Training Manual for Preventive Malaria - Ministry of Health

5B.4: MONITORING OF ADVERSE EFFECTS
DEFINITION OF TERMS
I) Adverse Drug Reaction (ADR)
The World Health Organization’s definition for Adverse Drug Reaction (ADR) is:
“a response to a medicine which is noxious and unintended, and which occurs at doses
normally used in man for the prophylaxis, diagnosis or therapy of disease, or for the
modification of physiological function.”.
What is important in this definition is that a patient experiences an unwanted and/or noxious
reaction following drug therapy. Individual factors may play an important role but the key point
is that the phenomenon experienced is noxious and unintended. An ADR is essentially an
“undesirable” reaction suffered by the patient and differs from “side effect” which is essentially
an unexpected therapeutic response – which may be “good” or “bad”.
II) Adverse Event
“Adverse event/experience” is any untoward medical occurrence that may present
during treatment with a pharmaceutical product but which does not necessarily have a
causal relationship with this treatment.
The basic point here is that an untoward event occurs during the use of a drug but that the drug
did not necessarily cause the event. Hence the term “adverse event” appears to be a broad one
encompassing “adverse drug reactions” (drug related) and other unwanted (but not drug related)
problems occurring during therapy.
To prevent duplication of reports, it is important for healthcare workers to enquire from patients
whether a report concerning the reaction they are reporting has already been submitted to the
NMCP or NCPv
III) ADVERSE DRUG REACTION (ADR) REPORT
An adverse drug reaction report is a detailed record of all relevant data associated with
the use of a medicine in a patient.
The information required in an ADR report for IPT is shown on Appendix 1. It is important to
stress that healthcare workers should try and send reports of ADRs even if they do not have all
the information required.
To prevent duplication of reports, it is important for healthcare workers to require from patients
whether a report concerning the reaction has already been submitted to the NMCP or NCPv.
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