What is a Medication Error

What is a Medication Error?

The Council defines a "medication error" as follows:

"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. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use."

The Council urges medication errors researchers, software developers, and institutions to use this standard definition to identify errors.

A medication error is any preventable event that may cause or lead to inappropriate medication use or harm to a patient. Since 2000, the Food and Drug Administration (FDA) has received more than 95,000 reports of medication errors. FDA reviews reports that come to MedWatch6, the agency's adverse event reporting program.

"These reports are voluntary, so the number of actual medication errors is believed to be higher," says Carol Holquist, R.Ph., Director of the Division of Medication Error Prevention and Analysis in FDA's Center for Drug Evaluation and Research.

FDA works with many partners to track medication errors, including the U.S. Pharmacopeia (USP) and the Institute for

Safe Medication Practices (ISMP). "Every report received

through the USP/ISMP Voluntary Medication Error Reporting

Program (MERP) automatically gets sent to FDA's MedWatch

program," says Mike Cohen, R.Ph., Sc.D., President of ISMP. "It

takes a cooperative approach to monitor errors, evaluate them,

and educate the public about strategies to keep errors from

happening again."

Medication errors occur for a variety of reasons. For example,

miscommunication of drug orders can involve poor handwriting,

confusion between drugs with similar names, poor packaging

design, and confusion of metric or other dosing units. "Medication errors usually occur because of multiple, complex

factors," says Holquist. "All parts of the health care

system—including health professionals and patients—have a

role to play in preventing medication errors

FDA works with many partners to track medication errors, including the U.S. Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP). "Every report received through the USP/ISMP Voluntary Medication Error Reporting Program (MERP) automatically gets sent to FDA's MedWatch program," says Mike Cohen, R.Ph., Sc.D., President of ISMP. "It takes a cooperative approach to monitor errors, evaluate them, and educate the public about strategies to keep errors from happening again."

Medication errors occur for a variety of reasons. For example, miscommunication of drug orders can involve poor handwriting, confusion between drugs with similar names, poor packaging design, and confusion of metric or other dosing units.

"Medication errors usually occur because of multiple, complex factors," says Holquist. "All parts of the health care system—including health professionals and patients—have a role to play in preventing medication errors."

FDA's Role

?Drug Name Review:

To minimize drug name confusion, FDA reviews about 400 drug names a year that

companies submit as proposed brand names. The agency rejects about one-third of the

names that drug companies propose.

?Drug Labels:

FDA regulations require all over-the-counter (OTC) drug products (more than 100,000) to have a standardized "drug facts label." FDA has also improved prescription drug package

inserts for health care professionals.

?Drug Labeling and Packaging:

FDA works with drug companies to reduce the risk of errors that may result from

similar-looking labeling and packaging, or from poor product design.

?Bar Code Label Rule:

In accordance with an FDA rule that went into effect in 2004, bar codes are required on

product labels for certain drugs and biologics such as blood. When used with bar code

scanner and computerized patient information systems, bar code technology can help

ensure that the right dose of the right drug is given to the right patient at the right time.

?Error Analyses:

FDA reviews about 1,400 reports of medication errors per month and analyzes them to

determine the cause and type of error.

?Guidances for Industry:

FDA is working on three new guidances—one on complete submission requirements for

anaylsis of trade names, one about the pitfalls of drug labeling, and another on best test

practices for naming drugs.

Public Education:

FDA spreads the message about medication error prevention through public health

advisories, medication guides, and outreach partnerships with other organizations.

Examples of Medication Errors

Misuse of Tussionex Prescription Cough Medicine:

On March 11, 2008, FDA informed health care professionals about adverse events and deaths in children and adults who have taken Tussionex Pennkinetic Extended-Release Suspension (Tussionex). Tussionex is a long-acting prescription cough medicine.

Hydrocodone, the narcotic ingredient in this medicine that controls cough, can cause life-threatening breathing problems when too much medicine is given at one time or when the medicine is given more frequently than recommended. Tussionex should not be used in children less than 6 years old.

Reports indicate that health care professionals have prescribed Tussionex for patients younger than the approved aged group of 6 years old and older, more frequently than the labeled dosing interval of every 12 hours ("extended release"), and that patients have administered the incorrect dose due to misinterpretation of the dosing directions and the use of inappropriate measuring devices. Overdose of Tussionex in older children, adolescents, and adults has also been associated with life-threatening and fatal breathing problems.

