Safe handling of hazardous drugs.

Background: This evidence-based practice guideline was developed to update and address new issues in the handling of hazardous drugs including being compliant with NAPRA (National Association of Pharmacy Regulatory Authorities) and USP 800 (United States Pharmacopeia) standards, the use of personal protective equipment and treatment in diverse settings including in the home setting. Methods: This guideline was developed from an adaptation and endorsement of existing guidelines and from three systematic reviews. Prior to publication, this guideline underwent a series of peer, patient, methodological and external reviews to gather feedback. All comments were addressed and the guideline was amended when required. This guideline applies to and is intended for all health care workers who may come into contact with hazardous drugs at any point in the medication circuit. Results: The recommendations represent a reasonable and practical set of procedures that the intended users of this guideline should implement to minimize the opportunity for accidental exposure. These recommendations are not limited to just the point of care, but cover the entire chain of handling of cytotoxics from the time they enter the institution until they leave in the patient or as waste. Conclusions: Decreasing the likelihood of accidental exposure to cytotoxic agents within the medication circuit is the main objective of this evidenced-based guideline. The recommendations differ slightly from previous guidelines due to new evidence.

Comparison of Use of Neoadjuvant Systemic Treatment for Breast Cancer and Short-term Outcomes Before vs During the COVID-19 Era in Ontario, Canada.

Importance: In response to an increase in COVID-19 infection rates in Ontario, several systemic treatment (ST) regimens delivered in the adjuvant setting for breast cancer were temporarily permitted for neoadjuvant-intent to defer nonurgent breast cancer surgical procedures. Objective: To examine the use and compare short-term outcomes of neoadjuvant-intent vs adjuvant ST in the COVID-19 era compared with the pre-COVID-19 era. Design, Setting, and Participants: This was a retrospective population-based cohort study in Ontario, Canada. Patients with cancer starting selected ST regimens in the COVID-19 era (March 11, 2020, to September 30, 2020) were compared to those in the pre-COVID-19 era (March 11, 2019, to March 10, 2020). Patients were diagnosed with breast cancer within 6 months of starting systemic therapy. Main Outcomes and Measures: Estimates were calculated for the use of neoadjuvant vs adjuvant ST, the likelihood of receiving a surgical procedure, the rate of emergency department visits, hospital admissions, COVID-19 infections, and all-cause mortality between treatment groups over time. Results: Among a total of 10 920 patients included, 7990 (73.2%) started treatment in the pre-COVID-19 era and 7344 (67.3%) received adjuvant ST; the mean (SD) age was 61.6 (13.1) years. Neoadjuvant-intent ST was more common in the COVID-19 era (1404 of 2930 patients [47.9%]) than the pre-COVID-19 era (2172 of 7990 patients [27.2%]), with an odds ratio of 2.46 (95% CI, 2.26-2.69; P < .001). This trend was consistent across a range of ST regimens, but differed according to patient age and geography. The likelihood of receiving surgery following neoadjuvant-intent chemotherapy was similar in the COVID-19 era compared with the pre-COVID-19 era (log-rank P = .06). However, patients with breast cancer receiving neoadjuvant-intent hormonal therapy were significantly more likely to receive surgery in the COVID-19 era (log-rank P < .001). After adjustment, there were no significant changes in the rate of emergency department visits over time between patients receiving neoadjuvant ST, adjuvant ST, or ST only during the ST treatment period or postoperative period. Hospital admissions decreased in the COVID-19 era for patients who received neoadjuvant ST compared with adjuvant ST or ST alone (P for interaction = .01 for both) in either setting. Conclusions and Relevance: In this cohort study, patients were more likely to start neoadjuvant ST in the COVID-19 era, which varied across the province and by indication. There was limited evidence to suggest any substantial impact on short-term outcomes.

Delivery of Cancer Care in Ontario, Canada, During the First Year of the COVID-19 Pandemic.

