Generic substitution of antiepileptic drugs: A systematic review of prospective and retrospective studies;Sustitución de medicamentos antiepilépticos por genéricos: Una revisión sistemática de estudios prospectivos y retrospectivos

Annals of Pharmacotherapy

Volumn 45, Issue 11, 2011, Pages 1406-1415

  Yamada, Mikiko ^a   Welty, Timothy E ^a  

^a UNIVERSITY OF KANSAS   (United States)

Author keywords

Antiepileptic drugs; Generic substitution; Seizures

Indexed keywords

ANTICONVULSIVE AGENT; CARBAMAZEPINE; GENERIC DRUG; PHENYTOIN;

BIOEQUIVALENCE; CINAHL; DRUG ABSORPTION; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; EPILEPSY; FOOD AND DRUG ADMINISTRATION; HEAD INJURY; HEALTH CARE UTILIZATION; HUMAN; MEDICAL SERVICE; MEDLINE; PRESCRIPTION; PRIORITY JOURNAL; REVIEW; SEIZURE; SYSTEMATIC REVIEW; TREATMENT DURATION; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT;

ANTICONVULSANTS; CLINICAL TRIALS AS TOPIC; DRUG SUBSTITUTION; DRUGS, GENERIC; EPILEPSY; HUMANS; PROSPECTIVE STUDIES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RETROSPECTIVE STUDIES; TREATMENT OUTCOME;

EID: 80155167227     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1Q349     Document Type: Review

References (39)

