what could go wrong? preventing medication errors before...

www.pharmacist.com DECEMBER 2015 • PharmacyToday 69

Abstract

Objectives: To explain strategies for identifying factors that contribute to medication errors and to define the process of failure mode and effects analysis (FMEA) and its role in health care quality improvement activities.

Data sources: National organizations that promote health care quality im-provement and medication safety and include discussion of FMEA. This informa-tion was supplemented with information from PubMed where appropriate.

Study selection: At the author’s discretion based on clinical relevance of the information presented to medication error prevention and the performance of FMEA.

Summary: Medication errors are an important issue facing the health care sys-tem. Experts have increasingly recognized that errors can be prevented by making the medication use system safer rather than relying on individual health care pro-viders to always perform perfectly. FMEA is a process used to proactively prevent medication errors rather than reacting to medication errors. The process allows FMEA team members to systematically evaluate the medication use process and determine the likelihood of a failure mode (i.e., an error), the likelihood that the er-ror would be detected, and the severity of the impact of the error on a patient. This information is then used to prioritize quality improvement activities and develop strategies that will improve the safety of medication use.

Conclusion: FMEA can be used to prevent medication errors in a wide range of health care settings and is a useful strategy for improving the medication use process.

Pharm Today. 2015;21(12);69–81

CPE

What could go wrong? Preventing medication errors before they happenAmerican Pharmacists Association

This manuscript was prepared by Judy Crespi Lofton, MS, on behalf of the American Pharmacists Association.

Learning objectives ■ Describe various types of medication

errors and the factors that contribute to them.

■ Explain strategies for identifying fac-tors that contribute to the occurrence of medication errors.

■ Define the process of failure mode and effects analysis (FMEA) and its role in health care quality improvement activities.

■ Describe how to use information gathered during FMEA to minimize the occurrence of medication errors, including the use of risk reduction and implementation strategies.

■ Identify common pitfalls that may occur when conducting FMEA.

The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education (CPE). The ACPE Universal Activity Number assigned to this activity by the accredited provider is 0202-0000-15-228-H05-P.

Advisory board: Donna Horn, PharmD, Director, Patient Safety–Community Pharmacy, Institute for Safe Medication Practices, Horsham, PA; and Karen M. Ryle, MS, BSPharm, Associate Chief of Pharmacy, Ambulatory Care, Massachusetts General Hospital, Boston

Disclosure: Donna Horn, PharmD; Karen M. Ryle, MS, BSPharm; and APhA’s editorial staff declare no conflicts of interest or financial interests in any product or service mentioned in this activity, including grants, employment, gifts, stock holdings, and honoraria. For complete staff disclosures, please see the APhA Accreditation Information section at www.pharmacist.com/education.

Development: This home-study continuing pharmacy education activity was developed by the American Pharmacists Association.

Accreditation informationProvider: American Pharmacists AssociationTarget audience: PharmacistsRelease date: December 1, 2015Expiration date: December 1, 2018Learning level: 2

ACPE number: 0202-0000-15-228-H05-PCPE credit: 2 hours (0.2 CEUs)Fee: There is no fee associated with this activity for members of the American Pharmacists As-sociation. There is a $25 fee for nonmembers.

www.pharmacytoday.org70 PharmacyToday • DECEMBER 2015

CPE PREVENTING MEDICATION ERRORS

ObjectivesThe purpose of this article is to explain strategies for identi-fying factors that contribute to medication errors and to de-fine the process of failure mode and effects analysis (FMEA) and its role in health care quality improvement activities.

Search methodology Data sources included national organizations that promote health care quality improvement and medication safety and include discussion of FMEA. This information was supple-mented with information from PubMed where appropriate.

BackgroundIn 2000, the Institute of Medicine (IOM) identified medica-tion errors as the most common type of health care error and reported that several thousand deaths can be attribut-ed to medication errors each year.1 This report, published as the book To Err is Human: Building a Safer Health System, led to broader recognition within the health care system that medication errors are a serious systematic problem requir-ing attention on the system level.1,2 The report stressed that errors were driven primarily by system-related factors rath-er than being the fault of individual health care providers.

The report led to the development of more robust ef-forts to prevent medication errors. The past decade has seen multiple systemwide initiatives designed to improve medication safe use, including expanded patient safety regulations from The Joint Commission (which sets annu-al National Patient Safety Goals designed to support safe medication use).

A preventable error?An oral anticoagulant is prescribed to S.R., a patient with atrial fibrillation, and S.R. subsequently experiences an intra-cranial hemorrhage (ICH). Is it possible that this event was due to a medication error?

Maybe.Novel oral anticoagulants are indicated for the reduction

of risk of stroke and systemic thromboembolism in patients with atrial fibrillation, and ICH is a known potential adverse event associated with oral anticoagulants. Therefore, it is possible that the ICH was an unfortunate adverse event.

However, appropriate prescribing of oral anticoagulants requires assessment of the patient’s risk for both stroke and bleeding. If these activities did not take place, then S.R.’s ICH may be attributed to a medication error.

