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

NCT ID: NCT06566560

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-10

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Oncology Pharmacy Drug Prescriptions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type OTHER

redispensing oral anticancer drugs

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Radboudumc

Nijmegen, Gelderland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Shirley Xie

Role: CONTACT

0611469114

Facility Contacts

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Shirley Xie

Role: primary

0611469114

Other Identifiers

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111109

Identifier Type: OTHER

Identifier Source: secondary_id

2020-7049

Identifier Type: -

Identifier Source: org_study_id

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