{
  "abstract": "Introduction 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.Methods and analysis 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.Ethics and dissemination 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.",
  "authors": [
    {
      "affiliations": [
        "Department of Clinical Pharmacology, Odense University Hospital, Odense, Denmark",
        "Department of Clinical Research, University of Southern Denmark, Odense, Denmark"
      ],
      "name": "Anne Suhr Thykjær Petersen"
    },
    {
      "affiliations": [
        "Department of Clinical Pharmacology, Odense University Hospital, Odense, Denmark",
        "Department of Clinical Research, University of Southern Denmark, Odense, Denmark"
      ],
      "name": "Kathrine Bendorff Moriat"
    },
    {
      "affiliations": [
        "Department of Pharmacy, Pharmacology and Toxicology, Radboud University Medical Center, Nijmegen, Netherlands"
      ],
      "name": "Charlotte Bekker"
    },
    {
      "affiliations": [
        "Hospital Pharmacy of Funen, Odense University Hospital, Odense, Denmark"
      ],
      "name": "Helle Houlbjerg Carlsen"
    },
    {
      "affiliations": [
        "Department of Clinical Pharmacology, Odense University Hospital, Odense, Denmark"
      ],
      "name": "Mette Marie Hougaard Christensen"
    },
    {
      "affiliations": [
        "Department of Clinical Pharmacology, Odense University Hospital, Odense, Denmark",
        "Department of Clinical Research, University of Southern Denmark, Odense, Denmark"
      ],
      "name": "Ann-Cathrine Dalgård Dunvald"
    },
    {
      "affiliations": [
        "Department of Clinical Pharmacology, Odense University Hospital, Odense, Denmark",
        "Department of Clinical Research, University of Southern Denmark, Odense, Denmark"
      ],
      "name": "Zandra Nymand Ennis"
    },
    {
      "affiliations": [
        "Department of Clinical Research, University of Southern Denmark, Odense, Denmark"
      ],
      "name": "Erika Björkström Gram"
    },
    {
      "affiliations": [
        "Department of Clinical Pharmacology, Odense University Hospital, Odense, Denmark",
        "Department of Clinical Research, University of Southern Denmark, Odense, Denmark"
      ],
      "name": "Daniel Pilsgaard Henriksen"
    },
    {
      "affiliations": [
        "Department of Clinical Pharmacology, Odense University Hospital, Odense, Denmark",
        "Department of Clinical Research, University of Southern Denmark, Odense, Denmark"
      ],
      "name": "Katrine Bitsch Johansen"
    },
    {
      "affiliations": [
        "Hospital Pharmacy of Funen, Odense University Hospital, Odense, Denmark"
      ],
      "name": "Mia Lolk Lund"
    },
    {
      "affiliations": [
        "Hospital Pharmacy of Funen, Odense University Hospital, Odense, Denmark"
      ],
      "name": "Michelle Lyndgaard Nielsen"
    },
    {
      "affiliations": [
        "Department of Clinical Pharmacology, Odense University Hospital, Odense, Denmark",
        "Department of Clinical Research, University of Southern Denmark, Odense, Denmark"
      ],
      "name": "Maria Lohman Obling"
    },
    {
      "affiliations": [
        "Department of Clinical Pharmacology, Odense University Hospital, Odense, Denmark",
        "Department of Clinical Research, University of Southern Denmark, Odense, Denmark"
      ],
      "name": "Lærke Karner Overgaard"
    },
    {
      "affiliations": [
        "Health Innovation Centre of Southern Denmark, Odense, Denmark"
      ],
      "name": "Caroline Strudwick"
    },
    {
      "affiliations": [
        "Department of Clinical Research, University of Southern Denmark, Odense, Denmark",
        "Department of Haematology, Odense University Hospital, Odense, Denmark"
      ],
      "name": "Hanne Vestergaard"
    },
    {
      "affiliations": [
        "Department of Clinical Pharmacology, Odense University Hospital, Odense, Denmark",
        "Department of Clinical Research, University of Southern Denmark, Odense, Denmark"
      ],
      "name": "Sidsel Arnspang Pedersen"
    }
  ],
  "title": "Redispensing oral anticancer drugs in Denmark (DANROAD): a national, multicentre, prospective implementation study protocol",
  "uid": "ac8e1513-f901-5081-b786-74708634d56d"
}