Revised: 23 May 2013

Committees

Minutes of the 36th meeting of the Medicines Classification Committee - 8 February 2007

Held in the Medsafe Boardroom, Level 6, Deloitte House, 10 Brandon Street, Wellington. Commencing at 9:30am.

Present

Dr Stewart Jessamine (Chair)
Dr David Galler
Mrs Andrea Shirtcliffe
Ms Natalie Gauld
Dr Jill Peckham
Dr Tim Healy
Mrs Carol Smith (Secretary)

In attendance Mr Matthew McCrone (Secretary, NDPSC)

1. Welcome

The Chairman welcomed members to the meeting and introduced the secretary of the Australian National Drugs and Poisons Schedule Committee (NDPSC). Members introduced themselves for the benefit of the visitor and the Chairman gave a brief description of the way meetings were run and how recommendations were normally agreed upon.

2. Apologies

There were no apologies.

3 CONFIRMATION OF THE MINUTES OF THE 34TH AND 35TH mEETINGS

The minutes of the 34th and 35th meetings were adopted as accurate records of those meetings and were signed by the Chairman.

4. Declaration of conflicts of interest

One of the members declared several interests which might have been considered to be in conflict with items on the agenda for the current meeting. These were discussed by the rest of the Committee in the absence of that member and it was agreed that there appeared to be no reasons to exclude the member from full participation in all items on the agenda.

5 matters arising

5.1 Letter from GlaxoSmithKline re protocol for treatment of paracetamol poisoning

At the previous meeting the Committee had recommended that slow release paracetamol tablets containing up to 665 milligrams of paracetamol per tablet should be reclassified from prescription medicine to restricted medicine. The Secretary reported that she had contacted GlaxoSmithKline according to the wishes of the Committee to request that the company should update its protocol for the treatment of paracetamol poisonings in hospital emergency rooms in order to accommodate appropriate treatment for possible poisonings with slow release paracetamol preparations. The company had responded positively stating that the appropriate update to the protocol was already in hand.

5.2 Oseltamivir

Following the exemption from classification for oseltamivir to allow sale by pharmacists during the influenza season to consumers over 12 years of age presenting at a pharmacy with the early symptoms of seasonal influenza, the Committee discussed the possibility of making the medicine available in a similar way to contacts and family members of consumers presenting with influenza symptoms. Members noted however, that this would be in conflict with their earlier recommendation that oseltamivir should not be used for the prophylaxis of influenza. While it was considered that such a measure could be of benefit to some consumers, it was decided that some kind of assessment of the response to the increased availability of oseltamivir should occur before the medicine were to be considered for wider availability. Research into the impact of increased availability of oseltamivir during the next influenza season would be desirable. It was suggested that an impact study would be a good subject for a student project.

It was agreed that no further recommendation should be made at this time and that access to oseltamivir should be returned to the agenda after there had been a period of market experience at the new level of access.

5.3 Diphenylpyraline

At the previous meeting the Committee had agreed to harmonise with Australia on the classification of diphenylpyraline solely as a prescription medicine on the grounds that it was a sedating antihistamine which was not available in either country. However, the Secretary reported that she had subsequently noted that the SUSDP still retained the S2 and S3 entries for diphenylpyraline which were standard for sedating antihistamines. Accordingly, the recommendation had not been implemented with the other recommendations from the previous meeting and the matter had been held back pending confirmation of the Australian scheduling position. It had since been ascertained that diphenylpyraline was intended to be scheduled only as S4 in Australia. The Secretary informed the Committee that the recommendation made at the last meeting could now be implemented and the change would come into effect with the recommendations from the current meeting.

6. Submissions for reclassification 6.1

Propamidine and dibromopropamidine (Brolene, Sanofi Aventis)

This was a company submission for the reclassification from pharmacy-only medicine to general sale for propamidine isethionate eye drops and dibromopropamidine isethionate eye ointment.

The NDPSC had also recommended that these two medicines should be removed from the New Zealand schedule in order to harmonise with the Australian scheduling. (see agenda item 8.1.3)

The Committee agreed that these were safe medicines for minor conditions. The toxicity profile appeared suitable for sale at general sale level. In addition, there would be a degree of consumer convenience in the proposed reclassification.

However, members felt strongly that it was inappropriate to treat eye infections at general sale level. Although pharmacist advice was not legally required in the sale of pharmacy-only medicines, pharmacists were often involved in the sale of eye products and consumers were often referred on for medical advice. While advice was available in a pharmacy, it was definitely not available in a supermarket.

One of the pharmacists commented that there were good guidelines in place for pharmacy assistants dealing with eye conditions. The matter was addressed in the handbook for pharmacy assistants in New Zealand but the member did not know the extent of its use. However, many pharmacies had an informal arrangement so that consumers seeking treatment for eye conditions were referred to the pharmacist.

It was noted that despite these products being unscheduled in Australia, they were not generally found in supermarkets there.

It was agreed that public knowledge about eye conditions was generally not good. , Cases were cited of irreversible sight-loss through inappropriate use of eye products. This reinforced the Committee's view that there should be advice available at the point of sale for these products.

