Transcript Chasing Zebras: A Case Study

Medication Safety:
An Ounce of Prevention
H. Gwen Bartlett, BS Pharmacy, PharmD, BCPS, BCCCP
Assistant Professor of Pharmacy Practice
Cardiology Specialty
Husson University
Bangor, ME
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Disclosure
I have no relevant financial or non-financial
conflicts of interest to disclose.
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“Dying from a disease is sometimes
unavoidable; dying from a medicine
is unacceptable.”
• Lepakhin V. Geneva 2005
3
Learning Objectives




Distinguish between a preventable verses a nonpreventable adverse drug event.
Describe the role that a latent failure (blunt end) may
play in an active failure (sharp end) with respect to
medication errors.
Evaluate how the recent national initiatives focused on
improving medication safety for high-risk patient
populations might impact your practice.
Summarize the potential impact of low health literacy
on medication safety.
4
Patients (our customers, friends,
family and….ourselves) Are At Risk!



Between 44,000 and 98,000
deaths are attributed to medical
errors in U.S. hospitals
7,000 deaths annually
attributable to medication
errors
Serious and PREVENTABLE
errors are occurring
Kohn KT, Corrigan JM, Donaldson MS, To Err Is Human: Building a Safer Health System. National Academies
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Press; Washington, DC 1999; http://www.nap.edu/openbook.php?record_id=9728 Accessed 9/1/15
Why is Medication Safety Important
to Pharmacy Practice?



2014 Pharmacy Technician
Certification Board → 1 hr CEU in
Patient Safety for recertification
Since 2006, included in Rx school
standards
9 states currently require Patient
Safety CEU for annual pharmacist
relicensure (i.e., Delaware, District of
Columbia, Florida, Iowa, Maryland,
New Mexico, Pennsylvania, New
York, and Ohio effective 1/15/16)
http://www.nap.edu/catalog/10681/health-professions-education-a-bridge-to-quality
https://www.ptcb.org/about-ptcb/news-room/news-landing/2014/04/21/ptcb-adds-new-patient-safety-cerequirement-for-recertification#.Ve1k9hHBzRY Accessed 9/1/15
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Medication-Related Errors:
Consistently Rank at the Top of Medical Errors

Reiterated significance of
medication errors


1 medication error per patient
per day of hospitalization
Naming (look-alike, soundalike), labeling, packaging
account for:
 33% medication errors
 30% fatalities
Aspden P, et al; Preventing Medication Errors; Washington DC; National Academies Press; Washington, DC
2007 http://www.nap.edu/catalog/11623/preventing-medication-errors-quality-chasm-series Accessed 9/1/15
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The Numbers Speak


3 billion prescriptions written annually
In 2006, 82% of U.S. adults reported taking at least
1 medication


29% take 5 or more
Over age 65:



57-59% take 4-9 and
17-19% take 10 or more
1.5 million preventable ADEs/yr → cost ~ $4 billion
National Action Plan for Adverse Drug Event Prevention U.S. Department of Health and Human Services,
Office of Disease Prevention and Health Promotion. (2014); Washington, DC.
http://health.gov/hcq/pdfs/ADE-Action-Plan-508c.pdf Accessed 9/1/2015
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Medication Error
“Any preventable event that may cause or lead to
inappropriate medication use or patient harm while
the medication is in the control of a health care
professional, patient, or consumer……..”
National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP);
http://www.nccmerp.org/about-medication-errors Accessed 9/5/15
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Medication Use Process:
Error at Any Step = Potential for Harm
Prescribing
Dispensing
Transcription
Administration
Selection/Storage
Prescribing/Transcribing
Preparation
38%
39%
Dispensing
Administering/Adherence
11%
12%
Monitoring
Leape LL, et al; Systems Analysis of Adverse Drug Events; JAMA; 1995;274; 35-43
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Relationship Between ADE’s and
Medication Errors
Patient experiences
undesired side effect
Errors that have the
potential to cause
patient harm
Errors that do
NOT have the
potential to
cause patient
harm
Note: ** Includes
errors of omission!
Preventable
Medication
Errors
Adverse
Drug
Event
Patient does not
respond as
expected to the
drug
New allergic
response
Preventable medication errors
that result in patient harm
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Close Calls Are Wake Up Calls!

