219
Views
17
CrossRef citations to date
0
Altmetric
Theme: Epilepsy - Review

Generic substitution of antiepileptic drugs

, , , &
Pages 1887-1898 | Published online: 09 Jan 2014

References

  • Forsgren L, Beghi E, Oun A, Sillanpaa M. The epidemiology of epilepsy in Europe – a systematic review. Eur. J. Neurol.12(4), 245–253 (2005).
  • Kobau R, Zahran H, Thurman DJ et al. Epilepsy surveillance among adults – 19 States, Behavioral Risk Factor Surveillance System, 2005. MMWR Surveill. Summ.57(6), 1–20 (2008).
  • Sander JW. The epidemiology of epilepsy revisited. Curr. Opin. Neurol.16(2), 165–170 (2003).
  • French JA, Kanner AM, Bautista J et al. Efficacy and tolerability of the new antiepileptic drugs, II: treatment of refractory epilepsy: report of the TTA and QSS Subcommittees of the American Academy of Neurology and the American Epilepsy Society. Epilepsia45(5), 410–423 (2004).
  • 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. Drugs70(5), 605–621 (2010).
  • Guberman A, Corman C. Generic substitution for brand name antiepileptic drugs: a survey. Can. J. Neurol. Sci.27(1), 37–43 (2000).
  • Berg MJ, Gross RA, Haskins LS, Zingaro WM, Tomaszewski KJ. Generic substitution in the treatment of epilepsy: patient and physician perceptions. Epilepsy Behav.13(4), 693–699 (2008).
  • Håkonsen H, Eilertsen M, Borge H, Toverud EL. Generic substitution: additional challenge for adherence in hypertensive patients? Curr. Med. Res. Opin.25(10), 2515–2521 (2009).
  • Chapman RH, Benner JS, Girase P et al. Generic and therapeutic statin switches and disruptions in therapy. Curr. Med. Res. Opin.25(5), 1247–1260 (2009).
  • Crawford P, Feely M, Guberman A, Kramer G. Are there potential problems with generic substitution of antiepileptic drugs? A review of issues. Seizure15(3), 165–176 (2006).
  • Duh MS, Paradis PE, Latremouille-Viau D et al. The risks and costs of multiple-generic substitution of topiramate. Neurology72(24), 2122–2129 (2009).
  • Stokes T, Shaw EJ, Juarez-Garcia A, Camosso-Stefinovic J, Baker R. Clinical Guidelines and Evidence Review for the Epilepsies: Diagnosis and Management in Adults and Children in Primary and Secondary Care. Royal College of General Practitioners, London, UK (2004).
  • American Academy of Neurology. Assessment: generic substitution for antiepileptic medication. Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology40(11), 1641–1643 (1990).
  • Liow K, Barkley GL, Pollard JR, Harden CL, Bazil CW. Position statement on the coverage of anticonvulsant drugs for the treatment of epilepsy. Neurology68(16), 1249–1250 (2007).
  • Endrenyi L, Midha KK. Individual bioequivalence – has its time come? Eur. J. Pharm. Sci.6(4), 271–278 (1998).
  • Bialer M, Midha KK. Generic products of antiepileptic drugs: a perspective on bioequivalence and interchangeability. Epilepsia51(6), 941–950 (2010).
  • Tothfalusi L, Speidl S, Endrenyi L. Exposure–response analysis reveals that clinically important toxicity difference can exist between bioequivalent carbamazepine tablets. Br. J. Clin. Pharmacol.65(1), 110–122 (2007).
  • Cloyd JC, Marino S, Birnbaum AK. Factors affecting antiepileptic drug pharmacokinetics in community-dwelling elderly. Int. Rev. Neurobiol.81, 201–210 (2007).
  • Gidal BE. Drug absorption in the elderly: biopharmaceutical considerations for the antiepileptic drugs. Epilepsy Res.68(Suppl. 1), S65–S69 (2006).
