Revised: 23 May 2013

Committees

Minutes of the 39th meeting of the Medicines Classification Committee - 25 June 2008

Held in the Medsafe Boardroom, Level 6, Deloitte House, 10 Brandon Street, Wellington. Commencing at 1:30pm.

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 Chris Laurenson
Secretariat, Expert Advisory Committee on Controlled Drugs
Mr Bruce Atmore
Secretariat, Expert Advisory Committee on Controlled Drugs
Mrs Kathy Daly
Medsafe(Until the end of item 5.2.3)

1. Welcome

The Chairman welcomed visitors to the meeting. Visitors and committee members introduced themselves briefly.

The Chairman also informed the Committee that two nominations had been received from the Pharmaceutical Society as possible replacements for Mrs Shirtcliffe whose term of office on the Committee had recently expired. Mrs Shirtcliffe was thanked for her valuable contribution over two terms of office on the Committee.

2. Apologies

There were no apologies.

3 CONFIRMATION OF THE MINUTES OF THE 38^TH MEETING

Members requested that a note should be made of the amendment to agenda item 5.2.1 on use of sedating antihistamines in children under two years of age.  The minutes quoted the Medsafe Report incorrectly in referring to deaths from use of these medicines having occurred in New Zealand.  Although deaths had been reported in children under two years of age these had not occurred in New Zealand.  This error had already been corrected in the minutes on the Medsafe website.

The Chairman corrected the error by deleting the words 'in New Zealand' from the appropriate part of the minutes and initialled the deletion.

The minutes were then accepted as an accurate record of the 38^th meeting and were signed by the Chairman.

4. Declaration of conflicts of interest

All but one of the members reported that they had no interests which would be in conflict with any of the items on the current agenda.

One member had declared some work done at least one year prior to the current meeting for various pharmaceutical companies including sales force effectiveness surveys and some training work on a prescription medicine.  This work could be perceived to pose a conflict of interest with the codeine-containing medicines on the current agenda.  While none of the work undertaken related specifically to over-the-counter medicines it was decided that, for the agenda item on codeine-containing medicines, this member should remain in the room to answer questions but otherwise should not take part in the discussion.

The same member also declared having worked on research around pharmacist experiences of oseltamivir supply paid by Roche and including travel to conferences in order to present the research.  It was agreed that the member should leave the room for the entirety of the oseltamivir discussion.

5 matters arising

5.1 Objections to recommendations made at the 38^th meeting

Iron

A query had been made about whether the recommendation made at the 38th meeting about the general sale classification of iron reflected the harmonised position with Australia and the intention of the committee.

The entry in the Gazette notice putting the Committee’s recommendation on iron into effect was therefore removed from the notice pending further investigation at the following meeting.

In order to harmonise with Australia the general sale status of iron in New Zealand should require a pack size limit of 750 milligrams only when each dose unit exceeded 5 milligrams.  The recommendation made at the previous meeting would result in all general sale iron products having to be limited to packs of not more than 750 milligrams.

It was agreed that the main point at issue was that of child poisonings.
If a pack size limit of 750 milligrams were applied to 5 milligram tablets a pack would be permitted to contain 150 tablets.  Members wondered if a child would be able to consume such a quantity.  It was noted that 40 milligrams per kilogram constituted a fatal dose for both adults and children. This would mean that a 10 kilogram child would need to consume approximately half of a 5 milligram pack containing 150 tablets to ingest a potentially fatal dose.

As at the previous meeting, there had been considerable discussion on how children might behave when ingesting iron tablets and whether or not the tablets had been prescribed or purchased as dietary supplements.  One member commented that one widely used dietary supplement product was particularly tasty and that both that product and those which were normally prescribed bore a close resemblance to sweets.

The Committee agreed that there was insufficient information available about the quantity and strength of tablets consumed in cases of child poisonings and whether these products had been prescribed or purchased as dietary supplements.  However, it was recognised that very few of the cases of reported child overdoses of iron had required medical intervention.  Bearing these factors in mind members agreed that there did not seem to be any evidence to justify classifying iron in a more restrictive manner than in Australia.  They therefore agreed to recommend that the upper pack size limit for general sale iron products should apply only to those packs containing more than 5 milligrams per dose unit.

