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1.
Clin Drug Investig ; 44(3): 175-181, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38363545

ABSTRACT

BACKGROUND AND OBJECTIVES: Data are limited regarding the safety associated with administering valproate sodium by intravenous push (IVP) compared with intravenous piggyback (IVPB). The objective of this retrospective pre-post analysis was to compare the safety profile of valproate administration via IVPB from March to May 2022 and IVP from June to August 2022. METHODS: A total of 890 IVPB and 440 IVP administrations were included. The major endpoint of this analysis was the incidence of infusion site reactions (infiltration or phlebitis). RESULTS: The incidence of documented intravenous (IV) site reactions demonstrated minimal differences between both IVPB and IVP administration cohorts. Based on the Naranjo algorithm, all IVPB and IVP infusion site reactions were classified as possible or doubtful. Additional safety endpoints included bradycardia, hypotension, or sedation attributable to valproate sodium administration. Similar safety profiles were observed, including valproate-associated bradycardia, hypotension, and sedation events. All safety events were further classified as possible or doubtful by the Naranjo algorithm. Time from pharmacist verification to valproate administration was also collected. The mean time from pharmacist order verification to valproate administration was significantly faster in the IVP cohort compared to the IVPB cohort. CONCLUSION: IVP valproate administration may be considered safe, allowing for more optimal clinical and operational outcomes in the acute care setting.


Subject(s)
Hypotension , Valproic Acid , Humans , Valproic Acid/adverse effects , Injection Site Reaction , Retrospective Studies , Bradycardia , Infusions, Intravenous
2.
Article in English | MEDLINE | ID: mdl-38028903

ABSTRACT

Objective: To evaluate the prevalence, risk factors, and clinical impact of delays in second doses of antibiotics in patients with sepsis. Design: Single-center, retrospective, observational study. Setting: Large teaching hospital. Patients: Adult patients who triggered an electronic sepsis alert in the emergency department (ED), received ≥2 doses of vancomycin or an antipseudomonal beta-lactam, and were discharged with an ICD-10 sepsis code. Methods: We assessed the prevalence of delays in second doses of antibiotics by ≥25% of the recommended dose interval and conducted multivariate regression analyses to assess for risk factors for delays and in-hospital mortality. Results: The cohort included 449 patients, of whom 123 (27.4%) had delays in second doses. In-hospital death occurred in 31 patients (25.2%) in the delayed group and 71 (21.8%) in the non-delayed group (p = 0.44). On multivariate analysis, only location in a non-ED unit at the time second doses were due was associated with delays (OR 2.75, 95% CI 1.20-6.32). In the mortality model, significant risk factors included malignant tumor, respiratory infection, and elevated Sequential Organ Failure Assessment (SOFA) score but not delayed second antibiotic doses (OR 1.19, 95% CI 0.69-2.05). In a subgroup analysis, delayed second doses were associated with higher mortality in patients admitted to non-intensive care units (ICUs) (OR 4.10, 95% CI 1.32-12.79). Conclusions: Over a quarter of patients with sepsis experienced delays in second doses of antibiotics. Delays in second antibiotic doses were not associated with higher mortality overall, but an association was observed among patients admitted to non-ICUs.

3.
J Pharm Pract ; 36(2): 281-285, 2023 Apr.
Article in English | MEDLINE | ID: mdl-34384303

ABSTRACT

Background: Recent shortages of intravenous (IV) fluids have resulted in healthcare systems converting administration of many medications from IV piggyback (IVPB) to IV push (IVP). Administering medications via IVP presents numerous advantages; however, IV site reactions such as phlebitis and infiltration may occur. Objective: The objective of this analysis is to evaluate the infusion site safety of ertapenem given as peripheral IVP compared to IVPB in adult patients. Methods: This was an institutional review board-approved, single-center, retrospective study. Patients, ages 18 or older, receiving IV ertapenem were identified. The major endpoints analyzed were IV site reactions including phlebitis and infiltration. The Naranjo Nomogram was utilized to assess the causality of the reactions to determine the likelihood of whether the event was caused by the medication itself or other factors. Results: To date, 283 administrations (92 patients) in the IVP group and 319 administrations (82 patients) in the IVPB group were analyzed. There were 13 IV site reactions compared to 8 in the IVP vs IVPB group, respectively (P-value = 0.16). Ten of the events in the IVP group were deemed "possible" and 2 deemed "doubtful," while the remaining event was considered "probable" per the Naranjo Nomogram. Of the events in the IVPB group, all 8 were found to be "possible." Conclusion: The administration of IVP ertapenem showed comparable rates of infusion site reactions compared to IVPB. Implementation of IVP ertapenem appears to be associated with infusion site safety similar to IVPB and should be considered safe to administer.


