This form is used to register as a Consultant with the Zaponex Treatment Access System (ZTAS®).
Checks will be made on the GMC register to verify that you are a specialist in the field of Psychiatry (or other relevant therapeutic area).
Once your specialty has been confirmed you can be accepted in the role of supervising clinician for patients to be treated with Zaponex.
Please complete all sections.
We will use the information provided on this form in accordance with the terms explained in the ZTAS privacy notice which is available from the ZTAS
Adverse event reporting
The ZTAS routinely monitors blood results for abnormalities in WBC, Neutrophils, Eosinophils and Platelets.Abnormalities in these parameters(i.e.where
outside agreed ZTAS ranges) are reported as adverse events to the Leyden Delta Drug Safety department, who may then contact the responsible
healthcare professional for further details.Upon review of your patient' s health and blood results, if you consider any other abnormalities to the blood
parameters(excluding those mentioned above) or if you signal abnormalities to physical or mental symptoms to be clinically significant, please ensure
that you report these as adverse events.Reports of adverse events can be made to the MHRA directly via the Yellow Card scheme at www.mhra.gov.uk/yellowcard
or the MHRA Yellow Card app.Adverse events should also be reported to Leyden Delta via firstname.lastname@example.org
or via telephone number 0207 3655 842.
This document is my statement of intent to participate in the prescribing and monitoring of Zaponex® (clozapine) in association with the ZTAS.Signing
of this form confirms my commitment to adhere to the Zaponex SPC and the ZTAS manual and confirms that I am an appropriate specialist for the
supervision of Zaponex therapy.Signing of this form also constitutes a confirmation of my understanding of, and commitment to, my responsibilities
in respect of maintaining the confidentiality of my patient's details and reporting adverse events, as detailed above. I understand that my registration
will be confirmed by a return letter, enclosing my unique user ID and password to the ZTAS system and that these details should not be shared, in order
to prevent unauthorised access to patient data. Should I no longer require access to the ZTAS, or if there are any changes to the patient data under my
care, I will inform ZTAS of this within 30 days.I have read the ZTAS privacy notice and understand how my personal data will be used by Leyden Delta.
- Zaponex may only be prescribed by a consultant or physician who is registered with the ZTAS
- Zaponex may only be prescribed for patients who are registered with the ZTAS
- There must always be a current, valid blood result for the patient before any Zaponex is dispensed