This document provides guidance on preparing quality adverse drug reaction (ADR) reports. It outlines 14 items that should be included in a complete ADR report: (1) patient information, (2) ethnic group, (3) ADR description, (4) time to onset, (5) date of reaction, (6) dechallenge and rechallenge, (7) extent of reaction, (8) seriousness of reaction, (9) outcome, (10) drug-reaction relationship, (11) suspected drug, (12) relevant investigations/laboratory data, and (13) reporter details. Filling out all required information accurately can help detect safety signals and improve causality assessment. Quality ADR reporting

1. QUALITY OF ADR
REPORTING
Nazmi Liana Azmi

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ADR REPORTING?

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HOW CAN YOU HELP?

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HRPZ II
2019 – 100
2020 – 120

5. INTRODUCTION

6.  Causality assessment
 Signal detection
A COMPLETE report is a USEFUL report
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WHY DOES QUALITY MATTER?

7. PREPARING A
QUALITY ADR
REPORT

8. VITAL
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9. 1. An identifiable patient
2. An identifiable reporter
3. An adverse reaction
4. A suspected drug
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4 MINIMUM CRITERIA OF REPORTING

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11. 1. Full IC no. / RN
2. Age (specify units i.e days, months, years)
3. Allergy status (not including current allergy in the report)
4. Weight (paediatric / chemotherapy patient)
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1. PATIENT INFORMATION

12. 1. Malay
2. Chinese
3. Indian
4. etc
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2. ETHNIC GROUP

13. INITIAL REPORT
 First submission of report to NPRA about a particular patient
involving a particular ADR
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INITIAL / FOLLOW-UP REPORT

14. FOLLOW-UP REPORT
 Submission of further reports related to the same case to
inform of additional information not mention previously or
which occurred after the initial report - changes of diagnosis,
additional reactions, changes of outcome of reaction etc.
 Mention the initial PhIS no. / online submission report
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INITIAL / FOLLOW-UP REPORT

15.  Tell the story
 Signs & symptoms, final diagnosis
 Include detailed relevant information e.g. brand switching,
rechallenge etc.
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3. ADR DESCRIPTION

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CUTANEOUS ADR?

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18. Time interval between 1st dose (initiation) of the drug
until 1st sign of the ADR e.g
 Immediately
 30 minutes
 1 hour
 2 days
 3 weeks
 4 months
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4. TIME TO ONSET

19.  Do not submit old ADR cases
 Submit only ADR cases that happened in the current
year or the year before, except if the reaction still on-
going until now
 State exact date of reaction e.g 17/10/2020
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5. DATE OF REACTION

20. Dechallenge
 stop drug/ reduce dose
 record the outcome (ADR improved or not improved)
Rechallenge
 giving one drug again under the same conditions as before
 skip at least one dosing interval (ADR must resolved at the
time of rechallenge)
 record the outcome (recurrence or no recurrence of ADR)20
6. DECHALLENGE & RECHALLEGE

21. Reaction subsided after stopping drug/ reducing dose?
‘YES’
 Positive dechallenge
 Stop medication/reduce dose & reaction improving / improved
‘NO’
 Negative dechallenge
 Stop medication/reduce dose but reaction worsen / no improvement
‘UNKNOWN’
 Unknown if the drug withdrawn or not (no information regarding dechallenge)
 Unknown reaction outcome either positive or negative dechallenge
‘N/A’
 If medication still continued 21
DECHALLENGE

22. Reaction reappeared after reintroducing drug?
‘YES’
 Positive rechallenge
 Reintroduced drug & reaction reappear
‘NO’
 Negative rechallenge
 Reintroduced drug but reaction did not appear
‘UNKNOWN’
 Rechallenge done but do not know of the outcome
‘N/A’
 No rechallenge done / no information on rechallenge
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RECHALLENGE

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7. EXTENT OF REACTION
8. SERIOUSNESS OF REACTION

24. Severity is a point of intensity of the ADR:
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SEVERITY

25. ADR that may result in the following outcomes:
 Death
 Life-threatening
 Requires/prolongs hospitalization
 Disability/incapacity
 Congenital anomaly
 N/A (not serious) 25
SERIOUSNESS

26. Condition of patient at time of reporting
 Recovered
 Recovering
 Not recovered
 Unknown
 Fatal- date and cause of death
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9. OUTCOME

27. Use WHO assessment scale
 Certain (C1)
 Probable (C2)
 Possible (C3)
 Unlikely (C4)
 Unclassifiable (C5)
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10. DRUG-REACTION RELATIONSHIP

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RULE OF THUMB

29.  Product brand name / generic name
 Dose & frequency given
 MAL and batch no.
 Therapy start date/ therapy stop date
 Indication
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11. SUSPECTED DRUG

30. Relevant information e.g.:
If ADR is hypokalaemia/ hypoglycaemia:
 Lab data: serum K+ or blood glucose
If ADR is fever:
 Lab data: temperature, WBC
Please note if none:
 No temperature taken / no blood investigation done
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12. RELEVANT INVESTIGATIONS /
LABORATORY DATA

31.  No known drug allergy (NKDA)
 History of allergy to….
 No history / history of …. e.g. epilepsy
 Underlying disease
 History of taking suspected medication previously &
the outcome
 Patient health status
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RELEVANT MEDICAL HISTORY

32.  Designation e.g. Specialist, MO, Pharmacist, PRP,
assistant pharmacist, Nurse, MA, Consumer
 Email address
 Tel no.
 Date of report: do not compile old reports
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13. REPORTER DETAILS

33. CONCLUSION

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You can make a difference
• Fill in the form completely and accurately
• Use the checklists
• Research e.g. VigiAccess, product leaflet
• Ask questions
• TELL OTHERS 

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THANK YOU FOR YOUR
ATTENTION!
Any questions?
Contact me at:
nazmiliana@moh.gov.my
0179224977