A medication error is "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer."74 An adverse drug event (ADE) is an untoward event or outcome associated with the use of a drug. The definition of ADEs includes medication errors as well as adverse reaction to a drug, drug interactions, and reactions. A medication error is a preventable ADE and vice versa. An adverse drug reaction is defined as "any noxious, unintended, and undesired effect of a medication, which occurs at doses used for prophylaxis, diagnosis, or therapy, excluding therapeutic failures, intentional and unintentional poisoning, and medication abuse, and also excluding ADEs because of medication administration errors, or noncompliance."98 Therefore, a medication error is not an adverse drug reaction but both are ADEs. This chapter will address medication errors and ADEs with a focused analysis of the relevant history and epidemiology, special at-risk populations, possible solutions, and the role of the medical toxicologist.
Patient safety is an area of great interest to many regulatory groups, such as the Joint Commission, hospital administrations, healthcare providers, and the general public. The interest has continued to grow since the publication of the Institute of Medicine report in 1999 which focused on the measures necessary to insure a safer healthcare system including medication errors and adverse effects.52 Medications errors represent up to 25% of all medical errors.42 The importance of medication errors is highlighted in another Institute of Medicine report that focused solely on medication errors.4 Many hospitals focus on medication safety through their pharmaceutical and therapeutics committees, patient safety committees, and medication safety committees.
Although medication safety developments have occurred throughout history, in the 1990s they became a major cause of concern. Table 139–1 shows a timeline of some important developments for medication safety.
Table 139–1. Historical Timeline of Medication Safety |Favorite Table|Download (.pdf)
Table 139–1. Historical Timeline of Medication Safety
|1820||United States Pharmacopeia (USP) is established in Washington, DC|
|1906||The Pure Food and Drugs Act is passed by Congress.|
|1927||The Bureau of Chemistry is reformed into Food, Drug, and Insecticide Administration and the Bureau of Chemistry and Soils.|
|1930||The Food, Drug, and Insecticide Administration was renamed the Food and Drug Administration (FDA).|
|1962||Kefauver-Harris Drug Amendments passed to ensure drug efficacy and greater drug safety.|
|President Kennedy proclaims the Consumer Bill of Rights which includes the right to safety, right to be informed, and right to choose.|
|1963||Representatives from FDA, USP, AMA and American Pharmacists Association form the United States Adopted Names Council to establish drug nomenclature.|
|1968||The FDA is placed in the Public Health Service after reorganization of the federal government health programs.|
|1970||The FDA requires the first patient package insert.|
|1975||The Institute of Safe Medication Practices's (ISMP) work ...|