According to guidelines from the American Heart As-sociation, the American College of Cardiology, and the Heart Rhythm Society, the need for anticoagulation in pa-tients with atrial fibrillation should be determined using the CHA2DS2-VASc scoring system. This system assigns one or two points for various risk factors and calculates a total score (Table 1).3 The score from the CHA2DS2-VASc system is used to determine whether patients are at low, moderate, or high risk for a stroke. According to these guidelines, it is reason-able to omit anticoagulation therapy for patients who are at low risk (score of 0). For patients at moderate risk (score of 1), clinicians can consider various approaches, including no an-tithrombotic therapy, treatment with an oral anticoagulant, or treatment with aspirin. Anticoagulation is recommended for patients who are at high risk, defined as a CHA2DS2-VASc score of 2 or greater.3

While the CHA2DS2-VASc score is used to identify pa-tients who would benefit from anticoagulation, it is impor-tant to weigh the benefits of therapy with the risks. Bleeding is the primary risk for patients receiving an oral anticoagu-lant. Bleeding risk should be assessed with the HAS-BLED tool (Table 2).4

The acronym HAS-BLED represents each of the bleeding risk factors. The HAS-BLED scores range from 0 to 9, with scores of 3 or greater indicating high risk of bleeding. Patients who are at high risk should not necessarily be excluded from treatment with an oral anticoagulant. Instead, they should be managed with extra caution and monitored more closely. Modifiable risk factors (e.g., uncontrolled hypertension, use of antiplatelet agents, nonsteroidal anti-inflammatory drugs [NSAIDs]) also should be addressed. In addition, patients should be educated about the risks of alcohol use.4

Renal function should also be assessed when prescrib-ing oral anticoagulants. Reduced doses are appropriate for patients with moderate to severe chronic kidney disease, and certain anticoagulants should be avoided in patients with end-stage disease or those who are on dialysis.3

S.R. is 68 years old but has no other risk factors on the CHA2DS2-VASc scale, indicating that his score is 1. Based on his age and use of NSAIDs and alcohol, his HAS-BLED score is 3. His renal function is normal. Therefore, he has a

Preassessment questionsBefore participating in this activity, test your knowledge by answering the following questions. These questions will also be part of the CPE assessment.

1. Which of the following actions would be considered an error of omission?a. Placing the wrong label on a prescription bottleb. Incorrectly calculating a dosage based on body weightc. Forgetting to place a warning label on a prescription bottled. Providing patients with inaccurate instructions for taking a

medication

2. How are failure modes prioritized for corrective action? a. Errors that are most likely to occur are addressed first.b. Errors that are least likely to be detected are addressed first.c. Errors that are easiest to address are corrected first.d. Errors with the highest risk priority numbers are addressed first.

3. Which of the following could be considered a drawback of FMEA?a. It is based on team members’ judgment and experiences rather

than objective assessments of the likelihood of an error to occur.b. It does not allow for prioritization of quality improvement efforts.c. It forces team members to act in “silos.”d. Individuals who are not involved in the FMEA team have no

opportunity to provide input in the process.



moderate stroke risk, indicating that treatment with an oral anticoagulant was an option but was not required, according to guidelines. However, he is also at high risk for bleeding, indicating that anticoagulant therapy was questionable and should only have been used with caution and thorough dis-cussion of risks and benefits.

A review of S.R.’s chart reveals that no HAS-BLED score is on file. Therefore, it appears that this information may have been overlooked when the anticoagulant was prescribed and dispensed.

Your conclusions upon reviewing S.R.’s file is that either his use of NSAIDs and alcohol should have been modified prior to implementation of anticoagulant therapy or that an-ticoagulant therapy should have been avoided at this time.

Types of medication errorsTo prevent errors, we must first understand what causes them. Quality improvement efforts that focus on address-ing a specific action of an individual health care provider are counterproductive because the individuals in the system become fearful of consequences and therefore are not forth-coming with information that could potentially be used to prevent future errors.5 Instead, voluntary reporting of medi-cation errors is now encouraged to allow for analysis of er-rors so that they can be prevented in the future. Following a serious error that results in patient harm, most organizations perform a root cause analysis (RCA) to determine what went wrong and to adjust the system to prevent it from happen-ing again. Such interventions can be effective for prevent-ing future errors of the same type. However, they do little to identify other types of errors or how to prevent errors before they happen.

What exactly is a medication error? The image of a med-ication error that often comes to mind is a wrong drug or wrong dosage error that results in harm to a patient. How-ever, many other types of errors result in suboptimal medica-

tion use and jeopardize patient safety. There are many approaches to defining and classifying

medication errors. The IOM report To Err Is Human defines an error as the failure of a planned action to be completed as intended (i.e., error of execution) or the use of a wrong plan to achieve an aim (i.e., error of planning).

The Committee on Data Standards for Patient Safety ex-panded the definition to also include errors of omission.2

The National Coordinating Council for Medication Er-ror Reporting and Prevention is even more comprehensive; it defines medication errors as “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 relat-ed to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compound-ing; dispensing; distribution; administration; education; monitoring; and use.”6

Errors can be classified as errors of either omission (not doing something, such as forgetting to verify patient data) or commission (doing something you should not, such as select-ing the wrong medication from the shelf.) Another approach divides errors into four categories: knowledge-based errors, rule-based errors, action-based errors (i.e., “slips,” including technical errors), and memory-based errors.7

Knowledge-based errors occur because the provider does not know that a problem could exist. For example, not knowing that co-fluampicil contains penicillins and pre-scribing co-fluampicil to a patient who is allergic would be a knowledge-based error. On the other hand, a memory-based error occurs when the prescriber forgets that the patient is allergic to penicillin when prescribing an antibiotic. Rule-based errors include both applying a good rule improperly (e.g., overriding an alert that has important information) and applying a bad rule. Action-based errors involve doing something incorrectly, such as writing diltiazem instead of diazepam, or adding the wrong ingredient to a mixture,

Pause and reflectCould changes to the pharmacy’s system have prevented this outcome?