  • Gilman JT, Duchowny M, Campo AE. Pharmacokinetic considerations in the treatment of childhood epilepsy. Paediatr. Drugs5(4), 267–277 (2003).
  • Battino D, Estienne M, Avanzini G. Clinical pharmacokinetics of antiepileptic drugs in paediatric patients. Part II. Phenytoin, carbamazepine, sulthiame, lamotrigine, vigabatrin, oxcarbazepine and felbamate. Clin. Pharmacokinet.29(5), 341–369 (1995).
  • Battino D, Estienne M, Avanzini G. Clinical pharmacokinetics of antiepileptic drugs in paediatric patients. Part I: phenobarbital, primidone, valproic acid, ethosuximide and mesuximide. Clin. Pharmacokinet.29(4), 257–286 (1995).
  • Lesser RP, Irace P, Kutt H et al. Enhanced gastrointestinal excretion of phenytoin in a patient with Crohn’s disease. Epilepsia25(3), 302–307 (1984).
  • Birnbaum AK. Pharmacokinetics of antiepileptic drugs in elderly nursing home residents. Int. Rev. Neurobiol.81, 211–220 (2007).
  • Patsalos PN, Perucca E. Clinically important drug interactions in epilepsy: general features and interactions between antiepileptic drugs. Lancet Neurol.2(6), 347–356 (2003).
  • Perucca E. Clinical pharmacology and therapeutic use of the new antiepileptic drugs. Fundam. Clin. Pharmacol.15(6), 405–417 (2001).
  • Endrenyi L, Tothfalusi L. Do regulatory bioequivalence requirements adequately reflect the therapeutic equivalence of modified-release drug products? J. Pharm. Pharm. Sci.13(1), 107–113 (2010).
  • Krauss GL, Davit BM, Caffo BS et al. Comparing bioequivalence of generic antiepilepsy drugs (AEDs). Neurology74(Suppl. 2), Abstract A303 (2010).
  • 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.15(11), 1787–1791 (1998).
  • Meyer MC, Straughn AB, Jarvi EJ, Wood GC, Pelsor FR, Shah VP. The bioinequivalence of carbamazepine tablets with a history of clinical failures. Pharm. Res.9(12), 1612–1616 (1992).
  • Silpakit O, Amornpichetkoon M, Kaojarern S. Comparative study of bioavailability and clinical efficacy of carbamazepine in epileptic patients. Ann. Pharmacother.31(5), 548–552 (1997).
  • Soryal I, Richens A. Bioavailability and dissolution of proprietary and generic formulations of phenytoin. J. Neurol. Neurosurg. Psychiatry55(8), 688–691 (1992).
  • Feely M, Crawford P, Kramer G, Guberman A. Risk management in epilepsy: generic substitution and continuity of supply. Eur. J. Hosp. Pharm. Sci.11(4), 83–87 (2005).
  • Chuang K, Krauss GL, Cao YJ. Evaluating FDA bioequivalence standards for generic carbamazepine formulations. Presented at: AAN 61st Annual Meeting. Seattle, WA, USA, 25 April–2 May 2009 (Poster #P05 085).
  • European Parliament. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community Code Relating to Medicinal Products for Human Use. European Parliament, Strasbourg, France (2004).
  • Schmidt D. Strategies to prevent overtreatment with antiepileptic drugs in patients with epilepsy. Epilepsy Res.52(1), 61–69 (2002).
  • Bauer J, Kronisch C. [Medical treatment of epilepsy: hidden dimensions]. Nervenarzt80(4), 386–398 (2009).
  • Lloyd A, McIntosh E, Price M. The importance of drug adverse effects compared with seizure control for people with epilepsy: a discrete choice experiment. Pharmacoeconomics23(11), 1167–1181 (2005).
  • Wilner AN. Physicians underestimate the frequency of generic carbamazepine substitution: results of a survey and review of the problem. Epilepsy Behav.3(6), 522–525 (2002).
  • IMS Health. What Is The Effect of Price Discount Contracts on Routine Care?. IMS HEALTH GmbH & Co. OHG, Frankfurt/Main (2010).
