Revised: 23 May 2013

Committees

Minutes of the 22nd meeting of the Medicines Classification Committee - 10 November 1999

Notes relevant to the 22^nd meeting of the Medicines Classification Committee held on 10 November 1999

All but one of the recommendations made at the 22^nd meeting were accepted by the Minister’s Delegate on 3 February 2000.

Wider access to nicotine-containing products for smoking cessation

The Committee's recommendation was not accepted by the Minister’s Delegate who accepted a counter proposal made by Medsafe. The Medsafe recommendation means that wider access to smoking cessation products can be implemented very quickly and without the need for changes to product labels. While the classification of all nicotine-containing products will remain unchanged, an exemption from classification status will be granted in the next Gazette notice (see Dates & Deadlines) so that they may be sold from smoking cessation clinics conducted under the auspices of appropriate registered health professionals. Those products which are currently pharmacy-only or restricted medicines will be available from smoking cessation clinics conducted under the auspices of registered pharmacists, nurses, psychologists or medical practitioners. Products which are currently prescription medicines will be available from clinics conducted under the auspices of registered medical practitioners only.

Three submissions for reclassification of pharmacy-only smoking cessation products containing nicotine are on the agenda of the 23^rd meeting of the Medicines Classification Committee for possible reclassification to general sale medicines. Medsafe is interested in receiving comments about these submissions. The closing date for receiving comments is 20 April 2000.

Harmonisation of New Zealand and Australian Schedules

Camphorated oil

The Australian National Drugs and Poisons Schedule Committee has informed Medsafe that the intention was for the prescription medicine classification for camphorated oil to be modified by the words ‘excluding admixtures’. Medsafe’s database shows that all known medicines containing camphor in New Zealand contain forms of camphor other than camphorated oil. Please inform the Secretary immediately if you are aware of any product containing camphorated oil so that Medsafe knows whether or not the entry in the New Zealand schedule will need to be modified. Pharmaceutical companies should not make label changes at this stage. The classification change will not be notified in the nextGazettenotice if products are likely to be affected.

Phenylephrine

Medsafe has now checked the cut-off point of 0.5% recommended by the Australian National Drugs and Poisons Schedule Committee as the upper limit for pharmacy-only oral preparations containing phenylephrine. Medsafe is satisfied that no New Zealand pharmacy-only products should change classification if the recommendation is implemented. Please contact the Secretary immediately if you are aware of a product that might be affected.

Pseudoephedrine

Medsafe has now checked the criteria recommended by the Australian National Drugs and Poisons Schedule Committee as suitable for pharmacy-only products containing pseudoephedrine. Medsafe is satisfied that no New Zealand pharmacy-only products should change classification if the recommendation is implemented. Please contact the Secretary immediately if you are aware of a product that might be affected

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Minutes:

Held in the medsafe conference room on the 18th floor of Grand Plimmer Tower, 4-6 Gilmer Tce, Wellington on Wednesday 10 November 1999, commencing at 9:30 am

• Present
• Welcome
• Apologies
• Confirmation of the minutes of the twenty-first meeting
• Declaration of conflict of interests
• Matters arising
  • Objections to recommendations made at last meeting
    • Hyoscine butylbromide
  • Medicines for wider consideration as part of a therapeutic group
    • Nasal corticosteroids
    • H₂-receptor antagonists
  • Paracetamol suppositories
  • Mupirocin
  • Procedure for out-of-session consultation
• Submissions for reclassification
  • Fluticasone
  • Mometasone furoate
  • Minoxidil 2% topical solution
  • Naproxen sodium 220mg & 275mg tablets
  • Sodium phosphate bowel preparations
  • Folic acid injection
• New medicines for classification
  • Medicines classified by the MAAC
  • Medicines classified by the NDPSC
  • Azelastine
• Harmonisation of NZ And Australian schedules
  • Arising from the last meeting
    • Solasadine
    • Tanacetum
    • Thyroid
    • Tryptophan
  • Recommendations from the 20th and 21st meetings of the NDPSC
    • Meeting No 21, May 1999
    • Meeting No 20, February 1999
• For the next meeting
• General business
  • Wider access to nicotine-containing products for smoking cessation
  • Contracts for payment of fees to committee members

PRESENT

Dr S Jessamine (Chair)
Mr D Thompson
Mr B McKone (until 3:30pm)
Ms M Ewen
Dr T Bevin
Dr G Wardrope (until 3pm)
Mrs C Smith (Secretary)

The meeting commenced at 9:35am.

1 WELCOME

The Chairman welcomed the Committee to the twenty-second meeting.
He introduced Ms Margaret Ewen as the new Ministry member following the resignation from Medsafe of Mrs Marilyn Anderson. Ms Ewen spoke briefly about her background and her role in Medsafe. She mentioned her particular interest in Consumer Medicine Information (CMI) and her desire to bring a consumer perspective to the Committee.

Dr Jessamine said that there were a number of new requests for classification change on the agenda and that harmonisation of the New Zealand and Australian schedules was progressing well.
He said that Dr Brian Priestly of the Therapeutic Goods Administration and Commonwealth representative on the Australian National Drugs and Poisons Schedule Committee (NDPSC) was expected to attend the meeting as an observer. He added that Dr Priestly was also a member of the Trans-Tasman Harmonisation Working Party and had a background in toxicology and pharmacy.

There was some general discussion about the reasons for the harmonisation project, its progress to date and possible ways of maintaining future harmonisation through joint submissions from pharmaceutical companies. It was agreed that harmonisation matters would be dealt with in more specific detail later on the agenda.

2 APOLOGIES

An apology was received from Dr Priestly during the course of the meeting.

3 CONFIRMATION OF THE MINUTES OF THE TWENTY-FIRST MEETING

The minutes of the twenty-first meeting were confirmed as an accurate record of that meeting and were signed by the Chairman. There was some discussion as to when minutes of meetings could be regarded as confirmed. The Secretary explained that members were given an opportunity to comment before the minutes were sent to the Minister or his or her delegate and that they should be regarded as final once they had been signed off by the Minister. It was agreed that the signing of the minutes by the Chair at the following meeting was a formality only as a six-month delay until minutes were confirmed was not feasible.

Dr Jessamine told members that, with the growing need for transparency and the increasing demand by journalists for access to minutes under the Official Information Act, it was likely that committee minutes would be published on the Medsafe web site in the near future. While Medsafe did not encourage journalists to approach members, it was not able to prevent the media from obtaining access to members' names. He also said that although members could not be prevented from speaking with the media it was preferable that they refer requests for information to an accredited media spokesperson who was, in this case, the Chairman.

4 DECLARATION OF CONFLICT OF INTERESTS

None of the members had interests which could be considered prejudicial to recommendations about any of the issues to be discussed at the meeting.

5 MATTERS ARISING

5.1 Objections to recommendations made at the previous meeting.

5.1.1 Hyoscine butylbromide (Buscopan tablets, Boehringer Ingelheim)

The company had objected to the Committee recommendation not to reclassify 10 milligram tablets from restricted medicine to pharmacy-only medicine. The secretary distributed copies of the Medsafe report which had been considered at the previous meeting and of the minutes relating to that agenda item.

It was noted that the company had attempted to address the issues raised by the Committee at the previous meeting in order to justify its recommendation to continue the restricted medicine classification. However, most members were still against a lower level of availability. Concern was expressed about the treatment of undiagnosed abdominal pain and the possibility of masking conditions such as acute appendicitis or gastric ulcer for which even a short delay would be undesirable. Even though the proposed pack size would allow only a short period of treatment, it was felt that further delays would be likely to ensue before a patient was able to obtain an appointment with a medical practitioner. For this reason, some members felt that a degree of professional advice was desirable in the sale of the product as most consumers were not competent to diagnose an unknown source of abdominal pain. Some members thought that many consumers would have already had their symptoms diagnosed and that intervention in the sale was therefore unnecessary. However, others did not regard restricted medicine classification as a barrier to access for these consumers.

It was also noted that the product was often used for the treatment of bladder spasm and that this was not an appropriate indication for pharmacy-only sale. Some members felt that wider availability could lead to a change in use of the product for indications other than those specified in the package information.

All members agreed that the company should be asked to include in the pack CMI produced in accordance with the New Zealand guidelines for CMI.

The majority of the Committee felt that there were sufficient safety concerns to justify a recommendation not to harmonise with the Australian classification for this product.

Recommendation

• That there be no change to the current restricted medicine classification of 10 milligram hyoscine butylbromide tablets
• That the company be asked to ensure that its package information meets the requirements for CMI in Volume 4 of The New Zealand Regulatory Guidelines for Medicines

5.2 Medicines for wider consideration as part of a therapeutic group

5.2.1 Nasal Corticosteroids

A review of all over-the-counter (OTC) nasal corticosteroids had been requested at the previous meeting. The request had arisen from a submission for the reclassification of beclomethasone 50 microgram nasal spray from restricted medicine to pharmacy-only medicine when for users over 18 years of age. The proposed review had resulted in several general responses, one specific response in respect of budesonide, and had led to submissions for two further nasal corticosteroids to be reclassified from prescription medicines to OTC status (see 6.1 and 6.2 below).

Australia had met the New Zealand classification of the three OTC nasal corticosteroids, beclomethasone, budesonide and flunisolide, and had accepted the same requirements as New Zealand for their sale as restricted medicines. The two schedules had, therefore, achieved harmonisation with regard to nasal corticosteroids. Any further review would need to be undertaken jointly and companies would need to make simultaneous submissions in both countries. For this reason the Committee was not required to make a recommendation at the current meeting with regard to either beclomethasone or to the therapeutic group as a whole.

Industry had been generally supportive of this approach to maintaining harmonisation and the company which had made the original submission for the reclassification of beclomethasone, had been happy to have a recommendation deferred on this basis.

Recommendation

That pharmaceutical companies interested in a change to pharmacy-only status for OTC nasal corticosteroids be asked to submit data simultaneously to both the Medicines Classification Committee and the National Drugs and Poisons Schedule Committee supporting such a change. Submissions should address issues relating to recommended lower age limits for OTC use. Proposals for classification change should remain within the current guidelines for OTC sale.

5.2.2 H2-receptor antagonists

A review of all OTC H₂-receptor antagonists had been requested at the previous meeting. The request arose from a submission for the reclassification of ranitidine 75 milligram tablets from restricted medicine to pharmacy-only medicine.

Australia had harmonised with the New Zealand classification for this group of medicines and had accepted the same requirements as New Zealand for their sale as restricted medicines. Further relaxation of the classification would need to be considered by both committees. Companies should be asked to make these submissions.

