2023年10月6日 星期五

"off-label use", Refresher Programs, Renaissance, freshers' week

Medtronic Product Linked to Problems


Medtronic's potent substance used in spine-repair surgery to promote bone growth has been linked to life-threatening complications in dozens of patients. Many of the complications have occurred during "off label" uses.



Refresher Programs, Renaissance

Refresher Programs Keep Graduates Up To Date
2007年07月19日13:38


Every freshers' week at Oxford, Christ Church Cathedral fill the church with candle and disco lights to invite new students to experience the space.

📷 Twitter | Rev Clare Hayns

#WelcomeToOxford
說明
refresher
noun [C]
a course to practise and improve skills, especially because you have not used them for a long time:
I went on a refresher course on new techniques in design to bring myself up to date.





Can your M.B.A. degree go stale?
你的MBA學位過時了嗎﹖

說明:can (POSSIBILITY)
modal verb
used to express possibility:
You can get stamps from the local newsagents.
You can get very nasty skin diseases from bathing in dirty water.
Smoking can cause cancer.
Noise can be quite a problem when you're living in a flat.
He can be really annoying at times (= He is sometimes very annoying).




That's what Michele Stafiniak, director, sales force administration, for GlaxoSmithKline's U.S. pharmaceuticals business, started wondering last December as she reflected on the past year and looked ahead to 2007. Coincidentally, she opened her mail to find an announcement of a new M.B.A. refresher program at Northwestern University's Kellogg School of Management in Evanston, Ill.
去 年12月﹐在葛蘭素史克公司(GlaxoSmithKline)美國製藥業務負責管理銷售團隊的米歇爾•斯坦弗尼克(Michele Stafiniak)不禁開始回顧過去、展望來年﹐這時候﹐她開始思考自己的MBA學位是不是漸漸過時了。巧得很﹐她打開電子郵件後就發現了來自西北大學 凱洛格商學院(Northwestern University's Kellogg School of Management)的信息﹐向她推介一項新的MBA進修課程。

說明: director 沒翻譯,這是中上級主管, 台灣稱為處長等等。
如上說明 refresher program不是"新的MBA進修課程"。它是專門"溫故知新"用的新的MBA課程。



'I was looking for some new challenges and an opportunity to brush up my skills,' says Ms. Stafiniak, who received her M.B.A. from Temple University in 1998. 'I thought the Kellogg program could differentiate me and open new doors.'

斯坦弗尼克女士說﹐“我正在尋找一些新的挑戰和機會來提高自己的技能。”“我想凱洛格商學院的課程可以讓我出類拔萃﹐為我的職業生涯帶來新的契機。”Stafiniak女士於1998年獲得坦普大學(Temple University)的MBA學位。
說明:

brush up on sth phrasal verb
to improve your knowledge of something already learned but partly forgotten:
I thought I'd brush up on my French before going to Paris.


Ms. Stafiniak and 13 other students signed up for the inaugural class in Kellogg's Renaissance Post-M.B.A. program. They spent two weeks on campus in April, boning up on the Sarbanes-Oxley Act, corporate governance reforms, and outsourcing and offshoring in operations and supply chains. Classes covered such topics as the global economy, hedge funds and leveraged buyouts, information-technology management, and leading and marketing in the 'nanosecond culture.'
斯 坦弗尼克女士及其他13名學生註冊了凱洛格商學院名為Renaissance的首期MBA後課程。4月份﹐他們在校園內度過了兩週﹐突擊鑽研《薩賓斯-奧 克斯利法》(Sarbanes-Oxley Act)﹐公司治理改革﹐業務和供應鏈外包以及離岸外包等內容。進修班課程涵蓋了全球經濟、對沖基金、杠杆收購、信息技術管理以及“毫微秒文化” (nanosecond culture)下的領導和營銷等廣泛內容。

說明:

Renaissance 通譯成"文藝復興" 。其實原意為"再生/新生"。

bone up phrasal verb INFORMAL
to learn as much as you can about something for a special reason:
She boned up on economics before applying for the job.
翻譯成{突擊鑽研}太奇怪



"off label"
adj.
Of or relating to a drug prescribed to treat a condition for which it has not been approved by the Food and Drug Administration.


Wikipedia article "Off-label use".
Off-label use is the practice of prescribing pharmaceuticals for a purpose outside the scope of a drug's approved label, most often concerning the drug's indication. In the United States, the Food and Drug Administration (FDA) requires numerous clinical trials to prove a drug's safety and efficacy in treating a given disease or condition. If satisfied that the drug is safe and effective, the drug's manufacturer and the FDA agree on specific language describing dosage, route and other information to be included on the drug's label. More detail is included in the drug's package insert.
However, once the FDA approves a drug for prescription use, they do not attempt to regulate the usage of the medicine, and so the physician makes decisions based on her or his best judgment. It is legal in the United States and in many other countries to use drugs off-label, including controlled substances such as opiates, even though it is a common misconception that it is unlawful to do so. Actiq, for example, is commonly prescribed off-label even though it is a Schedule II controlled substance. However, it is unlawful to market, advertise or otherwise promote the off-label use of drugs, including controlled substances.
Off-label use of medications is very common. Up to one-fifth of all drugs are prescribed off-label and amongst psychiatric drugs, off-label use rises to 31 percent (Radley, et al. 2006).[2] New drugs are often not tested for safety and efficacy specifically in children. Therefore, it is believed that between 50 percent and 75 percent of all medications prescribed by pediatricians in the U.S. are for off-label applications.[1]


用藥有適應症外用途 醫生必須事先告知?
痔瘡藥膏可以治療青春痘!避孕藥物能讓皮膚變得更好!利尿劑被用來減肥!治療攝護腺肥大的藥物,讓禿頭男重新長出頭髮!這些都是常見的Off label use(適應症外用途)運用案例,但萬一出了問題,卻容易引起醫療糾紛。
為此,衛生署醫事處最近行文給各大醫療院所,要求醫師在開立處方藥物時,如果患者疾病不在仿單適應症範圍時,就必須善盡告知的義務,以避免日後的醫療糾紛。
據了解,為了減少醫病糾紛,部分醫院已私下草擬病人、家屬同意書,要求醫師在使用Off label use藥物時,如果覺得可能引起嚴重副作用時,就應該讓病患或家屬在同意書上簽名。
但民眾到底該簽還是不簽呢?不簽,擔心影響醫病關係,醫師會不高興。但要是簽了名,服藥後,出了問題,會不會形同放棄了自身權益?
台灣醫療改革基金會研發組組長朱顯光指出,本來醫師與病人之間的醫療資訊就處於一個不對等的天平,就算病患簽了同意書,服藥之後,發生問題,要是醫師在醫療上站不出腳,患者仍然可以究責,要求賠償。
朱顯光建議,如果病患處於有立即危險時,家屬當然還是先簽,以搶救生命為先。如果是在門診,對於醫師所開立的藥物有疑問,可以先不領藥;回家再上衛生署或相關醫學會網站,查詢這顆藥物的適應症資料,以及了解是否得自費。
朱顯光也認為,儘管衛生署要求各大醫院應盡到告知義務,但實際上很難落實,大部分民眾不太可能拒絕領藥,當面挑戰醫師的醫學專業知識。
對於衛生署的這紙公文,台安醫院婦產科主任陳思銘也認為,立意良好,但執行上確實有困難。大部分民眾不懂得藥理作用,如果每開一顆Off label use藥物,都要講清楚,那不就得幫每個病人上藥理課。

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