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Varying rates of complications have been reported for prehospital sedation with ketamine, and the relationship to dosing has not been studied on a large scale. We evaluated the association between prehospital ketamine dosing and rates of intubations and other adverse events in patients with behavioral emergencies. Using the 2018/2019 ESO public-use research datasets, we included all non-traumatic, adult behavioral and drug-related EMS encounters with ketamine administration. Based on consensus guidelines, we stratified patients into "above" and "at/below" the maximum dosing for sedation (2 mg/kg IV/IO or 5 mg/kg IM) using the highest single dose of ketamine given. We created propensity scores for matched subjects using 1:1 propensity score matching. Using logistic regression, we compared rates of intubation and other airway interventions, antipsychotic coadministration, improvement reported by EMS, hypoxia, hypotension, and cardiac arrest between the two groups. We included 2383 patients: 478 in the above and 1905 in the at/below dose group. Above-dose ketamine was associated with a higher rate of intubation or supraglottic airway placement (6.4% v 3.3%, OR 2.0, 95% CI 1.00–3.90). Other airway interventions were similar (40.0% v 40.0%, OR 1, 95% CI 0.80–1.30). The above-dose group also showed a higher rate of improvement noted by EMS clinicians (92.5% v 88.7%, OR 1.6, 95% CI 1.01–2.40). The rates of antipsychotic coadministration, hypoxia, hypotension, and cardiac arrest were similar between the cohorts. Patients given ketamine doses above consensus recommendations for sedation appeared more likely to receive prehospital intubation but not more likely to experience other adverse events. [ABSTRACT FROM AUTHOR]

Background: This study aimed to elicit and quantify preferences for treatments for juvenile idiopathic arthritis (JIA). Methods: We conducted a discrete-choice experiment among adolescents with JIA in the United States (US) (n = 197) and United Kingdom (UK) (n = 100) and caregivers of children with JIA in the US (n = 207) and UK (n = 200). In a series of questions, respondents chose between experimentally designed profiles for hypothetical JIA treatments that varied in efficacy (symptom control; time until next flare-up), side effects (stomachache, nausea, and vomiting; headaches), mode and frequency of administration, and the need for combination therapy. Using a random-parameters logit model, we estimated preference weights for these attributes, from which we derived their conditional relative importance. Results: On average, respondents preferred greater symptom control; greater time until the next flare-up; less stomachache, nausea, and vomiting; and fewer headaches. However, adolescents and caregivers in the US were generally indifferent across varying modes and frequencies of administration. UK adolescents and caregivers preferred tablets, syrup, or injections to intravenous infusions. US and UK adolescents were indifferent between treatment with monotherapy or combination therapy; caregivers in the UK preferred treatment with combination therapy to monotherapy. Subgroup analysis showed preference heterogeneity across characteristics including gender, treatment experience, and symptom experience in both adolescents and caregivers. Conclusions: Improved symptom control, prolonged time to next flare-up, and avoidance of adverse events such as headache, stomachache, nausea, and vomiting are desirable characteristics of treatment regimens for adolescents with JIA and their caregivers. [ABSTRACT FROM AUTHOR]

Objective: Rare disease. Background: Cocaine is a highly addictive drug and its use has increased in recent years. It is the second most popular illicit drug in the United States and is the second most trafficked illicit drug in the world. Intravenous (i.v.) drug use leads to severe injury to the veins, including erythema, thrombophlebitis, vasoconstriction, necrosis, development of venous ulceration, and vein occlusion. Case Report: A 35-year-old man presented to our Emergency Department with a 3-day history of excruciating and progressive penile and scrotal pain after having injected cocaine in the dorsal vein of the penis. A genital examination revealed ulcerations and swelling on the ventral proximal penis and scrotum junction, with foul-smelling serous discharge. There was no crepitus. He also had stellate purpura with necrosis of the dorsum of the penis and tender bilateral inguinal lymphadenopathy. Computed tomography of the pelvis, with contrast, showed subcutaneous edema of the penis with ulceration of the penile tip on the right. It also revealed left inguinal adenopathy. Vasculitis and concomitant sexually transmitted disease were ruled out as well as Fournier gangrene, and he was started on i.v. broad-spectrum antibiotics. The patient's clinical condition improved with antibiotics and local wound care. Conclusions: Our case highlights the importance of taking a thorough history from i.v. drug users, as they are at risk of injecting drugs into unusual sites, such as the dorsal penile vein. It is important for the physician to counsel active i.v. drug users regarding possible complications of injecting drug into unusual sites. [ABSTRACT FROM AUTHOR]

Background: Remimazolam is a new benzodiazepine for procedural sedation and general anaesthesia. The aim of this study was to characterise its pharmacokinetic properties and safety in renally and hepatically impaired subjects.Methods: Two separate trials were conducted in patients with hepatic (n=11) or renal impairment (n=11) compared with matched healthy subjects (n=9 and n=12, respectively). The hepatic impairment trial was an open-label adaptive 'Reduced Design' trial, using a single bolus of remimazolam 0.1 mg kg-1 i.v., whereas the renal impairment trial was an open-label trial of a single bolus dose of remimazolam 1.5 mg i.v. Remimazolam plasma concentrations over time were analysed by population pharmacokinetic modelling.Results: Remimazolam pharmacokinetic properties were adequately described by a three-compartment, recirculatory model. Exposure in subjects with severe hepatic impairment was 38.1% higher (i.e. clearance was 38.1% lower) compared with healthy volunteers. This increase caused a slightly delayed recovery (8.0 min for healthy, 12.1 min for moderate, and 16.7 min for severe hepatic impairment). With renal impairment, plasma clearance was comparable with that measured in healthy subjects. Simulations of Cmax after a bolus dose of 10 mg showed no relevant impact of hepatic or renal impairment. The overall incidence of adverse events was low, and all adverse events were mild.Conclusions: As Cmax after a remimazolam bolus i.v. was not affected by hepatic or renal impairment, no dose adjustments are required. No unexpected adverse events related to remimazolam were seen in subjects with renal or hepatic impairment.Clinical Trial Registration: Hepatic impairment trial: ClinicalTrials.gov, NCT01790607 (https://clinicaltrials.gov/ct2/show/NCT01790607). Renal impairment trial: EudraCT Number: 2014-004575-23. [ABSTRACT FROM AUTHOR]

