Survey of Pediatric Pharmacy Residency Program Directors and Former Residents on Post-Graduate Training Paths.

Objective: There are currently no data comparing outcomes of traditional vs pediatric-focused PGY1 residency programs. The primary objective of the survey was to identify if a difference in resident preparedness for a PGY2 pediatric pharmacy residency exists between these PGY1 program types. Methods: This survey-based study included all PGY2 pediatric residency program directors (RPDs) in 2021 and PGY2 pediatric pharmacy residents who completed residency between 2016-2020. Information regarding training paths of residents, such as type of PGY1 completed, and preparedness at the start of a PGY2 pediatric residency was collected. Preparedness for both general and pediatric-specific elements were assessed. Results: A total of 101 respondents were included: 36 RPDs and 65 previous residents. RPDs felt residents who completed a pediatric-focused PGY1 were more prepared in baseline knowledge of pediatric diseases; otherwise, residents were similar across residency types in their perceived preparation for a PGY2. Pediatric-focused PGY1 residents felt significantly more prepared in pediatric baseline knowledge (96% vs 75%, p = 0.002) and managing pediatric emergencies (96% vs 50%, p = 0.002) than those who completed a traditional PGY1 program. There was no difference for patient care or clinical research skills. Residents in both groups obtained pediatric pharmacist jobs and felt equally prepared for transitioning into their first post-residency job. Conclusions: Despite a difference between the PGY1 resident groups in perceived baseline pediatric knowledge and preparedness to manage pediatric emergencies, similar post-residency jobs were obtained. Respondents felt equally prepared to begin their pediatric careers regardless of the type of PGY1 residency completed.

Neonatal Serum Gentamicin Concentrations and Outcomes Following Maternal Once-Daily Gentamicin Dosing.

OBJECTIVE: This study evaluated newborn gentamicin serum concentrations after birth and the effects on the newborn after extended interval gentamicin dosing in peripartum mothers. METHODS: This was a single-center, retrospective chart review of neonates born to mothers that received peripartum once-daily gentamicin dosing of approximately 5 mg/kg within 12 hours of delivery. A gentamicin serum concentration was obtained immediately after birth in the newborn. The primary outcome was initial neonatal gentamicin serum concentration after birth. Several secondary outcomes were evaluated including nephrotoxicity and ototoxicity. A subgroup analysis comparing baseline demographics of mother-newborn dyads with birth neonatal serum concentrations of less than 2 mcg/mL versus 2 mcg/mL or greater was performed. RESULTS: A total of 32 mother-newborn dyads were included. Newborns had a median gestational age of 39.4 weeks and median birth weight of 3.4 kg. The mean initial gentamicin serum concentration was elevated at 3.1 ± 1.9 mcg/mL among all newborns. The median maternal dose based on actual body weight in newborns with gentamicin serum concentrations less than 2 mcg/mL was 3.5 (IQR, 3.3-4.8) mg/kg versus 4.8 (IQR, 4.3-5.2) mg/kg in those that had serum concentrations of 2 mcg/mL or greater (p = 0.025). All newborn gentamicin serum concentrations were less than 2 mcg/mL for maternal doses given less than 1 hour prior to delivery (n = 8). There were no significant differences in nephrotoxicity or ototoxicity. CONCLUSIONS: Peripartum once daily dosing of gentamicin administered between 1 to 12 hours of birth may lead to clinically significant serum concentrations in newborns.

Use of Calcitonin for Hypercalcemia in a Premature Neonate With Congenital Mesoblastic Nephroma.

We report on a premature neonate (31 4/7 weeks' gestation) who presented with hypercalcemia secondary to congenital mesoblastic nephroma (CMN), the most common type of renal tumor in neonates. Typical presentation includes a palpable abdominal mass or swelling and may include abdominal pain, hematuria, fever, or hypertension. A less common complication of CMN is hypercalcemia of malignancy. Although the primary management strategy for hypercalcemia of malignancy is to treat the underlying disease, there are several agents that can be used as well for acute hypercalcemia including fluids, loop diuretics, corticosteroids, bisphosphonates, and calcitonin. However, there is minimal evidence to guide efficacious and safe treatment selection and dosing as hypercalcemia is a rare complication of this tumor type. This case adds to the current body of literature as only the second case of parathyroid hormone-related peptide-mediated hypercalcemia in a preterm neonate treated with calcitonin and is the first to specify a successful dose escalation strategy of calcitonin for this indication.

