Many patients around the globe do not have access to proper opioid analgesics – critical to the effective relief and management of cancer pain. This lack of access represent a serious public health problem. These conclusions are from the Global Opioid Policy Initiative (GOPI) project, a ground-breaking international collaborative survey which show that more than 4 billion people live in countries where regulations designed to to stem drug misuse, leave cancer patients suffering excruciating pain. The study results are published in the December 2013 supplement to Annals of Oncology.[1]

While national governments have to take action to stop drug abuse, appropriate pain relief is often hampered by lack of availability or barriers to accessibility of opioid analgesics. In many countries, poorly written laws and regulations restrict access to opioids analgesics and interfere with the medical availability of opioids for the relief of cancer pain. In many of these countries, logistics of these medications is so burdensome and complex that for physicians, nurses and pharmacists do not want to get involved.

Most of the world’s population lacks the necessary access to opioids for cancer pain management and palliative care, as well as acute, post-operative, obstetric and chronic pain…

Representatives from ESMO – the European Society for Medical Oncology, have urged governments to take urgent action to improve access to these medicines. To communicate the urgent patient needs, leader of a group of 22 partners, including the European Association of Palliative Care (EAPC), International Program at the Pain and Policy Studies Group (PPSG), University of Wisconsin Carbone Cancer Center, Union for International Cancer Control (UICC), World Health Organization (WHO) and others, have launched the first global survey to evaluate the availability and accessibility of opioids for cancer pain.[2]

“The GOPI study has uncovered a pandemic of over-regulation in much of the developing world that is making it catastrophically difficult to provide basic medication to relieve strong cancer pain,” noted Nathan Cherny, Chair of the ESMO Palliative Care Working Group and lead author of the report, from Shaare Zedek Medical Center, Jerusalem, Israel. “Most of the world’s population lacks the necessary access to opioids for cancer pain management and palliative care, as well as acute, post-operative, obstetric and chronic pain.”

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Horrendous consequences
“When one considers that effective treatments are cheap and available, untreated cancer pain and its horrendous consequences for patients and their families is a scandal of global proportions,” Cherny explained.

The study conducted in Africa, Asia, Latin America & the Caribbean and the Middle East assessed the availability of the seven opioid medications considered to be essential for the relief of cancer pain by the WHO Model List of Essential Medicines [3] and theInternational Association for Hospice and Palliative Care.[4]

The core list of essential medications presents a list of minimum medicine needs for a basic health?care system and includes the most efficacious, safe and cost?effective drugs for priority conditions which are selected on the basis of current and estimated future public health relevance, and potential for safe and cost?effective treatment. For the management of cancer pain those essential medications include codeine, oral oxycodone, transdermal fentanyl, immediate and slow release oral morphine, as well as injectable morphine, and oral methadone.

Over-regulation needs reform
While there are problems with the supply of these medicines in many countries, the main problem is over-regulation that makes it difficult for healthcare professionals to prescribe and administer them for legitimate medical use, the authors say. “This is a tragedy born out of good intentions,” Cherny said. “When opioids are over-regulated, the precautionary measures to prevent abuse and diversion are excessive and impair the ability of healthcare systems to relieve real suffering. The GOPI study has uncovered over-regulation in much of the developing world.”

“The next step is for international and local organizations working alongside governments and regulators to thoughtfully address the problems,” adds study co-author James Cleary, Director of the Pain and Policy Studies Group and Founding Director of the Palliative Medicine at the UW Carbone Cancer Center, Madison, Wisconsin, USA. “Regulatory reform must be partnered with education of healthcare providers in the safe and responsible use of opioid medication, education of the public to de-stigmatize opioid analgesics and improved infrastructure for supply and distribution,” he noted.

Concrete examples
There are already concrete examples of countries reforming their policies to improve access to opioid medicines, the study authors say, among them the Ukraine, which previously had a limited opioid formulary. “Concerted efforts supported by the Open Society Institute, reports from Human Rights Watch, together with the investment in local clinical champions through programmes such as the Pain and Policy Studies Group’s (PPSG) International Pain Policy Fellowship (IPPF) Program, have led to the government approving the manufacture and distribution of immediaterelease oral morphine in the Ukraine with concurrent changes in policy,” Cleary observed.

“The ongoing initiatives to reform regulations, improve accessibility and promote the education of clinicians and consumers in the effective use of opioid medications for the relief of cancer pain will require vision, determination and the same spirit of cooperation between organisations that made this study successful. The challenges are great, but no greater than our resolution to the task of making pain relief for cancer patients a reality irrespective of geography. Governments should look at the GOPI survey data for their country and take concrete actions to reduce the barriers,” Cherny concludes.

For more information:
[1] Global Opioid Policy Initiative project to evaluate the availability and accessibility of opioids for cancer pain management. Annals of Oncology, December 24, 2013 (Supplement 11) [Supplement]
[2] Cherny NI, Baselga J, de Conno F, Radbruch L. Formulary availability and regulatory barriers to accessibility of opioids for cancer pain in Europe: a report from the ESMO/EAPC Opioid Policy Initiative. Ann Oncol. 2010 Mar;21(3):615-26. doi: 10.1093/annonc/mdp581 [Article][PubMed]
[3] WHO Model List of Essential Medicines; 18th list (April 2013) [Article]
[4]International Association for Hospice & Palliative Care [Web]

[5] Over-regulation of Opioid Analgesics Catastrophic [Video]

Illustration: The map summarizes the number of regulatory barrier types that prevent cancer patients from accessing opioid analgesics for treating pain. Illustration courtesy: ESMO Pain & Policy Studies Group.

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