Revised: 23 May 2013

Committees

Minutes of the 32nd meeting of the Medicines Classification Committee - 25 November 2004

Introductory Statement for 32^nd MCC minutes on the web site.

Classification of Phenylephrine

Medsafe has submitted alternative advice to amend the first MCC recommendation about the general sale classification of phenylephrine. This advice has been accepted by the Minister's Delegate.

Medsafe supports the MCC recommendation for oral phenylephrine products to be general sales medicines in packs containing not more than 50 milligrams per recommended daily dose. However, Medsafe is of the opinion that a maximum pack size of 250 milligrams of phenylephrine should also apply to general sale phenylephrine products. This recommendation has been made after consideration of phenylephrine pack sizes which already have consent to market and those which are awaiting consent to market.

Medsafe is of the opinion that there was insufficient evidence in the material considered by the MCC to support a contraindication for use by consumers over 65 years of age. The current controls on liquid preparations containing phenylephrine do not require this age restriction. Nor do the controls on phenylephrine products sold in the UK require an upper age restriction on their use. Medsafe does not therefore support restricting the general sale of phenylephrine to persons under 65 years of age.

The amended recommendation is:

That phenylephrine for oral use should be a general sale medicine in products containing 50 milligrams or less per recommended daily dose and in packs containing 250 milligrams or less of phenylephrine per pack. Products recommending higher doses or larger pack sizes should be pharmacy-only medicines.

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

PRESENT

Dr Stewart Jessamine (Chair)
Dr Jill Peckham
Mrs Andrea Shirtcliffe
Mrs Natalie Gauld

1. Welcome

Due to an unavoidable flight delay, the meeting was unable to begin until a quorum was present. The meeting commenced at 12:30 pm

The Chairman announced that Dr Hughes was soon to resign from the Committee as she was about to take up a new position. He expressed thanks to Dr Hughes for her service to the Committee and congratulations on her new appointments as Professor in the Faculty of Medical and Health Sciences at Auckland University and Director of the Centre for Mental Health Research, Policy and Service Development at the University.

2. Apologies

Dr Frances Hughes
Dr Simon Ryder-Lewis

3. Confirmation of the minutes of the 31 ^st meeting

The minutes of the 31^st meeting were confirmed as an accurate record of that meeting and were signed by the Chairman.

4. Declaration of conflict of interests

Possible conflicts of interest were declared by some members. The Chairman was of the opinion that none of the matters declared would have any influence on recommendations about any of the items on the current agenda.

5. MATTERS ARISING from the 31 ^st meeting

5.1 Phenylephrine

At the 30^th meeting the Committee had considered a submission from Wyeth Consumer Healthcare requesting reclassification of phenylephrine to accommodate solid dose forms. The current scheduling had been expressed as a percentage to accommodate liquid dose forms. The Wyeth submission proposed a cut-off point of 10 milligrams or less per dose form for general sale and a pharmacy-only classification for solid dose forms containing more than 10 milligrams.

The Committee had countered the Wyeth submission with a proposal that the upper maximum dose for oral pharmacy-only products containing phenylephrine should be 10 milligrams and that there should be no oral phenylephrine products sold as general sale medicines. The Committee proposal was put on the agenda for the 31^st meeting but was deferred at that time pending comments from one of the stakeholder companies. These comments in support of the original Wyeth submission had subsequently been submitted and distributed to Committee members.

The Committee recognised that the change made in 1999, which allowed oral medicines to move to general sale in products containing 0.5% of phenylephrine, had been made according to the principles of harmonisation and on the grounds that none of the products currently on the New Zealand market would be affected by the change due to the presence of other pharmacy-only medicines in products containing 0.5% or less of phenylephrine. For those reasons no in-depth investigation had been deemed necessary. However, members agreed that a more thorough investigation was now required to justify a suitable classification for phenylephrine.

