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7/12/2017 1 FSHP 2017 ANNUAL MEETING Medication Errors – An Opportunity to Improve Medication Errors – An Opportunity to Improve Laura Monroe-Duprey, BS Pharm, PharmD Joanie Spiro Stevens, PharmD, BCPS 2017 ANNUAL MEETING #FSHP2017 Disclosure Disclosure Laura Monroe-Duprey - I do not have (nor does any immediate family member have) a vested interest or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation. Joanie Spiro Stevens - I do not have (nor does any immediate family member have) a vested interest or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation. 2017 ANNUAL MEETING #FSHP2017 Pharmacist Objectives Pharmacist Objectives Compare and contrast medication errors and adverse drug events (ADE) Describe methods and responsibilities for reporting errors Summarize Failure Mode Effects Analysis (FMEA) and Root Cause Analysis (RCA) Analyze pediatric and adult medication error examples Apply strategies for reducing medication risks 2017 ANNUAL MEETING #FSHP2017 Technician Objectives Technician Objectives Identify medication errors and adverse drug events (ADE) Recognize methods and responsibilities for reporting errors Define Failure Mode Effects Analysis (FMEA) and Root Cause Analysis (RCA) Summarize pediatric and adult medication error examples Describe strategies for reducing medication risks 2017 ANNUAL MEETING #FSHP2017 Have you ever made an error Have you ever made an error http://cartoonsmix.com/cartoons/cartoon-question-mark.html Accessed 5/10/17. 2017 ANNUAL MEETING #FSHP2017 “To err is human; to forgive, divine.” -Alexander Pope, An Essay on Criticism 1688 - 1744 “To err is human; to forgive, divine.” -Alexander Pope, An Essay on Criticism 1688 - 1744 http://poetry.eserver.org/essay-on-criticism.html Accessed 5/10/17.

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Page 1: Medication Errors – An Opportunity to Improve · Medication Errors – An Opportunity to Improve Laura Monroe-Duprey, BS Pharm, PharmD Joanie Spiro Stevens, PharmD, BCPS 2017 ANNUAL

7/12/2017

1

FSHP 2017 ANNUAL MEETING

Medication Errors –An Opportunity to ImproveMedication Errors –An Opportunity to ImproveLaura Monroe-Duprey, BS Pharm, PharmDJoanie Spiro Stevens, PharmD, BCPS

2017 ANNUAL MEETING

#FSHP2017DisclosureDisclosureLaura Monroe-Duprey - I do not have (nor does any immediate family member have) a vested interest or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation.

Joanie Spiro Stevens - I do not have (nor does any immediate family member have) a vested interest or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation.

2017 ANNUAL MEETING

#FSHP2017Pharmacist ObjectivesPharmacist Objectives• Compare and contrast medication errors and adverse

drug events (ADE) • Describe methods and responsibilities for reporting errors • Summarize Failure Mode Effects Analysis (FMEA) and Root

Cause Analysis (RCA)• Analyze pediatric and adult medication error examples• Apply strategies for reducing medication risks

2017 ANNUAL MEETING

#FSHP2017Technician ObjectivesTechnician Objectives• Identify medication errors and adverse drug events (ADE)• Recognize methods and responsibilities for reporting

errors• Define Failure Mode Effects Analysis (FMEA) and Root

Cause Analysis (RCA)• Summarize pediatric and adult medication error

examples• Describe strategies for reducing medication risks

2017 ANNUAL MEETING

#FSHP2017

Have you ever made an errorHave you ever made an error

http://cartoonsmix.com/cartoons/cartoon-question-mark.html Accessed 5/10/17. 2017 ANNUAL MEETING

#FSHP2017

“To err is human; to forgive, divine.”

-Alexander Pope, An Essay on Criticism

1688 - 1744

“To err is human; to forgive, divine.”

