#FSHP2019 Disclosure #FSHP2019...Alotaibi Y, et al. Saudi Med. 2017;38(12), 1173., Kaushal R, et al. BMJ Quality & Safety. 2002;11(3), 261-265. #FSHP2019 Patient Portals and Telemedicine

7/10/2019

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#FSHP2019

The Influence of Informatics and Drug Shortages on Changing the Landscape of Medication Errors

The Influence of Informatics and Drug Shortages on Changing the Landscape of Medication Errors

Katy Branch, PharmD, BCPSIT Manager Clinical Pharmacy and Research SystemsBroward Health

#FSHP2019DisclosureDisclosureI do not have (nor does any immediate family member have):– a vested interest in or affiliation with any corporate

organization offering financial support or grant monies for this continuing education activity

– any affiliation with an organization whose philosophy could potentially bias my presentation

#FSHP2019Professional Experience

2005 - PharmD

2005 - Clinical Pharmacist

2005 - 2006 -Pharmacy Manager

2006-2008 – Pharmacy Operations Coordinator

2011 - current – Clinical Pharmacy and Research Systems Manager, Residency Program Director PGY2

2008 - 2011 –Clinical Pharmacist

2010 - BCPS 2016 - CLSSGB

2016 – Current –Lecturer – Health Informatics Master’s Program

#FSHP2019Work Family Kids

#FSHP2019ObjectivesObjectives• Review medication error trends in the Electronic Health

Record (EHR)• Evaluate the role of informatics in medication error

prevention• Analyze the impact of drug shortages on medication errors• Examine the use of informatics to mitigate drug shortage

related medication errors• Discuss tools used to evaluate and optimize safe medication

processes, including root cause analysis

#FSHP2019Electronic Health Record Adoption2006• The American Hospital Association’s (AHA) Forward Momentum

Survey• 11% of hospitals have fully implemented an EHR• 57% of hospitals reporting a partially implemented EHR• 10% CPOE

• HIMSS Leadership Survey• 24% of hospitals reporting a fully functional EHR• 36% of hospitals reporting they had initiated the installation

process

Health IT US: Where We Stand. 2008., Pa Patient Saf Advis, 2017;14(1).1-8. Sulivan, T. Policy and Medicine. 2019.

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#FSHP2019HITECH Act 2009

“EHR could prevent errors, enhance patient safety, and improve efficiency”

Pa Patient Saf Advis, 2017;14(1).1-8.

#FSHP2019Electronic Health Record Adoption2015 • American Hospital Association (AHA), AHA Annual Survey

• 96% of non-federal acute care hospitals had a certified EHR• 78% of office-based physicians had adopted certified health IT

• Survey of Pharmacy Directors• 97% of hospitals implemented an EHR• 84.1% use CPOE• 93.7% BCMA

Health IT US: Where We Stand. 2008., Pa Patient Saf Advis, 2017;14(1).1-8. Sulivan, T. Policy and Medicine. 2019.

#FSHP2019

Medication error trends in the Electronic Health Record

https://play.kahoot.it/

#FSHP2019

EHRs Impact on Medication Errors

Effects of Electronic Prescribing on the Clinical Practice of a Family Medicine Residency: 63% reduction in medication errors

~2010 Family Medicine

A community hospital in Vermont implemented an EHR and reported:60% decrease in near-miss medication events

~2011 Healthcare Financial Management

A national survey of doctors:•88% report that their EHR produces clinical benefits •75% of providers report that their EHR allows them to deliver better patient care

~2012 National Conference on Health Statistics

EHRs don't just contain or transmit information; they "compute" it. That means that EHRs manipulate the information in ways that make a difference for patients

Health IT.gov, Improved Diag Pt Outcomes. 2017.

#FSHP2019EHRs May Reduce Risk

•Providing clinical alerts and reminders•Improving aggregation, analysis, and communication of patient information•Making it easier to consider all aspects of a patient’s condition•Supporting diagnostic and therapeutic decision making•Gathering all relevant information (lab results, etc.) in one place


#FSHP2019EHRs May Reduce Risk

•Support for therapeutic decisions•Enabling evidence-based decisions at point of care•Preventing adverse events•Providing built-in safeguards against prescribing treatments that would result in adverse events•Enhancing research and monitoring for improvements in clinical quality


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#FSHP2019

120 HIT related sentinel events = 3,375 sentinel events

Joint Commission. Safe use of Health IT. 2015 Mar 31;54:1-6.

Joint Commission Sentinel Events

3.6%

#FSHP2019Joint Commission Sentinel Events

Human-Computer

Interface, 33%

Workflow and Communication,

24%

Clinical Content, 23%

Internal Policies and culture, 6%

People/Training, 6%

Hardware and Software, 6%

External Factors, 1% System

Measurement and Monitoring,

1%

8 Socio-technical DimensionsJoint Commission. Safe use of Health IT. 2015 Mar 31;54:1-6.

#FSHP2019Human Computer Interface Medication Error

• 87-year-old female fell at home and sustained femoral neck (hip) fracture• In hospital patient was given a different medication than

prescribed by ordering provider• Root cause: Pharmacy system “auto-populated” Medicine

A when first three letters of Medicine B were typed by the ordering provider• Medication error went unnoticed for three weeks before

the patient expired

Joint Commission. Safe use of Health IT. 2015 Mar 31;54:1-6.

