Bioequivalence, Drugs with Narrow Therapeutic Index and The Phenomenon of Biocreep: A Critical Analysis of the System for Generic Substitution.
biocreep
bioequivalence
generics
narrow therapeutic index drugs
substitution
Journal
Healthcare (Basel, Switzerland)
ISSN: 2227-9032
Titre abrégé: Healthcare (Basel)
Pays: Switzerland
ID NLM: 101666525
Informations de publication
Date de publication:
26 Jul 2022
26 Jul 2022
Historique:
received:
29
06
2022
revised:
22
07
2022
accepted:
23
07
2022
entrez:
27
7
2022
pubmed:
28
7
2022
medline:
28
7
2022
Statut:
epublish
Résumé
The prescription of generic drugs represents one of the main cost-containment strategies of health systems, aimed at reducing pharmaceutical expenditure. In this context, most regulatory authorities encourage or obligate dispensing generic drugs because they are far less expensive than their brand-name alternatives. However, drug substitution can be critical in particular situations, such as the use of drugs with a narrow therapeutic index (NTI). Moreover, generics cannot automatically be considered bioequivalent with each other due to the biocreep phenomenon. In Italy, the regulatory authority has established the Transparency Lists which include the medications that will be automatically substituted for brand-name drugs, except in exceptional cases. This is a useful tool to guide prescribers and guarantee pharmaceutical sustainability, but it does not consider the biocreep phenomenon.
Identifiants
pubmed: 35893214
pii: healthcare10081392
doi: 10.3390/healthcare10081392
pmc: PMC9394341
pii:
doi:
Types de publication
Journal Article
Review
Langues
eng
Références
Bull Hist Med. 2011 Spring;85(1):93-131
pubmed: 21551918
JAMA. 2008 Dec 3;300(21):2514-26
pubmed: 19050195
Eur J Pain. 2021 May;25(5):969-985
pubmed: 33655678
Ann Intern Med. 2014 Sep 16;161(6):400-7
pubmed: 25222387
J Comp Eff Res. 2012 Nov;1(6):527-38
pubmed: 24236472
Epilepsia. 2021 Feb;62(2):285-302
pubmed: 33426641
JAMA Netw Open. 2021 Sep 1;4(9):e2124152
pubmed: 34495339
Clin Pharmacol Ther. 2022 Feb;111(2):470-476
pubmed: 34657284
Front Oncol. 2021 Mar 09;11:641450
pubmed: 33796467
BMJ. 2015 Jun 22;350:h3248
pubmed: 26101229
Health Aff (Millwood). 2010 Oct;29(10):1933-41
pubmed: 20829295
Clin Drug Investig. 2016 Apr;36(4):281-92
pubmed: 26818406
Neurology. 1987 Dec;37(12):1885
pubmed: 3120036
BMJ. 2010 Jun 01;340:c2548
pubmed: 20516014
Expert Rev Pharmacoecon Outcomes Res. 2010 Feb;10(1):73-85
pubmed: 20121565
Front Immunol. 2021 Jul 06;12:661882
pubmed: 34295328
PLoS Med. 2019 Mar 13;16(3):e1002763
pubmed: 30865626
Br J Clin Pharmacol. 2013 Jan;75(1):60-78
pubmed: 22554450
BMC Health Serv Res. 2015 Apr 15;15:159
pubmed: 25889173
Int J Psychiatry Clin Pract. 2019 Mar;23(1):2-13
pubmed: 30732488
J Manag Care Spec Pharm. 2014 May;20(5):467-76
