This section presents the Guidelines and provides additional documentation and guidance from authoritative sources. Six of the guidelines relate to national laws and regulations; ten guidelines relate to administrative policies, directives and practices that implement national laws and regulations. Where possible, results from the 1995 INCB survey (3) were used to describe what is known about the status of governments' policies in relation to the Guidelines. The Self-Assessment Checklist in Section X may be used as a practical guide to accomplish the evaluation. (See Annex 3 for a summary of the Guidelines.)

Guideline 1: Governments should examine their drug control policies for the presence of overly restrictive provisions that may impact their health care system in the delivery of pain relief, and take corrective action as needed.

In 1989, the INCB (9) stated that governments should:

"...examine the extent to which their health-care systems and laws and regulations permit the use of opiates for medical purposes, identify possible impediments to such use and develop plans of action to facilitate the supply and availability of opiates for all appropriate indications" (p. 17).

In 1995, an INCB survey (3) found that 57% of responding governments had examined whether there were factors in their health care systems and laws and regulations that impeded the use of opiates for medical purposes.

In response to this finding, the INCB (3) recommended in its 1995 report:

"Governments that have not done so should determine whether there are undue restrictions in national narcotics laws, regulations or administrative policies that impede prescribing, dispensing or needed medical treatment of patients with narcotic drugs, or their availability and distribution for such purposes, and should make the necessary adjustments" (p. 15).

The INCB (3) clearly recognized the limited resources that some countries face, when it stated in 1995 that:

"...less developed countries have more difficulty meeting basic health-care needs. Nevertheless, the Board encourages governments of such countries to make efforts to examine their medical needs for narcotic drugs as well as the impediments to their availability, to advise the Board of the results of those efforts and to inform the Board if it can be of assistance" (p. 14).

Guideline 2: National drug control policies should recognize that opioids are absolutely necessary for medical care, in particular for relief of pain and suffering.

The 1995 INCB report (3) found that 48% of responding governments reported that their laws recognize that narcotic drugs were indispensable for the relief of pain and suffering.

The Preamble to the 1961 Convention (16) recognizes that:

"...the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering..."

In its 1995 report, the INCB (3) stated that:

"Governments should determine whether their national narcotic laws contain elements of the 1961 Convention and the 1972 Protocol that take into account the fact that the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering..." (p. 16).

Guideline 3: National drug control policies should recognize the obligation of governments to ensure adequate opioid availability for all medical and scientific needs.

The 1995 INCB report (3) found that 63% of responding governments said that there was a provision recognizing the obligation of the national government to ensure availability of narcotic drugs for medical purposes.

The 1961 Convention (16), Article 4, declares that:

"the Parties [national governments] shall take such legislative and administrative measures as may be necessary...to limit exclusively to medical and scientific purposes the production, manufacture...distribution...and possession of drugs..."

Likewise, the INCB report (3) recommended in 1995:

"Governments should determine whether their national narcotic laws contain elements of the 1961 Convention and the 1972 Protocol that take into account...the fact that adequate provision must be made to ensure the availability of narcotic drugs for such purposes..." (p. 16).

Guideline 4: Governments should designate an authority for ensuring adequate availability of opioids for medical care.

The INCB (3) recommended in 1995 that:

"Governments should...take into account...the fact that adequate provision must be made to ensure the availability of narcotic drugs for such purposes...[and] that administrative responsibility has been established and that personnel are available for the implementation of those laws" (p. 16).

Guideline 5: Governments should develop, using information from relevant sources, a practical method to estimate realistically the medical and scientific needs for opioids.

In 1995, the INCB survey (3) showed that 59% of responding governments had not critically examined their methods for assessing medical need for opiates.

