Revised: 23 May 2013

Committees

Minutes of the 23rd meeting of the Medicines Classification Committee - 25 May 2000

Held in the Medsafe Conference Room, 18th Floor, Grand Plimmer Tower, 4-6 Gilmer Terrace, Wellington. Commencing 9:30am.

Present

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

In attendance

Dr N Rafter, Medsafe

The meeting opened at 9:35am

1 WELCOME

Dr Jessamine welcomed members to the twenty-third meeting of the Medicines Classification Committee. He introduced Dr Natasha Rafter who had recently joined Medsafe as a Medical Advisor and who was attending as an observer. Dr Rafter spoke briefly about her background and experience.

2 APOLOGIES

An apology was received from Dr B Priestly from the Australian National Drugs and Poisons Schedule Committee (NDPSC). Dr Priestly had intended attending the meeting but was unavoidably prevented by transport difficulties.

3 CONFIRMATION OF THE MINUTES OF THE TWENTY-SECOND MEETING

The minutes of the twenty-second meeting were confirmed as an accurate record of that meeting and were signed by the Chairman.

4 DECLARATION OF CONFLICT OF INTERESTS

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

5 MATTERS ARISING

5.1 Objection to a recommendation made at the 22nd meeting

Minoxidil 2% topical solution (Pacific)

Although this objection had been received over a month after the closing date for objections, the matter had been returned to the agenda as an objection. At the previous meeting the Committee had not recommended in favour of the general sale classification requested by the company and the company had been asked whether it wished to make a submission for pharmacy-only classification. The company had responded with a further submission for general sale classification.

The Committee agreed that objections should be considered only on new safety data. While members recognised that the concerns raised at the previous meeting about possible foeto-toxicity were unfounded, they agreed that this had not been the sole reason for their decision to recommend against a general sale classification.

An article from Scrip was brought to the attention of the Committee. This article reported that several mild cardiovascular side-effects had been reported in Japan with the use of a topical 1% product. However, the Committee found it difficult to place any weight on this report as the side-effects appeared to have occurred only in Japan. Products had been available over the counter in the USA for some time without evidence of significant side-effects. Members agreed that the medicine had a good over-all safety record but that side-effects and interactions with other medicines were possible.

There was some concern that general sale availability could alter the perception of the product causing it to be treated more like a cosmetic than a medicine by those selling and using products.

Limiting sale to hairdressing salons as a possible means of increasing access due to lowering of price was not possible under the legislation. In addition, a Pharmaceutical Society member pointed out that pharmacies were already able to offer good consumer discounts through bulk purchase. The Committee also expressed the opinion that access to appropriate advice would not be possible under conditions of sale in hairdressing salons.

It was noted that sale of 2% strength products was very low in New Zealand as 5% products were generally perceived to be more effective for a small increase on a fairly high initial outlay.

The Committee agreed that, while it was prepared to consider sale of 2% minoxidil products as pharmacy-only medicines if application were to be made for this classification status, it did not support a general sale classification. The reasons for this included the possibility of interactions with other medicines and the use by consumers with pre-existing hypertension and heart disease. It was felt that a pharmacy was an appropriate point of sale because of the availability of professional advice. A Pharmaceutical Society member said that training strategies for sale of products would be considered if 2% products were to become pharmacy-only medicines.

Recommendation

That there be no change to the restricted medicine classification of topical products containing 2% minoxidil.

5.2 receptor antagonists

Consideration of this therapeutic group had been deferred to allow comment from interested bodies and to allow companies to make similar submissions in Australia. There had been two submissions to be considered for reclassification to pharmacy-only status. These were for ranitidine 75 milligram tablets and famotidine 10 milligram tablets. Medsafe had completed a review of this therapeutic group.

It was noted that a later agenda item under harmonisation with the Australian schedule concerned a recommendation from the NDPSC to remove the dose limitations from the requirements for OTC (over-the-counter) H₂ receptor antagonists. It was suggested that the Committee should take this into account when considering the two current submissions which were both for strengths lower that those set earlier as maximum strength limits for sale as restricted medicines.

The Committee agreed that there were few concerns about the safety of either ranitidine or famotidine when used according to the requirements for OTC sale. Famotidine had been available as a general sale medicine in the USA for some time with no evidence of increase in hospital admissions or adverse reactions from OTC sale. Ranitidine was available as a general sale medicine in the UK and famotidine was also about to become available there on general sale. It was noted that 20mg omeprazole tablets were about to become available OTC in Sweden in small pack sizes and for similar indications.

Members commented that marketing issues were beginning to be used in submissions and that they would prefer that companies did not provide marketing strategies as part of their submissions. The Committee was not able to consider marketing issues.

Consideration was given as to whether, if a classification change be recommended, it should apply to the whole therapeutic group. The Committee felt there were safety concerns related to cimetidine which had not been addressed as no submission had been made for its reclassification. It was agreed that cimetidine should only be considered if a submission was made for its reclassification. Nizatidine was no longer marketed in New Zealand. In general it was thought that the Committee should consider only those medicines which it had been asked to consider. While alternative classifications had sometimes been recommended in the past, it was agreed that the Committee should make its future recommendations only on the classification which had been requested in the submission. However, members agreed that the Committee could indicate its willingness to consider a further submission for a different level of classification and invite companies to make such submissions.

The Committee recognised that a recommendation to reclassify ranitidine and famotidine to pharmacy-only medicine would mean that the recent harmonisation with Australia achieved for these medicines would be lost. The Chairman explained that the Australian committee would be able to use the normal objection process if it had any significant new data which would pose a public safety issue if ranitidine and famotidine were available at a pharmacy-only level of classification.

Members agreed that ranitidine and famotidine should be reclassified as pharmacy-only medicines under the same conditions as were currently required for sale as restricted medicines and that there should be no upper dose limit specified. The Committee would be willing to consider a submission for a similar classification change for cimetidine.

Recommendation

• That the Committee should consider only those medicines which it had been asked to consider.
• That the Committee should make recommendations only on the classification requested in the submission.

5.2.1 Ranitidine 75mg tablets (Zantac, GlaxoWellcome)

The submission for reclassification from restricted medicine to pharmacy-only medicine had been deferred from the twenty-first meeting

Recommendation

• That ranitidine should be reclassified from restricted medicine to pharmacy-only medicine when it fulfilled the requirements for sale as an OTC medicine as specified in Volume 1 of the New Zealand Regulatory Guidelines for Medicines.
• That a submission be made to the NDPSC for the rescheduling of ranitidine for consideration at the first available meeting.

5.2.2 Famotidine10mg tablets (Pepcid AC, Merck Sharp & Dohme).

The submission for reclassification from restricted medicine to pharmacy-only medicine had been deferred from the twenty-first meeting

This submission for reclassification from restricted medicine to pharmacy-only medicine resulted from the Committee’s earlier recommendation that the therapeutic group should be reviewed as a whole.

Recommendation

• That famotidine should be reclassified from restricted medicine to pharmacy-only medicine when it fulfilled the requirements for sale as an OTC medicine as specified in Volume 1 of the New Zealand Regulatory Guidelines for Medicines.
• That a submission be made to the NDPSC for the rescheduling of famotidine for consideration at the first available meeting.

6 SUBMISSIONS FOR RECLASSIFICATION

6.1 Alclometasone (Logoderm, Schering-Plough)/span>

This was a company submission for the reclassification of cream and ointment containing 0.5mg per gram as dipropionate from prescription medicine to restricted medicine.

The Chairman informed the Committee that a similar submission had recently been considered by the NDPSC which had recommended in favour of the change. There was a strength limit of 0.05% and a pack size limit of 30 grams.

 The Committee discussed firstly whether or not there were safety grounds which would justify a recommendation not to harmonise with Australia.

When compared with 1% hydrocortisone, the safety profile of 0.05% alclometasone was good. The Chairman said that this had been the basis of the recent Australian recommendation to reclassify alclometasone. Members agreed that they had no concerns about the safety of the product for OTC use.

However, there were some concerns about quality use of the medicine. It was generally agreed that the diagnosis of skin problems was difficult and that pharmacists did not have the skills to address this. Even medical practitioners often had difficulty with diagnosis. The Committee was concerned that, as 0.05% alclometasone appeared to be more potent than 1% hydrocortisone, users might experience an initial response. However, if underlying fungal or bacterial infection were present, these would persist and there would be an increased delay in receiving the correct treatment.

