Canadian monitoring program of the surface contamination with 11 antineoplastic drugs in 122 centers

Introduction Occupational exposure to antineoplastic drugs can lead to long-term adverse effects on workers’ health. Environmental monitoring is conducted once a year, as part of a Canadian monitoring program. The objective was to describe contamination with 11 antineoplastic drugs measured on surfaces. Methods Six standardized sites in oncology pharmacy and six in outpatient clinic were sampled in each hospital. Samples were analyzed by ultra-performance liquid chromatography coupled with tandem mass spectrometry (non-platinum drugs) and by inductively coupled plasma mass spectrometry (platinum-based drugs). The limits of detection (in ng/cm2) were: 0.0006 for cyclophosphamide; 0.001 for docetaxel; 0.04 for 5-fluorouracil; 0.0004 for gemcitabine; 0.0007 for irinotecan; 0.0009 for methotrexate; 0.004 for paclitaxel, 0.009 for vinorelbine, 0.02 for doxorubicine, 0.0037 for etoposide and 0.004 for the platinum. Sub-analyses were done with a Kolmogorov-Smirnov test Results 122 Canadian hospitals participated. Cyclophosphamide (451/1412, 32% of positive samples, 90th percentile of concentration 0.0160 ng/cm2) and gemcitabine (320/1412, 23%, 0.0036 ng/cm2) were most frequently measured on surfaces. The surfaces most frequently contaminated with at least one drug were the front grille inside the biological safety cabinet (97/121, 80%) and the armrest of patient treatment chair (92/118, 78%).The distribution of cyclophosphamide concentration was higher for centers that prepared ≥ 5000 antineoplastic drug preparations/year (p < 0.0001). Conclusions This monitoring program allowed centers to benchmark their contamination with pragmatic contamination thresholds derived from the Canadian 90th percentiles. Problematic areas need corrective measures such as decontamination. The program helps to increase the workers’ awareness.

Ethanol Exposure During the Intravenous Administration of Chemotherapeutic Drugs: An Analysis of Clinical Practice and a Literature Review

PURPOSE: Injectable cytotoxics may be formulated with ethanol. This study sought to quantify the amount of ethanol exposure during chemotherapy infusions. MATERIALS AND METHODS: We first reviewed the antineoplastic drugs (Anatomical Therapeutic and Chemical code L01) and oncologic supportive care drugs (eg, antiemetics) currently available in France, to identify preparations containing ethanol. The amount of ethanol in the final chemotherapy preparation was calculated. Next, we performed a 2-year, single-center, retrospective analysis of injectable antineoplastic drug compounding in routine clinical practice in a French university medical center. Finally, we reviewed our results with regard to the literature data. RESULTS: Ten of the 60 cytotoxic products on the market contained ethanol at concentrations of up to 790 mg/mL, depending on the drug, formulation, and supplier. Several final preparations contained more than 3 g of ethanol per infusion (the maximum recommended by the European Medicines Agency); this was notably the case for gemcitabine, paclitaxel (up to 20 g ethanol per injection, for both), and etoposide (up to 50 g ethanol per infusion). The analysis of our compounding activity showed that 3,172 (4.99%) of the 63,613 chemotherapy preparations (notably paclitaxel) contained more than 3 g of ethanol. None of the oncologic supportive care drugs contained ethanol. CONCLUSION: Patients are exposed to ethanol during the infusion of antineoplastic drugs. With a view to better patient care, physicians and pharmacists should carefully evaluate the risk of ethanol exposure throughout the course of cytotoxic drug treatment.

Knowledge about antineoplastic drugs: implications for the health of nursing workers in a general hospital

ABSTRACT Objectives: to understand, from a worker’s health perspective, the knowledge of nursing professionals about the use of antineoplastic drugs in a general hospital. Methods: a descriptive and exploratory study with a qualitative approach. It was conducted at a university hospital, between April and August 2018, with 35 nursing professionals who responded to a semi-structured interview. Thematic analysis was used for data treatment. Results: from the data, three thematic categories emerged, related to the nursing professionals’ knowledge about antineoplastic drugs and their effects on workers’ health; situations in which exposure to these drugs occurs; and protection mechanisms for the patient, the environment, and the worker. Final Considerations: the nursing professionals had little knowledge about antineoplastic drugs. The practices related to handling and the necessary protective measures to deal with these drugs were empirically determined and relatively subsidized the knowledge acquired by the professionals.