  • Pawloski M, Kerling F, Hercksen I et al. Interim analysis of an ongoing prospective study: use of lamotrigine generic drugs: experiences of the Epilepsy Center Erlangen. Presented at: 27th International Epilepsy Congress. Singapore, 8–12 July (2007).
  • LeLorier J, Duh MS, Paradis PE et al. Clinical consequences of generic substitution of lamotrigine for patients with epilepsy. Neurology70(22 Pt 2), 2179–2186 (2008).
  • Paradis PE, Latremouille-Viau D, Moore Y et al. Projected economic impact of clinical findings of generic entry of topiramate on G4 European countries. Curr. Med. Res. Opin.25(7), 1793–1805 (2009).
  • Paradis PE, Latrémouille-Viau D, Lefebvre P et al. Clinical consequences of generic substitution of topiramate. Presented at: 28th International Epilepsy Congress (ILAE). Budapest, Hungary, 28 June – 2 July (2009) (Poster P184).
  • Labiner DM, Paradis PE, Manjunath R et al. Generic antiepileptic drugs and associated medical resource utilization in the United States. Neurology74(20), 1566–1574 (2010).
  • Welty TE, Pickering PR, Hale BC, Arazi R. Loss of seizure control associated with generic substitution of carbamazepine. Ann. Pharmacother.26(6), 775–777 (1992).
  • Burkhardt RT, Leppik IE, Blesi K, Scott S, Gapany SR, Cloyd JC. Lower phenytoin serum levels in persons switched from brand to generic phenytoin. Neurology63(8), 1494–1496 (2004).
  • Gilman JT, Alvarez LA, Duchowny M. Carbamazepine toxicity resulting from generic substitution. Neurology43(12), 2696–2697 (1993).
  • 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.44(7), 270–273 (1990).
  • MacDonald JT. Breakthrough seizure following substitution of Depakene capsules (Abbott) with a generic product. Neurology37(12), 1885 (1987).
  • Wyllie E, Pippenger CE, Rothner AD. Increased seizure frequency with generic primidone. JAMA258(9), 1216–1217 (1987).
  • Di Bonaventura C, Fattouch J, Fabbrini G, Manfredi M, Prencipe M, Giallonardo TA. Switching from branded to generic antiepileptic drugs as a confounding factor and unpredictable diagnostic pitfall in epilepsy management. Epileptic Disord.9(4), 465–466 (2007).
  • Nielsen KA, Dahl M, Tommerup E, Wolf P. Comparative daily profiles with different preparations of lamotrigine: a pilot investigation. Epilepsy Behav.13(1), 127–130 (2008).
  • Berg MJ, Gross RA, Tomaszewski KJ, Zingaro WM, Haskins LS. Generic substitution in the treatment of epilepsy: case evidence of breakthrough seizures. Neurology71(7), 525–530 (2008).
  • 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. Epilepsia48(3), 464–469 (2007).
  • Devine ST, Weisbart E, Barron J, Behm A. Acute epilepsy exacerbations in patients switched between A-rated anti-epileptic drugs. Curr. Med. Res. Opin.26(2), 455–463 (2010).
  • Wilner AN. Therapeutic equivalency of generic antiepileptic drugs: results of a survey. Epilepsy Behav.5(6), 995–998 (2004).
  • Biraben A, De TB, Semah F, Rouaud T. [Use of generic anti-epilepsy drugs in France: survey of neurologists and review of the literature]. Rev. Neurol. (Paris)163(4), 455–461 (2007).
  • Haskins LS, Tomaszewski KJ, Crawford P. Patient and physician reactions to generic antiepileptic substitution in the treatment of epilepsy. Epilepsy Behav.7(1), 98–105 (2005).
  • Krämer G, Steinhoff BJ, Feucht M, Pfäfflin M, May TW. [Experiences with generic drugs in epilepsy patients. Results of an internet-based questionnaire study in Germany, Austria, and Switzerland]. Akt. Neurol.33, 431–438 (2006).