Recommendation

That iron should be classified as a general sale medicine when:

• in packs containing not more than 24 milligrams per recommended daily dose and
• in medicines containing not more that 5 milligrams per dose unit or
• in medicines containing more than 5 milligrams per dose unit and in packs containing not more than 750 milligrams of iron

5.2 Matters arising from the 38^th meeting

5.2.1 Cough and cold medicines in children under 2 years of age

Following the recommendation to reclassify sedating antihistamines to prescription medicines when for children under the age of two and recent moves in the United States of America, the Committee wished to consider whether or not all cough and cold preparations should be contraindicated for use in children under the age of two years.

Two different expert committees of the Federal Drugs Administration (FDA) in the United States, the Non-Prescription Drugs Advisory Committee and the Pediatric Advisory Committee had jointly considered a petition to the FDA to contra-indicate cough and cold medicines, including sedating antihistamines, for use in children under six years of age.  These committees had recommended that cough and cold medicines should not be used in children under two years of age.  Further investigation was to be undertaken with regard to use of these medicines in children from two to six years of age.

The Chairman reported that the Medicines Adverse Reactions Committee (MARC) had already moved to contraindicate all cough and cold medicines in children under 2 years of age.  This included nasal drops.  Saline drops and vapour rubs were excluded and could still be used in infants under 2.  The basis for the MARC recommendation was that there was very limited evidence of efficacy in this age group, an absence of evidence-based dosage advice and evidence of significant toxicity in overdose.  Medsafe had already commenced the process of phasing in changes to dose instructions on product labels.

Members agreed that, in view of action already taken as a result of the MARC recommendation, there was no need for reclassification of these medicines.  They suggested that an article should be published in Prescriber Update to inform doctors about use of cough and cold medicines in children under two.*

No further recommendation was required.

*Secretary’s note:
An update on cough and cold preparations was published in Prescriber Update in June 2008 (Vol 29 No. 1)

5.2.2 Chloramphenicol to restricted medicine in eye preparations

The Committee continued its consideration of whether chloramphenicol eye preparations should be reclassified from prescription medicines to restricted medicines with particular interest in matters relating to the possible development of antibiotic resistance and to proposals for pharmacist training in the sale of such products.

With regard to resistance, it was noted that there had been no response from the Institute of Environment and Research (ESR) to a query about resistance figures for chloramphenicol.

Consultation documents relating to the reclassification of chloramphenicol eye ointment from the Medicines and Healthcare Products Regulatory Authority (MHRA) in the United Kingdom had stated that there were no resistance issues to prevent reclassification to an OTC status. However, there had been no supportive data in the consultation material.  The Committee agreed that more information should be sought from the MHRA on resistance data to support the reclassification of chloramphenicol.

Members noted that the effects of chloramphenicol have been debated and a Cochrane review in 2006 noted that bacterial conjunctivitis is frequently self-limiting but that the use of antibiotics can speed recovery. Any advantages from reclassification would be small rather than outstanding.

It was agreed that a major advantage of OTC sale would be the avoidance of a delay in treatment which would be likely to occur through the need to consult with a doctor. However, members noted that some 65% of red-eye conditions were viral and differentiation between viral and bacterial infections was difficult. Doctors were reported to be recognising this and moving away from use of chloramphenicol for all eye infections. Even though there appeared to be little evidence of resistance at this point it was thought by some members that wider use could lead to the development of resistance and that increased use from OTC sale was undesirable.

The Committee agreed that pharmacist training would be important if chloramphenicol were to be reclassified. As there had been no response from a sponsor company there had been no proposal for pharmacist training in diagnosis and appropriate use of the medicine. The Pharmaceutical Society of New Zealand had suggested possibilities for educational material that might eventuate should this medicine be reclassified. It was reported that pharmacist training in use of the medicine was good in Great Britain and it was suggested that one or more of the New Zealand pharmacy professional bodies might provide guidance in the sale of these eye products. Standardisation of product doses and course instructions and of required warning statements would be necessary. It was noted that pharmacists were interested in treating eye conditions but that more training was necessary particularly in relation to the need for medical referral of contact lens wearers with eye problems.

