Interakcije antimikrobnih lekova i hrane: konzistentnost informacija za generičke lekove
Sažetak
Uvod/Cilj. Interakcije antimikrobnih lekova i hrane mogu kompromitovati efikasnost i bezbednost terapijskog režima, kao i nutritivni status bolesnika. Kako bi prevenirali iste, zdravstveni profesionalci konsultuju referentne izvore informacija. Sažetak karakteristika leka (Summary of Product Characteristics – SmPC) je osnov pouzdanog i objektivnog informisanja i, u slučaju generičkih proizvoda, sadržaj dokumenata bi trebalo da je konzistentan. Cilj istraživanja je bio da se za generičke antimikrobne proizvode uporede informacije o interakcijama sa hranom, i razmotri uticaj relevantnih faktora (vreme prve autorizacije i broj generičkih proizvoda) na ishod analize. Metode. SmPCs za sve generičke antimikrobne proizvode za sistemsku upotrebu su preuzeti sa web-sajta Agencije za lekove i medicinska sredstva Srbije i iskazi od značaja su ekstrahovani iz različitih sekcija dokumenta i upoređeni. Komparacija je bila bazirana na klasifikaciji iskaza o interakcijama u jednu od pet klasa: „efekat nutritivnog statusa na dejstvo leka”, „efekat hrane kao obroka na dejstvo leka”, „efekat specifičnog nutrijenta na dejstvo leka”, „efekat leka na status nurijenta” i „efekat leka na nutritivni status”. Rezultati. Ukupno 160 SmPCs je analizirano za 30 antimikrobnih lekova što je korespondiralo sa 46 doznih oblika [prosečan broj 3,48, standardna devijacija (SD) = 1,68); medijana 3,00, interkvartilni raspon (IKR) = 2); opseg: 2-9). Devet (30%) antimikrobnih lekova (azitromicin, klaritromicin, cefazolin, cefepim, pipemidinska kiselina, ciprofloksacin, levofloksacin, moksifloksacin i gentamicin) je imalo nekonzistentne informacije. Nekonzistentnost je bila u vezi sa različitim klasama interakcija i, u izvesnim slučajevima, mogla je imati klinički važne implikacije (gentamicin, fluorohinoloni). Postojanje većeg broja generičkih proizvoda je bilo povezano sa identifikovanim razlikama (p = 0,003). Zaključak. Jedna trećina generičkih antimikrobnih proizvoda je imala nekonzistentne iskaze o interakcijama lek-hrana. S obzirom na potencijalne kliničke implikacije, trebalo bi razmotriti strategije za dalju harmonizaciju ovih informacija.
Reference
Masur H. Foreword. In: Piscitelli SC, Rodvold KA, editors. Drug Interactions in Infectious Diseases. New York: Humana Press Inc; 2005. p. V‒VI.
Invirase®, 500 mg, film tablets [Summary of Products Charac-teristics]. Beograd: Roche DOO, 2017. [cited 2018 Aug 12] Available from: https://www.alims.gov.rs/ciril/files/lekovi/smpc/515-01-02378-16-001.pdf).
Schmidt LE, Dalhoff K. Food-Drug Interactions. Drugs 2002; 62(10): 1481‒502.
Djukic LJC, Terzic BM. The availability of reliable information about medicines in Serbia for Health Professionals. Hosp Pharmacol 2015; 2(1): 225‒34.
European Commission. A Guideline on Summary Product Characteristics (SmPC). September 2009. [cited 2018 Aug 10] Available from: https://ec.europa.eu/health/sites/health/ files/files/eudralex/vol-2/c/smpc_guideline_rev2_en.pdf
The European parliament and of the council. DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 on the Communi-ty code relating to medicinal products for human use. [cited 2018 June 21] Available from: https://ec.europa.eu/health/sites/ health/files/files/eudralex/vol-1/dir_2001_83_consol_2012/ dir_2001_83_cons_2012_en.pdf
Theuretzbacher U. Product information for parenteral colistin varies substantially across Europe. J Antimicrob Chemother 2014; 69(7): 1987‒92.
Boyd SA, Charani E, Lyons T, Frost G, Holmes AH. Information provision for antibacterial dosing in the obese patient: a sizea-ble absence? J Antimicrob Chemother 2016; 71(12): 3588‒92.
Sillo HB, Masota NE, Kisoma S, Rago L, Mgoyela V, Kaale EA. Conformity of package inserts information to regulatory re-quirements among selected branded and generic medicinal products circulating on the East African market. PLoS One 2018; 13(5): e0197490.
Karadima V, Kraniotou C, Bellos G, Tsangaris GT. Drug-micronutrient interactions: food for thought and thought for action. EMPA J 2016; 7(1): 10.
Boullata JI, Hudson LM. Drug-nutrient interactions: a broad view with implications for practice. J Acad Nutr Diet 2012; 112(4): 506‒17.
Edwards IR. A New Erice Report Considering the Safety of Medicines in the 21st Century. Drug Saf 2017; 40(10): 845‒9.
Ivanović LJ. Registar lekova 2017. Beograd: BB-Soft; 2017.
