FREQUENTLY ASKED QUESTIONS (Faq)

1. What is the national medication error rate? What standards are available for benchmarking?

A national or other regional medication error rate does not exist. It is not possible to establish a national medication error rate or set a benchmark for medication error rates. Each hospital or organization is different. The rates that are tracked are a measure of the number of reports at a given institution not the actual number of events or the quality of the care given. Most systems for measuring medication errors rely on voluntary reporting of errors and near-miss events. Studies have shown that even in good systems, voluntary reporting only captures the "tip of the iceberg." For this reason, counting reported errors yields limited information about how safe a medication-use process actually is. It is very possible that an institution with a good reporting system, and thus what appears to be a high error "rate," may have a safer system. For more detailed information see Medication Errors, a book available on our website, and the following articles.

• "If safety is your yardstick, measuring culture from the top down must be a priority" ISMP Medication Safety Alert!® March 22, 2007
• "Measuring up to medication safety" ISMP Medication Safety Alert!® March 10, 2005
• "Measuring medication safety: What works? What doesn't?" ISMP Medication Safety Alert!® Aug. 11, 1999
• "Four-pronged error analysis is "best practice" ISMP Medication Safety Alert!® Sept. 22, 1999
• "Benchmarking - when is it dangerous?" ISMP Medication Safety Alert!® Sept. 9, 1998

 In addition, on June 11, 2002, the National Coordinating Council for Medication Error Reporting and Prevention published a statement refuting the use of medication error rates. The statement, which is posted on the Council's Web site (www.nccmerp.org), states the "Use of medication error rates to compare health care organizations is of no value." The Council has taken this position for the following reasons:

• Differences in culture among healthcare organizations can lead to significant differences in the level of reporting of medication errors.
• Differences in the definition of a medication error among healthcare organizations can lead to significant differences in the reporting and classification of medication errors.
• Differences in the patient populations served by various healthcare organizations can lead to significant differences in the number and severity of medication errors occurring among organizations.
• Differences in the type(s) of reporting and detection systems for medication errors among healthcare organizations can lead to significant differences in the number of medication errors recorded.

According to the statement, the Council believes that there are no acceptable incidence rates for medication errors. The goal of every healthcare organization should be to continually improve systems to prevent harm to patients due to medication errors. Healthcare organizations should monitor actual and potential medication errors that occur within their organization, and investigate the root cause of errors with the goal of identifying ways to improve the medication-use system to prevent future errors and potential patient harm. The value of medication error reporting and other data gathering strategies is to provide the information that allows an organization to identify weaknesses in its medication-use system and to apply lessons learned to improve the system. The sheer number of error reports is less important than the quality of the information collected in the reports, the healthcare organization's analysis of the information, and its actions to improve the system to prevent harm to patients."

"The Council's recommendations support the concept that, at this time in the patient safety journey," said John R. Combes, M.D., past Council chairperson and senior medical advisor at The Hospital and Healthsystem Association of Pennsylvania and the American Hospital Association, "it is more important to create the open environment that encourages the reporting of errors and near errors than to develop less meaningful comparative error rates. The goal for an organization's medication safety programs," he continued, "is to learn as much as possible about active and latent error and through that understanding prevent harm to patients."

A medication error is “any error occurring in the medication use process.”

(Bates DW, Boyle DL, Vander Vliet MB, Schneider J, Leape L. 1995. Relationship between medication errors and adverse drug events. Journal of General Internal Medicine 10(4): 100–205.)

The National Coordinating Council for Medication Error and Prevention has approved the following as its working definition of 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 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."

Medication use is a complex process that comprises the sub-processes of medication prescribing, order processing, dispensing, administration, and effects monitoring. The key elements that affect the medication-use process are listed below. The interrelationships among these key elements form the structure within which medications are used.

