National survey on the effect of oncology drug shortages in clinical practice: A Hematology Oncology Pharmacy Association (HOPA) survey.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13609-e13609
Author(s):  
Sarah Hudson-Disalle ◽  
David L. DeRemer ◽  
Larry W Buie ◽  
Mark Hamm ◽  
Jeffrey Pilz ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Supportive Care ◽  
Cancer Patients ◽  
Medication Errors ◽  
The United States ◽  
Adverse Outcomes ◽  
Common Disease ◽  
Drug Shortages ◽  
Oncology Drug ◽  
The Impact

e13609 Background: Drug shortages are a clear and growing challenge. Prominent shortages included oncology medications and supportive care products essential for the care of cancer patients. Oncology drug shortages often result in disruptions in the timing of chemotherapy treatments, alterations in the dose or regimen administered, or even missed doses when alternative agents are unavailable. The purpose of this survey was to characterize the impact of oncology drug shortages across the United States, including the experiences of health care organizations, resource implications, and the impact on patient safety, patient care, and clinical trials. Methods: A 34-item online survey was distributed to HOPA membership of the Hematology Oncology Pharmacy Association to gather information on shortages of oncology drugs (i.e., all drugs essential in the care of cancer patients, including supportive care agents. Results: Sixty-eight organizations completed the survey; almost all completed by pharmacists, and analysis completed. Sixty-three percent of institutions reported one or more drugs shortages a month, with a 34.33% increase in 2019 from 2018. Sixty four percent of responded had incurred increased costs from oncology drugs shortages, with 7% noting reimbursement issues when switched to brand name therapies due to shortages. Treatment delays, reduced doses or alternative regimens were reported by 74.63% of respondents. The most common disease states which causes a dose delay of treatment included Acute Lymphocytic Leukemia, Lymphoma and Multiple Myeloma with dose reductions noted in 36.36%, 36.36 and 15.91%. The top five oncology drugs on shortage included epirubicin, flutamide, decitabine, mechlorethamine, dactinomycin with the top 5 supportive care drugs on shortage being noted as hydrocortisone, bivalirudin, promethazine, mycophenolate sodium and scopolamine. Respondents noted medication errors related to oncology drug shortages at 4.48%, with noted errors including incorrect conversion from iv to oral etoposide and incorrect EMR drug builds. Oncology Drug shortages impacted clinical trials in 13.4% of respondents in which 54.55% of respondents noting patients not being enrolled in clinical trials. Conclusions: A survey of US oncology pharmacists and technicians indicated that oncology drug shortages occurred frequently in 2020. Shortages led to delays in chemotherapy and changes in treatment or omission, complicated clinical research and increased the risk of medication errors and adverse outcomes.

scholarly journals Clinical impact of the etoposide injection shortage

2019 ◽  
Vol 26 (1) ◽  
pp. 187-192
Author(s):  
Hualy Li ◽  
Sarah K Cimino
Keyword(s):  
Adverse Events ◽  
Patient Care ◽  
Disease Progression ◽  
Medication Errors ◽  
The United States ◽  
Clinical Impact ◽  
Drug Shortage ◽  
Treatment Delays ◽  
Drug Shortages ◽  
The Impact

Purpose Drug shortages have become a constant challenge in patient care over the past two decades. In 2018, there was a shortage of etoposide injection in the United States. The purpose of this study was to analyze the impact of the etoposide injection shortage. Methods This single-center, retrospective chart review included patients prescribed an etoposide-containing chemotherapy regimen between January 2018 and August 2018. The primary objective was to determine the percentage of patients who required a change in treatment due to the etoposide injection drug shortage. For the secondary objectives, the following was compared between patients who received etoposide injection versus alternative etoposide formulations (etopophos injection or oral etoposide): adverse events, medication errors, treatment delays, disease progression, and drug costs. Results Twenty-two patients were included in this study. Overall, seven (32%) patients required a change in treatment due to the etoposide injection shortage. Of the seven patients, six required the use of an alternative etoposide formulation and one patient had etoposide omitted in at least one treatment cycle. There were no significant differences in adverse events, medication errors, treatment delays, or disease progression when comparing patients who received etoposide injection versus alternative etoposide formulations. The average drug cost per cycle was significantly higher in the patients who required a change in treatment. Conclusions To our knowledge, this is the first study to characterize the clinical impact of the etoposide injection shortage. Results from this study highlight the direct impact that drug shortages have on patient care.