  • Crawford P, Hall WW, Chappell B, Collings J, Stewart A. Generic prescribing for epilepsy: is it safe? Seizure5(1), 1–5 (1996).
  • McAuley JW, Chen AY, Elliott JO, Shneker BF. An assessment of patient and pharmacist knowledge of and attitudes toward reporting adverse drug events due to formulation switching in patients with epilepsy. Epilepsy Behav.14(1), 113–117 (2009).
  • Papsdorf TB, Ablah E, Ram S, Sadler T, Liow K. Patient perception of generic antiepileptic drugs in the Midwestern United States. Epilepsy Behav.14(1), 150–153 (2009).
  • Begley CE, Famulari M, Annegers JF et al. The cost of epilepsy in the United States: an estimate from population-based clinical and survey data. Epilepsia41(3), 342–351 (2000).
  • Cockerell OC, Hart YM, Sander JW, Shorvon SD. The cost of epilepsy in the United Kingdom: an estimation based on the results of two population-based studies. Epilepsy Res.18(3), 249–260 (1994).
  • Heaney D. Epilepsy at work: evaluating the cost of epilepsy in the workplace. Epilepsia40(Suppl. 8), 44–47 (1999).
  • Jacoby A, Buck D, Baker G, McNamee P, Graham-Jones S, Chadwick D. Uptake and costs of care for epilepsy: findings from a UK regional study. Epilepsia39(7), 776–786 (1998).
  • Duh MS, Cahill KE, Paradis PE, Cremieux PY, Greenberg PE. The economic implications of generic substitution of antiepileptic drugs: a review of recent evidence. Expert Opin. Pharmacother.10(14), 2317–2328 (2009).
  • Jobst BC, Holmes GL. Prescribing antiepileptic drugs: should patients be switched on the basis of cost? CNS Drugs18(10), 617–628 (2004).
  • Heaney DC, Begley CE. Economic evaluation of epilepsy treatment: a review of the literature. Epilepsia43(Suppl. 4), 10–16 (2002).
  • Begley CE, Beghi E. The economic cost of epilepsy: a review of the literature. Epilepsia43(Suppl. 4), 3–9 (2002).
  • Strzelczyk A, Reese JP, Dodel R, Hamer HM. Cost of epilepsy: a systematic review. Pharmacoeconomics26(6), 463–476 (2008).
  • LeLorier J, Duh MS, Paradis PE et al. Economic impact of generic substitution of lamotrigine: projected costs in the US using findings in a Canadian setting. Curr. Med. Res. Opin.24(4), 1069–1081 (2008).
  • Duh MS, Andermann F, Paradis PE, Weiner J, Manjunath R, Cremieux PY. The economic consequences of generic substitution for antiepileptic drugs in a public payer setting: the case of lamotrigine. Dis. Manag.10(4), 216–225 (2007).
  • Zachry WM, Doan QD, Clewell JD, Smith BJ. Case–control analysis of ambulance, emergency room, or inpatient hospital events for epilepsy and antiepileptic drug formulation changes. Epilepsia50(3), 493–500 (2008).
  • Helmers SL, Paradis PE, Manjunath R et al. Economic burden associated with the use of generic antiepileptic drugs in the United States. Epilepsy Behav.18(4), 437–444 (2010).
  • 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. JAMA300(21), 2514–2526 (2008).
  • de Wolf P, Brouwer WB, Rutten FF. Regulating the Dutch pharmaceutical market: improving efficiency or controlling costs? Int. J. Health Plann. Manage.20(4), 351–374 (2005).
  • Tootelian DH, Royer J, Johnson RC. Providing incentives to control health care costs and remain competitive in the marketplace: a pilot study. Health Mark. Q.15(2), 87–99 (1997).
  • Epilepsy Action. Position Statement – Consistency of Supply. British Epilepsy Association, Leeds, UK (2005).
  • Haymarket Publishing. MIMS. Haymarket Publishing Ltd, London, UK (2006).