Concern was also expressed about introducing more potent corticosteroids into the OTC market. Some members were of the opinion that the public had become blasé about the use of hydrocortisone during the years it had been available OTC. This attitude could be further reinforced if alclometasone were perceived to be a ‘stronger’ product and ‘better’ than hydrocortisone.

It was noted that, unlike hydrocortisone, alclometasone was effective for psoriasis and that, if it were safe, consumers might welcome a choice of treatment other than tar creams for conditions which had already been diagnosed.

Because of concerns about possible delay in diagnosis and uncertainty about the position of alclometasone on the steroid ‘ladder of potency’, the Committee decided to postpone a recommendation on the classification of alclometasone. Further information would be sought from the company on the Committee’s concerns. In addition, consultation would be undertaken with the New Zealand Dermatological Society. The matter would be placed on the agenda of the next meeting.

Recommendation

That further information be sought from the company and the Dermatological Society about the potency of topical alcolmetasone and its suitability for sale as a restricted medicine.

6.2 Nicotine in Gum and Patches

Submissions had been received from the Cancer Society, the Health Funding Authority and the Smokefree Coalition for the reclassification of nicotine in gum and patches from pharmacy-only to general sale medicine. At the previous meeting the Committee had recommended against smoking cessation products being made available through clinics conducted under the auspices of registered health professionals. However, Medsafe had provided parallel advice to the Minister in favour of wider access to accompany the Committee recommendation. The Medsafe recommendation had been accepted and had been put into effect on 13 April 2000.

It was thought that, in the light of the current political trend and the nature of the bodies requesting reclassification, a recommendation for wider access to smoking cessation products was likely to receive a favourable response. The Committee was reminded of the criteria for reclassification and advised that it should clearly document the reason for any recommendations made against these criteria. The Chairman pointed out that Medsafe had reviewed the safety data and supported wider access. Therefore it would be likely to submit parallel advice to the Minister once again should the Committee decide to recommend against wider access.

One member queried the value of the Committee if its recommendations were able to be overridden. The Chairman said that this had happened only on two previous occasions one of which related to smoking cessation products. He said that it was up to the Committee to produce well-documented evidence. The advice should be based on key areas of safety rather than on the like or dislike of a proposal. The role of the Ministry was also to provide advice to the Minister. If Medsafe were able to make a stronger case, the Minister or his or her delegate would be likely to accept the more convincing recommendation.

Opinion was divided about whether or not availability only through pharmacies posed a cost barrier to consumers. Some members were of the opinion that competition would result in lower prices. General sale availability would not prevent pharmacists from continuing to sell products at whatever price they wished.

A further possible barrier to pharmacy-only sale was also identified. Some members wondered whether those sections of the community about which there was most concern would normally visit pharmacies. It was suggested that not all consumers wishing to stop smoking might feel comfortable in a pharmacy environment but might use products if these could be obtained through other outlets.

The Committee discussed to what degree it was necessary to understand the nature of addiction and the need for ongoing support in order to change behaviour patterns. While the value of counselling and ongoing support was acknowledged by the Committee, some members thought that most benefit was obtained from the initial clinic session and that some consumers did not wish to be locked into clinic visits in order to obtain ongoing supplies of products. Some consumers also found that advice from a medical practitioner was sufficient and did not wish to attend clinics.

However, other members thought that use of the products without proper counselling would lead to lower success rates which would, in turn, undermine the perceived value of the products as useful adjuncts to smoking cessation.

While the above views focused on treatment of individuals, these views were countered by a further view that, as smoking was a public health issue, the problem should be treated as a public health intervention. Even if the success rate was low compared to placebo use for smoking cessation products without any form of counselling, some success should be regarded as better than none. Cost was regarded from this viewpoint as a significant barrier to access. Wider availability was seen as not requiring that there be any reduction in the current availability of advice or counselling.

Possible misuse of products was discussed. It was pointed out that smoking while using products was no longer regarded as a threat except in cases of unstable heart disease.

Use by children was also considered. It was generally accepted that children smoked more for the image than because of addiction. Use of nicotine patches did not produce the pleasurable effects obtained from smoking. While these effects could be obtained from chewing gum, it was agreed that the gum had to be chewed hard to obtain these effects. Chewing of gum was not perceived as ‘cool’ in the same way as smoking cigarettes.

As the Committee was unable to reach a consensus on whether or not nicotine contained in gum and patches for smoking cessation should be reclassified from pharmacy-only medicine to general sale medicine, a vote was held. It was necessary for the Chairman to exercise a casting vote.

Recommendation

• That nicotine should be reclassified from pharmacy-only medicine to general sale medicine when contained in chewing gum or transdermal patches for the purpose of smoking cessation.
• That a submission be made to the NDPSC for the rescheduling of nicotine in gum and patches for consideration at the first available meeting.

6.3  Piroxicam (Feldene Gel 0.5%, Pfizer)

This was a company submission for reclassification from pharmacy-only to general sale medicine.

Members noted that a similar submission had been considered by the NDPSC the previous week and that a recommendation had been made to reclassify to general sale.

The Committee discussed the absorption of topical piroxicam compared with that for oral preparations and agreed that absorption was significantly less for topical preparations. It was thought that the product would need to be used continuously for some 10 days before reaching a steady state of absorption.

Two types of side effects were identified as possible with use of topical piroxicam. The risks of anaphylaxis and asthma were seen as being similar to those for other non-steroidal anti inflammatory agents (NSAIAs).

Members thought that gastro-intestinal and renal effects were less likely to be a problem if the medicine was used correctly because of the lower absorption rate for topical products. However, they did note a case where a 75-year-old woman suffering from renal failure recovered after treatment with piroxicam gel was discontinued.

Abuse of products was also considered. Members recounted examples of renal failure in sports persons due to use of NSAIAs to improve performance. Some members felt that, as some players were certain to use topical products together with oral ones for the prevention of anticipated pain, they would prefer that the topical products most accessible would be those with a shorter half-life than piroxicam so that there was a lower risk of systemic absorption. However, it was agreed that the proposed classification change would not affect intentional misuse. Unintentional misuse would be avoided with the provision of correct package information.

The Committee also discussed whether a cut-off point should be retained as an upper limit for sale as a general sale medicine. It noted that an upper limit had not been applied to any of the other general sale topical NSAIAs. If a cut-off point were to be retained, the Committee was uncertain as to whether the current cut-off point of 1% should be carried over or whether the 0.5% requested by the company should be used. Members decided to harmonise with Australia on this issue.*

Recommendation

• That piroxicam for topical use should be reclassified to general sale medicine
• That the company be strongly urged to include in the pack, CMI prepared in accordance with Volume 4 of The New Zealand Regulatory Guidelines for Medicines.

*Secretary’s Note: The Draft minutes of the meeting of the NDPSC held in May 2000 indicated that the NDPSC had opted not to impose a cut-off point as an upper limit for general sale.

6.4 Zinc chloride/span>

This submission from Warner Lambert was for the reclassification of zinc chloride for external use from pharmacy-only to general sale medicine when used in mouthwash solutions containing 5% w/v or less.

The Chairman informed the Committee that zinc chloride was a general sale medicine in Australia but that it was currently under consideration to become a pharmacy-only medicine in medicines for external use containing more than 5%. This would bring strengths greater than 5% into line with the New Zealand classification. The Committee agreed without further discussion that New Zealand should harmonise with Australia on the classification of zinc chloride.

Recommendation

That zinc chloride should be reclassified from pharmacy-only medicine to general sale medicine when for external use in medicines containing 5% or less.

7 NEW MEDICINES FOR CLASSIFICATION

7.1 New chemical entities in medicines which had not yet been granted consent to market.

In recent years these had mainly had their classifications recommended by the Medicines Assessment Advisory Committee (MAAC). This activity had been taken over by the MAAC when the MCC ceased to operate for several years from 1987. When the MCC came back into operation the activity remained with the MAAC. However, as new medicine applications were often considered by the MAAC only shortly before they obtained consent to market, products were sometimes given consent to market before having been classified. In order to avoid this situation, the activity of classification was seen as being more appropriately undertaken by the MCC which could deal with the classification at an earlier stage. It was noted that the MAAC would no longer make recommendations on the classification of new chemical entities unless specialist input was required. A list of all new chemical entities requiring classification had been prepared by Medsafe together with a brief description of each substance. A similar list would be provided for each future meeting.

