Evaluation of oncology infusion pharmacy practices: A nationwide survey.

PURPOSE: Oncology care continues to evolve at a rapid pace including provision of infusion-based care. There is currently a lack of robust metrics around oncology infusion centers and pharmacy practice. The workgroup completed a nationwide survey to learn about oncology-based infusion pharmacy services offered. The objective was to highlight consistent, measureable oncology-based infusion pharmacy metrics that will provide a foundation to describe overall productivity including emphasis on high patient-safety standards. METHODS: A nationwide survey was developed via a workgroup within the Vizient Pharmacy Cancer Care Group beginning in April 2019 and conducted electronically via the Vizient Pharmacy Network from September to November 2020. The survey was designed to capture a number of key metrics related to oncology-based infusion pharmacy services. RESULTS: Forty-one sites responded to the survey. Responses highlighted hours of operation (median = 11.5), number of infusion chairs (median = 45). Staffing metrics included 7.1 pharmacist full-time equivalent (FTE) and 7.6 technician FTE per week. 80.5% of sites had cleanrooms and 95.1% reported both hazardous and nonhazardous compounding hoods. 68.3% of sites reported using intravenous (IV) technology, 50.0% measured turnaround time, and 31.4% prepared treatment medications in advance. CONCLUSION: There was variability among oncology infusion pharmacy practices in regard to survey responses among sites. The survey results highlight the need for standardization of established productivity metrics across oncology infusion pharmacies in order to improve efficiency and contain costs in the changing oncology landscape. The survey provides insight into oncology infusion pharmacy practices nationwide and provides information for pharmacy leaders to help guide their practices.

Effectiveness of third-generation chemotherapy on the survival of patients with advanced non-small cell lung cancer in Norway: a national study.

BACKGROUND: To investigate whether the introduction of modern third-generation chemotherapy was associated with survival benefits in a national population of patients with advanced non-small cell lung cancer (ANSCLC) and to explore geographical and temporary variations in the utilisation of chemotherapy. METHODS: All patients with ANSCLC in the Cancer Registry of Norway during 1994-2005 were included. Using sales of vinorelbine as an indicator for chemotherapy, annual county utilisation rates were calculated. Survival before and after the general introduction of vinorelbine and associations between survival and variations in utilisation in counties were investigated. In a subgroup, the predictors of having received chemotherapy were explored. RESULTS: Of 24 875 registered patients with lung cancer, 13 757 had ANSCLC. The annual utilisation of the indicator drug in Norway increased from 3.7 to 184.2 g (1998-2005). Median survival increased from 149 to176 days (p<0.001). The adjusted hazard ratio (HR) for a diagnosis after the introduction was 0.93 (95% CI 0.88 to 0.99). County utilisation rates of vinorelbine (increments of 100 mg/1000 inhabitants) were inversely associated with the risk of death (HR 0.84, 95% CI 0.73 to 0.98). County of residence predicted chemotherapy utilisation with odds ratios in the range 0.13 (95% CI 0.1 to 0.19) to 1.04 (95% CI 0.64 to 1.69), a county with traditionally high utilisation as reference. CONCLUSION: Utilisation of third-generation chemotherapy was associated with slightly increased survival of patients with ANSCLC. Geographical and temporal differences in utilisation indicate variable quality of delivered care.

A randomized phase III trial comparing standard and high-dose pemetrexed as second-line treatment in patients with locally advanced or metastatic non-small-cell lung cancer.

BACKGROUND: This phase III randomized trial compared pemetrexed 500 mg/m(2) (P500) with pemetrexed 900 mg/m(2) (P900) to determine whether higher dosing benefits non-small-cell lung cancer (NSCLC) patients as second-line therapy. PATIENTS AND METHODS: Patients with locally advanced or metastatic NSCLC, previously treated with platinum-based chemotherapy, were randomly assigned to receive i.v. P500 or P900 every 3 week. RESULTS: Accrual was terminated with 588/600 patients enrolled because an interim analysis indicated a low probability of improved survival and numerically greater toxicity on the P900 arm. P900 patients were permitted to continue treatment at P500. No statistical difference was observed between the treatment arms (P500 versus P900) for median survival {6.7 versus 6.9 months, hazard ratio [HR] = 1.0132 [95% confidence interval (CI) 0.837-1.226]}, progression-free survival [2.6 versus 2.8 months, HR = 0.9681 (95% CI 0.817-1.147)], or best overall tumor response [7.1% versus 4.3% (P = 0.1616)]. The incidence of drug-related grade 3/4 toxicity was typically <5% on both treatment arms, but was numerically higher on the P900 arm for most toxicity categories. CONCLUSIONS: P900 did not improve any efficacy measure over P500. P500 i.v. every 3 week remains the standard pemetrexed dose for second-line treatment of platinum-pretreated advanced NSCLC.