General discussion followed around issues relating to making joint submissions, their processing and the nature of their content. It was agreed that there was value in receiving a variety of views. Members noted that the main criterion for classification recommendations was safety and that marketing issues should not be considered. Joint meetings of the two committees was considered as one possibility in the future. At present, while Australian legislation allowed for a New Zealand member on the NDPSC, New Zealand legislation did not make it possible for an Australian member to belong to the MCC.

In answer to a query about how a difference of views between the two countries could be handled, Dr Jessamine suggested that as each committee had a protocol for objection, this mechanism could be used. Safety data could be submitted in support of an objection to a recommendation made by either committee.

Recommendation

That consideration of the reclassification of H₂-receptor antagonists should be deferred and pharmaceutical companies should be asked to make concurrent submissions to both the Medicines Classification Committee and the National Drugs and Poisons Schedule Committee.

5.3 Paracetamol suppositories

At the previous meeting the Committee had recommended that the classification of paracetamol suppositories should be made consistent with the classification of other solid dose forms of paracetamol. A Medsafe report was prepared showing the proposed wording for the consistent scheduling of paracetamol and indicating which products could be expected to change classification.

After discussion, some members felt reluctant to allow small pack sizes to be sold as general sale medicines without the advice of a pharmacist. While it was acknowledged that demand would probably be small and the potential for overdose low, some members felt that education would be required for use of these products and that this could not be addressed adequately in the package information.

One member pointed out that migraine sufferers benefited from administration of analgesics in suppository form and regarded the need to visit a pharmacy as a barrier to access.

However, the main concern for some members was that if consumers were not able to tolerate oral forms of paracetamol there could be a need to assess the underlying reason for this and the advice of a pharmacist should be available. There was concern about the potential for use when dehydrated by both adults and children.

While some members thought that any potential problems regarding issues such as dehydration and correct use of products could be dealt with in the package information in the same way as for other solid dose forms, others did not wish to see any change in classification and it was agreed that the current pharmacy-only classification should be retained at this time.

An independent Australian review of analgesics had been sent to the TGA for comment and New Zealand and Australia had agreed to stand by the recommendations made in the review when they became available.

Recommendation

That there be no change to the current pharmacy-only classification of paracetamol suppositories.

5.4  Mupirocin - advice on alternative forms of treatment.

The Committee had asked Medsafe to prepare an article for publication in Prescriber Update outlining alternative forms of OTC treatment to mupirocin following its reclassification from restricted medicine to prescription medicine. Medsafe had considered such an article would be more appropriate from another source. The Pharmacy Guild agreed to undertake this activity. Members stated that they felt the Pharmaceutical Society would be a more suitable body to undertake this activity as their newsletter was sent to all pharmacists whereas the Guild newsletter was sent only to Guild members.

5.5  Procedure for out-of-session consultation

Members discussed the Australian protocol for out-of-session consultation and were comfortable with the broad outline of the procedures. They agreed that the NDPSC document should be used as a basis for a similar protocol for the MCC. Dr Jessamine pointed out that there had been some recent changes to the Australian protocol and teleconferences were now considered as meetings. It was recognised that more frequent consultation could be required of the MCC as they met only twice a year whereas the NDPSC met four times annually. Some members expressed the hope that they would not be required to give out-of-session opinions on a frequent basis without some form of discussion as they found discussion valuable. Medsafe should be asked to investigate the possibility of setting up a secure web site where comments could be made before members expressed their views.

Recommendation

• That Medsafe draw up a protocol for out-of-session consultation for the Medicines Classification Committee based on that used by the National Drugs and Poisons Schedule Committee and that this protocol should be included in the Members' Handbook.
• That Medsafe investigate the possibility of a secure web site for members’ comments on classification issues.

6   SUBMISSIONS FOR RECLASSIFICATION

6.1  Fluticasone (Flixonase Aqueous Nasal Spray 50mcg, Glaxo Wellcome)

This was a company submission for reclassification from prescription medicine to restricted medicine. In 1996 when the Committee had recommended that some of the other nasal corticosteroids be moved to restricted medicine, fluticasone had been considered too new for OTC classification.

Discussion was centred around the potency of the product and the possibility of exceeding the stated daily dose.

Members were concerned that the potency of 50 microgram fluticasone was equivalent to 100 micrograms of beclomethasone. They did not wish to see 100 microgram beclomethasone available over the counter. Members reviewed the overall safety profile and considered that, while more potent locally, fluticasone had less systemic effect than beclomethasone. If 100 microgram beclomethasone were to be considered for OTC sale, a company would have to demonstrate that it was as safe as a 50 microgram dose. The dose instructions for fluticasone were for the application of one or two sprays in each nostril once a day as opposed to twice a day for beclomethasone. It was thought that the lower dose would probably be effective for some users.

Although some members were concerned that consumers invariably overused nasal sprays, it was thought that price would be a deterrent to exceeding the recommended dose. According to the data sheet, a massive dose would be required for any significant systemic absorption to occur.

It was noted that fluticasone nasal spray was a prescription medicine in Australia but that the company had also made a submission to the NDPSC for consideration the following week. Dr Jessamine said that it would be acceptable for the Committee to recommend a classification change if they felt this was justified. The NDPSC would be able to use the MCC objection process in which to present supporting safety data if it did not agree with the MCC recommendation.

The Committee agreed to recommend that 50 microgram fluticasone nasal spray should be moved to restricted medicine under the same conditions as for beclomethasone, budesonide and flunisolide. The daily dose should be one or two sprays in each nostril once a day and the maximum recommended daily dose should be 200 micrograms. These requirements should be included in the guidelines for OTC nasal corticosteroids in Volume 1 of The New Zealand Regulatory Guidelines for Medicines.

The Committee also agreed that, although there was a package insert included, the company should be asked to call this CMI in order to allow regulatory control of information received by consumers.

Committee was asked whether they thought that companies should use the same name for both prescription and OTC products. It was usual for companies to use a different name for OTC products. There had been some concern recently in Medsafe about the use of the same name for both presentations. Members thought that although confusion could arise from products with the same ingredient but in different packs and for different indications, there would be no safety issues provided the products were correctly labelled. They agreed that this was a marketing issue rather than one of safety.

Recommendation

• That fluticasone in nasal sprays containing up to 50 micrograms per actuation should be reclassified from prescription medicine to restricted medicine when:
  • the maximum recommended daily dose was no greater than 200 micrograms
  • the dose instructions were for one or two sprays into each nostril once daily
  • they were sold in the manufacturer’s original packs which conformed with the guidelines for OTC nasal corticosteroids in Volume 1 of The New Zealand Regulatory Guidelines for Medicines.
• That the company be asked to include New Zealand CMI as the package insert.

6.2 Mometasone Furoate (Nasonex Aqueous Nasal Spray 50mcg, Schering Plough)

This was a company submission for reclassification from prescription medicine to either restricted medicine or pharmacy-only medicine depending on the outcome of the review of all other OTC nasal corticosteroids.

The Committee recognised that although this was a potent corticosteroid, it had a good safety profile and very low bioavailability. However, members noted that the product had not been marketed quite long enough to meet the time requirement of 3 years of wide availability necessary to qualify for OTC sale in New Zealand. There was also very little experience with OTC use. In addition it was noted that the safety data provided was for fairly short-term use only. The Committee wished to see more ‘in use’ data before moving mometasone into the same category as the other OTC nasal corticosteroids. Members agreed that an immediate switch to OTC use would not provide an accurate picture of any future adverse reactions which might occur as few adverse reactions were reported by pharmacists. By keeping mometasone on prescription for a period of time a more accurate pattern of adverse reactions could be observed.

Members agreed that they would be happy to revisit the classification of mometasone after it had been on sale for a period of 12 months in New Zealand and when there was more local data or more 'in use' data available.

It was noted that a submission had also been made to the NDPSC for its meeting the following week.

Recommendation

That the classification of mometasone should remain prescription medicine but that the company should make another submission after the product had been on sale in New Zealand for one year.

Secretary's Note
During the week following the MCC meeting, a similar submission was considered by the NDPSC. The NDPSC recommended in favour of classifying mometasone in the same way as other OTC nasal corticosteroids and that the MCC should reconsider its recommendation for mometasone to remain a prescription medicine.

A postal consultation was conducted on the understanding that a majority decision would stand but that further telephone discussion would occur if serious doubts still existed. Four of the six members agreed to harmonise on this issue and to recommend that mometasone be reclassified as a restricted medicine. After discussion with the Chairman the other two members recommended in favour of the reclassification.

Final Recommendation

That, in the interest of Trans-Tasman harmonisation, mometasone should be classified as a restricted medicine in the same way as other OTC nasal corticosteroids.

6.3 Minoxidil 2% topical solution (Headway, Pacific)

This was a company submission for either an exemption for use by hairdressers or a reclassification from restricted medicine to general sale medicine.

The Committee agreed that it was impossible to limit the sale to occupational bodies not subject to registration. Nor would an undertaking by one company to market products in a certain way ensure that other companies marketed their products in the same way. In effect, the company was requesting a general sale classification.

Members were reluctant to see a shift from restricted medicine to general sale. There was concern about the potential for abnormal effects on libido and on foetal genitalia and some members felt that pharmacy-only should be the least restrictive classification. Others thought these concerns could be dealt with satisfactorily by warnings on the package information.

It was noted that the product was currently available on general sale in the USA without apparent problems. In Australia, 2% preparations were available as restricted medicines while higher concentrations remained prescription medicines.

The Committee agreed that the company should be consulted before being granted a level of classification other than that which it had requested. Members agreed that the company should be asked if it wished to submit concurrent applications to both New Zealand and Australia for the reclassification of 2% topical minoxidil to pharmacy-only medicine.

Recommendations

• That 2% topical minoxidil should not be reclassified from restricted medicine to general sale medicine
• That the company should be invited to make concurrent submissions to the MCC and the NDPSC for reclassification to pharmacy-only classification

6.4 Naproxen sodium 220mg & 275mg tablets (Aleve & Naprogesic, Roche)

This had been the fourth submission since 1996 seeking a change from restricted medicine to pharmacy-only medicine for 220mg (Aleve) tablets for indications other than for dysmenorrhoea. On each of the three previous occasions the Committee had recommended that 220 milligram naproxen sodium tablets remain restricted medicines.

The Chairman said that he thought the company should be commended on producing an interesting and innovative study in order to show that OTC naproxen was not more toxic than ibuprofen. When the Committee had been endeavouring to set up a framework for non-steroidal anti-inflammatory agents (NSAIAs) ibuprofen had been used as a benchmark for OTC safety. Robust data had now been gathered to show that there was no significant difference in safety between naproxen and ibuprofen with OTC use.

