• Pharmacovigilance
• Adverse Drug Reactions
• Suspected Adverse Event
• Reporting Adverse Event
• Importance of Reporting Adverse Event

Pharmacovigilance (ADR Monitoring)

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.

 Adverse Drug Reactions

Adverse Drug Reaction (ADR) is any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.

Suspected Adverse Event

Suspected Adverse Event (SAE) is an untoward medical occurrence that may appear during or after treatment with a drug, and believed to be caused by the drug.If the suspected drug is identified as a likely cause for the SAE (by an expert committee), it will be classified as an ADR.

Reporting of Adverse Events

Healthcare professional such as doctors, dentists, pharmacists and nurses are encouraged to report suspected adverse events encountered in their day to day practice. Using the ADR google form given by the following link here, you can report Adverse Events.

Adverse Drug Events Reporting

A copy of the form shall be forwarded to Adverse Drug Reaction Monitoring Unit of the Department of Pharmacology, Faculty of Medicine, University of Colombo, Kynsey Road, Colombo 08. (TP/ Fax: +94 112 697 483).

Importance of Reporting Adverse Events

When a new chemical entity (NCE) is first marketed, it would have been tested only in a limited number of patients/volunteers. Rare adverse drug reactions/events could be identified only after the drug is marketed and used by a much larger populations Safety information in use in special groups such as children, elderly, pregnant women etc. are not often available at the time of first marketing of a new drug.

• Suspected Adverse Reaction to Medicines / Borderline Products[PDF - 254 KB]
• Anaphylaxis Case Reporting Form [PDF - 255 KB]