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Local causes of essential medicines shortages from the perspective of supply chain professionals in Saudi Arabia

Saudi Pharm J. 2023 Jun;31(6):948-954. doi: 10.1016/j.jsps.2023.04.019. Epub 2023 Apr 24.

ABSTRACT

BACKGROUND: The global supply chains of essential medicines faced frequent disruptions over the past five years, particularly during the COVID-19 pandemic. Different causes of prescription drug supply interruptions have been identified in Saudi Arabia. However, studies have yet to explore the views of pharmaceutical supply chain personnel regarding the causes of these interruptions. Therefore, this study aimed to survey individuals working in the pharmaceutical supply chains about their views on the observed interruptions in the supply of some essential drugs.

METHODS: This was a questionnaire-based cross-sectional study. The 10-item questionnaire was created based on the findings of previously published research that investigated the root causes of essential drug shortages and the impact of COVID-19 pandemic on the supply chains of essential drugs in Saudi Arabia. Purposive sampling was used to identify individuals with at least one year of experience in the area of the pharmaceutical supply chain, and the data collection occurred between April 19th, 2022 and October 23rd, 2022. In addition, descriptive statistics (e.g., frequencies and percentages) were conducted to present the views of the respondents.

RESULTS: Seventy-nine pharmaceutical supply chain specialists accepted the invitation and completed the questionnaire. About two-thirds (69.62%) of the respondents reported that centralized pharmaceutical procurement negatively affected the supply chain of essential drugs. Procurement of unregistered medications by the Saudi Food and Drug Authority (SFDA), as well as generic drugs with a history of recalls, and failure to supply requested quantities were the three most commonly reported reasons behind the observed interruptions in the supply of some essential drugs according to those respondents with a negative view of the centralized procurement. Furthermore, failure of pharmaceutical companies to inform SFDA of potential drug shortages, manufacturing issues, poor demand forecasting, unpredictable increase in demand, and low prices of essential drugs were also believed to be behind the observed interruptions in the supply of some essential medicines.

CONCLUSION: The majority of surveyed pharmaceutical supply chain professionals held negative views about the role of centralized pharmaceutical procurement in exacerbating the issues with essential medicines supply chain. Future research should examine different strategies to improve purchasing and procurement practices in Saudi Arabia.

PMID:37234344 | PMC:PMC10205776 | DOI:10.1016/j.jsps.2023.04.019

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Assessment of knowledge, attitude, and practices of acute kidney injury incidence with co-administration of piperacillin/tazobactam and vancomycin among healthcare workers: A cross-sectional study

Saudi Pharm J. 2023 Jun;31(6):904-910. doi: 10.1016/j.jsps.2023.04.020. Epub 2023 Apr 24.

ABSTRACT

BACKGROUND: No studies have identified a link between acute kidney injury (AKI) incidence due to the co-administration of vancomycin and piperacillin/tazobactam (VPT) and healthcare providers’ knowledge, attitudes, and practices. We aimed to (1) assess the knowledge, attitudes, and practices towards AKI due to VPT co-administration among healthcare providers in Saudi Arabia, and (2) examine the relationship between healthcare providers’ knowledge and attitudes about AKI due to VPT co-administration and their practices.

METHODS: This cross-sectional study was conducted between February 2022 and April 2022. Healthcare providers, including physicians, pharmacists, and nurses, were included in the study population. The correlation coefficient assessed the relationship between knowledge, attitude, and practice. Spearman’s rho was used as a test statistic.

RESULTS: Of the invited healthcare providers, 192 responded to the survey. A significant difference in knowledge was found among healthcare providers for two variables: the definition of AKI (p < 0.001) and appropriate management of AKI due to VPT (p = 0.002). Physicians were found to rely less on the most common causative organisms of infection to guide empirical antibiotic therapy (p < 0.001). In addition, physicians were less likely to switch piperacillin/tazobactam to cefepime or meropenem in combination with vancomycin with AKI incidence (p = 0.001). A positive attitude towards the perceived AKI risk with VPT was positively correlated with avoiding using VPT unless no alternatives were available (Rho = 0.336) and taking protective measures when using VPT (Rho = 0.461).

