Literature DB >> 10364779

Management of narrow therapeutic index drugs.

M Burns1.   

Abstract

Summary. Narrow therapeutic index (NTI) drugs are agents for which small changes in systemic concentration can lead to significant changes in pharmacodynamic response. This may result in potentially subtherapeutic or toxic effects, particularly in patients with advanced age, comorbid illness, or those receiving multiple medications. Bioequivalence among generic and innovator drug products does not always ensure therapeutic equivalence, especially with regard to NTI drugs. Warfarin is a NTI drug for which substitution is now available and may occur routinely without the knowledge of the patient or practitioner. To avoid overanticoagulation or underanticoagulation, the additional cost of patient education and monitoring may actually exceed cost savings by using the less expensive generic drug product. When brand name drug is preferred by the practitioner, "no substition" must be specified on the prescription to avoid mandated generic interchange of warfarin and other NTI drugs.

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Year:  1999        PMID: 10364779     DOI: 10.1023/a:1008829403320

Source DB:  PubMed          Journal:  J Thromb Thrombolysis        ISSN: 0929-5305            Impact factor:   2.300


  17 in total

Review 1.  Generic substitutions for antiepileptic drugs.

Authors:  M R Nuwer; T R Browne; W E Dodson; F E Dreifuss; J Engel; I E Leppik; R H Mattson; J Penry; D M Treiman; B J Wilder
Journal:  Neurology       Date:  1990-11       Impact factor: 9.910

2.  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

Review 3.  Individual bioequivalence--a regulatory update.

Authors:  M L Chen
Journal:  J Biopharm Stat       Date:  1997-03       Impact factor: 1.051

4.  Generic warfarin: implications for patient care.

Authors:  A K Wittkowsky
Journal:  Pharmacotherapy       Date:  1997 Jul-Aug       Impact factor: 4.705

Review 5.  Oral anticoagulants. Mechanism of action, clinical effectiveness, and optimal therapeutic range.

Authors:  J Hirsh; J E Dalen; D Deykin; L Poller; H Bussey
Journal:  Chest       Date:  1995-10       Impact factor: 9.410

6.  Bioequivalence and narrow therapeutic index drugs.

Authors:  L Z Benet; J E Goyan
Journal:  Pharmacotherapy       Date:  1995 Jul-Aug       Impact factor: 4.705

7.  The generic drug approval process.

Authors:  P H Rheinstein
Journal:  Am Fam Physician       Date:  1993-12       Impact factor: 3.292

Review 8.  Bioequivalence requirements for generic products.

Authors:  R L Nation; L N Sansom
Journal:  Pharmacol Ther       Date:  1994 Apr-May       Impact factor: 12.310

9.  Risk factors for intracranial hemorrhage in outpatients taking warfarin.

Authors:  E M Hylek; D E Singer
Journal:  Ann Intern Med       Date:  1994-06-01       Impact factor: 25.391

10.  Different intensities of oral anticoagulant therapy in the treatment of proximal-vein thrombosis.

Authors:  R Hull; J Hirsh; R Jay; C Carter; C England; M Gent; A G Turpie; D McLoughlin; P Dodd; M Thomas; G Raskob; P Ockelford
Journal:  N Engl J Med       Date:  1982-12-30       Impact factor: 91.245

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  16 in total

1.  Physician attitudes concerning anticoagulation services in the long-term care setting.

Authors:  Leslie R Harrold; Jerry H Gurwitz; Janet P Tate; Richard Becker; Tammy Stuart; Anne Elwell; Martha Radford
Journal:  J Thromb Thrombolysis       Date:  2002-08       Impact factor: 2.300

2.  Generic Substitution Issues: Brand-generic Substitution, Generic-generic Substitution, and Generic Substitution of Narrow Therapeutic Index (NTI)/Critical Dose Drugs.

Authors:  Marian Sorin Paveliu; Simona Bengea; Fraga Silvia Paveliu
Journal:  Maedica (Buchar)       Date:  2011-01

Review 3.  Nano optical and electrochemical sensors and biosensors for detection of narrow therapeutic index drugs.

Authors:  Omid Heydari Shayesteh; Reza Mahjub; Akram Ranjbar; Katayoun Derakhshandeh; Mahdi Jamshidi
Journal:  Mikrochim Acta       Date:  2021-11-06       Impact factor: 5.833

4.  Levothyroxine Variations by Process Analytical Technology.

Authors:  James T Isaacs; Philip J Almeter; Bradley S Henderson; Aaron N Hunter; Thomas L Platt; Robert A Lodder
Journal:  Contact Context       Date:  2022-04-12

Review 5.  Protein engineering: a new frontier for biological therapeutics.

Authors:  Peter H Tobin; David H Richards; Randolph A Callender; Corey J Wilson
Journal:  Curr Drug Metab       Date:  2014       Impact factor: 3.731

Review 6.  Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis.

Authors:  Aaron S Kesselheim; Alexander S Misono; Joy L Lee; Margaret R Stedman; M Alan Brookhart; Niteesh K Choudhry; William H Shrank
Journal:  JAMA       Date:  2008-12-03       Impact factor: 56.272

Review 7.  Strategies for potentiation of ethionamide and folate antagonists against Mycobacterium tuberculosis.

Authors:  Kerstin A Wolff; Liem Nguyen
Journal:  Expert Rev Anti Infect Ther       Date:  2012-09       Impact factor: 5.091

8.  In vitro surfactant structure-toxicity relationships: implications for surfactant use in sexually transmitted infection prophylaxis and contraception.

Authors:  Ângela S Inácio; Katia A Mesquita; Marta Baptista; João Ramalho-Santos; Winchil L C Vaz; Otília V Vieira
Journal:  PLoS One       Date:  2011-05-16       Impact factor: 3.240

9.  Simulation of the AUC changes after generic substitution in patients.

Authors:  Dong-Seok Yim
Journal:  J Korean Med Sci       Date:  2009-02-28       Impact factor: 2.153

Review 10.  Influence of CYP2C9 and VKORC1 on patient response to warfarin: a systematic review and meta-analysis.

Authors:  Andrea L Jorgensen; Richard J FitzGerald; James Oyee; Munir Pirmohamed; Paula R Williamson
Journal:  PLoS One       Date:  2012-08-29       Impact factor: 3.240

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