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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 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

3
OVERALL APPROACH
  • Focus - the occurrence of errors anywhere along
    the entire pathway of medication use
  • Drugs with ubiquitous use, capacity to lead to
    errors, and severity of consequences
  • Different settings and populations
  • Both human psychosocial factors and technical
    system factors
  • Evaluations in sites prepared to rapidly
    implement the studies findings, which could then
    be evaluated in future studies

4
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

5
Project One Medication Errors Leading to
Hospitalization Among the Elderly (Joshua Metlay,
MD, PhD--PI)
  • Identify predisposing factors for hospitalization
    due to medication errors among the elderly
  • Develop a prediction rule to identify high risk
    elderly patients
  • Estimate costs associated with hospitalizations
    due to errors

6
DESIGN
  • Prospective cohort
  • 3 Drug Groups
  • Chronic vs. New Users
  • 5 Study Cohorts (insufficient numbers for new
    phenytoin)
  • One year enrollment
  • Two year follow-up

7
HYPOTHESES
  • Key risk factors include uncoordinated medical
    and pharmaceutical care, inadequate delivery of
    new medication instructions, visual and cognitive
    impairment, depression
  • Risk factors differ across types of drugs and new
    and old users

8
DRUG TARGETS
  • Focus on warfarin, phenytoin, digoxin
  • High risk drugs, frequently implicated in ADEs
    leading to hospitalization
  • Narrow therapeutic windows lead to drug level
    monitoring

9
Medication Grouping Enrolled in Study (surveyed)
N 5569
10
Cohort Characteristics N5569
11
Source of Medication Instructions (N5569)
12
Content of Medication Discussions with MD
(N5569)
13
Medication Dispensing Patterns in the Home
(N5569)
14
Project Two 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

15
PROJECT TWO STUDY DESIGN
  • Prospective cohort design, enrolling adult
    patients requiring warfarin who are treated at a
    outpatient pharmacist-managed 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)

16
Project Three Inpatient Medication Errors
Leading to Acute Renal Failure (Harold Feldman,
MD, MSCEPI)
  • To evaluate antibiotic monitoring practices that
    may predispose to ARF including
  • 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

17
PROJECT THREE STUDY DESIGN
  • Hospital-based case-control study nested within a
    cohort of hospitalized patients receiving
    aminoglycosides
  • Cases of ARF (defined by elevations in serum
    creatinine) occurring among patients receiving
    aminoglycoside antibiotics to be compared to
    random sample of controls 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

18
Project Four 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) affects
    houseofficers risk of medication errors
  • To determine if houseofficers experience of
    workplace stress affects the risk of medication
    errors
  • To determine how stressors interact with
    psychological profiles to influence the risk of
    medication errors

19
PROJECT FOUR STUDY DESIGN
  • A series of cross sectional studies
  • Data collection
  • 1) analysis of house-officers workloads, shifts,
    schedules 2) surveys of houseofficersat several
    points in their trainingabout workplace
    stressors and strain 3) one-on-one interviews
    with housestaff, pharmacists, IT staff 4)
    focus groups 5) observations on hospital floors,
    in pharmacy and meetings 6) psychometric
    personality inventory

20
PROJECT FOUR OUTCOMES
  • The near misses for medication errors detected
    by experienced pharmacistsin relation to
    houseofficers workloads, fatigue, schedules,
    rotations, shifts, experience, etc
  • Self-reported strains and errors in relation to
    workplace stressors
  • Analysis of the physician computer ordering
    system in preventing and in, perhaps,
    facilitating error

21
PROJECT FOUR QUALITATIVE SUMMARY OUTCOMES
  • An emerging theme focused on the errors created
    by technological solutions designed to reduce
    errors
  • Several examples illustrate the unintended harms
    caused by the commercial CPOE system (TDS)

22
AHRQ Center of Excellence for Patient Safety
Research and Practice
  • Now that we have developed hypotheses for
    possible interventions, who will evaluate them????

23
Center for Excellence in Patient Medication
Safety Investigative Teams
  • Brian L. Strom, MD, MPH PI Director, Admin Core
  • Dir, Data Collection Core
  • Joshua Metlay, MD, PhD Co-PI Proj Leader, Proj
    1
  • Co-Dir, Admin Core
  • David Asch, MD, MBA Dir, Dissemination Core
  • Lily Cheung, PharmD Co-investigator, Project 3
  • Abigail Cohen, PhD, MA Senior Project Manager
  • Dean Cruess, PhD Co-inv, Project 2
  • John Farrar, MD, MSCE, PhD Co-inv, Data
    Collection Core
  • Harold Feldman, MD, MSCE Project Leader, Project
    3

