FORM 2
Application for
APPROVAL TO PRESCRIBE SATIVEX® FOR AN UNAPPROVED USE
under Regulation 22 of the Misuse of Drugs
Regulations 1977
A completed and signed copy of this form must be submitted for each application for
Ministerial approval to prescribe Sativex® for an unapproved use in a specified
patient.
Please refer to the current New Zealand Sativex® data sheet when completing this
form (see http://www.medsafe.govt.nz/profs/Datasheet/s/sativexspray.pdf)
Please note that Sativex® is currently not funded by PHARMAC.
1.
PATIENT DETAILS
Full name of patient:
Full street address:
Date of Birth:
NHI Number:
NOTE: PATIENT INFORMED CONSENT
The patient should be advised that the use of Sativex® is on a trial basis and that the
treatment protocol requires the dose to be adjusted over time, and if reassessment indicates
no benefit, the treatment will be stopped.
The patient must sign the patient informed consent section below for this application to be
valid. This indicates that the patient is willing to use Sativex ® and they are aware of the
potential danger associated with its use, and that if Sativex® is abused or diverted then the
application and approval is no longer valid and that future applications will be declined.
2.
PATIENT INFORMED CONSENT
“I, the patient named above, am willing to use Sativex ® and I am aware of the
potential danger associated with its use. I am aware that if Sativex ® is abused
or diverted then this application and approval is no longer valid and that future
applications will be declined.”
Signature of above named patient
Date
v1.0
Page 1 of 6
FORM 2
3.
APPLICANT DETAILS
NOTE: APPLICANT ELIGIBILTY AND POTENTIAL EXCLUSION CRITERIA
The applicant must be a General Practitioner (GP) or specialist who “normally” provides
medical care to the patient, either for routine medical care, or for management of the specified
condition.
Health professionals with a documented history of abuse or diversion of controlled drugs, or
who have had their rights to prescribe controlled drugs limited under the Misuse of Drugs Act
1975 may be ineligible to prescribe. The applicant should not have any previous complaints
against them for drug or alcohol abuse, and Medicines Control (Ministry of Health) should
have no outstanding investigations or concerns about their prescribing pattern of Drugs of
Misuse.
Full name:
NZ Medical Council number:
Full practice address:
Details of patient history with physician:
Phone:
Fax:
Email:
Applicant eligibility criteria met (see note above)?
Yes
4.
No – please explain:
SPECIALIST ENDORSEMENT
NOTE: SPECIALIST ELIGIBILTY CRITERIA
Specialist assessment and endorsement of the proposal to use Sativex ®, and the proposed
patient management plan, must be issued by a practitioner who is registered with the New
Zealand Medical Council as being competent in the scope of practice appropriate to the
management of the specified condition to be treated. For example, treatment for cachexia
related to cancer should be endorsed by a registered oncologist or palliative care specialist.
Specialist endorsement is limited to oncologists, neurologists, anaesthetists and palliative
care specialists.
v1.0
Page 2 of 6
FORM 2
Full name:
NZ Medical Council number:
Full practice address:
Phone:
Fax:
Email:
Specialist endorsement eligibility criteria met (see note above)?
Yes
No
5.
PROPOSED TREATMENT DETAILS
5.1
Is the proposed use of Sativex® in this patient for a specified condition
(see note below)?
No
Yes – please provide details:
NOTE: PROPOSED USE
To be eligible for approval to prescribe Sativex® for an unapproved use the patient must have
a specified condition as follows:
 nausea, anorexia and wasting (cachexia) associated to cancer and AIDS; or
 chronic pain (including cancer pain) for which other pain relief treatments are ineffective or
have significant/severe adverse side-effects; or
 neuropathic pain (associated with conditions including multiple-sclerosis, stroke, cancer,
spinal cord injury, severe physical trauma, and peripheral neuropathy resulting from
diabetes); or
 muscle spasm and spasticity associated with spinal cord injury.
5.2
Does the patient have any other medical conditions?
No
Yes – please provide details:
v1.0
Page 3 of 6
FORM 2
5.3
Have other standard treatment options been trialled in this patient and
proven either ineffective in treating the specified condition and/or
controlling symptoms, are not tolerated, or are contraindicated (see note
below)?
No
Yes – please provide details:
NOTE: FAILURE OF OTHER PRESCRIPTION MEDICINES OR CURRENTLY AVAILABLE
TREATMENTS
To be eligible for approval to prescribe Sativex® for an unapproved use the patient must have
trialled adequate doses of standard treatments for the specified condition for appropriate
periods of time without sufficient therapeutic benefit, or the standard treatments are not
tolerated by the patient, or are contraindicated in the patient.
5.4
Is the proposed treatment protocol the same as that described in the
Dosage and Administration section of the Sativex® data sheet?
Yes
No – please provide details of proposed treatment protocol:
5.5
Is the use of Sativex® contraindicated in this patient (see note below)?
No
Yes – please provide details of contraindication(s) and proposed
patient management plan:
v1.0
Page 4 of 6
FORM 2
NOTE: CONTRAINDICATIONS
Approval may be declined if the patient has contraindications to the use of Sativex® as
described in the Contraindications section of the Sativex® data sheet.
5.6
Is this patient taking any medicines known to interact with Sativex®, as
described in the Interactions section of the Sativex® data sheet?
No
Yes – please provide details of interaction(s) and proposed
patient management plan:
5.7
Does this patient have a documented history of abuse or diversion of
controlled drugs (see note below)?
No
Yes – please provide details of history and proposed patient
management plan:
NOTE: HISTORY OF ABUSE OR DIVERSION
Approval may be declined if the patient has a documented history of abuse or diversion of
controlled drugs, or in the event that during the course of treatment with Sativex® should such
circumstance arise.
5.8
Please provide details of the proposed protocol for treatment cessation
in the event of lack of efficacy, adverse reactions, or if abuse/diversion
has been identified:
v1.0
Page 5 of 6
FORM 2
5.9
Please provide details of the proposed protocol for the return of
unwanted or unused Sativex®:
6.
ENDORSEMENT AND CONFIRMATION
We, the patient’s physician and the endorsing specialist, apply for Ministerial
approval to use Sativex® for an unapproved use in the above named patient
and confirm that the information supplied is true and correct.
We have conducted an analysis of the potential risks and benefits of Sativex ®
use in the above named patient and we consider the risk-benefit balance to be
positive in this patient.
Signature of patient’s physician
Date
Signature of endorsing specialist
Date
(End of FORM 2)
v1.0
Page 6 of 6