1.

WELCOME

2.

Apologies

3.

Confirmation of the Minutes of the 39th Meeting

4.

Declaration of Conflicts of Interest

5.

MATTERS ARISING

5.1

Blood and blood products

The Australian Appendix A exemption from scheduling for blood and blood products was discussed by the NDPSC at the October 2007 meeting. The wording of the exemption was later amended to avoid inadvertent capture of recombinant versions of other naturally occurring human proteins. The recommendation made at the last MCC meeting also needs to be amended if it is to avoid capture of these substances.

The current exemption from scheduling in Australia is as follows:

Human blood products including:

1. whole blood
2. blood components including red cells, white cells, platelets and plasma (including cryoprecipitate); and
3. the following plasma-derived therapeutic proteins and their equivalent recombinant alternatives:
   • albumin;
   • anticoagulation complex;
   • clotting factors;
   • fibrinogen;
   • protein C;
   • prothrombin complex concentrate; and
   • thrombin

The Committee will consider whether it wishes to amend its earlier recommendation to align more closely with the Australian exemption from scheduling for blood and blood products and to avoid capture of recombinant versions of other naturally occurring human proteins such as filgrastim, ancestim, interferon and erythropoietins.

5.2

Chloramphenicol for eye use

Ongoing discussion about whether or not chloramphenicol eye products should be reclassified from prescription medicines to restricted medicines.  Comments are sought particularly from product sponsor companies.

5.3

Codeine cut-off points and pack sizes for OTC sale

Ongoing consideration to determine suitable cut-off points and pack sizes for over-the-counter combination products containing codeine. A recommendation from the Codeine Working Party of the Australian National Drugs and Poisons Schedule Committee is expected in October 2008.

The MCC proposal from the 39^th meeting is that:

• pharmacy-only combination codeine 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.

5.4

Oseltamivir

Consideration of any relevant data available from the 2008 influenza season which might justify reclassification to restricted medicine from prescription medicine with an exemption allowing sale by pharmacists during the influenza season.

6.

Submissions for Reclassification

6.1.

Aloes for internal use

This is a Medsafe submission requesting a change to the classification of aloes when for internal use so that the pharmacy-only entry captures only the components responsible for stimulant laxative activity.

Aloin, the substance responsible for the laxative action, is present in the sap of aloe vera. It is not contained in the mucilaginous gel obtained from the leaves of aloe vera.

The proposal is that aloes for internal use should be classified as pharmacy-only medicines except when derived from the mucilaginous gel obtained from the leaves of aloe vera.

Aloin should continue to be classified as a pharmacy-only medicine.

6.2

Ketotifen fumarate 0.025% for ophthalmic use (Zaditen, Novartis)

This is a joint submission from Novartis and the New Zealand Association of Optometrists for the reclassification of 0.025% ketotifen fumarate eye drops from restricted medicine to pharmacy-only medicine and for an exemption to allow sale by registered optometrists.

6.3

Lansoprazole 15 milligram modified release capsule ( Solox Relief, Douglas)

This is a company submission for the reclassification of 15 milligram modified release capsules from prescription medicine to restricted medicine for the short-term, symptomatic relief of reflux-like symptoms in sufferers aged 18 years and over.

6.4

Omeprazole 10 milligram modified release capsule (AstraZeneca)

This is a company submission for reclassification of 10 milligram modified release capsules from prescription medicine to restricted medicine for relief of reflux-like symptoms (eg heartburn) in patients aged 18 and over.

6.5

Omeprazole 10 milligram modified release capsules ( Omezol, Pacific)

This is a company submission for reclassification from prescription medicine to restricted medicine for 10 milligram modified release capsules for the short-term, symptomatic relief of reflux-like symptoms in sufferers aged 18 years and over.

7.

New Medicines for Classification

8.

Harmoisation of New Zealand Australian Schedules

8.1

New chemical entities which are not yet classified in New Zealand.

8.2

Recommendations made by the NDPSC to the MCC in June 2008

8.2.1

Fluorides

The NDPSC has now finalised its review of the scheduling of fluorides.  The MCC will consider harmonising with the Australian cut-off points for different levels of classification.  The Australian classification is as follows:

S4/Prescription Medicine
In preparations for human use except when included in or expressly excluded from Schedule 2 or 3

S3/Restricted Medicine
For human topical use:

1. in liquid preparations containing 5500 mg/kg or less of fluoride
   ion, in  a container with a child-resistant closure except when included in or expressly excluded from Schedule 2; or
2. in non-liquid preparations containing 5500 mg/kg or less of fluoride ion except:
   1. in preparations for therapeutic use containing 1500 mg/kg or less of fluoride ion and, when containing more than 1000 mg/kg fluoride ion, compliant with the requirements of the Required Advisory Statements for Medicine Labels;
   2. in preparations for non-therapeutic use containing 1500 mg/kg or less of fluoride ion and, when containing more than 1000 mg/kg fluoride ion, labelled with warnings to the following effect:
      A: Do not swallow; and
      B: Do not use [this product/name of product in children six years of age or less; or
   3. in preparations supplied to registered dental professionals or by approval of an appropriate authority.

S2/Pharmacy-Only Medicine

1. in preparations for ingestion containing 0.5 mg or less of fluoride ion per dosage unit; or
2. in liquid preparations for topical use containing 1000 mg/kg.or less of fluoride ion, in a container with a child-resistant closure:
   1. for therapeutic use when compliant with the requirements of the Required Advisory Statements for Medicine Labels except in preparations containing 220 mg/kg or less of fluoride ion, in packs containing not more than 120 mg total fluoride when fitted with a child-resistant closure and compliant with the requirements of the Required Advisory Statements for Medicine Labels; or
   2. for non-therapeutic use when labelled with warnings to the following effect:
      1. Do not swallow; and
      2. Do not use [this product/name of product] in children six years of age or less,

      except in preparations containing 220 mg/kg or less of fluoride ion, in packs containing not more than 120 mg total fluoride, when fitted with a child-resistant closure and labelled with warnings to the following effect:

      1. Do not swallow; and
      2. Do not use [this product/name of product] in children six years of age or less,

      except in preparations containing 15 mg/kg or less of fluoride ion or preparations supplied to registered dental professionals or by approval of an appropriate authority.

The MCC will consider whether or not to harmonise with the above classification levels.  For the current NZ classification see: www.medsafe.govt.nz/profs/class/classintro.asp

8.2.2

Nitric Oxide

A prescription medicine entry for nitric oxide should be added to the New Zealand schedule.

8.2.3

Alglucosidase

The New Zealand prescription medicine entry for alglucosidase alfa should be amended to alglucosidase.

8.2.4

Glyceryl trinitrate for rectal use

Glyceryl trinitrate for rectal use should be classified as a restricted medicine.

The current schedule entry for glyceryl trinitrate for external use classifies rectal use as a pharmacy-only medicine. There is one current glyceryl trinitrate rectal product registered in New Zealand.

9.

For the Next Meeting

10.

General Business