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• W3161838400 abstract "“And don't speak too soonFor the wheel's still in spinAnd there's no tellin' whoThat it's namin'For the loser nowWill be later to winFor the times they are a-changin'”Bob Dylan (1964) In this issue, our Australian friend and colleague Roy Beran adds to the apparently never-ending literature warning against the use of generic antiseizure medications (ASMs) since their introduction for lamotrigine about 25 years ago [[1]Beran R Generic substitution and advice to patients –potential legal medicine consequences.Seizure. 2021; (in this issue)https://doi.org/10.1016/j.seizure.2021.03.016Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar]. His-major concern is that switches may be associated with bioequivalence problems leading to seizure recurrence or increase. He therefore recommends that physicians should use branded trade names on their prescriptions. In addition, he points to potential legal consequences associated with brand substitution when patients have not been warned of potential risks and experience serious consequences. He recommends that physicians should seek informed consent when they are switching from a branded to a generic product or between different generic medicines. This is in line with a series of earlier papers from him in this journal [e.g. [2]Manser D. Beran R.G. Clinical letter: brand substitution with generics - a potential mine field.Seizure. 2020; 83: 232-233Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar,[3]Beran R.G. Generic substitution and advice to patients - potential legal medicine consequences - from A (Australia) to U (United Kingdom or United States of America).Seizure. 2021; : S1059-S1311PubMed Google Scholar] as well as in others [e.g. 4Patel V. Cordato D.J. Dias M. Beran R.G. Changed constitution without change in brand name - the risk of generics in epilepsy.Epilepsy Res. 2012; 98: 269-272Crossref PubMed Scopus (11) Google Scholar, 5Beran R.G. Generic substitution in contravention of doctor's prescriptions.Intern Med J. 2015; 45: 1093Crossref PubMed Scopus (4) Google Scholar, 6Beran R.G. Generic substitution: when similar may not mean the same.Med Law. 2016; 35: 73-86Google Scholar, 7Beran R. Prescribing, using the proprietary ‘Trade’ name, is safer than using the generic active ingredient, as the defined identifier of the required medication.Pharmacl Sci Biomed Analysis J. 2021; 4 (https://scientificliterature.org/Pharmaceutics/Pharmaceutics-21-124.pdf): 124Google Scholar, 8Beran R.G. Generic substitution in patients whose illness has a narrow therapeutic index, such as epilepsy.Annal of Pub Health Epidemiol. 2020; 1 (https://irispublishers.com/aphe/pdf/APHE.MS.ID.000510.pdf): 1-5Google Scholar]. Roy Beran is Conjoint Professor at the South Western Clinical School of the University of New South Wales in Sydney, New South Wales, and Professor at the Medical School of the Griffith University in Broadbeach, Queensland, Australia, and finally Professor and Chair for Medical Law at the Sechenov Moscow First State University in Russia. In his latest paper in the current issue of Seizure, Beran essentially repeats his previously stated views. Although we are – by now - of the opinion that this is neither necessary nor justified, we first have to admit that we shared some of his concerns in the past [9Crawford P. Feely M. Guberman A. Krämer G. Are there potential problems with generic substitution of antiepileptic drugs? A review of issues.Seizure. 2006; 15: 165-176Abstract Full Text Full Text PDF PubMed Scopus (137) Google Scholar, 10Krämer G. Biraben A. Carreno M. et al.Current approaches to the use of generic antiepileptic drugs.Epilepsy Behav. 2007; 11: 46-52Abstract Full Text Full Text PDF PubMed Scopus (53) Google Scholar, 11Krämer G. Steinhoff B.J. Feucht M. et al.Experience with generic drugs in epilepsy patients: an electronic survey of members of the German, Austrian and Swiss branches of the ILAE.Epilepsia. 