The ‘Mistakes and Mishaps in Healthcare’ Movement

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Chapter: Pharmacovigilance: Teaching and Learning Pharmacovigilance

Well-publicized studies of mistakes and mishaps in care of hospitalized patients in both the United States (Brennan et al., 1991) and Australia (Wilson et al., 1995) led to substantially heightened levels of public interest in achieving less harm from customarily delivered health care.


THE ‘MISTAKES AND MISHAPS IN HEALTHCARE’ MOVEMENT

Well-publicized studies of mistakes and mishaps in care of hospitalized patients in both the United States (Brennan et al., 1991) and Australia (Wilson et al., 1995) led to substantially heightened levels of public interest in achieving less harm from customarily delivered health care. In the United States, a landmark Institute of Medicine report To err is human (Kohn et al., 2000) acted as a platform to launch a range of initiatives to draw attention to and improve patient safety.

Parallel action was taken in the United Kingdom and other countries to address rising public concern about the high levels of patient injury and morbid-ity occurring because of patient contact with estab-lished healthcare systems. In the United Kingdom, a pivotal report from the NHS chief medical offi-cer (Donaldson, 2000) led to the establishment of a National Patient Safety Agency that was tasked with reporting, analysing and disseminating the lessons of adverse events and ‘near misses’ involving British NHS patients.

Embedded within reports associated with this move-ment are the documentation of significant numbers of incidents associated with medication use, and by implication, unsafe healthcare practice. Recently, in the United Kingdom, 9% of reported patient safety incidents in acute hospitals and 21% of such incidents in general practice were noted to be associated with medications (Scobie et al., 2005). The relationship between medication errors and adverse drug events is complex, with medication errors being generally more common than adverse drug events. It has been estimated that about a third to a half of adverse drug events are typically associated with medication errors: however, of course, not all adverse drug events necessarily spring from medication errors (Morimoto et al., 2004).

The close intersection of medication error and adverse drug events now demands careful attention in curricula associated with pharmacovigilance. Whilst the generally accepted definition of medication error asserts that by their nature, such errors must be preventable (National Coordinating Council for Medi-cation Error Reporting and Prevention, 1995), and other respected workers in the field have suggested that medication errors might also be ‘ameliorable’: a kind of gradation of preventability (Morimoto et al., 2004). Morimoto and colleagues propose a comprehensive system for detecting and classifying medication-related incidents and suggest that in rela-tion to each such incident, gaugings can be taken of the level of severity, resultant disability, preventabil-ity or ameliorability as well as the stage and setting of care when such incidents occur (Figure 49.1).


There are clearly important implications for use of the term ‘error’ when applied to medication use. As an absolute term, the implication that such inci-dents must be preventable defies the logic of what is known about pharmacotherapy. When does a side effect of a drug become an adverse event, an ADR or a medication-related error? Clearly different players in the healthcare system will have different perceptions on this point.

For the patient (or the pharmacovigilist notic-ing events recorded in a healthcare database), what appears to be an error may well prove to have been a conscious judgement of perceived relative benefit and risk on the part of an individual prescriber.

‘Error’ may have occurred in such circumstances solely insofar as the decision to use a drug was not openly shared between prescriber and patient, with both parties being properly informed about potential benefits and risks associated with treatment. For the pharmacovigilist, whether an ‘error’ actually occurred often remains uncertain, depending on the distance in time and space from the event and its specific circumstances.

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