Near misses are preventable errors that don’t make
it to the patient

Safety nets worked

Near misses should be reported (but seldom are).
Those with potential for severe outcomes should be
examined: root cause analysis

Learn from other’s mistakes → teach others from them
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Preventable or Non-preventable or
Near Miss?
1.
Hyperkalemia (serum K+ 5.2 mEq/L) on routine follow-up basic
metabolic panel in a 48 y.o. female with an 8 year history of Type II
DM initiated on lisinopril 10 mg PO daily 2 weeks ago following a
second screening albuminuria level greater than 300 mg/day.
2.
Trimethoprim/sulfamethoxazole ordered for presumed uncomplicated
UTI in a 54 y.o. female, admitted for dofetilide loading, which
precipitated a pharmacist contacting the prescriber to recommend a
change in therapy to nitrofurantoin 100 mg PO BID.
3.
A left popliteal proximal DVT identified during bilateral lower extremity
ultrasound in a 38 y.o. male with idiopathic dilated cardiomyopathy
admitted for an acute exacerbation of heart failure 5 days ago and
placed on bed rest without DVT prophylaxis.
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Learning Objectives




Distinguish between a preventable verses a nonpreventable adverse drug event.
Describe the role that a latent failure (blunt end) may
play in an active failure (sharp end) with respect to
medication errors.
Evaluate how the recent national initiatives focused on
improving medication safety for high-risk patient
populations might impact your practice.
Summarize the potential impact of low health literacy
on medication safety.
14
Active Failure
I didn’t know that…..
Oh, I thought that…..
Knowledge
OOPS!!!
Performance
Behavior
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Aronson JK; Medication Errors: Definitions and Classification; Br J Clin Pharmacol; June 2009; 67(6):599-604
Each Layer Has the Potential to
Avert or Contribute to Error!
Reason, J; Human Error; 1990; Cambridge: University Press
http://patientsafetyed.duhs.duke.edu/module_e/swiss_cheese.html Accessed 9/6/15
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Active or Latent Failure?
Phlebotomist fails to identify the patient by 2 distinct
identifiers and obtains an INR on the wrong patient.

Active (error occurred): mistake → skill-based error or
slip (i.e., oops); rule-based (i.e., double identify good
rule, but not applied; or risky business?
Per-diem pharmacist filling in for an independent Rx in
rural Maine notes the shelves are organized by trade
name. Brintellix and Brilinta are stored next to each
other on the shelf.

Latent (error waiting to occur): FDA advisory re: name
confusion between vortioxetine and ticagrelor 7/30/15
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U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion.
(2014). National Action Plan for Adverse Drug Event Prevention. Washington, DC: Author.
http://health.gov/hcq/pdfs/ADE-Action-Plan-508c.pdf Accessed 9/11/15
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Following assessment of the patient, development
and completion of a formal SOAP note, and
determination of an appropriate dosing regimen,
the pharmacist forgets to enter the order for
vancomycin into the computer which goes
unrecognized until the following day. This
medication error would BEST be characterized as:
A. An example or an active failure; action-based error
B. An example of a latent failure; ineffective training
C. An example of an active failure; rule-based error
D. An example of a latent failure; uncertainty in role or
responsibility
ANSWER A: With the circumstances given, there is not suggestion of any deficiency in
training, environment, or equipment etc which are often contributors to latent failure.
Therefore, both B and D would be incorrect. So, since is an active error, one must
characterize whether there were likely rules in place for this procedure or simply an
intended action that wasn’t carried out (i.e., slip). The slip or lapse seems to fit this
scenario best.
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Error is the inevitable downside
of having a brain!
WHO 2010
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Learning Objectives




