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Improving Patient Safety by Reducing Medication Errors

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Title: Improving Patient Safety by Reducing Medication Errors


1
Improving Patient Safety by 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

2
Improving Patient Safety by Reducing Medication
Errors
  • Background
  • Patient Safety
  • Institutional Context
  • Theme
  • Overall Approach
  • Four Specific Projects

3
Improving Patient Safety by Reducing Medication
Errors
  • Background
  • Patient Safety
  • Institutional Context
  • Theme
  • Overall Approach
  • Four Specific Projects

4
Background
  • Patient Safety
  • Institutional Context

5
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

6
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

7
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

8
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

9
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

10
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

11
Risks Associated With the Use of Drugs
  • Adverse drug events are the most common
    iatrogenic causes of patient injuries

12
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13
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

14
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

15
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16
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

17
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

18
Medication Use Process
  • Diagnosis
  • Prescribing
  • Dispensing
  • Administration
  • Ingestion
  • Monitoring and control

19
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

20
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

21
Selected Determinants of Physician Prescribing
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

22
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

23
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24
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25
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.

26
Background
  • Patient Safety
  • Institutional Context

27
Drug Use and Effects Program
  • Adverse drug reaction reporting
  • Drug usage evaluation
  • Pharmacy cost containment

28
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

29
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30
  • 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
31
  • 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
32
CPUP-DUE
  • Starting in 1998, DUECs activities were extended
    to CPUP, and outpatient practice

33
July 1999-June 2000 DUEC Data Top Meds Resulting
in Reported ADRs (N608)
34
July 1999-June 2000 DUEC Data Top Meds Resulting
in Serious ADRs (N301)
35
July 1999-June 2000 DUEC Data Top Meds Resulting
in Admission (N148)
36
July 1999-June 2000 DUEC Data Most Common ADRs
37
Improving Patient Safety by Reducing Medication
Errors
  • Background
  • Patient Safety
  • Institutional Context
  • Theme
  • Overall Approach
  • Four Specific Projects

38
Improving Patient Safety by 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

39
Improving Patient Safety by Reducing Medication
Errors
  • Background
  • Patient Safety
  • Institutional Context
  • Theme
  • Overall Approach
  • Four Specific Projects

40
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

41
Improving Patient Safety by Reducing Medication
Errors Overall Organization
  • Four projects
  • Four cores
  • Administrative Core
  • Data Collection Core
  • Biostatistics and Data Management Core
  • Dissemination Core

42
Improving Patient Safety by Reducing Medication
Errors
  • Background
  • Patient Safety
  • Institutional Context
  • Theme
  • Overall Approach
  • Four Specific Projects

43
Project 1 Medication Errors Leading To
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

44
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

45
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

46
Project 2 Predictors for Poor Adherence 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

47
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)

48
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

49
Project 3 Inpatient Medication Errors Leading 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

50
Project 3 Inpatient Medication Errors Leading 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

51
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

52
Project 4 Medication Errors Related 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

53
Project 4 Medication Errors Related 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

54
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

55
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

56
Improving Patient Safety By Reducing Medication
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

57
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

58
PRIME Other Investigators
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