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140: Medication Safety and Adverse Drug Events

Brenna M. Farmer

HISTORY AND EPIDEMIOLOGY

Patient safety is of great interest to many regulatory groups, such as The Joint Commission, hospital administrations, health care professionals, and the general public. The interest has continued to grow since the publications of two reports by the Institute of Medicine. The first report, in 1999, focused on all medical errors and introduced measures necessary to ensure a safer health care system.85 The second report, in 2006, focused on reducing medication errors and adverse drug effects.83 These reports and others reveal that medications errors represent up to 25% of all medical errors.49 Many health care institutions address medication safety through their pharmacy and therapeutics (also commonly called drug and formulary), medication safety, patient safety, and quality improvement committees. Table 140–1 shows a timeline of some important developments in medication safety.

TABLE 140–1.Critical Events in the Evolution of Medication Safety
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TABLE 140–1. Critical Events in the Evolution 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 re-formed 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, American Medical Association (AMA), and American Pharmacists Association form the US 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 officially begins with a continuing column in Hospital Pharmacy
1987 The first ISMP list of dangerous drug abbreviations is printed in Nursing ‘87
1989 Agency for Health Care Policy and Research (AHCPR) is established as an agency in the Public Health Service in the Department of Health and Human Services
1991 Institute for Healthcare Improvement is founded as a not-for-profit organization to aid in improvement of health care quality
USP and ISMP create Medication Error Reporting Program (MERP)
1993 A consolidation of several adverse reaction reporting systems is launched as MedWatch, the FDA voluntary reporting system for problems associated with medical products
1996 The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) is formed
1997 National Patient Safety Foundation is established with patient safety as its sole purpose
ISMP founds a subsidiary, Medical Error Recognition and Revision Strategies (Med. E.R.R.S.), to work with drug companies to predict problems with names, labels, and packaging
1998 USP launches MEDMARX, an Internet-accessible medication errors reporting system for hospitals
Founding members of The Leapfrog Group ...

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