While members saw that there was some benefit to be gained from the proposed change they felt that there was potential for considerable loss and that the increase in risk outweighed any benefits. In this case the potential risk stemmed not from danger in the use of the products per se but from what could ensue as a result of inappropriate use. It was noted that adverse reactions data did not address the consequences of misdiagnosis of more serious conditions.

The Committee concluded that, in view of the potential for misdiagnosis, and inappropriate use which could lead to irreversible loss of sight, propamidine and dibromopropamidine should retain their pharmacy-only classification.

Recommendation

• That there be no change to the current pharmacy-only classification of propamidine and dibromopropamidine
• That the NDPSC should be recommended to adopt the New Zealand classification on the grounds that misdiagnosis or inappropriate use may have consequences which could lead to irreversible loss of sight.

7. New Medicines for classification

The Committee considered the descriptions of the new medicines which had been submitted by the Medicines Assessment Advisory Committee for classification.

Abatacept (Orencia) powder for injection

Abatacept is a co-stimulation modulator. It is indicated for reducing signs and symptoms, including major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs such as methotrexate or tumour necrosis factor blocking factors.

Aliskiren (Rasilez) tablets

Aliskiren is an orally active, non-peptide specific renin inhibitor. It is indicated for the treatment of hypertension.

Darunavir (Prezista) tablets

Darunavir is an inhibitor of HIV-1 protease.
The proposed indication is for the treatment of HIV infection in antiretroviral treatment experienced adult patients.

Dasatinib (Sprycel) tablets

Dasatinib is a potent inhibitor of multiple oncogenic kinases, cellular enzymes involved in the transmission of growth signals from the cell membrane to the nucleus.
The proposed indications are:

• The treatment of chronic myeloid leukaemia (CML) in patients who are resistant to or intolerant to imatinib.
• Treatment of Philadelphia-positive acute lymphoblastic leukaemia (Ph+ ALL).

Fosaprepitant (Emend IV)

Fosaprepitant dimeglumine is a prodrug of aprepitant, a substance p/neurokinin (NK1) receptor antagonist.
The proposed indication is for fosaprepitant in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of:

• Highly emetogenic cancer chemotherapy
• Moderately emetogenic cancer chemotherapy.

Lapatininb (Tykerb) tablets

Lapatinib ditosylate is a small molecule reversible tyrosine kinase inhibitor of ErbB1 and ErbB2 receptors. ErbB1 (EGFR) and ErbB2 (HER-2) receptors are frequently over-expressed or altered in human cancers.

The proposed indication is lapatinib in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress ErbH2 and who have received prior therapy including trastuzumab.

Natalizumab (Tysabri) concentrated infusion solution

Natalizumab is a recombinant humanised IgG4 monoclonal antibody produced in murine myeloma cells.

Tysabri is indicated only for the treatment of patients with relapsing forms of multiple sclerosis (MS) including relapsing, remitting MS and secondary progressive MS with on-going relapses, to delay the progression of physical disability and to reduce the frequency of clinical exacerbations.

Nepafenac (Nevanec) eye drops

Nepafenac is a prodrug which when applied topically to the eye rapidly penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, a potent nonsteriodal anti-inflammatory drug. Amfenac effectively inhibits the action of prostaglandin H synthase (cyclooxygenase), an enzyme required for prostaglandin production.
The proposed indication is for the inhibition and treatment of inflammation and pain when dosed beginning one day prior to cataract surgery.

Nilotinib (Tasigna) tablets

Niltotinib is a novel aminopyrimidine, a hightly effective competitive inhibitor of the protein tyrosine kinase activity of Bcr-Abl.
The proposed indication is the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myeloid leukaemia (CML) in adult patients resistant to or intolerant of at least one prior therapy including imatinib.

Paliperidone (Invega) prolonged release tablets

Paliperidone is a monoaminergic antagonist with a high affinity for serotoninergic and dopaminergic D2 receptors.
The proposed indication is for the treatment of schizophrenia, including acute treatment and recurrence prevention.

Rimonabant (Acomplia & Rimonabant Winthrop) film coated tablets

Rimonabant is the first member of a new class of compounds, the cannabinoid type 1 (CB1) receptor antagonists, which target a recently discovered physiological system, the endocannabinoid (EC) system.
The proposed indications are:

• management of multiple cardiovascular risk factors
• weight management
• dyslipidaemia
• type 2 diabetes
• an aid to smoking cessation and maintenance of abstinence
• prevention of weight gain associated with smoking cessation.

Ruboxistaurin (Arxxant) tablets

Ruboxistaurin is an isoform-selective inhibitor of protein kinase C β (PKC β), a key factor in the underlying pathophysiology of diabetic microvascular dysfunction and damage.
The proposed indication is for the treatment of diabetic retinopathy in people with moderate to severe nonproliferative diabetic retinopathy. Arxxant reduces the risk of vision loss in these patients.