The Committee considered the list of new chemical entities and recommended that all but two of these should be classified as prescription medicines.

A recommendation was deferred for desloratadine. The company had requested a pharmacy-only classification for desloratadine, the principal metabolite of loratadine. However, the Committee felt that the classification should be deferred until the safety data had been examined by the MAAC and there was evidence to show that desloratadine was not more toxic than loratadine.

TThe company making a submission for icodextrin also requested a pharmacy-only classification. The Committee agreed that pharmacy-only was an appropriate classification for this starch-derived glucose polymer for peritoneal dialysis.

Recommendation

• That the classification of desloratadine be deferred until further safety data had been examined.
• That icodextrin be classified as a pharmacy-only medicine
• That the following be classified as prescription medicines:
  • Alosetron Hydrochloride
  • Amisulpride
  • Amprenavir
  • Artemether
  • Balsalazide disodium
  • Brinzolamide
  • Dexmedetomidine
  • Esomeprazole
  • Etanercept
  • Exemestane
  • Ganirelix
  • Gatifloxacin
  • Lercanidipine hydrochloride
  • Levobupivacaine hydrochloride
  • Linezolid
  • Lumefantrine
  • Moxifloxacin hydrochloride
  • Nateglinide
  • Nimesulide
  • Oxaliplatin
  • Oxcarbazepine
  • Pioglitazone hydrochloride
  • Rapacuronium bromide
  • Risendronate Sodium
  • Sertindole
  • Sialoepoetin
  • Sirolimus
  • Tegafur
  • Tegaserod
  • Tenecteplase,
  • Trastuzumab
  • Unoprostone isopropyl
  • Uracil
  • Zaleplon

7.2 Substances of abuse

TThe Medsafe Compliance Team had requested that a number of anabolic steroids be added to the New Zealand schedule as prescription medicines. These had been recognised as anabolic agents by the International Olympic Committee and the Australian Sports Drug Agency but were not classified individually in New Zealand. The Committee recommended that these should be classified as prescription medicines.

Recommendation

• That the following anabolic agents should be classified as prescription medicines:
  • androstanolone
  • androstenediol
  • androstenedione
  • dehydrochlormethyltestosterone
  • metandienone
  • metenolone
  • 19-norandrostenediol
  • 19-norandrostenedione
  • trenbolone

8 HARMONISATION OF NZ AND AUSTRALIAN SCHEDULES

8.1 Items omitted from earlier NDPSC recommendations

The following recommendation made to the MCC from the NDPSC in May 1999 had been inadvertently overlooked.

The recommendation was that the following medicines be added to the New Zealand Schedule as prescription medicines:

• 4-aminopyridine
• aconite (aconitum spp)
• atamestane
• bromoform
• carbazochrome
• colchicum autumnale
• coumarin
• perfenoxone sodium (catalin)
• propionbacterium acnes
• thiourea

The Committee noted the following points:

• 4-aminopyridine: the rINN was fampridine
• Aconite was currently classified as a pharmacy-only medicine except for external use in medicines containing less than 0.2%. As New Zealand no longer had any products registered which contained aconite, the change could be made without regulatory impact. The brackets were considered unnecessary.
• Atamestane, bromoform, thiourea: there was no reference to any of these in Martindale.
• Colchicum autumnale: contained colchicine which was already classified as a prescription medicine. There was no need to specify ‘autumnale’ in the schedule.
• Coumarin: had been removed from the schedule some time ago. It should be reinstated as Australia had products registered which contained coumarin.
• Perfenoxone sodium (catalin): The correct spelling was pirfenoxone. Neither name was the rINN which was pirenoxine.

Recommendation

• That the following new prescription medicine entries be made in the schedule:
  • 4-aminopyridine
  • atamestane
  • bromoform
  • carbazochrome
  • catalin
  • colchicum
  • coumarin
  • pirfenoxone
  • propionbacterium acnesthiourea

• That aconite should be reclassified as a prescription medicine.

8.2 Benzoyl peroxide

NDPSC recommendation to include a prescription medicine entry in the New Zealand schedule./span>

This recommendation had been inadvertently omitted from the November minutes of the NDPSC.

The Committee noted that, in effect, the Australian scheduling now harmonised with that of New Zealand with regard to products marketed. However, there had been a recommendation for an upper limit of 10% for medicines permitted as pharmacy-only medicines. This would not affect the classification of any product currently on the New Zealand market.

Recommendation

That there be a new prescription medicine entry made for benzoyl peroxide ‘except in medicines for external use containing 10% or less."

8.3 Matters arising from the last meeting

8.3.1 Pregnenolone

At the previous meeting, the Committee had queried the inclusion of pregnenolone in the schedule until further clarification had been sought on the nature of pregnenolone and the reason for an exemption for external use. An explanation had subsequently been received from the Australian Therapeutic Goods Administration and the Committee agreed to accept the NDPSC recommendation to classify pregnenolone as a prescription medicine except for external use.

Recommendation

That pregnenolone be classified as a prescription medicine except when for external use.

8.3.2 Salicylic acid

At the previous meeting the Committee had recommended that an upper limit be agreed upon for sale as general sale medicine following an NDPS recommendation to remove salicylic acid from the schedule. A response had been received from Australia stating that the upper limit for such products was 40% and proposing this as a cut-off point between general sale and pharmacy-only medicine. The MCC was happy with this proposal and would wait for a formal recommendation from the NDPSC before finalising the classification of salicylic acid.

No recommendation was required at this point.

8.3.3 Dicophane

At the previous meeting the Committee had agreed with the NDPSC that dicophane was obsolete as a medicine and did not need to be included in either the Australian or the New Zealand schedules as a prescription medicine. However, it had omitted to recommend that dicophane should be removed from the New Zealand schedule as a pharmacy-only medicine. Members confirmed that dicophane should be removed at the next update to the First Schedule to the Medicines Regulations.

Recommendation

That dicophane should be removed from the First Schedule to the Medicines Regulations.

8.3.4 Strychnine, brucine, nux vomica

The Chairman said that the classification of these was still being resolved and was to be discussed at the next meeting of the Working-Party.

No recommendation was necessary at this point.

8.4 Recommendations made by the NDPSC to the MCC in August and November, 1999

Recommendations made by the Australian National Drugs and Poisons Schedule Committee (NDPSC) to the New Zealand Ministry of Health in August 1999

Terms used:

SUSDP

Australian Standard for the Uniform Scheduling of Drugs and Poisons

BAN

British Approved Name

USAN

United States Approved Name

INN International Non-proprietary Name

rINN Recommended International Non-proprietary Name

1 Ephedrine/Ephedra

Delete the entry for ephedra and reclassify ephedrine from pharmacy-only to prescription medicine./span>

The Committee noted that ephedrine hydrochloride was contained in 15 milligram and 30 milligram tablets and BP powder 100%. There was also an ephedrine sulphate 30mg/mL solution for injection. All were currently pharmacy-only medicines. In accordance with the recommendation concerning injectables made at the 22^nd meeting, the Committee agreed that the injectable product should be reclassified as a prescription medicine.

The Medsafe Compliance Team had indicated that it would like to see ephedrine classified as a prescription medicine to help control abuse.

It was thought that there was probably no problem about removing the plant, ephedra, from the schedule as ephedra would be covered by the ephedrine or pseudoephedrine entries. However, it was noted with interest that the Australians had asked New Zealand on a number of occasions to add the plant name as well as the alkaloid or other substance derived from the plant but, on this occasion, were asking New Zealand to remove the plant name from its schedule. Members felt that a consistent approach should be taken towards the scheduling of plants.

Recommendation

• That ephedrine should be reclassified from pharmacy-only to prescription medicine
• That ephedra should remain in the schedule pending further discussion with the NDPSC.

2 Minoxidil

Place an upper strength limit of 5% on products sold as restricted medicines.

New Zealand had no OTC products which contained more than 5% of minoxidil.

Recommendation

That an upper strength limit of 5% should be placed on minoxidil when sold as a restricted medicine.

3 Inositol nicotinate and nicotinamide

• reclassify nicotinamide from restricted medicine to general sale for all strengths
• reclassify inositol nicotinate from pharmacy-only medicine to restricted medicine

Members noted that nicotinamide appeared to be exempt from scheduling in Australia and wondered if this applied also to injections. They agreed that this would need to be resolved with Australia and that further work was necessary.
It was noted that there were no products in New Zealand or Australia containing inositol nicotinate.

