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.

The pharmacist's role in pediatric care is critical for the provision of safe medication use secondary to differences in physical development, frequent off label use of medications, need for dose calculations, and the lack of standard dosage forms. Many regulatory agencies, health care organizations, and professional societies support the pharmacist as a member of the interdisciplinary team. However, specific details showcasing how pharmacists impact the care of pediatric patients in a quantifiable and meaningful way have not been well described. The purpose of this article is to

Racemic albuterol and levalbuterol were associated with increased heart rate in pediatric cardiology patients. This increase was found to be equivalent.

BackgroundPatients with advanced cutaneous melanoma and persistent disease after checkpoint inhibitor therapy have poor outcomes and limited treatment options, highlighting a significant unmet medical need.1 Autologous TIL cell therapies have shown promise in this population attributable, in part, to their intrinsic and patient-specific antitumor activity2; however, no such therapies are approved. Made from each patient‘s digested and cryopreserved tumor, ITIL-168 is an autologous TIL cell therapy manufactured to offer an unrestricted T-cell receptor repertoire. A single-center compassionate use clinical series demonstrated the feasibility and clinical utility of an earlier version of ITIL-168.3 DELTA-1 is a global, multicenter phase 2 study to evaluate efficacy and safety of ITIL-168. DELTA-1 will enroll patients with melanoma relapsed after or refractory to PD-1 inhibitors (PD-1i), patients intolerant to PD-1i, and patients whose best response to PD-1i was stable disease.MethodsPatients aged ≥18 years with histologically confirmed advanced cutaneous melanoma, ECOG performance status 0–1, and adequate organ function will be enrolled in 1 of 3 cohorts. Cohort 1 (n≈80) will include patients who relapsed after or were refractory to ≥1 prior line of systemic therapy, including a PD-1i and, if BRAF-mutated, a BRAFi ± MEKi. Cohorts 2 and 3 (n≈25 each) will include patients intolerant to PD-1i and those with stable disease after ≥4 doses of PD-1i, respectively. After tumor resection for TIL harvest, patients must have ≥1 remaining measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Patients with uveal, acral, or mucosal melanoma, prior allogeneic transplant or cell therapy, and with central nervous system (CNS) disorder or symptomatic and/or untreated CNS metastases are ineligible. Patients will receive 5 days of lymphodepleting chemotherapy (cyclophosphamide ×2 days overlapping with fludarabine ×5 days) followed by a single ITIL-168 infusion (≥5×109 cells) and supportive short course high-dose IL-2. The primary endpoint is objective response rate (ORR) per central review. Key secondary endpoints include duration of response, progression-free survival, overall survival, disease control rate, TIL persistence, and safety. Hypothesis testing of ORR will be performed for cohort 1. Two interim analyses will occur after 20 patients in cohort 1 have been followed for ≥28 days (safety) and evaluated for response ≥3 months after ITIL-168 infusion (futility). The primary analysis will occur when all patients in the cohort 1 modified intent-to-treat population have been followed for ≥6 months after the first posttreatment disease assessment.AcknowledgementsMedical writing support was provided by Christopher Waldapfel, PharmD, of Instil Bio, Inc, and Phylicia Aaron, PhD, of Nexus GG Science, with funding from Instil Bio, Inc.ReferencesSchadendorf D, van Akkoi ACJ, Berking C, et al. Melanoma. Lancet 2018;392(10151):971–984.Borch TH, Anderson R, Ellebaek E, et al. Future role for adoptive T-cell therapy in checkpoint inhibitor-resistant metastatic melanoma. J Immunother Cancer 2020;8(2):e000668.Hawkins RE, Jiang Y, Lorigan PC, et al. Clinical feasibility and treatment outcomes with unselected autologous tumor infiltrating lymphocyte therapy in patients with advanced cutaneous melanoma. Cancer Res 2021;81(13):LB150.Ethics ApprovalAll patients will provide written informed consent. The study will be approved by the Institutional Review Board/Independent Ethics Committee at each site and conducted in accordance with the Good Clinical Practice Guidelines of the International Conference on Harmonisation.ConsentN/A; the abstract does not contain sensitive or identifiable patient information.

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.