Health Regulatory Agencies Research Articles

Social Media Food Ads Hype and Adolescent Obesity Upsurge in Nigeria

The devastating effect of obesity on humanity transcends race, regional barriers and national developmental status. This has become a global dilemma; as nations figures-out better ways of ensuring safe consumption pattern amongst all age brackets. The situation has become very complex due to the expanding effect of non-regulated social media ads on availability of all forms of eatable items in all facets of human endeavour. The aim of this research is to evaluate the pernicious effect of social media ads hype on obesity increase amongst adolescents and adults in in three (3) selected districts in Akwa Ibom State, Nigeria. The underlying issues to be unravelled by this study includes: the prevailing effect of un-regulated social network activities, the changing urban lifestyle of obese persons and the increased availability of low cost processed foods occasioned by global competitiveness and economic liberalization. The study covered a period of four years (2017-2021) by selecting medical centres from each of the three districts under study in which, relevant information was obtained to affirm obese person; We observed a steady annual percentage increase of (2018-2019 -20%, 2019 – 2020- 37% and 2020 -2021 – 32%), based om average Body Mass Index(BMI) of each individual that is above 30kg/m2. The conceptual framework adopted for the study is a combination of how social interaction affect consumption behavior through the interchange between; Personal consumption decision, interpersonal consumption decision, institutional influence on consumption pattern, neighborhood influence, and health regulatory processes/procedures. The study adopted descriptive research technique whereby questionnaires were administered to identify respondents, and comprehensive interviews were also conducted to obtain detail facts from respondents on areas that was not fully covered by the questionnaire, based on Systematic review of literature. The outcome revealed a significance interrelationship between the variables of the construct. The outcome of the study revealed an interrelationship between social media ads on food items and obesity amongst adolescence and adults in study area. The implication of the study, creates a pathway for future research to expand the age bracket to include children, and encourage health regulatory authorities to step up the process of control on unwholesome food advertising. The study recommended a policy framework that will regulate social food item to mitigate the health effect of obesity amongst the categories of persons under study.

Validation of the analytical method using the energy dispersive X-ray fluorescence technique (EDXRF) for application in pharmaceutical sciences

The determination of impurities in raw materials intended for the production of pharmaceutical products is important to guarantee the quality of the final product, as well as to avoid damage to health. Metallic impurities can exhibit toxic effects even at low concentrations and so permissible levels are defined by the regulatory agencies and pharmacopeias. However, few methods are presented in official compendia in Brazil. In this sense, fast, sensitive, and precise techniques such as the energy dispersive X-ray fluorescence technique (EDXRF) must be evaluated for the analysis of metals in materials for pharmaceutical use. This way, therefore, there is the need to investigate the presence of contaminants and their concentration levels. The major goal of this research work was to validate a method for using the Energy Dispersive X-Ray Fluorescence (EDXRF) technique to identify and quantify the chemical composition of raw materials and pharmaceutical products. The methodology used was based on the selection of a microcrystalline cellulose matrix, which was spiked with two classes of contaminant elements, Class 1 (Cd, Pb, As, Hg) and Class 2A (Co, V, Ni) as defined by ICH guideline Q3D. The qualitative and quantitative analyses were carried out using the EDXRF technique, which proved to be quite effective and met all the validation parameters required in the mandatory official compendia (Resolution of the Collegiate Board (RDC) of Brazilian Health Regulatory Agency (Anvisa) nº 166, July 24, 2017), such as selectivity, linearity, precision, detection limit, quantification limit and robustness. This study showed that EDXRF can be used as a technique for detection and quantification of elemental impurities belonging to Class 1 and Class 2A.

