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NCT Number: NCT06566560

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

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.

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Key information

Conditions

Cancer Drug Prescriptions Neoplasms Oncology Pharmacy

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

Location status: Recruiting

Location contact

Shirley Xie

CONTACT

[email protected]

0611469114

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

redispensing oral anticancer drugs

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:

  • the seal bag is unopened
  • the drug package is unopend and undamaged
  • the expiry date is ≥ 3 months
  • 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.

Primary outcomes

  1. 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

    Environmental impact will be measured in CO2-eq

  2. 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.

    Cost savings will be measured in euros

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 months

  2. 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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shirley Xie

CONTACT

[email protected]

0611469114

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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