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No access to opioids causes major problems for patients in many European Countries

Formulary availability and regulatory barriers to accessibility of opioids for cancer pain in Europe: a report from the ESMO/EAPC Opioid Policy Initiative
N. I. Cherny, J. Baselga, F. de Conno and L. Radbruch, Annals of Oncology, 2009 Volume 21, Issue 3 Pp. 615-626

A damning report from The European Pain Policy Initiative, a joint project of the European Society for Medical Oncology (ESMO) and the European Association for Palliative Care (EAPC) regarding the regulations and restrictions preventing cancer patients access to medication to relieve strong cancer pain.

The authors collected data from 21 Eastern European countries and 20 Western European countries to evaluated the formulary availability (lists of allowed opioid drugs) for the management of strong pain (Opioid analgesics) for each country, the cost of opioid medication to patients and the regulatory barriers that can make it more difficult, if not impossible, for cancer patients and their doctors to get access to these medications in a timely manner.

Prof. Nathan Cherny, the lead investigator and author of the report, said: “In most of Western Europe, the issues of availability and accessibility appear to be fairly good. In some eastern European countries, the situation is catastrophic. Many countries are in flagrant disregard of the regulatory guidelines of the International Narcotics Control Board, and we have highlighted the specific regulations and issues that need to be addressed to bring countries into compliance with the WHO and INCB guidelines. This is an issue of cancer patients’ human rights, and it’s not only a legal imperative, but a moral imperative for the WHO and individual European countries to address the findings of our report."

The report will be presented to the INCB, WHO, the EU, the ministries of health of the surveyed countries and will the focus of an intense coordinated lobby for regulatory reform in those counties with major problems.

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EAPC thanks the publishers Oxford University Press and Sage for having granted free access to both papers.

ESMO/EAPC Opioid Policy Initiative

The study found that in many European Countries (particularly in Eastern Europe) the balance between enabling cancer patients to receive the pain relief that they need, while, at the same time, preventing prescription drugs being diverted for substance abuse in illicit drug markets, is weighted too much in favour of the latter. They found that in some countries, particularly in Western Europe, access and availability was good (the UK was an example of a country that performed well in this respect), but in other countries, particularly in Eastern Europe, it was severely restricted. In countries, such as Lithuania, Tajikistan, Belarus, Albania, Georgia and Ukraine, some essential opioid medicines were completely unavailable.

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 recommend that opioids should be available for cancer patients at hospital and community levels and that physicians should be able to prescribe opioids according to the individual needs of each patient.
“While most governments allow physicians to prescribe opioids for patients, regulations vary among nations and in many countries, regulations to reduce substance abuse and to restrict the diversion of medicinal opioids into illicit markets unduly interfere with medical availability for the relief of pain.”

Regulations that restrict opioid prescribing and which contravene WHO and International Narcotic Control Board recommendations include: requiring special patient permits, limiting the authority of physicians to prescribe opioids according their professions even for cancer patients with strong pain, imposing arbitrary dose limits (that limit the ability to adjust the dose to individual patient needs), imposing severe limits on the duration of the prescription (less than sevens days supply per prescription), restricting opioid dispensing so that it’s harder for patients to access the medication, increasing bureaucratic burdens through the use of complex or poorly accessible prescription forms or complex reporting requirements, and intimidating health care providers and pharmacists with intimidatory legal sanctions.

“As problematic as each of these violations are alone, when they are sequential in the process of prescribing and dispensing, their affects are multiplied, and the impact on patient care is profound. This appears to be the situation in many East-European countries, particularly in Russia, Montenegro, Macedonia, Bosnia-Herzegovina, Lithuania, Belarus, Albania, Georgia and Ukraine.”

The report also highlights the problem of emergency and out of hour accessibility to strong pain medications. "Problems of severe cancer pain do not respect physicians working hours. Indeed, situations arise when patients have urgent need for the relief of severe pain when a physician may not be able to attend to them. In such circumstances, potential options for opioid prescription include 1) presenting to an emergency room, 2) contacting the physician to phone or fax an emergency prescription to a pharmacist, 3) having the attending nurse generate an emergency prescription or 4) having the pharmacist generate an emergency prescription. Very few countries in Europe make regulatory provision for these circumstances."

The report concludes with 4 major recommendations

  1. Formulary restrictions: While supporting the expansive formulary described by the IAHPC, the report recognizes that this may not be practicable in some parts of the world. The study, therefore, restricts its strongest endorsement to the standards of the WHO essential medicines list as a minimal standard for opioid formulary (including oral codeine, immediate release morphine, controlled release morphine tablets and injectable morphine). They also recommend that governments should not approve controlled release morphine, fentanyl or oxycodone, without first guaranteeing widely-available immediate release oral morphine.
  2. Regulatory restrictions: The report echo calls for government examination of drug control policies and repeal of over vigilant or excessive restrictions that impede good clinical care of cancer pain. Examples of such restrictions include: requirement for patients to have a special permit, or restrictions on care settings where opioids can be prescribed, restrictions on prescribing privileges to limited physician specialties, arbitrary dose limits, excessive restrictions on the number of day's supply that can be prescribed at one time and severe restrictions on the sites of opioid dispensing.
  3. Emergency prescribing: Regulatory provision should be made for emergency prescriptions of opioids for patients in severe pain who cannot obtain a physical prescription. ESMO and the EAPC support the approach of the Drug Enforcement Administration of the United States which permits emergency prescription by telephone or facsimile to the pharmacist. (The pharmacist must ensure the veracity and validity of the prescription prior to dispensing the medication)
  4. Special prescription forms: The requirement for special prescription forms is not considered an excessive burden per-se. It is essential however, that forms be readily available to prescribers and that the process of procuring them not be excessively burdensome so as to provide a disincentive to do so.
  5. Dispensing: Pharmacists must have the authority to correct technical errors in consultation with the prescribing physician.
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