The Consequences of Adverse Drug Events

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Chapter: Pharmacovigilance: Fatal Medication Errors and Adverse Drug Reactions - Coroners’ Inquests and Other Sources

Adverse drug events can cause considerable harm to a patient.


Adverse drug events can cause considerable harm to a patient. They can even be fatal. However, fatal adverse events are relatively rare, and the proportion of fatal cases in most spontaneous reporting schemes and post-marketing studies is low. There is consid-erable uncertainty about both the incidence of fatal reactions and their likely causes.

Deaths that result from drug treatment have implica-tions for patients, health care providers and the health care system. There is a major focus, both in the liter-ature and in the media, on deaths due to medication error, because they could, in an ideal world, have been avoided. The report from the Institute of Medicine in the United States, which extrapolated from infor-mation obtained in two relatively restricted hospi-tal surveys, excited a lot of media attention in 2000 when it suggested that as many as 98 000 deaths a year in the United States were because of ‘medical error’ (Kohn, Corrigan and Donaldson, 1999). Cases such as those of the young man Wayne Jowett, who died after the erroneous administration of intrathecal vincristine in place of intrathecal methotrexate, have also received wide press coverage and stimulated care-ful enquiry (Woods, 2001). In addition, the doctors who committed the medication error were charged with manslaughter, and one was convicted. This outcome is not unique, as the past decade has seen a marked increased in the number of legal proceedings being brought against doctors when their patients die because of a medical error (Ferner, 2000; Ferner and McDowell, 2006). Paradoxically, this censoriousness has come at the same time as a realisation that error is an inevitable part of the human condition, and that for processes to be safe, they have to be designed (‘engineered’) to be robust in the face of human error (Reason, 2000). These views should lead to ‘an open culture’, where those who make errors readily admit to them, so that they can be avoided in future. Open-ness is a distant goal when doctors face conviction for manslaughter after errors lead to a patient’s death.

Adverse events can also result from negligence, where medical staff clearly fall below the standards expected of them. A large study of medical records from 51 hospitals in New York state for patients treated in the year 1984, part of the classic Harvard Medical Practice Study, estimated that nearly 1% of patients suffered adverse events (not just medication errors) that were the result of negligence (Brennan et al., 2004). One quarter of the patients who suffered an adverse event due to negligence died.

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