Revised: 23 May 2013

Committees

Minutes of the 28th meeting of the Medicines Classification Committee - 19 November 2002

The Minister’s Delegate has accepted all but one of the recommendations made at the 28th meeting.

The Minister’s Delegate did not accept the second part of the recommendation for agenda item 6.4 in which the Committee recommended that Medsafe be asked to ensure that the trade name for the prescription version of the medicine in question should not be used for the over-the-counter(OTC) version of the same active ingredient.

Medsafe recognises that there could be wider implications for products already on the market if this part of the recommendation were to be put into effect. It recognises that the safety issues which were of concern to the MCC could possibly be resolved by the use of a defining statement linked to a company’s usual trade name in order to distinguish between its prescription product and its OTC product.

However, Medsafe recognises that there is an issue relating to the use of a single trade name for both prescription and OTC versions of products. It wishes to investigate more fully and consult with interested parties on this matter. The outcome will be reflected in an update to Volume 1 of the New Zealand Regulatory Guidelines for Medicines .

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

Present

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

In Attendance

Dr John McEwen, Chairman, Australian National Drugs and Poisons Schedule
Committee
Ms Sarita Von Afehlt (for omeprazole)

1. Welcome

The Chairman welcomed Dr John McEwen, newly elected Chairman of the Australian National Drugs and Poisons Schedule Committee (NDPSC). Dr McEwen spoke briefly about his background. Members introduced themselves to Dr McEwen.

2. Apologies

An apology was received from Dr Tim Bevin.

3. Confirmation of the minutes of the 27TH meeting

The minutes of the 27th meeting were confirmed as an accurate record of that meeting and were signed by the Chairman.

4. Declaration of conflict of interests

None of the members had any interests which were considered prejudicial to recommendations made about any of the agenda items to be discussed at the meeting.

5. MATTERS ARISING from the 27th meeting

5.1 Ephedra

Reconsideration of the recommendation to classify as a prescription medicine.

The Chairman explained that a decision had been made to treat material received following the Committee's recommendation to reclassify ephedra from pharmacy-only medicine to prescription medicine as an objection on the grounds that there was substantial valid safety data available which had not been considered at the time that the recommendation had been made.

It was noted that ephedra had been a scheduled medicine for many years and that there were no products registered for sale in New Zealand containing ephedra. Therefore any products currently available for retail sale were in breach of the Medicines Act 1981. Any recommendation made by the Committee would have no regulatory impact on legitimately marketed products.

The Committee agreed that the evidence supplied pointed to the fact that ephedra and other alkaloids contained in ephedra were absorbed and metabolised in the same way as ephedrine. Therefore the same safety concerns applied as for ephedrine which was already classified as a prescription medicine.

Members considered the Cantox Report which had been supplied as justification for the safety of ephedra in limited doses. They noted from this report that there had been a substantial number of adverse reactions and deaths reported in the USA and Canada. Trials had been undertaken across a broad spectrum of the population and included use for both athletic performance enhancement and weight loss. Whereas a higher adverse response would have been expected from use by overweight, therefore possibly less healthy range of consumers, results showed an unexpectedly high death rate amongst a potentially healthier and possibly younger range of athletes.

Because of the difficulties associated with reporting and recording adverse reactions to dietary supplements, such events in the USA and Canada were likely to have been underreported. It was agreed that, in the case of dietary supplements, lack of evidence could not be equated with no evidence.

A major concern was that the adverse effects resulting from consumption of ephedra, including increased blood pressure leading to possible stroke or heart attack were the direct result of the physiological effects of the alkaloids contained in ephedra rather than possible side-effects of the medicine.

Pharmacists felt that if ephedra or ephedrine products were to be available in a pharmacy environment there would be a significant increase in risk to a number of consumers who would be likely to shop in a pharmacy environment. Pharmacists would not be able to screen for risk factors or possible interaction with other medicines.

Members agreed that while it might be possible to include package warning statements in an environment where complementary products were regulated to some degree, this was not possible in New Zealand where no such regulation currently occurred.

The Committee agreed that, in the light of the nature of the drug culture in New Zealand, granting freer access to ephedra might contribute to the problem of abuse. A more restrictive level of access would provide a stronger tool to assist in abuse control. Members felt that Medsafe should be asked to increase its vigilance over the sale of illicit products.