Previous research has demonstrated the effectiveness of both extended-release injectable naltrexone (XR-NTX) and buprenorphine/naloxone (BUP-NX) in the treatment of opioid use disorder (OUD). However, studies using real-world samples with multiple medical and psychiatric comorbidities are lacking. The study's primary aims were to: (1) compare clinical presentations in an inclusive sample of OUD-diagnosed US military veterans receiving XR-NTX and BUP-NX, and (2) investigate differences in 90-day treatment outcomes between these two groups. Methods: The medical records of 79 patients receiving medications to treat OUD in a VA hospital's addiction outpatient treatment program were reviewed retrospectively. The analysis included all veterans who initiated medication treatment during the study period. Differences between medication groups on co-occurring diagnoses, treatment retention, and related outcomes were examined. Results: The two groups were similar in medical and psychiatric comorbidity, although the BUP-NX group were more likely to have a pain diagnosis. No statistically significant differences in retention or toxicology results were found between the two groups over the 90-day study period. The rate of positive urine screens for the BUP-NX group was 19.2% for opiates and 13.5% for other illicit substances, and 3.7% and 11.1% respectively for the XR- NTX group. Conclusion: There was no evidence that 90-days outcomes differed for veterans based on medication received, and there were more similarities than differences in clinical characteristics. Additional research is needed, including larger sample size and prospective randomized control trial to evaluate VA patients' treatment outcomes receiving BUP-NX or XR-NTX for OUD. [ABSTRACT FROM AUTHOR]

Acyclovir (ACV) is a nucleoside antivirus-free agent that was developed and marketed by Burroughs Well-come of the United States. Renal damage from ACV has been a major factor limiting its clinical application. Thus, the renal toxicity mechanism of ACV requires systematic study. In our previous study, we speculated that the nephrotoxicity of ACV may be associated with oxidative stress. In addition to the study of ACV's toxic effect in vivo, it is also necessary to explore the absorption and distribution of ACV in the body to further investigate the changes to ACV in the body. In this study, the toxicokinetics ACV in the kidney of the rat were explored using microdialysis, and the renal function of rats was measured. The results showed that high-dose ACV is associated with renal toxicity after a single intravenous injection or successive administration. [ABSTRACT FROM AUTHOR]

Modes of judicial execution of death sentence have to be determined in light of various objective factors like prevailing atmosphere of the international opinion, international norms and standards, contemporary penological theories and ever progressing standards of human decency. Though it's essential to adapt the most civilized method of judicial execution, nevertheless, what is more important is how that civilized process of execution is carried out. History is witness to the fact that how medical professionals have made invaluable contributions to make the existing modes of execution more civilized, humane and efficient by playing the most pivotal role. Medicalization of the process of judicial execution through intravenous lethal injection is not novel. However, currently direct participation of physicians in the implementation of the death penalty through intravenous lethal injection has become an extremely controversial subject, initiating voluminous intellectual debate at global platforms. Hence, an appropriate contouring of such participation is increasingly coming under sharp scrutiny on ethical and legal grounds. The question arises, will the physicians not be guilty of gross professional misconduct by refusing to oversee the executions and taking care of the condemned persons in their last crucial hours, thereby neglecting their ethical responsibility to minimize the suffering and maximize the comfort. Physicians need to fulfill their role as caregivers by actively participating in the implementation and development of lethal injection as the most humane mode of judicial execution. [ABSTRACT FROM AUTHOR]

A 66-year-old female was brought to the emergency department for acute-onset left-sided chest pain. Prior to arrival, she was at an outpatient appointment with a vascular surgeon for elective sclerotherapy treatment of her lower extremity varicose veins. After receiving an IV injection of polidocanol, she developed severe chest pain with left arm and jaw numbness for the first time in her life. Upon arrival to the ED, the patient reported that her symptoms had resolved. Electrocardiogram (ECG) on presentation was significant for T-wave inversions in leads V1-V3. An initial set of cardiac enzymes showed a troponin I level of 0.62 ng/mL, which subsequently increased to 2.26 ng/mL. Her echocardiogram was significant for mild left ventricular systolic dysfunction with apical hypokinesis (ejection fraction 50%). A repeat ECG showed new T-wave inversions compared to that from the time of admission. The patient eventually agreed to cardiac catheterization, which revealed patent vessels without coronary artery disease, supporting our diagnosis of Takotsubo syndrome and what is the first reported case of likely polidocanol-induced Takotsubo syndrome in the United States. [ABSTRACT FROM AUTHOR]

The purpose of these practice guidelines is to offer and share strategies for preventing extravasation and measures for handling drugs known to cause tissue necrosis, which may occur even with the most skilled experts at intravenous (IV) injection. Herein, general knowledge about extravasation is first described, including its definition, incidence, risk factors, diagnosis, differential diagnosis, and extravasation injuries. Management of extravasation includes nursing intervention and thermal application. At the first sign of extravasation, nursing intervention with following steps is recommended: stop administration of IV fluids immediately, disconnect the IV tube from the cannula, aspirate any remaining drug from the cannula, administer drug-specific antidote, and notify the physician. Local thermal treatments are used to decrease the site reaction and absorption of the infiltrate. Local cooling (ice packs) aids in vasoconstriction, theoretically limiting the drug dispersion. Although clear benefit has not been demonstrated with thermal applications, it remains a standard supportive care. The recommended application schedule for both warm and cold applications is 15 to 20 minutes, every 4 hours, for 24 to 48 hours. For prevention of extravasation, health professionals should be familiar with the extravasation management standard guidelines. They should regularly check the extravasation kit, assess patients' sensory changes, tingling or burning, and always pay attention to patients' words. The medical team's continuous education on extravasation is essential. With the practical use of these guidelines, it is expected to reduce the occurrence rate of extravasation and contribute to patient care improvement. [ABSTRACT FROM AUTHOR]

Prostate cancer was the most common form and had the second highest death rate of male cancer in the United States in 2015. Current diagnosis techniques, such as prostate-specific antigen tests, transrectal ultrasound scans, and biopsies, are often inconclusive, and in the latter case, invasive. Here, we explore the use of clofazimine hydrochloride nanoparticles (CFZ-HCl NPs), a repurposed formulation from an FDA-approved antimycobacterial agent, as a photoacoustic contrast agent for the evaluation of prostate cancer due to its macrophage-targeting capabilities and high optical absorbance at 495 nm. Using a transgenic adenocarcinoma of the mouse prostate (TRAMP) mouse model, our results indicate a preferential accumulation of intravenously injected CFZ-HCl NPs in cancerous prostates over normal prostates. Differences in accumulation of CFZ-HCl NPs between cancerous and normal prostates were determined using a two-wavelength unmixing technique via ex vivo photoacoustic imaging. Thus, intravenous injection of CFZ-HCl NPs leads to differences in the interactions of the particles with cancerous vs normal prostates, while allowing for photoacoustic detection and analysis of prostate cancer. These findings could lead to the development of a new noninvasive technique for the detection and monitoring of prostate cancer progression in an animal model that can potentially be translated to human patients. [ABSTRACT FROM AUTHOR]