Table 2. Bleeding risk assessmentAbbreviation Risk factor ScoreH Uncontrolled HTN 1

AAbnormal renal or hepatic function (1 point each) 2

S Previous stroke 1

BBleeding history or disposition (anemia) 1

L Labile INRs 1E Senior adult, age > 65 y 1

DDrugs (antiplatelets, NSAIDs, or alcohol) (1 point each) 2

Total scoreAbbreviations used: HTN, hypertension, INRs, international normalized ratios; NSAIDs, nonsteroidal anti-inflammatory drug.Source: Ref. 4.

Table 1. Stroke risk assessment in atrial fibrillationAbbreviation Risk factor ScoreC Congestive heart failure/LVEF < 40% 1H Hypertension 1A2 Age ≥ 75 y 2D Diabetes 1S2 Previous stroke, TIA, TE 2

VVascular disease, prior MI, aortic plaque, PAD 1

A Age 65–74 y 1Sc Sex category: female 1

Total scoreAbbreviations used: LVEF, left ventricular ejection fraction; TIA, transient isch-emic attack; TE, thromboembolism; MI, myocardial infarction; PAD, peripheral arterial disease.Source: Ref. 3.



such as an infusion.7

Considering S.R.’s case, although the medication was dis-pensed correctly, it does represent a medication error that re-sulted from a variety of system factors, including prescriber and dispensing knowledge and training and requirements for prescribing and dispensing anticoagulants.

Preventing medication errorsThe health care system is complex, and multiple factors con-tribute to most errors, rather than any one single act. The 2007 IOM report Preventing Medication Errors: Quality Chasm Series described an error in which an overdose of a medica-tion resulted in the death of an infant. The child was mis-diagnosed and subsequently received a 10-fold overdose of a medication that should have been administered via I.M. injection but was administered via I.V. The report detailed many failures that occurred throughout the medication use system that allowed the error to occur (Table 3).2

It should be evident as you review the table that the er-ror could have been prevented at many steps throughout the process. An RCA can identify these sources of errors and drive quality improvement errors to prevent similar errors in the future. But, what if these errors could have been pre-vented in the first place? How can the health care system be improved to make patient care safer overall?

Using FMEA to prevent errorsFailure mode and effects analysis (FMEA) is a strategy for analyzing potential sources of medication errors before er-rors occur. The FMEA process was originally developed by the military in the 1950s and was adopted by the aerospace industry in the 1960s. It has been widely adopted by many industries since to proactively prevent errors that could have disastrous consequences. Within health care, FMEA is used to improve patient safety in numerous settings. FMEA is rec-ommended by The Joint Commission as a method for proac-tive assessments.8

FMEA looks at the design of the system to assess what could go wrong and to design processes that will prevent an error from occurring in the first place. Rather than relying on 100% accuracy of health care providers, FMEA is based on the premise that errors are likely to occur even among in-dividuals who are highly trained, competent, and conscien-tious. It acknowledges that poor judgment and human error are part of the human experience and that it is not possible to fully eliminate individual human error. Therefore, the sys-tem must be set up to compensate for the limits of human ability.5

When conducting FMEA, team members systematically identify sources of error (i.e., failure modes) and determine the potential impact of those failures (i.e., effects analysis). FMEA focuses not simply on the processes that are per-

formed to complete a task; it also analyzes the underlying systems within which the processes operate. FMEA can then identify which parts of the process and system should be ad-justed to prevent errors from occurring.9 This allows for pre-emptive action so that the system will be designed to prevent errors.

FMEA processFMEA involves several steps, as follows.

Step 1. Determine what to evaluate. The first step is to select the activity or process to be evaluated. Performing FMEA for the entire pharmacy and all its processes and sub-processes would be overwhelming and impractical. There-fore, the FMEA should address a discrete topic such as use of a high-risk medication or the introduction of a new medi-cation into the pharmacy. Alternatively, the FMEA could be based around a process such as medication ordering, dis-pensing, or administration.

Step 2. Select team members. Next, identify the mem-bers of the FMEA team. Ideally, several staff members should be involved in the FMEA process, including individuals who are involved in various steps throughout the process. For example, within a hospital, a medication-related FMEA could include administrators, pharmacy staff, physicians, residents, nurses, patient safety experts, and individuals involved in transporting the medication. In an ambulatory care setting, team members might include the pharmacy manager, head technician, purchaser, corporate leadership, and others.

FMEA teams may have a leader who directs the process and reconvenes the team at a later date to assess the effective-ness of interventions. This leader may be involved through-out the FMEA process or at an administrative level to direct the team’s activities.

Encourage team members to openly share their experi-ences, particularly if they have ever experienced a near-miss or error. It is important to stress that this information is pro-tected and shared in the spirit of collaboration and quality improvement.

Step 3. Identify the steps of the process being evaluat-ed. Depending on the complexity of the process being evalu-ated, identifying all the steps can be a lengthy process. All members of the team should be involved and reach agree-ment that the steps accurately describe the process. Creating a flowchart to map out the steps is often a useful strategy to visualize the process. This can be done with a computer pro-gram or simply by using a whiteboard or post-it notes and flip charts. Table 4 shows an example of steps that could be identified for prescribing and dispensing a medication.

