To determine the waste reduction, net cost savings and environmental impact attained by redispensing oral anticancer drugs that go unused by patients compared with the standard practice of disposal.
ID
Source
Brief title
Condition
- Metastases
Health condition
Oncology
Research involving
Sponsors and support
Intervention
- Other intervention
Outcome measures
Primary outcome
To determine the cost-savings and environmental impact obtained by a redispensing program for unused oral anticancer drugs in routine clinical practice.
Secondary outcome
(1) To determine the usability of returned medication for redispensing and the reasons for quality disapproval. (2) To determine the proportion of returned unused oral anticancer drugs and reasons thereof. (3) To determine reasons for not wanting to participate in a redispensing program for oral anticancer drugs.
Background summary
New strategies targeting waste are required to improve financial and ecologic sustainability of expensive therapies, such as oral anticancer drugs, that frequently remain unused by patients. Redispensing unused oral anticancer drugs seems to be a promising strategy when drug quality is guaranteed.
Study objective
To determine the waste reduction, net cost savings and environmental impact attained by redispensing oral anticancer drugs that go unused by patients compared with the standard practice of disposal.
Study design
"The ROAD study was a prospective single-group intervention conducted in the outpatient pharmacies of 4 hospitals in the Netherlands from February 1, 2021, to February 1, 2023, with 12-month follow-up of each patient."
Intervention
"The redispensing of unused oral anticancer drugs: All participating patients will receive their prescribed oral anticancer drugs in the original manufacturer’s package supplemented with a validated time–temperature indicator (Elpro ITS temperature indicator, customer configuration) enclosed in a sealbag (Transposafe® sealbag). 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 sealbag is unopened 2) the medication’s outer packaging is undamaged 3) the expiry date is = 6 months 4) the medication has not been stored outside product label storage claim Oral anticancer drugs that meet all criteria are restocked, and consecutively redispensed to participating patients visiting the same outpatient pharmacy."
Study burden and risks
"No invasive or burdensome research is conducted on the participants: - Before the start of the study, written consent for participation is requested. - Participating patients are asked to return unused medication to the hospital pharmacy. This can be done during regular care and therefore does not place any additional burden on the patient. Pick-up options are offered to patients if needed. - Participating patients may receive redispensed packages of anticancer medication, but only closed, sealed packages are redispensed. The pharmacy ensures the quality of all redispensed packages, so no safety risk arises. "
Age
Inclusion criteria
Adult patients (≥18 years) with a clinical diagnosis of cancer using an oral anticancer drug that requires storage at room temperature according to the Summary of Product Characteristics (SmPC) are eligible for participation. This includes both patients that initiate an oral anticancer drug as patients that are already using an oral anticancer drug.
Exclusion criteria
Patients that do not understand the Dutch language, in written or spoken will be excluded from participation. Moreover, prescriptions that contain an amount of tablets that deviates from the regular package size, resulting in the pharmacy dispensing an opened package, will be excluded for redispensing.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9208 |
| Other | Commissie Mensgebonden Onderzoek Radboudumc : 2020-7049 |
Summary results
were redispensed, which reduced waste by 68.1% (95% CI, 67.7%-68.5%) compared with the standard practice (disposal). Redispensing unused oral anticancer drugs comprised 2.4% (95% CI, 2.2%-2.5%) of total drug costs, providing mean net annual cost savings of €576 (95% CI: 444 – 709) up to €1,348 (95% 1,039 – 1,697) per patient. Redispensing provided climate benefits of 1.9 (95%CI:1.5; -2.6) kg CO2-eq per patient per year."