24
Center for Excellence in Patient Medication
Safety Investigative Team
  • Sean Hennessy, PharmD, Co-inv, Project 1,
    Project 3,
  • MSCE, PhD Data Collection Core
  • Stephen Kimmel, MD, MSCE Project Leader, Project
    2
  • Robert Gross, MD, MSCE Co-inv, Project 2
  • Ross Koppel, PhD Project Leader, Project 4
  • Russell Localio, JD, MS Dir, Biostats Data
  • Management Core
  • Sandra Norman, PhD Co-Dir, Data Collection Core
  • Daniel Polsky, PhD Co-inv, Project 1

25
METHODS OF PROVIDING MEDICATION INSTRUCTIONS
26
Adherence to Warfarin Sodium Using Electronic
Pill-Cap Monitoring and the Millon Behavioral
Medicine Diagnostic Inventory
  • Adherence assessed with multiple techniques,
    electronic monitoring and psychosocial instrument
    that predict adherence.
  • Electronic monitoring device (MEMS caps)
  • Makes use of a microprocessor in the cap of the
    pill bottle to record exact dates/times the
    bottle is opened
  • A standard cutoff of gt 25 of days on which the
    prescribed dose was not taken was used to
    designate non-compliant participants
  • A 140-item T/F questionnaire (MBMD) that produces
    a number of psychosocial indices, including
    Problematic Compliance
  • Non-compliance was designated for participants
    with scores gt 75 on the Problematic Compliance
    Index

27
PROJECT TWO Study Design Participants
  • 44 participants, (28 men, 16 women, mean age
    51.514.7 years) beginning warfarin therapy at an
    anticoagulation clinic
  • Indications for warfarin included thrombosis,
    atrial fibrillation/flutter embolism, and
    myocardial infarction.
  • Pill cap adherence was monitored and averaged
    over the time of pill-cap use (minimum of 7
    days)
  • Participants completed the MBMD inventory, along
    with other psychosocial measures towards the
    start of pill-cap monitoring

28
PROJECT TWO 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

29
PROJECT TWO Results
  • Table 1. Adherence results

Adherent gt 75 of days with correct dose
taken for pill cap measurement and MBMD scores
of lt 75 on the Problematic Compliance Index
Table 2. Agreement of adherence results
(k.062)
30
PROJECT TWO Discussion
  • While the pill-cap monitoring and MBMD
    problematic compliance index produced similar
    percentages of adherent and non-adherent
    participants, a closer examination of the data
    found that the two measures did not have adequate
    statistical agreement.
  • It appears that the MBMD inventory assesses
    general medical compliance, while pill-cap
    monitoring limits compliance to pharmacological
    regimens.

31
PROJECT THREE Schematic Protocol
32
PROJECT THREE Abstraction Form
33
First Wave Sample Demographics (n261)
  • Female 44.8
  • White 66.3
  • Mean Age 29.6 yrs
  • PGY1 32.6
  • PGY2 32.2
  • PGY3 35.2

34
First Wave Specialty (n261)
  • Medicine 47.1
  • Neurology 10.7
  • General Surgery 10.0
  • Emergency Medicine 09.6
  • Ob/Gyn 06.9
  • Otorhyno 06.1
  • Family Medicine 05.7
  • Urology 02.3
  • Neurosurgery 01.5

35
Computerized Order Entry Survey Results Wave One
(n261)
36
Computerized Order Entry Survey Results Wave One
cont. (n261)
37
CPOE vs. Paper-Based Systems The Benefits of
CPOE (part 1)
  • 1) free of handwriting identification problems
  • 2) faster to reach the pharmacy
  • 3) less subject to error associated with similar
    drug names
  • 4) more easily integrated into medical records
    and decision support systems
  • 5) less subject to errors caused by use of
    apothecary measures
  • 6) easily linked to drug-drug interaction
    warnings
  • 7) more likely to identify the prescribing
    physician
  • 8) able to link to ADE reporting systems

38
CPOE vs. Paper-Based Systems The Benefits of
CPOE, Part II
  • 9) able to avoid specification errors, such as
    trailing zeros
  • 10) available and appropriate for training and
    education
  • 11) available for immediate data analysis,
    including post marketing reporting.
  • Also, with on-line prompts CPOE systems can
  • 12) link to algorithms to emphasize
    cost-effective medications
  • 13) reduce under-prescribing and
    over-prescribing and
  • 14) reduce the incorrect choice of drugs.

39
Increasing Interest in CPOE
  • CPOE adoption has, perhaps, gathered such strong
    support because its promise is so great, the
    effects of medication error so distressing, the
    circumstances of medication error so preventable,
    and the studies of CPOE so reassuring, albeit
    preliminary.

