{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,11,19]],"date-time":"2024-11-19T17:19:58Z","timestamp":1732036798210},"reference-count":20,"publisher":"Becaris Publishing Limited","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Comp. Eff. Res."],"published-print":{"date-parts":[[2017,7]]},"abstract":"<jats:p>\n            <jats:bold>Aim:<\/jats:bold>\n            Patient-reported outcomes associated with adverse events (AEs) reported with generics have not been evaluated. To map AEs associated with generics to the NIH Patient-reported Outcomes Measurement Information System.\n            <jats:bold>Methods:<\/jats:bold>\n            We mapped 381 AEs from 148 case reports of generic tamsulosin, levothyroxine and amphetamine\/dextroamphetamine to the physical, mental and social domain of the NIH Patient-Reported Outcomes Measurement Information System after reviewing 1237 case reports in the US FDA's Adverse Event Reporting System (FAERS; 2011\u20132013).\n            <jats:bold>Results:<\/jats:bold>\n            75%, 76% and 71% reports were classified under the physical domain for tamsulosin, levothyroxine and amphetamine\/dextroamphetamine, while 9%, 9% and 18% reports were classified under the mental domain, respectively.\n            <jats:bold>Conclusion:<\/jats:bold>\n            FAERS reveals several domains of patient-relevant concerns associated with generic drugs.\n          <\/jats:p>","DOI":"10.2217\/cer-2017-0006","type":"journal-article","created":{"date-parts":[[2017,7,7]],"date-time":"2017-07-07T13:11:57Z","timestamp":1499433117000},"page":"437-447","source":"Crossref","is-referenced-by-count":3,"title":["Patient-relevant outcomes associated with generic tamsulosin, levothyroxine and amphetamine in the FDA Adverse Event Reporting System: a pilot study"],"prefix":"10.57264","volume":"6","author":[{"given":"Sathiya Priya","family":"Marimuthu","sequence":"first","affiliation":[{"name":"Center for Drug Safety &amp; Effectiveness, Johns Hopkins Bloomberg School of Public Health, MD 21205, USA"},{"name":"Division of Clinical Pharmacology, Johns Hopkins School of Medicine, Baltimore, MD 21287, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Geetha","family":"Iyer","sequence":"additional","affiliation":[{"name":"Doctoral Student in Population Health Sciences, Harvard University, Boston, MA 02115, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jodi B","family":"Segal","sequence":"additional","affiliation":[{"name":"Center for Drug Safety &amp; Effectiveness, Johns Hopkins Bloomberg School of Public Health, MD 21205, USA"},{"name":"Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, MD 21205, USA"},{"name":"Division of General Internal Medicine, Johns Hopkins University School of Medicine, MD 21287, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sonal","family":"Singh","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Massachusetts Medical School, Worcester, MA 01655, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"36897","reference":[{"key":"e_1_3_3_3_2","unstructured":"General Pharmaceutical Association\n                                                                . \n                                                                Generic drugs savings in the US. seventh annual edition\n                                                                 (\n                                                                2015\n                                                                ). \n                                                                www.gphaonline.org\/media\/wysiwyg\/PDF\/GPhA_Savings_Report_2015.pdf\n                                                                ."},{"issue":"1","key":"e_1_3_3_4_2","doi-asserted-by":"crossref","first-page":"349","DOI":"10.1353\/hpu.0.0247","article-title":"Beliefs about prescription medications among patients with diabetes: variation across racial groups and influences on cost-related medication underuse","volume":"21","author":"Piette JD","year":"2010","unstructured":"Piette JD , Heisler M , Harand A , Juip M . Beliefs about prescription medications among patients with diabetes: variation across racial groups and influences on cost-related medication underuse . J. Health Care Poor Underserved 21 ( 1 ), 349 \u2013 361 ( 2010 ).","journal-title":"J. Health Care Poor Underserved"},{"issue":"6","key":"e_1_3_3_5_2","doi-asserted-by":"crossref","first-page":"574","DOI":"10.1016\/j.sapharm.2011.12.004","article-title":"Generic medications for you, but brand-name medications for me","volume":"8","author":"Keenum AJ","year":"2012","unstructured":"Keenum AJ , Devoe JE , Chisolm DJ , Wallace LS . Generic medications for you, but brand-name medications for me . Res. Social Adm. Pharm. 8 ( 6 ), 574 \u2013 578 ( 2012 ).","journal-title":"Res. Social Adm. Pharm."