Distinguish between a preventable verses a nonpreventable adverse drug event.
Describe the role that a latent failure (blunt end) may
play in an active failure (sharp end) with respect to
medication errors.
Evaluate how the recent national initiatives focused on
improving medication safety for high-risk patient
populations might impact your practice.
Summarize the potential impact of low health literacy
on medication safety.
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“Patients’ best source (and often ONLY source) of
information regarding the medications they have been
prescribed is on the prescription container label.”
“Lack of universal standards for labeling on
dispensed prescription containers is a root cause for
patient misunderstanding, nonadherence, and
medication errors.”
USP 36: General Chapter <17>: Prescription Container Labeling;
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WE NEED TO LOSE THE SPOON!!
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White Paper & Policy Statement
mL
Pediatrics; 135(4); April 2015
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All Oral Liquid Dosing Devices
Should Use METRIC dosing only!

National Alert Network (NAN)

Anticipated USP <17> update

Graduations “shall be legible and indelible, and the
associated volume markings shall be in metric units and
limited to a single measurement scale that corresponds with
the dose instructions on the prescription container label”
http://www.ismp.org/NAN/files/NAN-20150630.pdf
Accessed 9/7/15
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WHAT’S IN A LABEL?
(HUMAN/PATIENT-CENTERED DESIGN)
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The Essential Elements of A Drug
Facts Label!
http://www.fda.gov/Drugs/ResourcesForYou/ucm133411.htm
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USP <17> Official Standard
Universal Approach to Prescription Labeling




Organize → reflect how patients seek out and
understand; Minimize!
May 1, 2013
Emphasize instructions
Simplify language → clear, concise, familiar
Explicit instruction (not implicit or implied)



Separate dose from timing
2 → not two
Avoid numeracy (no HOURLY times)
USP General Chapter <17>: Prescription Container Labeling http://www.usp.org/uspnf/key-issues/usp-nf-general-chapter-prescription-container-labeling/download-usp-nfgeneral-chapter-prescription-container Accessed 9/1/2015
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USP <17> Standardized Label:
Promoting Patient Understanding




Include purpose for use → always ask preference
Limit auxiliary information
Address limited English proficiency
Improve readability





high-contrast print
simple, uncondensed font
sentence case
large font size
horizontal text only
USP General Chapter <17>: Prescription Container Labeling http://www.usp.org/usp-nf/keyissues/usp-nf-general-chapter-prescription-container-labeling/download-usp-nf-general-chapterprescription-container Accessed 9/1/2015
The Problem
Take one tablet orally once every day.
Take 1 tablet by mouth every morning.
Take one tablet for cholesterol.
Dozens of Different Ways to Say
“Take 1 tablet a day.”
Take 1 tablet 1 time daily.
Take ONE (1) tablet by mouth daily.
Take one pill by mouth at bedtime.
Take 1 tablet one time each day.
Take one tablet by mouth once daily.
Take one pill by mouth once each day.
Bailey, SC et al; Comparison or Handwritten and Electronically Generated Prescription Drug
Instructions; Ann Pharmacother; Jan 2009; 43(1):151-2
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A New Design (PCL):
User Friendly Interface
Sahm et al; What’s in a Label? An exploratory study of patient-centered drug instructions; Eur J Clin
Pharmacol; Nov 30, 2011 http://www.bumc.bu.edu/healthliteracyconference/files/2009/10/wolf.pdf
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THE PROBLEM WITH “APAP”
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ISMP Unsafe Drug Name Abbreviations
List Updated to Include:

APAP (added in 2012)


Not recognized as acetaminophen
NoAC (added in 2015)

No anticoagulant
https://www.ismp.org/tools/errorproneabbreviations.pdf
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2014 Poison Center Data Snapshot
https://aapcc.s3.amazonaws.com/pdfs/annual_reports/2014_Annual_Report_
Snapshot_FINAL.pdf
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The Vast Majority of Exposures
are UNintentional!
https://aapcc.s3.amazonaws.com/pdfs/annual_reports/2014_Annual_Report_
Snapshot_FINAL.pdf
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Minimizing Unintentional Acute
Liver Failure From Acetaminophen