Genotoxicity and toxicological evaluations of Brazilian red propolis oral ingestion in a preclinical rodent model

Ethnopharmacological relevanceBrazilian red propolis is a natural product known due to its medicinal properties. The efficacy of this natural resin has been proved; however, few studies report the safety of its oral use. Some toxic effects of natural products may not be expressed in traditional use, and preclinical studies are necessary to guarantee their safety. Health regulatory agency currently requires these non-clinical studies to develop drugs and herbal medicines, including genotoxic and oral toxicity tests. Aim of the studyAccomplish the preclinical toxicity studies of Brazilian red propolis extract (BRP) in rodents, including genotoxicity, acute and sub-chronic toxicities. Material and methodsGenotoxicity assays followed the erythrocyte micronucleus test protocol in a range of 500–2000 mg/kg BRP oral treatment on male Swiss mice. After an up-and-down procedure, acute oral toxicity (single dose) was performed on female Wistar Hannover rats, reaching a 2000 mg/kg BRP oral gavage concentration. Animals were monitored periodically until 14 days and euthanized for a macroscopic necropsy analysis. The sub-chronic oral toxicity test (90 days) was achieved with 1000 mg/kg of BRP on Wistar Hannover rats (males/females). Animals were monitored to evaluated behavioral and biometrical changes, then were euthanized to perfomed hematological, biochemical, and histopathological analyses. ResultsNo genotoxic effect of the BRP was detected. The acute toxicity indicated no toxicity of a single oral dose of 2000 mg/kg of BRP. The long-term oral toxicity performed with 1000 mg/kg of BRP altered water and food intake and the biometrics, hematological and biochemical parameters. Biochemical alterations in hepatic and renal parameters were detected only in the males. Despite the detection of biochemical alterations, no histopathological changes were detected in the organs of any group. ConclusionsBRP, at a higher dose, showed no signs of immediate toxicity. However, the obtained results suggest that the chemical composition and the intake of higher doses deserve special attention regarding possible toxicity.

Development and validation of a novel cosmetics safety assessment scale (CSAS): Factual understanding of cosmetic safety and fostering international awareness

Falsified cosmetics are increasingly common especially online through social media networks and mobile applications. This study developed and validated a novel tool to evaluate the safety of cosmetics and personal care products in the United Araba Emirates (UAE). This is methodological validation study and the data were derived from a cross-sectional study conducted on students and staff at Ajman University (AU) in the UAE. The study sample was selected via simple random sampling. The link to the survey was sent to potential respondents via email, and the responses were analysed using SPSS version 26. Content validity, factor analysis, and known group validity were employed to construct and validate an instrument that will enable the identification of cosmetics safety. The instrument's reliability was evaluated using test-retest reliability, internal consistency, item internal consistency (IIC), and intraclass correlation coefficients (ICCs). The study sample included 978 participants. The content validity index for the final 24-item scale was 0.84. The Kaiser-Meyer-Olkin value was 0.959 with a statistically significant Bartlett's test of sphericity (p <0.001). Factor analysis presented a three-component model. PCFA analysis found good fit values with 0.960 for the normed fit index, 0.977 for the comparative fit index, and 0.987 for the Tucker Lewis Index. All values were in excess of 0.95, and the root mean square error of approximation was below 0.06 (0.03); thus, the model had a good fit. Cronbach's alpha also showed good consistency of the overall instrument (0.963), and all factors had a Cronbach's alpha above 0.70. Each item on the instrument met the IIC correlation standard of ≥ 0.40, and there were good overall ICC statistics of 0.963 (0.959-0.966) for the instrument as a whole with statistical significance (p < 0.001). The instrument's test-retest reliability was assessed by correlating the respondents' identification scores at two time points with a four-week gap revealing a correlation coefficient of 0.870 (p-value <0.01). Participants holding a bachelor's degree were more likely to be able to identify safe and authentic cosmetics than those with a high-school educational level (p = 0.015). This study developed a novel validated instrument to determine the safety of cosmetics. The final questionnaire uses 24 items on three dimensions (13 items on hazard information, eight items on product identity, and three items on product handling and storage). The tool is concise and easy to complete, and it is suitable for use among the general population. The use of this instrument can promote greater collaboration between the consumer health regulatory authorities and inspection authorities thus increasing consumer satisfaction and public participation.

