Click here to report an Adverse Event
AE

frequently Asked Questions

Healthcare professional such as doctors, dentists, pharmacists, nurses and patients/ consumers can report suspected AEs.

Click here to report online –AE report link

Post or hand deliver to – University of Kelaniya Pharmacovigilance Centre, University of Kelaniya,P.O Box 6, Thalagolla Road, Ragama, Sri Lanka.

Hotline: +9411 4294459

Email: grpsg211@kln.ac.lk

Any adverse drug reactions (ADR) related to any medicine or medicine related product should be reported.

The serious adverse events, that are fatal, life-threatening, debilitating, causing congenital abnormalities, or need prolong hospitalization, should be reported even if the impact is well understood.

The following categories of ADR should be given additional attention.

1. All suspected reactions for new medicines

2. All serious or unexpected reactions for well-known medicines

3. Increased frequency of given reaction

4. All ADR associated with medicine-medicine, medicine – food or medicine – food supplement

5. ADR on special field of interest such as medicine abuse, and medicine used during pregnancy and lactation

6. Suspected ADR associated with medicine withdrawals

7. ADRs due to overdose or medication error

8. Lack of efficacy or pharmacy defects

The data of an AER report provide the most essential information to enable the maximum possible analysis. Therefore, submitting completed AE reports without missing data is important in analyzing the AE report.

The following information should be available at the very least to make a full AE report.

  1. Identifiable patient: The patient’s name, age, gender, and other identifying information should be included in the report.
  2. Suspected medicinal product: The name of the drug or other product that is suspected of causing the adverse reaction should be included in the report.
  3. Reaction: A detailed description of the adverse reaction should be included in the report, including the onset, duration, severity, and any other relevant information.
  4. Identifiable reporter: The name, contact information, and professional affiliation of the person reporting the adverse reaction should be included in the report.

Any suspected AE should be reported as soon as possible. Incase of serious AE the reporting should be done within 24 hours.

The reporter should send follow up information upon follow up of the AE case. Follow-up reports are required until the AE condition gets established. Follow up reports may be submitted email to the centre. The title of the email should contain the words “Follow-up” and the reference No. of the original AE report.