Disclosing Medical error Nau

Disclosing Medical Error to Patients

Konrad C. Nau, MD,FAAFP,CPEProfessor 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

Medical ErrorsAE

Preventable AE

Non-preventable

NearNearMiss

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.


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


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


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

0

10

20

30

40

50

60

70

Public Physicians

Have you been personally involved in preventable medical error in your own or your family member's

medical care ?

Yes

No

Don't Know

Harvard School of Public Health,2002,Medical Errors: Practicing Physician & Public Views

Medical Error Perception

0

10

20

30

40

50

60

Very Often SomewhatOften

Not VeryOften

Not Oftenat All

Don'tKnow

How often are Preventable Medical Errors are made?

Public Physicians

Harvard School of Public Health,2002,Medical Errors: Practicing Physician & Public Views

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

What do you disclose (and to whom) on morning rounds?

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.

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 ? Significant / serious Minor

Will disclosure promote patient autonomy? 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 You31%

Did not tell you69% 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 theyshould disclose error.

Nearly all patients want to be told about errors

Disclosure and ApologyOnly 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

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.”

Case: Physician orders penicillin for patient allergic to amoxil and patient has anaphylaxis requiring ICU treatment.

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 ? Full immediate disclosure

Apology Sincere remorse

Medical +/- financial compensation 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. Prepare for the meeting

2. Disclose the Error

3. Apologize

4. Establish a medical +/- fiscal plan

5. 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


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”


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 mal-outcome 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 ofone’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

Documents

Disclosing Medical error Nau