Step 4. Identify the failure modes, causes, and effects. Next, the FMEA team should list all possible failure modes (i.e., anything that could go wrong) for each step in the pro-cess. For each failure mode, all possible causes should be identified.

Asking questions that are used during an RCA may be

Pause and reflectAs you review Table 3, consider what systems-level approaches could have been implemented to prevent this error from occurring.



helpful when the causes of the failure mode are not readily apparent. Questions to ask include the following:10

■ Why might the failure occur? ■ When might the failure occur? ■ What might cause the failure to occur? (from a process

perspective) ■ Where might the failure occur?

For example, questions to ask when assessing the failure mode of selecting the wrong drug include the following:

■ Does the drug name look or sound similar to another drug name?

■ Will a drug with a similar name be listed in close proxim-ity on computer order entry screens?

■ Is the dosage or concentration clearly listed on the pack-age?

■ Will the product be stored near another product with a similar package?

■ Could stocking processes lead to the drug being stored in the wrong location?This information should be organized in a table, similar

to the example shown in Table 5. It is important to note that this FMEA is simply an example. While many vulnerabilities are consistent among facilities, there is variability based on numerous system and process factors. FMEA must be per-formed at each individual facility to identify location-specific sources of failure and to customize the improvements need-ed to reduce the risk of errors.

Step 5. Prioritize failure modes. To determine how to target quality improvement efforts, the team should identify a risk priority number (RPN) for each failure mode. The RPN is based on the likelihood that the error would occur, the likelihood that the error would be detected, and the severity

Table 4. Example of steps in prescribing and dispensing an anticoagulantStep Description1 Patient assessment and diagnosis2 Anticoagulant selection3 Anticoagulant prescribed4 Order sent to pharmacy5 Order entered into pharmacy computer6 Pharmacist review of safety and appropriateness7 Prescription preparation8 Pharmacist verification of medication before dispensingSource: Ref. 9.

Table 3. Sources of failure in each phase of the medication use system that led to an errorPhase Element Example of failure modes that occurredPrescribing

• Patient information • Incomplete clinical information led to decision to treat infant for congenital syphilis.• Patient education and communication dynamics

• Ineffective communication occurred with parents, including language barriers about the possibility of congenital syphilis and available treatment options.

• Drug information • Insufficient drug information for a nonformulary drug that was rarely used led to a prescription being written unclearly.

Ordering

• Drug information • Insufficient drug information for a nonformulary drug that was rarely used along with an unclear prescription led to a 10-fold overdosage.

• Staff education and staffing patterns

• Lack of staff with specialized training in use of the medication in question resulted in error.

• Quality control • Lack of maximum-dose warning on computer system resulted in lack of detection of an order for a 10-fold overdosage.

Dispensing

• Quality control • Lack of maximum-dose warning on computer system resulted in a 10-fold overdos-age of a medication being prepared and dispensed.

• Labeling, packaging, and nomenclature of drug

• Lack of unit dose system led to dispensing of two full syringes of medication that did not have a warning label indicating “for I.M. use only.”

• Staff education • No staff education was given for nonformulary drug. • Drug information • Insufficient information on the volume of medication that can be safely administered

to neonates led to dispensing the medication with directions to administer five I.M. injections to neonate.

Administration • Drug information • Insufficient drug information about various forms of penicillin G along with lack of information about dosage route in drug references led staff to believe that one drug was the brand name for another drug when they were two distinct products. Because staff mistakenly thought the two drugs were the same product, they did not recognize the problem with I.V. administration and decided to administer the drug via I.V. to avoid painful injections.

• Competency • Hospital had unclear prescriptive authority definitions that created a situation in which a nurse practitioner assumed authority to change the route of administration.

• Labeling, packaging, and nomenclature

• Manufacturer’s warning indicating “I.M. only” was not prominently placed on the syringe and was not seen.

Abbreviations used: I.M., intramuscular; I.V., intravenous.Source: Ref. 2.



of harm if the error reached the patient. For the likelihood of occurrence, the lowest score indi-

cates that the event is very unlikely to occur, and the high-est score indicates that the event is very likely to occur. For the likelihood of detection, the lowest score indicates that the failure mode is very likely to be detected, and the highest score indicates it is very unlikely to be detected. For severity, the lowest score indicates that it is very unlikely that harm

will occur, and the highest score indicates that it is very likely that severe harm will occur. For example, if a patient receives loratadine instead of desloratadine, it is very unlikely that the patient will experience any harm. On the other hand, pre-scribing an anticoagulant to a patient with a contraindication could result in serious injury or death.

Researchers have reported using different scales to rank each item. For example, some use a 1 to 5 scale, while others use a 1 to 10 scale.9,11 An example of a scale used in one setting is shown in Table 6.11 It is important to note that because the analysis is conducted prospectively, there are no actual data upon which to base the assessment of the likelihood of oc-

Pause and reflectDo the steps and possible failure modes identified in Table 4 and Table 5 align with the processes in your institution? How would you modify the steps and failure modes for your setting?