-Alexander Pope, An Essay on Criticism

1688 - 1744

http://poetry.eserver.org/essay-on-criticism.html Accessed 5/10/17.

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2017 ANNUAL MEETING

#FSHP2017Medication ErrorMedication ErrorDefinition: ”…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."

http://www.nccmerp.org/about-medication-errors Accessed 4/30/17 2017 ANNUAL MEETING

#FSHP2017Causes of Medication ErrorsCauses of Medication Errors• Cause:

• Rarely the failure of a single element or person

• Combined effects

• Types of failures:• Latent failures in the system• Active failures by people

• Solutions:• Recognize and correct latent failures• Increase redundancy• Establish systems to minimize risk of

medication errors

http://www.ismp.org/Newsletters/acutecare/articles/20020601.asp Accessed 4/30/17.http://patientsafetyed.duhs.duke.edu/module_e/swiss_cheese.html Accessed 5/10/17.

2017 ANNUAL MEETING

#FSHP2017Where Medication Errors OccurWhere Medication Errors OccurPrescribing

39-49%• Physician• Physician

extender• Pharmacist

Transcribing11-12%

• Physician• Physician

extender• Pharmacist• Nurse• Non-

healthcare professional

Dispensing11-14%

• Pharmacist• Pharmacy

technician• Pharmacy

student

Administering26-38%

• Nurse• Respiratory

therapist

Monitoring

• Physician• Physician

extender• Pharmacist• Nurse• Respiratory

therapist

Vogenberg FR, Benjamin D. The Medication-Use Process and the Importance of Mastering Fundamentals. Pharmacy and Therapeutics. 2011;36(10):651-652.Leape L, Bates DW, Cullen DJ, et al. Systems analysis of adverse drug events: ADE Prevention Study Group. JAMA. 1995;274(1):35–43.Bates D, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse drug events: Implications for prevention. ADE Prevention Study Group. JAMA. 1995;274(1):29–34.

Anywhere along the medication use process

2017 ANNUAL MEETING

#FSHP2017

Medication Errors vs. Adverse Drug EventsMedication Errors vs. Adverse Drug Events

2017 ANNUAL MEETING

#FSHP2017Adverse Drug Event (ADE)Adverse Drug Event (ADE)

Definition:An injury, large or small, caused by the use (including non-use) of a drug.

2 types of ADEs1) Preventable ADEs - Caused as a result of an error2) Non-preventable ADEs - Occur despite proper usage

a) Also known as an Adverse Drug Reaction (ADR)

Leape LL, Kabcenell A, Berwick DM, et al. Reducing adverse drug events. Breakthrough series Guide Institute for Healthcare Improvement, Boston, 1998, p.84-91. 2017 ANNUAL MEETING

#FSHP2017Adverse Drug Reaction (ADR)Adverse Drug Reaction (ADR)“any unexpected, unintended, undesired, or excessive response to a drugthat…• requires discontinuing the drug (therapeutic or diagnostic)• requires changing the drug therapy• requires modifying the dose (except for minor dosage adjustments) • necessitates admission to a hospital• prolongs stay in a healthcare facility• necessitates supportive treatment • significantly complicates diagnosis • negatively affects prognosis or • results in temporary or permanent harm, disability, or death.”

Includes allergic reactions and idiosyncratic reactions

American Society of Health-System Pharmacists. ASHP guidelines on adverse drug reaction monitoring and reporting. Am J Health-Syst Pharm. 1995;52(4):417-419.

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#FSHP2017

Miller MR, Robinson KA, Lubomski LH, et al. Medication errors in paediatric care: a systematic review of epidemiology and an evaluation of evidence supporting reduction strategy recommendations. Qual Saf Health Care. 2007;16:116-126.

