Medication Error Fda
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Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Drugs Home medication error statistics 2015 Drugs Drug Safety and Availability Medication Errors Section Contents Menu Drug Safety medication errors statistics 2014 and Availability Medication Errors medication error reports Medication errors cause at least one death every day and injure
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approximately 1.3 million people annually in the United States. Medication mishaps can occur anywhere in the distribution system: prescribing, repackaging, dispensing, administering, or monitoring. Common causes of such errors include:
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poor communication, ambiguities in product names, directions for use, medical abbreviations or writing, poor procedures or techniques, or patient misuse because of poor understanding of the directions for use of the product. In addition, job stress, lack of product knowledge or training, or similar labeling or packaging of a product may be the cause of, or contribute to, an actual or examples of medication errors potential error. CDER began receiving reports of medication errors in January 1992, when the U.S. Pharmacopeia began forwarding reports to the FDA. To evaluate and recommend appropriate action on these reports, the Medication Errors Subcommittee was formed in June 1992. In November 1993, the Agency began evaluating and coding MedWatch reports for medication errors and publicly stated that physicians and other health care professionals could report medication errors directly to the FDA through the MedWatch program. CDER responsibilities are not completed when the safety and effectiveness of a drug product are determined. The Center also has the responsibility for helping to ensure the safe use of the drugs it approves by identifying and avoiding proprietary names that contribute to problems in the prescribing, dispensing, or administration of the product. Because early identification of a potential confusing proprietary name is crucial, CDER reviews these proposed names, prior to approval of a new drug application, by means of the Office of Postmarketing Drug Risk Assessment (OPDRA) CDER's approach to medication errors is as follows: Prevent medication errors prior to a drug's appro
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Errors: Working to Improve Medication Safety Share Tweet Linkedin Pin it More sharing options medication errors in nursing Linkedin Pin it Email Print When Jacquelyn Ley shattered her elbow on the soccer field, her parents set out to find her medication errors in hospitals the best care in Minneapolis. "We drove past five other hospitals to get to the one we wanted," says Carol Ley, M.D., an occupational health physician. Her husband, an orthopedic surgeon, made sure Jacquelyn got the right http://www.fda.gov/Drugs/DrugSafety/MedicationErrors/ucm080629.htm surgeon. After a successful three-hour surgery to repair the broken bones, Jacquelyn, who was 9 at the time, received the pain medicine morphine through a pump and was hooked up to a heart monitor, breathing monitor, and blood oxygen monitor. Her recovery was going so well that doctors decided to turn off the morphine pump and to forgo regular checks of her vital signs.Carol Ley slept in her daughter's hospital room that night. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143553.htm When she woke up in the middle of the night and checked on her, Jacquelyn was barely breathing. "I called her name, but she wouldn't respond," she says. "I shook her and called for help." The morphine pump hadn't been shut down, but had accidentally been turned up high. The narcotic flooded Jacquelyn's body. She survived the overdose, but it was a close call. "If three more hours had gone by, I don't think Jacquelyn would have survived," Ley says. "Fortunately, I woke up."Ley was pleased with the way the hospital handled the error. "They came right out and said the morphine pump was incorrectly programmed, they told me the steps they were going to take to make sure Jacquelyn was OK, and they also told me what they were going to do to make sure this kind of mistake won't happen again. And that's very important to me." The hospital began using pumps that are easier to use and revamped nurses' training. Ley believes there were many contributors to the error, including the fact that it was Labor Day weekend and there were staff shortages. "It goes to show that this can happen to anyone, anywhere," says Ley, who now chairs the board of the National Patient Safety Foundation.Multiple FactorsSince 1992, the Food and Drug
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