Restraining orders among victims of intimate partner homicide.

BACKGROUND: Most intimate partner homicides (IPHs) follow a long history of violence and occur while the victim is ending the relationship. Restraining orders are a common legal recourse by which to seek protection from an abusive partner. This study expands on prior research by examining the restraining order history of IPH victims by characteristics of the victim, assailant, and homicide. METHODS: State-wide databases containing information about restraining orders and homicides were linked, and bivariate and multivariate statistics were then calculated to identify differences between IPH victims who had and had not been issued a restraining order. RESULTS: About 11% of 231 women killed by male intimates had been issued a restraining order. About one-fifth of the female IPH victims who had a restraining order were killed within 2 days of the order being issued; about one-third were killed within a month. Nearly half of those with a restraining order had been protected by multiple orders. Victims killed in a shared residence (versus elsewhere) had lower odds of having a restraining order, whereas victims from rural (versus urban) counties, married (versus dating) victims, and Latino (versus non-Latino) victim-offender dyads had higher odds of having a restraining order. The type of weapon used was not associated with whether the victim had been under the protection of a restraining order. CONCLUSIONS: Most female IPH victims did not have a restraining order when they were killed. Further research is needed to determine whether restraining orders protect against IPH and, if they do, on how to increase their utilization.

Acute and subchronic oral toxicity studies in rats of a hydrolyzed chicken sternal cartilage preparation.

Two acute and subchronic oral toxicity studies were conducted in rats to evaluate safety of a patented preparation of hydrolyzed chicken sternal cartilage (BioCell Collagen II) containing collagen type II, chondroitin sulfate, and hyaluronic acid. In the acute oral toxicity study, five males and five females of Sprague-Dawley rats were administered a single dose of 5000 mg of the test product per kg body weight and observed for 14 days. All animals survived and exhibited normal body weight gain throughout the study. Macroscopic necropsy examination conducted on day 15 revealed no gross pathological lesions in any of the animals. In the subchronic study, Sprague-Dawley rats (40 males, 40 females) were divided into four same-sex groups (10 animals/group). Animals in each group were administered daily either 0, 30, 300 or 1000 mg of the test product per kg of body weight for over 90 days. All animals survived and showed no significant changes in their body weights and histopathology. Although some differences were observed between the treated and control animals in several parameters, they were generally not dose-related or considered to be of toxicological significance. In conclusion, the results from the two oral toxicity studies with male and female young adult rats indicated that the test preparation from hydrolyzed chicken sternal cartilage collagen (BioCell Collagen II) was well tolerated at all four doses tested.

Detection of a ganglioside antigen associated with small cell lung carcinomas using monoclonal antibodies directed against fucosyl-GM1.

Monoclonal antibodies with an apparent specificity for fucosyl-GM1 (Fuc-GM1) were produced by the immunization of mice with Fuc-GM1 adsorbed to Salmonella minnesota bacteria and fusion of the spleen cells with the myeloma cell line Sp 2/0. The antibodies detected Fuc-GM1 with a unique ceramide composition containing 2-hydroxy fatty acids in 11 of 12 cases of small cell carcinoma of the lung. Trace amounts of Fuc-GM1 were detected in 1 of 11 squamous epithelial cell lung carcinomas. Fuc-GM1 was also detected in 1 of 7 pancreas carcinomas but was not detected in any of the other cancers analyzed. Small amounts of Fuc-GM1 without 2-hydroxy fatty acids were detected in normal adult pancreas, spleen, and brain but could not be detected in normal lung tissue. Fuc-GM1 with 2-hydroxy fatty acids is suggested to be a specific ganglioside associated with small cell lung carcinomas. The monoclonal antibodies directed against Fuc-GM1 may be useful for specific immunodiagnosis of small cell lung carcinomas and might also be useful for specific immunotherapy of these malignant tumors.

