Key Element

Latent Failures

Active Failures


warn that drug can be administered IM only.

  • Conflicting information about IV use of milky-white substances.

  • Lack of FDA requirement for “black box” or other vivid warning regarding IV administration of penicillin G benzathine in drug monographs.



  • Hospital had an unclear definition of prescriptive authority for nonphysicians.

  • Nurse practitioner assumed authority to change route of administration based on national protocol and current practice in hospital.

Labeling, Packing, and Nomenclature

  • Manufacturer’s warning for “IM use only” not prominently placed on syringe: syringe had to be rotated 180 degrees away from drug name to view the warning; plunger obscured the view after syringe prepared; “1,200,000” used instead of “1.2 million” units (errors occur when comma is misread).

  • Warning on syringe for “IM use only” not seen.

  • Ten-fold overdose not recognized.

  • Penicillin G benzathine administered intravenously.

SOURCE: Smetzer and Cohen, 1998.


Reason, J. 1990. The contribution of latent human failures to the breakdown of complex systems. Philosophical Transactions of the Royal Society of London, Series B 327, 475–484.

Smetzer JL, Cohen MR. 1998. Lessons from the Denver medication error/criminal negligence case: Look beyond blaming individuals. Hospital Pharmacy 33(6):640–657.

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