Importance: The COVID-19 pandemic has impacted cancer systems worldwide. Quantifying the changes is critical to informing the delivery of care while the pandemic continues, as well as for system recovery and future pandemic planning. Objective: To quantify change in the delivery of cancer services across the continuum of care during the COVID-19 pandemic. Design, Setting, and Participants: This population-based cohort study assessed cancer screening, imaging, diagnostic, treatment, and psychosocial oncological care services delivered in pediatric and adult populations in Ontario, Canada (population 14.7 million), from April 1, 2019, to March 1, 2021. Data were analyzed from May 1 to July 31, 2021. Exposures: COVID-19 pandemic. Main Outcomes and Measures: Cancer service volumes from the first year of the COVID-19 pandemic, defined as April 1, 2020, to March 31, 2021, were compared with volumes during a prepandemic period of April 1, 2019, to March 31, 2020. Results: During the first year of the pandemic, there were a total of 4 476 693 cancer care services, compared with 5 644 105 services in the year prior, a difference of 20.7% fewer services of cancer care, representing a potential backlog of 1 167 412 cancer services. While there were less pronounced changes in systemic treatments, emergency and urgent imaging examinations (eg, 1.9% more parenteral systemic treatments) and surgical procedures (eg, 65% more urgent surgical procedures), major reductions were observed for most services beginning in March 2020. Compared with the year prior, during the first pandemic year, cancer screenings were reduced by 42.4% (-1 016 181 screening tests), cancer treatment surgical procedures by 14.1% (-8020 procedures), and radiation treatment visits by 21.0% (-141 629 visits). Biopsies to confirm cancer decreased by up to 41.2% and surgical cancer resections by up to 27.8% during the first pandemic wave. New consultation volumes also decreased, such as for systemic treatment (-8.2%) and radiation treatment (-9.3%). The use of virtual cancer care increased for systemic treatment and radiation treatment and psychosocial oncological care visits, increasing from 0% to 20% of total new or follow-up visits prior to the pandemic up to 78% of total visits in the first pandemic year. Conclusions and Relevance: In this population-based cohort study in Ontario, Canada, large reductions in cancer service volumes were observed. While most services recovered to prepandemic levels at the end of the first pandemic year, a substantial care deficit likely accrued. The anticipated downstream morbidity and mortality associated with this deficit underscore the urgent need to address the backlog and recover cancer care and warrant further study.

The Association of Drug-Funding Reimbursement With Survival Outcomes and Use of New Systemic Therapies Among Patients With Advanced Pancreatic Cancer.

Importance: Gemcitabine-nab-paclitaxel (GEMNAB) and fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) both improve survival of patients with advanced pancreatic cancer when compared with single-agent gemcitabine in clinical trials. Objective: To describe changes in the survival of patients with advanced pancreatic cancer associated with sequential drug-funding approvals and to determine if there exist distinct patient populations for whom GEMNAB and FOLFIRINOX are associated with survival benefit. Design, Setting, and Participants: This population-based, retrospective cohort study examined all incident cases of advanced pancreatic cancer treated with first-line chemotherapy in Ontario, Canada (2008-2018) that were identified from the Cancer Care Ontario (Ontario Health) New Drug Funding Program database. Statistical analysis was performed from October 2020 to January 2021. Exposures: First-line chemotherapy for advanced pancreatic cancer. Main Outcomes and Measures: The main outcomes were the proportion of patients treated with each chemotherapy regimen over time and overall survival for each regimen. Cox proportional hazards regression models were used to compare overall survival between treatment regimens after adjustment for confounding variables, inverse probability of treatment weighting, and matching. Results: From 2008 to 2018, 5465 patients with advanced pancreatic cancer were treated with first-line chemotherapy in Ontario, Canada. The median (range) age of patients was 66.9 (27.8-93.4) years; 2447 (45%) were female; 878 (16%) had prior pancreatic resection, and 328 (6%) had prior adjuvant gemcitabine. During the time period when only gemcitabine and FOLFIRINOX were funded (2011-2015), 49% (929 of 1887) received FOLFIRINOX. When GEMNAB was subsequently funded (2015-2018), 9% (206 of 2347) received gemcitabine, 44% (1034 of 2347) received FOLFIRINOX, and 47% (1107 of 2347) received GEMNAB. The median overall survival increased from 5.6 months (95% CI, 5.1-6.0 months) in 2008 to 2011 to 6.9 months (95% CI, 6.5-7.4 months) in 2011 to 2015 to 7.6 months (95% CI, 7.1-8.0 months) in 2015 to 2018. Patients receiving FOLFIRINOX were younger and healthier than patients receiving GEMNAB. After adjustment and weighting, FOLFIRINOX was associated with better overall survival than GEMNAB (hazard ratio [HR], 0.75 [95% CI, 0.69-0.81]). In analyses comparing patients treated with GEMNAB and gemcitabine, GEMNAB was associated with better overall survival (HR, 0.86 [95% CI, 0.78-0.94]). Conclusions and Relevance: This cohort study of patients with advanced pancreatic cancer receiving first-line palliative chemotherapy within a universal health care system found that drug funding decisions were associated with increased uptake of new treatment options over time and improved survival. Both FOLFIRINOX and GEMNAB were associated with survival benefits in distinct patient populations.