Medication Error vs. ADEMedication Error vs. ADE

Medication Errors

Potential ADEs

ADEs

Preventable ADEs

Non-preventable ADEs (also known as ADRs)

2017 ANNUAL MEETING

#FSHP2017

Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi:https://doi.org/10.17226/11623.Takata GS, Mason W, Taketomo C. Development, Testing, and Findings of a Pediatric- Focused Trigger Tool to Identify Medication-Related Harm in US Children’s Hospitals. Pediatrics. 2008;121(4):e927-e935.

Incidence of Medication Errors and Adverse Drug EventsIncidence of Medication Errors and Adverse Drug Events

• ~1 medication error per patient per day• > 1.5 million preventable ADEs each year in the US

• ~400,000 of these occur in the hospital setting• Estimated annual cost of preventable ADEs = $3.5 billion• Underestimated due to variability of definitions used &

methods used to identify• Chart review• Voluntary reporting• Observation• Trigger method

2017 ANNUAL MEETING

#FSHP2017

Kaushal R, Bates DW, Landrigan C, et al. Medication Errors and Adverse Drug Events in Pediatric Inpatients. JAMA. 2001;285(16):2114-2120. doi:10.1001/jama.285.16.2114.

Incidence of Medication Errors and Adverse Drug EventsIncidence of Medication Errors and Adverse Drug Events

2017 ANNUAL MEETING

#FSHP2017

Factors Placing Pediatric Patients at Increased Risk for Medication Errors

Changing pharmacokinetic parameters at various ages and stages of development

Need for calculation of individualized doses based on patient’s age, weight (mg/kg), body surface area (mg/m2), and clinical conditionLack of available dosage forms and concentrations appropriate for administration to neonates, infants, and children. Frequently, dosage formulations are extemporaneously compounded and lack stability, compatibility, or bioavailability data

Need for precise dose measurement and appropriate drug delivery systems

Lack of published information or Food and Drug Administration-approved labeling regarding dosing, pharmacokinetics, safety, efficacy, and clinical use of drugs in the pediatric population

Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi:https://doi.org/10.17226/11623.Levine SR, Cohen MR, Blanchard NR, et al. Guidelines for preventing medication errors in pediatrics. J Pediatr Pharmacol Ther 2001;6:426-442.

2017 ANNUAL MEETING

#FSHP2017

2017 ANNUAL MEETING

#FSHP2017

ReportingReporting

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#FSHP2017To Err is HumanTo Err is HumanThe Quality of Health Care in America 1998 Project • Medical errors are major risk to public health• Medication errors alone, either while in a hospital or elsewhere, was estimated to account

for over 7,000 deaths annually• Public insulation• Liability insurance and culture contributions

Kohn L, Corrigan J, Donaldson M, eds. Washington, DC: Committee on Quality of Health Care in America, Institute of Medicine. National Academies Press; 1999. ISBN: 9780309068376. 2017 ANNUAL MEETING

#FSHP2017To Err is HumanTo Err is HumanRecommendations contained in this report suggest a four-tiered approach:

1. establish a national focus to create leadership, research, tools and protocols to enhance the knowledge base about safety;

1. Identify and learn from errors through immediate and strong mandatory reporting efforts, as well as the encouragement of voluntary efforts, both with the aim of making sure the system continues to be made safer for patients;

3. raise standards and expectations for improvements in safety through the actions of oversight organizations, group purchasers, and professional groups;

3. create safety systems inside health care organizations through the implementation of safe practices at the delivery level. This level is the ultimate target of all the recommendations.

2017 ANNUAL MEETING

#FSHP2017To Err is HumanTo Err is HumanMedication Error Reporting IOM Recommendation

• Recommendation 5.1Nationwide mandatory reporting system for providers which allows for collection of standard information

• Recommendation 5.2“Center of Patient Safety” to describe and disseminate information on voluntary reporting systems

• Recommendation 6.1Legislation to protect peer review patient safety data

• Recommendation 8.2Health Care organizations should implement proven medication safety practices

2017 ANNUAL MEETING

#FSHP2017To Err is HumanTo Err is HumanWhat is the benefit of MANDATORY reporting ?