A Mixed-Methods Investigation of Occupational Health Specialists’ Knowledge and Application of Pen-and-Paper Observational Methods for Ergonomics Assessment

OCCUPATIONAL APPLICATIONS Ergonomic risk assessment is a key step in managing work-related musculoskeletal disorders. Diverse assessment methods exist, and errors may occur if inappropriate methods are selected. Understanding the level of knowledge, how to use methods, and exploring factors affecting erroneous usage of these methods, can provide useful information for health and safety regulatory authorities and decision-makers to identify problems and determine an action plan to eliminate them. We found that Iranian occupational health specialists have little knowledge about the types of pen-and-paper observational methods (OMs), and most of them use a limited number of these methods. Content analysis of interviews identified three main categories of influential factors and 12 subcategories. The main categories were educational, individual, and organizational factors. These results suggest the need for more effort to ensure that practitioners possess better knowledge and skills in the selection and application of pen-and-paper OMs.

Detection methods for sub-nanogram level of emerging pollutants - Per and polyfluoroalkyl substances.

Per- and polyfluoroalkyl substances (PFAS) are organofluorine compounds has been manufactured for more than five decades and used in different purposes. Among persistent organic pollutants, PFAS are toxic, bioaccumulative in humans, wildlife, and global environment. As per environmental protection agency (EPA) guidelines, the perfluorooctanoate and perfluorooctane sulfonate permissible limit was 0.07ng/L in drinking water. When the concentration exceeds the acceptable limit, it has negative consequences for humans. In such a case, PFAS monitoring is critical, and a quick detection technique are highly needed. Health departments and regulatory agencies have interests in monitoring of PFAS presences and exposures. For the detection of PFAS, numerous highly precise and sensitive chromatographic methods are available. However, the drawbacks of analytical techniques include timely sample preparations and the lack of on-site applicability. As a result, there is an increasing demand for simple sensor systems for monitoring of PFAS in real field samples. In this review, we first describe the sample pre-treatment and analytical techniques for the detection of PFAS. Second, we broadly discussed available sensor system for the quantification of PFAS in different filed samples. Finally, future trends in PFASs sensor are also presented.

Nutritional Status of Iodine in a Group of Pregnant Women from the State of Minas Gerais Correlated with Neonatal Thyroid Function.

To evaluate the iodine sufficiency of pregnant women assisted in a University Hospital of Minas Gerais, and to correlate the urinary concentrations of maternal iodine with the fetal thyroid hormone levels at birth. Urinary iodine concentrations from 30 pregnant women with a singleton pregnancy and gestational age lower than 20 weeks were analyzed. Occasional samples of the mothers' urine were collected for the urinary iodine concentration dosage, and these were correlated with the newborns' thyroid-stimulating hormone (TSH) levels. The median iodine urinary concentration of this study's pregnant women population was 216.73 mcg/l, which is proper for the group, following the World Health Organization (WHO). No cases of neonatal hypothyroidism were reported in the study, which corroborates the iodine sufficiency in this population sample. This study shows that despite the increased demand for iodine from pregnant women and the Brazilian Health Regulatory Agency (ANVISA) recommendation of 2013 for reduction of salt iodization levels, the population of pregnant women attended in the prenatal ambulatory of normal risk from the Federal University of Minas Gerais is considered sufficient in iodine. As a higher sample is necessary for the confirmation of these findings, it is too early to recommend the universal supplementation of iodine for Brazilian pregnant women, and more studies must be carried out, considering that iodine supplementation for pregnant women in an area of iodine sufficiency is associated to the risks of the fetus's excessive exposure to iodine.

