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2041-1480
Zhu, Qian
Jiang, Guoqian
Chute, Christopher G
Journal Article
England
J Biomed Semantics. 2012 Dec 20;3(1):16. doi: 10.1186/2041-1480-3-16.

", "tags": [], "relations": {}, "dateAdded": "2019-01-25T19:53:04Z", "dateModified": "2019-02-11T15:17:28Z" } }, { "key": "R44GU9AY", "version": 20, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/R44GU9AY", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/R44GU9AY", "type": "text/html" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "creatorSummary": "Qian Zhu et al.", "parsedDate": "2012", "numChildren": 0 }, "data": { "key": "R44GU9AY", "version": 20, "itemType": "journalArticle", "title": "Profiling Structured Product Labeling with NDF-RT and RxNorm", "creators": [ { "creatorType": "author", "name": "Qian Zhu" }, { "creatorType": "author", "name": "Guoqian Jiang" }, { "creatorType": "author", "name": "Christopher G Chute" } ], "abstractNote": "The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by United States Food and Drug Administration (FDA) as a mechanism for exchanging drug product information. The SPL includes rich information about FDA approved clinical drugs, however, lack of linkage to standard drug ontologies hinders its meaningful use. In this paper, we present a framework that intends to map SPL drug labels with existing drug ontologies, NDF-RT (National Drug File Reference Terminology) and RxNorm. We also use existing categorical annotations to classify SPL drug labels into corresponding classes. We established the classification and relevant linkage for SPL drug labels using the following 3 approaches. First, we retrieved NDF-RT categorical information from the External Pharmacologic Class (EPC) indexing SPLs. Second, we used the RxNorm and NDF-RT mappings to classify and link SPLs with NDF-RT categories. Third, we profiled SPLs using RxNorm term type information. In the implementation process, we employed a Semantic Web technology framework, in which we stored the data sets from RxNorm, NDF-RT and SPLs into a RDF triple store, and executed SPARQL queries to retrieve data from customized SPARQL endpoints.", "publicationTitle": "Vaccine and Drug Ontology Studies 2012", "publisher": "", "place": "", "date": "2012", "volume": "", "issue": "", "section": "", "partNumber": "", "partTitle": "", "pages": "", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "", "citationKey": "", "url": "", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [ "54QJ6CSE" ], "relations": {}, "dateAdded": "2019-01-25T19:53:38Z", "dateModified": "2019-01-25T19:53:38Z" } }, { "key": "IXMY5KKW", "version": 20, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/IXMY5KKW", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/IXMY5KKW", "type": "text/html" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "creatorSummary": "Yu Lin and Yongqun He", "parsedDate": "2012", "numChildren": 0 }, "data": { "key": "IXMY5KKW", "version": 20, "itemType": "journalArticle", "title": "Ontology representation and analysis of vaccine formulation and administration, and their effects on vaccine immune responses", "creators": [ { "creatorType": "author", "name": "Yu Lin" }, { "creatorType": "author", "name": "Yongqun He" } ], "abstractNote": "Vaccine formulation and administration methods may affect vaccine efficacy and safety significantly. In this report, the detailed classifications and definitions of vaccine components and vaccine administration processes are represented using OWL within the framework of Vaccine Ontology (VO). Different use cases are then studied to show how different vaccine formulations and routes of administering vaccines affect the protection efficacy, general immune responses, and adverse events following vaccination. Our results indicate that the two factors, vaccine formulation and administration route, can independently affect host response outcomes after vaccination. These two factors also interact with each other in their influence to the vaccine immune responses. The adverse events of live attenuated and nonliving licensed vaccines approved by the US FDA were analysed and compared. The live attenuated and nonliving vaccines are usually administered in different routes and have different local and systematic adverse effect manifestations.", "publicationTitle": "Vaccine and Drug Ontology Studies 2012", "publisher": "", "place": "", "date": "2012", "volume": "", "issue": "", "section": "", "partNumber": "", "partTitle": "", "pages": "", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "", "citationKey": "", "url": "", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [ "54QJ6CSE" ], "relations": {}, "dateAdded": "2019-01-25T19:53:38Z", "dateModified": "2019-01-25T19:53:38Z" } }, { "key": "XWNJ87SV", "version": 20, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/XWNJ87SV", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/XWNJ87SV", "type": "text/html" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "parsedDate": "2009", "numChildren": 0 }, "data": { "key": "XWNJ87SV", "version": 20, "itemType": "journalArticle", "title": "", "creators": [], "abstractNote": "", "publicationTitle": "", "publisher": "", "place": "", "date": "2009", "volume": "16", "issue": "", "section": "", "partNumber": "", "partTitle": "", "pages": "", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "", "citationKey": "", "url": "", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [], "relations": {}, "dateAdded": "2019-01-25T19:53:38Z", "dateModified": "2019-01-25T19:53:38Z" } }, { "key": "EPYWPHYS", "version": 22, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/EPYWPHYS", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/EPYWPHYS", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/599270/items/3BGXRPR5", "type": "application/json" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "EPYWPHYS", "version": 22, "parentItem": "3BGXRPR5", "itemType": "note", "note": "

Schadow, Gunther R01 HS15377/HS/AHRQ HHS/United States Comparative Study Evaluation Studies Journal Article Research Support, U.S. Gov't, P.H.S. United States J Am Med Inform Assoc. 2009 Mar-Apr;16(2):211-9. doi: 10.1197/jamia.M2933. Epub 2008 Oct 24.

