New approaches are needed to tackle medication errors based on examining human and organisational factors across the entire pharmaceutical system

Medication errors are a major burden for health systems such as the NHS. The NHS has established a Never Events list which has recently been updated. Never Events are serious incidents that have been wholly preventable as guidance or safety. There is no agreed systematic approach involving all stakeholders across the system in investigating either never events or medication errors in general.

According to the European Medicines Agency, companies should use a lifecycle approach to reduce the likelihood of medication errors, starting at the drug design stage and continuing through product naming, packaging and labelling. Companies should avoid similar sounding names and ones that incorporate common stems from international non-proprietary names. Drug labelling should describe the drug and proper storage, preparation, dispensing, administration and tracing throughout the supply chain. However, there is incomplete regulatory jurisdiction over the healthcare system in the way it overlaps with the pharmaceutical system with a lack of clear leadership and team-working between both systems.

Failure Modes and Effects Analysis (FMEA) is a widely-used technique in healthcare and other industries as a systematic, method for evaluating a process to identify where and how it might fail and to assess the relative impact of different failures, in order to identify the parts of the process that are most in need of change. This has been recommended both by the CIOMS IX group and in recent European Medicines Agency guidelines as a technique for preventing medication error, especially when avoidable. In addition there is a widely used model of causation (STAMP or Systems-Theoretic Accident Model and Processes) that can be used to improve the design, operation, and management of potentially dangerous systems or products. Currently, neither has been evaluated systematically together in the evaluation of medication errors and, in particular, Never Events should they occur.

One pharmaceutically-related Never Event is overdose of Insulin due to abbreviations or incorrect device. Use of a systematic approach can help to prevent and mitigate medication errors associated with insulin by examining human and organisational factors across the pharmaceutical system and the way it interdigitates with the healthcare system.

Recently a unique pharmaceutical human factors group has been established within the Chartered Institute of Ergonomics and Human Factors which is a world first.

Through such a collaboration, we aim to demonstrate in this presentation is to determine is to illustrate what needs to be done to investigate eliminate pharmaceutically related Never Events from the system. by comparing FMEA and STAMP using the example of medication errors with insulin as a case study. Such a case study would

- Map out a typical care pathway for treatment with insulin

- Identify where failure /errors could occur and who are process controllers

- Prioritise the weak process points based on probability and severity

- Identify potential actions (safety constraints)that would help prevent the most important errors occurring.

Such a case study could form the basis for investigative training modules of how to tackle Never Events and be applied throughout the NHS