Comparison of Extracorporeal Life Support Anticoagulation Using Activated Clotting Time Only to a Multimodal Approach in Pediatric Patients.

OBJECTIVE: To evaluate an institutional practice change from an extracorporeal life support (ECLS) anticoagulation monitoring strategy of activated clotting time (ACT) alone to a multimodal strategy including ACT, activated partial thrombin time, heparin anti-factor-Xa, and thromboelastography. METHODS: This was a retrospective review of patients younger than 18 years on ECLS and heparin between January 2014 and June 2020 at a single institution. RESULTS: Twenty-seven patients used an ACT-directed strategy and 25 used a multimodal strategy. The ACT-directed group was on ECLS for a shorter median duration than the multimodal group (136 versus 164 hours; p = 0.046). There was a non-significant increase in major hemorrhage (85.1% versus 60%; p = 0.061) and a significantly higher incidence of central nervous system (CNS) hemorrhage in the ACT-directed group (29.6% versus 0%; p = 0.004). Rates of thrombosis were similar, with a median of 3 circuit changes per group (p = 0.921). The ACT-directed group had larger median heparin doses (55 versus 34 units/kg/hr; p < 0.001), required more dose adjustments per day (3.8 versus 1.7; p < 0.001), and had higher rates of heparin doses >50 units/kg/hr (62.9% versus 16%; p = 0.001). More anticoagulation parameters were supratherapeutic (p = 0.015) and fewer were therapeutic (p < 0.001) in the ACT-directed group. CONCLUSIONS: Patients with a multimodal strategy for monitoring anticoagulation during ECLS had lower rates of CNS hemorrhage and decreased need for large heparin doses of >50 units/kg/hr without an increase in clotting complications, compared with ACT-directed anticoagulation. Multimodal anticoagulation monitoring appears superior to ACT-only strategies and may reduce heparin exposure and risk of hemorrhagic complications for pediatric patients on ECLS.

Pediatric Perioperative Clinical Pharmacy Practice: Clinical Considerations and Management: An Opinion of the Pediatrics and Perioperative Care Practice and Research Networks of the American College of Clinical Pharmacy.

Pediatric perioperative clinical pharmacists are uniquely positioned to provide therapeutic and medication management expertise at a particularly vulnerable transition of care from the preoperative space, through surgery, and postoperative setting. There are many direct-patient care activities that are included in the role of the pediatric perioperative pharmacist, as well as many opportunities to develop effective, optimized, and safe medication use processes. This article outlines many of the areas in which a pediatric perioperative clinical pharmacist may intervene.

Dexmedetomidine Versus Fentanyl for Neonates With Hypoxic Ischemic Encephalopathy Undergoing Therapeutic Hypothermia.

OBJECTIVE: Therapeutic hypothermia reduces the risk of death and major disability in neonates with moderate-to-severe hypoxic ischemic encephalopathy (HIE). Opioids and benzodiazepines are used to manage agitation but contribute to hemodynamic and respiratory instability. The objective of this study was to evaluate the safety and efficacy of dexmedetomidine (DEX) compared with fentanyl (FENT) in neonates with HIE undergoing therapeutic hypothermia. METHODS: This was a retrospective, single-center study comparing outcomes in neonates with HIE undergoing therapeutic hypothermia who received FENT to those who received DEX. RESULTS: A total of 45 neonates were included (FENT, n = 19; DEX, n = 26). The DEX group had a decreased need for sedative bolus doses during therapeutic hypothermia compared with the FENT group; however, there was no difference in number of uncontrolled agitation scores or need for additional scheduled sedatives. The DEX group had a shorter time to discontinuation of sedatives after rewarming compared with the FENT group (0.52 versus 5 days, respectively; p = 0.001), shorter time to extubation after birth (3.1 versus 11.3 days, respectively; p = 0.004), and earlier time to resumption of feeds (8.5 versus 13 days, respectively; p = 0.03). A non-statistically significant reduction in seizures was noted (3 versus 7 subjects, respectively; p = 0.07). There was no difference in baseline characteristics, mortality, or adverse effects. CONCLUSIONS: The use of DEX during therapeutic hypothermia for HIE appears to provide comparable control of agitation to FENT with a reduced need for additional sedatives and may lead to an earlier time to extubation and discontinuation of sedatives.