purpose of this study was to understand perceptions of biologic therapies, barriers to care with biologic medications, and preferences for biologic therapy attributes. Methods: This mixed-methods study involved quantitative surveys and qualitative telephone interviews with patients and physicians from the United States. Participants described preferences for relevant attributes, and barriers to use of biologic medications. Participants rated, ranked, and indicated importance of preferences for different levels of key attributes including: mode of administration, administration setting, dosing frequency, number of injections, and time to onset of effect. Other attributes unique to each group were also included. Results: A total of 47 patients and 25 physicians participated. Patients ranked out-of-pocket costs, mode of administration, time to onset of efficacy, and administration setting as the most important attributes. Physicians ranked mode of administration, time to onset of efficacy, dosing frequency, and insurance reimbursement/access as most important. Both groups expressed preferences for less frequent administrations (Q8W over Q4W or Q2W) (all P<0.01) and subcutaneous (SC) over intravenous injection (both P<0.0001). Key patient barriers to biologic medications include location of treatment, administration time, scheduling, cost/insurance coverage, number of injections, and mode of administration. Physicians identified patient candidacy, convincing patients, administration setting, mode of administration, cost, and administrative burden as key barriers to initiating therapy; and efficacy, speed of onset, convenience of administration, cost, and patient compliance as barriers to staying on therapy. Conclusions: Patients and physicians expressed strong preferences for less frequent dosing, SC administration, and faster onset. Cost/insurance coverage and convenience issues were key barriers to use. Increased awareness and understanding of preferences and barriers may be useful in facilitating physician-patient conversations with the goal of individualizing treatment. [ABSTRACT FROM AUTHOR]

Background: Although antiemetics are commonly used to prevent postoperative nausea or vomiting, the failure rate is appreciable and there is currently no generally accepted standard for rescue treatment of postoperative nausea or vomiting after failed prophylaxis. This prospective, randomized, double-blind, parallel-group, placebo-controlled, multicenter study was designed to test the hypothesis that intravenous amisulpride, a dopamine D2/D3-antagonist, is superior to placebo at treating established postoperative nausea or vomiting after failed prophylaxis.Methods: A total of 2,285 adult patients undergoing surgery under general inhalational anesthesia and receiving standard antiemetic prophylaxis were enrolled at 23 sites in Canada, France, Germany, and the United States. Of these, 702 patients experienced postoperative nausea or vomiting in the 24-h period after surgery and were randomized to receive a single dose of 5 or 10 mg intravenous amisulpride or matching placebo. The primary endpoint was complete response, defined as no emesis or rescue antiemetic use for 24 h after study drug administration, excluding emesis in the first 30 min. Secondary endpoints included incidence of emesis and rescue medication use, nausea burden, time to treatment failure, and length of stay in postanesthesia care unit and hospital.Results: Complete response occurred in significantly more patients receiving 10 mg amisulpride (96 of 230, 41.7%) than placebo (67 of 235, 28.5%), a 13.2% difference (95% CI, 4.6 to 21.8; odds ratio, 1.80; P = 0.006). A 5-mg dose of amisulpride did not show a significant benefit (80 of 237, 33.8%); the difference from placebo was 5.2% (95% CI, 3.1 to 13.6; odds ratio, 1.24; P = 0.109). The total number of adverse events recorded and proportion of patients with at least one adverse event were comparable between the placebo and amisulpride groups. No clinically relevant toxicities were observed.Conclusions: A single 10-mg dose of intravenous amisulpride was safe and more effective than placebo at treating established postoperative nausea or vomiting in patients failing postoperative nausea or vomiting prophylaxis. [ABSTRACT FROM AUTHOR]

Purpose. The results of a study to determine the physical compatibility of ZTI-01 (fosfomycin for injection) in 0.9% sodium chloride or 5% dextrose during simulated Y-site administration with 37 i.v. antimicrobials and 58 nonantimicrobials are reported. Methods. Fosfomycin, an epoxide antibiotic with broad-spectrum activity against multidrug-resistant bacteria, is marketed in the United States only in an oral formulation with limited bioavailability, but an i.v. formulation is in development. Fosfomycin for injection and other evaluated drugs were reconstituted according to manufacturer recommendations and further diluted with 0.9% sodium chloride or 5% dextrose to the final desired concentrations. Y-site administration was simulated in glass culture tubes. Incompatibility was defined as changes in visual characteristics or a change in turbidity of >0.5 nephelometric turbidity units over the 120-minute observation period. Results. Of the 95 drugs tested, 16 were incompatible with fosfomycin in 0.9% sodium chloride, and 18 were incompatible with fosfomycin in 5% dextrose; incompatibility was observed with 10 of 37 antimicrobials, including the 3 commercially available amphotericin B products, anidulafungin, caspofungin, ceftaroline, ciprofloxacin, daptomycin, doxycycline, and isavuconazonium sulfate. Conclusion. Fosfomycin for injection at a concentration of 30 mg/mL was physically compatible with 73 of 95 (77%) of the i.v. drugs tested at concentrations used clinically in both 0.9% sodium chloride injection and 5% dextrose injection. Twenty-two drugs were deemed incompatible in at least 1 of the 2 diluents. [ABSTRACT FROM AUTHOR]

A deoxycytidine analog is a potential agent for the treatment of several cancers, which includes poorly prognostic pancreatic cancer. We previously developed deoxycytidine analog DFP-10917, and long-term/low-dose infusions of this analog has produced antitumor effects in leukemia cancer- and ovarian cancer-xenograft models. DFP-10917 is now undergoing clinical Phase III study in the United States for the treatment of patients with relapsed or refractory acute myeloid leukemia. PEG-drug conjugation has become a promising technique to improve the pharmacokinetic and pharmacodynamic properties of anti-cancer drugs. In the present study, we synthesized a novel PEG-drug conjugate of DFP-10917, referred to hereafter as DFP-14927, using a 4-armed CTPEG system to endow the DFP-10917 drug with favorable long-circulating properties that maximize its utility and antitumor efficacy. Intravenous injection of the synthesized DFP-14927 returned encouraging antitumor effects in a Panc-1 human pancreatic tumor- and a BxPC-3 human pancreatic tumor-xenograft models. These effects were comparable to that of free DFP-10917 as well as to that of gemcitabine, which is considered a standard in the treatment of pancreatic cancer. In vitro studies revealed that DFP-14927 inhibits cell division on human pancreatic cancer cell lines via arrest of the G2/M phase in the cell cycle, which is consistent with the effects of free DFP-10917. Intravenous administration of the newly synthesized DFP-14927 has induced G2/M arrest in human pancreatic tumor-xenograft murine models, which represents an improvement in the pharmacokinetics of DFP-10917. DFP-14927 could be an alternative for patients who cannot accept prolonged or continuous infusions of DFP-10917. • A PEG-drug conjugate of deoxycytidine analog, DFP-14927, was synthesized. • DFP-14927 produces antitumor effects on human pancreatic cancer-xenograft models. • DFP-14927 induces delay in cell division via G2/M arrest. [ABSTRACT FROM AUTHOR]