1. Patient information: Obtaining the patient’s pertinent demographic (age, weight) and clinical (allergies, lab results) information that will assist practitioners in selecting the appropriate medications, doses and routes of administration. Having essential patient information at the time of medication prescribing, dispensing and administration will result in a significant decrease in preventable adverse drug events (ADEs).
2. Drug information: Providing accurate and usable drug information to all healthcare practitioners involved in the medication-use process reduces the amount of preventable ADEs. Not only should drug information be readily accessible to the staff through a multitude of sources (drug references, formulary, protocols, dosing scales…), it is imperative that the drug information is up to date as well as accurate.
3. Communication of drug information: Miscommunication between physicians, pharmacists and nurses is a common cause of medication errors. To minimize the amount of medication errors caused by miscommunication it is always important to verify drug information and eliminate communication barriers.
4. Drug labeling, packaging and nomenclature: Drug names that look-alike or sound-alike, as well as products that have confusing drug labeling and non-distinct drug packaging significantly contribute to medication errors. The incidence of medication errors is reduced with the use of proper labeling and the use of unit dose systems within hospitals.
5. Drug storage, stock, standardization, and distribution: Standardizing drug administration times, drug concentrations, and limiting the dose concentration of drugs available in patient care areas will reduce the risk of medication errors or minimize their consequences should an error occur.
6. Drug device acquisition, use and monitoring: Appropriate safety assessment of drug delivery devices should be made both prior to their purchase and during their use. Also, a system of independent double-checks should be used within the institution to prevent device related errors such as, selecting the wrong drug or drug concentration, setting the rate improperly, or mixing the infusion line up with another.
7. Environmental factors: Having a well-designed system offers the best chance of preventing errors; however, sometimes the environment in which we work contributes to medication errors. Environmental factors that often contribute to medications errors include poor lighting, noise, interruptions and a significant workload.
8. Staff competency and education: Staff education should focus on priority topics, such as: new medications being used in the hospital, high- alert medications, medication errors that have occurred both internally and externally, protocols, policies and procedures related to medication use. Staff education can be an important error preventions strategy when combined with the other key elements for medication safety.
9. Patient education: Patients must receive ongoing education from physicians, pharmacists and the nursing staff about the brand and generic names of medications they are receiving, their indications, usual and actual doses, expected and possible adverse effects, drug or food interactions, and how to protect themselves from errors. Patients can play a vital role in preventing medication errors when they have been encouraged to ask questions and seek answers about their medications before drugs are dispensed at a pharmacy or administered in a hospital.
10. Quality processes and risk management: The way to prevent errors is to redesign the systems and processes that lead to errors rather than focus on correcting the individuals who make errors. Effective strategies for reducing errors include making it difficult for staff to make an error and promoting the detection and correction of errors before they reach a patient and cause harm.
    
    Using an interdisciplinary team approach, ISMP can perform risk assessment, assisting facilities in a critical analysis of their medication use systems. This comprehensive analysis is based on ISMP's Ten Key Elements of Medication Safety, and provides an objective perspective to current medication processes.

Many nurses during their training have learned about the “five rights” of medication use: the right patient, drug, time, dose and route.

However, the “five rights” focus on the nurse’s individual performance and does not reflect that responsibility for safe medication use lies with multiple individuals. Although the “five rights” serve as a useful check before administering medications, there are many other contributing factors to a staff member’s failure to accurately verify the “five rights,” despite their best efforts. For more detailed information, see the following articles.

• “Nurses’ rights regarding safe medication administration” ISMP Medication Safety Alert!® Nurse Advise-ERR July 2007
• The five rights: A destination without a map ISMP Medication Safety Alert!® Jan. 25, 2007
• “The five rights cannot stand alone” ISMP Medication Safety Alert!® Nurse Advise-ERR November 2004
• The "five rights" ISMP Medication Safety Alert!® April 7, 1999

While most medications have a large margin of safety, a small number of drugs have a high risk of causing injury when they are misused. We call these "high-alert medications" to draw attention to this characteristic so that all involved in their use will treat them with the care and respect that they require. Errors may or may not be more common with these drugs than with the use of any others; however, the consequences of the errors are more devastating. For this reason, special considerations are required. These medications often need to be packaged differently, stored differently, prescribed differently, and administered differently than others. Whenever possible, "forcing functions," methods that make it impossible for the drug to be given in a potentially lethal manner, should be developed and instituted. We recommend some of those forcing functions in the information that follows.

Click on this link for a list of "high-alert medications" for acute care which can be targeted for specific intervention to reduce the occurrence of medication errors associated with their use. Recommendations in preventing medication errors with "high alert medications" can be found in Medication Errors, a book available on our website.

ISMP has published a list of error-prone abbreviations. These abbreviations, symbols, and dose designations have been reported to ISMP through the ISMP Medication Error Reporting Program (MERP) as being frequently misinterpreted and involved in harmful medication errors. The Joint Commission (TJC) has established a National Patient Safety Goal that specifies that certain abbreviations must appear on an accredited organization’s do-not-use list as well, which can be found here.