Members concluded that they did not yet have sufficient information available to make a recommendation. The following actions were agreed upon:

• The MHRA should be approached with a request for data on safety issues, including resistance issues, which led to the reclassification of chloramphenicol
• ESR should be approached for data about resistance to chloramphenicol
• Views should be sought from ophthalmologists and optometrists
• Sponsor companies should be invited to make submissions for reclassification including proposals for training pharmacists in diagnosis of eye conditions and appropriate sale of chloramphenicol
• Input should be sought from the Pharmacy Council and the Pharmaceutical Society particularly with regard to pharmacist training.

The Committee agreed that when sufficient information from the above sources had been collected, the matter should be returned to the Committee for further consideration.

No recommendation was required at this point in time.

5.2.3 Codeine in over-the-counter combination products

Further consideration was given to the Medsafe request that the MCC should consider whether or not the current Controlled Drug Class CVI status for codeine as a pharmacy-only medicine was still appropriate for combination products containing increasingly larger doses of codeine.  Over recent years the quantity of codeine in combination products had risen from under 10 milligrams per dose unit to 15 milligrams of codeine phosphate and there was currently an application pending for consent to market a product containing 30 milligrams of codeine phosphate per dose unit in combination with 500 milligrams of paracetamol and in packs of up to 96 tablets.  Controlled Drug CVI status allowed for medicines containing up to 100 milligrams of codeine and several other similar ingredients to be classified as a pharmacy-only medicine as long as it was in combination with another active ingredient from which the codeine could not be readily extracted.

Medsafe had proposed that codeine should be classified as follows:

• Pharmacy-only combination medicines containing codeine should be limited to products containing 12 milligrams or less of codeine and in packs containing not more than 50 dose units
• Packs containing more than 12 milligrams of codeine but not more than 30 milligrams and in pack sizes of not more than 12 dose units should be restricted medicines
• Any codeine combination products qualifying as CVI controlled drugs other than those fulfilling the above criteria for pharmacy-only or restricted medicines should be classified as prescription medicines.

Medsafe was of the opinion that these limits would accommodate most of the pharmacy-only codeine products currently on the market without requiring a change to their current classification status.

The initial concerns related to codeine were those of abuse and misuse. While manufacture of homebake appeared to have peaked in the 1990s and had been largely superseded by other drugs of abuse, there appeared to be a growing number of cases of intentional abuse of codeine in combination products containing ibuprofen or paracetamol. There was also evidence of unintentional abuse due to increasing doses in order to maintain a desired effect or for attempted control of rebound headache. Members noted that differences in metabolism meant some people experienced much greater effects from codeine than others.

While it was possible to take large quantities of codeine in combination with ibuprofen, similar quantities of codeine in combination with paracetamol would lead to major liver problems. However, it was noted that there had been instances of deaths which were believed to have been attributed to consumption of codeine in combination with ibuprofen.

It was also noted that there had been problems associated with babies who were breastfed by mothers taking codeine at recommended doses for postnatal pain.

One of the pharmacists on the Committee reported that while sales of paracetamol with codeine had remained steady, there had been an increase in sales of codeine with ibuprofen. Consultation with Auckland Community Alcohol and Drugs Services had revealed that those who were misusing codeine products tended to be people with a past history of drug or alcohol abuse or with psychological problems. There were known to be a number of websites devoted to abuse of codeine and methods of extraction. Because of a lack of understanding of the dependence potential of these products there also appeared to be a trend towards the development of dependence in patients who had had no previous addiction issues.

The Committee agreed that it would not be advisable for medicines with ever-increasing quantities of codeine to continue to be available for self-selection at pharmacies and that there should be some additional controls on combination products containing codeine.

There was discussion on whether the controls should be on dose limits or on pack sizes. The Chairman reported that Australia was keen to establish a framework with small packs being sold at pharmacy-only level and larger packs at a more restrictive level of classification. In Britain there had been voluntary control on pack sizes. The upper limit had been reduced to 32 tablets and information on rebound headaches and potential for addiction was included in the product information.