Clinician Perspectives of COVID-19-Related Cancer Drug Funding Measures in Ontario.

The COVID-19 pandemic has a significant impact on cancer patients and the delivery of cancer care. To allow clinicians to adapt treatment plans for patients, Ontario Health (Cancer Care Ontario) issued a series of interim funding measures for the province's New Drug Funding Program (NDFP), which covers the cost of most hospital-delivered cancer drugs. To assess the utility of the measures and the need for their continuation, we conducted an online survey of Ontario oncology clinicians. The survey was open 3-25 September 2020 and generated 105 responses. Between April and June 2020, 46% of respondents changed treatment plans for more than 25% of their cancer patients due to the pandemic. Clinicians report broad use of interim funding measures. The most frequently reported strategies used were treatment breaks for stable patients (62%), extending dosing intervals (59%), and deferring routine imaging (56%). Most clinicians anticipate continuing to use these interim funding measures in the coming months. The survey showed that adapting cancer drug funding policies has supported clinical care in Ontario during the pandemic.

Reinventing the wheel: The incidence and cost implication of duplication of effort in patient education materials development.

OBJECTIVE: The development of patient education (PE) materials is costly and resource-intensive, and no mechanisms exist for sharing materials across cancer centers/hospitals to limit duplicated effort. The aim of this study was to explore the incidence and cost implication of duplicated PE efforts. METHODS: PE leaders from all (14) cancer centers in Ontario, Canada, submitted their collections of systemic therapy PE materials. Materials were categorized by topic and were coded as duplicate (more than one other material exists on the same topic and there was significant content and/or textual overlap), adapted (material was adapted from an existing material) or unique (no other material addresses the topic). RESULTS: 304 materials were included and <50 % of materials had duplicate content (n = 166, 55 %), a small proportion were adapted (n = 27, 9%), and less than half were unique (n = 111, 37 %). The majority of materials were considered amenable to adaptation meaning that the content was not dependent on a specific institutional context (n = 283, 93 %). The opportunity for cost savings if duplication of effort could be avoided is approximately $800 K for systemic therapy materials produced in cancer centers. CONCLUSION: There is need to refine the process for developing PE materials. Creating mechanisms of sharing can help facilitate equal access to materials and can result in significant cost savings. PRACTICE IMPLICATIONS: Efforts are needed to better coordinate the development of PE materials among patient educators. Better coordination would allow patient education programs to focus on other important challenges.

Evolving Best Practice for Take-Home Cancer Drugs.

