Med Pharma Trading DMCC - Adverse Drug Reaction Reporting Form

General Information

Patient's Full Name

Outpatient Medical Record Number

Date of Birth

Gender

Male

Female

Date of Onset of ADR/AE

Time of Onset of ADR/AE

Date of Resolution of ADR/AE

Time of Resolution of ADR/AE

Description of ADR/AE (including relevant laboratory and instrumental data)

Information about Suspected Drug (SD)

Brand Name, Dosage Form

Manufacturer, Country

Batch Number

Indications for Use

Single Dose

Frequency of Administration

Route of Administration

Start of SD Therapy

End of SD Therapy

Information on concomitant medications (excluding drugs used for PR correction)

1st medication

Concomitant medication

Indications

Single dose

Frequency of administration

Route of administration

Start of therapy with concomitant medication

End of therapy with concomitant medication

2nd medication

Concomitant medication

Indications

Single dose

Frequency of administration

Route of administration

Start of therapy with concomitant medication

End of therapy with concomitant medication

3rd medication

Concomitant medication

Indications

Single dose

Frequency of administration

Route of administration

Start of therapy with concomitant medication

End of therapy with concomitant medication

Other important information (diagnoses, allergies, pregnancy with duration, etc.)

Methods of PR Correction

Discontinuation of PLS

Yes

No

Was the discontinuation of PLS accompanied by the disappearance of PR?

Yes

No

Re-prescription of PLS?

Yes

No

Was there a recurrence of PR after re-prescribing PLS?

Yes

No

Change in PLS dosage

Yes

No

Is there a recurrence of PR/OE after changing the dosage regimen?

Yes

No

No correction of PR was performed

Yes

No

Medication therapy for PR/OE (specify drugs, dosage, duration of use)

Information about the person reporting the problem

Full Name

Phone

E-mail

Name and location of the healthcare facility or applicant