The Committee upheld its earlier recommendation on the grounds that the benefits of ephedra use were largely unfounded from the data supplied but there was well-documented evidence of risk in a healthy population.

Recommendation
  • That the Committee uphold its earlier recommendation to reclassify ephedra from pharmacy-only medicine to prescription medicine.
  • That the Medicines Control section of Medsafe should be asked to make extra effort to regulate the illicit use of ephedra.

5.2 Buccaline Berna

At the previous meeting the Committee had requested that Medsafe should be asked to determine whether or not this product was a vaccine so that it could be appropriately classified. The pharmacy-only entry for oral vaccines unless specifically listed elsewhere in the schedule, was to be removed from the schedule. The Committee had not been sure whether or not this entry had been interpreted as applying to Buccaline Berna. If it had, the product would become either a general sale medicine or a prescription medicine depending on whether two of the ingredients, haemophillus influenzae and pneumococcus I, II & III displayed vaccine activity. Medsafe had confirmed that, in view of the only approved indication for the product, "the oral antibacterial prophylaxis of the complications of colds", the product could only be viewed as a vaccine.

While there had been no evidence of harm over a long period of use, to justify removing the product from the market, the members doubted its efficacy. They noted that, due to the fact that this was a "grandfathered" product which had been available for a considerable length of time, there was no efficacy data on file. They also noted that, though no longer sold in Australia, the product had been actively promoted in New Zealand in recent times.

It was agreed that the company should be informed that both Medsafe and the Committee thought that Buccaline Berna should be classified as a prescription medicine. However, the Committee would be agreeable to giving consideration to a submission to reclassification to an over-the-counter category should the sponsor company wish to make such a submission. Because of the lack of information about the product, efficacy data as well as safety data would be required in the submission.

Recommendation
  • That Buccaline Berna should be classified as a prescription medicine
  • That the Committee would be willing to consider a submission from the sponsor company containing data to support a reclassification from prescription medicine to an over-the-counter classification.

5.3 Access to prochlorperazine for use with ECP

The Secretary informed the Committee that the means used by Medsafe to implement the recommendation to make prochlorperazine accessible to accredited pharmacists and nurses when selling the emergency contraceptive pill had not provided the most effective means of access. As there did not appear to have been access problems to date, Medsafe intended to remedy the problem in the next classification Gazette notice. The intention of the Committee remained clear and no new recommendation was required.

6. Submissions for reclassification

6.1 Intraocular viscoelastic products

Intraocular viscoelastic products were included in Appendix A of the Australian Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) and were exempt from scheduling in Australia. Until recently they had been pharmacy-only medicines in New Zealand because of the pharmacy-only injectable entry in the schedule which covered any injectable not more restrictively classified by its active ingredient. Recent recommendations from Australia to move hypromellose and hyaluronic acid, formerly unscheduled in New Zealand, to prescription medicine when contained in injections had caused an even wider classification discrepancy for a number of products. Pacific Pharmaceuticals had requested harmonisation for this group of products.

The Committee agreed that the most practical way to achieve harmonisation was to exempt these two substances from prescription status when in injections when they were contained in intraocular viscoelastic products.

Recommendation

That hypromellose and hyaluronic acid should be classified as prescription medicines when in injections except when contained in intraocular viscoelastic products.

6.2 Sodium picosulfate (Picoprep Powder, Baxter)

This was a company submission for reclassification from pharmacy-only medicine to prescription medicine when used as a laxative and to restricted medicine when used for bowel cleansing prior to diagnostic, medical or surgical procedures. The proposed change would bring the classification of sodium picolsulfate into line with that of sodium phosphate and those macrogols which were used for similar indications. The NDPSC had made a similar recommendation (see agenda item 8.2.4 below).

Members noted that while both the NDPSC and the company had requested a restricted medicine classification for sodium picosulfate when used for bowel cleansing, only the company had requested prescription status for oral laxatives. They agreed that the classification of sodium picosulfate should be consistent with that of sodium phosphate and the relevant macrogols. While the product concerned was marketed for both indications in New Zealand it was thought that it might be marketed only for bowel cleansing in Australia, hence the omission to recommend a prescription classification to the MCC when for oral laxative use. Members agreed that, on grounds of consistency, the NDPSC should be recommended to make a schedule entry for sodium picosulfate as S4 when used as an oral laxative.