Purpose: To establish a baseline for care and overall survival (OS) based upon contemporary first-line treatments prescribed in the era before the introduction of immune checkpoint inhibitors, for people with metastatic non-small cell lung cancer (NSCLC) without common actionable mutations. Methods: Using a nationally representative electronic health record data from the Flatiron dataset which included 162 practices from different regions in US, we identified patients (≥18 years old) newly diagnosed with stage IV NSCLC initiating first-line anticancer therapy (November 2012- January 2015, with follow-up through July 2015). Patients with documented epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) translocation were excluded. Anti-cancer drug therapy and overall survival were described overall, and by histology. Results: A total of 2,014 patients with stage IV NSCLC without known EGFR or ALK genomic tumor aberrations initiated systemic anticancer therapy, 22% with squamous and 78% with nonsquamous histology. Their mean (SD) age was 67 (10) years, 55% were male, and 87% had a smoking history. In nonsquamous NSCLC, carboplatin plus pemetrexed either without (25.7%) or with bevacizumab (16%) were the most common regimens; 26.6% of nonsquamous patients receiving induction therapy also received continuation maintenance therapy. In squamous NSCLC, carboplatin plus paclitaxel (37.6%) or nab-paclitaxel (21.1%) were the most commonly used regimens. Overall median OS was 9.7 months (95% CI: 9.1, 10.3), 8.5 months (95% CI: 7.4, 10.0) for squamous, and 10.0 months (95% CI: 9.4, 10.8) for nonsquamous NSCLC. Conclusion: The results provide context for evaluating the effect of shifting treatment patterns of NSCLC treatments on patient outcomes, and for community oncology benchmarking initiatives. [ABSTRACT FROM AUTHOR]

Objective: Plasma concentrations of B-type natriuretic peptide (BNP) and troponin are often measured for diagnostic purposes when patients are admitted with heart failure, but their prognostic value when measured soon after admission is uncertain. We aimed to investigate the added prognostic value of admission measurements of BNP and troponins in patients with acute heart failure.Methods and Results: Multivariable prognostic models for death or any worsening heart failure (WHF) or rehospitalization for WHF by 30 days, 30-day death or rehospitalization for WHF, and 90-day mortality were constructed using baseline data from the Value of Endothelin Receptor Inhibition with Tezosentan in Acute heart failure Studies (VERITAS) including BNP and troponin I. Of 1347 patients, the median (interquartile range) value of BNP was 422 (156-945) pg/mL and 855 (63%) had measurable troponin I. By 30 days, 432 patients had died or experienced WHF. Clinical variables had only moderate predictive performance that was not substantially improved by BNP or troponin I (c-indices 0.6528 and 0.6595, respectively). By 30 days, 150 patients died or were rehospitalized for WHF. The c-index using clinical variables (0.6855) was not improved by adding biomarkers. By 90 days, 135 patients had died. The c-index for mortality was somewhat better than for composite outcomes (0.7394) but improved little with biomarkers (0.7461).Conclusion: Routine clinical data recorded at the time of admission in patients with acute heart failure are poor at predicting recurrent admissions but somewhat better at predicting mortality. Neither BNP nor troponin measured at admission improved predictions; measurement closer to discharge, or of other novel biomarkers, might perform differently. [ABSTRACT FROM AUTHOR]

Context: Although patient-controlled analgesia (PCA) is an effective pain control modality, there is a lack of large studies on PCA safety in pediatric patients.Objectives: This study compared the delivery of morphine either via intravenous route (morphine IV) or via PCA device (morphine PCA) on risk of cardiopulmonary resuscitation (CPR) and mechanical ventilation (MV) using a large administrative database.Methods: We assembled a retrospective cohort of pediatric inpatients between five and 21 years old in 42 children's hospitals between 2007 and 2011 from the Pediatric Health Information System database. After propensity score matching, we created matched cohorts of morphine PCA and morphine IV patients, in both surgical and nonsurgical samples, who were similar on demographic, clinical, and hospital-level factors. We examined if PCA administration was associated with greater likelihood of CPR or MV up to two days after drug administration.Results: Surgical and nonsurgical patients administered morphine PCA generally had lower odds of having MV on the baseline day and up to two days after PCA exposure, although these estimates were not statistically significant. Similarly, PCA exposure was associated with about 20%-44% lower odds of same day CPR in both surgical and nonsurgical patients, with a slightly greater reduction in the odds of CPR in the surgical patients.Conclusion: In this large pediatric inpatient population, morphine administered via PCA device for surgical and nonsurgical pain was not associated with an increased risk of receiving CPR or MV, and was associated with slightly better safety outcomes than intravenous morphine. [ABSTRACT FROM AUTHOR]

Background: Information is limited regarding the cost of pulmonary exacerbations (PEx) among patients with cystic fibrosis in the United States.Methods: To examine PEx costs, medical chart data were linked to insurance claims for patients aged ≥6 years who had commercial coverage from a large US health insurer affiliated with Optum during 2008-2013. A PEx was categorized as an episode requiring newly started (1) oral antibiotics (PEx-O) or (2) intravenous (IV) antibiotics and/or inpatient stay (PEx-IV).Results: Among 241 patients, 88.0% had ≥1 PEx (2.9/year) of any type, and 48.1% had ≥1 PEx-IV. Prior PEx-IV was the strongest risk factor for subsequent PEx-IV. The mean cost per episode was $12,784 for PEx of any type and $36,319 for PEx-IV. Patients with worse lung function were more likely to experience a PEx and incurred higher annual PEx-related costs.Limitations: This was an observational study using a convenience sample of patients with commercial coverage from a large US health insurer whose medical charts were available for abstraction. Results of the study may not be generalizable to individuals with Medicaid coverage and other types of insurance, or to the uninsured.Conclusions: Most patients experience ≥1 PEx annually, and nearly half require IV antibiotics and/or inpatient stay at considerable cost. [ABSTRACT FROM AUTHOR]