VALIDATION OF LONGER FRESH STORAGE TIME FOR PERIPHERAL BLOOD STEM CELLS INTENDED FOR CLINICAL USE

Peripheral blood stem cells (PBSC) storage conditions may influence cell quality and/or functionality, which may directly impact recipients'clinical outcomes. Thus, the Brazilian Health Regulatory Agency (ANVISA) demands validation of fresh storage times greater than 48 (forty-eight) hours, with technical-scientific evidence about the quality and safety of the product. The aim of this study was to verify the effects of longer fresh storage times in the viability and functionality of PBSC intended for Hematopoietic Progenitor Cells (HPC) transplantation. Ten aliquots of PBSC units were analyzed. The samples were storage fresh at 2°C to 8°C. Measurements were performed immediately (I) and 72 h after PBSC collection storage (AS), by flow cytometry analysis and clonogenic assays. CD45+ and CD34+ cells viability, white blood cells (WBC) counts and CD34+ cell concentrations and colony forming units (CFU) were evaluated. All clonogenic assays were performed in duplicate with 1 × 10 4 cells/mL. The results of these assays were expressed as the arithmetical mean of the duplicates. A descriptive analysis and T-dependent test were performed (SPSS 15 software). : According to the in-process controls, the median interval between the end of collection and temporary storage was 72 hours, with the maximum time being 91 hours and 48 minutes and the minimum storage time being 69 hours and 25 minutes. This variation in storage time is due to the end time of some collections that were longer than the laboratory's operating hours, so the samples had to be analyzed within the possibilities of the routine. Median viability of CD34+ cells immediately after collection was 100%, minimum viability was 98.8%, so all cases were in compliance with the laboratory quality indicator target. The median viability of CD34+ cells after fresh storage was 99.75%. There were two cases with viability below 98%, and the minimum viability was 97.1%. The average loss of viability of CD34+ cells in relation to the mean obtained in fresh samples was 0.66%. One case had a 2.99% loss of viability. Despite the significantly decreased CD45+ cells viability after storage (I: 98,3%; AS: 90,4%; p =< 0,0001), no significative changes were noted in CD34+ cell viability (I: 100%; AS: 99,75%), as well as in WBC (I: 248350/μl; AS: 242705/μl) and CD34+ cells (I: 5,24 × 10 6 /kg; AS: 4,67 × 10 6 /kg) concentrations. Moreover, no significant decrease in colony-forming unit numbers was observed in units stored for 72 hours (I: 34,5; AS: 21,5). Despite the significant decrease in CD45+ cell viability after 72 hours storage, no significant changes were observed in CD34+ cell viability, as well as in WBC and CD34+ cell concentrations in the same period. These results are reinforced by the functional assays, in which no significant decrease in colony-forming unit numbers was observed and it also demonstrated that the cells maintain their proliferation and differentiation potential. These results lead to the assumption that the fresh storage time of 72 hours had no significative impact in variables of concern (CD34+ cells and clonogenic assays) and thus does not impact the quality and safety of the product. Nonetheless, despite the strong recommendation of infusing fresh graft as soon as possible, our data suggest that, when necessary, it is safe to use PBSC until 72h after collection.

DIVERSIDADE GENÉTICA ENTRE GENÓTIPOS DE MELÃO-DE-SÃO-CAETANO ACESSADA POR VARIÁVEIS MORFOAGRONÔMICAS

ABSTRACT Bitter melon (Momordica charantia L.) is a plant species recommended by the Brazilian Health Regulatory Agency (Anvisa) as hypoglycemiant. The characterization of plants is an essential step in any breeding program. The objective of the present work was to organize and characterize a bitter melon germplasm collection, based on morpho-agronomic characters, to assess its genetic diversity and identify genotypes of agronomic interest. Eighty-eight genotypes were characterized for 38 descriptors. Redundant descriptors were identified through Principal Component Analysis (PCA); after their exclusions, a new PCA was carried out to verify the dispersion among the genotypes. Groups in the PCA were defined using the kmeans clustering method. The groups were studied for phenotype pattern using radar chart. Populational diversity was estimated through Shannon and Pielou indexes. Intra group diversity was estimated through analysis of similarity (anosim). The relative importance of variables for diversity was also estimated. Seventeen variables were redundant. The genotypes were grouped into 5 groups. Groups G1 and G5 were antagonist regarding fruit and seed productions and fruit, leaf, and seed sizes. A trend of decrease in fruit, leaf, and seed sizes was found in groups from G1 to G5. The diversity was high. Intra group diversity was high among small fruit genotypes, and low for medium-sized fruit genotypes. The variable number of male flowers (NMFL) was identified as that presented the greatest contribution to estimation of diversity. The genotypes UFRRJ MSC072, 042, 028, and 087 stood out with the highest number of fruits produced.