40
Our Studys Genesis
  • Project objective The role of hospital workplace
    stressors (e.g., shifts, sleeplessness, new
    rotations) on housestaff medication prescribing
    errors.
  • The CPOE system emerged as a study focus when
    housestaff repeatedly told us it caused stress
    and error

41
Our CPOE Study Methods
  • Face-to-face intensive interviews with physicians
  • 5 focus groups with physicians
  • Shadowing docs as they entered orders and at
    handoffs
  • Executive interviews with leaders of Nurses,
    Medicine/Surgery, Pharmacy, IT
  • Face-to-face interviews with nurses and
    nurse-managers
  • Shadowed nurses and pharmacists processing
    orders, interacting with CPOE system
  • 72 item questionnaire to 90 sample of housestaff
    (9 questions about CPOE)

42
Measuring Success
  • CPOE systems are currently found in only 5 to 9
    of hospitals
  • CPOE systems efficacy (17 to 81 error
    reduction) usually focus on their advantages and
    are generally limited to single outcome studies,
    potential error reduction, or physician
    satisfaction

43
PROJECT FOUR QUALITATIVE SUMMARY OUTCOMES -1
  • Sometimes serious delays were caused because of
    the re-approval process for antibiotics done by
    infectious disease fellows
  • While a sticker is placed on chart the day before
    a renewal is needed, most rely on the computer
    system (TDS) which may not be updated due to the
    difficulty of working with the system to re-enter
    data

44
PROJECT FOUR QUALITATIVE SUMMARY OUTCOMES-2
  • Doctors sometimes use computer displays to judge
    lowest dose range of doses
  • TDS is not designed to illustrate dose or range
    information for clinical decisions
  • The dosages displayed reflect purchasing and
    warehousing considerations by the pharmacy
  • Computer gives a false sense of accuracy

45
PROJECT FOUR QUALITATIVE SUMMARY OUTCOMES-3
  • Doctor must go though 15 or more computer screens
    to discontinue a medication causing problems with
    missed information
  • If houseofficer is interrupted or in hurry,
    process maybe postponed and forgotten

46
PROJECT FOUR QUALITATIVE SUMMARY OUTCOMES-4
  • Nurses often don't record the administration of
    medications in the TDS system due to cumbersome
    and time consuming nature of interface
  • Doctors must assume medications given when
    ordered or find nurse and ask
  • System is updated only at the end of a shift to
    reconcile records
  • Accuracy questionable

47
PROJECT FOUR QUALITATIVE SUMMARY OUTCOMES-4
  • When a patient enters OR all medications stopped 
  • Surgeons must enter continuing and new
    medications into TDS for use after post-op 
  • When patient released from the post anesthesia
    care unit, the nurse pre-activates meds
  • But doctor must re-re-activate meds
  • This last step is too often forgotten

48
PROJECT FOUR PROGRESS AND PRELIMINARY FINDINGS
  • Creation and administration of house officer
    stressor inventory
  • Findings on differing causes of stress vs. causes
    of medication error
  • Findings on the role of CPOE systems as
    facilitator of error (in addition to its
    preventive role)
  • Findings of greater stress and error among
    residents compared to interns

49
Findings 22 medication error risks facilitated
by CPOE
  • I) Information Errors generated by fragmentation
    of data and failure to integrate the hospitals
    several computer and information systems
  • II. Human-Machine Interface Flaws Reflecting
    machine rules that do not correspond to work
    organization or usual behaviors

50
Ex Assumed Minimum Dose Assumed Dose Range
Information
  • 73 of housestaff use CPOE displays to determine
    low doses
  • 82 used CPOE displays to determine range of
    doses
  • 40 used CPOE to determine dosages at least a few
    times weekly 10 to 14 daily

51
Ex. Patient Selection--Screen Design
Inconsistent Color/Font Coding
  • 55 of housestaff Difficulty identifying the
    patient they were ordering for because of
    fragmented CPOE displays
  • 23 say this happened a few times weekly or more
    frequently

52
Our RECOMMENDATIONS concentrate on organizational
factors
  • Focus primarily on the organization of work not
    on technology. CPOE must only determine clinical
    actions if they improve care.
  • Aggressively examine the technology in use.
    Problems obscured by workarounds, medical problem
    solving ethos, and low housestaff status.
  • Substitution of technology for people is a
    misunderstanding of both. Aggressively fix
    technology when shown to be counter-productive.
    Failure to do so engenders alienation and
    dangerous workarounds.

53
Our RECOMMENDATIONS concentrate on organizational
factors
  • Episodic and incomplete error reporting are
    standard. Management belief in these reports
    obfuscates and compounds problems. Pursue errors
    second stories.
  • Plan for continuous revisions and quality
    improvement recognizing that all changes
    generate new error risks.

54
CPOE Tremendous Promise
  • But do not bend hospitals and clinicians around
    the CPOE system make CPOE work with other
    systems and with clinicians.
  • Our future research New CPOE systems may be
    better, but face the same and new challenges of
    integration with workflow, humans, and
    organizations.
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