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. 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. 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.

In the 1960s, Jick and colleagues began to focus on the safety of drugs in everyday practice, using a concurrent study approach instead of voluntary reporting. The authors found that 30% of the medical inpatients in their study experienced at least 1 ADR during their . . .

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