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Recruiting NCT06566560

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

No phase Interventional Cancer Oncology Pharmacy Drug Prescriptions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: redispensing oral anticancer drugs.
Who it may be relevant to
Registry conditions: Cancer, Oncology, Pharmacy, Drug Prescriptions. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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 sta

Primary outcome measures

  • 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]
  • 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.]
Secondary outcome measures (3)
  • 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]
  • 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]
  • 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.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

Netherlands · 1 center
  • Radboudumc — Nijmegen

Identifiers

NCT: NCT06566560 · 2020-7049 · 111109

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