How Sociodemographics, Presence of Oncology Specialists, and Hospital Cancer Programs Affect Accrual to Cancer Treatment Trials

2002 ◽  
Vol 20 (8) ◽  
pp. 2109-2117 ◽  
Author(s):  
Warren B. Sateren ◽  
Edward L. Trimble ◽  
Jeffrey Abrams ◽  
Otis Brawley ◽  
Nancy Breen ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Health Insurance ◽  
Cancer Treatment ◽  
Cancer Patients ◽  
Asian American ◽  
The United States ◽  
Health Maintenance ◽  
Treatment Trials ◽  
The Impact

PURPOSE: We chose to examine the impact of socioeconomic factors on accrual to National Cancer Institute (NCI)–sponsored cancer treatment trials. PATIENTS AND METHODS: We estimated the geographic and demographic cancer burden in the United States and then identified 24,332 patients accrued to NCI-sponsored cancer treatment trials during a 12-month period. Next, we examined accrual by age, sex, geographic residence, health insurance status, health maintenance organization market penetration, several proxy measures of socioeconomic status, the availability of an oncologist, and the presence of a hospital with an approved multidisciplinary cancer program. RESULTS: Pediatric patients were accrued to clinical trials at high levels, whereas after adolescence, only a small percentage of cancer patients were enrolled onto clinical trials. There were few differences by sex. Black males as well as Asian-American and Hispanic adults were accrued to clinical trials at lower rates than white cancer patients of the same age. Overall, the highest observed accrual was in suburban counties. Compared with the United States population, patients enrolled onto clinical trials were significantly less likely to be uninsured and more like to have Medicare health insurance. Geographic areas with higher socioeconomic levels had higher levels of clinical trial accruals. The number of oncologists and the presence of approved cancer programs both were significantly associated with increased accrual to clinical trials. CONCLUSION: We must work to increase the number of adults who enroll onto trials, especially among the elderly. Ongoing partnership with professional societies may be an effective approach to strengthen accrual to clinical trials.

scholarly journals Multicenter point prevalence evaluation of the utilization and safety of drug therapies for COVID-19 at the onset of the pandemic timeline in the United States

2021 ◽  
Author(s):  
Nathaniel J Rhodes ◽  
Atheer Dairem ◽  
William J Moore ◽  
Anooj Shah ◽  
Michael J Postelnick ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Therapy ◽  
Supportive Care ◽  
The United States ◽  
Primary Objective ◽  
Point Prevalence ◽  
Medical Centers ◽  
Academic Medical ◽  
History Of ◽  
Secondary Objective

Abstract Disclaimer In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose There are currently no FDA-approved medications for the treatment of coronavirus disease 2019 (COVID-19). At the onset of the pandemic, off-label medication use was supported by limited or no clinical data. We sought to characterize experimental COVID-19 therapies and identify safety signals during this period. Methods We conducted a non-interventional, multicenter, point prevalence study of patients hospitalized with suspected/confirmed COVID-19. Clinical and treatment characteristics within a 24-hour window were evaluated in a random sample of up to 30 patients per site. The primary objective was to describe COVID-19–targeted therapies. The secondary objective was to describe adverse drug reactions (ADRs). Results A total of 352 patients treated for COVID-19 at 15 US hospitals From April 18 to May 8, 2020, were included in the study. Most patients were treated at academic medical centers (53.4%) or community hospitals (42.6%). Sixty-seven patients (19%) were receiving drug therapy in addition to supportive care. Drug therapies used included hydroxychloroquine (69%), remdesivir (10%), and interleukin-6 antagonists (9%). Five patients (7.5%) were receiving combination therapy. The rate of use of COVID-19–directed drug therapy was higher in patients with vs patients without a history of asthma (14.9% vs 7%, P = 0.037) and in patients enrolled in clinical trials (26.9% vs 3.2%, P < 0.001). Among those receiving drug therapy, 8 patients (12%) experienced an ADR, and ADRs were recognized at a higher rate in patients enrolled in clinical trials (62.5% vs 22%; odds ratio, 5.9; P = 0.028). Conclusion While we observed high rates of supportive care for patients with COVID-19, we also found that ADRs were common among patients receiving drug therapy, including those enrolled in clinical trials. Comprehensive systems are needed to identify and mitigate ADRs associated with experimental COVID-19 treatments.

