Update on Patient Safety from

the Pharmacy Perspective

Larry Clark, Pharm.D., M.S., BCPS

Director of Oncology & Pharmacy
St. Mary’s Hospital
 Objectives

• Understand & describe strategies to

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

• General discussion of regulatory and

advocacy organizations
• Medication Errors & ADEs
• Barcoding
• Automation – Safety Perspective
• Medication Reconciliation
• Guidelines & Protocols
 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
 Institute of Medicine Report
To 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
 Institute of Medicine Report
To 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
 Institute of Medicine Report
To Err is Human…

• Greater attention by FDA to drug safety

• Inclusion of patient safety in organizational
goals
• Implementation of proven medication
safety practices
 Patient’s 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%)
 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
 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.
 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 patient’s current medications upon the patient’s
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 patient’s 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.
• Coalition of > 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)
 Leapfrog’s 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.
 How Leapfrog Works
• Building Transparency
Through 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 Rewards
Leapfrog 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 Leapfrog’s
quality and safety practices.
• Creating Consistency and Leverage for Change
Working with other organizations to develop and recommend other quality
and safety initiatives for both hospitals and physician offices.
 Institute for Healthcare Improvement
(IHI) – 100,000 Lives Program
• Deploy Rapid Response Teams…at the first sign of patient decline
• Deliver Reliable, Evidence-Based Care for Acute Myocardial
Infarction…to prevent deaths from heart attack
• Prevent Adverse Drug Events (ADEs)…by implementing
medication reconciliation
• Prevent Central Line Infections…by implementing a series of
interdependent, scientifically grounded steps called the “Central Line
Bundle”
• Prevent Surgical Site Infections…by reliably delivering the correct
perioperative care
• Prevent Ventilator-Associated Pneumonia…by implementing a
series of interdependent, scientifically grounded steps called the
“Ventilator Bundle”
 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.
 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
 Causes of Medication Errors

• Transcription
– Poor handwriting
– Order misinterpretation
– Unclear orders
– Incorrect order entry by Pharmacy
– Incorrect transcription by RN
– Labeled incorrectly or ambiguously
 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
 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
 Causes of Medication Errors

• Monitoring
– Incomplete or insufficient monitoring
– Lab test ordering issues
– Drug information unavailable or insufficient
– Fragmentation of care system
 Where Do Errors
Transcribing
Occur?

Ordering
Preparing

12%
Transcribing
Administering
39% 11%
Prescribing
Dispensing

(Leape LL et al. Systems analysis of

adverse drug events. JAMA 38%
1995;274:35-43.) Administering
 Where Should We Place Our
Efforts?

Prescribing Transcribing Dispensing Administering

Medication
Phase Error 39% 12% 11% 38%
Distribution
Per 100 Errors 39 12 11 38
Intercept rate 48% 33% 34% 2%
# of Errors 20 8 7 37
Which Reach
the Patient
True Error 28% 11% 10% 51%
Rate

*JAMA 95 Vol 274 #1 p 35-43 “Systems Analysis of Adverse Drug Events” Lucian Leape
Medication Misadventures
Classification
 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
 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
 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
 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
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
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
 Proven Medication Safety
Practices

• Unit dose (82%)

• Physician order entry (55%)
• Bar coding (virtual elimination of
administration errors)
• Pharmacists rounds (preventable ordering
ADEs 66%)
 Barcoding - Benefits
• Decreased administration errors
• Improves documentation
• Productivity improvements
– Billing
– Nursing
• Allergy checking
• Patient Education
• Elimination of MAR reconciliation
• Inventory Management
 Barcoding – Barriers

• Lack of standardization
• Barcodes on products
• Cost of systems
• Tied to implementation of new HISs
• Implementation
• Workarounds
 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
 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.
 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 patient’s current list of
medications against the physician’s admission,
transfer, and/or discharge orders
 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
 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
 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
 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
 Improvement & Implementation
Strategies

• Failure Mode Effects Analysis (FMEA)

• FOCUS-PDCA
• Rapid Cycle Improvement Processes
• RCA
• Kaizen, LEAN, Six Sigma
• Committees
 Conclusion

• There’s lots to do!

• Institutions should assess their current
policies
– Reporting
– Review
– Assessment
• Assess distribution systems
 Conclusion
• Assess all error types
– Prescribing
– Dispensing
– Administration
• Intense analysis
• Trend analysis
• Remove blame!
• Think systems!
I don’t want to make the wrong
mistake.
Yogi Berra