medication errors - june 2021

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Identifying and Correcting Factors that Contribute to Medication Errors

Dana Saffel, PharmDCPh, BCGP, FASCP

President, CEO

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Disclosure

• Dr. Saffel has no vested interest in 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.

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Objectives

• After attending this presentation, you should be able to: – State the importance of medication reconciliation.– Review strategies for conducting an efficient medication reconciliation.– Give examples of common errors discovered during a medication reconciliation.

– Define and review common types of medication errors and the factors that impact the occurrence of medical errors.

– Examine the impact medication errors have on patient safety and healthcare systems.– Describe root cause analysis and failure modes and effects analysis (FMEA) and their roles in

identifying medication errors.

– Identify error-prone situations and processes to improve patient outcomes.– Review responsibilities for reporting medication errors.

– Recognize the role pharmacists and health providers have on preventing medication errors.– Discuss common strategies used to minimize medication errors.

– Examine strategies for public education on medication errors.

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Medication Errors

Defining the Problem

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Medication Error

• Preventable event that may cause or lead to:– Inappropriate medication use– Patient harm

• Occurs while the medication is in the control of the healthcare professional, patient, or consumer

• Related to:– Professional practice, health care products, procedures & systems

including:• Prescribing• Order communication• Labeling • Packaging• Nomenclature• Compounding

• Dispensing • Distribution• Administration• Education• Monitoring• Use

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Types of Errors

• Latent Error– Hidden problems within

health care systems that contribute to adverse event

• Active Error– Errors occurring at the

point of interface between humans and a complex system

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Where Medication Errors Can Occur

• Ordering– Wrong patient– Wrong diagnosis– Wrong drug– Wrong dose– Wrong route

• Preparing/Dispensing– Wrong drug– Wrong diluent– Wrong concentration– Wrong patient

• Administration– Wrong patient– Wrong drug– Wrong dose– Wrong route– Wrong rate

• Monitoring– Too much or too little– Wrong timing– No/little patient education

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Medication Use Process

• Patient education

/COMMUNICATING

- labeling/packaging

- storage

What’s Missing?Medication Reconciliation

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Medication Errors Occur Throughout the Medication Use Process• Can occur anywhere in the medication use process but are most frequent

during:– Prescribing (39% - 49%)

– Administering (26% - 38%)

• Errors include:– Omission errors – failure to administer an ordered medication dose– Improper dose/quantity errors – any medication dose, strength, or quantity that

differs from that prescribed– Unauthorized drug errors – medication dispensed or administered was not

authorized by the prescriber (includes wrong-drug errors)

Institute of Medicine Report. 2006 9

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Medications Commonly Implicated in Medication Errors

16.2%

4.6%3.1% 2.7% 2.3% 2.2% 2.0% 1.7% 1.7% 1.4%

0.0%2.0%4.0%6.0%8.0%

10.0%12.0%14.0%16.0%18.0%

Insulin

Morphine

Heparin

Hydromorphone

Warfarin

Fentanyl

Potassiu

m Chloride

Vancomycin

Enoxaparin

Di ltiazem

© USP MedMarx Annual Report 2008 p. 393 10

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Medication Errors Frequently Occur During Transitions in Care

Transitions in Care“The movement of patient

between healthcare locations, providers, or different levels of care within the same location

as their needs change…”

National Transitions in Care Coalition. www.ntocc.org. Accessed June 8, 2015 11

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Medication Reconciliation

• A process for obtaining and documenting a complete and accurate list of a patient’s current medicines upon admission and comparing this list to the prescriber’s admission, transfer and/or discharge orders to identify and resolve discrepancies. – This is done to avoid medication errors such as omissions,

duplications, dosing errors, or drug interactions.

• Should be conducted at every transition of care in which new medications are ordered or existing orders rewritten.

