Efficiency and safety of high-dose undiluted intravenous push levetiracetam loading doses compared to intravenous infusion in seizing patients: A retrospective cohort study.

OBJECTIVE: Intravenous (IV) push (IVP) is an alternative administration method for levetiracetam, but evidence evaluating it compared to IV piggyback (IVPB) for loading doses in acutely seizing patients is limited, particularly in patients with status epilepticus (SE). This study aimed to compare the efficiency and safety of IVP versus IVPB levetiracetam loading doses. METHODS: This was a single-center sequential retrospective study conducted in adult (≥18 years) patients who received an IV levetiracetam loading dose (>2000 mg or ≥20 mg/kg) for acute or suspected seizure. The primary outcome was time to administration, compared between doses given as IVP versus IVPB. Secondary outcomes included rates of adverse events (AEs), rescue benzodiazepine or antiseizure medication administration, intubation, and intensive care unit (ICU) admission between groups. RESULTS: A total of 246 patients were included; 116 received IVP and 130 received IVPB loading doses. Median age was 56 years; most patients were male (62%) and White (60%) and had witnessed seizures (67%). Doses were administered for SE in 32 (27.5%) and 46 (35.4%) patients in the IVP and IVPB arms, respectively. Median time to administration was shorter in the IVP group (12 vs. 38 min, p < .001). Bradycardia (1.7% vs. 2.3%, p = .99), hypotension (7.8% vs. 12%, p = .30), sedation (6% vs. 12.3%, p = .09), intubation (10% vs. 8%, p = .37), ICU admission (32% vs. 39%, p = .31), and rescue medication administration (8.6% vs. 14.6% p = .10) were similar between groups. In SE patients, IVP was associated with shorter time to administration (12 vs. 44 min, p = .003) and lower odds of ICU admission after adjustment for age, dose, Status Epilepticus Severity Score, and seizure history (adjusted odds ratio = .23, 95% confidence interval = .06-.81). SIGNIFICANCE: IVP reduced time to levetiracetam administration versus IVPB and was not associated with more AEs. Rescue agent use, intubation, and ICU admission were similar between arms, but IVP may reduce ICU admissions in SE patients. Prospective studies should assess the effectiveness of IVP versus IVPB.

Feasibility of Laboratory Equipment-Based Simulation Methods to Assess the Impact of Vehicle Transportation on Product Quality of mAb Dosing Solutions.

Therapeutic monoclonal antibody (mAb) products for intravenous (IV) administration generally require aseptic compounding with a commercially available diluent. When the administration site is located away from the preparation site, the prepared dosing solution may need to be transported in a vehicle. The impact of vehicle transportation on the product quality of mAbs needs to be evaluated to define safe handling and transportation conditions for dosing solutions. The design and execution of actual vehicle transportation studies require considerable resources and time. In this study, we systematically developed three different laboratory equipment-based methods that simulate vehicle transportation stresses: orbital shaker (OS), reciprocating shaker (RS), and vibration test system (VTS)-based simulation methods. We assessed their feasibility by comparing the impact on product quality caused by each simulated method with that caused by actual vehicle transportation. Without residual polysorbate 80 (PS80) in the mAb dosing solution, transportation via a cargo van led to a considerable increase in the subvisible particle counts and did not meet the compendial specifications for the light obscuration method. However, the presence of as low as 0.0004%w/v (4 ppm) PS80 in the dosing solution stabilized the mAb against vehicle transportation stresses and met the compendial specifications. Vehicle transportation of an IV bag with headspace resulted in negligible micro air bubbles and foaming in both PS80-free and PS80-containing mAb dosing solutions. These phenomena were found to be comparable to the VTS-based simulated method. However, the OS- and RS-based simulated methods formed significantly more micro air bubbles and foaming in an IV bag with headspace than either actual vehicle transportation or the VTS-based simulated method. Despite the higher interfacial stress (micro air bubbles and foaming) in the dosing solution created by the OS- and RS-based simulated methods, 0.0004%w/v (4 ppm) PS80 in the dosing solution was found to be sufficient to stabilize the mAb. The study shows that under appropriate simulated conditions, the OS-, RS-, and VTS-based simulated methods can be used as practical and meaningful models to assess the impact and risk of vehicle transportation on the quality of mAb dosing solutions.

Design, synthesis and biological evaluation of 6-chloro-quinolin-2-one derivatives as novel FXIa inhibitors.

A series of 6-chloro-quinolin-2-one derivatives were designed and synthesized as FXIa inhibitors by exploration of P1, P1 prime and P2 prime groups. Each compound was accessed for inhibitory effect on FXIa and some of them were evaluated in the clotting assay. 14c demonstrated excellent in-vitro potency (FXIa IC50: 15 nM, 2 x aPTT: 6.8 µM) and good in-vivo efficacy (prolonged in-vivo aPTT by more than 1-fold but not PT). Moreover, the pharmacokinetics property of 14c were evaluated following intravenous administration in rats, which indicated that 14c probably will be a clinical candidate for intravenous administration.

The efficacy and safety of continuous intravenous tirofiban for acute ischemic stroke patients treated by endovascular therapy: a meta-analysis.

