Classification of Medicines

Agenda Items for the 25^th Medicines Classification Committee Meeting

Agenda items for the 25^th meeting of the Medicines Classification Committee to be held in April or May 2001

Comments are invited from interested parties. These should be received by the Secretary, Medicines Classification Committee, PO Box 5013 Wellington by 6 April 2001
To download company submissions please click on the company name. Medsafe reports will be available later.

MATTERS ARISING FROM THE 24TH MEETING

Paracetamol The MCC is seeking comment on whether or not pack sizes should be reduced for general sale.  This follows the results of a British study, Reduction in Incidence of Severe Paracetamol Poisoning, published in The Lancet, Vol 355, in June 2000.  Current maximum pack sizes for general sale are:

Australia 12.5 grams
New Zealand 10 grams
UK 8 grams

Submissions for reclassification

Aconite A Weleda submission for reclassification of alkaloids of aconite from prescription medicine to allow pharmacy-only sale at some strengths and for a change to the level for exemption from scheduling.
Weleda submission (Microsoft Word document 61KB)
Report on appropriate classification for Aconite (Microsoft Word document 41KB)

Belladonna A Weleda submission for modification to the current cut-off points for restricted and pharmacy-only medicines and a change to the exemption from scheduling. For details refer to the company submission.
Weleda submission (Microsoft Word document 60KB)

Emergency contraceptive pill (ECP) (morning-after pill)
A medsafe proposal to revisit the possibility of making emergency contraception available over the counter.  The Committee had earlier recognised the Yuzpe regimen as being sufficiently safe for OTC sale but, for a number of reasons, the recommendation had not proceeded.  A safer, single-ingredient regimen containing levonorgestrel only has since become available and it is this regimen which will now be considered by the MCC.  The levonorgestrel only regimen is available over the counter in Britain, France and several other countries.  Please note that the MCC will consider comments on issues related to consumer safety and ease of access.  It does not make recommendations on moral or ethical issues.

Hydrocyanic acid A Weleda submission for reclassification from prescription medicine to allow pharmacy-only sale at some strengths and for a change to the level for exemption from scheduling.  For details refer to the company submission.
Weleda submission (Microsoft Word document 54KB)
Report on appropriate classification for Hydrocyanic acid (Microsoft Word document 51KB)

Hyoscine, hyoscyamine, hyoscyamus A Weleda submission for amendments to the schedule entries for hyoscine and hyoscyamine and to their proposed exemption limit and for additional, consistent entries for hyoscyamus. For details refer to the company submission.
Weleda submission (Microsoft Word document 61KB)

Paracetamol 665mg modified release tablets.  A GlaxoSmithKline submission for reclassification from prescription medicine to pharmacy-only medicine
GlaxoSmithKline submission (Microsoft Word document 135KB)

Sabadilla A Weleda submission for reclassification from prescription medicine to allow pharmacy-only sale at some strengths and for a change to the level for exemption from scheduling. For details refer to the company submission
Weleda submission (Microsoft Word document 60KB)

Harmonisation of NZ and Australian Schedules

Outstanding recommendations from the Australian National Drugs and Poisons Schedule Committee (NDPSC) to the MCC

Prescription medicines in Australia which should be added to the New Zealand schedule:

ambucetamide
octatropine
phenthimentonium bromide
pipenzolate
piperidolate
tigloidine

There are no medicines registered in New Zealand containing any of the above substances.

Anticholinergics recommended for change from restricted medicine to prescription medicine:

adiphenine
ambutonium bromide
benzilonium bromide
hexocyclium methylsulphate
mepenzolate
methanelinium bromide
oxybutinin
oxyphencyclimine
oxyphenonium bromide
penthienate
tiemonium iodide
tricyclamol
tridihexethyl

Oxybutinin tablets and syrup would be affected by a classification change

Clidinuim bromide
From pharmacy-only to prescription medicine.  There would be no regulatory effect as the only product registered in New Zealand also contains a controlled drug which determines its classification.

Herbal medicines for which exemption from prescription status has been requested
Various members of the complementary medicines sector have requested a delay in implementing a recommendation to classify the medicines listed below as prescription medicines.  Those who requested a delay and any other interested bodies should now submit safety date to support a concentration at which these medicines would be safe for general sale.  The medicines are:

Injectable medicines
A basic principle of harmonisation previously agreed by both countries is that, where their schedules did not harmonise, they would adopt the less restrictive classification unless there were valid safety issues for the medicines concerned.  In the case of injectable medicines the Medicines Classification Committee has accepted a recommendation from the Australian Natonal Drugs and Poisons Schedule Committee that, on safety grounds, all injectable medicines which were already prescription medicines in Australia should become prescription medicines in New Zealand.

Application of this recommendation has resulted in the following changes or proposed changes in respect of injectable medicines:

¹ A cut-off point in strength would be necessary to allow alcohol to remain general sale when used as an excipient or in parenteral nutritional replacement preparations. Suggestions as to an appropriate level to accommodate the above products as general sale medicines would be welcome.

