Clinical utility of anti-interleukin 5 monoclonal therapy in asthma using a national, centralised, outcome-based system of drug access.

INTRODUCTION: Interleukin 5 (IL-5) inhibitors are an important therapeutic advance in the management of severe, refractory, eosinophilic asthma. However, their utilisation should be targeted to maximise their benefits. This study used multisite, centralised, national data collected over 18 months to perform an observational integrated, retrospective, cohort study of selection criteria for initiation and continuation of IL-5 inhibitor treatment in Ireland. MATERIALS/PATIENTS AND METHODS: We used data from 230 patients who were given anti-IL-5 monoclonal therapy (reslizumab, mepolizumab or benralizumab) in Ireland between 2018 and 2020. Reimbursement of these drugs in Ireland requires fulfilling eligibility criteria defined by the Acute Hospitals Drugs Management Programme with continued reimbursement requiring ongoing submission of clinical data demonstrating clinical effectiveness. RESULTS: IL-5 inhibitor use for 18 months was associated with a total reduction in asthma-associated hospital admissions of 108 (p=0.036) and in non-hospital exacerbations of 85 in 18 months (p=0.014). Respiratory-associated GP visits were reduced from 637 in 12 months to 89 at 6 months and 210 at 18 months of treatment (p<0.001). Oral corticosteroid requirement was reduced or stopped entirely (p<0.001). Subgroup analysis of one site replicated these results and showed a significant reduction in the Asthma Control Questionnaire Score (p<0.001) CONCLUSIONS: Selected patients continued on IL-5 treatment to 18 months had significantly reduced exacerbations, GP visits, oral corticosteroid use and asthma-associated hospitalisations. These results show that anti-IL-5 therapy, in carefully selected and monitored patients with asthma, results in significant improvements in clinical outcomes in a real-world setting.

Introduction of a dose-banding system for parenteral chemotherapy on a haematology-oncology day ward.

INTRODUCTION: The increasing incidence of cancer and the finite capacity of hospital aseptic compounding units pose a serious challenge to the provision of cancer care. Chemotherapy dose-banding is a method of rationalising parenteral chemotherapy dosing and supply, whereby patient-individualised doses are rounded to predetermined banded doses. The banded doses may be outsourced as stock items which increases the supply capacity of the aseptic compounding unit. METHODS: Kotter's 8-step change management model was used to structure the implementation of dose-banding of 5-fluorouracil 46-h infusers on the haematology-oncology day ward in St. James's Hospital, Dublin. The impact of dose-banding on local practice was assessed through pre- and post-implementation surveys of stakeholders. RESULTS: In-house surveys of pharmacy, medical and nursing staff identified a generally favourable attitude towards implementing changes in the parenteral chemotherapy supply system, with some resistance to change evident. Dose-banding of 5-fluorouracil 46-h infusers was implemented successfully on the haematology-oncology day ward. Dose rationalisation and flexibility of re-allocation of standard banded doses between patients were the primary benefits of dose-banding found. Post-implementation surveys showed that clinical staff were in favour of adopting dose-banding into standard practice; however, they were cautious about the degree to which the results of this limited study would be translated into substantive benefits if dose-banding was adopted for all suitable preparations. CONCLUSION: The success of the implementation process and the favourable opinions of stakeholders shown in the post-implementation survey enabled the dose-banding service to be extended to a further nine drugs. Kotter's 8-step change management model was a useful tool for structuring this process change in St. James's Hospital.

Patient Test Preference for Colorectal Cancer Screening and Screening Uptake in an Insured Urban Minority Population.

The study examines the role of patient colorectal cancer (CRC) screening test preference and CRC screening uptake in an insured, urban minority population. Study subjects were enrolled in a randomized controlled trial to promote CRC screening. The interventions were educational, with an emphasis on colonoscopy screening. Subjects were 50+ years of age, fully insured for CRC screening, and out of compliance with current CRC screening recommendations. This paper includes those who answered a question about CRC screening test preference and indicated that they intended to receive such a test in the coming year (n = 453). CRC screening uptake was ascertained from medical claims data. Regardless of test preference, few received CRC screening (22.3 %). Those preferring the home stool test (HST) were less likely to get tested than those preferring a colonoscopy (16.6 vs 29.9 %, χ(2) = 9.9, p = .002). Preference for HST was more strongly associated with beliefs about colonoscopy than with knowledge about colonoscopy. In the context of an RCT emphasizing colonoscopy screening for CRC, patients expressing a preference for HST are at heightened risk of remaining unscreened. Colonoscopy should be recommended as the preferred CRC test, but HSTs should be accessible and encouraged for patients who are averse to colonoscopy.Clinical trials.gov: Identifier: NCT02392143.

A Randomized Trial to Compare Alternative Educational Interventions to Increase Colorectal Cancer Screening in a Hard-to-Reach Urban Minority Population with Health Insurance.

This randomized controlled trial assessed different educational approaches for increasing colorectal cancer screening uptake in a sample of primarily non-US born urban minority individuals, over aged 50, with health insurance, and out of compliance with screening guidelines. In one group, participants were mailed printed educational material (n = 180); in a second, participants' primary care physicians received academic detailing to improve screening referral and follow-up practices (n = 185); in a third, physicians received academic detailing and participants received tailored telephone education (n = 199). Overall, 21.5% of participants (n = 121) received appropriate screening within one year of randomization. There were no statistically significant pairwise differences between groups in screening rate. Among those 60 years of age or older, however, the detailing plus telephone education group had a higher screening rate than the print group (27.3 vs. 7.7%, p = .02). Different kinds of interventions will be required to increase colorectal cancer screening among the increasingly small population segment that remains unscreened. ClinicalTrials.gov Identifier: NCT02392143.