Introduction: Tirofiban is a non-peptide selective glycoprotein IIb/IIIa receptor inhibitor with a short half-life. The research assesses the efficacy and safety of continuous intravenous tirofiban in patients with acute ischemic stroke (AIS) undergoing endovascular therapy (ET). Methods: A systematic search of Pubmed, Embase, Web of Science, and Cochrane Library databases is conducted from inception until January 26, 2024. Eligible studies are included based on predefined selection criteria. Efficacy outcomes (favorable functional outcome and excellent functional outcome) and safety outcomes (symptomatic intracranial hemorrhage [sICH], any intracranial hemorrhage [ICH], and 90-day mortality) are calculated using odds ratios (OR) and 95% confidence intervals (CI). Results: A total of 4,329 patients from 15 studies are included in the analysis. The results indicate a significant trend toward favorable functional outcomes in the tirofiban group (OR, 1.24; 95% CI, 1.09-1.42; p = 0.001). In terms of safety outcomes, tirofiban does not increase the risk of sICH (OR, 0.90; 95% CI, 0.71-1.13; p = 0.35) or any ICH (OR, 0.97; 95% CI, 0.70-1.34; p = 0.85), but it significantly decreases 90-day mortality (OR, 0.75; 95% CI, 0.64-0.88; p = 0.0006). A subgroup analysis suggests that continuous intravenous tirofiban demonstrates better efficacy (OR, 1.24; 95% CI, 1.09-1.42; p = 0.001) for patients with AIS undergoing rescue ET with even better results when used in combination with intra-arterial and intravenous administration (OR, 1.25; 95% CI, 1.07-1.451; p = 0.005). Conclusion: Continuous intravenous tirofiban is effective and safe for patients with AIS undergoing rescue ET, particularly when combined with intra-arterial tirofiban. Systematic review registration: PROSPERO, identifier CRD42023385695.

Comprehensive Ocular and Systemic Safety Evaluation of Polysialic Acid-Decorated Immune Modulating Therapeutic Nanoparticles (PolySia-NPs) to Support Entry into First-in-Human Clinical Trials.

An inflammation-resolving polysialic acid-decorated PLGA nanoparticle (PolySia-NP) has been developed to treat geographic atrophy/age-related macular degeneration and other conditions caused by macrophage and complement over-activation. While PolySia-NPs have demonstrated pre-clinical efficacy, this study evaluated its systemic and intraocular safety. PolySia-NPs were evaluated in vitro for mutagenic activity using Salmonella strains and E. coli, with and without metabolic activation; cytotoxicity was evaluated based on its interference with normal mitosis. PolySia-NPs were administered intravenously in CD-1 mice and Sprague Dawley rats and assessed for survival and toxicity. Intravitreal (IVT) administration in Dutch Belted rabbits and non-human primates was assessed for ocular or systemic toxicity. In vitro results indicate that PolySia-NPs did not induce mutagenicity or cytotoxicity. Intravenous administration did not show clastogenic activity, effects on survival, or toxicity. A single intravitreal (IVT) injection and two elevated repeat IVT doses of PolySia-NPs separated by 7 days in rabbits showed no signs of systemic or ocular toxicity. A single IVT inoculation of PolySia-NPs in non-human primates demonstrated no adverse clinical or ophthalmological effects. The demonstration of systemic and ocular safety of PolySia-NPs supports its advancement into human clinical trials as a promising therapeutic approach for systemic and retinal degenerative diseases caused by chronic immune activation.

Accidental Intravenous Administration of Simethicone in a 4-Year-Old Patient: A Case Report.

Simethicone is an antiflatulent medication exclusively administered orally, thus its systemic effects remain unknown. We present a case of an inadvertent intravenous administration of simethicone to a 4-year-old patient, precipitating respiratory difficulty, cyanosis, and altered mental status. The patient's condition improved rapidly with appropriate interventions, leading to discharge in a fully recovered state. To date, only one documented instance of intravenous simethicone administration exists in medical literature.

Compatibility studies of selected multichamber bag parenteral nutrition with fluconazole.

OBJECTIVE: Fluconazole (FLZ) is a drug widely used in the treatment of fungal infections including the treatment of immunocompromised patients, HIV-infected patients, and cancer patients. Critically ill patients often require the administration of drugs with parenteral nutrition (PN). The safety of this combination should be defined before the drug and PN are administered in one infusion line. This study aimed to determine the compatibility of FLZ with six selected multichamber bag parenteral nutrition. METHODS: FLZ solution for infusion was combined with PNs in appropriate proportions, considering most clinical situations resulting from different possible administration rates of the preparations. Samples were visually assessed, and pH, osmolality, turbidity, particle size (dynamic light scattering and light obscuration methods), and zeta potential were measured. These measurements were made immediately after combining the solutions and after 4 h of storage at 23 ± 1°C. RESULTS: FLZ combined with PNs did not cause changes observed visually. The turbidity of the samples was <0.4 NTU. The average particle size of the lipid emulsion was below 300 nm, and the PFAT5 parameter was ≤0.02%. The absolute value of the zeta potential of the PN + FLZ samples was higher for 5 out of 6 PN than the corresponding value for PN immediately after activation. Changes in pH and osmolality during 4 h of sample observations were within acceptable limits. CONCLUSION: Compatibility of the FLZ with six multichamber bag PN was confirmed. Hence, those preparations can be administered to patients in one infusion line using the Y-site.

