A question of balance: the overconsumption and unavailability of internationally controlled drugs

Ensuring the use of controlled drugs for medical and scientific purposes

Narcotic drugs such as cocaine, opium and heroin were appreciated and enthusiastically applied worldwide in medicine until their addictive properties and therapeutic limitations in wide-scale application were recognized. It was soon universally accepted that the health and social risks that such drugs posed to individual consumers and society largely outweighed the benefits derived from their medical use. Manufacture of and international trading in those drugs became subject to national and international regulation.

As the global regulatory system received wide acceptance, manufacture of and trading in many drugs with a high dependence potential, such as opium and cocaine, for medical purposes quickly diminished. Yet, in the absence of perfect alternatives, many less-than-ideal narcotic drugs and psychotropic substances continue to be used today as pharmaceuticals for the treatment of diseases and the alleviation of pain and other forms of human suffering. Ensuring adequate availability, under regulated conditions, for medical purposes is an important task of government authorities. Controlled drugs must also be available for scientific purposes to permit research on safer drugs for the same and related purposes.

Although unavailability of drugs may deprive patients of their fundamental rights and the opportunity for relief from pain, excessive availability of drugs may result in the diversion of such drugs to illicit trafficking and drug abuse, leading to drug dependence, and may thus cause unnecessary suffering.

The synergy produced by easy availability, inappropriate use of controlled medicinal drugs and spreading illicit consumption of drugs is well documented. Drug abuse has reached significant levels in the past as a result of unregulated, medically inappropriate consumption of controlled drugs. In many countries, both developed and developing, Governments have been extending control to an increasing number of psychotropic substances used for medical purposes since 1971.

National regulatory controls and the international control system have been applied more consistently and more universally during the last two decades and have thus become more effective. Those achievements have to be maintained and bettered in the future.

Governments, in cooperation with the International Narcotics Control Board, therefore have to monitor closely the supply of and demand for such drugs. In its report for 1999, the Board reviewed the adequacy of the supply of controlled drugs for the relief of pain and suffering. The Board noted with concern the continuing global disparities in the actual availability and the unjustifiable discrepancies in the consumption of important licit narcotic drugs and psychotropic substances in different regions.

Unlimited or excessive availability and inappropriate or non-medical use of controlled drugs are as much of a concern to the Board as insufficient supply. On the basis of its previous reviews, the Board considers that there is sufficient reason to believe that unregulated, excessive drug supply and consumption trends in certain countries may be continuing and that new problems may be developing.

Medical requirements and availability: two variables to be assessed and adjusted

The national supply of drugs in general should correspond to medical (and scientific) needs as closely as possible and, therefore, it is important to assess those needs as accurately as possible. For narcotic drugs and psychotropic substances, a close balance is even more important given their abuse potential and the risk that they may be diverted into illicit markets. Figures for global consumption of licit drugs show that the bulk of the medicine continues to be consumed in a handful of countries, and the proportion is even higher for narcotic drugs and psychotropic substances. Economically weak countries and the poorer segments of society continue to have little or no access to medicines and medical care, and the treaty system can do little in this respect.

Most developing countries lack the resources and expertise required for determining medical needs and adjusting drug supply to meet those needs. Medical practice shows undesirably large variations attributable to a chronic shortage of staff and inadequate training and information. At the same time, experience shows that the actual availability of drugs tends to exceed drug requirements in many developed countries. In such countries, societal, cultural and attitudinal factors that influence consumption distort the perception and measurement of real medical needs.

Comparisons of consumption data between countries and regions appear to be the most useful indicators for discerning differences in consumption levels and unusual trends requiring attention. The Board has pointed out in its recent reports the large and consistent differences between the consumption levels of countries in North America and those in Europe. Reported annual figures show that the consumption of amphetamine-type stimulants is considerably higher in the United States of America than in countries in Europe and elsewhere, whereas the consumption of benzodiazepine-type sedative hypnotics and anxiolytics is consistently higher in European countries.

Largely due to economic limitations, drug consumption levels are considerably lower in developing countries. Large inter-country variations are also typical of developing countries; some countries consume considerably higher quantities per capita than the majority, whereas many others report virtually no consumption.

Excessive drug consumption that is medically unjustified, predominantly in developed countries, has a number of general and sometimes country-specific causes and driving forces, the most significant of which are the commercial, sociocultural and educational environments in those countries. Similarly, newly gained wealth or affluence appears to be the origin of quickly growing drug consumption in countries and territories experiencing rapid economic growth (for example, in Malaysia, Singapore and Thailand and in the Hong Kong Special Administrative Region of China), especially if such consumption (anorectics) is perceived to be part of a new fashion.

In developed countries, the prevalence of anxiety and insomnia and the consumption of sedative hypnotics are growing, the elderly being the main group of consumers. The Board notes with concern the frequent long-term use (beyond one year and sometimes indefinitely) of psychotropic substances for treating psychological reactions to social pressure without a diagnosis for a specific disorder. Recent surveys indicate that 70- 95 per cent of illnesses are managed by self-care in many countries and this tendency has an important influence on medical practice and on the clinician-patient relationship in general.