PURPOSE: Take-home cancer drugs (THCDs) have become a standard treatment of many cancers. Robust guidelines have been developed for intravenous chemotherapy drugs, but few exist for THCDs with a focus on decentralized models. Hence, Ontario Health (Cancer Care Ontario) established the Oncology Pharmacy Task Force (OPTF) to develop consensus-based recommendations on best practices for THCDs to ensure that patients receive safe, consistent, high-quality care in the community once they leave the cancer center/practice with a prescription. METHODS: The OPTF included 34 members with comprehensive representation. Guidance from leading authorities was extracted through literature review, thematically analyzed, and synthesized to develop 29 recommendations. The consensus process (> 70% agreement) included a three-step modified Delphi method followed by an extensive review process. RESULTS: Sixteen recommendations were developed: training and education for providers (2), drug access (1), prescribing (4), patient and family/caregiver education (3), communication (1), dispensing (3), monitoring for patient adherence and adverse effects (1), and incident reporting (1). CONCLUSION: Through a rigorous methodology, the OPTF derived a robust set of recommendations similar to the ASCO/Oncology Nursing Society and ASCO/National Community Oncology Dispensing Association guidelines, further validating and strengthening the applicability across multiple jurisdictions, including those with decentralized models. Unique aspects in a decentralized model include the need for two pharmacy professionals, with one doing cognitive verification of the script and the other dispensing the medication; moreover, they optimize interprofessional communication between community providers and the cancer center/practice health care team.

Reducing dexamethasone antiemetic prophylaxis during the COVID-19 pandemic: recommendations from Ontario, Canada.

PURPOSE: People with cancer face an elevated risk of infection and severe sequelae from COVID-19. Dexamethasone is commonly used for antiemetic prophylaxis with systemic therapy for cancer. However, dexamethasone is associated with increased risk of viral and respiratory infections, and causes lymphopenia, which is associated with worse outcomes during COVID-19 infections. Our purpose was to minimize dexamethasone exposure during antiemetic prophylaxis for systemic therapy for solid tumors during the COVID-19 pandemic, while maintaining control of nausea and emesis. METHODS: We convened an expert panel to systematically review the literature and formulate consensus recommendations. RESULTS: No studies considered the impact of dexamethasone-based antiemetic regimens on the risk and severity of COVID-19 infection. Expert consensus recommended modifications to the 2019 Cancer Care Ontario Antiemetic Recommendations. CONCLUSION: Clinicians should prescribe the minimally effective dose of dexamethasone for antiemetic prophylaxis. Single-day dexamethasone dosing is recommended over multi-day dosing for regimens with high emetogenic risk excluding high-dose cisplatin, preferably in combination with palonosetron, netupitant, and olanzapine. For regimens with low emetogenic risk, 5-HT3 antagonists are recommended over dexamethasone.

Dosing practices and risk factors for bleeding in patients receiving enoxaparin for the treatment of an acute coronary syndrome.

OBJECTIVES: To describe dosing practices and to identify risk factors for bleeding in patients with an acute coronary syndrome (ACS) who received treatment with enoxaparin. DESIGN: Retrospective chart review. SETTING: Coronary care unit of a tertiary-care teaching hospital. PATIENTS: Patients with a discharge diagnosis of an ACS who received at least one dose of enoxaparin, 1 mg/kg, were eligible for this study. Enoxaparin dosing practices, factors that might influence the safety of enoxaparin administration, and bleeding events were documented. Multivariable regression analysis was used to identify independent predictors of bleeding in this clinical setting. RESULTS: Of 208 patients with an ACS who received enoxaparin, 48 patients (23%) received a dose that was > 10% or < 10% of the recommended 1 mg/kg dose, 18 patients (9%) did not have body weight documentation to guide enoxaparin dosing, and 17 patients (8%) had significant renal impairment (serum creatinine > 150 micromol/L), with the potential for bioaccumulation of enoxaparin. There were 35 bleeding events (17%), of which 8 events (4%) were major. Risk factors for any bleeding (major or minor) were increasing patient age (odds ratio [OR], 1.57; 95% confidence interval [CI], 1.13 to 2.20), coadministered nonsteroidal anti-inflammatory or antiplatelet drug therapy (OR, 2.38; 95% CI, 1.06 to 5.38), and number of enoxaparin doses (OR, 2.15; 95% CI, 1.25 to 3.68). Risk factors for major bleeding were increasing patient age (OR, 2.56; 95% CI, 1.05 to 6.28) and coadministered clopidogrel (OR, 7.70; 95% CI, 1.16 to 51.9). CONCLUSION: In this clinical practice assessment of patients with an ACS, the use of enoxaparin was suboptimal, with the potential to increase bleeding complications. Coadministered clopidogrel, other drugs that affect hemostasis, and increasing age conferred an increased bleeding risk.