Fda Medication Error Report
Contents |
Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Drugs Home Drugs Drug Safety and Availability medication errors statistics 2014 Medication Errors Medication Errors Related to Drugs Share Tweet Linkedin Pin it More medication error statistics 2015 sharing options Linkedin Pin it Email Print Within the Center for Drug Evaluation and Research (CDER), the Division of Medication what is a measured amount of drug called Error Prevention and Analysis (DMEPA) reviews medication error reports on marketed human drugs including prescription drugs, generic drugs, and over-the-counter drugs. DMEPA uses the National Coordinating Council for Medication Error Reporting and Prevention
Examples Of Medication Errors
(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; how to prevent medication errors distribution; administration; education; monitoring; and use."DMEPA includes a medication error prevention program staffed with healthcare professionals. Among their many duties, program staff review medication error reports sent to MedWatch, evaluate causality, and analyze the data to provide solutions to reduce the risk of medication errors to industry and others at FDA.Additionally, DMEPA prospectively reviews proprietary names, labeling, packaging, and product design prior to drug approval to help prevent medication errors.Although DMEPA encourages manufacturers to perform their due diligence when naming their drug products and we strive to avoid approving confusing proprietary names for drug products, there are cases of adverse events where a name of a marketed product is identified as a source of confusion and error. Therefore, we continue to encourage healthcare providers, patients and consumers to report all medication errors to MedWatch so that we can be made aware of potential problems related to drug names and the Agency can provide effective interventions that will minimize further errors. In some situations, changing a proprietary name while the product is marketed may be necessary to address safety issues resulting from the name confusion errors.DMEPA also works closely with federal partners, patient safety organizations such as
Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Archived Content The content on this page is provided for reference purposes only. This medication errors in hospitals content has not been altered or updated since it was archived. Search Archive Submit
Medication Errors In Nursing
archive search Drugs Home Drugs Drug Safety and Availability Medication Errors Medication Errors - Reports and Articles Share Tweet Linkedin Pin it
Medication Error Definition
More sharing options Linkedin Pin it Email Print All articles from Drug Topics are reprinted with the permission of Drug Topics, Medical Economics Co, April 2002. Wisniewski L; Holquist C. The absence of a trade http://www.fda.gov/drugs/drugsafety/medicationerrors/ name does not equal a generic drug (PDF - 2MB).Drug Topics 2005, Oct 10.Mahmud AR; Holquist C. Allergic reactions associated with food (PDF - 75KB).Drug Topics 2004, Jan 10.Wisniewski L; Holquist C. Generic name confusion (PDF - 192KB).Drug Topics, 2003, Oct 6.Kim HJ; Phillips J. Medication errors associated with serzone and seroquel (PDF - 60KB). Drug Topics 2002; Jan 7; 146(1); 38.Lee M; Phillips J. Transdermal patches: high risk for error? (PDF - http://www.fda.gov/Drugs/DrugSafety/MedicationErrors/ucm115751.htm 52KB) Drug Topics 2002; April 1; 146(7); 54.Thomas MR; Hoquist C; Phillips J. Med error reports to FDA show a mixed bag (PDF - 73KB).Drug Topics 2001; Oct. 1; 145(19); 23.Holquist C; Phillips J. Curbing med errors involving Anzemet, Bentyl (PDF - 58KB).Drug Topics 2001; July 2; 145(13); 42.Holquist C; Phillips J. How FDA reviews drug names (PDF - 58KB). Drug Topics 2001; April 2;145(17): 36. FDA Performance Plan 2002:Reduce adverse events related to medical products (PDF 825KB). This section of the Performance Plan describes FDA's strategies to reduce preventable deaths and injuries associated with the use of medical products.Retrospective analysis of mortalities associated with medication errors. This American Journal of Health-System Pharmacy article by Jerry Phillips, Associate Director, Office of Drug Safety, and others, discusses the types, causes, contributing factors, and patient demographics of fatal medication errors.Food and Drug Administration Science Background: Safety of Sodium Phosphates Oral Solution(2001). The Division of Over-the-Counter Drug Products has posted a science backgrounder that provides safety information to health care practitioners concerning dosage warnings about the risks of sodium phosphate products.Final Summary of Food and Drug Administration (FDA) Action Items - Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact(2001).To Err is Human: Building a Safer Health System. This 1999 report from the Institute
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 Mistakes http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048644.htm 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) has received medication error 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 errors, including the medication errors in 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 medicine is given more frequently than recommende