#FSHP2019Workflow and Communication Medication Error

• 3-year-old female presented in ED with high fever and vomiting and other severe flu-like symptoms

• During transport, EMT communicated to ED nurse that patient’s weight was 34, without specifying unit

• Pharmacist filled medications per order for a 34 kg (75 lbs) patient rather than 34 lb patient

• Patient’s condition declined due to fluid and medication overdose• Root Cause: The ED system accepted both kg and lbs without validation

and the pharmacy system did not allow the pharmacist to see the patient's age to validate the dosage

• Error was identified, dosing corrected, length of stay was extended, and child survived Image:

https://www.cdc.gov/ncbddd/childdevelopment/positiveparenting/toddlers2.html Joint Commission. Safe use of Health IT. 2015 Mar 31;54:1-6.

#FSHP2019

• 889 medication-error reports listed Health Information Technology (HIT) as a contributing factor - January 1 to June 30, 2016

Pennsylvania Patient Safety Authority

Pa Patient Saf Advis, 2017;14(1).1-8.

#FSHP2019

ECRI Institute PSO Deep Dive: Health IT

• Analysis consisted of 171 health IT events during a 9 week reporting period• Events were analyzed by

severity and health IT systems involved

ECRI Institute PSO Deep Dive: Health Information Technology. 2012.

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#FSHP2019ECRI Institute PSO Deep Dive: Interface Issues

Human-computer• Entering the wrong data 32% • Retrieving the wrong record 25%

Computer• System interfaces 28% • System configurations 23%


#FSHP2019ECRI Institute PSO Deep Dive: Top 5 Issues

1. System Interface Issues2. Wrong Input3. Software Issue-System

Configuration4. Wrong Record Retrieved5. Software Issue-

Functionality


#FSHP2019EHR-Related Medication Errors in Two ICUsEHR-Related Medication Errors in Two ICUs

• Of the 1,622 medication safety events that occurred, 34% (551) were EHR related

Carayon P, et al. J Healthc Risk Manag. 2017;36(3):6-15.

#FSHP2019EHR-Related Medication Errors in Two ICUsEHR-Related Medication Errors in Two ICUs

Carayon P, et al. J Healthc Risk Manag. 2017;36(3):6-15.

#FSHP2019MEDMARX Data Analysis• 1.04 million medication errors were reported to MEDMARX• 63,040 were reported as CPOE related

Schiff, G. D., et al. BMJ Qual Saf. 2015; 24(4). 264-271.

#FSHP2019One-Third of Pediatric Medication Errors Due to Usability IssuesOne-Third of Pediatric Medication Errors Due to Usability Issues

• #1 reported challenges were associated with system feedback and the visual display • Design• Implementation• Customization• Use of EHRs

Other64%

Usability Issue36%

9000 Pediatric Safety Reports

One-third of peds medication errors due to usability issues. 2018.

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#FSHP2019Key Takeaways

•EHR adoption has increased significantly over the last 10 years•Information technology interventions have great potential to decrease medication errors•Regulatory agencies are categorizing medication errors as having a HIT component


•Usability is the highest contributing factor for HIT related medication errors•The ordering and administration stages of the medication process have the highest EHR medication error rates

#FSHP2019

Evaluate the role of informatics in medication error prevention

https://play.kahoot.it/

#FSHP2019Clinical Informatics

"Clinical informaticians transform health care by analyzing, designing, implementing, and evaluating information and communication systems that enhance individual and population health outcomes, improve patient care, and strengthen the clinician-patient relationship."

Gardner R, et al. J. Amer Med Informatics. 2009;16(2), 153-157.


IT Programmer <-> Clinical Informatics <-> Clinician


IT Programmer <-> Clinical Informatics <-> Clinician

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#FSHP2019Pharmacy Informatics

Edillo, N. Pharm Purc & Prod. 2011; 8(4), 26-29.

#FSHP2019Computerized Provider Order Entry (CPOE)

CPOE with CDS• A metaanalysis found CPOE with clinical decision support resulted in

significant reduction in medication errors ~50% (RR:0.46; 95% CI 0.31 to 0.71)

• Brigham and Women's Hospital 83% reduction in medication errors with a CPOE system with advanced decision support

CPOE• A basic CPOE system without a clinical decision support system showed

that it did not improve overall patient safety or reduce medication errors

Kaushal R, et al. BMJ Quality & Safety. 2002;11(3), 261-265., Alotaibi Y, et al. Saudi Med. 2017;38(12), 1173.

#FSHP2019Clinical Decision Support (CDS)

CDS• The use of on screen reminders for physicians resulted in minor

to modest improvements in process adherence, medication ordering, vaccination, laboratory ordering and clinical outcomes.

• 33% of alerts were ignored by the ordering physician• “Tiering” and “automation of alerts” resulted in improved

physician’s compliance to CDS alerts• Odds of success were greater for CDS systems that demanded

the healthcare provider to justify the reason when over-riding CDS advice

Alotaibi Y, et al. Saudi Med. 2017;38(12), 1173.

