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).

 

To be completed by the physician

 

The Agreement

  This Agreement must be completed by the physician responsible for treatment of the patientís diabetes (referred to below as Ďthe physicianí).

  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 patientís diabetes is transferred to another physician.

  In the event of the care of the patientís 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 patientís 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 patientís 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.

Wockhardt UK Limited

To be completed by the physician, a copy retained by the physician and the original returned to the Company.

 

I, the undersigned, undertake responsibility for the administration and safe use of Hypurin insulin in _______________________________________(please enter patientís full name).

I confirm that the patient is unable to tolerate any form of human insulin or analogue and therefore can not be treated with human insulin or with analogues. I am aware that the FDA will only consider the importation of bovine or porcine insulin (including Hypurin) for patients who can not be treated with human insulin or analogues.

Physicianís 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: ______________________________________________

 

* Physicianís signature: __________________________________            * Date: ________________