Elsevier

The Lancet

Volume 387, Issue 10028, 16–22 April 2016, Pages 1644-1656
The Lancet

Articles
Use of and barriers to access to opioid analgesics: a worldwide, regional, and national study

https://doi.org/10.1016/S0140-6736(16)00161-6Get rights and content

Summary

Background

Despite opioid analgesics being essential for pain relief, use has been inadequate in many countries. We aim to provide up-to-date worldwide, regional, and national data for changes in opioid analgesic use, and to analyse the relation of impediments to use of these medicines.

Methods

We calculated defined daily doses for statistical purposes (S-DDD) per million inhabitants per day of opioid analgesics worldwide and for regions and countries from 2001 to 2013, and we used generalised estimating equation analysis to assess longitudinal change in use. We compared use data against the prevalence of some health disorders needing opioid use. We surveyed 214 countries or territories about impediments to availability of these medicines, and used regression analyses to establish the strength of associations between impediments and use.

Findings

The S-DDD of opioid analgesic use more than doubled worldwide between 2001–03 and 2011–13, from 1417 S-DDD (95% CI −732 to 3565; totalling about 3·01 billion defined daily doses per annum) to 3027 S-DDD (−1162 to 7215; totalling about 7·35 billion defined daily doses per annum). Substantial increases occurred in North America (16 046 S-DDD [95% CI 4032–28 061] to 31 453 S-DDD [8121–54 785]), western and central Europe (3079 S-DDD [1274–4883] to 9320 S-DDD [3969–14 672]), and Oceania (2275 S-DDD [763–3787] to 9136 S-DDD [2508–15 765]). Countries in other regions have shown no substantial increase in use. Impediments to use included an absence of training and awareness in medical professionals, fear of dependence, restricted financial resources, issues in sourcing, cultural attitudes, fear of diversion, international trade controls, and onerous regulation. Higher number of impediments reported was significantly associated with lower use (unadjusted incidence rate ratio 0·39 [95% CI 0·29–0·52]; p<0·0001), but not when adjusted for gross domestic product and human development index (0·91 [0·73–1·14]; p=0·4271).

Interpretation

Use of opioid analgesics has increased, but remains low in Africa, Asia, Central America, the Caribbean, South America, and eastern and southeastern Europe. Identified impediments to use urgently need to be addressed by governments and international agencies.

Funding

International Narcotics Control Board, UN.

Introduction

For more than 50 years, a UN convention has maintained that certain medicines are “indispensable for the relief of pain and suffering”, so that their availability “must be” ensured.1 This position is often affirmed.2 Yet, more than 5 billion people worldwide had little or no access to essential analgesics, such as codeine or morphine, between 2011 and 2013.3 In 2009, more than 90% of worldwide use of opioid analgesics occurred in the USA, Canada, Australia, New Zealand, and several European countries.4 Use in that year was deemed low in 21 countries and very low in more than 100.4 Inadequate access is inconsistent with international agreements, such as the Universal Declaration of Human Rights,5 which includes the right to medical care and encompasses palliative care. Authors of UN reports have stressed the need to redress this inequity for 25 years.4, 6, 7

Calls to close the so-called pain divide reiterate the concerns,8, 9 and country-level initiatives seem capable of improving availability.9, 10, 11 A descriptive study of use against need was published in 2011 using 2006 data,12 a study of regional use published in 2014 analysed data from 1980 to 2011,13 and a study of country use for some but not all world regions was done in 2013.14 Yet, no analysis of changes in opioid analgesic use applying longitudinal statistical methods has been done, along with any study of the nature and effect of barriers to availability and use of these medicines. Contemporary information about the significance of change in use and the effects of impediments to use (along with factors such as gross domestic product [GDP] and country development) are needed to inform decision making. This study provides an assessment of changes to opioid analgesic use worldwide, regionally, and nationally, from 2001 to 2013. We identify the nature and significance of impediments to an increase of the availability of these medicines.

These data are timely because the UN General Assembly will hold its Special Session on the World Drug Problem (UNGASS 2016) in New York, NY, USA, in April, 2016. Information about the changes in and impediments to use of opioid analgesics can help deliberations and assist in specifying of policies to improve availability.

Research in context

Evidence before this study

Evidence considered before doing this study drew on International Narcotics Control Board data and reports plus a search of the literature. Between Jan 1, 2001, and Nov 19, 2015, we searched MEDLINE, with no language restrictions, identifying 1788 publications (after excluding 110 duplicate citations). A full list of search terms is given in the appendix. We identified several other important efforts to characterise the worldwide situation before our study, including estimates of use against need in 2006, use in 2011, and barriers to accessibility, but not for all regions. No previous research has established the extent of change in use or the association between impediments and use with appropriate longitudinal and multivariate statistical analytic approaches.

Added value of this study

Our findings provide an up-to-date analysis of worldwide, regional, and national opioid analgesic medicine use compared with clinical need for management of cancer and HIV, and we provide an analysis of impediments that are determinants of use. We show the extent of progress that has occurred during a decade worldwide in terms of a doubling of use, but while use has substantially increased in many regions, change in use in low-income and middle-income regions remains low, and use unbalanced. The number of impediments to availability reported by countries is significantly associated with unadjusted use, as are country gross domestic product and country level of development as indexed by the Human Development Index after adjustment.

Implications of all the available evidence

Many low-income and middle-income countries continue to fail to provide adequate opioid analgesic medicine for pain. Attention should be paid to the impediments faced by countries, and international and national policies and action should support an agenda for change within the next decade.

Section snippets

Data sources

Countries provided data to the International Narcotics Control Board (INCB) on one aspect of availability of opioid analgesic medicines, specifically the amounts that each country's competent national authority estimates are needed and used annually, including reporting of medicines destroyed, losses during manufacture, and so on. This information was verified by the INCB using data from export and import notifications. We assess these data in terms of defined daily doses for statistical

Results

By May 18, 2015, 106 countries or territories (appendix), equating to 75% of the world's population, had responded to the questionnaire about determinants of use, a response rate consistent with previous exercises.14 Figure 1, Figure 2 show evidence of increased use of opioid analgesics between 2001–03 and 2011–13. Some increase in use is evident in the Middle East and Latin America. Small increases have occurred in Russia and in some countries in central Asia, but levels of use remain low

Discussion

A doubling in worldwide use of opioid analgesic medicines occurred between 2001–03 and 2011–2013. Use remains unevenly spread across regions, as reported in descriptive studies previously.13, 14 In this study, to our knowledge, we have shown for the first time that high-income countries, particularly in North America, Oceania, and western and central Europe, account for the growth of use, with significantly higher use than all other regions for every year after 2001 unadjusted, but without a

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