The classification of oral phenylephrine was discussed at length by the Committee. The following points were raised:

• Effectiveness seemed limited from the literature which had been reviewed due in part to variable bioavailability and short half-life.
• Consumers would have increased convenience if oral products were available in supermarkets, although it would perhaps be less desirable in that they would not always have access to a health professional when purchasing.
• Although oral phenylephrine was currently classified as general sales at less than 0.5% in New Zealand and Australia, it had not, to date, been in any general sale products in New Zealand. Any products containing phenylephrine at that level also contained more restrictively classified ingredients which resulted in a higher level of classification. Two supermarkets checked in Australia for one of the Committee members did not have any oral phenylephrine products on sale.
• Phenylephrine had variable bioavailability with up to 38% bioavailability due to metabolism through the gut wall. Some other agents which are metabolised through the gut wall and have low bioavailability had been subject to important drug interactions. However, this seemed unlikely with phenylephrine according to communications with an interactions expert. Nor did the literature review reveal this problem.
• Other decongestant products currently available were pseudoephedrine which was classified as Pharmacy Only and topical nasal decongestants which were also Pharmacy Only but which could be exempted from this status to allow sale from airports. As pseudoephedrine could be made into methamphetamine, an oral alternative OTC product would be useful.
• Phenylephrine had a good therapeutic index. The effect on blood pressure was at doses which were substantially higher than those required for decongestant purposes.
• Phenylephrine has low toxicity, although on rare occasions it can cause manic episodes. Phenylpropanolamine, in the same class of medicines, was withdrawn in the United States due to an increased risk of strokes. There was some concern in the paper published in Stroke (2003) that other sympathomimetics might also increase the risk of strokes. However, the risk for other sympathomimetics appeared to be less than with phenylpropanolamine. One stroke patient in the paper had used nasal phenylephrine, none had used oral phenylephrine.
• CARM data for both pseudoephedrine and phenylephrine did not reveal an excessive number of complaints. There were only 19 adverse reaction reports for phenylephrine since 1965, most of which could not have been prevented by health professional intervention in the sale of the product. It was noted that phenylephrine had not been widely used in New Zealand in the past ten years. However, it was widely used in the United Kingdom where it was on general sale (whereas pseudoephedrine was pharmacy only) and where a variety of combination products was available. A literature search on phenylephrine adverse effects was reassuring in the relatively few reports which had been made. Given its general sales status in the United Kingdom and its wide use there, problems would be expected to have been found or to appear in the literature.
• While pseudoephedrine had been used to make methamphetamine, this did not appear to be occurring with phenylephrine. Compared to pseudoephedrine, phenylephrine had quite a different structure and conversion to methamphetamine was likely to be technically difficult. If it proved possible in the future to manufacture methamphetamine from phenylephrine and this were to occur, it could be reclassified appropriately at that time. A letter to the British Journal of Psychiatry (1986) noted that dependence does occur with some sympathomimetics. A community pharmacist with post-graduate qualifications in addiction who was consulted by one of the Committee members was aware of people who abused sympathomimetics by taking high doses. However, this practice did not appear to be wide-spread, as it was unknown to many other pharmacists spoken to by the Committee member, and not brought up in submissions to the Committee.
• Phenylephrine was unlikely to be used inappropriately apart from the abuse noted above. It would be used mainly for colds or hay fever which could be self-diagnosed and was unlikely to be used in cases when the person needed to see a doctor.
• Precautions for use were not extensive. The usual sympathomimetic points applied although the effect on blood pressure seems to have been overstated in the past. Elderly people may have increased risk.
• Possible drug interactions included MAOIs, tricyclic antidepressants (theoretical rather than reported), selegiline, moclobemide and methyldopa. Use in people taking antihypertensives had been studied and, apart from an upward trend in one study, had not shown significant effect. A short-term small increase in blood pressure was not considered important in an otherwise well person with hypertension controlled by anti-hypertensives. These issues could be addressed in the labelling.
• There could be a potential danger for consumers to double-up on sympathomimetic ingredients taking, for example, phenylephrine in a product from a supermarket and pseudoephedrine in a product bought from a pharmacy. This potential already existed with paracetamol and other medicines, and common-sense and approved labelling would usually prevent this.
• As there might be products available in slow release forms in the future, incorporating into the classification a total daily dose rather than individual dosage unit dosing should allow for this without the need for further reclassification. A recommended maximum daily dose of 50 milligrams was thought to be a suitable cut-off point for general sale.
• Concern was expressed about abuse for manic reactions. However, this seemed to be a rare idiosyncratic reaction which could not be foreseeable by either a pharmacist or a doctor.