Intravenous application of human umbilical cord mesenchymal stem cells alleviate neuropathic pain by suppressing microglia activation in rats.

Objective: Neuropathic pain has been considered as one of the most serious chronic pain subtypes and causes intolerable suffering to patients physically and mentally. This study aimed to verify the analgesic effect of intravenous administration of human umbilical cord mesenchymal stem cells (HUC-MSCs) upon rats with chronic constriction injury (CCI)-induced neuropathic pain and the concomitant mechanism via modulating microglia. Methods: 30 male SD rats were randomized divided into three groups (n = 10 per group): Sham + Saline group (S&S group), CCI + Saline group (C&S group) and CCI + HUC-MSCs group (C&U group). Rats were injected with either saline or HUC-MSCs via the caudal vein on the 7th day after modelling. The paw mechanical withdrawal threshold (PMWT) and thermal withdrawal latency (TWL) of the ligation side were measured before (day 0) and after (day 1, 3, 5, 7, 9, 11, 13, and 15) modelling. On day 15 after modelling, western-blotting and immunofluorescent staining were used to assess the expressive abundance of Iba-1 (a typical biomarker of activated microglia) in the ligation side of the spinal cord dorsal horn, and ultrastructural changes of the ligation of sciatic nerve were evaluated by transmission electron microscope (TEM). Results: Compared with the S&S group, PMWT and TWL in the C&S group were significantly decreased on day 5 and then persisted to day 15 after modelling (C&S vs S&S, P < 0.05), while a significant amelioration of mechanical hyperalgesia (day 13, day 15) and thermal allodynia (day 9, day 11, day 15) was observed in the C&U group (C&U vs C&S, P < 0.05). Meanwhile, the expression of Iba-1 was significantly suppressed by systemic infusion of HUC-MSCs in the C&U group according to western-blotting and immunofluorescent staining analyses (P < 0.05). With the aid of TEM detection, we intuitively noticed the efficacious reconstruction of the laminate structure of the sciatic nerve ligation, elimination of mitochondrial swelling, and formation of new myelination were noted on day 15 after modelling in the C&U group. Conclusions: Overall, intravenous administration of HUC-MSCs systemically revealed an ameliorative effect upon CCI-induced neuropathic pain in SD rats by inhibiting microglia activation in the dorsal horn of the impaired spinal cord and alleviating sciatic nerve injury. Our findings supply new references for the further development of HUC-MSCs-based cytotherapy for neuropathic pain administration.

Prospects of Intravenous Coenzyme Q10 Administration in Emergency Ischemic Conditions.

Coenzyme CoQ10 (CoQ10) is an endogenous lipid-soluble antioxidant that effectively protects lipids, proteins, and DNA from oxidation due to its ability to undergo redox transitions between oxidized and reduced forms. Various oxidative stress-associated infectious and somatic diseases have been observed to disrupt the balance of CoQ10 concentration in tissues. As a high molecular weight polar lipophilic compound, CoQ10 exhibits very limited oral bioavailability, which restrains its therapeutic potential. Nevertheless, numerous studies have confirmed the clinical efficacy of CoQ10 therapy through oral administration of high doses over extended time periods. Experimental studies have demonstrated that in emergency situations, intravenous administration of both oxidized and reduced-form CoQ10 leads to a rapid increase in its concentration in organ tissues, offering protection for organ tissues in ischemic conditions. This suggests that the cardio- and neuroprotective efficacy of intravenously administered CoQ10 forms could present new opportunities in treating acute ischemic conditions. Based on these findings, the review provides reasoning supporting further research and implementation of CoQ10 dosage forms for intravenous administration in emergency situations into clinical practice.

Histopathological and Immunohistochemical Mechanisms of Bone Marrow-Derived Mesenchymal Stem Cells in Reversion of Gastric Precancerous Lesions.

BACKGROUND: Gastric cancer (GC) stands as one of the most prevalent cancer types worldwide, holding the position of the second leading cause of cancer-related deaths. Gastric lesions represent pathological alterations to the gastric mucosa, with an elevated propensity to advance to gastric cancer. Limited research has explored the potential of stem cells in the treatment of gastric lesions. METHODS: This study aimed to explore the potential of intravenous transplantation of labeled bone marrow-derived mesenchymal stem cells (BMMSCs) to inhibit the progression of precancerous gastric lesions. RESULTS: In the gastric lesion disease model group, the rat tissue exhibited noteworthy mucosal atrophy, intestinal metaplasia, dysplasia, and inflammatory cell infiltration. Following the infusion of BMMSCs, a notable decrease in gastric lesions was found, with atrophic gastritis being the sole remaining lesion, which was confirmed by morphological and histological examinations. BMMSCs that were colonized at gastric lesions could differentiate into epithelial and stromal cells, as determined by the expression of pan-keratin or vimentin. The expression of vascular endothelial growth factor was significantly elevated following BMMSC transplantation. BMMSCs could also upregulate the production of humoral immune response cytokines, including interleukin (IL)-4 and IL-10, and downregulate the production of IL-17 and interferon-gamma, which could be highly associated with the cellular immune response and inflammation severity of the lesions. CONCLUSIONS: BMMSC transplantation significantly reduced inflammation and reversed gastric lesion progression.

