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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06566560
Enrollment
2500
Registered
2024-08-22
Start date
2024-01-10
Completion date
2024-12-31
Last updated
2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Drug Prescriptions, Oncology, Pharmacy

Brief summary

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.

Interventions

OTHERredispensing 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.

Sponsors

Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The environmental impact of redispensing unused oral anticancer drugs of verified quality compared to standard practice of disposal.From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 monthsEnvironmental impact will be measured in CO2-eq
Cost-savings obtained by redispensing unused oral anticancer drugs of verified quality compared to standard practice of disposal.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

Secondary

MeasureTime frame
The proportion of usability of returned medication for redispensing and the reasons for quality disapproval.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.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.From date of first invitation to participate in the study until the end of the recruitment period, up to 8 months.

Countries

Netherlands

Contacts

Primary ContactShirley Xie
Shirley.Xie@radboudumc.nl0611469114

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026