On the basis of the points above, most members were happy for phenylephrine to remain available on general sale below a certain level. One member did not want to see oral phenylephrine purchased from supermarkets because of concern about the potential for manic episodes and the fact that consumers expected supermarket products to be very safe. However, it had been agreed that neither pharmacists nor doctors, could predict such reactions.

The Committee agreed by majority vote that oral phenylephrine at a recommended maximum daily dose of 50 milligrams should be classified as general sale medicine and medicines containing a higher recommended daily dose should be pharmacy-only medicines. This classification would accommodate both solid and liquid dose forms.

Package information should contain warnings about use by older consumers, use with heart disease and interactions with other medicines. Medsafe should seek advice about whether age 65 was an appropriate cut-off above which general sale classification was contraindicated. The NDPSC should be asked to consider a similar level of classification. The matter should be reviewed in two years by the joint scheduling committee. At that time data should be sought from the Alcohol and Drug Service, pharmaceutical companies and CARM.

Recommendation

• That phenylephrine for oral use should be a general sale medicine in products containing 50 milligrams or less per recommended daily dose for consumers under 65 years of age. Products recommending higher doses or use by the elderly should be pharmacy-only medicines.
• That the NDPSC should be asked to consider a similar classification for phenylephrine
• That the classification should be reviewed by a joint committee in two years.

5.2 Orlistat (Xenical, Roche)

At the previous meeting the Committee had considered a company submission for reclassification from prescription medicine to restricted medicine for 120 milligram orlistat capsules for weight control. Members had agreed that orlistat was sufficiently safe to be made available over the counter as a restricted medicine provided adequate procedures were followed at the point of sale. However, the Committee felt strongly that a face-to-face consultation should be mandatory before any initial sale of the product. This would ensure not only that the product was not available to unsuitable consumers, but also that support and appropriate advice was provided. Members were concerned that a change to restricted medicine would permit legal internet sales without the need for face-to-face consultations with pharmacists.

It was decided that, before any recommendation was made to change the classification of orlistat, the Pharmacy Council should be consulted about whether it was possible to ensure a face-to-face consultation before the initial sale of the product.

The Chairman stated that there were three issues which needed to be addressed before a recommendation could be made. The first was the response to the Committee's request for assurance of face-to-face consultation for an initial sale of the product.

A response was tabled at the meeting in the form of a draft document from the newly-formed Pharmacy Council entitled Protocol for the Sale and Supply of Pharmacist Only Medicines for Chronic Conditions. Members were happy with the contents of this document which would apply, not only to orlistat, but also to a number of other medicines for chronic conditions. They noted that points 1 and 5 of the protocol would permit internet sales of restricted medicines for chronic conditions. In order to ensure that orlistat and other restricted medicines for chronic conditions were sold only after face-to-face consultation and that such products were not sold solely over the internet, the following amendments were suggested to point number 1 of the protocol:

• While the Committee would like face to face consultations every 6 months for the sale of orlistat they realised that this was not necessarily appropriate for other medicines for chronic conditions. They therefore suggested that the relevant part of the first sentence should read: "......the pharmacist should conduct face-to-face consultation s (plural) with the patient whenever possible as dictated by best practice... ". This would allow pharmacists to apply specific conditions to the sale of individual medicines for chronic conditions where appropriate.
• In the latter part of that same sentence the Committee requested that the wording be amended to : "unless due to disability or geographical isolation within New Zealand...".
• In order to emphasise the Committee's intention that internet sales should not be made to people residing outside New Zealand, the Committee suggested the additional sentence to point number 1 of the protocol: Pharmacists should not offer pharmacist-only medicines for sale to patients who are outside New Zealand.