Introduction: Little is known about trends in national rates of injection-related skin and soft tissue infections (SSTI) and their relationship to the structural risk environment for heroin users. Use of Mexican-sourced "Black Tar" heroin, predominant in western US states, may have greater risk for SSTI compared with eastern US powder heroin (Colombian-sourced) due to its association with non-intravenous injection or from possible contamination.Methods: Using nationally representative hospital admissions data from the Nationwide Inpatient Sample and heroin price and purity data from the Drug Enforcement Administration, we looked at rates of hospital admissions for opiate-related SSTI (O-SSTI) between 1993 and 2010. Regression analyses examined associations between O-SSTI and heroin source, form and price.Results: Hospitalization rates of O-SSTI doubled from 4 to 9 per 100,000 nationally between 1993 and 2010; the increase concentrated among individuals aged 20-40. Heroin market features were strongly associated with changes in the rate of SSTI. Each $100 increase in yearly heroin price-per-gram-pure was associated with a 3% decrease in the rate of heroin-related SSTI admissions. Mexican-sourced-heroin-dominant cities had twice the rate of O-SSTI compared to Colombian-sourced-heroin-dominant cities.Discussion: Heroin-related SSTI are increasing and structural factors, including heroin price and source-form, are associated with higher rates of SSTI hospital admissions. Clinical and harm reduction efforts should educate heroin users on local risk factors, e.g., heroin type, promote vein health strategies and provide culturally sensitive treatment services for persons suffering with SSTI. [ABSTRACT FROM AUTHOR]

Importance: All intravenous (IV) iron products are associated with anaphylaxis, but the comparative safety of each product has not been well established.Objective: To compare the risk of anaphylaxis among marketed IV iron products.Design, Setting, and Participants: Retrospective new user cohort study of IV iron recipients (n = 688,183) enrolled in the US fee-for-service Medicare program from January 2003 to December 2013. Analyses involving ferumoxytol were limited to the period January 2010 to December 2013.Exposures: Administrations of IV iron dextran, gluconate, sucrose, or ferumoxytol as reported in outpatient Medicare claims data.Main Outcomes and Measures: Anaphylaxis was identified using a prespecified and validated algorithm defined with standard diagnosis and procedure codes and applied to both inpatient and outpatient Medicare claims. The absolute and relative risks of anaphylaxis were estimated, adjusting for imbalances among treatment groups.Results: A total of 274 anaphylaxis cases were identified at first exposure, with an additional 170 incident anaphylaxis cases identified during subsequent IV iron administrations. The risk for anaphylaxis at first exposure was 68 per 100,000 persons for iron dextran (95% CI, 57.8-78.7 per 100,000) and 24 per 100,000 persons for all nondextran IV iron products combined (iron sucrose, gluconate, and ferumoxytol) (95% CI, 20.0-29.5 per 100,000) , with an adjusted odds ratio (OR) of 2.6 (95% CI, 2.0-3.3; P < .001). At first exposure, when compared with iron sucrose, the adjusted OR of anaphylaxis for iron dextran was 3.6 (95% CI, 2.4-5.4); for iron gluconate, 2.0 (95% CI 1.2, 3.5); and for ferumoxytol, 2.2 (95% CI, 1.1-4.3). The estimated cumulative anaphylaxis risk following total iron repletion of 1000 mg administered within a 12-week period was highest with iron dextran (82 per 100,000 persons, 95% CI, 70.5- 93.1) and lowest with iron sucrose (21 per 100,000 persons, 95% CI, 15.3- 26.4).Conclusions and Relevance: Among patients in the US Medicare nondialysis population with first exposure to IV iron, the risk of anaphylaxis was highest for iron dextran and lowest for iron sucrose. [ABSTRACT FROM AUTHOR]

Background: Quinidine gluconate, the only U.S. Food and Drug Administration-approved treatment for life-threatening malaria in the United States, has a problematic safety profile and is often unavailable in hospitals.Objective: To assess the safety and clinical benefit of intravenous artesunate as an alternative to quinidine.Design: Retrospective case series.Setting: U.S. hospitals.Patients: 102 patients aged 1 to 72 years (90% adults; 61% men) with severe and complicated malaria. Patients received 4 weight-based doses of intravenous artesunate (2.4 mg/kg) under a treatment protocol implemented by the Centers for Disease Control and Prevention between January 2007 and December 2010. At baseline, 35% had evidence of cerebral malaria, and 17% had severe hepatic impairment. Eligibility required the presence of microscopically confirmed malaria, need for intravenous treatment, and an impediment to quinidine.Measurements: Clinical and laboratory data from each patient's hospital records were abstracted retrospectively, including information from baseline through a maximum 7-day follow-up, and presented before a physician committee to evaluate safety and clinical benefit outcomes.Results: 7 patients died (mortality rate, 6.9%). The most frequent adverse events were anemia (65%) and elevated hepatic enzyme levels (49%). All deaths and most adverse events were attributed to the severity of malaria. Patients' symptoms generally improved or resolved within 3 days, and the median time to discharge from the intensive care unit was 4 days, even for patients with severe liver disease or cerebral malaria. More than 100 concomitant medications were used, with no documented drug-drug interactions.Limitation: Potential late-presenting safety issues might occur outside the 7-day follow-up.Conclusion: Artesunate was a safe and clinically beneficial alternative to quinidine. [ABSTRACT FROM AUTHOR]

Rationale: Numerous substituted cathinone drugs have appeared in recreational use. This variety is often a response to legal actions; the scheduling of 3,4-methylenedioxypyrovalerone (MDPV; 'bath salts') in the USA was followed by the appearance of the closely related drug α-pyrrolidinopentiophenone (alpha-PVP; 'flakka'). Objectives: This study aimed to directly compare the efficacy and potency of alpha-PVP with that of MDPV. Methods: Groups of male Wistar rats were trained in the intravenous self-administration (IVSA) alpha-PVP or MDPV under a fixed-ratio 1 schedule of reinforcement. An additional group was examined for locomotor and body temperature responses to noncontingent administration of MDVP or alpha-PVP (1.0, 5.6, and 10.0 mg/kg, i.p.). Results: Acquisition of alpha-PVP (0.1 mg/kg/infusion) IVSA resulted in low, yet consistent drug intake and excellent discrimination for the drug-paired lever. Dose substitution (0.05-0.25 mg/kg/infusion) under a fixed-ratio 1 schedule confirmed potency was similar to MDPV in prior studies. In direct comparison to MDPV (0.05 mg/kg/infusion), rats trained on alpha-PVP (0.05 mg/kg/infusion) responded for more infusions but demonstrated similar drug-lever discrimination by the end of acquisition. However, the dose-response (0.018-0.56 mg/kg/infusion) functions of these drugs under a progressive-ratio schedule of reinforcement reflected identical efficacy and potency. Peak locomotor responses to MDPV or alpha-PVP were observed after the 1.0 mg/kg, i.p. dose and lasted ∼2 h. Modest body temperature decreases were of similar magnitude (∼0.75 °C) for each compound. Conclusions: The potency and efficacy of MDPV and alpha-PVP were very similar across multiple assays, predicting that the abuse liability of alpha-PVP will be significant and similar to that of MDPV. [ABSTRACT FROM AUTHOR]

