Methods: As part of the routine pharmacovigilance activities of C/T, Merck reviewed 4 individual medication error reports received within the first 3 months after launch. An analysis was carried out to identify potential safety signals, to determine if those signals could be validated or refuted, and to determine the next steps.
Results: The root-cause analysis of the 4 identified medication error reports showed that the main issue was a misinterpretation of product strength from pharmacists and other health care providers. With other antibiotic combination products, US pharmacy staff are used to seeing the total dose per vial and not the dose of each component. The presentation of the strength statement on the vial label was cited by the reporters as the cause of error and confusion resulting in the incorrect calculation of doses. Two of the errors were intercepted at the pharmacy level. In the other 2 reports, the patients received an overdose without an adverse event. In response to these reports, Merck Sharp and Dohme Corp. proposed to: 1) immediately inform the US Food and Drug Administration (FDA) of those medication errors and the proposed mitigation plan; 2) change the carton, container and product labeling, adding the total dose of C/T to the vial; and 3) distribute a Dear Healthcare Provider Communication letter. The FDA accepted the mitigation plan and issued a Drug Safety Communication regarding these medication errors with C/T to the FDA website.
Conclusion: Postmarketing surveillance is essential for proactive identification of safety signals including medication errors. Pharmacovigilance facilitated rapid identification of a safety signal regarding medication errors, and, upon validation, rapid development of additional risk minimization measures in order to minimize further errors and risk to patients.
A. M. Marr,
Merck Sharp and Dohme Corp.:
M. Salas, Merck Pharmaceuticals: Shareholder , Salary