In 1995, the INCB report (3) recommended that:

"Governments and the [International Narcotics Control] Board need to have accurate information about medical needs for narcotic drugs. In the case of narcotic drugs that are opiates, it is particularly important to accurately estimate all medical needs because the Board must make arrangements well in advance to cultivate a sufficient quantity of poppy plants. In making these decisions, the Board considers a number of factors, including recent consumption trends, Governments' estimates of future medical needs, trends in health problems that could affect the amount needed in the future, as well as actions being planned by Governments and others to better address those problems" (p. 1).

"Governments should establish a system to collect information from medical facilities that care for surgical, cancer and other patients, from organizations that are working to improve the rational use of narcotic drugs and from manufacturers, distributors, exporters and importers and should establish groups of knowledgeable individuals to assist in obtaining information about changing medical needs" (p. 15-16).

Article 19, paragraph 4 of the 1961 Convention (16) states:

"The Parties shall inform the Board of the method used for determining quantities shown in the estimates and of any changes in the said method."

The participants of the WHO Meeting on the Comprehensive Management of Cancer Pain (6) in 1986 suggested:

"Governments should encourage health care workers to report to the appropriate authorities any instance in which oral opioids are not available for cancer patients who need them" (p. 36).

Guideline 6: Governments should furnish to the INCB annual estimates of the quantities of narcotic drugs needed for medical and scientific purposes for the following year.

Article 19, paragraph 1 of the 1961 Convention (16) states:

"The Parties shall furnish to the Board each year for each of their territories, in the manner and form prescribed by the Board, estimates on forms supplied by it in respect of the following matters: (a) Quantities of drugs to be consumed for medical and scientific purposes; (b) Quantities of drugs to be utilized for the manufacture of other drugs, of preparations in Schedule III, and of substances not covered by this Convention; (c) Stocks of drugs to be held as at 31 December of the year to which the estimates relate..."

Article 12, paragraph 3 of the 1961 Convention (16) states:

"If any State fails to furnish estimates in respect of any of its territories by the date specified, the Board shall, as far as possible, establish the estimates. The Board in establishing such estimates shall to the extent practicable do so in co-operation with the Government concerned."

The 1995 INCB report (3) recommended that:

"Governments submit annually to the Board official estimates of the next year's requirements for narcotic drugs... In 1989, the Board requested Governments to critically examine their methods of assessing domestic medical need and to make the changes required to ensure that future estimates would accurately reflect the medical need...If past consumption trends for narcotic drugs are stable, future needs can be estimated by averaging the amounts consumed in recent years and adding a margin for unforeseeable increases. If medical demand for one or more narcotic drugs is increasing in response to unmet needs, the method of estimation should take into account the extent of unmet needs and the potential effects on future demand of efforts to improve the rational use of narcotic drugs" (p. 8).

"To implement these responsibilities, Governments enact laws and take administrative and enforcement measures. Each Government estimates annually the amount of narcotic drugs that will be needed to satisfy all medical and scientific requirements in the country for the next year. The International Narcotics Control Board evaluates, confirms and publishes the amount of narcotic drugs for each Government. Each Government may then manufacture or import narcotic drugs within that amount, and distribute them to medical facilities for the treatment of patients" (p. 1).

In assessing their annual estimates for opioids, governments should take into account past consumption trends and anticipate future demand by increasing their estimates as suggested by INCB to sufficiently cover their actual needs. The INCB (3) recommends that governments increase their estimates of requirements of narcotic drugs from year to year to allow for the possibility of increased consumption that may be due to education and heightened awareness. In countries or territories where there is rapid economic and social development, or where present consumption is low due to inadequate pain management, or where there is recent expansion of pain relief programmes, subsequent increases in the annual estimate may be expected to be relatively higher than in other countries:

"Governments should add to their annual estimates of requirements for narcotic drugs a margin of 10 per cent to allow for the possibility of increased consumption... and, if need be, should add an even greater margin in countries or territories where there is rapid economic and social development" (p. 16).

Guideline 7: Governments should furnish a supplementary estimate to the INCB if it appears that the availability of narcotic drugs will fall short of medical needs, or to meet emergency needs or exceptional medical demand.