Table 5. Example of failure mode and effects analysis for prescribing and dispensing a medicationSteps Failure mode Failure causes Failure effectsPatient assessment and diagnosis

• Incorrect diagnosis/ medication unnecessary

• Knowledge deficit, lack of needed laboratory information

• Patient receives unnecessary medication

• Contraindicated drug • Knowledge deficit, not aware of current or prior treatment, drug–disease interactions,unreliable patient history

• Patient receives contraindi-cated drug

Selection of medication to prescribe

• Selecting the wrong drug • Knowledge deficit, patient data not available

• Patient receives wrong drug

Medication prescribed • Wrong dosage, frequency, form, or route of administration

• Knowledge deficit, information about drug not available

• Overdose or subtherapeutic dose/therapy does not meet standard of care

• Unsafe concomitant therapy • Prior therapy not discontinued, inadequate drug reconciliation, drug interaction not identified

• Increased risk of adverse events

Order sent to pharmacy Order not received in pharmacy • Communication mishap • Delay in therapy• Delay in receiving/processing • Pharmacy workflow issues, inadequate

staffing, environmental factors, interruptions• Delay in therapy

• Order misunderstood • Illegible order, misunderstood abbrevia-tions, misread decimal point, sound-alike/look-alike names, faxed order unclear

• Patient receives wrong drug, wrong dose

Order entered into pharmacy computer

• Order entered incorrectly • Poorly designed software, absent/ineffec-tive alerts, look-alike drug names

• Patient receives wrong drug, wrong dose

• Order entered in the wrong patient profile

• Similar patient names, lack of second patient identifier, illegible order, poorly designed software, environmental factors/interruptions

• Delay in therapy, medication dispensed to wrong patient, wrong patient receives medication

Pharmacist review of safety and appropriateness

• Order not reviewed/evaluated by pharmacist

• Time constraints, environmental factors, interruptions

• Incorrect therapy possible, delay in therapy

• Indication/appropriateness not verified

• Lack of necessary patient information, inadequate reconciliation process

• Patient receives wrong therapy, wrong dose

• Contraindication/interactions/unsafe dose or route of administration not detected

• Knowledge deficit, nonformulary drug, lack of necessary patient information, inadequate computer alerts

• Contraindicated therapy, inappropriate therapy, wrong therapy, wrong dose

Prescription preparation

• Wrong drug, dose, concentration, drug form

• Look-alike/sound-alike drugs stored near each other, look-alike drug sent from wholesaler, label ambiguity, inappropriate preparation technique, knowledge deficit


• Wrong packaging/labeling applied

• Inappropriate technique when preparing medications, knowledge deficit, environmental factors, interruptions


Pharmacist verification of medication before dispensing

• Check not completed • Inadequate staffing, time constraints, inefficient workflow

• Error not detected

• Check failed to detect error • Human factors, environmental factors, check does not include review of initial order

• Error not detected



currence or detection. Rather, the score is determined by the FMEA team members’ judgment. Each member of the team should have an opportunity to provide input on assignment of the RPN.

The three scores are then multiplied to calculate the RPN. For example, if the risk of “wrong dosage selected” has a like-lihood of occurrence of 3, a likelihood of detection of 6, and a severity of 6, then the RPN would be 3 × 6 × 6 = 108. Using a 1 to 5 scale, the lowest possible score is 1, and the highest possible value is 125. Using a 1 to 10 scale, the highest pos-sible score is 1,000. An example that focuses on the prescrib-ing and dispensing of anticoagulant medication is shown in Table 7.

After completing this process, the FMEA team can iden-tify the failure modes with the highest RPNs as the failure modes associated with the likeliness to cause the greatest harm. These failure modes should be the priorities for qual-ity improvement activities so that limited resources can be used wisely. In the example in Table 7, the top five RPNs are highlighted.

Step 6. Identify actions to reduce harm. Next, the FMEA team should develop a plan to reduce harm from the highest-ranking failure modes by analyzing each element of the pro-cess and exploring strategies that could prevent or mitigate the failure mode. Table 8 lists general strategies that can be used to reduce harm from failure modes.

Redesigning the process to reduce the likelihood of fail-ure modes requires assessing which steps in the process should be eliminated, modified, or implemented to reduce the risk. Principles of process redesign include the follow-ing:10

■ Reducing reliance on memory ■ Incorporating checklists and protocols ■ Incorporating redundancy ■ Improving information access ■ Reducing hand-offs ■ Standardizing procedures, displays, and layouts ■ Using forcing functions ■ Simplifying procedures ■ Adopting standardized forms or order sets for prescrip-

tions (practical in health care systems but not community pharmacies)

■ Adjusting workflow processes ■ Modifying environmental factors ■ Reducing interruptions

Certain types of interventions are more relevant to certain types of errors. For example, knowledge-based er-rors can be addressed through education and training or through computerized decision-support tools.7 These types of interventions may also be helpful for technical errors. Rule-based errors could be addressed by modifying the rules. Memory-based errors are often the most difficult to address but can be managed through systems that support appropriate actions, such as checklists, redundancies, and computerized systems.

Software systems that support safe use are often used as a system improvement to reduce errors. However, it is important to acknowledge that while such systems can re-duce some types of errors, they may introduce new potential sources of error and should also be carefully implemented and subjected to ongoing quality improvement efforts. New systems should also undergo FMEA prior to their implemen-tation.

Table 9 provides examples of actions that could be imple-mented to address the highest RPNs from Table 7.

Step 7. Implement the proposed changes. The FMEA team should discuss and analyze each of the proposed changes to assess whether they will change the RPN. Clearly communicate the proposed changes to all other individuals who are involved in the process, and give them an opportu-nity to provide input before the change is implemented.

