Improving Patient Safety by Reducing Medication Errors

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Improving Patient Safetyby Reducing Medication
Errors

• Brian L. Strom, M.D., M.P.H.
• Professor of Biostatistics and Epidemiology
• Center for Clinical Epidemiology and
  Biostatistics
• University of Pennsylvania School of Medicine

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Improving Patient Safetyby Reducing Medication
Errors

• Background
• Patient Safety
• Institutional Context
• Theme
• Overall Approach
• Four Specific Projects

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Improving Patient Safetyby Reducing Medication
Errors

• Background
• Patient Safety
• Institutional Context
• Theme
• Overall Approach
• Four Specific Projects

4
Background

• Patient Safety
• Institutional Context

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Background Patient Safety

• Patient Safety and Medical Errors
• The Culture of Medical Practice, Root Causes, and
  Predisposing Factors
• Risks Associated With the Use of Drugs
• Medication Errors
• The Elderly at Risk
• Drug Class of Risk
• Determinants of Physician Prescribing Errors
• Patient Adherence and Medication Errors
• Technological and Other Innovations

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Patient Safety and Medical Errors

• Iatrogenic injuries up to 180,000 US deaths each
  year, and disability or prolongation of hospital
  stay in another 1.3 million
• Medical errors 44,000-98,000 annual deaths, more
  than MVA, breast cancer, or HIV
• Medical errors annual costs of 17-29 billion

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Definitions

• Patient safety freedom from accidental injury
  ensuring patient safety involves the
  establishment of operational systems and
  processes that minimize the likelihood of errors
  and maximize the likelihood of intercepting them
  when they occur
• Adverse event an injury resulting from a
  medical intervention
• An error failure of a planned action to be
  completed as intended or use of a wrong plan to
  achieve an aim the accumulation of errors
  results in accidents

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Philosophy To Err is Human Building a Safer
Health System

• Even apparently single events or errors are due
  most often to the convergence of multiple
  contributing factors
• Preventing errors and improving safety for
  patients requires a systems approach in order to
  modify the conditions that contribute to errors
• The problem is not bad people the problem is
  that the system needs to be made safer.
• Concern is not about substandard or negligent
  care, but rather, errors made by even the best
  trained, brightest, and most competent
  professional health caregivers and/or patients

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The Culture of Medical Practice,Root Causes, and
Predisposing Factors

• Historically
• Perfectionism, stoicism, and an expectation that
  practitioners should function without error
• Errors considered a failure of character, and
  admitted or discussed rarely
• JCAHO concept of root cause faulted for implying
  that a single factor can be identified as cause

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The Culture of Medical Practice,Root Causes, and
Predisposing Factors

• Instead, a systems approach
• Examines interdependent elements interacting to
  achieve a common aim, thus focuses on both human
  and non-human elements
• Investigates the interrelationships between
  humans, the tools they use, and their environment

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Risks Associated With the Use of Drugs

• Adverse drug events are the most common
  iatrogenic causes of patient injuries

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Risks Associated With the Use of Drugs

• Type A reactions are the result of an exaggerated
  but otherwise usual pharmacological effect of the
  drug
• dose-related, predictable, less serious, common
• patients receiving more drug than customarily
  required, a conventional amount but metabolize or
  excrete the drug unusually slowly, on an
  additional drug which interferes with excretion
  or metabolism, or are overly sensitive to the
  drug
• In principle, these factors all are predictable
  and thereby potentially preventable
• These complications could all be considered
  medication errors

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Risks Associated With the Use of Drugs

• Type B reactions are aberrant effects
• Uncommon, not related to dose, potentially more
  serious, but unpredictable
• May be due to hypersensitivity reactions or
  immunologic reactions, or some other
  idiosyncratic reaction to the drug, either due to
  some inherited susceptibility or some other
  factor
• Most difficult to predict
• Yet, historically have represented the major
  focus of commercial and regulatory interest, and
  thereby the major focus of pharmacoepidemiology
  studies of adverse drug reactions

