Redispensing oral anticancer drugs in Denmark (DANROAD): a national, multicentre, prospective implementation study protocol.

Abstract

Unused oral anticancer drugs (OADs) represent substantial financial and environmental waste. In Denmark, medicines worth ~€55 million are destroyed annually, many unopened and unexpired. Redispensing unused OADs has proven feasible and cost-saving in the Netherlands, but has not been tested in a Danish context. The Redispensing of Oral Anti-cancer Drugs in Denmark (DANROAD) study aims to evaluate the economic, environmental and implementation feasibility of a national redispensing programme. DANROAD is a national, multicentre, prospective observational study with two phases: a single-site pilot at Odense University Hospital, followed by a national rollout. Eligible patients (≥18 years, prescribed an OAD with expected treatment ≥3 months) will be enrolled after providing informed consent. OADs will be dispensed in sealed bags with temperature loggers; unused OADs returned at routine visits will undergo quality control and, if eligible, be redispensed. The primary outcome is the net economic balance (value of redispensed OADs minus operational costs). Secondary outcomes include avoided greenhouse gas emissions (life cycle assessment), patient and professional acceptance (qualitative analyses) and medication waste metrics (return rates, eligibility, disqualification reasons). Quantitative and qualitative data will be analysed separately and integrated. The Danish Medicines Agency has approved the regulatory framework for redispensing. The Regional Ethics Committee confirmed that formal approval was not required. Written informed consent will be obtained from all participants. The study is preregistered in the Open Science Framework (no. 7nh65). Findings will be disseminated via peer-reviewed journals, conferences, stakeholder reports and lay summaries.