2007; 48: 609-611Crossref PubMed Scopus (28) Google Scholar, 12Steinhoff B.J. Runge U. Witte O.W. et al.Substitution of anticonvulsant drugs.Ther Clin Risk Manag. 2009; 5: 449-457Crossref PubMed Google Scholar, 13Trinka E. Krämer G. Graf M. Requirements for generic antiepileptic medicines: a clinical perspective.J Neurol. 2011; 258: 2128-2132Crossref PubMed Scopus (11) Google Scholar]. However, carefully performed cross-over studies comparing serum concentrations as well as efficacy and tolerability of different generics [[14]Privitera M.D. Welty T.E. Gidal B.E. et al.Generic-to-generic lamotrigine switches in people with epilepsy: the randomised controlled EQUIGEN trial.Lancet Neurol. 2016; 15: 365-372Abstract Full Text Full Text PDF PubMed Scopus (76) Google Scholar] and generic and branded drugs [[15]Berg M. Welty T.E. Gidal B.E. et al.Bioequivalence between generic and branded lamotrigine in people with epilepsy: the EQUIGEN randomized clinical trial.JAMA Neurol. 2017; 74: 919-926Crossref PubMed Scopus (32) Google Scholar], prospective comparative studies on quality of life [[16]Olsson P. Reimers A. Källén K. Quality of life after switching to generic levetiracetam - a prospective comparative study.Epilepsy Behav. 2019; 96: 169-174Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar,[17]Giometto S. Baglietto L. Conte M. et al.Use of antiseizure medications and safety of branded versus generic formulations: a comparative study on Tuscan administrative databases.Epilepsy Behav. 2021; 117107876Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar], and a recent re-analysis of data relating to 117 oral generic products of second-generation ASMs approved in Europe showed that the 90% confidence intervals (90% CIs) for area under the drug concentration vs time curve (AUC) were narrow and within 90−111% for 99% of generic products assessed (with the exception of gabapentin products) [[18]Odi R. Franco V. Perucca E. Bialer M. Bioequivalence and switchability of generic antiseizure medications (ASMs): a re-appraisal based on analysis of generic ASM products approved in Europe.Epilepsia. 2021; 62: 285-302Crossref PubMed Scopus (5) Google Scholar]. Last not least, our clinical experience has caused us to change our mind since our earlier expressions of concern. We agree with Roy Beran that the use of generic ASMs may still be problematic, but we don´t agree with his view of possible reasons. The only problems we agree with are the sometimes problematic supply of generic ASMs and – not mentioned by Beran – the very important and so far mostly ignored nocebo effect when physicians warn their patients or even ask for informed consent before prescribing generics [19Flaten M.A. Simonsen T. Olsen H. Drug-related information generates placebo and nocebo responses that modify the drug response.Psychosom Med. 1999; 61: 250-255Crossref PubMed Scopus (166) Google Scholar, 20Weissenfeld J. Stock S. Lüngen M. Gerber A. The nocebo effect: a reason for patients' non-adherence to generic substitution?.Pharmazie. 2010; 65: 451-456PubMed Google Scholar, 21Faasse K. Petrie K.J. The nocebo effect: patient expectations and medication side effects.Postgrad Med J. 2013; 89: 540-546Crossref PubMed Scopus (123) Google Scholar, 22MacKrill K. Petrie K.J. What is associated with increased side effects and lower perceived efficacy following switching to a generic medicine? A New Zealand cross-sectional patient survey.BMJ Open. 2018; 8e023667Crossref PubMed Scopus (14) Google Scholar, 23Rezk M.F. Pieper B. To See or NOsee: the debate on the nocebo effect and optimizing the use of biosimilars.Adv Ther. 2018; 35: 749-753Crossref PubMed Scopus (25) Google Scholar, 24Vulto A.G. Non-pharmacological effects in switching nedication: the nocebo effect in switching from originator to biosimilar agent.BioDrugs. 2018; 32: 397-404Crossref PubMed Scopus (64) Google Scholar, 25Odinet J.S. Day C.E. Cruz J.L. Heindel G.A. The biosimilar nocebo effect? A systematic review of double-blinded versus open-label studies.J Manag Care Spec Pharm. 