World Health Organization Guidelines

Ensuring Balance in National Policies on Controlled Substances, Guidance for Availability and Accessibility of Controlled Medicines

The WHO Policy Guidelines for Controlled Substances provide guidance on policies and legislation with regards to availability, accessibility, affordability and control of medicines made from substances regulated under the international drug control conventions, herein referred to as “controlled medicines”. Their scope encompasses “all controlled medicines”, but with a specific focus on essential medicines. Controlled medicines play an important role in several areas of medicine, including pain treatment, treatment of opioid dependence, emergency obstetrics, psychiatry and neurology. The availability, accessibility and affordability of controlled medicines are important issues for all countries, but problematic for most of them.

This book elaborates on the background and then provides 21 guidelines on various topics: content of drug control legislation and policy; authorities and their role in the system; policy planning for availability and accessibility; healthcare professionals; estimates and statistics; procurement; and nationally listed drugs. Each guideline has an elucidation and a description of the legal context. The Country Assessment Checklist enables the user to determine which guidelines still need to be worked on. A CD-ROM provides additional information.

Target audience: policy-makers, regulators (in government, administrative departments, national competent authorities) and politicians; academia and civil society; healthcare professionals and their organizations; individuals (including patients and their families) and organizations whose area of work or interest is drug control or public health.

The guidelines are endorsed by the International Narcotics Control Board. Endorsement by the United Nations Office on Drugs and Crime has been requested.

To learn more, read:  Ensuring Patient Access to Essential Medicines While Minimizing Harmful Use: a Revised WHO Tool to Improve National Drug Control Policy

This article summarizes each guideline and outlines the constituents who can actively participate in making controlled medicines available to the patients who need them.

The languages listed below are PDF versions.  Hard copies are available in English and French from: WHO Bookshop.  

Cover:  WHO Guidelines Armenian (1.36Mb) Bulgarian (704kb)
English (559kb) French (3.33Mb)
Georgian (1.30Mb) Greek (855kb)
Hungarian (860kb) Khmer (1.54Mb)
Polish (876kb) Russian (835kb)
Serbian (715kb) Slovak (871kb)
Slovenian (791kb) Turkish (912kb)