The ROAD 2.0 to Sustainable Medication Use: Redispensing Unused Oral Anticancer Drugs

August 20, 2024 updated by: Radboud University Medical Center

Cost-savings and Environmental Impact Obtained From Redispensing Unused Oral Anticancer Drugs

The goal of this prospective intervention study is to investigate the effectiveness of redispensing unused oral anticancer drugs.

The main questions it aims to answer are:

  • What are the cost-savings of redispensing unused oral anticancer drugs?
  • What is the environmental impact of redispensing unused oral anticancer drugs?

Researchers will compare redispensing unused oral anticancer drugs to the standard practice of disposal.

Participants will receive their oral anticancer drugs in a sealed bag with a temperature indicator if needed. They will be asked to return any unused oral anticancer drugs to the pharmacy during their next visit to the hospital.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of all ages
  • A clinical diagnosis of cancer using an oral anticancer drug that requires storage at room temperature according to the Summary of Product Characteristics (SmPC).

Exclusion Criteria:

  • Patients that do not understand the Dutch or English language, in written or spoken.
  • Patients receiving prescriptions that contain an amount of tablets that deviates from the regular package size, resulting in the pharmacy dispensing an opened package

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intervention
Other: redispensing oral anticancer drugs

Participants will receive oral anticancer drugs according to their regular prescriptions, distributed in the original manufacturer's package. Following the guideline, some oral anticancer drug (i.e. requiring temperature storage up to 25C degrees) will be supplemented with a validated temperature indicator (Timestrip Neo, customer configuration), enclosed with a seal bag. Patients are requested to return unused oral anticancer drugs to the outpatient pharmacy that distributed them.

Pharmacy staff will assess the quality of returned oral anticancer drugs, applying the following criteria:

  1. the seal bag is unopened
  2. the drug package is unopend and undamaged
  3. the expiry date is ≥ 3 months
  4. the medication has not been stored outside the product label storage claim

Oral anticancer drugs that meet all criteria are restocked, and consecutively redispensed to participants visiting the same outpatient pharmacy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The environmental impact of redispensing unused oral anticancer drugs of verified quality compared to standard practice of disposal.
Time Frame: From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months
Environmental impact will be measured in CO2-eq
From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months
Cost-savings obtained by redispensing unused oral anticancer drugs of verified quality compared to standard practice of disposal.
Time Frame: From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months.
Cost savings will be measured in euros
From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
The proportion of usability of returned medication for redispensing and the reasons for quality disapproval.
Time Frame: From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months
From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months
The proportion of returned unused oral anticancer drugs and reasons thereof.
Time Frame: From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months
From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months
Patients' reasons for not wanting to participate in a redispensing program for oral anticancer drugs.
Time Frame: From date of first invitation to participate in the study until the end of the recruitment period, up to 8 months.
From date of first invitation to participate in the study until the end of the recruitment period, up to 8 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-7049
  • 111109 (Other Identifier: PaNaMa)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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