The Committee agreed that the company had provided the information that it required. It agreed that naproxen tablets in strengths of up to 250 milligrams should be reclassified to pharmacy-only medicine in packs of up to 30 dose units and with no limitation on the approved indications. The Committee also wished to see included in the pack CMI produced in accordance with The New Zealand Regulatory Guidelines for Medicines Volume 4: CMI.

Recommendation

• That naproxen be classified as a pharmacy-only medicine when in packs containing 250 milligrams or less per dose form and not more than 30 tablets or capsules.
• That the company be asked to include CMI in the pack produced in accordance with The New Zealand Regulatory Guidelines for Medicines Volume 4: CMI.

6.5  Sodium phosphate (Fleet Phospho-Soda Buffered Saline Laxative, Baxter)

This was a company submission for reclassification from prescription medicine to restricted medicine for harmonisation with Australia. In October 1997 the Committee had recommended that sodium phosphate in oral bowel preparations be reclassified from general sale to prescription medicine following life-threatening adverse effects resulting from incorrect use. The company had objected to the recommendation but the objection had been overruled. A similar course of events had taken place in Australia but the objection had been successful and the Australian classification was now equivalent to that of restricted medicine. He said that the company wished to withdraw the indication for use as a laxative and that the product information had improved. He also pointed out that the company had now provided evidence to show that sodium phosphate was as safe as the alternative product, polyethylene glycol, which was less restrictively classified.

Members agreed to recommend that sodium phosphate be reclassified as a restricted medicine when indicated only for bowel cleansing in preparation for medical, surgical or diagnostic procedures. Reference to its use as a laxative should be removed from all packaging and product information. Guidelines to this effect would need to be included in The New Zealand Regulatory Guidelines.

This course of action would mean that oral sodium phosphate would remain a prescription medicine when used as a laxative. The Committee recognised that, although harmonisation could be achieved for this product, overall harmonisation for oral sodium phosphate would not be achieved.

Recommendation

That sodium phosphate should be classified as a restricted medicine when contained in oral preparations for bowel cleansing prior to diagnostic, medical or surgical procedures.

6.6 Folic Acid injection (Abbott)

This was a company submission for reclassification from pharmacy-only medicine to restricted medicine in order to harmonise with Australia. As the company proposal would affect products other than those for which the submission had been made and would not result in harmonisation of the over-all scheduling of folic acid, the Committee felt that the matter should not be addressed at this time. It agreed that folic acid would be considered in due course as part of the harmonisation process with Australia and that the company's concerns would be resolved as a result of that process.

Recommendation

That harmonisation of the classification of folic acid should be undertaken at a later date as part of the harmonisation project with Australia.

7   NEW MEDICINES FOR CLASSIFICATION

7.1  Medicines classified by the MAAC

The Committee had been provided with a list of new chemical entities for which the Medicines Assessment Advisory Committee had already recommended a prescription medicine classification. Members agreed that these should be added to the Schedule.
It was noted that r-metHuSCF had already been classified as filgrastim.

Recommendation

That the following new chemical entities be classified as prescription medicines:

7.2  Medicines classified by the NDPSC

As part of the harmonisation project the NDPSC had submitted to the MCC Secretary a dossier containing names and descriptions of all new chemical entities which had been scheduled as prescription medicines in Australia between May 1998 and August 1999. The MCC Secretary noted that by the end of the current meeting all but two of these medicines would also have been classified in New Zealand as part of their registration process. Members had been provided with the descriptions of the two medicines which still needed to be added to the New Zealand Schedule in order to harmonise with that of Australia. These were leflunomide* and eptifibatide.* The Committee agreed that these should be added to the New Zealand Schedule.

*Note: Although these were given as the Australian Approved Names, they are also the recommended International Non-proprietary Names.

Recommendation

That eptifibatide and leflunomide be classified as prescription medicines.

7.3  Azelastine - new indication

A New Medicine Application had been received for an ophthalmic azelastine preparation. Azelastine was currently scheduled as pharmacy-only medicine for nasal use. A suitable classification was therefore required for ophthalmic use. The company had requested a pharmacy-only classification.

The Committee noted that the product was mainly marketed internationally as a prescription medicine and was not available in the USA or Australia. It was available OTC in a very limited market only. Nor was there any indication of how long the product had been available OTC. As there did not appear to be any post-marketing data or safety data with regard to use as a prescription medicine, the Committee was reluctant to recommend an OTC classification until such data became available.

Recommendation

That azelastine should be classified as a prescription medicine for ophthalmic use until significant post-marketing data was available to demonstrate its safety.

8   HARMONISATION OF NZ AND AUSTRALIAN SCHEDULES

8.1  Arising from the last meeting

These medicines had been removed from the Gazettelist to allow interested bodies the opportunity for comment before a classification change came into effect.

8.1.1 Solasadine

Medsafe had consulted with the National Nutritional Foods Association (NNFA) about any of the NDPSC recommendations which it thought might possibly be used in dietary supplements. The NNFA had responded that it had no interest in this alkaloid and agreed that it should be classified as a prescription medicine.

Recommendation

That solasadine be classified as a prescription medicine.

8.1.2 Tanacetum

The NDPSC recommendation was for tanacetum vulgare to be scheduled as a prescription medicine in products containing more than 0.8% of oil of tansy. The NNFA had responded with a request that the cut-off point for general sale be raised to 1%. The NNFA had not produced safety data to support this request. However, the NDPSC had based its recommendation on toxicology data. Members agreed that the NNFA could make a submission to both the NDPSC and the MCC if it were able to produce data to support a change to the cut-off point for general sale. Meanwhile they agreed to accept the NDPSC recommendation.

It was noted that on this occasion it was necessary to be specific about classifying the actual species in order to avoid classifying tanacetum parthenum which was used in complementary health products.

Recommendation

That tanacetum vulgare be classified as a prescription medicine in products containing more than 0.8% of oil of tansy.

8.1.3 Thyroid

The NDPSC recommendation was for thyroid to become a prescription medicine in New Zealand. However, Medsafe noted that there were products containing dried thyroid on sale as dietary supplements in New Zealand. The NNFA had been consulted but had not responded on this matter. No other comments were received. As there had been reports of adverse reactions and even death from the use of thyroid products, the Committee agreed that thyroid should be added to the schedule as a prescription medicine.

Recommendation

That thyroid should be classified as a prescription medicine.

8.1.4 Tryptophan

The NDPSC recommendation was for tryptophan to become a prescription medicine when the recommended daily dose was more than 100 milligrams. However, the NNFA had claimed that earlier problems associated with the use of tryptophan were due to contamination rather than to toxicity of the active ingredient. It had requested a maximum recommended daily dose of 1500 milligrams for general sale. However, safety data had not been provided to support this request.

The Committee noted that Martindale remained non-committal on the matter of toxicity. It was also noted that there were interactions between tryptophan and some other medicines and that the types of claims made by the NNFA were therapeutic rather than dietary. However, the Committee agreed that the NNFA should be given an opportunity to support its claim for an increase in the cut-off point between general sale and prescription medicine. Members suggested a time limit of 31 July 2000 for the NNFA to submit safety data to both the MCC and the NDPSC in support of a maximum recommended daily dose of 1500 milligrams as general sale medicine. If suitable submissions containing supporting safety data had not been received by that date the NDPSC recommendation should come into effect.

Recommendation

That tryptophan should become a prescription medicine after the end of July 2000 for products containing recommended daily doses greater than 100 milligrams unless the National Nutritional Foods Association had made appropriate submissions to both the Medicines Classification Committee and the National Drugs and Poisons Schedule Committee in support of an increase to this limit.

8.2 Recommendations from the 20th and 21st meetings of the NDPSC

The following recommendations had been made to Medsafe by the NDPSC at meetings held in May and February 1999. For each of the following items the NDPSC recommendation is stated first and is followed by any comments and recommendations from the MCC.

Terms Used

SUSDP

refers to the Australian schedule, The Standard for the Uniform Scheduling of Drugs and Poisons.

INN

International Non-proprietary Name (name of choice for harmonisation)

rINN

Recommended International Non-proprietary Name

BAN

British Approved Name

USAN

United States Adopted Name

Part I

Used by the NDPSC when referring to the part of the First Schedule to the Medicines Regulationslisting prescription medicines.

Part II

Used by the NDPSC when referring to the part of the First Schedule to the Medicines Regulationslisting restricted medicines.

Part III

Used by the NDPSC when referring to the part of the First Schedule to the Medicines Regulationslisting pharmacy-only medicines.

Meeting No 21 May 1999

Point 1

On the grounds of harmonisation, the NDPSC should be advised to:
recommend to the NZ MOH to modify the current Part I entry for digitalis to read:
"digitalis (being digitalis purpurea or digitalis lanata)"

The Committee saw no conflict of classification. It agreed the recommended modifications were unnecessary as ‘digitalis’ covered all sub-species. It also felt the modifications were too restrictive as they left any other possible sub-species unclassified.

Recommendation

That the NZ entry for digitalis remain unchanged.

Point 2

On the grounds of harmonisation, the NDPSC should recommend to the NZ MOH that the following Part I entries be modified to read:
"strophanthin; except when specified elsewhere in this schedule"
"lanatosides; except when specified elsewhere in this schedule"

Members noted that strophanthin was not specified elsewhere in the New Zealand schedule. Nor was there reference to any of the lanatosides as other than prescription medicines. They agreed that the recommendation appeared unnecessary.

Recommendation

That the entries for lanatosides and strophanthin remain unmodified in the New Zealand schedule.

Point 3

The NDPSC should be advised to recommend to the NZ MOH that it adopt the following drugs into Part I, Schedule I to the Medicines Regulations:

• Hydroxyprogesterone
• Megestrol
• Normethandrone
• Oestriol
• Progesterone
• Testolactone
• Pregnenolone acetate, except in preparations for topical use

Members noted that testolactone was already included in the New Zealand schedule.

The Secretary said that she had been able to find no reference to pregnenolone acetate. Martindale referred to pregnanolone, a naturally occurring metabolite of progesterone which had been studied for use as an intravenous anaesthetic. There was no mention of a topical use. Its recommended International Non-proprietary Name (rINN) was eltanolone. Martindale also referred to pregneninolone which was scheduled in New Zealand under its rINN, ethisterone. It appeared to be no longer used and was given by mouth. She said that Australia had declined to comment at that stage.

The Committee agreed that this matter should be clarified with the NDPSC before an entry was made in the schedule. They agreed that the other medicines, except testolactone, should be added as prescription medicines.

