CDM Exam 2 Ethics Required Readings © 2010 Nasser El-Okdi
I. Medical Errors
A. Disclosing Errors (Lo, Bernard)
i. Error refers to a failure of a plan to be completed as intended or the use of a wrong plan to achieve an aim
1. Can be either acts or omissions
2. May or may not result in harm to patients
a. When no harm is done it is called a Near Miss or Close call
3. May or may not be avoidable
ii. Adverse events are defined as undesired patient outcomes that result from medical care rather than from the underlying disease
1. Includes situations when treatment plan was appropriate and carried out correctly.
iii. Reasons not to disclose errors to patients or surrogates
1. The physician is not really responsible for the error
a. Individual physicians should not be held morally responsible for actions and events beyond their control
i. Therefore blaming the physician will not enhance patient safety, unless it is negligent/intentional behavior
b. Remedial education programs can be effective only in situations in which there is a deficiency of knowledge/skill
c. Most errors are a result of systems-level responses that provide additional defenses against the adverse consequences of errors
i. E.g., Coding, computerized ordering, etc.
ii. Addressing this issue is most effective
d. Uncertainty over cause and responsibility should not deter physicians from informing patients or surrogates about the error
2. Disclosure would harm the patient or the surrogate
a. Patients may worry unnecessarily à stress may prevent patients from seeking necessary care or accepting interventions
3. Disclosure would harm Healthcare professionals
a. May respond with anger, lawsuit, or leaving physician’s practice
b. Patients become more upset if they believe physciains are not forthright about an error
c. Concern over reputations and careers are also an issue
iv. Reasons to disclose errors to surrogates
1. Disclosure respects the patient
a. Patients want even minor errors disclosed to them, and they seek an apology when it occurs
b. Disclosure reassures them that they are receiving complete information about their care and would enhance their trust in physicians
c. Under the doctrine of informed consent physicians have an affirmative duty to provide the patient or surrogate with pertinent information about the patient’s condition and options for care
i. Goes beyond merely responding honestly to questions
2. Disclosure Benefits the Patient
a. Enables patients or surrogates to take steps to mitigate the harms that the error caused (e.g., monitoring and follow Tx)
b. May also allow patients to be compensated for harms resulting from errors (e.g. prolonged hospital stay, loss of income, etc.)
i. Patients will not be able to negotiate such compensation unless they are aware of the error
3. Disclosure benefits the physician
a. Apologizing is the expected social response and a prerequisite to making amends and being forgiven
b. May mitigate adverse impacts on physicians livelihood
i. Patients less likely to change doctors or pursue legal action if apology is given
c. Non-disclosure may worsen situation for patient, and legal liability may also be greater if the physician conceals negligent actions
i. More likely to sue the physician
4. Disclosure maintains the public trust
a. If the public perceives a pattern of nondisclosure, patients might believe that doctors are more concerned with protecting themselves then doing what’s best for patients
v. What should the physician say to patients?
1. JCAHCO requires hospitals to tell patients when unanticipated outcomes occur
2. The physician’s responsibility to the patient should prevail over any self-interest in concealing the error
3. The physician should take the initiative in disclosing relevant information
a. Physicians should explicitly acknowledge that an error has occurred and offer an apology
b. The physician needs to explain the error and its consequences.
c. The physician should explain what can and will be done to mitigate the harms to the patient and prevent this from recurring
4. A partial apology might be worse than none b/c paptients mmight view them as evasive and mean-spirited. Also patients tend to probe for details making partial disclosure a very bad idea.
vi. Situations in which disclosure is controversial
1. The error caused no harm
a. Near misses still need to be reported to quality improvement programs in order to identify system problems.
b. Burdening the patients with this information may have obvious negative impacts (loss of confidence in hospital/doctor)
c. Disclosure is likely to strengthen the doctor-patient relationship b/c patients respect physicians for being honest.
