Artículos de revistas
Levothyroxine And The Problem Of Interchangeability Of Drugs With Narrow Therapeutic Index [levotiroxina E O Problema Da Permutabilidade De Drogas De Estreito Intervalo Terapêutico]
Registro en:
Arquivos Brasileiros De Endocrinologia E Metabologia. , v. 55, n. 7, p. 429 - 434, 2011.
42730
2-s2.0-82955189768
Autor
Ward L.S.
Institución
Resumen
The exchange of a prescribed drug by other similar, by generic products and even by custom products has become common practice in our country, often ignoring basic tenets of bioequivalence, interchangeability, stability and characteristics of the pharmaceutical compounds. In the case of drugs of narrow therapeutic index, such as levothyroxine, these problems are intensified, putting the effectiveness of treatment and patient health at serious risk. We review the pertinent legislation, emphasizing the characteristics of levothyroxine and adverse effects that limit the interchangeability of the compound. © ABE&M todos os direitos reservados. 55 7 429 434 Haas, J.S., Phillips, K.A., Gerstenberger, E.P., Seger, A.C., Potential savings from substituting generic drugs for brand-name drugs: Medical expenditure panel survey (2005) Ann Intern Med, 142 (11), pp. 891-897. , 1997-2000 Midha, K.K., McKay, G., Bioequivalence: Its history, practice, and future (2009) AAPS J, 11 (4), pp. 664-670 Shrank, W.H., Cox, E.R., Fischer, M.A., Mehta, J., Choudhry, N.K., Patients' perceptions of generic medications (2009) Health Aff (Millwood), 28 (2), pp. 546-556 (2007) Aprovar O Regulamento Técnico Para Medicamentos Genéricos, p. 2007. , Brasil. Anvisa. Resolução RDC n. o 16 de 2 de março de, Diário Oficial da União, Brasília, DF Chow, S.C., Liu, J.P., (2000) Design and Analysis of Bioavailability and Bioequivalence Studies, , New York: Marcel Dekker Crommelin, D., Bermejo, T., Bissig, M., Damiaans, J., Krämer, I., Rambourg, P., Biosimilars, generic versions of the first generation of therapeutic proteins: Do they exist? (2005) Contrib Nephrol, 149, pp. 287-294 Kresse, G.B., Biosimilars: Science, status, and strategic perspective (2009) Eur J Pharm Biopharm, 72 (3), pp. 479-486 European Medicines Agency, , http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf, Guideline on the investigation of bioequivalence. CPMP/EWP/QWP/1401/98 Rev.1/Corr **, Published in London, 20 January 2010. Disponível em: Nightingale, S.L., Morrison, J.C., Generic drugs and the prescribing physician (1987) JAMA, 258 (9), pp. 1200-1204 Levy, G., What are narrow therapeutic index drugs? (1998) Clin Pharmacol Ther, 63 (5), pp. 501-505 Prescription Drugs Products (1997) Levothyroxine Sodium Federal Register 62, pp. 43535-43538. , http://www.gpo.gov/fdsys/pkg/FR-1997-08-14/html/97-21575.htm, Docket number 97N-0314, Disponível em Palylyk-Colwell, E., Jamali, F., Dryden, W., Friesen, E., Koven, S., Mohamed, I., Bioequivalence and interchangeability of narrow therapeutic range drugs (1998) J Pharm Pharmaceut. Sci, 1 (1), pp. 2-7 (1992), http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/bio/biorepc_biorapc-eng.php, Health Protection Branch, Health Canada, Conduct and analysis of bioavailability and bioequivalence studies part A: oral dosage formulations, not in modified released form, of drugs used for systemic effects, having complicated or variable pharmacokinetics, Disponível em, Acesso em: Jul 2011(1997) FDA Position On Product Selection For 'narrow Therapeutic Index' Drugs, 54 (14), pp. 1630-1632. , Am J Health Syst Pharm Turner, M.R., Camacho, X., Fischer, H.D., Austin, P.C., Anderson, G.M., Rochon, P.A., Levothyroxine dose and risk of fractures in older adults: Nested case-control study (2011) BMJ, 342. , http://www.bmj.com/content/342/bmj, d2238, doi:10.1136/bmj.d2238. Disponível em Donangelo, I., Braunstein, G.D., Update on subclinical hyperthyroidism (2011) Am Fam Physician, 83 (8), pp. 933-938 Klein, I., Ojamaa, K., Thyroid hormone and the cardiovascular system (2001) N Engl J Med, 344 (7), pp. 501-509 Lazarus, J.H., Screening for thyroid dysfunction in pregnancy: Is it worthwhile? (2011) J Thyroid Res, , 2011:397012 Casey, B.M., Dashe, J.S., Wells, C.E., McIntire, D.D., Byrd, W., Leveno, K.J., Subclinical hypothyroidism and pregnancy outcomes (2005) Obstet Gynecol, 105 (2), pp. 