August 2011 → NCPDP White Paper re:
acetaminophen: completely spell out all active
ingredients
January 2013 → Standard concomitant use + liver
warning label on Rx in harmony w/ OTC
 Prioritized to print in top 3 warning labels
January 2014 → FDA mandated manufacturer
compliance with 325 mg limit per tab/cap for all
prescription products
 Does NOT apply to OTC
NCPDP Recommendations for Improved Prescription Container Labels for Medicines Containing Acetaminophen;
January 2013 1.1; http://ncpdp.org/NCPDP/media/pdf/wp/NCPDPacetaminophen WPv1.1_31jan2013.pdf 37
Accessed 09/5/2015
Movement In the Right Direction
re: OTC Acetaminophen!

August 2015, FDA issued guidance document for OTC
oral liquid products containing acetaminophen
 Does NOT establish legally enforceable responsibilities

Key recommendations labeled for use in < 12 y.o.:
 Single-ingredient: “160 mg/5 mL” or “160 mg per 5 mL”
 Images of child should be appropriately representative
 Dosing directions only in mL
 Product package should include dosage delivery device
 Dosage delivery device calibrated units expressed as mL
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guida38
nces/UCM417568.pdf
Upcoming Challenges



2014 U.S. Access Board
Best Practices →
patient-centered labeling
for visually impaired
Market 21 million blind
and millions more with
low vision
Label → affixed to
container, not folded,
and not obscure original
typed label; font > 18
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http://www.accessamed.com/downloads/AccessaMed%20White%20Paper%202013.pdf
Learning Objectives




Distinguish between a preventable verses a nonpreventable adverse drug event.
Describe the role that a latent failure (blunt end) may
play in an active failure (sharp end) with respect to
medication errors.
Evaluate how the recent national initiatives focused on
improving medication safety for high-risk patient
populations might impact your practice.
Summarize the potential impact of low health literacy
on medication safety.
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Scope of Low Health Literacy

90 million Americans may be at risk





1 out of 5 reads at the 5th grade level or below
Average American reads at the 8th to 9th grade level
Annual health care costs are 4 times higher with
low literacy skills
Only 25-50% of all patients take medications as
directed
Medication misuse has resulted in > 1 million ADE’s
annually in the U.S.
http://c.ymcdn.com/sites/www.npsf.org/resource/collection/9220B314-9666-40DA-89DA9F46357530F1/AskMe3_Stats_English.pdf
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The Impact of Low Health Literacy

Served to raise awareness of, at
the time, an underappreciated
challenge

2006 formed the Roundtable on
Health Literacy

Lack of health literacy costs U.S.
> $100 BILLION annually
Neilson-Bohlman L, Panzer A, Kindig D; Health Literacy: A Prescription to End Confusion; National
Academies Press; Washington, DC, 2004; https://iom.nationalacademies.org/ Reports/2004/HealthLiteracy-A-Prescription-to-End-Confusion.aspx Accessed 9/7/15
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What does Health Literacy Mean?

“Degree to which people can obtain, process, and
understand the basic health information and
services they need to make appropriate health
decisions.”
http://www.healtheddesign.com/blog/2015/2/3/healthliteracy-and-medication-safety
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Health Literacy
Universal Precautions!

Structure your care as if EVERY patient/customer
may have limited health literacy

It isn’t enough to simply hand individuals easier to
read information
Brega AG, et al; AHRQ Health Literacy Universal Precautions Toolkit, Second Edition. AHRQ
Publication No. 15-0023-EF) Rockville, MD. 2015; http://www.ahrq.gov/professionals/qualitypatient-safety/quality-resources/tools/literacy-toolkit/index.html
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Teach-back: A Powerful Tool
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Conclusion

Be proactive in identifying opportunities enhanced
patient/medication safety, and thus quality of care

Pay close attention, but report when it fails → share
what you’ve learned.