Recommendation
  • That sodium picosulfate should be classified as a prescription medicine when used as an oral laxative and a restricted medicine when used for bowel cleansing prior to diagnostic, medical or surgical procedures
  • That the NDPSC should be recommended to classify sodium picosulfate as S4 when used as an oral laxative.

6.3 Flurbiprofen 10 milligram lozenges (Strepfen, Boots)

This was a company submission for reclassification from restricted medicine to pharmacy-only medicine for throat lozenges containing 10 milligrams or less in each lozenge. The Committee noted that a recent similar submission in Australia had led to a change to the pharmacy-only equivalent, S2. Overall the Committee was satisfied with the safety profile of the medicine for sale at pharmacy-only level at the requested strength. Although there were concerns about use by asthmatics and about use with other NSAIAs the risks were no greater than for other NSAIAs at that level of classification. Pharmacy-only classification would still enable an element of pharmacist advice in the sale if required and consumers could still be referred to a doctor if this was considered necessary. In terms of consumer convenience, the product was considered to be extremely effective. The Committee agreed to recommend in favour of a change to pharmacy-only medicine.

Recommendation

That flurbiprofen should be reclassified from restricted medicine to pharmacy-only medicine when in throat lozenges containing 10 milligrams or less per lozenge.

6.4 Diclofenac 12.5 milligram tablets

This was a submission from Pharmaceutical Solutions Ltd for reclassification from restricted medicine to pharmacy-only medicine for 12.5 milligram tablets or capsules in packs of not more than 20.

Discussion centred on comparison with other similar non-steroidal anti-inflammatory agents. The data provided compared diclofenac with naproxen on the grounds that if naproxen was safe for pharmacy-only sale then diclofenac was also safe for sale at that level. Members noted the absence of comparison with ibuprofen which they would have considered to be a more appropriate benchmark. However, data indicated that the daily dose for 12.5 milligram diclofenac was almost as safe as 1200 milligram daily dose of ibuprofen and that the company appeared to have reduced the dose of diclofenac to meet this level of safety. However, the rates of hepatic damage did appear to be marginally higher than for ibuprofen. These rates were difficult to assess as no access had been given to the papers which referred to hepatic damage.

However, members agreed that the potential for misuse was small and there was a need for consistency in that 250 milligram naproxen tablets were already available as a pharmacy-only medicine. Nor was there any limit to the amount of aspirin available despite its side-effects. It was agreed that 12.5 milligram diclofenac tablets should be available as pharmacy-only medicines when sold in packs of not more than 20 tablets.

The Committee was strongly opposed to the use of the name Voltaren for this new product. The name Voltaren had strong associations with long-term treatment of osteoarthritis. This was considered an inappropriate use for a pharmacy-only medicine. Members wished that Medsafe be asked to ensure that no lower-dose pharmacy-only tablet be permitted to use this name.

Recommendation
  • That diclofenac should be reclassified from restricted medicine to pharmacy-only medicine when in tablets or capsules containing 12.5 milligrams or less and in packs containing not more than 20 dose units
  • That Medsafe be asked to ensure that the name Voltaren not be permitted for this product.

6.5 Solanaceous plants and alkaloids

This was a Weleda submission for a change to the level for exemption from scheduling for atropa belladonna, atropine, hyoscine, hyoscyamine and hyoscyamus niger. The company now appeared satisfied with the harmonised cut-off points for pharmacy-only and prescription medicine for these medicines but had made a submission to support the view that the cut-off points per litre or per kilogram of 100 micrograms (atropine) and 10 micrograms (hyoscine and hyoscyamine) for exemption from scheduling as specified in the Australian schedules were too low for the plant alkaloids. Application of the same cut-off points to the plant entries would be both inconsistent and too high.

The Secretary said that she was aware of the inconsistency of using the same cut-off point for both the plant material and the alkaloids contained in the plants. She was currently resolving this inconsistency in the New Zealand schedule by expressing the cut-off point for plants in terms of total alkaloid content. The exercise had not yet been completed and would not have been evident at the time the Weleda submission had been made. This revision should resolve one aspect of the company's submission. The Committee agreed that the cut-off point should apply only to plants where none of the alkaloids contained in them were specified separately in the schedule.

The Committee noted that the Weleda submission had been based on the earlier proposed framework for herbal medicines which allowed one hundredth of the minimum lethal dose of alkaloids per pack to be sold as general sale medicine. Members agreed that they were happy with this from a safety perspective. Applying an exemption from scheduling of 300 micrograms per litre or per kilo to all three alkaloids would ensure that general sale packs would contain one tenth of the concentration of pharmacy-only packs and considerably less than a fatal dose regardless of pack size.

