Global Opioid Use Continues to Be 'Feast or Famine'

Roxanne Nelson, BSN, RN

February 29, 2016

Opioids remain a cornerstone for the relief of both acute and chronic pain, yet the so-called "pain divide" between the "haves and have nots" continues to prevail.

Use of opioid analgesics has substantially increased in many regions, but this use is decidedly unbalanced globally, according to a new analysis published online February 3 in the Lancet.

The worldwide use of opioid analgesic medicines doubled between 2001-2003 and 2011-2013, but this increase in use was largely confined to North America, western and central Europe, and Oceania.

In contrast, countries in other regions have not shown any real increase in use.

The study was based on an availability report from the International Narcotics Control Board (INCB), which was issued as a supplement to their 2015 annual report.

According to the INCB's availability report, an estimated 5.5 billion people, or 75% of the global population, continue to have limited or no access to essential painkillers, such as codeine or morphine.

About 92% of morphine used worldwide is consumed by only 17% of the population, primarily in the United States, Canada, Western Europe, Australia, and New Zealand, where consumption has increased significantly since the early 1990s and where there is growing concern about prescription drug abuse.

Several obstacles to the availability of pain relief medications have been cited by various countries. "The main barrier reported in the last survey of countries is lack of training of medical professionals, in most cases due to the lack of palliative care in the health system," said lead author Stefano Berterame, PhD, chief of the Narcotic Control and Estimates Section of the INCB. "Regulatory issues and complicated administrative procedures are second."

Other issues include cost, which is a factor that is increasing in importance, he told Medscape Medical News. "Similarly, there are cultural barriers and stigma and prejudice associated with opioid analgesics that also play a part."

Many countries also cited fear of drug dependence, problems in sourcing from industry or imports, fear of diversion to illicit channels, and fear of criminal prosecution.

Dr Berterame pointed out that in the Lancet analysis, investigators compared the consumption patterns with two more general development indicators, the Human Development Index, and gross domestic product per capita.

"The analysis shows that these two factors are strongly related to consumption," he said. "Therefore, barriers exists and certainly need to be addressed. However, without an overall improvement of the economic and social conditions of many countries, it is unlikely that ad hoc interventions are going to be sustainable."

Long-term and Ongoing Issue

For more than half a century, a United Nations convention has maintained that certain medicines are "indispensable for the relief of pain and suffering" and that their availability must be ensured.

However, that has not come to pass. A 2012 report, for example, initiated by the European Society of Medical Oncology (ESMO) in collaboration with other groups, reported that cancer patients are not getting adequate pain relief in many parts of the world.

That ESMO global survey found that very few of the countries included in the survey provided all seven opioid drugs that are considered essential for the relief of cancer pain. Often, fewer than three products were available, availability was limited, and the products were not subsidized or were only weakly subsidized by the government.

"The situation has changed so little in regions with low-income and middle-income countries that improvement remains unlikely in the absence of specific strategies to deal with the impediments to increased availability," write the authors of the current Lancet study.

Much of the increase in use observed in high-income countries is at least partly due to long-term prescribing for noncancer pain, they note. "But the absence of real growth in use in most of the world shows a continuing absence of provision of these essential medicines."

First-World Issues — Misuse and Overuse

Although there is severe underuse of opioid analgesics in many parts of the world, the United States is experiencing the opposite problem — misuse, illicit use, and overuse.

The annual number of deaths from opioid overdoses now exceeds the number of deaths caused by motor vehicle accidents.

In response, the US Food and Drug Administration has initiated a multicomponent plan to reverse this seeming "epidemic" while still providing pain patients access to effective medication.

The fear of diversion is one of the barriers cited by nations with limited access. "There are various measures that can be implemented to reduce the risk of misuse without making it difficult for patient to have access," said Dr Berterame. "One is the online registration of prescriptions to reduce doctor shopping, which has produced some results already in some US states."

The pharmaceutical industry needs to be made aware of the social costs of overprescribing that in some cases is related to their marketing practices. Dr Stefano Berterame

"It is also necessary to make the medical practitioners more responsible in their prescribing," he added. "The pharmaceutical industry needs to be made aware of the social costs of overprescribing that in some cases is related to their marketing practices."