Recommendation

• That the following be added to the New Zealand schedule as prescription medicines:
  • Hydroxyprogesterone
  • Megestrol
  • Normethandrone
  • Oestriol
  • Progesterone
• That the NDPSC be asked to clarify the recommendation to add pregnenolone to the New Zealand schedule.

Point 4

On the grounds of harmonisation, the NDPSC should be advised to:
modify the current SUSDP schedule 4 entry for the sex hormone "fosfestrol" to read:
"fosfestrol (diethylstilbestrol diphosphate)"
recommend to the NZ MOH that it modify its Part I entry for "diethylstilbestrol" to read likewise.

Members agreed that two hormones seemed to have been confused in the recommendation. Diethylstilbestrol had been included in the NZ schedule because it was the rINN for stilboestrol, the British Approved Name (BAN), under which it had been scheduled formerly. They thought this entry should remain.

According to Martindale, diethylstilbestrol diphosphate was a synonym for fosfestrol while stilboestrol (BAN) appeared to refer to diethylstilbestrol dipropionate (rINN).

The Committee thought therefore that a single entry for diethylstilbestrol would provide comprehensive cover but that, for clarity and harmonisation, a separate entry should be made for fosfestrol. It was agreed that a recommendation should be made to the NDPSC to make an entry for diethylstilbestrol in The Standard for the Uniform Scheduling of Drugs and Poisons(SUSDP) on the grounds that it is the rINN and because it is included in the New Zealand schedule. There would then be no need to add diethylstilbestrol diphosphate in brackets as it would be covered in both schedules by the diethylstilbestrol entry.

Recommendation

• That a prescription medicine entry for fosfestrol be made in the New Zealand schedule
• That a recommendation be made to the NDPSC to make an entry for diethylstilbestrol in the SUSDP under the agreed principles of harmonisation as a prescription medicine.

Point 5

On the grounds of harmonisation, the NDPSC should be advised to:
recommend to the NZ MOH to adopt the sex hormone "stilboestrol" into Part I, Schedule I to the Medicines Regulations as shown:
"stilboestrol (diethylstilbestrol)".

Although stilboestrol had been removed from the New Zealand schedule several years ago in favour of the rINN, diethylstilbestrol, the Committee agreed that it should be reinstated in the interest of harmonisation. As a separate entry for diethylstilbestrol was also in the schedule there was no need to add it in brackets to the stilboestrol entry.

Recommendation

That stilboestrol should be reinstated into the NZ schedule as a prescription medicine.

Point 6

On the grounds of harmonisation, the NDPSC should be advised to recommend to the NZ MOH to modify its current entry for polyoestradiol to read:
"Polyestradiol"

As polyestradiol is the rINN, the Committee agreed to accept the recommendation.

Recommendation

That the New Zealand schedule entry for polyoestradiol be changed to polyestradiol.

Point 7

On the grounds of harmonisation, the NDPSC should be advised to recommend to the NZ MOH that it adopt the following drugs into Part I, Schedule I to the Medicines Regulations:

• Mephenesin
• Laudexium methylsulphate

It was noted that laudexium metilsulfate was the INN. Members thought that although there was unlikely to be confusion between an INN and another medicine name when the alternative name differed only in the replacement of 'ph' with 'f' or of 'methyl' with 'metil' an explanatory note would be useful at the beginning of the schedule. It was considered unnecessary to bracket alternative names where the difference in spelling was small.

Recommendation

• That mephenesin and laudexium metilsulfate should be added to the New Zealand schedule as prescription medicines.
• That an explanatory note should be added to the schedule about the use of spelling according to INNs.

Point 8

On the grounds of harmonisation, the NDPSC should be advised to recommend to the NZ MOH to delete the current Part III entry for "pregnancy test kits".

In effect, this was a request to change the classification of pregnancy test kits from pharmacy-only to general sale. Members noted that pregnancy test kits were not regarded as medicines in Australia but were designated as such in the Medicines Act. The change would mean harmonisation for labelling purposes. They noted that the MCC had looked favourably at such a change several years previously but opted for the status quo because of lack of positive response from companies. Although a number of products would be affected, no response had arisen from the first stage of the consultation process.

Recommendation

That pregnancy test kits be reclassified from pharmacy-only to general sale medicines.

Point 9

On the grounds of harmonisation, the NDPSC should be advised to recommend to the NZ MOH that it modify its current entry for somatropin to read:
"Somatropin (human growth hormone)"

Members agreed that the addition appeared unnecessary for either harmonisation or clarity. As somatropin was the BAN and USAN as well as the INN it seemed unnecessary to look for a further description. For consistency, the same would need to be done for a large number of other medicines.

Recommendation

That there be no modification to the current entry for somatropin.

Point 10

The NDPSC should be advised to recommend to the NZ MOH to adopt the following entries into Part I, Schedule I to the Medicines Regulations
Desmopressin (DDAVP)
Goserelin (includes goserelin acetate)
Protirelin (thyrotrophin releasing factor)
Thyrotrophin (TSH)

Members agreed that there was no conflict of harmonisation for any of these.
Desmopressin and thyrotrophin were already included in the schedule. As these names were both the INN and the BAN, further names appeared unnecessary. The bracketed entry for Goserelin was considered unnecessary in the New Zealand schedule. Protirelin was also already included, as was an entry for its synonym, thyrotrophin releasing factor.

Recommendation

That the above entries in the New Zealand schedule remain unmodified by the bracketed additions.

Point 11

The NDPSC should be advised to recommend to the NZ MOH that it adopt "felypressin" into Part I, Schedule I to the Medicines Regulations.

This seemed to have been left out of the New Zealand schedule in error some years ago.

Recommendation

That felypressin should be added to the New Zealand schedule as a prescription medicine.

Point 12

On the grounds of harmonisation, the NDPSC should be advised to recommend to the NZ MOH that "luteinising hormone" be adopted into Part I, Schedule I to the Medicines Regulations.

Although this would appear to be adequately covered in both schedules by the entries for gonadotrophins/gonadotropic hormones, members agreed that an entry could be made in the interest of harmonisation.

Recommendation

That luteinising hormone should be added to the New Zealand schedule as a prescription medicine.

Point 13

The NDPSC should be advised to recommend to the NZ MOH that it adopt the following drugs into Part I, Schedule I to the Medicines Regulations:
Khellin
Visnadine

Recommendation

That khellin and visnadine should be added to the schedule as prescription medicines.

Point 14

The NDPSC should be advised to recommend to the NZ MOH that it:
modify its Part I generic entry for follicle stimulating hormone to read:
"Follicle stimulating hormone except when specified elsewhere in the schedule"

adopt the following drugs into Part I, Schedule I to the Medicines Regulations:
"Follitropin alpha (recombinant human follicle-stimulating hormone)"
"Follitropin beta (recombinant human follicle-stimulating hormone)"
"Urofollitrophin (human follicle stimulating hormone)"
"Human chorionic gonadotropin except in pregnancy kits"

The Committee noted that all these were already scheduled in the New Zealand schedule as prescription medicines.
Follicle stimulating hormone was not specified anywhere other than as a prescription medicine.
Follitropins alpha and beta were already covered by both the entry for follitropin and also that for follicle stimulating hormone. As follitropin was both the rINN and BAN, further descriptions appeared unnecessary.
The bracketed description of Urofollitropin did not appear accurate. Martindale described urofollitropin as a gonadotrophin having follicle-stimulating activity rather than as being a human follicle stimulating hormone. Urofollitropin was both the rINN and the BAN.
Members also noted that human chorionic gonadotropin was covered by the entry for gonadotrophic hormones. As it was no longer used in pregnancy test kits in New Zealand there was no need for the bracketed exception.

Recommendation

That there be no change to the schedule entries for the above medicines.

Point 15

On the grounds of harmonisation, the NDPSC should be advised to recommend to the NZ MOH that it reinstate azapetine into Part I, Schedule I to the Medicines Regulations.

The Committee noted that New Zealand had recently removed azapetine from the schedule because no reference could be found to it. Unless the Australians had a reason to retain this obsolete medicine, members felt it should be removed from the SUSDP.

Recommendation

That the NDPSC be recommended to remove azapetine from the SUSDP.

Point 16

On the grounds of harmonisation, the NDPSC should be advised to:

• recommend to the NZ MOH to:
  adopt the following drugs into Part I, Schedule I to the Medicines Regulations:
  Debrisoquine
  Dihydralazine
  Guanacline
  Practolol
  
• modify the current Part I entry for "rauwolfia" to read:
  "Rauwolfia spp. including rauwolfia serpentina"

No reference could be found to guanacline and the Committee agreed this should be queried with Australia before a change was made to the New Zealand schedule. No need was seen for further clarification of rauwolfia in the NZ schedule as the current entry covered all species. The remaining medicines could be added.

Recommendation

• That the following be added to the New Zealand schedule as prescription medicines:
  • Debrisoquine
  • Dihydralazine
  • Practolol
• That no change be made to the current entry for rauwolfia. That the NDPSC be asked to clarify the recommendation to add guanacline to the New Zealand schedule as a prescription medicinei

Point 17

The NDPSC should be advised to recommend to the NZ MOH that it:
delete the Part II entries for butyl nitrite and octyl nitrite and reschedule these to Part I; and
adopt Part I entries for isoamyl nitrite and isobutyl nitrite.

It was noted that New Zealand had no products registered which contained these substances.

Recommendation

That isoamyl nitrite and isobutyl nitrite should be added to the New Zealand schedule as prescription medicines. That butyl nitrite and octyl nitrite should be reclassified from restricted medicine to prescription medicine.

Point 18

The NDPSC should be advised to recommend to the NZ MOH that it delete the Part III entry for amyl nitrite and replace it by the following entry in Part I:

"amyl nitrite; except when sold from outlets under the toxic substances regulations 1983 to sell sodium cyanide paste for the purpose of vertebrate control"

Members did not see the recommended classification change as providing a barrier to access as an antidote and agreed that the classification change should be implemented.

Recommendation

That amyl nitrite should be reclassified from pharmacy-only to prescription medicine and should maintain its current exemption from classification status for use as an antidote

Point 19

On the grounds of harmonisation, the NDPSC should be advised to recommend to the NZ MOH that it modify the following Part I entries as shown:
Alcuronium salts
Atracurium besylate
Cisatracurium besylate
Hexamethonium bromide
Mivacurium chloride
Pancuronium bromide
Pipecuronium bromide
Rocuronium bromide
Suxamethonium salts
Vecuronium bromide

It was noted that these medicines were all covered in the New Zealand schedule. There was no need to specify the salts as they were already covered in the introductory statement. There was no conflict of harmonisation.

Recommendation

That no change be made to the schedule entries for the above medicines.