", "tags": [], "relations": {}, "dateAdded": "2019-01-25T19:53:37Z", "dateModified": "2019-01-25T19:53:37Z" } }, { "key": "EL8PBTWW", "version": 22, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/EL8PBTWW", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/EL8PBTWW", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/599270/items/AWIEB8R4", "type": "application/json" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "EL8PBTWW", "version": 22, "parentItem": "AWIEB8R4", "itemType": "note", "note": "

from splitting #1614

", "tags": [], "relations": {}, "dateAdded": "2019-01-25T19:53:37Z", "dateModified": "2019-01-25T19:53:37Z" } }, { "key": "AWIEB8R4", "version": 20, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/AWIEB8R4", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/AWIEB8R4", "type": "text/html" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "creatorSummary": "Erica Marcos and Yongqun He", "parsedDate": "2013", "numChildren": 1 }, "data": { "key": "AWIEB8R4", "version": 20, "itemType": "journalArticle", "title": "The Ontology of Vaccine Adverse Events (OVAE) and its usage in representing and analyzing vaccine adverse events", "creators": [ { "creatorType": "author", "name": "Erica Marcos" }, { "creatorType": "author", "name": "Yongqun He" } ], "abstractNote": "Licensed human vaccines can induce various adverse events in vaccinated patients. Many known vaccine adverse events (VAEs) have been recorded in the package inserts of commercial vaccine products. To better represent and analyse VAEs, we developed the Ontology of Vaccine Adverse Events (OVAE) as an extension of the Ontology of Adverse Events (OAE) and the Vaccine Ontology (VO). OVAE has been used to represent and classify the adverse events recorded in package insert documents of commercial vaccines licensed by the USA Food and Drug Administration (FDA). OVAE currently includes over 1100 terms, including 87 distinct types of VAEs associated with 63 human vaccines licensed in the USA. Specific VAE occurrence rates associated with different age groups have been recorded in OVAE. SPARQL scripts were developed to query and analyse the OVAE knowledge base data. The top 10 vaccines accompanying with the highest numbers of VAEs and the top 10 VAEs most frequently observed among vaccines were identified and analysed. Different VAE occurrences in different age groups were also analysed. The ontological representation and analysis of the VAE data associated with licensed human vaccines improves the classification and understanding of vaccine-specific VAEs which supports rational VAE prevention and treatment and benefits public health.", "publicationTitle": "Vaccine and Drug Ontology Studies 2013", "publisher": "", "place": "", "date": "2013", "volume": "", "issue": "", "section": "", "partNumber": "", "partTitle": "", "pages": "", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "", "citationKey": "", "url": "", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [ "54QJ6CSE" ], "relations": {}, "dateAdded": "2019-01-25T19:53:37Z", "dateModified": "2019-01-25T19:53:37Z" } }, { "key": "3BGXRPR5", "version": 20, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/3BGXRPR5", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/3BGXRPR5", "type": "text/html" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "creatorSummary": "G. Schadow", "numChildren": 1 }, "data": { "key": "3BGXRPR5", "version": 20, "itemType": "journalArticle", "title": "Structured product labeling improves detection of drug-intolerance issues", "creators": [ { "creatorType": "author", "name": "G. Schadow" } ], "abstractNote": "OBJECTIVES: This study sought to assess the value of the Health Level 7/U.S. Food and Drug Administration Structured Product Labeling (SPL) drug knowledge representation standard and its associated terminology sources for drug-intolerance (allergy) decision support in computerized provider order entry (CPOE) systems. DESIGN: The Regenstrief Institute CPOE drug-intolerance issue detection system and its knowledge base was compared with a method based on existing SPL label content enriched with knowledge sources used with SPL (NDF-RT/MeSH). Both methods were applied to a large set of drug-intolerance (allergy) records, drug orders, and medication dispensing records covering >50,000 patients over 30 years. MEASUREMENTS: The number of drug-intolerance issues detected by both methods was counted, as well as the number of patients with issues, number of distinct drugs, and number of distinct intolerances. The difference between drug-intolerance issues detected or missed by either method was qualitatively analyzed. RESULTS: Although <70% of terms were mapped to SPL, the new approach detected four times as many drug-intolerance issues on twice as many patients. CONCLUSION: The SPL-based approach is more sensitive and suggests that mapping local dictionaries to SPL, and enhancing the depth and breadth of coverage of SPL content are worth accelerating. The study also highlights specificity problems known to trouble drug-intolerance decision support and suggests how terminology and methods of recording drug intolerances could be improved.", "publicationTitle": "J Am Med Inform Assoc", "publisher": "", "place": "", "date": "0000 Mar", "volume": "", "issue": "2", "section": "", "partNumber": "", "partTitle": "", "pages": "211-9", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "Journal of the American Medical Informatics Association : JAMIA", "DOI": "10.1197/jamia.M2933", "citationKey": "", "url": "", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "1067-5027 (Print) 1067-5027", "archive": "", "archiveLocation": "18952933", "shortTitle": "", "language": "eng", "libraryCatalog": "NLM", "callNumber": "", "rights": "", "extra": "", "tags": [ { "tag": "Algorithms Drug Hypersensitivity/*prevention & control Drug Labeling/*standards *Drug Therapy" }, { "tag": "Computer-Assisted Humans Knowledge Bases *Medical Order Entry Systems Medical Subject Headings United States United States Food and Drug Administration" } ], "collections": [ "54QJ6CSE" ], "relations": {}, "dateAdded": "2019-01-25T19:53:37Z", "dateModified": "2019-01-25T19:53:37Z" } }, { "key": "RJ7EENH5", "version": 22, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/RJ7EENH5", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/RJ7EENH5", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/599270/items/JWMBJBPW", "type": "application/json" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "RJ7EENH5", "version": 22, "parentItem": "JWMBJBPW", "itemType": "note", "note": "