Rimexolone (Vexol) eye drops

Rimexolone is a novel corticosteroid that displays limited systemic absorption and local anti-inflammatory activity following topical administration as an eye drop suspension.
The proposed indication is the treatment of post-operative inflammation following ocular surgery; for the treatment of the palperbral and bulbal conjunctiva, cornea, and anterior segment of the globe.

Vildagliptin (Galvus) tablets

Vildagliptin belongs to a new class of oral anti-diabetic drugs, known as islet enhancers, and has been developed for the treatment of type 2 diabetes mellitus
In view of the fact that these were all new chemical entities and were all indicated for conditions requiring medical supervision in their use, members agreed that these should be classified as prescription medicines.

Recommendation

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

• Abatacept
• Aliskiren
• Darunavir
• Dasatinib
• Fosaprepitant
• Lapatinib
• Natalizumab
• Nepafenac
• Nilotinib
• Paliperidone
• Rimexolone
• Rimonabant
• Ruboxistaurin
• Vildagliptin

8. Harmonisation of NZ and Australian schedules

The following recommendations had been made to the MCC by the NDPSC in 2006.

8.1 Boron

The Chairman pointed out that there were several issues associated with the harmonisation of boron. The first concerned appropriate nomenclature for schedule entries. While the SUSDP entries referred to boron, the New Zealand schedule classified boron as boric acid. There was some discussion around which of the names would cover the whole range of boron-related substances. Members considered that "boron, including boric acid and borax" should cover all possibilities. It was agreed that the NDPSC should be asked to comment on this suggestion.

The second issue was to establish a safe cut-off point for exemption from scheduling for products used in complementary medicines. The NDPSC had recommended that the MCC should harmonise with the Australian classification for boron.

In New Zealand boric acid was currently classified as pharmacy-only in medicines containing more than 2% and general sale in medicines containing 2% or less.

The SUSDP classified boron as a prescription/S4 medicine in:

• preparations for internal use containing more than 3 milligrams per recommended daily dose
• glycerines and honeys of borax or boric acid
• preparations for vaginal use
• preparations for dermal paediatric use being:
  • dusting powders or
  • other preparations containing more than 0.35% of boron
• other preparations for dermal use containing more than 0.35% of boron except for antifungal preparations

The Committee observed that the SUSDP S4 entry was atypical in that all the inclusions were listed in the entry. This had obviously been designed to prohibit products available at the time the entry was made and was contrary to the usual SUSDP entries which listed exclusions rather than inclusions. Members agreed that, for consistency, the NDPSC should be recommended to use the normal cascade effect for the S4 boron entry and list only those medicines which were excluded from S4 status.

It was suggested that the following S4 entry or words of similar meaning should cover all exigencies:
except:

• for internal use in medicines containing X milligrams or less per recommended daily dose
• for dermal use in medicines containing X% or less
• when present as an excipient

The Committee questioned the need for an exemption for antifungal preparations. They agreed that, not only were there better antifungal products available, but also that absorption of boron would occur through broken skin and that this use should be discouraged. It was agreed that the NDPSC should be recommended to remove the exemption for the use of boron as an antifungal from the schedule entry.

Members discussed the recommended cut-off points of 3 milligrams per recommended daily dose for internal use and 0.35% concentration for dermal use and concluded that they needed to know what products were available in New Zealand. If there were products containing higher doses or concentrations than those proposed, members wanted to know how much these products contained and whether there was safety data available to justify the higher doses or concentrations. It was noted that data to hand seemed to suggest that 10-18 milligrams of boron per day could be taken for life without any toxic effects. The minimum toxic dose appeared to be approximately 3.6 grams for children and 15 grams for adults. In view of these figures the Committee felt that the recommended cut-off points in the Australian schedule might be unnecessarily conservative. It was agreed that further information should be sought before adopting these cut-off points.

There was also discussion about uses other than therapeutic use for boron. Boron was known to be used to poison ants and the Committee was interested to learn whether or not pharmacies still sold boron for non-therapeutic uses.

In conclusion the Committee decided that a recommendation to change the classification of boron should not be made at this point. The following course of action was agreed upon:

1. The NDPSC should be consulted over the suggested nomenclature to be used for the boron S4 schedule entry
2. The NDPSC should be recommended to use the normal cascade effect for the S4 schedule entry as suggested by the MCC
3. The NDPSC should be recommended to remove the exemption for antifungal medicines from the S4 schedule entry for boron
4. Consultation should occur with the complementary medicines sector through the normal process on the Medsafe website to establish the nature and strength of products already on the New Zealand market. If there were products available which contained more than the proposed cut-off points of 3 milligrams per recommended maximum daily dose for internal use or 0.35% for dermal use, sponsor companies should be invited to provide safety data to support these higher doses or concentrations.
5. The Pharmaceutical Society should be approached to inquire whether or not boron/borax was sold for non-therapeutic purposes.

The matter should be returned to the Committee when the above course of action had been completed.

8.2 Cathine

The NDPSC had recommended that cathine should be classified as a prescription medicine.

