were no topical medicines registered in New Zealand containing more than 2.5% of selenium. The Committee agree therefore to accept the less restrictive classification for topical selenium products.

Recommendation

That the following classification should apply to selenium:

Prescription medicine:

except when specified elsewhere in the schedule; except for oral use in medicines containing 150 micrograms or less per recommended daily dose; except for external use in medicines containing 3.5% or less of selenium sulfide

Pharmacy-only medicine:

for oral use in medicines containing 300 micrograms or less and more than 150 micrograms per recommended daily dose; for external use in medicines containing more than 3.5%

General sale medicine:

for oral use in medicines containing 150 micrograms or less per recommended daily dose; for external use in medicines containing 3.5% or less of selenium sulfide

8.4 Vitamin A

The NDPSC recommended that New Zealand should adopt a schedule entry which would allow topical preparations containing 1% or less of vitamin A to be general sale medicines. Topical preparations containing more than 1% were prescription medicines in Australia. The New Zealand schedule did not currently make provision for topical products.

It was noted that there were two current topical prescription medicines products on the New Zealand database which contained 0.05% vitamin A acid. These were covered under the prescription medicine entry for tretinoin which is the rINN for vitamin A acid.

The Committee agreed that an exemption from the prescription medicine status of vitamin A should be added to the current prescription medicine entry to allow topical products to be general sale medicines when in products containing 1% or less. It was also agreed that the current prescription medicine entry should be amended to refer only to products for oral use.

Recommendation

That vitamin A should be classified as a prescription medicine when:

• for oral use in medicines containing more than 3000 micrograms of retinol equivalents per recommended daily dose except in parenteral nutrition replacement preparations
• for external use except in medicines containing 1% or less

8.5 Benzydamine

The NDPSC recommended that benzydamine for dermal use should be exempt from scheduling.

Members noted that this recommendation did not apply to mouth and throat applications. These would remain pharmacy-only. Benzydamine was currently a pharmacy-only medicine for external use in New Zealand. A number of dermal products would be affected by the change.

Members also noted that there had been support from the sponsor company for this change in the form of the submission material which had recently been considered by the NDPSC in making its decision for benzydamine for dermal use to be exempt from scheduling.

The MCC was happy with the data supplied by both the sponsor company and the NDPSC and agreed to harmonise on the unscheduled status of benzydamine for dermal use.

Recommendation

That benzydamine for dermal use should become a general sale medicine.

8.6 Potassium Chloride

The NDPSC recommendation was for New Zealand to make a new prescription medicine entry for potassium chloride for internal use except when in products:

• containing less than 600 milligrams per dose unit
• for oral rehydration
• for oral bowel cleansing prior to diagnostic, medical and surgical procedures
• for enteral feeding

These exemptions would be general sale or unscheduled medicines.

Members noted that potassium chloride was currently covered by the potassium entry in the New Zealand schedule. There were several oral products which were currently pharmacy-only but would become general sale medicines if the recommendation were implemented. Members also noted that New Zealand might need to include medicines for dialysis to the above exceptions from prescription status.

At the time of the last MCC meeting the NDPSC still had some queries to resolve around the 600 milligram per dose unit cut-off point for prescription medicines. It had been drawn to the attention of the NDPSC that care was needed in order to avoid inadvertent capture as prescription medicines of glucosamine sulfate complexed products containing potassium chloride. After further discussion the NDPSC had confirmed that 600 milligrams was an appropriate level to avoid capturing such products.

Having considered the discussion by the NDPSC, the MCC came to the conclusion that the death resulting from potassium chloride poisoning on which the NDPSC had based its decision to classify potassium chloride as a prescription medicine was not linked to the level of access to the product and could have occurred regardless of the classification level of the product. In addition, the risk of misuse to avoid dehydration in tropical Queensland was not relevant in New Zealand. There had been no evidence of problems in New Zealand linked to use or misuse of potassium chloride and members were satisfied that the controls in pharmacies were such that no change was required.

The Committee declined the NDPSC recommendation to harmonise with Australia on the grounds that there was no public safety reason to move to a more restricted level of access. It was agreed that the quantity of elemental potassium present in glucosamine sulfate complexed products should be investigated to ensure that the current classification of potassium did not inadvertently capture such products. This would be discussed at the 38th meeting.

Recommendation

• That there should be no change to the current scheduling of potassium
• That the NDPSC should be recommended to harmonise with New Zealand on the scheduling of potassium

8.7 Ibuprofen 400 milligram tablets

The NDPSC had recommended that restricted medicines containing 400 milligram ibuprofen tablets should carry package warnings against use for children under 12 years of age.

Although this warning was likely to be covered already under the labelling requirements for 400 milligram ibuprofen tablets for over-the-counter sale, the Committee agreed that the warning should be added to the schedule entry in the interest of harmonisation.

