Global study reveals pandemic of untreated cancer pain due to over-regulation of pain medicines

A ground-breaking international collaborative survey, published today in Annals of Oncology, shows that more than half of the world's population live in countries where regulations that aim to stem drug misuse leave cancer patients without access to opioid medicines for managing cancer pain.

The results from the Global Opioid Policy Initiative (GOPI) [1] project show that more than 4 billion people live in countries where regulations leave suffering excruciating pain.

National governments must take urgent action to improve access to these medicines, says the European Society for Medical Oncology, leader of a group of 22 partners that have launched the first global survey to evaluate the availability and accessibility of opioids for cancer pain.

"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," says 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 , as well as acute, post-operative, obstetric and ."

"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 says.

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 [2] and the International Association for Hospice and Palliative Care [3]. Those essential medications include codeine, oral oxycodone, transdermal fentanyl, immediate and slow release oral morphine, as well as injectable morphine, and oral methadone.

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," says Cherny. "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 organisations 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 destigmatize opioid analgesics and improved infrastructure for supply and distribution," he says.

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 says.

"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.

More information: [1] The "Global Opioid Policy Initiative project to evaluate the availability and accessibility of opioids for cancer pain management" is published as a Supplement of Annals of Oncology, free access available here: annonc.oxfordjournals.org/content/24/suppl_11.toc. This survey is a follow-up of the Europe-wide survey conducted in 2010 by ESMO and EAPC. "Formulary availability and regulatory barriers to accessibility of opioids for cancer pain in Europe: a report from the ESMO/EAPC Opioid Policy Initiative" (annonc.oxfordjournals.org/cont… c4-a525-450ec88e932d)

[2] www.who.int/medicines/publicat… Final_web_8Jul13.pdf

[3] www.hospicecare.com

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