pubmed: 24761818
Eur J Pain. 2018 Feb;22(2):216-241
pubmed: 29105941
Curr Neuropharmacol. 2022;20(2):412-431
pubmed: 34191699
Eur J Pharm Sci. 2013 Nov 20;50(3-4):476-83
pubmed: 23981332
Clin Ther. 2003 Jun;25(6):1578-92
pubmed: 12860486
Pharmacy (Basel). 2020 Aug 25;8(3):
pubmed: 32854271
Epilepsy Behav. 2015 Nov;52(Pt A):14-8
pubmed: 26386779
J Pain Res. 2014 Oct 17;7:589-608
pubmed: 25378948
Pain Physician. 2008 Mar;11(2 Suppl):S105-20
pubmed: 18443635
Neurology. 2008 Aug 12;71(7):525-30
pubmed: 18695164
Front Pharmacol. 2020 Nov 30;11:621934
pubmed: 33329008
Appl Health Econ Health Policy. 2014 Oct;12(5):537-46
pubmed: 25005492
J Clin Invest. 2007 Nov;117(11):3185-7
pubmed: 17975665
Front Pharmacol. 2011 Jan 07;1:141
pubmed: 21833180
Pharmaceuticals (Basel). 2010 Aug 05;3(8):2470-2494
pubmed: 27713363
Sci Rep. 2021 Oct 19;11(1):20689
pubmed: 34667256
Am J Manag Care. 2011 Sep;17 Suppl 11:S276-87
pubmed: 21999760
J Clin Pharm Ther. 2020 Oct;45(5):892-903
pubmed: 31986228
JAMA Neurol. 2017 Aug 1;74(8):919-926
pubmed: 28654954
Int J Mol Sci. 2018 Jan 13;19(1):
pubmed: 29342845
Front Pharmacol. 2021 Oct 08;12:755052
pubmed: 34690785
Molecules. 2021 Aug 02;26(15):
pubmed: 34361825
Front Pharmacol. 2019 Sep 12;10:1024
pubmed: 31572196
Int J Cardiol Heart Vasc. 2020 Jan 23;26:100465
pubmed: 32021902
Seizure. 2006 Apr;15(3):165-76
pubmed: 16504545
J Clin Psychiatry. 2001;62 Suppl 5:4-9; discussion 23-4
pubmed: 11305846
J Psychopharmacol. 2007 Jul;21(5):459-60
pubmed: 17664245
Eur J Clin Invest. 2014 Oct;44(10):933-9
pubmed: 25132063
Int J Mol Sci. 2021 Apr 21;22(9):
pubmed: 33919241
Front Pharmacol. 2021 Jul 21;12:705405
pubmed: 34366858
Eur J Epidemiol. 2016 Apr;31(4):351-68
pubmed: 26620809
Adv Health Econ Health Serv Res. 2010;22:3-27
pubmed: 20575226
Pain Pract. 2011 May-Jun;11(3):230-9
pubmed: 20807350
Br J Clin Pharmacol. 2010 Sep;70(3):335-41
pubmed: 20716231
Clin Pharmacol Ther. 2015 Mar;97(3):286-91
pubmed: 25669762
Drugs. 2010 Mar 26;70(5):605-21
pubmed: 20329806
Ann Hematol. 2021 Feb;100(2):481-485
pubmed: 33415425
Eur J Paediatr Neurol. 2009 Mar;13(2):87-92
pubmed: 18790656
Eur J Clin Pharmacol. 2015 May;71(5):549-67
pubmed: 25870032
AAPS J. 2015 Jul;17(4):891-901
pubmed: 25840883
Eur J Intern Med. 2014 Oct;25(8):745-50
pubmed: 25200803
Biomedicines. 2021 Sep 24;9(10):
pubmed: 34680428
Lancet Neurol. 2007 May;6(5):465-8
pubmed: 17434101
Pharmacogenomics. 2012 Nov;13(15):1719-40
pubmed: 23171337
Front Pharmacol. 2020 Sep 25;11:588132
pubmed: 33101042
Lancet. 2019 Apr 13;393(10180):1547-1557
pubmed: 30983590
Eur J Pain. 2017 Jan;21(1):3-19
pubmed: 27991730
Cancer Med. 2020 Jun;9(12):4160-4165
pubmed: 32319737
Epilepsy Res. 2012 Feb;98(2-3):269-72
pubmed: 22030125
Clin Pharmacokinet. 2009;48(10):625-33
pubmed: 19743885