Page 137 WHO - Guidelines on the pharmacological treatment of persisting pain in children with medical illness

Under the Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol, the
quantity of controlled substances manufactured or imported into a country must not exceed the
official government estimates. Therefore, the submission of adequate estimates to the INCB is crucial
when importing controlled substances, as exporting countries will refuse to export additional narcotic
substances to a country that has used up the quantity it is allowed to import for the calendar year.

The responsibility for determining the amount of opioids needed to meet medical and scientific
requirements in a country rests entirely with the government, although the Board may examine the
estimates and request additional information and clarification. If countries fail to establish estimates
of annual narcotics requirements, the INCB determines them on their behalf. In such cases, the Board
informs the competent national authority of the country concerned of their estimates and requests the
authority to review them.

A6.6 the importance of reliable estimates

The World Health Organization and the International Narcotics Control Board are working on a joint
guide for estimating requirements for substances under international control. This is a particularly
important step in the supply cycle of opioid analgesics as it ensures the uninterrupted supply of these
essential medicines. Countries introducing or enlarging the coverage of pain relief services will need to
forecast adequately the quantities of opioid analgesics that will be increasingly supplied in the health
system.

If an annual estimate proves to be inadequate, the competent national authority can submit
supplementary estimates to the INCB at any time during the course of the year. However, the competent
national authority will be requested to provide an explanation of the circumstances necessitating
additional drug quantities. As far as possible, such supplementary estimates should only be used in the
case of unforeseen circumstances and for the introduction of new treatments (126).

The market availability of controlled substances is confined to the estimates submitted to the
INCB. Hence, it is crucial for managers and other parties concerned with the procurement of
strong opioids to be aware of national estimates for the relevant drugs. The Board publishes
changes in the estimates received from governments on a monthly basis on the Internet
(www.incb.org), or on a quarterly basis in the form of a hard copy technical report sent to
governments, as a guide to exporting countries.

A6.7 Domestic manufacture of strong opioid analgesics

After a country has received confirmation of its estimates from the INCB, it may start manufacturing
or importing procedures for opioid analgesics under Schedule I. The Single Convention requires
governments to license individuals and enterprises involved in the manufacture of opioid medicines.
In order to prevent the diversion of these strong opioids to illicit markets, manufacturers must make
resources available for record-keeping and security procedures, and for the provision of secure facilities
from the moment the raw materials are acquired until the finished products are distributed.

In addition, governments should assure the quality of the manufactured medicines, such as through
enforcing Good Manufacturing Practices, and the requirement of a market authorization by the national
medicines regulatory authority.

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