Curatolo W, Liu P, Johnson BA, Hausberger A, Quan E, Vendola T, et al. Effects of food on a gastrically degraded drug: azithromycin fast-dissolving gelatin capsules and HPMC cap-sules. Pharm Res 2011; 28(7): 1531‒9.
Foulds G, Luke DR, Teng R, Willavize SA, Friedman H, Curatolo WJ. The absence of an effect of food on the bioavailability of azithromycin administered as tablets, sachet or suspension. J Antimicrob Chemother 1996; 37 Suppl C: 37‒44.
Péter S, Navis G, de Borst MH, von Schacky C, van Orten-Luiten ACB, Zhernakova A, et al. Public health relevance of drug-nutrition interactions. Eur J Nutr 2017; 56(Suppl 2): 23‒36.
Sim J, Wright CC. The kappa statistic in reliability studies: use, interpretation, and sample size requirements. Phys Ther 2005; 85(3): 257‒68.
Landis JR, Koch GG. The measurement of observer agreement for categorial data. Biometrics 1977; 33(1): 159‒74.
San Miguel MT, Martinez JA, Vargas E. Food-drug interactions in the summary of product characteristics of proprietary me-dicinal products. Eur J Clin Pharmacol 2005; 61(2): 77‒83.
Velissaris D, Karamouzos V, Marangos M, Pierrakos C, Karaniko-las M. Pharmacokinetic changes and dosing modification of aminoglycosides in critically ill obese patients: a literature re-view. J Clin Med Res 2014; 6(4): 227‒33.
Kamei C, Sugimoto Y, Muroi N, Tasaka K. Effects of various ce-phem antibiotics on ethanol metabolism and their structure-activity relations. J Pharm Pharmacol 1986; 38(11): 823‒8.
Yanagihara M, Okada K, Nozaki M, Tsurumi K, Fujimura H. Ce-phem antibiotics and alcohol metabolism. Jpn J Antibiot 1985; 38(3): 634‒42.
Rao PS, Goodwani S, Bell RL, Wei Y, Boddu SH, Sari Y. Effects of ampicillin, cefazolin and cefoperazone treatments on GLT-1 expressions in the mesocorticolimbic system and ethanol in-take in alcohol-preferring rats. Neuroscience 2015; 295: 164‒74.
Chou HW, Wang JL, Chang CH, Lee JJ, Shau WY, Lai MS. Risk of severe dysglycemia among diabetic patients receiving levofloxacin, ciprofloxacin, or moxifloxacin in Taiwan. Clin Infect Dis 2013; 57(7): 971‒80.
Kabbara WK, Ramadan WH, Rahbany P, Al-Natour S. Evalua-tion of the appropriate use of commonly prescribed fluoro-quinolones and risk of dysglycemia. Ther Clin Risk Manag 2015; 11: 639‒47.
Parekh TM, Raji M, Lin YL, Tan A, Kuo YF, Goodwin JS. Hy-poglycemia after antimicrobial drug prescription for older pa-tients using sulfonylureas. JAMA Intern Med 2014; 174(10): 1605‒12.
Eriksson R, Aagaard L, Jensen LJ, Borisova L, Hørlück D, Brunak S, et al. Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulato-ry authorities in Denmark and the USA. Pharmacol Res Per-spect 2014; 2(3): e00038.
Cornelius VR, Liu K, Peacock J, Sauzet O. Variation in adverse drug reactions listed in product information for antidepres-sants and anticonvulsants, between the USA and Europe: a comparison review of paired regulatory documents. BMJ Open 2016; 6(3): e010599.
Alshammari TM, Devadasu VR, Rathnam RP. Comparison of the safety information on drug labels in three developed coun-tries: the USA, UK and Canada. Saudi Pharm J 2017; 25(8): 1103‒7.
Nanji AA, Denegri JF. Hypomagnesemia associated with gen-tamicin therapy. Drug Intell Clin Pharm 1984; 18(7‒8): 596‒8.
DiNicolantonio JJ, O'Keefe JH, Wilson W. Subclinical magnesium deficiency: a principal driver of cardiovascular disease and a public health crisis. Open Heart 2018; 5(1): e000668.
Duke J, Friedlin J, Li X. Consistency in the safety labeling bio-equivalent medications. Pharmacoepidemiol Drug Saf 2013; 22(3): 294‒301.
Arguello B, Salgado TM, Laekeman G, Fernandez-Llimos F. De-velopment of a tool to assess the completeness of drug infor-mation sources for health care professionals: A Delphi study. Regul Toxicol Pharmacol 2017; 90: 87‒94.
Ni Y, Jensen K, Kouskoumvekaki I, Panagiotou G. NutriChem 2.0: exploring the effect of plant-based foods on human health and drug efficacy. Database (Oxford) 2017; 2017: doi:10.1093/database/bax044.
Hens B, Van Den Abeele J, Rubbens J, Keirsebilck M, Roelens J, Schreurs C, et al. Evaluation of real-life dosing of oral medi-cines with respect to fluid and food intake in a Dutch-speaking population. J Clin Pharm Ther 2017; 42(4): 467‒74.
Pliva, Inc. v. Mensing, 131 S.Ct. 2567 (2011).
Mutual Pharmaceutical Co. v. Bartlett , 133 S.Ct. 2466 (2013).
Rafferty v. Merck & Co., Inc., SJC-12347 (2018).