Seizure outcomes following the use of generic versus brand-name antiepileptic drugs: A systematic review and meta-analysis

Drugs

Volumn 70, Issue 5, 2010, Pages 605-621

  Kesselheim, Aaron S ^a   Stedman, Margaret R ^a   Bubrick, Ellen J ^b   Gagne, Joshua J ^a   Misono, Alexander S ^a   Lee, Joy L ^a   Brookhart, M Alan ^c   Avorn, Jerry ^a   Shrank, William H ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

^c IL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTICONVULSIVE AGENT; APOCARBAMAZEPINE; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CARBAMAZEPINE; CARMAPINE; CARZEPINE; CLOBAZAM; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; EPILEPTIN; EPSOLIN; GABAPENTIN; GENERIC DRUG; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LAMOTRIGINE; PANITAL; PHENYTOIN; TOPIRAMATE; UNCLASSIFIED DRUG; VALPROIC ACID; ZONISAMIDE;

ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DISEASE CONTROL; DRUG SUBSTITUTION; DRUG UTILIZATION; DRUG WITHDRAWAL; EMBASE; EMERGENCY CARE; EPILEPSY; HEALTH CARE UTILIZATION; HOSPITAL ADMISSION; HOSPITALIZATION; HUMAN; MEDLINE; MORBIDITY; OBSERVATIONAL STUDY; OUTPATIENT CARE; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SEIZURE; SYSTEMATIC REVIEW; TREATMENT OUTCOME;

ANTICONVULSANTS; DRUGS, GENERIC; EVIDENCE-BASED MEDICINE; HUMANS; ODDS RATIO; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK ASSESSMENT; SEIZURES; THERAPEUTIC EQUIVALENCY; TREATMENT OUTCOME;

EID: 77949936751     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.2165/10898530-000000000-00000     Document Type: Article

References (48)

