Browsing by Author "Patel, Dhwani"

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    Analytical evaluation of drug package inserts in India.
    (2015-03) Solank, Sandip Natwarlal; Chhaiya, Sunita B; Mehta, Dimple S; Trivedi, Madhav; Acharya, Tejas; Patel, Dhwani
    Background: A drug package insert or prescribing information is a document provided along with a prescription medication to provide additional information about that drug. Drug package inserts are approved by the administrative licensing authority. A package insert is intended to provide information for the safe and effective use of the respective drug. Product information provided by pharmaceutical companies has been determined to be far from adequate and not conforming with requirement of Indian regulatory. Hence, it was decided to conduct a study to assess the presentation and completeness of clinically important information provided in the currently available package inserts in India. Methods: Package inserts were provided by five pharmacies on request. The package inserts were collected in 10 weeks’ period and then they were analyzed for presentation and completeness of clinical information according to heading mentioned in Section 6.2 and 6.3 of schedule D of Drug and Cosmetic Rule, 1945. If the information was present under relevant heading, it was scored as one. Otherwise as score of zero was assigned. Total score for each heading was calculated by adding the score from the individual package inserts. Results: 70 package inserts were included in the study. None of the reviewed package inserts contained all the sections as required by the Drugs and Cosmetics Act. Total 15 headings were evaluated under both Section 6.2 and 6.3, highest value for the presence of heading were 12 out of 15 heading evaluated. That shows the best value of compliance was 80%. Conclusion: Accurate drug product information is important for the safe and effective use of medicines. Hence, pharmaceutical companies and regulators should ensure that accurate and up to date product information is provided in the package inserts.
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    Antibiotic Resistant Pattern of threatening pathogen Acinetobacter baumannii in a tertiary care hospital
    (Educational Society for Excellence, 2024-02) Mavani, Monika; Parmar, Kajal; Patel, Dhwani; Javadekar, Tanuja; Date, Vidya S
    Introduction: Acinetobacter species are aerobic gram-negative bacteria that are ubiquitous in nature. Being a multidrug-resistant and an invasive pathogen, Acinetobacter baumannii is one of the major causes of nosocomial infections in the current healthcare system. It has been recognized as an agent of pneumonia, septicemia, meningitis, urinary tract and wound infections, and is associated with high mortality. We aimed this study to evaluate resistance pattern of a threatening pathogen i.e., Acinetobacter baumannii. Materials and method: The present study was conducted in Microbiology Department of SBKSMIRC, Dhiraj Hospital, Waghodia, Gujarat during May 2022 to December 2022. This study included all Acinetobacter baumannii isolated from all ages and microbiological specimens which were referred to Central Microbiology Laboratory of Dhiraj Hospital. The Non-Lactose fermenting, oxidase negative organisms are kept in VITEK 2 automated system for identification and sensitivity. All isolates identified as Acinetobacter baumannii were included in the study. Results: This study included a total of 52 isolates of A.baumannii. Out of which 33% were respiratory samples (sputum, Endo-tracheal secretions), 33% were pus samples, 11% were urine samples and 23% were included in other (blood, CSF, Body fluids). The most resistant drug was ceftriaxone (88.46%). Tigecycline was found to be 100% sensitive.Conclusion: This study concludes that Tigecycline is the only drug which is most sensitive for A. baumannii and other higher drugs such as Polymixin B, Colistin etc. shows less resistance. Acinetobacter infection would remain a therapeutic challenge in our hospital and health care settings due to the increasing rate of Acinetobacter species with traits of MDR and resistance to high potent antimicrobial agents.