After redesigning the process, conduct a FMEA on the new process and pilot test it before widespread implemen-tation to prevent creating new, unforeseen errors. Soliciting regular feedback throughout the pilot phase as well as con-ducting a formal assessment after a predetermined period are important components of the pilot phase. If the pilot proves successful, the changes can be implemented on a wid-er scale. Following widespread implementation, the process should again be reviewed to assess whether improvements in the RPN were made and determine whether the FMEA was effective. The FMEA team leader or other administrators should interview or reconvene members of the FMEA team as part of the quality improvement process for this review.

Table 6. Sample failure mode and effects analysis rating scaleOccurrence Detection Severity

Score Failure mode probability Score Likelihood of detection Score Severity of injury1 Remote (~1 in 10,000) 1 Very high (detected 9/10 times) 1 No injury, or only patient monitoring

2 Low (~1 in 1,000) 2 High (detected 7/10 times) 2Temporary injury needing additional intervention or treatment

3 Moderate (~1 in 250) 3 Medium (detected 5/10 times) 3Temporary injury with longer hospital stay or increased level of care

4 High (~1 in 100) 4 Low (detected 2/10 times) 4 Permanent effects on body functions5 Very high (~1 in 20) 5 Remote (detected 0/10 times) 5 Death or permanent loss of major body functionsSource: Ref. 11.



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ther

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ents

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SummaryFMEA is a risk management strategy that enables collabora-tive team efforts to proactively improve the safety and qual-ity of the medication use process. The interdisciplinary na-ture of the process allows for a more comprehensive analysis

of safety than other approaches that retrospectively review the causes of errors.

One advantage of FMEA is that it draws on team mem-bers’ experiences with near misses by allowing input on situ-ations in which errors in the process occurred but were iden-tified before they reached the patients. This allows correction of these situations before another error occurs that does reach the patient. Lessons can be learned from the team’s ex-periences that prevent harm.

Another advantage of FMEA is that it allows for iden-tification of priorities for quality improvement efforts. The collaborative and interdisciplinary nature of the process fa-cilitates acceptance of changes to the medication use process that support safety. Furthermore, the FMEA process increas-es awareness of medication safety issues.

However, while team members bring their experience with the medication use process, the FMEA process is based

Tabl

e 7.

Con

tinue

d • Wro

ng d

rug/

dose

/co

ncen

trat

ion/

drug

fo

rm

• Loo

k-al

ike/

soun

d-al

ike

drug

s st

ored

nea

r eac

h ot

her,

look

-alik

e dr

ug s

ent f

rom

who

lesa

ler,

labe

l am

bigu

ity, i

napp

ropr

iate

pre

para

tion

tech

niqu

e, k

now

ledg

e de

ficit

• Wro

ng th

erap

y,

wro

ng d

ose

33

1090

Pres

crip

tion

prep

arat

ion

Phar

mac

ist

verif

icat

ion

of

med

icat

ion

be-

fore

dis

pens

ing

• Wro

ng p

acka

ging

/la

belin

g ap

plie

d• I

napp

ropr

iate

tech

niqu

e w

hen

prep

arin

g

med

ictio

ns, k

now

ledg

e de

ficit,

env

ironm

enta

l fa

ctor

s, in

terr

uptio

ns

• Wro

ng th

erap

y,

wro

ng d

ose

33

872

• Che

ck n

ot c

ompl

eted

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dequ

ate

staf

fing,

tim

e co

nstr

aint

s,

inef

ficie

nt w

orkf

low

• Err

or n

ot d

etec

ted

26

896

• Che

ck fa

iled

to

dete

ct e

rror

• Hum

an fa

ctor

s, e

nviro

nmen

tal f

acto

rs,

chec

k do

es n

ot re

view

initi

al o

rder

• Err

or n

ot d

etec

ted

26

896

a Top

five

RPN

s

Pause and reflectDo the actions identified in Table 9 sound reasonable? Would it be feasible to implement similar changes in your practice?

Table 8. Actions to reduce harm from failure modesFailure mode

Likely to occurUnlikely to be detected

Likely to cause severe harm

Assess causes and determine if any can be eliminated or modified to reduce the likelihood of the failure mode.

Identify events that could occur prior to the failure mode that could indicate that the failure might happen.

Identify signs and symptoms that indicate a failure mode has occurred, and train staff to recognize these signs and symptoms and perform early intervention.

Add constraints to the system that cause the error to be impossible to make.

Add a step to the process to prevent the failure mode.

Provide resources, such as antidotes, at points of care where immedi-ate action may be required.

Add verification steps such as alert screens or independent double-checks.

Add technologi-cal alerts, such as adding an alarm to a device to indicate when an unsafe situ-ation is likely.

Source: Ref. 9.


CPE PREVENTING MEDICATION ERRORSTa

ble

9. A

ctio

ns to

add

ress

failu

re m

odes

with

hig

hest

RPN

s

Step

sFa

ilure

mod

eFa

ilure

cau

ses

Failu

re e

ffect

s

Like

lihoo

d of

oc

curr

ence

(1

–10)

Like

lihoo

d of

det

ectio

n (1

–10)

Seve

rity

(1

–10)

Risk

pri

ority

nu

mbe

r (RP

N)Ac

tions

to re

duce

oc

curr

ence

of f

ailu

reSe

lect

ion

of

med

icat

ion

to

pres

crib

e

• Sel

ectin

g th

e w

rong

dr

ug• K

now

ledg

e de

ficit,

pa

tient

dat

a no

t av

aila

ble

• Pat

ient

rece

ives

w

rong

dru

g4

86

192

• Req

uire

dia

gno-

sis

to a

ccom

pany

pr

escr

iptio

ns, s

eek

clar

ifica

tion

dire

ctly

w

ith p

resc

riber

, add

co

mpu

ter a

lert

s fo

r lo

ok-a

like

and

soun

d-al

ike

drug

s.M

edic

atio

n pr

escr

ibed

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afe

conc

omita

nt

ther

apy

• Prio

r the

rapy

not

di

scon

tinue

d, in

adeq

uate

dr

ug re

conc

iliat

ion,

dru

g in

tera

ctio

n no

t ide

ntifi

ed

• Inc

reas

ed

risk

of a

dver

se

even

ts

58

832

0• I

mpr

ove

med

ica-

tion

reco

ncili

atio

n pr

oces

ses,

impl

emen

t sy

stem

ale

rts

that

re

quire

con

firm

atio

n of

pat

ient

sta

tus.

