scholarly journals Analysis of information asymmetry in the instructions for medical use on the example of Enterol

2021 ◽  
pp. 94-101
Author(s):  
І. Л. Чухрай ◽  
С. Є. Шунькіна
Keyword(s):  
Clostridium Difficile ◽  
Active Pharmaceutical Ingredient ◽  
Drug Related Problems ◽  
The Czech Republic ◽  
Asymmetry Of Information ◽  
Pharmaceutical Markets ◽  
Antibiotic Associated Diarrhea ◽  
Improper Use ◽  
Pregnancy And Lactation ◽  
Patient’S Perception

There may be variations in the texts of instructions for medical use of medicines (hereinafter – the instructions) containing the same active pharmaceutical ingredient, and registered in the pharmaceutical markets of different countries. First of all this applies to medicines manufactured in one country and distributed to other countries. Therefore, there are questions related to incorrect use of medicines due to the existing asymmetry of information. This problem is especially relevant in connection with tourist activity and labour migration. The aim of the study was to identify discrepancies in the instructions of Enterol, registered in different countries. The materials of the study were the registers of medicines in France, Ukraine, Belarus, Bulgaria, Poland, the Czech Republic and Russia, as well as the texts of instructions of Enterol (Biocodex, France), registered in the above countries. Methods of generalization, systematization, as well as contextual and comparative analysis were used. It was found that the original (French) instruction has two indications for the use of Enterol (treatment of acute diarrhea in children under 12 years old; prevention of antibiotic-associated diarrhea caused by Clostridium difficile or recurrence of diarrhea caused by Clostridium difficile), while Belarusian and Russian instructions have one indication. Polish instruction contains 5 indications, while Bulgarian and Czech – 8. The largest number of indications for the use of Enterol (11) is given in Ukrainian instruction. A contradictory information is in the sections «Therapeutic Indications», «Posology and method of administration», «Contraindications», «Undesirable effects», «Special warnings and precautions for use», including «Pregnancy and lactation». In the text of one instruction there is no information available in the text of another, and none of the instructions is identical to the instructions of Enterol, registered in France (country of manufacture). Actually, these information discrepancies, as well as the patient's perception of information, can lead to improper use of medicines and, as a consequence, drug-related problems. Thus, to minimize the asymmetry of information, the applicant during the registration of the drug must submit a notarized translation of the manufacturer's instructions.

Clostridium difficile in piglets in the Czech Republic

2012 ◽  
Vol 57 (2) ◽  
pp. 159-161 ◽  
Author(s):  
Jana Goldová ◽  
Anna Malinová ◽  
Alexander Indra ◽  
Libor Vítek ◽  
Pavel Branny ◽  
...  
Keyword(s):  
Czech Republic ◽  
Clostridium Difficile ◽  
The Czech Republic

scholarly journals Clinical and microbial characterization of toxigenic Clostridium difficile isolated from antibiotic associated diarrhea in Egypt

2020 ◽  
Author(s):  
Sherein G. Elgendy ◽  
Sherine A. Aly ◽  
Rawhia Fathy ◽  
Enas A.E. Deaf ◽  
Naglaa H. Abu Faddan ◽  
...  
Keyword(s):  
Risk Factors ◽  
Clostridium Difficile ◽  
Pediatric Patients ◽  
Direct Detection ◽  
Diagnostic Methods ◽  
Adult Patients ◽  
Specific Method ◽  
Healthcare Associated Infection ◽  
Direct Pcr ◽  
Antibiotic Associated Diarrhea

Background and Objectives: Clostridium difficile infection (CDI) has become a significant healthcare-associated infection throughout the world and is particularly important in developing countries. This study aimed to investigate clinical characterization and risk factors related to toxigenic C. difficile infection in adult and pediatric patients, antimicrobial susceptibility pattern. Also, to evaluate different diagnostic methods for rapid detection of C. difficile associated diarrhea (CDAD) in Egypt. Materials and Methods: Stool samples were collected from 95 pediatric patients and 37 adult patients suffering from antibiotic associated diarrhea and were subjected to direct toxin immunoassay and culture on cycloserine/cefoxitin/fructose agar. The presence of tcdA and tcdB genes was tested by PCR. Results: Toxigenic C. difficile was isolated from pediatric and adult patients at a rate of 17.89% (17/95) and 27% (10/37) respectively. The sensitivity and specificity of direct PCR from stool are (100%, 100% and 82.4%, 100%) in adult and pediatric samples respectively. The susceptibility of C. difficile to vancomycin and metronidazole were found to be 66.7% and 48.2% respectively. Conclusion: Diabetes mellitus, prior antibiotic treatment, hematological malignancy on chemotherapy, malnutrition, neutropenia and Ryle feeding are risk factors for development of CDAD. Tight restriction of unnecessary antibiotic uses is necessary in our locality. Direct detection of toxin genes in stool by PCR is sensitive and specific method for early detection of C. difficile.