Effectiveness of Tranexamic Acid in Trauma Patients: A Systematic Review.

Tranexamic acid (TXA), a fibrinolytic agent, effectively inhibits plasminogen activation, thereby reducing fibrinolysis and hemorrhage. This study focused on its application in trauma patients undergoing emergency surgery, a critical area due to trauma's significant role in mortality. Our investigation involved a meticulous screening of randomized controlled trials from databases including Scopus, PubMed, Web of Science, and Cochrane. The findings indicate that TXA intervention is promising in enhancing outcomes for trauma patients. However, the drug's effectiveness may vary based on the specific nature of the medical condition. In summary, robust evidence suggests that TXA can diminish blood loss, lower transfusion rates, reduce complications, and improve hemoglobin and hematocrit levels in surgical patients. Consequently, TXA should be considered a crucial medication, readily available to mitigate morbidity and mortality in surgical settings. Future research should explore factors influencing TXA's effectiveness in traumatic brain injury cases and across a broad spectrum of surgical scenarios in diverse patient populations. This would further guide clinicians in refining and optimizing the use of TXA.

Bioinspired zwitterionic triblock copolymers designed for colloidal drug delivery: 2 - Biological evaluation.

In this work, poly(lactide) nanoparticles were equipped with a bioinspired coating layer based on poly[2-(methacryloyloxy)ethyl phosphorylcholine] and then evaluated when administered to the lungs and after intravenous injection. Compared to the plain counterparts, the chosen zwitterionic polymer shell prevented the coated colloidal formulation from aggregation and conditioned it for lower cytotoxicity, protein adsorption, complement activation and phagocytic cell uptake. Consequently, no interference with the biophysical function of the lung surfactant system could be detected accompanied by negligible protein and cell influx into the bronchoalveolar space after intratracheal administration. When injected into the central compartment, the coated formulation showed a prolonged circulation half-life and a delayed biodistribution to the liver. Taken together, colloidal drug delivery vehicles would clearly benefit from the investigated poly[2-(methacryloyloxy)ethyl phosphorylcholine]-based polymer coatings.

Efficacy of Switching From Oral to Intravenous Administration for Dexamethasone-Induced Hiccups in CyberKnife Radiotherapy: A Case Report.

Steroids are commonly used for medical purposes. While hiccups are a recognized side effect of steroid therapy, we have not found any reports of hiccups interfering with the progress of radiotherapy. A case of dexamethasone (DEX)-induced hiccups (DIH) during CyberKnife radiotherapy (CKR) is presented. A 42-year-old man with neurofibromatosis type I had a history of malignant peripheral schwannomas originating in the right femur. We started to perform CKR with oral DEX at an increased dose of 4 mg/day for the recurrence of cranial metastasis and primary lesions. Severe hiccups developed four days after the increased DEX dose. DEX was stopped six days after CKR initiation, and the hiccups subsided over the next four days. However, the CKR procedure was not possible due to the patient's worsening swelling of the head and thigh lesions, which prevented the proper fit of the mesh face mask and body fixation device. Intravenous (IV) DEX 6.6 mg/day was initiated, which allowed the resumption of CKR due to reduced swelling of the lesions. The CKR was completed due to the absence of hiccups following the transition to IV DEX. DIH could occur even at a dosage of 4 mg/day when taken orally. Our case suggests the significance of recognizing DIH during radiotherapy. Switching the administration from oral to IV DEX may be an option for dealing with DIH.

The hemostatic and anti-inflammatory effects of intravenous single-dose of tranexamic acid in double-segment posterior lumbar interbody fusion: a case control study.

This study aims to observe the hemostatic and anti-inflammatory effects of intravenous administration of tranexamic acid (TXA) in dual segment posterior lumbar interbody fusion (PLIF). The data of 53 patients with lumbar disease treated with double-segment PLIF were included in this study. The observation group was received a single-dose intravenous of TXA (1 g/100 mL) 15 min before skin incision after general anesthesia. The control group was not received TXA. The observation indicators included postoperative activated partial prothrombin time (APTT), thrombin time (PT), thrombin time (TT), fibrinogen (FIB), platelets (PLT), and postoperative deep vein thrombosis in the lower limbs, surgical time, intraoperative bleeding volume, postoperative drainage volume, transfusion rate, postoperative hospital stay, red blood cell (RBC), hemoglobin (HB), hematocrit (HCT), C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) on the 1st, 4th, 7th, and last tested day after surgery. All patients successfully completed the operation, and there was no deep vein thrombosis after operation. There was no statistically significant difference in postoperative APTT, PT, TT, FIB, PLT, surgical time, and postoperative hospital stay between the two groups (p > 0.05). The intraoperative bleeding volume, postoperative drainage volume, and transfusion rate in the observation group were lower than those in the control group, and the differences were statistically significant (p < 0.05). There was no statistically significant difference in RBC, HB, HCT, CRP, and ESR between the two groups on the 1st, 4th, 7th, and last tested day after surgery (p > 0.05). Intravenous administration of TXA in dual segment PLIF does not affect coagulation function and can reduce bleeding volume, postoperative drainage volume, and transfusion rate. Moreover, it does not affect the postoperative inflammatory response.

