Discrepancies in drug labeling texts as a cause of medication errors

2019 ◽  
Vol 2019 (3) ◽  
pp. 59-62
Author(s):  
Анна Кузьмина ◽  
Anna Kuz'mina ◽  
Ирина Асецкая ◽  
Irina Aseckaya ◽  
Виталий Поливанов ◽  
...  
Keyword(s):  
Oral Administration ◽  
Clavulanic Acid ◽  
Medication Errors ◽  
Active Substance ◽  
Medicinal Products ◽  
Suspected Drug ◽  
Drug Labeling ◽  
Spontaneous Reports ◽  
Amoxicillin Clavulanate ◽  
Amoxicillin Clavulanic Acid

Contradictions in drug labeling texts for various medicinal products with the same active substance can cause medication errors. We found discrepancies in the Russian drug labeling texts for cefotaxime and oral forms of amoxicillin/clavulanic acid, 500 + 125 mg. We analyzed Russian database of spontaneous reports. In 18.5% spontaneous reports with cefotaxime as a suspected drug and in 22.0% spontaneous reports with amoxicillin/clavulanate in forms for oral administration as a suspected drug we detected medication errors resulted from deviations from those items of approved drug labels which were not harmonized for different drug manufacturers. Such problems require the participation of regulatory authorities in order to eliminate existing discrepancies.

scholarly journals Influence of TEM-1 β-Lactamase on the Pharmacodynamic Activity of Simulated Total versus Free-Drug Serum Concentrations of Cefditoren (400 Milligrams) versus Amoxicillin-Clavulanic Acid (2,000/125 Milligrams) against Haemophilus influenzae Strains Exhibiting an N526K Mutation in the ftsI Gene

2007 ◽  
Vol 51 (10) ◽  
pp. 3699-3706 ◽  
Author(s):  
M. Torrico ◽  
L. Aguilar ◽  
N. González ◽  
M. J. Giménez ◽  
O. Echeverría ◽  
...  
Keyword(s):  
Haemophilus Influenzae ◽  
Oral Administration ◽  
Clavulanic Acid ◽  
Bactericidal Activity ◽  
Theoretical Calculations ◽  
Point Of View ◽  
Release Formulation ◽  
Extended Release Formulation ◽  
Amoxicillin Clavulanic Acid ◽  
Free Serum

ABSTRACT The aim of this study was to explore bactericidal activity of total and free serum simulated concentrations after the oral administration of cefditoren (400 mg, twice daily [bid]) versus the oral administration of amoxicillin-clavulanic acid extended release formulation (2,000/125 mg bid) against Haemophilus influenzae. A computerized pharmacodynamic simulation was performed, and colony counts and β-lactamase activity were determined over 48 h. Three strains were used: ampicillin-susceptible, β-lactamase-negative ampicillin-resistant (BLNAR) (also resistant to amoxicillin-clavulanic acid) and β-lactamase-positive amoxicillin-clavulanic acid-resistant (BLPACR) strains, with cefditoren MICs of ≤0.12 μg/ml and amoxicillin-clavulanic acid MICs of 2, 8, and 8 μg/ml, respectively. Against the ampicillin-susceptible and BLNAR strains, bactericidal activity (≥3 log10 reduction) was obtained from 6 h on with either total and free cefditoren or amoxicillin-clavulanic acid. Against the BLPACR strain, free cefditoren showed bactericidal activity from 8 h on. In amoxicillin-clavulanic acid simulations the increase in colony counts from 4 h on occurred in parallel with the increase in β-lactamase activity for the BLPACR strain. Since both BLNAR and BLPACR strains exhibited the same MIC, this was due to the significantly lower (P ≤ 0.012) amoxicillin concentrations from 4 h on in simulations with β-lactamase positive versus negative strains, thus decreasing the time above MIC (T>MIC). From a pharmacodynamic point of view, the theoretical amoxicillin T>MIC against strains with elevated ampicillin/amoxicillin-clavulanic acid MICs should be considered with caution since the presence of β-lactamase inactivates the antibiotic, thus rendering inaccurate theoretical calculations. The experimental bactericidal activity of cefditoren is maintained over the dosing interval regardless of the presence of a mutation in the ftsI gene or β-lactamase production.