Objective: Hepatitis C virus (HCV) incidence has been increasing among young injection drug users (IDUs). This analysis examined whether the emerging practice of prescription opioid (PO) injection is associated with self-reported HCV among young IDUs. Methods: Young IDUs ( n = 162) aged 18-25-years-old who indicated recent misuse of prescription drugs were sampled in New York and Los Angeles during 2009-2011. Participants reported lifetime PO injection history and results from their most recent HCV test as well as demographic characteristics and lifetime drug use. Bivariate analyses examined relationships between covariates and both lifetime PO injection and HCV positivity. Poisson regression examined the associations between lifetime PO injection, HCV positivity, and significant covariates. Results: A majority reported lifetime PO injection (72.2%) and 30.9% self-reported being HCV positive. Lifetime PO injectors were nearly three times more likely to report being HCV positive than non-PO injectors (adjusted incidence rate ratio (AIRR): 2.69, p < 0.05) after controlling for socio-demographic and other drug use variable. Additionally, substituting POs for heroin (AIRR: 2.27, p < 0.05), growing up in a lower social class (AIRR: 1.67, p < 0.05), age (AIRR: 1.12, p < 0.05), age of injection initiation (AIRR: 0.87, p < 0.001), and history of being prescribed stimulants (AIRR: 0.64, p < 0.05) were independently associated with HCV positivity. Conclusions: Findings suggest that PO injection should be given further consideration as a contributing factor to rising HCV infection among young adults in the US. [ABSTRACT FROM AUTHOR]

Abstract: Nanodispersed drug delivery systems for the intravenous injection have successfully overcome the hurdle of drug approval in the European Union and the United States. Although there is a need for highly advanced nanocarrier devices they have not been the result of a rational formulation design but were developed as stand-alone products in a long chain of case-by-case studies. This review focuses on aspects in development, composition, and manufacture of these innovative dosage forms that are relevant for the translation into new drug products. [Copyright &y& Elsevier]

This review summarizes the current state-of-the-art regarding the endovascular management of acute ischemic stroke. Beginning with intravenous tissue plasminogen activator, this paper traces the gradual shift of systemic thrombolysis from a competing to complementary treatment modality. Intra-arterial thrombolysis, mechanical thrombectomy with the Merci (Concentric Medical, Mountain View, California) and Penumbra (Penumbra, Inc., Alameda, California) systems, angioplasty, primary intracranial stenting, and emerging stentriever devices are sequentially reviewed. Ultimately, this paper lays the foundation for current endovascular stroke management and considers future areas of progress and research. [ABSTRACT FROM AUTHOR]

Given the important role of insulin in the treatment of diabetes mellitus and in light of common barriers to insulin use, new strategies for insulin delivery by routes other than intravenous and subcutaneous injection have been investigated since the discovery of insulin in the 1920s. Most companies researching and developing pulmonary administration systems for the use of insulin announced the termination of product development following the failure of the first US FDA-approved inhaled insulin product, Exubera®. One company in particular continued their pursuit of a useful inhaled insulin product. MannKind Corporation has developed a powder formulation of insulin that allows for a high percentage of the administered insulin to be absorbed via the lung. Their product, AFREZZA© (Technosphere® insulin), is currently under review by the FDA for use in patients with diabetes. Technosphere® insulin appears to overcome some of the barriers that contributed to the market withdrawal of Exubera® by the manufacturer. Studies with Technosphere ® insulin have shown it to be a unique insulin formulation in that it is very rapid acting, has a relatively short duration of action, and is efficacious in terms of improved glycemic control without contributing to increased weight gain or the incidence of hypoglycemia when compared with other prandial insulin products. Additionally, Technosphere® insulin has demonstrated a favorable safety and tolerability profile in clinical studies to date. [ABSTRACT FROM AUTHOR]

Objectives: We have developed an image-guided surgical system based on invisible near-infrared fluorescent light. Presently, the only clinically available near-infrared fluorophore is indocyanine green, which fluoresces at approximately 800 nm and is used for coronary angiography. Our objective was to determine whether methylene blue, already US Food and Drug Administration approved for other indications, has useful near-infrared fluorescence properties for image-guided cardiac surgery. Methods: The optical properties of methylene blue were measured after dissolution in 100% serum. Biodistribution and clearance were quantified in organs and tissue after intravenous bolus injection of 2 mg/kg methylene blue in 3 rats. Coronary arteriography and cardiac perfusion were imaged in real time after intravenous bolus injection of 1 mg/kg methylene blue in 5 pigs with coronary obstructions. Coronary angiography and acute thrombi were assessed by using 800-nm fluorophores, indocyanine green, and IR-786–labeled platelets, respectively. Results: The peak absorbance and emission of methylene blue as a near-infrared fluorophore occur at 667 nm and 686 nm, respectively. After intravenous injection, methylene blue provides highly sensitive coronary angiography. A lipophilic cation, methylene blue is extracted rapidly into tissue, with myocardium displaying unusually high uptake. Methylene blue permits real-time visualization and quantitative assessment of myocardial perfusion. Because of absent spectral overlap, use of 2 independent fluorophores in our imaging system permits simultaneous quantification of perfusion, venous drainage, and/or intravascular thrombi. Conclusions: Methylene blue is an effective near-infrared fluorophore that provides direct visualization of coronary arteriography and cardiac perfusion. In conjunction with approximately 800-nm near-infrared fluorophores, important functional assessments during cardiac surgery are also possible. [Copyright &y& Elsevier]

The article discusses issues concerning the implementation of wireless intravenous (IV) infusion pump technology. According to the authors, IV infusion pump allows for remote device management, monitoring of medication administration practices, prompt intervention of medication errors and timely clinical education regarding near misses. They add that IV infusion pumps have been responsible for improvements in the accuracy and continuity of IV drug delivery, but they are also involved in 35 to 60% of the estimated 700,000 adverse drug events occurring annually in the U.S. They also discuss the weighted evaluation tool for IV infusion pumps, strategic planning for wireless infusion technology and advantages of implementing intelligent pump technology.