from splitting #1614

", "tags": [], "relations": {}, "dateAdded": "2019-01-25T19:53:36Z", "dateModified": "2019-01-25T19:53:36Z" } }, { "key": "BW9X6FQY", "version": 20, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/BW9X6FQY", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/BW9X6FQY", "type": "text/html" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "creatorSummary": "Smith", "parsedDate": "2012", "numChildren": 0 }, "data": { "key": "BW9X6FQY", "version": 20, "itemType": "journalArticle", "title": "Exploring Adverse Drug Effect Discovery from Data Mining of Clinical Notes", "creators": [ { "creatorType": "author", "firstName": "Joshua Carl", "lastName": "Smith" } ], "abstractNote": "When considering both recommended and excessive medication dosages, almost\nall drugs have potentially serious adverse effects. Adverse effects (AEs) are any harmful\nor unintended reactions to medication. AEs can occur at doses normally used for\ntreatment or because of overdose. Due to known limitations in premarketing medication\ntrials (1–3), identification of adverse effects requires vigilant post-marketing surveillance.\nAgencies and investigators have recognized the potential for Electronic Medical Record\nSystems (EMRs) to characterize clinical correlations in large numbers of patients using\nprescription medications.\nThis thesis project explores one aspect of using EMRs to detect single drug\ningredient AEs – specifically, the feasibility of mining History and Physical (H&P) exam\nnotes to detect concurrent mentions of single drug ingredients and clinical findings\n(including both symptoms and diseases). In the remainder of this document, the term\n\"drug\" will refer to a single (active) drug ingredient (as opposed to a multi-component\n\"combination\" medication or an inert ingredient), unless otherwise stated. Our approach\nidentifies drug and finding concepts using Natural Language Processing (NLP) of clinical\ntext. We hypothesize (based on previous work (2; 4–6)) that drug-finding pairs occurring\nin a higher-than expected number of records signify an underlying relationship between\ndrug and finding. If one can distinguish which pairs occur for known reasons, then one\ncan postulate that the remaining pairs occur for unknown reasons -- especially previously\nunrecognized potential adverse effects", "publicationTitle": "", "publisher": "", "place": "", "date": "2012", "volume": "", "issue": "", "section": "", "partNumber": "", "partTitle": "", "pages": "", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "", "citationKey": "", "url": "", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [ "54QJ6CSE" ], "relations": {}, "dateAdded": "2019-01-25T19:53:36Z", "dateModified": "2019-01-25T19:53:36Z" } }, { "key": "XR6JAFI4", "version": 20, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/XR6JAFI4", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/XR6JAFI4", "type": "text/html" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "creatorSummary": "Yoon et al.", "parsedDate": "2012", "numChildren": 0 }, "data": { "key": "XR6JAFI4", "version": 20, "itemType": "journalArticle", "title": "Detection of adverse drug reaction signals using an electronic health records database: Comparison of the Laboratory Extreme Abnormality Ratio (CLEAR) algorithm", "creators": [ { "creatorType": "author", "firstName": "D", "lastName": "Yoon" }, { "creatorType": "author", "firstName": "MY", "lastName": "Park" }, { "creatorType": "author", "firstName": "NK", "lastName": "Choi" }, { "creatorType": "author", "firstName": "BJ", "lastName": "Park" }, { "creatorType": "author", "firstName": "JH", "lastName": "Kim" }, { "creatorType": "author", "firstName": "RW", "lastName": "Park" } ], "abstractNote": "Electronic health records (EHRs) are expected to be a good source of data for pharmacovigilance. However, current\nquantitative methods are not applicable to EHR data. We propose a novel quantitative