Cathine was noted to be a constituent of catha, the leaves of the catha edulis plant. It was used as an anorectic. Catha edulis was scheduled as a Class C controlled drug under the Misuse of Drugs Act. Another of its constituents, cathinone, was a Class B controlled drug. There was no entry for cathine in any of the New Zealand schedules. However, the Committee noted that norpseudoephedrine was a synonym for cathine and that norpseudoephedrine was scheduled as a class B controlled drug. Therefore cathine was considered to be already scheduled under the Misuse of Drugs Act and should be added to the list of controlled drugs which could not be harmonised at this point in time.

No recommendation was required but the Committee agreed that the NDPSC should be informed of the status of cathine in New Zealand.

8.3 Propamidine and dibromopropamidine (see 6.1 above) 8.4 Azelastine 0.05% eye drops

The recommendation was to reclassify azelastine from prescription medicine to restricted medicine when in topical eye preparations containing 0.05% or less. Nasal preparations should remain pharmacy-only medicines.

The Committee noted that there was one azelastine eye drop preparation registered in New Zealand which would be affected by this change but that no comment had been received from the sponsor company.

They agreed that azelastine was safe for over-the-counter ophthalmic use and that there were other similar products already available. There appeared to be no evidence of interactions with other medicines. Hay fever was regarded as being different from infection and easily identified by the consumer. The Committee agreed that azelastine eye preparations should be reclassified as restricted medicines.

Recommendation

That azelastine should be reclassified as a restricted medicine when in ophthalmic medicines containing 0.05% or less of azelastine.

8.5 Salicylic acid

In both countries salicylic acid was a restricted medicine in products containing more than 40% and unscheduled in products containing 40% or less. In NZ the schedule entry applied to external use whereas in Australia it applied to dermal use. The NDPSC had recommended that New Zealand should change 'external' to 'dermal' in order to harmonise.

It was noted that in New Zealand there were topical oral gels containing choline salicylate which would be affected if 'external' were changed to 'dermal' in New Zealand. Choline salicylate could also be used in the ear and given orally in doses of up to 870 milligrams four-hourly.

It seemed sensible therefore to adopt separate schedule entries for choline salicylate in New Zealand particularly in view of the fact that choline salicylate was a recommended International Non-proprietary Name in its own right. Choline salicylate was a derivative of salicylic acid. Derivatives of substances are covered by the parent entry in the SUSDP but are not covered by the introductory statement in the New Zealand schedule. With regard to the general sale choline salicylate products currently on the New Zealand market, 10% maximum concentration and pack sizes of not more than 15 grams was considered a suitable cut-off point for general sale. Products above this cut-off point should be prescription medicines.

Recommendations

• That salicylic acid should be a general sale medicine in preparations for dermal use containing 40% or less
• That salicylic acid should remain a restricted medicine in preparations other than dermal preparations containing 40% or less
• That choline salicylate should be a general sale medicine in preparations containing 10% or less and in packs containing 15 grams or less
• That choline salicylate should be a prescription medicine except in preparations containing 10% or less and in packs containing 15 grams or less
• That the NDPSC should be recommended to consider similar entries for choline salicylate.

8.6 Oxiconazole

The NDPSC recommendation was to add a prescription medicine entry for oxiconazole "except when specified elsewhere" to the New Zealand schedule in order to harmonise fully. The NDPSC had already agreed to harmonise on the over-the-counter classifications for external use in the New Zealand schedule.

Members noted that application of the recommendation would have no regulatory effect on products on the New Zealand market as oxiconazole did not appear to be used other than for external use. They agreed to harmonise by adding a prescription medicine entry to the New Zealand schedule.

Recommendation

That oxiconazole should be classified as a prescription medicine except when specified elsewhere in the schedule.

8.7 New chemical entities

The NDPSC had recommended that the following new chemical entities should be added to the New Zealand schedule as prescription medicines:

• Palifermin
• Rasagilin
• Olmesartan
• Lanthanum
• Pegvisoment
• Lapatinib
• Nilotinib

The Committee noted that lapatinib and nilotinib had already been dealt with under agenda item 7. Members agreed, that according to the agreed principles of harmonisation, the remaining medicines should be added to the New Zealand schedule as prescription medicines.

Recommendation

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

• Palifermin
• Rasagilin
• Olmesartan
• Lanthanum
• Pegvisoment

8.8 Nasal corticosteroids for OTC sale

The NDPSC recommendation was for the MCC to adopt the indication and age restriction into the pharmacy-only schedule entries.

These were essentially harmonised in that the indications and the age restriction were requirements in the New Zealand Regulatory Guidelines for pharmacy-only nasal corticosteroids. Adopting this recommendation would have no regulatory effect on any of the products currently on the New Zealand market.

The recommendation applied to the following medicines:

• Beclomethasone
• Budesonide
• Fluticasone
• Mometasone
• Triamcinolone

All the above corticosteroids were indicated for the prophylaxis or treatment of allergic rhinitis in adults and children over 12 years of age when sold as pharmacy-only medicines.

The Committee agreed that the indications and age limit should be added to each of their respective pharmacy-only schedule entries.