#FSHP2019Barcode Medication Administration (BCMA)

Young J, et al. J. of Pt Safety. 2010;6(2), 115-120.

#FSHP2019

• A controlled trial found the use of ADCs resulted in a 28% (p<0.05) reduction in the rate of medication errors in a hospital critical care unit (RR: 0.7; NNT: 4)

• A robot decreased dispensing errors from 2.9% to 0.6% in adult inpatients

Automated Dispensing Cabinets (ADC)

Alotaibi Y, et al. Saudi Med. 2017;38(12), 1173., Kaushal R, et al. BMJ Quality & Safety. 2002;11(3), 261-265.

#FSHP2019Patient Portals and Telemedicine

Patient Portals• Many studies have shown that patient portals improve outcomes of

preventive care and disease awareness and self-management • No evidence that they improve patient safety outcomes

Virtual Visits• Studies have shown that telemedicine is as effective as face to face care with

regard to specific clinical outcomes but there is limited evidence regarding patient safety outcomes

E-Consults• Limited evidence about the efficacy and safety of e-consults, but studies have

shown that e-consults may reduce patient wait times for specialist appointments and opinions

Alotaibi Y, et al. Saudi Med. 2017;38(12), 1173.

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#FSHP2019

Is having the technology enough?

#FSHP2019Technology Implementation

Mortality• Implemented

in 6 days

Mortality• Months of

careful planning

2 Healthcare systems – Same CPOE system


#FSHP2019Technology Design – Medication ReconciliationTechnology Design – Medication Reconciliation

EHR1 EHR 2

Horsky J, et al. J Amer Med Informatics. 2017; 25(5), 465-475.

#FSHP2019

748 Drug Comparisons

EHR 1 EHR 2

Errors made 41 (11% error rate) 12 (3% error rate) P < .0001

Clinicians made multiple Errors

11 (65%) 4 (24%)

Clinicians made accurate reconciliations

6 (35%) 12 (71%)

Technology Design – Medication ReconciliationTechnology Design – Medication Reconciliation

Horsky J, et al. J Amer Med Informatics. 2017; 25(5), 465-475.

#FSHP2019Technology Design – Look Alike Sound AlikeTechnology Design – Look Alike Sound Alike

cycloSERINE vs. cycloSPORine68.7% error rate

Rash-Foanio C, et al. Amer J of Health-System Pharm. 2017; 74(7), 521-527.

#FSHP2019

• Error prevention strategies• Tallman lettering

• Incomplete and conflicting evidence• Provide both brand and generic names• Indication alerts at the time of CPOE

• shown to reduce rates of drug-name errors• Automated detection

• can further enhance identification of drug-name confusion errors

LASA drug pair + Diagnostic claim + Indication

Technology Design – Look Alike Sound AlikeTechnology Design – Look Alike Sound Alike

Rash-Foanio C, et al. Amer J of Health-System Pharm. 2017; 74(7), 521-527.

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#FSHP2019

• Cincinnati Children’s Hospital Medical Center• 55,770 orders

• Amoxicillin - 18,162 (33%)• Amoxicillin-clavulanate - 6,371 (11%)• Clindamycin - 31,237 (56%)

• 77% overdose-related alerts were overridden• 38% of orders alerted as overdoses were determined to

be true overdoses = 62% false positives• 539 actual overdose orders

Technology Design - Overdose

Kirkendall E, et al. J Amer Med Informatics. 2017;24(2), 295-302.

#FSHP2019

Intervention• Amoxicillin

• Single dose maximum from 875 to 2000 mg• Daily dose limit to 4000 mg

• Amoxicillin-clavulanate• Adjust to account for the clavulanate portion of the drug, which

limits both the frequency of administration as well as the amount of amoxicillin that can be prescribed

• Clindamycin• Single dose maximum from 450mg to 900mg

Technology Design Overdose


#FSHP2019Technology Design Overdose

• Decreased alert burden

• Improved response to decision support alerts


#FSHP2019

How do we ensure safe technology?

#FSHP2019

Health IT cannot operate in a vacuum



"Clinical informaticians transform health care by analyzing, designing, implementing, and evaluating information and communication systems that enhance individual and population health outcomes, improve patient care, and strengthen the clinician-patient relationship."

Gardner R, et al. J. Amer Med Informatics. 2009;16(2), 153-157.

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#FSHP2019Key Takeaways•Clinical informatics are key professional in designing, analyzing, implementing, and evaluating technology to improve patient care and minimize errors•Pharmacy informatics professionals are involved in automation supporting every stage of the medication process

#FSHP2019Key Takeaways•How organizations plan, implement and use Health IT plays a role in how well technology prevents medication errors•Health IT does not operate in a vacuum and must be considered within the context of all of the dimensions that affect the development, implementation, and ongoing application of health IT in a complex healthcare system

#FSHP2019

The impact of drug shortages on medication errors

#FSHP2019We can get some but it is a…• Different size• Different strength• Different packaging• Different manufacturer• Not enough!

vs.

The Economics of Drug Shortages. 2018.

#FSHP2019Does a drug shortage impact the risk of a medication error occurring?