In 1995, an INCB survey (3) showed that 60% of responding governments had submitted supplementary estimates to the Board because of unforeseen increases in medical need. When furnishing a supplementary estimate, governments should always include an explanation of the circumstances necessitating the increase. Although supplementary estimates should not become a common practice, it is recommended that supplementary estimates be furnished by the Competent Authority and communicated via facsimile to the Board in order to act expeditiously on these requests.

In 1998, the WHO Expert Committee on the Use of Essential Drugs (7) stated:

"Following the recommendation of the Committee at its previous meeting, endorsed subsequently by the International Narcotics Control Board, an international consensus was established at the United Nations Commission on Narcotic Drugs in 1996 on the application of simplified control measures to permit the use of morphine in emergency situations. On the basis of this consensus, WHO has developed model guidelines on the simplified control procedures and distributed them to national drug regulatory authorities" (p. 57).

In 1995, the INCB (3) stated:

"If there are unforeseen increases in medical demand, Governments may submit supplementary estimates to the Board at any time. Requests for supplementary estimates are acted on expeditiously" (p. 1).

"If medical demand exceeds the estimates, governments may submit supplementary estimates at any time; these are examined and confirmed expeditiously by the Board. In recent years, the number of supplementary estimates has increased significantly" (p. 8).

Article 12, paragraph 5 of the 1961 Single Convention (16) declares:

"The Board, with a view to limiting the use and distribution of drugs to an adequate amount required for medical and scientific purposes and to ensuring their availability for such purposes, shall as expeditiously as possible confirm the estimates, including supplementary estimates, or, with the consent of the Government concerned, may amend such estimates."

Article 21, paragraph 4 (b) of the 1961 Convention (16) states that:

"...Parties shall not during the year in question authorize any further exports of the drug concerned to that country or territory, except: (i) In the event of a supplementary estimate being furnished for that country or territory in respect both of any quantity over- imported and of the additional quantity required, or (ii) In exceptional cases where the export, in the opinion of the Government of the exporting country, is essential for the treatment of the sick."

Guideline 8: Governments should submit annual statistical reports to the INCB on the production, manufacture, trade, use and stocks of narcotic drugs.

Article 20, paragraph 1 of the 1961 Convention (16) declares:

"The Parties shall furnish to the Board for each of their territories, in the manner and form prescribed by the Board, statistical returns on forms supplied by it in respect of the following matters: (a) Production or manufacture of drugs; (b) Utilization of drugs for the manufacture of other drugs, of preparations in Schedule III and of substances not covered by this Convention, and utilization of poppy straw for the manufacture of drugs; (c) Consumption of drugs; (d) Imports and exports of drugs and poppy straw; (e) Seizures of drugs and disposal thereof; (f) Stocks of drugs as at 31 December of the year to which the returns relate; and (g) Ascertainable area of cultivation of the opium poppy."

Guideline 9: Governments should establish a dialogue with health care professionals about the legal requirements for prescribing and dispensing narcotic drugs.

In 1995, an INCB survey (3) of impediments to opioid availability identified health care professionals' fear of legal sanctions as a significant impediment. Specifically, the reluctance to prescribe or stock opiates was attributed to concerns about legal sanctions; this was the third most-frequently ranked impediment (47% of respondents).

In 1989, the INCB (9) recommended that:

"Health professionals... should be able to...[provide opiates]...without unnecessary fear of sanctions for unintended violations...[including]...legal action for technical violations of the law...[that]...may tend to inhibit the prescribing or dispensing of opiates" (p. 15).

The INCB report (3) further suggested in 1995:

"Governments should communicate with health professionals about the legal requirements for prescribing and dispensing narcotic drugs and should provide an opportunity to discuss mutual concerns" (p. 16).

