A guide on how to fill up the ADR form properly

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