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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.“
In all medicines, there are both active and inactive ingredients. The inactive ingredients in the medicine are called excipients. These inactive ingredients hold the medicine together, give the medicine its colour or make it easier to swallow. Generic medicines can look different because the inactive ingredients in the generic medicine may be different to the inactive ingredients in the original medicine.
Since generic companies do not have to make the medicine from scratch or, in most cases, pay for the research, development and marketing of a new medicine, and do not have to carry out the same range of clinical trials that the original medicine has to go through, it costs less for them to put the medicine on the market. Generic medicines are also cheaper because of competition. When different makers of a medicine are competing against each other prices come down.
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