It was agreed that a recommendation should be made to the NDPSC to adopt a similar cut-off point in Appendix G of the SUSDP in the interest of harmonisation and in order to allow continued access to homoeopathic products available on the New Zealand market.

Recommendation
  • That the cut-off point for exemption from scheduling for atropine, hyoscine and hyoscyamine should be increased to 300 micrograms per litre or per kilogram
  • That the NDPSC should be recommended to adopt a similar cut-off point in Appendix G of the SUSDP

6.6 Omeprazole 20 milligram tablets (Losec MUPS, AstraZeneca)

This was a company resubmission for classification from prescription medicine to restricted medicine for 20 milligram tablets. At the 26th meeting the Committee had queried the proposed indications and dose instructions presented in a submission for the reclassification of 10 milligram tablets. The indication in the resubmission had been amended to "the 24-hour prevention of frequent heartburn and indigestion" for 20 milligram tablets.

The Committee had already considered the safety of the medicine and had no serious concerns about its suitability for over-the-counter use from a safety point of view.

However, there were still concerns about the indications sought. Members queried the definition of "frequent heartburn" which was not defined in the product information. They were not happy about continuous use of the product over a two-week period for symptoms which were intermittent and agreed that there were other medicines available which would deal with the symptoms more efficiently on an "as required' basis. They felt that prolonged prevention using a medicines with the potency of omeprazole did not fit in with the principles of over-the-counter indications.

There was also concern about the potential of a medicine with the potency of omeprazole to mask underlying pathology, particularly with repeat courses. Members agreed that, in spite of warnings in the package information, consumers would tend to take repeat courses if they felt the medicine was working. The Committee felt strongly that people with recurrent gastric disease should undergo endoscopic investigation.

The Committee agreed that the product was not suitable for sale as a restricted medicine for continuous use over 14 days for the 24-hour prevention of frequent heartburn. No particular benefits were apparent for consumers as they had access to better products for immediate symptom relief. On the other hand, there was potential for a delay of at least one 14-day course of treatment if more serious underlying causes were masked by use of the product. Members agreed that omeprazole should retain its current status as a prescription medicine.

Recommendation

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

7. New Medicines for classification

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

In the interest of Trans-Tasman harmonisation, gadobendate dimeglumine would be appropriately classified as a general sale medicine along with other contrast agents.

More information was required on the nature of the product containing policosanol. The Committee acknowledged that policosanol was sold as a complementary medicine in Australia but no claims were permitted. If the product were to be marketed in New Zealand with the proposed indication, the treatment of elevated cholesterol, the product would need to be considered alongside other entities with a similar indication. Consideration would also need to be given to the degree of professional intervention required for the diagnosis and monitoring of the approved indication.

The remainder of the list was considered suitable for classification as prescription medicine.

Recommendation
  • That consideration of the classification of policosanol be postponed pending further information about the nature of the product
  • That gadobendate dimeglumine be classified as a general sale medicine
  • That the following be classified as prescription medicines:
    • Adalimumab
    • Ibritomomab tiuxetan
    • Memantine hydrochloride
    • Gefitinib
    • Poractant alfa
    • Alefacept

8. Harmonisation of NZ and Australian schedules

8.1 Outstanding harmonisation issues

8.1.1 Glyceryl trinitrate and isosorbide dinitrate

Although formerly harmonised, it appeared that the NDPSC had omitted to forward a further recommendation to the MCC after moving oral forms of isosorbide dinitrate in doses containing 10 milligrams or less and glyceryl trinitrate from S2 (pharmacy-only) to S3 (restricted medicine). The Committee agreed that these products would be more appropriately classified as restricted medicines and should be reclassified in the interest of harmonisation.

Recommendation
  • That glyceryl trinitrate for oral use should be reclassified from pharmacy-only medicine to restricted medicine
  • That isosorbide dinitrate in medicines containing 10 milligrams or less per dose form should be reclassified from pharmacy-only medicine to restricted medicine

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

8.2.1 Nicotine for inhalation

The NDPSC had recommended that inhaled nicotine be classified in the same way as nicotine in transdermal patches and in gum. It had recommended that New Zealand adopt a similar scheduling outcome. The recommendation had arisen from a company submission in Australia for reclassification from S3 (restricted medicine) to S2 (pharmacy-only medicine).