Point 20

The NDPSC should be advised to recommend to the NZ MOH that it adopt "pentamethonium bromide" into Part I, Schedule I to the Medicines Regulations.

The Committee agreed that pentamethonium was sufficient and also more comprehensive as there was also an iodide.

Recommendation

That pentamethonium be added to the New Zealand schedule as a prescription medicine.

Point 21

On the grounds of harmonisation, the NDPSC should recommend to the NZ MOH that it change the Part I entry for "botulinum toxin" to read: "botulinum toxins"

Recommendation

That the entry for 'botulinum toxin' should be amended to 'botulinum toxins'.

Point 22

The NDPSC should be advised to recommend to the NZ MOH to adopt "lidoflazine" into Part I, Schedule I to the Medicines Regulations.

Recommendation

That lidoflazine should be add to the New Zealand schedule as a prescription medicine.

Point 23

The NDPSC should be advised to recommend to the NZ MOH that it delete the current Part III entry for "salicylic acid".

Members noted that salicylic acid was currently pharmacy-only for external use in medicines containing more than 12.5% and that the NDPSC recommendation would result in a number of wart removal products moving to general sale. While they did not consider that the preparations already marketed would constitute a danger if sold as general sale medicines, they were concerned that even products containing very high percentages of salicylic acid would be available without classification. For that reason they wished to consult further with the NDPSC to find a cut-off point which would allow products in both countries to harmonise with the lower classification but also prevent the unrestricted sale of higher concentrations.

Recommendation

That New Zealand should harmonise with Australia to accommodate products currently sold in both countries as general sale medicines but that an upper limit should be set in both countries to limit unrestricted sale at high levels of concentration.

Point 24

The NDPSC should be advised to:
recommend to the NZ MOH that the following drugs be adopted into Part I, Schedule I to the Medicines Regulations:
Potassium perchlorate
Liothyronine (triidothyronine)

Liothyronine, the rINN (also the BAN) was considered sufficient. As the SUSDP does not have a separate entry for triidothyronine, no confusion would arise.

Recommendation

That potassium perchlorate and liothyronine should be added to the New Zealand schedule as prescription medicines.

Point 25

On the grounds of harmonisation, the NDPSC should be advised to recommend to the NZ MOH that the Schedule 4 and Part I entries for thyroxine should read:
"Thyroxine (includes thyroxine sodium)"

The bracketed addition was considered unnecessary in the New Zealand schedule. There was no conflict of harmonisation.

Recommendation

That the entry for thyroxine should remain unchanged.

Point 26

On the grounds of harmonisation, the NDPSC should be advised to:
Recommend to the NZ MOH that:

1. "yohimbine" be adopted into Part I, Schedule I of the Medicines Regulations
2. the current Part I entry for thymoxamine should be modified to read:
   "Thymoxamine (includes thymoxamine hydrochloride)"

The Committee agreed that there would be no problem reclassifying yohimbine from pharmacy-only to prescription medicine as there were no products registered in New Zealand containing yohimbine. The bracketed addition to thymoxamine was considered unnecessary.

Recommendation

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

Point 27

The NDPSC should be advised to recommend to the NZ MOH to adopt the following antidotes into Part I, Schedule I to the Medicines Regulations:
Digoxin antibody
Cysteamine

Members queried whether digoxin antibody was intended as a synonym for Digoxin-specific Antibody Fragments to which there was reference in Martindale. They agreed to adopt it into the schedule but requested clarification of its correct name first. They noted that Australia had declined to respond to an earlier query about this

Recommendation

That cysteamine should be added to the New Zealand schedule as a prescription medicine. That the NDPSC should be asked to clarify the name of digoxin antibody before it was added to the New Zealand schedule as a prescription medicine.

Point 28

The NDPSC should be advised to:
recommend to the NZ MOH to adopt the following drugs into Part I, Schedule I to the Medicines Regulations:
Acokanthera schimperi
Calotropis (calotropis spp.)
Coronilla
Hemerocallus (hemerocallus flava)
Orthopterin

The Committee noted that there was no reference in Martindale to a medicinal use for any of these plants other than acokanthera. The bracketed additions were considered too restrictive. Members agreed that acokanthera schimperi was already classified in both schedules as ouabain, a cardiac glycoside obtained not only from acokanthera schimperi but also from acokanthera ouabaio and strophanthus gratus. Acokanthera was therefore considered to provide a more comprehensive cover if another entry was necessary.

Recommendation

• That the following plants be added to the New Zealand schedule as prescription medicines:
  • Acokanthera
  • Calotropis
  • Coronilla
  • Hemerocallus
  • Orthopterin

Meeting No 20, February 1999

Point 1

The NDPSC should be advised to recommend to the MOH NZ, on the grounds of public health, to reschedule clioquinol from Part III to Part I.

The Committee noted that clioquinol was already a prescription medicine for internal use and that it did not have a pharmacy-only classification. External use was general sale. However, members agreed that no products would be affected by such a change. While there were several external products containing clioquinol, all of these also contained a prescription medicine.

Recommendation

That clioquinol should be classified as a prescription medicine for both internal and external use.

Point 2

The NDPSC should be advised to recommend to the MOH, NZ to reschedule mupirocin from Part II to Part I, Schedule I of the Medicines Regulations.

Action had already been taken on this recommendation and mupirocin had already been reclassified as a prescription medicine. A recommendation was not required.

Point 3

The NDPSC should be advised to:
recommend to MOH that it adopt benzoylmetronidazole into Part I, Schedule I of the Medicines Regulations.

Members noted that this should be benzoyl metronidazole. As the rINN was metronidazole benzoate, it was already covered in the NZ schedule by the entry for metronidazole. There was no conflict of harmonisation. However, it was agreed that benzoyl metronidazole could be added in the interest of harmonisation.

Recommendation

That benzoyl metronidazole be added to the New Zealand schedule as a prescription medicine.

Point 4

The NDPSC should be advised to: delete the current Schedule 4 entry for di-iodohydroxyquinoline (iodoquinol) and replace it by the following:
"di-iodohydoxyquinoline (iodoquinol) except:

• for oral use
  when included in Schedule 3"

recommend to the MOH, NZ that it adopt the above entry for di-iodohydroxyquinoline into Part I and replace the current Part II entry by the following : "di-iodohydroxyquinoline (iodoquinol) for vaginal use"
The NDPSC recommendation was for di-iodohydroxyquinoline (iodoquinol) to become a prescription medicine except for oral use and vaginal use. Vaginal use was to remain restricted medicine. The MCC recognised that as New Zealand had no uses other than vaginal, a prescription medicine entry would not affect any products and could be implemented without regulatory impact. However, if di-iodohydroxyquinoline were to be exempt for oral use, oral use would then become general sale. That would defeat the purpose of the Australian scheduling where oral use was prohibited under Appendix C. To counter this situation, the New Zealand schedule would need to have a prescription medicine entry for di-iodohydroxyquinoline except for vaginal use. Then oral products would become prescription medicines rather than general sale medicines. The regulatory process would then ensure that di-iodohydroxyquinoline was not used in oral products because its degree of toxicity would prevent consent to market being granted to any oral product containing di-iodohydroxyquinoline.

Recommendation

That di-iodohydroxyquinoline be classified as a prescription medicine except for vaginal use and a restricted medicine for vaginal use.

Point 5

The NDPSC should be advised to recommend to the MOH, New Zealand, to adopt the following drugs into Part I Schedule I of the Medicines Regulations:
Pamaquin
Sontoquine
Mepacrine

The Committee noted that the INN for pamaquin was pamaquine and that no reference
had been found to sontoquine.

Recommendation

That pamaquine, sontoquine and mepacrine should be added to the New Zealand schedule as prescription medicines.

Point 6

The NDPSC should be advised to recommend to the MOH NZ to adopt delavirdine (including delavirdine mesylate) and nelfinavir (including nelfinavir mesylate) into Part I, Schedule I to the Medicines Regulations.

Nelfinavir was noted as being already scheduled as a prescription medicine. The bracketed additions were considered unnecessary in the New Zealand schedule.

Recommendation

That delavirdine be added to the New Zealand schedule as a prescription medicine.

Point 7

The NDPSC should be advised to:
recommend to MOH, New Zealand to adopt penciclovir into Part I as follows:
"penciclovir except when specified elsewhere in this schedule"

The Committee agreed that the intention was for penciclovir to be a pharmacy-only medicine in New Zealand only when for the external treatment of herpes labialis. Any other use should be classified as prescription medicine. To date only topical creams had consent to market but it was noted that two products in the form of powders for infusion had now applied for consent to market.

Recommendation

That penciclovir be classified as a prescription medicine except for topical use for the treatment of herpes labialis.

Point 8

The NDPSC should be advised to delete the current Schedule 4 and Schedule 2 entries for idoxuridine and replace them with the following Schedule 4 entry:

"idoxuridine except in preparations containing 0.5 per cent or less for dermal use"

The MOH should be advised to adopt the same wording for the Part I entry.

Members recognised that, in effect, the recommendation was for: dermatological to change to dermal for the prescription medicine entry. (This had already been done) dermal preparations containing 0.5% or less should change from pharmacy-only to general sale medicine
They noted that two cold sore products would become general sale medicine as a result of the classification change.

Recommendation

That idoxuridine in preparations for dermal use containing 0.5% or less should be reclassified from pharmacy-only medicine to general sale medicine.

Point 9.

The NDPSC should be advised to :
modify the current Schedule 4, 3 and 2 entries for podophyllum resin to read respectively:
"podophyllum resin (podophyllin) except when included in Schedule 2 or 3"

"podophyllum resin (podophyllin) in preparations for external use containing 20 per cent or less of podophyllin except when included in Schedule 2"
"podophyllum resin (podophyllin) in preparations for external use containing 10 per cent or less of podophyllin"

The MOH should be recommended to modify the Part I and II entries for podophyllin to be consistent with the above entries and to add a Part III entry as follows:

• "podophyllum resin (podophyllin) in preparations for external use containing 10 per cent or less of podophyllin"

The Committee interpreted the above recommendation to mean:

• change the NZ entries from 'podophyllum' to 'podophyllum resin (podophyllin)'
• make a new pharmacy-only entry for external products containing 10% or less
• specify for external use for all OTC entries

Members agreed that changing the name of the entry would limit the New Zealand coverage which was initially for extracts and tinctures rather than resin (see First Schedule, 1984). Leaving the name as podophyllum would cover these as well as resin for both countries. As podophyllin was given in Martindale as one of several synonyms for podophyllum resin, its use was not practical for broader coverage. The Committee considered, therefore, that the New Zealand entry for podophyllum was a more more suitable name under which to harmonise the entries of both countries and that a recommendation should be made for the NDPSC to adopt the New Zealand entry.

