Division Medication Error Prevention Analysis
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Office of Medical Products and Tobacco About the Center for Drug Evaluation and medication error prevention strategies Research Office of Surveillance and Epidemiology (OSE) - Divisions Share Tweet Linkedin Pin it More sharing options Linkedin Pin
Medication Error Prevention Powerpoint
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 and Epidemiology medication error prevention videos 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 safety-related issues for medication error prevention initiative 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 utilization team provides denominator data, or conte
& Bioassays Resources...DNA & RNABLAST (Basic Local Alignment Search
Medication Error Prevention For Healthcare Providers
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Medication Error Prevention Initiative Emory Healthcare
RNA Resources...Data & SoftwareBLAST (Basic Local Alignment Search Tool)BLAST (Stand-alone)Cn3DConserved Domain Search Service (CD Search)E-UtilitiesGenBank: BankItGenBank: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm169536.htm SequinGenBank: tbl2asnGenome ProtMapGenome WorkbenchPrimer-BLASTProSplignPubChem Structure SearchSNP Submission ToolSplignVector Alignment Search Tool (VAST)All Data & Software Resources...Domains & StructuresBioSystemsCn3DConserved Domain Database (CDD)Conserved Domain Search Service (CD Search)Structure (Molecular Modeling Database)Vector Alignment Search Tool (VAST)All http://www.ncbi.nlm.nih.gov/pubmed/20210712 Domains & Structures Resources...Genes & ExpressionBioSystemsDatabase of Genotypes and Phenotypes (dbGaP)E-UtilitiesGeneGene Expression Omnibus (GEO) Database Gene Expression Omnibus (GEO) DatasetsGene Expression Omnibus (GEO) ProfilesGenome WorkbenchHomoloGeneMap ViewerOnline Mendelian Inheritance in Man (OMIM)RefSeqGeneUniGeneAll Genes & Expression Resources...Genetics & MedicineBookshelfDatabase of Genotypes and Phenotypes (dbGaP)Genetic Testing RegistryInfluenza VirusMap ViewerOnline Mendelian Inheritance in Man (OMIM)PubMedPubMed Central (PMC)PubMed Clinical QueriesRefSeqGeneAll Genetics & Medicine Resources...Genomes & MapsDatabase of Genomic Structural Variation (dbVar)GenBank: tbl2asnGenomeGenome ProjectGenome ProtMapGenome WorkbenchInfluenza VirusMap ViewerNucleotide DatabasePopSetProSplignSequence Read Archive (SRA)SplignTrace ArchiveAll Genomes & Maps Resources...HomologyBLAST (Basic Local Alignment Search Tool)BLAST (Stand-alone)BLAST Link (BLink)Conserved Domain Database (CDD)Conserved Domain Search Service (CD S
Environmental Health Food and Nutrition Global Health Health Care Workforce Health Services, Coverage, and Access Public Health Quality and Patient Safety Select Populations and Health Disparities http://www.nationalacademies.org/hmd/Activities/Quality/MedicationErrors.aspx Substance Abuse and Mental Health Veterans Health Women's Health Print Print http://www.psqh.com/analysis/2-dispelling-a-few-myths/ Activity Identifying and Preventing Medication Errors Type: Consensus Study Topics: Quality and Patient Safety Board: Board on Health Care Services Activity Description Congress mandated The Institute of Medicine to "carry out a comprehensive study of drug safety and quality issues in order medication error to provide a blueprint for system-wide change." The objectives of the study, as defined by Congress in the Medicare Modernization Act of 2003 (Section 107(c)), were to: Develop a full understanding of drug safety and quality issues through an evidence-based review of literature, case studies, and analysis. This review considered the nature and medication error prevention causes of medication errors, their impact on patients, the differences in causation, impact and prevention across multiple dimensions of health care delivery-- including patient populations, care settings, clinicians, and institutional cultures. Attempt to develop credible estimates of the incidence, severity, costs of medication errors that are useful in prioritizing resources for national quality improvement efforts and influencing national health care policy. Evaluate alternative approaches to reducing medication errors in terms of their efficacy, cost-effectiveness, appropriateness in different settings and circumstances, feasibility, institutional barriers to implementation, associated risks, and the quality of evidence supporting the approach. Provide guidance to consumers, providers, payers, and other key stakeholders on high-priority strategies to achieve both short-term and long-term drug safety goals, to elucidate the goals and expected results of such initiatives and support the business case for them, and to identify critical success factors and key levers for achieving success. Assess the opportunities and key impediments to broad nationwide implementat
Safety Environment and Facilities Magazine Current Issue Subscriber Services Archives Resources All Resources Webinars Videos Whitepapers Forms & Tools Events Career Center Forums About Mission Statement Editorial Advisory Board Authors Partners Sponsorship Contact Privacy Policy Analyses Uncategorized Dispelling a Few Myths February 10, 2016 ‐ Michelle Clarke By the Institute for Safe Medication Practices Now that 2016 is underway, the Institute for Safe Medication Practices (ISMP) would like to extend its sincere thanks to the many healthcare providers, consumers, advocacy groups, organizations, agencies, and companies that have allowed us to be part of their journey to reduce patient harm from medication errors. It has been both a distinct privilege and a profound responsibility to touch the lives of so many during the past year. Since becoming a charitable organization more than two decades ago, ISMP has pursued a singular mission to advance patient safety worldwide by empowering the healthcare community, including consumers, to prevent medication errors. As we were making plans for 2016, we came across several relatively common but inaccurate beliefs about ISMP held by some in the healthcare industry, beliefs that could impact our work. We would like to dispel these myths by providing some general information about ISMP. If you still have questions or are confused about our organization after reading the information that follows, we encourage you to contact us directly (ismpinfo@ismp.org). Myth 1: ISMP is a regulatory, standards-setting, accrediting, or certifying organization. ISMP works in an expert advisory capacity only, with neither the power to set minimum standards of care, nor the authority to certify, regulate, or accredit individuals or organizations based on any standards of care, including those associated with medication safety. While we often support the minimum standards of care required by regulatory, standards-setting, accrediting, and certifying agencies, ISMP also attempts to raise the bar by recommending alternative but practical, high-leverage strategies to improve medication safety. These strategies are based on best practices documented in the literature and learned via ISMP medication error reporting programs, on-site consulting, research, expert consensus building, and advocacy work. As such,