Antimicrobial drug-nutrition interactions: Consistency of information for generic drugs

Abstract

Introduction/Aim. Antimicrobial drug-nutrition interactions can compromise the efficacy and safety of therapeutic regimen, as well as the nutritional status of the patient. In order to prevent them, health professionals consult the reference sources of information. Summary of Product Characteristics (SmPC) is the basis for reliable and objective informing, and in the case of generic products the content of documents should be consistent. The aim of the study was to compare information on antimicrobial drug-nutrition interactions for generic products, and to consider the influence of relevant factors (the time of the first authorization and the number of generic products) on the outcome of evaluation. Methods. SmPCs for all generic antimicrobial products for systemic use were retrieved from the Medicines and Medical Devices Agency of Serbia website, and statements of interest were extracted from different sections and were compared. The comparison was based on classification of statements on interaction into one of five classes: "effect of nutrition status on drug action", "effect of food in general on drug action", "effect of specific nutrient on drug action", "effect of drug on nutrient and metabolic status", or "effect of drug on nutrition status". Results. A total of 160 SmPCs were evaluated for 30 antimicrobial drugs corresponding to 46 dosage forms (mean number 3.48 (SD=1.68); median 3.00 (IQR=2); range: 2-9). Nine (30%) antimicrobials (azithromycin, clarithromycin, cefazolin, cefepime, pipemidic acid, ciprofloxacin, levofloxacin, moxifloxacin and gentamicin) had inconsistent information. The inconsistency was related to different classes of interactions, and in some cases it could have clinically important implications (gentamicin, fluoroquinolones). The existence of a larger number of generic products was related to identified differences (p=0.003). Conclusion. One third of generic antimicrobial products had inconsistent drug-nutrition interaction statements. Given the potential clinical implications, strategies for further harmonization of information should be considered. ApstraktUvod/Cilj. Interakcije antimikrobnih lekova i hrane mogu kompromitovati efikasnost i bezbednost terapijskog režima, kao i nutritivni status pacijenta. Kako bi prevenirali iste, zdravstveni profesionalci konsultuju referentne izvore informacija. Sažetak karakteristika leka (eng. 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 za generičke antimikrobne proizvode komparirati informacije o interakcijama sa hranom, i razmotriti 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 veb-sajta Agencije za lekove i medicinska sredstva Srbije; i iskazi od značaja su ekstrahovani iz različitih sekcija dokumenta i komparirani. Komparacija je bila bazirana na kla...