Implementation of an Inhaled Nitric Oxide Weaning Protocol and Stewardship in a Level 4 NICU to Decrease Inappropriate Use.

OBJECTIVE: Inhaled nitric oxide (iNO) is an effective but expensive treatment of pulmonary hypertension in newborns, with limited data regarding weaning. Our institution implemented a multidisciplinary iNO weaning protocol and stewardship to reduce inappropriate use of iNO. The objective of this study was to evaluate our institutional iNO usage before and after implementation. METHODS: Single-center study comparing a retrospective control group to a prospective cohort after implementation of an iNO weaning protocol. All infants in the neonatal intensive care unit (NICU) who received iNO during the study timeframe were included. The primary outcome was duration of iNO per course. RESULTS: A total of 47 courses of iNO occurred during the pre-protocol timeframe compared with 37 courses in the post-protocol timeframe. Median iNO usage per course was 149 hours (IQR, 63-243) in the pre-protocol group versus 59 hours (IQR, 37-122) in the post-protocol group (p = 0.008). Length of stay was significantly longer in the pre-protocol group (p = 0.02), likely related to significantly longer ventilator days in the pre-protocol group (p = 0.02). Compliance with initiation of weaning when recommended per the protocol was 72%, and the incidence of successful weaning was 74%. CONCLUSIONS: The implementation of an iNO weaning protocol in the NICU significantly decreased iNO usage by approximately 60% with no notable negative effects.

Quality improvement and reconciliation process for automated dispensing cabinet medication overrides.

PURPOSE: To describe a pharmacist-led reconciliation process for automated dispensing cabinet (ADC) medication override setting maintenance at an academic medical center. SUMMARY: ADC override management requires alignment of people, processes, and technology. This evaluation describes system-wide improvements to enhance institutional medication override policy compliance by establishing a formalized evaluation and defined roles to streamline ADC dispense setting management. A pharmacist-led quality improvement initiative revised the institutional medication override list to improve medication dispensing practices across an academic medical center campus with a pediatric hospital and 2 adult hospitals. This initiative included removal of patient care unit designations from the medication override list, revision of institutional override policy, creation of an online submission form, and selection of ADC override metrics for surveillance. A conceptual framework guided decisions for unique dosage forms and interdisciplinary engagement. Employing this framework revised workflows for stakeholders in the medication-use process through clinical pharmacist evaluation, existing shared governance structure communication, and pharmacy automation support.The revised policy increased the number of medications available for override from 80 to 106 (33% increase) and unique dosage forms from 166 to 191 (15% increase). The total number of medication dispense settings was reduced from 5,600 to 541 (90% decrease). The proportion of override dispenses compliant with policy increased from 59% to 98% (P < 0.001). Median monthly ADC overrides remained unchanged following policy revision (P = 0.995). ADC override rate reduction was observed across the institution, with the rate decreasing from 1.4% to 1.2% (P < 0.001). Similar ADC override rate reductions were observed for adult, pediatric, and emergency department ADCs. CONCLUSION: This initiative highlights pharmacists' role in leading institutional policy changes that influence the medication-use process through ADC dispensing practices. A pharmacist-led reconciliation process that removed practice area designations from our medication override policy streamlined ADC setting maintenance, increased the compliance rate of ADC override transactions, and provided a formalized process for future evaluation of medication overrides.

Comparison of Neonatal Outcomes With and Without Prophylaxis With Indomethacin in Premature Neonates.

