New guideline calls for improved global access to controlled medicines
The World Health Organization (WHO) has released a rapid communication outlining its new guideline on balanced national policies for controlled medicines. The guideline was officially presented during a high-level side event at the Seventy-eighth World Health Assembly. It is designed to support countries in ensuring safe, equitable and affordable access to essential controlled medicines which are critical for treating acute and chronic pain, mental health conditions, substance use disorders and other serious health issues.
Controlled medicines, such as opioids, benzodiazepines, barbiturates, amphetamines and dissociative anaesthetics like ketamine, are drugs that have authorized use for medical or scientific purposes. They should be used under careful regulation as they have properties that can increase health risks if used for non-medical purposes and they can be associated with drug use disorders and drug dependence, unless rational use is ensured. But they also have essential life-improving properties, reducing suffering and improving health and well-being when used appropriately for treating specific medical conditions.
However, the majority of the world's population lives in countries with limited or no access to affordable, quality-assured controlled medicines, even when they are proven to be safe and effective for treatment. And there is a major access and equity gap; for example, in 2021, over 80% of the world's morphine was distributed to high-income countries, which leaves out 5.5 million terminal cancer patients and millions of others suffering from acute illness and end-of-life suffering in low- and middle-income countries (LMICs). Studies show that 75% of people living with epilepsy in LMICs do not receive treatment.
The updated WHO guideline offers a clear roadmap for Member States to develop and implement balanced national policies that support the medical and scientific use of controlled medicines while protecting individuals and communities from the risks associated with non-medical use.
Key highlights include:
- ensuring accurate and timely quantification of controlled medicines based on current consumption and projected needs;
- banning misleading and unethical marketing practices;
- strengthening procurement and supply chain systems using appropriate tools and technologies to enhance traceability, reduce stockouts and waste, and ensure equitable distribution;
- enabling local production where feasible;
- facilitating continuous access to opioid agonist treatment in all clinically needed settings; and
- promoting robust training for health-care professionals and public education campaigns for safe, informed use.
The rapid communication announced today will be followed by the full document of the "WHO guideline on balanced national controlled medicines policies to ensure medical access and safety" to be released online in June 2025.
