Drug safety

Drug safety refers to the process by which the Food and Drug Administration (FDA) learns about the safety profile of a drug before approving it to be marketed to the public and monitors its safety once it is in the marketplace. Allmedicines have risks. According to FDA, injuries from approved medicines areone of the top 10 causes of death in the United States.

FDA uses state-of-the-art tools and techniques to detect rare and unexpectedrisks more rapidly and take corrective action more quickly. These include testing and surveillance of drugs, and developing policies, guidance and standards for drug labeling, current good manufacturing practices, clinical and goodlaboratory practices, and industry practices that demonstrate that drugs aresafe. Drug risks include product quality defects, known side effects, medication errors, and uncertainties. Product quality defects are controlled through good manufacturing practices, monitoring and surveillance. Most injuries and deaths are due to known side effects which are identified in the drug's labeling; these can be avoidable (by appropriate use of the drug) or unavoidable(e.g., some drugs have side effects even when used appropriately, such as nausea from antibiotics). Medication errors occur when the drug is given incorrectly or the wrong drug or dose is given. Risks from uncertainties includes unexpected side effects, long-term effects, and uses of the drugs in groups ofpeople (e.g., children or seniors) who were not studied in the clinical trials (e.g., a rare event which occurs in fewer than 1 in 10,000 people would not be identified by normal pre-market testing).

In order for a new drug to be approved, the drug's sponsor (usually a pharmaceutical company) submits a new drug application (NDA) with detailed reports on the drug's properties, development, manufacture, and testing results. The sponsor must conduct clinical trials in three phases (I, II, and III) to showthat the drug is safe and effective. These trials have many goals. The safetygoals are as follows. Phase I seeks to assess safety in healthy volunteers.Phase II and Phase III seek to establish long-term safety in a larger group of people, this time patients with the target disease. During these trials, adverse reactions are closely monitored. When FDA believes that the benefits ofa drug outweigh its risks, the agency approves it.

Since it is impossible for FDA to learn everything about a drug's safety profile before approval, the agency uses a post-marketing surveillance system tomonitor the safety of marketed drugs. FDA uses MedWatch, a medical product reporting program, to gather information about adverse drug and biologic eventsand drug quality problems. The agency uses this information, and informationit gathers from other sources, to reassess drug risks and recommend ways tomanage those risks.

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