Joint Commission Sentinel Event Alert Issue 35, January 25, 200612

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Medication Reconciliation

MedicationOrders

Admission

Discharge

Transfer Within System

Verify Medications Taken at Home (Best Possible

Medication History [BPMH])

Reconcile Home Medications with

Those Ordered on Admission

Reconcile Home Medications with

Those Ordered on Discharge

Reconcile Home Medications with Those

Ordered on Transfer

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Errors Commonly Found During Medication Reconciliation

51%

22%

21%

4% 2%

Incorrect / Missing Dose

Drug Commission

Incorrect / MissingFrequency

Incorrect Drug Drug Omission

Hart C, et al. A program using pharmacy technicians to collect medication histories in the emergency department. P T. 2015;40(1):56-61

• Incorrect or Missing Doses -record lists a different dose than what the patient is being given, or does not list the dose

• Incorrect or Missing Frequency – records lists an incorrect administration time

• Drug Commission - the record lists a drug that the patient is not actually taking

• Drug Omission - error is related to an action not taken

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Society of Hospital Medicine. https://www.hospitalmedicine.org/clinical-topics/medication-reconciliation/. Accessed April 2, 2019. 17

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https://www.hospitalmedicine.org/clinical-topics/medication-reconciliation/

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18Society of Hospital Medicine. https://www.hospitalmedicine.org/clinical-topics/medication-reconciliation/. Accessed April 2, 2019. 18

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Strategies to Reduce the Risk of Medication Errors

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Educate Yourself About Medication Safety

• ISMP Lists, Publications, and Tools• High Alert Medications, Commonly Confused Medications

• Targeted Medication Safety Best Practices for Hospitals

• Self Assessments• Medication Safety Alerts• Quarterly Action Agendas • Guidelines

• FDA Safety Communications

Institute for Safe Medication. www.ismp.org. Accessed August 26, 2016.

www.ismp.org

www.fda.gov/Drugs/DrugSafety

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https://www.hospitalmedicine.org/clinical-topics/medication-reconciliation/

https://www.ismp.org

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www.ismp.org/tools/confuseddrugnames.pdf 24

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www.ismp.org. Accessed April 3, 2019. 25

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http://www.ismp.org/

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https://www.ismp.org/sites/default/files/attachments/2018-10/highAlert2018new-Oct2018-v1.pdf. Accessed April 3, 2019.

High Alert Medications in the Acute Care Setting

* A list of High Alert Medications in the Community setting is also available.

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www.fda.gov/Drugs/DrugSafety 28

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https://www.ismp.org/sites/default/files/attachments/2018-10/highAlert2018new-Oct2018-v1.pdf

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Beers Criteria

• The AGS Beers Criteria® is an explicit list of Potentially Inappropriate Medications (PIMs) that are typically best avoided by older adults in most circumstances or under specific situations, such as in certain diseases or conditions.

• Beers criteria are widely used by:– Clinicians– Educators– Researchers– Healthcare administrators– Regulators

Beers Update Expert Panel. JAGS 00:1–21,2019.

Criteria are intended for use in adults 65 years and older in all ambulatory, acute, and institutionalized settings of care, except for the hospice and palliative care settings.

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Beers Criteria Update 2019

• Intention:– To improve medication selection– Educate clinicians and patients– Reduce adverse drug events– Serve as a tool for evaluating quality of care, cost, and patterns of drug use of older

adults• Content is divided into 6 tables

– Table 1: Designations of Quality of Evidence and Strength of Recommendations– Table 2: Medications that are Potentially Inappropriate in Most OA– Table 3: Drug-Disease or Drug-Syndrome Interactions That May Exacerbate the

Disease or Syndrome– Table 4: Medications to be Used with Caution in OA– Table 5: Clinically Important Drug-Drug Interactions That Should Be Avoided in OA– Table 6 Medications That Should Be Avoided or Have Their Dosage Reduced With

Varying Levels of Kidney Function in OA– Table 7: Drugs with Strong Anticholinergic Properties

1. Beers Update Expert Panel. JAGS 00:1–21,2019. 2. Centers for Medicare and Medicaid Services. State Operations Manual Appendix PP - Guidance to Surveyors for Long Term Care

Facilities. (Rev. 173, 11-22-17).