2017 ANNUAL MEETING

#FSHP2017Ten Year JourneyTen Year JourneyMedicare Modernization Act of 2003• Mandated the Centers for Medicare and Medicaid

Services to sponsor study by IOM“To formulate a national agenda

by developing estimates of the incidence of such errors and determining the efficacy of prevention strategies”

Preventing Medication Errors: Quality Chasm Series http://books.nap.edu/catalog11623.htmlaccessed 5.09.17 2017 ANNUAL MEETING

#FSHP2017

Ten Year JourneyTen Year Journey

http://www.nap.edu accessed 5.09.17

Health Care Organizations

so that progress toward improved medication safety can be accurately demonstrated (2007)

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2017 ANNUAL MEETING

#FSHP2017Reporting ErrorsReporting Errors

2017 ANNUAL MEETING

#FSHP2017

Patient Rights to Their Medication ManagementPatient Rights to Their Medication Management

Be the source of control for all medication management decisions that affect them (that is, the right to self-determination).Accept or reject medication therapy on the basis of their personal values.Be adequately informed about their medication therapy and alternative treatments.Ask questions to better understand their medication regimen.Receive consultation about their medication regimen in all health settings and at all points along the medication-use process. Designate a surrogate to assist them with all aspects of their medication management.Expect providers to tell them when a clinically significant error has occurred, what the effects of the event on their health (short- and long-term) will be, and what care they will receive to restore their health.Ask their provider to report an adverse event and give them information about how they can report the event themselves.

Ten Year JourneyTen Year Journey

2017 ANNUAL MEETING

#FSHP2017Ten Year Journey Ten Year Journey Issues for Nurses, Physicians and Pharmacists Patient Discussions

• Review the patient’s medication list routinely and during care transitions.*JC

• Review different treatment options.

• Review the name and purpose of the selected medication. *HCAPHS

• Discuss when and how to take the medication. *BOP

• Discuss important and likely side effects and what to do about them. *HCAPHS

• Discuss drug–drug, drug–food, and drug–disease interactions.

• Review the patient’s or surrogate’s role in achieving appropriate medication use.

• Review the role of medications in the overall context of the patient’s health

2017 ANNUAL MEETING

#FSHP2017

2017 ANNUAL MEETING

#FSHP2017Where to reportWhere to report

https://www.fda.gov/Safety/MedWatch/default.htm accessed 4.23.17

Contact your health-care provider right away so that they can advise you on the necessary actions to take. Also, urge the provider to report the problem to FDA's MedWatch hotline, at 800-FDA-1088. Your health care provider, however, is not required to report to FDA. Therefore, consumers can report problems directly. For more information, visit MedWatch.

2017 ANNUAL MEETING

#FSHP2017Reporting ErrorsReporting ErrorsPrescription or over-the-counter medicines, as well as medicines administered to hospital patients or at outpatient

infusion centers

Biologics (including blood components, blood and plasma derivatives, allergenic, human cells, tissues, and cellular and tissue-based products (HCT/Ps))

Medical devices (including in vitro diagnostic products)

Combination productsSpecial nutritional products (infant formulas, and medical foods)CosmeticsFoods/beverages (including reports of serious allergic reactions)

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2017 ANNUAL MEETING

#FSHP2017Reporting Reporting What Not to Report to FDA MedWatch:TobaccoSafety Reporting Portalhttps://www.safetyreporting.hhs.gov/fpsr/WorkflowLoginIO.aspx?metinstance=D432215BCD68831461E102E11540AD46662CAE5D

Vaccines: Report vaccine events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/esub/indexInvestigational (study) drugs: Report investigational (study) drug adverse events as required in the study protocol and send to the address and contact person listed in the study protocol.http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227351.pdf

Reporting on Dietary Supplementshttp://www.fda.gov/Food/DietarySupplements/ReportAdverseEvent/default.htm

