lavie 2009-12-29 12:47
癲癇藥物的自殺警訊加強臨床責任
出處：WebMD醫學新聞
December 16, 2009 (麻州波士頓) — 抗癲癇藥物的新警訊將對醫師有重要的醫療法律涵義。這是在美國癲癇協會第63屆年度科學會議中的重大新聞議題。
去年此時，美國食品藥物管理局(FDA)指示所有抗癲癇藥物製造商，納入自殺風險增加之警訊。這個警訊清楚明確地聲明，需篩檢和自殺有關的精神異常。一年後的現在，責任歸屬上有所混淆，且並非所有病患都被監控。專家認為，這是會讓醫師在法庭上處於不利的缺失。
Rush大學醫學中心的Andres Kanner醫師在受訪時表示，神經科醫師應注意病患有無發生任何症狀，並紀錄於病歷。我們無法承擔不熱心的指控。
Kanner醫師提到對此議題感到挫折，他是癲癇協會一個精神專案小組的協調者，他表示會遵守FDA的警訊，即便他不認同。
他向Medscape Neurology表示，我們回顧FDA的資料，並不同意該後設分析的結論，我們不支持納入所有的抗癲癇藥物。Kanner醫師的團隊向該局提出這些和其他顧慮，且計畫繼續努力溝通。
一名健康法專家、William Mandell律師表示，不論同意與否，當局之規定有重要的法律意義。我認為，指稱該建議是根據不佳的科學來安慰自己，反而是讓自己陷入危險的假象。
Mandell先生指出，FDA有權做出這些決定，且該警訊很清楚，做出決定不篩檢使用抗癲癇藥物病患之憂鬱、自殺思想或行為、不尋常的心情，只是讓你更可能限於不利情況。
【法律上的意義】
Mandell先生強調開方醫師的體認和警覺之重要性，他表示，你負有責任且須尊重FDA的警訊。
但是，由神經科醫師監控精神異常顯然會有抗拒聲浪。聽眾們陸續發言表示關於醫師進行非專業領域事務、無止盡的檢查表還要加入更多項目、使用非特定或未確效的篩檢方法等顧慮。
加州大學洛杉磯分校的Rochelle Caplan醫師表示，神經科醫師不需要詢問精神狀況的時代已經結束。Caplan醫師是小兒神經精神科醫師，也是本會議講師。她表示，醫界對病患負有責任，必須合作表述這些議題。
印第安那大學的David Dunn醫師表示，醫師應將自殺列為詢問的標準問題之一。
史丹佛大學的John Barry醫師表示同意，他指出，篩檢工具可以有幫助且有效。
雖然會議聽眾對於抗癲癇藥物是否加強自殺風險有所辯論，大家似乎有一點達到共識：癲癇病患的自殺風險增加。
Caplan醫師表示，對於我們已經知道處於風險增加的病患進行例行性評估，將可以改善照護品質。
會議結束時，Mandell先生指出，病患和家屬的良好關係是最佳的風險管理方法，我們需要有常識和人道方法。
講者並未在這專題小組會議中討論他們的財務關係。
美國癲癇協會(AES)第63屆年度科學會議：精神專案小組會議。2009年12月8日。
Suicide Warning on Epilepsy Drugs Intensifies Clinical Responsibility
Medscape Medical News
December 16, 2009 (Boston, Massachusetts) — New warnings on antiepileptic drugs will have important medical-legal implications for clinicians. This was the sobering news specialists heard here at the American Epilepsy Society 63rd Annual Scientific Conference.
It was this time last year that the US Food and Drug Administration (FDA) instructed all manufacturers of antiepileptic drugs to include a warning indicating an increased risk of suicide. The warning clearly and unambiguously states the need to screen for psychiatric disorders associated with suicide. One year later, there is confusion about where this responsibility lies, and not all patients are being monitored. It is a gap that specialists say could leave clinicians at risk in a court of law.
"Neurologists must monitor patients for the emergence of any symptoms and document this activity in charts," Andres Kanner, MD, from Rush University Medical Center in Chicago, Illinois, said during an interview."We cannot afford to be lackadaisical."
Dr. Kanner expressed frustration about this issue. He is coordinator of a psychiatry special interest group for the epilepsy society and says that he will adhere to the FDA warning even though he does not agree with it.
"We reviewed the data from the FDA and do not agree with the conclusions of the meta-analysis," he told Medscape Neurology. "We do not support the inclusion of all antiepileptic drugs." Dr. Kanner's group has raised these and other concerns to the agency and plans to continue these efforts.
But agree or not, William Mandell, a lawyer specializing in health law, warned that the regulatory decision has important legal implications. "I think it would be dangerous to take false comfort in the notion the advisory is based on faulty science," he said.
"The FDA has the authority to make these decisions and the warning is clear," Mr. Mandell noted. "Any decision not to screen patients treated with antiepileptic drugs for depression, suicidal thoughts or behavior, and unusual changes in mood could open you up to potential liability."
Legal Implications
Mr. Mandell emphasized the importance of awareness and vigilance among prescribing physicians. "You are accountable and must respect the FDA warning," he said.
But neurologists monitoring for psychiatric disorders? The resistance in the room was palpable. One by one, attendees took the microphone to raise concerns about clinicians working outside their area of expertise, having to add more items to an endless checklist, and using nonspecific or nonvalidated screening approaches.
Rochelle Caplan, MD, from the University of California, Los Angeles, said the era where neurologists did not need to ask about psychiatric well-being is over. Dr. Caplan is a pediatric neuropsychiatrist and speaker at the meeting. She says the medical community has a responsibility to patients and must work together to address these issues.
Regularly evaluating a group of patients we already know are at increased risk will improve quality of care.
David Dunn, MD, from Indiana University at Indianapolis, said that clinicians should be asking about suicide as a standard question.
John Barry, MD, from Stanford University in California, said he agrees and pointed out that screening tools can be beneficial and efficient.
Although meeting attendees debated whether antiepileptic drugs heighten suicide risk, there was 1 point everyone in the room seemed to agree on: patients with epilepsy are at increased risk of suicide.
"Regularly evaluating a group of patients we already know are at increased risk will improve quality of care," Dr. Caplan said.
At the end of the day, Mr. Mandell added, "A good relationship with patients and their families is the best risk management. We need common sense and a humane approach."
The speakers did not discuss their financial relationships at this special interest group meeting.
American Epilepsy Society (AES) 63rd Annual Scientific Conference: Psychiatry Special Interest Group Meeting. December 8, 2009.