There was considerable discussion about what comprised an efficacious dose or a safe dose and at what level OTC pack sizes should be set. It was agreed that there was insufficient information at this stage to make a recommendation about cut-off levels for OTC sale and that more information should be sought prior to the next meeting. A proposal for these cut-off points should be advertised on the agenda for the next meeting in order to elicit responses about cut-off points from sponsor companies and other parties. However, it was agreed that a maximum of 15 milligrams per dose unit or 30 milligrams per recommended dose should be applied immediately as an upper limit for OTC sale. Recommended doses and dose units above this level should be classified as prescription medicines.

After more general discussion the Committee agreed that the following action should be taken:

• Any combination product containing more than 15 milligrams of codeine per dose unit should be reclassified as a prescription medicine immediately.
• Further consultation should be undertaken prior to the 30^th meeting about suitable cut-off points and pack size limits for pharmacy-only and restricted medicine levels of access based on the following proposal:*
  • pharmacy-only combination products should contain 12 milligrams or less of codeine per dose unit with a maximum recommended treatment period of 7 days and an upper pack size limit of 50 dose units.
  • restricted medicine combination products should contain 15 milligrams or less but more than 12 milligrams of codeine per dose unit and an upper pack size limit of 25 dose units.
  • all combination products containing more than 15 milligrams of codeine per dose unit should be prescription medicines.   Lower pack size limits for prescription medicine classification would be established after upper limits for pharmacy-only and restricted medicines had been finalised.
• Pharmaceutical companies should be asked to provide package information about rebound headaches and about the potential for addiction.
• Pharmacy professional bodies and pharmacy marketing groups should be notified that it is inappropriate to display codeine-containing products in dump bins and the Pharmacy Council should be asked to provide guidance to pharmacists about the display of these products.

Recommendation

That combination medicines containing more than 15 milligrams of codeine per dose unit and which comply with all other requirements for pharmacy-only sale as specified in Part VI(a) of the Third Schedule to the Misuse of Drugs Act 1975 should be reclassified from pharmacy-only medicines to prescription medicines.

* Secretary’s note
The NDPSC will shortly be discussing a different set of options for the classification of codeine in combination products.  These should be taken into account during the consultation period for the agenda of the 40^th meeting.

5.2.4 Potassium in glucosamine sulfate complexed dietary supplements

At the previous meeting the Committee had made the following recommendation:

• That potassium should be classified as a pharmacy-only medicine when for internal use:
  • in slow release or enteric coated forms
  • in medicines containing more than 100 milligrams per recommended dose
  • in glucosamine sulfate complexed products containing 100 milligrams or less of elemental potassium per recommended dose except when carrying a label warning against use with kidney problems and a statement of the potassium content per dose
  • except in medicines for oral rehydration therapy, parenteral nutrition replacement or dialysis
• That potassium should be a general sale medicine when:
  • for external use
  • for internal use in medicines containing 100 milligrams or less per recommended dose
  • in glucosamine sulfate complexed products containing 100 milligrams or less of elemental potassium and carrying a label warning against use with kidney problems and a statement of the potassium content per dose
  • in medicines for oral rehydration therapy, parenteral nutrition replacement or dialysis
• That Medsafe should be asked to write an article for 'Prescriber Update' informing doctors that glucosamine can be a significant source of potassium.

Medsafe had responded pointing out that glucosamine products were not currently regulated as medicines in New Zealand.  Therefore Medsafe would have no means of identifying glucosamine sulfate complexed products, establishing their potassium content or enforcing label warnings.  Implementation of this recommendation could also cause some complementary products to become scheduled medicines requiring consent to be marketed as medicines.  Medsafe did not consider this to be a desirable outcome for complementary products which had not shown any previous evidence of harm caused by their potassium content.

Medsafe had not supported the Committee recommendation and asked that the matter be returned to the Committee in order to seek a more feasible way of implementing its earlier recommendation for glucosamine sulfate complexed dietary supplements to carry a statement of the amount of potassium per dose and a warning against use by consumers with kidney problems.

