scholarly journals Compliance to GMP guidelines for Herbal Manufacturers in East Africa: A Position Paper

2021 ◽  
Author(s):  
Victoria Kwesiga ◽  
Zita Ekeocha ◽  
Stephen Robert Byrn ◽  
Kari L Clase
Keyword(s):  
Herbal Medicines ◽  
Good Manufacturing Practice ◽  
Control Measures ◽  
Outcome Variable ◽  
Maturity Level ◽  
Chi Square ◽  
Complementary Medicines ◽  
National Drug ◽  
Chi Square Test ◽  
Global Increase

With the global increase in the use of traditional and complementary remedies for the prevention and treatment of illness, the quality and safety of these medicines have become a significant concern for all regulatory authorities. Herbal medicines are the most commonly used form of traditional and complementary medicines in the world and the efficacy and safety of herbal medicines, like conventional medicines, largely depends on their quality from planting to harvesting, preprocessing and final processing. Due to the inherent complexity of herbal medicines, often containing an array of active compounds, the primary processing of herbal medicines has a direct influence on their quality. Quality concerns are the reason why the medicines regulatory agencies insist that manufacturers of medicines strictly follow Good Manufacturing Practices since it is an essential tool to prevent instances of contamination, mix-ups, deviations, failures and errors. However, a strict application of GMP requirements is expensive and would drive the prices of the manufactured products up. As a result, a maturity level grading of facilities is proposed as a way of justifying the costs incurred for manufacturers desiring to reach a broader market and investing in continuous improvement. 36 Good Manufacturing Practice (GMP) inspection reports of local herbal manufacturers conducted by National Drug Authority were analyzed to establish the type and extent of deficiencies to GMP requirements for local herbal manufacturers in Uganda. The different GMP chapters and related sub-parameters constituted the variables used for the analysis of conformity to requirements. The primary outcome variable was the conclusion regarding compliance or noncompliance of the inspected local herbal manufacturing facility. GMP parameters that were frequently defaulted by local herbal manufacturers and the corresponding frequencies were identified. The Pearson Chi-square test was applied independently on each category to find the association that existed between conformity and the questions in each category. Only 22% (8) of the 30 inspected facilities were found to comply with GMP requirements, as per National Drug Authority (NDA) guidelines; while the majority of the facilities, 28 (78%), were found not to comply. Of the facilities inspected, 25 were undergoing GMP inspection for the first time. A total of 1,236 deficiency observations were made in the 36 inspection reports reviewed for the study. The mean for all deficiencies was 34.3, and the standard deviation was 15.829. 91.5% of the facilities did not have mechanisms for a record of market complaints; 80.9% did not meet documentation requirements; 78.9% did not have quality control measures in place, and 65.7% did not meet stores requirements. By encouraging a culture of self/voluntary improvement through the introduction of listing of manufacturers based on a maturity level grading, the National Drug Authority will improve the Herbal Medicines sector as per the mandate of improving the herbal medicine industry. Also, increased sensitization of all relevant stakeholders regarding the requirements for GMP should be intensified.

scholarly journals The Retreated Tendency of the COVID-19 Pandemic

2021 ◽  
Author(s):  
Zhengkang Zuo
Keyword(s):  
World War Ii ◽  
Time Window ◽  
Discharge Rate ◽  
Statistical Tests ◽  
T Test ◽  
Control Measures ◽  
Local Policy ◽  
Chi Square ◽  
Chi Square Test ◽  
Complex Phenomena