The second matter to be discussed was the material received from EDEN (Eating Difficulties Education Network) which brought to the Committee's attention two recent papers which indicated that the use of orlistat impaired gall bladder emptying thereby elevating the risk of gallstone formation, particularly in obese users who already had an increased risk of gallstone formation. While members agreed that these studies did show that orlistat slowed gall bladder contractions, they felt that the studies were too small to be conclusive and there was insufficient safety concern to affect their earlier decision. There were no data to date from CARM to indicate gall bladder problems with use of orlistat.

The third issue related to the indication for sale of orlistat over the counter. The Committee thought that it was probably incorrect to indicate its use for people with a body mass index (BMI) of greater than 30 because this implied that the medicine should be discontinued if the BMI dropped below 30. Members agreed that the BMI should be over 30 at the initial consultation and that clarity over this matter should be sought from the company.

Recommendation

• That clarity should be sought from the company about the indication for sale of orlistat for users with a BMI greater than 30.
• That the Pharmacy Council be asked to make the amendments suggested by the Committee to its Protocol for the Sale and Supply of Pharmacist Only Medicines for Chronic Conditions or any alternative amendments which would reflect the intention of the Committee
• That, pending a satisfactory resolution of the two matters above, orlistat should be reclassified to restricted medicine in medicines containing 120 milligrams or less.

Secretary's Note:   The two matters have been resolved satisfactorily and the reclassification of orlistat will proceed accordingly.

6. Submissions for reclassification

6.1 Ketotifen eye drops 0.025% (Zaditen, Novartis)

The Committee had recently declined a company submission for reclassification to pharmacy-only medicine. This was based on concerns about the quality of the pharmacovigilance systems in the countries where the products had already been made available over the counter. However, the Committee had indicated its willingness to consider a further submission to restricted medicine.

The Committee was now happy with the company submission for reclassification of ketotifen 0.025% eye drops from prescription medicine to restricted medicine.

It was noted that the proposed label did not have a New Zealand address and members expressed a desire for the address and phone number of a New Zealand sponsor to be included on the label.

Recommendation

That ketotifen be reclassified from prescription medicine to restricted medicine when in eye drop preparations containing 0.025% or less.

7 New Medicines for classification

The Committee agreed that all the new chemical entities forwarded from the Medicines Assessment Advisory Committee for classification should be classified as prescription medicines.

Recommendation

That the following medicines be classified as prescription medicines

• Articaine
• Bortezomib
• Fulvestrant
• Palonosetron
• Terlipressin

8. Harmonisation of New ZealAnd and Australian schedules

8.1 Harmonisation matters arising or outstanding

8.1.1 Fluorides

Although the fluorides schedule entries for New Zealand had been harmonised with those of Australia, there were still difficulties surrounding the harmonisation of classification of some general sales items, particularly mouth washes for oral hygiene. The difficulties arose from the different regulatory requirements in each country for products of this nature. An increase in the level of fluorides permitted as general sale or unscheduled medicines would resolve these problems.

The NDPSC had proposed that the upper cut-off level for general sale for external use in oral hygiene products other than pastes, gels or powders for cleaning the teeth should be raised from 0.01% or less to 220 milligrams or less per litre or per kilogram. In addition a pack size limit of 120 milligrams of total fluoride ion should be imposed on general sale products.

The MCC had no problems regarding the safety of fluorides used at the proposed new levels and recognised that it would allow some mouthwash products which had recently moved to pharmacy-only medicine to revert to their former general sale level of classification. The Committee agreed that the schedule entries for fluorides should be amended to reflect the NDPSC recommendations and that Medsafe should compile appropriate wording to put the recommendations into effect.

It was anticipated that the increase in the amount of fluoride permitted at general sale level should affect only mouthwashes. Classification levels for all other products containing fluoride should remain unchanged.