Specificity and sensitivity of the SeLECT score in predicting late seizures in patients undergoing intravenous thrombolytic treatment and the effect of diabetes mellitus and leukoaraiosis / Especificidade e sensibilidade do escore SeLECT na predição de convulsões tardias em pacientes submetidos a tratamento trombolítico intravenoso e o efeito do diabetes mellitus e leucoaraiose

Abstract Background Seizures after stroke can negatively affect the prognosis of ischemic stroke and cause a decrease in quality of life. The efficacy of intravenous (IV) recombinant tissue plasminogen activator (rt-PA) treatment in acute ischemic stroke has been demonstrated in many studies, and IV rt-PA treatment has been increasingly used around the world. The SeLECT score is a useful score for the prediction of late seizures after stroke and includes the severity of stroke (Se), large artery atherosclerosis (L), early seizure (E), cortical involvement (C), and the territory of the middle cerebral artery (T). However, the specificity and sensitivity of the SeLECTscore have not been studied in acute ischemic stroke patients that received IV rt-PA treatment. Objective In the present study, we aimed to validate and develop the SeLECT score in acute ischemic stroke patients receiving IV rt-PA treatment. Methods The present study included 157 patients who received IV thrombolytic treatment in our third-stage hospital. The 1-year seizure rates of the patients were detected. SeLECT scores were calculated. Results In our study, we found that the SeLECT score had low sensitivity but high specificity for predicting the likelihood of late seizure after stroke in patients administered IV rt-PA therapy. In addition to the SeLECT score, we found that the specificity and sensitivity were higher when we evaluated diabetes mellitus (DM) and leukoaraiosis. Conclusion We found that DM was an independent risk factor for late seizures after stroke in a patient group receiving thrombolytic therapy, and late seizures after stroke were less frequent in patients with leukoaraiosis.

Resumo Antecedentes As convulsões após o AVC podem afetar negativamente o prognóstico do AVC isquêmico e causar uma diminuição na qualidade de vida. A eficácia do tratamento com ativador do plasminogênio tecidual recombinante (rt-PA) intravenoso (IV) no AVC isquêmico agudo foi demonstrada em muitos estudos, e o tratamento com rt-PA IV tem sido cada vez mais usado em todo o mundo. A pontuação SeLECT é uma pontuação útil para a previsão de convulsões tardias após AVC e inclui a gravidade do AVC (Se), aterosclerose de grandes artérias (L), convulsão precoce (E), envolvimento cortical (C) e o território do meio artéria cerebral (T). No entanto, a especificidade e a sensibilidade do escore SeLECT não foram estudadas em pacientes com AVC isquêmico agudo que receberam tratamento IV com rt-PA. Objetivo No presente estudo, objetivamos validar e desenvolver o escore SeLECT em pacientes com AVC isquêmico agudo recebendo tratamento IV com rt-PA. Métodos O presente estudo incluiu 157 pacientes que receberam tratamento trombolítico IV em nosso hospital de terceiro estágio. As taxas de convulsão de 1 ano dos pacientes foram detectadas. Os escores SeLECT foram calculados. Resultados Em nosso estudo, descobrimos que o escore SeLECT apresentou baixa sensibilidade, mas alta especificidade para prever a probabilidade de convulsão tardia após AVC em pacientes que receberam terapia IV com rt-PA. Além do escore SeLECT, descobrimos que a especificidade e a sensibilidade foram maiores quando avaliamos diabetes mellitus (DM) e leucoaraiose. Conclusão Descobrimos que DM foi um fator de risco independente para convulsões tardias após AVC em um grupo de pacientes recebendo terapia trombolítica, e convulsões tardias após AVC foram menos frequentes em pacientes com leucoaraiose.

Construção e validação de ferramenta preventiva sobre incompatibilidade medicamentosa em via Y / Construction and validation of a preventive tool on drug incompatibility in the Y-route / Construcción y validación de una herramienta preventiva de incompatibilidad de medicamentos en la ruta Y

