癌症疼痛是歐洲的“公衛災難”
作者：Nick Mulcahy
出處：WebMD醫學新聞
February 24, 2010 — 在歐洲許多國家中，病患接受藥物緩解癌症疼痛有「諸多限制考量」，根據一篇新報告，這導致了癌症疼痛治療不夠，造成的相關痛苦可說是「公衛災難」。
這個問題在東歐更是普遍，因為對於鴉片類藥物有一些錯誤概念且擔心它們的濫用會導致嚴重的管理問題。
舉例而言，在喬治亞，門診病患的鴉片類藥物調劑許可，被限制在管區警察局內的特定藥局內。
在烏克蘭，鴉片類藥物處方僅限一天藥量，遠不及瑞典、荷蘭與芬蘭的90天藥量。
根據歐洲腫瘤內科協會(ESMO)以及歐洲緩和照護協會(EAPC)聯合發表的報告，在一些國家中，醫師們擔心刑事告訴，因此在癌症病患的疼痛治療上就會有所考量而治療不夠。
該報告發表於三月份的腫瘤醫學誌(Annals of Oncology)，使用的資料來自2007/08年對一些在該國的腫瘤科或緩和照護領域中之資深醫師的調查。
此項調查蒐集了21個東歐國家與20個西歐國家，以及以色列的藥物處方集與管理規定的資料。
第一作者、Nathan Cherny醫師在歐洲的會議中提出之前發表的資料時表示，各地的醫師都對我們將此狀況公諸於世表達祝賀之意，希望藉此公開討論而促進相關當局採取行動。
Cherny醫師來自以色列耶路撒冷Shaare Zedek醫學中心，也是ESMO的緩和照護工作小組成員，他表示，良好的病患照護與管制保護之間需取得平衡。
不過，這個平衡觀點對許多政府而言似乎是對牛彈琴。
他向Medscape Oncology表示，國際麻醉藥管制委員會以及世界衛生組織都建議立法規範，且已經推動多年。
根據2月22日線上版Palliative Care期刊的編輯評論，至少從1961年開始，公部門就已經開始尋求緩解疼痛之麻醉藥品的適當法規。
編輯、威斯康辛大學癌症中心的James Cleary與另外兩位編輯指出，近十年來，東歐國家還是面臨這個問題。
編輯們指出，雖然西歐的鴉片類藥品使用有顯著增加，但東歐在過去20多年幾乎沒有改變。
【處方集與費用：東歐與西歐的比較】
新版ESMO/EAPC報告的主要目標是，評估與報告鴉片類藥品的取得性以及法律和管理方面的障礙，來評估整個歐洲國家的情況。
為了確認可取得性，作者們著眼在各國處方集與WHO的必要藥品清單(可待因；口服立即釋放、口服控制釋放、注射型嗎啡)，以及國際安寧與緩和照護協會的緩和照護必要藥品清單(除了和WHO相同的藥品之外，加上口服立即釋放型oxycodone；經皮吸收型fentanyl transdermal；以及口服立即釋放型美沙酮)的相關部分。
為了評估過度管理，作者們使用衍伸自WHO對於鴉片類藥品管理的原則，且將其與各國的管理進行比較。
除了希臘和土耳其，西歐多數國家的鴉片類藥品處方集提供了不同的選項。
研究作者們指出，大多數的西歐國家中，癌症病患可以免費取得多數的鴉片類藥物。
東歐國家情況則不同，報告指出，許多東歐國家的鴉片類處方集有相當的限制。
有些國家，例如克羅埃西亞、捷克、愛沙尼亞、匈牙利、拉脫維亞、羅馬尼亞、塞爾維亞和斯洛伐克共和國，提供所有的必要藥品且多數是免費的或者補助超過75%。
不過，在阿爾巴尼亞、白俄羅斯、喬治亞、立陶宛、塔吉克和烏克蘭，處方集嚴重不足，無法取得必要的藥品。
【官僚阻礙！即使是西歐也是】
研究者觀察指出，一般而言，鴉片類處方集限制最多的國家，在取得上的管理障礙也最多。
研究者寫道，多數東歐國家以及少數西歐國家要求病患，特別是門診病患，須有許可證或登記以取得接受鴉片類藥物處方緩解癌症疼痛的資格，有時候連安寧照護案例也要。
在各西歐國家中，處方醫師必須有許可證，所有東歐和多數西歐國家要求雙人或三人處方，需使用特定的格式，而困難發生在從政府獲得這些格式，在阿爾巴尼亞、丹麥、愛沙尼亞與拉脫維亞，醫師們需購買他們的處方格式。
處方上的限制在整個歐洲有很大的差異，許多東歐國家限制鴉片類處方需小於3週，阿爾巴尼亞、白俄羅斯、喬治亞、立陶宛、摩爾多瓦、俄羅斯與烏克蘭限制在1週。
整個歐洲的另一個重要問題是，很少很少國家允許醫師使用電話或傳真處方，這個阻礙了緊急疼痛處置，特別是晚上或者病患離家時。
研究作者們也指出，至少有10個國家在管理上將鴉片類藥物污名化，例如「危險藥品」或「毒藥」。
ESMO/EAPC報告提出一系列的重要建議，或許，最值得一提的是政府撤銷那些阻礙了癌症疼痛之良好臨床照護的過度嚴格或過多的限制。ESMO與EAPC資助此報告。
Ann Oncol. 2010;21:615-626. Palliat Med. 線上發表於2010年2月22日。
Cancer Pain is "Public Health Catastrophe" in Europe
By Nick Mulcahy
Medscape Medical News
February 24, 2010 — Patient access to medication to relieve cancer pain is "profoundly restricted" in many European countries. The resulting undertreatment of cancer pain and the related suffering are a "public health catastrophe," according to a new report.