CONCLUSION: Deviation has been observed in the knowledge, attitudes, and practices of AKI incidence with the co-administration of piperacillin/tazobactam and vancomycin among healthcare workers. Interventions at the organizational level are recommended to guide best practices.

PMID:37234343 | PMC:PMC10205774 | DOI:10.1016/j.jsps.2023.04.020

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Awareness, perception, and barriers of healthcare providers toward the revised consensus guideline for therapeutic monitoring of vancomycin

Saudi Pharm J. 2023 Jun;31(6):955-961. doi: 10.1016/j.jsps.2023.04.025. Epub 2023 Apr 28.

ABSTRACT

BACKGROUND: A revised consensus guideline published in 2020 recommended transitioning vancomycin monitoring to the area under the concentration-time curve over 24 h to minimum inhibitory concentration (AUC24/MIC). The decision to transition to AUC24/MIC monitoring or to continue trough-based monitoring is made at the institutional level and is influenced by several factors, including healthcare providers and system-related factors. Changing current practices is expected to be difficult, and it is important to understand healthcare providers’ perceptions and potential barriers before the transition. This study assessed the awareness and perception of physicians and pharmacists toward the revised guideline and identified barriers to their implementation in Kuwait.

METHODS: A cross-sectional survey that employed a self-administered questionnaire was used. A random sample of physicians (n = 390), clinical microbiologists (n = 37), and clinical pharmacists (n = 48) across six Kuwaiti public hospitals were surveyed. Descriptive and comparative statistical analyses were performed. Factors associated with awareness and perceptions among the participants were identified.

RESULTS: The response rate was 85.3% (n = 431). Participants had a high (median = 75%) awareness score for the updated vancomycin guideline, as well as a positive perception (median = 5). The main factor identified to affect the awareness and perception of participants following the group analysis was the years of experience. The main barriers identified were a lack of training to perform vancomycin AUC24 calculations, a lack of accurate documentation sample time, and a long turnaround time for serum levels, which might hinder the implementation of the updated guideline.

CONCLUSION: Physicians, clinical microbiologists, and pharmacists working in Kuwait public hospitals were aware of the 2020 vancomycin monitoring guidelines with positive perceptions. Participants agreed on the several barriers to transitioning to the AUC24/MIC approach, which should be considered by stakeholders before implementation.

PMID:37234339 | PMC:PMC10205763 | DOI:10.1016/j.jsps.2023.04.025

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A comparative evaluation of micro shear bond strength and microleakage between the resin-modified glass ionomer cement and residual dentin following excavation of carious dentin using Carie CareTM and conventional caries removal in primary teeth: an in vitro study

F1000Res. 2023 Mar 24;12:332. doi: 10.12688/f1000research.131919.1. eCollection 2023.

ABSTRACT

Background: The bond between the dentin and restorative material contributes to the success of the restoration. Structural changes associated with prepared dentin may influence the bonding of restorative materials. The present study evaluates the bond between the resin-modified glass ionomer cement (RMGIC) and residual dentin following excavation of carious dentin using Carie Care TM and conventional caries removal in primary teeth.

METHODS: 52 primary teeth with dentinal caries were randomly grouped into group I, where caries removal was done using the conventional method, and group II which used Carie Care TM. All the teeth were restored using RMGIC. Micro shear bond strength between the residual dentin and the cement was tested using universal testing machine and the dye penetration method was used for microleakage testing. Independent t-test was performed for intergroup comparison. Pearson chi-square test was carried out to evaluate the microleakage patterns in the enamel and dentin.

RESULTS: The mean micro-shear bond strength of group I was 6.03±1.6 and that of group II was 8.54±2.92; this difference was statistically significant with a p-value of 0.012. Microleakage was higher in the test group (1.38±0.51) than the control group (0.77±0.6) and was significant with a p value of .036.

CONCLUSIONS: Papain-based chemomechanical agent Carie Care TM can be used as an alternative method to conventional caries removal. However, further studies need to explore methods to improve the marginal sealing capacity of RMGIC to the residual dentin after chemomechanical caries removal.