Recommendation

• That inositol nicotinate should be reclassified as a restricted medicine.
• That further information should be sought about how Australia dealt with injectable nicotinamide.

4 Definitions

Adopt the following SUSDP definitions:

Dermal use:

application to the skin primarily for localised effect.

Transdermal use:

application to the skin primarily for systemic effect.

External use:

application in the ears, eyes or nose or to a body surface other than in the mouth, rectum, vagina, urethra or other body orifice.

Internal use

administration:

1. orally, except for topical effect in the mouth; or
2. for absorption and the production of a systemic effect,
   1. by way of a body orifice other than the mouth; or
   2. parenterally, other than by application to unbroken skin.

Topical use application for the purpose of producing a localised effect on the surface of the organ or within the tissue to which it is applied.

Medsafe Comments

Internal and external use are defined in the Medicines Regulations 1984. The definitions are based on the English definitions. There is some conflict with the Australian definitions above. The Australian definition of topical use is mainly included in external use in New Zealand when applied to the anal canal, ear, eye, mucosa of the mouth, nose, skin, teeth throat or vagina where local action only is required and where extensive systemic absorption will not occur. Application to the urethra would be an internal use under the above definition rather than external as in Australia. A change to the Medicines Regulations would be necessary to alter this definition of external use in New Zealand.

It is not considered necessary to harmonise the definitions of external and internal in order to harmonise the schedules. (See 5 below)

As the MCC is not responsible for determining wording used in the schedule, this is a matter for Medsafe rather that for the MCC.

The Committee noted the Medsafe comments. Dr Jessamine said that these had already been forwarded to the next meeting of the Working Party for consideration and that a recommendation was not necessary at this point.

5 Adopt the following table into the NZ Regulatory Guidelines for Medicines .

NDPSC CLASSIFICATION AND WORDING OF SCHEDULE ENTRIES.

When describing a preparation for application to the:	Recommendations for defined terms	Recommendations for descriptors To be used in schedule entries)
Eye (drops, lotions)	Topical External	For ophthalmic use For ocular use In eye drops containing…
Ear (drops, douches)	Topical External	For topical use in the ear In ear drops containing…..
Nasal passages [drops, inhalations, sprays] (where local effect is intended)	Topical External	In nasal preparations containing… For nasal use For topical use in the nose
Nasal passages [drops, inhalations, sprays] (where systemic effect is intended)	Internal	In nasal preparations containing… For nasal use
Teeth or mucosa of mouth, gums or throat (where local effect is intended)	Topical	For topical oral use In preparations for topical use For topical use in the …..
Mucosa of mouth (where systemic effect is intended)	Internal	For buccal use For sublingual use
Skin (where local effect is intended)	External Topical Dermal	For external use For topical use on the skin For dermal use
Skin (where systemic effect is intended)	External Transdermal	For transdermal use.
Anal canal [rectum] (where local effect is intended)	Topical	For topical rectal use
Anal canal [rectum] (where systemic effect is intended)	Internal	For rectal use
Vagina (where local effect is intended)	Topical	For topical vaginal use
Vagina (where systemic effect is intended)	Internal	For vaginal use
Urethra (where local effect is intended)	Topical	For topical urethral use
Urethra (where systemic effect is intended)	Internal	For urethral use
Lungs and bronchi (where local effect is intended)	Topical	For topical use in the lung Use by inhalation In metered dose aerosols In capsules of dry powder for inhalation…..
Lungs and bronchi (where systemic effect is intended)	Internal	Use by inhalation For inhalational…………
The oral route	Internal	In oral preparations For oral use
Injection	Internal	In preparations for injection

Medsafe Comments

There is conflict in some areas between the definitions of internal and external use, particularly with regard to the urethra and lungs. New Zealand could not accept all of the recommendations for defined terms as in the central column without a change to the Medicines Regulations. However, harmonisation of schedules is possible regardless of the individual differences in definitions. The descriptors in the third column are what are used in the schedules. These can be modified for use in either schedule without the need for a regulation change.

For example, products used in the lungs are all inhaled whether they are defined as external or internal in Australia. ‘For inhalation’ would suffice in both schedules. Similarly, there was no need in either schedule to specify whether urethral, vaginal, or rectal medicines were internal or external. Such detail is more appropriate in a product database than in a schedule. If there were to be scheduling differences between the two uses the difference would most likely be determined by strength and would be marked by a cut-off point in the maximum strength permitted for external use.

The aim for the New Zealand schedule since 1994 has been to keep the content as ‘clean’ and user-friendly as possible. This accounts for the lack of brackets and reduction of descriptors where possible. For example, New Zealand had relied on the ‘external use’ definition for ear preparations and had not needed to schedule them specifically as ear preparations. While this approach might not always work, it was used where possible to avoid unnecessary clutter in the schedule.

Some of the proposed descriptions appear somewhat ponderous. ‘For inhalational …’ and ‘use by inhalation would be more simply expressed by ‘for inhalation’. Similarly, ‘in preparations for injection’ need only be ‘for injection’.

‘For topical oral use’ would be a useful tool to distinguish between products used topically to treat conditions of the mouth from those which are taken internally and those which are absorbed through the oral mucosa.

For scheduling purposes, it seems unnecessary to specify that a powder is dry. The presence of water of crystallisation would not affect the level of classification of the active ingredient. Such detail is considered unnecessary in a schedule. Similarly ‘for inhalation’ could be used to schedule any product taken into the lungs whether internal or external. The classification would not be affected by whether the product was external or internal.

MCC/Medsafe and the NDPSC should ignore the differences in the definitions of external use and internal use in their respective legislation and should aim for harmonisation of the descriptors used in their respective schedules. The aim of both schedules should be for the maximum ease of use with the minimum detail necessary for accurate and easily-understood classification.

The following simplified descriptors are proposed by Medsafe with the recognition that other approaches might be necessary in some cases.

MEDSAFE PROPOSED WORDING OF SCHEDULE ENTRIES.

When describing a preparation for application to the:	Recommendations for descriptors To be used in schedule entries)
Eye	For ophthalmic use In eye drops containing…
Ear	For external use For aural use In ear drops containing…..
Nasal passages (where either local or systemic effect is intended)	For nasal use In nasal preparations/sprays containing…
Teeth or mucosa of mouth, gums or throat (where local effect is intended)	For topical oral use For topical use For topical use in the … In throat lozenges
Mucosa of mouth (where systemic effect is intended)	For buccal use For sublingual use
Skin (where local effect is intended)	For external use For topical use For dermal use
Skin (where systemic effect is intended)	For transdermal use.
Anal canal (where either local or systemic effect is intended)	For rectal use
Vagina (where either local or systemic effect is intended)	For vaginal use
Urethra (where either local or systemic effect is intended)	For urethral use
Lungs and bronchi (where either local or systemic effect is intended)	For inhalation In (metered dose?) aerosols
The oral route	In oral preparations For oral use
Injection	For injection

The Committee noted the Medsafe comments and the alternative proposed descriptors to be used in both schedules without the need to harmonise over the definitions of internal and external use.

The Chairman informed the Committee that this proposal had already been forwarded to the NDPSC Working Party for consideration at the next meeting in July.

No recommendation was required at this stage.

6 Salbutamol and terbutaline

Reclassify salbutamol and terbutaline from prescription medicine to restricted medicine as follows:

1. salbutamol as the only therapeutically active substance:
   1. in metered aerosols delivering 100 micrograms or less of salbutamol per metered dose; or
   2. in capsules of dry powder for inhalation delivering 200 micrograms or less of salbutamol per dose.
2. Terbutaline as the only therapeutically active substance in metered aerosols delivering 250 micrograms or less of terbutaline per metered dose.

A recommendation was deferred about these medicines in order to allow for Medsafe to consult fully with interested bodies and to establish a New Zealand position about the OTC availability of inhaled salbutamol and terbutaline.

The matter would be discussed at the following meeting.

7 Exemptions from scheduling

Examine mechanisms other than exemption from scheduling under the Medicines Regulations 1984 to allow access to scheduled medicines for registered health professionals as this raises legal difficulties for Australia.

It was noted that prescribing rights for a wider range of registered health professionals might take care of this in the future. However, this was acknowledged as being outside the Committee’s and Medsafe’s terms of reference. No alternative course of action was open. Meanwhile, the present arrangement should stand. No recommendation was required.

