Adverse Effects

An adverse drug reaction is a noxious, unintended response to a health product. The term is broader than “allergy.” A predictable pharmacologic effect may become harmful when the dose is excessive, clearance falls, or the patient has little physiologic reserve. An immune-mediated reaction may occur at a usual dose. A medication incident can involve prescribing, dispensing, preparation, administration, or monitoring. A near miss exposes a system vulnerability even when it does not reach the patient or cause harm. Disease progression can imitate an adverse effect, so timing alone never proves causation. The first question is not “Which label fits?” It is “What threatens the patient now?” New wheezing, hypotension, shallow respirations, rapidly changing mental status, severe bleeding, or loss of airway protection requires immediate ABC support and activation of the rapid response or code team according to the patient’s condition. Notify the prescriber immediately while emergency care proceeds. Once the patient is stable, document the suspected reaction and promptly submit it through the organization’s medication-safety process. Hospitals must report documented serious adverse drug reactions and medical device incidents to Health...