Download ECKERD PHARMACY RISK MANAGEMENT PROGRAM

Reducing Medication Errors –
Update 2007
David B. Brushwood, R.Ph., J.D.
The University of Florida
College of Pharmacy
Learning Objectives
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Describe the threats to quality that are
present in pharmacy practice.
Describe techniques and procedures that
can be used to reduce pharmacy errors.
Develop practices that will facilitate
pharmacy error detection and prevention.
Facilitate the development of collaborative
practices that are sensitive to risk
management concerns.
Liability For Medication Errors
Types of Tort Liability
 Intentional
 Negligence
 Strict Liability
 Product Liability
 Nuisance
 Defamation
Elements of Negligence
 Action or Omission
 Duty of Care
 Breach of Duty
 Actual Cause
 Proximate Cause
 Damages
Traditional Pharmacist Negligence
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Order Processing Error
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Wrong
Wrong
Wrong
Wrong
Wrong
drug
directions
strength
dosage form
patient
Other Errors
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Breach of confidentiality
Improper compounding
Emerging Pharmacist Liability
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Courts are now dealing with expanded
pharmacist ability an recognition of preventable
problems with drug therapy.
Basic Rule: No “generalized” duty to warn.
Exceptions:
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Obvious inadequacy on the face of the order.
Special knowledge of the pharmacist.
Increased consumer expectation through advertising
or other affirmation.
Voluntary undertaking to provide service.
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
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
CQI and the Florida BOP
64B16-27.300 Standards of Practice -- Continuous Quality Improvement
Program.
(1) "Continuous Quality Improvement Program" means a system of standards and
procedures to identify and evaluate quality-related events and improve patient
care.
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(2) "Quality-Related Event" means
the inappropriate dispensing of a
prescribed medication including:
(a) a variation from the prescriber's
prescription order, including, but not
limited to:
1. dispensing an incorrect drug;
2. dispensing an incorrect drug
strength;
3. dispensing an incorrect dosage
form;
4. dispensing the drug to the wrong
patient; or
5. providing inadequate or incorrect
packaging, labeling, or directions.
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(b) a failure to identify and
manage:
1. over-utilization or
under-utilization;
2. therapeutic duplication;
3. drug-disease
contraindications;
4. drug-drug interactions;
5. incorrect drug dosage or
duration of drug treatment;
6. drug-allergy interactions; or
7. clinical abuse/misuse.
CQI Components
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P&P Manual
CQI Committee
Record QREs
Review Record at least once every 3
months
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staffing levels
workflow
technological support
Summarization Document
Protection from Discovery
Get It In Writing
P&P Manual
Forms
Pharmacist Final Check
Partner Check
QRE Causal Followup
Checklists
Responding to Complaints
Ambiguous Rx's
Quality Process
Guidelines
Quality Consult
Explaining Problems
Documenting Errors
Enforcement Activity
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Inspector looks for evidence of CQI
program and compliance.
Inspector is educator and enabler, to
prevent errors not react to them.
Punishment for failure to conduct CQI, not
for failure to be perfect.
Changing the Face of
Medication Errors
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Facts of the Powers case
 Patient had visited physician at least 25 times in 6 months.
 Prescriptions for OxyContin, Percocet, Soma Xanax, Valium
 Patient died from “combined drug overdose (oxycodone,
diazepam).”
Allegations of negligence in Powers case
 Rxs filled too frequently
 Two opioids are “contraindicated,” opioid and
benzodiazepine are “contraindicated.”
 High doses of opioids indicate addiction.
Court of Appeals (intermediate court)
 Reversed dismissal of case by trial court.
 Certified question to Supreme Court due to prior precedent.
Prior Relevant Florida Case Law
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McLeod case
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Pysz case
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OBRA-90 does not establish private right of action.
Sanderson case
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LTCF has no duty to perform DRR, but amendment permitted.
Johnson case
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Pharmacist has no duty to warn that single C-II hypnotic may be
addictive.
Sharp case
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Pharmacist has no duty to warn that drug is defective.
Pharmacist who voluntarily undertakes to counsel must do so
with due care.
Dee case
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Duty to inquire when C-II Rx is 4 months old.
Powers Case Arguments to
Florida Supreme Court
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Polarized adversarial perspective of litigation
does not reflect “radical center” viewpoint.
Pharmacy Argument
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McLeod established “clear line” limiting pharmacist
liability to order processing error.
Expanded liability for pharmacist would jeopardize
physician-patient relationship.
Patient Argument
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Pharmacists have the ability to discern problems.
Patients expect pharmacists to consult when
problems arise.
Florida Supreme Court Decision
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“We have determined that there is no
actual conflict and that we should exercise
our discretion and discharge jurisdiction of
this cause.”
Effect of opinion is to reinstate case
against pharmacy.
All previous opinions are good law.
Case now continues in preparation for
trial.
Establishing the Standard of Care
in Pharmacy
To avoid liability for medication errors a
pharmacist must be competent and caring.
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Types of Competence
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Technical
Judgmental
Types of Care
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Normative
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Ability
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Knowledge
Skill
These are factors
within a professonal
role.
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Quasi-normative
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What should be done
under ordinary
circumstances.
What should be done
under special
circumstances.