In 1990, the WHO Expert Committee on Cancer Pain Relief and Active Supportive Care (4) recognized that:

"Health care workers may be reluctant to prescribe, stock or dispense opioids if they feel that there is a possibility of their professional licenses being suspended or revoked by the governing authority in cases where large quantities of opioids are provided to an individual, even though the medical need for such drugs can be proved" (p. 39).

Then, in 1996, the WHO Expert Committee on Cancer Pain Relief and Active Supportive Care (5) stated:

"It is understood that regulatory requirements for physicians, nurses and pharmacists to dispense opioids to patients will differ from country to country. However, the following are general guidelines that can be used to develop a practical system.

Legal authority: Physicians, nurses and pharmacists should be legally empowered to prescribe, dispense and administer opioids to patients in accordance with local needs.

Accountability: They must dispense opioids for medical purposes only and must be held responsible in law if they dispense them for non-medical purposes. Appropriate records must be kept. If physicians are required to keep records other than those associated with good medical practice, the extra work incurred should be practicable and should not impede medical activities. Hospitals and pharmacists must be legally responsible for safe storage and the recording of opioids received and dispensed. Reasonable record keeping and accountability provisions should not discourage health care workers from prescribing or stocking adequate supplies of opioids" (p. 57-58).

Likewise, health care professionals are encouraged to establish a dialogue with governments. In 1995, the INCB (3) stated:

"Educational institutions and non-governmental health-care organizations, including the International Association for the Study of Pain and other health-care representatives, should establish ongoing communication with Governments about national requirements for the medical use of narcotic drugs, unmet needs for narcotic drugs and impediments to the availability of narcotic drugs for medical purposes" (p. 18).

Guideline 10: National drug control authorities and health care professionals should cooperate to ensure the availability of opioid analgesics for medical and scientific purposes, including for the relief of pain.

The INCB and the WHO have made several recommendations that necessitate exchange of information and communication between regulators and health care professionals. The WHO Expert Committee on Cancer Pain Relief and Active Supportive Care (5) found in 1996 that:

"Communication between health workers and drug regulators is essential in order to ensure that each understands the other's aims. It is important for pain management experts and medical associations to understand about the national estimate of opioid needs, and be aware of the concerns of regulators. Opioid abuse is a reality, and health care workers must cooperate in the campaign to prevent diversion. It is also important for regulators to learn about the importance of pain relief both for individual patients and for public health in general. Information about cancer pain, where and how cancer patients are treated, and the training of health care personnel will help regulators whose job it is to ensure the integrity of the distribution system. The knowledge that opioid use needs to increase will help regulators to make appropriate changes in the annual estimate"(p. 49).

The INCB (3) has recommended several subject areas that should be the focus of the communication between regulators and health professionals:

"Governments should establish a system to collect information from medical facilities that care for surgical, cancer and other patients, from organizations that are working to improve the rational use of narcotic drugs and from manufacturers, distributors, exporters and importers and should establish groups of knowledgeable individuals to assist in obtaining information about changing medical needs" (p. 15-16).

"Governments should inform health professionals about the WHO analgesic method for cancer pain relief" (p. 16).

"Governments should communicate with health professionals about the legal requirements for prescribing and dispensing narcotic drugs and should provide an opportunity to discuss mutual concerns" (p. 16).

"Educational institutions and non-governmental health-care organizations, including the International Association for the Study of Pain and other health-care representatives, should teach students in health-care professions and licensed practitioners about the rational use of narcotic drugs, their adequate control and the correct use of terms related to dependence...[and]...should establish ongoing communication with Governments about national requirements for the medical use of narcotic drugs, unmet needs for narcotic drugs and impediments to the availability of narcotic drugs for medical purposes" (p. 18).

From time to time, physicians may be pressured to provide controlled substances for persons who are not their patients, or for other than legitimate medical purposes. Such

pressure may pose a threat to the safety and security of medical practitioners. Succumbing to such pressure is also illegal and unethical medical practice. Thus, one area of cooperation between governments and national medical associations should be to recognize such pressures if they exist, address the source of such pressure, and devise ways to support physicians to resist such pressures.