Introdução: A terapia com medicamentos endovenosos é muito utilizada nas unidades hospitalares, porém, possui uma elevada chance de incidentes, principalmente quando os medicamentos são administrados simultaneamente em via Y. Essa prática pode resultar em incompatibilidades medicamentosas classificadas em reações físicas e químicas. Objetivo: Construir e validar uma ferramenta preventiva de incompatibilidade medicamentosa em via Y. Método: Estudo metodológico com abordagem quantitativa. Foi desenvolvido em três etapas: Levantamento bibliográfico, construção e diagramação do material e por fim, a validação da ferramenta preventiva. Para validação, a ferramenta preventiva foi submetida ao processo de validação de face e conteúdo por juízes com expertise na temática. Resultados: Construiu-se e validou-se uma ferramenta preventiva através da busca de dados na literatura com a participação de sete juízes especialistas na temática. Os itens avaliativos referentes a tabela de incompatibilidade medicamentosa quanto aos objetivos, estrutura, apresentação e relevância da ferramenta preventiva foi considerada válida, pois foram julgados como adequado pelos especialistas. Conclusão: A validação de conteúdo, foi considerada válida pelos juízes, portanto, espera-se que o material alcance o seu objetivo ao ser aplicado durante a prática clínica. Dessa forma, será disponibilizado à instituição para que seja utilizado, favorecendo a prevenção de danos e contribuindo para a segurança dos pacientes, bem como melhorando a qualidade da assistência e educação em saúde.

Introduction: Intravenous drug therapy is widely used in hospital units, however, it has a high chance of incidents, especially when drugs are administered simultaneously in a Y route. This practice can result in drug incompatibilities classified into physical and chemical reactions. Objective: To build and validate a preventive tool for drug incompatibility in the Y pathway. Method: Methodological study with a quantitative approach. It was developed in three stages: bibliographic survey, construction and layout of the material and finally, the validation of the preventive tool. For validation, the preventive tool was submitted to the face and content validation process by judges with expertise in the subject. Results: A preventive tool was built and validated through the search for data in the literature with the participation of seven expert judges on the subject. The evaluative items referring to the medication incompatibility table regarding the objectives, structure, presentation and relevance of the preventive tool were considered valid, as they were judged as adequate by the specialists. Conclusion: The content validation was considered valid by the judges, therefore, it is expected that the material reaches its objective when applied during clinical practice. In this way, it will be made available to the institution for use, favoring the prevention of damage and contributing to patient safety, as well as improving the quality of health care and education.

Introducción: La farmacoterapia intravenosa es ampliamente utilizada en las unidades hospitalarias, sin embargo, tiene una alta probabilidad de incidencias, especialmente cuando los fármacos se administran simultáneamente en una vía Y. Esta práctica puede dar lugar a incompatibilidades medicamentosas clasificadas en reacciones físicas y químicas. Objetivo: Construir y validar una herramienta preventiva de incompatibilidad de medicamentos en la vía Y. Método: Estudio metodológico con enfoque cuantitativo. Se desarrolló en tres etapas: relevamiento bibliográfico, construcción y diagramación del material y finalmente, la validación de la herramienta preventiva. Para la validación, la herramienta preventiva fue sometida al proceso de validación facial y de contenido por jueces expertos en el tema. Resultados: Se construyó y validó una herramienta preventiva a través de la búsqueda de datos en la literatura con la participación de siete jueces expertos en el tema. Los ítems evaluativos referentes a la tabla de incompatibilidad de medicamentos en relación a los objetivos, estructura, presentación y relevancia de la herramienta preventiva fueron considerados válidos, pues fueron juzgados como adecuados por los especialistas. Conclusiones: La validación del contenido fue considerada válida por los jueces, por lo tanto, se espera que el material alcance su objetivo al ser aplicado durante la práctica clínica. De esta forma, se pondrá a disposición de la institución para su uso, favoreciendo la prevención de daños y contribuyendo a la seguridad del paciente, además de mejorar la calidad de la atención y educación en salud.

Estrategias para la prevención de errores en la administración de medicamentos intravenosos / Strategies for the Prevention of Errors in the Administration of Intravenous Medication / Estratégias para a prevenção de erros na administração de medicamentos intravenosos

Los medicamentos que son administrados erróneamente pueden producir efectos adversos, los cuales pueden causar afectaciones en el paciente y gastos adicionales en las instituciones. Los cuatro errores más comunes en la administración de medicamentos por vía intravenosa son dosis incorrectas del medicamento, volumen incorrecto, mezclas incorrectas e incompatibilidad farmacológica. El nivel de conocimiento farmacológico en el profesional de enfermería cobra especial importancia. Objetivo: analizar la literatura disponible sobre estrategias utilizadas para prevenir la ocurrencia de estos errores en la administración de medicamentos intravenosos por parte del personal enfermería desde el año 2010 al 2019. Método: se realizó una revisión integrativa (RI) para dar respuesta a la pregunta: ¿cuál es la evidencia disponible sobre estrategias para la prevención de errores en la administración de medicamentos por vía intravenosa? Se utilizaron bases datos entre las que se encuentran OVID, ScienceDirect, SciELO, Medline Complete, Academic Search Complete, PubMed y Guías de Prácticas Clínicas, con límite de tiempo entre 2010 y 2019. Resultado: se identificaron 17 publicaciones sobre estrategias de prevención de errores en la administración de medicamentos por vía Intravenosa, se clasificaron los resultados en 3 grupos relacionados con dosis, volumen, mezclas e incompatibilidades y con factores extrínsecos del paciente. Conclusiones: el número de estudios en cuanto a la prevención de errores en la administración de los medicamentos intravenosos es reducido al igual que el rigor metodológico; respecto a las estrategias de minimización de errores, prevalece la utilización de dispositivos electrónicos (bombas inteligentes, códigos electrónicos, etiquetado), comunicación asertiva, creación y adherencia a las guías y protocolos (principalmente en fármacos analgésicos y antibióticos) , fortalecimiento de los conocimientos individuales (educación continua, temas farmacológicos y capacitación en habilidades técnicas) y la generación de una estandarización en la preparación y administración de medicamentos intravenosos.