Abstract Background: The novel virus (COVID-19) pandemic threats the global most since the World War II yet difficult to design effective policy to respond it because widely utilized models only support to predict the future tendency within a narrow time-window. Besides, existing pandemic metrics are sensitive to the detecting policy ( p <0.001), which make them hard to reveal the real infection phenomena, because the fluctuation of these metric values may be an outcome of a suddenly changed detecting policy instead of real infection increase or decrease. Methods: We developed a Benchmark, Amendment and Validation model (BAVM) to make the above complex phenomena clearer, and combined with the hypothesis of potential periodicity of COVID-19 to devote jointly the retreated prediction of pandemic within a broad time-window. Onward, we utilized 113 countries’ epidemic data from January 21, 2020 to August 31, 2020 and detecting policies to carry out our methodology, then validated the results through statistical tests involving chi -square test, one t-test and independent t test. Results: Results exhibit the 4-month of potential periodicity between two adjacent peaks of pandemic ( t =–1.56, p =12.4%). Besides, whether or not the peak emergence has no effect on COVID-19 dynamic trajectory, but the time to firstly peak affects. Meanwhile, uprising the quarantine rate exhibits the earlier expedition towards the first peak emergence (9.7% vs. 6.2%, p =4.1%). On the contrary, the delay of first peak increased the infection rate (0.6% vs. 0.3%, p =1.5%) but also the discharge rate (65% vs. 74%, p =3.8%). Moreover, the indication of the retreated tendency of COVID-19 pandemic is that the next peak should emerge but in fact vanished after one periodicity. Otherwise, the pandemic enters into the next worse phase, typical of high mortality (5% vs. 3.4%, p =5.3%) and low discharge rate (65.8% vs. 74.1%, p =4.2%). Conclusion: To recognize the retreated tendency of this pandemic is quite significant for either the global or the local policy-making, especially in the regular epidemic prevention, control measures and work resumption.

scholarly journals INTRACAPSULAR FEMORAL NECK FRACTURES

2018 ◽  
Vol 25 (09) ◽  
pp. 1317-1322
Author(s):  
Muhammad Jawad Ahmed ◽  
Maryam Shahid ◽  
Muhammad Hammad Ahmed ◽  
Bilal Nazarq
Keyword(s):  
Femoral Neck ◽  
Functional Outcome ◽  
Femoral Neck Fractures ◽  
Outcome Variable ◽  
P Value ◽  
Bipolar Hemiarthroplasty ◽  
Chi Square ◽  
Neck Of Femur ◽  
Chi Square Test ◽  
Walking Aid

Objectives: To compare of functional outcomes in terms of post-operativemobility for unipolar versus bipolar un-cemented hemiarthroplasty in elderly patients withdisplaced intracapsular femoral neck fractures. Study Design: Randomized Control Trial.Setting: Department of Orthopedics Bahawal Victoria Hospital, Bahawalpur. Period: April 2015to October 2016. Methodology: Sample size is (calculated by taking n6 =138, confidenceinterval 95, power of study 80, P1= 33%, P2=13%) 69 in each group. Sampling technique usedwas non probability consecutive sampling. All patients who meet the inclusion criteria presentingto orthopedic unit of Nishtar Hospital Multan with fracture neck of femur were selected for study.Patients were divided into two groups randomly by lottery method and enrolled for unipolaror bipolar hemiarthroplasty. Chi-square test was used to compare outcome variable in bothgroups. A p-value < 0.05 was considered statistically significant. Effect modifiers like age andsex was controlled by stratification. Chi square test was applied to see significant difference.Results: Overall, there were 100% (n=138) patients in this study, both genders. The mean ageof the patients was 66.35±4.29 years. (Range: 60 to 80years)Mean age and SD of group A (nowalking aid) was 54.52 ± 3.10 and in group B (walking aid) 54.99 ± 3.19. Time up go score wasnoted as successful 33.3% (n=46) and 66.7% (n=92) as unsuccessful. Walking aid was notedin 65.2% (n=90) patients. Functional outcome was noted as good in 26.8% (n=37) patientsand noted as bad in 73.2% (n=101) patients. Out of 100% (n=38) patients, good outcomewas 26.3% (n=10) unipolar and 73.7% (n=28) bipolar. Out of 100% (n=100) Bad outcomewas 59% unipolar and bipolar 41%. Conclusion: Functional outcome in term of mobility isbetter in case of bipolar prosthesis as compared to unipolar. Thus in our conclusion bipolarprosthesis is preferred procedure as compared to unipolar hemiarthroplasty in treating patientswith displaced intracapsular femoral neck fracture.

