Page 135 WHO - Guidelines on the pharmacological treatment of persisting pain in children with medical illness

A6.2 the single convention on narcotic Drugs and

opioid analgesics

The Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol (94) is the principal
international treaty regulating the control of opioids. It seeks to limit the production, manufacture,
exportation, importation, distribution, trade, use and possession of narcotic drugs exclusively to
medical and scientific purposes. The Single Convention distinguishes among four types of classification:
Schedule I, Schedule II, Schedule III and Schedule IV. Each schedule refers to a number of control
measures to be applied according to the gravity of drug abuse and dependence produced by the listed
substances.

Morphine and the other strong opioids considered for safe switching in children with persisting pain
(fentanyl, hydromorphone, oxycodone and methadone) are listed under Schedule I. In order to comply
with the Single Convention, countries should take the following measures for narcotic substances listed
under Schedule I:
• estimate the annual medical and scientific requirements and submit their estimates to the INCB for
confirmation;
• limit the total quantities manufactured and imported to the estimates, taking into account the
quantity exported;
• ensure they remain in the hands of licensed parties for trade and distribution within the country;
• require a medical prescription be dispensed for their use;
• report to the INCB on the amount imported, exported, manufactured, consumed and on the stocks
held;
• maintain a system of inspection of manufacturers, exporters, importers, and wholesale and retail
distributors of narcotic drugs, and of medical and scientific institutions that use such substances; and
ensure premises, stocks and records are inspected;
• take steps to prevent the diversion and abuse of these substances.

The Single Convention states in its preamble: “recognizing that the medical use of narcotic drugs
continues to be indispensable for the relief of pain and suffering and that adequate provision must be
made to ensure the availability of narcotic drugs for such purposes.” Thus, this puts an obligation on
the countries that are Parties to the international conventions to ensure the medical availability of the
controlled substances.

A6.3 Drug misuse versus patient need

The Single Convention recognizes that governments have the right to impose further restrictions, if they
consider it necessary, to prevent diversion and misuse of opioids. However, this right must be continually
balanced against the responsibility to ensure opioid availability for medical purposes.

In deciding the appropriate level of regulation, governments should bear in mind the dual aims of the
Single Convention. The INCB has observed that, in some countries, fear of drug misuse has resulted in
laws and regulations, or interpretations of laws and regulations, which make it unnecessarily difficult to
obtain opioids for medical use:

… prevention of availability of many opiates for licit use does not necessarily guarantee the
prevention of the abuse of illicitly procured opiates. Thus, an overly restrictive approach to the licit
availability of opiates may, in the end, merely result in depriving a majority of the population of
access to opiate medications for licit purposes. (122)

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