Closed-system drug-transfer devices plus safe handling of hazardous drugs versus safe handling alone for reducing exposure to infusional hazardous drugs in healthcare staff.

BACKGROUND: Occupational exposure to hazardous drugs can decrease fertility and result in miscarriages, stillbirths, and cancers in healthcare staff. Several recommended practices aim to reduce this exposure, including protective clothing, gloves, and biological safety cabinets ('safe handling'). There is significant uncertainty as to whether using closed-system drug-transfer devices (CSTD) in addition to safe handling decreases the contamination and risk of staff exposure to infusional hazardous drugs compared to safe handling alone. OBJECTIVES: To assess the effects of closed-system drug-transfer of infusional hazardous drugs plus safe handling versus safe handling alone for reducing staff exposure to infusional hazardous drugs and risk of staff contamination. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, OSH-UPDATE, CINAHL, Science Citation Index Expanded, economic evaluation databases, the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov to October 2017. SELECTION CRITERIA: We included comparative studies of any study design (irrespective of language, blinding, or publication status) that compared CSTD plus safe handling versus safe handling alone for infusional hazardous drugs. DATA COLLECTION AND ANALYSIS: Two review authors independently identified trials and extracted data. We calculated the risk ratio (RR) and mean difference (MD) with 95% confidence intervals (CI) using both fixed-effect and random-effects models. We assessed risk of bias according to the risk of bias in non-randomised studies of interventions (ROBINS-I) tool, used an intracluster correlation coefficient of 0.10, and we assessed the quality of the evidence using GRADE. MAIN RESULTS: We included 23 observational cluster studies (358 hospitals) in this review. We did not find any randomised controlled trials or formal economic evaluations. In 21 studies, the people who used the intervention (CSTD plus safe handling) and control (safe handling alone) were pharmacists or pharmacy technicians; in the other two studies, the people who used the intervention and control were nurses, pharmacists, or pharmacy technicians. The CSTD used in the studies were PhaSeal (13 studies), Tevadaptor (1 study), SpikeSwan (1 study), PhaSeal and Tevadaptor (1 study), varied (5 studies), and not stated (2 studies). The studies' descriptions of the control groups were varied. Twenty-one studies provide data on one or more outcomes for this systematic review. All the studies are at serious risk of bias. The quality of evidence is very low for all the outcomes.There is no evidence of differences in the proportion of people with positive urine tests for exposure between the CSTD and control groups for cyclophosphamide alone (RR 0.83, 95% CI 0.46 to 1.52; I² = 12%; 2 studies; 2 hospitals; 20 participants; CSTD: 76.1% versus control: 91.7%); cyclophosphamide or ifosfamide (RR 0.09, 95% CI 0.00 to 2.79; 1 study; 1 hospital; 14 participants; CSTD: 6.4% versus control: 71.4%); and cyclophosphamide, ifosfamide, or gemcitabine (RR not estimable; 1 study; 1 hospital; 36 participants; 0% in both groups).There is no evidence of a difference in the proportion of surface samples contaminated in the pharmacy areas or patient-care areas for any of the drugs except 5-fluorouracil, which was lower in the CSTD group than in the control (RR 0.65, 95% CI 0.43 to 0.97; 3 studies, 106 hospitals, 1008 samples; CSTD: 9% versus control: 13.9%).The amount of cyclophosphamide was lower in pharmacy areas in the CSTD group than in the control group (MD -49.34 pg/cm², 95% CI -84.11 to -14.56, I² = 0%, 7 studies; 282 hospitals, 1793 surface samples). Additionally, one interrupted time-series study (3 hospitals; 342 samples) demonstrated a change in the slope between pre-CSTD and CSTD (3.9439 pg/cm², 95% CI 1.2303 to 6.6576; P = 0.010), but not between CSTD and post-CSTD withdrawal (-1.9331 pg/cm², 95% CI -5.1260 to 1.2598; P = 0.20). There is no evidence of difference in the amount of the other drugs between CSTD and control groups in the pharmacy areas or patient-care areas.None of the studies report on atmospheric contamination, blood tests, or other measures of exposure to infusional hazardous drugs such as urine mutagenicity, chromosomal aberrations, sister chromatid exchanges, or micronuclei induction.None of the studies report short-term health benefits such as reduction in skin rashes, medium-term reproductive health benefits such as fertility and parity, or long-term health benefits related to the development of any type of cancer or adverse events.Five studies (six hospitals) report the potential cost savings through the use of CSTD. The studies used different methods of calculating the costs, and the results were not reported in a format that could be pooled via meta-analysis. There is significant variability between the studies in terms of whether CSTD resulted in cost savings (the point estimates of the average potential cost savings ranged from (2017) USD -642,656 to (2017) USD 221,818). AUTHORS' CONCLUSIONS: There is currently no evidence to support or refute the routine use of closed-system drug transfer devices in addition to safe handling of infusional hazardous drugs, as there is no evidence of differences in exposure or financial benefits between CSTD plus safe handling versus safe handling alone (very low-quality evidence). None of the studies report health benefits.Well-designed multicentre randomised controlled trials may be feasible depending upon the proportion of people with exposure. The next best study design is interrupted time-series. This design is likely to provide a better estimate than uncontrolled before-after studies or cross-sectional studies. Future studies may involve other alternate ways of reducing exposure in addition to safe handling as one intervention group in a multi-arm parallel design or factorial design trial. Future studies should have designs that decrease the risk of bias and enable measurement of direct health benefits in addition to exposure. Studies using exposure should be tested for a relevant selection of hazardous drugs used in the hospital to provide an estimate of the exposure and health benefits of using CSTD. Steps should be undertaken to ensure that there are no other differences between CSTD and control groups, so that one can obtain a reasonable estimate of the health benefits of using CSTD.

