Wockhardt UK Limited
Compassionate Use/ Named Patient Supply:
Drug
Safety (Pharmacovigilance) Agreement for Hypurin Insulin
Supply
of Hypurin insulin to the patient is conditional upon completion of this Drug
Safety (Pharmacovigilance) Agreement (referred
to below as the Agreement).
·
This Agreement must be completed by the physician responsible for
treatment of the patient’s diabetes (referred to below as ‘the
physician’).
·
Submission by the physician of a newly completed and signed Agreement
will be required each time an order for Hypurin insulin is placed by the
patient. The patient refers to the applicant requesting supply of Hypurin
insulin.
·
The physician must inform the Company, within five working days of the
change occurring, if the care of the patient’s diabetes is transferred to
another physician.
·
In the event of the care of the patient’s diabetes transferring to
another physician, the other physician will also be required to complete and
submit an Agreement.
Adverse
drug reactions (ADRs)
Wockhardt
UK Limited (the Company) must comply with pharmacovigilance legislation which
includes ADR reporting and monitoring of the risk-benefit balance of its
products.
·
The physician must report to the Company any ADRs experienced by the
patient that are considered by the physician to be caused by Hypurin insulin.
·
The ADR report must be submitted to the Company within five working
days of the physician becoming aware of the ADR.
·
Details of the ADR/s must be submitted to the Company using Form 1
(page 3 of this Agreement).
Form
1 should be completed by the physician and should be faxed or emailed to the
Company.
Fax:
00 44 1978 661 702, email: drug.safety@wockhardt.co.uk.
Communication
with the patient
The
Company must ensure that the patient communicates directly with and obtains
all advice on his or her diabetes treatment from the physician.
·
The Company can not communicate directly with the patient
regarding technical or medical aspects of Hypurin insulin or its use.
·
The patient must direct all enquiries of this nature to the physician
responsible for treatment of his/her diabetes.
·
Contact with the Company on matters of this nature must be made by the
physician responsible for treatment of the patient’s diabetes.
·
Communication received by the Company directly from the patient, will
be forwarded within two working days of receipt, to the physician responsible
for treatment of the patient’s diabetes.
Continued
supply of Hypurin insulin
The
Company is obliged to monitor and act accordingly in the event of an
unfavourable risk-benefit balance.
·
The Company reserves the right to cease supply of Hypurin insulin if
there is evidence indicating that the risk-benefit balance is unfavourable for
the patient.
·
Supply of Hypurin insulin will cease if the terms of this Agreement are
not fulfilled.
I, the undersigned, undertake responsibility for the administration and safe use of Hypurin insulin in _______________________________________(please enter patient’s full name).
Physician’s
details:
(*
mandatory fields)
*
Name: _________________________________________________________________
*
Title
(for example, Senior Endocrinologist):
__________________________________________________
*
Full postal address:
_____________________________________________________________________
*
Telephone
number: _____________________
*
Fax
and / or email address(both where available):
Fax:
______________________________________
Email:
_____________________________________
Hospital/clinic
web site address: ____________________________________________________________
Deputy/locum
physician in absence of physician:
______________________________________________
*
Physician’s signature: __________________________________
*
Date:
________________