'Tragedy' of Millions of Cancer Patients Not Getting Opioids

Roxanne Nelson

December 04, 2013

Millions of cancer patients around the world are not receiving adequate pain relief with opioid analgesics because of problems with regulatory restrictions and a lack of access and availability.

More than half of the global population resides in nations where legal and bureaucratic restrictions on opioid drugs, which were introduced to stop abuse and drug trafficking, are preventing cancer patients from getting pain relief, according to a groundbreaking international collaborative survey published as a supplement to the December issue of the Annals of Oncology.

In fact, an estimated 5 billion people live in countries with little or no access to pain relief, even for those with advanced disease.

The Global Opioid Policy Initiative (GOPI) "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," according to Nathan Cherny, MD, who is head of the oncology and palliative medicine unit at the Shaare Zedek Medical Center in Jerusalem, Israel, and one of the authors of the report.

This is a tragedy born out of good intentions.

"This is a tragedy born out of good intentions," said Dr. Cherny, who is also chair of the European Society for Medical Oncology (ESMO) Palliative Care Working Group. "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," he said in a statement.

"The GOPI study has uncovered over-regulation in much of the developing world," he explained. The result is that "most of the world's population lacks the necessary access to opioids for cancer pain management and palliative care, as well as for acute, postoperative, obstetric, and chronic pain."

A preliminary report of the findings was presented at the 2012 ESMO Congress, and were reported at that time by Medscape Medical News.

Worldwide Data: 87% of Global Population

The report was initiated by the ESMO, working in collaboration with the European Association of Palliative Care (EAPC), the Pain and Policies Study Group at the University of Wisconsin Carbone Cancer Center in Madison, the Union for International Cancer Control (UICC), and the World Health Organization (WHO). Among the 22 partners are many local oncology and palliative care organizations, which helped collect the data.

The survey evaluated 79 countries and 25 Indian states, representing 87% of the global population. It is a follow-up of the 2010 Europe-wide survey conducted by the ESMO and EAPC, which collected data on drug formularies and regulations from 21 Eastern European countries and 20 Western European countries, including Israel.

In Africa, Asia, the Caribbean, Latin America, and the Middle East, the ESMO and its partners assessed the availability of the 7 opioids designated to be essential for the relief of cancer pain by the WHO Model List of Essential Medicines and the International Association for Hospice and Palliative Care: codeine, oral oxycodone, transdermal fentanyl, immediate- and slow-release oral morphine, injectable morphine, and oral methadone.

Imbalance Between Need and Regulation

In an ESMO interview posted online November 28, Julie Torode, PhD, deputy CEO and advocacy and program director of the UICC, noted that one of the 2014 goals of her organization is to raise awareness about barriers to care and access to pain relief. There is a "real imbalance between the need to regulate these drugs and make sure that they don't get diverted into the black market" and the need to make them available to patients who really need them, she said. "What we find is a major imbalance across the world; only 7 counties use 80% of the world's morphine. That means all other countries have inadequate use of morphine."

Only 7 countries use 80% of the world's morphine.

According to the WHO, an estimated 5.5 million terminal cancer patients, and millions of others suffering from acute illness and end-of-life pain, have little or no access to opioids. There are "vast and unacceptable disparities" in access to pain relief between developed and developing countries. This disparity is exemplified by the fact that just 4 countries — Australia, Canada, the United Kingdom, and the United States — use 69% of the world's opioids, whereas low- and middle-income countries use just 7%.

However, problems exist even in high-income developed nations. In Japan, for example, there are issues at the practitioner and patient level. "There is no problem with access to opioids in Japan, but there are problems," explained Kazuo Tamura, MD, from the School of Medicine in Fukuoka University, Japan, in an ESMO interview. Many Japanese patients, especially those who are older, continue to harbor fears about narcotic addiction, said Dr. Tamura, who is also the ESMO regional representative for Japan. "Physicians treating cancer patients tend to prescribe a low dose of opioids at an inappropriate schedule," he explained. "So the problem is patients' self-restriction of opioids and the physician's prescribing of low doses."

He contends that this is a difficult issue that will take time to resolve. Dr. Tamura pointed out that cancer has been the leading cause of death in Japan since 1981, and this trend will probably continue in the near future. Because of this, the Cancer Control Act was initiated in 2007. "One part of this Act is the equal access to standard cancer medicine, including palliative medicine," he said.