Image: http://pathmakers-inc.com/2016/10/31/change-and-the-airplane-analogy/

#FSHP2019What is a drug shortage?FDA• Shortage = Demand >

Supply• Manufacturers are required

by law to report with in 5 business days

ASHP: • Supply issue • Voluntary reporting once

the shortage is verified with manufacturers

Reported shortages – May 10th, 2019

121Reported shortages – May 10th, 2019

230

Drug Shortages: Non-Compliance Notif Req. 2018.

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#FSHP2019Drug Shortages Trends

Federal Efforts to Prevent Drug Shortages. 2018.

#FSHP2019Persistent Drug Shortages

• (10/2007) 5% dextrose/0.45% sodium chloride = longest active shortage

• (02/2012) Lidocaine Hydrochloride injection

• (05/2012) Potassium Chloride injection• (01/2014) Sodium Chloride 0.9%

Injection Bags• (05/2015) Calcium chloride injection• (04/2016) Yellow Fever Vaccine YF-

VAX

Federal Efforts to Prevent Drug Shortages. 2018., Maryann M, et al. Amer J of Health-System Pharm. 2018;75(23), 1903-1908.

#FSHP2019Why are drug shortages occurring?• Shortages of active pharmaceutical

ingredients or raw materials • Manufacturing-quality problems• Production delays and lack of capacity • Poor ordering practices, stockpiling,

hoarding• Unique market for drug products • Manufacturer business decisions

Image: https://goo.gl/images/wYKwYo

Fox E, et al. Amer J Health-System Pharm. 2018;75(21), 1742-1750.

#FSHP2019Vulnerability of the Drug Supply Chain• Hurricane Maria, September 20, 2017• Single manufacturer having ~ 50% of the market share

Image: https://www.nesdis.noaa.gov/content/eye-hurricane-maria-approaches-puerto-rico

News Clip

Image: http://www.pharmexec.com/country-report-puerto-rico?pageID=2

Fox E, et al. Amer J Health-System Pharm. 2018;75(21), 1742-1750., Konrad W, CBS News. 2018.

#FSHP2019Pharmacy Director’s Perception of Drug Shortages

• Survey of 1516 Pharmacy Directors• 193 Respondents

• 1 to 10 med errors – 53% n=97•Greater than 30 med errors – 2.2% n=4

McLaughlin M, et al. J of Managed Care Pharm. 2013;19(9), 783-788.

#FSHP2019Effects on Patient Care

•Alternative therapy85.3%•Delay of therapy 70.8%• Increased patient

monitoring 49.1%• Patient Complaints 38%

Image: https://jerryfahrni.com/2011/12/gpha-reveals-the-ari-to-address-drug-shortages/


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#FSHP2019

Medication Errors and Patient Outcomes


#FSHP2019

“providing safe and appropriate drug therapy has become extremely challenging during shortages and has led to numerous instances of unsafe practices, compromised care, and potentially harmful errors.”

ISMP Survey on Drug Shortages

• 300 respondents• 55% - more than 20 drugs were

involved in shortages during the 6 months prior to the survey

• 71% - unable to provide patients with the recommended drug

• 47% - patients received a less effective drug

• 75% delay in therapy

ISMP; Drug Short Cont Compr Pt Care. 2018.

#FSHP2019

Unsafe practices risk of an error

• Dispensing medications in vials to be administered via IV push -> previously IVPB• Administering IV push medications

rapidly when they should be administered more slowly via a syringe pump• Diluting or reconstituting medications

in saline flush syringes due to shortages of normal saline

• Purchasing drug from the gray market• Compounding products in the

pharmacy and in the operating room that were previously available as premixed solutions or injectables• Providing medications in

concentrations that differ from what was typically used for direct injectables

ISMP Survey on Drug Shortages


#FSHP2019

• DOPamine• 400 mg per 250 mL bags were unavailable• 800 mg per 250 mL administer by error

Image: https://ndclist.com/ndc/0409-7810

Wrong Dose


#FSHP2019Wrong Dose?

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#FSHP2019

• HYDROmorphone• 0.5 mg syringes were unavailable• 1 mg administered by error

Wrong Dose


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#FSHP2019Wrong Drug

National Shortage –

Sodium Bicarbonate

Injectable

Compounding Error

A 4-month-old girl developed

encephalopathy, seizures, and

respiratory compromise as a

result of baclofen toxicity

Lau B, et al. J Ped Pharm & Therap. 2016;21(6), 527-529.

#FSHP2019

• Impact of a remifentanil supply shortage on mechanical ventilation in a tertiary care hospital - A retrospective comparison

Alternative Therapy

Klaus D, et al. Critical Care. 2018;22(1), 267.

#FSHP2019

•Association Between US Norepinephrine Shortage and Mortality Among Patients With Septic Shock

• n= 27,835 patients• Hospital mortality rate not on shortage - 35.9%• Hospital mortality rate on shortage - 39.6%•Absolute Mortality Difference - 3.7 %, (1.5-6)

P=0.03 •Adjusted Odds ratio - 1.15, (1.01-1.3) P=0.03

Alternative Therapy

Vail E, et al. Jama, 2017;317(14), 1433-1442.