OBJECTIVE: Historically, prophylactic indomethacin (pINDO) has been used in some institutions for patent ductus arteriosus (PDA) in extremely low birthweight neonates while other institutions have used it as prophylaxis for intraventricular hemorrhage (IVH). The objective of this study was to evaluate the incidence of IVH and PDA with or without pINDO in premature neonates. METHODS: This was a retrospective, single-center study comparing neonatal outcomes in neonates weighing 1250 grams or less who received pINDO (pINDO group) to those who did not (No pINDO group) after our institution discontinued its routine use. RESULTS: A total of 399 infants were included for analysis (pINDO, n = 141; No pINDO, n = 258). No difference was found between pINDO and No pINDO groups in incidence of any IVH (18% vs 14%, respectively) or severe IVH (7% vs 3%, respectively) when adjusting for gestational age and antenatal corticosteroids. Although the incidence of moderate-to-large PDA was lower in the pINDO group (13% vs 23%, respectively, adjusted p = 0.002), there was no significant difference for PDA requiring surgery (4% vs 3%, respectively). Results demonstrated a higher incidence of bronchopulmonary dysplasia (BPD) in the pINDO group (55% vs 41%, respectively, adjusted p = 0.014). CONCLUSION: No difference in the incidence of IVH, severe IVH, or PDA requiring surgery was observed between groups, whereas an increase in BPD was seen with use of pINDO. These data support our institutional practice change to discontinue routine use of pINDO in premature neonates. Further research is needed to guide clinical practice.

Review of Fluconazole Treatment and Prophylaxis for Invasive Candidiasis in Neonates.

Invasive candidiasis accounts for approximately 10% of nosocomial infections in preterm infants, with an incidence of 1% to 4% among neonatal intensive care unit (NICU) admissions and a mortality as high as 20% to 30%. These outcomes warrant improved treatment and prevention strategies for infants at highest risk. The Infectious Diseases Society of America provides guidelines on antifungal medications for the prophylaxis and treatment of candidiasis in NICUs; however, there are still variations in practice on the use of fluconazole for prophylaxis and treatment of invasive candidiasis. This review provides specific information regarding fluconazole activity, pharmacokinetics, and a literature evaluation of dosing strategies and comparisons to other treatments in the neonatal population.

Evaluation of Appropriateness and Cost Savings of Pharmacist-Driven Palivizumab Ordering.

OBJECTIVES: Guidelines by the AAP for the use of palivizumab prophylaxis for respiratory syncytial virus (RSV) recommend administration within 72 hours prior to discharge for selected high-risk patient populations. Our institution historically administered palivizumab on a fixed-day schedule of Mondays and Thursdays, but adjusted the practice in fall 2017 to a pharmacist-driven flex-schedule based on anticipated discharge date. This review evaluated the effect of pharmacist-driven palivizumab ordering on the appropriateness of palivizumab administrations, based on AAP and institutional recommendations. Additionally, this review evaluated for effects on institutional cost. METHODS: This was a retrospective single-center evaluation including patients for whom palivizumab was ordered between July 1, 2016, and June 30, 2018. Patients in the 2016-2017 RSV season were in the fixed-day group, while patients in the 2017-2018 RSV season were in the flex-schedule group. RESULTS: A total of 142 palivizumab doses were evaluated. Overall, 97% of administrations were for an appropriate indication. All doses administered inappropriately (n = 4) occurred in the fixed-day group. In the fixed-day group, 48.6% of doses were given within 72 hours prior to discharge, which increased to 70.1% in the flex-schedule group (p = 0.01). The amount of drug saved by batching was 1 vial for every 4.9 patients in the fixed-day group, and 1 vial for every 4.8 patients in the flex-schedule group. CONCLUSIONS: There was a statistically significant improvement in compliance with AAP recommendations following the implementation of pharmacist-driven flex-schedule for palivizumab, compared to a fixed-day batching schedule. There was no significant difference in cost.

Comparison of Neonatal Outcomes With the Use Cefotaxime Versus Ceftazidime in a Neonatal Intensive Care Unit.