PMID:37234338 | PMC:PMC10206442 | DOI:10.12688/f1000research.131919.1

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Anti-cariogenic property of Carica papaya, Trachyspermum ammi, Caesalpinia crista linn extracts and their effect on human oral keratinocytes

J Oral Maxillofac Pathol. 2023 Jan-Mar;27(1):26-32. doi: 10.4103/jomfp.jomfp_151_21. Epub 2023 Mar 21.

ABSTRACT

OBJECTIVES: Dental caries is a dynamic and composite process. The multifactorial etio-pathogenesis thus influences the initiation and the progression of the disease. The prime pathogenic bacterium includes Streptococcus mutans, Lactobacillus sp and Actinomyces viscosus. The purpose of this in vitro study was to analyze the antimicrobial property of the test herbal extracts and also their effects on the human oral keratinocytes.

MATERIALS AND METHODS: The bacterial strains S. mutans (American Type Culture Collection [ATCC]-25175); Lactobacillus species (ATCC 4356) and A. viscosus (ATCC 15987) were cultured in the specific culture media-Mitis Salivarius Bacitracin, Man Rogosa Sharpe and Enrichment media, respectively. The test extracts were exposed to the cultured plates and the mean zone of inhibition was measured. The test herbal extracts were also tested for deleterious effects on oral keratinocytes via the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) assay. Independent Student’s t-test and analysis of variances were performed.-25175); Lactobacillus species (ATCC 4356) and A. viscosus (ATCC 15987) were cultured in the specific culture media-Mitis Salivarius Bacitracin, Man Rogosa Sharpe and Enrichment media, respectively. The test extracts were exposed to the cultured plates and the mean zone of inhibition was measured. The test herbal extracts were also tested for deleterious effects on oral keratinocytes via the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) assay. Independent Student’s t-test and analysis of variances were performed.

RESULTS: The extracts of Carica papaya, Trachyspermum ammi and Caesalpinia crista linn inhibited the growth of bacteria and the antimicrobial effect was found to be statistically significant at the neat/standard concentration (100 μg/ml). The three extracts showed a cell viability range 96%-99% indicating that the test extracts did not produce or display any deleterious effects on the oral keratinocytes.

CONCLUSIONS: The three test herbal extracts possess effective anti-cariogenic properties with near par with the efficacy of chlorhexidine and T. ammi proved to be the most potent. The extracts at different concentrations also proved to be safe, noncytotoxic producing a range of 96%-99% of cell viability of the oral keratinocytes.

PMID:37234333 | PMC:PMC10207211 | DOI:10.4103/jomfp.jomfp_151_21

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Inhibitory effect of garlic and omam extracts on Mucor circinelloides, a fungus causing mucormycosis: An in vitro study

J Oral Maxillofac Pathol. 2023 Jan-Mar;27(1):71-75. doi: 10.4103/jomfp.jomfp_45_22. Epub 2023 Mar 21.

ABSTRACT

CONTEXT: Mucor circinelloides is reported to be the second among the most common causative agents of emerging mucormycosis. It is intrinsically resistant to most known antifungals. Further the use of antifungals cause side effects. Traditional knowledge system for treating various ailments is stronger in India and it also backs deriving various bioactive compounds from herbal sources, in the modern system of medicine. Therefore, two most commonly used culinary herbal materials viz., ginger and omam were studied in vitro against M. circinelloides, as an alternate to antifungal drugs.

AIMS: To explore the traditional herbal resources as alternate to Amphotericin B to use against M. circinelloides, a fungus causing mucormycosis.

METHODS AND MATERIAL: Aqueous extracts of garlic and omam were prepared and tested against M. circinelloides, at different concentrations. A positive control with Amphotericin B and negative control without any supplements were also maintained. The inhibitory effect was assessed by adopting optical density (OD) measurement method in SD broth and SD Agar Well Plate using spore suspension as inoculum.

STATISTICAL ANALYSIS USED: Paired student T test was employed using SPSS Version 1.6.

RESULTS AND CONCLUSIONS: Both garlic and omam extracts were found to inhibit the M. circinelloides and their MICs were 600 and 700 μL/mL. It is comparable with the MIC of Amphotericin B, 200 μg/mL. Thus, the regular use of garlic and omam can reduce the risk of possible mucormycosis and these herbs can be explored for drug formulations against M. circinelloides.