Medsafe also suggested an alternative level of classification for potassium which harmonised with the Australian cut-off point between pharmacy-only and general sale medicine of 600 milligrams of potassium chloride per recommended dose.  The intention of the Medsafe recommendation was to preserve the current status of glucosamine sulfate complexed products.

Medsafe’s alternative advice had been submitted to the Minister’s Delegate alongside the Committee recommendation.  The Minister’s Delegate had accepted the following advice from Medsafe on the classification of potassium:

• That potassium should be classified as a pharmacy-only medicine when for internal use:
  • in slow release or enteric coated forms
  • in medicines containing more than 100 milligrams per recommended dose
  • in glucosamine sulfate complexed products containing more than 600 milligrams of potassium chloride per recommended dose
  • except in medicines for oral rehydration therapy, parenteral nutrition replacement or dialysis
• That potassium should be a general sale medicine when:
  • for external use
  • for internal use in medicines containing 100 milligrams or less per recommended dose
  • in glucosamine sulfate complexed products containing 600 milligrams or less of potassium chloride per dose
  • in medicines for oral rehydration therapy, parenteral nutrition replacement or dialysis
• That Medsafe should be asked to write an article for Prescriber Update informing doctors that glucosamine can be a significant source of potassium.

The Committee acknowledged that the only difference between its own recommendation and that of Medsafe was to the requirements for glucosamine sulfate complexed complementary products containing 600 milligrams or less but more than 100 milligrams of potassium chloride per dose.  Bearing in mind that complementary products containing up to 600 milligrams per dose were permitted in Australia and that there did not appear to have been problems in either Australia or New Zealand relating to the potassium content in glucosamine sulfate complexed products, the Committee agreed that Medsafe’s advice should apply.  The proposed schedule entries for potassium should be modified slightly to maintain the current classification of potassium while ensuring that glucosamine complexed products containing 600 milligrams or less of potassium chloride were not inadvertently captured as pharmacy-only medicines.

Recommendation

• That potassium should be classified as a pharmacy-only medicine when for internal use:
  • in slow release or enteric coated forms
  • in medicines containing more than 100 milligrams per recommended dose
  • except in medicines for oral rehydration therapy, parenteral nutrition replacement, dialysis or in glucosamine sulfate complexed products containing 600 milligrams or less of potassium chloride per recommended dose.
• That potassium should be a general sale medicine when:
  • for external use
  • for internal use in medicines containing 100 milligrams or less per recommended dose except in glucosamine sulfate complexed products containing 600 milligrams or less of potassium chloride per recommended dose
  • in medicines for oral rehydration therapy, parenteral nutrition replacement, dialysis
• That Medsafe should be asked to write an article for 'Prescriber Update' informing doctors that glucosamine can be a significant source of potassium.

Secretary’s note:
Additions to the current schedule entry for potassium to effect the recommendation are shown in italics.

6. Submissions for reclassification

6.1. Oseltamivir (Tamiflu, 75 mg capsules Roche)

This was a company submission for the reclassification of oseltamivir capsules from prescription medicine to restricted medicine.

Oseltamivir capsules were currently classified as prescription medicines but were exempt from prescription medicine status when sold by a registered pharmacist between May and September each year to a person over the age of 12 years presenting in a pharmacy with early symptoms of influenza.

As well as a change of classification, the company submission sought to remove the requirement for face-to-face consultation with a pharmacist as a condition of sale and the seasonal restriction of sales only during the influenza season.

There was considerable discussion of the benefits and drawbacks of removing the requirement for face-to-face consultation and of allowing the product to be sold at any time of year.  While year-round purchase would allow access to the product for travellers returning from the Northern Hemisphere, correct diagnosis would be difficult.  The positive predictive value of symptoms used in the diagnostic algorithm would decrease significantly outside the peak influenza period.  This meant that reliance on the presence of key symptoms could increase the rate of misdiagnosis as symptoms could apply to a range of conditions.  With the current arrangement pharmacists were informed when influenza was prevalent in their area.