In 1986, the World Medical Association (17) declared:

"Physicians must have the professional freedom to care for their patients without interference. The exercise of the physician's professional judgement and discretion in making clinical and ethical decisions in the care and treatment of patients must be preserved and protected" (p. 1).

Guideline 11: Governments should ensure, in cooperation with licensees, that the procurement, manufacture, and distribution of opioid medications are accomplished in a timely manner so that there are no shortages of supply, and that such medications are always available to patients when they are needed.

In some instances, even in the absence of any specific regulatory impediments in national drug control policy, the process by which a country procures and/or distributes opioid medications may prevent an adequate supply of medication from reaching the patient. The WHO and the INCB have addressed this situation.

In 1986, the participants of the WHO Meeting on the Comprehensive Management of Cancer Pain (6) found that:

"There is a lack of flexibility in existing drug distribution systems that prevents a wider variety of professional health care workers from prescribing and/or distributing drugs for relief of cancer pain" (p. 29).

"The proliferation of national laws and/or administrative measures regulating the prescription and distribution of opioid drugs necessary for cancer pain relief has hindered access by patients to these drugs" (p. 28).

In 1990, the WHO Expert Committee on Cancer Pain Relief and Active Supportive Care (4) declared:

"Manufacturers and/or distributors should be empowered to import, manufacture, stock and distribute opioids in keeping with the international drug conventions and good medical practice" (p. 39).

In 1996, the WHO Expert Committee on Cancer Pain Relief and Active Supportive Care (5) stated:

"After the estimate has been confirmed by the INCB, a country may either import or manufacture opioids. In both cases, the participants in the distribution chain should endeavour to ensure that the supply is reliable. Interruptions in the distribution of opioids is distressing for both patients and families and must be avoided" (p. 50).

In 1995, the INCB report (3) recommended that:

"Governments that have not done so should determine whether there are undue restrictions in national narcotics laws, regulations or administrative policies that impede prescribing, dispensing or needed medical treatment of patients with narcotic drugs, or their availability and distribution for such purposes, and should make the necessary adjustments (Emphasis added)" (p. 15).

"Governments that experience interruptions in supply of narcotic drugs because of delays in importation or for other reasons should examine the situation and develop a system to accomplish in a timely manner the steps involved, such as issuing licences, arranging for payment, carrying out paperwork, transporting the drugs, taking the drugs through customs and distributing the drugs to medical facilities" (p. 16).

Guideline 12: Governments should permit and encourage the distribution and availability of opioid medications throughout the country, in order to maximize physical access of patients to pain relief medications while maintaining adequate controls to prevent diversion and abuse.

The WHO Expert Committee on Cancer Pain Relief and Active Supportive Care (4) found in 1990 that:

"It is usually in the patient's best interest to return home if adequate health care support is available: discharge from an institution enhances the patient's autonomy and therefore self-esteem" (p. 56).

In 1996, the WHO Expert Committee on Cancer Pain Relief and Active Supportive Care (5) further clarified that:

"Opioids should be available in locations that will be accessible to as many cancer patients as possible" (p. 58).

Guideline 13: Governments should establish and promote a national cancer control programme that includes cancer pain relief and palliative care as a priority for health care resources, including education about the WHO Analgesic Method and provision of pain relief and palliative care.

A 1995 INCB survey (3) found that 65% of responding governments reported that they had issued national polices and guidelines to improve the medical use of opioid analgesics for a range of medical conditions, including for pain. In addition, 52% of the governments said that they had sponsored, supported, or endorsed educational programmes in their countries to improve the medical use of opioids. Sixty percent said that they had endorsed the WHO Analgesic Method.

