The Experts below are selected from a list of 42 Experts worldwide ranked by ideXlab platform
Thomas Felix - One of the best experts on this subject based on the ideXlab platform.
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Pharmacovigilance Considerations for Biosimilars in the USA
BioDrugs, 2015Co-Authors: Gustavo Grampp, Thomas FelixAbstract:In 2015, five or more biosimilars may be approved in the USA. Because no two biologic medicines are identical, postapproval safety monitoring will be critical to detect potential differences in safety signals between a biosimilar, its reference product, and other biosimilars. Postapproval safety monitoring in the USA uses two signal detection systems: spontaneous reporting systems (SRSs) and active surveillance (AS) systems. Both depend on accurate identification of the specific product(s) dispensed or administered to patients, which may be compromised when products from multiple manufacturers share common Drug Nomenclature or coding. Product identification can present challenges across different healthcare settings, including inpatient and ambulatory care. Common oral-dosage Drugs are predominantly dispensed directly to patients by pharmacists, whereas most injectable Drugs, including biologics, are administered to patients by healthcare professionals in outpatient clinics or hospitals. Thus, the effectiveness of SRS and AS mechanisms in both pharmacy and medical channels must be given greater consideration as biotechnology matures. In this article, we describe these systems and their limitations. We identify challenges and opportunities for product-specific safety surveillance of biologics in both the pharmacy and medical settings and provide recommendations to improve biologic safety surveillance under the current and future systems envisioned in the Drug Quality and Security Act. As biosimilars are integrated into existing pharmacovigilance systems, distinguishable nonproprietary names and codes for all biologics, as well as other opportunities to improve traceability (e.g., increased use of barcodes), must be considered to ensure patient safety and confidence in this new class of Drugs.
Amos Abioye - One of the best experts on this subject based on the ideXlab platform.
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integrated approach to Drug Nomenclature
2021Co-Authors: Amos AbioyeAbstract:Abstract The innovation-driven advancements in contemporary science and clinical practice have led to the proliferation of small molecule and macromolecule Drugs (biologics) that cannot be characterized unequivocally. This poses a lot of challenges to Drug Nomenclature systems. Also, the confusion and potential medication errors caused by the multiple proprietary and nonproprietary names of Drugs across many countries and between manufacturers are high orders of global concern. Frantic efforts have been made by the World Health Organization (WHO), Food Drug and Administration (FDA), United States Pharmacopeia (USP), United States Adopted Names (USAN) Council, British Approved Names (BAN), British Pharmacopeia (BP), Australian Approved Names (AAN), Japanese Accepted Names (JAN), etc. to develop and implement Drug Nomenclature programs and policies in their respective countries as well as trans-regional harmonization of nonproprietary names of Drugs. However, it has been a great challenge to achieve unified internationally acceptable nonproprietary names of Drugs across all countries. The regulatory complexities and regional variations in Drug Nomenclature as well as potentially confusing names of Drugs, such as look-alike and sound-alike, are potential risks for medication errors that could cause serious harm to the patients. This chapter reviews the principles, classifications, global trends, current challenges, and future advancements in global Nomenclature of medicinal products. It is envisioned that a patient-centered integrated global Nomenclature system and transdisciplinary partnership would foster a pathway to global unity in the diversity of Drug Nomenclature system where the key stakeholders will engage with each other in the best interest of the patient. This would allow identification, dissemination, and integration of best practices and opportunities for deeper collaboration across the regulatory agencies, practitioners, patients, and Drug manufacturers.
Reich, David L. - One of the best experts on this subject based on the ideXlab platform.
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Extraction and Mapping of Drug Names from Free Text to a Standardized Nomenclature
American Medical Informatics Association, 1Co-Authors: Levin, Matthew A., Krol Marina, Doshi, Ankur M., Reich, David L.Abstract:Free text fields are often used to store clinical Drug data in electronic health records. The use of free text facilitates rapid data entry by the clinician. Errors in spelling, abbreviations, and jargon, however, limit the utility of these data. We designed and implemented an algorithm, using open source tools and RxNorm, to extract and normalize Drug data stored in free text fields of an anesthesia electronic health record. The algorithm was developed using a training set containing Drug data from 49,518 cases, and validated using a validation set containing data from 14,655 cases. Overall sensitivity and specificity for the validation set were 92.2% and 95.7% respectively. The mains sources of error were misspellings and unknown but valid Drug names. These preliminary results demonstrate that free text clinical Drug data can be efficiently extracted and mapped to a controlled Drug Nomenclature
Gustavo Grampp - One of the best experts on this subject based on the ideXlab platform.
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Pharmacovigilance Considerations for Biosimilars in the USA
BioDrugs, 2015Co-Authors: Gustavo Grampp, Thomas FelixAbstract:In 2015, five or more biosimilars may be approved in the USA. Because no two biologic medicines are identical, postapproval safety monitoring will be critical to detect potential differences in safety signals between a biosimilar, its reference product, and other biosimilars. Postapproval safety monitoring in the USA uses two signal detection systems: spontaneous reporting systems (SRSs) and active surveillance (AS) systems. Both depend on accurate identification of the specific product(s) dispensed or administered to patients, which may be compromised when products from multiple manufacturers share common Drug Nomenclature or coding. Product identification can present challenges across different healthcare settings, including inpatient and ambulatory care. Common oral-dosage Drugs are predominantly dispensed directly to patients by pharmacists, whereas most injectable Drugs, including biologics, are administered to patients by healthcare professionals in outpatient clinics or hospitals. Thus, the effectiveness of SRS and AS mechanisms in both pharmacy and medical channels must be given greater consideration as biotechnology matures. In this article, we describe these systems and their limitations. We identify challenges and opportunities for product-specific safety surveillance of biologics in both the pharmacy and medical settings and provide recommendations to improve biologic safety surveillance under the current and future systems envisioned in the Drug Quality and Security Act. As biosimilars are integrated into existing pharmacovigilance systems, distinguishable nonproprietary names and codes for all biologics, as well as other opportunities to improve traceability (e.g., increased use of barcodes), must be considered to ensure patient safety and confidence in this new class of Drugs.
Sabine Koppkubel - One of the best experts on this subject based on the ideXlab platform.
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41 Drug Nomenclature
The Practice of Medicinal Chemistry (Second Edition), 2003Co-Authors: Sabine KoppkubelAbstract:Most products available on the market are nowadays identified by a trade name. This is also true in the pharmaceutical field. The existence of an international Nomenclature for pharmaceutical substances, in the form of International Nonproprietary Names for pharmaceutical substances (INNs), has proved since 1950 to be important for the safe prescription and dispensing of medicines to patients, and for communication and exchange of information among health professionals worldwide. INNs identify pharmaceutical substances by unique names that are globally recognized and are public property. Nonproprietary names, also called generic or common names, are intended to be used as public property without restraint, i.e., nobody should own any rights on their usage. These names are usually designated by national or international Nomenclature commissions. Both trade names and nonproprietary names are normally published first in the form of proposals. Although both nonproprietary names and trade names may appear similar in form to an outsider, there is, in fact, a big difference. First, nonproprietary names are designations to identify the active pharmaceutical Drug substance rather than the final product. Second, the selection of a nonproprietary name follows established rules so that the name itself communicates to the medical and pharmaceutical health professional, to which therapeutic or pharmacological group the active Drug substance belongs.
