title: Consensus building on access to controlled medicines: a four-stage Delphi consensus procedure.
abstract: BACKGROUND
  In 2011, the World Health Organization (WHO) published the policy guidelines Ensuring Balance in National Controlled Substances Policies-Guidance for Availability and Accessibility of Controlled Medicines, presenting a revised version of the previous guidelines from 2000.
  
  
  OBJECTIVE
  To describe the consensus process that guided the revision of the guidelines.
  
  
  METHODS
  A four-stage revision process was undertaken with a panel of 29 international experts from palliative care, public health, and harm reduction: 1) a qualitative inventory of required changes by means of a structured checklist, 2) & 3) a two-round online consensus Delphi process about the draft revision of the guidelines, and 4) a WHO advisory meeting for the discussion of remaining controversies and final issues.
  
  
  RESULTS
  The qualitative inventory resulted in a draft revision of the guidelines meeting requirements on different levels, such as a broader focus and more accurate evidence. Operationalization of the guidelines was improved by specifying measures, procedures, and responsibilities. The Delphi procedure provided concrete indications for the rewording of both the guidelines and the associated text. During the advisory meeting, any persistent disagreements were systematically discussed to achieve consensus on the new version of the guidelines.
  
  
  CONCLUSIONS
  The four-stage multimethod consensus process resulted in a substantial revision to the WHO guidelines. This takes into account the increase in knowledge about opioid medication since the first edition of the guidelines. Disagreement emerging from the process underlines the complexity of preparing guidance because of the delicate balance between need and control.
authors.affiliation: Department of Palliative Medicine, University Hospital Bonn, Bonn, Germany. Electronic address: saskia.juenger@ukb.uni-bonn.de.
authors.forename: Saskia
authors.initials: S
authors.lastname: Jünger
authors.forename: Sarah
authors.initials: S
authors.lastname: Brearley
authors.forename: Sheila
authors.initials: S
authors.lastname: Payne
authors.forename: Aukje K
authors.initials: AK
authors.lastname: Mantel-Teeuwisse
authors.forename: Thomas
authors.initials: T
authors.lastname: Lynch
authors.forename: Willem
authors.initials: W
authors.lastname: Scholten
authors.forename: Lukas
authors.initials: L
authors.lastname: Radbruch
mesh_terms: D000701:Analgesics, Opioid / Q000592:standards*; D003697:Delphi Technique; D004335:Drug and Narcotic Control; D019317:Evidence-Based Medicine; D038622:Internationality; D017410:Practice Guidelines as Topic; D014944:World Health Organization
chemical_list: D000701:Analgesics, Opioid
keywords: Access to controlled medicines; Delphi method; Single Convention on Narcotic Drugs; World Health Organization; consensus process; pharmaceutical policy; policy guidelines