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Non-Disclosure of Medical Errors – Law and Ethics

Ethics of Open Disclosure of Medical Errors

A new survey, Primary care physicians’ willingness to disclose oncology errors involving multiple providers to patients BMJ Qual Saf 2016;25:787-795, has found that the majority of primary care physicians given 2 hypothetical scenarios involving diagnosis of cancer, would not fully disclose a harmful medical error.  In both scenarios, more than half would not volunteer an apology or would offer only a vague expression of regret.

Disclosure to a patient of a medical error that has resulted in serious harm is almost universally agreed upon in Western countries: Fein SP, Hilborne LH, Spiritus EM,  et al,  The many faces of error disclosure: a common set of elements and a definition.  J Gen Intern Med. 2007;22(6):755-761.

The moral principle of beneficence means that a doctor must not do harm to others. When a patient seeks medical treatment they expect that competent treatment will be provided. Disclosure of medical errors by the doctor to the patient should be seen as a part of the principles of beneficence and non-maleficence. A patient should be told if they have been harmed by medical treatment.

Additionally, the principle of autonomy implies that a patient should have full information about their treatment and any medical errors that have occurred. Informed decision making about subsequent treatment decisions can only be made if the patient has been told about the error. A patient has the right to be told the truth. A failure to disclose the error compromises patient autonomy. Ghazal et al, J Clin Res Bioeth 2014, 5:2, A Medical Error: To Disclose or Not to Disclose, argue that according to Kant theory, and the principles of beneficence and autonomy, a “professional should strive for more truth telling and disclosure of medical errors.”

Legal Implications of Non-Disclosure of Medical Errors

In addition to ethical reasons as to why a patient should be told of a medical error, doctors have a legal duty to obtain informed consent to medical treatment, and breach of this legal duty may result in an action in medical negligence. In Wighton v Arnot [2005] NSWSC 637, the treating surgeon suspected that his patient sustained a nerve injury during surgery. Early disclosure and treatment would have greatly improved the patient’s prognosis. Doctors should be made aware that open discussion about a medical error may be required by law in their State or Country.

The way forward

As far back as 2001, in the United States, the Joint Commission on Accreditation of Health Care Organizations (JCAHO) mandated an open disclosure of any critical event affecting a patient. This was seen as an essential component for accreditation of health organisations.

In Australia, the Open Disclosure Framework was released by the Australian Commission on Safety and Quality in Health Care in 2013. Open disclosure by health service organisations is an accreditation requirement of the National Safety and Quality Health Service Standards (the NSQHS Standards).

Some countries have standards in place that encourage organisations and individual healthcare practitioners to report medical errors and openly discuss these errors with their patients. However, legislation mandating open disclosure seems to vary between States.

Whilst studies suggest that doctors are reluctant to discuss medical errors with their patients, it is important that doctors are educated as to the ethical principles, moral duties and legal obligations to disclose medical errors. Doctors should also be made aware of research which suggests patients are less likely to sue if they have been informed of the error and have received an apology.

In addition to doctor education, health care organisations need to create an environment conducive to disclosure. This can be done by integrating patient safety activities with risk management and providing training and support for healthcare providers such as doctors and nurses.

 

 

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Overview of Ethics in Medicine

The fundamental responsibility of a health care professional such as a doctor is to promote and restore health, prevent illness and alleviate suffering. Every life should be respected, and the dignity of the patient should be respected.

Before an ethical dilemma can be resolved, it is important that one has a firm grasp of all the facts including the patient’s diagnosis, prognosis, what the patient has been told and what they understand, and what the patient’s values are.

Where the law establishes a clear course of action, legal obligations should be followed. However, in situations where there is no clear legal requirement, the course of action may be unclear and hence the issue becomes an ethical one. Healthcare ethics is a difficult but interesting area where moral principles, medicine and science interact.

Care and compassion are important, as are the moral principles of:

  1. Beneficence: healthcare should be of benefit to the patient- their health, welfare, comfort.
  2. Autonomy: all decision-making should ultimately be the patient’s. Informed consent is important in this regard.
  3. Non-maleficence: avoidance of harm to the patient.
  4. Justice:  a patient should receive reasonable, dignified and equal access to medical care.

Some areas where clinicians are faced with dilemmas pertaining to healthcare ethics include:

  1. Balancing safety of health care with efficiency and limited resources.
  2. Improving access to healthcare.
  3. Addressing end of life issues in the context of increasing average life expectancies and aging populations.
  4. Access to medications which can be costly but life saving.
  5. Allocation of limited donor organs.
  6. Patient confidentiality.
  7. Disclosure of medical errors.

Many ethical dilemmas may have medico-legal implications. It is important that a clinician practises evidence-based medicine, is aware of their legal duties to a patient, and provides a reasonable standard of care that would hold up to professional review should there be any accusations of medical negligence.