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Setting Priorities for Medication Safety in the Neonatal Intensive Care Setting

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Otago District Health Board (ODHB) ... Create systems map of medication use process ... Health care industry and regulatory bodies. For pharmaceutical brand ... – PowerPoint PPT presentation

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Title: Setting Priorities for Medication Safety in the Neonatal Intensive Care Setting


1
Setting Priorities for Medication Safety in the
Neonatal Intensive Care Setting
  • Desirée Kunac
  • Research Fellow
  • School of Pharmacy
  • University of Otago
  • Dunedin, New Zealand

2
Background
  • Adverse Drug Events of major concern
  • Medication errors preventable events
  • Adverse Drug Reactions non-preventable
  • Both economic and clinical consequences
  • ADE rates in NZ 1.9 comparable to overseas 0.7
    to 6.5 50 deemed preventable
  • Paediatric data limited, but suggests that
    neonates may be at greater risk of events
  • Ross et al, 2000 retrospective review of med
    errors, UK
  • Kaushal et al, 2001 prospective study of
    potential adverse drug events, USA

3
Neonatal Medication Safety Issues
  • Prescribing
  • Lack of clinical trial data on efficacy and
    safety
  • Dose calculations based on rapidly changing
    weight
  • Dispensing
  • Few commercial paediatric formulations
  • Complex calculations and dilutions
  • Administration
  • Small dose volumes, low rates of flow
  • Accurate dose measurement and delivery vital
  • Monitoring
  • Difficult to assess adverse effects
  • Limitations on tests

4
Neonatal Medication Safety Issues
  • Small errors can have serious consequences that
    could have life long sequelae

5
Project Setting New Zealand
6
Project Setting Dunedin, NZ
7
Project Setting Dunedin, NZ
8
Project Setting NICU, Dunedin Hospital
  • Otago District Health Board (ODHB)
  • Planning, funding and providing government funded
    health care services
  • Health Care Otago (HCO)
  • Principal provider of hospital and related
    services
  • Owned and operated by ODHB
  • Dunedin Hospital
  • Hub of HCOs operation

9
Project Setting NICU, Dunedin Hospital
ODHB
HCO
Dunedin Hospital
NICU
10
Local Neonatal Unit Issues
  • Handwritten prescriptions, no CPOE
  • Illegible, incomplete, abbreviations
  • Non-integrated systems
  • Lack of timely access to lab data, drug info
  • Use of floor stock
  • Preparation of doses by nurses on unit
  • Verbal orders and lack of standardised
    concentrations of infusions
  • Poor design of unit, lack of space
  • Relocation to larger unit proposed

11
Setting priorities for medication
safety Detection of error
12
Application of Human Factors Principles
  • Knowledge of human capabilities and limitations
  • Systematically applied to processes
  • To achieve compatibilities in the design of
    interactive systems of people, machines and
    environments
  • To ensure effectiveness, safety and ease of
    performance

13
Application of Human Factors Principles
Socio-technical systems analysis (STSA)
Failure mode and effects analysis (FMEA)
  • Systematic assessment of process or product
  • To identify potential vulnerabilities
  • Useful if lack of evidence but abundance of
    expertise

Structured approach to identify hazards
Recommended by ISMP to prevent medication errors
14
Application of Human Factors to Neonatal
Intensive Care
  • Complex medication use system
  • Lack of data but a wealth of expertise
  • Voluntary reporting system underutilised
  • Small errors can have serious consequences, life
    long effects

15
Aim
  • To provide a basis for setting priorities for
    medication safety in neonatal intensive care by
    identification and ranking of potential
    vulnerabilities using FMEA within a STSA framework

16
Method
  • Establish multidisciplinary panel for project
  • Create systems map of medication use process
  • Identify potential failure modes, their causes
    and effects, at each step in the process using a
    systems approach
  • Organisation
  • Environment
  • Technology
  • Personnel

17
  • 4. Panel to independently rate each failure mode
    for
  • Occurrence (O)
  • Severity (S)
  • Likelihood of Detection (D)
  • to allow calculation of the Risk Priority Score
    (RPS)
  • RPS O x S x D
  • Median of the 8 RPS used to obtain overall
    ranking of failure modes
  • Calculations performed using STATA 6.0 for
    windows

18
Results 1. Eight panel members
  • Child Health Service Leader
  • Pharmacy Service Leader
  • NICU Director
  • NICU Nurse Manager
  • NICU Consultant
  • NICU Registrar
  • NICU Nurse
  • NICU pharmacist

19
Results 2. Systems map of process
20
Results 2. Systems map of process (cont)
21
Results 3. Failure modes, causes, effects
  • Panel identified
  • 72 failure modes
  • 193 associated causes and effects

22

23
Results 4. Risk Priority Scores - summary
  • Median Risk Priority Scores range 33 to 273
  • (see summary handout)
  • Lowest rankings
  • Pharmacy preparation, label not printed due to
    printer malfunction RPS 35
  • Decide on therapy, suboptimal therapy due to
    cultural influences of parents RPS 33
  • Top ranking issues
  • Perceived general lack of awareness of medication
    safety issues RPS 273
  • Administration related issues
  • Wrong dose (RPS 265), wrong dilution (RPS
    249),
  • wrong time admin (RPS 245)

24
Results 4. Risk Priority Scores top 30
25
Discussion
  • Use of FMEA within a STSA framework has enabled
  • Identification and ranking of potential
    vulnerabilities in the NICU medication use
    process
  • Determination of priorities for medication safety
  • Severity (top ranking RPS)
  • By stage in process
  • By personnel (pharmacy, nursing, prescribers)
  • By systems

26
Discussion
  • Multidisciplinary panel
  • Sharp and blunt end representatives
  • FMEA within STSA framework
  • Consideration of all integrating systems
  • Frequency
  • Potential vulnerabilities across entire process
  • Highest risk procedures administration stage

27
Discussion
  • Data will be useful for planning of new neonatal
    unit
  • environmental issues (space, lighting, noise)
  • Technology (ready access to patient and drug
    information)
  • Organisation (safe storage of medications)
  • Report of recommendations to HCO management
  • Basis for comparison of RPS of redesigned
    processes

28
Discussion
  • Limitations
  • Small number on panel
  • Missed failure modes
  • Priority analysis severe, high risk procedures

29
Future direction
  • NICU
  • Application to other unit processes and
    procedures (eg. Discharge of patients from
    hospital to home)
  • Health care providers
  • Application to other health care processes or
    systems (eg assessment of new products or
    devices)
  • Other high risk patient groups (eg elderly,
    oncology)
  • Health care industry and regulatory bodies
  • For pharmaceutical brand names, packaging,
    labeling

30
Conclusions
  • Proactive risk assessment using FMEA and STSA
    techniques have been used successfully in
    industry
  • Beneficial where there is lack of data but an
    abundance of expertise
  • Application of FMEA within STSA framework appears
    to be useful in setting priorities for medication
    safety in NICU
  • Useful in parallel with retrospective methods of
    error detection and prevention

31
Acknowledgements
  • Multidisciplinary panel
  • Dr Roland Broadbent, Bev Howarth, Linda Moir, Dr
    David Reith, Jan Seuseu, Melissa Witbrock, Dr
    Kang
  • Assoc Prof Karen Swisher, VCU
  • Dr Ben-Tzion Karsh, VCU mentor
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