We often receive requests for an evidence base regarding the use of abbreviations. For example, we have been asked for controlled studies that show populations with a significantly lower incidence of patient harm where "dangerous" abbreviations are not used. There really isn't any research on this topic, just the reports we keep publishing and those that get national press. In fact we often cite a statement by Leape, Berwick, and Bates [JAMA, Volume 288(4). July 24, 2002 (501-7)] saying that a study would never be done on the need for leading zeroes (0.1 mg not .1 mg) and that one isn't necessary. We have always advocated that it’s time to stop thinking "it hasn't happened here so why should I change?"

Drug names that can be confused, especially those names that look or sound alike, can increase the risk for medication errors. Errors involving these problematic name pairs may occur when a prescriber interchanges the two medications when writing an order, when someone misinterprets a written order, when a person taking a verbal order does not hear the order as intended, when selecting a medication when entering an order into a computer system or when obtaining medications from storage. A common contributor to these types of name mix-ups is what human-factors experts call confirmation bias (see FAQ #9). ISMP’s List of Confused Drug Names, which includes look-alike and sound-alike name pairs that have been involved in medication errors published in the ISMP Medication Safety Alert! ®. Errors involving these medications were reported to ISMP through the ISMP Medication Errors Reporting Program (MERP).

The Joint Commission (TJC) has established a National Patient Safety Goal that requires each accredited organization identify and, at a minimum, annually review a list of look-alike/sound-alike drugs used in the organization, and take action to prevent errors involving the interchange of these drugs (NPSG.03.03.01). An organization’s list of look-alike/sound-alike drugs must contain a minimum of 10 drug combinations. You can find TJC’s list of drug names at TJC’s website. Note: Names that appear on TJC's list of look-alike or sound-alike names have been noted in with a double asterisk (**) on ISMP’s List of Confused Drug Names.

Tallman lettering involves highlighting the dissimilar letters in two names to aid in distinguishing between the two. In addition to ISMP, several studies (see references below) have shown that highlighting sections of drug names using tall man (mixed case) letters can help distinguish similar drug names, making them less prone to mix-ups. ISMP, FDA, The Joint Commission, and other safety conscious organizations have promoted the use of tall man letters as one means of reducing confusion between similar drug names. To promote standardization, ISMP has created a list of Look-Alike Drug Name Sets With Recommended Tall Man Letters.

• Use of tall man letters is gaining wide acceptance ISMP Medication Safety Alert!® July 31, 2008

References
Filik R, Purdy K, Gale A, Gerrett D. Drug name confusion: evaluating the effectiveness of capital (“Tall Man”) letters using eye movement data. Social Science & Medicine 2004;59(12):2597-2601.

Filik R, Purdy K, Gale A, Gerrett D. Labeling of medicines and patient safety: evaluating methods of reducing drug name confusion. Human Factors 2006;48(1):39-47.

Grasha A. Cognitive systems perspective on human performance in the pharmacy: implications for accuracy, effectiveness, and job satisfaction. Alexandria (VA): NACDS; 2000 Report No. 062100.

FDA. Name differentiation project. Center for Drug Evaluation and Research. 2002; www.fda.gov/CDER/Drug/MedErrors/nameDiff.htm.

The Joint Commission. NPSG: Identify and, at a minimum, annually review a list of look-alike/sound-alike drugs used in the organization, and take action to prevent errors involving the interchange of these drugs; www.jointcommission.org/NR/rdonlyres/C92AAB3F-A9BD-431C-8628-11DD2D1D53CC/0/LASA.pdf.

National Association of Boards of Pharmacy. “TALL MAN” letter utilization for look-alike drug names. 2008; www.nabp.net/ftpfiles/AM/104/104thAMResolutions/(1)%20TALL%20MAN%20Letter%20Utilization%20for%20Look-Alike%20Drug%20Names.pdf.

Confirmation bias refers to a type of selective thinking whereby individuals select out what is familiar to them or what they expect to see, rather than what is actually there. Many errors often occur when practitioners, due to familiarity of certain products, see the one they think it is rather than what it is. It is human nature for people to associate items by certain characteristics. It is very important for the health care community to recognize the role that confirmation bias may play in medication errors and to work together to address associated problems.

• Inattentional blindness: What captures your attention? ISMP Medication Safety Alert!® February 26, 2009
• Novel way to prevent medication errors ISMP Medication Safety Alert!® July 31, 1996

An independent double-check of a high-alert medication is a procedure in which two clinicians separately check (alone and apart from each other, then compare results) each component of prescribing, dispensing, and verifying the high-alert medication before administering it to the patient. While technological solutions such as computerized prescriber order entry and bar coding systems have great potential to detect human error, manual redundancies such as independent double checks still play an important role in error detection. Studies show that manual redundancies detect about 95% of errors. Independent double checks serve two purposes: to prevent, though not dependably, a serious error from reaching a patient; and just as important, to bring attention to the systems that allow the introduction of human error. Independent double checks should be done on error prone processes such as the use of high alert medications. A sample checklist of an independent double check is available in the December 2008 issue of the ISMP Medication Safety Alert!® Nurse Advise-ERR.

