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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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

Первичные конечные точки

• The environmental impact of redispensing unused oral anticancer drugs of verified quality compared to standard practice of disposal. [Срок оценки: 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. [Срок оценки: From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months.]

Вторичные конечные точки (3)

• The proportion of usability of returned medication for redispensing and the reasons for quality disapproval. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: From date of first invitation to participate in the study until the end of the recruitment period, up to 8 months.]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Нидерланды · 1 центр

• Radboudumc — Nijmegen

Идентификаторы

NCT: NCT06566560 · 2020-7049 · 111109

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