Chapter 61
Adverse Drug Reaction Reporting
A leading cause of harm
Adverse Drug Reactions
An estimated 1.5 million injuries occur each year from medication errors, and tens of thousands of deaths -- some studies rank medication errors among the leading causes of death in the US. Adverse drug reactions (ADRs) cause significant morbidity and mortality, and one-third to one-half of ADRs are believed to be preventable.
Terms like adverse drug reaction, adverse drug event, side effect, and medication error are often used interchangeably but do not always mean the same thing.
Three Key Definitions
A MEDICATION ERROR (NCCMERP) is any PREVENTABLE event that may cause inappropriate use or harm while the medication is in the control of a professional, patient, or consumer. An ADVERSE EVENT (FDA) is any untoward medical occurrence that does NOT have to have a causal relationship with treatment. An ADVERSE DRUG REACTION (WHO) is a response that is noxious and unintended at normal doses.
📖 “~1.5 million injuries/year from medication errors; tens of thousands of deaths (a leading cause). ADRs cause morbidity/mortality; 1/3 to 1/2 preventable. Medication error (NCCMERP): preventable event causing inappropriate use/harm while med in control of professional/patient/consumer. Adverse event (FDA): untoward occurrence, no causal relationship required. ADR (WHO): noxious, unintended response at normal doses.”