Recommendation

That the pharmacy-only schedule entries for beclomethasone, budesonide, fluticasone, mometasone, and triamcinolone should be amended to include the indications for the prophylaxis or treatment of allergic rhinitis in adults and children over 12 years of age.

8.9 Etidronic acid

The recommendation was to harmonise with the Australian classification. Etidronic acid was a prescription medicine in New Zealand but was unscheduled in Australia when in topical medicines containing 1% or less. Members noted that no New Zealand products would be affected by the change and they agreed to adopt the recommendation.

Recommendation

That etidronic acid should be classified as a prescription medicine except when in medicines for external use containing 1% or less.

8.10 Lobeline

The recommendation was to add a new pharmacy-only entry for lobeline to cover the alkaloid contained in lobelia. This was for consistency with the Australian schedule. No New Zealand products would be affected. The current exemptions for smoking or burning would apply to the new entry. The Committee agreed to adopt the recommendation.

Recommendation

That a new pharmacy-only entry should be made in the schedule for lobeline except when in preparations for smoking or burning.

8.11 Levonorgestrel for emergency contraception

The NDPSC had recommended that levonorgestrel should be reclassified from prescription medicine to restricted medicine when used for emergency contraception in order to harmonise with Australia.

Members were unanimous in that, if the recommendation were to be implemented, provision would need to be made for continued access by family planning nurses. Nurse designated prescribing could allow access for nurses at a later date but provision would need to be made in the interim. It was agreed that, if the recommended change were implemented, Medsafe should effect the most appropriate way to ensure continued access for accredited nurses.

Safety of the product for sale at a restricted medicine level did not pose any problems for members as this aspect had already been considered in depth at the time when the emergency contraceptive was made available to accredited pharmacists and nurses.

It was reported that pharmacists had responded well to the process of accreditation and were comfortable with this though some felt that the process could be shorter. Of approximately 2400 pharmacists registered in New Zealand, some 1500 had been accredited to sell the emergency contraceptive. Of the remainder, a number of these would be employed in hospital pharmacies and other places where accreditation to sell the product would not be necessary. Most pharmacies were thought to have someone accredited to sell the emergency contraceptive.

The Committee questioned the need for pharmacists to require accreditation for the sale of this medicine if it were to be reclassified when accreditation was not required for any of the other restricted medicines. It was suggested that, rather than legislate for accreditation, responsibility for accreditation should rest with the Pharmacy Council. Those who did not wish to sell the emergency contraceptive need not undergo the accredited training.

There was some concern that the product could be on display if it were to become a restricted medicine, and that sales might sometimes be made inappropriately by pharmacy assistants. However, members agreed that all the information for correct use was included in the package insert and it was the pharmacist's ethical responsibility to ensure that it was not sold inappropriately

The Committee noted that, to date, the wider availability of the emergency contraceptive did not appear to have reduced the abortion rate. This was thought to be due in part to the fact that there was little consumer awareness about the product. While there was no reason to prevent advertising, the company had not so far chosen to adverise. It was suggested that the sponsor company should be contacted to see if it would like to promote the product.

Members concluded that they were in agreement that the emergency contraceptive pill should be reclassified to restricted medicine with the following provisos:

Nurses should continue to have the same level of access to emergency contraception. Medsafe should put appropriate measures in place to ensure this.

Pharmacists should still require accreditation for the sale of the emergency contraceptive but that responsibility for accreditation should rest solely with the appropriate professional body. The Secretary should notify the Pharmacy Council, the Pharmaceutical Society and the Pharmacy Guild.

Recommendation

• That levonorgestrel should be classified as a restricted medicine when sold for emergency contraception
• That levonorgestrol should be exempt from its classification status when used for emergency contraception and sold by nurses recognised by their professional body as having competence in the field of sexual and reproductive health.

8.12 Lithium

The NDPSC had recommended that lithium should be exempt from scheduling when in preparations containing 0.25% of lithium as an excipient and that this exemption should apply only to dermal products.

In the interest of harmonisation, the Committee agreed to exempt pharmacy-only dermal medicines from scheduling when they contained 0.25% of lithium as an excipient.

Recommendation

• That the schedule entries for lithium be amended as follows:

  Prescription;

  except when specified elsewhere in the schedule;
  except when present as an excipient in dermal medicines containing 0.25% or less

  Pharmacy-only;

  for dermal use in medicines containing 1% or less
  except in medicines containing 0.01% or less;
  except when present as an excipient in dermal medicines containing 0.25% or less

• That dermal medicines containing less than 0.01% and dermal medicines containing 0.25% or less as an excipient should be general sale medicines.

8.13 Pyridoxine, pyridoxamine, pyridoxal

The NDPSC had recommended that the MCC should consider making new schedule entries for pyridoxamine and pyridoxal which were consistent with the entry for pyridoxine.

The Committee noted that pyridoxine was a general sale medicine in products containing 200 milligrams per recommended daily dose and was a prescription medicine in products above 200 milligrams per recommended daily dose. Members agreed that additional entries should be made for pyridoxamine and pyridoxal.

