REPORT ON SUSPECTED ADVERSE DRUG REACTIONS

NATIONAL CENTRE FOR ADVERSE DRUG REACTIONS MONITORING

Email: [email protected] Website: www.npra.gov.my
(Please report all suspected adverse drug reactions including those for vaccines, health supplements and traditional products. Do not
hesitate to report if some details are not known. Mandatory fields are marked with *, but please give as much other information as
you can. Identities of Reporter, Patient and Institution will remain Confidential.)
REPORT No. (for official use only): ………………………………………………………………………………..
PATIENT INFORMATION
Please tick (if applicable):
I.C. No. / R/N / Initials *Age *Gender (please tick) Wt (kg) *Ethnic Group Initial Report
Male Female
Follow-up Report

*ADVERSE REACTION DESCRIPTION (inc. sequence of adverse events, details of rechallenge, interactions)

Time to onset mins/ hours/

mins/ hours/days/
days/months/
months/years
years Date start of DD / MM / YYYY Date end of DD / MM / YYYY
of reaction : (please circle) reaction : reaction :

Reaction subsided after stopping drug / reducing dose : Yes No Unknown N/A (drug continued)

Reaction reappeared after reintroducing drug : Yes No Unknown N/A (not reintroduced)
Extent of reaction : Mild Moderate Severe

Seriousness Life Caused or prolonged Caused disability Caused birth N/A

of reaction : threatening hospitalisation or incapacity defect (not serious)

Treatment of adverse reaction & action taken :

Recovered Not Date &

Outcome : Recovering Unknown Fatal:
fully recovered Cause of death:…………....................

Drug-reaction relationship : Certain Probable Possible Unlikely Unclassifiable

*Suspected Drug(s) : N/A: Not applicable
Dose &
Batch / Lot Therapy Dates
Product / Generic Name Frequency MAL No. Indication
No. Start Stop
Given

For Vaccines Only: Vaccine dose (please circle) : 1st/

1st /2nd/
2nd3rd/
/ 3rdbooster/
/ booster/ others: ______
others Diluent Batch / Lot No. :

Concomitant Drug(s) / Other Vaccine(s) given just prior to AEFI [adverse events following immunisation] (please state ‘NIL’ if none) :
Dose & Therapy Dates
Batch / Lot
Product / Generic Name Frequency MAL No. No.
Indication
Given Start Stop

(Please attach additional sheets if necessary)

Relevant Medical History

Relevant Investigations / Laboratory Data
(e.g.: hepatic / renal dysfunction, allergies, pregnancy status, etc)

Reporter Details
*Name : *Institution Name
& Address :

Designation : *Tel No :
*Email Address : Date of Report : Signature : revision-01

Submission of a report does not constitute an admission that medical personnel or the products caused or contributed to the reaction. Thank you for reporting.
 ADR Reporting Guide
Before submitting your ADR report, do check if you have inserted the following information.
*Please try to fill every section in the ADR form overleaf, stating ‘none / nil’ if applicable. A complete report is a useful report.

NO. IMPORTANT POINTS TO NOTE

1 Definitions:
(i) Time to onset of reaction: time interval between first dose (initiation) of the drug until first sign of the ADR.
(ii) Initial report: First submission of report to NPRA of a particular patient involving a particular ADR.
(iii) Follow-up report: Submission of further reports related to the same case to inform of additional information not
mentioned previously or which occurred after the initial report. Please mention the date of initial report for
reference.
2 Please specify any previous history of allergy (including drugs, food, etc.).

3 Include information on any concomitant medications or underlying illnesses? (Please state ‘nil’ if none)
Date started and stopped for each medication
Please state ‘cont’ for any medication still continued after the ADR

4 Please state the specific indication of the suspected drug

(e.g.: ‘pneumonia due to S. Pneumoniae’ - not ‘infection’ or ‘antibiotic’).

5 If the ADR reappeared after reintroducing drug (rechallenge), please describe the rechallenge fully (dose given, timing,
brand used, etc.) under section ‘Adverse Reaction Description’.

6 Please specify if any treatment was given for the ADR, or if the suspected drug was stopped, what alternative drug was
started and how the patient responded.
7 Please include the latest / current outcome of the patient (e.g. recovered fully, not recovered).
If possible, follow-up the patient periodically until the final outcome is known.
A follow-up report may be sent in to update on the final outcome of the patient.

8 Skin reactions: Please describe the specific type and location of the skin reaction.
(Use the Cutaneous ADR form and guide available on www.npra.gov.my)

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9 Do keep your own record of details enabling you to contact the patient or trace the case notes later on if necessary
(e.g. IC number, patient name and phone number).

Please refer to our website for additional guidance on ADR Reporting, or contact us at [email protected] if you have any queries.

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Laporan Kesan Advers Ubat
Bahagian Regulatori Farmasi Negara (NPRA)
Kementerian Kesihatan Malaysia

PUSAT PEMONITORAN KESAN ADVERS UBAT KEBANGSAAN

BAHAGIAN REGULATORI FARMASI NEGARA
LOT 36, JALAN UNIVERSITI
46200 PETALING JAYA

SELANGOR

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