postmarketing surveillance\nalgorithm, the Comparison of Laboratory Extreme Abnormality Ratio (CLEAR ), for detecting adverse drug reaction (ADR)\nsignals from EHR data. The methodology involves calculating the odds ratio of laboratory abnormalities between a\nspecific drug-exposed group and a matched unexposed group. Using a 10-year EHR data set, we applied the algorithm to\ntest 470 randomly selected drug–event pairs. It was found possible to analyze a single drug–event pair in just 109 ± 159\nseconds. In total, 120 of the 150 detected signals corresponded with previously reported ADRs (positive predictive value\n(PPV) = 0.837 ± 0.113, negative predictive value (NPV) = 0.659 ± 0.180). By quickly and efficiently identifying ADR signals\nfrom EHR data, the CLEAR algorithm can significantly contribute to the utilization of EHR data for pharmacovigilance.", "publicationTitle": "Clinical pharmacology and therapeutics", "publisher": "", "place": "", "date": "2012", "volume": "91", "issue": "3", "section": "", "partNumber": "", "partTitle": "", "pages": "467", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "", "citationKey": "", "url": "http://onlinelibrary.wiley.com/store/10.1038/clpt.2011.248/asset/cptclpt2011248.pdf?v=1&t=ikqznfuw&s=1cf4ed07de616dfa06e5abc76414160ae92ba9bb", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [ "54QJ6CSE" ], "relations": {}, "dateAdded": "2019-01-25T19:53:36Z", "dateModified": "2019-01-25T19:53:36Z" } }, { "key": "JWMBJBPW", "version": 20, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/JWMBJBPW", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/JWMBJBPW", "type": "text/html" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "creatorSummary": "Qian Zhu et al.", "parsedDate": "2013", "numChildren": 1 }, "data": { "key": "JWMBJBPW", "version": 20, "itemType": "journalArticle", "title": "Standardized Drug and Pharmacological Class Network Construction", "creators": [ { "creatorType": "author", "name": "Qian Zhu" }, { "creatorType": "author", "name": "Guoqian Jiang" }, { "creatorType": "author", "name": "Liwei Wang" }, { "creatorType": "author", "name": "Christopher G. Chute" } ], "abstractNote": "Dozens of drug terminologies and resources capture the drug and/or drug class information, ranging from their coverage and adequacy of representation. No transformative ways are available to link them together in a standard way, which hinders data integration and data representation for drug-related clinical and translational studies. In this paper, we introduce our preliminary work for building a standardized drug and drug class network that integrates multiple drug terminological resources, using Anatomical Therapeutic Chemical (ATC) and National Drug File Reference Terminology (NDF-RT) as network backbone, and expanding with RxNorm and Structured Product Label (SPL). In total, the network consists of 39,728 drugs and drug classes. Meanwhile, we calculated and compared structure similarity for each drug / drug class pair from ATC and NDF-RT, and analysed constructed drug class network from chemical structure perspective.", "publicationTitle": "Vaccine and Drug Ontology Studies 2013", "publisher": "", "place": "", "date": "2013", "volume": "", "issue": "", "section": "", "partNumber": "", "partTitle": "", "pages": "", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "", "citationKey": "", "url": "", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [ "54QJ6CSE" ], "relations": {}, "dateAdded": "2019-01-25T19:53:36Z", "dateModified": "2019-01-25T19:53:36Z" } }, { "key": "FKUL44WJ", "version": 22, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/FKUL44WJ", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/FKUL44WJ", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/599270/items/NBD7VPVW", "type": "application/json" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "FKUL44WJ", "version": 22, "parentItem": "NBD7VPVW", "itemType": "note", "note": "

