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Adverse Drug Reactions

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.

Click here to download the SUSPECTED ADVERSE REACTION TO MEDICINES / BORDERLINE PRODUCTS

Click here to download the ANAPHYLAXIS CASE REPORTING FORM