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Opioid over-regulation can leave cancer patients in intolerable pain

By Kate Kelland

LONDON (Reuters) - A "pandemic of over-regulation" of opioid-based painkillers such as morphine and fentanyl means billions of cancer patients around the world suffer intolerable pain, researchers said on Thursday.

Describing what they said was a "scandal of global proportions", researchers from the Global Opioid Policy Initiative (GOPI) said governments that over-regulate should consider the unintended consequences of restricting access to medicines and change their approach.

More than 4 billion people live in countries - many of them in emerging and developing regions - where regulations, often imposed over the risk of addiction to the drugs, leave the patients in excruciating pain, they wrote in a global analysis published in the Annals of Oncology journal.

"This is a tragedy born out of good intentions," said Nathan Cherny, from Israel's Shaare Zedek Medical Center in Jerusalem, who led the study.

"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 study, conducted in Africa, Asia, the Middle East, Latin America and the Caribbean looked at the availability of the seven opioid medications considered by the World Health Organisation to be essential for the relief of 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," Cherny said.

"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."

The drugs studied were codeine, oral oxycodone, transdermal fentanyl, immediate and slow release oral morphine, injectable morphine and oral methadone.

As well as being very effective painkillers, opioids are highly addictive. One of the best-known is Oxycontin, a long-acting form of oxycodone which is often linked with tales of drug addiction among celebrities in the United States.

U.S. drug regulators said in September that labels on long-acting opioids should contain stronger warnings highlighting the dangers of addiction and abuse.

Yet the situation in other countries is very different.

The GOPI study found that while there were problems with the supply of opioids in many countries, the main problem was the over-regulation, making it difficult for doctors to prescribe and administer them for legitimate medical use.

James Cleary of the Palliative Medicine at the University of Wisconsin Carbone Cancer Center, who co-led the study, said regulatory reform should be coupled with education of health workers about safe and responsible use of opioid drugs.

"The next step is for international and local organizations working alongside governments and regulators to thoughtfully address the problems," he said.

The authors pointed to Ukraine as one example of a country which used to have very restrictive laws but is now reforming its policy to improve access to opioids.

(Editing by Alison Williams)

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