2018; 24: 952-959PubMed Google Scholar, 26Spanou I. Mavridis T. Mitsikostas D.D. Nocebo in biosimilars and generics in neurology: a systematic review.Front Pharmacol. 2019; 10: 809Crossref PubMed Google Scholar, 27MacKrill K. Kleinstäuber M. Petrie K.J. The effect of rebranding generic medicines on drug efficacy and side effects.Psychol Health. 2019; 34: 1470-1485Crossref PubMed Scopus (2) Google Scholar]. One advantage of the newer ASMs like lamotrigine and levetiracetam is that – contrary to claims made by Beran [[8]Beran R.G. Generic substitution in patients whose illness has a narrow therapeutic index, such as epilepsy.Annal of Pub Health Epidemiol. 2020; 1 (https://irispublishers.com/aphe/pdf/APHE.MS.ID.000510.pdf): 1-5Google Scholar] and others – they don´t actually have a narrow therapeutic range. In addition, levels of these drugs vary markedly during the course of the day, as shown for one of our patients in Fig. 1. These fluctuations are at least as impressive as minor changes associated with switching from a branded to a generic ASM. Over the last few years epilepsy patient associations [[28]Vandenplas Y. Simoens S. Van Wilder P. Vulto A.G. Huys I. Informing patients about biosimilar medicines: the role of European patient associations.Pharmaceuticals (Basel). 2021; 14: 117Crossref PubMed Scopus (19) Google Scholar] as well as other stakeholders [[29]Barbier L. Simoens S. Vulto A.G. Huys I. European stakeholder learnings regarding biosimilars: Part I - Improving biosimilar understanding and adoption.BioDrugs. 2020; 34: 783-796Crossref PubMed Scopus (25) Google Scholar,[30]Barbier L. Simoens S. Vulto A.G. Huys I. European stakeholder learnings regarding biosimilars: Part II - Improving biosimilar use in clinical practice.BioDrugs. 2020; 34: 797-808Crossref PubMed Scopus (22) Google Scholar] have reached a positive opinion on the use of generics and biosimilars in clinical practice. In addition, some epilepsy societies like the Antiseizure Medications Commission of the Italian League against Epilepsy [[31]Roberti R. Casarella A. Iudice A. et al.Antiseizure Medications Commission of the Italian League against Epilepsy LICE. Appropriate use of generic and branded antiseizure medications in epilepsy: updated recommendations from the Italian League Against Epilepsy (LICE).Epilepsy Behav. 2021; 116107804Abstract Full Text Full Text PDF PubMed Scopus (4) Google Scholar] have updated their recommendations and now stipulate that patients “should be assured of generics' safety and efficacy and carefully informed with practical advice, particularly when the switching is associated with aspect modifications (e.g. color and shape changes) of the pill or the packaging”. One particular absurdity relates to generic and branded levetiracetam: in Germany UCB pharma sell identical pills as branded “Keppra” or as “Levetiracetam UCB”. The only differences between these two medications are the name and the price (by a factor of five). So called “key opinion leaders” (KOLs) such as ourselves as well as members of Advisory Boards and scientific epilepsy societies should take care not to let themselves be instrumentalized by major pharmaceutical companies. Generic Substitution and Advice to Patients –Potential Legal Medicine Consequences – From A (Australia) to U (United Kingdom or United States of America)Seizure - European Journal of EpilepsyVol. 91PreviewGeneric substitution has become a long standing popularly accepted ‘chatchcry’ on the basis of health economics and hence formulary inclusion [1]. It has been widely adopted to reduce the burgeoning cost of health care provision, the claim being that the generic substitute is of almost identical efficacy as is the parent compound upon which the generic is based [2]. This may not always be the case, depending upon the salt, potentially used to modify the compound, thought to be the active ingredient in the innovative, parent compound [3]. 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• W3161838400 title "The times they are a-changin – Don´t panic with a generic!" @default.
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