Measuring the Incremental Cost of Clinical Cancer Research

2001 ◽  
Vol 19 (1) ◽  
pp. 105-110 ◽  
Author(s):  
Dana P. Goldman ◽  
Michael L. Schoenbaum ◽  
Arnold L. Potosky ◽  
Jane C. Weeks ◽  
Sandra H. Berry ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Treatment ◽  
Incremental Cost ◽  
Cancer Patients ◽  
Phase Ii ◽  
The United States ◽  
Phase Iii ◽  
Ongoing Effort ◽  
Cancer Trials ◽  
The Cost

PURPOSE: To summarize evidence on the costs of treating patients in clinical trials and to describe the Cost of Cancer Treatment Study, an ongoing effort to produce generalizable estimates of the incremental costs of government-sponsored cancer trials. METHODS: A retrospective study of costs will be conducted with 1,500 cancer patients recruited from a randomly selected sample of institutions in the United States. Patients accrued to either phase II or phase III National Cancer Institute–sponsored clinical trials during a 15-month period will be asked to participate in a study of their health care utilization (n = 750). Costs will be measured approximately 1 year after their trial enrollment from a combination of billing records, medical records, and an in-person survey questionnaire. Similar data will be collected for a comparable group of cancer patients not in trials (n = 750) to provide an estimate of the incremental cost. RESULTS: Evidence suggests insurers limit access to trials because of cost concerns. Public and private efforts are underway to change these policies, but their permanent status is unclear. Previous studies found that treatment costs in clinical trials are similar to costs of standard therapy. However, it is difficult to generalize from these studies because of the unique practice settings, insufficient sample sizes, and the exclusion of potentially important costs. CONCLUSION: Denials of coverage for treatment in a clinical trial limit patient access to trials and could impede clinical research. Preliminary estimates suggest changes to these policies would not be expensive, but these results are not generalizable. The Cost of Cancer Treatment Study is an ongoing effort to provide generalizable estimates of the incremental treatment cost of phase II and phase III cancer trials. The results should be of great interest to insurers and the research community as they consider permanent ways to finance cancer trials.

The impact of beta-lactam allergy labels on hospitalized children

2020 ◽  
pp. 1-7
Author(s):  
Trahern W. Jones ◽  
Nora Fino ◽  
Jared Olson ◽  
Adam L. Hersh
Keyword(s):  
Length Of Stay ◽  
Pediatric Patients ◽  
The United States ◽  
Adverse Outcomes ◽  
Hospitalized Children ◽  
Beta Lactam ◽  
Healthcare Facilities ◽  
Antibiotic Allergy ◽  
Hospitalization Costs ◽  
The Impact

Abstract Background and objectives: Antibiotic allergy labels are common and are frequently inaccurate. Previous studies among adults demonstrate that β-lactam allergy labels may lead to adverse outcomes, including prescription of broader-spectrum antibiotics, increased costs, and increased lengths of stay, among others. However, data among pediatric patients are lacking, especially in the United States. In this study, we sought to determine the impact of β-lactam allergy labels in hospitalized children with regards to clinical and economic outcomes. Method: This retrospective cohort study included pediatric patients 30 days to 17 years old, hospitalized at Intermountain Healthcare facilities from 2007 to 2017, who received ≥1 dose of an antibiotic during their admission. Patients with β-lactam allergies were matched to nonallergic patients based on age, sex, clinical service line, admission date, academic children’s hospital or other hospital admission, and the presence of chronic, comorbid conditions. Outcomes included receipt of broader-spectrum antibiotics, clinical outcomes including length of stay and readmission, and antibiotic and hospitalization costs. Results: In total, 38,906 patients were identified. The prevalence of antibiotic allergy increased from 0.9% among those < 1 year peaked at 10.6% by age 17. Patients with β-lactam allergy received broader-spectrum antibiotics and experienced higher antibiotic costs than nonallergic controls. However, there were no differences in the length of stay, readmission rates, or total number of days of antibiotics between allergic and nonallergic patients. Conclusions: Hospitalized pediatric patients with β-lactam allergy labels receive broader-spectrum antibiotics and experience increased antibiotic costs. This represents an important opportunity for allergy delabeling and antibiotic stewardship.