Phar

mac

ist r

evie

w

of s

afet

y an

d ap

-pr

opria

tene

ss

• Ord

er n

ot re

view

ed/

eval

uate

d by

pha

rmac

ist

• Tim

e co

nstr

aint

s,

envi

ronm

enta

l fac

tors

, In

terr

uptio

ns

• Inc

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ct

ther

apy

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ible

, de

lay

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618

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ake

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ifica

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, im

-pr

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cess

.• I

ndic

atio

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prop

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-ne

ss n

ot v

erifi

ed• L

ack

of n

eces

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tient

info

rmat

ion,

inad

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te re

conc

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proc

ess

• Wro

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4• M

ake

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kflo

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ifica

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, req

uire

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to a

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-pa

ny p

resc

riptio

ns.

• Con

trai

ndic

atio

n/in

ter-

actio

ns/u

nsaf

e do

se o

r ro

ute

of a

dmin

istr

atio

n no

t det

ecte

d

• Kno

wle

dge

defic

it,

nonf

orm

ular

y dr

ug,

lack

of n

eces

sary

pat

ient

in

form

atio

n, in

adeq

uate

co

mpu

ter a

lert

s

• Con

trai

ndic

ated

th

erap

y, in

appr

o-pr

iate

ther

apy,

w

rong

ther

apy,

w

rong

dos

e

68

838

4• S

et u

p co

mpu

ter

aler

ts th

at c

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d fla

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e ne

ed fo

r pa

tient

info

rmat

ion.



on team members’ subjective perceptions and judgments. Objective systematic observations of the likelihood of an er-ror or its detection are not included in the process. There-fore, FMEA should not be the only component of efforts to improve the safety of the medication use process. Rather, FMEA should be coupled with other strategies such as ongo-ing reporting of near-misses as well as thorough review of processes and procedures if an error does occur. In addition, clinical best-practice guidelines and evidence-based inter-ventions should be implemented to promote standardization and reduce errors and adverse events.12

References1. Kohn LT, Corrigan JM, Donaldson MS, eds. To err is human: build-

ing a safer health system. Washington, DC: National Academy Press, Institute of Medicine; 1999.

2. Aspden P, Wolcott J, Bootman JL, Cronenwett LR, eds. Preventing medication errors: quality chasm series. Washington, DC: National Academy Press, Institute of Medicine; 2007.

3. January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guide-line for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014;129:2071–104.

FMEA resources FMEA Info Centre www.fmeainfocentre.com

Institute for Healthcare Improvement FMEA Tools http://app.ihi.org/Workspace/tools/fmea/AllTools.aspx

Institute for Safe Medication Practices www.ismp.org/tools/FMEA.asp

National Coordinating Council for Medication Error Reporting and Prevention www.nccmerp.org

Pause and reflectReview S.R.’s case and the actions to address failure modes in Table 9. Could some of the actions listed in Table 9 have prevented S.R.’s ICH? For example, if the system required the presence of a HAS-BLED score prior to prescribing an anticoagulant, could his ICH have been prevented? Could such changes improve the use of anticoagulants in your practice? Are they feasible changes, and what would need to happen to implement them? What other types of provider education, patient education, or system requirements could have improved the medication use process?

4. Lane DA, Lip GY. Use of the CHA(2)DS(2)-VASc and HAS-BLED scores to aid decision making for thromboprophylaxis in nonvalvular atrial fibrillation. Circulation. 2012;126:860–5.

5. Latino RJ. Optimizing FMEA and RCA efforts in health care. ASHRM Journal. 2004;24:21–28.

6. National Coordinating Council for Medication Error Reporting and Prevention. About Medication Errors. www.nccmerp.org/about-medication-errors. Accessed October 6, 2015.

7. Aronson JK. Medication errors: definitions and classification. Br J Clin Pharmacol. 2009;67:599–604.

8. Joint Commission on Accreditation of Healthcare Organizations. An introduction to FMEA: using failure mode and effects analysis to meet JCAHO’s proactive risk assessment requirement. Failure Modes and Effect Analysis. Health Devices. 2002;31:223–6.

9. Institute for Healthcare Improvement. All FMEA tools. http://app.ihi.org/Workspace/tools/fmea/AllTools.aspx. Accessed October 14, 2015.

10. American Society for Healthcare Risk Management. Strategies and tips for maximizing failure mode and effect analysis in an organiza-tion. J Healthc Risk Manag. 2002;22:9–12.

11. Lago P, Bizzarri G, Scalzotto F, et al. Use of FMEA analysis to re-duce risk of errors in prescribing and administering drugs in pae-diatric wards: a quality improvement report. BMJ Open. 2012;2(6).

