Update on Patient Safety from the Pharmacy Perspective

1
Update on Patient Safety from the Pharmacy
Perspective

• Larry Clark, Pharm.D., M.S., BCPS
• Director of Oncology Pharmacy
• St. Marys Hospital

2
Objectives

• Understand describe strategies to decrease
  medication errors and adverse drug events
• Describe barriers to implementation of strategies
  and how to address them

3
Outline

• General discussion of regulatory and advocacy
  organizations
• Medication Errors ADEs
• Barcoding
• Automation Safety Perspective
• Medication Reconciliation
• Guidelines Protocols

4
Institute of Medicine

• 44,000-98,000 deaths annually
• Adverse events in 2.9-3.7 of admissions
• Costs 17 - 29 billion annually
• Medication errors 7,000 deaths annually
• Preventable ADEs result in 4,700/admission
  additional cost
• 2/100 of admits experience preventable ADR
• 2.8 million annually for a 700 bed hospital

5
Institute of Medicine ReportTo Err is Human

• Recommendations of the report lay out four-tiered
  approach
• Establish a national focus
• Identify and learn from errors (reporting
  systems)
• Raising standards and expectations
• Creating safety systems

6
Institute of Medicine ReportTo Err is Human

• Creation of a Center for Patient Safety
• Mandatory reporting of adverse events resulting
  in death or serious harm
• Voluntary reporting system
• Extend peer review protection
• Greater attention to patient safety

7
Institute of Medicine ReportTo Err is Human

• Greater attention by FDA to drug safety
• Inclusion of patient safety in organizational
  goals
• Implementation of proven medication safety
  practices

8
Patients Top Concerns in Hospitals Health
Systems

• Receiving the wrong medication (61)
• Drug interactions (58)
• Treatment costs (58)
• Medical procedure complications (56)
• Inadequate information (53)
• Infection (50)
• Medication side effects (49)

9
JCAHO National Patient Safety Goals

• Goal 1- Improve the accuracy of patient
  identification.
• Use at least two patient identifiers
• Goal 2 - Improve the effectiveness of
  communication among caregivers.
• Repeat verify
• Dangerous abbreviations

10
JCAHO National Patient Safety Goals

• Goal 3 - Improve the safety of using medications.
• Standardize and limit the number of drug
  concentrations available in the organization.
• Identify and, at a minimum, annually review a
  list of look-alike/sound-alike drugs used in the
  organization, and take action to prevent errors
  involving the interchange of these drugs.
• Label all medications, medication containers
  (e.g., syringes, medicine cups, basins), or other
  solutions on and off the sterile field in
  perioperative and other procedural settings.

11
JCAHO National Patient Safety Goals

• Goal 8 - Accurately and completely reconcile
  medications across the continuum of care.
• Implement a process for obtaining and documenting
  a complete list of the patients current
  medications upon the patients admission to the
  organization and with the involvement of the
  patient. This process includes a comparison of
  the medications the organization provides to
  those on the list.
• A complete list of the patients medications is
  communicated to the next provider of service when
  a patient is referred or transferred to another
  setting, service, practitioner or level of care
  within or outside the organization.

12

• Coalition of gt 170 members including Fortune 500
  companies and public-sector purchasers
  representing more than 36 million Americans and
  more than 67 billion in healthcare expenditure
• Rewarding providers for 3 initiatives
• Computerized physician order entry (CPOE)
• Evidenced-based hospital referral (EHR)
• ICU physician staffing (IPS)

13
Leapfrogs CPOE Patient Safety Standard

• Requires physicians to enter 75 of hospital
  medication orders via a computer system that is
  linked to prescribing error prevention software
• Demonstrates, via a test now under development by
  the Institute for Safe Medication Practices and
  First Consulting Group, that their inpatient CPOE
  system can intercept at least 50 of common
  serious prescribing errors and
• Requires that physicians electronically document
  a reason for overriding an interception prior to
  doing so.

