The importance of medication safety has been recognized for many years,
but only recently has it reemerged as a major public health issue based on
numerous recent studies and high-profile safety events.1 Drug
safety dates back to the 1950s, when in response to reports of chloramphenicol-associated
aplastic anemia, the American Medical Association established an adverse drug
reaction (ADR) reporting system and the Food and Drug Administration began
requiring pharmaceutical manufacturers to report ADRs.1 This
effort to detect heretofore unknown, serious adverse effects of medications
in postmarket use relied on voluntary reporting, which also became common
practice in most health care organizations.
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