12. Schriefer J, Leonard MS. Patient safety and quality improvement: an overview of QI. Pediatr Rev. 2012;33:353–9.



CPE AssessmentInstructions: This assessment must be taken online; please see “CPE information” sidebar for further instructions. The online system will present these questions in random order to help reinforce the learning opportunity. There is only one correct answer to each question.

1. Which of the following actions would be considered an error of omission?a. Placing the wrong label on a prescription bottleb. Incorrectly calculating a dosage based on body

weightc. Forgetting to place a warning label on a prescription

bottled. Providing patients with inaccurate instructions for

taking a medication

2. Applying the wrong label to a prescription bottle can be classified as which of the following types of medi-cation errors?a. Knowledge-based errorb. Memory-based errorc. Rule-based errord. Action-based error

3. In the patient case S.R., which of the following actions would most likely have prevented the occurrence of his intracranial hemorrhage?a. Double-checking the patient’s weight to ensure

proper dosageb. Performing a more thorough patient assessment and

modifying risk factors before treatmentc. Verifying that the medication was appropriate based

on the patient’s diagnosisd. Confirming the prescription with the prescriber

4. Not knowing the appropriate route of administration for a specific medication can be classified as which of the following types of medication errors? a. Knowledge-based errorb. Memory-based errorc. Rule-based errord. Action-based error

5. Insufficient drug information for a nonformulary drug that is rarely used can be classified as which of the following types of medication errors?a. Knowledge-based errorb. Memory-based errorc. Rule-based errord. Action-based error

6. Which of the following pieces of information is in-cluded in a FMEA table?a. Rates of medication errors that have occurred in the

past.b. Comparisons of the facility’s error rates with rates in

other facilities. c. Likelihood that an error will be detected.d. The individual who is at fault if the error occurs.

7. What is the highest possible risk priority number that can be assigned when conducting FMEA?a. 100b. 125c. 1000d. It depends on the scale being used.

CPE informationTo obtain 2.0 contact hours (0.2 CEUs) of CPE credit for this activity, you must complete the online assessment and evaluation. A statement of credit will be awarded for a passing grade of 70% or better on the assessment. You will have two opportunities to successfully complete the as-sessment. Pharmacists who successfully complete this activity before December 1, 2018, can receive CPE credit. Your statement of credit will be available upon successful completion of the assessment and evaluation and will be stored in your My Training Page and on CPE Monitor for future viewing/printing.CPE instructions:1. Log in or create an account at pharmacist.com, and select LEARN from the top of the page; select Continuing Education, then Home Study

CPE to access the Library. 2. Enter the title of this article or the ACPE number to search for the article and click on the title of the article to start the home study. 3. To receive CPE credit, select Enroll Now or Add to Cart from the left navigation and successfully complete the assessment (with randomized

questions) and evaluation. 4. To get your CPE credit, click “Claim” on the right side of the page. You will need to provide your NABP e-profile ID number to obtain and print

your CPE transcript from CPE Monitor.Live step-by-step assistance is available Monday through Friday from 8:30 am to 5:00 pm ET at APhA Member Services at 800-237-APhA (2742) or by e-mailing [email protected].



8. An important distinction between root cause analysis (RCA) and failure mode effects analysis (FMEA) is that only FMEAa. Applies to all types of medication errorsb. Is relevant to all types of health care settingsc. Seeks to prevent errors before they occurd. Can use a team approach to analyzing errors

9. Which of the following is the first step in conducting a FMEA?a. Determining what to evaluateb. Selecting FMEA team membersc. Identifying sources of errorsd. Reviewing errors that have occurred

10. How are failure modes prioritized for corrective ac-tion? a. Errors that are most likely to occur are addressed

first.b. Errors that are least likely to be detected are ad-

dressed first.c. Errors that are easiest to address are corrected first.d. Errors with the highest risk priority numbers are

addressed first.

11. Which of the following actions would best mitigate the risk of severe harm if a patient erroneously re-ceives a medication? a. Stocking medication antidotes at points of careb. Educating the patient about the purpose of the medi-

cationc. Adding warning labels to the medicationd. Requiring computerized prescription order entry

12. Which of the following actions would best mitigate the risk of a failure mode with a low likelihood of detection?a. Educating the patient about the purpose of the medi-

cationb. Adding alarms to the system that can indicate when

an error has occurredc. Adopting standardized forms or order sets for pre-

scriptionsd. Require computerized prescription order entry

13. Once an action has been selected to address the failure mode, the FMEA team should firsta. Seek input on the likely benefits of the action from

other individuals who will be involved in its imple-mentation.

b. Conduct a pilot test of the action.c. Conduct a root cause analysis.d. Implement the action throughout the organization.

14. Which of the following statements about measuring the effectiveness of a FMEA is true? a. FMEA’s effectiveness can only be measured by as-

sessing error rates before and after it is conducted.b. Effectiveness can be measured by conducting a

FMEA on the new process and calculating a new RPN.

c. FMEA is subjective; therefore, its effectiveness can-not be measured.

d. A FMEA is considered effective only if all future er-rors are eliminated.

15. Which of the following could be considered a draw-back of FMEA?a. It is based on team members’ judgment and experi-

ences rather than objective assessments of the likeli-hood of an error to occur.

b. It does not allow for prioritization of quality im-provement efforts.

c. It forces team members to act in “silos.”d. Individuals who are not involved in the FMEA team

have no opportunity to provide input in the process.

what could go wrong? preventing medication errors before...

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