Clinical epidemiology of Clostridium difficile infection among hospitalized patients with antibiotic-associated diarrhea in a university hospital of Brazil

Anaerobe ◽  
2018 ◽  
Vol 54 ◽  
pp. 65-71 ◽  
Author(s):  
Guilherme Grossi Lopes Cançado ◽  
Rodrigo Otávio Silveira Silva ◽  
Maja Rupnik ◽  
Amanda Pontes Nader ◽  
Joana Starling de Carvalho ◽  
...  
Keyword(s):  
Clostridium Difficile ◽  
Clostridium Difficile Infection ◽  
Clinical Epidemiology ◽  
Hospitalized Patients ◽  
University Hospital ◽  
Antibiotic Associated Diarrhea

scholarly journals 2422. Effectiveness of a Probiotic for Primary Prevention of Clostridium difficile Infection and Antibiotic-Associated Diarrhea among Hospitalized Patients Receiving Broad-Spectrum Antibiotics

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S836-S837
Author(s):  
Khanh-Linh Le ◽  
Heather Young ◽  
Timothy C Jenkins ◽  
Robert Tapia ◽  
Katherine C Shihadeh
Keyword(s):  
Primary Prevention ◽  
Clostridium Difficile ◽  
Clostridium Difficile Infection ◽  
Broad Spectrum ◽  
Hospitalized Patients ◽  
Broad Spectrum Antibiotic ◽  
Probiotic Group ◽  
Broad Spectrum Antibiotics ◽  
Days Of Therapy ◽  
Antibiotic Associated Diarrhea

Abstract Background Prior to 2016, Denver Health Medical Center had a higher-than-expected rate of hospital onset Clostridium difficile infection (HO-CDI). A multifaceted CDI prevention plan was implemented, including the use of a probiotic as primary prevention for HO-CDI and antibiotic-associated diarrhea (AAD) in inpatients receiving broad-spectrum antibiotics. We aimed to study the effectiveness of probiotic use in this clinical context. Methods During the intervention, inpatient orders for a broad-spectrum antibiotic triggered a best practice advisory recommending once daily co-administration of 100 billion units of a probiotic containing Lactobacillus casei, L. rhamnosus, and L. acidophilus (BioK+ ®). To evaluate effectiveness and safety of this intervention, we performed a retrospective cohort study including adult inpatients who received > 24 hours of a broad-spectrum antibiotic between April 2016 and March 2018. The primary endpoint was the incidence of HO-CDI (> 3 days after admission) compared between patients who received antibiotics alone vs. antibiotics plus the probiotic. Secondary endpoints were the incidence of AAD, defined as a negative CDI test after antibiotic initiation, and the incidence of Lactobacillus species identified in clinical cultures. Results 3,291 patients were included; 1,835 received antibiotics alone and 1,456 received antibiotics plus the probiotic. Baseline characteristics between groups were similar, except patients in the antibiotic alone group had a greater incidence of cirrhosis and proton-pump inhibitor use (16.1% vs 10.1%, P < 0.001; 39.1% vs 31.5%, P < 0.001). Length of stay and antibiotic days of therapy were longer in the antibiotic plus probiotic group [6 days (IQR, 3–11) vs 6 days (IQR, 4–12), P = 0.014; 4 days (IQR, 3–7) vs 5 days (IQR, 3–7), P < 0.001]. The incidence of HO-CDI (37, 2% vs 35, 2.4%; P = 0.450) and AAD (231, 12.6% vs 199, 13.7%; P = 0.362) were similar between groups. Lactobacillus was identified in at least one clinical culture from 0.2% (3/1835) and 0.3% (4/1456) of patients in the antibiotic alone group and antibiotic plus probiotic group, respectively (P = 0.497). Conclusion In hospitalized patients receiving broad-spectrum antibiotics, co-administration of a probiotic did not appear to reduce the incidence of HO-CDI or AAD. Disclosures All authors: No reported disclosures.

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