Association between olfactory dysfunction and COVID-19 severity: A prospective study in a highly complex hospital in Peru

2021 ◽  
pp. 014556132110666
Author(s):  
Olenka Alcas ◽  
Diego Saldaña ◽  
Andy Triveño ◽  
Miguel Salazar ◽  
Paola Mejía
Keyword(s):  
Latin American ◽  
Olfactory Dysfunction ◽  
Outcome Variable ◽  
Inverse Association ◽  
Chi Square ◽  
Exact Test ◽  
Latin American Region ◽  
Exposure Variable ◽  
Chi Square Test ◽  
A Prospective Study

Introduction Olfactory dysfunction has been included among the early symptoms of coronavirus disease (COVID-19). Evidence suggests that a relationship exists between the duration of olfaction disorders and the probability of developing severe COVID-19. Given the scope of the COVID-19 pandemic, this study aimed to determine the frequency of smell alteration and its association with the severity of COVID-19 in a referral hospital in Peru, which is one of the most affected countries in the Latin American region. Materials and Methods This study was an observational, prospective cohort study that included patients with COVID-19 who were treated at the Hospital Nacional Edgardo Rebagliati Martins from August to November 2020. To assess the association, the chi-square test of independence or Fisher’s exact test was performed. The outcome variable was COVID-19 severity, and the exposure variable was olfactory dysfunction. The first data collection was in the emergency department and the follow-up was via telephone. Results A total of 179 patients were included. The mean age was 61.6 ± 15.5 years, and 129 patients (72.1%) were male. Olfactory dysfunction was observed in 43 patients (24%). An inverse association was found between age and olfactory dysfunction ( P = .002). No significant association was found between COVID-19 severity level and olfactory alteration ( P = .056). However, a direct association was found between COVID-19 severity and age ( P = .003), cough ( P < .001), and respiratory distress ( P = .003). Conclusion This study did not find any association between the severity of COVID-19 and olfactory dysfunction. It showed a low incidence rate of smell alteration compared with studies from other regions. Moreover, smell alteration was associated with younger age.

scholarly journals Monitoring of Lutzomyia longipalpis Lutz & Neiva, 1912 in an area of intense transmission of visceral leishmaniasis in Rio Grande do Norte, Northeast Brazil

2010 ◽  
Vol 19 (1) ◽  
pp. 39-43 ◽  
Author(s):  
Sthenia Santos Albano Amóra ◽  
Claudia Maria Leal Bevilaqua ◽  
Edmilson de Castro Dias ◽  
Francisco Marlon Carneiro Feijó ◽  
Paula Gabriela Melo de Oliveira ◽  
...  
Keyword(s):  
Visceral Leishmaniasis ◽  
Population Density ◽  
Disease Transmission ◽  
Rainy Season ◽  
Rio Grande ◽  
Control Measures ◽  
Northeastern Brazil ◽  
Lutzomyia Longipalpis ◽  
Chi Square ◽  
Chi Square Test

Urban increase of visceral leishmaniasis (VL) in Brazil is associated with the adaptation of its vector, Lutzomyia longipalpis, to environments modified by humans. The present study reports the results of an entomological monitoring of L. longipalpis and the effect of environmental variables on its population density. Sandflies were captured in the municipality of Mossoró, State of Rio Grande do Norte, Northeastern Brazil, from January 2005 to December 2006. Two CDC light traps were placed monthly for four consecutive nights in the peridomicile of selected households. Data analysis was based on the chi-square test and linear regression. A total of 2,087 sandflies were captured, 99.86% of which were L. longipalpis. A higher proportion of females were captured (p < 0.05). Monthly analysis of the variables temperature, relative humidity and rainfall did not show a significant influence on population density. However, there were seasonal differences: approximately 70% of sand flies were captured during the rainy season (p < 0.05). The predominant species, L. longipalpis, is present in substantial number, representing a public health risk. Therefore, because of higher prevalence during the rainy season, we recommend intensified VL control measures before and during this season to reduce the risk of disease transmission.

