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In the U.S., the government’s Food and Drug Administration (FDA) must approve any drug – whether it’s prescription or over-the-counter – before it can be sold. The FDA evaluates the safety of a drug by looking at side effects, how it’s manufactured, results of animal testing and clinical trials, and more. The FDA also monitors a drug’s safety after approval.
(the earliest form of the word is the Mycenaean Greek pa-ma-ko, attested in Linear B syllabic script[2]).
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. 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.“
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