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Medication Errors

• Adverse drug event (ADE) is an injury resulting
  from a drug
• Between 2.4 and 6.5 of hospitalized pts
  estimated to have ADEs, prolonging hospital stays
  by an average of two days and increase costs by
  2,000-2,600 per pt
• More than 7,000 deaths were attributed to
  medication error in the US in 1993
• Med errors are highly preventable

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Medication Errors

• Of 10,070 med orders
• 530 med errors were identified
• 25 ADEs 35 potential ADEs
• Five (20) of the ADEs associated with medication
  errors all preventable
• Although medication errors are common, relatively
  few result in ADEs
• Targeting those errors that are most likely to
  cause ADEs will have the greatest public health
  impact

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Medication Use Process

• Diagnosis
• Prescribing
• Dispensing
• Administration
• Ingestion
• Monitoring and control

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The Elderly at Risk

• Rates of ADEs rise with age
• Incidence of adverse events in pts aged gt65
  almost twice as high as in younger patients
• Incidence of preventable adverse events in pts
  aged gt 65 almost twice as high as in younger
  patients
• Percentage of ADEs due to negligence markedly
  higher among elderly
• In the outpatient elderly population, almost a
  quarter have received at least 1 of 20
  contraindicated drugs a fifth had received two
  or more such drugs

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Drug Class of Risk

• Hospital data
• ADEs analgesics, antibiotics, anticoagulants
• Med errors antimicrobials, cardiovascular
  agents, gastrointestinal agents, non-narcotic
  analgesics and antipyretics
• USP MedMARx program warfarin, insulin, heparin,
  cefazolin, vancomycin, lorazepam, potassium
  chloride, meperidine, furosemide, and famotidine
• 41 of 100 consultations for nephrotoxicity were
  iatrogenic, half drug-induced 7 from
  antibiotics, 5 from diuretics, 4 from NSAIDs, 3
  from ACE inhibitors, and 1 from a contrast medium

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Selected Determinants of PhysicianPrescribing
Errors

• Lack of patient practitioner edn/training
• Incomplete patient information
• Lack of information resources available to
  prescribing docs dispensing pharmacists
• Reliance on error-prone manual checks for
  drug-drug interactions
• Multiple and changing formularies
• Lack of access to widely disbursed pt data
• Commercial influences
• Time constraints and interruptions

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Patient Adherence and Medication Errors

• In ambulatory setting, the pts role is key
• Nearly 3 billion new and repeat prescriptions are
  filled in the ambulatory setting in the US, an
  increase of 50 in seven years
• Estimates of the frequency of drug-related
  hospital admissions have varied from 0.2 to 22
  of all hospitalizations, with most studies
  reporting figures between 3 and 10
• gt5 hospital admissions attributed to drugs, 23
  induced by poor adherence
• Meta-analysis of 7 studies and 2942 admissions
  attributed 5.5 of admissions specifically to
  drug therapy nonadherence, including over-use,
  under-use, and erratic use of drugs

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Technological and Other Innovations

• Process changes bar-coding colored wristbands
  for allergies unit dosing computerized
  physician order entry standardizing processes
  such as doses, times, scales, prescription
  writing, and rules automated dispensing devices
  automated medication administrative records
  computerized adverse drug event detection robots
  for filling outpatient prescriptions etc.
• Programs adding a pharmacist to patient-care
  rounds, pharmacokinetic monitoring services, etc.

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Background

• Patient Safety
• Institutional Context

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Drug Use and Effects Program

• Adverse drug reaction reporting
• Drug usage evaluation
• Pharmacy cost containment

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Goals of the DUEC Program

• Improve the quality of patient care by improving
  the clinical use of medications and minimizing
  adverse drug reactions
• Decrease hospital costs by eliminating the
  inappropriate use of drugs or by offering
  acceptable low cost substitutions
• Decrease liability associated with the
  inappropriate use of high risk drugs
• Bring HUP into compliance with JCAHO requirements
• Contribute new methodology and new clinical
  information to hospital pharmacoepidemiology

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• ADE Annual Report

Targeted Surveillance
700
600
500
400
JCAHO
300
200
100
0
1986
1988
1990
1992
1994
1996
1998
ADE Reports
Radiology
Source DUEC Confidential / Peer Review Only
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• Adverse Drug Experiences - 1998