Practice health literacy universal precautions unless
proven otherwise.
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Medication Safety:
An Ounce of Prevention
30 mL
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POST-ASSESSMENT QUESTIONS
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Question # 1: Which of the following case
vignettes BEST represents a preventable
adverse drug event?
A.
B.
C.
D.
A 68 y.o. male discharged 3 months earlier following a new stroke
complicated by seizure. Patient was discharged on carbamazepine and
now presents with acute mental status changes presumed to be second to
serum Na+ 119 mEq/L.
A 53 y.o. female is admitted to ICU with severe sepsis. Her husband
shares the only past medical history is his wife suffered a MVA 6 years
earlier requiring a splenectomy. A review of her hospital and clinic EHR is
devoid of any record of vaccinations other than influenza.
A 27 y.o. male intubated trauma patient placed on fentanyl and propofol for
analgesia and sedation. On day 2 of ICU stay, serum triglycerides were
520 mg/dL. The propofol is discontinued and a midazolam drip is started.
A 64 y.o. male with no known allergies has advanced Stage 4 CKD. His
progressive anemia is so severe that the decision is made to convert from
oral to parenteral iron. He develops an anaphylactic reaction with the first
test dose of InFed.
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Question #2: Which of the following would
be most likely to optimize patient safety by
identifying sources of latent failures?
A.
Lack of independent double checks prior to dispensing
B.
Incomplete patient information such as comorbidities
C.
Excess or insignificant computer warnings or alerts
D.
Open supportive environment for discussing errors/near
misses
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Question #3: The National Council for
Prescription Drug Products (NCPDP)
recently published a patient safety white
paper that provides best practice guidance
to mitigate patient risk associated with
dosing of liquid medications. According to
this document, what is the preferred unit of
measure for all oral liquid formulations?
A.
B.
C.
D.
drops
tsp
mL
cc
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POST ASSESSMENT KEY
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Post Assessment Question #1: Answer B is correct. Of the options listed, this
is the only example of an adverse drug event which was preventable. Note a
preventable adverse drug event can involve an error of omission (i.e., an
untreated indication). According to the 2016 Adult Immunization schedule this
patient should be vaccinated for encapsulated organisms which include:
 Pneumococcal
 13-valent pneumococcal conjugate vaccine (PCV13); 23-valent
pneumococcal polysaccharide vaccine (PPSV23) at least 8 weeks later.
REPEAT 23-valent pneumococcal polysaccharide (PPSV23) in 5 years.
Revaccinate 23-valent pneumococcal polysaccharide (PPSV23) at age 65
 Meningococcal
 Serogroup A, C, W, and Y meningococcal vaccine (MenACWY); REPEAT
MenACWY at least 8 week later. Revaccinate MenACWY every 5 years
 Haemophilus influenza type B
Hyponatremia, although a known side effect of carbamazepine, is not predictable
and hence not preventable. Likewise, propofol is mixed in 1% lipid emulsion and
is associated with hypertriglyceridemia. Anaphylactic reactions to parenteral iron
products are very rare. There are some products which large-scale observational
studies suggest may be associated with less frequency than dextran containing
formulations (i.e., iron sucrose). However, none of the above were prescribed,
inappropriately, forseeable, or preventable. Answers A, C, and D are not correct.
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Post Assessment Question #2: Answer D is
correct. Answers A, B, and C are all examples of
latent failures which can predispose active failure or
the “sharp end”. Latent failures, also referred to as
contributing factors, are weaknesses in structure
that support medication processes. They are often
subtle and “worked around” or tolerated until a slip
or individual failure exposes the failure which often
occur in combination (i.e., swiss cheese). An open
supportive environment allowing discussion of
errors and near misses is one of the best ways to
identify the latent failure and correct it.
Post Assessment Question # 3: Answer C is
correct. In March, 2014, NCPDP published a white
paper recommending best practice to decrease
dosing errors associated with oral liquid medications.
Among the recommendations is the standard unit of
measure of mL. In addition, it is recommended to
AVOID cc, ml, or ML and the term milliliters spelled
out. The Institute of Safe Medication Practice (ISMP)
suggests a proposed change to United States
Pharmacopeia (USP) General Chapter <17>:
Prescription Container Labeling which will also
endorse provision of a dosing device to accompany
oral liquid products that are labeled in metric units
ONLY! As such, answers A, B, and D are incorrect.
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