Clinical and economic impact of generic versus brand name meropenem use in an intensive care unit in Colombia

Ordóñez, Karen; Feinstein, Max M.; Reyes, Sergio; Hernández-Gómez, Cristhian; Pallares, Christian; Villegas, María Virginia

doi:10.1016/j.bjid.2019.06.010

Cited by 5 publications

(4 citation statements)

References 20 publications

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“…Differences between brand-name meropenem and meropenem generics marketed in foreign countries, including Japan [19], India [22], and European countries [11], have been reported by several studies [11,[19][20][21][22]. This study, for the first time, characterized critical pharmaceutical features, including particle morphologies, solubility, numbers of insoluble particles, stability, residual solvents, and antimicrobial effects, of BNM and six major GPs marketed in China.…”

Section: Discussionmentioning

confidence: 90%

“…Meropenem generics have been widely used across the world. Previous studies have characterized differences between brand-name meropenem and its generics marketed overseas in terms of pharmaceutical features as well as therapeutical efficacies [11,[19][20][21][22]. Previous studies compared brand-name meropenem and its generics in Colombia and found that the therapeutic nonequivalence of meropenem products might be attributed to the different susceptibility to dihydropeptidase I (DHP-I) hydrolysis [20].…”

Section: Introductionmentioning

confidence: 99%

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Comparison of Pharmaceutical Characteristics between Brand-Name Meropenem and Its Generics

Yang

Fujimura

et al. 2021

Antibiotics

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This study aimed to provide comparative information of pharmaceutical properties, including particle morphology and distribution uniformity, solubility, presence of residual solvent and insoluble particles, and antimicrobial activities, between brand-name meropenem (Mepem®, BNM) and its six generic products (GPs A-F) marketed in China. Particles of GP-A and -C in dry powder had similar diameters of BNM, while other GPs were larger. Only BNM and GP-A were completely dissolved within 100 s in the lab condition. No insoluble particles >25 μm in diameter were detected in BNM and GP-E. Regarding stability of GPs solutions evaluated by concentration of open-ring metabolites at 6 h and 8 h, BNM showed the lowest open-ringed metabolite concentrates. Residual solvent of acetone detected in one GP showed the maximum value, while ethanol and ethyl acetate were detected both in product E and product F. The concordance rates (%) of minimum inhibitory concentration (MIC) of each generic compared to BNM were 89.5, 85, 87.5, 88, 88.5, and 86.5, respectively, although no significant difference was reached in MIC. Pharmaceutical characteristic differences between the BNM and GPs identified in this study could provide insights into understanding the deviations in the drug manufacturing processes of generic drugs.

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Section: Discussionmentioning

confidence: 90%

Section: Introductionmentioning

confidence: 99%

Comparison of Pharmaceutical Characteristics between Brand-Name Meropenem and Its Generics

Yang

Fujimura

et al. 2021

Antibiotics

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“…Ordonez et al (2019) [30] included only patients with documented Gram-negative infections susceptible to meropenem to maximize the likelihood of successful treatment with the selected antibiotics.…”

Section: Summary Of Resultsmentioning

confidence: 99%

Clinical Equivalence between Generic Versus Branded Antibiotics: Systematic Review and Meta-Analysis

et al. 2023

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Regulatory authorities authorize the clinical use of generic drugs (GD) based on bioequivalence studies, which consist of the evaluation of pharmacokinetics after a single dose in vitro or in healthy individuals. There are few data on clinical equivalence between generic and branded antibiotics. Our aim was to synthesize and analyze the available evidence on the clinical efficacy and safety of generic antibiotics compared to their original formulations. A systematic review was performed on Medline (PubMed) and Embase and validated through Epistemonikos and Google Scholar. The last search was conducted on 30 June 2022. Meta-analyses of clinical cure and mortality outcomes were performed. One randomized clinical trial (RCT) and 10 non-randomized intervention studies were included. No differences in clinical cure were observed between groups in the meta-analysis (OR = 0.89, 95% CI [0.61–1.28]; I2 = 70%, p = 0.005). No difference was observed between groups when considering the use of carbapenems for overall mortality (OR = 0.99, 95% CI [0.63–1.55]; I2 = 78%) or death associated with infections (OR = 0.79, 95% CI [0.48–1.29], I2 = 67%). Most of the studies were observational, and the duration of follow-up, the characteristics of the participants, and the sites of infections were heterogeneous. Due to the uncertainty of the evidence, it is not possible to contraindicate the use of generics, which is an important strategy to expand access.

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“…Although from a theoretical point of view, both drugs should perform similarly, some experiences have questioned the efficacy of generics, compared to original antibiotics [4,5]. One study showed that the use of generic meropenem was associated with higher mortality in critically ill patients [6]. The reasons for these findings are not fully elucidated.…”

Section: Introductionmentioning

confidence: 99%

Impact of Generic Entry on Hospital Antimicrobial Use: A Retrospective Quasi-Experimental Interrupted Time Series Analysis

et al. 2021

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Background: The impact of antimicrobials generic entry (GE) is controversial. Their introduction could provide an economic benefit yet may also increase their consumption, leading to a higher risk of resistance. Our aim was to analyze the impact of GE on trends of antimicrobial consumption in an acute-care hospital. Methods: A retrospective quasi-experimental interrupted time series analysis was conducted at a 400-bed tertiary hospital in Barcelona, Spain. All antimicrobials for systemic use for which a generic product entered the hospital from January 2000 to December 2019 were included. Antimicrobial consumption was expressed as DDD/100 bed days. Results: After GE, the consumption of cefotaxime (0.09, p < 0.001), meropenem (0.54, p < 0.001), and piperacillin-tazobactam (0.13, p < 0.001) increased, whereas the use of clindamycin (−0.03, p < 0.001) and itraconazole (−0.02, p = 0.01) was reduced. An alarming rise in cefepime (0.004), daptomycin (1.02), and cloxacillin (0.05) prescriptions was observed, despite not achieving statistical significance. On the contrary, the use of amoxicillin (−0.07), ampicillin (−0.02), cefixime (−0.06), fluconazole (−0.13), imipenem–cilastatin (−0.50) and levofloxacin (−0.35) decreased. These effects were noticed beyond the first year post GE. Conclusions: GE led to an increase in the consumption of broad-spectrum molecules. The potential economic benefit of generic antibiotics could be diluted by an increase in resistance. Antimicrobial stewardship should continue to monitor these molecules despite GE.

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Clinical and economic impact of generic versus brand name meropenem use in an intensive care unit in Colombia

Cited by 5 publications

References 20 publications

Comparison of Pharmaceutical Characteristics between Brand-Name Meropenem and Its Generics

Comparison of Pharmaceutical Characteristics between Brand-Name Meropenem and Its Generics

Clinical Equivalence between Generic Versus Branded Antibiotics: Systematic Review and Meta-Analysis

Impact of Generic Entry on Hospital Antimicrobial Use: A Retrospective Quasi-Experimental Interrupted Time Series Analysis

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