Continuous versus alternating combination chemotherapy for advanced small cell carcinoma of the lung.

In a 2-year period, 146 patients with small cell carcinoma of the lung, staged as having extensive disease, were randomized to receive either continuous chemotherapy consisting of (a) 1-(2-chloroethyl-3-cyclohexyl-1-nitrosourea, cyclophosphamide, methotrexate, and vincristine followed by (b) 4'-demethylepipodophyllotoxin 9-[4,6-O-(R) ethylidene-beta-D-glucopyranoside] and doxorubicin at progression of disease or a regimen of (a) alternating with (b). Seventy-six patients received the continuous regimen; 70 patients received alternating treatment. Response rates were 68 and 72%, respectively. The median duration of response was 16 weeks in patients receiving continuous treatment compared to 28 weeks in patients receiving alternating treatment (p less than 0.05). No survival time difference was observed between the groups, median survival being 36 and 38 weeks, respectively. Four patients became long-term survivors (5.6 +, 5.5 +, 5.1, and 4.7 + years). All received alternating therapy. Six toxic deaths were observed among patients receiving continuous therapy compared to only one death among those in the alternating regimen. In conclusion, alternating combination chemotherapy leads to prolonged duration of remission. Duration of survival is not prolonged in uncured patients, but an increased possibility of long-term disease-free survival cannot be precluded.

Immunohistological detection of fucosyl-GM1 ganglioside in human lung cancer and normal tissues with monoclonal antibodies.

With the aid of a highly specific murine monoclonal antibody, F12, an immunofluorescence method was elaborated that allowed sensitive and specific detection of the ganglioside antigen fucosyl-GM1 (IV2FucII3NeuAcGgOse4Cer) in different types of human lung cancer and normal tissues. Nineteen of 21 cases of small cell lung cancer were positive with the F12 immunofluorescence method as compared to 2 of 10 squamous epithelial cell lung cancers and 1 of 5 large cell lung cancer specimens. Specimens of lung adenocarcinoma (8 cases) and bronchial carcinoid (3 cases) were all negative, as were 2 examined cases of neuroblastoma. No fucosyl-GM1 could be detected in normal lung and bronchus. However, in thymus, spleen, and lamina propria of the small intestine sparsely distributed clusters of small round cells were stained as well as intramural ganglionic cells of the small intestine and islet cells of the pancreas. All other normal tissues tested were negative. Results obtained with immunofluorescence closely agreed with immunochemical determination of fucosyl-GM1 in lipid extracts of tissues. Our findings suggest that fucosyl-GM1 is strongly associated with small cell cancer of the lung and demonstrate that this tumor-associated antigen can be detected with high sensitivity and specificity with an immunofluorescence method based on the use of the F12 monoclonal antibody.

Two schedules of teniposide with or without cisplatin in advanced non-small-cell lung cancer: a randomized study of the European Organization for Research and Treatment of Cancer Lung Cancer Cooperative Group.

PURPOSE: We conducted a randomized trial to investigate the value of the addition of cisplatin to teniposide (VM26) and to investigate the schedule dependence of the topoisomerase II inhibitor VM26, in advanced non-small-cell lung cancer (NSCLC) patients. PATIENTS AND METHODS: Two hundred twenty-five NSCLC patients were randomized to receive VM26 120 mg/m2 on days 1, 3, and 5 or 360 mg/m2 on day 1 only, either as a single drug or in combination with cisplatin 80 mg/m2 on day 1. Cycles were repeated every 3 weeks. Response rates, side effects, and survival were compared according to the 2 x 2 factorial design of this study. RESULTS: The response rate of the two cisplatin-containing arms was superior to that of the two arms that contained VM26 only (22% v 6%, P < .001); progression-free survival and survival times were also longer in the cisplatin-containing arms (median, 4.3 v 2.2 months, P = .003; median 7.2 v 5.9 months, P = .008, respectively). Toxicity was significantly higher in the cisplatin-containing arms; the most frequent side effects were leukopenia, nausea and vomiting, and alopecia. The schedule of VM26 did not significantly influence the response rate, progression-free survival interval, or survival duration. However, the response rate of the 1-day administration was significantly lower than that of the 3-day administration when given as single drugs. CONCLUSION: The addition of cisplatin to VM26 improves the response rate, progression-free survival interval, and survival duration over VM26 alone, although at the cost of a significant increase in toxicity. Cisplatin should be considered as the basis for combination chemotherapies in advanced NSCLC.

