The Medical Council of Ireland has always encouraged open disclosure. In their 2016 edition of its Guide to Professional Conduct and Ethics, it provides: “Open disclosure is supported within a culture of candor… Patients and their families, where appropriate, are entitled to honest, open and prompt communication about adverse events that may have caused them harm.
"When discussing events with patients and their families, you should: acknowledge that the event happened; explain how it happened; apologise, if appropriate; and assure patients and their families that the cause of the event will be investigated and efforts made to reduce the chance of it happening again.”
The Health Service Executive and the State Claims Agency launched a policy on open disclosure in 2013, having piloted it at two hospitals – the Mater in Dublin and Cork University Hospital – from October 2010 until October 2012.
However, despite the policy and encouragement of open disclosure, many doctors practice defensive medicine. This can partly be explained by the legal position and the lack of safeguards in place, which leaves the medical profession vulnerable to claims of medical negligence.
The long anticipated Civil Liability (Amendment) Act 2017 sought to address this by, among other things, creating legislative safeguards for the medical profession by promoting a culture of open disclosure. The act provides that any open disclosure and/or apology within the provisions of the act shall not invalidate insurance, constitute admission of liability or fault, or not be admissible in proceedings. Importantly, section 12 of the act states that a health-service provider ‘may’ make an open disclosure – however, there is no requirement to do so.
The act defines a ‘patient-safety incident’ as “an incident which has caused an unintended or unanticipated injury or harm to the patient and which occurred in the course of the provision of a health service to that patient”.
By contrast, the new Patient Safety Bill 2018 – which more closely resembles British law – requires open disclosure of any serious patient-safety incident.
According to the bill, ‘mandatory open disclosure’ requires the disclosure, by a health-service provider, of a “serious patient safety incident [that] is any unintended or unanticipated injury or harm to a service user that occurred during the provision of a health service.”
Like the act, the bill retains safeguards to prohibit any adverse effect on civil liability or insurance cover arising from an apology or disclosure.
Curiously, however, the bill’s explanatory note, while referring to such protections, states that notifications of reportable incidents or other patient safety incidents would be admissible in evidence for other civil proceedings and in criminal proceedings. The bill does not, however, provide examples of ‘other’ civil proceedings, but one might question whether professional inquiries – including those by the Medical Council or Bord Altranais – would fall within the definition of such other civil proceedings.
The first-ever empirical study evaluating similar laws in the United States found that laws that protect doctors who apologise for errors may actually impel more patients to sue. Benjamin J McMichael found that the effect of the apology laws was mixed. There was evidence to suggest that malpractice claims against surgeons could be reduced by such law, but they also had a perverse effect on patients’ propensity to litigate, in particular against non-surgeons.
The study found that, while apology laws do encourage physicians to apologise, the laws actually appeared to increase the number of lawsuits against non-surgeons and had little effect on the number of lawsuits against surgeons: “Assuming it is easier to detect the malpractice of a surgeon than a non-surgeon (which is likely, given that surgical errors are more obvious to patients than nonsurgical errors, like misdiagnosis or failure to refer), the increase in the probability of a lawsuit for non-surgeons and the absence of an increase for surgeons is consistent with apology laws encouraging apologies that contain a signal of malpractice.”
The study found that “apologies may alert patients to errors they would not have discovered otherwise, encouraging them to file suit instead of settling or dropping their claims before filing in court”.
The empirical analysis examined over 1.6 million hospital stays of heart-attack patients and found no evidence that apology laws reduced defensive medicine.
Further, apology laws do not decrease the intensity of treatment received by patients but, rather, they actually increase the medical resources used to treat heart-attack patients, consistent with an increase in defensive medicine.
If apology laws decreased malpractice pressure, physicians should be more comfortable sending patients home a little earlier. However, the reverse is true – physicians kept patients in longer in the presence of such laws.
Moreover, the lack of guidance about apologies could lead to confusion, with poorly executed apologies and ‘botched’ apologies blamed for an increase in the risk of patients suing.
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In conclusion, while it is ethically the right thing for a medical practitioner to acknowledge and/or apologise where a mistake, error, or patient-safety incident has occurred, mandatory open disclosure within the Irish healthcare system – akin to the duty of candour in Britain – may be welcomed.
One could argue that it would be unwise to advise any medical professional to acknowledge and/or apologise where a patient-safety incident occurred without having safeguards in place, otherwise one would be effectively fuelling medical negligence claims. Apology laws that protect disclosure are more common internationally. International experience indicates that open disclosure will happen when fostering the development of an open and honest culture. This would be in line with the Medical Council’s Guide to Professional Conduct and Ethics for medical practitioners, which refers to patients being entitled to honest, open, and prompt communication about adverse events that may have caused them harm, such as the present cervical cancer scandal.