The WHO Expert Committee on Cancer Pain Relief and Active Supportive Care (4) in 1990 recommended the following:

"Governments should establish national policies and programmes for cancer pain relief and palliative care...[and] ensure that cancer pain relief and palliative care programmes are incorporated into their existing health care systems: separate systems of care are neither necessary nor desirable...[and that] health care workers (physicians, nurses, pharmacists, or other categories appropriate to local needs) are adequately trained in palliative care and the relief of cancer pain...[and] review their national health policies to ensure that equitable support is provided for programmes of palliative care in the home..." (p. 65).

In 1995, the World Health Organization guideline on "National Cancer Control Programmes" (18) stated:

"Most cancer in the world is incurable when diagnosed. Even in the developed countries, where prolonged survival has been achieved in a substantial proportion of cases, 50% of cancer patients will die of their disease. Palliative care therefore deserves high priority in cancer therapy, and will be required in 80% of cases in some countries. The relative simplicity and inexpensiveness of palliative care justify considerable attention being given to that aspect of cancer control worldwide" (p. 82).

The 1995 INCB report (3) found that:

"Governments should inform health professionals about the WHO analgesic method for cancer pain relief" (p. 16).

Guideline 14: Terminology in national drug control policy should not have the potential to confuse the medical use of opioids for pain with drug abuse or drug dependence.

According to a survey of governments conducted by the INCB (3), the impediment to improving availability and use of opioids most frequently identified by government drug control agencies was concern about drug abuse (72%). Furthermore, 54% of the governments indicated that their narcotic law defined addiction or drug dependence, and 43% required patients who received opioid prescriptions to be reported to the government. Section V describes terminological problems and clarifies in detail the meaning of these key terms.

Guideline 15: In their efforts to prevent diversion, governments should avoid undue restrictions impacting on patient care decisions which are ordinarily medical in nature. Such decisions as the amount of drug prescribed and duration of treatment should be made by the physician and be based on individual patient needs.

A 1995 INCB survey (3) found that, for hospital patients, 60% of the responding governments did not set a maximum amount, and 80% did not set a maximum length of time for which opioids could be prescribed at one time. For patients who live at home, 49% of responding governments did not set a maximum quantity, and 72% did not set a maximum length of time, for which morphine could be prescribed.

The WHO Expert Committee on Cancer Pain Relief and Active Supportive Care (5) found in 1996 that:

"Medical decisions: Decisions concerning the type of drug to be used, the amount of the prescription and the duration of therapy are best made by medical professionals on the basis of the individual needs of each patient, and not by regulation" (p. 58).

Guideline 16: National drug control policy should avoid prescription requirements that may unduly restrict physician and patient access to pain relief.

A 1995 INCB survey (3) found that 35% of responding governments reported that special government prescription forms were not necessary for a physician to prescribe morphine. For example, some governments require physicians to use complicated prescription forms with several parts that need to be completed separately and which are available in limited quantity and from few places in the country.

Article 30, paragraph 2 (b) of the 1961 Convention (16) declares:

"[Governments shall]...(i) Require medical prescriptions for the supply or dispensation of drugs to individuals. This requirement need not apply to such drugs as individuals may lawfully obtain, use, dispense or administer in connection with their duly authorized therapeutic functions; and (ii) If the Parties deem these measures necessary or desirable, require that prescriptions for drugs in Schedule I should be written on official forms to be issued in the form of counterfoil books by the competent governmental authorities or by authorized professional associations."

The WHO Expert Committee on Cancer Pain Relief and Active Supportive Care (4) recommended in 1990 that:

"Record-keeping and authorization requirements should not be such that, for all practical purposes, they eliminate the availability of opioids for medical purposes. Multiple-copy prescription programmes are cited as means of reducing careless prescribing and 'multiple doctoring' (patients registering with several medical practitioners in order to obtain several prescriptions for the same, or similar, drugs). There is some justification for this, but the extent to which these programmes restrict or inhibit the prescribing of opioids to patients who need them should also be questioned" (p. 39).