The Committee saw no problem about creating a pharmacy-only entry for 10% or less as no products would be affected. However, they realised that if the name of the entry were to change, the cut-off points of 10% and 20% might need to be recalculated.

Recommendation

• That, subject to possible need to recalculate the cut-off points, the New Zealand entries for podophyllum should be amended to read:
  • Prescription
    • podophyllum: except when specified elsewhere in the Schedule
  • Restricted
    • podophyllum: in medicines for external use containing 20% or less but more than 10%
  • Pharmacy-only
    • podophyllum: in medicines for external use containing 10 percent or less
      
• That the NDPSC be recommended to harmonise with the above entries.

Point 10.

The NDPSC should be advised to:
modify the current Schedule 4, 3 and 2 entries for podophyllotoxin to read respectively:

• "podophyllotoxin except when included in Schedule 2 or 3"
• "podophyllotoxin in preparations for external use containing 4 per cent or less of podophyllotoxin except when included in Schedule 2"
• "podophyllotoxin in preparations for external use containing 2 per cent or less of podophyllotoxin"

recommend to the MOH NZ to adopt the above entries into Parts I, II and III respectively.

Members thought this set of entries would be unnecessary as an entry for podophyllum would also cover podophyllotoxin. However, they were agreeable to making the entries in the interest of harmonisation provided the percentages were consistent with those for podophyllum as amended in the previous recommendation. They agreed that these two recommendations would need to be resolved together.

Recommendation

That further consultation be undertaken with the NDPSC about the need for schedule entries for podophyllotoxin and whether these entries were consistent with the entries for podophyllum

Point 11

The NDPSC should be advised to recommend to the NZ MOH that it adopt the general Australian position that injectable formulations of substances classified as Part II or III, should be classified as "prescription only" products under Part I, Schedule I of the Medicines Regulations.

The MCC noted that the NDPSC wished the recommendation to apply only to preparations that were already classified S4 in Australia. Therefore, the recommendation was modified by the addition of the following words after 'Medicines Regulations':

• 'where they appear as Schedule 4 in Australia'.

The MCC recognised that while the NDPSC recommendation would go some way towards harmonising the classification of injectable medicines, further work would be required to find a way of harmonising fully on an on-going basis. Discrepancies between most current injectable medicines which were already classified would be resolved during the harmonisation project. However, unless a change were made to the New Zealand schedule, there would be no indication of an ongoing intention for injectable medicines to be prescription medicines.

The possibility of changing the classification of injectables to prescription medicine except when specified elsewhere in the schedule was discussed. The Committee recognised that there would then need to be a schedule entry for any medicine which was used in an injectable product including those which were currently general sale. This would include water for injection. An additional problem would remain in that vitamin and other nutritional preparations which were exempt from scheduling in Australia, could not become general sale medicines in New Zealand using this method of classification because general sale medicines were not included in the schedule.

Recommendation

That New Zealand agree in principal that all injectable medicines which are prescription medicines in Australia should be prescription medicines in New Zealand. That Medsafe should work towards finding a method to implement the harmonisation of injectable medicines.

Point 12

On the grounds of harmonisation, the NDPSC should be advised to:
modify the current Schedule 4 and 3 entries for cetirizine to read:

• Schedule 4: "cetirizine in preparations for injection"
• Schedule 2: "cetirizine except when in schedule 4"

recommend to the MOH NZ that it adopt equivalent entries in Part I and Part III for cetirizine.

As cetirizine was only taken orally and there was no evidence to suggest cetirizine would be administered by injection, the Committee queried the inclusion of this prescription medicine entry. They noted that Australia had declined to comment on the matter. While they saw no problem about making a prescription medicine entry, they felt that the matter would be dealt with more sensibly by making a prescription medicine entry for cetirizine except when specified elsewhere in the schedule, and by specifying the currently approved use in the pharmacy-only entry

Recommendation

That cetirizine should be classified as a prescription medicine except when specified elsewhere in the schedule That the current pharmacy-only entry for cetirizine should be amended by the addition of the words 'for oral use'

Point 12.

On the grounds of harmonisation, the NDPSC should be advised to :
modify the current Schedule 4 and 3 entries for fexofenadine to read:

• Schedule 4: "fexofenadine in preparations for injection"
• Schedule 2: "fexofenadine except when in Schedule 4"

recommend to the MOH NZ that it adopt equivalent entries in Part I and Part III for fexofenadine.

As for cetirizine, the Committee noted that similar entries fexofenadine would ensure that uses other than oral should be prescription medicines.

Recommendation

That fexofenadine should be classified as a prescription medicine except when specified elsewhere in the schedule. That the current pharmacy-only entry for fexofenadine should be amended by the addition of the words 'for oral use'

Point 14.

On the grounds of harmonisation, the NDPSC should be advised to:
modify the SUSDP Schedule 4 and 3 entries for loratadine to read:

• Schedule 4: " loratadine in preparations for injection."
• Schedule 2: " loratadine except when in Schedule 4"

recommend to the MOH NZ that it adopt equivalent wording to the revised SUSDP entries for loratadine into Part I and Part III , Schedule I of the Medicines Regulations.
Comments were as for cetirizine and fexofenadine.

Recommendation

That loratadine should be classified as a prescription medicine except when specified elsewhere in the schedule.
That the current pharmacy-only entry for loratadine should be amended by the addition of the words 'for oral use'

Point 15

On the grounds of harmonisation, the NDPSC should be advised to :
modify the SUSDP Schedule 4 and 3 entries for levocabastine to read:

• Schedule 4: "levocabastine except when in Schedule 2"
• Schedule 2: "levocabastine in (topical?) eye or nasal preparations"

recommend to the MOH NZ that it modify its Part I and Part III entries for levocabastine to be equivalent to the revised SUSDP entries.

As levocabastine is used only in the nose or eye, the addition of a prescription medicine entry appeared unnecessary. Members agreed that this could be treated in the same way as the other non-sedating antihistamines.

Recommendation

That levocabastine should be classified as a prescription medicine except when specified elsewhere in the schedule. That the current pharmacy-only entry for levocabastine should be amended by the addition of the words 'for nasal or ophthalmic use'.

Point 16.

The NDPSC should be advised to:
recommend to the MOH, NZ that it modify its current Part II entry for isopropamide as follows:

• Part I: "isopropamide except when specified elsewhere in this schedule"
• Part III: "isopropamide for dermal use"

As New Zealand no longer had products containing isopropamide the Committee saw no problems in implementing the recommendation.

Recommendation

That isopropamide be reclassified from restricted medicine to prescription medicine except for dermal use which should become pharmacy-only medicine

Point 17.

The NDPSC should be advised to recommend to the MOH, NZ that the current entry for procyclidine be modified to read:

• Part I: "procyclidine except when specified elsewhere in this schedule."
• Part III: "procyclidine in preparations containing 5 per cent or less of procyclidine for dermal use"

The recommended change was from prescription medicine to pharmacy-only medicine for dermal use in medicines containing 5% or less.

As no products would be affected, the Committee agreed to the proposed change.

Recommendation

That procyclidine should become a pharmacy-only medicine in dermal preparations containing 5 per cent or less and the current prescription medicine entry should be amended accordingly.

Point 18.

The NDPSC should be advised to:
recommend to the MOH, NZ that it adopt the following entry:

• Part I: "diphemanil methylsulphate except in preparations for dermal use"

The Committee agreed that there was no need to specify methylsulphate in the New Zealand schedule. Diphemanil was currently a general sale medicine. However, the classification change would not have any regulatory impact as there were no products in New Zealand other than for dermal use.

Recommendation

That diphemanil be reclassified from general sale to prescription medicine except for dermal use.

Point 19.

The NDPSC should be advised to recommend to the MOH, NZ that the following drugs be adopted into Part I, Schedule I to the Medicines Regulations.
Diethazine
Ethopropazine

The Committee noted that the rINN for ethopropazine was profenamine.

Recommendation

That diethazine and ethopropazine be added to the New Zealand schedule as prescription medicines.

Point 20.

The NDPSC should be advised to:
modify the existing Schedule 4 entry for glycopyrrolate to read:

• "glycopyrrolate (glycopyrronium) in preparations for injection"

adopt a Schedule 3 entry:

• "glycopyrrolate (glycopyrronium) except when in Schedule 4"

recommend to the NZ MOH to adopt the same wording into its Part I and Part II entries for glycopyrronium respectively.

Members noted that this was already harmonised. They did not feel that the INN should be replaced by the USAN though agreed that this could be added in brackets if required. It was agreed that the change from 'parenteral use' to 'in preparations for injection' should be made at a later date when harmonisation had been reached on such wording and the change was made throughout the schedule. Therefore no further recommendation was required.

Point 21.

The NDPSC should be advised to recommend to the NZ MOH that the following drugs be adopted into Part I, Schedule I to the Medicines Regulations regulations:
Dinitrocresols
Dinitronaphthols
Dinitrothymols
Dicophane
Propoxur

As dicophane and propoxur had since been deleted from Schedule 4 there was no longer a need for their inclusion in the New Zealand schedule. The other 3 medicines had already been added as prescription medicines. Therefore no recommendation was required.

Point 22.

On the grounds of harmonisation, the NDPSC should be advised to:
recommend to the NZ MOH that it adopt a pack size limitation of 100 dosage units for its Part III entry for solid dose forms of ibuprofen.

As there were no New Zealand OTC ibuprofen products containing more that 100 dose units, members agreed that there would be no regulatory impact from the proposed recommendation.

Recommendation

That the pharmacy-only entry for oral solid dose ibuprofen be amended in order to limit pack sizes to no more than 100 dose units.

Point 23.

The NDPSC should be advised to:
recommend to the NZ MOH that the following drugs be adopted into Part 1, Schedule I to the Medicines Regulations:
Arsenic
Camphotamide
Fencamfamin
Leptazol
Nikethamide

Members noted that arsenic had already been added as a prescription medicine. They also noted that the rINN for leptazole was pentetrazole.

Recommendation

That the following medicines be added to the New Zealand schedule as prescription medicines:

Camphotamide	Fencamamin
Leptazol	Nikethamide

Point 24

The NDPSC should be advised to:
recommend to the NZ MOH to delete its current Part III entries for lobelia and lobeline and replace these by:

• "lobelia except in preparations for smoking or burning"
• "lobeline except in preparations for smoking or burning"

The Committee noted that New Zealand had no entry for lobeline as the lobelia entry was considered to provide adequate coverage. Members noted that New Zealand had no lobelia or lobeline products for smoking or burning. However, they noted that such a change would put its classification out of line with that of nicotine

Recommendation

That lobelia should be reclassified as a general sale medicine when used for smoking or burning

Point25.