scholarly journals A comparative study between amoxicillin + clavulanic acid and levofloxacin in the management of acute maxillary sinusitis at RIMS, Ranchi

2017 ◽  
Vol 4 (1) ◽  
pp. 185
Author(s):  
Sandeep Kumar ◽  
Abha Kumari
Keyword(s):  
Clavulanic Acid ◽  
Maxillary Sinusitis ◽  
Medical Sciences ◽  
Oral Amoxicillin ◽  
Group I ◽  
Amoxicillin Clavulanate ◽  
Amoxicillin Clavulanic Acid ◽  
The Mean ◽  
Group Ii ◽  
And Gender

<p class="abstract"><strong>Background:</strong> Acute rhinosinusitis is an acute viral or bacterial in which there is inflammation of the mucosa of the nose and paranasal sinuses. The aim of study was to compare the efficacy of oral amoxicillin-clavulanate with levofloxacin in the management of acute maxillary sinusitis.</p><p class="abstract"><strong>Methods:</strong> The present prospective study was conducted in the Department of ENT, Rajendra Institute of Medical Sciences, Ranchi during a period of 8 months i.e. from July 2016 to June 2017. In Group I patients 1 gm of amox­icillin-clavulanate was given two times a day and in Group II, 500 mg of Levo­floxicin was given once a day for a period of 10 days. Patient’s complete demographic details were recorded including name, age and gender. Xylometazoline nasal spray and steam inhalations were given to all the patients.  </p><p class="abstract"><strong>Results:</strong> The mean age of the subjects was 36.43±6.43 years. In both the groups, majority of the subjects were between 36-45 years of age. There were 34.7% (52) in Group I and 38.7% (n=58) in Group II who belonged to this age group. Least number of subjects was those aged more than 48 years. There were 88% subjects (n=132) in group I and 86% (n=129) subjects in Group II in whom complete resolution of symptoms was seen.</p><p><strong>Conclusions:</strong> From the above study we can conclude that both amoxicillin–clavulanic acid and levofloxacin are equally efficacious in managing cases of acute sinusitis. In this study there was no difference in the rate and duration of resolution amongst both the groups.</p>

scholarly journals Sinus Tissue Pharmacokinetics After Oral Administration of Amoxicillin/Clavulanic Acid

2000 ◽  
Vol 110 (6) ◽  
pp. 1050-1055 ◽  
Author(s):  
Paulo Borges Dinis ◽  
Maria Concei????o Monteiro ◽  
Maria Luz Martins ◽  
Nuno Silva ◽  
Augusto Gomes
Keyword(s):  
Oral Administration ◽  
Clavulanic Acid ◽  
Tissue Pharmacokinetics ◽  
Amoxicillin Clavulanic Acid

scholarly journals Detecting medication errors associated with the use of beta-lactams in the Russian Pharmacovigilance database

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anna V. Kuzmina ◽  
Irina L. Asetskaya ◽  
Sergey K. Zyryanov ◽  
Vitaliy A. Polivanov
Keyword(s):  
Medication Errors ◽  
Adverse Reactions ◽  
Bacterial Resistance ◽  
Viral Infections ◽  
Automatic Identification ◽  
Beta Lactam ◽  
Beta Lactams ◽  
Suspected Drug ◽  
Spontaneous Reports ◽  
Pharmacovigilance Database

Abstract Background Comprehensive analysis of all available data in spontaneous reports (SRs) can reveal previously unidentified medication errors (MEs). Methods To detect MEs, we performed a retrospective analysis of SRs submitted to the Russian pharmacovigilance database in the period from January 01, 2012, to August 01, 2014. This study evaluated SRs of cases where beta-lactam antibiotics were the suspected drug. Results A total of 3608 SRs were analyzed. MEswere detected in 1043 reports (28.9% of all cases). The total number of detected errors was 1214. Reporters themselves indicated MEs in 29 SRs. A term denoting an ME was selected in the “Adverse Reactions” section in 18 of these SRs, whereas in the other 11 reports information on the ME was found only in the “Case narrative” section. MEs were associated with wrong indications in 32.5% of the cases; 61.0% of these cases were viral infections. Various dosing regimen violations constituted 29.7% of MEs. A contraindicated drug was administered in 17.3% of all detected MEs, most commonly to a patient with a history of allergy to the suspected drug or severe hypersensitivity reactions to other drugs of the same group. Conclusion Automatic identification of MEs in the pharmacovigilance database is sometimes precluded by the absence of a code for the respective episode in the “Adverse Reactions” section, even when the error was detected by the reporter. The most frequent types of MEs associated with the use of beta-lactams in Russia are the leading risk factors of growing bacterial resistance.

