Medication errors during treatment with new oral anticancer agents: consequences for clinical practice based on the AMBORA study

Background: Substantial racial and socioeconomic disparities in metastatic RCC (mRCC) have persisted following the introduction of targeted oral anticancer agents (OAAs). The relationship between patient characteristics and OAA access and costs that may underlie persistent disparities in mRCC outcomes have not been examined in a nationally representative patient population. Methods: Retrospective SEER-Medicare analysis of patients diagnosed with mRCC between 2007–2015 over age 65 with Medicare part D prescription drug coverage. Associations between patient characteristics, OAA receipt, and associated costs were analyzed in the 12 months following mRCC diagnosis and adjusted to 2015 dollars. Results: 2,792 patients met inclusion criteria, of which 32.4%received an OAA. Most patients received sunitinib (57%) or pazopanib (28%) as their first oral therapy. Receipt of OAA did not differ by race/ethnicity or socioeconomic indicators. Patients of advanced age (> 80 years), unmarried patients, and patients residing in the Southern US were less likely to receive OAAs. The mean inflation-adjusted 30-day cost to Medicare of a patient’s first OAA prescription nearly doubled from $3864 in 2007 to $7482 in 2015, while patient out-of-pocket cost decreased from $2409 to $1477. Conclusion: Race, ethnicity, and socioeconomic status were not associated with decreased OAA receipt in patients with mRCC; however, residing in the Southern United States was, as was marital status. Surprisingly, the cost to Medicare of an initial OAA prescription nearly doubled from 2007 to 2015, while patient out-of-pocket costs decreased substantially. Shifts in OAA costs may have significant economic implications in the era of personalized medicine.

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Primary care oncology model (PCOM): Implementation of a model integrating primary and oncology care for patients taking oral anticancer agents.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.tps1587 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. TPS1587-TPS1587

Author(s):

Emily R. Mackler ◽

Karen B. Farris ◽

Katie S. Gatwood ◽

Amna Rizvi-Toner ◽

Alex Wallace ◽

...

Keyword(s):

Primary Care ◽

Anticancer Agents ◽

Chronic Conditions ◽

Lymphocytic Leukemia ◽

Chronic Obstructive ◽

Multiple Chronic Conditions ◽

Hiv Intervention ◽

Patient Reported ◽

Chronic Medications ◽

Oral Anticancer Agents

TPS1587 Background: Non-adherence to oral anticancer agents (OAA) has been reported among 30% of individuals. Often, individuals with cancer are not just managing their new OAA but also medications to treat multiple chronic conditions (MCC). Multiple factors contribute to the extent patients on OAAs and MCC medications adhere to therapy. The objective of this study is to improve medication, symptom, and disease management of patients with hematological malignancies and MCC through care coordination between pharmacists. Methods: Design. This is a multi-center prospective single arm pilot study at two academic medical centers in Michigan and Tennessee. Subjects. Ninety participants will be recruited, 60 from site 1 and 30 from site 2. Inclusion criteria are: adults > 18 years, diagnosed with and initiating oral treatment for chronic myeloid leukemia, chronic lymphocytic leukemia, or multiple myeloma, diagnoses of at least 2 chronic conditions, where one is type 2 diabetes, hypertension, congestive heart failure, depression/anxiety, gastroesophageal reflux disease, hyperlipidemia, or chronic obstructive pulmonary disease, taking at least two chronic medications, and able to provide electronic consent. Exclusion criteria are: inability to speak English, and diagnosis of type 1 diabetes or HIV. Intervention. Participants will complete two Patient Reported Outcome Measures (PROMs) for their OAA that will be reviewed by the oncology pharmacist, with follow-up to the care team if needed. Participants will be scheduled for a Comprehensive Medication Review with a primary care pharmacist for up to two visits for their chronic medications. The intervention over 2 months, and the oncology and primary care pharmacists communicate via electronic health record about medications, symptoms, and disease control. Outcomes. The primary endpoints are (a) dose-adjusted adherence by proportion days covered (PDC) for the OAA and (b) PDC for chronic condition medications, assessed using 6 months of prescription claims. Data will be collected from patients using REDCap surveys and abstracted data will be entered into REDCap. Implementation by pharmacists and patient acceptability will be examined. Analysis. The association of OAA and chronic medication adherence (PDC) will be examined via correlation. Participant demographics,clinical characteristics, and the symptom experience from the PROM will be described. Using CMR results, medication problems, recommendations, and changes will be provided. Program implementation will be assessed and patient perceptions obtained from post-CMR interviews. A joint display for the quantitative and qualitative data for feasibility, appropriateness, and acceptability from pharmacists will be completed. Results: Screening and recruitment has begun. Clinical trial information: NCT04595851 and NCT04663100.

