Revised: 23 May 2013
Committees
Minutes of the out-of-session meeting of the Medicines ClassificationCommittee - December 2005
OUTCOME OF MEDICINES CLASSIFICATION COMMITTEE OUT-OF-SESSION CONSULTATION DECEMBER 2005 AGENDA 34A
Participants
Dr S Jessamine
Dr J Peckham
Dr S Ryder-Lewis
Ms N Gauld
Mrs A Shirtcliffe
1. Amphotericin objection to recommendation to reclassify
The Pharmaceutical Society had 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 had been made on the grounds that due process had not been observed in the consultation process. The standard consultation process had subsequently been undertaken. The company concerned had reiterated its earlier support of the proposed reclassification to prescription medicine to harmonise with the Australian scheduling. No other responses had been received.
Comments submitted by the Pharmaceutical Society in support of its objection were provided.
Background material in support of the National Drugs and Poisons Schedule Committee (NDPSC) recommendation to reclassify amphotericin to prescription medicine was also provided.
As two of the members requested further discussion on this matter, consensus was not achieved and the matter will be discussed at the next meeting.
Recommendation
That the objection to the reclassification of amphotericin from restricted medicine to prescription medicine for the treatment of oral candidiasis should be discussed at the next meeting.
2. New chemical entities for classification
The following new chemical entities had been referred to the Committee by the Medicines Assessment Advisory Committee.
Deferasirox is proposed for the treatment of patients with chronic iron overload due to blood transfusions.
Tigecycline is a novel glycylcycline antibiotic with expanded broad spectrum antibiotic activity.
All five members agreed that these new chemical entities should be prescription medicines.
Recommendation
That deferasirox and tigecycline should be classified as prescription medicines.
3. Icodextrin
The NDPSC had recommended that icodextrin be reclassified from pharmacy-only medicine to general sale on the grounds that the intention was that medicines for dialysis should be general sale medicines in NZ and that icodextrin was unscheduled in Australia.
All but one of the respondents agreed that icodextrin should become a general sale medicine.
One member wished for further discussion before making a recommendation. However, the member’s queries were subsequently resolved in a telephone discussion with the chairman and the member agreed that icodextrin should be aligned with other dialysis medicines.
Recommendation
That icodextrin should become a general sale medicine.
4. Quassia
The NDPSC recommended that quassia should be removed from the schedule on the basis of harmonisation at the lower level of access. There were no products containing quassia registered in New Zealand.
A brief description from Martindale was provided including its former use as a bitter, an enema for the expulsion of threadworms and an application for the treatment of pediculosis. Other non-therapeutic uses included use as a flavouring agent and to denature alcohol.
All but one of the respondents agreed that quassia should become a general sale medicine.
One member wished for further discussion before making a recommendation. However, the member’s queries were subsequently resolved in a telephone discussion with the chairman and the member agreed that quassia should be removed from the schedule as a pharmacy-only medicine.
Recommendation
That quassia should become a general sale medicine.
5. Darifenacin and Cetuximab
The NDPSC had recommended that, on the grounds of harmonisation, 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.
All five participants agreed that these new chemical entities should be added to the schedule as prescription medicines.
Recommendation
That darifenacin and cetuximab should be added to the schedule as prescription medicines.
6. Adrafinil
Adrafinil had 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. Evidence of misuse was supplied in support of the request for classification.
Adrafinil is not scheduled in New Zealand but is chemically related to modafinil which is a prescription medicine taken orally for mental function impairment in the elderly.
All participants agreed that adrafinil should be classified as a prescription medicine.
Recommendation
That adrafinil should be classified as a prescription medicine.
7. Quinine
The NDPSC had 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 was recommended to the current general sale classification of quinine in medicines containing 50 milligrams or less per recommended daily dose.
There are no restricted medicine products on the New Zealand market which are packaged specifically for the prevention of cramp.
Material in support of the recommendation was provided from the NDPSC.
All 5 participants agreed that quinine should no longer be available as a restricted medicine for the treatment of cramp.
Recommendation
That quinine should be classified as a prescription medicine except when in medicines containing 50 milligrams or less per recommended daily dose.
