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.
Subject(s)
Medication Errors/prevention & control , Medication Therapy Management/organization & administration , Pharmacists/organization & administration , Pharmacy Service, Hospital/organization & administration , Safety Management/standards , Adult , Age Factors , Child , Clinical Pharmacy Information Systems/organization & administration , Clinical Pharmacy Information Systems/standards , Drug Compounding/standards , Drug Dosage Calculations , Education, Pharmacy , Education, Pharmacy, Continuing , Humans , Medical Order Entry Systems/organization & administration , Medical Order Entry Systems/standards , Medication Therapy Management/standards , Pharmacists/standards , Pharmacy Service, Hospital/standards , Practice Guidelines as Topic , Professional RoleABSTRACT
BACKGROUND: To our knowledge, no data exist regarding the effect of levalbuterol and racemic albuterol on heart rate in pediatric cardiology patients. OBJECTIVE: To compare heart rate change in pediatric cardiology patients receiving levalbuterol and/or racemic albuterol. The secondary objective was to identify characteristics associated with heart rate changes observed with these drugs. METHODS: A review of electronic medical records at a pediatric academic hospital was conducted to determine the equivalence of heart rate change in patients receiving levalbuterol or racemic albuterol. Patients receiving at least 3 doses of levalbuterol and/or racemic albuterol during the study period were included if they were younger than 18 years and had a diagnosis of congenital heart disease (CHD), cardiomyopathy, or supraventricular tachycardia. Patients were excluded if they received a ß-blocker or continuous racemic albuterol or did not have documented pre- and postdose heart rates. RESULTS: One hundred ninety-two patients were included. One hundred forty-two received racemic albuterol, 40 received levalbuterol, and 10 received both racemic albuterol and levalbuterol. The mean increase in heart rate for patients receiving racemic albuterol and levalbuterol was 6.8 beats/min and 6.2 beats/min, respectively (p = 0.01). In patients with CHD, the racemic albuterol group experienced a mean heart rate increase of 6.6 beats/min compared to 6.3 beats/min in the levalbuterol group (p = 0.01). Equivalence was also determined in patients without surgical intervention and patients receiving concomitant cardiac and respiratory medications. Equivalence was not established in other analyzed subgroups secondary to insufficient sample sizes. CONCLUSIONS: Racemic albuterol and levalbuterol were associated with increased heart rate in pediatric cardiology patients. This increase was found to be equivalent.