Vilar, S
Ryan, P B
Madigan, D
Stang, P E
Schuemie, M J
Friedman, C
Tatonetti, N P
Hripcsak, G
eng
R01 GM107145/GM/NIGMS NIH HHS/
R01 LM006910/LM/NLM NIH HHS/
R01 LM010016/LM/NLM NIH HHS/
2014/09/25 06:00
CPT Pharmacometrics Syst Pharmacol. 2014 Sep 24;3:e137. doi: 10.1038/psp.2014.35.

", "tags": [], "relations": {}, "dateAdded": "2019-01-25T19:53:35Z", "dateModified": "2019-01-25T19:53:35Z" } }, { "key": "ESDAVL3P", "version": 22, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/ESDAVL3P", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/ESDAVL3P", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/599270/items/EU65N9B9", "type": "application/json" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "ESDAVL3P", "version": 22, "parentItem": "EU65N9B9", "itemType": "note", "note": "

Ryan, P B
Madigan, D
Stang, P E
Schuemie, M J
Hripcsak, G
eng
R01 LM006910/LM/NLM NIH HHS/
2014/01/23 06:00
CPT Pharmacometrics Syst Pharmacol. 2013 Sep 18;2:e76. doi: 10.1038/psp.2013.52.

", "tags": [], "relations": {}, "dateAdded": "2019-01-25T19:53:35Z", "dateModified": "2019-01-25T19:53:35Z" } }, { "key": "NBD7VPVW", "version": 20, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/NBD7VPVW", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/NBD7VPVW", "type": "text/html" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "creatorSummary": "Vilar et al.", "parsedDate": "2014", "numChildren": 1 }, "data": { "key": "NBD7VPVW", "version": 20, "itemType": "journalArticle", "title": "Similarity‐Based Modeling Applied to Signal Detection in Pharmacovigilance", "creators": [ { "creatorType": "author", "firstName": "S", "lastName": "Vilar" }, { "creatorType": "author", "firstName": "PB", "lastName": "Ryan" }, { "creatorType": "author", "firstName": "D", "lastName": "Madigan" }, { "creatorType": "author", "firstName": "PE", "lastName": "Stang" }, { "creatorType": "author", "firstName": "MJ", "lastName": "Schuemie" }, { "creatorType": "author", "firstName": "C", "lastName": "Friedman" }, { "creatorType": "author", "firstName": "NP", "lastName": "Tatonetti" }, { "creatorType": "author", "firstName": "G", "lastName": "Hripcsak" } ], "abstractNote": "One of the main objectives in pharmacovigilance is the detection of adverse drug events (ADEs) through mining of healthcare databases, such as electronic health records or administrative claims data. Although different approaches have been shown to be of great value, research is still focusing on the enhancement of signal detection to gain efficiency in further assessment and follow-up. We applied similarity-based modeling techniques, using 2D and 3D molecular structure, ADE, target, and ATC (anatomical therapeutic chemical) similarity measures, to the candidate associations selected previously in a medication-wide association study for four ADE outcomes. Our results showed an improvement in the precision when we ranked the subset of ADE candidates using similarity scorings. This method is simple, useful to strengthen or prioritize signals generated from healthcare databases, and facilitates ADE detection through the identification of the most similar drugs for which ADE information is available.", "publicationTitle": "CPT: pharmacometrics & systems pharmacology", "publisher": "", "place": "", "date": "2014", "volume": "3", "issue": "9", "section": "", "partNumber": "", "partTitle": "", "pages": "1-9", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "CPT: pharmacometrics & systems pharmacology", "DOI": "", "citationKey": "", "url": "http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4211266/pdf/psp201435a.pdf", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "25250527", "shortTitle": "", "language": "", "libraryCatalog": "", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [ "54QJ6CSE" ], "relations": {}, "dateAdded": "2019-01-25T19:53:35Z", "dateModified": "2019-01-25T19:53:35Z" } }, { "key": "EU65N9B9", "version": 19, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/EU65N9B9", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/EU65N9B9", "type": "text/html" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "creatorSummary": "Ryan et al.", "parsedDate": "2013", "numChildren": 1 }, "data": { "key": "EU65N9B9", "version": 19, "itemType": "journalArticle", "title": "Medication‐Wide Association Studies", "creators": [ { "creatorType": "author", "firstName": "PB", "lastName": "Ryan" }, { "creatorType": "author", "firstName": "David", "lastName": "Madigan" }, { "creatorType": "author", "firstName": "PE", "lastName": "Stang" }, { "creatorType": "author", "firstName": "MJ", "lastName": "Schuemie" }, { "creatorType": "author", "firstName": "G", "lastName": "Hripcsak" } ], "abstractNote": "Undiscovered side effects of drugs can have a profound effect on the health of the nation, and electronic health-care databases offer opportunities to speed up the discovery of these side effects. We applied a \"medication-wide association study\" approach that combined multivariate analysis with exploratory visualization to study four health outcomes of interest in an administrative claims database of 46 million patients and a clinical database of 11 million patients. The technique had good predictive value, but there was no threshold high enough to eliminate false-positive findings. The visualization not only highlighted the class effects that strengthened the review of specific products but also underscored the challenges in confounding. These findings suggest that observational databases are useful for identifying potential associations that warrant further consideration but are unlikely to provide definitive evidence of causal effects.", "publicationTitle": "CPT: pharmacometrics & systems pharmacology", "publisher": "", "place": "", "date": "2013", "volume": "2", "issue": "9", "section": "", "partNumber": "", "partTitle": "", "pages": "1-12", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "CPT: pharmacometrics & systems pharmacology", "DOI": "", "citationKey": "", "url": "http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4026636/pdf/psp201352a.pdf", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "24448022", "shortTitle": "", "language": "", "libraryCatalog": "", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [ "54QJ6CSE" ], "relations": {}, "dateAdded": "2019-01-25T19:53:35Z", "dateModified": "2019-01-25T19:53:35Z" } }, { "key": "FLPAEXBC", "version": 22, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/FLPAEXBC", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/FLPAEXBC", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/599270/items/CJX4AD9I", "type": "application/json" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "FLPAEXBC", "version": 22, "parentItem": "CJX4AD9I", "itemType": "note", "note": "

Guney, Emre
Menche, Jorg
Vidal, Marc
Barabasi, Albert-Laszlo
eng
England
2016/02/03 06:00
Nat Commun. 2016 Feb 1;7:10331. doi: 10.1038/ncomms10331.