14
How Leapfrog Works

• Building TransparencyThrough fielding a
  voluntary survey The Leapfrog Group Hospital
  Quality and Safety Survey - to hospitals that
  asks them whether they meet four quality and
  safety practices or leaps.
• Incentives and RewardsLeapfrog helps employer
  members either directly or through their health
  plans to provide incentives and rewards to
  hospitals that improve the quality of the care
  they provide to patients by implementing
  Leapfrogs quality and safety practices.
• Creating Consistency and Leverage for
  ChangeWorking with other organizations to
  develop and recommend other quality and safety
  initiatives for both hospitals and physician
  offices.

15
Institute for Healthcare Improvement (IHI)
100,000 Lives Program

• Deploy Rapid Response Teamsat the first sign of
  patient decline
• Deliver Reliable, Evidence-Based Care for Acute
  Myocardial Infarctionto prevent deaths from
  heart attack
• Prevent Adverse Drug Events (ADEs)by
  implementing medication reconciliation
• Prevent Central Line Infectionsby implementing a
  series of interdependent, scientifically grounded
  steps called the Central Line Bundle
• Prevent Surgical Site Infectionsby reliably
  delivering the correct perioperative care
• Prevent Ventilator-Associated Pneumoniaby
  implementing a series of interdependent,
  scientifically grounded steps called the
  Ventilator Bundle

16
Other Regulatory Special Interest Groups

• Institute for Safe Medication Practices
• National Coordinating Council for Medication
  Error Reporting and Prevention (NCC MERP)
• ASHP APhA
• Drug Safety Institute
• FDA
• Etc.

17
Causes of Medication Errors

• Therapy choice and prescribing
• Lack of knowledge
• Lack of readily available information
• Regimen complexity
• Multiple formularies
• Poor handwriting
• Dangerous Abbreviations
• Failure to transmit order to pharmacy
• Errors of omission

18
Causes of Medication Errors

• Transcription
• Poor handwriting
• Order misinterpretation
• Unclear orders
• Incorrect order entry by Pharmacy
• Incorrect transcription by RN
• Labeled incorrectly or ambiguously

19
Causes of Medication Errors

• Dispensing
• Incorrect drug selected
• Inadequate information available to RPh
• Patient information data
• Drug information
• Look-alike or sound-alike drugs
• Drug storage issues
• Staffing
• Distribution systems

20
Causes of Medication Errors

• Administration
• Incorrect or inadequate information available to
  RN
• Improper storage lighting
• Look-alike sound-alike drugs
• Doses requiring split tablets or multiple tablets

21
Causes of Medication Errors

• Monitoring
• Incomplete or insufficient monitoring
• Lab test ordering issues
• Drug information unavailable or insufficient
• Fragmentation of care system

22
Where Do Errors Occur?
Transcribing
Prescribing
Dispensing
(Leape LL et al. Systems analysis of adverse
drug events. JAMA 199527435-43.)
Administering
23
Where Should We Place Our Efforts?
JAMA 95 Vol 274 1 p 35-43 Systems Analysis of
Adverse Drug Events Lucian Leape
24
Medication Misadventures Classification
25
Medication Errors ADEs - Measurement

• Voluntary Reporting Systems
• Goal Increase Reporting
• Used to identify areas for improvement
• Fair Just Culture
• Chart Review Systems
• Goal Decreased ADEs
• Able to measure improvement
• Time Consuming

26
Systems Approach to Medical Errors

• The majority of errors are caused by poor systems
• Need to remove blame from the system
• Need to collect variances near misses
• System analysis must replace blame
• Emphasis on systems improvements
• Must be multidisciplinary

27
Systems Approach to Preventing Errors

• Avoid reliance on memory and vigilance
• Simplify processes
• Standardize processes
• Constraints and forcing functions
• Protocols and checklists
• Improve information access

28
Systems Approach to Preventing Errors

• Reduce hand-offs
• Increase feedback and staff involvement
• Decrease sound-alike and look-alike drugs
• Careful storage and segregation
• Careful automation

