Risk management of medication errors: a novel conceptual framework.

Background: Medication error is a common cause of patient harm. The study aims to propose a way to manage the risk of medication errors in a novel way, by identifying practice areas where mitigating patient harm should be prioritized using a risk management approach.

Methods: Suspected Adverse Drug Reactions (sADRs) in Eudravigilance database over three years were reviewed to identify preventable medication errors. These were classified using a new method based upon the root cause underlying pharmacotherapeutic failure. The correlation between severity of harm and type of medication error, and other clinical parameters was investigated.

Results: Overall, 2294 medication errors were identified from Eudravigilance, of which 1300 (57%) were due to pharmacotherapeutic failure. Most cases of preventable medication error involved prescribing (41%) and administration (39%). The variables which significantly predicted severity of medication errors were pharmacological group, patient age, number of drugs prescribed, and route of administration. The drug classes most strongly associated with harm included cardiac drugs, opioids, hypoglycaemics, antipsychotics, sedatives, and antithrombotic agents.

Conclusion: The findings of this study highlight the feasibility of using a novel conceptual framework to identify areas of practice at risk of pharmacotherapeutic failure where Interventions by healthcare professionals in these areas are most likely to improve medication safety.