It was noted that the requirement for face-to-face consultation had been introduced to prevent internet sales and the Committee was reluctant to make any amendment to the level of access which would allow internet sales.

Telephone consultation with patients would eliminate the need for infectious patients to present in person at a pharmacy.  This would be in line with the Ministry’s public health advice during the influenza season that patients should stay home to avoid spreading the virus.  However, it was noted that the advice to stay at home was intended to refer to the workplace rather than to collecting medicine from a pharmacy.  Telephone consultation would also allow pharmacists to deliver the medicine, or courier it to influenza sufferers in remote areas or to sell it to a carer on behalf of a patient too ill to go to a pharmacy.

One of the pharmacists suggested that removal of the need for face-to-face consultation would enable pharmacists to provide a valuable service to businesses by getting sick workers back to work earlier.  Some members were uncomfortable with this scenario, fearing that there could be exploitation of such an arrangement.

The Committee noted that New Zealand was the only country so far to make oseltamivir available without a prescription.  Australia had recently rejected a second application for sale of oseltamivir without a prescription as a pharmacist-only/S3 medicine.

The Committee noted the data provided describing the emergence of an influenza strain which demonstrated increased resistance to oseltamivir.  The data reports of increased resistance indicated that the emergence of the resistant strain appeared to be the result of genetic drift rather than to selective pressure on the virus secondary to use of oseltamivir.  The finding that resistance to oseltamivir was highest in countries where oseltamivir was rarely prescribed and was lowest in Japan, the country with the highest rate of use of oseltamivir, supported the Committee’s conclusion.  The Committee noted that increased monitoring in New Zealand had found no reports of resistant isolates of influenza being identified in the 2007 influenza season.  The rate of resistance to oseltamivir in New Zealand remained unchanged.  The Committee was reassured that the monitoring system in New Zealand was of high quality and was included in the global monitoring programme for influenza.

Overall, the Committee concluded that there was not yet sufficient evidence of use of the product to determine how well it had performed during an influenza season.  The previous winter had been a relatively light influenza season and sales had been comparatively low.  In addition, public awareness of the changed level of access to oseltamivir was unlikely to have peaked.  One member reported that there had been a maximum sale of only 180 units either sold or prescribed in any one week.  Members wondered whether a change of classification would make any difference to these figures.  They agreed that they would prefer to gather more data from pharmacists or others on how successful the current level of availability had been over the current influenza season before recommending any change to the current arrangement.  They agreed that there should be no change to the classification of oseltamivir at this stage but that the matter should be returned to the Committee at such time as more information became available.

Recommendation

That there be no change to the current classification of oseltamivir.

7. New Medicines for classification

The following new chemical entities had been forwarded from the Medicines Assessment Advisory Committee for classification.

Etravirine (Intelence)

Etravirine is a non-nucleoside reverse transcriptase inhibitor of human immunodeficiency virus type 1.

The proposed indication is for use in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus type 1 infection in antiretroviral treatment-experienced adult patients, including those with non-nucleoside reverse transcriptase inhibitor resistance.

Alpha₁-proteinase inhibitor (human) (Zemaira)

Human Alpha₁-proteinase inhibitor is understood to be the primary antiprotease in the lower respiratory tract, where it inhibits neutrophil elastase.

The proposed indication is for chronic augmentation and maintenance therapy in individuals with alpha₁-proteinase inhibitor deficiency and clinical evidence of emphysema.

Maraviroc (Celsentri)

Maraviroc is the first agent of a new pharmacological class of antiretroviral agents known as CCR5 antagonists which act on a human cellular target to prevent infection of the cell by HIV-1.

The proposed indication is for use in combination with other antiretroviral medicinal products for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable.

Lenalidomide (Revlimid)

Revlimid is the lead ImiD of a class of proprietary novel immunomodulatory drugs derived from thalidomide’s structure. Based on the molecular structure of thalidomide, lenalidomide hasbeen developed with a view to improving the immunomodulatory effect of the parent compound whilst providing a better profile.

The proposed indication is for use in combination with dexamethasone in patients with multiple myeloma whose disease has progressed after one therapy.