Prevalence of cancer chemotherapy-related problems, their relation to health-related quality of life and associated supportive care: a cross-sectional survey.

PURPOSE: The purpose of this study was to identify the treatment-associated problems that most impact on patients undergoing cancer chemotherapy, how problems relate to experiences of supportive care and variations in experience between cancer treatment centres. METHODS: A survey administered to patients at six cancer centres in England explored variations of prevalence of 17 cancer chemotherapy-associated problems and associated supportive care. Problem items were identified as the most frequently experienced and severe when experienced in a scoping and consensus exercise. A health-related quality of life (HRQoL) measure, the EQ5D, was included to measure impact of problems. RESULTS: A total of 363 completed questionnaires were returned (response rate 43 %, median 61 %). The most prevalent problem was 'tiredness/fatigued' (90 %), followed by 'changes in taste & smell' (69 %) and 'difficulty managing everyday tasks' (61 %). Significant variations in problem prevalence existed between centres, and some common problems were rarely reported in the literature. Regression analysis found that almost all problems were significantly associated with HRQoL, with social/emotional problems having as much impact on HRQoL as physical/psychological side effects of treatment. Greatest effect size was for difficulty managing everyday tasks. Respondents reported significant variations in supportive care between centres, with more supportive care received for physical/psychological problems than for social/emotional problems. Findings indicated that patients who received increased supportive care experienced less severe problems. CONCLUSION: The most common and distressing chemotherapy-associated problems were identified. These problems are mitigated by quality supportive care. Routine measurement and monitoring of problem items and supportive care are warranted to facilitate benchmarking and service improvements both within and between cancer centres.

A web-based intervention (RESTORE) to support self-management of cancer-related fatigue following primary cancer treatment: a multi-centre proof of concept randomised controlled trial.

PURPOSE: Cancer-related fatigue (CRF) is a frequent and distressing symptom experienced after cancer treatment. RESTORE is the first web-based resource designed to enhance self-efficacy to manage CRF following curative-intent treatment. The aim of this study is to test the proof of concept and inform the design of an effectiveness trial. METHODS: A multi-centre parallel-group two-armed (1:1) exploratory randomised controlled trial (RCT) with qualitative process evaluation was employed in the study. Participants (≥18 years; ≤5 years post treatment with moderate to severe fatigue) were recruited and randomly assigned to RESTORE or a leaflet. Feasibility and acceptability were measured by recruitment, attrition, intervention adherence, completion of outcome measures and process evaluation. Change in self-efficacy to manage CRF was also explored. Outcome measures were completed at baseline (T0), 6 weeks (T1) and 12 weeks (T2). Data were analysed using mixed-effects linear regression and directed content analysis. RESULTS: One hundred and sixty-three people participated in the trial and 19 in the process evaluation. The intervention was feasible (39 % of eligible patients consented) and acceptable (attrition rate 36 %). There was evidence of higher fatigue self-efficacy at T1 in the intervention group vs comparator (mean difference 0.51 [-0.08 to 1.11]), though the difference in groups decreased by 12 weeks. Time since diagnosis influenced perceived usefulness of the intervention. Modifications were suggested. CONCLUSION: Proof of concept was achieved. The RESTORE intervention should be subject to a definitive trial with some adjustments. Provision of an effective supportive resource would empower cancer survivors to manage CRF after treatment completion. TRIAL REGISTRATION: ISRCTN67521059.

