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Safety of Medicines - A Guide to Detecting and Reporting Adverse Drug Reactions - Why Health Professionals Need to Take Action
(2002; 16 pages)
Table of Contents
View the documentIntroduction
View the documentGlossary
View the documentThe magnitude of the problem
View the documentWhy postmarketing surveillance and reporting ADR is needed
View the documentWhy pharmacovigilance is needed in every country
View the documentHow voluntary reporting on ADRs can prevent new medicine tragedies from developing
View the documentHow voluntary reporting on ADRs can influence labelling
View the documentWhy health professionals are in the best position to detect and report on ADRs
View the documentHow to recognize ADRs
View the documentWhat should be reported?
View the documentHow to report ADRs?
View the documentReferences
View the documentAcknowledgements

How to recognize ADRs

Since ADRs may act through the same physiological and pathological pathways as different diseases, they are difficult and sometimes impossible to distinguish. However, the following step-wise approach may be helpful in assessing possible drug-related ADRs:

1. Ensure that the medicine ordered is the medicine received and actually taken by the patient at the dose advised;

2. Verify that the onset of the suspected ADR was after the drug was taken, not before and discuss carefully the observation made by the patient;

3. Determine the time interval between the beginning of drug treatment and the onset of the event;

4. Evaluate the suspected ADR after discontinuing the drugs or reducing the dose and monitor the patient's status. If appropriate, restart the drug treatment and monitor recurrence of any adverse events.

5. Analyse the alternative causes (other than the drug) that could on their own have caused the reaction;

6. Use relevant up-to-date literature and personal experience as a health professional on drugs and their ADRs and verify if there are previous conclusive reports on this reaction. The National Pharmacovigilance Centre and Drug Information Centres are very important resources for obtaining information on ADR. The manufacturer of the drug can also be a resource to consult;

7. Report any suspected ADR to the person nominated for ADR reporting in the hospital or directly to the National ADR Centre.

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