Cases & Commentaries

The Wrong Shot: Error Disclosure

Spotlight Case
Commentary By Thomas H. Gallagher, MD; Wendy Levinson, MD

Case Objectives

  • Describe the rationale for disclosing
    harmful errors to patients.
  • Describe the specific information that
    patients want disclosed following a harmful error.
  • Define the "disclosure gap" and the
    barriers that contribute to the difficulty health care workers
    experience in disclosing errors to patients.
  • Recognize the emotional impact that
    errors have on health care workers and how these emotions can
    impair the disclosure process.
  • List specific steps that institutions
    can take to enhance the disclosure of harmful errors to
    patients.

Case & Commentary: Part 1

A 10-year-old child from India presented to
his pediatrician's office for a school physical. The child had no
past medical history, was in excellent health, and all
immunizations were up to date with the exception of Hepatitis B.
The physician discussed the issues around vaccination with the
patient's father and obtained consent. The nurse drew up the
vaccine and the physician administered it. After administration,
the physician went to record the lot number and discovered that a
dose of vaccine for Hepatitis A had been given instead of Hepatitis
B.

Adverse drug-related events are common in both
the inpatient and the outpatient setting. Studies of hospitalized
patients find that up to 6.5% had an adverse drug event and about
25% of those were preventable.(1) While less
is known about adverse drug events in outpatients, a recent study
demonstrated that over 25% of outpatients had experienced a recent
adverse drug event, with 40% of those being either ameliorable or
preventable.(2)

Ethicists have long recommended that patients be
told about all harmful errors, to demonstrate respect for patients
and foster honesty in the patient-provider relationship.(3,4)
Increasingly, hospital policies and regulatory agencies also
require disclosure of "unanticipated outcomes."(5) Yet
disclosure of errors, particularly discussion of the details of the
event, continues to be uncommon. In one recent national survey of
both the public and physicians, only one-third of respondents who
had personally experienced a medical error said that the involved
health care professionals had disclosed the error or apologized to
them.(6)

When a harmful error takes place, patients first
want an explicit, jargon-free statement that an error occurred and
a basic description of what the error was and why it
happened.(7) Patients
dislike explanations that seem evasive. Second, patients want to
understand the implications of the error for their health and how
their health care workers will deal with the consequences. Third,
patients want to know how the physician, other health care workers,
and the health care system will learn from this error;
understanding how future errors will be prevented is more important
to patients than many physicians appreciate. Fourth, patients want
their physician to apologize, which demonstrates that the physician
genuinely cares about what happened.

However, health care workers may hesitate to
provide this information to patients. Studies of physicians'
attitudes have identified several important barriers to disclosure,
such as physicians' fear of litigation, concern about whether the
information might harm patients, and discomfort with how to share
the information.(7-9) These
barriers can lead physicians to "choose their words carefully" when
talking to patients about errors, mentioning the adverse event but
avoiding explicitly stating that an error occurred. In addition,
physicians want to apologize to patients but worry that doing so
will increase their legal liability. Physicians further wonder
whether to take personal responsibility for an error, especially
given the patient safety movement's emphasis that most errors are
not failures of individual providers but rather breakdowns in the
system of care.

This "disclosure gap"—namely the mismatch
between recommendations that all harmful errors be disclosed to
patients and the evidence that, in practice, such disclosure is
uncommon—has two potential interpretations. Clinicians may
appreciate that error disclosure is "the right thing to do" but
experience insurmountable obstacles in their attempts to tell
patients about errors. Alternatively, this disclosure gap may
reflect under-appreciated but morally relevant complexities in the
decision about whether and how to disclose errors to patients. For
example, the patient in this case suffered minimal if any harm; it
is even possible that the inadvertent administration of a dose of
Hepatitis A vaccine may have helped the patient. Little is known
about whether disclosure of errors that cause minor harm or
disclosure of near misses is desirable from either patients' or
physicians' perspectives.

Case & Commentary: Part 2

Without hesitation, the physician informed the
father that the wrong vaccine had mistakenly been given to the boy.
He explained the usual indications for Hepatitis A vaccination and
emphasized that this vaccine would not bring any harm to the boy
and may even protect him from illness in the future. He suggested
that the boy still receive the Hepatitis B vaccine. The father
became extremely angry. He refused to allow further vaccination and
proceeded to report the incident to the clinic
administrator.

Patients' reactions to hearing about such an
event depend in part on the content of the disclosure as well as
the communication skills used to deliver this information. Patients
especially value understanding how an error happened and how
recurrences will be prevented, information physicians (as in this
case) often fail to share with patients. We believe that an
essential component of narrowing the disclosure gap is for
physicians to begin conceiving of error disclosure not as "service
recovery" but rather as an integral component of quality
improvement.(10) The father
might have been less angry had he learned that, as a result of this
error, such vaccines were now being stored in separate and clearly
labeled spots in the physician's office. Furthermore, the need to
tell the family about an error's cause and prevention may stimulate
the physician to think more critically about why the error happened
and develop a robust prevention plan, thereby enhancing the quality
of future care. Determining exactly how an error happened and
formulating a plan for preventing recurrences can be especially
challenging in the outpatient setting, where the resources to
conduct formal error
analyses may be absent.

