What Severe Medication Errors Reported to Health Care Supervisory Authority Tell About Medication Safety?

Abstract

Objectives: This study investigated severe medication errors (MEs) reported to the National Supervisory Authority for Welfare and Health (Valvira) in Finland and evaluated how the incident documentation applies to learning from errors.

Methods: This study was a retrospective document analysis consisting of medication-related complaints and authoritative statements investigated by Valvira in 2013 to 2017 (n = 58).

Results: Medication errors caused death or severe harm in 52% (n = 30) of the cases (n = 58). The majority (83%; n = 48) of the incidents concerned patients older than 60 years. Most likely, the errors occurred in prescribing (n = 38; 47%), followed by administration (n = 15; 19%) and monitoring (n = 14; 17%). The error process often included many failures (n = 24; 41%) or more than one health professional (n = 16; 28%). Antithrombotic agents (n = 17; 13%), opioids (n = 10; 8%), and antipsychotics (n = 10; 8%) were the therapeutic groups most commonly involved in the errors. Almost all error cases (91%; n = 53) were assessed as likely or potentially preventable. In 60% (n = 35) of the cases, the organization reported actions taken to improve medication safety after the occurrence of the investigated incident.

Conclusions: Medication errors reported to the national health care supervisory authority provide a valuable source of risk information and should be used for learning from severe errors at the level of health care systems. High age remains a key risk factor to severe MEs, which may be associated with a wide range of medications including those not typically perceived as high-alert medications or high-risk administration routes. Despite being complex processes, the severe MEs have a great potential to lead to developing systems, processes, resources, and competencies of health care organizations.

FIGURE 1

Data inclusion and collection protocol for MEs investigated by the National Supervisory Authority for Welfare and Health (Valvira) in Finland in 2013 to 2017.

FIGURE 2

Reported actions taken by health care organizations to improve medication safety after the ME had occurred. The strength of the actions classified according to the IHI Action Hierarchy.