8 Generic statements

Adopt the following generic statements to describe prescription medicines:

adrenocortical hormones
antibiotic substances
antihistamines
benzodiazepines; except where specified in the schedules to the Misuse of Drugs Act 1975
sulfonamides

The Committee noted that as New Zealand already had an entry for cortisone and other steroidal hormones of the adrenal cortex, this could be considered to be already harmonised. However, there also needed to be an exemption for adrenal extract for dermal use containing 0.02% or less of ketosteroids. This should be pointed out to the NDPSC.

Antibiotic substances were noted as being listed separately. As not all antibiotic substances were prescription medicines, a qualifying statement would be required.

As most antihistamines were pharmacy-only medicines in New Zealand a qualifying statement would also be needed if a prescription medicine entry were made in the schedule.

All benzodiazepines which were previously in the schedule had been reclassified as controlled drugs. As there was no generic entry for benzodiazepines in the Misuse of Drugs schedules, there was potential for a benzodiazepine not listed to be unscheduled and therefore not subject to border control. The above recommendation would cover such contingencies.

Sulfonamides were listed separately and the need for a generic entry was considered unnecessary.

Recommendation

• That the following generic statements be entered in the New Zealand schedule as prescription medicines
  • adrenocortical hormones; except adrenal extract for dermal use containing 0.02% or less of ketosteroids
    antibiotic substances; except when specified elsewhere in the Schedule
    antihistamines; except when specified elsewhere in the Schedule.
  • benzodiazepines; except when specified in the Third Schedule to the Misuse of Drugs Act 1975

9 Obsolete medicines

After the harmonisation process is completed, the NDPSC and the MCC should give consideration to the feasibility of removing from their schedules obsolete drugs, drug classes and generic entries which are prescription medicines.

The Committee felt that this was a good idea, particularly for generic entries. Medsafe’s policy in recent years had been to remove generic entries from the schedule and concentrate on listing each individual medicine. There were some exceptions to cover particular circumstances as, for example, anabolic steroids for purposes of abuse control.

It was agreed that a number of obsolete medicines had been added to the schedule recently which need not have been added at all.
Members noted that care would be needed not to remove medicines which might be subject to abuse or which should not be contained in alternative preparations such as herbal remedies or dietary supplements.

Recommendation

• That obsolete medicines and most generic statements should be removed from the schedules.
• That obsolete medicines and obsolete generic entries which were obvious candidates for removal in the near future, should not be added to the schedule.

10 Antigens

The recent recommendation to add ‘antigens’ as a prescription medicine was an error. The recommended entry should read:

‘antigens for human use by injection, except when separately specified in this schedule’

It was noted that New Zealand had an antigen skin test kit which was a prescription medicine and which was not administered by injection. The addition of ‘for human use by injection ‘ would make the test kit into a general sale medicine. There did not appear to be any antigens in the Medsafe database which were specified elsewhere in the schedule with OTC classifications.

It was also noted that Tubersol (Mantoux test) contained tuberculin purified protein derivative. It had been entered in the Medsafe database as a vaccine but would have been more accurately classed as an antigen. As a vaccine it had been classified as a prescription medicine. The proposed amendment to the entry for antigens would change the classification to general sale.

The Committee agreed that the classification status of these products in Australia should be established before a recommendation could be made to harmonise these products.

Recommendation

That the Australian classification status of antigen skin tests should be established so that the Committee could consider how to harmonise the classification of these products.

11 Formebolone /formyldienolone

Delete the prescription medicine entry for formyldienolone and add the synonym to the entry for formebolone, as shown:

formebolone (formyldienolone).

The Committee agreed that when synonyms were considered necessary in the schedule and they were not recognisable as synonyms it would be far more user-friendly to include two separate entries. Members thought it was immaterial if there were two entries for one substance. They agreed that it would allow the substance to be found in either a visual or a computer search. If the above recommendation were adopted, anyone searching visually in the schedule for formyldienolone would find it only by chance. Other examples of the same problem would occur with formoterol/eformoterol and stiboestrol/diethylstilbestol. No benefit could be seen from the use of bracketed synonyms in the schedule.

Recommendation

• That there be a policy to add both names to the schedule where synonyms were considered necessary and when they were sufficiently different to be unrecognisable as synonyms.
• That the use of brackets for synonyms be discontinued.
• That the NDPSC be informed of this recommendation.

12 Tetraethylammonium

Add tetraethylammonium salts as a prescription medicine.

See below.

13 Quaternary ammonium compounds

Entries for individual quaternary ammonium compounds should be modified by the addition of the word ‘salts’eg:

• tetraethylammonium salts
• demacarium salts
• ambenonium salts

It was noted that New Zealand had no products containing these three groups of substances. It was practice in the New Zealand schedule to rely on the cover statement at the beginning of the schedule and not to specify salts even when the substance could only be used as a medicine when in the form of a salt. This applied also to metals which were not usually used in their base metal form. There was no conflict of harmonisation.

Recommendation

That the schedule entries for quaternary ammonium compounds remain unchanged.

14 Cefamandole and cefazolin

Amend the current entries for cefamandole and cefazolin to read:

cefamandole (cephamandole)
cefazolin (cephazolin)

The earlier comment about use of brackets applied. In this case the synonyms were considered sufficiently similar for the use of an alternative to the INN (ph rather than f) to be necessary. A recommendation made by the Committee at the 22^nd meeting was seen as able to take care of any possible confusion. The recommendation was that a note should be added to the beginning of the schedule explaining that the name of first choice under which to search was the INN but that other names such as the BAN, USAN, the Australian Approved Name or any other alternative name, should all be tried before it was assumed that a substance was unscheduled.

Recommendation

That there be no change to the current entries for cefamandole and cefazolin.

15 Injections

Change all entries 'for parenteral use' to read 'in preparations for injection' or 'for use by injection'

Members agreed that 'for injection' should be used. If there was a need for further description, which was rare as most injections were to become prescription medicines, then the entry should continue '…in medicines containing….'.

Recommendation

That all schedule entries 'for parenteral use' should be changed to 'for injection'.

16 Phenazopyridine and propyphenazone

Reclassify phenazopyridine and propyphenazone from pharmacy-only medicine and restricted medicine respectively to prescription medicine .

There were no products in New Zealand containing either medicine.

Recommendation

That phenazopyridine and propyphenazone be reclassified from pharmacy-only medicine and restricted medicine respectively to prescription medicine.

17 Salicylamide

Adopt the following prescription medicine entry:

salicylamide when combined with aspirin, caffeine or paracetamol or any derivative of these substances.

It was noted that there were no products registered in New Zealand which contained such combinations. However, it was not normal practice for New Zealand to classify OTC products as prescription medicines because they were in combination.

It was also noted that the only New Zealand product containing salicylamide was Calm U tablet which combined salicylamide with diphenhydramine. Because the product was indicated for sedation it was classified as a restricted medicine when in limited pack sizes.

Although there would be no regulatory effect, there seemed little point, on consistency grounds, in making the recommended classification change.

Recommendation

• That salicylamide should not be reclassified as a prescription medicine when combined with aspirin, caffeine or paracetamol or any derivative of these substances.
• That the NDPSC should be informed of this recommendation.

18 nitrous oxide

Reclassify nitrous oxide from restricted medicine to prescription medicine.

The Committee agreed that, while reclassification would not change the use or storage of products in a way which would make them less susceptible to abuse, implementation of the recommendation should not provide a barrier to access.

Recommendation

That nitrous oxide be reclassified from restricted medicine to prescription medicine.

19 H2  Antagonists

Remove the dose limitations for the restricted medicine entries for cimetidine and famotidine from the schedule.

Schedule entries for cimetidine famotidine nizatidine and ranitidine to read:

for the relief of symptoms of gastro-oesophegal reflux in packs containing not more than 14 days’ supply

The Committee noted that the NDPSC had harmonised with New Zealand on the H₂ antagonists by making them available as restricted medicines in limited pack sizes and for limited indications. As the Australian classification did not place maximum limits on the strength permitted for OTC sale, New Zealand would now need to remove the strength limits in order to harmonise with the least restrictive classification.

Recommendation

That the maximum dose limits for the restricted medicine entries for cimetidine and famotidine and also for ranitidine should be removed from the schedule.