Erroneous intravenous medication administration can produce adverse effects, which can cause affectations in the patient and additional expenses for the institutions. The four most common errors in intravenous medication administration are wrong doses, wrong volume, wrong mixes, and pharmacological incompatibility. The level of pharmacological knowledge in nursing professionals is essential. Objective: to analyze the available literature on strategies used to prevent these errors in the administration of intravenous medications by nursing staff from 2010 to 2019. Method: an integrative review (IR) was carried out to answer the question: what is the available evidence on strategies for preventing errors in the administration of intravenous medication? Databases were used, including OVID, ScienceDirect, SciELO, Medline Complete, Academic Search Complete, PubMed, and Clinical Practice Guidelines, with a period limit between 2010 and 2019. Results: 17 publications were identified on strategies for preventing errors in the administration of intravenous medication. The results were classified into 3 groups related to dose, volume, mixtures,and incompatibilitiesand with factorsextrinsicto the patient. Conclusions: the number of studiesregarding the prevention oferrorsissmall,asisthemethodologicalrigor.Regarding thestrategiestominimizeerrors,the use ofelectronic devices prevails (smart pumps, electronic codes, labeling); assertive communication, creation, and adherence to guidelines and protocols (mainly in analgesic drugs and antibiotics); strengthening of individual knowledge (continuing education in pharmacological issues and training in technical skills) and the generation of standardization in the preparation and administration of intravenous medication.

Os medicamentos administrados de forma incorreta podem produzir efeitos adversos, que podem causar afetações no paciente e gastos adicionais nas instituições. Os quatro erros mais comuns na administração intravenosa de medicamentos são doses erradas, volume errado, misturas erradas e incompatibilidade farmacológica. O nível de conhecimento farmacológico do professional de enfermagem é especialmente importante. Objetivo: analisar a literatura disponível sobre as estratégias utilizadas para prevenir a ocorrência desses erros na administração de medicamentos intravenosos por professionais de enfermagem no período de 2010 a 2019. Método: foirealizada umarevisão integrativa(RI) pararesponderà questão:Quaisasevidências disponíveissobreestratégias de prevenção deerros naadministração de medicamentos intravenosos? Foram utilizadas bases de dados,entreas queestao OVID, ScienceDirect, SciELO, Medline Complete, Academic Search Complete, PubMed e Guías de Práticas Clínicas, com limite de tempo entre 2010 e 2019. Resultado: foram identificadas 17 publicações sobre estratégias de prevenção de erros na administração de medicamentos por via intravenosa, os resultados foram classificados em três grupos relacionados a dose, volume, misturas e incompatibilidadeseafatoresextrínsecosao paciente. Conclusões: o número deestudos sobre prevenção deerros naadministração de medicamentos intravenosos é pequeno, assim como o rigor metodológico. Em relação às estratégias para minimizar erros, prevalece o uso de dispositivos eletrônicos (bombas inteligentes, códigos eletrônicos, rotulagem), comunicação assertiva, criação e adesão a diretrizes e protocolos (principalmente em fármacos analgésicos e antibióticos), fortalecimento dos conhecimentos individuais(educação continuada, questõesfarmacológicasetreinamento emhabilidadestécnicas)ea geração de uma padronização no preparo e administração de medicamentos intravenosos.

In(compatibility) of intravenous drugs in critical units: adult cohort / In(compatibilidad) de medicamentos intravenosos en unidades críticas: cohorte de adultos / In(compatibilidade) de medicamentos intravenosos em unidades críticas: coorte de adultos

ABSTRACT Objectives: To analyze potential (in)compatibilities of intravenous drugs based on the scheduling prepared by the nursing team. Methods: historic cohort (retrospective) with 110 adults in critical units. Intravenous medications were identified concomitantly, whose pairs were analyzed for (in) compatibility using the screening system Trissel's™ 2 Compatibility IV-Micromedex 2.0. Parametric and non-parametric statistic were used according to the nature of the variable. Results: 565 pairs of drugs were identified. Of these, 44.9% were compatible; and 8.8%, potentially incompatible. Most potentially incompatible pairs involved substances with alkaline pH such as phenytoin (32%) and sodium bicarbonate (8%) and weak acids such as midazolam (12%) and dobutamine (6%), which could result in precipitate formation. Conclusions: almost half of the mixtures simultaneously administrated was compatible, which indirectly reflects in the organized work between the nursing team and the clinical pharmaceutic in the discussions and decisions related to time scheduling.

