FORM 1
Application for
APPROVAL TO PRESCRIBE SATIVEX® FOR AN APPROVED 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 approved 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:
2. PROPOSED TREATMENT DETAILS
2.1 Is the proposed use of Sativex® in this patient an approved use (see
note below)?
No → use is unapproved (use FORM 2)
Yes
NOTE: ELIGIBILITY
®
To be eligible for approval to prescribe Sativex for an approved use the proposed use of
®
Sativex in the patient must be for an approved indication (see the Indications section of the
®
Sativex data sheet).
2.2 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:
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FORM 1
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.
2.3 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:
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.
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. For an approved use, the specified condition refers to a condition specified in the
®
Indications section of the Sativex data sheet.
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.
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FORM 1
Full name:
NZ Medical Council number:
Full practice address:
Details of patient history with physician:
Phone: Fax: Email:
3.1 Applicant eligibility criteria met (see note above)?
Yes No – please explain:
4. SPECIALIST ENDORSEMENT
NOTE: SPECIALIST ELIGIBILTY CRITERIA
®
Specialist assessment and endorsement of the proposal to use Sativex 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 an approved use, a specified condition refers to a condition specified in the Indications
®
section of the Sativex data sheet.
Full name:
NZ Medical Council number:
Full practice address:
Phone: Fax: Email:
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FORM 1
4.1 Specialist endorsement eligibility criteria met (see note above)?
Yes No
5. ENDORSEMENT AND CONFIRMATION
We, the patient’s physician and the endorsing specialist, apply for Ministerial
approval to use Sativex® for an approved use in the above named patient, and
confirm that the information supplied is true and correct.
Signature of patient’s physician Date
Signature of endorsing specialist Date
(End of FORM 1)
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