Clinical trial NCT06566560: The ROAD 2.0 to Sustainable Medication Use: Redispensing Unused Oral Anticancer Drugs
Official title: Cost-savings and Environmental Impact Obtained From Redispensing Unused Oral Anticancer Drugs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Oncology
Pharmacy
Drug Prescriptions
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: The environmental impact of redispensing unused oral anticancer drugs of verified quality compared to standard practice of disposal.
timeFrame: From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months
measure: Cost-savings obtained by redispensing unused oral anticancer drugs of verified quality compared to standard practice of disposal.
timeFrame: From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months.
Secondary outcomes:
measure: The proportion of usability of returned medication for redispensing and the reasons for quality disapproval.
timeFrame: From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months
measure: The proportion of returned unused oral anticancer drugs and reasons thereof.
timeFrame: From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months
measure: Patients' reasons for not wanting to participate in a redispensing program for oral anticancer drugs.
timeFrame: From date of first invitation to participate in the study until the end of the recruitment period, up to 8 months.
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
References: