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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.“
When a pharmaceutical company first develops a medicine, it takes out a patent to make sure it has the exclusive right to produce and market the medicine with a particular active ingredient. The active ingredient is the chemical in the medicine that makes the medicine work. These original medicines are often marketed under the pharmaceutical company�s trade-marked name and can be called the �originator brand� or the �branded� medicine.
Generic medicines are produced in factories all over the world. These factories must be approved by international regulators, including Medsafe, before they can provide medicines to New Zealand. Often, the factories that produce generic medicines are also producing the active ingredient for brand-name medicines. It doesn�t matter where in the world the factory producing the generic medicine is, the approval process and the standards for the medicines are the same. Generic medicines are often produced by major pharmaceutical companies that also develop original brand-name medicines. Many brand-name companies are now buying or going into partnership with generic medicines companies to expand the range of products they produce and broaden their revenue base.
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