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Medical errors represent a leading cause of morbidity and mortality, both in the United States and throughout the world.1 Medication errors are by far the most prevalent type of medical error in all care settings, and for all patient populations,2 and as noted in a seminal article on patient safety, the most common cause of iatrogenic adverse events.3 As most medication errors are arguably preventable, strategies to promote medication safety are an essential component of patient safety and quality improvement initiatives. This chapter will address medication safety, with a focus on issues unique to the pediatric population.

Definitions and Epidemiology

A medication error can be defined as “a failure in the medication process that leads to, or has the potential to lead to harm to the patient.”4 These failures may occur in the manufacturing and/or compounding of medications, or may occur during the medication use process, which encompasses drug prescribing, dispensing, administration, and subsequent drug monitoring. An adverse drug event (ADE) is a medication error that results in any injury (eg, physical, mental, physiological) to the patient. Fortunately, the vast majority of medication errors do not result in harm to patients. It has been estimated that one in seven medication errors have the potential to cause patient harm, with just one in 100 medication errors causing an injury.5

ADEs represent the largest single category of adverse events due to medical error experienced by hospitalized patients, accounting for nearly 20% of all injuries sustained.6 As might be expected, ADEs are associated with increased morbidity and mortality, prolonged hospital length of stay, and higher healthcare costs.7

The Institute of Medicine (IOM) reported in January of 2000 that from 44,000 to 98,000 deaths occur annually in the United States from medical errors.1 Of this total, an estimated 7,000 deaths occur due to ADEs.1 In their 2007 report on medication error, the IOM estimated that between 380,000 and 450,000 preventable ADEs occurred annually in the hospitals of the United States.2 Assuming an estimated 400,000 preventable ADEs annually, the projected cost of ADEs at that time was 3.5 billion dollars.8

Other studies on the incidence of ADEs in hospitalized patients have formulated significantly higher estimates. A meta-analysis of prospective studies estimated that 6.7% of the hospitalized patients in the United States will have a serious ADE, with an associated fatality rate of 0.32%.9 If accurate, this would translate to greater than 2.2 million serious events, causing well over 100,000 deaths. This would position ADEs as the fourth leading cause of death in the United States. ADEs result in an estimated 700,000 emergency department visits annually, prompting an estimated 120,000 hospital admissions, and countless ambulatory care encounters.10 All of these data are for adult patients.

Studies within the pediatric population indicate that the rate of medication ...

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