Impact of Peritoneal Dialysis Dose Guidelines on Clinical Outcomes

2005 ◽  
Vol 25 (3_suppl) ◽  
pp. 95-98 ◽  
Author(s):  
David N. Churchill
Keyword(s):  
Clinical Trials ◽  
Peritoneal Dialysis ◽  
Clinical Practice ◽  
Adverse Effects ◽  
Randomized Clinical Trials ◽  
Intervention Group ◽  
The United States ◽  
Dialysis Dose ◽  
Middle Molecules ◽  
The Impact

The objective was to review the rationale for the Kidney Disease Outcomes Quality Initiative (K/DOQI) recommendations for adequacy of peritoneal dialysis and to evaluate the impact of these recommendations on clinical practice and patient survival. The K/DOQI recommendations were based on large observational studies; the target weekly Kt/V value of 2.0 assumed equivalence of peritoneal and renal clearances. This assumption is no longer considered correct. The impact on clinical practice was evaluated by an examination of temporal trends before and after publication of the guidelines in 1997. In the United States and The Netherlands, there had been a trend toward increased delivered total Kt/V prior to 1997, and there was no acceleration in this trend after 1997. Two randomized clinical trials have implemented these guidelines with increased peritoneal Kt/V (or creatinine clearance) used to achieve the K/DOQI target in the intervention group. This was not associated with improved survival, compared to a lower Kt/V, in either of the randomized clinical trials. Among the explanations for the failure to improve outcome are potential adverse effects of increasing the dialysis dose. These include increased intraperitoneal pressure associated with increased exchange volume, failure to increase clearance of middle molecules, and increased exposure to glucose. Strategies that increase peritoneal clearance without exposure to these potential adverse effects include more-frequent exchanges rather than increased exchange volume, and decreased exposure to glucose and glucose degradation products. Pending such studies, current K/DOQI guidelines should be updated in a timely manner.

scholarly journals A National Study of Oncology Nurses Discussing Cancer Clinical Trials With Patients

2019 ◽  
Vol 41 (12) ◽  
pp. 1747-1760
Author(s):  
Susan A. Flocke ◽  
Nora L. Nock ◽  
Sarah Fulton ◽  
Seunghee Margevicius ◽  
Sharon Manne ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Behavioral Control ◽  
The United States ◽  
Subjective Norms ◽  
Oncology Nurses ◽  
Equation Modeling ◽  
National Study ◽  
Perceived Behavioral Control ◽  
Oncology Nurse

In the United States less than 10% of cancer patients engage in clinical trials. Although most oncology nurses have multiple opportunities to discuss clinical trials with patients, barriers including attitudes and social norms may impede these discussions. Guided by the Theory of Planned Behavior, we developed and evaluated measures for attitudes, subjective norms, and perceived behavioral control of nurses for discussing clinical trials with cancer patients. Of the 18,000 Oncology Nurse Society members invited, 1,964 completed the survey. Structural equation modeling and internal consistency reliability were used to evaluate items and constructs. We found that overall model fit and reliability was good: Confirmatory Fit Index (CFI) = 0.91, Root Mean Square Error of Approximation (RMSEA) = 0.05; attitudes, 21 items, alpha = 0.84; perceived behavioral control, 10 items, alpha = 0.85; and subjective norms, 9 items, alpha = 0.89. These measures of attitudes, subjective norms, and perceived behavioral control show good reliability and initial evidence of validity.

Use of placebo in cancer medicine: The experience of a National Clinical Trials organization

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6104-6104
Author(s):  
J. L. Pater ◽  
W. Parulekar
Keyword(s):  
Clinical Trials ◽  
Supportive Care ◽  
Study Design ◽  
Standard Of Care ◽  
Phase Iii ◽  
Design Data ◽  
Standard Of Care Treatment ◽  
Prevention Trials ◽  
The Impact ◽  
Phase Iii Studies

6104 Background: The use of placebos in cancer clinical trials requires careful evaluation. Factors that must be considered include the impact of placebo on endpoint measurement, the efficacy of placebo relative to standard of care treatment, patient altruism/acceptance of a non-active intervention and the resulting increase in complexity of study conduct with respect to randomization, drug supply, data management, analysis and the unblinding process. Methods: We reviewed the experience of the National Cancer Institute of Canada Clinical Trials Group with the use of placebo in the randomized phase III setting from 1982–2005. Results: Since 1982, 34 studies were identified that utilized a placebo as part of study design. Data is presented below according to the type of study and date of study activation. The numbers in brackets represent those studies in which placebo was used alone in the control arm. Supportive care studies were the most common type of study employing a placebo as part of study design and constituted almost 50% of our Group’s experience. Therapeutic studies involving placebo were conducted in multiple sites including breast (4), lung (6), myeloma (1), melanoma (1), ovary (1) and pancreas (1). Conclusion: Phase III studies involving a placebo constitute an important part of our clinical trial activity and cross the spectrum of supportive care, therapeutic and prevention trials. The use of placebo in cancer studies may increase due to the relative ease of blinding in studies that evaluate targeted, oral therapies with minimal toxicities as well as the need for unbiased assessment of increasingly used endpoints such as time to progression. [Table: see text] No significant financial relationships to disclose.

