ABSTRACT
PURPOSE: Failure mode and effects analysis (FMEA) was used to identify safety risks of unfractionated heparin (UFH) use and to develop and implement countermeasures to improve safety. METHODS: FMEA was used to analyze the transportation, preparation, dispensation, administration, therapeutic monitoring, and disposal of UFH in a tertiary care, freestanding pediatric hospital. The FMEA was conducted in a stepwise fashion. First, frontline staff mapped the different steps within the UFH use process. Next, key stakeholders identified potential failures of each process step. Finally, using calibrated scales, the stakeholders ranked the likelihood of occurrence, severity, and detectability for each potential failure's cause. The rankings were used to prioritize high-risk areas on which to focus efforts for improvement countermeasures. RESULTS: The analysis revealed 233 potential failures and 737 unique potential causes. After ranking of all identified potential causes, 45 were deemed high scoring. Those 45 causes were further refined into 13 underlying contributing causes. To address the contributing causes, selected team members developed 22 countermeasures. The FMEA showed that implementation of the countermeasures reduced the level of mathematical risk. CONCLUSION: FMEA was helpful in identifying, ranking, and prioritizing medication risks in the UFH use process. Twenty-two countermeasures were developed to reduce potential for error in the riskiest steps of the process.
ABSTRACT
PURPOSE: Risks and vulnerabilities of the medication-use process in nonpediatric institutions that also serve pediatric patients are reviewed, and guidance on risk mitigation strategies is provided. SUMMARY: There are many risks and vulnerabilities in the medication-use process as it relates to pharmacotherapy for pediatric patients admitted to adult institutions. Mitigation of these risks is critical and should encompass various available resources and strategies. Special emphasis should be placed on use of technology to improve overall safety. Available literature recommends optimization of technology and resource use, institutional support for pediatric pharmacists' involvement in managing pediatric medication use, and provision of early exposure to pediatric patients in pharmacist training programs as additional methods of mitigating risks associated with pediatric medication use in adult institutions. Adult hospitals that provide care for pediatric patients should assess their processes in order to identify hospital-specific interventions to promote pediatric medication safety. CONCLUSION: Pediatric medication safety frameworks in U.S. adult institutions vary widely. Treating pediatric patients involves risks in all areas of the medication-use process. Optimizing technology, utilizing external resources, supporting a pediatric pharmacist, and providing early-career exposure to pediatric patients are methods to mitigate risks in institutions that primarily serve adult patients.
