The characteristics of medicines expose people taking those medicines to the risk of adverse drug reactions.
Medicines risk
The characteristics
of medicines expose people taking those medicines to the risk of adverse drug
reactions. There are a number of terms which are used to describe adverse drug
reactions and these have been defined by the World Health Organization:
An adverse drug reaction (ADR) is a response to a medicine
which is noxious and unintended, and which occurs at doses normally used in
man.
Adverse drug
reactions are associated with the way the individual patient responds to the
medicine. The patient may exhibit an unexpected or exagger-ated response to the
medicine which is unpleasant for the patient. Adverse drug reactions may be
side-effects. A side-effect is ‘any unintended effect of a pharmaceutical
product occurring at doses normally used by a patient which is related to the
pharmacological properties of the drug’. For example, a patient might
experience an unexpectedly large reduction in blood pressure following
administration of a licensed dose of an antihypertensive medicine. Such a
reaction is related to the pharmacology of the drug.
Sometimes adverse
drug reactions are not related to the pharmacology of the drug and are
unpredictable. These unexpected adverse reactions are less common than
side-effects but have the potential to be more serious. An unexpected adverse
reaction is ‘an adverse reaction, the nature or severity of which is not
consistent with domestic labelling or market authorisation, or expected from
characteristics of the drug’. Serious adverse events are those events with the
potential for permanent patient harm, including death. A serious adverse event
is any event that falls into one of the following categories:
·
is fatal
·
is life-threatening
·
is permanently/significantly disabling
·
requires or prolongs hospitalisation
·
causes a congenital anomaly
·
requires intervention to prevent permanent impairment or
damage.
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