INFORMATION FOR HEALTH PROFESSIONALS
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Notes relevant to the 22nd meeting of the Medicines Classification Committee held on 10 November 1999
All but one of the recommendations made at the 22nd 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 23rd 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 nextGazette
notice 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
MINUTES OF THE TWENTY-SECOND MEETING OF THE MEDICINES CLASSIFICATION COMMITTEE 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.
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
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
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
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
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
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:
| aldesleukin ancestim antithrombin III aviptadil bambuterol becaplermin bivalirudin capecitabine celecoxib cetrorelix cholera vaccine cidofovir dalfopristin dofetilide efavirenz entacapone glimepiride |
hylan polymer imiglucerase interleukins leflunomide lepirudin mangafodipir naratriptan palivizumab pramipexole quinupristin repaglinide telmisartan tirofiban troglitazone zafirlukast zanamivir ziprasidone |
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 Gazette list 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 Regulations listing prescription medicines. |
| Part II | Used by the NDPSC when referring to the part of the First Schedule to the Medicines Regulations listing restricted medicines. |
| Part III | Used by the NDPSC when referring to the part of the First Schedule to the Medicines Regulations listing pharmacy-only medicines. |
| Hydroxyprogesterone Megestrol Normethandrone |
Oestriol Progesterone |
Debrisoquine
Dihydralazine
Practolol
Recommendation
That the entry for thyroxine should remain unchanged.
Acokanthera
Calotropis
Coronilla
Hemerocallus
Orthopterin
for oral use
when included in Schedule 3"
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.
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.
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
| 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 |
"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
‘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
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
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
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
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
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.
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.
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.
"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.
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.
| Camphotamide Leptazol |
Fencamfamin Nikethamide |
"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.
| 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
‘in medicines other than for smoking cessation'
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.
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
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
'in solid dose form in packs containing not more than 30 tablets or capsules for the treatment of dysmenorrhoea'
| Clenbuterol Clorprenaline Dipivefrin Etilefrin hydrochloride Fenproporex |
Hydroxyephedrine Isometheptene Mefenorex Propylhexedrine |
| 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 |
| 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
"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
oral preparations containing more than 0.5% (subject to Medsafe confirmation)
nasal preparations containing more than eye preparations containing 5% or less
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
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
| Adonis Ammi visnaga Apocynum Convallaria Cymarin Erysimum |
Oleander Oleandrin Strophanthin-k Strophanthus Thevetia hevetin |
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.
10.1 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 fees 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.