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Annals of Oncology Advance Access originally published online on April 20, 2006
Annals of Oncology 2006 17(6):885-887; doi:10.1093/annonc/mdl073
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© 2006 European Society for Medical Oncology

editorial

Problems of opioid availability and accessibility across Europe: ESMO tackles the regulatory causes of intolerable and needless suffering

N. I. Cherny1,*, R. Catane2 and P. A. Kosmidis3,4

1 Shaare Zedek Medical Center, Medical Oncology, Jerusalem; 2 Sheba Medical Center, Oncology, Tel Aviv, Israel; 3 Hygeia Hospital, Oncology, Athens, Greece; 4 European Society of Medical Oncology, Past President, Lugano, Switzerland

* E-mail: chernyn{at}netvision.net.il

The bare minimum that one can do for a patient with advanced and incurable cancer is to ensure that pain is adequately relieved. Sadly, many patients in Europe do not receive this minimum of treatment. Whereas some of the western European countries have regulations that make opioids widely available at minimal cost to patients in need, for a great many others availability and accessibility are severely hampered by either restrictive laws and regulations or, at times, by the lack of affordable formulations.

It is widely recognized that there are major problems with opioid availability and accessibility across Europe and, as a consequence, many patients are suffering. This conclusion has been reached independently by the Opioids and Pain European Network (OPEN) report ‘The White Paper on Opioids and Pain: a Pan-European Challenge’ [1Go]; The Open Society Institute International Palliative Care Initiative, led by Professor Kathleen Foley (www.soros.org/initiatives/pdia/focus_areas/a_international_palliative); the International Observatory on End of Life Care (www.eolc-observatory.net), led by Professor David Clark and the International Narcotics Control Board [2Go], The World Health Organization [3Go] and the Council of Europe [4Go].

As the largest body of cancer clinicians in Europe, The European Society of Medical Oncologists (ESMO) views this matter with utmost gravity. That so many of our patients suffer unnecessarily is an intolerable situation that must be addressed with rigor, urgency and persistence. The issues contributing to this problem are widespread and they relate both to the availability of opioids and to their accessibility.

problems of availability and accessibility

Availability refers to what the law will entitle to patients. Limits to availability relate to drug types, dosages and duration of therapy. Clearly, the manufacture and distribution of illicit drugs must be controlled. But in enacting legislation to control illicit drug use, severely restrictive regulations often adversely affect cancer patients with compelling and legitimate need for pain relief. Legislative restrictions impact on the range of available medications (formulary restrictions), dose restrictions and limits to the duration of therapy prescribed in a single prescription. Examples of such restrictions are outlined in Table 1. Accessibility refers to the ability to obtain legally available medication. Limits to accessibility may be caused by restrictions to the prescription process, dispensing process or economic factors (Table 2).


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Table 1. Barriers to opioid availability

 

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Table 2. Barriers to opioid accessibility

 
eastern Europe as a specific problem

Although there is evidence of problems in many European states, there is overwhelming evidence to suggest that it is a major problem in Eastern Europe. At a recent meeting of the ESMO Palliative Care Working Group, a Romanian oncologist described the impact of working in a cancer center with no access to morphine. In a meeting of Oncologists and Palliative Care Clinicians from Eastern Europe held in Hungary under the auspices of the Open Society Institute, clinicians related harrowing stories of patients unable to access opioids for relief of pain. The problems described were endemic: no immediate release oral morphine, medications only available from a regional pharmacy (sometimes many miles from the patient), patients needing special authorization to receive opioids, severe limitations on permitted doses, physicians needing to pay for special prescription books. In some countries the only available opioids were expensive formulations of controlled release tablets or patches.

ESMO and advocacy

If ESMO cannot advocate for its patients, who can? We have heard from the ESMO membership that they see the management of pain as a core task and priority [5Go]. This has been enshrined in the ESMO policy statement on the role of the oncologist in the palliative care of patients with advanced and incurable cancer [6Go]. This commitment must now be expressed through a pan European Policy Initiative to evaluate and report opioid availability and accessibility and to then take steps to address identified shortcomings with policymakers, legislators and regulators.

