TABLE 1

Glossary of terms

Error An act of commission (doing something
wrong) or omission (failing to do the right
thing) that leads to an undesirable outcome.

Medical Error

The failure to complete a planned action as intended or the use of the wrong plan to achieve an aim.

Medication Error

Any preventable event that may cause or lead to inappropriate medication use or patient harm, while the medication is in the control of the healthcare professional, patient or consumer. Such events may be related to professional practice, healthcare products, procedures and systems, including prescribing; order communication; product labeling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.

Active Error

Readily apparent failures that occur at the point of contact between a human and part of a larger system.

Latent Error

Less apparent failures, organization or design that contribute to the occurrence of errors or allowed them to cause harm to patients.

Adverse Event Any injury caused by medical care.

Adverse Drug Event (ADE)

An adverse event involving medication use.

Potential ADE

A medication error or other drug-related mishap that reached the patient but happened not to produce harm.

Adverse Drug Reaction (ADR)

Adverse effect produced by the use of a medication in the recommended manner.

Near miss

An event or situation that did not produce harm, but only because of chance.

Mistake

Reflect failures during attentional behaviors or incorrect choices; involves insufficient knowledge or failure to correctly interpret information.

Human Factor

The study of human abilities and characteristics as they affect the design and smooth operation of equipment, systems and jobs.

System Approach

The view that most errors reflect predictable human failings in the context of poorly designed systems.

the 21st Century was published. This report focuses on broad changes that can be made to the healthcare system to prevent errors from occurring and allow optimal delivery of health care. According

to this report the healthcare system should aim to achieve six goals to improve quality of care. The goals for the system should be that it is:

• safe,

• effective,

TABLE 2

NCC MERP Index for Categorizing Medication Errors*

TYPE OF ERROR/

CATEGORY RESULT

NO ERROR

Category A Circumstances or events that have the capacity to cause error.
Category B An error occurred, but the medication did not reach the patient.
Category C An error occurred that reached the patient but did not cause harm.
Category D An error occurred that resulted in the need for increased
patient monitoring, but no patient harm.

ERROR, HARM Category E

An error occurred that resulted in the need for treatment or intervention and caused temporary patient harm.

Category F An error occurred that resulted in initial or prolonged hospitalization and caused temporary patient harm.

An error occurred that resulted in permanent patient harm.

An error occurred that resulted in a near-death event (e.g. anaphylaxis, cardiac arrest)

Category G Category H

ERROR, DEATH

Category I An error occurred that resulted in patient death.

* The Council’s definition of “harm” is “death, or temporary or permanent impairment of body function/structure requiring intervention.” Intervention may include monitoring a patient’s condition, change in therapy or active medical or surgical treatment.

• patient-centered,

• timely,

• efficient and

• equitable. ⁹

The most recent report was released in 2006. Preventing Medication Errors: Quality Chasm Series summarizes the approaches necessary to decrease the prevalence of errors. The report recommends that the involvement of the patient, pharmacist, prescriber, manufacturer and healthcare agency is necessary to implement these changes. ¹⁰ This report estimates there to be 1. 5 million medication errors each year in the United States, with 800,000 occurring in long-term care facilities, 450,000 in hospital settings and 530,000 in outpatient centers. ⁶ These are just estimates; actual numbers may be much higher. The IOM initiative is an ongoing process, and the goal of the Committee on the Quality of Health Care in America is to continue to release reports that provide strategies and recommendations for preventing and reducing medication errors.

HISTORY OF ERROR REPORTING

There are more than 100 medical associations, pharmacies, pharmacy organizations and healthcare institutions that work with the Food and Drug Administration (FDA) in ensuring the safety and efficacy of all marketed medical products. Many of these organizations and institutions participate in the identification and reporting of medical errors.

MedWatch, which is the FDA Safety Information and Adverse Event Reporting Program, serves both healthcare professionals and the public. This program allows the FDA to provide important and timely information about safety issues concerning prescription and nonprescription drugs, biologics, medical and radiation-emit-ting devices and nutritional products. Safety alerts, recalls, withdrawals and labeling changes also are available through MedWatch. Goals of this reporting system include educating and promoting awareness about adverse drug event reporting and to ensure that drug safety information is adequately com-

municated to the public and medical community. ¹¹

The U.S. Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP) are MedWatch partners that created the USP-ISMP Medication Errors Reporting Program (MERP). This program, similar to Med Watch, is a voluntary reporting program that provides analysis of the cause of errors and recommendations for prevention. Information sent to this program is disseminated to the FDA. In 1997, ISMP established Med-ERRS (Medical Error Recognition and Revision Strategies), which works with pharmaceutical manufacturers to prevent errors that result from confusing or misleading naming, labeling, packaging and device design.

In 1995, USP formed the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP), which is comprised of 23 national medical and pharmacy organizations. The mission statement of the NCC MERP is to maximize the safe use of medications and