1. Strom BL. Generic drug substitution revisited. N Engl J Med 1987 Jun 4; 316 (23): 1456-1462
2. Shrank WH, Hoang T, Ettner SL, et al. The implications of choice: prescribing generic or preferred pharmaceuticals improves medication adherence for chronic conditions. Arch Intern Med 2006 Feb 13; 166 (3): 332-337
3. Goldman DP, Joyce GF, Zheng Y. Prescription drug cost sharing: associations with medication and medical utilization and spending and health. JAMA 2007 Jul 4; 298 (1): 61-69
4. Kesselheim A, Fischer M, Avorn J. Extensions of intellectual property rights and delayed adoption of generic drugs: effects on Medicaid spending. Health Aff (Millwood) 2006; 25: 1637-1647
5. Food and Drug Administration Center for Drug Evaluation and Research. Guidance for industry: bioavailability and bioequivalence studies for orally-administered drug products-general considerations. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2003 Mar. Revision 1 [online]. Available from URL http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guida nces/ucm070124.pdf [Accessed 2010 Jan 21].
6. Food and Drug Administration. Therapeutic equivalence of generic drugs: letter to health practitioners. 1998 Jan 28 [online]. Available from URL: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedand Approved/ApprovalApplications/AbbreviatedNewDrug ApplicationANDAGenerics/ ucm073182.htm [Accessed 2010 Jan 21]
7. Beck M. Inexact copies: how generics differ from brand names. Wall Street Journal 2008 April 22: D1
8. Meredith P. Bioequivalence and other unresolved issues in generic drug substitution. Clin Ther 2003 Nov; 25 (11): 2875-2890
9. Browne TR, Holmes GL. Epilepsy. N Engl J Med 2001 Apr 12; 344 (15): 1145-1151
10. Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med 2000 Feb 3; 342 (5): 314-319
11. Perucca E, Albani F, Capovilla G, et al. Recommendations of the Italian League against Epilepsy working group on generic products of antiepileptic drugs. Epilepsia 2006; 47 Suppl. 5: 16-20
12. Jobst BC, Holmes GL. Prescribing antiepileptic drugs: should patients be switched on the basis of cost? CNS Drugs 2004; 18 (10): 617-628
13. Makus KG, McCormick J. Identification of adverse reactions that can occur on substitution of generic for branded lamotrigine in patients with epilepsy. Clin Ther 2007 Feb; 29 (2): 334-341
14. Welty TE, Pickering PR, Hale BC, et al. Loss of seizure control associated with generic substitution of carbama-zepine. Ann Pharmacother 1992 Jun; 26 (6): 775-777
15. Wyllie E, Pippenger CE, Rothner AD. Increased seizure frequency with generic primidone. JAMA 1987 Sep 4; 258 (9): 1216-1217
16. Berg MJ, Gross RA, Tomaszewski KJ, et al. Generic substitution in the treatment of epilepsy: case evidence of breakthrough seizures. Neurology 2008 Aug 12; 71 (7): 525-530
17. Rubenstein S. Industry fights switch to generics for epilepsy. Wall Street Journal 2007 Jul 13: A1
18. Sipkoff M. Mandatory generic substitution continues to be questioned. Drug Topics 2008; 152 (4): 45-46
19. Hawaii Revised Statutes. y328-92(3)(c) [2008] Tennessee Code Annotated. y53-10-210 (2009) Utah Code Annotated.
20. y58-17b-605 (2008) National Conference of State Legislatures. Condition-specific drug substitution legislation: epilepsy [online]. Available from URL http://www.ncsl.org/programs/health/ rx-substitution08.htm [Accessed 2010 Jan 21].
21. Kramer G, Biraben A, Carreno M,et al. Current approaches to the use of generic antiepileptic drugs. Epilepsy Behav 2007 Aug; 11(1): 46-52
22. Pharmaceutical Care Management Association. Undermining generic drug substitution: the cost of generic carve-out legislation. 2008 Oct [online]. Available from URL http://www.pcmanet.org/wp-content/uploads/2008/11/generic- carve-out-final1.pdf [Accessed 2010 Jan 21]
23. Sipkoff M. The epilepsy battle in the war between brands and generics. Manag Care 2008 Mar; 17 (3): 24-27
24. Eban K. Are generic drugs a bad bargain? Self 2009 Jun [online]. Available from URL: http://www.self.com/health/2009/06/dangers-of-generic-drugs [Accessed 2010 Feb 16]
25. Kesselheim AS, Misono AS, Lee JL, et al. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA 2008 Dec 3; 300 (21): 2514-2526
26. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996 Feb; 17 (1): 1-12
27. Deeks JJ, Dinnes J, D'Amico R, et al. Evaluating non-randomised intervention studies. Health Technol Assess 2003; 7 (27): 1-173
28. Elbourne DR, Altman DG, Higgins JP, et al. Meta-analyses involving cross-over trials: methodological issues. Int J Epidemiol 2002 Feb; 31 (1): 140-149
29. Hodges S, Forsythe WI, Gillies D, et al. Bio-availability and dissolution of three phenytoin preparations for children: developmental medicine and child neurology 1986; 28 (6): 708-712
30. Kishore K, Jailakhani BL, Sharma JN, et al. Serum phenytoin levels with different brands. Indian J Physiol Pharmacol 1986 Apr-Jun; 30 (2): 171-176
31. Jumaoas A, Bella I, Craig B, et al. Comparison of steadystate blood levels of two carbamazepine formulations. Epilepsia 1989 Jan-Feb; 30 (1): 67-70
32. Hartley R, Aleksandrowicz J, Bowmer CJ, et al. Dissolution and relative bioavailability of two carbamazepine preparations for children with epilepsy. J Pharm Pharmacol 1991 Feb; 43 (2): 117-119
33. Soryal I, Richens A. Bioavailability and dissolution of proprietary and generic formulations of phenytoin. J Neurol Neurosurg Psychiatry 1992; 55 (8): 688-691
34. Wolf P, May T, Tiska G, et al. Steady state concentrations and diurnal fluctuations of carbamazepine in patients after different slow release formulations. Arzneimittelforschung 1992 Mar; 42 (3): 284-288
35. Oles KS, Penry JK, Smith LD, et al. Therapeutic bioequivalency study of brand name versus generic carbamaze-pine. Neurology 1992 Jun; 42 (6): 1147-1153
36. Silpakit O, Amornpichetkoon M, Kaojarern S. Comparative study of bioavailability and clinical efficacy of carba-mazepine in epileptic patients. Ann Pharmacother 1997 May; 31 (5): 548-552
37. Vadney VJ, Kraushaar KW. Effects of switching from Depakene to generic valproic acid on individuals with mental retardation. Ment Retard 1997 Dec; 35 (6): 468-472
38. Thompson SG. Why sources ofheterogeneityinmeta-analysis shouldbeinvestigated. BMJ 1994 Nov 19; 309 (6965): 1351-1355
39. Christopher A, Levine M, McConnell D. A comparison of two brands of carbamazepine in young patients with epilepsy. Can J Hosp Pharm 1993; 46 (2): 62-71
40. Andermann F, Duh MS, Gosselin A, et al. Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes. Epilepsia 2007 Mar; 48 (3): 464-469
41. LeLorier J, Duh MS, Paradis PE, et al. Clinical consequences of generic substitution of lamotrigine for patients with epilepsy. Neurology 2008 May 27; 70 (22 Pt 2): 2179-2186
42. Zachry 3rd WM, Doan QD, Clewell JD, et al. Case-control analysis of ambulance, emergency room, or inpatient hospital events for epilepsy and antiepileptic drug formulation changes. Epilepsia 2009; 50 (3): 493-500
43. Duh MS, Paradis PE, Latremouille-Viau D, et al. The risks and costs of multiple-generic substitution of topiramate. Neurology 2009 Jun 16; 72 (24): 2122-2129
44. Rascati KL, Richards KM, Johnsrud MT, et al. Effects of antiepileptic drug substitutions on epileptic events requiring acute care. Pharmacother 2009 Jul; 29 (7): 769-774
45. Hansen RN, Campbell JD, Sullivan SD. Association between antiepileptic drug switching and epilepsy-related events. Epilepsy Behav 2009 Aug; 15 (4): 481-485
46. Berg MJ, Gross RA, Haskins LS, et al. Generic substitution in the treatment of epilepsy: patient and physician perceptions. Epilepsy Behav 2008 Nov; 13 (4): 693-699
47. Wilner AN. Therapeutic equivalency of generic antiepileptic drugs: results of a survey. Epilepsy Behav 2004 Dec; 5 (6): 995-998
48. Papsdorf TB, Ablah E, Ram S, et al. Patient perception of generic antiepileptic drugs in the Midwestern United States. Epilepsy Behav 2009 Jan; 14 (1): 150-3