Division Of Medication Error Prevention And Analysis
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Fda Medication Error Reporting
Evaluation and Research Office of Surveillance and Epidemiology (OSE) - Divisions Share Tweet Linkedin Pin it More sharing options Linkedin
U.s. Food And Drug Administration Medication Error Reports
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 of Six divisions: Office of Pharmacovigilance
Medication Error Prevention For Nurses
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 in DPV-I and DPV-II detect safety signals and assess medication error prevention strategies 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 safety risks detected through spontaneous reports or through systematic review of the scientific literature. In addition, our drug utiliz
Health Search databasePMCAll DatabasesAssemblyBioProjectBioSampleBioSystemsBooksClinVarCloneConserved DomainsdbGaPdbVarESTGeneGenomeGEO DataSetsGEO ProfilesGSSGTRHomoloGeneMedGenMeSHNCBI Web SiteNLM CatalogNucleotideOMIMPMCPopSetProbeProteinProtein ClustersPubChem medication error prevention powerpoint BioAssayPubChem CompoundPubChem SubstancePubMedPubMed HealthSNPSRAStructureTaxonomyToolKitToolKitAllToolKitBookToolKitBookghUniGeneSearch termSearch Advanced Journal list medication error prevention videos Help Journal ListHosp Pharmv.48(8); 2013 SepPMC3847979 Hosp Pharm. 2013 Sep; 48(8): 623–629. Published medication error prevention initiative online 2013 Sep 17. doi: 10.1310/hpj4808-623PMCID: PMC3847979ISMP Medication Error Report Analysis Copyright and License information ►Copyright © 2013 Thomas Land Publishers, Inc.AbstractThese http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm169536.htm medication errors have occurred in health care facilities at least once. They will happen again—perhaps where you work. Through education and alertness of personnel and procedural safeguards, they can be avoided. You should consider publishing accounts of errors in your newsletters and/or presenting http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3847979/ them at your inservice training programs.Your assistance is required to continue this feature. The reports described here were received through the Institute for Safe Medication Practices (ISMP) Medication Errors Reporting Program. Any reports published by ISMP will be anonymous. Comments are also invited; the writers’ names will be published if desired. ISMP may be contacted at the address shown below.Errors, close calls, or hazardous conditions may be reported directly to ISMP through the ISMP Web site (www.ismp.org), by calling 800-FAIL-SAFE, or via e-mail at gro.pmsi@ofnipmsi. ISMP guarantees the confidentiality and security of the information received and respects reporters’ wishes as to the level of detail included in publications.Hosp Pharm. 2013 Sep; 48(8): 623–629. » Nalbuphine-Naloxone Mix-ups 2013 Sep; 48(8): 623–629. Published online 2013 Sep 17. doi: 10.1310/hpj4808-623Nalbuphine-N
Copyright, Trademark (Dr. Copyright is off this month - although some might say that he's always been a bit off - so our very own Dr. Trademark has stepped to the plate to hit more http://garson-law.com/fda-division-medication-error-prevention-analysis/ of your burning legal questions out of the park.) Dear Doc.: I was given a prescription for Noroxin to treat a UTI, but when I got back from Rite-Aid, the bottle they gave me contained Neurontin, which is used to treat epilepsy and pain. Somebody messed up, and from what I read, this could have been very dangerous. Why can't someone keep this from happening by making sure that drug names are medication error not confusingly similar? Signed, Confused Patient Dear Confused: Unlike regular trademarks for things like tractors, condoms and laundry detergent, names used on drugs are supposed to be unique, not confusing, and truthful. There is even an office at the US Food and Drug Administration (FDA) that is supposed to approve trademarks for drugs in an effort to prevent the over 1.3 million injuries each year that result from drug name confusion. Even medication error prevention though a drug company may be able to register a drug trademark with the Patent and Trademark Office (PTO), that does not mean that it will be approved by the FDA. The FDA's Division of Medication Error Prevention and Analysis (DMEPA) reviews all proposed names for confusing similarity to the names of other drugs or drug ingredients, including both trademarks and "established" or generic names. DMEPA typically rejects about one-third of all names reviewed. Some of the issues DMEPA hopes to avoid include names that suggest potentially exaggerated efficacy claims; names that could lead to erroneous prescriptions (e.g., wrong drug or dosage); and names that look or sound confusingly similar to other drug names. According to the FDA, there are some ways to reduce the risk that a name will be found misleading during approval: Avoid names referring to an inactive ingredient in a way that suggests effectiveness; Avoid incorporating a generic name; Avoid names implying unique effectiveness (e.g., wonder or cure); and Avoid using terms that imply maximum strength, such as "Ultra," "Max," "Pro," or "Super." Similar precautions can reduce the risk of using a name that the FDA will consider prone to cause medication errors such as names containing numbers. For example, some pharmacists interpreted "Percocet 5" to mean five tablets per dos