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

NCT06566560 | Recruiting

• 2 other identifiers: 2020-7049111109
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Oncology; Pharmacy; Drug Prescriptions

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Cost savings will be measured in euros

  From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months.

Secondary Outcomes (3)

• 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.

Study Arms (1)

Intervention

OTHER

Other: redispensing oral anticancer drugs

Interventions

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: 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.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Shirley Xie

CONTACT

0611469114; Shirley.Xie@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 22, 2024
• Study Start: January 10, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)