藥品標示

保守派主張奈米產品應有特別的標示，觀望派則認為奈米產品是否標示，現階段仍 應個案論斷。鑒於兩說皆無排除奈米產品應標示之可能，故本文以下簡介美國的藥品相 關標示內容，以供參考。

另外，藥品上市之自由因藥品上市許可制之存在，而受有嚴格的限制；同時，消費 者選購處方藥之自由，亦因「專家中介原則」之存在，而受到限制或剝奪。換句話說，

無醫師處方，病患無法合法取得處方藥。鑒於處方藥之使用具有特殊的危險性與許多的 注意事項等，故處方藥相關標示內容原則上係針對專業醫療照護者之需求而設，而有別 於一般產品標示係直接針對消費者需求而設，本文特此敘明。

272 SeeABOOD, supra note 143, at 45.

273 See id.

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6.5.1 標籤（The Commercial Container Label）

藥品標籤應包含製造商、包裝公司（packer）或經銷商 （distributor）之名稱與地址、

藥品名稱、成分資訊、非活性成分的名稱、商名或專稱名字、重量、容量、建議使用劑 量、處方藥標示、使用途徑、檢驗號碼（control number）、藥劑師指示、保存期限等²⁷⁴

未來若「奈米藥品」定義與範圍得以確定，且主管機關認為奈米產品有統一額外標 示之必要者，廠商可參考 21 C.F.R. §201.1、§201.55 與§201.100 之規定。目前處方藥的 標籤規定，處方藥須於標籤加註「限醫師處方使用」（Rx Only）或「注意：聯邦法禁止 未經醫師處方之配藥」（Caution: Federal law prohibits dispensing without prescription）

。

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6.5.2 仿單（The Package Insert）

。

仿單應包含專業健康照護者所需要的科學與醫療資訊，以供藥品作安全與有效之使 用，且應注意相關資訊不得有誤、誤導或具有廣告的性質。

鑒於仿單資訊內容過於龐雜，美國醫療實務通常不以仿單為藥品資訊的主要來源，

故 FDA 於 2000 年開始重新評估，並於 2006 年作出最終的藥品標示調整。新的仿單調 整重點在於使仿單更容易閱讀、記憶，並使專業健康照護者可更快速地搜尋必要資訊，

故新的仿單應設有醒目專區，並包含：警告訊息（Boxed Warnings）、適應症、使用方法、

劑量與使用途徑。

若病患使用藥品，可能受到嚴重損害或死亡者，FDA 可能要求相關訊息須列入警告 訊息（Black Box Warnings）之中，惟後續的調查報告顯示，許多醫師仍無注意到相關警 示或根本未加以注意。事實上，若專業健康照護者能注意警示並進行風險管理者，美國 許多上市藥品可能即可免於藥品下市之命運。

另外，針對病患懷孕期間用藥之警告，依 21 C.F.R. §201.57 (c)(9)之規定，除非符合 排除條件，否則仿單應包含警示資訊，並可分為五類：

1. 妊娠類別 A（Pregnancy Category A）：

若藥品具有以懷孕女性為受試者之適當與良好（well-controlled）的人體臨床試驗研 究，且研究並未顯示出藥品具有傷害胎兒之風險者，仿單仍應包含以下訊息：「妊娠類 別A：研究顯示懷孕女性使用本藥品將無增加胎兒畸型之風險，但研究無法排除所有的 損害可能性，故本藥品仍應僅於妊娠病患具明確需求時使用²⁷⁶

274 See id. at 68.

。」，並描述該人體臨床

275 See id.

276 Pregnancy Category A. Studies in pregnant women have not shown that (name of drug) increases the risk of fetal abnormalities if administered during the first (second, third, or all) trimester(s) of pregnancy. If this drug is used during pregnancy, the possibility of fetal harm appears remote. Because studies cannot rule out the possibility of harm, however, (name of drug) should be used during pregnancy only if clearly needed.

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277 Reproduction studies have been performed in (kinds of animal(s)) at doses up to (x) times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to (name of drug).

278 Pregnancy Category B. Reproduction studies have been performed in (kind(s) of animal(s)) at doses up to (x) times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to (name of drug). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

279 Pregnancy Category B. Reproduction studies in (kind(s) of animal(s)) have shown (describe findings) at (x) times the human dose. Studies in pregnant women, however, have not shown that (name of drug) increases the risk of abnormalities when administered during the first (second, third, or all) trimester(s) of pregnancy. Despite the animal findings, it would appear that the possibility of fetal harm is remote, if the drug is used during pregnancy. Nevertheless, because the studies in humans cannot rule out the possibility of harm, (name of drug) should be used during pregnancy only if clearly needed.

80 救）足以正當化用藥風險者，藥品標示應於「警告與注意事項」（Warnings and Precautions）

中包含以下訊息：「懷孕女性使用本藥品將會傷害胎兒，病患於懷孕中或服藥期間懷孕

280 Pregnancy Category C. (Name of drug) has been shown to be teratogenic (or to have an embryocidal effect or other adverse effect) in (name(s) of species) when given in doses (x) times the human dose. There are no adequate and well-controlled studies in pregnant women. (Name of drug) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

281 Pregnancy Category C. Animal reproduction studies have not been conducted with (name of drug). It is also not known whether (name of drug) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. (Name of drug) should be given to a pregnant woman only if clearly needed.

282 (Name of drug) can cause fetal harm when administered to a pregnant woman. (Describe the human data and any pertinent animal data.) If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be ap-prised of the potential hazard to a fetus.

283 (Name of drug) may (can) cause fetal harm when administered to a pregnant woman. (Describe the human data and any pertinent animal data.) (Name of drug) is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

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與有效性資料、警示、注意事項與藥品禁忌症內容皆將涵蓋於仿單之內，以幫助專業健 康照護者選用藥品、調劑；故相較於單純的奈米標示，其他的具體指示、標示內容，恐 更有助於專業健康照護者進行風險管控，而使奈米標示流於形式化，而易為專業健康照 護者所忽略。