Recommendation

That pyridoxamine and pyridoxal should be classified as prescription medicines when in medicines containing more than 200 milligrams per recommended daily dose and general sale medicines in medicines containing 200 milligrams or less per recommended daily dose.

8.14 Sabadilla

New evidence had been presented to the NDPSC by Weleda and considered alongside the MCC recommendation for Australia to harmonise with New Zealand. The new evidence indicated that the general exemption of 10 milligrams per litre or per kilogram provided adequate coverage for Weleda products to be sold as general sale medicines. This meant that the previous pack-size and daily dose limits in the New Zealand schedule were considered to be no longer necessary.

The NDPSC recommended that the pharmacy-only and general sale entries should be deleted from the New Zealand schedule. In the light of the new evidence received by the NDPSC from Weleda, the single prescription medicine schedule entry should have no impact on homoeopathic products already on the market.

The NDPSC also recommended the inclusion of the botanical name, schoenocoulon officinale in the schedule.

The Committee agreed to recommend that all but the prescription medicine entry for sabadilla should be removed from the schedule. In addition, in the interest of harmonisation a prescription entry should also be made for schoenocoulon officinale.

Recommendation

• That sabadilla should be classified as a prescription medicine
• That a new prescription medicine entry should be made in the schedule for schoenocoulon officinale

8.15 Diclofenac as a pharmacy-only medicine

The schedule entries for diclofenac had previously been harmonised in all but one aspect. However, in Australia, pharmacy-only oral diclofenac was required to have a maximum recommended daily dose of 75 milligrams. The NDPSC had recommended that the MCC should harmonise on this recommended daily dose limit.

Members agreed that, as there had been no comment from a sponsor company, this dose limit was likely to be in effect already for any diclofenac products on the market. However, they queried the consistency of this recommendation in that maximum daily doses were not required in the SUSDP for some other non-steroidal anti-inflammatory medicines available as S2/pharmacy-only medicines,. They noted that while there was a maximum daily dose required for ibuprofen at S2 level, there was no such requirement for mefenamic acid or naproxen although adverse effects for this class were frequently dose related. It was agreed that the recommended daily dose for mefenamic acid would be the same whatever the level of classification in that it was used only for a single indication, dysmenorrhoea. Even though mefenamic acid might be used by consumers in a younger age range and for shorter periods of time than other analgesics, members felt that the requirement for a recommended maximum daily dose should apply to pharmacy-only preparations containing mefenamic acid as well as to those containing naproxen. This should be considered at the next meeting after consultation with sponsor companies as to what this dose should be.

Meanwhile, the maximum recommended daily dose for pharmacy-only diclofenac should be implemented and the NDPSC should be asked to consider applying maximum recommended daily doses to mefenamic acid and naproxen products sold as S2 medicines.

Recommendations

• That pharmacy-only medicines containing diclofenac should have a maximum recommended daily dose of 75 milligrams
• That Medsafe should consult with sponsor companies to ascertain an appropriate recommended maximum daily dose for mefenamic acid and naproxen tablets marketed as pharmacy-only medicines
• That the NDPSC should be recommended to consider applying a maximum recommended daily dose to S2 medicines containing naproxen and mefenamic acid.

8.16 Ibuprofen

The NDPSC had recommended that New Zealand harmonise with Australia on the requirements for pharmacy-only/S2 solid dose ibuprofen products to be limited to 100 units per pack and a maximum daily dose of 1200 milligrams.

New Zealand and Australia were already harmonised on these requirements. However, in NZ the requirements were currently included in the New Zealand Regulatory Guidelines for Medicines rather than in the schedule entry. They had been omitted from the schedule entry for ibuprofen in order to simplify an already lengthy entry. However, in the interest of closer alignment of the wording of both schedules in readiness for the commencement of the Australia New Zealand Therapeutic Products Authority, New Zealand had been asked to include the pack size limit and maximum daily recommended dose in the schedule entry.

The Committee observed that the rewording of the schedule entry for pharmacy-only ibuprofen to include these two requirements would have no regulatory impact on the classification of any of the registered products containing ibuprofen. This item had been included on the agenda in the interest of transparency in order to explain the anticipated change to the pharmacy-only schedule entry for ibuprofen.

Members agreed that the addition of the requirement for an upper pack size limit of 100 solid dose forms and a maximum recommended daily dose of no more than 1200 milligrams should be added to the pharmacy-only entry in the New Zealand schedule.

Recommendation

That the requirement for a pack size limit of 100 tablets and a recommended daily dose of not more than 1200 milligrams should be added to the pharmacy-only schedule entry for ibuprofen.

8.17 Liquorice, deglycyrrhizinised

The NDPSC had recommended that deglycyrrhizinised liquorice, should be removed from the New Zealand schedule.

Deglycyrrhizinised liquorice was exempt from scheduling under Appendix B in Australia. It was likely to have been classified as a prescription medicine in New Zealand because it was formerly indicated for the treatment of peptic ulcer. As this indication was no longer relevant, members agreed that the schedule entry should be removed.