For more information, see FDA Issues Alert on Tussionex7 at

and the FDA Public Health Advisory8

Overdoses of Cough and Cold Products in Children:

Roughly 7,000 children ages 11 and younger are treated in hospital emergency rooms each year because of overdoses of OTC cough and cold medication, according to a recent study by the Centers for Disease Control and Prevention. About two-thirds of those incidents occurred when children took medication without a parent's knowledge. Parents should keep medication out of children's reach and should never describe medication as "candy."

OTC cough and cold products can be harmful if more than the recommended amount is used, if they are given too often, or if more than one product containing the same active ingredient is used. In January 2008, FDA issued a public health advisory recommending that OTC cough and cold products not be used in infants and children under 2.

Serious injuries and deaths have resulted from such errors as misunderstanding directions and failing to use the measuring devices that come with the medicine. For more information, see OTC Cough and Cold Products: Not for Infants and Children Under 2 Years of Age9.

Overdoses of Acetaminophen:

Taking too much of the pain reliever acetaminophen can lead to serious liver damage. The drug is sold under brand names such as Tylenol and Datril, and is also available in many cough and cold products, prescription pain relievers, and sleep aids.

To avoid accidental overdosing, consumers should not take more than the recommended dose on the label. Also, acetaminophen should not be taken for more days than recommended, and should not be taken with other drug products that also contain acetaminophen without direction from a health care provider.

Parents should be cautious when giving acetaminophen to children. For example, the infant drop formula is three times more concentrated than the children's liquid. So parents need to be sure to give the appropriate dose.

Misuse of Fentanyl Patches:

FDA has issued warnings about the fentanyl transdermal system, an adhesive patch that delivers an opioid called fentanyl through the skin. An opioid is a potent pain medicine. It is also sometimes called a narcotic drug. Other examples of opioids include hydrocodone, morphine, and oxycodone.

The directions on the product label and package insert of the fentanyl transdermal system should be followed exactly in order to avoid overdose. Fentanyl patches should not be used for short-term acute pain, pain that is not constant, or for pain after an operation. The patch is only for moderate-to-severe chronic pain that is expected to last for any number of weeks or longer and that cannot be managed by acetaminophen-opioid

combinations, nonsteroidal analgesics, or as-needed dosing with

short-acting opioids.

Fentanyl patches are mostly prescribed for patients with cancer. Recent reports to FDA describe deaths and life-threatening side effects after doctors and other health care professionals inappropriately prescribed the patch to relieve pain after surgery, for headaches, or for occasional or mild pain in patients who were not opioid tolerant.

In other cases, patients have used the patch incorrectly. The patients replaced the patch more frequently than directed in the instructions, applied more patches than prescribed, or applied heat to the patch. All of these cases resulted in dangerously high fentanyl levels in the blood.

For more information, see FDA Issues Second Safety Warning on Fentanyl Skin Patch10

FDA Public Health Advisory11

Overdoses with Methadone:

FDA has issued a public health advisory cautioning practitioners to avoid overdoses when they are prescribing methadone or managing patients taking the drug.

Since the 1970s, methadone has been primarily used in treating drug abuse, but it is increasingly being used to treat pain. FDA issued the advisory because of reports of life-threatening adverse events and death in patients receiving methadone for pain control. Like other opioids, methadone causes slowed breathing, affects heart rate, and can also interact with other drugs. An overdose can occur because methadone stays in the body longer than the pain relief lasts.

For more information, see FDA's Public Health Advisory on methadone12 Mix-ups Between Edetate Disodium and Edetate Calcium Disodium:

Both edetate disodium and edetate calcium disodium work by binding with heavy metals or minerals in the body, allowing them to be passed out of the body through the urine. Edetate calcium disodium was approved to treat severe lead poisoning. Edetate disodium was approved as an emergency

treatment for certain patients with very high levels of calcium in the blood or certain patients with heart rhythm problems resulting from high amounts of the medication digoxin in the blood.

But a number of uses that are not approved by FDA have emerged. These include the removal of other heavy metals from the blood and the treatment of heart disease, commonly referred to as "chelation therapies."

In January 2008, FDA issued a public health advisory, warning that some children and adults have died when they were mistakenly given edetate disodium instead of edetate calcium disodium (calcium disodium versenate), or when edetate disodium was used for chelation therapies and other uses not approved by FDA.

The drugs are easily mistaken for each other because they have very similar names and are both commonly referred to only as "EDTA." One of FDA's recommendations is that the abbreviation not be used.