1. Gidal BE, Tomson T Debate: substitution of generic drugs in epilepsy: is there cause for concern? Epilepsia 2008;49(suppl 9):56-62.DOI 10.1111/j.1528-1167.2008.01927.x
2. Kramer G, Biraben A, Carreno M, et al. Current approaches to the use of generic antiepileptic drugs. Epilepsy Behav 2007;11:46-52.DOI 10.1016/j.yebeh.2007.03.014
3. Anderson GD. Pharmacokinetic, pharmacodynamic, and pharmacogenetic targeted therapy of antiepileptic drugs. Ther Drug Monit 2008;30: 173-80. DOI 10.1097/FTD.0b013e318167d11b
4. Tomson T, Dahl ML, Kimland E. Therapeutic monitoring of antiepileptic drugs for epilepsy. Cochrane Database Syst Rev 2007:CD002216. DOI 10.1002/14651858.CD002216.pub2
5. Liow K. Understanding patients'perspective in the use of generic antiepileptic drugs: compelling lessons for physicians to improve physician/patient communication. BMC Neurol 2009;9:11. DOI 10.1186/1471-2377-9-11
6. Epilepsy Foundation Board of Directors. Position on switching of antiepileptic drugs. www.epilepsyfoundation.org/advocacy/care/genedrev.cfm (accessed 2010 May 31).
7. American Epilepsy Society. The substitution of different formulations of antiepileptic drugs for the treatment of epilepsy. www.aesnet.org/index.cfm?objectid = 77B16A48-E7FF-0F41-218E9CB3E54919D4 (accessed 2010 Jun 30).
8. Epilepsy Society of Australia Committee. ESA position statement: generic drug use in epilepsy. www.epilepsy-society.org.au/pages/guidelines2.php (accessed 2011 Aug 23).
9. Food and Drug Administration, Center for Drug Evaluation and Research. Statistical criteria for bioequivalence. In: Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, eds. Approved drug products with therapeutic equivalence evaluations. 31st ed. Washington, DC: US Department of Health and Human Services, 2011, viii-ix.
10. Davit BM, Nwakama PE, Buehler GJ, et al. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann Pharmacother 2009; 43:1583-97. DOI 10.1345/aph.1M141
11. Bureau of Policy, Science and International Programs, Therapeutic Products Directorate. Guidance for industry: bioequivalence requirements: critical dose drugs. www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm (accessed 2011 Jul 28).
12. Committee for Medical Products for Human Use (CHMP). Narrow therapeutic index drugs. In: European Medicines Agency, ed. London: European Medicines Agency, 2010:16.
13. Kesselheim AS, Stedman MR, Bubrick EJ, et al. Seizure outcomes following the use of generic versus brand-name antiepileptic drugs: a systematic review and meta-analysis Drugs 2010;70:605-21. DOI 10.2165/10898530-000000000-00000
14. Beyenburg S, Stavem K, Schmidt D. Placebo-corrected efficacy of modern antiepileptic drugs for refractory epilepsy: systematic review and meta-analysis. Epilepsia 2010;51:7-26. DOI 10.1111/j.1528-1167.2009.02299.x
15. Edlund W, Gronseth G, So Y, Franklin G Definition for classification of evidence. Clinical practice guideline process manual. 2004 ed. St. Paul, MN: American Academy of Neurology, 2005:57.
16. Andermann F, Duh MS, Gosselin A, Paradis PE. Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes. Epilepsia 2007;48:464-9. DOI 10.1111/j.1528-1167.2007.01007.x
17. Gagne JJ, Avorn J, Shrank WH, Schneeweiss S. Refilling and switching of antiepileptic drugs and seizure-related events. Clin Pharmacol Ther 2010;88:347-53. DOI 10.1038/clpt.2010.90
18. Labiner DM, Paradis PE, Manjunath R, et al. Generic antiepileptic drugs and associated medical resource utilization in the United States. Neurology 2010;74:1566-74. DOI 10.1212/WNL.0b013e3181df091b
19. Rascati KL, Richards KM, Johnsrud MT, Mann TA. Effects of antiepileptic drug substitutions on epileptic events requiring acute care. Pharmacotherapy 2009;29:769-74. DOI 10.1592/phco.29.7.769
20. Duh MS, Paradis PE, Latremouille-Viau D, et al. The risks and costs of multiple-generic substitution of topiramate. Neurology 2009;72:2122-9. DOI 10.1212/WNL.0b013e3181aa5300
21. Zachry WM 3rd, Doan QD, Clewell JD, Smith BJ. Case-control analysis of ambulance, emergency room, or inpatient hospital events for epilepsy and antiepileptic drug formulation changes. Epilepsia 2009;50:493-500. DOI 10.1111/j.1528-1167.2008.01703.x
22. LeLorier J, Duh MS, Paradis PE, et al. Clinical consequences of generic substitution of lamotrigine for patients with epilepsy. Neurology 2008;70:2179-86. DOI 10.1212/01.wnl.0000313154.55518.25
23. Aldenkamp AP, Rentmeester T, Hulsman J, et al. Pharmacokinetics and cognitive effects of carbamazepine formulations with different dissolution rates. Eur J Clin Pharmacol 1998;54:185-92. DOI 10.1007/s002280050443
24. Silpakit O, Amornpichetkoon M, Kaojarern S. Comparative study of bioavailability and clinical efficacy of carbamazepine in epileptic patients. Ann Pharmacother 1997;31:548-52.
25. Oles KS, Penry JK, Smith LD, Anderson RL, Dean JC, Riela AR. Therapeutic bioequivalence study of brand name versus generic carbamazepine. Neurology 1992;42:1147-53.
26. Hartley R, Aleksandrowicz J, Ng PC, McLain B, Bowmer CJ, Forsythe WI. Breakthrough seizures with generic carbamazepine: a consequence of poorer bioavailability? Br J Clin Pract 1990;44:270-3.
27. Jumao-as A, Bella I, Craig B, Lowe J, Dasheiff RM. Comparison of steady-state blood levels of two carbamazepine formulations. Epilepsia 1989;30:67-70. DOI 10.1111/j.1528-1157.1989.tb05283.x
28. Chen SS, Allen J, Oxley J, Richens A. Comparative bioavailability of phenytoin from generic formulations in the United Kingdom. Epilepsia 1982;23:149-52. DOI 10.1111/j.1528-1157.1982.tb05062.x
29. Pineyro-Lopez A, Pineyro-Garza E, Gomez-Silva M, et al. Bioequivalence of single 100-mg doses of two oral formulations of topiramate: an open-label, randomized-sequence, two-period crossover study in healthy adult male Mexican volunteers. Clin Ther 2009;31:411-7.DOI 10.1016/j.clinthera.2009.02.001
30. Srichaiya A, Longchoopol C, Oo-Puthinan S, Sayasathid J, Sripalakit P, Viyoch J. Bioequivalence of generic lamotrigine 100-mg tablets in healthy Thai male volunteers: a randomized, single-dose, two-period, two-sequence crossover study. Clin Ther 2008;30:1844-51.DOI 10.1016/j.clinthera.2008.10.018
31. Revankar SN, Desai ND, Bhatt AD, et al. Comparison of absorption rate and bioavailability of two brands of carbamazepine. J Assoc Physicians India 1999;47:699-702.
32. Yacobi A, Zlotnick S, Colaizzi JL, et al. A multiple-dose safety and bioequivalence study of a narrow therapeutic index drug: a case for carbamazepine. Clin Pharmacol Ther 1999;65:389-94. DOI 10.1016/S0009-9236(99)70132-3
33. Olling M, Mensinga TT, Barends DM, Groen C, Lake OA, Meulenbelt J. Bioavailability of carbamazepine from four different products and the occurrence of side effects. Biopharm Drug Dispos 1999;20:19-28. DOI 10.1002/(SICI)1099-081X(199901)20:1<19::AID -BDD152>3.0.CO; 2-Q
34. Meyer MC, Straughn AB, Mhatre RM, Shah VP, Williams RL, Lesko LJ. The relative bioavailability and in vivo-in vitro correlations for four marketed carbamazepine tablets. Pharm Res 1998;15:1787-91. DOI 10.1023/A:1011929300613
35. Bialer M, Yacobi A, Moros D, Levitt B, Houle JM, Munsaka MS. Criteria to assess in vivo performance and bioequivalence of generic controlled-release formulations of carbamazepine. Epilepsia 1998;39:513-9. DOI 10.1111/j.1528-1157.1998.tb01414.x
36. Center for Drug Evaluation and Research, Food and Drug Administration. Therapeutic equivalence evaluations codes. http://webcache.googleusercontent.com/search?q=cache:H_1OU62vAwYJ:www.fda.ov/drugs/developmentapprovalprocess/ucm079068.htm+AA+rate+AB +rate+generic&cd = 8&hl = en&ct = clnk&gl = us&source = www.google. com (accessed 2011 Aug 3).
37. Centers for Disease Control and Prevention Data & statistics. www.cdc. gov/epilepsy/ (accessed 2011 Aug 3).
38. Kobau R, Zahran H, Thurman DJ, et al. Epilepsy surveillance among adults-19 states, behavioral risk factor surveillance system, 2005. www.cdc.gov/mmwr/preview/mmwrhtml/ss5706a1.htm?s_cid = ss5706a1_e (accessed 2011 Aug 3).
39. Food and Drug Administration. Summary minutes of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AdvisoryCommitteeforPharmaceuticalScienceandClinicalPharmacology/UCM272111.pdf (accessed 2011 Oct 6).