An organization’s “culture” can be found in the pattern of shared basic assumptions about the organization’s values (what is important), beliefs (how things work), and behaviors (the way we do things) that have been taught to the workforce in both explicit and implicit ways.(2) Thus, the culture encompasses both the observable customs, behavioral norms, stories, and rites that occur in an organization as well as the unobservable assumptions, values, beliefs, and ideas shared by groups.

The most common means of measuring organizational culture is to survey an adequate sampling of staff. Two examples of validated survey tools can be found on the Web sites of the Agency for Health- care Research and Quality (AHRQ) (www.ahrq.gov/QUAL/hospculture/) and the Health Research and Education Trust (HRET) (www.hret.org/hret/programs/saq.html). These tools, which were both launched in 2004, can be downloaded free of charge. In March 2006, ARHQ also began gathering eligible survey data into a central repository, which may become the first nationally available comparative database on organizational culture. For more information see the article below.

• “If safety is your yardstick, measuring culture from the top down must be a priority” ISMP Medication Safety Alert!® March 22, 2007

Medication errors are rarely the result of one person making an error, but rather a series of system failures that allowed an error to occur. Analysis of medication errors should include looking at the system causes of medication errors to prevent future events and evaluating the behavior of the staff involved in the medication error. For more detailed information about at-risk behavior, see the following articles.

• Patient safety should NOT be a priority in healthcare! Part I: Why we engage in "at-risk behaviors"  ISMP Medication Safety Alert!® Sept. 23, 2004
• Reducing "at-risk behaviors" Part II of Patient safety should NOT be a priority in healthcare!  ISMP Medication Safety Alert!® Oct. 7, 2004
• Our long journey towards a safety-minded Just Culture Part I: Where we've been ISMP Medication Safety Alert!® Sept. 7, 2006
• Our long journey towards a safety-minded Just Culture Part II: Where we're going ISMP Medication Safety Alert!® Sept. 21, 2006

Medication error risk points can be identified through a five-pronged analysis of errors. The first two prongs are reactive in nature, and include 

1. Investigation and analysis of practice site specific errors that have caused some degree of patient harm and
2. Analysis of practice site aggregate medication error data (e.g., trends by particular drugs or storage location of drugs involved in errors) whether or not harm has occurred.

Equally important are the other three prongs. Proactive in nature, these include

1. The investigation and analysis of "near misses" (errors that have the potential to reach the patient or cause patient harm),
2. Analysis of “external” errors, those that have occurred in other organizations (using the ISMP Medication Safety Alert!®, the Action Agendas, TJC’s Sentinal Event Advisories, or news stories),  and
3. Identification of potential risk points using proactive risk assessment tools (such as the ISMP Self-Assessment, FMEA, or staff surveys).

Each prong contains valuable information about weaknesses in the system which, collectively, can lead to the identification of effective error-reduction strategies.

Failure Mode and Effects Analysis (FMEA) is a proactive method used to reduce the frequency and consequences of errors. It is a way of analyzing a system’s design in order to evaluate the potential for failures within that system, and determines what the potential effects may be. One way to implement FMEA is to form a committee to identify failure modes. Examples of common failure modes include errors in calculations (doses and flow rates), storage of high alert medications in patient care areas and failure to check patient’s armband before administering medications. You can find more information on the use of FMEA in healthcare in the following article or on the ISMP website.

ISMP is not a professional association or member organization. It is the nation’s only 501c (3) nonprofit organization devoted entirely to medication error prevention and safe medication use. There are ways, however, to be involved with and advance ISMP’s medication safety work.

