title: A novel drug management system in the Febuxostat versus Allopurinol Streamlined Trial: A description of a pharmacy system designed to supply medications directly to patients within a prospective multicenter randomised clinical trial.
abstract: Trials of investigational medicinal products are required to adhere to strict guidelines with regard to the handling and supply of medication. Information technology offers opportunities to approach clinical trial methodology in new ways. This report summarises a novel pharmacy system designed to supply trial medications directly to patients by post in the Febuxostat versus Allopurinol Streamlined Trial.
  
  
  
  A bespoke web-based software package was designed to facilitate the direct supply of trial medications to Febuxostat versus Allopurinol Streamlined Trial participants from a pharmacy based in the Medicines Monitoring Unit, University of Dundee.
  
  
  
  To date, 65,467 packs of medication have been dispensed using the system to 3978 patients. Up to 238 packs per day have been dispensed.
  
  
  
  The Medicines Monitoring Unit Febuxostat versus Allopurinol Streamlined Trial drug management system is an effective method of administering the complex drug supply requirements of a large-scale clinical trial with advantages over existing arrangements. A low rate of loss to follow-up in the Febuxostat versus Allopurinol Streamlined Trial may be attributable to the drug management system.
authors.affiliation: Medicines Monitoring Unit (MEMO) and Hypertension Research Centre, Division of Cardiovascular and Diabetes Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK arogers@dundee.ac.uk.
authors.forename: Amy
authors.initials: A
authors.lastname: Rogers
authors.affiliation: Medicines Monitoring Unit (MEMO) and Hypertension Research Centre, Division of Cardiovascular and Diabetes Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.
authors.forename: Robert Wv
authors.initials: RW
authors.lastname: Flynn
authors.affiliation: Medicines Monitoring Unit (MEMO) and Hypertension Research Centre, Division of Cardiovascular and Diabetes Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.
authors.forename: Patrick
authors.initials: P
authors.lastname: McDonnell
authors.affiliation: Medicines Monitoring Unit (MEMO) and Hypertension Research Centre, Division of Cardiovascular and Diabetes Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.
authors.forename: Isla S
authors.initials: IS
authors.lastname: Mackenzie
authors.affiliation: Medicines Monitoring Unit (MEMO) and Hypertension Research Centre, Division of Cardiovascular and Diabetes Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.
authors.forename: Thomas M
authors.initials: TM
authors.lastname: MacDonald
mesh_terms: D000493:Allopurinol / Q000627:therapeutic use; D000069465:Febuxostat / Q000627:therapeutic use; D006074:Gout Suppressants / Q000627:therapeutic use; D006801:Humans; D015337:Multicenter Studies as Topic; D010593:Pharmaceutical Services / Q000458:organization & administration*; D011177:Postal Service; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012984:Software
chemical_list: D006074:Gout Suppressants; D000069465:Febuxostat; D000493:Allopurinol
keywords: Clinical trials; Internet; drugs; investigational; pharmaceutical services; pharmacy