", "tags": [], "relations": {}, "dateAdded": "2019-01-25T19:53:34Z", "dateModified": "2019-01-25T19:53:34Z" } }, { "key": "CJX4AD9I", "version": 19, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/CJX4AD9I", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/CJX4AD9I", "type": "text/html" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "creatorSummary": "Guney et al.", "parsedDate": "2016", "numChildren": 1 }, "data": { "key": "CJX4AD9I", "version": 19, "itemType": "journalArticle", "title": "Network-based in silico drug efficacy screening", "creators": [ { "creatorType": "author", "firstName": "Emre", "lastName": "Guney" }, { "creatorType": "author", "firstName": "Jörg", "lastName": "Menche" }, { "creatorType": "author", "firstName": "Marc", "lastName": "Vidal" }, { "creatorType": "author", "firstName": "Albert-László", "lastName": "Barábasi" } ], "abstractNote": "The increasing cost of drug development together with a significant drop in the number of new drug approvals raises the need for innovative approaches for target identification and efficacy prediction. Here, we take advantage of our increasing understanding of the network-based origins of diseases to introduce a drug-disease proximity measure that quantifies the interplay between drugs targets and diseases. By correcting for the known biases of the interactome, proximity helps us uncover the therapeutic effect of drugs, as well as to distinguish palliative from effective treatments. Our analysis of 238 drugs used in 78 diseases indicates that the therapeutic effect of drugs is localized in a small network neighborhood of the disease genes and highlights efficacy issues for drugs used in Parkinson and several inflammatory disorders. Finally, network-based proximity allows us to predict novel drug-disease associations that offer unprecedented opportunities for drug repurposing and the detection of adverse effects.", "publicationTitle": "Nature Communications", "publisher": "", "place": "", "date": "2016", "volume": "7", "issue": "", "section": "", "partNumber": "", "partTitle": "", "pages": "10331", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "Nature communications", "DOI": "", "citationKey": "", "url": "http://www.ncbi.nlm.nih.gov/pubmed/26831545", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "26831545", "shortTitle": "", "language": "", "libraryCatalog": "", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [ "54QJ6CSE" ], "relations": {}, "dateAdded": "2019-01-25T19:53:34Z", "dateModified": "2019-01-25T19:53:34Z" } }, { "key": "CI52FS5V", "version": 19, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/CI52FS5V", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/CI52FS5V", "type": "text/html" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "creatorSummary": "Georgi", "parsedDate": "2010", "numChildren": 0 }, "data": { "key": "CI52FS5V", "version": 19, "itemType": "journalArticle", "title": "The FDA black box warning system: the utmost in drug and patient safety?", "creators": [ { "creatorType": "author", "firstName": "Andrew T", "lastName": "Georgi" } ], "abstractNote": "THE FDA BLACK BOX WARNING SYSTEM: THE UTMOST IN DRUG AND PATIENT\nSAFETY? Andrew Georgi (Sponsored by Paul Barash, MD, and Loreta Grecu, MD).\nDepartment of Anesthesiology, Yale University School of Medicine, New Haven, CT.\nOf the 7856ψ\npharmaceutical products under the purview of the Food and Drug\nAdministration (FDA), over six hundred have a black box warning (BBW). As the FDA’s highest\nlevel of warning included on drug package inserts, this notation is reserved for those drugs that\npose significant risks leading to “death or serious injury”. However, the types of warnings that\nwarrant this distinction have not been clearly identified and are not always readily justifiable. In\naddition, great variability exists among the drugs resources charged with transmitting this critical\ninformation to healthcare professionals and the public.\nThe objective of this paper is to establish the most comprehensive list of drugs with a\nBBW, classify their content according to organ systems, and in doing so evaluate the consistency\nof information presented by these widely-used drug resources. This was accomplished by crossreferencing\nand analyzing the drug BBW information from four resources: DailyMed,\nMicromedex, Facts & Comparisons, and BlackBoxRx.\nSix hundred and thirty-five drug/drug combinations were identified as having a BBW.\nThe most frequently affected organ systems were cardiovascular and pulmonary with 200/635\nand 144/635 drug BBWs, respectively. DailyMed was the most comprehensive list with 551/635\ndrugs, still a shortfall of 13%. The four lists were in complete agreement for 416/635 (65%) of\nthe drugs listed. This highlights the FDA’s need to review the black box warning system and\ndetermine how best to communicate this drug information accurately and efficiently to the\nhealthcare community.", "publicationTitle": "", "publisher": "", "place": "", "date": "2010", "volume": "", "issue": "", "section": "", "partNumber": "", "partTitle": "", "pages": "", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "", "citationKey": "", "url": "", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [ "54QJ6CSE" ], "relations": {}, "dateAdded": "2019-01-25T19:53:34Z", "dateModified": "2019-01-25T19:53:34Z" } }, { "key": "6RXC7BQQ", "version": 22, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/6RXC7BQQ", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/6RXC7BQQ", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/599270/items/794WAX7U", "type": "application/json" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "6RXC7BQQ", "version": 22, "parentItem": "794WAX7U", "itemType": "note", "note": "

Kesselheim, Aaron S
Franklin, Jessica M
Avorn, Jerry
Duke, Jon D
eng
K08HS18465-01/HS/AHRQ HHS/
KL2RR025760/RR/NCRR NIH HHS/
Comparative Study
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.
England
2013/04/27 06:00
BMJ Qual Saf. 2013 Sep;22(9):727-34. doi: 10.1136/bmjqs-2012-001704. Epub 2013 Apr 25.