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    Antibiotic Sensitivity Pattern of Burkholderia cepacia complex in blood stream infections in a tertiary care hospital
    (Educational Society for Excellence, 2024-02) Patel, Dhwani; Mavani, Monika; Parmar, Kajal; Javadekar, Tanuja; Lakhani, Sucheta
    Introduction: Burkholderia cepacia complex (BCC) is ubiquitous in nature, present in water, soil, and plants. BCC is comprised of Gram-negative non-lactose-fermenting bacteria. Gram negative, non lactose fermenting Burkholderia cepacia complex has emerged as an opportunistic nosocomial pathogen causing significant morbidity and mortality in hospitalized patients owing to its high antibiotic resistance. This study was aimed to determine prevalence of Burkholderia cepacia complex and to evaluate sensitivity pattern of Burkholderia cepacia complex in blood stream infections in Dhiraj Hospital, Gujarat which is a tertiary care hospital and teaching institute. Materials and Methods: The present study was conducted in the Department of Microbiology for a period from January 2022 to December 2022 of Dhiraj General Hospital, SBKS MI & RC, Waghodia, Gujarat. All samples were received in central laboratory and blood cultures were processed in BD BACTEC FX40. The positive culture bottles were sub cultured on Mac Conkey agar, Blood agar and Nutrient agar and were incubated for 24 hours at 37?C.The data was collected and analyzed statistically. Results: During the study period 31 positive samples for BCC were isolated from a total of 612 culture samples, thus the prevalence rate was 5.06% in our setup. BCC was found majorly in ICUs (65%) and in wards (35%).The isolates showed maximum sensitivity to Co-Trimoxazole (83.87%), followed by Ceftazidime (58.06%), Meropenem (54.83%) and Minocycline (51.61%).Conclusion: From various studies and our study we could conclude that there were variations in the results of drug sensitivity. So, there is need to properly isolate and do antibiotic sensitivity testing for better patient management. Prompt diagnosis is essential step to reduce mortality and establish infection control practices.
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    Prevalence of Methicillin-resistant Staphylococcus aureus and its antibiotic sensitivity in clinical samples in Tertiary Care Hospital
    (Educational Society for Excellence, 2024-03) Parmar, Kajal; Patel, Dhwani; Mavani, Monika; Javadekar, Tanuja; Patel, Rachana
    Introduction: Staphylococcus aureus is responsible for causing a variety of human infections, which may range from minor skin diseases to life-threatening infections. It colonizes healthy individuals and causes severe infection in hospitalized patients. Staphylococcus aureus infections used to respond to ß-lactam and related group of antibiotics but the emergence of Methicillin-resistant S. aureus (MRSA) has posed a serious therapeutic challenge. The present study aimed to determine prevalence of Methicillin-resistant Staphylococcus aureus in Dhiraj General Hospital, Gujarat and to determine antibiotic sensitivity pattern of Methicillin resistant Staphylococcus aureus in various samples and to determine inducible clindamycin resistance strains out of Methicillin resistant Staphylococcus aureus at Dhiraj General Hospital. Materials and methods: The present study was conducted in Microbiology Department of SBKS MI and RC during January 2022 to December 2022. The study comprised of 114 coagulase-positive staphylococci (COPS), isolated from a total of 1470 clinical specimens (like pus, blood, urine, high vaginal swab, sputum, etc.) of patients admitted in Dhiraj General hospital attached to SBKS MI and RC, Hospital, Waghodia, Gujarat. All the isolates were identified by standard procedures.Antimicrobial susceptibility test was carried out on each bacterial isolate using the disc diffusion method on Muller Hinton agar (MHA). Data were entered and analyzed statistically. Results: During one year of study period, a total of 1470 positive culture samples were there. Out of that, 114 positive samples of Staphylococcus aureus were isolated. Out of total Staphylococcus aureus positive samples, 24 strains of Methicillin resistant Staphylococcus aureus (MRSA) were detected. Out of total MRSA, 10 inducible clindamycin resistant Staphylococcus aureus were detected. Conclusion: To conclude, we can say that Vancomycin and Teicoplanin is the drug of choice in MRSA patients. As MRSA is an alarming issue for the health system, one should always think about drug sensitivity test before starting treatment.