Strategic Improvement of Oral Antineoplastic Investigational Agents Compliance

Abstract

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.

Keywords

• clinical trials
• compliance
• investigational
• nonadherence
• oral antineoplastic
• phase 1
• quality improvement