Effect of occupational exposure to antineoplastic drugs on DNA damage in nurses: a cross-sectional study

BackgroundAlthough the therapeutic effect of antineoplastic drugs is incontestable, these agents can also potentially act as carcinogens, mutagens and/or teratogens in people. The aim of this study was to assess the effect of occupational exposure to antineoplastic drugs on DNA damage, assessed by the comet assay and cytokinesis-block micronucleus (CBMN) assay, in nurses.MethodsThe cross-sectional study enrolled 305 nursing staff members from 7 public hospitals in Shenzhen who handled antineoplastic drugs, and 150 healthy nursing staff members who were not exposed to antineoplastic drugs as the control group. DNA damage was assessed by the comet and CBMN assay. Multiple linear regressions and logistic regressions models were used to analyse the effect of occupational exposure to antineoplastic drugs on DNA damage.ResultsAfter adjustment for confounding factors, compared with non-exposure to antineoplastic drugs, exposure to antineoplastic drugs was positively related to tail moment, olive moment, tail length and tail DNA per cent, and adjusted β or OR (95% CI) was 0.17 (0.08 to 0.26), 0.18 (0.10 to 0.27), 1.03 (0.47 to 1.60) and 1.16 (1.04 to 1.29) (all p<0.05). Moreover, similar significant relationships were observed for the biomarkers of the CBMN assay. Additionally, other than age, there was no interaction between antineoplastic drug exposure and other variables for the levels of biomarkers of the CBMN assay and the comet assay.ConclusionsThe present results showed that exposure to antineoplastic drugs was positively related to the risk of DNA damage in nurses. The results imply that occupational exposure to antineoplastic agents is an important global public health problem that requires urgent attention.

Analysis of novel antineoplastic drugs treatment impact on the federal project «cancer control» goals achievement

The Federal project “Cancer Control” was launched in 2019. Its main objective is to reduce mortality from malignant neoplasms in Russia. The main goal of this research is to develop a methodology for assessment of innovative drugs treatment impact on reducing mortality from neoplasms (including malignant) and testing it in the case of some novel drugs. Materials and methods. Firstly, we assessed the number of patients, who annually can start a novel drug treatment. Afterwards we estimated the number of deaths, which could be avoided due to the efficacy differences between innovative drugs compared to the standard of care in terms of overall survival. Obtained results were than correlated to the reduction in malignant mortality ratio needed to achieve annually (comparing to the basis 2020). For the approbation of the model, we chose durvalumab, osimertinib and olaparib, which are indicated for lung and ovarian cancer treatment. Results. Annually 6 746 patients can start the treatment: 2 391 with durvalumab, 2 334 with osimertinib, 2 021 with olaparib. In the 2021-2023 frame durvalumab treatment can help to avoid 779 deaths, osimertinib treatment can help to avoid 723 deaths, olaparib treatment can help to avoid 679 deaths (totally 10,8% of reduction in deaths needed to achieve 2021-2023 goals). Conclusion. Novel antineoplastic drugs treatment leads to a quantifiable reduction in mortality from malignant neoplasms in Russia.

Suspected Adverse Drug Reactions in Pediatric Cancer Patients in China: An Analysis of Henan Province Spontaneous Reporting System Database

