cf) suspected adverse event reporting form...cf) suspected adverse event reporting form identities...
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Cf) Suspected Adverse Event Reporting FormIdentities of reporter, patient, institution, and product trade name(s) will remain confidential
FOR OFFICE USE ONLY
AE report number Date received
A. PATIENT INFORMATION
Name/Initial: Address:
Contact number:
*Age--------- Weight(Kg)-------*Gender □Male □ FemaleOOther
Pregnant : □ Yes □No□ Unknown□Not applicable
B. SUSPECTED ADVERSE EVENT INFORMATION
*Type of event Suspected product
□ Adverse drug reaction Brand/Trade name __ _ _ _ _ _ _ _ _ _ * Generic name with strength _ _ _ _ __ _
□ Product quality problem *Indication - ------------------------------
□ Medication error *Medication Start Date ________ _ End Date ____________ _
□ Others(Please specify) Dosage Form _____________ * Frequency (Daily Dose) _______ _
Batch/Lot number __________ _ Manufacturer ___________ _
*Describe event including relevant tests and laboratory results:
*Event start Date-------------�
*Event stopped Date ______________
Action taken after reaction:
□ Dose stoppedD Dose reducedD No action taken
Seriousness of the adverse event:
0 Not serious 0 Hospitalization or prolongation of hospitalization 0 Disability or permanent damage 0 Congenital anomaly / birth defect 0 Life threatening 0 Death 0 Other Medically important
Other relevant history: (pre-existing medical history)
Was the adverse event treated? D Yes D No
If yes, please specify:
Did reaction subside after stopping/ reducing the dose of the
suspected product? D Yes D No D Not applicable
Did reaction appear after reintroducing the suspected product?
0 Yes O No O Not applicable
*Outcomes attributed to the adverse event:
D Recovered
D Recovered/resolved with sequella D Not recovered
D UnknownD Fatal (date of death: )
-------------
D Hypersensitivity D Allergies D Liver or kidney problems D Smoking 0 Alcohol O Diabetes
D Others (Please specify) :
C. *OTHER CONCOMITANT MEDICINE INFORMATION
Brand/Trade Name Generic name Indication Dosage form Strength & Frequency
Page 1 of2
Revision no. 02Form no. 08-05-MKT-001-F01
MR/01.05.2019
MR/09.05.2019
D. *REPORTER INFORMATION
*Name & Address-------------------------- - - - - - - - - --
*Email address ______________________ _ *Mobile phone _ _ _ _ _ _ _ _ _
*Occupation _______________________ _ *Signature _ _ _ _ _ _ _ _ _ _
*Date of this report submission _______________________________ _
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Page 2 of2 MR/09.05.2019
Send all completed forms to: Medical Services & Pharmacovigilance Dept.
The ACME Laboratories Ltd. 1/4, Kallayanpur,
Mirpur, Dhaka 1207, Bangladesh
Tel: 9004194-6, Ext. 170,
Helpline number: +8801799998997
Fax: 88-02-9121153,
E-mail: [email protected]
General instructions for completing the form:
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Fill in as much information as possible. Do not leaveanything blank. If unknown, write “unknown” or “n/a”if not applicable.
Additional pages can be used/added if necessary.
What to report : •
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•
•
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Serious adverse drug reactions
Unknown or unexpected AD Rs
All suspected reactions to new drugs
Unexpected therapeutic effects
All suspected drug interactions
Product quality problems
Treatment failures
Medication errors
How to report : Suspected and observed drug-related reactions must be reported using the electronic version of the reporting form in a fillable pdf available on the ACME website (www.acmeglobal.com).ADE reports can be submitted via Email ([email protected])
In emergency cases when forms are not readily available ADE reports can also be made to the MSPD by helpline number (+8801799998997)
* Mandatory Information