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Drug Shortages: Process for Evaluating Impact on Patient Safety

Purpose 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. Methods 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. Results 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. Conclusion 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.