IntroductionAdverse drug reactions (ADRs) in pediatric cancer patients have not yet received due attention in the world. Antineoplastic drugs are frequently related to ADRs. Few studies focus on the ADR and the intervention measures in pediatric cancer patients.MethodsADR reports submitted to Henan Adverse Drug Reaction Monitoring Center from 2016 to 2020 for individuals aged from birth to 17 years (including 17 years) were included. Data were analyzed with respect to gender, age, disease types, past history of ADR, occurrence time of ADR, polypharmacy, route of administration, off-label drug use, name of suspected drugs per ADR report, and severity of ADR reports.ResultsA total of 431 ADR reports related to antineoplastic drugs in pediatric patients were collected, 31.55% were serious ADRs (SADRs). The median age of patients was six years (inter quartile range, IQR: 3-11), the age groups with higher reporting rates were concentrated in 1-3-year-olds (130). Past history of ADR, occurrence time of ADR and polypharmacy were statistically associated with SADR. Myelosuppression was the most frequent ADR (15.55%), cytarabine was the most frequent drug (26.22%). The signal mining method produced 14 signals, three signals were off-label ADRs.ConclusionsThis study described the characteristics of ADRs in pediatric cancer patients. By conducting signal mining method, three off-label ADRs need further study. We should pay more attention to these ADRs and develop relative management strategies. More researches are needed to achieve a better understanding of the characteristics of ADRs in pediatric cancer patients of China.

Profile of The Judicialization In Pharmaceutical Assistance And Expenses With Antineoplastics: A Cross-Sectional, Descriptive Study Based On A Set of All The Lawsuits Filed Between The Years 2016 To 2018 In of A State In Northeastern Brazil

Background: The judicialization of healthcare for acquiring medication is not an isolated occurrence in Brazil, it may also be observed in other Latin American countries, regardless of the existence of a universal health system, in Brazil, the Unified Health System. The search for justice, in terms of medications, has existed ever since the high demand for treating the Acquired Immunodeficiency Syndrome, while currently, the protagonist is cancer. Since pharmaceutical assistance is the area within Unified Health System, which is responsible for maintaining access to medications, the aim of this article is to describe the profile of judicialization in the pharmaceutical assistance of a state in Northeastern Brazil of economic significance, according to the characteristics of the lawsuits, regarding: the plaintiff filing the lawsuit; the medical and health information; the expenditure on acquiring the requested medications; and the relevance of spending on antineoplastic drugs. Methods: This was a cross-sectional, descriptive study based on a set of lawsuits filed between 2016-2018 at the Litigation Center in the State Health Department of Pernambuco.Results: A total of 2,947 lawsuits were analyzed that contained at least one requested medication, with a predominance of males (51.7%); and in which 49.8% of the requests originated in the Unified Health System, and were primarily from patients in the Metropolitan region of the state capital. The most frequent ICDs for cancer were C61, C71 and C50. The median overall expense of the lawsuits was U$1,734.94. Considering only antineoplastic drugs, expenditure exceeded U$7,500 per lawsuit over the three years, given that the median unit price of antineoplastic drugs is approximately U$65.00 compared to U$4.00 for non-antineoplastic drugs. Conclusion: The present study is of relevance as a matter of public health, and how the profile of judicialization behaves as a tool for managing and improving decision-making in times of economic austerity.

Improving nurses’ performance in the safe handling of antineoplastic agents: a quasi-experimental study

Background The safe and standard handling of antineoplastic drugs can reduce the effects of occupational exposure and promote safe behaviors in nurses. Thus, the present study aimed to determine the effects ofstandard guidelines education on the safe handling of antineoplastic drugs among oncologynurses in Ardabil, Iran. Methods Thequasi-experimental study with a one-group pretest-posttest design was performed among 32 nursesworking in the oncology wards of two educational hospitals in Ardabil city, during 2020. Allthe nurses in the wards who met the inclusion criteria participated in the study. The data were collectedby usinga demographic information form and nurses’knowledge assessment questionnaire regardingthe standard guidelines for working with antineoplastic drugs, and a standard checklist for examiningtheir performance in this regard. Subsequently, they were analyzed by descriptive (mean and standard deviation) and inferential statistics (t-test)and Pearson’s correlation coefficient) in SPSS 22. Results The mean and standard deviation of the knowledge and performance scores of the oncology nurses was59.56±6.41and 18.96±2.54 respectively, which changed to 66±4.82 and 32.03±2.45 respectively three months after training. The results of the t-test represented a statistically significant difference between the level of knowledge and performance before and after the intervention (P=0.001). Conclusions Based on the results, the standard guidelines education improved the nurses’ knowledge and performance on the safe handling of antineoplastic drugs in the chemotherapy wards. Therefore, it is advised to increase the awareness of the oncology nurses in this regard in the planning and policy-making ofhealthcare centers.