Reporting on Veterinary Medicine Productshttp://www.fda.gov/animalveterinary/safetyhealth/reportaproblem/ucm055305.htm

Reports FDA Does Not Handle (e.g. CPSC, FTC, State Health Departments) http://www.fda.gov/Safety/ReportaProblem/QuestionsandAnswersProblemReporting/default.htm

2017 ANNUAL MEETING

#FSHP2017FDA reports processFDA reports process

https://www.fda.gov/Safety/MedWatch/default.htm accessed 4.23.17

Medwatch

FDA CDERDDI

DSOB

2017 ANNUAL MEETING

#FSHP2017Reporting ErrorsReporting ErrorsThe National Alert Network (NAN) publishes the alerts from the National Medication Errors Reporting Program. NAN encourages the sharing and reporting of medication errors, so that lessons learned can be used to increase the safety of the medication use system.

www.nccmerp.org/report-medication-errors accessed 5.14.17 2017 ANNUAL MEETING

#FSHP2017

Reporting ErrorsReporting Errors

The mission NCCMERP 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.

2017 ANNUAL MEETING

#FSHP2017Reporting ErrorsReporting Errors• Recognize methods and responsibilities for reporting

errors• MedMarx• https://www.fda.gov/Safety/MedWatch/default.htm• https://vaers.hhs.gov/index• co-sponsored by the Centers for Disease Control and Prevention (CDC) and the

Food and Drug Administration (FDA). VAERS is a post-marketing safety surveillance program, collecting information about adverse events (possible side effects) that occur after the administration of vaccines licensed for use in the United States.

2017 ANNUAL MEETING

#FSHP2017

Reporting ErrorsReporting Errors• Why do we report errors ?• What do the number of errors

reported at our facility mean ?• What are the challenges with

voluntary reporting ?

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#FSHP2017

Reporting ErrorsReporting Errors Best Designs• Simple, intuitive• Requirement for front line

staff- only information easily known

• Non-punitive• Ability to be anonymous

2017 ANNUAL MEETING

#FSHP2017

Medication Error Examples

Medication Error Examples

2017 ANNUAL MEETING

#FSHP2017Categorizing Medication Errors – NCC MERPCategorizing Medication Errors – NCC MERP

http://www.nccmerp.org/sites/default/files/indexColor2001-06-12.pdf accessed 4/30/172017 ANNUAL MEETING

#FSHP2017Medication Error AssessmentMedication Error Assessment

http://www.nccmerp.org/sites/default/files/indexColor2001-06-12.pdf accessed 4/30/17

2017 ANNUAL MEETING

#FSHP2017AlgorithmAlgorithm

http://www.nccmerp.org/sites/default/files/algorColor2001-06-12.pdf accessed 4/30/172017 ANNUAL MEETING

#FSHP2017

RCARCA

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#FSHP2017RCARCARoot Cause Analysis • The “When’s”• The “Why’s”

2017 ANNUAL MEETING

#FSHP2017RCARCAWhat is a Root Cause ?• A root cause is a factor that caused the original variance• Ideal state - permanently eliminate through process

improvement• Root cause analysis uses tools, techniques and other

approaches with goal of cause finding• Can there be multiple root causes ?

2017 ANNUAL MEETING

#FSHP2017RCARCA

Computer OSA

Bipap

Location of pt

PA orderingMedication dose

2017 ANNUAL MEETING

#FSHP2017

Failure Mode Effects Analysis (FMEA)

Failure Mode Effects Analysis (FMEA)

2017 ANNUAL MEETING

#FSHP2017What is a FMEA?What is a FMEA?Process used to prospectively identify and prioritize failures in the system

Failure• When a system or part of a system performs in a way that is

not intended or desirable.Mode

• The way or manner in which something, such as a failure, can happen. Failure mode is the manner in which something can fail.

Effects• The results or consequences of a failure mode.

