Drug Shortages: Process for Evaluating Impact on Patient Safety

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Drug shortages can seriously impact patient safety. The objective of this study was to develop safety assessment checklists for use during a drug shortage, whether the same drug is available or an alternative is required.


A failure modes and effects analysis (FMEA) was conducted following the Institute for Healthcare Improvement’s FMEA tool. Each step of the medication use process was reviewed for the potential impact of a shortage-related event. The likelihood of occurrence, likelihood of detection, and severity of potential harm were determined and rated by a multidisciplinary team. To supplement the results of the FMEA, a survey focusing on the perception of patient safety during a drug shortage was developed and sent to various e-mail lists. These data were used to develop the safety assessment checklists.


Common safety concerns associated with drug shortages in multiple areas of the medication use process include possible look-alike sound-alike issues and delays in patient care. The FMEA and survey results noted that unfamiliarity with an alternative agent was a high vulnerability during a shortage where an alternative is required. The potential for incorrect doses was the greatest concern during a shortage where the same drug is available, but in a different concentration or presentation.


Drug shortages create patient safety risks. Safety assessment checklists for use when the same drug is available and when an alternative is required during a drug shortage were developed to aid institutions in preventing patient safety impacts.

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