Adverse Drug Reactions
Adverse Drug Reactions (ADR) is a response to a drug which is noxious and unintended, and which occurs at a dose normally given, by the proper route.
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
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.
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 form given here, adverse events can be reported to
|Address||:||Director, Medical Technology & Supplies
No: 120, Norris Canal Road, Colombo 10
|Telephone||:||+94 11 2698896, +94 11 2698897|
|Fax||:||+94 11 2689704|
A copy of the form shall be forwarded to Adverse Drug Reaction Monitoring Unit of the Department of Pharmacology, Faculty of Medicine, Kynsey Road, Colombo 08. (TP/ Fax: 0112697483)
Importance of reporting adverse events
When a new drug (NCE) is first marketed, it would have been tested only in a limited number of patients. Rare adverse drug reactions 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.