#FSHP2019

Big problem, Even bigger impact

Delay of Therapy

Impact

Increased Mortality

Wrong Concentration

Prolonged Hospital Stay

Wrong Dose

Production Delay

Problem

Drug Shortage

Management Difficulties

https://dribbble.com/shots/1104190-Iceberg


• Drug Shortages continue to be at an elevated level• Surveys are the primary source of information available

correlating drug shortages and medication errors• Shortages can contribute to medication errors and

suboptimal patient outcomes• Drug shortages have led to unsafe practices which may

increase risk of error

#FSHP2019

Examine the use of informatics to mitigate drug shortage related medication errors

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#FSHP2019ASHP’s Recommendation on Drug Shortages

Planning for drug shortages• Drug product shortage team • Resource allocation committee • Process for approving alternative therapies • Process for addressing ethical considerations

• Pharmacy• Med staff• Nursing• Admin• Risk• Informatics• Education• Finance


#FSHP2019

Shortage

Operational Assessment

ImplementTherapeutic assessment

Impact Analysis

Communicate

Final plan

ASHP’s Recommendation on Drug Shortages


#FSHP2019Pharmacy Informatics Role


#FSHP2019Point of Ordering

• One off orders• Order Sets

#FSHP2019Point of Ordering

• Therapeutic Substitution functionality

#FSHP2019Point of Ordering• Clinical Decision Support (CDS)


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#FSHP2019Pharmacist Verification


Shortage Alert! - Medication X

Shortage Alert! – Medication X on short supply until further notice (mm/yyyy)

Authorized use ONLY for the following indications: -Indication A-Indication B-Indication C

Otherwise consider the following therapeutic alternates:-Alternate 1-Alternate 2-Alternate 3

#FSHP2019Dispensing/Administration

•Compounding software• Barcodes and BCMA•ADCs• Library/CDS

• eMAR• CDS

• Infusion pumps

#FSHP2019Drug Shortage Web Applications

• Utilizes data for proactive identification of drugs shortages

• Automates assessments and impact

• Creates action plans and tracks

Identify

Assess

Manage

The Drug Shortage App, Logicstream, 2019.




• Queue Management


#FSHP2019Drug Shortage Key Resources

• ASHP Drug Shortage Resource Center: www.ashp.org/shortages

• FDA: www.fda.gov/Drugs/DrugSafety/DrugShortages

• FDA Vaccines, biologics: https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/ucm

• CDC: Current Vaccine Shortages & Delays: https://www.cdc.gov/vaccines/hcp/clinical-resources/shortages.html

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#FSHP2019Key Takeaways• Create a drug shortage team and management process• The drug shortage team should be interdisciplinary and

include informatics• Evaluate the entire medication use process when

determining the drug shortage action plan• Ensure all automated systems supporting the medication

process are updated when a drug shortage is present• Take advantage of technology resources to assist with

managing drug shortages

#FSHP2019

Discuss tools used to evaluate and optimize safe medication processes, including root cause analysis

#FSHP2019

“Develop a proactive, methodical approach to Health IT process improvement that includes assessing patient safety risks. Use the SAFER Guides for EHRs checklists, Failure Mode and Effects Analysis, or a similar method to identify potential system failures before they occur.”

Joint Commission. Safe use of Health IT. Sentinel Event Alert. 2015 Mar 31;54:1-6.

#FSHP2019SAFER Guides

Office of the National Coordinator for Health Information Technology (ONC)• Supports the adoption of health information

technology and the promotion of nationwide health information exchange to improve health care. •ONC is organizationally located within the Office

of the Secretary for the U.S. Department of Health and Human Services (HHS).

SAFER Guides. Health IT.gov, 2018.

#FSHP20199 SAFER Guides


#FSHP2019SAFER Guides Purpose

Make the use of Health IT by clinicians, staff and patients safe and appropriate:• Configure the IT system to ensure the clear display

of accurate patient identity information on all screens and printouts at each step of the clinical workflow

Use Health IT to Monitor and Improve Safety:• Monitor key EHR safety metrics via dashboards

• Help desk use• System uptime and downtime• Alert overrides• Number of EHR-related legal claims• The percentage of prescriptions entered

through CPOE

Make health IT hardware and software safe and free from malfunctions:• Back up data and applications and have

redundant hardware systems• Create, make available and regularly review

health IT downtime and reactivation policies


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#FSHP2019SAFER Guides Checklist


#FSHP2019SAFER Guides Worksheet


#FSHP2019

ECRI Self Assessment Tool for Health IT • Project Planning• Vendor Contract Review• Work Practices and

Redesign • Policies and Procedures • Data Exchange• System Testing• Staff Training and Support• Event Reporting and

Response


#FSHP2019Technology Design Guidelines

ISMP, Resource List; 2019.

#FSHP2019

• Safe Presentation• Drug Names• Doses, Dosing Units, Weights,

Measures, and Directions• Product Selection Menus and

Search Choices• Complete Medication Orders

or Prescriptions

• Electronic System Design Features • Medication Information• Patient Information Associated with

Medication Safety• Other Topics Requiring Further

Investigation and Standards• Human factors• Standard process for combination and

compounded products

ISMP, Guide for Safe Electr Com of Med Info; 2019.

#FSHP2019

• To be effective• Reach their target audience• Be at the right time• Be relevant• Lead the recipients to respond appropriately

• To ensure that a warning is noticed• Capture attention• Appropriately placed so their usefulness is maximized

• Design Factors• Target audience • Source credibility• Clinical importance• Font Size/Style• Letter case• Signal Words• Color

ISMP, Designing Effective Warnings; 2019.