Dr. Torode agrees that some of the barriers are misconceptions about the use of narcotics. "We also find controls are imposing restrictions on prescriber activity," she said. "There is a lot of anxiety on the patient and prescriber side."

Although there were a few exceptions, the GOPI project found that most countries in Africa, Asia, the Caribbean, Latin America, and the Middle East are failing to consistently or adequately alleviate pain in cancer patients. In countries where opioids are available, the cost to the patient and "pervasive over-regulation' make them almost virtually inaccessible to the millions who need them.

Access Limited in All Regions

In all regions surveyed, opioids were on national essential medicines lists, but they were not consistently available anywhere. With only a few exceptions, codeine and at least one, and frequently more, morphine formulations were on national lists. However, in many of the countries studied, and in all of the Indian states studied, fewer than 3 of the 7 medicines were routinely available in hospital dispensaries and pharmacies. In Africa, 91% of countries include opioids on their essential medicine lists, but only 13% reported that immediate-release morphine is always available.

All of the regions surveyed showed similar inconsistencies between adherence to global standards at the national policy level and the actual range and availability of these drugs to patients in need.

A Basic Human Right

For decades, it has been understood that morphine is an essential drug for advanced cancer patients.

Augusto Caraceni, MD, director of the Virgilio Floriani Hospice and palliative care unit at the National Cancer Institute of Milan, explained that in general, pain management and palliative care are still low priorities in many healthcare systems.

"What surprised me more from the international data is the fact that for decades it has been understood that morphine is an essential drug for advanced cancer patients, as well as untreatable illnesses," Dr. Caraceni said in an ESMO interview. "Even after the WHO campaign, which is now about 30 years old, to disseminate morphine and other opioids to treat cancer pain, we still see how difficult it is to get appropriate medications in so many countries around the world."

Key Barriers Identified

We still see how difficult it is to get appropriate medications in so many countries around the world.

A number of barriers exist that contribute to the limited access. "One is the low priority in healthcare systems. The second is the stigma associated with the use of opioids," because they are misused and a source of international crime, Dr. Caraceni explained. "On top of this is the culturally specific aspect, which has to do with the priority of pain control as a human right."

In addition to the limited availability of essential opioids, the survey reported several other key findings. With few exceptions, the ability of clinicians to prescribe and dispense opioid drugs is impeded by "outdated and unnecessarily stringent legal and regulatory restrictions."

Almost all of the countries surveyed had strict policies and regulations that blocked adequate pain medication being integrated into patient care. In addition, in all regions, there were limitations on the type of hospitals or units that permitted opioids to be dispensed, the dose and length of time allowed for a single prescription, and the clinicians allowed to prescribe. These restrictions serve to "disincentivize clinicians from prescribing and create insurmountable barriers for pharmacists and families seeking access to pain medicine," according to the GOPI report.

Other key elements are concern about safety and addiction to opioids and the misconception that they should only be used for dying patients. These issues, along with a lack of awareness about their effectiveness in relieving pain and suffering, has led to a reduced demand for opioids from patients and their families.

In addition, patients who do seek access often face a number of administrative barriers and cost, such as complicated prescription forms, limited government subsidization, inflated drug costs, and strict limits on the dose of medicine provided, regardless of the degree of pain.

Finally, inadequate clinician education and recurring misconceptions add to the barriers. The ESMO and its partners note that clinicians "must be educated, informed, and legally empowered to prescribe as they see fit based on individual patient needs." They add that there is "broad consensus among the international community that inadequate education and training of healthcare providers is one of the most pervasive and urgent obstacles to address."

Moving forward, governments, civil society, and international agencies need to come together to put new models, policies, and approaches for pain management into place, the report notes, although it cautions that no single approach will work across all regions. The ESMO-led collaborative survey has laid the groundwork by providing detail on key advocacy and policy priorities. If these are addressed, accesses to pain medicines could rapidly improve throughout the world, the GOPI report concludes.

Dr. Torode notes that this is already beginning. UICC's campaign targets public health organizations and the other key bodies, including the United Nations Commission of Narcotic Drugs. "We're working with the commission to try to sensitize them to the need for a balance between regulation and the needs of patients," she said. "We are having good responses and we need to take it forward, and the survey is providing concrete data at the country level."

The study was funded by the coordinating partner organizations. The authors have disclosed no relevant financial relationships.

Ann Oncol. 2013;24(Suppl 11). Table of contents


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