Background. Pharmaceutical compounding, the manipulation of ingredients to create a customized medication, is a widespread practice. In January 2005, the Centers for Disease Control and Prevention was notified of 4 cases of Pseudomonas fluorescens bacteremia that were traced to contaminated heparinized saline intravenous flush syringes prepared as a compounded medical product. Patients and Methods. We reviewed medical records of symptomatic patients with P. fluorescens-positive cultures of blood specimens or sections of explanted catheters, reviewed the production process of syringes, performed syringe cultures, compared isolates by pulsed-field gel electrophoresis (PFGE), and examined catheters by scanning electron microscopy. Results. We identified 80 patients in 6 states with P. fluorescens-positive cultures during December 2004-March 2006. Sixty-four patients (80%) had received a diagnosis of cancer. Seventy-four (99%) of 75 patients for whom information about catheter type was available had long-term indwelling catheters. Thirty-three (41%) of 80 cases were diagnosed 84-421 days after the patient's last potential exposure to a contaminated flush (delayed-onset cases). Compared with patients with early infection onset, more patients with delayed infection onset had venous ports (100% versus 50%; ). By P < .001 PFGE, clinical isolates from 50 (98%) of 51 patients were related to isolates cultured from unopened syringes. Scanning electron microscopy of explanted catheters revealed biofilms containing organisms morphologically consistent with P. fluorescens. Conclusion. This outbreak underscores important challenges in ensuring the safety of compounded pharmaceuticals and demonstrates the potential for substantially delayed infections after exposures to contaminated infusates. Exposures to compounded products should be considered when investigating outbreaks. Patients exposed to contaminated infusates require careful follow-up, because infections can occur long after exposure. [ABSTRACT FROM AUTHOR]

These medication errors have occurred in health care facilities at least once. They will happen again--perhaps where you work. Through education and alertness of personnel and procedural safeguards, they can be avoided. You should consider publishing accounts of errors in your newsletters and/or presenting them at your inservice training programs. Your assistance is required to continue this feature. The reports described here were received through the United States Pharmacopeia (USP) Medication Errors Reporting Program (MERP), which is presented in cooperation with the Institute for Safe Medication Practices (ISMP). If you have encountered medication errors and would like to report them, you may call USP toll-free, 24 hours a day, at 800-233- 7767 (800-23-ERROR). Any reports published by ISMP will be anonymous. Comments are also invited; the writers' names will be published if desired. ISMP may be contacted at the address shown below. Errors, close calls, or hazardous conditions may be reported through the ISMP (www.ismp.org) or USP (www.usp.org) Web sites or communicated directly to ISMP by calling 800-FAIL-SAFE or via e-mail at ismpinfo@ismp.org. ISMP guarantees the confidentiality and security of the information received and respects reporters' wishes as to the level of detail included in publications. [ABSTRACT FROM AUTHOR]

The article focuses on nursing care to maintain central venous access devices (CVAD) and prevent complications, based on the updated Infusion Nursing Standards of Practice in the United States. It discusses measures that nurses can take to prevent catheter-related bloodstream infections. The article presents guidelines for CVAD management.

The availability of long-acting risperidone injection may increase adherence and lead to improved clinical and economic outcomes for individuals with schizophrenia. The objective of this study was to assess the cost effectiveness of long-acting risperidone, oral risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, and haloperidol depot in patients with schizophrenia over 1 year from a healthcare system perspective. Published medical literature, unpublished data from clinical trials and a consumer health database, and a clinical expert panel were utilized to populate a decision analytical model comparing the seven treatment alternatives. The model captured rates of patient compliance, the rates, frequency and duration of relapse, incidence of adverse events, and healthcare resource utilization and associated costs. Primary outcomes were expressed in terms of percentage of patients relapsing per year, number of relapse days per year (number and duration of relapses per patient per year), and total direct 2003 medical cost per patient per year. On the basis of model projections, the proportions of patients experiencing a relapse requiring hospitalization in 1 year were 66% for haloperidol depot, 41% for oral risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole, and 26% for long-acting risperidone, whereas the proportions of patients with an exacerbation not requiring hospitalization were 60% for haloperidol depot, 37% for oral risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole, and 24% for long-acting risperidone. The mean number of days of relapse requiring hospitalization per patient per year were 28 for haloperidol depot, 18 for oral risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole, and 11 for long-acting risperidone, whereas the mean number of days of exacerbation not requiring hospitalization were eight for haloperidol depot, five for oral risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole, and three for long-acting risperidone. This would translate into direct medical cost savings with long-acting risperidone compared with oral risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, and haloperidol depot of US dollars 161, 1425, 508, 259, 1068, and 8224, respectively. These findings were supported by sensitivity analyses. The utilization of long-acting risperidone is predicted to result in better clinical outcomes and lower total healthcare costs than its comparators, oral risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, and haloperidol depot. Long-acting risperidone may therefore be a cost saving therapeutic option for patients with schizophrenia. [ABSTRACT FROM AUTHOR]

The article presents information on the findings of a study assessing the differential impact of educational interventions aimed at reducing HIV risk behaviors. Recent data have suggested that educational interventions aimed at reducing HIV risk behaviors have shown some success. But these interventions do not always reduce risk behavior and the success of interventions may be related to participant characteristics. The majority of the 741 participants in the study who completed an AIDS educational intervention report decreasing five out of six risk behaviors including unprotected sex and drug injection. Different variables were also found to be related to changes in the various risk behaviors. It was also found that the gender and education level were also not related to changes in any of the risk behaviors. Implications include the importance of developing approaches to retain higher proportions of younger participants, males and homeless in interventions. It was found to be particularly important to develop specific approaches to retain women in interventions. Another finding is that very little is known about the effectiveness of HIV prevention interventions in low seroprevalence and less urban areas and federally funded studies for injection drug abusers in the United States have focused on large cities only.

To identify previously unrecognized sources for acquiring acute hepatitis B and non-A, non-B (NANB) hepatitis, we interviewed patients with these types of hepatitis who were reported to two county health departments in the United States and matched control subjects for known and potential risk factors for acquiring hepatitis. Of 218 patients with hepatitis B and 140 patients with NANB hepatitis, 46% and 53%, respectively, had no commonly recognized source for infection. When these patients were compared with control subjects, significantly more patients with hepatitis B had multiple heterosexual partners, accounting for 14% of all hepatitis B infections; more patients with NANB hepatitis either had sexual or household contact with a person who had hepatitis in the past or had multiple heterosexual partners, accounting for 11% of all NANB infections. This is the first study to suggest that heterosexual transmission may play an important role in the spread of NANB hepatitis. [ABSTRACT FROM AUTHOR]