² To achieve the desired general sale classification for nutrition replacement preparations for parenteral administration, it will be necessary to amend the schedule entries for all classified ingredients of such solutions. Medsafe has so far identified colecalciferol, folic acid, vitamin A, tryptophan, zinc chloride, iron and fluoride in this category. Sponsor companies were asked to alert Medsafe to any other schedule entries which need to be modified to give effect to the proposal.

³ Provision will be necessary for its continued general sale status when used as an excipient in an injection. Comments on a suitable concentration cut-off point to accommodate this use would be welcome.

To put these changes into effect it will be necessary to remove the pharmacy-only entry for injectable medicines from the schedule so that injectable medicines are classified according to their active ingredients.

Other changes related to harmonisation of injectables

• Acetylcysteine. As acetylcysteine is present as an excipient in some contact lens preparations, a general sale category for external use will be necessary.
• Fluorescein. Preparations other than for injection should become general sale in line with the NDPSC recommendation considered by MCC at the 24th meeting.
• Hyaluronic acid (sodium hyaluronate). To move to general sale except for injection to harmonise fully with Australia.

Pseudoephedrine
Harmonisation of pack sizes. The Australian upper pack size limit for uncompounded tablets is 30 dose units of 60mg or less each rather than 60 dose units as considered at the last meeting.

Salbutamol and Terbutaline
Since publication of the recommendation below, the NDPSC has given further consideration to the classification of salbutamol and terbutaline and has made a further recommendation.

The recommended harmonised position for salbutamol and terbutaline is described in the table below.

Reasons for the recommended classifications

The proposed harmonised position would increase the availability of inhalers containing salbutamol and terbutaline as the only active ingredient by making them available without prescription from a pharmacist.

Increasing access to these products has been proposed to New Zealand as inhaled metered dose aerosols and dry powder inhalers have been available over the counter in Australia as restricted medicines for a period of more than 5 years with no evidence of harm from their use.

However, due to evidence of abuse of oral products, and concerns about the toxicity of high doses of salbutamol and terbutaline, the recommendation is to move oral doses forms of these substances back to prescription medicine status in New Zealand.

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

Terbutaline as the only therapeutically active substance in metered aerosols delivering 250 micrograms or less of terbutaline per metered dose.

Although the NDPSC has not yet made a recommendation about harmonising oral forms of salbutamol and terbutaline, the MCC also wishes to consult on these.  The current classification of both medicines is as follows:

Oral forms available in New Zealand as restricted medicines are:

Trichloroacetic acid
The Pharmaceutical Society did not support the recommendation to remove trichloroacetic acid from the schedule on the grounds that the raw chemical was thought to be used for therapeutic purposes such as skin peeling and the removal of tattoos.  The MCC is seeking further information on therapeutic uses of trichloroacetic acid.

Recommendations made by the Australian National Drugs and Poisons Schedule Committee to the Medicines Classification Committee in August 2000

Abbreviations used:

1. Loperamide
   Amend the pharmacy-only entry to limit pack sizes to a maximum of 20 dosage units.  Approximately 50% of NZ products wuld become prescription medicines.
   
   
2. Triamcinalone acetonide nasal sprays
   Move from prescription medicine to restricted medicine for the short-term treatment or prophylaxis of seasonal allergic rhinitis in adults and children 12 years and over when in aqueous nasal sprays delivering 55 micrograms or less per actuation when the maximum recommended daily dose is 220 micrograms and the pack contains a maximum of 120 actuations.

Recommendations made by the NDPSC to the MCC in November 2000

1. Lithium
   Amend the pharmacy-only entry to allow preparations containing 0.01% or less to be unscheduled medicines.
   
   
2. Acetylcysteine
   To be pharmacy-only when for oral use.  See also the item on injectable medicines.  Final harmonised position to be:
   

   PM	injection, inhalation
   PO	oral use
   GS	external use ie, contact lens solutions

   
   
   

3. Glyceryl trinitrate, isosorbide dinitrate
   The following classifications should apply:
   
   Glyceryl trinitrate

   PM	injection, transdermal patches
   PO	oral preparations, dermal and rectal preparations
   All transdermal patches would move from PO to PM

   
   Isosorbide dinitrate

   PM	except in oral preparations containing 10mg or less per dose unit
   PO	in oral preparations containing 10mg or less per dose unit
   One product would move from PO to PM

4. Isoetharine
   Adopt the INN which is isoetarine.  Delete the RM entry so that all dose forms are prescription medicines.  There are no longer any products registered in NZ containing isoetharine.
   
   
5. Rimiterol
   Delete the RM entry so that all dose forms are prescription medicines.  There are no remiterol products which are registered as restricted medicines in New Zealand.
   
   
6. Isoprenaline
   Delete the PO entry.  There are no PO products registered in New Zealand which contain isoprenaline.
   
   
7. Salcatonin
   Add to the schedule as a PM.  Medsafe has previously considered the calcitonin entry to provide adequate cover for salmon calcitonin.
   
   
8. Tasonermin
   Add to the schedule as a PM.  This is a new chemical entity which does not have consent to market in NZ.