Fda Division Medication Error Prevention Analysis
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Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products About FDA Home medication error definition About FDA FDA Organization Office of Medical Products and Tobacco About the
Medication Errors Statistics
Center for Drug Evaluation and Research Office of Surveillance and Epidemiology (OSE) - Divisions Share Tweet Linkedin Pin medication errors in nursing it More sharing options Linkedin Pin it Email Print Office of Surveillance and Epidemiology (OSE) Home OSE Organization(PDF - 84KB) OSE Organization Text Version The Office of Surveillance and Epidemiology consists types of medication errors of Six divisions: Office of Pharmacovigilance and Epidemiology Division of Pharmacovigilance I Division of Pharmacovigilance II Division of Epidemiology I Division of Epidemiology II Office of Medication Error Prevention and Risk Management Division of Medication Error Prevention and Analysis Division of Risk Management Office of Pharmacovigilance and Epidemiology (OPE) Division of Pharmacovigilance (DPV I & DPV II) Safety Evaluators and Medical Officers
Medication Errors Statistics 2015
in DPV-I and DPV-II detect safety signals and assess safety-related issues for all marketed drug and therapeutic biologic products. They use a variety of surveillance tools including adverse event report data, published scientific literature, and preclinical, clinical, and pharmacologic knowledge of the products to provide scientific and clinical evaluation that leads to various regulatory actions and communications for safe use of the marketed products. Division of Epidemiology (DEPI I & DEPI II) Our epidemiologists conduct active drug safety surveillance using Sentinel’s ARIA system (Active Risk Identification and Analysis), and .review drug safety-related epidemiologic study protocols and study reports that are required of manufacturers as post marketing requirements (PMRs) and commitments. They serve as the Agency lead in ensuring that the PMRs conducted by sponsors meet the best practices in epidemiology and can provide robust and actionable evidence to inform regulatory decision making following initial approval. They evaluate safety signals that arise by putting them into the context of drug use, the existing body of evidence in the scientific literature, and by mounting FDA-sponsored epidemiologic studies as needed to quantify and characterize drug safet
Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Drugs preventing medication errors Home Drugs News & Events From our perspective: Working to prevent proprietary examples of medication errors drug name confusion Share Tweet Linkedin Pin it More sharing options Linkedin Pin it Email Print Lubna Merchant,
Medication Error Articles
M.S., Pharm.D., Deputy Director of the Division of Medication Error Prevention and Analysis, discusses the agency’s role in preventing medication errors caused by proprietary (brand) name confusion.About medication errorsFDA uses http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm169536.htm a definition of medication error from the National Coordinating Council for Medication Error Reporting and Prevention. That is, a medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm. These errors can occur while the medication is in the control of the health care professional, patient, or consumer.Medication errors can occur at any http://www.fda.gov/Drugs/NewsEvents/ucm485317.htm time in the medication use process, including during prescribing, dispensing, administering, and monitoring. A medication error can result in patients getting the wrong formulation, strength, dose, frequency, or even the wrong drug. Approximately 54,000 suspected U.S. medication error cases were submitted to FDA in 2014.Drug name confusion can cause medication errorsThere are many ways in which drug name confusion can cause medication errors, such as similarity in spelling and pronunciation that result in prescribing or dispensing of the wrong medication. In addition, analysis of name confusion errors has shown that other factors, such as shared strength or dose between products, may also contribute to name confusion and has led to errors involving drugs with similar names. However, this is not always the case as errors have also been reported despite differences in product strength.Another contributing factor that can lead to drug name confusion is confirmation bias, the tendency to search for, interpret, or recall information in a way that confirms one's beliefs or hypotheses. When a product has been on the market for some time and has name recogn
Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products For Consumers Home For Consumers Consumer Updates Avoiding Medication http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048644.htm Mistakes Share Tweet Linkedin Pin it More sharing options Linkedin Pin it Email Print On This Page: Examples of Medication Errors FDA's Role NOTE: Go to "6 Tips to Avoid Medication Mistakes" for more easy steps you can follow. A medication error is any preventable event that may cause or lead to inappropriate medication use or harm to a patient. Since 2000, the Food and Drug Administration (FDA) medication error has received more than 95,000 reports of medication errors. FDA reviews reports that come to MedWatch, the agency's adverse event reporting program. "These reports are voluntary, so the number of actual medication errors is believed to be higher," says Carol Holquist, R.Ph., Director of the Division of Medication Error Prevention and Analysis in FDA's Center for Drug Evaluation and Research. FDA works with many partners to track medication medication errors statistics errors, including the U.S. Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP). "Every report received through the USP/ISMP Voluntary Medication Error Reporting Program (MERP) automatically gets sent to FDA's MedWatch program," says Mike Cohen, R.Ph., Sc.D., President of ISMP. "It takes a cooperative approach to monitor errors, evaluate them, and educate the public about strategies to keep errors from happening again." Medication errors occur for a variety of reasons. For example, miscommunication of drug orders can involve poor handwriting, confusion between drugs with similar names, poor packaging design, and confusion of metric or other dosing units. "Medication errors usually occur because of multiple, complex factors," says Holquist. "All parts of the health care system—including health professionals and patients—have a role to play in preventing medication errors." back to top Examples of Medication Errors Misuse of Tussionex Prescription Cough Medicine: On March 11, 2008, FDA informed health care professionals about adverse events and deaths in children and adults who have taken Tussionex Pennkinetic Extended-Release Suspension (Tussionex). Tussionex is a long-acting prescription cough medicine. Hydrocodone, the narcotic ingredient in this medicine that controls cough, can cause life-threatening breathing problems when too much medicine is given at one time or when the medici