SECTION I - PURPOSE AND AUDIENCE

The purpose of these self-assessment Guidelines is to encourage governments to achieve better pain management by identifying and overcoming regulatory barriers to opioid availability.² These Guidelines may also be used to develop balanced national (including state, provincial or territorial authorities where relevant) drug control policies where none already exist. (See Annex 1 for definition of “national policy.”) “Balance” refers to the dual purpose of preventing illegal trafficking and diversion, while ensuring their availability for medical and scientific purposes, in particular for the treatment of pain and suffering (see Section VII for further discussion).

² There are three levels of barriers to adequate pain management: economic, medical and regulatory. While these Guidelines focus solely on regulatory issues, it is well understood that economic and medical barriers play major roles in the inadequate treatment of pain. For example, in some countries, for economic reasons, health care professionals are encouraged to use more expensive and less effective pharmaceutical products. This may exacerbate inadequate availability, both for the health care system in general, and for the individual patient. In some countries, scarce medical resources are spent on expensive curative treatments that are futile for patients with late-stage cancer (4). Such policies preclude the provision of palliative care. Finally, medical education that does not address pain management contributes to inadequate pain management.

This document is intended for those who make national drug control policy, as well as those who implement it. It may also be used by health care professionals and their organizations to encourage cooperation with governments and to facilitate further education.

This document accomplishes its purpose in several ways:

I. Background information is presented about the global problem of inadequate cancer pain relief (Section II);

II. Information is provided about why opioids (i.e., narcotic drugs, opiates³) are needed for the medical management of pain (Section III);

³ See Annex 1 for an explanation of “opiate” and “opioids,” and other key terms used in this publication.

III. Information is given about the inadequate availability of opioid analgesics in most countries (Section IV);

IV. The reasons for inadequate availability are given, with specific reference to the overly restrictive regulation of pain medications under some national drug control policies (Section V);

V. A rationale is presented for governments to assess national policies for balance (Section VI);

VI. The method that was used to develop guidelines for conducting a self-assessment is described (Section VII);

VII. The Guidelines are presented to encourage consensus in the adoption of balanced national drug control policy. They are based on international medical and regulatory consensus that national drug control policy should be balanced (Section IX);

VIII. A checklist of questions is provided to guide the self-assessment (Section X);

IX. Reference information is provided;

X. Ordering information for key resources is provided in Annex 2; and

XI. A directory of the government offices responsible for narcotic regulation (National Competent Authorities) is available from the INCB at the following:

website http://www.incb.org
telephone +43-1-26060-4277, facsimile +43-1-26060-5867/5868