The third part of the Framework focuses on the adverse medication event itself.

VIII. Adverse medication event

When the adverse medication event happens there are a number of issues to be considered including:
  • Early Detection – this may include risk factor identification and close monitoring following commencement of the medication regimen.
  • Disclosure – as soon as possible notify the consumer and where appropriate the carer of the adverse medication event and provide opportunities for debriefing and support as consistent with the jurisdictional health disclosure policy. Engage the consumer and carer in discussions about the response plan as consistent with the jurisdictional health disclosure policy.
  • Early Response/Action – may include dissemination of information about the ADE to improve overall system response and awareness of the issue and thereby reduce future ADEs.
  • Early Prioritising of Actions. Aspects to be considered include:
    • The most effective action
    • The most comprehensive action and
    • The ability to achieve an immediate outcome
  • Longer Term Planning.
Underlying these issues is the need to establish a course of action, which may have strategic timelines e.g. three to five years, during which the first area of focus is on hospital level of reporting of adverse medication events. This reporting should be in such a way that the results are reasonably comparable even though the actual results may be delivered from a variety of proprietary information system programmes, or via manual documentation. Such a process would include an initial survey of the current methods of recording adverse events, definitions used, software programmes used, manual recording systems used, and a comparison between these systems and the National Information System. Then a feasibility analysis should occur, to determine the extent that this information can be drawn together at a national level. Barriers to integration need to be identified, and appropriate funding directed in a targeted way to overcoming those barriers. The aim would be to have meaningful national data on adverse events. It would also be sensible to have a parallel aim from the outset, of including a recording system for community-based reports of adverse events. Such community-based reports could be reported, and an analysis of trends also reported from that information. The organisation could elaborate this process further, notably from ADRAC.

There have been a number of studies to more specifically identify risks, gaps and deficiencies as described earlier in the Framework and these studies and similar studies will form part of the necessary means to identify specific adverse medication events and the areas that will need attention and related data collection. The particular area of focus that has been highlighted is identification of high risk drugs and high risk situations and it is expected there will be further developments in these and similar areas. A further important area is the development of long term side effects in patients - both those currently recognised (e.g. tardive dyskinesia, metabolic syndrome) and those that may be identified in the future. This focus will require the longitudinal monitoring and studies of cohorts over many years. The outcomes may then be reflected into promotion and prevention as well as monitoring and trend analysis. Top of page

The private sector is likely to cooperate with a system like this, but a barrier will be the extra cost involved in any changes to existing systems, and in providing reports for National collections. Such barriers need to be identified early, and the most cost-effective ways to collect and report data should be investigated. Systems that simplify National reporting by using data systems used at the local level to create local and National reports at the same time are likely to be the most acceptable. The use of a standard data dictionary and common messaging languages (e.g. XML, HL7) may be key aspects of the early analysis. A more definitive version of the process would need to be taken back to the hospitals at an early stage to determine their view of the feasibility. These approaches should build on work already in train by the national e-health transition authority (NEHTA) and related areas of work that have been commenced by other organisations.

  • Survey current methods of recording adverse events at the hospital reporting level including definitions used, software programs used and manual programs used.
  • Determine how the above information can be integrated at a national level.
  • Consider ways of including a recording system for community based reports of adverse events.
  • Consider ways to involve the private sector in the development of a national information system.
  • Consider cost effective ways to collect and report data.
  • Build on approaches already in place by organisations such as National E-Health Transition Authority (NEHTA) and related areas of work commenced by other organisations.