Recommendation

• That the prescription medicine entry for fluoride should be amended to read:
  • for internal use except in parenteral nutrition replacement preparations or in medicines containing 2.2 milligrams or less per dose form
  • for external use in medicines other that pastes, gels or powders for cleaning the teeth containing more that 2.5% except when used in practice by a registered dental therapist; except in medicines containing 220 milligrams or less per litre or per kilogram and in packs containing not more than 120 milligrams of total fluoride
• That the restricted medicine entry should remain unchanged as:
  • in pastes, gels or powders for cleaning the teeth containing more than 0.1%
• That the pharmacy-only entry should be amended to read:
  • for internal use in medicines containing 2.2 milligrams or less per dose form of sodium fluoride
  • for external use in medicines other than pastes, gels or powders for cleaning the teeth containing 2.5% or less ; except in medicines containing 220 milligrams or less per litre or per kilogram and in packs containing not more than 120 milligrams of total fluoride
• That the following should be general sale medicines:
  • pastes, gels or powders for cleaning the teeth containing 0.1% or less
  • parenteral nutrition replacement preparations
  • oral hygiene products other than pastes, gels or powders for cleaning the teeth containing 220 milligrams or less per litre or per kilogram and in packs containing not more than 120 milligrams of total fluoride
  • other medicines containing 15 milligrams or less per litre or per kilogram

8.1.2 Antihistamines

The Committee had postponed consideration of the classification of antihistamines until the NDPSC had completed its review of the classification of these substances. This review had since been completed.

The following classification categories had been adopted by the NDPSC. The Committee noted that these classifications related to oral doses and that antihistamines in injectable products should be prescription medicines.

Prescription medicine

• Antihistamines or combination products with the potential for serious abuse.

Restricted medicine

• Single-ingredient sedating antihistamines
• sedating antihistamines in combination with active ingredients other than a sympathomimetic decongestant except when in the bed-time dose of a day/night preparation.

Pharmacy-only medicine

• Non-sedating antihistamines in either single-ingredient preparations or in combination products containing other pharmacy-only or unscheduled ingredients.
• Sedating antihistamines in combination products when one of the active ingredients is a sympathomimetic decongestant and the product is indicated for the relief of symptoms of coughs colds or influenza.
• Sedating antihistamines in the bedtime dose of day/night combination preparations for the relief of symptoms of coughs colds or influenza. The bedtime dose is not required to contain a sympathomimetic decongestant.
• Meclozine and diphenhydramine in limited pack sizes for travel sickness.* Promethazine has already been reclassified to S2 (pharmacy-only) when in packs of 10 for this use.

While accepting the above principles, the Committee was aware of several products which would move to restricted medicine in New Zealand and which they felt needed opportunity for input from interested bodies. These included:

• A travel sickness product containing cyclizine which did not have the exemption for sale in travel packs which was applicable in New Zealand to some other antihistamine travel sickness products
• A night-time only capsule containing paracetamol and diphenhydramine
• A paediatric syrup containing paracetamol and doxylamine
• A tablet containing paracetamol, codeine and doxylamine.

The last of these was already classified in Australia as S3 so that harmonisation would be achieved. However, the remainder of the above products did not appear to be sold in Australia. For that reason their status in the overall classification of antihistamines might not have been considered. Members thought that sponsor companies for the above products should be consulted for their views on the proposed reclassification and should be given an opportunity to support the continuation of their current classification status if they so wished. It was agreed that opinions should also be sought from the Pharmacy Council and the Pharmacy Guild.

There was some concern at the lack of input from sponsor companies with regard to the proposed reclassification of antihistamines and it was suggested that sponsors could be expecting the publication of a list of proposed changes to individually named antihistamines before the changes came into effect. For that reason, the Committee agreed to accept the broad principals of the NDPSC with regard to the classification of sedating antihistamines except when they applied to the products mentioned above. They decided to delay implementation of the changes in the Gazette until after the next meeting. A complete list of the proposed schedule entries for all sedating antihistamines would be published in conjunction with the agenda for the next meeting. In the interim, consultation would be undertaken with sponsor companies for products listed above which did not appear to have been taken into account in the NDPSC recommendations.

