More than half of the world’s population – over 4 billion people — lives in countries where regulations aimed at preventing drug abuse have left cancer patients without access to opioid medicines to manage their cancer pain, according to a ground-breaking international survey, published in Annals of Oncology.
The survey by the Global Opioid Policy Initiative (GOPI) looked at 104 developing countries in Africa, Latin American, the Caribbean and the Middle East. It assessed the availability of seven opioid medications considered to be essential for the relief of cancer pain by the World Health Organization: codeine, oxycodone, fentanyl, immediate and slow release oral morphine, as well as injectable morphine, and methadone.
While there are problems with the supply and cost of these medicines in many countries, the main barrier to access is over-regulation that makes it difficult for healthcare professionals to prescribe and administer opioids for legitimate medical use. The report blames “excessively zealous drug controllers” for much of the problem, a complaint increasingly heard in developed nations like the United States.
“In many countries excessively zealous drug controllers or policy makers, or poorly considered laws and regulations to restrict the diversion of medicinal opioids into illicit markets, profoundly interfere with the medical availability of opioids for the relief of pain,” the report states.
“Often, the logistics of the treatment of pain with opioids is so burdensome or complex for physicians, nurses, and pharmacists as to be a major disincentive to the use of opioids in the treatment of 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,” said lead author Nathan Cherny, Chair of the European Society for Medical Oncology.
“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.”
The report found that cancer patients, their families, and caretakers often have to “cajole doctors, chase after permits, wait excessively in inconveniently located pharmacies, and return for frequent refills of prescriptions.”
In some countries, fear of criminal prosecution is so high that health care providers deliberately under-treat patients to avoid risk of persecution or prosecution.
“This is a tragedy born out of good intentions,” added 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 next step is for international and local organizations working alongside governments and regulators to thoughtfully address the problems,” said study co-author James Cleary, Director of the Pain and Policy Studies Group and Founding Director of Palliative Medicine at the University of Wisconsin Carbone Cancer Center.
“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.”