},{"key":"e_1_3_3_6_2","unstructured":"Bharmal\n                                                                        M Viswanathan\n                                                                        S\n                                                                . \n                                                                Patient-level feedback from later studies provides a multitude of valuable answers to all stakeholders\n                                                                . \n                                                                Applied Clinical Trials\n                                                                 (\n                                                                2009\n                                                                ). \n                                                                www.appliedclinicaltrialsonline.com\/shilpa-viswanathan\n                                                                ."},{"key":"e_1_3_3_7_2","unstructured":"USFDA guidance for industry: patient-reported outcome measures: use in medical product developement to support labelling claims\n                                                                 (\n                                                                2009\n                                                                ). \n                                                                www.fda.gov\/downloads\/drugs\/guidance%20compliance%20regulatory%20information\/guidance\/UCM193282.pdf\n                                                                ."},{"key":"e_1_3_3_8_2","unstructured":"Reports received and reports entered into FAERS by year\n                                                                 (\n                                                                2015\n                                                                ). \n                                                                www.fda.gov\/Drugs\/GuidanceComplianceRegulatoryInformation\/Surveillance\/AdverseDrugEffects\/ucm070434.htm\n                                                                ."},{"key":"e_1_3_3_9_2","article-title":"An Algorithm to Identify Generic Drugs in the FDA Adverse Event Reporting System","author":"Iyer G","year":"2017","unstructured":"Iyer G , Marimuthu SP , Segal JB An Algorithm to Identify Generic Drugs in the FDA Adverse Event Reporting System . Drug Saf. 10.1007\/s40264-017-0550-1 ( 2017 ).","journal-title":"Drug Saf."},{"issue":"5","key":"e_1_3_3_10_2","doi-asserted-by":"crossref","first-page":"S3","DOI":"10.1097\/01.mlr.0000258615.42478.55","article-title":"The patient-reported outcomes measurement information system (PROMIS): progress of an NIH roadmap cooperative group during its first two years","volume":"45","author":"Cella D","year":"2007","unstructured":"Cella D , Yount S , Rothrock N The patient-reported outcomes measurement information system (PROMIS): progress of an NIH roadmap cooperative group during its first two years . 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Arthritis Care Res. 69 ( 1 ), 133 \u2013 142 ( 2017 ).","journal-title":"Arthritis Care Res."},{"issue":"10","key":"e_1_3_3_12_2","doi-asserted-by":"crossref","first-page":"2333","DOI":"10.1007\/s11136-015-0992-9","article-title":"Validation of the PROMIS physical function measures in a diverse US population-based cohort of cancer patients","volume":"24","author":"Jensen RE","year":"2015","unstructured":"Jensen RE , Potosky AL , Reeve BB Validation of the PROMIS physical function measures in a diverse US population-based cohort of cancer patients . Qual. Life Res. 24 ( 10 ), 2333 \u2013 2344 ( 2015 ).","journal-title":"Qual. 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Drug Saf. 35 ( 6 ), 437 \u2013 446 ( 2012 ).","journal-title":"Drug Saf."},{"issue":"21","key":"e_1_3_3_16_2","doi-asserted-by":"crossref","first-page":"2514","DOI":"10.1001\/jama.2008.758","article-title":"Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis","volume":"300","author":"Kesselheim AS","year":"2008","unstructured":"Kesselheim AS , Misono AS , Lee JL Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis . 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Book"}],"container-title":["Journal of Comparative Effectiveness Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/becarispublishing.com\/doi\/pdf\/10.2217\/cer-2017-0006","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,3,19]],"date-time":"2023-03-19T12:40:47Z","timestamp":1679229647000},"score":1,"resource":{"primary":{"URL":"https:\/\/becarispublishing.com\/doi\/10.2217\/cer-2017-0006"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,7]]},"references-count":20,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2017,7]]}},"alternative-id":["10.2217\/cer-2017-0006"],"URL":"https:\/\/doi.org\/10.2217\/cer-2017-0006","relation":{},"ISSN":["2042-6305","2042-6313"],"issn-type":[{"value":"2042-6305","type":"print"},{"value":"2042-6313","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,7]]}}}