Transcript Disclosing Medical error Nau

Disclosing Medical Error to
Patients
Konrad C. Nau, MD,FAAFP,CPE
Professor and Chair, Department of Family Medicine
WVU Health Sciences Center-Eastern Division
Objectives
Review the incidence of error
 Explore the obligation of error disclosure
 Discuss the evidence about physician and
patient expectations of error disclosure
 Enumerate the risks & benefits of medical
error disclosure
 Learn an effective method of disclosing
medical error to patients

Patient Safety vocabulary

Medical Error
Failure of a planned action to be completed as
intended
 Use of a wrong plan to achieve an aim.


Adverse Event
Injury that results from medical care
 Not a part of the natural disease process

Medical Errors &
Adverse Events
Non-preventable
Medical Errors
AE
Near
Miss
Preventable AE
Serious Medical Errors
Error Happens

The commitment of medical errors is “ an
inevitable accompaniment of the human
condition”
Lucian Leape JAMA 1994
Medicine is a “probabilistic science”
 Complex systems of care

Location of Medical Care/Error
Incidence of Medical Error

Intensive Care Units

20% of ICU pts had an Adverse Event
 45%
were preventable
 13% were life threatening or fatal

15 serious errors/100 patient-days
 11%
potentially life threatening
 61% occurred during execution of medication
treatments

Slips and lapses were most common reason
Crit Care Med. 2005 Aug;33(8):1694-700.
Incidence of Medical Error

Hospitals
3.7% of admissions experience iatrogenic AE
 28% of AE due to negligence
 14% of AE lead to death

N Engl J Med. 1991 Feb 7;324(6):370-6.

6.5 Adverse Drug Events/100 admissions
Incidence of Medical Error

Ambulatory clinics
Medline/Embase review
 Medical error in 5 – 80 /100,000 visits

 Mostly

diagnosis and treatment related
Prescription errors identified in 11% of all
prescriptions
 Mostly
dose related
Fam Pract. 2003 Jun;20(3):231-6
Incidence of Medical Error

Ambulatory clinics
Risk management database study
 8 academic clinics over 5.5 years
 3.7 reported Adverse Events / 100,000 visits

 23%
caused permanent disabling injury
 3% caused death

83% were preventable
J Fam Pract. 1997 Jul;45(1):40-6.
Personal Experience of
Medical Error
Have you been personally involved in preventable
medical error in your own or your family member's
medical care ?
70
60
50
Yes
No
Don't Know
40
30
20
10
0
Public
Physicians
Harvard School of Public Health,2002,
Medical Errors: Practicing Physician & Public Views
Medical Error Perception
How often are Preventable Medical Errors are made?
Public
Physicians
60
50
40
30
20
10
0
Very Often Somewhat
Often
Not Very
Often
Not Often
at All
Harvard School of Public Health,2002,
Medical Errors: Practicing Physician & Public Views
Don't
Know
Disclosure of Medical Error
Obligation for Error Disclosure

“The man is a doctor….Where else but in
medicine do you find men and women who
never admit a mistake? Who talk more than
they listen, and feel entitled to withhold
crucial information?”



Marjorie Williams
Washington Post, December 2003
Commentary on Howard Dean, MD and his
US Presidential bid.
Sources for Obligation of
Error Disclosure
AMA Code of Medical Ethics
 American College of Physician’s Ethics
Manual
 Consequentialist Theory
 Deontological Theory or Principalism

AMA Code of Medical Ethics
When a patient experiences significant medical
complications that may have resulted from the
physician’s mistake or judgment:
 the physician is ethically required to inform the
patient of all the facts necessary to ensure
understanding of what has occurred,
 so as to enable the patient to make informed
decisions regarding future medical care

Council on Ethical and Judicial Affairs. (1997)
American College of Physicians
“physicians should disclose to patients
information about procedural or judgment
errors made during care
 if such information is material to the patient’s
well-being “

ACP Ethics Manual (1998)
American College of Physicians

Although medical errors do not
necessarily constitute improper,
negligent, or unethical behavior,

failure to disclose them are all three.
ACP Ethics Manual (Annals Int Med 1998)
Ritchie JH, Davies SC (BMJ 1995)
AMA & ACP Ethics
Professional groups clearly mandate
disclosure of “significant” medical error
 Unclear about obligation to disclose “minor
errors”


Minor = errors without material consequence to
patient’s well being.
Consequentialist Theory
Supports behavior that maximizes net good
 Requires specifying harms and benefits to a
specifically identified moral group
 Problem: multiple moral groups are involved
in medical error

Patient
 Physician
 Nurse
 Hospital Administration

Consequentialist Theory
Medical Error Case:
During a weekend checkout mixup, Resident A
mistakenly orders laxative for Patient X, instead
of Patient Y. Patient X has several diarrhea stools
during the night.

What do you disclose (and to whom) on
morning rounds?
Deontological Theory or
Principalism
Deontological theories hold that some rights
must not be violated even if it would produce
the most overall good.
 Principles in Tension


Principle of Patient Autonomy
 Freedom
to choose
 Informed Consent principle

Principle of Non-maleficence
 Legal/ethical
term for “Do no harm”
 Similar to medical term “primum non nocere”
"Primum non nocere"

“First do no harm” (Latin)
Roman physician Galen
 Introduced to US and British medicine in 1860


“As to disease make a habit of two things —
to help, or at least to do no harm. The art
consists in three things - the disease, the
patient, and the physician.”
Hippocrates in Epidemics, Book 1
 Not in the Hippocratic Oath

Medical Error: Pt Autonomy &
"Primum non nocere"

Did the error harm the
patient ?



Will disclosure promote
patient autonomy?