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Pharmacoeconomics Evaluations of Oral Anticancer Agents: Systematic Review of Characteristics, Methodological Trends, and Reporting Quality

Value in Health Regional Issues ◽

10.1016/j.vhri.2018.05.003 ◽

2018 ◽

Vol 16 ◽

pp. 46-60 ◽

Cited By ~ 1

Author(s):

Ahmad Al Kadour ◽

Wafa Al Marridi ◽

Daoud Al-Badriyeh

Keyword(s):

Systematic Review ◽

Anticancer Agents ◽

Reporting Quality ◽

Oral Anticancer Agents

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Adherence enhancing interventions for oral anticancer agents: A systematic review

Cancer Treatment Reviews ◽

10.1016/j.ctrv.2013.07.004 ◽

2014 ◽

Vol 40 (1) ◽

pp. 102-108 ◽

Cited By ~ 43

Author(s):

Tim Mathes ◽

Sunya-Lee Antoine ◽

Dawid Pieper ◽

Michaela Eikermann

Keyword(s):

Systematic Review ◽

Anticancer Agents ◽

Oral Anticancer Agents

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Oral anticancer agents: a prospective pilot study of a patient educational surgery run by a pharmacist and a nurse

European Journal of Hospital Pharmacy ◽

10.1136/ejhpharm-2012-000074.265 ◽

2012 ◽

Vol 19 (2) ◽

pp. 185.2-185

Author(s):

D. Conde-Estévez ◽

D. Gómez-Ulloa ◽

A. Vila Bundó ◽

J. Mateu-de Antonio ◽

M. Florit ◽

...

Keyword(s):

Pilot Study ◽

Anticancer Agents ◽

Prospective Pilot Study ◽

Oral Anticancer Agents

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Patients’ knowledge and awareness of safe handling of oral anticancer agents at Sultan Qaboos University Hospital in Oman

Journal of Oncology Pharmacy Practice ◽

10.1177/10781552211056238 ◽

2021 ◽

pp. 107815522110562

Author(s):

Moataz M Hassan ◽

Dhabya Al-Marzooq ◽

Hanan Al-Habsi ◽

Amna Al-Hashar ◽

Murtadha Al-Khabori ◽

...

Keyword(s):

Cancer Patients ◽

Anticancer Agents ◽

Oral Chemotherapy ◽

University Hospital ◽

National Guidelines ◽

Cross Sectional Survey ◽

Cross Sectional ◽

Safe Handling ◽

Chemotherapy Drugs ◽

Oral Anticancer Agents

Background Safe handling of oral anticancer agents is of great concern. There is a lack of clear, national guidelines on how patients can safely handle and dispose of unwanted medications. We aimed to evaluate the safe handling, storage, and disposal of oral anticancer drugs among cancer patients and caregivers at home. Method This cross-sectional survey of adult cancer patients (or their adult caregivers) used a closed-ended questionnaire from May 2019 to March 2020. Results A total of 257 patients (50 ± 15 years; range: 18–93 years) were enrolled; however, only 91% (233/257) reported self-administering oral anticancer medications. Caregivers were more likely to administer oral anticancer agents for patients ≥60 years than those <40 years old (63% vs. 8%; P = 0.001). Most patients (52%; 133/257) did not wash their hands after administering the drug; 74% (164/222) of the respondents reported that their medications were kept in a bedroom cabinet, while 18% (40/222) stored their medications in a refrigerator, and 5% (12/222) in a kitchen cabinet. A total of 55% (68/124) of patients returned their excess oral chemotherapy medications to the hospitals; however, 36% (45/124) disposed of their unused oral chemotherapy drugs in a household garbage container. Conclusion While two-thirds of patients stored their oral anticancer medications properly, more than half used inappropriate handling procedures. Disposal practices were inconsistent and did not adhere to the reported international guidelines.

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Expanding pharmacy practice through the use of pharmacy technicians as process navigators to facilitate patient access of oral anticancer agents

Journal of the American Pharmacists Association ◽

10.1016/j.japh.2019.03.003 ◽

2019 ◽

Vol 59 (4) ◽

pp. 586-592 ◽

Cited By ~ 1

Author(s):

Gary Lau ◽

Laura Alwan ◽

Mary Chi ◽

Michelle Lentz ◽

Katie Hone ◽

...

Keyword(s):

Anticancer Agents ◽

Pharmacy Practice ◽

Patient Access ◽

Pharmacy Technicians ◽

Oral Anticancer Agents

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Oral Anticancer Drugs: How Limited Dosing Options and Dose Reductions May Affect Outcomes in Comparative Trials and Efficacy in Patients

Journal of Clinical Oncology ◽

10.1200/jco.2013.53.0204 ◽

2014 ◽

Vol 32 (15) ◽

pp. 1620-1629 ◽

Cited By ~ 36

Author(s):

Vinay Prasad ◽

Paul R. Massey ◽

Tito Fojo

Keyword(s):

Clinical Trials ◽

Anticancer Agents ◽

Comparative Effectiveness ◽

Clinical Effectiveness ◽

Effectiveness Trials ◽

Cancer Medicine ◽

Poor Tolerability ◽

Dose Reductions ◽

Comparative Trials ◽

Oral Anticancer Agents

Historically, cancer medicine has avoided the problem of unequal dosing by comparing maximum-tolerated doses of intravenous regimens with proportionate dose reductions for toxicity. However, in recent years, with the development of numerous oral anticancer agents, dosing options are arbitrarily and increasingly limited by the size of pills. We contend that an underappreciated consequence of pill size is unequal dosing in comparative clinical trials and that this can have an impact on outcomes. We discuss how comparative effectiveness trials can be unbalanced and how the use of doses that are not sustainable might affect outcomes, especially marginal ones. We further argue that because of their poor tolerability and their limited dosing options, which often result in large dose adjustments in response to toxicity, the real-world clinical effectiveness of oral anticancer agents may be diminished and may not emulate results achieved in registration trials.

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