Discrepancies Between the Cost of Advanced Lung Cancer Treatment and How Much Is Reimbursed by the Brazilian Public Healthcare System

ObjectiveLung cancer is the leading cause of cancer-related death worldwide, and most patients are diagnosed of advanced disease. Molecular-targeted therapy and immunotherapy increase survival among these patients. In this study, we compared the cost of the best treatments available with the amount reimbursed by the Brazilian public healthcare system (Sistema Único de Saúde [SUS]) to treat advanced lung cancer. MethodsThe authors divided lung cancer into 10 subtypes according to histology and molecular profile. A panel of experts defined the best treatment sequencing for each subtype. The authors considered only drug costs retrieved from the Brazilian Health Regulatory Agency official data. The progression-free survival of each regimen was considered as treatment duration. The cost estimate included all postprogression therapies weighted by each subtype proportional frequency. The amount reimbursed by SUS was the sum of the monthly budget accumulated during the estimated treatment duration and then for the proportional frequency of each subtype. ResultsThe budget reimbursed by SUS for treating each advanced lung cancer case in Brazil is R$8000.00 in average whereas the cost estimate for the best treatment available is R$729 454.00 per case, which represents a difference of 9118%. The budget impact to ensure the reimbursement needed to acquire the best treatments available was estimated in near R$13 billion annually. ConclusionsThe cost estimate of the best treatment available for advanced lung cancer in Brazil is much higher than the amount reimbursed by SUS. This budgetary gap leads to a major access barrier that may compromise the survival outcomes of SUS users.

Examples of Outcome Reporting Bias in Vaccine Studies: Illustrating How Perpetuating Medical Consensus Can Impede Progress in Public Health.

Introduction: Outcome reporting bias in vaccine studies is a widespread problem among all researchers who have a tendency to report selective results and conclusions that support their beliefs and values or those of sponsoring agencies. Especially during the COVID-19 pandemic, this bias surfaced through the unprecedented proliferation of conflicting vaccine studies. Many researchers strongly recommend and report on the safety and effectiveness of the COVID-19 vaccine. Those researchers who embrace the COVID-19 vaccine and vaccines, in general, are often dismissive of other researchers who present views that differ from medical orthodoxy and oppose medical consensus.Methods: The aim of this analysis is to critically evaluate seven vaccine studies using qualitative and/or quantitative approaches to identify outcome reporting bias and assess its potential impact on the stated conclusions that align with medical consensus. Four studies claim to have found no association between autism and (a) blood levels of mercury, (b) measles, mumps, and rubella (MMR) vaccine, and (c) thimerosal-containing vaccines. Three other studies claim no association exists between infant mortality rate and the number of vaccine doses, universal varicella vaccination and herpes zoster, and pandemic influenza vaccines and fetal losses.Results: The presence of outcome reporting bias and independent reanalysis demonstrated an impact on both the direction and magnitude of the observed effect - raising questions concerning the robustness of the original study design and conclusions and challenging the current medical consensus. Medical consensus has exonerated vaccines as having any causal relationship to autism spectrum disorders (ASDs), yet no other reasonable cause has been proposed. Medical consensus attributes significant ASD increases to better case ascertainment and broadened clinical diagnosis. According to 2018 data, an estimated 1 in 44 eight-year-olds has been identified with ASD. From 1990 to 2019, there have been an estimated two million new cases of ASD in the US, with lifetime social costs exceeding $7 trillion (in 2019 dollars). Can perpetuating medical consensus impede the advancement of public health? Or has it already done so?Conclusions: Conflicts of interest (e.g., financial) that abound between health regulatory agencies and the pharmaceutical industry impact what is ultimately reckoned as medical consensus. Outcome reporting bias that is inherent to all researchers to some degree, obscures medical and scientific truth. Advancement of public health requires that researchers have integrity and an openness and willingness to collaborate to resolve contradictory findings. In fact, it is usually through meticulous, rigorous, scientific investigation of contradictory findings that medical science has advanced and contributed to improvements in public health - since medical consensus and orthodoxy can be incorrect.

