Strategic Improvement of Oral Antineoplastic Investigational Agents Compliance

Background: The use of oral antineoplastic agents has increased in cancer medicine. However, the convenience of oral medication carries the risk of nonadherence and dosing errors, which could jeopardize therapeutic benefits and patient safety. This is a quality improvement project to investigate rea...

Full description

Bibliographic Details
Main Authors: Anas Alshawa, Jing Gong, Valerie Marcott, Rabia Khan, Valentine Boving, Lakeshia Brown, Jeff Beno, Ed Kheder, Siqing Fu
Format: Article
Language:English
Published: Innovative Healthcare Institute 2019-02-01
Series:Global Journal on Quality and Safety in Healthcare
Subjects:
Online Access:https://jqsh.org/doi/pdf/10.4103/JQSH.JQSH_23_18
_version_ 1811164513127366656
author Anas Alshawa
Jing Gong
Valerie Marcott
Rabia Khan
Valentine Boving
Lakeshia Brown
Jeff Beno
Ed Kheder
Siqing Fu
author_facet Anas Alshawa
Jing Gong
Valerie Marcott
Rabia Khan
Valentine Boving
Lakeshia Brown
Jeff Beno
Ed Kheder
Siqing Fu
author_sort Anas Alshawa
collection DOAJ
description Background: The use of oral antineoplastic agents has increased in cancer medicine. However, the convenience of oral medication carries the risk of nonadherence and dosing errors, which could jeopardize therapeutic benefits and patient safety. This is a quality improvement project to investigate reasons for nonadherence and medication errors in patients receiving oral investigational treatment at the Phase 1 Department at MD Anderson Cancer Center, Houston, Texas. Early-phase clinical trials have an enormous impact on drug development and patient safety, not much has been done to evaluate adherence in patients receiving investigational oral antineoplastic agents. Materials and Methods: We examined our clinic dynamic including the initial encounter, follow-up phone calls, medication administration, and patient adherence the following visit. Then we explored and classified the main possible reasons for nonadherence and medication error across the workflow. Results: When examining potential deficiencies in the clinic flow, which are actionable and carry high impact, we found the initial encounter had a significant room for improvement and errors happened when instructions provided were unclear, not correct, or contradicted with the prescription or the label. Furthermore, the follow-up calling was also an important step to monitor and improve compliance. However, it was not a consistent practice and lacked a standardized format. Lastly and although the multistep reconciliation process for oral medication is important to monitor compliance, it was complex, had multiple manual aspects, and added substantial burden on the research staff. Conclusion: In this project, our goal was to shed light on the possible causes of oral medication errors and nonadherence in clinical trials. We proposed feasible measures including educational, training, and adherence monitoring tools. We will continue to monitor and evaluate our data to see any positive or negative impact from our interventions.
first_indexed 2024-04-10T15:22:30Z
format Article
id doaj.art-4e996b5468614e128dd41d069b5da096
institution Directory Open Access Journal
issn 2666-2353
2589-9449
language English
last_indexed 2024-04-10T15:22:30Z
publishDate 2019-02-01
publisher Innovative Healthcare Institute
record_format Article
series Global Journal on Quality and Safety in Healthcare
spelling doaj.art-4e996b5468614e128dd41d069b5da0962023-02-14T13:13:30ZengInnovative Healthcare InstituteGlobal Journal on Quality and Safety in Healthcare2666-23532589-94492019-02-0151010.4103/JQSH.JQSH_23_18i2589-9449-2-1-5Strategic Improvement of Oral Antineoplastic Investigational Agents ComplianceAnas Alshawa0Jing Gong1Valerie Marcott2Rabia Khan3Valentine Boving4Lakeshia Brown5Jeff Beno6Ed Kheder7Siqing Fu81 Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston,1 Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston,1 Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston,1 Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston,3 Department of Quality Measurement and Engineering,4 Department of Patient Education Office and3 Department of Quality Measurement and Engineering,1 Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston,1 Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston,Background: The use of oral antineoplastic agents has increased in cancer medicine. However, the convenience of oral medication carries the risk of nonadherence and dosing errors, which could jeopardize therapeutic benefits and patient safety. This is a quality improvement project to investigate reasons for nonadherence and medication errors in patients receiving oral investigational treatment at the Phase 1 Department at MD Anderson Cancer Center, Houston, Texas. Early-phase clinical trials have an enormous impact on drug development and patient safety, not much has been done to evaluate adherence in patients receiving investigational oral antineoplastic agents. Materials and Methods: We examined our clinic dynamic including the initial encounter, follow-up phone calls, medication administration, and patient adherence the following visit. Then we explored and classified the main possible reasons for nonadherence and medication error across the workflow. Results: When examining potential deficiencies in the clinic flow, which are actionable and carry high impact, we found the initial encounter had a significant room for improvement and errors happened when instructions provided were unclear, not correct, or contradicted with the prescription or the label. Furthermore, the follow-up calling was also an important step to monitor and improve compliance. However, it was not a consistent practice and lacked a standardized format. Lastly and although the multistep reconciliation process for oral medication is important to monitor compliance, it was complex, had multiple manual aspects, and added substantial burden on the research staff. Conclusion: In this project, our goal was to shed light on the possible causes of oral medication errors and nonadherence in clinical trials. We proposed feasible measures including educational, training, and adherence monitoring tools. We will continue to monitor and evaluate our data to see any positive or negative impact from our interventions.https://jqsh.org/doi/pdf/10.4103/JQSH.JQSH_23_18clinical trialscomplianceinvestigationalnonadherenceoral antineoplasticphase 1quality improvement
spellingShingle Anas Alshawa
Jing Gong
Valerie Marcott
Rabia Khan
Valentine Boving
Lakeshia Brown
Jeff Beno
Ed Kheder
Siqing Fu
Strategic Improvement of Oral Antineoplastic Investigational Agents Compliance
Global Journal on Quality and Safety in Healthcare
clinical trials
compliance
investigational
nonadherence
oral antineoplastic
phase 1
quality improvement
title Strategic Improvement of Oral Antineoplastic Investigational Agents Compliance
title_full Strategic Improvement of Oral Antineoplastic Investigational Agents Compliance
title_fullStr Strategic Improvement of Oral Antineoplastic Investigational Agents Compliance
title_full_unstemmed Strategic Improvement of Oral Antineoplastic Investigational Agents Compliance
title_short Strategic Improvement of Oral Antineoplastic Investigational Agents Compliance
title_sort strategic improvement of oral antineoplastic investigational agents compliance
topic clinical trials
compliance
investigational
nonadherence
oral antineoplastic
phase 1
quality improvement
url https://jqsh.org/doi/pdf/10.4103/JQSH.JQSH_23_18
work_keys_str_mv AT anasalshawa strategicimprovementoforalantineoplasticinvestigationalagentscompliance
AT jinggong strategicimprovementoforalantineoplasticinvestigationalagentscompliance
AT valeriemarcott strategicimprovementoforalantineoplasticinvestigationalagentscompliance
AT rabiakhan strategicimprovementoforalantineoplasticinvestigationalagentscompliance
AT valentineboving strategicimprovementoforalantineoplasticinvestigationalagentscompliance
AT lakeshiabrown strategicimprovementoforalantineoplasticinvestigationalagentscompliance
AT jeffbeno strategicimprovementoforalantineoplasticinvestigationalagentscompliance
AT edkheder strategicimprovementoforalantineoplasticinvestigationalagentscompliance
AT siqingfu strategicimprovementoforalantineoplasticinvestigationalagentscompliance