幾個概念：用藥錯誤，毒性，藥品不良反應

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(1) 用藥錯誤

根據FDA的定義：

Specifically, a medication error is "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use."

醫生開錯藥，藥房抓錯藥，病人吃錯藥（低血壓病人吃了高血壓藥），都是medication error 的原因。 FDA專門有個部門負責預防 medication errors.

Within the Center for Drug Evaluation and Research (CDER), the Division of Medication Error Prevention and Analysis (DMEPA) reviews medication error reports on marketed human drugs including prescription drugs, generic drugs, and over-the-counter drugs. The DMEPA uses the National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) definition of a medication error.

（2）毒性

Toxicity is the degree to which a substance can damage an organism. Toxicity can refer to the effect on a whole organism, such as an animal, bacterium, or plant, as well as the effect on a substructure of the organism, such as a cell (cytotoxicity) or an organ such as the liver (hepatotoxicity). （wiki）

西藥開發過程中的毒性控製是至關重要的一環。毒性對一個新藥的成敗有一票否決權。詳細可參見俺以前寫的文章：

再說現代藥物（西藥）的毒性控製 [健康養生] - 26484915(11625 bytes ) 2014-07-12

（3）藥品不良反應

Adverse drug reaction (ADR, or adverse drug effect) is a broad term referring to unwanted, uncomfortable, or dangerous effects that a drug may have. ADRs can be considered a form of toxicity; however, toxicity is most commonly applied to effects of overingestion (accidental or intentional—see Poisoning) or to elevated blood levels or enhanced drug effects that occur during appropriate use (eg, when drug metabolism is temporarily inhibited by a disorder or another drug). Side effect is an imprecise term often used to refer to a drug's unintended effects that occur within the therapeutic range. Because all drugs have the potential for ADRs, risk-benefit analysis (analyzing the likelihood of benefit vs risk of ADRs) is necessary whenever a drug is prescribed. (The Merck Manual)

(4) 藥品不良反應監測與報告