The epidemiology of obsessive-compulsive disorder in five US communities.

The prevalence of obsessive-compulsive disorder was measured in five US communities among more than 18,500 persons in residential settings as part of the National Institute of Mental Health (Bethesda, Md)--sponsored Epidemiologic Catchment Area program. Lifetime prevalence rates ranged from 1.9% to 3.3% across the five Epidemiologic Catchment Area sites for obsessive-compulsive disorder diagnosed without DSM-III exclusions and 1.2% to 2.4% with such exclusions. These rates are about 25 to 60 times greater than had been estimated on the basis of previous studies of clinical populations.

Thallium-201 myocardial imaging during coronary vasodilation induced by oral dipyridamole.

Myocardial perfusion imaging of 201TI injected during maximum exercise has been an important diagnostic tool for coronary artery disease. Pharmacologic coronary vasodilation by i.v. infusion of dipyridamole may be used in lieu of exercise stress for purposes of diagnostic perfusion imaging. However, i.v. dipyridamole is not currently available from commercial sources for widespread routine use. Accordingly, this study was carried out in order to determine whether high dose, oral dipyridamole would be useful as a coronary vasodilator for purposes of diagnostic perfusion imaging. Fifty-eight patients undergoing diagnostic coronary arteriography also had myocardial perfusion imaging with 201TI under conditions of rest, maximum exercise stress, and high dose oral dipyridamole. Of those patients who had a defect on exercise thallium images, 75% also had a perfusion defect on thallium images after high dose oral dipyridamole. These results indicate that oral dipyridamole causes sufficient coronary arteriolar vasodilation and increase of coronary flow in nonstenotic arteries to identify perfusion defects comparable to those seen on maximum exercise stress in at least 75% of cases. In 25% of patients with exercise defects, no perfusion defect was seen after oral dipyridamole. Thus, oral dipyridamole is a potent coronary vasodilator, comparable to exercise stress in most cases, but in a minority of patients may not be comparable to exercise stress.

Violence and women's health. The role of epidemiology.

Survival, a basic indicator of health, indicates that violence is a threat to the health of women. Furthermore, the quality of women's lives is compromised by the threat of violence, which creates a sense of chronic endangerment. "Stranger danger" is a misplaced emphasis; community-based investigations in the past decade have underscored that women are at highest risk of homicide, physical assault, and sexual assault at the hands of a man they know, often their husband or male intimate. Potential contributions of the science of epidemiology are identified and the relative absence of epidemiologists working in the field is noted. Violence against women may be an important, although often ignored, confounding variable or effect modifier in studies of women's health.

Three cases of dental technician's pneumoconiosis related to cobalt-chromium-molybdenum dust exposure.

Dental technician's pneumoconiosis (DTP) is a rather recent finding in subjects exposed to the dust generated in dental laboratories producing metal-framed removable partial dentures from alloys based on cobalt, chromium, and molybdenum. This study presents details of the first three Swedish cases of DTP with some emphasis on the diagnostic procedures and the dust exposure. A follow-up of at least 5 years from diagnosis is included.

The effect of pulmonary hypertension on systolic function of the right ventricle.

This study sought to determine if the right ventricular ejection fraction (RVEF) could be used to diagnose pulmonary hypertension noninvasively. The right ventricular ejection fraction was measured with gated blood pool radionuclide ventriculography and compared to hemodynamic measurements made within 48 hours in 57 subjects. There was a significant inverse relationship between the RVEF and pulmonary artery pressure (r = .57, p less than .001) and the sensitivity of RVEF greater than .45 in diagnosing pulmonary hypertension was .76. Other significant determinants of right ventricular function, including right coronary disease, left ventricular function and tricuspid regurgitation, were also considered.