OBJECTIVES: There is a national drug shortage of cefotaxime, and ceftazidime is recommended as an alternative to cefotaxime for neonates. This study evaluated culture-positive late-onset sepsis (LOS), multidrug resistant organisms (MDROs), and other neonatal outcomes with the use of ceftazidime compared with cefotaxime in neonates. METHODS: This was a single-center, retrospective cohort study of neonatal subjects who received at least 24 hours of ceftazidime or cefotaxime between April 1, 2015, and August 1, 2017. Subjects were excluded if they received the alternate antibiotic for more than 24 hours. RESULTS: A total of 101 subjects were included (ceftazidime, n = 58; cefotaxime, n = 43). Median gestational ages were significantly different between groups (28.1 [IQR, 25.0-36.6] weeks versus 32.3 [IQR, 26.9-37.4] in the ceftazidime and cefotaxime groups, respectively, p < 0.05). Results showed a non-statistically significant increased incidence of culture-positive LOS (17.2% versus 2.3%, respectively, adjusted OR 6.51 [95% CI, 0.78-55.23], p = 0.09) and MDRO infections (5.2% versus 0%, respectively, p = 0.26) with the use of ceftazidime compared with cefotaxime. There was a statistically significant increased risk of stage II to III necrotizing enterocolitis (NEC) with the use of ceftazidime (22.4% versus 2.3%, respectively, adjusted OR 9.68 [95% CI, 1.18-79.45], p = 0.04). CONCLUSIONS: This study found a statistically significant increase in stage II to III NEC with the use of ceftazidime compared with cefotaxime. There was a higher rate of culture-positive LOS and MDRO infections with ceftazidime, but this was not significant. Further research is warranted to assess the implications ceftazidime use in neonates.

Evaluation of Timing and Dosing of Caffeine Citrate in Preterm Neonates for the Prevention of Bronchopulmonary Dysplasia.

OBJECTIVE: The aim of this study was to evaluate the timing and dosing of caffeine therapy in relation to the development of bronchopulmonary dysplasia (BPD). METHODS: This was a single-center, retrospective cohort study comparing early (days of life 0-2) to late (day of life 3 or greater) caffeine initiation in extremely low birth weight neonates, with a secondary analysis of large (10 mg/kg/day) to small dose (5 mg/kg/day) caffeine. RESULTS: There were 138 patients in the primary timing analysis. The early caffeine group had a lower incidence and reduced odds of the composite outcome of BPD or all-cause mortality, compared with the late caffeine group (64% vs. 88%, respectively; adjusted p < 0.05; adjusted OR 0.36 [95% CI 0.13-0.98]). No statistically significant difference was found between dosing groups (p = 0.29) in the primary outcome; however, there was a lower rate of patent ductus arteriosus requiring treatment (p = 0.05) and decreased likelihood of discharging home on oxygen (p = 0.02) in the large-dose group compared with the small-dose group. CONCLUSIONS: Early caffeine initiation significantly decreased the incidence of BPD or all-cause mortality in extremely low birth weight neonates. Patients receiving large-dose caffeine had improved secondary outcomes, although no difference in BPD was noted. Further studies are needed to determine the optimal dosing of caffeine.

ACCP Clinical Pharmacist Competencies.

The purpose of the American College of Clinical Pharmacy (ACCP) is to advance human health by extending the frontiers of clinical pharmacy. Consistent with this mission and its core values, ACCP is committed to ensuring that clinical pharmacists possess the knowledge, skills, attitudes, and behaviors necessary to deliver comprehensive medication management (CMM) in team-based, direct patient care environments. These components form the basis for the core competencies of a clinical pharmacist and reflect the competencies of other direct patient care providers. This paper is an update to a previous ACCP document and includes the expectation that clinical pharmacists be competent in six essential domains: direct patient care, pharmacotherapy knowledge, systems-based care and population health, communication, professionalism, and continuing professional development. Although these domains align with the competencies of physician providers, they are specifically designed to better reflect the clinical pharmacy expertise required to provide CMM in patient-centered, team-based settings. Clinical pharmacists must be prepared to complete the education and training needed to achieve these competencies and must commit to ongoing efforts to maintain competence through ongoing professional development. Collaboration among stakeholders will be needed to ensure that these competencies guide clinical pharmacists' professional development and evaluation by educational institutions, postgraduate training programs, professional societies, and employers.