20 Theophylline and aminophylline

The NDPSC and the MOH should carry out a joint review on the public health and safety issues related to the OTC availability of theophylline and aminophylline liquid preparations.

Members noted that the following pharmacy-only products contained theophylline:

Product	Amount
Amcal expectorant syrup	1.5%w/v + guaiphenesin 0.75%
Broncelix expectorant syrup	15mg/mL + guaiphenesin 7.5mg/m
Brondecon Elixir	10mg/mL + guaiphenesin 5mg/mL
Cough Expectorant Syrup (Douglas)
Nuelin Syrup	80mg/15mL

There were no products containing liquid aminophylline though there was an application pending for a 25mg/mL oral solution.

The Committee agreed that a review could be avoided if the NDPSC found a low dose was acceptable as pharmacy-only medicine. A 1.5% or 2% cut-off point would allow the combination products to retain their current status and allow the non-combination products to be prescription medicines. A cut-off point would be required for theophylline only. All aminophylline could be classified as prescription medicine.

The Chairman informed the Committee that a person had already been approached to undertake the review. The reviewer and the NDPSC should be informed of the Committee’s opinion.

Recommendation

• That the NDPSC and the person nominated to review the classification of liquid aminophylline and theophylline should be notified of the Committee’s support for the following:
  • apply a cut-off point of a maximum of 2% for liquid theophylline to allow existing New Zealand cough mixture products to remain pharmacy-only but to make asthma products available only as prescription medicines.
  • reclassify aminophylline to prescription medicine for all strengths of liquid dose form.

21 Emetine

Reclassify emetine from pharmacy-only medicine in preparations containing more than 0.05% to prescription medicine except in preparations containing 0.2% or less of emetine.

There were no products registered in New Zealand which contained emetine. The Committee was informed that the proposed cut-off point between general sale and prescription had been checked by Medsafe against products containing ipecacuahna. New Zealand was found to have two pharmacy-only and six general sale products containing ipecacuahna. Of these it was thought that one of the pharmacy-only products would become general sale and two products containing 0.3% and 2% would become prescription medicines.

Recommendation

• That emetine be classified as a prescription medicine in medicines containing more than 0.2%.
• That the ipecacuahna entry be amended accordingly.

22 Lodoxamide

Lodoxamide should be classified as a prescription medicine except for ophthalmic use which remains pharmacy-only medicine.

According to Martindale lodoxamide had not proved effective when taken orally or by inhalation. Members noted that there were no products listed internationally other than eye products. Therefore the need for a prescription medicine classification appeared unnecessary.

Recommendation

That there be no change to the classification of lodoxamide.

23 Methazolamide

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

Recommendation

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

24 Metoclopramide

The restricted medicine entry should be altered to read:

metoclopramide when compounded with paracetamol in divided preparations, packed and labelled only for the treatment of nausea associated with migraine, in packs of not more than 10 dosage units.

The Committee noted that the indication was not included in the New Zealand schedule. As it was included for prochlorperazine it was logical that the indication should also be included for metoclopramide. However, members agreed that the current New Zealand wording was less cumbersome and should be retained.

Recommendation

That the restricted medicine entry for metoclopramide should read:

• when compounded with paracetamol in packs of not more than 10 tablets or capsules for the treatment of nausea associated with migraine.

25 Paraldehyde

Paraldehyde should be reclassified as a prescription medicine at all strengths.

As the only product registered in New Zealand was a prescription medicine, there would be no regulatory impact from the change.

Recommendation

That paraldehyde be reclassified as a prescription medicine at all strengths.

26 Bismuth

Bismuth should be reclassified as a prescription medicine

‘except bismuth formic iodide or bismuth subiodide in dusting powders containing 3 per cent or less of bismuth.’

Members noted that neither of these was referred to in Martindale .

They also noted that the New Zealand classification was pharmacy-only for external use and restricted medicine for internal use. New Zealand had no external products registered but there were three internal ones in the Medsafe database. Of these, one was the subject of an application for consent to market and one was about to be discontinued. That left one product on the market which would change to prescription medicine.

Recommendation

That bismuth be reclassified to prescription medicine except for external use in medicines containing 3% or less.

27 Antisera

The earlier recommendation for a prescription medicine entry for antisera should be amended to read:

antisera (immunosera) in medicines for injection.

The Committee questioned whether there would be an antiserum administered other than by injection and, if so, would it be suitably classified as a general sale medicine. It was seen to be safer to include all antisera in the prescription category rather than to exclude possible non-injectables by making them general sale medicines.

Recommendation

That there be no change to the current prescription medicine entry for antisera.

28 Actinomycin D (dactinomycin)

Delete the entry for dactinomycin and modify the actinomycin D entry to read:

actinomycin D (dactinomycin)

The above recommendation recognised the New Zealand entries for dactinomycin and actinomycin D could be combined, as was the case in the SUSDP.

The Committee agreed that as dactinomycin was the rINN and BAN and also the USAN, it should not be removed from the New Zealand schedule. Actinomycin D could be removed without any confusion occurring as New Zealand had only one product registered using the name dactinomycin. If Australia required that actinomycin D be retained, then it should be retained as a separate entry (see comments about use of brackets in No. 14 above).

Recommendation

• That the New Zealand schedule should retain both entries for dactinomycin and actinomycin D
• That actinomycin D should be flagged as a suitable candidate for future removal from both the Australian and New Zealand schedules.

29 Adenosine

Amend the prescription medicine entry for adenosine entry to read:

adenosine in preparations for injection

The Committee agreed that there was no need for this amendment which implied other routes of administration with a general sale classification.

Recommendation

That there be no change to the prescription medicine entry for adenosine in the New Zealand schedule.

30 Angiotensin

Adopt angiotensin amide as a prescription medicine

It was noted that the rINN combined this into one word.

Recommendation

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

31 Caramiphen

Reclassify caramiphen from restricted medicine to prescription medicine.

Members noted that there were no products registered in New Zealand containing caramiphen.

Recommendation

That caramiphen be reclassified from restricted medicine to prescription medicine.

32 Diethazine

Adopt diethazine as a prescription medicine.

Recommendation

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

33 Hydrocyanic acid

Reclassify hydrocyanic acid from pharmacy-only and restricted medicine to prescription medicine for all strengths.

It was noted that there were no products registered in New Zealand containing hydrocyanic acid.

Recommendation

That hydrocyanic acid be reclassified from pharmacy-only and restricted medicine to prescription medicine for all strengths.

34 Oestriol, paramethasone and trestolone

Adopt oestriol, paramethasone and trestolone as prescription medicines.

The Committee observed that oestriol and paramethasone were already included as prescription medicines in the New Zealand schedule.
There was no reference in Martindale to Trestolone.

Recommendation

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

35 Pentamidine

Replace the current entry for pentamidine isethionate with:

pentamidine (includes pentamidine isethionate).

The Committee noted that the entry in the New Zealand schedule was ‘pentamidine’ and that there was no need for the bracketed addition.

Recommendation

That there be no change to the current schedule entry for pentamidine.

36 Pentolinium

Replace the current entry for pentolinium with:

pentolinium salts

As New Zealand had no products containing pentolinium and Martindale had no reference to any therapeutic use for this substance, members considered there was no point in altering the schedule entry and that it should be removed from the schedule if Australia did not have any products containing this.

Recommendation

• That there should be no change to the current schedule entry for pentolinium
• That a recommendation be made to the NDPSC that pentolinium be removed from both schedules.

37 Polymethylene bistrimethylammonium compounds

Adopt the following generic entry as a prescription medicine

polymethylene bistrimethylammonium compounds

The Committee agreed that this was probably one of the generic entries which should be deleted from the schedules. There was no reference in Martindale or the Merck Index to indicate what medicines were included in this group. If there were any products containing these they would be scheduled individually. Either way, the entry was seen as unnecessary. (See comments about generic entries in No.9 above.)

Recommendation

• That polymethylene bistrimethylammonium compounds should not be added to the New Zealand schedule.
• That the NDPSC be recommended to remove the generic entry for polymethylene bistrimethylammonium compounds from the SUSDP.

38 Sisomicin

Modify the current prescription medicine entry for sisomycin to read: sisomicin (sisomycin)

Members agreed that the alternative spelling recommended by the NDPSC was not given as alternative spelling in Martindale . They agreed that it was sufficiently similar not to require a second entry. (See No.14 above.)