", "tags": [], "relations": {}, "dateAdded": "2019-01-25T19:53:33Z", "dateModified": "2019-01-25T19:53:33Z" } }, { "key": "XFH5H5DV", "version": 19, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/XFH5H5DV", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/XFH5H5DV", "type": "text/html" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "creatorSummary": "Tervonen et al.", "parsedDate": "2010", "numChildren": 0 }, "data": { "key": "XFH5H5DV", "version": 19, "itemType": "journalArticle", "title": "Current Status and Future Perspectives of Drug Information Systems", "creators": [ { "creatorType": "author", "firstName": "Tommi", "lastName": "Tervonen" }, { "creatorType": "author", "firstName": "Bert", "lastName": "e Brock" }, { "creatorType": "author", "firstName": "Pieter", "lastName": "e Graeff" }, { "creatorType": "author", "firstName": "Hans", "lastName": "Hillege" } ], "abstractNote": "The information lifecycle of a drug starts already during the drug discovery phase and continues far\ninto the future in prescription- and adverse-effect databases. In this paper, we describe the past\nliterature and existing technology of Drug Information Systems (DIS). We develop a mapping of DIS\nto the phased drug lifecycle taking into account the system information contents. The mapping shows\nthat currently there is a lack of DIS providing efficacy- and safety data in a suitable format. This lack\nseverely hinders the possibility of physicians, researchers, as well as regulatory authorities and the\npharmaceutical industry, to make quantitative analyses of efficacy and safety over a wide range of\ndrugs.", "publicationTitle": "ECIS", "publisher": "", "place": "", "date": "2010", "volume": "", "issue": "", "section": "", "partNumber": "", "partTitle": "", "pages": "", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "", "citationKey": "", "url": "", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [ "54QJ6CSE" ], "relations": {}, "dateAdded": "2019-01-25T19:53:33Z", "dateModified": "2019-01-25T19:53:33Z" } }, { "key": "794WAX7U", "version": 19, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/794WAX7U", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/794WAX7U", "type": "text/html" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "creatorSummary": "Kesselheim et al.", "numChildren": 1 }, "data": { "key": "794WAX7U", "version": 19, "itemType": "journalArticle", "title": "Speaking the same language? International variations in the safety information accompanying top-selling prescription drugs", "creators": [ { "creatorType": "author", "firstName": "Aaron S", "lastName": "Kesselheim" }, { "creatorType": "author", "firstName": "Jessica M", "lastName": "Franklin" }, { "creatorType": "author", "firstName": "Jerry", "lastName": "Avorn" }, { "creatorType": "author", "firstName": "Jon D", "lastName": "Duke" } ], "abstractNote": "BACKGROUND: The official prescribing information document distributed with a prescription drug is a key source of safety information, but it may include excessive or insufficient details. OBJECTIVES: To compare prescribing information approved by the US Food and Drug Administration with the UK, Canada and Australia to identify content differences in safety warnings. METHODS: For 20 top-selling prescription drugs, we used an automated natural language processing tool to calculate the number and severity of reported adverse drug reactions (ADRs). We fit hierarchical Poisson models and included fixed effects for other prescribing information characteristics. Separately, we analysed the appearance and content of 'black box' warnings. RESULTS: There was substantial variation in safety content of approved prescribing information. Canada had the highest median ADRs per drug (138 (IQR 86-234)) and the UK had the lowest (84 (IQR 51-111)). The number of ADRs reported was on average 50% higher in Canada compared with the USA (ratio of ADRs/document: 1.5, 95% CI 1.4 to 1.6, p<0.001). By contrast, there were on average 15% fewer ADRs listed in the UK compared with the USA (ratio of ADRs/document 0.85 (95% CI 0.78 to 0.93, p<0.001), and 21% fewer ADRs listed in Australia compared with the USS (ratio of ADRs/document 0.79, 95% CI 0.74 to 0.85, p<0.001). There were no variations in ADR severity. The presence and qualitative content of boxed warnings also showed substantial diversity. CONCLUSIONS: International variations exist in the presentation of safety data in drug prescribing information, which may have important implications for patient safety. Better international coordination is necessary to enhance use of this information for patient decision-making.", "publicationTitle": "BMJ quality & safety", "publisher": "", "place": "", "date": "0000 Sep", "volume": "22", "issue": "9", "section": "", "partNumber": "", "partTitle": "", "pages": "bmjqs-2012-001704", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "BMJ quality & safety", "DOI": "", "citationKey": "", "url": "http://www.ncbi.nlm.nih.gov/pubmed/23620531", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "23620531", "shortTitle": "", "language": "", "libraryCatalog": "", "callNumber": "", "rights": "", "extra": "", "tags": [ { "tag": "*Consumer Product Safety" }, { "tag": "*Developed Countries" }, { "tag": "*Prescription Drugs" }, { "tag": "Drug Labeling/*standards" }, { "tag": "Humans" }, { "tag": "Natural Language Processing" }, { "tag": "Poisson Distribution" } ], "collections": [ "54QJ6CSE" ], "relations": {}, "dateAdded": "2019-01-25T19:53:33Z", "dateModified": "2019-01-25T19:53:33Z" } }, { "key": "RQWYEWKG", "version": 22, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/RQWYEWKG", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/RQWYEWKG", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/599270/items/JQDD4A2E", "type": "application/json" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "RQWYEWKG", "version": 22, "parentItem": "JQDD4A2E", "itemType": "note", "note": "