• Report Errors. ISMP learns about errors happening across the nation because they are reported to the ISMP Medication Error Reporting Program (MERP). These errors are analyzed, and the “lessons learned” are then shared with the healthcare community. All information reported to ISMP is kept confidential.  In addition, further protections are available for information reported to ISMP because we are a certified Patient Safety Organization (PSO) by the Agency for Healthcare Quality and Research.
• Subscribe to ISMP publications. ISMP offers four different newsletters. More detailed information and subscription information are available on the website.
• Use the action agendas to identify risk. Action agendas are published four times a year with the ISMP Medication Safety Alert!® and three times a year with the ISMP Medication Safety Alert!® Community/Ambulatory Edition. These provide actionable, achievable, safety recommendations for your organization.
• Use the safety tools available on the ISMP website. ISMP offers a wide range of resources and information to help healthcare practitioners in a variety of healthcare settings prevent errors and ensure that medications are used safely. All of the ISMP tools listed here are free, downloadable, and easy to use.
• Attend an education program or ask ISMP to speak at yours. ISMP offers teleconferences on timely topics in medication safety, educational symposia at leading healthcare meetings, and knowledgeable and articulate speakers from varied health disciplines that can provide expert advice and education on patient safety issues.
• Enlist the help of the ISMP Consult Team. ISMP Consulting Services bring decades of safety experience based largely on the interdisciplinary review of thousands of reports to the ISMP Medication Error Reporting Program (MERP) as well as hundreds of visits to healthcare organizations nationwide. With our extensive knowledge and understanding of the system-based causes of medication error, ISMP consulting staff is uniquely positioned to work confidentially and objectively alongside all types of practitioners and organizations seeking to develop and/or maximize their success within current medication safety initiatives.
• Contract with ISMP as your PSO for medication safety work. PSOs are organizations that have improvement of patient safety and quality as their primary mission and activities. They are being established by HHS under the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act). Pharmacy and Therapeutics, Patient Safety, and Quality committees in hospitals, health systems, and other healthcare organizations such as community pharmacies, outpatient centers, and physician practices can now work with ISMP under its PSO status to aggregate and analyze their internal information to better enable the identification and reduction of the risks and hazards associated with medication use in patient care. ISMP also can work with other PSOs to provide expert analysis as part of the services offered to their clients.
• Become a member of our advisory board. ISMP publishes several newsletters, and they wouldn’t be possible without the expertise of our advisory boards. If you have a strong background in medication safety and are interested in becoming a reviewer for any of our newsletters, please send an e-mail with your contact information to ismpinfo@ismp.org.
• Donate to ISMP. Donations from individuals and organizations have made it possible for ISMP to continue to build on its more than 30 years of experience in helping health professionals keep patients safe. Every donor is gratefully acknowledged, and donations are tax deductible to the full extent of the law.

ISMP launched a consumer website, www.consumermedsafety.org, at the end of 2008. ConsumerMedSafety.org contains many free resources for consumers including articles and news stories. You can also sign up to receive free, customized alerts to keep you and your loved ones informed about safety issues affecting the medications you take. ISMP also publishes a consumer newsletter, available by subscription on our website.

While nurses and house staff may find the Rule of 6 convenient, we’ve previously written about problems with its use (in our June 12, 1999 issue). First, the Rule of 6 is used primarily for nursing IV admixture, an at-risk procedure that bypasses pharmacy preparation and subsequent double-check systems. Additionally, some medications, such as dopamine, may be available in vials of varying concentrations, increasing the risk of an error.

Next, a mathematical calculation is required, which is always an error-prone process if done manually. Obtaining an accurate weight has been a challenge in hospitals that have asked pharmacy to use the Rule of 6 to prepare solutions for nurses. Inconsistency has resulted in problems, too. People who use the Rule of 6 may assume that all solutions dosed in mcg/kg/minute are prepared in this fashion. If a different concentration is used, infusion rates may be adjusted incorrectly.

Another concern is that solutions prepared using the Rule of 6 may result in fluid overload if dose adjustments are necessary. For example, an increase in a dopamine infusion from 5 mcg/kg/minute to 10 mcg/kg/minute would result in an infusion rate of 10 mL/hour, which alone could consume the total daily fluid requirement for a small neonate (240 mL/24 hours). Thus, physicians may order a double or triple concentration, which greatly increases the risk of an error.

Finally, the Rule of 6 results in drug waste. Only a portion of the drug vial is typically needed to prepare the solution, so the remaining drug is wasted or single-dose containers are inappropriately reused. With these problems in mind, and considering the Joint Commission requirements for standard concentrations, it’s clear that hospitals need to adopt standard concentrations for pediatric and neonatal solutions, abandon use of the Rule of 6, and have pharmacy prepare and dispense these solutions while on site.

One final note - standard concentrations for infusions will be needed to maximize the functionality of “smart pumps,” which alert nurses to unsafe dose limits and programming errors. Your efforts to standardize pediatric drug infusions now will pay off when this technology is available for syringe pumps