Subject(s)
Phlebitis , Adult , Humans , Adolescent , Ertapenem/adverse effects , Retrospective Studies , Infusions, Intravenous , Injections, Intravenous , Pharmaceutical Preparations , Phlebitis/etiology
4.
Am J Emerg Med ; 63: 127-131, 2023 01.
Article in English | MEDLINE | ID: mdl-36371934

ABSTRACT

BACKGROUND: Administration of 3% sodium chloride through a peripheral venous catheter is associated with risk of infusion-related adverse events (IRAE) due to its high osmolarity. Given this concern and the paucity of data regarding these events, many hospitals have policies that require central line administration of 3% sodium chloride. OBJECTIVE: The objective of this analysis was to evaluate the incidence of IRAE associated with peripheral administration of 3% sodium chloride. METHODS: This analysis included patients who received 3% sodium chloride via a peripheral venous catheter between May 2017 and August 2019. The major endpoint of this analysis was the overall incidence of IRAE, defined as the documentation of infiltration or phlebitis. A multivariable logistic regression was performed to identify potential risk factors (e.g., age, infusion rate, infusion duration, peripheral venous catheter location, and needle gauge) for development of IRAE. RESULTS: A total of 706 administrations in 422 patients were included. Seventy-four (10.5%) administrations were associated with a documented event. Based on the Infusion Nurses grading scale for infiltration or phlebitis, 48% of the events in this analysis were grade 1 in severity. Duration of infusion of 3% sodium chloride was found to be associated with an increased odds of an IRAE (OR per 1 h 1.02, 95% CI 1.01-1.02) in the multivariable analysis. Age, infusion rate, peripheral venous catheter location, and needle gauge were not independently associated with an increased risk of an IRAE. CONCLUSION: These data suggest that IRAE occurred more frequently when 3% sodium chloride was administered over a longer duration and the majority of events were mild with no permanent tissue injury. It may be reasonable to consider peripheral administration of 3% sodium chloride in the acute care setting for a short duration, although additional studies are needed to continue to evaluate its safety.


Subject(s)
Catheterization, Peripheral , Saline Solution , Humans , Sodium Chloride , Osmolar Concentration , Saline Solution/administration & dosage , Saline Solution/adverse effects , Catheterization, Peripheral/adverse effects
5.
Drug Saf ; 45(1): 19-26, 2022 01.
Article in English | MEDLINE | ID: mdl-34716562

ABSTRACT

INTRODUCTION: Medication administration via intravenous push presents multiple potential advantages; however, there may be an increased risk of adverse drug reactions. In 2020, Brigham and Women's Hospital changed levetiracetam intravenous administration to intravenous push (IVP). OBJECTIVE: The purpose of this analysis was to compare the safety profile of IVP to intravenous piggyback (IVPB) levetiracetam administration. METHODS: This institutional review board-approved, single-center, pre-post analysis was performed between 1 November, 2019 and 30 May, 2020. The electronic health record was used to identify all administrations of intravenous levetiracetam greater than 1000 mg in patients ≥ 18 years old. The major safety outcomes included hypotension, bradycardia, drug-induced sedation, and intravenous site reactions such as phlebitis and infiltration. The major efficiency outcome was the time from pharmacy order verification to first-dose administration. RESULTS: A total of 498 administrations in 162 patients were included in the analysis: 252 administrations in 84 patients in the IVP group and 246 administrations in 78 patients in the IVPB group. The incidence of bradycardia was 7 vs 3 (3.2% vs 1.5%, p = 0.34); hypotension 10 vs 6 (5.2% vs 3.5%, p = 0.44); sedation 21 vs 36 (19.3% vs 27.9%, p = 0.12); and peripheral IV site reactions 0 vs 1 (0% vs 0.6%, p = 0.39) in the IVP vs IVPB groups, respectively. The median time between order verification and first-dose administration was significantly reduced in the IVP vs IVPB group (23.5 vs 55 min, p < 0.001). CONCLUSIONS: Intravenous push levetiracetam administration of doses up to 4000 mg was associated with a similar incidence of cardiovascular, sedation, and infusion site-related adverse events compared to IVPB and resulted in a significant reduction in time to first-dose administration. Intravenous push levetiracetam in doses as high as 4000 mg may be considered safe with appropriate monitoring.