Analysis• The detailed examination of the elements or structure of a

process.

http://www.jcrinc.com/assets/1/14/FMEA10_Sample_Pages.pdf Accessed 5/14/17. 2017 ANNUAL MEETING

#FSHP2017How to Conduct an FMEAHow to Conduct an FMEA

http://www.mentorhealth.com/control/joint-commission-requirements-on-fmea Accessed 4/29/17.

5• Identify causes of the failure mode

6• Assess the severity, probability, likelihood

of detection for each failure mode

7• Implement actions to reduce the

occurrence of the highest ranked failure modes

8• Maintain the redesigned process

1• Select a high risk process

2• Create flow chart of the process

3• Determine each step that can fail (failure

modes)

4• Evaluate possible and potential

consequence that each failure mode can have

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#FSHP2017FMEA Review of Each Step of the ProcessFMEA Review of Each Step of the Process

Rate the following on a scale of 1-10• Severity – 10 = most severe effect• Probability – 10 = very likely to occur• Detection – 10 = very unlikely to detect

Risk Priority Number = Severity x Probability x Detection

https://www.patientsafety.va.gov/professionals/onthejob/hfmea.asp Accessed 4/20/17.http://www.ihi.org/resources/Pages/Tools/FailureModesandEffectsAnalysisTool.aspxAccessed 5/22/17.

Step in Process

Failure Modes

Proximate Causes

Effects Severity Probability Likelihoodof Detection

Risk Priority Number

Actions to Reduce Failure Mode

2017 ANNUAL MEETING

#FSHP2017FMEA Scoring SystemFMEA Scoring System

http://www.ihi.org/resources/Pages/Tools/FailureModesandEffectsAnalysisTool.aspx Accessed 5/22/17.

ProbabilityRemote (1): no known occurrence; or happens < 10 % of the time

Low (3): possible, but no known data; or happens 10 - 30 % of the time

Moderate (5): documented but less frequent; or happens 40 - 60% of the time

High (7): documented and frequent; or happens 70-80% of the time

Very high (10): documented, almost certain; or happens 90-100% of the time

SeverityNo effect (1)

Slight annoyance (2): may affect the system

Moderate system problem (3): may affect the patient

Major system problem (5): may affect the patient

Minor injury (7): temporary patient harm

Major injury (9): permanent lessening of body function, surgical intervention required, disfigurement

Terminal injury or death (10)

2017 ANNUAL MEETING

#FSHP2017FMEA Scoring SystemFMEA Scoring System

http://www.ihi.org/resources/Pages/Tools/FailureModesandEffectsAnalysisTool.aspx Accessed 5/22/17.

Likelihood of DetectionVery high (1): error almost always detected; or we’ll catch it 9 of 10 times

High (3): error likely to be detected; or we’ll catch it 7 of 10 times

Moderate (5): moderate likelihood of detection; or we’ll catch it 5 of 10 times

Low (8): low likelihood of detection; or we’ll catch it 2 of 10 times

Remote (10): detection not possible at any point; or we’ll never catch it! (0 of 10)

2017 ANNUAL MEETING

#FSHP2017FMEA Pediatric Hospital ExampleFMEA Pediatric Hospital Example• Hundreds of patient specific oral medication doses are

dispensed from the pharmacy each day.• Potential for numerous errors:

• Wrong medication, concentration, dose• Inappropriate storage conditions• Expired medication or medication not available• Contamination• Dispensing delay

• Evaluate our oral fill list process.