The Charlson comorbidity index can be used prospectively to identify patients who will incur high future costs.

BACKGROUND: Reducing health care costs requires the ability to identify patients most likely to incur high costs. Our objective was to evaluate the ability of the Charlson comorbidity score to predict the individuals who would incur high costs in the subsequent year and to contrast its predictive ability with other commonly used predictors. METHODS: We contrasted the prior year Charlson comorbidity index, costs, Diagnostic Cost Group (DCG) and hospitalization as predictors of subsequent year costs from claims data of fund that provides comprehensive health benefits to a large union of health care workers. Total costs in the subsequent year was the principal outcome. RESULTS: Of the 181,764 predominantly Black and Latino beneficiaries, 70% were adults (mean age 45.7 years; 62% women). As the comorbidity index increased, total yearly costs increased significantly (P<.001). At lower comorbidity, the costs were similar across different chronic diseases. Using regression to predict total costs, top 5th and 10th percentile of costs, the comorbidity index, prior costs and DCG achieved almost identical explained variance in both adults and children. CONCLUSIONS AND RELEVANCE: The comorbidity index predicted health costs in the subsequent year, performing as well as prior cost and DCG in identifying those in the top 5% or 10%. The comorbidity index can be used prospectively to identify patients who are likely to incur high costs. TRIAL REGISTRATION: ClinicalTrials.gov NCT01761253.

Identification of risks associated with the prescribing and dispensing of oral anticancer medicines in Ireland.

BACKGROUND: Oral anticancer medicines (OAM) facilitate transfer of cancer care into the community, where safeguards developed in hospitals that control their prescribing, dispensing and administration may not exist. OBJECTIVE: To determine if the systems of prescribing and dispensing OAM in Ireland facilitate clinical verification of the prescription, thereby ensuring treatment is tailored and appropriate for the patient. SETTING: Randomly selected community pharmacies in Ireland and all Irish hospitals with cancer services. METHOD: A questionnaire was sent to a random selection of Irish community pharmacists. A different questionnaire was sent to all Irish hospitals treating cancer patients. One hundred OAM prescriptions were retrospectively reviewed, to assess the information presented and the potential barriers to a community pharmacist performing a clinical verification of the prescription. MAIN OUTCOME MEASURE: Community pharmacist survey: problems experienced when dispensing OAM and risk factors identified with the current system. Hospital pharmacist survey: proportion of hospitals that clinically verify prescriptions for parenteral versus oral anticancer medicines and associated policies. OAM prescription review: proportion of OAM prescriptions that contained sufficient information for a community pharmacist to clinically verify the prescription and safely dispense the medication. RESULTS: Sixty-four percent of community pharmacist respondents felt they did not have enough information available to them to safely dispense these prescriptions, and 74 % felt that patients are at risk with the current Irish system of prescribing and dispensing OAM. Irish hospitals do not have systems to ensure that all OAM prescriptions are clinically verified by a pharmacist. Seventeen different agents were prescribed on the prescriptions reviewed. The information provided to the community pharmacist would have allowed them to clinically verify 7 % of the OAM prescriptions. CONCLUSION: Prescriptions for OAM reach the community pharmacist with little chance that they have been clinically verified in the hospital and the medicine reaches the patient with little chance that the community pharmacist has been able to clinically verify it. Healthcare risks are increased when inadequate information about patients and their medicines are available. Appropriate specialist practitioners should be provided nationally to clinically oversee each stage of the OAM use process.

Cytotoxic chemotherapy for pregnancy-associated breast cancer: single institution case series.

BACKGROUND: Pregnancy-associated (PA) breast cancer is a rare disease state that poses unique management challenges, specifically controlling the cancer and maximizing the survival of the expectant mother balanced with the health and safety of the developing fetus. As more women delay pregnancy into their 30s and 40s it is expected that this may become a more important clinical problem in the future. Existing data on PA-breast cancer comes from case series using older chemotherapy drugs. A review of practice was carried out to assess current experience with PA-breast cancer, particularly relating to current cytotoxic drugs and targeted agents. METHODS: The St James's Hospital breast cancer registry, a prospectively maintained database, was used to identify cases of PA-breast cancer over a 6.5-year period and a chart review carried out. Chemotherapy administered during pregnancy, breast cancer specific outcomes, and fetal outcomes were assessed. RESULTS: Five patients were identified with PA-breast cancer; median age 34 years (range 28-35). The median gestation at presentation was 18 weeks (range 14-29). Four women received chemotherapy during pregnancy; three received doxorubicin and cyclophosphamide (AC) and one paclitaxel. These agents were generally well tolerated. At median gestation of 36 weeks (range 35-40 weeks) four elective caesareans and one spontaneous delivery occurred. There were no fetal abnormalities. CONCLUSIONS: Common cytotoxics can safely be delivered in pregnancy. Further research on newer therapies such as trastuzumab is needed.