The Committee noted that nicotine in gum and transdermal patches was general sale medicine, not pharmacy-only medicine in New Zealand and that moving inhaled nicotine to the same level of classification as that in gum and patches would not harmonise with Australia. Members interpreted the NDPSC recommendation as requesting that New Zealand adopt a pharmacy-only classification for inhaled nicotine products.

Members recalled that the inhaled nicotine products had initially been classified more restrictively than nicotine contained in gum or patches because it was a new product and a more obvious cigarette substitute than the earlier products. However, there appeared to have been no specific safety issues linked to the inhaled route of administration and the Committee was now happy to comply with the principles of harmonisation and to see these products classified less restrictively. It was agreed that the current exemption from classification status when used in smoking cessation clinics run by appropriate registered health professionals should continue to apply.

The Committee requested that a copy of the Quitline Smoking Cessation Programme report on the outputs and outcome of the programme be obtained for members' information.

Recommendation
  • That nicotine for inhalation should be reclassified from restricted medicine to pharmacy-only medicine except when sold from a smoking cessation clinic run under the auspices of a registered medical practitioner, nurse, pharmacist or psychologist.
  • That Medsafe be asked to obtain a copy of the Quitline Smoking Cessation Programme report on the outputs and outcome of the programme.

8.2.2 Clobetasone

The NDPSC had recommended that clobetasone be reclassified to restricted medicine in preparations for dermal use containing 0.05% or less in packs containing 30 grams or less.

Clobetasone at 0.05% was identified as a moderately-potent corticosteroid as opposed to 1% and 0.5% hydrocortisone which were classified in Martindale as being of mild potency. Members agreed that the 0.05% clobetasone product proposed for sale in Australia appeared to be comparable in efficacy to 1% hydrocortisone. They noted that the over-the-counter pack size was small, the indications reduced and the warning statements increased. As the product had not been previously marketed in Australia there was no data available as a result of its use there.

The MCC had recently agreed not to harmonise on a similar recommendation to make alclomethasone, another moderately-potent corticosteroid, available over the counter. If clobetasone were to be reclassified, alclomethasone would also need to be reconsidered for reclassification. There was general agreement that a move to make these two moderately-potent corticosteroids available over the counter could lead to submissions for even more potent corticosteroids to be made more freely available. The Committee displayed a degree of reluctance to change its benchmark of 1% hydrocortisone for over-the-counter sale for topical corticosteroids.

Issues of concern to the Committee centred on the potential for skin thinning, use on the face and long-term use. Members agreed that adverse effects relating to these concerns were probably not widely reported. Not a great deal of research had been conducted in this area and available data were patchy.

Matters relating to the ability of pharmacists to make a correct diagnosis and the feasibility of doing this were also discussed. The Committee was divided about whether issues relating to diagnosis, side-effects and incorrect use could be dealt with adequately in a pharmacy. It was noted that the pharmacy environment was changing and that many pharmacies now had private areas which facilitated diagnosis.

There was also discussion about whether or not the medicine would be used correctly or if consumers would tend towards chronic use or shared use. While it was thought that pharmacy control was probably sufficient to deal with this in a small town it was considered possibly not sufficient in a city environment. It was noted that there was wide use of over-the-counter hydrocortisone and a similar use pattern would be likely to develop for other steroid products. Members agreed generally that any of the indications proposed for over-the-counter clobetasone could be dealt with using hydrocortisone. If a problem had not been resolved after a week of treatment with hydrocortisone, some members felt strongly that the consumer should be referred to a medical practitioner.

The Chairman pointed out that the Committee had made a previous policy decision not to allow steroids more potent than 1% hydrocortisone to be available over the counter. He said that there were two conflicting principles and that the Committee needed to consider whether it was more important to uphold the benchmark of 1% hydrocortisone or to follow the principle of harmonisation and accept the least restrictive classification.

The Committee felt that more information was required about the use and safety of mild to moderate corticosteroids before a recommendation could be made about whether or not to reclassify. It was suggested that a study of the safety of mild to moderate topical corticosteroids with a view to their becoming available as restricted medicines would be a useful subject for a pharmacy student summer project under one of the studentships sponsored by the Pharmaceutical Society. Dermal nurse specialists were also suggested as a possible source of valuable information. It was agreed that Medsafe should seek comment from these nurses and should write to the Pharmaceutical Society requesting that such a study be undertaken by a pharmacy student.