Similar tendencies may be seen in many developing countries and in younger age groups. Correcting mood and behaviour through controlled drugs is becoming widespread. Thus, for Governments, keeping the supply and consumption of drugs, especially controlled drugs, in line with medically justified levels is not only an important public health issue but also an economic issue.

Effects of the drug distribution chain on use

a) Impact of the manufacturing industry

Because of the continuing expansion of free trade, it is of the utmost importance that manufacturers exhibit responsible and ethical behaviour in the promotion of all medicinal products. The regulatory requirements concerning narcotic drugs and psychotropic substances destined for medical purposes represent additional responsibilities for manufacturers. Many manufacturers are in principle convinced that it is in their interest to accept those responsibilities and comply with national and international regulatory requirements. Experience shows, however, that certain policies in company sales and promotion practices may interfere with sound health policy. Examples include the continuing manufacture of, trade in, and promotion of: (a) certain controlled drugs when better treatment options or safer alternative drugs are available (e.g. the continuing promotion of amphetamine-type substances for weight control); and (b) drugs or preparations that have been insufficiently tested on specific target groups of consumers, such as children, pregnant women or the elderly. For ethical reasons, few psychotropic medicines have been adequately tested for safety and efficacy in children, although there are high rates of prescribing. This situation has been the subject of critical review.

In some countries, company sales promotion is often addressed to not only physicians but also the public, circumventing prohibitions on advertising. Direct advertisement frequently portrays drugs as common consumer goods, thus encouraging higher drug consumption. Free promotional samples are distributed through company representatives and company-owned distributors in developed and developing countries alike. The continuing existence of such aggressive sales methods may be a sign of inadequate government regulations and/or of weak enforcement of existing regulations. Such sales promotion characterizes, for example, the medicine markets of countries with quickly changing market structures, such as countries in central and eastern Europe. Other problems include:

• The quality and comprehensiveness of drug-related information made available to doctors and patients by pharmaceutical manufacturers often show unacceptable variations.
• Ethical norms for medicinal drug promotion developed by the pharmaceutical industry and by the World Health Organization (WHO) do not appear to be observed by some companies.
• Drugs, including prescription medicines, are increasingly being advertised on the Internet by a wide range of companies.
• In many countries, unregulated drug markets called "street markets" continue to operate parallel to and often in the absence of licensed pharmacies.

There is a need for concerted international efforts in which bona fide pharmaceutical manufacturers take an active part in eradicating such illegal drug supply channels.

b) Impact of medical practice

The medical profession bears an important responsibility for appropriate drug dispensing in general and for the prescribing of controlled drugs in particular. It is the prescriber who determines the choice of drug, its dosage, duration and termination and, ultimately, the availability of a particular psychoactive drug for a given patient. The clinician enjoys a great degree of professional freedom and discretion in such decisions. The clinician-patient interaction involves responsibilities on the part of both, the extent of which is influenced by the culture of the country in question. Continued education of the public in drug use is indispensable.

Significant cross-national and country-specific variations in psychiatric morbidity and drug use data indicate, inter-alia, that there continue to be considerable variances in medical practice between otherwise similar countries and sometimes even within countries. In spite of the recognition of the urgent need for harmonization and standardization, consensus in these areas has developed rather slowly.

Inappropriate prescription of controlled psycho-active medicines includes uninformed prescribing; inconsistent or lax prescribing; willful and consistent mis-prescribing for abuse; and self-prescribing and self-administration.

Many detailed studies suggest that excessive reliance on pharmacological treatment of mental disorders and psychiatric conditions, with a preference for finding quick solutions exclusively through the use of pharmaceuticals, is a significant contributing factor in countries with overconsumption. Several recent studies, however, show that the use of multiple drugs (polypharmacy), often in irrational combinations, in inadequate dosages and for excessively long treatment periods, continues to be quite common. Such medical practice is contrary to the principles of cost-effectiveness and rational evidence-based therapy and is a waste of resources.

The Board has noted in recent years useful national and international initiatives to promote agreed-on definitions of syndromes, better diagnostic criteria, adequate therapeutic approaches and good prescribing practices for some previously controversial health conditions for which psychoactive drugs are being used. Regional efforts in these areas, including training for health personnel, appear to be increasing.

Telemedicine and Internet prescribing may greatly facilitate access to medical and pharmaceutical services for large segments of society at lower cost. At the same time, the potential for errors and intentional misuse is considerable. Substituting direct patient-doctor contact by electronic communication is problematic, particularly in relation to the diagnosis of psychiatric disorders and the prescription of controlled drugs. Efforts to regulate this quickly developing technical area, which has just started, require close cooperation among countries and the relevant international bodies.

These issues demonstrate the complexity of the problems that need to be addressed in efforts to improve drug-prescribing behaviour. Professional knowledge, personal preferences, interpersonal relationships and the environment in which physicians and patients interact influence such behaviour. Any lasting improvements can only be expected in the long term as a result of coherent and continuing education and training.