Recommendation

That there be no change in the New Zealand schedule to the current entry for sisomicin.

39 Eformoterol (formoterol)

Delete the prescription medicine entry for formoterol and amend the eformoterol entry to: eformoterol (formoterol)

Members agreed that, as the rINN was formoterol, it should be retained. It was noted that New Zealand would need to retain both entries because products were registered using the BAN, eformoterol. Two individual entries should remain for ease of identification in the schedule. (See No 11 above.)

Recommendation

That there be no change to the entries for formoterol and eformoterol in the New Zealand schedule.

40 galantamine, mitoxantrone, nitrogen mustard and triethylene thiophosphoramide

Reword the schedule entries for galantamine, mitoxantrone, nitrogen mustard and triethylene thiophosphoramide to read:

galanthamine (galantamine)
mitozantrone (mitoxantrone)
mustine (nitrogen mustard)
thiotepa (triethylene thiophosphoramide).

It was noted that galantamine and mitoxantrone were INNs and should remain in the schedule. There was considered to be insufficient potential for confusion to require separate entries for galanthamine and mitozantrone.
Mustine was noted as being the BAN. Although the rINN was chlormethine, it was in neither schedule and seemed an unnecessary addition at that point. New Zealand products had been registered as mustine but had since been discontinued. Nitrogen mustard should be removed from the New Zealand schedule and would therefore no longer be required in brackets in the Australian schedule.

As thiotepa was the rINN and New Zealand products were registered under that name, there was no need for an entry for triethylene thiophosphoramide in the New Zealand schedule. If Australia was in a similar position the entry could be removed from both schedules.

Recommendation

• That the New Zealand schedule entries for galantamine and mitoxantrone remain unchanged.
• That nitrogen mustard be removed from both the New Zealand and the Australian schedules.
• That if there were no products registered in Australia using the name triethylene thiophosphoramide, this should also be removed from both schedules.

41 Methacholine

Modify the current entry for methacholine to ‘methacholine salts’

It was noted that New Zealand had no products containing this. Comments were as for other quaternary ammonium compounds. (See 13 above).

Recommendation

That there be no change to the New Zealand schedule entry for methacholine.

42 Permethrin

Change the cut-off point between general sale and prescription medicine from 1% to 5%.

It was noted that, if the recommendation were implemented the following prescription medicines would become general sale medicines:
Lyclear Dermal Topical Cream 5%w/w
Lyderm Topical Cream 5%w/w
Quellada-P Lotion 5%w/v

Once the Committee heard that products of this strength had been available in Australia for a number of years as unscheduled medicines without apparent problems, members overcame their initial safety concerns and agreed to accept the recommended change to the cut-off point between general sale and prescription medicine.

Recommendation

That the cut-off point between general sale and prescription medicine for permethrin be changed from 1% to 5%.

43 Tiludronic acid

Change the entry for tildronic acid to:

tiludronic acid (includes disodium tiludronate).

This was regarded as unnecessary in the New Zealand schedule.

Recommendation

That there be no change to the current schedule entry for tiludronic acid.

44 Triperidol

The New Zealand schedule has entries for both triperidol and trifluperidol. These are synonyms. There should be one entry :

Trifluperidol (triperidol)

The Committee agreed that triperidol should be removed from the New Zealand schedule. It was not given in Martindale as an optional name and may have been a trade name included by mistake at an earlier date. There were no products registered in New Zealand containing trifluperidol.

Recommendation

That the entry for triperidol be removed from the New Zealand schedule.

45 Absolute alcohol

The significant differences between Australia and New Zealand in legislative controls over absolute alcohol preclude harmonisation of scheduling. The New Zealand Ministry of Health should investigate whether alternative mechanisms exist that may be utilised to control absolute alcohol in pharmacies, if the substance was removed from the First Schedule to the Medicines Regulations.

Members agreed that there did not appear to be any therapeutic use for absolute alcohol. Once compounded with another substance, it ceased to be absolute and became, therefore, general sale. This entry was seen as having caused problems for a number of years. It was agreed that the entry should be removed from the schedule.

Recommendation

That the entry for absolute alcohol be removed from the New Zealand schedule.

46 Aminacrine

Reclassify aminacrine from restricted medicine to general sale medicine.

The Committee noted that one product would change classification if the recommendation were implemented. It agreed to the change.

Recommendation

That aminacrine be reclassified from restricted medicine to general sale medicine.

47 Amorolfine

Reinstate amorolfine as a prescription medicine except when specified elsewhere in the schedule.

Members noted that, according to Martindale, amorolfine was inactive when given systemically and this limited its use to topical application for superficial infections. Therefore they felt it was illogical to schedule amorolfine for uses other than the topical applications for which it was already scheduled.

Recommendation

That amorolfine should not be reinstated as a prescription medicine.

48 Brucine

Reclassify brucine from pharmacy-only and restricted medicine to prescription medicine for all strengths.

The Committee agreed that this recommendation could be implemented without regulatory impact as there were no products registered in New Zealand containing brucine. However, it was recognised that the entries for brucine, strychnine and nux vomica need to be made consistent.

The Chairman said that the matter had been reviewed by the Australians and was due to be discussed at a Working Party meeting in the near future.
The Committee would wait for a further recommendation from the NDPSC.

49 Croton oil

Reclassify croton oil from restricted medicine to prescription medicine .

As there were no medicines in New Zealand containing croton oil, the change could be made without regulatory impact.

Recommendation

That croton oil be reclassified from restricted medicine to prescription medicine.

50 Guanidine

Reclassify guanidine from restricted medicine to prescription medicine.

As neither country had any products the Committee agreed that this would be a good candidate to remove from the schedule. According to Martindale it did not appear to have been a very effective medicine.

Recommendation

• That guanidine be removed from the New Zealand schedule
• That the NDPSC be recommend not to add guanidine to the SUSDP.

51 Pralidoxime

Reclassify pralidoxime from restricted medicine to prescription medicine.

As neither country had any products containing pralidoxime the Committee thought that this would be a good candidate to remove from the schedule. However, it noted that pralidoxime had already been added to the SUSDP as a prescription medicine.

Recommendation

That pralidoxime should be reclassified from restricted medicine to prescription medicine.

52 Prampine

Reclassify prampine from restricted medicine to prescription medicine. The prescription medicine entry should read:

prampine salts.

This was another entry which should have been removed from both schedules rather than added to the SUSDP. Neither country had any products containing prampine. There was no reference to it in Martindale. The Medsafe database did not list any prampine salts.

Recommendation

That prampine be reclassified from restricted medicine to prescription medicine.

53 Quebracho and yohimbine

Reclassify quebracho from restricted medicine to prescription medicine. Delete all reference to yohimbine as a pharmacy-only medicine.

It was noted that there was no reference to quebracho in Martindale .
Yohimbine had already been reclassified as a prescription medicine.

Recommendation

That quebracho be reclassified from restricted medicine to prescription medicine.

54 Sabadilla

Reclassify sabadilla from restricted medicine to prescription medicine.

The Committee noted that veratrine was a mixture of alkaloids obtained from the seeds of the sabadilla plant. It was extremely toxic and should never be taken internally. It was once used externally as an analgesic and parasiticide but even used this way there was danger of systemic poisoning from absorption.

Recommendation

That sabadilla should be reclassified from restricted medicine to prescription medicine.

55 Savin oil

Reclassify savin oil from restricted medicine to prescription medicine.

As savin oil was listed in Appendix C in the SUSDP, it was agreed that harmonisation was not possible. Although any form of classification would have the same regulatory effect, the Committee agreed to the recommendation. There were no registered products to be affected by the change.

Recommendation

That savin oil be reclassified from restricted medicine to prescription medicine.

56 Sulfacetamide

Amend the restricted medicine entry for sulfacetamide so that there is an upper limit of 10% of sulfacetamide permitted in medicines for ophthalmic use for sale as a restricted medicine.

Members noted that the change would not affect the classification of any existing products.

Recommendation

That the restricted medicine entry for sulfacetamide be amended so that there is an upper limit of 10% of sulfacetamide permitted in medicines for ophthalmic use for sale as a restricted medicine.

57 Santonin

Adopt santonin into the schedule as a restricted medicine.

Recommendation

That santonin be added to the New Zealand schedule as a restricted medicine.

