Literature DB >> 11005701

Is generic prescribing acceptable in epilepsy?

F M Besag1.   

Abstract

There is considerable debate about the role of generic prescribing for people with epilepsy. The arguments go beyond simple considerations of cost on one hand and the possibility of toxicity or loss of seizure control on the other. The concepts of bioavailability and bioequivalence require further consideration. The measures that are currently used may not apply equally well to all situations. For example, additional measures may be needed for controlled-release preparations and in the other special cases. There is an extensive literature on the bioequivalence of various phenytoin preparations. This anticonvulsant drug is poorly soluble in water, has nonlinear kinetics and has a narrow therapeutic range, implying that problems with bioequivalence are likely to occur. This is borne out by clinical experience. There are a few published investigations on carbamazepine. The systematic studies, on the whole, fail to show major differences in bioequivalence between the various formulations. There is sparse information on the comparison between generic and proprietary formulations of other anticonvulsant drugs. Whatever arguments might be put forward supporting brand name or generic prescribing, there are strong reasons for recommending tight control on the consistency of anticonvulsant drugs, both generic and proprietary. There is also a strong case for ensuring that the physician who signs the prescription remains in control of the situation and that any decisions that the physician makes should be based on accurate and reliable information.

Entities:  

Mesh:

Substances:

Year:  2000        PMID: 11005701     DOI: 10.2165/00002018-200023030-00001

Source DB:  PubMed          Journal:  Drug Saf        ISSN: 0114-5916            Impact factor:   5.606


  38 in total

1.  Assessment: generic substitution for antiepileptic medication. Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology.

Authors: 
Journal:  Neurology       Date:  1990-11       Impact factor: 9.910

2.  Bioavailability of phenytoin. A comparison of two preparations.

Authors:  M J Stewart; B R Ballinger; E J Devlin; A Y Miller; A C Ramsay
Journal:  Eur J Clin Pharmacol       Date:  1975-12-19       Impact factor: 2.953

3.  Outbreak of anticonvulsant intoxication in an Australian city.

Authors:  J H Tyrer; M J Eadie; J M Sutherland; W D Hooper
Journal:  Br Med J       Date:  1970-10-31

4.  Untoward effects of generic carbamazepine therapy.

Authors:  G Koch; J P Allen
Journal:  Arch Neurol       Date:  1987-06

5.  Breakthrough seizure following substitution of Depakene capsules (Abbott) with a generic product.

Authors:  J T MacDonald
Journal:  Neurology       Date:  1987-12       Impact factor: 9.910

6.  Letter: Bioavailability of phenytoin.

Authors:  P Tammisto; K Kauko; M Viukari
Journal:  Lancet       Date:  1976-01-31       Impact factor: 79.321

7.  Comparative study of bioavailability and clinical efficacy of carbamazepine in epileptic patients.

Authors:  O Silpakit; M Amornpichetkoon; S Kaojarern
Journal:  Ann Pharmacother       Date:  1997-05       Impact factor: 3.154

8.  Double-blind randomized study comparing brand-name and generic phenytoin monotherapy.

Authors:  M Mikati; N Bassett; S Schachter
Journal:  Epilepsia       Date:  1992 Mar-Apr       Impact factor: 5.864

9.  Bioavailability and dissolution of proprietary and generic formulations of phenytoin.

Authors:  I Soryal; A Richens
Journal:  J Neurol Neurosurg Psychiatry       Date:  1992-08       Impact factor: 10.154

10.  Bio-availability and dissolution of three phenytoin preparations for children.

Authors:  S Hodges; W I Forsythe; D Gillies; H Remington; A Cawood
Journal:  Dev Med Child Neurol       Date:  1986-12       Impact factor: 5.449

View more
  9 in total

1.  Equivalence-by-design: targeting in vivo drug delivery profile.

Authors:  Mei-Ling Chen; Vincent H L Lee
Journal:  Pharm Res       Date:  2008-10-28       Impact factor: 4.200

2.  Interchangeability of generic anti-epileptic drugs: a quantitative analysis of topiramate and gabapentin.

Authors:  Marc Maliepaard; Nikola Banishki; Christine C Gispen-de Wied; Steven Teerenstra; André J Elferink
Journal:  Eur J Clin Pharmacol       Date:  2011-04-15       Impact factor: 2.953

3.  Comparison of dissolution profiles and serum concentrations of two lamotrigine tablet formulations.

Authors:  Mladena Lalic; Ana Pilipovic; Svetlana Golocorbin-Kon; Ksenija Gebauer-Bukurov; Ksenija Bozic; Momir Mikov; Jelena Cvejic
Journal:  Drugs R D       Date:  2011

4.  Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

Authors:  Md Motiur Rahman; Yasser Alatawi; Ning Cheng; Jingjing Qian; Annya V Plotkina; Peggy L Peissig; Richard L Berg; David Page; Richard A Hansen
Journal:  Epilepsy Res       Date:  2017-06-13       Impact factor: 3.045

5.  Refilling and switching of antiepileptic drugs and seizure-related events.

Authors:  J J Gagne; J Avorn; W H Shrank; S Schneeweiss
Journal:  Clin Pharmacol Ther       Date:  2010-07-14       Impact factor: 6.875

6.  Exposure-response analysis reveals that clinically important toxicity difference can exist between bioequivalent carbamazepine tablets.

Authors:  Laszlo Tothfalusi; Szilvia Speidl; Laszlo Endrenyi
Journal:  Br J Clin Pharmacol       Date:  2007-08-15       Impact factor: 4.335

Review 7.  Prescribing antiepileptic drugs: should patients be switched on the basis of cost?

Authors:  Barbara C Jobst; Gregory L Holmes
Journal:  CNS Drugs       Date:  2004       Impact factor: 5.749

Review 8.  A composite screening tool for medication reviews of outpatients: general issues with specific examples.

Authors:  Peter A G M De Smet; Wilma Denneboom; Cees Kramers; Richard Grol
Journal:  Drugs Aging       Date:  2007       Impact factor: 3.923

9.  Understanding patients' perspective in the use of generic antiepileptic drugs: compelling lessons for physicians to improve physician/patient communication.

Authors:  Kore Liow
Journal:  BMC Neurol       Date:  2009-03-17       Impact factor: 2.474

  9 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.