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 drug reactions (ADR) or cases of lack of efficacy should also be reported.
- You may also report ADR caused by using non-registered product or cosmetic product.
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 cases?
- If you encounter any side effects or adverse drug reactions, you may refer back to the doctor/pharmacist/nurse at healthcare facility where you get your medicine from.
- You can also report any ADR by using Reporting Form for Medicine Complaint by Consumers (BPFK 419). Please download the form from www.bpfk.gov.my 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,
- Selangor.or
ii) Fax to 03-79567151
Please provide as much detail as possible, by providing all the information as required in the form.
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 (AEFI)
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 investigation 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) Your contact number
ii) Healthcare facility of vaccination taken
As the officer will need to contact you and the healthcare facility.
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) How can I report AEFI cases?
If you encounter any side effects or adverse drug reactions after vaccination, you may refer back to the doctor/pharmacist/nurse at healthcare facility where you get your vaccine from.
You can also report any ADR by using Reporting Form for Medicine Complaint by Consumers (BPFK 419). Please download the form from www.bpfk.gov.my 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,
Selangor.
ii) Fax to 03-79567151
9) What are the cases that need to be investigated?
All cases need to be investigated. The NPCB will provide feedback to reporter after investigation has been completed.