{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T23:44:55Z","timestamp":1777419895070,"version":"3.51.4"},"reference-count":23,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2012,5,1]],"date-time":"2012-05-01T00:00:00Z","timestamp":1335830400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2012,5]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Concerns that antiepileptic brand-to-generic interchange results in disruption of seizure control are widespread. However, little within-patient evidence exists examining such interchanges.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To compare within-patient seizure control before and after the interchange of a branded to a single-source generic Phenytoin among patients with seizures in a managed care organization.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>This was a pre-post, self-controlled, retrospective study. Adults with a history of seizure who used Dilantin Kapseals 100 mg extended Phenytoin sodium, USP, capsules and whose therapy was interchanged to Taro Pharmaceuticals\u2019 AB-rated generic extended phenytoin sodium capsules, USP, 100 mg between July 2007 and May 2008 were included. Study outcomes included the comparisons of the proportions of patients with at least emergency department (ED) visit\/inpatient hospitalization and medical office visit\/nonoffice consultation for acute seizure in the 6 months before and after interchange. Outcomes were confirmed with manual chart reviews and adjusted for potential confounding medication use.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>A total of 222 patients were included in the study. Patients were primarily middle-aged (mean 56 years), equally mixed by sex (47% female); most had nonintractable seizures. The majority of patients (~70%) were on phenytoin as monotherapy and had equivalent rates of purchases for potentially confounding medications in both pre- and postinterchange time periods (all p &lt; 0.05). Low serum concentrations were detected more often in the postinterchange study period (adjusted p &lt; 0.001). Despite this, there were low proportions of patients with confirmed seizure events that resulted in an ED visit\/inpatient hospitalization in both pre- and postinterchange periods (both 6.3%, adjusted p = 0.937). The proportion of patients with confirmed seizure events diagnosed at a medical office visit was not significantly different between the preinterchange and postinterchange periods (12.2% vs 11.3%, adjusted p = 0.545).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>NO increased proportion of seizures was observed within patients when branded phenytoin was interchanged to an AB-rated, single-source, generic equivalent. More rigorous studies should be conducted to more thoroughly evaluate patient tolerability and drug efficacy when antiepileptic drugs are interchanged from brand to generic formulations.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1345\/aph.1q601","type":"journal-article","created":{"date-parts":[[2012,5,2]],"date-time":"2012-05-02T00:11:57Z","timestamp":1335917517000},"page":"650-658","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":3,"title":["Clinical Outcomes Associated with Brand-to-Generic Phenytoin Interchange"],"prefix":"10.1177","volume":"46","author":[{"given":"Shilpa A","family":"Kinikar","sequence":"first","affiliation":[{"name":"Pharmacy Department, Kaiser Permanente Colorado, Denver, CO; Clinical Assistant Professor, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Delate","sequence":"additional","affiliation":[{"name":"Pharmacy Department, Kaiser Permanente Colorado, Aurora; Clinical Instructor, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C Mindy","family":"Menaker-Wiener","sequence":"additional","affiliation":[{"name":"Department of Neurology, Colorado Permanente Medical Group, Kaiser Permanente Colorado, Denver"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William H","family":"Bentley","sequence":"additional","affiliation":[{"name":"Department of Neurology, Colorado Permanente Medical Group, Kaiser Permanente Colorado, Denver"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2012,5,1]]},"reference":[{"key":"bibr1-aph.1Q601","doi-asserted-by":"publisher","DOI":"10.1212\/01.wnl.0000259400.30539.cc"},{"key":"bibr2-aph.1Q601","unstructured":"Position statement on the substitution of different formulations of antiepileptic drugs for the treatment of epilepsy. American Epilepsy Society press release. Hartford, CT, November 29, 2007."},{"key":"bibr3-aph.1Q601","unstructured":"Pfizer medication information. Dilantin (phenytoin sodium) 100-mg extended oral capsules, http:\/\/www.pharmalot.com\/wp-content\/uploads\/2008\/05\/dilantin-letter.jpg (accessed 2012 Feb 8)."},{"key":"bibr4-aph.1Q601","volume-title":"Dilantin Kapseals (phenytoin) 100 mg","author":"Package insert","year":"2006"},{"key":"bibr5-aph.1Q601","volume-title":"Dilantin (phenytoin) 100-mg extended oral capsules","author":"Package insert","year":"2009"},{"key":"bibr6-aph.1Q601","volume-title":"Extended phenytoin sodium capsules USP, 100 mg","author":"Package insert","year":"2006"},{"key":"bibr7-aph.1Q601","unstructured":"Kee VR, Gilchrist B, Granner MA, Sarrazin NR, Carnahan RM. Mini-Sentinel systematic evaluation of health outcome of interest definitions for studies using administrative data: seizure, convulsion, epilepsy report. http:\/\/mini-sentinel.org\/work_products\/HealthOutcomes\/Mini-Sentinel-HOI-Evidence-Review-Seizure-Convulsion-Epilepsy-Report.pdf (accessed 2011 Aug 10)."},{"key":"bibr8-aph.1Q601","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.1981.154"},{"key":"bibr9-aph.1Q601","doi-asserted-by":"publisher","DOI":"10.1212\/01.WNL.0000142091.47698.A2"},{"key":"bibr10-aph.1Q601","doi-asserted-by":"publisher","DOI":"10.1111\/j.1469-8749.1986.tb03921.x"},{"key":"bibr11-aph.1Q601","volume-title":"Antiepileptic drugs","author":"Johannessen SI","year":"2002"},{"key":"bibr12-aph.1Q601","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1167.2008.01561.x"},{"key":"bibr13-aph.1Q601","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1157.2000.tb02950.x"},{"key":"bibr14-aph.1Q601","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1167.2006.00657.x"},{"key":"bibr15-aph.1Q601","first-page":"171","volume":"30","author":"Kishore K","year":"1986","journal-title":"Indian J Physiol Pharmacol"},{"key":"bibr16-aph.1Q601","doi-asserted-by":"publisher","DOI":"10.1136\/jnnp.55.8.688"},{"key":"bibr17-aph.1Q601","doi-asserted-by":"publisher","DOI":"10.2165\/10898530-000000000-00000"},{"key":"bibr18-aph.1Q601","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1167.2008.01703.x"},{"key":"bibr19-aph.1Q601","doi-asserted-by":"publisher","DOI":"10.1592\/phco.29.7.769"},{"key":"bibr20-aph.1Q601","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2009.05.019"},{"key":"bibr21-aph.1Q601","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2010.90"},{"key":"bibr22-aph.1Q601","doi-asserted-by":"publisher","DOI":"10.1001\/archneur.64.11.1595"},{"key":"bibr23-aph.1Q601","doi-asserted-by":"publisher","DOI":"10.17925\/USN.2008.04.01.40"}],"container-title":["Annals of Pharmacotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1345\/aph.1Q601","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1345\/aph.1Q601","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T11:11:49Z","timestamp":1777374709000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1345\/aph.1Q601"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,5]]},"references-count":23,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2012,5]]}},"alternative-id":["10.1345\/aph.1Q601"],"URL":"https:\/\/doi.org\/10.1345\/aph.1q601","relation":{},"ISSN":["1060-0280","1542-6270"],"issn-type":[{"value":"1060-0280","type":"print"},{"value":"1542-6270","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012,5]]}}}