A series examining issues from ethics to the evidence in evidence-based medicine, the influence of medical journals to the role of Big Pharma in our present and future health. Bill Madden and Tina Cockburn consider the open disclosure of medical mistakes in Australia. It’s generally accepted that open disclosure (“the open discussion of incidents that result in harm to a patient while receiving health care”) is the right thing to do. Elements of open disclosure include an expression of regret and a factual explanation of what happened, the potential consequences and the steps being taken to manage the event and prevent recurrence. The primary goals of open disclosure are to ensure that patients are made aware of medical errors (to enable proper treatment and compensation where appropriate); identify systemic problems and improve patient safety; and to minimise unnecessary litigation. In 2003, the Australian Council for Safety and Quality in Health Care (ACSQHC) obtained endorsement from the Australian Health Ministers of a National Open Disclosure Standard. The standard is a resource, with no legal standing, designed to assist those seeking to implement open disclosure. And it’s currently under review. Obligations and barriers Since July 1 2010, Australia has had a national registration and accreditation scheme for ten health professions, including doctors. The scheme saw the adoption of a widely supported code developed in 2009 by the Australian Medical Council. On the issue of error, the Medical Board of Australia Code of Conduct (Good Medical Practice: A Code of Conduct for Doctors in Australia) reminds doctors that: “[3.10] When adverse events occur, you have a responsibility to be open and honest in your communication with your patient, to review what has occurred and to report appropriately”. The Code makes it clear (at [3.10.3]) that this ethical duty extends to explaining to the patient, as promptly and fully as possible, what has happened and the anticipated short-term and long-term consequences. So the obligation is clear enough – but is it complied with? Various studies around the world, such as a recent Australian study, have identified barriers to open disclosure by clinicians when things go wrong in health care. These blockages include concerns about personal, professional and legal consequences of disclosure, as well as adequacy of communication skills. In a detailed review of the literature about open disclosure published in September 2011, the authors raise the issue of the “incident disclosure gap”. This is the gap between incidents that require disclosure and incidents that are disclosed. They conclude that consensus is forming that only around a third of incidents are disclosed. Other countries In the United Kingdom, individual medical professionals have similar good medical practice obligations to their Australian counterparts. They are also expected to disclose errors to their patients in the event of an adverse event. Further, the National Health Service (NHS) Constitution contains a pledge that “when mistakes happen steps will be taken to acknowledge them, apologise, explain what went wrong and put things right quickly and effectively”. But the UK Commons Committee recently heard evidence that despite such ethical duties, the NHS does not always admit when things go wrong. Nor does it offer an explanation - either proactively or in response to questioning. So in that country, a stronger contractual duty was recommended and the idea has met with government approval. Following a listening exercise to reflect on and improve the government’s proposals for modernising the NHS, the following statement was made (at 4.47) in the June 2011 Government response to the NHS Future Forum report: “…we could strengthen transparency of organisations and increase patient confidence by introducing a ‘duty of candour’: a new contractual requirement on providers to be open and transparent in admitting mistakes. We agree. This will be enacted through contractual mechanisms…” Some contractual duties exist in Australia – but are more needed? Ways to proceed It may be possible to confirm the extent to which disclosure of adverse events happens by reference to patients’ records. But a recent retrospective study of 5,375 records from the Netherlands found only 498 adverse events identified in the sample. Only 18 of the 498 (3.6%) records with references to adverse events were found in one or more of the four reporting systems that had been put in place. Research designed to clarify the position in Australia could begin with an audit of health complaints commission matters, focusing on whether the doctor has explained to the patient as promptly and fully as possible what has happened. In New South Wales, for example, the NSW Health Care Complaints Commission Annual Report 2010 states (page 7) that there were 223 complaints assessed as raising serious issues that warranted investigation in 2009-2010, so a nationwide analysis shouldn’t be too onerous. Another interesting analysis could be of the 2,500 or so notifications to public and private medical indemnity insurers each year. These are reported in the AIHW Private and public sector medical indemnity claims report in Australia 2007–2008. The research could look at whether a matter for which a doctor felt warranted a precautionary notification of a potential claim to an insurer was appropriately matched by the provision of information to a patient. Faced with the English concerns and the Netherlands research, an evidence-based assessment of compliance with the ethical duty to disclose adverse events is certainly warranted in Australia. Source