RESUMEN Objetivos: analizar las (in)compatibilidades potenciales de medicamentos intravenosos basado en el aplazamiento de horarios realizado por equipo de enfermería. Métodos: cohorte histórica (retrospectiva) con 110 adultos de unidades críticas. Identificaron medicamentos intravenosos aplazados de modo concomitante, cuyas duplas han analizadas cuanto a la (in)compatibilidad por medio del sistema de screening Trissel's™ 2 Compatibility IV-Micromedex 2.0. Utilizó estadística paramétrica y no paramétrica segundo naturaleza de la variable. Resultados: identificaron 565 duplas de medicamentos. De estas, 44,9% compatibles; y 8,8%, potencialmente incompatibles. Mayoría de las duplas potencialmente incompatibles envolvió substancias con pH alcalino como fenitoína (32%) y bicarbonato de sodio (8%) y ácidos débiles como midazolam (12%) y dobutamina (6%), las cuales podrían resultar en precipitación. Conclusiones: casi mitad de las misturas aplazadas simultáneamente fue compatible, aspecto que, indirectamente, refleja el trabajo orquestado entre el equipo de enfermería y el farmacéutico clínico en las discusiones y decisiones acerca del aplazamiento de horarios.

RESUMO Objetivos: analisar as (in)compatibilidades potenciais de medicamentos intravenosos com base no aprazamento de horários realizado pela equipe de enfermagem. Métodos: coorte histórica (retrospectiva) com 110 adultos de unidades críticas. Identificaram-se medicamentos intravenosos aprazados de modo concomitante, cujas duplas foram analisadas quanto à (in)compatibilidade por meio do sistema de screening Trissel's™ 2 Compatibility IV-Micromedex 2.0. Utilizou-se estatística paramétrica e não paramétrica segundo natureza da variável. Resultados: identificaram-se 565 duplas de medicamentos. Destas, 44,9% foram compatíveis; e 8,8%, potencialmente incompatíveis. A maioria das duplas potencialmente incompatíveis envolveu substâncias com pH alcalino como fenitoína (32%) e bicarbonato de sódio (8%) e ácidos fracos como midazolam (12%) e dobutamina (6%), as quais poderiam resultar em precipitação. Conclusões: quase metade das misturas aprazadas simultaneamente foi compatível, aspecto que, indiretamente, reflete o trabalho orquestrado entre a equipe de enfermagem e o farmacêutico clínico nas discussões e decisões acerca do aprazamento de horários.

Custo-minimização da troca entre imunoglobulinas de diferentes vias e marcas: sustentabilidade relacionada ao tratamento na saúde suplementar / Cost minimizing the switching between immunoglobulin of different routes and brands: of treatment-related in the supplementary health

Objetivo: Avaliar custo-minimização da troca entre as versões intravenosa (IVIg) e subcutânea (SCIg) das imunoglobulinas (Ig) em operadora de saúde com mais de 500.000 vidas. Métodos: Estudo retrospectivo, transversal, descritivo, seguido de custo-minimização entre os pacientes que utilizaram IVIg, de 1º de outubro de 2018 a 30 de setembro de 2019. Simulou-se a troca entre as IVIg e SCIg, objetivando descrever a economia de uma hipotética substituição. Estabeleceram-se como critérios de exclusão: o não pagamento e a liberação com dose acima de 60.000 mg. Após exclusão, calcularam-se as despesas totais, somando-se os custos do produto e taxas de infusão. Resultados: Evidenciou-se que 133 pacientes, totalizando 1.175 liberações, utilizaram IVIg no período avaliado. Identificou-se a utilização de 34.797.500 mg de IVIg, por 10 especialidades, totalizando R$ 12.408.192,50 de despesas. Quando aplicada simulação, há uma potencial economia de recursos de até 29,83%, dependendo da SCIg escolhida. Conclusão: A análise econômica no tratamento com imunoglobulinas evidenciou significativa relevância, pois contribui com o uso adequado da terapêutica garantindo a sustentabilidade do sistema de saúde. Medicamentos subcutâneos apresentam-se como uma opção custo-minimizatória em comparação ao tratamento intravenoso para saúde suplementar brasileira.

Objective: Cost-minimization evaluation of the switch from intravenous (IVIg) to subcutaneous (SCIg) immunoglobulin (Ig) in a Brazilian Health Maintenance Organization (HMO), with more than 500.000 lives. Methods: This is a retrospective, transversal and descriptive study, followed by a cost-minimization analysis among patients using IVIg between 2018, October, 1st and 2019, September, 30th. The simulation was performed supposing the exchange from IVIg to SCIg, in order to calculate possible savings. Exclusion criteria: non-payment (gloss), and infusions with doses above 60.000 miligrams. After exclusion, total expenditures were calculated by summing product and infusion costs. Results: There were133 patients, with1,175 IVIg infusion events in the period evaluated. It was identified the use of 34,797,500 milligrams of IVIg, for 10 specialties, with R$ 12,408,192.50 of final expenditure. The simulation previews hypothetical reduction in the final cost of up to 29.83%, depending on the SCIg brand chosen. Conclusion: The economic analysis in the treatment with immunoglobulins showed significant relevance, as it contributes to the appropriate use of therapy ensuring the sustainability of the health system. Subcutaneous drugs are a cost-minimizing option compared to intravenous treatment for Brazilian HMOs.