239-245 Abalovich, M., Gutierrez, S., Alcaraz, G., Maccallini, G., Garcia, A., Levalle, O., Overt and subclinical hypothyroidism complicating pregnancy (2002) Thyroid, 12 (1), pp. 63-68 Pop, V.J., Brouwers, E.P., Vader, H.L., Vulsma, T., van Baar, A.L., de Vijlder, J.J., Maternal hypothyroxinaemia during early pregnancy and subsequent child development: A 3-year follow-up study (2003) Clin Endocrinol (Oxf), 59 (3), pp. 282-288 Biondi, B., Cooper, D.S., Benefits of thyrotropin suppression vs. the risks of adverse effects in differentiated thyroid cancer (2010) Thyroid, 20 (2), pp. 135-146 Cooper, D.S., Doherty, G.M., Haugen, B.R., Kloos, R.T., Lee, S.L., Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer (2009) Thyroid, 19 (11), pp. 1167-1214. , American Thyroid Association (ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated Thyroid Cancer Ward, L.S., Maciel, R.M.B., Camargo, R.Y., Teixeira, G.V., Tincani, A.J., Kulcsar, M.A.V., (2011) Câncer Diferenciado Da Tireoide: Seguimento, , http://www.projetodiretrizes.org.br/, Em: Projeto Diretrizes Associação Médica Brasileira e Conselho Federal de Medicina (editores). Editora AMB/CFM, Disponível em, Jul 2011 Hennessey, J.V., Malabanan, A.O., Haugen, B.R., Levy, E.G., Adverse event reporting in patients treated with levothyroxine: Results of the pharmacovigilance task force survey of the American Thyroid Association, American Association of Clinical Endocrinologists, and The Endocrine Society (2010) Endocr Pract, 16 (3), pp. 357-370 (2008) Electronic Orange Book, , www.fda.gov/cder/ob/docs/queryai.htm.Acesso.em, Disponível em:, Jul 2011 Carr, D., McLeod, D.T., Parry, G., Thornes, H.M., Fine adjustment of thyroxine replacement dosage: Comparison of the thyrotrophin releasing hormone test using a sensitive thyrotrophin assay with measurement of free thyroid hormones and clinical assessment (1988) Clin Endocrinol (Oxf), 28 (3), pp. 325-333 Blakesley, V.A., Current methodology to assess bioequivalence of levothyroxine sodium products is inadequate (2005) AAPS J, 7 (1), pp. E42-E46 (2008) Ministério Da Saúde Série B. Textos Básicos De Saúde, p. 2011. , http://portal.saude.gov.br/portal/arquivos/multimedia/paginacartilha/docs/FTN.pdf, Formulário Terapêutico Nacional, Disponível em, Acesso em: Jul Vargens, D.D., Neves, R.R., Bulzico, D.A., Ojopi, E.B., Meirelles, R.M., Pessoa, C.N., Association of the UGT1A1-53(TA)n polymorphism with L-thyroxine doses required for thyrotropin suppression in patients with differentiated thyroid cancer (2011) Pharmacogenet Genomics, 21 (6), pp. 341-343 Devdhar, M., Drooger, R., Pehlivanova, M., Singh, G., Jonklaas, J., Levothyroxine replacement doses are affected by gender and weight, but not age (2011) Thyroid, 21 (8), pp. 821-827 Ward, L.S., The difficult patient: Drug interaction and the influence of concomitant diseases on the treatment of hypothyroidism (2010) Arq Bras Endocrinol Metabol, 54 (5), pp. 345-352 (2007) Questions and Answers On Levothyroxine Products, , http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/default.htm, FDA, Disponível em, Acesso em: Jul Flynn, R.W., Bonellie, S.R., Jung, R.T., Macdonald, T.M., Morris, A.D., Leese, G.P., Serum thyroid-stimulating hormone concentration and morbidity from cardiovascular disease and fractures in patients on long-term thyroxine therapy (2010) J Clin Endocrinol Metab, 95 (1), pp. 186-193 Bagattoli, R.M., Vaisman, M., Lima, J.S., Ward, L.S., Estudo de adesão ao tratamento do hipotiroidismo (2000) Arq Bras Endo Metab, 44 (6), pp. 483-487 Somwaru, L.L., Arnold, A.M., Joshi, N., Fried, L.P., Cappola, A.R., High frequency of and factors associated with thyroid hormone over- -replacement and under-replacement in men and women aged 65 and over (2009) J Clin Endocrinol Metab, 94 (4), pp. 1342-1345 (2011), 28. , http://www.endosociety.org/advocacy/insider/2011/SocietyTestifiesonNeedtoReviseMethodforDeterminingBioequivalencStandards_art1.cfm, The Endocrine Society. Endocrine insider. July, Disponível em, Acesso em, Jul 2011Joint statement on the U.S. Food and Drug Administration's decision regarding bioequivalence of levothyroxine sodium (2004) Thyroid, 14 (7), p. 486. , American Thyroid Association Endocrine Society American Association of Clinical Endocrinologists