The ROAD 2.0 to Sustainable Medication Use: Redispensing Unused Oral Anticancer Drugs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorRadboud University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
redispensing oral anticancer drugs
Other interventionParticipants 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.
Treatment groups
2,500 Participants
are divided into 1 treatment groupGroup A: InterventionOther 1 intervention
Trial outcomes
Primary outcomes
1
The environmental impact of redispensing unused oral anticancer drugs of verified quality compared to standard practice of disposal.
Environmental impact will be measured in CO2-eq
Time frame
From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months2
Cost-savings obtained by redispensing unused oral anticancer drugs of verified quality compared to standard practice of disposal.
Cost savings will be measured in euros
Time frame
From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months.Secondary outcomes
1
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 months2
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 months3
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.Sponsors and contacts
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Source ClinicalTrials.gov