Recommendation

That the restricted medicine entry for ibuprofen 400 milligram tablets should be amended to show that the product is not indicated for children under 12 years of age.

8.8 Clotrimazole for use on nails

The recommendation was to amend the pharmacy-only schedule entry to accommodate use for fungal infections of the nails.

This could be effected either by specifying use on the nail or changing 'dermal' to 'external' as for other topical antifungals.

Members noted that New Zealand did not have a nail preparation containing clotrimazole and that Martindale did not include the treatment of nail infections as one of the uses of clotrimazole. However, they agreed that the use of 'external' rather than 'dermal' in the pharmacy-only entry would accommodate nail preparations should the need arise.

Recommendation

That the pharmacy-only schedule entry for clotrimazole should be amended to accommodate use on the nail.

8.9 Azacitidine

The NDPSC recommended that azacitidine should be added to the New Zealand schedule as a prescription medicine.

Azacitidine was described as an antimetabolite antineoplastic with general properties similar to those of cytarabine.
Members agreed that azacitidine should be classified as a prescription medicine.

Recommendation

That azacitidine should be classified as a prescription medicine.

8.10 Guanidine

The NDPSC recommended that guanidine should be added to the New Zealand schedule as a prescription medicine.

Guanidine was previously unscheduled in Australia and listed in the New Zealand schedule as a restricted medicine. It was removed from the New Zealand schedule on the recommendation of the MCC in May 2000 on the grounds that it had proven not to be very effective and was now obsolete. At the same time the MCC had recommended that the NDPSC did not add this substance to the SUSDP. However, guanidine had subsequently been scheduled as a prescription medicine in Australia.

The Committee agreed that guanidine should be restored to the schedule as a prescription medicine on the grounds that there were no medicines containing guanidine registered in either country.

Recommendation

That guanidine should be classified as a prescription medicine.

8.11 Ivabradine

The NDPSC recommended that ivabradine should be added to the New Zealand schedule as a prescription medicine.

Ivabradine was described as a new medicine for the treatment of chronic stable angina due to atherosclerotic coronary artery disease in patients with normal sinus rhythm who are unable to tolerate or who have a contraindication to the use of beta blockers.

Members agreed that ivabradine should be a prescription medicine.

Recommendation

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

8.12 Butoconazole for vaginal use

The NDPSC recommended that there should be a new entry in the New Zealand schedule to allow butoconazole to be sold as a restricted medicine when in products for vaginal use.

This was in line with the classification of other antifungal medicines and the Committee agreed to this recommendation.

Recommendation

That butoconazole should be classified as a restricted medicine when for vaginal use.

8.13 Prochlorperazine for oral use

The NDPSC recommended that the restricted medicine entry in the New Zealand schedule should be amended from '10 tablets' to '10 oral dose units' to allow for capsules or other possible oral dose forms.

The Committee agreed that the restricted medicine schedule entry should be amended using wording consistent with that normally used in the New Zealand schedule so as to accommodate other possible oral dose forms.

Recommendation

That the restricted medicine entry for prochlorperazine should be amended to accommodate oral dose forms other than tablets.

8.14 Tiprinavir

The NDPSC recommended that tiprinavir should be added to the New Zealand schedule as a prescription medicine.

Tiprinavir was described as a non-peptide HIV-protease inhibitor with antiviral activity against HIV.

The Committee agreed that triprinavir should be included in the schedule as a prescription medicine.

Recommendation

That tiprinavir should be classified as a prescription medicine.

8.15 Methyl salicylate

The NDPSC recommended that a prescription medicine entry should be made in the New Zealand schedule for methyl salicylate for internal use.

The Committee noted that methyl salicylate was unscheduled in New Zealand. Members also noted that there were two current internal products registered in New Zealand which would become prescription medicines if the recommendation were implemented. The first was a general sale antacid, which was likely to be sold on both sides of the Tasman and which contained 1.04 milligrams of methyl salicylate per tablet as an excipient. The second product was a systemic transdermal patch containing 6.29% of methyl salicylate as an active ingredient. Further investigation of the patch product revealed that although it was registered as a systemic transdermal product, the action was intended to be topical rather than systemic and it would be classified as a dermal product. Therefore, the Committee was happy for there to be a prescription medicine entry in the schedule for methyl salicylate for internal use. However, an exemption would be needed to cover the excipient in the antacid tablet and it was proposed that the amount contained in the product in question would be appropriate.

The Committee agreed that this exemption should also be adopted in Australia in order to avoid capture of the general sale antacid product in its prescription medicine entry for methyl salicylate for internal use.