The initial step in this process is to obtain a country by country assessment of barriers to availability and accessibility of opioids for cancer patients. The National Representatives of ESMO, in cooperation with the Palliative Care Working Group have taken it upon themselves to undertake this task.

This is no small challenge. In taking on this task, ESMO has two discrete advantages over international bodies such as the International Narcotics Control Board or the World Health Authority. The first advantage is that we have an important local presence in every country in which we operate. Cancer is an important disease with a major epidemiological impact and, consequently, medical oncologists play a vital community role. Furthermore, by caring diligently for patients with cancer, oncologists earn a special and distinct credibility as professional patient advocates for the needs of patients with cancer.

With data in hand we will be in a strong position to launch a pan European initiative based on knowledge of what the problems are and where they exist. In this realm of public health, advocacy work with legislators and regulators can at times reap great rewards, as has been the case in the United Kingdom where substantial reforms have been formulated (Appendix) [7Go]. In other settings, however, it can be slow, tiresome and frustrating. Great patience, perseverance and political savvy will be needed. The task ahead is substantial, but we dare not shirk it.

appendix

Summary of the key recommendations from ‘Safer management of controlled drugs’: the Government's response to the Fourth Report of the Shipman Inquiry.

Education
The Government will review the curricula for undergraduate and postgraduate education so that all newly graduating healthcare professionals understand the legal requirements and have the knowledge and skills to use controlled drugs appropriately and safely as an integral part of high quality care.
Physician prescribers
All physicians with a ‘license to practice’, or its equivalent, by the appropriate professional or registration body. Beyond this, good practice guidance will be strengthened to make clear that prescribers should not prescribe beyond the limits of their competence and experience, and that disregarding this principle will result in fitness to practice procedures. A medical practitioner convicted or cautioned in connection with a controlled drugs offence may have restrictions placed on practice and prescribing.
Prescription limits
The Government will issue guidance making clear that single prescriptions for opioids should normally be limited to a supply of 28/30 days, unless exceptional circumstances (such as a patient traveling abroad) require this time to be extended.
Validity of prescription forms
The Government proposes to amend the Misuse of Drugs Regulations 2001 to limit the validity of prescriptions for opioids to 28/30 days.
Amendment of prescription forms
The Government will redesign the standard NHS prescription form allowing for the inclusion of the patient's ID and a marker whenever the prescription is for a controlled drug.
Pharmacists
Will be allowed to correct technical errors in controlled drug prescriptions when the pharmacist is confident that the intention of the prescribers is clear, and he/she is willing to accept professional responsibility for dispensing the prescription in the form in which it is presented.
Monitoring of prescription forms
Pharmacies dispensing such prescriptions will send copies of the form to a central data repository for analysis.
Supplementary prescribers
The Government will introduce legislation enabling supplementary prescribers (nurses and pharmacists) to prescribe controlled drugs where there is genuine need and where patient safety can be assured.

References

1. Opioids and Pain European Network (OPEN) of Minds. The White Paper on Opioids and Pain: a Pan-European Challenge 2005.

2. The International Narcotics Control Board. Report 2004.

3. World Health Organisation. Achieving Balance in National Opioids Control Policy: Guidelines for Assessment. Geneva: World Health Organisation 2000.

4. Council of Europe. Recommendation Rec(2003)24 of the Committee of Ministers to member states on the organisation of palliative care and explanatory memorandum, 2003.

5. Cherny NI, Catane R. Attitudes of medical oncologists toward palliative care for patients with advanced and incurable cancer: report on a survey by the European Society of Medical Oncology Taskforce on Palliative and Supportive Care. Cancer 2003; 98: 2502–2510.[CrossRef][Web of Science][Medline]

6. Cherny NI, Catane R, Kosmidis P. ESMO takes a stand on supportive and palliative care. Ann Oncol 2003; 14: 1335–1337.[Free Full Text]

7. Blunkett D, Reid J. Safer Management of Controlled Drugs: The Government's Response to the Fourth Report of the Shipman Inquiry. London: Her Majesty's Government 2004.


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