scholarly journals Selection of Effective Herbal Medicines for Parkinson’s Disease Based on the Text Mining of the Classical Korean Medical Literature Donguibogam

2021 ◽  
Vol 42 (4) ◽  
pp. 130-142
Author(s):  
Hyo Won Bae ◽  
Tae Wook Lee ◽  
Byung Tae Choi ◽  
Hwa Kyoung Shin ◽  
Young Ju Yun
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Medical Literature ◽  
Statistical Tests ◽  
Herbal Medicines ◽  
Symptomatic Treatment ◽  
Mean Value ◽  
Wilcoxon Test ◽  
Chi Square ◽  
Chi Square Test

Objectives: The prevalence of Parkinson’s disease is on an upward trend along with an increase in the aging population but there is no available treatment that halts the progression of neurodegeneration. This study reports a numerical analysis on Donguibogam and suggests novel herbal drugs, which have never been researched before but found to be deemed effective in this study.Methods: Referring to 71 Korean medicine symptom terms that represent the symptoms of Parkinson’s disease, 4170 prescriptions described in Donguibogam were classified into two groups based on whether their main effects were effective for Parkinson’s disease or not. Comparing the two groups, the chi-square test was performed to select statistically significant herbs, while the t-test, Wilcoxon test, and descriptive statistics were performed to determine the appropriate dose.Results: One hundred and twenty-seven prescriptions effective for Parkinson’s disease were identified. The chi-square test determined 17 herbs that are effective for symptomatic treatment. Among the medicinal herbs, the authors suggest Osterici seu Notopterygii Radix et Rhizoma, Ephedrae Herba, Aconiti Tuber, Myrrha, Sinomeni Caulis et Rhizoma, and Aconiti Kusnezoffii Tuber as herbal candidates that have never been studied for Parkinson’s disease. Through the statistical tests, it was judged that the mean value of the dose of the entire prescription was the appropriate dose for each herb.Conclusions: Seventeen herbs were selected for Parkinson’s disease and the appropriate daily dose were calculated. Furthermore, this study presented a new process that applies a statistical method to traditional medical literature and preselecting herbs deemed effective for specific diseases.

scholarly journals Early mannitol administration improves clinical outcomes of pediatric patients with brain edema

2018 ◽  
Vol 27 (4) ◽  
pp. 244-9 ◽  
Author(s):  
Putu A. Sekarningrum ◽  
Dyah K. Wati ◽  
IGN Made Suwarba ◽  
I Nyoman B. Hartawan ◽  
Dewi S. Mahalini ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Clinical Outcome ◽  
Brain Edema ◽  
Clinical Outcomes ◽  
Pediatric Patients ◽  
Pediatric Intensive Care ◽  
Outcome Variable ◽  
Chi Square ◽  
Primary Outcome Variable ◽  
Chi Square Test

Background: Mannitol 20% is used to treat patients with decreased consciousness and as the first line of treatment to reduce intracranial pressure (ICP). However, its application in pediatric patients is still based on minimal evidence. This study was performed to determine the predictive factors of clinical outcomes in pediatric patients with brain edema in the pediatric intensive care unit (PICU).Methods: This prospective cohort study was conducted in the PICU, Sanglah Hospital Denpasar, Bali, Indonesia. The subjects were chosen by consecutive sampling from July 2016 to July 2017. The primary outcome variable was the patient’s clinical outcome. A chi-square test was used to evaluate the association between the timing of mannitol administration and the patient’s clinical outcome. Multivariate analysis was performed on all variables with p≤0.25.Results: Forty-one patients were included in the study, 65% of them were male, 65% had good nutritional status, 90% had non-traumatic brain injury, and 73% had confirmed intracranial infection. The risk of sequelae or death for patients in a coma was 1.8 times greater than that of non-comatose patients (p=0.018; CI 95% 1.119–3.047). Based on the timing of mannitol administration from the onset of decreased consciousness, the risk of sequelae or death in patients who received mannitol after 24 hours was 2.1 times higher than that in patients who received mannitol within 24 hours (p=0.006; CI 95% 1.167–3.779). Based on multivariate analysis, only two variables were associated with the patient’s clinical outcome: pediatric Glasgow coma scale (PGCS) ≤3 (p=0.03) and timing of mannitol administration >24 hours (p=0.01).Conclusion: Early administration (<24 hours) of mannitol and high PGCS are related to favorable outcomes in patients with brain edema in the PICU.

