Phizer Animal Health - Australia - Reporting Of Adverse Drug Effects

Editor: The following information was received from Jean Townsend whose contributions to canine health and information are immeasurable!  Our great admiration for this woman is matched by that of hundreds of dog owners whose pets have been spared suffering.  She was instrumental in TDP's first Project - Prescription Inserts. 

I made an inquiry to Pfizer in Australia as to where one could report adverse drug effects.  The following was received:

Subj:    RE: Enquiry%20from%20pfizeranimalhealth.com.au
Date:   06/03/2002 9:10:39 PM Eastern Daylight Time
From:   Kellie.Lorschy@Pfizer.com (Lorschy, Kellie)
To: LuSwinton@aol.com ('LuSwinton@aol.com')

Dear Jean,
Suspected adverse side effects of any veterinary drug in Australia should be reported to the National Registration Authority for Agricultural and Veterinary Chemicals (NRA) and/or the manufacturer.  It will then be the manufacturer's responsibility to investigate the case and submit a report to NRA for their consideration.

If you wish to advise Pfizer of any suspected side effects that have occurred in Australia for Rimadyl or any other of its products, you may contact us at Pfizer Animal Health Group, PO Box 57, West Ryde.  NSW 2114. Alternatively you may contact the NRA at PO Box E240, Kingston ACT  2604 using the attached form.

Sincerely

Kellie Lorschy
Veterinary Services
Pfizer Animal Health
PO Box 57
West Ryde 2114
Australia
Ph (02) 9850 3343
Fax (02) 9850 3399

This is a copy of the form that was attached to the original e-mail from Kellie Lorschy:
______________________________________________________________________
NATIONAL REGISTRATION AUTHORITY FOR AGRICULTURAL AND VETERINARY CHEMICALS

ADVERSE EXPERIENCE REPORTING FORM for veterinary chemical products


The NRA recommends that you send a copy of this report to the product Registrant. Please tick the most appropriate box and provide as many details of the incident as possible.

I am a:
Veterinarian        Registrant      Farm or Animal Owner    Other


I am reporting:

Adverse animal reaction           Adverse human reaction             Other
(please
(including side effects,          Lack of effect                            
specify)
toxicity allergy)                                                            
                   _______________

Has the product Registrant been notified?       Yes         No

Product Details:

Product Name:_______________________________________________________
NRA Number (on label)___________Batch No: ___________Expiry Date:________
Registrant (or manufacturer):____________________________________________
Active Constituent(s): _________________________________________________
Storage details: _______________________________________________________ (eg
at room temperature, refrigerated, stored in shed etc)
Is a sample available?          Yes             No

Animal Details:
Species: ______________________________ Breed: _______________________
Sex: ______________ Age: ________________ Estimated Weight: ____________
Number treated: __________ Number affected: _________ Number dead: _______
Why was the product used: (Disease/condition being treated): _________________
___________________________________________________________________


Treatment details:
Date and time of treatment: _________________________________________
Date and time of symptoms first noticed: _______________________________
Date and time of death/recovery: ______________________________________
Dose/frequency/duration as used: ____________________________________

Environmental conditions prior to/at initial treatment (eg weather, pasture
conditions, water available):
_________________________________________________________________

Was any other treatment given at the same time? If so, what?:
_________________________________________________________________

Description of events following treatment – management of problems and
outcome (include results of laboratory tests and post mortem):
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________

Reporting veterinarian or product Registrant:
Name:____________________________________________________________

Address:______________________________________________________________________

________________________________________________________________
Telephone:_________________________Fax:_____________________________
Signature:__________________________________________________________

Owner of animal(s):

Name:_____________________________________________________________

Address:___________________________________________________________
__________________________________________________________________
__________________________________________________________________
Telephone:________________________________Fax:______________________
Signature:__________________________________________________________


Registrants only:  Please attach a detailed report (if available) including
action taken or proposed.


Please return to:

Adverse Experience Reporting Program
National Registration Authority
PO Box E240
Kingston  ACT  2604

Enquiries:  (02) 6272 5158

As part of the Government's regulatory reform strategy all Commonwealth Departments and agencies are required to have time boxes included on their external forms.

Optional:   For organisations with less than 20 people   -   in an effort to simplify paperwork on small business, the Government needs to track the time it takes to complete existing forms.    Please estimate: 0the time actually spent reading the instructions, working on the question and obtaining the information, and 1the time spent by all employees in collecting and providing this information. 

……………….days………………………………hours…………………………………minutes    
______________________________________________________________________

Regards,

Jean Townsend
(Always for George - Always for the Rimadyl Dogs - on Every Continent - in
Every Country)
http://hometown.aol.com/luswinton/myhomepage/memorial.html
"A single voice may not be heard, but the voices of many
cannot be ignored. " ~ Author Unknown