Women’s contribution to medicine in Bahrain: leadership and workforce

BackgroundWomen make up a significant proportion of workforce in healthcare. However, they remain underrepresented in leadership positions relating to healthcare for a multitude of reasons: balancing personal and work duties, favoritism toward men, lack of support from colleagues and mentors, as well as other factors. This study aims to recognize the contribution made by women in the Bahraini healthcare sector by determining the gender distribution in Bahrain’s medical schools, government hospitals, Ministry of Health, and National Health Regulatory Authority.MethodsData were collected from the Bahraini Ministry of Health, National Health Regulatory Authority, Salmaniya Medical Complex, King Hamad University Hospital, Bahrain Defence Force Royal Medical Services, the College of Medicine and Medical Sciences in the Arabian Gulf University, and the Royal College of Surgeons in Ireland-Bahrain. Only physicians who held a Bachelor of Medicine and Surgery and a valid license to practice from NHRA were eligible to participate. Descriptive statistics were used to derive the frequencies and percentages of physicians with the following leadership positions: (1) top administrative positions (e.g., Chief executive officer); (2) heads of departments; (3) heads of committees; and (4) academic positions (e.g., Professor). Data were also collected from the two medical schools in Bahrain to see the trend in female enrollment into medical schools since 2004.ResultsThe results of the study indicated that leadership positions were mostly held by males in Bahrain (59.4% vs. 40.6%). However, Bahraini males and females equally dominated academic positions. Male physicians also dominated surgical specialties; however, female Bahraini physicians slightly surpassed male Bahraini physicians at the specialist and consultant levels (female to male: 11.9% vs. 10.4% and 33.2% vs. 30.4%, respectively). Furthermore, more females were reported to have general licenses. A trend analysis since 2004 showed that female medical students’ representation was higher than males over the years.ConclusionsThis study highlights the increasing trend of women’s participation and contribution to medicine in Bahrain. The data indicated continued growth in the number of female medical students and physicians. As such, it is likely that females will have a bigger impact on healthcare in the future with potential to hold more leadership positions in Bahrain.

1320MO New oncologic drugs since 2010: Differences in approval and access between the United States, Europe and Brazil

Progress in cancer treatment happen, partly, as a result of the creation of new anticancer drugs (ACD). New ACDs with novel mechanisms of action were developed by the discovery of new targets or different ways to block them, yet access to these drugs is uneven across different countries. Our objective is to compare the new ACDs approved since 2010 by the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Brazilian Health Regulatory Agency (ANVISA).

Boron nitride nanotubes for extraction of angiotensin receptor blockers from human plasma

The limitations of silica-based sorbents boosted the development of new extraction phases. In this study, boron nitride nanotubes functionalized with octadecyl groups were used for the first time as sorbent for extraction of losartan and valsartan, the most used angiotensin receptor blockers in the clinical practice, from human plasma. The nanotubes were synthesized using the chemical vapor deposition technique, purified by acid treatment, functionalized with octadecylamine in a microwave reactor, and characterized by different techniques. The functionalized nanotubes were packed in solid phase extraction cartridges. Extraction conditions were optimized by means of a 23 factorial design with center points. The separation was performed on a biphenyl core-shell (100 × 4.6 mm; 2.6 µm) column, using 0.1 % (v/v) triethylamine solution and methanol (pH 3.2) as mobile phase, at 0.7 mL/min, in gradient elution. The injection volume was 10 µL and fluorescence detection was performed at excitation and emission wavelengths of 250 and 375 nm, respectively. The developed method was validated according to Brazilian Health Regulatory Agency (ANVISA), United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA) guidelines and presented selectivity, precision, accuracy, and linearity in the concentration ranges of 50–1200 ng/mL for losartan and 20–1700 ng/mL for valsartan. Recoveries higher than 80 % were obtained. The method was fit for the quantification of losartan in plasma samples from patients under antihypertensive therapy, being useful in therapeutic drug monitoring, pharmacokinetics and bioequivalence studies.