  • Scottish Intercollegiate Guidelines Network. Diagnosis and Management of Epilepsy in Adults. A National Guideline. Royal College of Physicians, Edinburgh, UK (2003).
  • Perucca E, Albani F, Capovilla G, Bernardina BD, Michelucci R, Zaccara G. Recommendations of the Italian League against Epilepsy working group on generic products of antiepileptic drugs. Epilepsia47(Suppl. 5), 16–20 (2006).
  • Krämer G, Dennig D, Schmidt D et al. [Generics in antiepileptic drug therapy: what has to be considered?]. Akt. Neurol.32, 275–278 (2005).
  • LFCE. Recommendations on the Use of Generics for the Treatment of Epilepsy. French Chapter of the International League Against Epilepsy, Bron, France (2008).
  • Brainwave. Submission to the Oireachtas Joint Committee on Health and Children in respect of the proposed substitution by generic AEDs (anti-epileptic drugs) of branded AEDs. Epilepsy News37, 4–5 (2008).
  • AFSSAPS. Substitution of Antiepileptic Medications. Press release, Agence française de sécurité sanitaire des produits de santé, Paris, France (2008).
  • Antiepileptic drugs: the drawbacks of generic substitution. Lancet Neurol.9(3), 227 (2010).
  • Heaney DC, Sander JW. Antiepileptic drugs: generic versus branded treatments. Lancet Neurol.6(5), 465–468 (2007).
  • Manjunath R, Davis KL, Candrilli SD, Ettinger AB. Association of antiepileptic drug nonadherence with risk of seizures in adults with epilepsy. Epilepsy Behav.14(2), 372–378 (2009).
  • Johnston A, Stafylas P, Stergiou GS. Effectiveness, safety and cost of drug substitution in hypertension. Br. J. Clin. Pharmacol.70, 320–334 (2010).
  • Gagne JJ, Avorn J, Shrank WH, Schneeweiss S. Refilling and switching of antiepileptic drugs and seizure-related events. Clin. Pharmacol. Ther.88(3), 347–353 (2010).
  • Liow K. Understanding patients’ perspective in the use of generic antiepileptic drugs: compelling lessons for physicians to improve physician/patient communication. BMC Neurol.9, 11 (2009).
  • Hattingh HL. Pharmacists’ responsibility and potential liability regarding generic substitition. Med. Law28(4), 697–704 (2009).
  • European Commission Enterprise Directorate-General. Marketing authorisation. In: Procedures for Marketing Authorisation (Volume 2A). European Commission Enterprise Directorate-General, Brussels (2006).
  • Borgherini G. The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs. Clin. Ther.25(6), 1578–1592 (2003).
  • Nashef L, Fish DR, Garner S, Sander JW, Shorvon SD. Sudden death in epilepsy: a study of incidence in a young cohort with epilepsy and learning difficulty. Epilepsia36(12), 1187–1194 (1995).
  • Kitson A, Shorvon S. Clinical Standards Advisory Group. Services for Patients with Epilepsy. Department of Health, London, UK (2000).
  • Shorvon SD. The epidemiology and treatment of chronic and refractory epilepsy. Epilepsia37(Suppl. 2), S1–S3 (1996).
  • Hanna NJ, Black M, Sander JW et al.The National Sentinel Clinical Audit of Epilepsy-Related Death. Epilepsy – Death in the Shadows. The Stationery Office, Norwich, UK (2002).
  • Epilepsy: safety, excess mortality and sudden death. Epilepsia44(Suppl. 6), 19–20 (2003).
  • Schmidt D, Loscher W. Uncontrolled epilepsy following discontinuation of antiepileptic drugs in seizure-free patients: a review of current clinical experience. Acta Neurol. Scand.111(5), 291–300 (2005).
  • Tomson T, Walczak T, Sillanpaa M, Sander JW. Sudden unexpected death in epilepsy: a review of incidence and risk factors. Epilepsia46(Suppl. 11), 54–61 (2005).

Websites

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.