OA – Older Adults

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How To Begin Using These Resources Tomorrow

• If you participate on P&T committees, include these resources for regular review in committee

• Regularly visit key websites or receive push alerts– Email list serves, social media, podcasts– Maintain awareness of key contemporary safety issues

and publications.• Enlist learners to help regularly review these resources

– Good practice to model – Provides contemporary educational content– Incorporate into syllabus

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How To Engage In Your Organization’s Safety Program

• Actively engage in reporting safety events– If you have ideas for solutions share those

• Encourage others to report• Proactively identify potentially unsafe situations – don’t

wait for an error to occur to report• Ask to attend committee meetings, involvement in process

improvement groups.• Foster the culture of safety by supporting those around you

– Celebrate great catches– Encourage others to report

• Regularly consult and use the resources mentioned today

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Recommendations to Address the Top 10 Medication Errors Reported in 2019

Institute for Safe Medication Practices. ISMP Medication Safety Alert! Acute Care newsletter. https://apha.us/ISMP2019Errors. Accessed July 25, 2020.

1 Selecting the wrong medication after entering the first few letters of the drug name

Assign a minimum # of letter characters to select high-alert medications

2 Daily instead of weekly methotrexate for non-oncologic conditions

3 Errors and hazards due to look-alike labeling of manufacturer’s products

Purchase products from a variety of manufacturers, affix auxiliary labels, utilize barcode scanning

4 Misheard drug orders/recommendations during verbal/telephone communication

Receiver should spell-back drug name and read back entire order and state the dose in simple numbers (e.g., say one, five for fifteen)

5 Unsafe “overrides” with automated dispensing cabinets

Overrides should only be available in emergency situations and drugs available via override should be in limited quantities

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Problem Recommendation

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Recommendations to Address the Top 10 Medication Errors Reported in 2019 (con’t)

Institute for Safe Medication Practices. ISMP Medication Safety Alert! Acute Care newsletter. https://apha.us/ISMP2019Errors. Accessed July 25, 2020.

6 Unsafe practices associated with adult IV push medications

Dispense all IV push medications in a ready-to-administer form.

7 Wrong route (intraspinal injection) errors with tranexamic acid

Store vials on side so labels are clearly visible and store separately to avoid mix-up with normal spinal errors

8 Unsafe labeling of prefilled syringes and infusions by 503b compounders

9 Unsafe use of syringes for vinca alkaloids Use minibags only

10 1,000-fold overdoses with zinc

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Problem Recommendation

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https://apha.us/ISMP2019Errors

https://apha.us/ISMP2019Errors

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Educate the Public About Medication Safety

• 2009 FDA Consumer Update – Six Steps to Avoid Medication Mistakes1. Find out the name of your medication2. Ask questions about how to use the medication3. Know what your medication is for4. Keep all of your healthcare providers informed5. Keep a list of all your medications with you6. Utilize a computerized medication box

https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm096403.htm Accessed April 5, 2019. 37

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Formalized Process for Evaluating Medication Safety

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Root Cause Analysis vs Failure Mode and Effects Analysis

• RCA – Root Cause Analysis– Reactive – process initiated

after an error has already occurred

– Asks key questions:• What process failed?• Human vs Technology?• How can we change moving

forward?– Assumes one primary

cause of the error

• FMEA - Failure Mode and Effects Analysis– Proactive – process initiated

to evaluate potential pitfalls and vulnerabilities of processes

– Asks key questions:• IF this process fails, what is

the outcome? • Is this outcome acceptable?

• Senders JW. Qual Saf Health Care 2004; 13: 248-9.• The Institute of Safe Medication Practices www.ismp.org/tools/FMEA.asp 39

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https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm096403.htm

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Failure Modes and Effects Analysis (FMEA)

• A proactive tool, technique and quality method that enables the identification and prevention of process or product errors before they occur. – Within healthcare, the goal is to avoid adverse events that could potentially

cause harm to patients, families, employees or others in the patient care setting.