Recommendation

• That the broad principals of classifying sedating antihistamines as recommended by the NDPSC should be accepted with the exception of those products which did not appear to have been taken into account in the NDPSC recommendations
• That implementation of the recommendations should be delayed until a further round of consultation had been undertaken based on the proposed schedule wording for each individual antihistamine
• That the Pharmacy Guild, the Pharmacy Council and the relevant sponsor companies should be consulted about the above products which did not appear to have been taken into consideration under the NDPSC recommendation.

8.1.3 NDPSC response to MCC recommendations

There were no outstanding responses from the NDPSC to be reported to the MCC.

8.2 Recommendations made by the NDPSC to the MCC in February 2004

8.2.1 Pyridoxine

The NDPSC had recommended that pyridoxine should be classified as a prescription medicine in oral preparations containing more than 200 milligrams per recommended daily dose.

The MCC agreed with the NDPSC discussion which supported the classification of prescription medicine for products containing more than 200 milligrams per recommended daily dose. Products containing 200 milligrams or less per recommended daily dose should remain as general sale medicines.

Recommendation

That pyridoxine should be classified as a prescription medicine except in oral preparations containing 200 milligrams or less per recommended daily dose.

8.2.2 Mercury and methylmercury

The NDPSC had recommended that the cut-off point for exemption from scheduling should be amended from 10 milligrams per litre or per kilogram to:

mercury:

1 milligram per litre or per kilogram

methylmercury:

300 micrograms per litre or per kilogram

It was noted that methylmercury was not currently scheduled in either New Zealand or Australia.

Weleda had submitted a request seeking exemption from classification for medicines containing 10 milligrams per litre or per kilogram when contained in products with a recommended weekly dose of not more than 0.5 milligrams of mercury.

The Committee considered the Weleda submission in conjunction with the figures provided in the NDPSC discussion. Members concluded that a weekly dose of 0.5 milligrams, when taken in conjunction with mercury from food and environmental sources, could exceed the World Health Organisation's provisional tolerable weekly intake of mercury and methylmercury of 0.1 and 0.3 milligrams respectively per person per week for a 60 kilogram person. The Committee therefore decided not to agree to the Weleda proposal but to amend the New Zealand schedule to accommodate the NDPSC recommendation.

Recommendation

• That the prescription entry for mercury be amended by the addition of the words "except in medicines containing 1 milligram of mercury per litre or per kilogram".
• That a prescription medicine entry should be made for methyl mercury with an exemption of 300 micrograms of methyl mercury per litre or per kilogram.

8.2.3 Nicotine in lozenges

The NDPSC had recommended that nicotine lozenges should be reclassified to general sale medicine along with nicotine in gum and transdermal patches.

It was noted that the recommendation would also apply to sublingual tablets in New Zealand

None of the MCC members had any issues relating to the safety of nicotine in lozenges in comparison with other dose forms already available as general sale medicines. They were happy with the evidence gathered by the NDPSC in support of the change. However, there was strong feeling on the part of some members that better results were obtained where professional advice and support were available at the point of sale and the product should remain available only from pharmacies. Other members were of the opinion that reclassification to general sale did not preclude pharmacy sales and that consumers would still have the option to seek advice. As consensus was not reached, a vote was taken.

Recommendation

That nicotine in medicines for smoking cessation should be reclassified from pharmacy-only medicine to general sale medicine when in lozenges or sublingual tablets.

8.2.4 Mitragyna speciosa

The NDPSC had requested that the MCC consider whether or not it wished to schedule mitragyna speciosa and mitragynine. Members noted that products could be obtained from a New Zealand source via the internet. They felt that as this was a substance with abuse potential, as shown by the evidence collected by the NDPSC, scheduling was justified. Although scheduling as prescription medicine in New Zealand would not result in the same regulatory outcome as S9 scheduling in Australia, it would provide a tool to assist in the control of the plant and its alkaloid.

Recommendation

That mitragyna speciosa and mitrogynine should be classified as prescription medicines.

8.3 Recommendations made by the NDPSC to the MCC in June 2004

8.3.1 Triamcinolone for buccal use

The NDPSC recommended that the restricted medicine entry for triamcinolone should be amended to limit sales of products at this level of classification to medicines containing 0.1% or less and in packs of 5 grams or less.