2017 ANNUAL MEETING

#FSHP2017FMEA Ex. – The ProcessFMEA Ex. – The ProcessOral List Prints

Labels are separated by

drug and storage condition

Bulk bottle selected and set on counter with

labels

Expiration and personnel

number written on labels

Strip of individual doses separated for 1 medication

Individual doses drawn into

syringeLabel syringe

Bulk bottle and individual

syringes lined up for checking

Pharmacist verifies final

productPharmacist signs

labelIndividual syringes

are bagged

Bagged doses sorted into bins

based on storage location

Bagged doses separated into

unit bins

Bulk bottles returned to

storage location 2017 ANNUAL MEETING

#FSHP2017FMEA Ex. Review of Each ProcessFMEA Ex. Review of Each ProcessStep in Process

Failure Modes

Proximate Causes

Effects Severity Probability Likelihoodof Detection

Risk Priority Number

Actions to Reduce Failure Mode

Bulk bottle and individual syringes lined up for checking.

a) Wrong bottle placed next to syringes.b) Confusion of bottle placement before or after syringes drawn up from that bottle.c) Syringe mixed in with those from another medication.

1) Human error2) Workflow interruptions (phone calls, STAT orders, etc)3) Environmental factors4) Limited space on counter

a) Patient could receive wrong med.

5 5 3 75 1) Implement bag system to group doses with bulk bottle for each medication2) Reduce environmental factors & workflow interruptions, when possible3) Provide appropriate staff for effective process:-Added technician position to help with the 10 pm list4) Address space constraints:-Created an additional list at 10 pm to reduce the volume of the 5 pm list

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2017 ANNUAL MEETING

#FSHP2017FMEA Ex. Top Risk Priority Numbers (RPN)FMEA Ex. Top Risk Priority Numbers (RPN)

• Bulk bottle and individual syringes lined up for checking RPN: 75

• Pharmacist verifies final product RPN: 75

• Labels are separated by drug and storage condition RPN: 63

• Bulk bottle selected and set out on counter with corresponding labels RPN: 63

2017 ANNUAL MEETING

#FSHP2017FMEA Ex. Summary of ActionsFMEA Ex. Summary of Actions• Implement bag system to group doses with bulk bottle for each

medication• Provide appropriate staffing for effective process

• Add technician position to help with the 10 pm list• Address space constraints

• Create an additional list at 10 pm to reduce the volume of the 5 pm list• Add a blank label with black division line in between each

medication and strength that prints on list• Provide training with computerized inventory system &

expectation to remove bulk bottle when new bottle opened• Place label from inventory system on bottle when removed from system

2017 ANNUAL MEETING

#FSHP2017FMEA Ex. Summary of Actions Cont.FMEA Ex. Summary of Actions Cont.• Separate bins containing look alike/sound alike medications

and utilize tall man lettering on bin labels • Pull 1 bulk bottle at a time to fill 1 strip of labels• Place refrigerate sticker on bottles requiring refrigeration• Provide training to ensure storage requirements are known• Create separate area for pharmacists to check syringes • Reduce environmental factors & workflow interruptions

2017 ANNUAL MEETING

#FSHP2017

Strategies to Reduce Error Risk

2017 ANNUAL MEETING

#FSHP2017

https://www.ismp.org/newsletters/ambulatory/archives/200602_4.asp Accessed 5-12-17. 2017 ANNUAL MEETING

#FSHP2017Fail-safes and ConstraintsFail-safes and ConstraintsUse• Most powerful and

effective strategy• Involve system changes

in product design or how individuals interact

Example• Preventing scanning on

administration unless the pharmacist verification sticker has been placed on the label

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2017 ANNUAL MEETING

#FSHP2017Forcing FunctionsForcing FunctionsUse• Creation of a “hard stop” to ensure important information

is provided before proceedingExample• Hospital Formulary

2017 ANNUAL MEETING

#FSHP2017Forcing Functions - ExamplesForcing Functions - Examples• Requiring an

acknowledgement of high dose

• Requiring an indication & duration

2017 ANNUAL MEETING

#FSHP2017Forcing Functions - ExampleForcing Functions - Example• Medication warning messages require an

acknowledgement reason

2017 ANNUAL MEETING

#FSHP2017Automation and ComputerizationAutomation and ComputerizationPros• Limit reliance on memory• Lessen potential for human

error

Example• Computerized physician

order entry software that includes clinical decision support

2017 ANNUAL MEETING

#FSHP2017Automation and Computerization -ExamplesAutomation and Computerization -Examples