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#FSHP2019

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• Approval and Maintenance• Specific Criteria

• IV/epidural solutions/medications• Electrolytes and compounded

products• Doses that include fractional amounts• Chemotherapy orders• Etc.

• Format• Layout and directions for use• Font style/type• Prompts for patient information• Use of symbols, abbreviations,

dose designations, punctuation

• Content• Development• Content of medication orders

ISMP, Guide for Stand Order Sets; 2010.

#FSHP2019

• Display Important Patient and Drug Information

• Develop Procedures for Accurate ADC Withdrawal and Transfer to the Bedside for Administration

• Provide Staff Education and Competency Validation

• Provide Ideal Environmental Conditions Establish ADC System Security

• Provide Profiled ADCs and Monitor System Overrides

• Maintain Appropriate ADC Configuration and Functionality

• Maintain Optimal ADC Inventory• Implement Safe ADC Stocking and

Return Processes

ISMP, Guide for ADCs; 2019.

#FSHP2019

• Infrastructure• Drug Library• Continuous Quality Improvement • Data• Clinical Workflow• Bi-directional Smart Infusion Pump

Interoperability with the EHR

• Smart Infusion Pump Summit in 2018• Draft status

• Comments were accepted through 5/2/19

ISMP, Guide for Smart Pumps; 2019.

#FSHP2019Technology “Safety” Scores

Leapfrog Hospital Survey Content; 2019.

#FSHP2019Tools to Evaluate Safe Medication Process

• Failure Mode Effect Analysis (FMEA)

• Root Cause Analysis (RCA)

• Aggregate Root Cause Analysis or Common Cause Analysis (CCA)

Proactive

Responsive

Trends

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#FSHP2019

STEPS 1. Select a process to analyze

2. Charter and select team facilitator and members

3. Describe the process

4. Identify what could go wrong during each step of the process

5. Pick which problems to work on eliminating

6. Design and implement changes to reduce or prevent problems

7. Measure the success of process changes

Failure Mode Effect Analysis (FMEA)

CMS, Guide FMEA Analysis.

#FSHP2019

STEPS 1. Identify the event to be investigated and gather preliminary information2. Charter and select team facilitator and members

3. Describe what happened

4. Identify the contributing factors

5. Identify the root causes

6. Design and implement changes to eliminate the root causes

7. Measure the success of changes

Root Cause Analysis (RCA)

CMS, Guidance for Performing RCA.

#FSHP2019Performance Improvement Team• Multidisciplinary team• Number depends on the

scope• Include staff members• Team members should be

familiar with the process• Leadership should facilitate

and sponsor

Sample Team• Pharmacy• Med staff• Nursing• Ancillary Departments• Administration• Risk• Informatics• Education• Finance


#FSHP2019RCA – Identifying the Contributing Factors (step 4)


#FSHP2019RCA – Identifying the Root Cause (step 5) – 5 Why’s technique


#FSHP2019RCA – Criteria to complete

• Potential for significant patient harm•Actual patient harm• Recurrent events• Events with high alert meds•Deviations from safe practices

Larson C, Medication Safety Officer's Handbook. ASHP, 2013

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#FSHP2019Root Cause Analysis (RCA)

Define 1 Define the problem2. Map Process

Measure 3. Gather data4. Cause/Effect Analysis (Seeking Root Cause)

Analyze 5. Verifying root cause with data6. Solutions & Prevention steps development (including cost/benefit)

Implement 7. Pilot of implementation8. Implementation

Control 9. Control/Monitoring Plan (including Process Metrics)10. Lessons Learned

https://www.isixsigma.com/tools-templates/cause-effect/final-solution-root-cause-analysis-template/

#FSHP2019RCA – Process Mapping


#FSHP2019RCA – Cause/Effect Diagram


#FSHP2019RCA – Recommended Solutions


#FSHP2019

Image: https://www.slideshare.net/oeconsulting/root-cause-analysis-by-operational-excellence-consulting

#FSHP2019Aggregate Root Cause Analysis

Neily J, et al. JC Quality and Safety. 2003;29(8), 434-439.

Allows an organization to identify the depth and breadth of system vulnerabilities• Aggregates data• Identifies common causes

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#FSHP2019Aggregate Root Cause AnalysisSTEPS

1. Charter team

2. Flow chart the general steps in the process

3. Use text to describe how the team reviewed the general process in the system

4. Identify resources

5. Determine the focus of the review

6. Determine the root cause or contributing factors

7. Develop root/cause contributing factors using five rules of causation (NCPS triage card)

8. Determine the action to address root cause

9. Write outcome measure for action

10. Present analysis and actions to leadership for concurrence

11. Implement actions an evaluate effectiveness: conduct aggregate root cause analyses on a regular basis

Neily J, et al. JC Quality and Safety. 2003;29(8), 434-439.

#FSHP2019Root Cause Analysis Aggregate Root Cause Analysis

Single case or a few related cases Many or all cases

Event directed (examine a single event or adverse trend of related events)

Time or trend directed (examine all cases in a time period)

Efficient for diagnosing process, protocol and technology causes

Efficient for diagnosing people, leadership and environment care causes.