Kuhn, Michael
Letunic, Ivica
Jensen, Lars Juhl
Bork, Peer
eng
England
2015/10/21 06:00
Nucleic Acids Res. 2016 Jan 4;44(D1):D1075-9. doi: 10.1093/nar/gkv1075. Epub 2015 Oct 19.

", "tags": [], "relations": {}, "dateAdded": "2019-01-25T19:53:32Z", "dateModified": "2019-01-25T19:53:32Z" } }, { "key": "B9CHG4H4", "version": 22, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/B9CHG4H4", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/B9CHG4H4", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/599270/items/SFPE6PN9", "type": "application/json" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "B9CHG4H4", "version": 22, "parentItem": "SFPE6PN9", "itemType": "note", "note": "

Shimazawa, Rumiko
Ikeda, Masayuki
eng
Comparative Study
Research Support, Non-U.S. Gov't
England
2013/01/29 06:00
Pharmacoepidemiol Drug Saf. 2013 Mar;22(3):306-18. doi: 10.1002/pds.3408. Epub 2013 Jan 28.

", "tags": [], "relations": {}, "dateAdded": "2019-01-25T19:53:32Z", "dateModified": "2019-01-25T19:53:32Z" } }, { "key": "JQDD4A2E", "version": 19, "library": { "type": "group", "id": 599270, "name": "SPL-Review", "links": { "alternate": { "href": "https://www.zotero.org/groups/spl-review", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/599270/items/JQDD4A2E", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/spl-review/items/JQDD4A2E", "type": "text/html" } }, "meta": { "createdByUser": { "id": 13493, "username": "jschneider", "name": "Jodi Schneider", "links": { "alternate": { "href": "https://www.zotero.org/jschneider", "type": "text/html" } } }, "creatorSummary": "Kuhn et al.", "numChildren": 1 }, "data": { "key": "JQDD4A2E", "version": 19, "itemType": "journalArticle", "title": "The SIDER database of drugs and side effects", "creators": [ { "creatorType": "author", "firstName": "Michael", "lastName": "Kuhn" }, { "creatorType": "author", "firstName": "Ivica", "lastName": "Letunic" }, { "creatorType": "author", "firstName": "Lars Juhl", "lastName": "Jensen" }, { "creatorType": "author", "firstName": "Peer", "lastName": "Bork" } ], "abstractNote": "Unwanted side effects of drugs are a burden on patients and a severe impediment in the development of new drugs. At the same time, adverse drug reactions (ADRs) recorded during clinical trials are an important source of human phenotypic data. It is therefore essential to combine data on drugs, targets and side effects into a more complete picture of the therapeutic mechanism of actions of drugs and the ways in which they cause adverse reactions. To this end, we have created the SIDER ('Side Effect Resource', http://sideeffects.embl.de) database of drugs and ADRs. The current release, SIDER 4, contains data on 1430 drugs, 5880 ADRs and 140 064 drug-ADR pairs, which is an increase of 40% compared to the previous version. For more fine-grained analyses, we extracted the frequency with which side effects occur from the package inserts. This information is available for 39% of drug-ADR pairs, 19% of which can be compared to the frequency under placebo treatment. SIDER furthermore contains a data set of drug indications, extracted from the package inserts using Natural Language Processing. These drug indications are used to reduce the rate of false positives by identifying medical terms that do not correspond to ADRs.", "publicationTitle": "Nucleic acids research", "publisher": "", "place": "", "date": "0000 Jan 4", "volume": "44", "issue": "D1", "section": "", "partNumber": "", "partTitle": "", "pages": "gkv1075", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "Nucleic acids research", "DOI": "", "citationKey": "", "url": "http://www.ncbi.nlm.nih.gov/pubmed/26481350", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "26481350", "shortTitle": "", "language": "", "libraryCatalog": "", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [ "54QJ6CSE" ], "relations": {}, "dateAdded": "2019-01-25T19:53:32Z", "dateModified": "2019-01-25T19:53:32Z" } } ]