• FMEA as a Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) Project Tool– Assessment tool for diagnosis to opportunity– Prevention tool for high level risk – define scope and process being studied– JCAHO Standard Req. L.D. 5.2 (www.jcaho.com)– Preventive tool– Reduce risk of sentinel events– Reduce high risk of medical care system error

• Never too late to start FMEA42

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FMEA Definitions

• Failure Modes - Manners in which a product or process may fail– For Product-related FMEA, the smallest structural element which is a part or

interface• Examples: Dispensing software, computer systems, automated dispensing

machines, packaging systems, bar-code readers– For Process-related FMEA, the smallest structural element which is a

process instruction designated in the design• Examples: Pharmacy layout, prescription flow, staffing patterns, safety checks &

verification process, delivery route,

• Effective Control Measure: A barrier that eliminates or substantially reduces the likelihood of a hazardous event occurring

• Hazard Analysis: The process of collecting and evaluating information on hazards associated with the selected process. – Purpose: to develop a list of hazards that are of such significance that they

are reasonably likely to cause injury or illness if not effectively controlled

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Who Uses FMEA

• Engineers and Designers worldwide in:– Military– Aviation– Nuclear power– Aerospace– Chemical process industries– Automotive industries

• Has been around for over 50 years• Goal has been, and remains today, to prevent accidents from

occurring

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http://www.jcaho.com/

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Rationale for FMEA in Healthcare

• Historically…– Accident prevention has not been a primary focus of hospital, LTC

or community healthcare – Misguided reliance on “faultless” performance by healthcare

professionals– Healthcare systems were not designed to prevent or absorb errors

• Organizations just reactively changed and were not typically proactive

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JCAHO Standard L.D.5.2

• Leaders ensure that an ongoing, proactive program for identifying risks to patient safety and reducing medical/health care errors is defined and implemented.– This effort is undertaken so that processes, functions and services can be

designed or redesigned to prevent healthcare errors.– Proactive identification and management of potential risks to patient

safety have the obvious advantage of preventing adverse occurrences, rather than simply reacting when they occur.

– Proactive approach avoids the barriers created by hindsight bias and fear of disclosure, embarrassment, blame, and punishment that can arise in the wake of an actual event

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JCAHO Standard L.D.5.2

• Identify and prioritize high-risk processes• Select at least one high-risk process, annually• Identify potential “failure modes ”• Identify possible effects for each “failure mode”• Conduct root cause analysis for the most critical effects• Redesign the process to minimize the risk of that failure mode or to

protect patients from its effects• Test and implement the redesigned process• Measure of effectiveness of redesigned process• Implement a strategy to maintain the effectiveness of the redesigned

process over time

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5-Step FMEA Process

1. Define the Topic– Define the Scope of the FMEA along with a clear definition of the process to be studied.

2. Assemble the Team– Multidisciplinary team of 6 to 10 individuals who are Subject Matter Expert(s) plus advisor

3. Graphically Describe the Processa) Develop and Verify the Flow Diagram (this is a process vs. chronological diagram)

b) Consecutively number each process step identified in the process flow diagram.c) If the process is complex identify the area of the process to focus on (manageable bite)d) Identify all sub processes under each block of this flow diagram. Consecutively letter these sub-

steps.e) Create a flow diagram composed of the sub processes.

4. Conduct the Hazard Analysisa) List Failure Modes

b) Determine Severity & Probabilityc) List all Failure Mode Causes

5. Identify Actions and Outcome Measuresa) Describe an action for each failure mode cause that will eliminate or controlb) Identify outcome measures that will be used to analyze and test the re-designed

process

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Basic FMEA Process for Pharmacy

Step 3 a-e

Step 4a Step 4b Step 4c Step 5a Step 5b

DESCRIBE THE PROCESSDetermine how medication

will be procured, packaged, dispensed,

delivered and used (from purchase to administration)

