Frequently Asked Questions (FAQ) on ADR & AEFI Reporting
1. What kind of cases should I report?
You are encouraged to report all cases where either a healthcare professional or the registration holder believes that there is a possible causal relationship between the reaction and the drug in question. However, all cases which are serious and unexpected must be reported.
Cases of overdose (accidental or intentional) that lead to suspected serious and unexpected adverse reactions or cases of lack of efficacy should also be reported.
2. What kind of cases do I not need to report?
Reports on pregnancy should not be forwarded before the outcome is known, unless unintended pregnancy is suspected as an adverse reaction.
When using cytotoxic drugs or other preparations of a highly toxic nature, it will not be necessary to report those serious reactions which are well known to be frequent.
3. How can I report ADR and AEFI cases?
You can report any ADR or AEFI cases using the Blue Form, and send via any one of these methods upon completion:
i) Mail the hardcopy to:
Pusat Pemonitoran Kesan Advers Ubat Kebangsaan
Biro Pengawalan Farmaseutikal Kebangsaan
Peti Surat 319, Jalan Sultan,
46730 Petaling Jaya,
ii) Fax to 03-79567151
iii) Online submission via www.bpfk.gov.my
4. Who do I contact if I have any queries?
For any queries, you can call our general line at 03-78835400 and ask for the Pharmacovigilance Section.
Adverse Events Following Immunisation:
5. Is reporting of AEFI different from reporting ADR?
Reporting of AEFI is similar to reporting of ADR. They differ in the type of information which are important in order to facilitate monitoring of the events.
6. What is the important information required for reporting of AEFI?
Apart from the information that is important for ADR reporting, the following information is especially important for reporting of AEFI:
i) Product registration number
ii) Batch number
iii) Dose number
7. What are the cases that need to be reported?
Cases with any adverse event occurring after the administration of a vaccine need to be reported.
8. Which form do I use to report AEFI?
For minor reactions: Monitoring of Minor Adverse Events Following Immunisation Form
For serious cases:
- Blue Form - Report on Suspected ADR, and
- AEFI Investigation Form
For cases involving cutaneous adverse reactions: Clinical Manisfestation of Cutaneous Adverse Drug Reaction (ADR) Form, in addition to either (i) or (ii) above.
9. What are the cases that need to be investigated?
All serious cases need to be investigated.
10. What are the cases that are considered serious?
Cases where the event resulted in the following outcomes are considered as serious:
i) Patient died
iii) Requires / prolongs hospitalisation
iv) Causes significant disability / incapacity
v) Congenity anomaly
*[Note: the above FAQ content can also be viewed under our Section on "FAQ" here]