PMID:37234326 | PMC:PMC10207184 | DOI:10.4103/jomfp.jomfp_45_22

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Estimation of salivary and serum CYFRA 21-1 levels in patients with oral squamous cell carcinoma

J Oral Maxillofac Pathol. 2023 Jan-Mar;27(1):98-102. doi: 10.4103/jomfp.jomfp_130_22. Epub 2023 Mar 21.

ABSTRACT

BACKGROUND: Cytokeratins are the largest sub-group of intermediate filaments and represent the most abundant proteins in epithelial cells. CYFRA 21-1 (human cytokeratin fragment antigen 21-1) is a soluble fragment of cytokeratin 19 known to increase in various malignancies.

AIM: The present study is aimed to estimate salivary and serum levels of CYFRA 21-1 in oral squamous cell carcinoma (OSCC) patients and to compare them with healthy controls.

SETTINGS AND DESIGN: A prospective, case-control study.

MATERIAL AND METHODS: This study included a total of 80 subjects, comprising 40 OSCC patients and 40 healthy controls. Saliva and blood samples were collected from the study population, and serum and salivary CYFRA 21-1 levels were measured by enzyme-linked immunosorbent assay.

STATISTICAL ANALYSIS USED: The statistical tests applied were independent t-test, ANOVA test for comparison, and Post hoc test for correlation. A P value of < 0.05 was considered statistically significant.

RESULTS: A statistically significant increase in salivary and serum CYFRA 21-1 levels was observed between OSCC and control groups and with an increase in the pathological tumour node metastasis stage and histopathological grade of OSCC. On correlating salivary and serum CYFRA 21-1 values, there were 3-fold higher salivary levels than serum.

CONCLUSION: CYFRA 21-1 can be suggested as a tumour marker that can be used for the early diagnosis of the OSCC. Further prospective studies with a larger sample size and advanced techniques recommended before CYFRA 21-1 can be recommended for routine clinical use.

PMID:37234320 | PMC:PMC10207219 | DOI:10.4103/jomfp.jomfp_130_22

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Analysis of Inheritance patterns, gender dimorphism and their correlation in lip and palm prints – A cross-sectional study

J Oral Maxillofac Pathol. 2023 Jan-Mar;27(1):130-137. doi: 10.4103/jomfp.jomfp_535_22. Epub 2023 Mar 21.

ABSTRACT

BACKGROUND: Forensic sciences deal with key areas to be included in judicial makeup that has been approved by both the court and the scientific community, which distinguishes truth from counterfeit. Lip and palmprints are one of a kind and do not change during the lifetime of a person unless any pathologies.

OBJECTIVES: To evaluate the heritability, and gender dimorphism of lip and palm prints among parents and their offspring.

METHODS: A total of 280 participants were included in the study. Lip and palm prints were collected from participants using a digital camera. The photographic data obtained is subjected to Adobe Photoshop and analysed for inheritance. Gender dimorphism is evaluated by the predominant lip pattern and palm ridge count in four designated areas.

RESULTS: A positive resemblance of 28.4% was found between parents and offspring in lips, and for the right palm, it was 60.2% and 55.12% for the left palm (principal lines) which are statistically insignificant. In all six quadrants, the most predominant lip pattern found in males is type 5, and in females, type 11. The mean palm ridge density was significantly higher among females than males in all designated areas.

CONCLUSION: The digital method of analysing lip and palm print images with Adobe Photoshop 7 software is a convenient method that allows for better visualisation and easier lip and palm print recording and identification. Considerable inheritance patterns and gender dimorphism were observed that aid in personal identification.

PMID:37234319 | PMC:PMC10207223 | DOI:10.4103/jomfp.jomfp_535_22

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Correlation of serum trace elements (Fe, Cu, and Zn) in the blood samples of Indian patients with leukoplakia, oral squamous cell carcinoma, and normal subjects

J Oral Maxillofac Pathol. 2023 Jan-Mar;27(1):76-79. doi: 10.4103/jomfp.jomfp_29_22. Epub 2023 Mar 21.

ABSTRACT

CONTEXT: Trace elements (iron, copper, and zinc), leukoplakia, and oral squamous cell carcinoma.

AIMS: To study and correlate serum trace element (iron, copper, and zinc) levels in leukoplakia, oral squamous cell carcinoma, and normal subjects.