“Penciclovir”

“Penciclovir”

The impact of stress and its influencing factors among dentists during the COVID-19 pandemic in Kingdom of Bahrain

Background: It is well known that all medical professions are linked to work stress, including dentistry, which is seen as facing high risk due to the nature of the job, especially the working conditions. This study aimed to assess the impact of stress and its influencing factors among dentists during the coronavirus disease 2019 (COVID-19) pandemic in Bahrain. Methods: A cross-sectional survey was designed to assess the impact of stress and its influencing factors among Bahraini dentists. A total of 306 participants were randomly selected from 1489 registered professionals in the NHRA (National Health Regulatory Authority Bahrain). Results: Out of 306 participants invited in the survey, 253 responded. Overall, the participants reported moderate stress. All the variables of the study showed different effects, but the highest stressor with a strong correlation was “fear of social isolation” (FI) at the significance level of 0.01 (β= 0.393, t= 5.090, p &lt; 0.05= (0.000) with f2 = 0.201 above 0.15 and less than 0.35, which was considered as a moderate effect size of approximately (20%), which strongly supported the hypothesis that researchers have proposed. Overall, the total effect for all stressors was 30 % which was considered as a moderate effect size. All hypotheses were supported except Burden of caring for patients → OUTCOME due to insufficient evidence. R² values of independent variables were above 95% for the variance of dentists’ outcomes, which is considered an excellent fit to the data as evidenced by the squared multiple correlations (R2 ) values for the dependent variables. Conclusions: The study is unique based on its findings that reveal the impact of stress among dentists. Moreover, the results of this study may serve as guidance for future monitoring of dental practitioners’ burnout, anxiety, and workload.

COVID-19 Vaccines and Roles of the Health Regulatory Authority in Tunisia.

Given the unstoppable spread of coronavirus disease (COVID-19), the development of a vaccine was needed to contain the pandemic. In such a situation of global emergency, regulatory authorities ensured timely, safe, and equitable access to the vaccine.This article aims to outline the roles of the Tunisian regulatory authority, the Directorate of Pharmacy and Medicines (DPM) at the Ministry of Health, in registration and procurement of the COVID-19 vaccine.Requirement to grant the Exceptional Provisional Authorizations of Marketing (EPAM) for COVID-19 vaccines was 27 days versus 869 days for conventional marketing authorizations (MAs). The DPM has optimized its activity through: early dialogue with manufacturers, online submission, the use of distance communication technologies. It has demonstrated unprecedented flexibility through the continuous and rolling review approach.Regulatory authorities in Tunisia and around the world have partnered with manufacturers to speed up administrative procedures while ensuring the quality, safety, and efficacy of vaccines.

Development of Consensus-Based Recommendations to Prevent/Minimize Medication Errors in the Perioperative Care of Patients with Epilepsy: A Mixed-Method