The MCC recognised that this amendment would have not regulatory effect on the products already on the New Zealand market and agreed to harmonise on the classification of triamcinolone.

Recommendation

That the restricted medicine entry for triamcinolone should be amended to:
"for buccal use in medicines containing 0.1% or less of triamcinolone acetonide and in pack sizes no greater than 5 grams".

8.3.2 Porcine pancreatic enzymes

The NDPSC had recommended that all porcine pancreatic enzymes should be prescription medicines. The recommendation was based on the following:

• that contamination with porcine parvovirus and potential risk of human infection could not be ruled out
• available data suggested that benefits associated with treatment of pancreatic exocrine insufficiency with porcine pancreatic enzymes outweighed the potential risk of porcine parvovirus contamination of these products
• the risk-benefit ratio for the use of porcine pancreatic enzymes for conditions unrelated to pancreatic insufficiency as OTC or complementary products was too high and those products should be withdrawn.

The Committee agreed with the conclusions drawn by the NDPSC and felt that the risk of transmission of animal to human disease was too great to justify sale of these products at a general sale level. Members were aware that there were likely to be a number of complementary products and dietary supplements on the market which would be affected by the change. While it was not known whether porcine parvovirus caused illness in humans, it was likely to be present in the raw and dried products used to make pancreatic enzymes. It was agreed therefore that the benefits outweighed the risks for the treatment of cystic fibrosis but that the opposite applied to products used as dietary supplements. As bovine pancreatic enzymes were not recognised as posing a comparable risk, these would still remain available as general sale products.

Recommendation

• That pancreatic enzymes should be reclassified to prescription medicine except in medicines containing bovine pancreatic enzymes with 20 000 BP units or less of lipase activity.
• That medicines containing bovine pancreatic enzymes with 20 000 BP units or less of lipase activity should remain general sale medicines.

8.3.3 Treprostinil and ciclesonide

The NDPSC recommended that these two new chemical entities be added to the schedule as prescription medicines.

The MCC agreed to this recommendation in the interest of harmonisation.

Recommendation

That treprostinil and ciclesonide be added to the schedule as prescription medicines.

9. For the next meeting

9.1 Zanamivir (Relenza) and oseltamivir (Tamiflu)

One of the Committee members had proposed that these two medicines should be considered as possible candidates for future reclassification from prescription medicine to restricted medicine and had undertaken some initial research.

Members thought that these products could be useful for both consumers and employers as the rate of absenteeism from influenza might be reduced. In addition, OTC availability could reduce the number of doctors' visits, thereby reducing the spread of viruses in surgeries.

However, they recognised that there could be problems relating to its use in possible future epidemics, mistaken use for those with meningitis and the possible emergence of resistance.

The Chairman said that a company submission for oseltamivir had already been considered in Australia. While the NDPSC was happy with some aspects of OTC availability, there was concern about how a reclassification would fit in with pandemic planning. No decision had yet been made about its scheduling and the matter was due to be discussed again at the following meeting in February 2005.

The Committee was happy for oseltamivir to be added to the next agenda as there was considerable information available about the medicine. Although it was thought to have fewer adverse effects than oseltamivir, there was less information available about zanamivir. Members agreed that the company marketing the product should be contacted to see if it wished to make a submission to the next meeting of the MCC.

Recommendation

• That oseltamivir be added to the agenda of the next meeting
• That the company marketing zanamivir should be contacted to see if it wished to make a submission for the reclassification of that medicine.

9.2 Trimethoprim

A Committee member had proposed trimethoprim as a possible candidate for either reclassification from prescription medicine to restricted medicine or for sale by an accredited pharmacist.

Members noted that there were resistance issues associated with trimethoprim and there was a relatively high level of resistance in urinary tract infections. They also noted that some antibiotics, in particular mupirocin and clindamycin, had been made available over the counter but had had to be returned to prescription status due to an increase in resistance.