• IV room processing and tracking software• Inventory tracking software• Databases that provide warning related to allergies, drug

interactions, or doses outside the recommended range

2017 ANNUAL MEETING

#FSHP2017StandardizationStandardizationPro• Reduces complexity and

variation of a processUse• Uniform model to adhere

to when performing tasks

Cons• Less effective than

previous strategies when used alone

• Relies on human vigilance to ensure the process is followed

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#FSHP2017Standardization - ExamplesStandardization - Examples• Order sets • Medication administration

http://www.snjourney.com/ClinicalInfo/Meds/Calc.htm2017 ANNUAL MEETING

#FSHP2017RedundanciesRedundanciesPro• Reduces the likelihood

both individuals will make the same error

Use• Incorporate duplicate

steps or an additional individual in the process

Con• Potential failure if the

redundancy is omitted or ignored

2017 ANNUAL MEETING

#FSHP2017Redundancies - ExamplesRedundancies - ExamplesChemotherapy verification

Filling of patient specific doses

2017 ANNUAL MEETING

#FSHP2017Redundancies - ExamplesRedundancies - ExamplesDouble check of high alert medications

2017 ANNUAL MEETING

#FSHP2017Redundancies - ExamplesRedundancies - ExamplesPatient counseling

2017 ANNUAL MEETING

#FSHP2017Reminders and ChecklistsReminders and ChecklistsUse• Highlight important

information

Example• Look-alike, sound-alike

lists & alerts built into order entry system

Example• Auxiliary stickers to

distinguish dose, route, storage

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#FSHP2017Rules and PoliciesRules and PoliciesPro• Guide staff toward an

intended positive outcome

Use• Combine with other

strategies that target the system

Cons• Potential to add

unnecessary complexity• May be met with

resistance especially when implemented in response to an error

• Use relies on memory

2017 ANNUAL MEETING

#FSHP2017EducationEducationPro• Increases awareness to

topic

Example:

Use• In combination with other

strategies

Con• Effect relies on the

individual’s ability to remember the information presented

2017 ANNUAL MEETING

#FSHP2017

Automated Response

2017 ANNUAL MEETING

#FSHP2017

AUTOMATED RESPONSE • A response done over and

over again as part of a routine

• A repetitive learned behavior during the course of a person’s experience

• A reaction to a specific input

2017 ANNUAL MEETING

#FSHP2017

Limitations on Human Performance• Multi-tasking• Dependence on heuristics

when under time limits or stress conditions

• Environmental• Fatigue- high or low volume• Normalization of deviance• Distractions

2017 ANNUAL MEETING

#FSHP2017

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2017 ANNUAL MEETING

#FSHP2017

2017 ANNUAL MEETING

#FSHP2017

2017 ANNUAL MEETING

#FSHP2017

2017 ANNUAL MEETING

#FSHP2017

Best Practice#11When compounding sterile preparations , perform an independent verification to ensure the proper ingredients (medications and diluents) are added, including confirmation of the proper amount (volume) of each ingredient prior to its addition to the final container

2017 ANNUAL MEETING

#FSHP2017

Other Resources • ISMP quarterly reports• ASHP online• CDC :https://www.cdc.gov/medicationsafety/library.html• FDA : https://www.fda.gov/Drugs/DrugSafety/default.htm

2017 ANNUAL MEETING

#FSHP2017ErrorsErrorsHuman Tendency

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2017 ANNUAL MEETING

#FSHP2017 FSHP 2017 ANNUAL MEETING

Medication Errors –An Opportunity to ImproveMedication Errors –An Opportunity to ImproveLaura Monroe-Duprey, BS Pharm, PharmDJoanie Spiro Stevens, PharmD, BCPS