Empathic communication techniques can also help
physicians respond to patients' anger.(11)
Empathy refers to the process of understanding and explicitly
acknowledging patients' feelings, and listening carefully as
patients share their distress. As in other difficult communication
situations, such as delivering bad news, the health care
professional must listen attentively and offer support when a
patient is expressing a powerful emotion, whether the emotion is
sadness, anxiety, or even anger.(12) Usually,
the intensity of the patient's feeling will diminish as the
physician listens, acknowledges, and, when appropriate, validates
the feeling in a caring fashion. Communicating empathically can be
especially challenging in the setting of an error, when the
patient's upset emotions may be explicitly directed at the
physician.

For some patients, anger following a medical
error leads them to file a malpractice claim. Considerable debate
currently exists about whether full disclosure of medical errors
makes malpractice claims more or less likely. Many have argued that
skillful disclosure may assuage such anger and lessen the chances
of a malpractice claim.(13-15) However,
skeptics argue that the reason few injured patients actually sue is
because they were unaware that the error occurred, and that more
open disclosure could actually precipitate lawsuits.(16) Even a
remote chance that error disclosure could prompt a malpractice suit
is worrisome to physicians, given the impact such a claim could
have on physicians' already skyrocketing malpractice premiums, as
well as the need to report successful claims to the National
Practitioner Databank and hospital credentials committees.
Wholesale tort reform and adoption of a no-fault malpractice system
would clearly facilitate full disclosure of errors to patients.
Yet, the current political climate is unlikely to support such
dramatic tort reform.(17) In the
meantime, individual clinicians must still decide what to tell
patients about medical errors. Overall, we recommend that
clinicians respond to medical errors with an underlying assumption
of full disclosure, but work closely with experienced risk managers
throughout the disclosure process to minimize unanticipated legal
risks.

Case & Commentary: Part 3

After the vaccine incident, the physician in
this case felt responsible for the loss of trust and the missed
opportunity to administer an important vaccine to a child.

Physicians frequently experience powerful
emotions following a medical error.(7,18-20) As
highly responsible individuals, it is not surprising that most
physicians will feel a sense of shame and culpability for errors,
disappointment about failing to practice medicine to their own
standards, and fear about possible law suits. For some physicians,
the emotional aftermath of an error can include physical symptoms
such as sleeplessness, difficulty concentrating, and anxiety.

We believe that addressing health care workers'
emotional needs following errors is critically important. The
presence of such emotional distress can diminish physicians'
well-being and impair the disclosure process. Some distraught
physicians may mistakenly assume that an adverse event was due to
an error and disclose this information to the patient, when on
closer analysis the adverse event was actually not preventable. For
other physicians, feelings of guilt and embarrassment can prevent
them from disclosing a serious error to the patient. While
physicians may desire to discuss the circumstances of the error and
their feelings with a trusted colleague, many risk managers warn
that such conversations between physicians can be subpoenaed in a
court of law.

Institutions can take several steps to improve
error disclosure. First, they can provide emotional support for
health care workers as an explicit component of their patient
safety program. In addition, they should offer communication skills
training and the opportunity for physicians to practice disclosing
errors, analogous to workshops that teach physicians to discuss
other difficult topics such as end-of-life care. We have used
standardized patients to allow surgeons to practice disclosing a
major error and to receive feedback; to date, these surgeons report
this to be a valuable and novel learning experience. Finally,
education of physicians and other health care workers about the
causes and prevention of errors can dispel the misperception that
errors are usually the fault of individual providers.

Take-Home Points

  • Harmful errors should be disclosed
    to patients. Such disclosure should include an explicit statement
    that an error occurred, basic information about the error's cause
    and prevention, and an apology.
  • Physicians should seek help from institutional
    risk managers or others skilled in disclosure before discussing an
    error with a patient.
  • Greater attention
    should be paid to the relationship between error disclosure and
    quality improvement.
  • Institutions should support error disclosure both
    by providing communication skills training and by implementing
    programs to support health care workers' upset emotions following a
    medical error.
  • Further research is
    needed about the relationship between disclosure and malpractice,
    as well as on the factors that influence physicians' approach to
    error disclosure.
  • Effective error disclosure could enhance patient
    safety and improve the quality of
    care.

Thomas H. Gallagher,
MD
Assistant Professor of Medicine, Medical History & Ethics
University of
Washington

Wendy Levinson,
MD
Professor of Medicine
St. Michael's Hospital
University of Toronto

Faculty Disclosure: Drs. Gallagher and
Levinson have declared that neither they, nor any immediate member
of their family, have a financial arrangement or other relationship
with the manufacturers of any commercial products discussed in this
continuing medical education activity. In addition, their
commentary does not include information regarding investigational
or off-label use of pharmaceutical products or medical devices.

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