For more information, see FDA's Public Health Advisory on Edetate Disodium13 (marketed as Endrate and generic products)

This article appears on FDA's Consumer Updates page14, which features the latest on all FDA-regulated products.

Updated: February 20, 2009

About Us

About the Foundation

Our Mission

(amended by the NPSF? Board January 2003)

Improve the Safety of Patients

We accomplish this through our efforts to:

?Identify and create a core body of knowledge;

?Identify pathways to apply the knowledge;

?Develop and enhance the culture of receptivity to patient safety;

?Raise public awareness and foster communications about patient safety; and

?Improve the status of the Foundation and its ability to meet its goals.

NPSF can make a long term, measurable difference by serving as a central voice, and

NPSF will lead the transition from a culture of blame to a culture of safety. Our Vision

(amended by the NPSF? Board January 2003)

The National Patient Safety Foundation is the indispensable resource for individuals and organizations committed to improving the safety of patients.

We Believe...

(amended by the NPSF? Board November 1998)

?Patient safety is central to quality health care as reflected in the Hippocratic Oath: "Above All, Do No Harm".

?Prevention of patient injury, through early and appropriate response to evident and potential problems, is the key to patient

safety.

?Continued improvement in patient safety is attainable only through establishing a culture of trust, honesty, integrity and open communications.

?An integrated body of scientific knowledge and the infrastructure to support its development are essential to advance patient safety significantly.

?Patient involvement in continuous learning and constant communication of information between care givers, organizations and the general public will improve patient safety.

?The system of health care is fallible and requires fundamental change to sustainably improve patient safety.

Our Definitions

(approved by the NPSF? Board July 2003)

?PATIENT SAFETY

The prevention of healthcare errors, and the elimination or

mitigation of patient injury caused by healthcare errors.

?HEALTHCARE ERROR

An unintended healthcare outcome caused by a defect in the

delivery of care to a patient. Healthcare errors may be errors of

commission (doing the wrong thing), omission (not doing the right thing), or execution (doing the right thing incorrectly). Errors may be made by any member of the healthcare team in any healthcare

setting.

The National Patient Safety Foundation is a not-for-profit organization with

501(c)(3) status and all donations are tax-deductible to the extent allowed by

law.

NPSF? Board

The National Patient Safety Foundation (NPSF) has a tier structure designed to allow the organization the ability to address the needs of the patient and improve patient safety in the delivery of health care.

The members of the Board of Directors, chaired by Gary S. Kaplan, MD, FACMPE, provide strategic and operational oversight and are vested with the Foundation’s fiduciary responsibility.

The larger Board of Governors, currently chaired by Gregg S. Meyer, MD, MSc, focuse s on program direction in keeping with NPSF’s mission and fundraising to support initiatives.

The Lucian Leape Institute at the National Patient Safety Foundation, launched in 2007, functions as a think tank to define strategic paths and issue calls to action for the field of patient safety and is intended to provide vision and context for the many efforts underway within the health care system. Through its Roundtables, it issues reports that will guide the work of the field and challenge the system to address the issues critical to making the system safer.

Vision

No patient will be harmed by a medication error.

Mission

The mission of the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) is to maximize the safe use of medications and to increase awareness of medication errors through open communication, increased reporting and promotion of medication error prevention strategies.

Goals

?Stimulate the development and use of reporting and evaluation systems by individual health care organizations

?Stimulate reporting to a national system for review, analysis, and development of recommendations to reduce and ultimately prevent medication errors

?Examine and evaluate the causes of medication errors

?Increase awareness of medication errors and methods of prevention throughout the health care system

?Recommend strategies for system modifications, practice standards and guidelines, and changes in packaging and labeling.

Objectives

?Promote reporting, discussion and communication about safe medication use, medication errors and error-prone processes, and error-prevention strategies

?Develop and broadly disseminate NCC MERP's recommendations and other work products related to reporting, understanding, and prevention of medication errors

?Collaborate with other interested stakeholders to address special topics related to medication errors and patient safety initiatives

Strategies

Medication Error Reporting

?Heighten awareness of reporting systems available to or within health care organizations

?Stimulate and encourage reporting and sharing of medication errors both nationally and locally

?Develop standardization of classification systems for the collection of medication error reports so that databases will reflect reports and categorization systems

?Encourage systems and provide targeted feedback so that appropriate prevention strategies can be developed and implemented in facilities