There was also doubt about ease of diagnosis. Trimethoprim was not always necessary for urinary tract problems but OTC availability would inevitably lead to wider use. Access to a laboratory was seen as being desirable for correct use. In addition the Committee recognised that there were issues relating to use during pregnancy although pharmacists were accustomed to dealing with this matter. There was also a slight possibility of serious side-effects.

Overall the Committee agreed that trimethoprim would not be a suitable candidate for reclassification to an over-the-counter level of classification. No recommendation was required.

9.3 Clobetasone

Clobetasone was proposed by one of the Committee members as a possible candidate for future reclassification from prescription medicine to restricted medicine for 0.05% topical preparations.

The Committee noted that alclometasone should be considered in conjunction with clobetasone as at previous meetings. They recognised that both were due for 2-year review following an earlier MCC recommendation not to harmonise with Australia by making packs containing 0.05% available as restricted medicines.

Both clobetasone and alclometasone had been available over the counter for several years in Australia and the UK since the earlier recommendation was made. During that time no evidence of major problems associated with over-the-counter use had been reported in these countries. However, a dermatologist had been quoted as saying there could be a positive result from reclassification in that there might be better and earlier treatment of flare-up conditions. Use of these medicines in New Zealand was reported to be small.

In addition, specialists were now involved in the training of pharmacists and pharmacies were better equipped to provide private areas for consultation with consumers. Moreover, it was not envisaged that pharmacists would be required to diagnose the conditions for which the products were indicated as the products would be indicated for flare-up of previously diagnosed conditions which the consumer would easily recognise.

It was agreed that the companies should be asked to put in submissions for reclassification of clobetasone and alclometasone to harmonise with the classification status already adopted in Australia and that both medicines should be added to the agenda of the next meeting.

Recommendation

• That 0.05% topical preparations of alclometasone and clobetasone should be placed on the agenda of the next meeting for consideration for classification to restricted medicine.
• That the respective sponsor companies be asked if they wished to submit comments in support or otherwise of the proposed reclassification.

9.4 Kava

The Committee noted that kava had been scheduled in Australia but regarded as a dietary supplement in New Zealand. The Australian prescription medicine schedule entry was as follows:

Piper methysticum (kava) except:

1. in preparations for oral use containing dried whole or peeled rhizome or
   containing aqueous dispersions or aqueous extracts of whole or peeled rhizome
   when labelled with a recommended daily dose of 250 milligrams or less of
   kavalactones:
   1. containing more than 25 milligrams of kavalactones per dose, labelled with the
      statement:
      WARNING : Not for prolonged use. Not recommended for use by pregnant or
      lactating women. May harm the liver;
   2. in tablet or capsule form containing 125 milligrams or less of kavalactones per
      tablet or capsule or:
   3. in the form of a teabag when the amount of dried whole or peeled rhizome does
      not exceed 3 grams
2. in topical preparations for use on the rectum, vagina or throat containing dried
   whole or peeled rhizome or containing aqueous dispersions or aqueous extracts
   of whole or peeled rhizome; or
3. in dermal preparations.

It was agreed that kava should be discussed at the next meeting.

Recommendation

That kava should be placed on the agenda of the thirty-third meeting for consideration for reclassification to harmonise with the Australian classification.

9.5 Felypressin

The Committee noted that felypressin, a vasoconstrictor agent used in combination with local anaesthetics, was classified as a prescription medicine. However, it was known to be widely used by dental therapists. A request had been made to reclassify felypressin to allow anaesthetic agents containing felypressin to continue to be available to dental therapists without resorting to standing orders.

It was noted that Citanest was the only product on the Medsafe database which contained felypressin. It was used in combination with prilocaine. Prilocaine had already been exempted from prescription status when used in practice by a dental therapist. Members agreed that a similar exemption could be applied to felypressin to allow continued access by dental therapists. As no change of classification would be required the exemption could be put into effect at the same time as classification changes from the current meeting.

Recommendation

That felypressin be exempt from prescription status when in combination with a local anaesthetic and used in practice by a dental therapist.

10. General business

There were no items of general business.

The meeting closed at 4.05pm