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Steps 3a-e


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IDENTIFY POTENTIAL FAILURE MODES throughout the entirety

of the defined processcomputer systems, dispensing software, physical layout & lighting, workflow, staffing

delivery method

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Steps 3a-e


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DETERMINE THE SEVERITY OF FAILURE AND PROBABILITY that

current or developed processes would minimize

potential for failure and/or harm






delivery method

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Steps3a-3


LIST ALL FAILURE MODE CAUSES

use Root Cause Analysis or similar brain

storming techniques

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delivery method

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Steps3a-e

Step 4a Step 4b Step 4d Step 5b Step 5c

DESCRIBE AN ACTION for each failure mode

cause that will eliminate or control

more bar codes, redesign workflow, more staff

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storming techniques



delivery method

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Steps3a-e

Step 4a Step 4b Step 4d Step 5b Step 5c

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storming techniques

IDENTIFY OUTCOME MEASURE(S)

that will be used to analyze and test the re-designed process


of the defined processcomputer systems, dispensing software, physical layout & lighting, workflow, staffing,

delivery method

DESCRIBE AN ACTION for each failure mode

cause that will eliminate or control

more bar codes, redesign workflow, more staff

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Let’s Try It Together

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Step 3 Example: Getting to Work

Wake up Get Dressed

Start the Car

Drive to Work

Park the Car

Walk into Work

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1 2 3 4 5 6

3a - Create flow diagram3b – Consecutively number each step3c – If process is complex, choose an area to focus on3d – If necessary, list sub-process steps

1a Hit snooze on alarm

1b Again, hit snooze on alarm

1c Get out of bed

1d Find fuzzy slippers

2a Get coffee

2b Take shower

2c Find clean clothes

2d Find shoes

3a Find keys

3b Find wallet

3c Look for bag

3d Look for coffee & bagel

4a Coffee in cupholder

4b Bagel on seat

4c Listen to traffic report

4d Choose route

5a Notice and take exit

5b Negotiate turn

5c Find spot

5d Turn off car

6a Collect bag, coffee and bagel

6b Close and lock car door

6c Begin walking

6d Return for keys

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Step 4a Example: Determine Failure Modes

1aHit snooze on

alarm

1bAgain, hit snooze on

alarm

1cGet out of bed

1dFind fuzzy slippers

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Failure Modes

1. Turn off alarm2. Unplug alarm 3. Break alarm clock

Wake-up Sub-Process Flow Diagram

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FMEA Form

Hit Snooze Button (1a)

Step 4 – Hazard Analysis Step 5 - Identify Actions or Rationale for Stopping

Failure Mode:First evaluate mode before determining potential causes Potential

Causes

Scoring Decision Tree Analysis

Action Type

ControlAccept

Eliminate

Actions or Rationale

for Stopping

Outcome Measure

Per

son

Res

pons

ible

Man

agem

ent

Con

curr

ence

Sev

erity

Pro

babi

lity

Haz

ard

Sco

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Sin

gle

Wea

knes

s P

oint

?

Exi

stin

g C

ontro

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easu

re?

Det

ecta

bilit

y?

Pro

ceed

?

1a(1) Turn off alarm

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Step 4b – Hazard Analysis

Prob

abili

ty

SeverityCatastrophic Major Moderate Minor

Frequent 16 12 8 4

Occasionally 12 9 6 3

Uncommon 8 6 4 2

Remote 4 3 3 1

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Probability Rating• Frequent - Likely to occur

immediately or w ithin a short period (may happen several times in one year)

• Occasional - Probably w ill occur (may happen several times in 1 to 2 years)

• Uncom m on - Possible to occur (may happen sometime in 2 to 5 years)

• Rem ote - Unlikely to occur (may happen sometime in 5 to 30 years

Death or major permanent

loss of function,

suicide, rape, surgery on

wrong patient or part

Permanent lessening of

body function, disfigurement,

surgical intervention

required

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FMEA Decision Tree Analysis

Does this hazard involve a sufficient likelihood of occurrence and severity to warrant that it be

controlled? (e.g. Hazard Score >/= 8)

CRITICALITYIs this a single point weakness in the process?

