Transcript Patient Safety and Risk Management: Medication Error

Patient Safety and Risk Management:
Medication Error Prevention in Pharmacy
David B. Brushwood, R.Ph., J.D.
Professor of Pharmaceutical Outcomes and Policy
The University of Florida College of Pharmacy
Learning Objectives
List the challenges and opportunities for
improved patient safety in pharmacy practice.
 Describe the operation of root cause analysis and
failure mode and effects analysis.
 Discuss strategies for error reduction and
prevention in pharmacy.
 List techniques that pharmacists can use to
prevent medication errors.
 Describe the organization of pharmacy systems
to manage the risk of medication errors.
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Who says the system is broken?
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The media
 Television programs
 Magazines
 Newspapers
State regulators
The courts
The IOM Report
But…
 No pharmacist wants to make a mistake
 No pharmacy manager wants pharmacists to
make a mistake
Maybe the system just needs to be organized
better.
Building a Safer Healthcare System
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James Reason, Human Error
Principles
 Policies
 Procedures
 Practices
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Fallibility is a part of the human condition.
 We can’t change the human condition.
 We can change the conditions under which
people work.
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Reason’s Principles
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Safety is everybody’s
business.
We must accept setbacks
and anticipate errors.
Safety issues should be
reviewed regularly.
Past events should be
reviewed and changes
implemented.
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After a mishap,
concentrate on fixing the
system, not on blaming
individuals.
Effective error reduction
depends on the collection,
analysis and dissemination
of data.
Error reduction must be
proactive.
Reason’s Policies
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Safety information has
direct access to the top.
Everyone helps everyone
else.
Meetings on safety are
attended by staff at every
level.
Messengers are rewarded,
not shot.
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The culture of safety must
be just.
Reporting must include
qualified indemnity,
separation of discipline
from data collection.
Discipline should involve
peers and agree as to the
difference between
acceptable and
unacceptable behavior.
Reason’s Procedures
Training in the recognition and recording of
errors.
 Feedback on recurrent error patterns.
 Awareness that procedures cannot cover all
circumstances; on the spot training.
 Protocols written with those doing the job.
 Procedures must be workable, available, and
supported.
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Reason’s Practices
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Rapid, useful, and intelligible feedback on lessons
learned and actions needed.
Bottom up information listened to and acted on.
When mishaps occur
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Listen carefully.
Apologize.
Objectively explain what happened, if known.
Assure patient lessons will be learned.
DeCordova v. State of Colorado
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The Issue: Whether a pharmacist has
committed malpractice based simply on the
evidence that the pharmacist has made a
mistake.
DeCordova: The Facts
“Because of a risk of neonatal infection, the
attending physicians ordered that the infant
receive a specified dosage of an intravenous
antibiotic every twelve hours.”
 “Because the hospital pharmacy made an
error in preparing the medication, the infant
received approximately five times the
prescribed dosage.”
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DeCordova: The Issues
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“Defendants at trial and on appeal have argued that,
because it can be predicted that a certain
percentage of errors will occur in filling pharmacy
orders, and because not all errors are negligent, the
jury could have reasonably inferred that the mistake
made by the University’s pharmacy was the type of
calculation error that was due not to negligence, but
rather to a statistical error rate that cannot be
eliminated.”
DeCordova: The Results
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“Some negligence in the course of human
endeavors is predictable. The mere fact that a
certain percentage of errors will predictably
occur provides no basis to infer that an error
on a particular occasion was free of
negligence. To err is human. To forgive divine.
To be responsible for injuries caused by
undisputed negligence is the law of this state.”
DeCordova Case Summary
It is usually impossible to discover the cause of
pharmacy errors.
 Negligence and the making of mistakes are
usually viewed as being different, but in
pharmacy they are the same.
 Pharmacy is a “no mistakes” profession.
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Error in Medicine
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“Forgive and Remember”
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“That humans make 0.1 percent errors on prescriptions may be
forgivable; that hospitals don’t take obvious actions to protect
themselves and patients, well within state-of-the-art, is not.”
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Charles Bosk
Michael Millenson
“Almost all accidents result from human error, it is now
recognized that these errors are usually induced by faulty systems
that ‘set people up’ to fail. The great majority of effort in
improving safety should focus on safe systems, and the health care
organization itself should be held responsible for safety.”
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The IOM Report
Alternative Self-Regulatory Responses
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Do Nothing.
Punishment.
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Advantages
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Practical Appeal.
Political Appeal.
Emotional Appeal.
Disadvantages
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Ineffective
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Too little
Too much
Unreliable
Unfair
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Centralized Data
Reporting and Feedback
Centralized QA
Program
Error Prevention Clinic
Mandatory Error
Prevention CE
Mandatory CQI
Harco Drugs v. Holloway
669 So.2d 878 (Ala. 1995).
“The prescription was illegible. The pharmacist
gave the plaintiff Tambocor, an antiarrhythmic
drug used by cardiologists. It is undisputed that
the prescription actually called for Tamoxifen.
The pharmacist did not attempt to call the
physician to verify the accuracy of her reading of
the prescription and did not even try to question
Ms. Holloway about why her oncologist was
supposedly prescribing a heart medication for
her.”
Harco, cont’
“We note that the jury was also informed of 233
incident reports that had been prepared by Harco
employees during the three years preceding the
incident. This evidence, in addition to evidence of
complaints filed with the State Board of Pharmacy and
the evidence of lawsuits filed alleging misfilled
prescriptions, was relevant to show Harco’s
knowledge of problems, and Harco’s having failed to
initiate sufficient institutional controls over the
manner in which prescriptions were filled.”
Harco: Summary
Individual pharmacists must be competent and
caring within a practice system.
 Pharmacies must provide the best possible system
so that pharmacists will succeed.
 A good system of institutional controls organizes
the system as interlinked processes with defined
steps, it records success/failure, and it empowers
everyone to reflect on the past and improve in the
future.
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CQI as a Risk Management System
RPh. & P.T. dispense according to established Procedures
Quality related event
occurs
Quality
Consult
held
Incident Reports and
near-miss documentation
Quality Supervisor
Reviews
Quality Supervisor
Reviews
Management Kept
Informed of Progress
Quality Inservice
Developed
Management Reviews Policies and
Adjusts PRN
Fixing the Process With Specific Techniques
Select and use techniques that put theory into
practice.
 Use the techniques to catch or absorb errors.
 Recommit to existing policies.
 Develop new techniques with consensus of all
stakeholders.
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“Mark-It”
 Identify
those prescription items
causing "problems"
 Place colored tape on that part
of the shelf-or put on different
shelf
 To cause "a second thought"
Basket System
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Reduces likelihood of prescriptions for one patient
being confused with those for another patient.
All items for a patient’s prescription are placed in a
basket.
“Two-Second Rule”
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No vial is left with a label and without medication for any
longer than two seconds.
Same for any vial with medication and without a label.
Sack Check
Check medication label with name on sack.
 Check name and phone number on sack with
person requesting medication.
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Pharmacist Only Questions
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Why does my medication
look different this time?
Why are the directions
different from those my
doctor told me?
Are you sure you spelled
my doctor’s name
correctly?
If I’m allergic to aspirin can
I take this?