The NDPSC should be advised to:
recommend to the NZ MOH that on the grounds of harmonisation it modify its Part I, II and III entries for nicotine to read:

Part I:	"nicotine (including preparations for nasal administration), except when specified elsewhere in this schedule"
Part II:	"nicotine for use as an aid in withdrawal from tobacco smoking, in preparations for inhalation or sublingual use"
Part III:	"nicotine for use as an aid in withdrawal from tobacco smoking, in preparations for transdermal use or in chewing gum"

The Committee understood this to be a request to reword the schedule entries without changing the current classification. The rationale behind this seemed to be to keep nicotine in the prescription category for all uses other than for withdrawal from tobacco smoking. While Martindale listed other areas where use of nicotine had been investigated (Tourette’s syndrome, ulcerative colitis, skin disorders, alzheimer’s), it did not list any proprietary products world-wide which appeared to be for other than smoking cessation. The Committee questioned whether there was a need to exclude areas where the product was shown to be of no particular benefit as such products would be unlikely to obtain consent to market. If products for new indications were submitted for consent to market the classification would be examined in the light of the new evidence which would be necessary for consent to be obtained.

If it was considered necessary in the interests of harmonisation to retain a classification for products for indications other than smoking cessation, members agreed that these could be captured in the prescription entry in the schedule rather than repeated for every other entry. This would mean that the schedule entries would be much less complex.

Recommendation

That the prescription entry for nicotine be amended by the addition of the words

• 'in medicines other than for smoking cessation'

That the NDPSC be recommended to adopt the NZ wording for its schedule entries.

Point 26.

The NDPSC should be advised to:
recommend to the NZ MOH that it delete the Part II entry for strychnine;
recommend to the NZ MOH that it adopt the following entry into Part I, Schedule I of the Medicines Regulations:

"strychnos spp. (includes strychnos nux vomica) except when specified elsewhere in this schedule"

As New Zealand had no products, the reclassification from restricted medicine to prescription medicine would not pose a problem.

Members noted that as nux vomica was one of the strychnos species, there would be no need for the bracketed addition. However, strychnine was also derived from others of the species. Therefore strychnine would provide a more comprehensive cover.

Nux vomica was classified as a pharmacy-only medicine in New Zealand. According to Martindale it contains strychnine and brucine. Brucine was noted as being classified restricted medicine above 0.2% and pharmacy-only below this strength. It was agreed that these conflicts of classification needed to be resolved before a recommendation could be made. The use of nux vomica in homoeopathic medicines was seen as a possible reason for its classification as a pharmacy-only medicine. Any higher classification would prevent its use in a homoeopathic preparation.

As the NDPSC had acknowledged that there could be difficulties in Australia with the recommended scheduling of strychnine, the Committee thought it best to await a further recommendation on this matter.

Recommendation

That the MCC wait for a further recommendation from the NDPSC on the classification of strychnine.

Point 27.

The NDPSC should be advised to recommend to the NZ MOH that it adopt lindane into Parts I and III, Schedule I to the Medicines Regulations as shown:

• Part I: lindane except when specified in Part III
• Part III: lindane in medicines for external use containing 2 per cent or less of lindane

Reclassification from pharmacy-only to prescription medicine was recommended except in medicines for external use containing 2% or less which should remain pharmacy-only. Members noted that all New Zealand products were topical and contained less than 2%.

Recommendation

That lindane should be reclassified as prescription medicine except in topical medicines containing 2% or less which should remain pharmacy-only medicine.

Point 28.

The NDPSC should be advised to recommend to the NZ MOH that it:
modify its Part III entry for chlorbutol to read:

"chlorbutol in topical preparations containing 5 per cent or less of chlorbutol, except in preparations containing 0.5 per cent or less of chlorbutol as a preservative"

and include an entry in Part II
"chlorbutol; except when specified elsewhere in this schedule"

The recommendation was for reclassification from pharmacy-only to restricted medicine in preparations containing more than 5%. This was seen as being unlikely to affect any of the products on the NZ market. Preparations containing between 0.5% and 5% should remain pharmacy-only medicine. Those containing 0.5% or less as a preservative should remain general sale. The Committee thought that there was no need to specify use as a preservative as there would be little therapeutic value at this strength.

Recommendation

That chlorbutol should be reclassified as a restricted medicine in preparations containing more than 5%.That the NDPSC be recommended to delete reference to use as a preservative in the S2 entry for chlorbutol in the SUSDP.

Point 29.

The NDPSC should be advised to recommend to the NZ MOH to adopt the following wording for its Part I entry for crystal violet:

"crystal violet except when used as a dermal marker"
Members noted that a dermal marker was not defined as a medicine in New Zealand and that the schedule therefore did not apply. No recommendation was required.

Point 30.

On the grounds of harmonisation, the NDPSC should be advised to:

recommend to the NZ MOH that it modify the Part I and Part II entries for hexachlorophane to read respectively:

• Part I: "hexachlorophane; in preparations for use on infants; or in other preparations, except when specified elsewhere in the schedule"
• Part II: "hexachlorophane; in medicines containing 3 per cent or less, but more than 0.75 per cent of hexachlorophane; except in medicines for use on infants as specified in Part I"

The Committee noted that neither the New Zealand schedule nor the SUSDP had a restricted medicine entry for hexachlorophane. They considered this was likely to be an error in the minutes and was probably meant to be Part III.

Whether or not products are used on specific recipients seemed to the Committee to be a labelling rather than a scheduling issue which would be better dealt with in The New Zealand Regulatory Guidelines for Medicines. There did not appear to be a conflict of harmonisation with cut-off points between different levels of classification

Recommendation

That, in order to harmonise with Australia, an item be prepared for inclusion in The New Zealand Regulatory Guidelines for Medicines describing the appropriate use of hexachlorophane with particular reference to use on infants

Point 31.

The NDPSC should be advised to recommend to the NZ MOH that it adopt the following analgesic or anti-inflammatory drugs into Part I, Schedule I to the Medicines Regulations.
Acetylmethyldimethyloximidophenylhydrazine
Tolfenamic acid

No reference (including a more user friendly name) could be found to the first of these. Australia had declined to provide further information.

Recommendation

That acetylmethyldimethyloximidophenylhydrazine and tolfenamic acid be added to the New Zealand schedule as prescription medicines.

Point 32

The NDPSC should be advised to:
recommend to the NZ MOH, on public health grounds, to reschedule acetanilide to Part I and to delete the Part III entry.  The Part I entry should read:
"acetanilide and alkyl acetanilides"
The Committee noted that acetanilide was currently classified as general sale in medicines containing 0.5% or less and pharmacy-only above this but that there were no products registered in New Zealand which contained this. They agreed to recommend that acetanilide be reclassified to prescription medicine but felt that changing the entry to 'acetanilides' would be neater and would obviate the need to add alkyl acetanilides to both schedules.

Recommendation

That acetanilides be reclassified as prescription medicines.That the NDPSC be recommended to make a similar entry in the SUSDP.

Point 33

The NDPSC should be advised to recommend to the NZ MOH that it delete its Part III entry for bufexamac and adopt the following Part I entry:

• "bufexamac except:
  • in medicines for dermal use containing 5 per cent or less of bufexamac; or
  • in suppositories"

Members noted that three of the four pharmacy-only products in New Zealand would go to general sale as they contained 5% or less. It was possible that the remaining product containing 5.1% might become a prescription medicine. New Zealand had no bufexamac suppositories.

Recommendation

That bufexamac be reclassified from pharmacy-only medicine to prescription medicine except in suppositories or in dermal preparations containing 5 per cent or less.
That bufexamac be reclassified from pharmacy-only medicine to general sale medicine in suppositories or in dermal preparations containing 5 per cent or less.

Point 34.

On public health grounds, the NDPSC should be advised to recommend to the NZ MOH that camphorated oil (camphor liniment BP) be rescheduled from Part III to Part I, Schedule I to the Medicines Regulations.

Recommendation

That camphorated oil should be reclassified from pharmacy-only medicine to prescription medicine.

Point 35.

the NDPSC should be advised to recommend adoption of the following "prescription only" entry in both countries:
"ketorolac (includes ketorolac trometamol)"

This was considered unnecessary in the New Zealand schedule. No recommendation was required.

Point 36.

The NDPSC should be advised to:
recommend to the NZ MOH that it delete its Part III entry for mefenamic acid and replace it by the following:

"mefenamic acid (in divided preparations for oral use) in packs of 30 or less dosage units for the treatment of dysmenorrhoea"

The recommendation was for an increase from 20 to 30 in the number of tablets permitted as pharmacy-only and for the removal of the upper limit of 250 milligrams for each dose unit. The Committee felt the proposed wording was fairly unwieldy and not in line with the normal New Zealand style.

Recommendation

That the pharmacy-only entry for mefanamic acid be reworded to read;

• 'in solid dose form in packs containing not more than 30 tablets or capsules for the treatment of dysmenorrhoea'

That the NDPSC be recommended to accept the above wording into the SUSDP

Point 37

On the grounds of harmonisation, the NDPSC should:
recommend to the NZ MOH that it adopt the following Part I and Part III entries respectively:
"phenazone except when specified elsewhere in this schedule"
"phenazone for external use"

It was noted that New Zealand had no products containing phenazone.

Recommendation

That phenazone be reclassified from pharmacy-only medicine to prescription medicine except for external useThat the pharmacy-only entry be amended for external use only

Point 38

The NDPSC should be advised to recommend to the NZ MOH that it modify its current Part I entries for ecothiopate and pilocarpine to read:
"ecothiopate (including ecothiopate iodide)"
"pilocarpine except in preparations containing 0.025 per cent or less of pilocarpine"

The bracketed addition to ecothiopate was considered unnecessary in the New Zealand schedule.
Members noted that no New Zealand products containing pilocarpine would change classification as they all contained more than 0.025%.

Recommendation

That the prescription medicine entry for pilocarpine be amended so that products containing 0.025% or less become general sale medicines.

Point 39.

The NDPSC should be advised to:
recommend to the NZ MOH that it adopt the following drugs into Part I, Schedule I to the Medicines Regulations:
Ambenonium chloride
Demacarium bromide
Galanthus (galanthus nivalis)

The Committee agreed that the individual listing of salts was not required in the New Zealand schedule. The correct spelling for demecarium was also noted.

Members agreed that galanthus was already covered by the prescription medicine entry for galantamine. However, they were agreeable to a further entry if necessary. As Martindale referred only to another of the snowdrop species as having a therapeutic purpose galanthus nivalis was considered too specific.

