DHMH – MARYLAND MEDICAID PHARMACY PROGRAM
PLEASE FAX FORM TO 410-333-5398
Date of Report: Report Completed by:
Attach Clinical notes and all pertinent documentation (i.e. labs) associated with current ADR or Therapeutic failure.
Has patient tried generic before? Yes No If Yes, give date:
Has patient been compliant on regimen? Yes No If No, why not:
Is Patient currently on other medications? Yes No If yes, attached complete list.
**NOTE: Prescriber must have witnessed or has documentation that the manifestation of adverse events is linked to generic drug. Completion of form does not
automatically grant approval. Incomplete forms will be returned.
A. PATIENT INFORMATION
Patient’s Name:
MA ID #:
Sex: M F DOB:
Weight: Ibs Age:
Phone #:
B. ADVERSE EVENT, PRODUCT PROBLEM OR ERROR
(Check all that apply)
1. Adverse Event
Problem with Different Manufacturer of Same Medicine
2. Outcomes Attributed to Adverse Event (Check all that apply)
Life –threatening
Hospitalization – initial or prolonged
Required Intervention to Prevent Permanent Impairment/Damage
(Devices)
Other
3. Date of Event (mm/dd/yyyy)
4. Describe Event , Problem or Product Use Error
5. Relevant Tests/Laboratory Data, Including Dates
6. Other Relevant History, Including Pre-existing Medical Conditions (e.g.,
allergies, race, pregnancy, smoking and alcohol use, liver/kidney problems, etc.)
C. PRODUCT AVAILABILITY
Product Available for Evaluation? (Do not send product to FDA)
Yes No
D. SUSPECT PRODUCT(S)
1. Name, Strength, Manufacturer (from product label)
#1 Name:
Strength: Exp. Date:
Manufacturer: Lot #:
#2 Name:
Strength: Exp. Date:
Manufacturer: Lot #:
2. Dose or Amount Frequency Route
#1
#2
3. Dates of Use (If unknown, give
duration from/to or best estimate)
#1
#2
5. Event Abated After Use Stopped
or Dose Reduced?
#1 Yes No
#2 Yes No
4. Diagnosis or Reason for Use
(Indication)
#1
#2
6. Event Reappeared After
Rechallenge?
#1 Yes No
#2 Yes No
E. DEGREE OF CERTAINTY THAT THE ADVERSE DRUG
REACTION IS DUE TO GENERIC
Definite. The reaction follows a reasonable temporal sequence after generic drug
exposure or a toxic blood level of the generic drug has been established in body fluids or
tissues. The reaction follows a recognized response to the suspected generic drug. The
reaction is confirmed by improvement on withdrawing the generic drug and reappears on
re-exposure. “Other than drug causes” such as other or toxins or concomitant disease
states that can cause similar clinical reactions are ruled out.
Probable. The reaction follows a reasonable temporal sequence after generic drug
exposure. The reaction follows a recognized response to the suspected generic drug.
The reaction is confirmed by withdrawal but not by re-exposure of the generic drug. The
reaction cannot be reasonably explained by known characteristics of the recipient’s
clinical state.
Possible. The reaction follows as temporal sequence after generic drug exposure.
The reaction follows a possible recognized pattern to the suspected generic drug. The
reaction could be explained by the recipient’s clinical state (i.e. other than the suspected
generic drug).
Doubtful. The reaction is likely to be related to factors other than the suspected
generic drug.
Negative. The finding clearly eliminates the possibility of a drug reaction caused
by the generic version of the drug.
F. REPORTER
Prescriber’s Name:
Degree:
Signature:
NPI #
Address:
Phone #
Fax #
Did the prescriber witness the ADR? Yes No
Has the ADR been previously reported to the FDA? Yes No
PLEASE PRINT OR TYPE CLEARLY USING BLACK INK.
(mm/dd/yy)
DHMH-MARYLAND MEDICAID PHARMACY PROGRAM
Please fax form to 866-440-9345
Rev. 03/2011