Tocilizumab (Tocilizumab Roche).

Toculizumab is a novel recombinant humanised anti-human monoclonal antibody of the immunoglobulin G1 sub-class.

The proposed indication is for the treatment of moderate to severe active rheumatoid arthritis in adult patients.  Tocilizumab can be used alone or in combination with methotrexate and/or other disease-modifying anti-rheumatic drugs.

Dapoxetine hydrochloride (Priligy)

Dapoxetine is a potent and selective inhibitor of serotonin reuptake.  The proposed indication is for the treatment of premature ejaculation in men 18 to 64 years of age who have all of the following:

• Persistent or recurrent ejaculation with minimal sexual stimulation before, on or shortly after penetration and before the patient wishes; and
• Marked personal distress or interpersonal difficulty as a consequence of PE; and
• Poor control over ejaculation.

Sugammadex (Bridion)

Sugammadex is a modified gamma-cyclodextrina which encapsulates rocuronium or vecuronium molecules and forms a tight irreversible complex leading to complete reversal of neuromuscular blockade.

The proposed indication is the reversal of neuromuscular blockade induced by rocuronium or vecuronium.

Idursulfase (Elaprase).

Idusulfase is a recombinant human enzyme iduronate-2-sulphatase.

The proposed indication is for the treatment of patients with Hunter syndrome, also known as Mucopolysaccharidosis II.

The Committee agreed that the indications for these new chemical entities were all for conditions requiring medical intervention in their treatment.  None was of a nature which required inclusion as a controlled drug under the Misuse of Drugs Act 1975.

Recommendation

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

• Alpha₁-proteinase inhibitor (human)
• Dapoxetine hydrochloride
• Etravirine
• Idursulfase
• Lenalidomide
• Maraviroc
• Sugammadex
• Tocilizumab

8. Harmonisation of New Zealand and Australian schedules

8.1 Update on harmonisation matters

The secretary reported that, other than some new chemical entities which were classified in New Zealand but not in Australia, there did not appear to be any further items which had been harmonised by the Australian national Drugs and Poisons Schedule Committee (NDPSC) since the previous meeting of the MCC in December 2007.  She reported that there were very few harmonisation matters still outstanding.  Some of these would be resolved at the current meeting.  There were several items including fluorides, which were still being considered by the NDPSC.  These would not be brought to the MCC for consideration until the NDPSC had reached a final position.

8.2 Recommendations made by the NDPSC to the MCC in October 2007 and February 2008

8.2.1 Cadmium compounds and cadmium sulfide

The NDPSC had recommended that the MCC be asked to make prescription medicine entries in the schedule in order to prevent human therapeutic use of these substances and to harmonise with entries in the SUSDP.

The Committee agreed that, because of its toxicity, cadmium should not be used for therapeutic purposes.  However, in order to allow for possible homoeopathic use it was decided that, rather than make cadmium a prescription medicine at all strengths, the general exemption of 10 milligrams per litre or per kilogram should apply.

Members also agreed that a single generic entry for cadmium as a prescription medicine afforded adequate cover for both compounds and salts.

Recommendation

That a new entry should be made in the schedule to classify cadmium as a prescription medicine.

8.2.2 Fractionated and recombinant blood products

The NDPSC had recommended that New Zealand should harmonise with Australia on the level of access to fractionated and recombinant blood products.  These were exempt from scheduling under Appendix A of the Australian schedule.  In New Zealand all blood products except Factor VIII were currently classified as prescription medicines.  Factor VIII had already been reclassified to general sale medicine some years earlier in order to harmonise with the Australian level of access.

The Committee acknowledged that the closest that New Zealand could do to align with the Australian exemption from scheduling for these products would be to reclassify all fractionated and recombinant blood products to general sale.  Members thought that risks from a classification change would be low as products were supplied only from hospitals or blood centres and would continue to be distributed through the same routes if they were to be reclassified.  There appeared to have been no problems in Australia relating to blood products available on an unscheduled basis.  Products would still require evaluation at the current level before gaining consent to be marketed.