Significant / serious
Minor
Empowered to make
therapy or provider choices
Will disclosure of the error
harm the patient ?


Emotional distress
Erode patient trust
Error Disclosure: Physicians

Physicians generally feel they SHOULD
disclose medical error (iatrogenic incident)
70% of European Intensivists (Vincent,1998)
 80% of MSIV and Residents (Sorokin,2005)
 71% of Emergency Physicians (Hobgood,2005)
 ___% of Family Physicians (Gallagher,2003)

Error Disclosure: Physicians
But……
 Fewer Physicians actually DO or WOULD
disclose an iatrogenic incident
30% in general (Rosner,2000)
 32% of European Intensivists tell patients/families
(Vincent,1998)
 24% of House Officers tell patients (Wu, 1997)
 54% of House Officers tell attendings (Wu, 1997)

Error Disclosure: Patients

Most Patients Desire Disclosure
76% of Emergency Dept patients
(Hobgood,2002)
 98% of California Internal Medicine pts
(Witman,1996)
 98.8% of New England Health Plan pts
(Mazor,004)
 99% of parents of North Carolina Pediatric pts
(Hobgood,2005)

Error Disclosure: Patients
Reaction of Health Care Professional
to Medical Error
Told You
31%
Did not tell
you
69%
Harvard School of Public Health,2002,
Medical Errors: Practicing Physician & Public Views
Effects of Non-Disclosure

When patients learn of error from someone
other than physician they feel:
Anger
 Bitterness
 Betrayal
 Sense of humiliation
 Loss of trust
 Suspicion of cover-up

The Disclosure & Apology Gap
Most doctors feel they
should disclose error.
Nearly all patients want
to be told about errors
Disclosure and Apology
Only occurs 30% of the time
Apology

Disclosure




Ethical obligation
Informed Consent
Truth Telling
Involves telling what
happened

Apology





Therapeutic obligation
Allows patient healing
Allows doctor healing
Allows patient to
recognize our humanity
Involves expressing you
are sorry
Apology
Case: Physician orders penicillin for patient
allergic to amoxil and patient has anaphylaxis
requiring ICU treatment.
3 apologies : what do they really say ?
 “I’m sorry that you had to go through that reaction.”
 “I’m sorry I ordered the penicillin, but I was up all
night and I guess I was tired.”
 “I’m sorry I ordered the penicillin that we know you
are allergic to.”
Why the Disclosure Gap
Apology is hard to do
 Medical errors are often complex
 Lack of physician training in this special
communication skill
 Fear of loss of reputation
 Fear of causing emotional damage to the
patient
 Fear of increasing liability/lawsuits

The Process of Disclosing
Medical Error to Patients
Western Cultural
Expectations in Errors
(Berlinger & Wu ,J Med Ethics 2005)
 Confession


Full disclosure to the patient
Repentance
Apologize
 What will be done to prevent recurrence


Forgiveness
Physicians need to forgive themselves so that
learning from the incident and healing can
begin.
 Foundation laid for possible future patient
forgiveness of the physician.

What Patients Desire After
Medical Error

What happened ?


Apology


Sincere remorse
Medical +/- financial compensation


Full immediate disclosure
How will patient get through this
What is being done to prevent future errors?

Sense that their tragedy may help others
Error Disclosure Process
1.
2.
3.
4.
5.
Prepare for the meeting
Disclose the Error
Apologize
Establish a medical +/- fiscal plan
Outline how future similar errors will be
prevented
1. Prepare for the Disclosure
Get your facts straight
 Discuss significant errors with colleagues
who can assist you (Risk Mgr., VPMA)
 Notify your liability carrier
 Set the scene

Private
 Give patient option for support to be present
 Interruption free

2. Disclose the Error
DO
 Maintain “open body language”
 First fire a warning shot.
 Simply state the error in layman’s terms.
 Stop talking…and let the patient react.
 Answer the patient’s questions
 Touch patient -“hands - elbows area”
2. Disclose the Error
DO NOT
 Adopt “closed body posture”
 Use medical jargon
 Forget to BE QUIET
 Get defensive about questions
 Guess at facts you are not absolutely certain
about
 Inappropriately touch the patient by patting
on the head or shoulder
3. Apology
DO
 Make a sincere apology
 Take responsibility
DO NOT
 Make excuses. “I’m sorry, but………”
 Finger point
 Blame others
4. Establish medical +/- fiscal
plan
How will the harm be treated
 Empower the patient

Choice for second opinion/consultant
 Possible transfer of care may be entertained


Financial Plan
May come in later conversations
 How will medical bills from this incident be
handled
 Will there be a negotiated payment for “injury”


Open the door for another meeting
5. How will future errors be
prevented
Gives patients a sense that someone else
might be helped as result of their tragedy
 Will you be doing a Root Cause Analysis ?
 Give them a sense of timeframe for your
actions

Medical Disclosure
BENEFITS


Makes the process more
“human” for physician
and patient
May reduce needless
litigation for maloutcome and minor
errors
RISKS


Patient will suspect
“cover-up” if disclosure
facts are not complete
and truthful.
You may feel
disappointed if you don’t
prevent litigation in
gross negligence that
results in death or major
disability.
Optimal Role of your
Organization
Set an institutional expectation that patients
are entitled to disclosure and apology
 Train staff in communicating about adverse
events
 Develop support systems

For the injured patient
 For the “the second victims of medical error” (the
professionals who contributed to the error)

Conclusion
“The most fruitful lesson is the conquest of
one’s own error.
 Whoever refuses to admit error may be a great
scholar but he is not a great learner.
 Whoever is ashamed of error will struggle
against recognizing and admitting it, which
means that he struggles against his greatest
inward gain.”

Goethe, Maxims and Reflections