scholarly journals Comparative Bacteriological Efficacy of Pharmacokinetically Enhanced Amoxicillin-Clavulanate against Streptococcus pneumoniae with Elevated Amoxicillin MICs and Haemophilus influenzae

2005 ◽  
Vol 49 (3) ◽  
pp. 908-915 ◽  
Author(s):  
Valerie Berry ◽  
Jennifer Hoover ◽  
Christine Singley ◽  
Gary Woodnutt
Keyword(s):  
Streptococcus Pneumoniae ◽  
Haemophilus Influenzae ◽  
Clavulanic Acid ◽  
Rat Model ◽  
Plasma Concentrations ◽  
Bacterial Strains ◽  
Positive Strain ◽  
Amoxicillin Clavulanate ◽  
Amoxicillin Clavulanic Acid ◽  
Computer Controlled

ABSTRACT A new pharmacokinetically enhanced formulation of amoxicillin-clavulanate (2,000 mg of amoxicillin/125 mg of clavulanate twice a day; ratio 16:1) has been designed, with sustained-release technology, to allow coverage of bacterial strains with amoxicillin-clavulanic acid MICs of at least 4/2 μg/ml. The bacteriological efficacy of amoxicillin-clavulanate, 2,000/125 mg twice a day, ratio 16:1, was compared in a rat model of respiratory tract infection versus four other amoxicillin-clavulanate formulations: 8:1 three times a day (1,000/125 mg), 7:1 three times a day (875/125 mg), 7:1 twice a day (875/125 mg), and 4:1 three times a day (500/125 mg); levofloxacin (500 mg once a day); and azithromycin (1,000 mg on day 1 followed thereafter by 500 mg once a day). Bacterial strains included Streptococcus pneumoniae, with amoxicillin-clavulanic acid MICs of 2/1 (one strain), 4/2, or 8/4 μg/ml (three strains each), and Haemophilus influenzae, one β-lactamase-positive strain and one β-lactamase-negative, ampicillin-resistant strain. Animals were infected by intrabronchial instillation. Antibacterial treatment commenced 24 h postinfection, with doses delivered by computer-controlled intravenous infusion to approximate the concentrations achieved in human plasma following oral administration. Plasma concentrations in the rat corresponded closely with target human concentrations for all antimicrobials tested. Amoxicillin-clavulanate, 2,000/125 mg twice a day, ratio 16:1, was effective against all S. pneumoniae strains tested, including those with amoxicillin-clavulanic acid MICs of up to 8/4 μg/ml and against β-lactamase-producing and β-lactamase-negative ampicillin-resistant H. influenzae. These results demonstrate the bacteriological efficacy of pharmacokinetically enhanced amoxicillin-clavulanate 2,000/125 mg twice a day (ratio 16:1) against S. pneumoniae with amoxicillin-clavulanic acid MICs of at least 4/2 μg/ml and support clavulanate 125 mg twice a day as sufficient to protect against β-lactamase in this rat model.

Pharmacokinetics of Amoxicillin/Clavulanic Acid Combination after Oral Administration of New Suspensions Formulation in Human Volunteers

2007 ◽  
Vol 3 (3) ◽  
pp. 265-269
Author(s):  
Sayed Abolfazl Mosta . ◽  
Kianoush Dormiani . ◽  
Yahya Khazaie . ◽  
Abbas Azmian . ◽  
Mohammad Reza Zargar .
Keyword(s):  
Oral Administration ◽  
Clavulanic Acid ◽  
Human Volunteers ◽  
Amoxicillin Clavulanic Acid
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