These are factors of
professional role.
Collaborative Drug Therapy Management in
Florida 64B16-27.830
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Prescriber Care Plan
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Transferable Patient Care Record
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Initial drug therapy.
Labs to be ordered, monitored, interpreted.
Conditions for execution of subsequent orders.
Contact with physician.
Patient-Specific Orders
Progress Notes
Pharmacy
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Distinct Pharmaceutical Care area (sit down).
CQI Program
Collaborative Practice
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This is teamwork. Welcome to the team.
We are all equal, but some are more equal than
others.
Problems with pharmacists on the team.
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The “thin skinned” pharmacist.
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“Fraidy Cat” pharmacist.
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“The doctor ignored me and treated me like a child. I’ll
never make a another recommendation to her.”
“My doctors accept 100% of the recommendations I make.”
“Rambo” pharmacist.
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“I am going to document in the patient’s chart the evidence
that supports my views and force them to respect me as the
drug expert.”
Documentation
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It is the most important activity, because it
endures.
“If if isn’t documented, then it didn’t happen.”
Established evidence of the value of consultant
pharmacy services.
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Payors
Surveyors
Inspectors
Lawyers
However… There are risk management
implications of documentation. It is a source of
errors.
Beginning the Progress Note
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Strongly Recommend …..
Recommend …..
Suggest ……
Consider …..
Perhaps consider …..
The degree of “handcuffing” decreases as
the list continues down from top to
bottom.
Hypothetical #1
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Documenting Patient Interviews and Observations
A new patient Rx for BP med you suspect may affect
mental status.
You note: “Hypertension: [Drug] started yesterday for
BP 160/105. Pt has 3 year Hx of being disoriented to
time and place, but alert. No other complaints. Will
monitor BP and possible sedation secondary to
[Drug].”
Next two times: “Disoriented as to place and time,
alert, no complaints.”
4th time your findings are same, but patient less alert.
You write: “Hypertension: Patient’s BP 140/90
indicates less anxious. ___________________ [Drug]
side effect suspected. Consider change to [Drug],
much less sedation.
Fill In The Blank
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“No change except less alert.”
“Disoriented as to place and time, less alert.”
“Disoriented as to place and time, no
complaints.”
“Disoriented as to place and time, less alert,
no complaints.”
“Mental status observed—no change. Less
alert, no complaints.”
“Mental status observed, shows patient less
alert but there are no complaints.”
Hypothetical #2
Documenting an Error
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New chemo order, patient has experienced
unanticipated nausea. Order for quantity
in 3 divided doses. PCP reflects this
quantity 3 times daily. You correct it. You
do not know if there will be permanent
injury
You write: Drug overdose: ___________.
Continue monitoring for toxicity.
Fill In The Blank
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“Problem with Dose. Reduction Made.”
“Complaints of severe nausea. Dose reduced consistent
with order.”
“Patient complains of nausea and other adverse effects
typical of high dose chemotherapy. Miscommunication
caused overdose. Dose reduced.”
Adverse effects for the past two days were far more
severe than usual. Should have given this more attention.
Dose reduced.”
“Suddenly realized dose too high. Patient previously not
experiencing problems. Dose reduced. Injury probably
not serious.”
“Patient repeatedly complained of nausea and other
adverse effects associated with chemotherapy, but I did
not believe this was dose related. For the first time
noticed dose higher than ordered, and reduced dose
immediately. Extent of injury unknown.”
Hypothetical #3
Documenting Blame
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PCP for new patient with OA. Pt says pain
excruciating for 3 years. FP treated with
ASA 325mg tid; did not believe pain
severe, distrusted NSAIDs.
You write: Osteoarthritis. ____________.
Severe pain for 3 years. Pursuant to PCP,
Rx ASA 600mg PO q4h regimen.
Fill In The Blank
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“Patient says family practitioner undertreated the
pain.”
“Patient says her famly practitioner treated her with
aspirin.”
“Patient says her family practitioner has been treating
the pain.”
“Patient says her family practitioner would not give her
anything stronger than aspirin.”
“Patient says her family practitioner did not believe
pain was real and gave her only aspirin.”
“Patient says she was followed by her family
practitioner who did not recognize seriousness of
pain.”
Hypothetical #4
Patient Expectations
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Pursuant to PCP, Pt will have gentamicin
for up to 4 weeks. Informed Consent has
been given, OBRA-90 has been complied
with. She has been told many times
about potential toxicity. Patient asks,
“How do you think I will do on this
medication?”
What should you say?
Select the Best Choice
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“Serious side effects are exceedingly rare.”
“It’s a safe drug and you can expect to do just
fine.”
“It is routine drug therapy and nothing much
ever goes wrong.”
“You can be optimistic. Serious adverse effects
are not common.”
“Everyone I know who has used this drug did
very well.”
“If you believe everything is going to turn out
fine, then it will.”
Doing The Right Thing
May Not Be Enough
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The Seven Cs
Be Correct—Accuracy with no coverups.
Be Complete—Necessary for quality care.
Be Concise—No “told ya so” notes.
Be Consistent—Don’t break a pattern.
Be Cautious—This is enduring material.
Be Concerned—And let it show.
Be Caring—The patient comes first.