Subject(s)
Bradycardia , Hypotension , Academic Medical Centers , Administration, Intravenous , Adolescent , Bradycardia/chemically induced , Bradycardia/epidemiology , Female , Humans , Hypotension/chemically induced , Hypotension/epidemiology , Infusions, Intravenous , Levetiracetam/adverse effects , Retrospective Studies
6.
J Clin Pharmacol ; 61(7): 848-856, 2021 07.
Article in English | MEDLINE | ID: mdl-33554338

ABSTRACT

Dexmedetomidine-associated fever has been reported in the literature and can lead to lengthy workups and unnecessary antibiotic exposure. We conducted a systematic review to evaluate and describe the evidence of fever or hyperthermia caused by dexmedetomidine in adult patients. Data sources included PubMed/MEDLINE, EMBASE, CINAHL, and Web of Sciences. English-language studies of any design published from inception through April 2020 including conference abstracts were included. The target population was hospitalized adult patients. Quality of evidence was determined based on GRADE recommendations and risk of bias assessed using the Evidence Project Risk of Bias tool. Naranjo scores were assessed to determine the likeliness of adverse event being caused by dexmedetomidine. All data were extracted independently and with the guidance of a medical librarian. Four hundred and eighty-eight total citations were found on formal search, with 329 left after removal of duplicates. Independent record screening was performed, leaving 17 citations including 4 retrospective cohort studies, 1 case series, and 12 case reports. Quality of evidence ranged from very low to low for identified analyses. Evidence with patient-level data (case reports and series) were combined to establish a cohort for descriptive results. The median Naranjo score was 4 (range, 3 to 8), and dexmedetomidine doses ranged from 0.1 to 2 µg·h/kg. Obesity and cardiac surgery appear to be significant risk factors. Dexmedetomidine-associated fever appears uncommon, but the true incidence is unknown. Clinicians should keep dexmedetomidine-associated fever in their differential, and stewardship programs should consider assessing for this adverse effect in their patient monitoring.


Subject(s)
Dexmedetomidine/adverse effects , Fever/chemically induced , Hypnotics and Sedatives/adverse effects , Dose-Response Relationship, Drug , Humans , Risk Factors
7.
Ann Pharmacother ; 55(9): 1127-1133, 2021 09.
Article in English | MEDLINE | ID: mdl-33455436

ABSTRACT

BACKGROUND: Although approved by the Food and Drug Administration for intramuscular administration only, analyses have described the administration of intravenous push (IVP) olanzapine, particularly for acute agitation. The safety and efficacy of IVP olanzapine has mostly been limited to emergency department patients. OBJECTIVE: To evaluate the safety of IVP olanzapine administration in the inpatient setting. METHODS: This single-center, retrospective analysis was conducted between July 1, 2018, and December 31, 2019, at Brigham and Women's Hospital in Boston, Massachusetts. Adult patients who received at least 1 dose of IVP olanzapine were included in the analysis. Safety endpoints analyzed included the following adverse drug events (ADEs): hypotension, bradycardia, cardiac arrhythmias, extrapyramidal adverse effects, and respiratory depressive events. Data on IV site reactions, including phlebitis and infiltration, were also collected. RESULTS: A total of 1,247 IVP administrations of olanzapine were identified across 252 patients. Two or more doses were received by 159 patients (63.1%). Most administrations (66%) took place in intensive care units, with 33% administered on general medicine wards. Overall, 104 administrations (8.3%) were associated with at least 1 ADE. Hypotension and bradycardia occurred in 62 (5.2%) and 16 (1.3%) administrations, respectively. Phlebitis occurred with 8 administrations (1.4%). All other adverse events were rare (<1%). CONCLUSION AND RELEVANCE: Hypotension, the most commonly noted ADE, occurred more frequently than in previous studies. IVP olanzapine appears to be a safe route of administration in hospitalized patients, including those receiving multiple doses. Further studies are required to evaluate the effect of IV olanzapine on hemodynamics.


Subject(s)
Antipsychotic Agents , Academic Medical Centers , Administration, Intravenous , Adult , Antipsychotic Agents/adverse effects , Benzodiazepines/adverse effects , Female , Humans , Olanzapine/adverse effects , Retrospective Studies
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