We reviewed 92 published and unpublished studies of the prevalence of infection with the human immunodeficiency virus (HIV) among intravenous drug users (IVDUs) in the United States. Human immunodeficiency virus seroprevalence among IVDUs in drug treatment programs in the United States ranged from 0% to 65%. Seroprevalence was highest in the Northeast (10% to 65%) and Puerto Rico (45% to 59%); lower in the South Atlantic (7% to 29%) and in the metropolitan areas of Atlanta, Ga (10%), Detroit, Mich (7% to 13%), and San Francisco, Calif (7% to 13%); and 5% or less in other areas of the West, the Midwest, and the South. Among IVDUs seen in drug treatment programs, risk of infection was not associated with gender or age but was associated with black and Hispanic ethnicity, male homosexual orientation, and certain intravenous drug-use practices. Cross-sectional and cohort studies indicated increases in seroprevalence of between 0% and 14% per year among IVDUs in treatment. We estimated that between 61,000 and 398,000 IVDUs in the United States were infected with human immunodeficiency virus, or 5% to 33% of the IVDU population. High rates of infection among IVDUs in treatment in the Northeast indicate the potential for rapid spread in regions where rates are currently low. An urgent need exists to monitor human immunodeficiency virus infection levels and trends more widely and to develop effective programs to reduce the further spread of human immunodeficiency virus infection among IVDUs. [ABSTRACT FROM AUTHOR]

From 1981 to 1988, eighty percent of all women with the acquired immunodeficiency syndrome (AIDS) reported to the Centers for Disease Control were of reproductive age. Six pregnancy-associated deaths due to AIDS in this country have been reported in the medical literature. We identified 20 unpublished cases of women who died of AIDS during or within one year after termination of pregnancy. Analysis showed that these women were mostly black or Hispanic, half were intravenous drug abusers, and most died of Pneumocystis carinii pneumonia. Each pregnancy had an obstetric complication, primarily preterm delivery. The interval between diagnosis of AIDS and the death of these women ranged from one day to 15 months, with a mean interval of 113 days. Multiple reporting sources increased case detection and should be used for future investigations. Prospective case-control studies are needed to determine any further relationship between pregnancy complications and AIDS. [ABSTRACT FROM AUTHOR]

Intravenous drug users are the second largest group to develop the acquired immunodeficiency syndrome, and they are the primary source for heterosexual and perinatal transmission in the United States and Europe. Understanding long-term trends in the spread of human immunodeficiency virus among intravenous drug users is critical to controlling the acquired immunodeficiency syndrome epidemic. Acquired immunodeficiency syndrome surveillance data and seroprevalence studies of drug treatment program entrants are used to trace seroprevalence trends among intravenous drug users in the borough of Manhattan. The virus entered this drug-using group during the mid-1970s and spread rapidly in 1979 through 1983. From 1984 through 1987, the seroprevalence rate stabilized between 55% and 60%--well below hepatitis B seroprevalence rates. This relatively constant rate is attributed to new infections, new seronegative persons beginning drug injection, seropositive persons leaving drug injection, and increasing conscious risk reduction. [ABSTRACT FROM AUTHOR]

This article focuses on indications and uses of intravenous nitroglycerin during cardiac surgery. Since the release of commercially prepared intravenous nitroglycerin (NTG) by the U.S. Food and Drug Administration this year, interest in and use of this form of the drug is growing. In this article current indications and usage of intravenous NTG during the preoperative period, induction and maintenance of anesthesia, cardiopulmonary bypass, and in the postoperative period. The drug has been shown to be extremely valuable when patients receiving it have been titrated to physiologically measured end-points by the use of a pulmonary artery catheter. With improvements of surgical and anesthetic techniques including the use of intravenous NTG, hospital mortality at Emory University School of Medicine since 1976 has been 0.8%.

The article investigates the symptomatic effects of infusing sodium lactate with the symptomatic effects developed by the infusion of sodium bicarbonate in the U.S. The investigation uses ten healthy men as subjects, all of which are unfamiliar with the purpose of the study who for pay volunteered to undergo three infusion experiments. The subjects were randomly induced with 500 millimolar sodium lactate, 500 millimolar sodium bicarbonate and 555 millimolar glucose in 150 millimolar sodium chloride in different days. The results indicate that there is a slight difference in the major symptoms produced by the two substances and that with neither the sodium lactate nor the sodium bicarbonate infusion was onslaught of symptoms associated with any significant blood lactate elevations.

On 23 October 2009, the commissioner of the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for peramivir for intravenous injection, an unapproved neuraminidase inhibitor used for treating certain hospitalized adult and pediatric patients infected with 2009 H1N1 influenza. This was the first EUA of an unapproved drug product. This report summarizes the critical contributions of the clinical pharmacology review team in support of the peramivir EUA. [ABSTRACT FROM AUTHOR]

The article covers issues related to medication errors in the U.S. as of December 2007. It emphasizes that the lack of standardization makes the selection of appropriate dosing method difficult and errors are common. It discusses the case of a nurse who misadministered the talc intravenously, which was intended to be used in performing a pleurodesis on a patient with a pleural effusion.

Copyright © 2004 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Several states systematically collect data to assess whether the anesthesia administered was sufficient-the same data used by researchers to show that the concentration of sodium thiopental in the blood of executed prisoners was not enough to ensure loss of consciousness and that these inadequate levels of anesthesia were not the result of pharmacokinetic changes after death. This activity could constitute human subjects research under existing law. [ABSTRACT FROM AUTHOR]

In October 2013, Missouri officials abandoned a plan to execute a convicted murderer using a novel method-an injection of propofol. The name of this drug became a household word after propofol played a role in singer Michael Jackson's death, but this has been a popular therapeutic drug for many years. Clinicians use it in intensive care, surgery, and common procedures like colonoscopy. After deciding to halt the execution, Missouri governor Jay Nixon told corrections officials to come up with a different lethal injection protocol. But that was not a simple assignment. Missouri had proposed using propofol because officials had faced barriers to obtaining the drugs previously used for executions. Corrections officials in death penalty states are finding it harder to secure drugs for lethal injection. [ABSTRACT FROM AUTHOR]

The article focuses on the issue of drug shortages in the U.S. It mentions that injectable medications and anti-infective drugs have conceived adverse effect by shortages in drugs. It includes that the U.S. Food and Drug Administration's (FDA) efforts have helped avert numerous new drugs shortages in 2012. It adds that economic pressures and aging infrastructure have made injectable medication related products vulnerable to production disruption. It says that the FDA may alert other companies that they should increase production in case when a particular company declines to continue producing a drug.

Focuses on the Venofer (iron sucrose) protocol for intravenous iron administration, developed by the Peritoneal Dialysis Center, Middle Tennessee/Dialysis Clinic Inc., Nashville, Tennessee. Evaluation of the Venofer protocol for safety; Total number of patients which received Venofer treatment as of February 2004; Advantages of the Venofer protocol.