Investigate cause and effect relationship directly

Infer cause and effect relationship using existing analysis

Lowers rate of harm by 50% every 2 years Lowers the rate of serious patient harm by 50% every 2 years, with 10% the resource allocation as RCA.

McGinley P, et al. Common Cause Analysis. 2010.

#FSHP2019Strength of Error Reduction Strategies

High Impact• Automate• Forcing Functions• Fail-safe

Mechanisms


#FSHP2019Key Takeaways• Develop a proactive, methodical approach to Health IT

process improvement • Tools and guidance are available for safe use of electronic

health records• Consult best practice guidelines when planning, implementing

and using Health IT• Complete self assessments to ensure safe use of Health IT • Conduct thorough event analysis and investigation of

medication errors• Interdisciplinary team involvement is essential when reviewing

safety events• Consider the strength of error reduction strategies when

creating action plans

#FSHP2019

References

Schiff, G. D., Amato, M. G., Eguale, T., Boehne, J. J., Wright, A., Koppel, R., ... & Bates, D. W. (2015). Computerised physician order entry-related medication errors: analysis of reported errors and vulnerability testing of current systems. BMJ Qual Saf, 24(4), 264-271.

Health Information Technology in the United States: Where We Stand, 2008 - FOLIO Home. (n.d.). Retrieved from https://folio.iupui.edu/bitstream/handle/10244/784/hitreport.pdf

Pennsylvania Patient Safety Authority. (n.d.). Medication Errors Attributed to Health Information Technology | Advisory. Retrieved from http://patientsafety.pa.gov/ADVISORIES/Pages/201703_HITmed.aspx

Sulivan, T. The Current State of Health IT and EHR in America. (2019, February 25). Policy and Medicine. Retrieved from https://www.policymed.com/2019/03/the-current-state-of-health-it-and-ehr-in-america.html

Improved Diagnostics & Patient Outcomes. (n.d.). Retrieved from https://www.healthit.gov/topic/health-it-basics/improved-diagnostics-patient-outcomes

Safe use of Health Information Technology. (2015, March 31). Retrieved from https://www.jointcommission.org/sea_issue_54/

ECRI Institute PSO Deep Dive: Health Information Technology. (2012, December). Retrieved from https://www.ecri.org/components/PSOCore/Pages/DeepDive0113_HIT.aspx?source=print

#FSHP2019

References

Carayon, P., Du, S., Brown, R., Cartmill, R., Johnson, M., & Wetterneck, T. B. (2017, January 18). EHR‐related medication errors in two ICUs. Retrieved from https://onlinelibrary.wiley.com/doi/full/10.1002/jhrm.21259

One-third of peds medication errors due to usability issues. (2018). Retrieved from https://login.ezproxy.net.ucf.edu/login?auth=shibb&url=https://search-ebscohost-com.ezproxy.net.ucf.edu/login.aspx?direct=true&db=edsgao&AN=edsgcl.562113116&site=eds-live&scope=site

Gardner, R. M., Overhage, J. M., Steen, E. B., Munger, B. S., Holmes, J. H., Williamson, J. J., ... & AMIA Board of Directors. (2009). Core content for the subspecialty of clinical informatics. Journal of the American Medical Informatics Association, 16(2), 153-157.

Edillo, N. (2011). Drug shortages: A pharmacy informatics perspective. Pharm Purc & Prod, 8(4), 26-29.

Kaushal, R., & Bates, D. W. (2002). Information technology and medication safety: what is the benefit?. BMJ Quality & Safety, 11(3), 261-265.

Alotaibi, Y. K., & Federico, F. (2017). The impact of health information technology on patient safety. Saudi medical journal, 38(12), 1173.

Young, J., Slebodnik, M., & Sands, L. (2010). Bar code technology and medication administration error. Journal of patient safety, 6(2), 115-120.

Horsky, J., Drucker, E. A., & Ramelson, H. Z. (2017). Higher accuracy of complex medication reconciliation through improved design of electronic tools. Journal of the American Medical Informatics Association, 25(5), 465-475.

Rash-Foanio, C., Galanter, W., Bryson, M., Falck, S., Liu, K. L., Schiff, G. D., ... & Lambert, B. L. (2017). Automated detection of look-alike/sound-alike medication errors. American Journal of Health-System Pharmacy, 74(7), 521-527.

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#FSHP2019

References

Kirkendall, E. S., Kouril, M., Dexheimer, J. W., Courter, J. D., Hagedorn, P., Szczesniak, R., ... & Spooner, S. A. (2017). Automated identification of antibiotic overdoses and adverse drug events via analysis of prescribing alerts and medication administration records. Journal of the American Medical Informatics Association, 24(2), 295-302.

Gardner, R. M., Overhage, J. M., Steen, E. B., Munger, B. S., Holmes, J. H., Williamson, J. J., ... & AMIA Board of Directors. (2009). Core content for the subspecialty of clinical informatics. Journal of the American Medical Informatics Association, 16(2), 153-157.

