Classification of Medicines
Clarification of the Medicines Classification Committee's
(MCC) decision for sedating antihistamines
16 December 2005
Medsafe has received a number of questions about the classification of sedating antihistamines following its decision gazetted on 8 September 2005 to harmonise the status of these medicines with that in Australia. To improve understanding, the framework for classification of these medicines and Medsafe's interpretation of the framework are set out below.
Further information on the MCC's decision is on Medsafe's website www.medsafe.govt.nz where the minutes of the 30th, 32nd and 33rd meetings of the MCC and the schedule entry for each individual sedating antihistamine can be found.
Classification principles
As sedating and non-sedating antihistamines cause different side effects and have different risks of being abused or overused, the MCC agreed with the scheduling committee in Australia that these two classes of medicines should be classified differently. As sedating antihistamines pose a higher risk of abuse and carry more severe side effects, both scheduling committees recommended that all sedating antihistamines should be treated in the same way and classified more restrictively. The MCC in New Zealand and the Australian National Drugs and Poisons Schedule Committee (NDPSC) consulted widely on the appropriate restrictions for the sedating antihistamines before settling on the classifications framework listed below.
New Zealand Medicines Schedule entry:
| "sedating antihistamine substance"; | except when specified elsewhere in this Schedule | Prescription |
| "sedating antihistamine substance" | for oral use except when specified elsewhere in this Schedule | Restricted |
| "sedating antihistamine substance" | for oral use when combined with one or more other therapeutically active ingredients for the treatment of coughs, colds or influenza when at least one of the other active ingredients is a sympathomimetic decongestant or in a day/night pack containing "sedating antihistamine substance" in the bed-time dose and in preparations for adults and children over two years of age | Pharmacy Only |
Interpretation:
Medsafe's interpretation of the schedule entry is that:
Sedating antihistamines included in preparations that are not oral dose forms are Prescription Medicines.
Products that are oral dose forms of sedating antihistamines are Restricted Medicines if the sedating antihistamine:
- is the only active ingredient; or
- is in combination with other active ingredients not including a sympathomimetic decongestant; or
- is included in any combination pack other than a night-time dose of a day/night pack; or
- is indicated for use in children over the age of two years.
Products that are oral dose forms of sedating antihistamines are Pharmacy-Only medicines if the sedating antihistamine:
- is combined with one or more other therapeutically active ingredients for the treatment of coughs, colds or influenza when at least one of the other active ingredients is a sympathomimetic decongestant, and is packed and labelled only for use in adults and children two years of age and above; or
- is included as an ingredient of the night-time dose of a day/night pack containing other therapeutically active ingredients for the treatment of coughs, colds or influenza when at least one of the other active ingredients in the pack is a sympathomimetic decongestant and is packed and labelled only for use in adults and children two years of age and above; or
- is approved for use as a motion sickness preparation and is in a sealed container of not more than 10 tablets or capsules except when sold at a transport terminal or aboard a ship or plane.#
# N.B. oral products approved for use in motion sickness that contain sedating antihistamines (other than cyclizine) while labelled as "Pharmacy-only medicines" can also be sold from transport terminal or aboard a ship or plane.
Cyclizine containing products for motion sickness are "Restricted Medicines".
Meclozine pack-size limit for Pharmacy-only pack is 12 tabs.
See schedule for further details.
Further changes to schedule entry possible
The Australian National Drugs and Poisons Schedule Committee (NDPSC) has recently recommended to the MCC that it should amend the Pharmacy-Only entry for sedating antihistamines to remove the "indications" advice. This proposal would allow combination packs for the treatment of allergies to be available as Pharmacy-Only medicines. The MCC will consider this recommendation for harmonisation at its first meeting in 2006.