# Presentation: 087959

## Department of Veterans Affairs Policy on Disclosing Adverse Events to Patients

- Noel Eldridge, MS
- Executive Officer
- VA National Center for Patient Safety
- _[noel.eldridge@va.gov](mailto:noel.eldridge@va.gov)_
- 6/6/05

- Dept. of VA National Center for Patient Safety

## Background

- The information in this briefing is based on a report of the National Ethics Committee (NEC) of the Veterans Health Administration (VHA).
- The policy is also in the VHA Patient Safety Improvement Handbook, and is the subject of a VHA Directive currently in preparation.
- See: _[http://www1.va.gov/vhapublications/](http://www1.va.gov/vhapublications/)_  (searchable) for documents.

- Dept. of VA National Center for Patient Safety

## NEC Report: Disclosing Adverse Events to Patients

- Institutional and professional policies that require the routine disclosure of adverse events to patients were first seen in the mid-1980s.  Codified in VHA in 1995.
- There are frequent questions about the basis of the policies and how they should be implemented.

- Dept. of VA National Center for Patient Safety

## Disclosure

- An important topic that seems frequently misunderstood.
- It may not always be done when it should be.
- The topic benefits from discussion – not just at conferences, but primarily at health care facilities.

- Dept. of VA National Center for Patient Safety

## The Bottom Line

- Routine disclosure is obligatory if:
- The adverse event has a perceptible effect on the patient that was not discussed in advance as a known risk....or
- The adverse event necessitates a change in the patient’s care...or
- The adverse event potentially poses a significant risk to the patient’s future health, even if the likelihood of that risk is extremely small....or
- The adverse event involves providing a treatment or procedure without the patient’s consent.

- Dept. of VA National Center for Patient Safety

## Disclosure & Discussion

- It’s sort of semantics, but...
- The word _“disclosure”_ suggests revealing or exposing something that is otherwise concealed.
- In general, something that occurred as a result of the inexorable progression of a disease or following a patient’s informed choice about treatment needs to be “_discussed_,” not “disclosed.”

- Dept. of VA National Center for Patient Safety

## Context

- Some clinicians may fail to disclose adverse events to patients even though they believe that disclosure is the right thing to do.
- For example, in a [non-VA] study of clinicians’ responses to a hypothetical case in which a drug error led to a patient’s death, one-third of the clinicians said they would disclose only incomplete or inaccurate information to the patient’s family.
- Utility and Duty as two bases for disclosing...

- Dept. of VA National Center for Patient Safety

## Utilitarian Ethics Basis for Recommendations

- Values actions that produce the greatest balance of benefit over harm...
- Evidence suggests that disclosure of adverse events is beneficial to patients, clinicians, and organizations.
- Timely disclosure makes it possible to initiate remedial care.
- Disclosure may also reduce a patient’s anxiety about what already occurred.
- In addition, patients who are fully informed are more likely to cooperate with treatment.

- Dept. of VA National Center for Patient Safety

## More Utilitarianism:Transparency Can Aid Action

- An organization that demonstrates institutional support for truthfulness and transparency by encouraging disclosure of adverse events to patients may help reduce the likelihood that similar events will occur in the future, and thereby improve the overall quality of patient care.

- Dept. of VA National Center for Patient Safety

## Duty-Based Ethics Basis for Recommendations

- Health care professionals have a duty to be truthful to their patients.  There are 3 foundations of the duty of “truth telling.”
- Respect for patient autonomy requires that patients be provided with information that they need to make health care decisions.
- Truth telling is part of an implicit promise professionals make to patients to act in the patient’s best interest..
- Truth telling is essential to assuring that patients trust their physicians. The therapeutic relationship relies on trust and is threatened by deception or concealment of information.

- Dept. of VA National Center for Patient Safety

## What Adverse Events Warrant Disclosure? 

- Disclosure of adverse events to patients should not be limited to cases in which the injury is obvious or severe.

- Dept. of VA National Center for Patient Safety

## 1) Disclosure is called for whenever an adverse event has a perceptible effect on the patient that was not discussed in advance as a known risk

- Dept. of VA National Center for Patient Safety

## ...perceptible effect on the patient that was not discussed...(1 of 4)

- _Whether the effect is perceptible only to the clinician, to the patient or family, or is obvious to all_. For example, a patient develops seriously abnormal liver function tests as a complication of a medication or procedure. Such an adverse event should be disclosed, even if the patient experiences no overt symptoms.

- Dept. of VA National Center for Patient Safety

## ...perceptible effect on the patient that was not discussed...(2 of 4)

- _Even if the effect is not actually harmful._ For example, the wrong side or wrong body part is shaved in preparation for surgery, but the mistake is discovered before surgery is performed. Although one could argue no real harm was done, disclosure is nonetheless required.

- Dept. of VA National Center for Patient Safety

## ...perceptible effect on the patient that was not discussed...(3 of 4)

- _Whether the effect is physical, psychological, or both._ For example, a patient who receives a double dose of pain medication may feel inexplicably “fuzzy-headed.” The adverse event must be disclosed even if there was no discernible physical effect.

- Dept. of VA National Center for Patient Safety

## ...perceptible effect on the patient that was not discussed...(4 of 4)

- _Whether the effect is actual or anticipated._ For example, if a patient is mistakenly given a dose of furosemide (a diuretic that dramatically increases urine output), disclosure is required because a perceptible effect is expected to occur.

- Dept. of VA National Center for Patient Safety

## 2) Disclosure is called for any time an adverse event necessitates a change in the patient’s care. 

- Dept. of VA National Center for Patient Safety

## ...any time an adverse event necessitates a change ...(1 of 1)

- An extreme example is an improperly performed surgical procedure that necessitates further (i.e., corrective) surgery. A less extreme example is a medication error that necessitates close observation, extra blood tests, or follow up visits that would otherwise not be required.

- Dept. of VA National Center for Patient Safety

## 3) Disclosure is called for when the adverse event potentially poses a significant risk to the patient’s future health, even if the likelihood of that risk is extremely small. 

- Dept. of VA National Center for Patient Safety

## ... potentially poses a significant risk to the patient’s future health... (1 of 1)

- For example,** **accidental exposure of a patient to a toxin associated with a rare but recognized serious long-term effect (e.g., increased incidence of cancer) requires disclosure.

- Dept. of VA National Center for Patient Safety

## 4) Disclosure is called for whenever the adverse event involves providing a treatment or procedure without the patient’s consent. 

- Dept. of VA National Center for Patient Safety

## ... providing a treatment or procedure without the patient’s consent...(1 of 1)

- Patients have a fundamental right to be informed about what is done to them and why. For example, if a patient, while under anesthesia, undergoes an additional unanticipated procedure, the adverse event should be disclosed regardless of whether the patient experiences any ill effects.

- Dept. of VA National Center for Patient Safety

## Other events?

- As a general rule, disclosure to patients of adverse events that do not fall in the above categories is optional and at the discretion of the clinicians involved. Cases should be considered individually and in relation to the specific circumstances.

- Dept. of VA National Center for Patient Safety

## Other topics in the Report ...

*Who Should Disclose?*
*When Should Disclosure Occur?*
*How Should Adverse Events Be Disclosed?*

- Dept. of VA National Center for Patient Safety

## Conclusion

- Although a variety of psychological and cultural factors may make clinicians and organizations reluctant to disclose adverse events to patients, the arguments favoring routine disclosure are compelling...

- Dept. of VA National Center for Patient Safety