58 Acetic acid

Adopt the following wording in place of the current pharmacy-only entry for glacial acetic acid :

acetic acid (excluding its salts and derivatives) and preparations containing more than 80 per cent of acetic acid (CH₃ COOH).

It was agreed that the current New Zealand entry for acetic acid had caused problems and that the recommendation should resolve these.

Recommendation

• That the current pharmacy-only entry for glacial acetic acid be amended to read:
  • acetic acid (excluding its salts and derivatives) and preparations containing more than 80 per cent of acetic acid (CH₃COOH).

59 Carbetapentane

Modify the wording of the pharmacy-only entry for carbetapentane to read:

carbetapentane except in preparations containing 0.5 per cent or less of carbetapentane.

The Committee felt that there was no lack of harmonisation with the wording of the New Zealand pharmacy-only entry ‘in medicines containing more than 0.5%’. It was acknowledged that New Zealand used positive statements where possible and that there was no need to change the wording in the schedule.

Recommendation

That there be no change to the schedule entries for carbetapentane.

60 Etafedrine

Adopt etafedrine into the schedule as a pharmacy-only medicine.

Recommendation

That etafedrine be added to the schedule as a pharmacy-only medicine.

61 8-hydroxyquinoline

Adopt the following pharmacy-only entry into the schedule:

8-hydroxyquinoline and its non-halogenated derivatives for human therapeutic use, except in preparations containing 1 per cent or less of such substances.

It was noted that there was no reference to this in Martindale nor any indication of how the non-halogenated derivatives could be identified.

Recommendation

That 8-hydroxyquinoline and its non-halogenated derivatives be added to the schedule as a pharmacy-only medicine except in medicines containing 1% or less of such substances.

62 Mercuric oxide

Adopt "mercuric oxide in ointments for ocular use" as a pharmacy-only medicine.

There was general agreement that the use of mercury was discouraged in medicines. For that reason mercury had been reclassified to restricted medicine in New Zealand. Members thought the recommendation was probably in order to accommodate Golden Eye Ointment (1% mercuric oxide) which was no longer marketed in New Zealand. There were no other products in the Medsafe database.

Recommendation

• That a pharmacy-only entry be made for mercuric oxide for ophthalmic use.
• That the words: ‘except when specified elsewhere in the schedule’ be added to the current restricted medicine entry for mercury.

63 Methoxamine

Reclassify methoxamine from pharmacy-only to:

prescription

in injections

pharmacy-only;

except

1. in injections; or
2. in preparations for external use
   containing 1 per cent or less of methoxamine.

It was noted that there were no products to be affected by the change.

Recommendation

That the classification of methoxamine be changed to:

prescription medicine

except for external use

pharmacy-only medicine

for external use in medicines containing more than 1%

general sale

for external use in medicines containing 1% or less

64 Papaverine

Reclassify papaverine from restricted medicine to

prescription

in preparations for injection

pharmacy-only

except when specified elsewhere in the schedule

The Committee noted that there were two injectable products which would become prescription medicines. New Zealand had no preparations other than for injection.

Recommendation

That papaverine be reclassified from restricted medicine to:

prescription

for injection

pharmacy-only

except for injection

65 Phedrazine

Adopt phedrazine into the schedule as a pharmacy-only medicine.

Recommendation

That phedrazine be added to the schedule as a pharmacy-only medicine.

66 Potassium chlorate

Adopt the following pharmacy-only entry into the schedule:

potassium chlorate; except in preparations containing 10 per cent or less of potassium chlorate.

Members thought this could be covered by our current entries for potassium. More information was required about the nature of the products the SUSDP entry was to cover. Further consultation with Australia was required.

Recommendation

That further clarification be sought from the NDPSC about the nature of the Australian products the entry was to cover and whether or not the New Zealand entry for potassium covered this.

67 Tymazoline

Adopt tymazoline into the schedule as a pharmacy-only medicine.

Recommendation

That tymazoline be added to the schedule as a pharmacy-only medicine.

68 Dinitrophenols

Dinitrophenols had been omitted from the previous Working Party’s recommendation No 110 at its meeting in October 1998.
Dinitrophenols should be classified as prescription medicines.

Recommendation

That dinitrophenols be classified as prescription medicines.

69 Sodium cromoglycate

Reclassify to prescription medicine except when specified elsewhere in the schedule.

The Committee noted that sodium cromoglycate was already classified as a prescription medicine except for nasal and ophthalmic use. The classification harmonised with that of Australia. It was felt that the wording was more helpful in the New Zealand schedule than that in the NDPSC recommendation because it provided sufficient information to obviate the need to search for further schedule entries. It was noted that it had been New Zealand policy to make balancing statements in the schedule wherever possible in the interest of clarity and that this should continue.

Recommendation

That the prescription medicine entry for sodium cromoglycate remain unchanged.

Recommendations made by the NDPSC to the NZ Ministry of Health at its 25^th meeting in November 1999

1 Radiographic contrast media

Radiographic contrast media should be exempt from scheduling.

The Committee considered the relevant extract from the NDPSC minutes with particular reference to the comments made by the New Zealand member of that committee.

It was agreed that, whereas radiographic contrast media were regarded more as devices by most other regulatory bodies, New Zealand legislation specified that they should be medicines. As there was no way to exempt medicines from scheduling, they would have to become general sale medicines if they were to be harmonised with Australia.

While it appeared inconsistent to make these prescription medicines into general sale medicines while other OTC injectables were being changed to prescription medicines in order to harmonise with Australia, this was acknowledged as the only way to harmonise the classification of this group of products.

Members agreed that although there were risks associated with the use of these medicines, they had no abuse potential and were of no use without an x-ray machine. Preparations had no therapeutic value and no physiological effect. There appeared to have been no problems arising from a long period of availability in other countries in products marketed as other than classified medicines.

The Committee noted that New Zealand regarded injectable radiographic contrast media as higher risk medicines. A change to their classification would not alter this. Products would continue to received the same degree of evaluation afforded to all higher risk medicines. However, it would no longer be possible to require products to have approved data sheets.

Recommendation

That radiographic contrast media be reclassified from prescription medicines to general sale medicines.

Secretary’s note:
It has since been recognised that some of the chemical entities listed in the NDPSC recommendation as radiographic contrast media for exemption from scheduling are classed in Martindale as magnetic resonance contrast media rather than as radiographic contrast media. (eg gadodiomide and gadopentetic acid) It will be necessary to determine whether magnetic resonance contrast media were intended to be included in the NDPSC recommendation. If this is the case, as appears evident from the medicines listed for exemption, then a more general term such as ‘contrast media’, or the additional use of the term ‘magnetic resonance contrast media’ will be required.

It is also noted that medicines used in ultrasound contrast media (see Martindale ) are already regarded as general sale medicines in New Zealand. While galactose is unscheduled, contrast media containing galactose are currently pharmacy-only medicines because they are administered by injection. For consistency an amendment may need to be made to the schedule entry for injectable medicines exempting them from classification when contained in contrast media.

2 Iodine

Pharmacy-only products for internal use should bear the following warning statements in letter not less than 1.5mm in height:

• caution- total iodine intake may exceed recommended level when taking this preparation; and
• warning- contains iodine- do not take when pregnant except on physician’s advice.

This was seen as a labelling issue rather than a scheduling issue and more appropriately dealt with in the Regulatory Guidelines .

Recommendation

• That there be no change to the schedule entry for iodine
• That labelling requirements for iodine for internal use should be included in Volume 1 of the New Zealand Regulatory Guidelines for Medicines so that the requirements are harmonised for both countries.

3 Melengestrol

Add melengestrol to the New Zealand schedule as a prescription medicine.

Members noted that there was no reference to this in Martindale .

Recommendation

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

9 FOR THE NEXT MEETING

It was agreed that there would still be a number of harmonisation issues to be dealt with at the next meeting including the classification of inhaled salbutamol and terbutaline. Therefore new medicines for reclassification should not be actively sought until the harmonisation exercise was nearing completion.

10 GENERAL BUSINESS

The secretary explained that the reason members had been asked to attend the meeting after the expiry date of their term of office was because the legislation made particular provision for this. Nominations had recently been received and the appointment/reappointment process could therefore proceed. It was hoped that the new membership would be well in place before the next meeting in October or November. A meeting date would be negotiated once it was known who the Committee members would be.

New contracts were issued for members’ signatures in order to replace expired contracts and to allow members to be paid for work undertaken for the meeting.

The meeting closed at 4pm