Integrating clinical pharmacy services into patient care in an early-phase clinical trial clinic.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18228-e18228
Author(s):  
Dazhi Liu ◽  
Thu Oanh Dang ◽  
Stephen Harnicar ◽  
Katherine Kargus ◽  
Lauren A Evans ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Supportive Care ◽  
Clinical Pharmacist ◽  
Early Phase ◽  
Treatment Options ◽  
Cancer Center ◽  
Protocol Violation ◽  
Patients With Cancer ◽  
The Impact

e18228 Background: Early phase clinical trials have broadened treatment options for patients with cancer. Expert management of these new therapies is essential to positive patient outcomes. At Memorial Sloan Kettering Cancer Center, the Developmental Therapeutic Center (DTC) satisfies this need. Oncology clinical pharmacists collaborate with other healthcare professionals to maximize the benefits of drug therapy and minimize toxicities. The purpose of this project is to describe the interventions from a clinical pharmacist assigned to the DTC. Methods: A clinical pharmacist joined DTC to serve adult patients with cancer undergoing clinical trials. The clinical pharmacist acted as a liaison between pharmacy team and medical team, and sees patients during their trial eligibility screening and follow-up visits. The interventions were documented by the clinical pharmacist in patients’ medical charts and email communications. All interventions during 1 month were retrospectively collected and categorized into supportive care optimization, protocol violation prevention, and operational. Results: The oncology clinical pharmacist was involved in 115 patient visits for trial eligibility screening or protocol follow-up. A total of 769 interventions were addressed including supportive care optimization (40.2%), protocol violation prevention (24.7%), and operational (35.1%). Conclusions: The oncology clinical pharmacist is actively engaged in many aspects of cancer care at the early phase trial clinic. Our results demonstrate the vital role of an oncology clinical pharmacist. The impact of these categorized intervention areas would require a formal outcome and cost-saving analysis. [Table: see text]

Association of baseline cardiovascular risk factors and health care utilization and costs in elderly breast cancer patients enrolled in SWOG clinical trials.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 11508-11508
Author(s):  
Dawn L. Hershman ◽  
Cathee Till ◽  
Jason Dennis Wright ◽  
Melissa Kate Accordino ◽  
Riha Vaidya ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Healthcare Costs ◽  
Disease Risk ◽  
Breast Cancer Patients ◽  
Increased Risk ◽  
Clinical Records ◽  
The Impact

11508 Background: Cardiovascular-disease risk factors (CVD-RFs) increase the risk of cardiac events in women undergoing chemotherapy. Less is known about the impact of CVD-RFs on healthcare utilization and costs. Methods: We examined breast cancer patients treated uniformly on SWOG clinical trials from 1999-2011. We identified baseline diabetes, hypertension, hypercholesterolemia, and coronary artery disease (CAD) by linking trial records to Medicare claims; obesity was identified using clinical records. The outcomes were emergency room visits (ER), hospitalizations and costs. Multivariable logistic and linear regression were used. Results: Among the 708 patients included in the analysis, 160 (22.6%) experienced 234 separate hospitalizations, and 193 (27.3%) experienced 311 separate ER visits. Diabetes, hypertension, hypercholesterolemia, and CAD were all associated with increased risk of hospitalizations and ER visit. Hypertension had the strongest association, with more than a threefold risk of hospitalization for those with hypertension compared to those without (OR [95% CI], 3.16 [1.85-5.40], p<0.001). For those with ≥3 CVD-RFs, the risk of hospitalization was greater compared to 0 or 1 CVD-RFs (OR [95% CI], 2.74 [1.71-4.38], p<0.001). Similar results were seen for ER visits. In the first 12 months after trial registration, patients with diabetes ($38,324 vs $30,923, 23.9% increase, p=0.05), hypercholesterolemia ($34,168 vs $30,661, 11.4% increase, p=0.02), and CAD ($37,781 vs $31,698, 19.2% increase, p=0.04) had statistically significantly higher total healthcare costs. Additionally, those with 2 significant CVD-RFs ($35,353 vs. $28,899, 22.3% increase, p=.005) had higher total healthcare costs. Conclusions: Our study demonstrates that the presence of both CVD-RFs and ER visits and hospitalizations are frequent among elderly BC patients. The risk of ER visits and hospitalizations is higher among patients with CVD-RFs, and increases with the number of RFs. Better management of CVD-RFs and more aggressive symptom management may be required to reduce both physical and financial toxicities to elderly patients undergoing BC therapy.

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