tem may fail, while RCA reviews a quality failure that already took place and considers how to implement change so it does not occur again.
In 1997, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) mandated the use of RCA when investigating any sentinel event, which is defined as an event causing death or serious injury. RCA already is being used in hospitals, and industry and community pharmacists also can use these tools to identify the root cause of an incident and identify actions for improvement. Although the studies are limited, Knudsen et al. performed a root cause analysis of errors that occurred during the transcription phase in 40 randomly selected community pharmacies. 23 The study identified four root causes of error, including handwriting on prescriptions, drug confusion (similar drug names, strength and dosing), lack of concentration caused by interruptions and lack of control of the prescription label. The overall conclusion from the study was that root cause analysis shows potential for identifying underlying causes of error and improvement of patient safety. Unfortunately, despite using RCA, it is impossible to know if the identified cause was the actual cause, the process is time-consuming and regardless of the analysis the event already occurred. 22 RCA software is
available for institutions and pharmacies to purchase. This software allows any information and data collected to be shared with other institutions with the goal of preventing future incidents. The Public Health Foundation, which is part of the National Center for Patient Safety, provides a guideline and checklist for performing RCA when an event or near miss occurs (Table 8). 24
PREVENTING MEDICATION ERROR
According to the 2006 IOM report, Preventing Medication Errors, approaches to decreasing and preventing errors require changes from prescribers, pharmacists, industry, governmental health agencies and patients. The IOM Committee on Quality of Care and the NCC MERP have proposed many recommendations, some of which already have been implemented into the healthcare system. Some recommendations may be environment-specific, such as the recommendations for management of drugs in non-healthcare settings (e.g. schools, summer camps and prisons), while others, such as the recommendations relating to verbal orders, are applicable to a variety of settings. A complete list of recommendations can be found at www.nccmerp.org/council-Recs.html.
attention to names, packaging and labeling of pharmaceuticals. One of the most notable changes has been the Name Differentiation Project in 2001 for sound-alike and look-alike drugs. 27 The Office of Generic Drugs requested that manufacturers revise the appearance of certain drug names on the label using “TALL MAN” letters (e.g., Bupropion to BuPROPion and Buspirone to BusPIRone). Since 2000, several governmental agencies including the FDA, USP and the United States Adopted Names (AMA USAN) Council, have mandated changes to drugs involved with errors or those having the potential to cause error. The most recent change, which took place in 2005, was changing the Alzheimer’s medication Reminyl to Raza-dyne as a result of confusion with the diabetes medication Amaryl. 28 Other recommendations to minimize name confusion have been to discourage manufacturers from placing large company names or logos on the immediate container and taking a prospective approach with use of FMEA in designing the packaging of a drug. 29
Manufacturers
Manufacturers play an important role in minimizing medication errors through
TABLE 9
Medication Safety Resources
Agency for Healthcare Research and Quality Institute for Safe Medication Practices Institute of Medicine
www.ahrq.gov www.ismp.org www.iom.org
National Coordinating Council for Medication Error Reporting and Prevention
National Patient Safety Foundation
U.S. Pharmacopeia
Pharmacists need to be aware of medications whose names are similar, as well as those products which, due to the number of doses and/or formulations, may be easily confused. Similar sounding or similar looking drugs should not be stored on shelves next to each other. Additional signage or reminders that prompt the pharmacists or technician(s)
to verify the dose and/or formulation should also be considered. When manufacturers take steps to differentiate similar products (e.g. using color coding to differentiate doses), efforts should be taken to assure that all
www.nccmerp.org www.npsf.org www.usp.org
TABLE 8
Steps for Root Cause Analysis
Step One • Construct a simple flowchart of the event or an outline of the story that progresses chronologically
• Determine what you do and do not know about the incident
• Gather as much information from the event as possible
• Interview those involved, as well as witnesses
• Ask “Who or what was involved”
• Ask “Where and when did the incident happen”
• Ask “What was the incident”
• Ask “How did it happen”
Step Two
• Construct a detailed flowchart of events and identify where the process failed
• Analyze the information to determine the contributing factors and causes
• Consider patient factors, communication factors and human factors
Step Three
• Make recommendations and develop a report based on the contributing factors identified
• Recommendations should be able to be implemented
• Recommendations should identify an individual responsible for implementation
staff are aware of and familiar with the new label.
Prescribers
Prescribers play an important role in assuring patient safety and preventing medication errors. The issues that are most relevant to pharmacists have to do with selection of correct dose and communication (written and oral). In order to minimize errors, prescribers must ensure that all written orders are legible and complete. This includes avoiding use of error-prone abbreviations and awareness of the published ISMP lists of high-alert medications and confused drug names. When in doubt, a pharmacist should not hesitate to contact the prescriber for clarification. Pharmacists and pharmacy technicians also should be aware of abbreviations that are especially prone to error. For example, the letter “U,” intended as an abbreviation for units, if written poorly, may appear to be the number zero and could result in a tenfold increase in dose.
Prescribers also should avoid vague directions and especially “take as directed.” Again, pharmacists can play a role in addressing this issue by contacting the prescriber and requesting specific directions. Trailing or terminal zeros may also be problematic.
Prescribers should be encouraged to include the indication for the medication. Such patient demographics as age, weight and other information necessary to verify appropriate drug dosing also should be included on a prescription. This may be especially important when the patient is a child.
Verbal orders should be limited to urgent situations and phoned in directly to the pharmacist when possible. 16 Requirements for verbal orders are the same as described for written orders. The NCC MERP recommendations to reduce medication errors associated with verbal orders also include:
• Provide a mechanism to ensure authenticity of the prescriber,
References:
http://www.cedrugstorenews.com/40100008006H05
http://www.nccmerp.org/councilRecs.html
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