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Keywords:

  • Diversion;
  • illegal markets;
  • low and middle income countries;
  • opioid medicine;
  • under prescription.

Unavailability of medical narcotics often results from a fear of dependence. Conversely, illegal markets lead governments to control production and importation, further limiting access to patients in need. However, making narcotics available increases the risk of drug diversion and addiction. Where should we draw the line?

There is a widespread, growing need for opioid medicine linked to changes in life expectancy, with a concomitant increase in chronic disorders, particularly cancer and human immunodeficiency virus (HIV). The World Health Organization (WHO) estimates that in 2008, 7.6 million people died of cancer. As relief from physical, psychosocial and spiritual problems can be achieved in more than 90% of advanced cancer patients through palliative care, improved access to oral morphine is essential for the treatment of more than 80% of cancer patients in terminal phases [1]. In practice, most treated patients do not become dependent as a result of rational medical use of opioid medicines [2].

According to the United Nations, there are between 12 and 14 million people who abuse heroin and 15.9 million people injecting drugs [3]. Overall, WHO [4] has estimated that in 2009 there were 33.3 million people living with HIV. Medicines such as methadone and buprenorphine must therefore be part of a comprehensive package of interventions [5].

It has been estimated that by 2010 there will be 20 million new cases of cancer per year. More than two-thirds of these cases will occur in developing countries, where opioids (specifically morphine) will continue be indispensable due to their affordability and efficacy [6].

These medicines are controlled under the Convention of Narcotic Drugs. This convention was designed to ensure the availability of narcotic drugs for medical and scientific purposes, while ensuring that such drugs are not diverted for illicit purposes. To date, 184 countries have become parties to this international drug control convention, and have therefore accepted the obligation to implement them. The International Narcotics Control Board (INCB) is responsible for monitoring the implementation of this treaty objective [7].

This is a subject that highlights international disparities; access to essential medicines is limited for the poorer sectors of society and for developing countries. According to the Union for International Cancer Control [8], 70% of the deaths due to cancer and 99% of HIV-related deaths occur in low- and middle-income countries (LAMIC), yet only a small proportion of the global production of morphine is available in these countries. According to the INCB [9], 93% of global morphine consumption occurs in Australia, Canada, New Zealand, the United States of America and several European countries, leaving more than 80% of the world population with insufficient or no analgesia. As a result, more than 3.4 million people die of cancer or HIV each year in severe pain without pain relief [8], and only 2% of injecting drug users in developing countries receive treatment for opioid dependence with opioid medicines [2].

According to INCB [10], barriers to access of pain and substitution medication are not linked to the supply of raw materials for the production of opioid analgesics. Primarily, other supply challenges are affecting availability. International regulations state that countries must provide detailed annual estimates and reports for narcotic substances to INCB to procure or produce controlled medicines. Formulating reliable estimates is often a barrier to accessing controlled medicines. In addition, procurement of narcotic substances is subject to a complex exportation and importation system of licences and certificates, which can be a lengthy process and difficult to manage.

Barriers are also found in other spheres, including: (i) limited medical knowledge of doctors and other health professionals expressed in concerns over iatrogenic addiction that might result in low prescription; (ii) fear of diversion that often results in overly restrictive regulations beyond the requirements of international drug conventions; (iii) erroneous beliefs among the population in need that may prevent them for accepting this type of medications; and (iv) economic and financial conditions coupled with the limitations of health systems.

Conversely, in some countries, increased availability of opioids for medical purposes has created markets for diversion. In the United States, for example, the country with the highest consumption of narcotic analgesics [8], pain killers are commonly abused without prescription. According to the 2008 US National Survey on Drug Use and Health, 1.9% of the population aged 12 and over reported having used pain relievers without prescription in the month prior to the survey [11]. Emergency department mentions of opioid analgesics increased by 111% from 2004 to 2008 [12]. According to Compton [13], the rising number of prescriptions, attention by the media and advertising, easy access thorough family and friends and incomplete knowledge and monitoring of prescriptions explain the increase in pharmaceutical abuse.

In contrast, Mexico is a country with a high degree of underutilization of pain relievers, much lower than required for its cancer mortality rates [10]. Mexican national household surveys report rates of ever use for narcotics without medical prescription in individuals aged 12–65 years of age to be 0.14% for males and 0.15% for females [14].

Unavailability of medicines results in suffering that goes unrelieved, while excess availability often results in overmedication and suffering of a different nature. The line should be drawn in such a way that medicines are available for those who need them, and more actions are required to limit negative consequences to the extent possible. INCB [9] recommends measures such as raising awareness of the problem; training professionals and educating the public; adopting guidelines for diagnosis, therapy decisions and prescribing; ethically monitoring drug marketing; and developing better, safer therapeutic agents. Recommendations for the prevention of diversion include legislation; the establishment of a comprehensive registration and authorization system; supervision and data collection on prescription drug abuse; and monitoring the use of counterfeit substances and the internet for smuggling.

Developing countries require a better system for estimating and assessing medical needs. Many patients could be helped by making pharmaceuticals available under preferential conditions with the international community, international organizations and the pharmaceutical industry having a major role to play in this.

References

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  3. References