(e.g. failure will result in system failure)

Does an EFFECTIVE CONTROL MEASURE exist for the identified hazard?

DETECTABILTYIs the hazard so obvious and readily apparent that

a control measure is not warranted?

PROCEEDTo FMEA Step 5

YES

YES

NO

NO

NO

STOP

NO

YES

YES

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FMEA Form (Step 4a & 4b)



Failure Mode:First evaluate mode before determining potential causes

Potential Causes


Action Type

ControlAcceptE liminate

Actions or

Rationale for

Stopping

Outcome Measure

Per

son

Res

pons

ible

Man

agem

ent C

oncu

rren

ce

Sev

erity

Pro

babi

lity

Haz

ard

Sco

re

Sin

gle

Wea

knes

s P

oint

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Exi

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Det

ecta

bilit

y?

Pro

ceed

?


Maj

or

Occ

assi

onal

9 N N Y

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FMEA Form (Step 5)



Failure Mode:First evaluate mode before determining potential causes

Potential Causes


Action Type

ControlAcceptE liminate

Actions or

Rationale for

Stopping

Outcome Measure

Per

son

Res

pons

ible

Man

agem

ent C

oncu

rren

ce

Sev

erity

Pro

babi

lity

Haz

ard

Sco

re

Sin

gle

Wea

knes

s P

oint

?

Exi

stin

g C

ontro

l M

easu

re?

Det

ecta

bilit

y?

Pro

ceed

?


Maj

or

Occ

assi

onal

9 N N Y

1a (1)a

Missed snoozebutton M

ajor

Occ

assi

onal

9 N N Y Eliminate Purchase new clock

Purchase by certain dateMM/DD/YR

YOU YOU

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Putting FMEA Into Practice

Table Team Activity

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Step 1 – Select the Process To Be Examined

• Define the scope (Be specific and include a clear definition of the process or product to be studied). This FMEA is focused on:

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Step 2 – Assemble the Team

FMEA Number_____________ Date Started ______________ Date Completed_____________ Team Members 1.2. 3. 4. 5. 6. Team Leader ____________________________________ Are all affected areas represented? YES / NO Are different levels and types of knowledge represented on the team? YES / NO Who will take minutes and maintain records?___________________________

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Step 3 – Map the Process

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Step 4 – Hazard Analysis and Step 5 – Identify Actions

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PROCESS STEP (or Sub-Step) _________________________


Failure Mode:First evaluate mode before determining potential causes Potential

Causes


Action Type

ControlAccept

Eliminate

Actions or Rationale

for Stopping

Outcome Measure

Per

son

Res

pons

ible

Man

agem

ent

Con

curr

ence

Sev

erity

Pro

babi

lity

Haz

ard

Sco

re

Sin

gle

Wea

knes

s P

oint

?

Exi

stin

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ontro

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easu

re?

Det

ecta

bilit

y?

Pro

ceed

?

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Let’s Wrap it Up J

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Medication Safety Resources

• Institute for Safe Medication Practice (www.ismp.org) – Look-alike Sound-alike medications– Newsletters– High-Alert Medications

• The Joint Commission (www.Jointcommission.org)– Medication Management Standards– Sentinel Event Alerts

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Medication Safety Resources

• Pharmacy List-Servers– American Society of Health Systems Pharmacists (ASHP)– American College of Clinical Pharmacy (ACCP)– University Health-System Consortium (UHC)

• Your own Facility Policies and Procedures– Medication-specific protocols– Overview of processes from procurement to administration

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Take-Home Points

• Most medication errors are multifactorial, involving more than one process and more than one line of responsibility.

• Failure Modes and Effects Analysis (FMEA) can assist in designing systems and processes that prevent or reduce the risk of error.

• Medication errors, if they occur, should also be analyzed from a systems perspective by members of an interdisciplinary team and the underlying process should undergo full FMEA

• Pharmacists are uniquely suited to provide oversight to the medication use process.

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Thank You!

Medication safety is everyone’s

responsibility!

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medication errors - june 2021

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