Serious/
Idiosyn
400
Mild/
350
ldiosyn
300
33
250
25
200
150
100
50
Mild/
Serious/
0
Dose
15
Dose
27
FDA Reports - 51
ADE 434
Source DUEC Confidential / Peer Review Only
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CPUP-DUE

• Starting in 1998, DUECs activities were extended
  to CPUP, and outpatient practice

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July 1999-June 2000 DUEC DataTop Meds Resulting
in Reported ADRs (N608)
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July 1999-June 2000 DUEC DataTop Meds Resulting
in Serious ADRs (N301)
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July 1999-June 2000 DUEC DataTop Meds Resulting
in Admission (N148)
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July 1999-June 2000 DUEC DataMost Common ADRs
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Improving Patient Safetyby Reducing Medication
Errors

• Background
• Patient Safety
• Institutional Context
• Theme
• Overall Approach
• Four Specific Projects

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Improving Patient Safetyby Reducing Medication
Errors Theme

• AHRQ Center of Excellence for Patient Safety
  Research and Practice
• Theme Improving Patient Safety Through Reduction
  of Errors in the Medication Use Process
• PRIME Program for Reduction In Medication Errors

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Improving Patient Safetyby Reducing Medication
Errors

• Background
• Patient Safety
• Institutional Context
• Theme
• Overall Approach
• Four Specific Projects

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Overall Approach

• Entire range of places where errors can arise
• Select drugs with ubiquitous use, capacity to
  lead to errors, and severity of the consequences
  of errors
• Include different settings and various
  populations
• Examine both human psychosocial factors and
  technical system factors
• Perform evaluations in sites prepared to rapidly
  implement the studies findings, implementations
  that could then be evaluated in future studies
• Take advantage of local versions of existing
  systems, to evaluate those characteristics which
  protect against errors, and those which do not

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Improving Patient Safetyby Reducing Medication
ErrorsOverall Organization

• Four projects
• Four cores
• Administrative Core
• Data Collection Core
• Biostatistics and Data Management Core
• Dissemination Core

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Improving Patient Safetyby Reducing Medication
Errors

• Background
• Patient Safety
• Institutional Context
• Theme
• Overall Approach
• Four Specific Projects

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Project 1 Medication Errors LeadingTo
Hospitalization Among The Elderly(Joshua Metlay,
MD, PhD--PI)

• To identify predisposing factors for
  hospitalizations due to errors in medication use
  among large, representative cohorts of
  community-dwelling elderly patients initiated or
  maintained on warfarin, phenytoin, or digoxin
• To develop a prediction rule to identify elderly
  patients at high risk for hospitalization due to
  errors in use of these drugs
• To estimate the costs associated with
  hospitalization due to errors in use of these
  drugs

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Project 1 Study Design

• Prospective cohort study enrolling members of
  PACE
• Five cohort studies new and chronic users of
  phenytoin, new users of warfarin, chronic users
  of warfarin, new users of digoxin, and chronic
  users of digoxin
• Baseline interviews to identify psychosocial,
  behavioral, clinical risk factors
• Coordination of medical and pharmaceutical care,
  existence of methods for communicating
  instructions for new medications, level of home
  support, and level of visual and cognitive
  function

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Project 1 Outcomes

• Outcome of interest hospitalization due to
  dose-related errors in medication use
• Regular subject phone contact using a screening
  instrument to identify all hospitalizations and
  exclude those unlikely to be medication related
• Medical records abstracted to confirm the nature
  of the hospitalization, timing in relation to
  drug use, and drug level at admission
• Drug-specific analyses identifying predisposing
  factors for hospitalization, and developing a
  prediction rule to identify subjects at high risk
  of hospitalization due to medication errors

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Project 2 Predictors for PoorAdherence to
Warfarin Therapy(Stephen Kimmel, MD, MSCE--PI)

• To determine the clinical, demographic,
  organizational, behavioral, and psychosocial
  predictors of poor adherence
• To develop a predictive index that can identify
  patients at high risk for medication errors
  before starting therapy