i. It may also promote patient well being (e.g. in drug allergies)
ii. Patients themselves may call attention to errors, making it difficult to disclose after the fact
iii. Little risk to disclose near misses, b/c patient not harmed therefore less likely to sue
2. Outcome would have been poor even without the error
a. In such situations the physicians should NOT say that an error was a contributing factor.
i. However the physician’s belief that the error caused no harm to the patient might be biased or self-serving.
ii. Should consult experienced colleague for advice
b. If family members ask physicians whether everything was done to prevent an adverse outcome.
i. On a literal level it would be deceptive to say that everything was done when the physician knows otherwise.
ii. The physician also needs to respond to the concerns of the survivors who ask what they could have done differently
3. Adverse outcome could NOT have been avoided
a. The physician needs to review the case to be certain that he standard of care was followed even though the patient agreed to the risks of the procedure.
b. The physician is still required to explain the unintended adverse outcome and express regret over it.
vii. Disclosing Errors by Trainees to an Attending Physician
1. Disclosure of serious errors by trainees to supervising physicians
a. Attending physicians are ethically and legally responsible for patient care.
i. Information should not be withheld b/c it may jeopardize patient care
ii. Attending may learn of such errors even if trainees do not disclose them.
iii. Failure to disclose error is worse than making them in the first place
iv. Covering up errors raises doubts about reliability, trustworthiness, and character.
b. Responses to errors by trainees.
i. Elicit and acknowledge the trainee’s emotional distress
ii. Review the medical issues and decisions
1. Supervisor can help the trainee learn from the error and make constrictive changes to prevent further ones.
iii. Discuss how to disclose the error to the patient or surrogate
viii. Errors by other health care workers
1. Ethical issues regarding errors by other health care workers
a. The reasons for disclosing errors to patients hold for errors by other healthcare workers as well as one’s own errors
b. Facts of the case may be unclear when others are involved
c. May interfere with self interests (i.e. parities may become irate and stop referring patients)
d. Physicians in training may fear retaliation from a senior physician who is making errors
e. Patients/family may vent on the reporting physician, not the responsible party
2. Responses to errors by other healthcare workers
a. Wait for the patient to ask
i. Problematic because physicians have an affirmative obligation noto disclose relevant information honestly to patients
b. Ask the other physician to disclose
i. The previous physician might choose not to tell the patient or might provide misleading information about the error
c. Arrange a joint conference
i. This approach allows the other physician to take the lead in revealing the error while ensuring that eh discussion is appropriate.
d. Tell the patient
i. It may undermine the relationships between the patients and previous physicians and between the two physicians
ii. Would be preferable to give the other physician the opportunity to talk the patient first
B. Uses of Error: Systemic Causes
i. Basically the author encountered many errors during his first year residency at one hospital
1. The atmosphere was heavy with little discussion of published evidence or management options, just instructions and recriminations
ii. After he switched hospitals (even busier) the errors stopped
1. This hospital had no private practice and the consultants commuted to work together in , were friends, and were accessible at all times
2. Had an open, sensitive, Hippocratic atmosphere that promoted intense communication with radiology and nuclear medicine.
3. Everyone learned from their mistakes as a team, became therapeutic conservatives, supported each other, and made constant use of library and medical reviews
iii. This was due to a difference in service management
C. Causes of Prescribing errors in hospital inpatients: a prospective study
i. Background:
1. To prevent errors made during prerscription of drugs, we need to know why they arise
2. Errors made during drug prescription are the most common type of avoidable medication error, and are hence an important target for improvement
ii. Findings:
1. Results suggest that most mistakes were made because of slips in attention, or because prescribers did not apply relevant rules.
2. Doctors identified many risk factors (work, environment, workload, whether or not they were prescribing for their own patient, communication within their team, physical and mental well being, and lack of knowledge).
