Medicines: access to controlled medicines (narcotic and psychotropic substances)
- Psychotropic and narcotic substances must be available for medical use, for example, in treatment of pain, epilepsy, opioid dependence and use in emergency obstetric care, yet access to these and other controlled essential medicines is limited.
- Fear of abuse and dependence is a major factor limiting access to opioid analgesics. In practice, most patients do not become dependent from rational medical use of opioid medicines to relieve pain.
- Access to pain treatment increased over the past two decades, but only in a small number of countries. In 2003, six developed countries accounted for 79% of global morphine consumption, while developing countries accounted for just 6%.
- Only 2% of injecting drug users in developing countries receive treatment for opioid dependence with controlled medicines.
- About 90% of people with epilepsy in Africa go untreated with essential medicines including phenobarbital, a controlled substance.
- About 70 000 maternal deaths during childbirth could be prevented each year if treatment of post-partum bleeding by either oxytocin or ergometrine, a controlled medicine, was available.
Controlled medicines are medicines that have a therapeutic use, but that can also be subject to abuse through non-medical use. Controlled medicines are listed under the international conventions on narcotic and psychotropic substances.1 ,2 ,3 These conventions have been established to prevent abuse, dependence, harm and illicit drug trafficking, while recognizing the need to make psychotropic and narcotic substances available for medical and scientific use.
Access to controlled medicines: global situation
Some controlled medicines are identified by WHO as essential medicines, which address priority health care needs of the population.
Table: Examples of conditions treated using controlled, essential medicines
|Condition||Controlled essential medicine||Type of substance|
|Moderate to severe acute and chronic pain||Morphine||Narcotic|
|Opioid dependence (e.g. heroin dependence)||Methadone, buprenorphine||Narcotic, psychotropic|
|Epilepsy||Phenobarbital and Benzodiazepines||Psychotropic|
|Emergency obstetric care||Ergometrine and ephedrine||Precursor*|
|* Precursors are substances used in the production of psychotropic and narcotic drugs.|
Access to essential medicines that are controlled under the UN conventions is often limited, especially in developing countries.
Access to morphine – for pain treatment – has increased over the past two decades but only in a small number of countries. In 2003, six developed countries accounted for 79% of the total global morphine consumption, while developing countries, representing 80% of the world's population, accounted for just 6%.4
There are 16 million injecting drug users globally, of which 11 million inject heroin.5 In developing countries, only 2% of these users receive treatment with methadone or buprenorphine for opioid dependence.6
An estimated 75% of people with epilepsy in developing countries may not receive the treatment they need with essential medicines including controlled medicines. In Africa, 90% of people with epilepsy go untreated with essential medicines including phenobarbital, in part because it is a controlled medicine.
Postpartum bleeding results in 132 000 maternal deaths every year. Use of oxytocin and ergometrine, a controlled medicine, immediately after the delivery of the baby reduces the risk of severe postpartum bleeding by more than half.
Barriers to access
Balanced access to controlled medicines is needed to maximize availability for safe and rational use to treat medical conditions while minimizing availability for abuse and dependence.
Barriers to accessing controlled medicines include:
- Limited medical knowledge.
- Overly restrictive regulations and lack of enabling policies.
- Supply challenges.
1. Limited medical knowledge. In many parts of the world, medical schools do not teach rational use of opioid medicines. Without correct information, health professionals and patient families often avoid using opioid analgesics, such as morphine, to relieve pain. For example, fear of abuse and dependence have been main reasons for limiting access to controlled medicines, in particular opioid analgesics. In practice, however, most people do not become dependent from rational medical use of opioid medicines to relieve pain.
2. Overly restrictive regulations and lack of enabling policies. National legislation in many countries includes provisions beyond the requirements of the international drug conventions, making it difficult to access controlled essential medicines in the health system. Several countries make importation, storage, distribution and dispensing of controlled medicines more restrictive than requested by the conventions.
For example, controlled anti-epileptic medicines are often unduly restricted in their use for fear of abuse and diversion to the illicit drug market. And while the use of methadone and buprenorphine have proven to be effective in treating opioid dependence, the criminalization of injecting drug users is heavily affecting the provision of such treatment to people in need in several countries.
3. Supply challenges. Countries must provide detailed annual estimates and reports for narcotic substances to the International Narcotic Control Board to procure or produce controlled medicines. Formulating reliable estimates is often a barrier to accessing controlled medicines. In addition, procurement of both narcotic and psychotropic substances is subject to a complex exportation and importation system of licenses and certificates, which can be a lengthy process and difficult to handle.
In response to the World Health Assembly and the United Nations' Economic and Social Council requests in 20057 , WHO developed the Access to Controlled Medications Programme (ACMP) in consultation with the International Narcotics Control Board (INCB) and a number of nongovernmental organizations.
The Access to Controlled Medications Programme aims to improve access to controlled medicines by addressing legislative, administrative, policy, supply and educational issues that act as barriers to access to these essential medicines.
The Programme’s work involves:
- raising awareness about the problems of access to these medicines;
- developing treatment guidelines including pain guidelines;
- updating policy guidelines on how to achieve balance between control of substance abuse and access to essential controlled medicines;
- optimizing methods and tools to estimate countries’ needs for opioid medicines such as morphine and methadone.
1. United Nations single convention on narcotic drugs, 1961.
2. United Nations convention on psychotropic substances, 1971.
3. United Nations convention against illicit traffic in narcotic drugs and psychotropic substances, 1988.
4. International Control Narcotic Board. The report of the International Control Narcotic Board for 2004, New York, United Nations, 2005.
5. UNODC World Drug Report 2007. Reference quoted in the 2009 WHO Guidelines for psychologically assisted pharmacological treatment of opioid dependence.
6. Harm reduction developments, Open Society Institute-International Harm Reduction Association, New York, 2008
7. By the UN Economic and Social Council (ECOSOC) resolution 2005/25 and the World Health Assembly (WHA) resolution WHA 58.22.