Revised: 19 June 2013
Committees
Medicines Classification Committee Out-of-Session Consultation December 2005 Agenda 34A
- Amphotericin objection to recommendation to reclassify
The Pharmaceutical Society has objected to the recommendation made at the 33rd meeting to reclassify amphotericin from restricted medicine to prescription medicine when in lozenges for the treatment of oral candidiasis. The objection was made on the grounds that due process had not been observed in the consultation process. The standard consultation process has now been undertaken. The company concerned has reiterated its earlier support of the reclassification to prescription medicine to harmonise with the Australian scheduling. No other response has been received.
Material submitted by the Pharmaceutical Society in support of the objection has been provided.
Background material in support of the National Drugs and Poisons Schedule Committee (NDPSC) recommendation to reclassify amphotericin to prescription medicine has also been provided.
- New chemical entities for classification
These are new chemical entities in medicines which have not yet received consent to market and have been referred to the Committee by the Medicines Assessment Advisory Committee.
Deferasirox
Tigecycline - Icodextrin
A recommendation from the NDPSC to reclassify from pharmacy-only medicine to general sale on the grounds that:
- the intention is that medicines for dialysis should be general sale medicines in NZ
- icodextrin is unscheduled in Australia.
- Quassia
The NDPSC has recommended that quassia should be removed from the schedule on the basis of harmonisation at the lower level of access. There are no products registered in NZ which contain quassia.
According to Martindale quassia is the dried stem wood of Jamaica quassia or Surinam quassia. It has been used as a bitter. It was formerly given as an enema for the expulsion of threadworms and was applied for pediculosis. It may also be used as a flavour in foods, drinks and confectionery. Extracts of quassia or preparations containing its triterpinoid bitter principle quassin are used to denature alcohol.
- Darifenacin and Cetuximab
The NDPSC has recommended that darifenacin and cetuximab should be added to the schedule as prescription medicines.
Darifenacin is indicated for the treatment of overactive bladder, with the symptoms of urgency, urge urinary incontinence or frequency.
Cetuximab is indicated for the treatment of patients with metastatic colorectal cancer that has been demonstrated to be epidermal growth factor receptor positive and whose disease has progressed or is refractory to irinocetan based therapy.
- Adrafinil
Adrafinil has been referred to the MCC for classification as a prescription medicine by the Medicines Control section of Medsafe following growing concern about increased imports and potential abuse of this substance as a party drug.
Adrafinil is not scheduled in NZ but is chemically related to modafinil which is a prescription medicine taken orally for mental function impairment in the elderly.
- Quinine
The NDPSC has recommended that the restricted medicine entry for quinine for the prevention of cramp should be removed from the schedule and quinine should be reclassified as a prescription medicine except in medicines containing 50 milligrams or less per recommended daily dose. No change is recommended to the current general sale classification of quinine in medicines containing 50 milligrams or less per recommended daily dose.
There are no longer any restricted medicine products on the New Zealand market which are packaged specifically for the prevention of cramp.