3. Organizational factors were also identified, and included inadequate training, low perceived importance of prescribing, a hierarchical medical team, and an absence of self-awareness of errors.
iii. Interpretation:
1. To reduce prescribing errors, hospitals would train junior doctors in the principles of drug dosing before they start prescribing, and enforce good practice in documentation.
2. They should also create a culture in which prescription writing is seen as important, and formally review interventions made by pharmacists, locum arrangements, and the workload of junior doctors and make doctors aware of situations in which they are likely to commit errors.
iv. Other important concepts
1. Latent conditions are organizational processes and management decisions à lead to
2. Error producing conditions: environmental, team, individual, or task factors that affect performance à lead to
3. Active failures
a. Error- failure of planned sequence of actions to achieve desired goal because an adequate plan was incorrectly executed (skill based slips or memory based lapses) or because and inadequate plan was made (rule based or knowledge based mistakes)
i. Slips- actions in which there are recognition or selection failures
ii. Lapses- failure of memory or attention
iii. Mistakes: incorrect choice of objective, or choice of an incorrect path to achieve it
b. Violation- instances in which rules of correction behavior are consciously ignored
4. Defenses are designed to protect against hazards and mitigate consequence of failure. These can be inadequate as a result of latent conditions. Examples include nurses;/pharmacists, thought processes, etc.
II. Informed Consent and Refusal of Care
A. Informed Consent (Lo, Bernard)
i. What is informed Consent?
1. Agreement with the physicians recommendations
a. Patients usually agree with the physicians’ recommendations (common in acute illness when goals are clear, or one option is superior)
b. Consenting the patient- implying that it is foregone conclusion that the patient will agree.
2. Right to Refuse intervention
a. Competent patients have the power to reject their physicians recommendations about care
3. Choice among alternatives
a. A broader view of informed consent holds that patients should have the positive right to choose among feasible options in addition to the negative right to refuse unwanted interventions
4. Shared decision making
a. Repeated discussions allow physicians to educate patients about their conditions and alternatives for care, help them deliberate, make recommendations, and try to persuade them to accept the recommendations
ii. Reasons for informed Consent and Shared Decision Making
1. Respect Patient Self-Determination
a. People want to make decisions about their bodies and healthcare in accordance with their values and goals
b. Patient choice should be promoted because in most clinical settings, different goals and approaches are possible, outcomes are uncertain, and an intervention might cause both benefit and harm.
c. Physicians cannot accurately predict patient’s preferences.
2. Enhance the patient’s well being
a. Patient well-being can be judged only in terms of the patients goals and values.
b. Especially important when there are trade-offs between short-term and long-term treatment approach, when there is a small chance of a grave outcome, when the patient has unusual aversions toward risk or certain outcomes, and when there is uncertainty and disagreement among physicians.
c. Increases sense of control, self-efficacy, and adherence to plans for care inpatients.
3. Fulfill Legal Requirements
a. Physicians make patients sign informed consent forms leading to mechanical approach to informed consent amongst some physicians
b. Patients become cynical about informed consent due to legal issues.
iii. Requirements for informed Consent
1. Information to discuss with patients
a. The nature of the test or treatment
b. The benefits, risks and consequences of the intervention
i. Risks that are common knowledge, already known to the patient, of trivial impact, or very infrequent do not need to be discussed.
ii. Physicians DO need to discuss serious but rare risks, such as death or stroke.
iii. There is psychosocial risk as well (stigma, discrimination, etc.)
c. The alternatives and their benefits, risks and consequences
i. The alternative of NO INTERVENTION should be discussed
1. Explain adverse consequences of the refusal
ii. Patients may ask about outcomes of certain surgeons, doctors etc., as well as experience, the role of trainees in their healthcare
d. Physicians must take the initiative in discussing information rather than wait for patients to ask questions (patients don’t know which questions to ask)
e. The extent of disclosure will depend on clinical context
i. If there is only one realistic option that is highly efficacious, detailed consent is of little value.