The problem is most prevalent in Eastern Europe, where a combination of misconceptions about opioid medications and fears about their illicit use have led to severe regulations.
For instance, in Georgia, dispensing privileges for outpatient opioids are restricted to special pharmacies in district police stations.
In Ukraine, prescriptions for opioids are limited to a 1-day supply, compared with the 90-day supply allowed in countries such as Sweden, the Netherlands, and Finland.
In some countries, clinicians fear criminal prosecution and therefore deliberately undertreat pain in cancer patients, according to the report, which was issued jointly by the European Society for Medical Oncology (ESMO) and the European Association for Palliative Care (EAPC).
The report, published in the March issue of the Annals of Oncology, uses findings from a 2007/08 survey of senior clinicians holding leadership positions in their respective European countries in oncology or palliative care.
The survey collected data about drug formularies and regulations from 21 Eastern European countries and 20 Western European countries, including Israel.
Clinicians everywhere have congratulated us on bringing this situation to light.
"Clinicians everywhere have congratulated us on bringing this situation to light, with the hope that exposure and discussion will prompt the relevant authorities into action," said lead author Nathan Cherny, MD, referring to earlier presentation of data from the report at meetings in Europe.
Dr. Cherny, who is from Shaare Zedek Medical Center in Jerusalem, Israel, and is a member of the Palliative Care Working Group of ESMO, said that there needs to be a balance between good patient care and diversion protection.
However, the idea of balance has fallen on deaf ears in many governments, he suggested.
"The International Narcotic Control Board and the World Health Organization [WHO] have recommended legislative guidelines and have been promoting them for years," he told Medscape Oncology.
Declarations by public bodies seeking adequate provision of narcotics for pain relief date from at least 1961, according to an editorial about the report published online February?22 in Palliative Care.
There has been little change in the last 20 years in Eastern Europe.
In recent decades, Eastern Europe continues to be a problem area, note editorialist James Cleary, MB, from University of Wisconsin Carbone Cancer Center in Madison, and his 2 colleagues.
"While there has been a significant increase in opioid consumption in Western Europe, there has been little change in the last 20 years in Eastern Europe," note the editorialists.
Formularies and Cost: Eastern vs Western Europe
The principle aim of the new ESMO/EAPC report is to "evaluate and report on opioid availability and the legal and regulatory barriers to accessibility across the countries of Europe."
To determine availability, the authors looked at national formularies in relation to the WHO essential drugs list (codeine; and oral immediate-release, oral controlled-release, and injectable morphine) and the International Association for Hospice and Palliative Care list of essential medicines for palliative care (the same drugs as the WHO, plus oral immediate-release oxycodone; fentanyl transdermal; and oral immediate-release methadone).
To assess overregulation, the authors used the principles derived from the WHO guidelines on opioid regulations and compared them with each country's regulations.
Except for Greece and Turkey, the opioid formularies of most countries in Western Europe provide a range of options with different opioids.
In the majority of Western European countries, most opioids are available at no cost to patients with cancer pain, the report authors note.
Eastern Europe is a different story. The opioid formularies in "many Eastern Europe countries are substantially limited," notes the report.
Some countries, such as Croatia, the Czech Republic, Estonia, Hungary, Latvia, Rumania, Serbia, and the Slovak Republic, provide all essential medicines and most are either free or available at a subsidy of more than 75%.
However, there are "severe formulary deficiencies" characterized by unavailability of essential medicines in Albania, Belarus, Georgia, Lithuania, Tajikistan, and Ukraine.
Bureaucratic Impediments, Even in Western Europe
In general, the countries with the most limited opioid formularies tend to have the greatest number of regulatory barriers to accessibility, observe the study authors.
Most of the Eastern European and a minority of the Western European countries require that patients, particularly outpatients, receive a permit or be registered to be eligible to receive opioid prescriptions for the management of cancer pain — even in hospices in some cases, write the study authors.
In various Eastern European countries, prescribing physicians must also have a permit. All Eastern and most Western European countries require prescriptions in duplicate or triplicate. Special forms must be used and difficulties occur in getting the forms from the government. In Albania, Denmark, Estonia, and Latvia, physicians need to purchase their prescription forms, report the authors.
Prescription limits vary widely throughout Europe. Many of the Eastern European countries restrict opioid prescriptions to a supply of less than 3 weeks, and Albania, Belarus, Georgia, Lithuania, Moldova, Russia, and Ukraine restrict supply to a week.
Another major problem throughout Europe is that "few" countries allow physicians to prescribe by phone or fax. This hampers any kind of emergency pain management, especially at night or when patients are away from their homes.
The study authors also note that at least 10 of the countries evaluated referred to opioids with stigmatizing terms in their regulations, including "dangerous drugs" and "poisons."
The ESMO/EAPC report makes a series of "major recommendations," perhaps the most notable being that governments repeal "over vigilant or excessive restrictions that impede good clinical care of cancer pain."
The report was funded by ESMO and EAPC.
Ann Oncol. 2010;21:615-626.