The Economics of Drug Shortages. (2018, November 27). Retrieved from Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions Presentation in Washington Marriott Metro Center, Washington, DC

Pathmakers Inc. (n.d.). Change and the Airplane Analogy. Retrieved from http://pathmakers-inc.com/2016/10/31/change-and-the-airplane-analogy

Center for Drug Evaluation and Research. (n.d.). Drug Shortages: Non-Compliance With Notification Requirement. Retrieved from https://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm403902.htm

Fox, E. R., & McLaughlin, M. M. (2018). ASHP guidelines on managing drug product shortages. American Journal of Health-System Pharmacy, 75(21), 1742-1750.

Federal Efforts to Prevent Drug Shortages. (2018, November 27). Retrieved from Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions Presentation in Washington Marriott Metro Center, Washington, DC

U.S. Food and Drug Administration. (n.d.). FDA Drug Shortages: Current and Resolved Drug Shortages and Discontinuations Reported to FDA. Retrieved November 27, 2018, from https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm

#FSHP2019

References

Maryann, M. A., Erin R, F., Mark S, Z., Jesse M, P., & John N, V. D. A. (2018). Longitudinal trends in US shortages of sterile solutions, 2001–17. American Journal of Health-System Pharmacy, 75(23), 1903-1908.

Konrad, W. (2018, February 12). Why so many medicines are in short supply months after Hurricane Maria. Retrieved from https://www.cbsnews.com/news/why-so-many-medicines-arel-in-short-supply-after-hurricane-maria/

McLaughlin, M., Kotis, D., Thomson, K., Harrison, M., Fennessy, G., Postelnick, M., & Scheetz, M. H. (2013). Effects on patient care caused by drug shortages: a survey. Journal of Managed Care Pharmacy, 19(9), 783-788.

GPhA reveals the ARI to address drug shortages. (2011, December 18). Retrieved from https://jerryfahrni.com/2011/12/gpha-reveals-the-ari-to-address-drug-shortages/

Drug Shortages Continue to Compromise Patient Care. (2018, January 11). Retrieved January 28, 2019, from https://www.ismp.org/resources/drug-shortages-continue-compromise-patient-care

Lau, B., Khazanie, U., Rowe, E., & Fauman, K. (2016). How a drug shortage contributed to a medication error leading to Baclofen toxicity in an infant. The Journal of Pediatric Pharmacology and Therapeutics, 21(6), 527-529.

Klaus, D. A., de Bettignies, A. M., Seemann, R., Krenn, C. G., & Roth, G. A. (2018). Impact of a remifentanil supply shortage on mechanical ventilation in a tertiary care hospital: a retrospective comparison. Critical Care, 22(1), 267.

Vail, E., Gershengorn, H. B., Hua, M., Walkey, A. J., Rubenfeld, G., & Wunsch, H. (2017). Association between US norepinephrine shortage and mortality among patients with septic shock. Jama, 317(14), 1433-1442.

Iceberg. (n.d.). Retrieved from https://dribbble.com/shots/1104190-Iceberg

#FSHP2019

References

The Drug Shortage App – Your Early Warning Drug Shortage Solution. (n.d.). Retrieved January 28, 2019, from https://logic-stream.net/platform/drug-shortage-management-software/

SAFER Guides. (n.d.). Retrieved from https://www.healthit.gov/topic/safety/safer-guides

Resource Library: Institute for Safe Medication Practices. (2019, February 28). Retrieved from https://www.ismp.org/resources?field_resource_type_target_id[33]=33#resources--resources_list

Guidelines for Safe Electronic Communication of Medication Information. (2019). Retrieved from https://www.ismp.org/node/1322

Your attention please... Designing effective warnings. (n.d.). Retrieved from https://www.ismp.org/resources/your-attention-please-designing-effective-warnings-0

Guidelines for Standard Order Sets. (n.d.). (2010). Retrieved from https://www.ismp.org/guidelines/standard-order-sets

Leapfrog Hospital Survey Content. (2019, March 29). Retrieved from http://www.leapfroggroup.org/ratings-reports/leapfrog-hospital-survey-content

Guidance for Performing Failure Mode and Effects Analysis ... (n.d.). Retrieved from https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/QAPI/downloads/GuidanceForFMEA.pdf

Guidance for Performing Root Cause Analysis (RCA) with PIPs. (n.d.). Retrieved from https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/QAPI/downloads/GuidanceforRCA.pdf

#FSHP2019

References

Final Solution Via Root Cause Analysis (with a Template). (2017, June 22). Retrieved from https://www.isixsigma.com/tools-templates/cause-effect/final-solution-root-cause-analysis-template/

Neily, J., Ogrinc, G., Mills, P., Williams, R., Stalhandske, E., Bagian, J., & Weeks, W. B. (2003). Using aggregate root cause analysis to improve patient safety. The Joint Commission Journal on Quality and Safety, 29(8), 434-439.

McGinley, P., Clapper, C., & Crea, K. (2010, May 22). Common Cause Analysis. Retrieved from https://www.psqh.com/analysis/common-cause-analysis/

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Documents

#FSHP2019 Disclosure #FSHP2019...Alotaibi Y, et al. Saudi Med. 2017;38(12), 1173., Kaushal R, et al. BMJ Quality & Safety. 2002;11(3), 261-265. #FSHP2019 Patient Portals and Telemedicine