The Committee agreed to recommend that fractionated and recombinant blood products should be reclassified as general sale medicines.  Medsafe should identify which of the schedule entries needed to be amended to reflect this change.

Recommendation

That fractionated and recombinant blood products should be reclassified from prescription medicines to general sale medicines.

8.3 New medicines which are prescription medicines in Australia but which are not scheduled in New Zealand.

8.3.1 Panitumumab

Panitumumab is a recombinant human IgG2 Kappa monoclonal antibody that binds to the epidermal growth factor (EGRF) specifically on both normal and tumour cells.  The proposed indications are for the treatment of EGFR expressing, metastatic colorectal carcinoma in patients who have disease progression following treatment with fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy.

Panitumumab would already be classified as a prescription medicine under the generic entry for monoclonal antibodies.  However, the Committee agreed that a separate entry should be made in the schedule.

Recommendation

That a new entry should be made in the schedule for panitumumab as a prescription medicine.

8.3.2 Miglustat

Miglustat is an N-alkylated imino sugar, a synthetic analogue of D-glucose.  It actively reduces substrate production as an inhibitor of the enzyme glucosylceramide synthase which is a glucosyl transferase enzyme responsible for the first step in the synthesis of most glycosphingolipids.

The proposed indications are for the oral treatment of patients with mild to moderate Type 1 Gaucher disease for whom enzyme replacement therapy is unsuitable and for oral maintenance therapy of patients with Type 1 Gaucher disease stabilised on enzyme replacement therapy.

The Committee agreed that miglustat should be classified as a prescription medicine.

Recommendation

That miglustat should be classified as a prescription medicine.

8.3.3 Agomelatine

Agomelatine is a melatonin agonist and a serotonin receptor antagonist.  The proposed indication is for the treatment of major depression.

The Committee agreed that this indication required medical supervision and that agomelatine should be classified as a prescription medicine.

Recommendation

That agomelatine should be classified as a prescription medicine

8.3.4 Zonisamide

Zonisamide is an anticonvulsant.  The proposed indication is for adjunctive therapy in the treatment of adult patients with partial seizures, with or without secondary generalisation.

Members noted that zonisamide had already been approved for use in a number of countries.  They agreed that, because of the nature of the condition for which the medicine was indicated, zonisamide should be classified as a prescription medicine.

Recommendation

That zonisamide should be classified as a prescription medicine.

9. FOR FUTURE MEETINGS

9.1 Agenda items to be returned to the 30^th meeting

The following items from the current agenda would be carried to the 30^th meeting:

• Chloramphenicol for reclassification from prescription medicine to restricted medicine when for ophthalmic use. (see agenda item 5.2.2)
• Codeine in combination products to establish cut-off points and/or maximum pack sizes for over-the-counter sale.  (See agenda item 5.2.3)
• Oseltamivir for possible reclassification from prescription medicine to restricted medicine if adequate data is available. (see agenda item 6.1)

9.2 Possible candidates for consideration at future meetings

Members discussed a number of medicines which they thought might be suitable for reclassification from prescription medicines to over-the-counter medicines.  They agreed that sponsor companies should be encouraged to make submissions for these medicines and that general comment should also be sought.  A further opportunity for more specific comment would be available to interested bodies once a submission for a particular medicine had been made and posted on the Medsafe website as a forthcoming agenda item.

The medicines suggested were:

• Influenza vaccine
• Steroid inhalers
• Oral combined contraceptives
• Oral progestogen only contraceptives
• Topical calcipotriol (for self-treatment after diagnosis has occurred)
• Pantoprazole
• Domperidone
• Mebeverine
• Simvastatin and other statins
• Oral aciclovir for genital herpes and possibly for shingles
• Azithromycin for chlamydia

10 General Business

The Chairman told the Committee that he would like to investigate the use of electronic means to provide the agenda papers for meetings. While this would require that members to do all their preparatory work at a computer, it would cut down on the need to carry large amounts of paper and for the need for multiple photocopying of agenda papers. He said that the NDPSC now received all its papers on CD. While there had been some initial doubts from NDPSC members, they were now happy with this method. The Committee agreed that it would be willing to trial this.