scholarly journals Prevalence and Predictors of Contraceptives Use among Women Aged (15–49 years) with Induced Abortion History in Ghana

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Mohammed Gazali Salifu ◽  
Kamaldeen Mohammed
Keyword(s):  
Statistical Significance ◽  
Secondary Data ◽  
Induced Abortion ◽  
Outcome Variable ◽  
Chi Square ◽  
Safe Abortion ◽  
Modern Contraceptives ◽  
Chi Square Test ◽  
History Of ◽  
Widespread Access

Background. The incidence of abortion in Ghana ranges from 27 per 1000 to 61 per 1000 women, causing gynecological complications and maternal mortality. The use of modern contraceptives and its associated factors among women aged 15–49 years have been documented. However, utilization of modern contraceptives specifically among women with induced abortion history is underreported. This study therefore aimed at determining the proportion and identifying predictors of contraceptives use in this underreported population. Methods. This study used secondary data from the 2017 Ghana Maternal Health Survey (GMHS) for the analysis. The analysis is on a weighted sample of 3,039 women aged (15–49 years) with a history of induced abortion. Both descriptive and inferential methods were employed. The chi-square test, univariate and multivariate logistic regression techniques were used to assess statistical associations between the outcome variable and the predictors. Statistical significance was set at 95% confidence interval and p values ≤0.05. Results. Out of the 3,039 participants, 37% (95% CI: 34.6, 38.84) used contraceptives. We identified women’ age, union, place of residence, knowledge of fertile period, total pregnancy outcomes, and region as strong significant (95% CI, p≤0.05) predictors of post induced abortion contraceptives use. Conclusion. Contraceptives use among this vulnerable population is low. Therefore, there is a need to provide widespread access to postabortion contraception services and enhance efforts to efficiently integrate safe abortion practices law into health services in Ghana.

scholarly journals A nationwide study on the knowledge, awareness, and practices towards COVID-19 in Saudi Arabia

2021 ◽  
Vol 20 (1) ◽  
pp. 161-167
Author(s):  
Yaser M. Alahmadi ◽  
Sultan S. Al Thagfan
Keyword(s):  
Saudi Arabia ◽  
Clinical Symptoms ◽  
Face Mask ◽  
Control Measures ◽  
Chi Square ◽  
Cross Sectional ◽  
Attitudes And Practices ◽  
Chi Square Test ◽  
Respiratory Droplets ◽  
Self Administered Questionnaire

Purpose: To investigate public knowledge, awareness and practice regarding COVID-19 in Saudi Arabia.Methods: A cross-sectional descriptive study was conducted, with a 16-item self-administered questionnaire. Data was collected using social media as the platform a day after the lockdown commenced in Saudi Arabia and data collection lasted from March 25 to April 25, 2020. Chi-square test was performed to determine the association between the variables.Results: The results showed that 96 % (n = 1505) of adults were aware of the clinical symptoms of COVID-19 and 57.9 % (n = 908) correctly identified that a stuffy nose and sneezing were less common in persons infected with the virus. A majority (95.4 %, n = 1495) agreed that there was no established therapeutic treatment for COVID-19. Further, 91.7 % (n = 1437) agreed that the virus could spread via respiratory droplets and only 46.2 % (n = 724) acknowledged that wearing face mask helped prevent transmission. The results also showed that 83.2 % (n = 1299) of the participants thought that visiting crowded places increased the likelihood of transmission.Conclusion: The findings of this study reveal that adults in Saudi Arabia are cognizant of COVID-19 and maintained good attitudes and practices regarding it. Furthermore, health education programs aimed at improving awareness of the disease and appropriate control measures will be beneficial in curbing the virus pandemic. Keywords: Saudi Arabia, Coronavirus, Pandemic, COVID-19, Flu, Symptoms

scholarly journals Analysis of the Death-Leading Accident in Working with Boom Reclaimer Device using the Tripod beta and SCAT Combined Method in a Steel Company