Recommendation
  • That 0.05% topical clobetasone should remain a prescription medicine pending further information
  • That information about the safety of moderately potent topical corticosteroids should be sought from dermal nurse specialists
  • That the Pharmaceutical Society should be asked to allocate a study of this topic to a pharmacy student as a summer project.

8.2.3 Epoetin alfa

Add to the schedule for clarity. Make a similar entry for epoetin beta.

It was noted that these were synthetic analogues of erythropoietin and were therefore already covered in the schedules of both countries. As Martindale also made reference to epoetin gamma, it was agreed that a single new entry for epoetins would be more efficient without loss of clarity.

Recommendation

That a new schedule entry should be made to classify epoetins as prescription medicines.

8.2.4 Sodium picosulfate

Reclassify to restricted medicine when used in oral preparations for bowel cleansing prior to diagnostic, medical or surgical procedures.

This matter was dealt with under agenda item 6.2. Note that the earlier recommendation also included the scheduling of sodium picosulfate as a prescription medicine when used as an oral laxative.

9. For the next meeting

The Chairman suggested that the harmonisation of fluorides had not been completed and that there had been enquiries from affected parties as to when this would be considered. While solid dose forms had been harmonised there was still some difference in the scheduling of dentifrices and other oral hygiene products. It was agreed that the harmonisation of fluorides should be added to the agenda of the next meeting.

10. General business

10.1 Nurse competency for ECP

One of the members updated the Committee on the progress which had been made by nurses in the setting-up and maintenance of competencies to enable nurses to supply the levonorgestrel emergency contraceptive pill. Between 700 and 800 nurses were believed to have attained accreditation in this field to date. Most of these were nurses who already specialised in family planning.

10.2 Pharmacist competency for ECP

A Pharmaceutical Society member reported on progress made by pharmacists in the sale of the emergency contraceptive. He said that this had been very good professionally for pharmacists and a surprisingly high number of pharmacists had undertaken the required training. The training programme consisted of a pre-reading requisite followed by a three-hour course and concluded with a test.

10.3 Response to NDPSC comments on progress of the harmonisation process

The Secretary drew the Committee's attention to a remark in the minutes of the 35th minutes of the NDPSC held in June 2002 in which "the meeting expressed some disappointment with the current loss of goodwill and momentum given to the retrospective human medicines scheduling harmonisation process". She said that she would like it recorded that there had been lack of neither momentum nor goodwill. Despite very limited resources, Medsafe had worked hard to consult on the recommendations made by the NDPSC and to take these recommendations along with any comment from the consultation process, to the MCC. The MCC had considered and made its own recommendations on all the recommendations made by the NDPSC from the commencement of the harmonisation project up to and including recommendations made by the NDPSC in February 2002. This was as close as was possible given the time constraints imposed by the requirements of the New Zealand consultation process. The Chairman added that an impression of lack of goodwill may have arisen from his inability to attend two consecutive NDPSC meetings due to other unavoidable commitments.

10.4 Thiourea

Thiourea had recently been added to the New Zealand schedule as a prescription medicine in order to harmonise with the Australian schedule. At that time there were no medicines registered in New Zealand which contained thiourea. However, shortly afterwards consent to market was sought for a product containing a small amount of thiourea as an excipient. As the product was an injectable containing no scheduled products other than thiourea, its appropriate classification was pharmacy-only medicine. The Committee agreed that a cut-off point should be agreed below which thiourea should be available as a general sale medicine.

Recommendation

That thiourea should be classified as a prescription medicine except in medicines containing 0.1% or less of thiourea.

10.5 Membership

The Secretary informed members that the term of membership for the Pharmaceutical Society and Medical Association members was due to expire in November 2003 and that she would shortly be approaching both organisations seeking new nominations. One current member had served only one of the two permitted three-year terms and was eligible for reappointment. The other three members had served the maximum statutory term of six years and were not able to continue their membership. As some members had had difficulties finding locums to allow them to attend meetings it was agreed that this potential problem should be pointed out at the time new nominations were sought in order to avoid appointing members who would have on-going difficulties in this area. It was noted that early February was a good time to seek nominations from the Pharmaceutical Society.

10.6 Date for the next meeting

The first two weeks in May were agreed on as being convenient for the next meeting.

The meeting closed at 3pm

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