Recommendation

• That a prescription medicine entry should be made in the schedule for methyl salicylate when for internal use except when present as an excipient in medicines containing 1.04% or less per dose form
• That the NDPSC should be recommended to add a similar exemption to the corresponding methyl salicylate entry in the SUSDP.

8.16 Rifampicin/rifamycin

Medsafe had acted on an earlier recommendation to remove one of these from the schedule on the grounds that they were synonyms.

Medsafe had later observed that these two rINNs did not appear to be synonymous and suggested that both should be retained in the schedule. Rifampicin applied only to rifamycin AMP. Rifamycin applied to the sodium salt. This had since been recognised in Australia and the recommendation had been amended to retain both entries.

Recommendation

That there should be prescription medicine entries in the schedule for both rifampicin and rifamycin.

8.17 Sodium nitrite

The NDPSC recommended that sodium nitrite should be exempted from scheduling when present as an excipient.

Members noted that sodium nitrite was not used as an excipient in any product registered in New Zealand. However, they noted that this exemption was already in effect and no recommendation was required.

8.18 Methoxamine

The NDPSC recommended that New Zealand should harmonise with the Australian classification for prescription medicine when for injection.

In New Zealand methoxamine was a prescription medicine except for external use, a pharmacy-only medicine when in external medicines containing more than 1% and general sale in medicine containing 1% or less. These are already harmonised. There are no products registered in New Zealand which contain methoxamine.

The Committee noted that there was already harmonisation at this level in that any injectable products would already be prescription medicines under the current New Zealand schedule. The Committee noted that the pharmacy-only and general sale classification for external medicines containing methoxamine were already harmonised. However, members noted that, as there was no cover in the SUSDP for any internal products other than those which were for injection, any such internal products would be unscheduled medicines. Although methoxamine did not appear to be used internally by oral administration, the current New Zealand entry was seen to provide more comprehensive coverage and the Committee agreed that the NDPSC should be recommended to harmonise on the more comprehensive coverage. This would also be in line with the policy for medicines to be prescription medicines if there were no products in either country.

Recommendation

That the NDPSC should be recommended to harmonise with New Zealand on the prescription medicine classification for methoxamine for internal use.

8.19 Datura/Stramonium

The NDPSC had recommended that the MCC should replace the entry for Datura spp with entries for Datura stramonium and Datura tatula and delete the restricted medicine entry for stramonium.

It was noted that the SUSDP contained entries for the two named datura species as well as an additional, almost identical entry for datura species in general. While it had been agreed that a general entry should be made only when it was the intention to capture three or more of any particular species, the MCC noted that the repetition in these entries was unnecessarily long and repetitive. In addition, there were others in the datura species, notably datura metel, datura sanguinea and datura innoxia. It appeared that most, if not all of these were noted for their hallucinogenic properties and would be more appropriately captured in the datura schedule entries rather than be left unscheduled. The Committee concluded therefore that a single entry for datura species would be more appropriate and recommended that the NDPSC harmonise with the New Zealand schedule entries for datura species.

In addition, the MCC felt that the corresponding entries for stramonium should remain in the schedule in order to avoid confusion and to make the document as user-friendly as possible.

Recommendation

• That the NDPSC should be recommended to harmonise with New Zealand on a single set of entries for datura species
• That the NDPSC should be recommended to include schedule entries for stramonium which are consistent with those for datura species.

8.20 Diamthazole

The recommendation was to add diamthazole to the schedule as a prescription medicine. There was no reference in Martindale to diamthazole. Members requested that the NDPSC should provide some information about this medicine in order for them to make an informed recommendation.

Recommendation

That the NDPSC should be asked to provide information about diamthazole.

8.21 Di-isopropylamine dichloroacetate

The recommendation was that di-isopropylamine dichloroacetate should be added to the New Zealand schedule as a prescription medicine.

Members noted that di-isopropylamine dichloroacetate was listed in Martindale as di-isopropylammonium dichloroacetate. Preparations containing this substance had sometimes been described as pangamic acid. It was a vasodilator that had been given in peripheral and cerebral vascular disorders. Members agreed that this should be a prescription medicine.

Recommendation

That a new prescription medicine entry should be made in the schedule for di-isopropylamine dichloroacetate

8.22 Felbinac

The recommendation was to delete the pharmacy-only entry for external use and make a new entry in the New Zealand schedule for felbinac as a prescription medicine.

However, the Committee noted that there was one current external topical gel product in New Zealand which contained 3% felbinac. Therefore members agreed that, while they were happy for a prescription medicine entry to be made in the schedule, they saw no reason for the current product to be reclassified and thought that the NDPSC should be asked to harmonise on the less restrictive classification.

Recommendation

• That a new prescription medicine entry should be made in the schedule for felbinac except for external use
• That the pharmacy-only entry for felbinac should remain unchanged
• That the NDPSC should be recommended to harmonise on the less restrictive classification for felbinac.