This study explored medication errors in the perioperative care of patients with epilepsy and developed consensus-based recommendations to prevent/minimize these errors. A mixed method was used in this study. Medication error situations were explored in semi-structured in-depth interviews with nurses (n=12), anesthesiologists (n=5), anesthesia technicians (n=5), surgeons (n=4), neurologists (n=4), and patients with epilepsy (n=10). The qualitative data were analyzed using the qualitative interpretive description approach. A two-round Delphi technique was used among nurses (n=22), anesthesiologists (n=9), anesthesia technicians (n=7), surgeons (n=7), and neurologists (n=5). A total of 1400minutes of interview time was analyzed in this study. Of the panelists, 39 (78.0%) agreed that patients with epilepsy present unique challenges to providers of perioperative care that make them prone to medication errors. The interviewees in this study described 32 different medication error situations that occurred while providing perioperative care services to patients with epilepsy. In this study, 35 consensus-based recommendations to prevent/minimize medication errors in the perioperative care of patients with epilepsy were developed. The findings of this study are informative to decision-makers in health care facilities and other stakeholders in health regulatory authorities who need to design measures to prevent/minimize medication errors and improve perioperative outcomes of patients with epilepsy. Studies are needed to investigate if these recommendations can be effective in preventing/reducing medication errors in the perioperative care of patients with epilepsy.

Using Twitter data to understand public perceptions of approved versus off-label use for COVID-19-related medications.

ObjectiveUnderstanding public discourse on emergency use of unproven therapeutics is essential to monitor safe use and combat misinformation. We developed a natural language processing (NLP)-based pipeline to understand public perceptions of and stances on COVID-19-related drugs on Twitter across time.MethodsThis retrospective study included 609,189 US-based tweets between January 29th, 2020 and November 30th, 2021 on four drugs that gained wide public attention during the COVID-19 pandemic: 1) Hydroxychloroquine and Ivermectin, drug therapies with anecdotal evidence; and 2) Molnupiravir and Remdesivir, FDA-approved treatment options for eligible patients. Time-trend analysis was used to understand the popularity and related events. Content and demographic analyses were conducted to explore potential rationales of people’s stances on each drug.ResultsTime-trend analysis revealed that Hydroxychloroquine and Ivermectin received much more discussion than Molnupiravir and Remdesivir, particularly during COVID-19 surges. Hydroxychloroquine and Ivermectin were highly politicized, related to conspiracy theories, hearsay, celebrity effects, etc. The distribution of stance between the two major US political parties was significantly different (p < 0.001); Republicans were much more likely to support Hydroxychloroquine (+55%) and Ivermectin (+30%) than Democrats. People with healthcare backgrounds tended to oppose Hydroxychloroquine (+7%) more than the general population; in contrast, the general population was more likely to support Ivermectin (+14%).ConclusionOur study found that social media users with have different perceptions and stances on off-label versus FDA-authorized drug use across different stages of COVID-19, indicating that health systems, regulatory agencies, and policymakers should design “targeted” strategies to monitor and reduce misinformation for promoting safe drug use. Our analysis pipeline and stance detection models are made public at https://github.com/ningkko/COVID-drug.

Dose response and risk assessment: Evolutionary foundations

The present paper indicates that the origin of the LNT concept for ionizing radiation was based on insufficient understanding of evolution, which precluded the possibility of repair of gene mutation. The denial of such repair processes had important implications, leading to a belief in a linear dose response and thus in Hermann J Muller's proclamation of a Proportionality Rule for ionizing radiation. The paper documents how the lack of repair concept dominated the radiation geneticist community to the 1960s leading to the establishment of the linear no threshold dose response (LNT) model for radiation and chemical reproductive and cancer risk assessment. Research from the late 1950s onward would establish the occurrence, generality, and efficacy of genetic and cellular repair processes. While the assumption of a lack of gene mutation repair was wrong, Muller was correct that dose-response concepts need to be founded on mechanistic understandings of evolution. Such mechanisms require the integration of constitutive and inducible adaptive and repair mechanisms that operate in the low-dose zone. This perspective reflects the comment of Dobzhansky (1973) that “nothing makes sense in biology except in light of evolution.” While this is a powerful scientific dictum, it assumes a correct understanding of evolution, something that the origins of the LNT dose response lacked. Such modern mechanistic repair developments reveal that the historical foundations of LNT were flawed from the start. Nonetheless, they have been carried forward to the present time, principally by environmental health regulatory agencies that decoupled risk assessment policy from a sound evolutionary foundation.