A root-cause analysis (RCA) should be completed in the event of a:

A medication recall typically arises from safety concerns about a specific product that has already been distributed. While recalls may require investigation, the focus is on the product itself rather than a systematic analysis of underlying causes related to errors or near misses.

Predictable side effects are typically known and documented outcomes of medication use that do not indicate system failures or errors. Since they are expected from the drug's pharmacological profile, they do not necessitate the same level of analysis as a near miss, which involves unexpected risks.

A drug utilization review (DUR) is an evaluation process aimed at ensuring appropriate medication use and identifying potential problems in prescribing practices. While DURs contribute to medication safety, they are not specifically focused on analyzing incidents or errors such as near misses, thus not warranting an RCA.