A phase II study of vincristine in malignant mesothelioma--a negative report.

A total of 23 consecutive, previously untreated patients with radiographically evaluable, malignant pleural mesothelioma were treated in a phase II study with vincristine. Vincristine was given i.v. at a dose of 1.3 mg/m2 once weekly for 4 weeks, then every 2 weeks. No response was observed. The result suggests that vincristine has little or no therapeutic value in the treatment of malignant mesothelioma.

Transgenerational patterns of suicide attempt.

The clinical assumption that suicide attempts demonstrate familial aggregation was examined with data from a survey of 2,304 community residents. Approximately 1 in 15 persons (6.6%) in the general population was aware that a parent, sibling, son, or daughter had attempted suicide. Self-reports of suicide attempts were more common among persons with than without a family history of suicide (13.0% vs. 2.8%, p less than .05). Nearly 1 in 4 persons who attempted suicide (24.8%) reported a family history of suicide. In addition to being female and unmarried, respondent mental disorder, parent mental disorder, and parent suicide attempt each exerted independent direct effects on the risk of respondent suicide ideation. Parent attempt was not significantly associated with respondent suicide attempt when a host of risk factors were held constant. Possible mediating factors are discussed, focusing on social isolation as an underlying factor.

Depression in the community: an investigation into age of onset.

Age of onset of any lifetime depressive disorder was investigated to identify periods of the life course associated with increased risk of depression. In this large community-based sample of adults, one fourth of those with a major depressive disorder at some point in their lives reported onset during childhood or adolescence; over one half reported onset by age 25. Women were likely to have an earlier onset of depression than were men; non-Hispanic Whites and Mexican Americans born in the United States reported earlier onset than did Mexican-American immigrants. Age of onset did not appear to be consequential in terms of the number, type, or severity of the symptoms occurring during the worst depressive episode or with the probability of relapse. These findings imply that age of onset may contribute to group differences in prevalence rates.

Handgun sales, beer sales, and youth homicide, California, 1972-1993.

Whether regulating access to firearms and alcohol will reduce violent injuries is an important policy question. Empirical answers are difficult to obtain because only observational data are available. The present study estimated the association of firearm sales and alcohol sales with subsequent homicides, after adjusting statistically for potential confounders (e.g., unemployment rates) using California data from 1972 through 1993. Handgun sales and beer sales were lagged one year and used to explain variation in the homicides of Californians (e.g., 1990 sales were used to explain 1991 homicides). Differences across population groups were investigated, with a focus on 15- to 34-year-olds, the highest risk age group. Even when taking potential confounders in the base population into account, beer sales and handgun sales generally are associated positively one year later with homicide, particularly among young men. Reducing beer sales may reduce homicides. And, although they represent a small fraction of existing firearms, regulating the number of handguns sold may reduce the number of homicides.

Community and dating violence among adolescents: perpetration and victimization.

PURPOSE: Adolescents are both the perpetrators and victims of violence in the United States. To reduce violence, it is important to identify those most at risk within particular contexts. METHODS: A social learning framework was used to investigate involvement in violence in a survey of 719 high school students. Four outcomes (community violence perpetration, community violence victimization, dating violence perpetration, and dating violence victimization) were examined as a function of demographic characteristics, exposure to violence, and several potential mediating variables. RESULTS: Exposure to weapons and violent injury in the community was the sole consistent predictor across the four outcomes. Gender generally was an important correlate of violence; there were substantial gender differences in the correlates of dating violence perpetration and victimization, but relatively few gender differences in the correlates of community violence involvement. Other demographic characteristics typically were of limited importance, and were largely accounted for by exposure to violence or other mediators. Personal norms about the circumstances under which the use of violence is perceived as justified were important for three of the four outcome: community violence perpetration, and dating violence perpetration and victimization. CONCLUSIONS: Being exposed to violence in one context appears to have crossover effects to victimization and perpetration in another context. Furthermore, victimization and perpetration often co-occur.