8.23 Polysulfated glycosaminoglycans

The NDPSC recommended that a class entry should be made to the New Zealand schedule to classify these medicines as prescription medicines.

Although these were likely to be listed by individual names in both schedules the Committee agreed to recommend the inclusion of the class entry.

Recommendation

That a new prescription medicine entry should be made in the schedule for polysulfated glycosaminoglycans.

8.24 Picric acid

The NDPSC recommendation was to reclassify picric acid as a prescription medicine and to add a separate entry for trinitrophenol which was a synonym. It was noted that there was no INN for this substance.

Members noted that although picric acid was currently a general sale medicine in New Zealand, there were no registered medicines containing picric acid and the recommended change would have no regulatory impact on any products on the market. Therefore, they agreed to harmonise on this classification.

Recommendation

that picric acid should be classified as a prescription medicine

that a separate prescription medicine entry should be made for trinitrophenol

8.25 Ketoprofen

The recommendation was that the wording of the schedule entry exempting ketoprofen from scheduling should be amended from 'external' use to 'dermal' use. This amendment would have no regulatory impact on products on the New Zealand market. The Committee agreed to the change to the wording of the schedule entry.

Recommendation

That the prescription medicine schedule entry for ketoprofen should be amended to read: "except for dermal use; except when specified elsewhere in the schedule".

8.26 Pyrithione zinc

The NDPSC recommended that New Zealand should amend the wording of the schedule entries for pyrithione zinc from 'external use' to 'treatment of the scalp'.

Implementation of this recommendation would have no regulatory effect on any of the general sale products currently on the New Zealand market. The Committee agreed to harmonise on this recommendation.

Recommendation

That the pharmacy-only entry in the schedule for pyrithione zinc should be amended to read: "for treatment of the scalp in medicines containing more than 2%".

8.27 Vitamin D

The NDPSC recommended that New Zealand should harmonise on the wording of the Australian prescription medicine entry for vitamin D by making the recommended maximum daily dose of 25 micrograms applicable only to products for internal use in order to avoid any inadvertent capture of external products.

The Committee agreed that it was not the intention that external products should be captured by the schedule entry and that the entry should be amended to reflect this.

Recommendation

That the prescription medicine schedule entry for Vitamin D should be amended to read: "for internal use in medicines containing more than 25 micrograms per recommended daily dose except in parenteral nutrition replacement preparations"

8.28 Viprynium

The NDPSC had recommended that viprynium should be cross-referenced to pyrvinium in the New Zealand schedule.

Members noted that the New Zealand schedule did not use cross referencing but that two separate entries are made where necessary to avoid possible confusion. They noted that the rINNM was pyrvinium and that this should be the name of choice. As there were no medicines in New Zealand containing this substance a change in nomenclature was unlikely to cause confusion. They agreed that the viprynium entry should be changed to pyrvinium.

Recommendation

That the current schedule entry for viprinium should be amended to pyrvinium.

8.29 Dextromethorphan

In May 2002 the Committee had declined a recommendation from the NDPSC to harmonise with the Australian scheduling. There was no provision for unscheduled dextromethorphan products in Australia. However, the MCC could see no safety grounds at the time to justify reclassifying those dextromethorphan products in New Zealand which were general sale medicines. Although the MCC declined to harmonise, there was no recommendation made at the time for the NDPSC to harmonise on the less restrictive classification.

It was noted that there were approximately 20 general sale current products registered on the New Zealand database which contained dextromethorphan.

No further information had come to hand to cause the Committee to revise its earlier recommendation for lower-dose dexthromethorphan products to remain general sale medicines and members agreed that a formal recommendation should be made to the NDPSC to harmonise on the less restrictive New Zealand classification.

Recommendation

That, on the grounds of harmonisation at the less restrictive level, the NDPSC should be recommended to harmonise with New Zealand on the classification of dextromethorphan.

9. For the next meeting

• Boron for harmonisation with Australia. (See agenda item 5.2)
• Mefena
• Chloramphenicol for eye use for reclassification from prescription medicine to over-the-counter availability. (See agenda item 5.3).
• mic acid and naproxen (See agenda item 5.4)
• Nicotinic acid (See agenda item 5.5)
• Ranitidine (See agenda item 6.3)
• Aspirin in combination products (See agenda item 8.1)
• Iron (See agenda item 8.2)

10 General business

10.1 Reclassification of ephedrine and pseudoephedrine in the UK.

The Chair brought to the attention of the Committee the fact that ephedrine and pseudoephedrine were currently under consideration for reclassification as prescription medicines in Britain. He said that although these had recently become controlled drugs in New Zealand they were still available over the counter. He informed the Committee that there could be future moves to further limit the availability of these medicines in this country.

The meeting ended at 3:40pm