Guidance on the management of diarrhoea during cancer chemotherapy.

Diarrhoea induced by chemotherapy in cancer patients is common, causes notable morbidity and mortality, and is managed inconsistently. Previous management guidelines were based on poor evidence and neglect physiological causes of chemotherapy-induced diarrhoea. In the absence of level 1 evidence from randomised controlled trials, we developed practical guidance for clinicians based on a literature review by a multidisciplinary team of clinical oncologists, dietitians, gastroenterologists, medical oncologists, nurses, pharmacist, and a surgeon. Education of patients and their carers about the risks associated with, and management of, chemotherapy-induced diarrhoea is the foundation for optimum treatment of toxic effects. Adequate--and, if necessary, repeated--assessment, appropriate use of loperamide, and knowledge of fluid resuscitation requirements of affected patients is the second crucial step. Use of octreotide and seeking specialist advice early for patients who do not respond to treatment will reduce morbidity and mortality. In view of the burden of chemotherapy-induced diarrhoea, appropriate multidisciplinary research to assess meaningful endpoints is urgently required.

A snapshot of innovation: chemotherapy delivery in the UK.

Chemotherapy is a major part of NHS care. Aroud 200 hospitals deliver chemotherapy services within their facilities, in community clinics and in the patients' homes. The safety of such services has attracted attention resulting in the production of a service template for the future by the National Chemotherapy Advisory Board in 2009. Its report recognized opportunities for redesigning services and recommended optimising the development of non-medical staff. The UK chemotherapy partnership was established to help professionals involved in chemotherapy share their experiences of improving and developing services and roles. This short article places the need for the UK Chemotherapy Partnership website in context and describes the origins of the Partnership as well as future plans.

Effectively managing chemotherapy-induced nausea and vomiting.

This article examines the unpleasant side effect of chemotherapy-induced nausea and vomiting (CINV). What was once the main reason for withdrawing from treatment is now much more tolerable owing to the advent of modern antiemetics. However, because of the improvements in these antiemetics, the focus on CINV appears to have lapsed. Despite this, some patients continue to experience problems and under-report this side effect. This article looks at the mechanism of CINV and clarifies terminology and definitions surrounding it. Risk factors are discussed and management strategies advised, including appropriateness of modern antiemetics and non-pharmacological strategies. To conclude, a brief look at nursing implications and self-management strategies are explored.

National Chemotherapy Advisory Group report: implications for nurses.

As a group of senior cancer nurses, the U.K. Oncology Nursing Society (UKIONS) Board welcomes the recommendations from the National Chemotherapy Advisory Group report, believing that it will improve the services offered to patients and strengthen the leadership role of nurses who work in cancer care. This article explains the key tenets of the report from a nursing perspective and considers the effect it will have on chemotherapy services and on the profession as a whole.

Improving outcomes of short peripheral vascular access in oncology and chemotherapy administration.

A short peripheral intravenous catheter or cannula (PIVC) is frequently used to deliver chemotherapy in oncology practice. Although safe and easy to insert, PIVCs do fail, leading to personal discomfort for patients and adding substantially to treatment costs. As the procedure of peripheral catheterization is invasive, there is a need for greater consistency in the choice, insertion and management of short PIVCs, particularly in the oncology setting where there is a growing trend for patients to receive many different courses of IV treatment over a number of years, sometimes with only short remissions. This article reviews best practice with respect to PIVCs in cancer patients and considers the necessity for bundling these actions. Two care bundles, addressing both insertion and ongoing care and maintenance, are proposed. These have the potential to improve outcomes with the use of short PIVCs for vascular access in oncology practice.

Report on the 2014 UKONS Annual Conference Belfast, 14-15 November 2014: focus on living with and beyond cancer, patient information and support, and innovations in treatment and care.

The UK Oncology Nursing Society's (UKONS) annual conference focused on three major themes. These were 'Living With and Beyond Cancer', 'Patient Information and Support', and 'Innovations in Treatment and Care'. It featured a wide range of presentations, industry satellites, exhibitions, poster discussions. and workshops. Presenters ranged from those eminent in their particular field to those gracing the speaker's podium for the first time. The rich variety of presentations covered policy, cancer trends, clinical developments, care initiatives, personal development, and advances in practice. There was a strong emphasis on skills, knowledge, values, and attitudes, with the most junior and novice nurses mixing with experienced and highly esteemed practitioners.

Non-medical prescribing of chemotherapy: engaging stakeholders to maximise success?