Recommendation

That the prescription medicine entry for deglycyrrhizinised liquorice should be removed from the schedule.

8.18 Chlorquinaldol

The NDPSC had recommended that the general sale entry be removed from the schedule on the basis that there were no general sale items registered in either country. Currently chlorquinaldol was classified as a prescription medicine only when for internal use. The Committee agreed that there should be a single, unqualified prescription medicine entry for chlorquinaldol which would cover both internal and external uses.

Recommendation

That chlorquinaldol should be classified as a prescription medicine.

8.19 Deslorelin

The NDPSC recommendation was to add deslorelin to the schedule as a prescription medicine. Deslorelin is an analogue of gonadorelin which is a prescription medicine. Deslorelin was not scheduled in New Zealand.

The Committee agreed that, in the interest of harmonisation, deslorelin should be added to the schedule as a prescription medicine.

Recommendation

That deslorelin should be classified as a prescription medicine.

8.20 Dimethoxanate

The NDPSC recommendation was to add dimethoxanate to the schedule as a prescription medicine. Dimethoxanate is a cough suppressant scheduled as S4 in Australia.

The Committee agreed that, in the interest of harmonisation, dimethoxanate should be added to the schedule as a prescription medicine.

Recommendation

That dimethoxanate should be added to the schedule as a prescription medicine.

8.21 Fomivirsen

The NDPSC recommendation was to add fomivirsen to the schedule as a prescription medicine. Fomivirsen is an antiviral used in the treatment of cytomegalovirus retinitus.

The Committee agreed that, in the interest of harmonisation, fomivirsen should be added to the schedule as a prescription medicine.

Recommendation

That fomivirsen should be added to the schedule as a prescription medicine.

8.22 Lefetamine

The NDPSC recommended that lefetamine be added to the schedule as a prescription medicine. Lefetamine hydrochloride has analgesic properties and has been administered by intramuscular or subcutaneous injection.

The Committee agreed that, in the interest of harmonisation, lefetamine should be added to the schedule as a prescription medicine.

Recommendation

That lefetamine should be added to the schedule as a prescription medicine.

8.23 Ipriflavone

The NDPSC recommendation was to add ipriflavone to the schedule as a prescription medicine. Ipriflavone is a synthetic isoflavinoid that inhibits resorption of bone.

The Committee agreed that, in the interest of harmonisation, ipriflavone should be added to the schedule as a prescription medicine.

Recommendation

That ipriflavone should be added to the schedule as a prescription medicine.

8.24 Lodoxamide

The NDPSC recommendation was to add a prescription medicine entry for lodoxamide for uses other than in the eye in order to harmonise with Australia. Both countries classify lodoxamide as a pharmacy-only medicine when for ophthalmic use. Lodoxamide is used only in the eye.

The Committee agreed that, in the interest of harmonisation' a prescription medicine entry should be made. There would be no regulatory impact on medicines already on the market. Current eye products would retain their pharmacy-only classification.

Recommendation

That a prescription medicine entry be made in the schedule for lodoxamide when in medicines other than for ophthalmic use.

8.25 Pipradrol

The NDPSC recommendation was to add pipradrol to the schedule as a prescription medicine.. Pipradrol is a CNS stimulant which is administered orally.

The Committee agreed that, in the interest of harmonisation, pipradrol should be added to the schedule as a prescription medicine.

Recommendation

That pipradrol should be added to the schedule as a prescription medicine.

8.26 Riluzole

The NDPSC recommendation was to add riluzole to the schedule as a prescription medicine.. Riluzole is a glutamate agonist used in the management of amyotrophic lateral sclerosis.

The Committee agreed that, in the interest of harmonisation, riluzole should be added to the schedule as a prescription medicine.

Recommendation

That riluzole should be added to the schedule as a prescription medicine.

8.27 Scoplia carniolica

The NDPSC recommendation was to add scopolia carniolica to the schedule as a prescription medicine.. Scopolia carniolica contains tropane alkaloids.

The Committee agreed that, in the interest of harmonisation, scopolia carniolica should be added to the schedule as a prescription medicine.

Recommendation

That scopolia carniolica should be added to the schedule as a prescription medicine.

8.28 Tipepidine

The NDPSC recommendation was to add tipepidine to the schedule as a prescription medicine.. Tipepidine is a cough suppressant which is claimed also to have an expectorant action.

The Committee agreed that, in the interest of harmonisation, tipepidine should be added to the schedule as a prescription medicine.

Recommendation

That tipepidine should be added to the schedule as a prescription medicine.

8.29 Tolpropamine

The NDPSC recommendation was to add tolpropamine to the schedule as a prescription medicine.. Tolpropamine is an antihistamine which has been used topically for skin disorders.

The Committee agreed that, in the interest of harmonisation, tolpropamine should be added to the schedule as a prescription medicine.

Recommendation

That tolpropamine should be added to the schedule as a prescription medicine.

8.30 Mercuric oxide

The NDPSC recommendation was to add mercuric oxide to the schedule as a prescription medicine. Mercuric oxide was currently a pharmacy-only medicine in both countries when for ophthalmic use. However, there were no longer any products registered in either country.