SETTINGS AND DESIGN: The present study comprised a total of 80 patients, which included 30 patients of leukoplakia, 30 patients of oral squamous cell carcinoma, and the normal control group comprising 20 healthy individuals who were not having any relevant medical, dental, and habit history.

SUBJECTS AND METHODS: Peripheral blood samples of a volume of 10 ml each will be collected by anti-cubical vein puncture from control groups and from patients suffering from leukoplakia and oral squamous cell carcinoma. The blood will be collected in a plain red top vein puncture tube without additives or anti-coagulants and allowed to stand undisturbed to clot at room temperature, and serum will be separated from the cells by centrifugation at 4°C at a speed of 3000 rev/min, the separated sera will be kept at -20°C until analysis is performed.

ESTIMATION OF SERUM IRON ZINC AND COPPER LEVELS: The estimation of serum zinc (Zn) and copper (Cu) levels is performed by atomic absorption spectrometry (AAS). In the present study, the estimation of copper and zinc levels was conducted by using an atomic absorption spectrophotometer (model no: AA-6300 SHIMADZU, Japan). Serum iron estimation is performed using the kit RANDOX (siedel, 1984).

STATISTICAL ANALYSIS USED: Statistical analysis is performed by the paired and Scheffe tests.

RESULTS: From the results, it was concluded that there was a decrease in serum iron and zinc levels and copper had increased serum levels.

CONCLUSIONS: It was concluded that evaluation of serum trace elements can be a cost-effective and non-invasive alternative for screening, diagnosis, and monitoring of pre-malignant lesions such as leukoplakia and malignant lesions such as oral squamous cell carcinoma. Thus, these parameters can be used as biomarkers that provide important tools in formulating an adequate diagnosis, treatment plan, and prognosis for oral squamous cell carcinoma.

PMID:37234317 | PMC:PMC10207197 | DOI:10.4103/jomfp.jomfp_29_22

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Expression of stathmin in oral squamous cell carcinoma and its correlation with tumour proliferation

J Oral Maxillofac Pathol. 2023 Jan-Mar;27(1):103-108. doi: 10.4103/jomfp.jomfp_202_22. Epub 2023 Mar 21.

ABSTRACT

BACKGROUND: Stathmin is a member of microtubule-associated protein. Inhibition of Stathmin expression can interfere with tumour progression and also alter the sensitivity of tumour cells to microtubule-targeting agents. Thus, it could be a potential therapeutic target for planning new treatment strategies.

OBJECTIVE: To study expression of Stathmin in different histological grades of oral squamous cell carcinoma (OSCC) and its correlation with Ki67 index.

MATERIALS AND METHODS: This study was an observational retrospective and prospective study conducted during a period of two and half years from January 2015 to June 2017 at ESI-PGIMSR Maniktala, Kolkata where 52 cases of OSCC were studied. Haematoxylin and eosin sections were reviewed and representative paraffin blocks were selected. Immunostains were performed using antibody clones for Stathmin and Ki67. For Stathmin scoring, Segersten scoring system was applied. Statistical analysis was done by Graph Pad Prism using Krusher Wallis Test and one-way ANOVA test. Spearman’s coefficient was used to establish corelation between Ki 67 and Stathmin overexpression.

RESULTS: In this study, it is found that strong Stathmin expression score (4-9) was detected mostly (82.35%) in moderately differentiated (MD) OSCC and poorly differentiated (PD) OSCC (100%), whereas in contrast, 60% of well-differentiated OSCC showed negative-to-weak Stathmin score (1-3). Mean Ki67-labelling index for well-differentiated carcinoma was 32.37%, for moderately differentiated carcinoma was 60.89, and poorly differentiated carcinoma was 86.15%, which demonstrated increased tumour cell proliferation with progression of histological grades of OSCC.

CONCLUSION: Stathmin expression was higher in MD OSCC to PD OSCC compared to well-differentiated carcinoma and its overexpression was significantly correlated with Ki67 index. Thus, Stathmin is overexpressed in higher grades and is correlated with high proliferation of tumour with a potential role as therapeutic target.

PMID:37234316 | PMC:PMC10207213 | DOI:10.4103/jomfp.jomfp_202_22