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VigiBase is a World Health Organization's (WHO) global Individual Case Safety Report (ICSR) database that contains ICSRs submitted by the participating member states enrolled under WHO's international drug monitoring programme. It is the single largest drug safety data repository in the world.
Therapeutic drug monitoring (TDM) is a branch of clinical chemistry and clinical pharmacology that specializes in the measurement of medication levels in blood. Its main focus is on drugs with a narrow therapeutic range , i.e. drugs that can easily be under- or overdosed. [ 1 ]
Pharmaceutical codes are used in medical classification to uniquely identify medication. They may uniquely identify an active ingredient , drug system (including inactive ingredients and time-release agents) in general, or a specific pharmaceutical product from a specific manufacturer.
ICD-10 is the 10th revision of the International Classification of Diseases (ICD), a medical classification list by the World Health Organization (WHO). It contains codes for diseases, signs and symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or diseases. [1]
The ICD-10 Clinical Modification (ICD-10-CM) is a set of diagnosis codes used in the United States of America. [1] It was developed by a component of the U.S. Department of Health and Human services, [ 2 ] as an adaption of the ICD-10 with authorization from the World Health Organization .
Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. [1] The REMS program was formalized in 2007.
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The ICD-10 Procedure Coding System (ICD-10-PCS) is a US system of medical classification used for procedural coding.The Centers for Medicare and Medicaid Services, the agency responsible for maintaining the inpatient procedure code set in the U.S., contracted with 3M Health Information Systems in 1995 to design and then develop a procedure classification system to replace Volume 3 of ICD-9-CM.