The Committee noted that if mercuric oxide were reclassified to prescription medicine for all uses it would be covered by the entry for mercury and a separate entry would no longer be required.

Recommendation

• That the pharmacy-only entry for mercuric oxide be removed from the schedule.
• That the NDPSC be advised that there was no longer any need for a separate schedule entry for mercuric oxide.

8.31 Nicotinic acid/nicotinamide

The NDPSC had recommended that the MCC should delete nicotinamide from the New Zealand schedule and reword the nicotinic acid entry to harmonise with that in the SUSDP

In New Zealand both nicotinic acid and nicotinamide were currently restricted medicines when containing more than 100 milligrams per dose and general sale below this cut-off.

In Australia nicotinic acid was harmonised with the New Zealand but the S3 entry exempted nicotinamide as below:

Nicotinic acid: except

1. in preparations containing 100 mg or less per dose form
2. nicotinamide

The Chairman informed the Committee that the NDPSC had given further consideration to this matter at its October 2006 meeting and felt that discussion on nicotinic acid and nicotinamide should be held over until the NDPSC had finalised its position on these medicines.

The Committee agreed to postpone its recommendation on this agenda item and to consider the matter at the next meeting.

9 For the next meeting

9.1 Boron

See agenda item 8.1 above.

9.2 Chloramphenicol

One of the members requested that chloramphenicol for use in the eye should be considered for reclassification as an over-the-counter medicine. It was agreed that the secretary should contact the sponsor companies to ask if they would be prepared to make submissions for reclassification.

9.3 Mefenamic acid and naproxen

It was agreed earlier in the meeting that these two medicines should be considered at the next meeting with a view to establishing a suitable maximum recommended daily dose for packs sold as pharmacy-only medicines. (See agenda item 8.15)

9.4 Nicotinic acid and nicotinamide

Members wished to defer making a recommendation on nicotinic acid and nicotinamide until they had considered the outcome and any agenda material from the October 2006 meeting of the NDPSC.

9.5 Antihistamines in children under two years of age

See below.

10 General business 10.1

Antihistamines in children under two years of age

Some of the members had expressed a desire for further discussion about the earlier recommendation to classify these medicines as prescription medicines when for children under two years of age. There had been a number of enquiries about the reasons for the Committee's recommendation.

The Chairman informed the Committee that since the previous meeting an FDA Alert had also been published warning against the use of phenylephrine and pseudoephedrine in cough and cold preparations for children under two years of age. He added that some of the combination products implicated in the adverse reactions might also have contained antihistamines.

In summarising the reasons for the recommendation to make sedating antihistamines available only on prescription for children under two years of age, the Chairman pointed out that antihistamines were not particularly effective as cough and cold medicines. In addition, the products were undoubtedly misused for sedation in children in this age group. He said that the Committee needed to consider whether or not it wanted sedating antihistamines to be used in this way. He added that there was no information to show whether the adverse reactions in children in this age group related only to promethazine or whether it was a class effect which manifested itself because promethazine was used more frequently than other sedating antihistamines. He concluded that it was up to the sponsor companies to prove that their products were safe and the Committee had received no such information.

It was agreed that the matter should be returned to the agenda for the 38th meeting.

10.2 References in the First Schedule to the Medicines Regulations to the Toxic Substances Regulations 1983

The Secretary informed the Committee that the Toxic Substances Regulations had recently been superseded by new legislation. Queries as to the correct part of the new legislation to refer to in the schedule had not received a response at the time of the meeting. Reference to the Toxic Substances Regulations appeared to be relevant only to the entries for amyl nitrite and atropine.

The Committee agreed that the same level of access should continue to apply and that Medsafe should make any amendments to the schedule which were required to ensure continued access.

10.3 Access to amyl nitrite as an antidote to cyanide poisoning

Medicines Control had notified the Secretary that amyl nitrite as an antidote to cyanide poisoning was permitted for sale from outlets licensed to sell only sodium cyanide paste for vertebrate pest control. However, potassium cyanide was also used for vertebrate pest control and Medicines Control had requested an amendment to the amyl nitrite schedule entry to legalise the supply in conjunction with both of the above cyanide salts.

The Committee agreed that access should be extended and recommended that this could be achieved by amending the schedule entry to apply to cyanide rather than to sodium cyanide.

Recommendation

That the reference to the cyanide sodium salt should be removed from the schedule entry for amyl nitrite to allow amyl nitrite to be available as an antidote to any cyanide salt used for vertebrate pest control.

10.4 Reappointment of members

The Secretary informed the non-Ministry members that their term of office was due to expire. However, all had expressed a desire to serve for a further term of office and their respective nominating bodies had agreed that they were happy for their nominees to do this. The necessary paperwork to implement this had been forwarded to the Minister and members were due to receive letters of reappointment shortly.

10.5 Date for the next meeting

Some time after the first week in May was acceptable to members for the 37th meeting. A more precise date could be set once the agenda was ready to be published for consultation on the Medsafe website.

The meeting closed at 2:45 pm