Friday, March 5, 2010

Europe in Dark Ages on Pain Relief. Is U.S. Next?

According to a newly reported study, patients with cancer in much of Europe are being denied access to pain relief because of over-zealous regulations restricting the availability and accessibility of opioid-based medications. While this appears to be an egregious breach of basic human rights, reminiscent of medieval medicine, equally disturbing is a possibility that the United States might be headed backward in that direction.

The study, published in the cancer journal Annals of Oncology on February 22 [Cherny et al. 2010] and also reported in Science Daily [2010], was a joint investigation of the availability and accessibility of opioids for the relief of cancer pain by the European Society for Medical Oncology (ESMO) and the European Association for Palliative Care (EAPC). Investigators examined data from 21 Eastern European countries in comparison with data from 20 Western European countries. In some countries, particularly in Western Europe, access to and availability of opioid analgesics was reasonably good, for example, the UK performed well in this respect. However, in Eastern Europe — including countries such as Lithuania, Tajikistan, Belarus, Albania, Georgia, and Ukraine — some essential opioid medicines were completely unavailable and restrictions on those at hand were intolerable.

The researchers found that in many countries the balance between providing cancer patients needed pain relief while, at the same time, preventing prescription-opioid abuse is drastically skewed in favor of the latter. They write: "Preventing drug abuse is important, but it should not hinder patients' ability to receive the care they need and deserve. This is the approach of the WHO (World Health Organization) and the INCB (International Narcotics Control Board).” Both organizations recommend that opioids should be available for cancer patients at hospital and community levels and that healthcare providers should be able to prescribe opioids according to the individual needs of each patient. In contrast, the researchers describe the current situation as follows…
"In some countries, pain relief is hampered by lack of availability or barriers to accessibility of opioid analgesics. In many countries, excessively zealous 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. 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 involvement."

"These burdens are compounded for patients and their families who, in many situations, must cajole doctors, chase after permits, wait excessively in inconveniently located pharmacies and return for frequent refills of prescriptions or any correction on a prescription that may not have been written with adequate attention to required details. In some countries, the degree of legal intimidation is such that fear of criminal prosecution contributes to deliberate undertreatment by clinicians to avoid risk of persecution or prosecution."
COMMENTARY: One particularly disturbing aspect is that the researchers were examining the undertreatment specifically of cancer pain, for which there should be clear understandings of pathophysiology, pain severity, and patient needs for strong analgesics. They did not even consider chronic pain conditions in which the etiology, pathology, and extent of pain are often less well defined and poorly understood; so, one can only imagine how much more difficult it must be for patients in Eastern Europe to obtain adequate relief for chronic pain.

Equally of concern, we wonder if the quoted text above may one day describe the situation in the United States. Although the U.S. currently benefits from an extensive selection of approved opioid analgesics, the regulatory climate already seems unbalanced toward averting opioid misuse and abuse at the expense of prescriber autonomy and patient access. Aside from the chilling effects of legal regulations and their aggressive enforcement in the U.S., which is a separate topic, is it also possible that the REMS (Risk Evaluation and Mitigation Strategies) initiative being imposed by the Food and Drug Administration (FDA) might lead to conditions akin to those in Eastern Europe? Already, two newer opioid analgesics — Onsolis® and the just-approved Exalgo™ — carry burdensome REMS programs that will clearly restrict availability and access to those products [these REMS were described in prior blogposts — Onsolis here and Exalgo here]. As new REMS, and perhaps other regulations, are imposed on additional analgesics, will the U.S. be headed toward a public health catastrophe due to the undertreatment of pain and ensuing suffering? What do YOU think? Comment below.

> Cherny NI, Baselga J, de Conno F, Radbruch L. Formulary availability and regulatory barriers to accessibility of opioids for cancer pain in Europe: a report from the ESMO/EAPC Opioid Policy Initiative. Ann Oncol. 2010;21:615-626 [
PDF available here].
> European Society for Medical Oncology. Inadequate access to opioid-based pain relief is a human rights issue for cancer patients. Science Daily [online]. 2010(Feb) [
available here].

Additional Information:
## For an editorial separately published in conjunction with the Cherny et al. study, see: Cleary JF, Hutson P, Joranson D. Access to therapeutic opioid medications in Europe by 2011? Fifty years on from the Single Convention on Narcotic Drugs. Palliative Medicine. 2010;24:109-110 [
PDF available here].
## Leading scholars and public health specialists have formed a new consortium that will work to identify and remove barriers in Europe that prevent people from accessing critical opioid medications. The Access to Opioid Medication in Europe (ATOME) project will include a substantial review of 12 countries’ policies and legislation on opioid medicines [
see press release PDF here].