Preventable fatal adverse drug reactions and drug intoxications in a Swedish population

Katja Hakkarainen Apotekare Nordiska högskolan för folkhälsovetenskap, Göteborg

Anna K Jönsson Med Dr Nordiska högskolan för folkhälsovetenskap, Göteborg

Olav Spigset Professor Division of Clinical Pharmacology, St. Olav University Hospital, Trondheim, Norway

Henrik Druid Docent Rättsmedicinalverket, Rättsmedicinska avdelningen, Karolinska Institutet, Stockholm

Anne Hiselius Apotekare Landstinget i Jönköpings län, Jönköping

Staffan Hägg Docent Klinisk Farmakologi, Hälsouniveristetet, Linköping

Bakgrund

Several studies indicate that the medical burden of fatal adverse drug reactions (ADRs) is significant. However, the preventability of fatal ADRs in the general population is largely unknown. The aim of this study was to determine the proportion of preventable fatal ADRs and drug intoxications in a Swedish population.

Metod

Every seventh randomly selected deceased person during 1 January 2001 - 31 December 2001 in three counties in south-eastern Sweden was identified in the Cause of Death Register. Fatal ADRs and intoxications were identified from relevant case records (hospitals and/or primary care centres and medicolegal files) by a retrospective expert review. Clinical specialists evaluated the preventability of all identified fatal ADRs and drug intoxications in a stepwise manner utilizing well-established preventability criteria.

Resultat

In 1574 deceased study subjects, 58 (3.7%; 95% CI 2.8%, 4.6%) cases of fatal ADRs (49 cases) or drug intoxications (9 cases) were identified in 57 subjects. Of 49 fatal ADRs, 14% (7 fatalities) was considered definitely or possibly preventable (table 1). All 9 fatal drug intoxications were considered possibly preventable. Thus, a total of 15 persons (26%) were considered to have a definitely or possibly preventable fatal ADR or drug intoxication. This corresponded to 0.95% of all deceased subjects.

Sammanfattning

Based on this population-based study, a significant proportion of fatal ADRs and drug intoxications is preventable.