Sativex® Oromucosal Spray - Requirements for Prescribers
Reviewed: January 2012
What is Sativex®?
Sativex® is an oromucosal (mouth) spray containing cannabis extracts that administers a metered, actuated dose.
Each 100 microlitre spray contains 2.7 mg delta-9-tetracannabinol (THC) and 2.5 mg cannabidiol (CBD).
What is Sativex® approved for?
In New Zealand Sativex® is approved for use as an add-on treatment for symptom improvement in patients with moderate to severe spasticity due to Multiple Sclerosis who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.
Any other use of Sativex® is an unapproved use of this medicine in New Zealand.
Prescribers should be aware that the clinical safety and efficacy has not been fully investigated in other medical conditions and the long-term usefulness of this medicine has not been established. Irrespective of whether prescribing is for an approved or unapproved use, extended periods of treatment should be periodically re-evaluated to examine the long-term safety and efficacy of the medicine for the individual patient.
Currently Sativex® is not funded by PHARMAC.
Sativex® and risk of diversion, abuse and misuse
Sativex® is considered to be a desirable and divertible pharmaceutical due to the inherent nature of its active substances. Because it is a cannabis preparation, Sativex® is classified as a Schedule 2 Class B (1) drug product under Misuse of Drugs Act 1975.
It is unclear what proportion of patients who are chronically exposed to Sativex® (cannabinoids) will develop either psychological or physical dependence. At therapeutic doses, Sativex® may produce side-effects that are interpreted as a euphoria or cannabis-like "high".
As with all controlled drugs, prescribers should monitor patients who receive Sativex® for signs of excessive use, abuse and misuse. Patients with a personal or family history of substance abuse (including drug or alcohol abuse) are at higher risk of addiction than other patients with chronic severe disease.
Approval required before prescribing
Ministerial approval is required before Sativex® can be prescribed by a New Zealand registered medical practitioner, for any use, under regulation 22 of the Misuse of Drugs Regulations 1977.
As part of the approval process each application for approval must be signed by an appropriate vocationally registered practitioner ("specialist").
Before making an application to prescribe Sativex®, prescribers should familiarise themselves with the following information:
- The New Zealand Sativex® data sheet, available at: http://www.medsafe.govt.nz/profs/Datasheet/s/sativexspray.pdf (Adobe PDF document 167 KB)
To apply for approval to prescribe Sativex® in a specified patient, practitioners must complete one of the following application forms:
- Application for approved use of Sativex® (FORM 1) (Microsoft Word document 96 KB)
- Application for unapproved use of Sativex® (FORM 2) (Microsoft Word document 114 KB)
All applications and correspondence should be sent to:
Ministry of Health
PO Box 5013