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Context: 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., Objectives: 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., Conclusion: 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., (Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)