AIM: This study report examines the views and experiences of professional stakeholders about non-medical prescribing (NMP) of chemotherapy. BACKGROUND: The introduction of open formulary NMP has created opportunities to radically change health-care delivery. For chemotherapy services, the most recent advice from the National Chemotherapy Advisory Group [Department of Health (2009) Chemotherapy Services in England, ensuring quality and safety: a report from the National Chemotherapy Advisory Group, London Her Majesty's Stationary Office] clearly endorses the development of nurse- or pharmacist-led chemotherapy clinics. This is very much welcomed but is based on very limited evidence as to their effectiveness. DESIGN: A fourth-generation evaluation study. METHODS: A purposeful sample of 23 stakeholders connected with the chemotherapy service was used. A serial data collection technique with individual interviews followed by uni-professional focus groups was adopted. Finally, a multi-professional focus group was held to determine the strategic way forward. Data were collected in 2009-2010. RESULTS: The study illuminated the key features necessary to maximise success of NMP in chemotherapy clinics and captures the importance of good working relationships. Whilst different practice models will emerge, fundamental and core to services is the need for good team working, established and effective communication strategies, and most importantly avoiding isolation in practice. This study additionally reinforced any evaluation takes place within preexisting political contexts and in particular medical dominance. Not all medical colleagues agreed with or wanted NMP for their patients, highlighting difficulties of developing new models of working within a resisting culture. CONCLUSION: No objections to NMP of chemotherapy were found, but, clearly, the context of practice needs to be agreed and supportedby all professional stakeholders. What is already known about this topicOpen formulary non-medical prescribing has been rapidly introduced over the past decade.Little research has been conducted in acute care and none in the chemotherapy setting.Cancer policy recommends the introduction of nurse-led chemotherapy clinics.What this paper addsNon-medical prescribing (NMP) in chemotherapy is appropriate with the right model of practice.Well-established professional relationships are a key to success.NMP is not appropriate in isolation of the multidisciplinary team (MDT).Implications for practice and/or policyNurses need to demonstrate the value of non-medical prescribing in chemotherapy using available metrics.Models of practice need to ensure good communication channels, MDT working, and transparency of prescribing.

Helping patients discuss CINV management: development of a Patient Charter.

In April 2012, an Expert Group of specialist cancer nurses working in a variety of settings (e.g. chemotherapy delivery, chemotherapy service design, research, nurse leadership and patient information/advocacy) participated in telephone/web-based meetings, with the aim of sharing current experience of chemotherapy-induced nausea and vomiting (CINV) management, and reaching a consensus on the development of a Patient Charter, designed to help patients understand CINV management, and setting out key questions they may wish to ask their healthcare professionals.

Hospital inpatient self-administration of medicine programmes: a critical literature review.

AIM: The Department of Health, pharmaceutical and nursing bodies have advocated the benefits of self-administration programmes (SAPs), but their implementation within UK hospitals has been limited. Perceived barriers are: anticipated increased workload, insufficient resources and patient safety concerns. This review aims to discover if benefits of SAPs are supported in the literature in relation to risk and resource implications. METHOD: Electronic databases were searched up to March 2004. Published English language articles that described and evaluated implementation of an SAP were included. Outcomes reported were: compliance measures, errors, knowledge, patient satisfaction, and nursing and pharmacy time. RESULTS: Most of the 51 papers reviewed had methodological flaws. SAPs varied widely in content and structure. Twelve studies (10 controlled) measured compliance by tablet counts. Of 7 studies subjected to statistical analysis, four demonstrated a significant difference in compliance between SAP and controls. Eight studies (5 controlled) measured errors as an outcome. Of the two evaluated statistically, only one demonstrated significantly fewer medication errors in the SAP group than in controls. Seventeen papers (11 controlled) studied the effect of SAPs on patients' medication knowledge. Ten of the 11 statistically analysed studies showed that SAP participants knew significantly more about some aspects of their medication than did controls. Seventeen studies (5 controlled), measured patient satisfaction. Two studies were statistically analysed and these studies suggested that patients were satisfied and preferred SAP. Seven papers studied pharmacy time, three studied nursing time but results were not compared to controls. CONCLUSIONS: The paucity of well-designed studies, flawed methodology and inadequate reporting in many papers make conclusions hard to draw. Conclusive evidence that SAPs improve compliance was not provided. Although patients participating in SAPs make errors, small numbers of patients are often responsible for a large number of errors. Whilst most studies suggest that SAPs increase patient's knowledge in part, it is difficult to separate out the effect of the educational component of many SAPs. Most patients who participated in SAPs were satisfied with their care and many would choose to take part in a SAP in the future. No studies measured the total resource requirement of implementing and maintaining a SAP.