Tools for investigating and managing medicines risk

Tools for investigating and managing medicines risk

Root cause analysis

RCA is the tool that is most commonly used to identify underlying reasons for an adverse event. RCA aims to find out what happened, why it happened and what will prevent it from happening again.

Evidence provided by individuals involved in the incident allows contri-butory factors to be identified and used in error prevention strategies. RCA is a relatively simple process, although it may be complicated by the complexity of the issue or the number of personnel involved. Success depends on the clarity of information provided and presented, the generation of practical and feasible recommendations and ensuring that actions taken to prevent future similar events are the correct ones. Ideally RCA should remove the temptation to jump to conclusions about the reasons for failure and imple-ment an inappropriate intervention. A variety of tools for mapping and ana-lysing information gathered during an incident and for generating solutions are available. Some of these are listed in Table 12.3. The NPSA has published a toolkit describing these in more detail.

Failure mode and effects analysis

Whereas RCA is a tool used to analyse retrospectively incidents to identify a cause, failure modes and effects analysis (FMEA) is used to identify risks in systems before they fail and potentially result in an incident. It can be used to predict the risks associated with systems already in place and also to predict the risks associated with potential solutions while they are still in consider-ation, to ensure that the solution is going to have the desired outcome and not introduce new risks.

FMEA is usually conducted by a multidisciplinary group, ensuring that the views of all disciplines involved in a process are considered. The process is mapped and the potential failures at the stages of the process under scrutiny are described. The failures are scored according to the probability of occur-rence (O), the severity of the outcome if the failure reached the patient (S) and the likelihood that the failure would be detected before it reached the patient (D). A failure or an error very likely to happen, unlikely to be detected and likely to harm the patient would attract a high score. The aims of risk reduc-tion strategies are to reduce the risk score of any given stage of the process. Barriers to failure can be proposed to reduce risks. However, new risks associated with risk reduction strategies must also be scored to ensure that overall a safer system is developed.

Barriers to error

Barriers are defences and controls that are in place to increase the safety of a system. Barriers usually fall into one of four types:

1. physical barriers

2. natural barriers

3. human action barriers

4. administrative barriers.

Physical barriers are the most effective and may even be failsafe, eliminating all possibility of error. Human action barriers and administrative barriers are the least reliable. In healthcare, human and administrative barriers are heavily relied on as solutions to problems. However, these barriers are weak and, wherever possible, should only be considered alongside more robust solutions to problems. Table 12.4 gives examples of types of barriers in recommenda-tions made by the NPSA to reduce risks with specific aspects of medicines use.