Medication Error Understanding

?Assess current knowledge of medication errors through ongoing efforts (for example, literature searches) to gather data associated with the scope of problems, types of

errors, causes and sources of errors, and clinical and financial impact on patients and the health care delivery system

?Identify gaps in research that hinder the understanding of medication errors

?Promote research to expand knowledge regarding medication errors, their causes, and the effectiveness of interventions

Medication Error Prevention

?Encourage standardization of processes to prevent error-prone aspects of drug procurement, prescribing, dispensing, administration, disposal

?Encourage shared accountability and systems-based solutions to enhance the safety of medication use and to minimize the potential for human error

?Promote/encourage the safe use and understanding of technology in the prevention of medication errors

?Increase awareness of the need for distinctive packaging, labeling, and nomenclature of products associated with actual or potential medication errors

?Educate consumers and patients regarding strategies to prevent medication errors for both prescription and nonprescription medications

?Educate health care professionals about causes of medication errors and strategies for prevention

Special Topics

?Conduct literature reviews and environmental assessments related to special topics that have been identified as potentially related to safe medication use

?Convene special meetings to review special topics and propose related actions

?Prepare and disseminate documents (i.e., white papers) describing special topics and proposing solutions for improving medication use

ISMP Mission and Vision Statement Our Mission

To advance patient safety worldwide by empowering the healthcare community, including consumers, to prevent medication errors.

We accomplish this through our interdisciplinary efforts to:

?Collect and analyze reports of medication-related hazardous conditions,

near-misses, errors, and other adverse drug events.

?Disseminate timely medication safety information, risk-reduction tools, and error-prevention strategies.

?Educate the healthcare community and consumers about safe medication

practices.

?Collaborate with other patient safety organizations, educational institutions, governmental agencies and other healthcare stakeholders.

?Advocate the adoption of safe medication standards by accrediting bodies,

manufacturers, policy makers, regulatory agencies, and standards-setting

organizations.

Conduct research to provide evidence-based safe medication practices.

Our Vision

To be the premier independent, patient safety organization leading the effort to prevent medication errors and adverse drug events.

ISMP Medication Errors Reporting

Program (MERP)

The ISMP Medication Errors Reporting Program (MERP), operated by the Institute for Safe Medication Practices (ISMP), is a confidential national voluntary reporting program that provides expert analysis of the system causes of medication errors and disseminates recommendations for prevention. Regulatory agencies and manufacturers are notified of needed changes in products when safety is of concern. Without reporting, such events may go unrecognized and thus important epidemiological and preventive information would be unavailable. ISMP is a federally certified patient safety organization (PSO), providing legal protection and confidentiality for submitted patient safety data and error reports.

Errors, near-errors or hazardous conditions may be reported to the program. These include, but are not limited to, administering the wrong drug, strength, or dose of medications; confusion over look-alike/sound-alike drugs; incorrect route of administration; calculation or preparation errors; misuse of medical equipment; and errors in prescribing, transcribing, dispensing, and monitoring of medications. This information will be sent to third parties such as the Food and Drug Administration (FDA) MedWatch program and to the manufacturer/labeler. You will have the option of including your identity and location on these copies. MERP reporters are encouraged to submit associated materials such as product photographs, containers, labels, prescription order scans, etc, that help support the information being submitted. ISMP guarantees confidentiality of information received and respects reporters' wishes as to the level of detail included in publications.

Case studies are published by ISMP to alert healthcare professionals and others about recommendations to prevent errors. Your identity, affiliation, and location are not revealed in these reports. The information, excluding your name and contact

information unless you grant permission, will be forwarded to the Food and Drug Administration, the manufacturer and others to inform them about pharmaceutical labeling, packaging, and nomenclature issues that may foster errors by their design. When reporting errors, please include the following:

1.Describe the error or preventable adverse drug reaction. What went

wrong?

2.Was this an actual medication error (reached the patient) or are you

expressing concern about a potential error or writing about an error that was discovered before it reached the patient?

3.Patient outcome.

4.Type of practice site (hospital, private office, retail pharmacy, drug

company, long-term care facility, etc).

5.The generic name (INN or official name) of all products involved.

6.The brand name of all products involved.

7.The dosage form, concentration or strength, etc.

8.How was the error discovered/intercepted?

9.Please state your recommendations for error prevention.

Please do not submit any patient identifiable information when forwarding medication error reports to ISMP.