1) What is the scope of ADR Monitoring?
Reporters are encouraged to report any suspicious adverse event, especially on:
- Newly registered drugs
- Reactions encountered with generic products which are not commonly associated with the equivalent market leader product
- Off-label indications
- Doses differing from the recommended doses
- Newly registered drugs
- Reactions encountered with generic products which are not commonly associated with the equivalent market leader product
- Off-label indications
- Doses differing from the recommended doses
2) What should not be reported?
Reactions to food products and unprocessed herbs should not be reported as these products are beyond the jurisdiction of the Drug Control Authority (DCA).
3) What to report?
If Healthcare Professionals feel that it is cumbersome to report trivial, common and well documented adverse reactions, they should report reactions which are serious, unexpected or unlabeled to the DCA.
4) How to report?
Please go to the NPRA portal > Professional > Reporting.
i. Online reporting.
OR
ii. Download the ADR form, fill in and submit via one of these methods:
a) Email a scanned copy to: Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya..">Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya..
OR
b)
Mail the hardcopy to:
Pusat Pasca Pendaftaran Produk & Kawalan Kosmetik
Bahagian Regulatori Farmasi Negara (NPRA)
Lot 36, Jalan Universiti,
46200 Petaling Jaya, Selangor.
OR
c) Fax to: 03-79567151.
Please provide as much information as possible, by completing all the information as required in the form.
i. Online reporting.
OR
ii. Download the ADR form, fill in and submit via one of these methods:
a) Email a scanned copy to: Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya..">Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya..
OR
b)
Mail the hardcopy to:
Pusat Pasca Pendaftaran Produk & Kawalan Kosmetik
Bahagian Regulatori Farmasi Negara (NPRA)
Lot 36, Jalan Universiti,
46200 Petaling Jaya, Selangor.
OR
c) Fax to: 03-79567151.
Please provide as much information as possible, by completing all the information as required in the form.
5) Basic principles of efficient reporting.
i. Report the event soon after it occurs.
ii. Report whilst the patient is still with you.
iii. Ask the patient particularly about other products taken.
iv. If any additional data is available later, send in a supplementary note.
v. In cases where a foetus or suckling infant sustains an ADR, information of both the parent and the child/fetus should be provided.
vi. Always write legibly.
vii. All reports must have minimum the following four data elements:
a) An identifiable patient
b) An identifiable reporter
c) A suspected drug
d) An adverse event
ii. Report whilst the patient is still with you.
iii. Ask the patient particularly about other products taken.
iv. If any additional data is available later, send in a supplementary note.
v. In cases where a foetus or suckling infant sustains an ADR, information of both the parent and the child/fetus should be provided.
vi. Always write legibly.
vii. All reports must have minimum the following four data elements:
a) An identifiable patient
b) An identifiable reporter
c) A suspected drug
d) An adverse event
6) Is there any guideline available for ADR reporting and monitoring?
The Malaysian Pharmacovigilance Guidelines is available in NPRA website.
