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Pharmacovigilance
Suneel Kadekars
LEADS
Pharmacovigilance is the science and activities relating to the knowledge, detection, assessment and prevention of adverse effects or any drug-related problem
Adverse Drug Reaction (ADR)
An adverse drug reaction is a noxious and unintended response to a medicine and which occurs at doses normally used or above the normal expected levels in man for diagnosis or used in treatment of diseases, or for the modification of physiological function.
Adverse drug reactions are also caused when new drugs are tested on humans.
What is the difference between an ADR and a side effect?
A side effect can be defined as any unintended effect of a pharmaceutical product occurring at doses normally used in humans, which is related to the pharmacological properties of the drug. Such effects may or may not be beneficial. Side effects can often be predicted.
However, when a side effect occurs above the usual/expected level, it becomes an adverse drug reaction.
Who should report ADRs?
All health care professionals/workers, site staffs including doctors, principal investigators, CRCs related to the trial in progress need to report all suspected adverse reactions to drugs to the ethics committees and the sponsors
What are the benefits of ADR reporting?
Reporting of adverse drug reactions benefits in several ways such as
Guaranteeing Patient Safety
Improving Quality of Care Offered to Patients
Enhancing Patient Confidence in Practitioners
Contributing to knowledge on Drug Safety issues
ADR Forms can also be downloaded from http://www.nafdacnigeria.org/pharmacovigilance.htm
Article submitted Thursday, September 25, 2008
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