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Medication Error Definition
it Email Print Within the Center for Drug Evaluation and Research (CDER), the Division of Medication Error Prevention and Analysis
Medication Error In Nursing
(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 (NCCMERP) definition of a medication error.
Types Of 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."DMEPA includes a medication medication error examples 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 Institute for Safe Medication Practices (ISMP), standard setting organizations such as the United States Pharmacopeia (USP), and fo
the U.S. Food and Drug Administration (FDA) have launched a national education campaign to help eliminate one of the most common but medication error articles preventable sources of medication errors—the use of ambiguous medical abbreviations. Some causes of medication error abbreviations, symbols and dose designations are frequently misinterpreted and lead to mistakes that result in patient harm. medication error classification The ISMP-FDA campaign seeks to promote safe practices and prevent serious and even potentially fatal mistakes when communicating medication orders. The campaign focuses on eliminating the use http://www.fda.gov/drugs/drugsafety/medicationerrors/ of error-prone abbreviations by healthcare professionals and students, medical communications and publishing professionals, the pharmaceutical industry, and FDA staff. ISMP and the FDA plan to reach those audiences through targeted educational materials, articles in professional journals, and presentations at key conferences and meetings. ISMP and FDA recommend that ISMP’s List of Error-Prone Abbreviations, Symbols, and https://www.ismp.org/Tools/abbreviations/ Dose Designations be referenced whenever and wherever medical information is being communicated. This includes internal communications, telephone/verbal prescriptions, computer-generated labels, labels for drug storage bins, medication administration records, and pharmacy and prescriber computer order entry screens, as well as product labeling, industry promotional materials, and medical publications. Some of the abbreviations on ISMP’s list are included in the current Joint Commission on Accreditation of Healthcare Organizations (JC) National Patient Safety Goal 2B, a “do not use” list of error-prone abbreviations, but ISMP’s full listing includes additional medical notations that have been associated with medication errors reported to the ISMP Medication Errors Reporting Program. In addition, ISMP and FDA are making available the following toolkit of resource materials. ONLINE ABBREVIATIONS CAMPAIGN TOOLKIT ISMP Error-Prone Abbreviatons List. A comprehensive, printable two-page list of abbreviations, symbols, and dose designations that should NEVER be used in medical communications. Brochure on Error-Prone Abbreviations. Outlines the scope of the problem and provides a short list of some of the most common a
new drugs because approving a bad drug (Type I error) has more severe consequences for the FDA than does failing to approve a good drug (Type II error). In the former case at least some http://marginalrevolution.com/marginalrevolution/2015/08/is-the-fda-too-conservative-or-too-aggressive.html victims are identifiable and the New York Times writes stories about them and how they died because the FDA failed. In the latter case, when the FDA fails to approve a good drug, people die but the bodies are buried in an invisible graveyard. In an excellent new paper (SSRN also here) Vahid Montazerhodjat and Andrew Lo use a Bayesian analysis to model the optimal tradeoff in clinical trials between sample size, Type I and Type II medication error error. Failing to approve a good drug is more costly, for example, the more severe the disease. Thus, for a very serious disease, we might be willing to accept a greater Type I error in return for a lower Type II error. The number of people with the disease also matters. Holding severity constant, for example, the more people with the disease the more you want to increase sample size to reduce Type I of medication error error. All of these variables interact. In an innovation the authors use the U.S. Burden of Disease Study to find the number of deaths and the disability severity caused by each major disease. Using this data they estimate the costs of failing to approve a good drug. Similarly, using data on the costs of adverse medical treatment they estimate the cost of approving a bad drug. Putting all this together the authors find that the FDA is often dramatically too conservative: …we show that the current standards of drug-approval are weighted more on avoiding a Type I error (approving ineffective therapies) rather than a Type II error (rejecting effective therapies). For example, the standard Type I error of 2.5% is too conservative for clinical trials of therapies for pancreatic cancer—a disease with a 5-year survival rate of 1% for stage IV patients (American Cancer Society estimate, last updated 3 February 2013). The BDA-optimal size for these clinical trials is 27.9%, reflecting the fact that, for these desperate patients, the cost of trying an ineffective drug is considerably less than the cost of not trying an effective one. (The authors also find that the FDA is occasionally a little too aggressive but these errors are much smaller, for example, the authors find that for prostate cancer therapies the optimal significance level is 1.2% compared to a standard rul
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