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Project 2 Study Design

• Prospective cohort design, enrolling adult
  patients requiring warfarin who are treated at
  the outpatient pharmacist-managed HUP
  Anticoagulation Clinic (AC)
• Patients presenting to the AC clinic will be
  identified at the start of therapy and followed
  throughout their course
• An addition to a funded NIH study designed to
  examine the effects of genetic polymorphisms and
  adherence on clinical outcomes (INR levels,
  bleeding, and thromboembolism)

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Project 2 Data Collection

• Data collection 1) demographics, 2) clinical
  characteristics, 3) health-care structure
  characteristics, 4) pill taking practices, 5)
  psychosocial variables, 6) study outcomes
• The primary outcome is adherence, to be measured
  using an electronic data monitoring system

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Project 3 Inpatient Medication ErrorsLeading to
Acute Renal Failure(Harold Feldman, MD, MSCE--PI)

• Explore the predisposing factors for
  inappropriate inpatient aminoglycoside dosing
  that leads to acute renal failure, examining
• The failure to use pharmacokinetic monitoring
• Delays in initiating pharmacokinetic monitoring
• Failure to implement recommendations from the
  pharmacokinetic monitoring service
• Pharmacokinetic monitoring service
  characteristics/procedures systems

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Project 3 Inpatient Medication ErrorsLeading to
Acute Renal Failure

• Secondary aims are to identify other potentially
  modifiable predisposing factors for acute renal
  failure among patients receiving aminoglycoside
  antibiotics, including
• Systems to assure interactions with nursing and
  pharmacy to avoid drug errors, supervision on the
  teaching service, etc.
• Type of clinical service
• Other potentially modifiable predisposing factors
  for acute renal failure among pts receiving
  aminoglycosides

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Project 3 Study Design

• Hospital-based case-control study nested within a
  cohort of HUP patients receiving aminoglycosides
• Cases of ARF occurring among patients receiving
  aminoglycoside antibiotics will be identified by
  DUEC, and compared to controls selected randomly
  who are not experiencing ARF
• Data collection structured review of medical
  records and evaluation of their interaction with
  the pharmacokinetic monitoring service prior to
  the occurrence of ARF for the cases, or during an
  analogous exposure time for controls

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Project 4 Medication ErrorsRelated to Workplace
Stressors(Ross Koppel, PhD--PI)

• To determine if, and to what extent, the
  organization of work within a hospital, e.g.,
  schedules, shifts, workloads, etc., affects
  houseofficers commission of medication errors
• To determine if houseofficers experience of
  workplace stress (the cognitive, behavioral,
  physiological, and psychological experience of
  stress--called strains) increase the risk of
  medication errors

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Project 4 Medication ErrorsRelated to Workplace
Stressors

• To determine how hospital workplace stressors
  interact with houseofficers strains to influence
  the risk of medication errors
• To determine how hospital workplace stressors and
  strains interact with houseofficers baseline
  psychological profiles to influence the risk of
  medication errors

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Project 4 Study Design

• A series of cross sectional studies
• Data collection 1) analysis of houseofficers
  workloads, shifts, and schedule data from
  hospitals 2) surveys administered to
  houseofficers at several points in their training
  about workplace stressors and the personal
  experiences of stress (strain) 3) one-on-one
  interviews about workplace organization and
  stressors 4) focus groups on this topic and 5)
  an annual psychometric personality inventory

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Project 4 Outcomes

• The near misses for medication errors detected
  by the DUEC-supervised Pharmacy Intervention
  Program
• In particular, each houseofficer will be
  evaluated for the numbers of HUP interventions
  required by their prescriptions, using the number
  of HUP inpatient prescription orders they have
  written as the denominator

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Improving Patient Safety By ReducingMedication
Errors Overall Goal

• To improve patient safety by identifying the
  factors that predispose to medication errors, and
  to create a research base for the design of
  interventions to reduce the frequency of
  medication errors

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PRIME Project/Core PIs

• Project 1 Josh Metlay, MD, PhD
• Project 2 Stephen Kimmel, MD, MSCE
• Project 3 Harold Feldman, MD, MSCE
• Project 4 Ross Koppel, PhD
• Core A Brian Strom, MD, MPH
• Core B Brian Strom, MD, MPH
• Core C Russell Localio, JD, MS
• Core D David Asch, MD, MBA

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PRIME Other Investigators