29
Medication Misadventures Policy Essentials

• Multidisciplinary input
• Risk Management, Pharmacy, Quality, Nursing,
  Physicians
• FDA reporting of rare/severe ADRs
• FDA reporting of errors associated with drug
  product issues
• Severity Rating
• Probability classification

30
Medication Misadventures Policy Essentials

• Intense analysis for severe ADRs
• Investigation of significant potential errors
• Use of national error reporting system
• Variance reporting system
• Easy
• Efficient
• Non-punitive

31
Proven Medication Safety Practices

• Unit dose (82)
• Physician order entry (55)
• Bar coding (virtual elimination of administration
  errors)
• Pharmacists rounds (preventable ordering ADEs 66)

32
Barcoding - Benefits

• Decreased administration errors
• Improves documentation
• Productivity improvements
• Billing
• Nursing
• Allergy checking
• Patient Education
• Elimination of MAR reconciliation
• Inventory Management

33
Barcoding Barriers

• Lack of standardization
• Barcodes on products
• Cost of systems
• Tied to implementation of new HISs
• Implementation
• Workarounds

34
Automation-Opportunities to Leverage Barcoding

• Inventory Management Reduced Dispensing Errors
• UD Packaging
• Carousel Technology
• Unit Based Dispensing Devices
• Automate Purchasing Functions
• Automated Anesthesia Carts
• Automated Syringe Packagers
• TPN Compounders
• External Compounding

35
Medication Reconciliation

• Experience from hundreds of organizations has
  shown that poor communication of medical
  information at transition points is responsible
  for as many as 50 percent of all medication
  errors and up to 20 percent of adverse drug
  events in the hospital
• Estimates reveal that 46 of medication errors
  occur on admission or discharge from a clinical
  unit/hospital when patient orders are written.
• A study conducted at Johns Hopkins University on
  the medication reconciliation process in an adult
  intensive care unit found that medication orders
  were changed for 94 percent of the patients
  following reconciliation. Twenty - four weeks
  after the implementation of the process ,nearly
  all errors were eliminated from discharge orders.

36
Medication Reconciliation Definition

• Reconciliation is a process of identifying the
  most accurate list of all medications a patient
  is taking including name, dosage, frequency,
  and route and using this list to provide
  correct medications for patients anywhere within
  the health care system.
• Involves comparing the patients current list of
  medications against the physicians admission,
  transfer, and/or discharge orders

37
Medication Reconciliation

• Admission, Transfer, Discharge
• Admission Most Important?
• Admission Most Difficult?
• Discharge Tie to Discharge Education
• Methods
• Physician vs. RN vs. Pharmacist
• Use of Technology
• Time Consuming 15-120 minutes for detailed
  admission medication history

38
Common Data Set Networks

• Many efforts currently underway to develop
  ability to exchange clinical information
• Healthcare informatics standards HL7
• Will allow body of information to follow the
  patient
• Challenge will be maintaining data medication
  regimen
• Tremendous benefit for medication reconciliation

39
Guidelines Protocols Why We Need Them

• The emergence of new types of evidence which can
  change the way we treat patients
• The fact that although we need this evidence
  daily, we don't get it
• The resultant deterioration in the currency of
  our clinical knowledge
• Traditional approaches to medical education don't
  solve this problem
• An alternative approach has been shown to help

40
Guidelines Protocols - Barriers

• Acceptance of the use is increasing
• Paper systems make access and use difficult
• Filing systems inadequate
• Lack of knowledge of existence
• Updating complex most current form not
  available
• CPOE EMR tremendously facilitates use

41
Improvement Implementation Strategies

• Failure Mode Effects Analysis (FMEA)
• FOCUS-PDCA
• Rapid Cycle Improvement Processes
• RCA
• Kaizen, LEAN, Six Sigma
• Committees

42
Conclusion

• Theres lots to do!
• Institutions should assess their current policies
• Reporting
• Review
• Assessment
• Assess distribution systems

43
Conclusion

• Assess all error types
• Prescribing
• Dispensing
• Administration
• Intense analysis
• Trend analysis
• Remove blame!
• Think systems!

44
I dont want to make the wrong mistake. Yogi
Berra