However, tightening regulations can have a negative effect on patients who legitimately need pain medication. James Cleary, MD, associate professor of medicine and director of palliative medicine at the University of Wisconsin Hospital and Clinics and lead author of an accompanying editorial, noted that regulations in the United States were initially changed to improve access to opioids for cancer patients and hospice patients, including those with AIDS.

"This was primarily focused on morphine with no increase in misuse or diversion," he told Medscape Medical News.

But with the introduction of new opioids, pharmaceutical companies began developing new formulations, such as Oxycontin (Purdue Pharma LP) and the fentanyl patch (Duragesic, Janssen Pharmaceuticals, Inc).

"With a lack of comprehensive pain management programs and the action of companies, there was a rapid growth in opioid consumption," Dr Cleary said. "This was both in medical practice and also illicit use."

As an example, physicians were permitted to dispense opioids in Florida until 2012.

"This allowed the flourishing of opioid pill mills and opioid consumption," he said. "Closing that loophole by the Florida legislature has resulted in a reduction in a number of negative indicators regarding opioid use."

But on the downside, "as pointed out by Attorney General Bondi, we are seeing an impact on legitimate pain patients," Dr Cleary explained.

Balancing Access

In the editorial, Dr Cleary and two coauthors from his institution note that the role of the INCB is similar to that of the railway controller: "ensuring the function of the complex system that balances access to opioids for medical use with the risk of misuse and diversion."

There are opportunities to correct the system that is driving this inequity of opioid access, they contend.

A multipronged approach is needed for each member nation, one that addresses policies and regulations governing use of opioid medicines, availability, and accessibility of these medicines and that provides education of clinicians and the public about their use, the editorialists write.

The Global Opioid Policy Initiative has also outlined "next steps" that can be taken to increase access.

"WHO and non-governmental organisations should support member states to implement the WHO Palliative Care resolution, individual governments should assess their regulatory structures for over- regulation and do the necessary legislative and regulatory reforms to ensure accessibility to essential pain-relieving drugs, and pain and palliative care advocates need to continue to engage with international and regional organisations within civil society," they write.

And as nations discuss the war on drugs, the worldwide inequity in access to morphine and similar opioids needs to be addressed, Dr Cleary and colleagues add.

Study Details

The goal of the current survey was to provide up-to-date worldwide, regional, and national data for changes in the use of opioid analgesics and to analyze barriers to use.

Dr Berterame and colleagues surveyed 214 countries or territories about impediments to the availability of these drugs, and they calculated the defined daily doses for statistical purposes (S- DDD) per million inhabitants per day of opioid analgesics worldwide and for regions and countries from 2001 to 2013.

They found that overall, the S-DDD of opioid analgesic use more than doubled in a decade ― from 1417 S-DDD (about 3.01 billion defined daily doses per annum) in 2001-2003 to 3027 S-DDD (about 7.35 billion defined daily doses per annum) in 2011-2013.

There were substantial increases in North America (16,046 S-DDD to 31,453 S-DDD), western and central Europe (3079 S-DDD to 9320 S-DDD), and Oceania (2275 S-DDD to 9136 S-DDD).

A higher number of reported that barriers to use was significantly associated with lower use of opioids (unadjusted incidence rate ratio, 0.39; P < .0001). But the differences were no longer significant when adjustment was made for gross domestic product and the Human Development Index (0.91; P = .4271).

The authors note that these data are timely, because the UN General Assembly will be holding its Special Session on the World Drug Problem in New York City in April 2016. "Information about the changes in and impediments to use of opioid analgesics can help deliberations and assist in specifying of policies to improve availability," they write.

The study was funded by the INCB and the United Nations. The authors of the study have disclosed no relevant financial relationships. Dr Clearly and his coauthors of the editorial have received grants from Open Society Foundations and the US Cancer Pain Relief Committee.

Lancet. Published online February 3, 2016. Abstract, Editorial


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