2018 ◽  
Author(s):  
Akbr REZAGHOLIAN ◽  
Nabiollah MANSOURI ◽  
Tooraj DANA
Keyword(s):  
Statistical Tests ◽  
Control Measure ◽  
Control Measures ◽  
Combined Method ◽  
Original Design ◽  
Steel Company ◽  
Chi Square ◽  
Balance Weight ◽  
Chi Square Test ◽  
The Relationship

Introduction: The purpose of this study was to combine the two methods of Tripod beta and SCAT to analyze the accidents, explain their leading details, and track the roots of events at the depth of organizational layers.Methods: This analytical-descriptive study was carried out in one of the steel companies in Iran. To conduct the study, we analyzed one of the death- leading events using the combination of SCAT and Tripod methods. We investigated the relationship between variables and analyzed the intermediate and root causes of the event by Tripod beta method.  Moreover, we proposed some control measures in the SCAT cause and effect table. The information achieved from the questionnaire and effects of the accidents' causes were studied and rated using the chi-square test and Friedman test, respectively.Results: The most important direct cause of the accident was "removal of bucket wheel (in the Boom Claimer device) from the shaft". The most important intermediary cause of the event was "lack of an appropriate immune system at the time of balance weight release". The most important rudimentary cause of the event was "inappropriate location of the device cabin in the original design". Furthermore, the most important control measure was “using harvesting equipment with new design".Conclusion: According to the statistical tests, we found a systematic connection between root causes and intermediate causes of the incident. Moreover, we observed that the effect of root causes and intermediary causes were not similar regarding the accident.

scholarly journals Hafidh, THE LEVEL OF KNOWLEDGE OF HEALTH CARE WORKERS WITH THE LATENT TUBERCULOSIS

2021 ◽  
Vol 8 (1) ◽  
pp. 98-103
Author(s):  
Hafidh Bagus Aji Prasetyo ◽  
Raden Mas Soerjo Adji ◽  
Andreas Arie Setiawan ◽  
Setyo Gundi Pramudo
Keyword(s):  
Significant Relationship ◽  
Health Workers ◽  
Latent Tuberculosis ◽  
Control Measures ◽  
Chi Square ◽  
Cross Sectional ◽  
Increased Risk ◽  
Chi Square Test ◽  
Latent Tb ◽  
Level Of Knowledge

ABSTRACT Background : Pulmonary tuberculosis is a contagious infectious disease caused by the Mycobacterium tuberculosis. Health workers have an increased risk of contracting tuberculosis, because they are exposed to TB in their workplaces. The absence of hospital control measures against TB infection makes the risk factor becomes high. Health workers often make contact with TB sufferers. In a good body condition, although infected by TB germs, it does not manifest as a disease or called latent TB. However, latent TB sufferers still have the risk of being active in certain conditions, which then becomes a source of new TB transmission. Objective: This study aims to look at the level of knowledge of health workers towards the incidence of Latent TB in the Hospital. Method : The research method is cross-sectional using a sample of health workers who work in hospitals. The sample size of this study was 46 people using purposive sampling. This study has a variable Health worker knowledge about TB disease and Latent TB incidence. The method of data analysis using Chi Square Test. Result : The results were not significant between the level of knowledge and the incidence of Latent TB in health workers (p = 0.584). While the use of masks with the incidence of latent TB had a significant relationship (p=0,001). Conclusion : There is no significant relationship between the level of knowledge with the incidence of Latent TB in health workers. While the use of masks with the incidence of latent TB has a significant relationship. Keywords : Tuberculin Skin Test, Awareness, Incident, Workplaces.

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