Recommendation

That ambenonium, demecarium and galanthus be added as prescription medicines to the New Zealand schedule.

Point 40

The NDPSC should be advised to recommend to the NZ MOH to adopt the following drugs into Part I, Schedule I to the Medicines Regulations:
Clenbuterol
Clorprenaline
Dipivefrin
Etilefrin hydrochloride
Fenproprex
Hydroxyephedrine
Isometheptene
Mefenorex
Propylhexedrine

Members noted the correct spelling of fenproporex. They also noted that the rINN for hydroxyephedrine was olixofrine.

Recommendation

That the following medicines be added to the New Zealand schedule as prescription medicines.

Clenbuterol	Hydroxyephedrine
Clorprenaline	Isomethheptene
Dipivefrin	Mefenoex
Etilefrin hydrochloride	Propylhexedrine
Fenproporex

Point 41

The NDPSC should be advised to recommend to the NZ MOH to delete the current Part III entry for adrenaline and replace it by the following:

• Part I: "adrenaline; except when specified elsewhere in this schedule;
  except in medicines containing 0.02 per cent or less of adrenaline"
• Part II: "adrenaline in medicines containing 1 per cent or less of adrenaline;
  except in medicines containing 0.02 per cent or less of adrenaline"

The Committee thought the wording for the prescription medicine entry was confusing in that it implied that everything containing more than 0.02% was prescription medicine. It was suggested that this be reworded. Members wished to ensure that the proposed cut-off points would accommodate adrenaline products contained in emergency kits. It was agreed that these would be available as restricted medicines and that the classification would not prove a barrier to access.

Recommendation

• That adrenaline should be reclassified as:
  • Prescription Medicine;
    • in medicines containing more than 1%
  • Restricted Medicine;
    • in medicines containing 1% or less and more than 0.02%
  • General Sale;
    • in medicines containing 0.02% or less
• That the NDPSC adopt similar wording in the SUSDP.

Point 42.

The NDPSC should be advised to recommend to the NZ MOH that it delete the Part III entry for "noradrenaline" and reschedule to Part I, Schedule I to the Medicines Regulations.
The Committee noted that New Zealand had one pharmacy-only injectable product which should be reclassified as a prescription medicine in order to harmonise with other injectables.

Recommendation

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

Point 43

The NDPSC should be advised to:

delete the SUSDP Schedule 4, 3 and 2 entries for pseudoephedrine and replace them by the following:

• S4: "pseudoephedrine (includes all preparations for stimulant, appetite-suppression or weight-control purposes) except when included in Schedule 2"
• S2: "pseudoephedrine (other than in preparations for stimulant, appetite-suppression or weight-control purposes), with a recommended daily dose not exceeding 240mg of pseudoephedrine:
  1. in preparations containing 60mg or less of pseudoephedrine per recommended dose; or
  2. in slow release preparations"
• recommend to the NZ MOH that it delete the current Part III entry for pseudoephedrine and replace this by entries in Part I and Part III respectively, as given above.

The Committee noted that pseudoephedrine was currently classified as pharmacy-only medicine for all strengths. There were no products on the market other than decongestants or cough preparations. Members found the NDPSC recommendations unnecessarily wordy and felt the same effect could be obtained by having the pharmacy-only entry specify the permitted indications. The schedule entries could then read:

Prescription

except when specified elsewhere in the schedule

Pharmacy-only

in cough or decongestant preparations in either slow release forms or in preparations containing not more than 60 milligrams per dose, and when the recommended daily dose is not more than 240 milligrams

As there were a number of products containing pseudoephedrine which the Committee would not wish to see reclassified to a more restrictive level of availability, members agreed that individual products should be checked to ensure that the recommended dose limits were suitable before accepting the recommendation. As some products were in liquid form it was suggested that the dose limits might also be expressed as percentages.

Recommendation

• That the recommended dose limits be checked against the New Zealand OTC pseudoephedrine products before accepting the NDPSC recommendation.
• That the NDPSC be recommended to adopt the New Zealand approach to the wording of its schedule entries for pseudoephedrine.

Point 44.

On the grounds of harmonisation, the NDPSC should be advised to recommend to the NZ MOH to:
modify the Part I entry for phenylephrine to read:

"phenylephrine in preparations for injection; and in preparations for ophthalmological use containing more than 5 per cent of phenylephrine"

modify the Part III entry for phenylephrine to read:
"phenylephrine:
in oral preparations containing more than 0.5 per cent of phenylephrine;
in nasal preparations containing more than 1 per cent of phenylephrine; except when sold at an airport; or
in preparations for ophthalmological use containing 5 per cent or less of phenylephrine, except in preparations containing less than 1 per cent of phenylephrine"

Members agreed that the recommended wording appeared rather complex. If phenylephrine were to become a prescription medicine except when specified elsewhere in the schedule, then injections and higher dose ophthalmic preparations would be captured without the need to list them. The New Zealand exemption for use at an airport would no longer be necessary as these products would become general sale medicines. It was also noted that the optometrist exemption for use of 2.5% preparations would need to be removed from the schedule as those products would become pharmacy-only medicines. Removal of these exemptions would further simplify the schedule entries.

As for pseudoephedrine, the cut-off point for oral dose forms would need to be checked by Medsafe against the products on the market to ascertain whether or not these were suitable.

Recommendation

• That phenylephrine be reclassified as a prescription medicine except when specified elsewhere in the schedule.
• That phenylephrine be classified as a pharmacy-only medicine in:
  • oral preparations containing more than 0.5% (subject to Medsafe confirmation)
  • nasal preparations containing more than eye preparations containing 5% or less
• That the NDPSC be recommended to adopt the New Zealand approach to the wording of its schedule entries.

Point 45.

The NDPSC should be advised to recommend to the NZ MOH that the words "for inhalation or parenteral use" be deleted from the current Part I entry for tulobuterol.

In effect this meant that all tulobuterol products would become prescription medicines. The restricted medicine entry would therefore need to be deleted. As tablets and elixir containing tulobuterol were no longer marketed, the Committee agreed that the classification change should occur.

Recommendation

That tulobuterol be classified as a prescription medicine for all dose forms.

Point 46.

The NDPSC should be advised to:
recommend to the NZ MOH that it adopt the following drugs into Part I, Schedule I to the Medicines Regulations:

• Glibornuride
• Glimepiride

recommend to the NZ MOH that it reschedule glucagon from Part III to Part II

Members noted that three glucagon products would change from pharmacy-only to restricted medicine. This would make the classification of glucagon consistent with that of insulin.

Recommendation

That glibornuride and glimepiride should be added to the New Zealand schedule as prescription medicines. That glucagon should be reclassified from pharmacy-only medicine to restricted medicine.

Point 47.

The NDPSC should be advised to:
recommend to the NZ MOH that it adopt the following drugs into Part I, Schedule I to the Medicines Regulations:

• Adonis
• Ammi visnaga
• Apocynum (apocynum spp.)
• Convollaria (convollaria spp.)
• Cymarin
• Erysimum (erysimum canescens)
• Lanatoside C
• Oleander (nerium oleander)
• Oleadrin
• Strophanthin-k
• Strophanthus (strophanthus spp.)
• Thevetia (thevetia neriifolia)
• Thevetin

The committee noted that it appeared to be the cardiac glycoside that the Australian schedule was trying to capture. There were some queries about whether it was necessary to schedule the actual plant as well as the glycoside, alkaloid, or other derivative having a therapeutic purpose. Scheduling the plant alone would leave synthesised ingredients unclassified.

Members thought that ammi visnaga might be better scheduled as khellin (see Recommendation No 13 from the May meeting) which is obtained by extraction from the dried ripe fruit of Ammi visnaga or by synthesis. Scheduling as Ammi visnaga would not capture the latter.

As cymarin is a cardiac glycoside obtained from the roots of apocynum cannibum, this entry seemed redundant.

The correct spelling of convallaria was noted. No further reference to species was considered necessary.

Lanatoside C was already scheduled in New Zealand under the entry for lanatosides. The Committee recommended that this more comprehensive classification should be adopted into the SUSDP.

Members thought 'oleadrin' was probably intended to be 'oleandrin' which is a cardioactive glycoside obtained from oleander.

In all cases it was considered that the information in brackets was unnecessarily restrictive and that more comprehensive cover would be gained without these additions.

Recommendation

• That the following be added to the New Zealand schedule as prescription medicines: That phenylephrine be classified as a pharmacy-only medicine in:
  • Adonis
  • Ammi visnaga
  • Apocynum
  • Convallaria
  • Cymarin
  • Erysimum
  • Oleander
  • Oleandrin
  • Strophanthin-k
  • Strophanthus
  • Thevetia hevetin
• That the NDPSC be recommended to change the S4 entry for 'lanatoside C' in the SUSDP to ‘lanatosides’.
  

9 FOR THE NEXT MEETING

No specific candidates for reclassification were noted at that stage. Members were aware that there would be a large number of harmonisation issues to be discussed at the next meeting. As this was likely to be the last meeting for some members due to expiry of membership, no date was proposed for the following meeting.

10 GENERAL BUSINESS

10.1 Wider access to nicotine-containing products for smoking cessation

Dr Jessamine told the Committee that there had been recent expressions of interest from the National Health Committee, the National Heart Foundation and some Independent Practitioners Associations about ways of making smoking cessation products more easily accessible. He said that, while submissions for reclassification could be expected from some bodies in the following year, Medsafe had suggested a way in which wider access might be possible in the interim with the minimum of regulatory impact. Medsafe proposed applying exemptions from classification status for nicotine products when used in smoking cessation clinics conducted under the auspices of appropriate registered health professionals. This meant that products which were currently pharmacy-only or restricted medicines could be sold from premises other than pharmacies, not only by pharmacists but also by nurses and psychologists. The nasal spray which was a prescription medicine, could be sold in the same manner from clinics run under the auspices of a registered medical practitioner. No labelling changes would be required by companies marketing the products.

All members agreed that compliance was far greater if smoking cessation were undertaken as part of an organised programme. However, some members felt strongly that pharmacists should be involved in these programmes. As there was not a great deal of support for the Medsafe proposal, it was agreed that the matter should be deferred until submissions were received.

Recommendation

That there be no granting of exemptions from classification status to allow wider access to smoking cessation products through smoking cessation clinics conducted under the auspices of appropriate registered health professionals.

10.2 Contracts for payment of fee to Committee members

Drafts of these contracts had been sent to members for their comments and final documents had been posted to them. The Secretary informed members that these contracts would need to be signed and returned before full payment could be made for costs incurred for the current meeting.

The meeting closed at 4:36pm.