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The new coronavirus disease 2019 (COVID-19) has spread swiftly globally. People were in danger of infection and psychological stress as a result of the pandemic. Due to the shutdown of schools, the academic calendars of educational institutions were thrown off. The effects of COVID-19 on the academic performance and psychological well-being of college students were investigated in this paper. A proportionate stratified random sampling procedure was used to select students from the Seventh-day Adventist College of Education in Agona-Ashanti for the study. Data was collected using a questionnaire that included the 7-item Generalized Anxiety Disorder Scale (GAD-7). We found that following the temporary shutdown of schools, students’ test scores did not alter much. Mild anxiety was reported by 32.8% of respondents, moderate anxiety by 17.7%, and severe anxiety by 6.1%. Gender and family financial stability were found to be protective factors against anxiety in students. However, having an associate who contracted COVID-19, as well as the location of the student community and the people students stayed with, were not risk factors for increased anxiety. In correlation analysis, economic influence, effects on everyday living, academic delays, and effects on social support were all found to be negatively associated with anxiety symptoms. Furthermore, being concerned about academic delays had a minor effect on students’ anxiety symptoms. The government and college authorities should work together to provide counselling services to students to reduce the psychological effects of pandemics on students.

The Human Monkeypox virus has received significant research interest in recent times. While few researchers have studied the effects of vaccination on human-to-animal or animal-to-human Monkeypox transmission, others just studied the effects of treatment on human Monkeypox. In this article, we made the proposition of a deterministic vaccine model that deals with the dynamics of the effects of vaccination and treatment on human Monkeypox in sub-Saharan Africa. We investigated the effects of vaccination on the various epidemiological classes qualitatively. The findings from the analysis of the model are that the model possesses two equilibria, locally asymptotically stable disease-free equilibrium (DFE) when an epidemiological threshold - the effective reproductive number is less than unity, and locally asymptotically stable endemic equilibrium when the number is greater than unity. We then corroborated the theoretical findings with numerical simulations, which reveal that when the rate of vaccination is increased resulting in many newly born persons in the populace being vaccinated, the prevalence of the deadly scourge is significantly reduced, while newly born individuals that miss vaccination experience a drastic torment of the deadly disease that often occasion death. Further revelation from the simulations is that when greater efforts is geared towards vaccination of individuals in the population, the loss of more people to the scourge of the virus would be greatly reduced.

AbstractThe spread of the novel coronavirus disease (COVID-19) has caused disruptions in the academic calendars of educational institutions. Globally, countries temporarily closed their schools as a measure to curb the spread of the virus. Students resorted to online lectures to continue their education. This article examined the challenges faced by college of education students during their online studies. Using a proportionate stratified random sampling procedure, students from the Seventh-day Adventist College of Education, Agona-Ashanti, were sampled for the study. A questionnaire was used as the instrument for data collection. Data was analyzed using IBM SPSS (version 25). The results show that slow internet speed, high cost of data, poor mobile network coverage and insufficient data were the major internet connectivity challenges students faced during the online studies. The Mann-Whitney and Kruskal-Wallis tests showed that gender and programme of study significantly influenced students’ participation in the online lectures (p˂.05) but the location (rural, urban and peri-urban) of the communities of students and level of education did not significantly impact students’ participation in the online lectures (p˃.05). A majority of the students perceived that COVID-19 negatively affected their studies. The government and telecommunication companies should work together to improve communication and internet services in the country to facilitate online studies.

Background: Adverse drug/device reactions (ADRs) can result in severe patient harm. We define very serious ADRs as being associated with severe toxicity, as measured on the Common Toxicity Criteria Adverse Events (CTCAE)) scale, following use of drugs or devices with large sales, large financial settlements, and large numbers of injured persons. We report on impacts on patients, clinicians, and manufacturers following very serious ADR reporting., Methods: We reviewed clinician identified very serious ADRs published between 1997 and 2019. Drugs and devices associated with reports of very serious ADRs were identified. Included drugs or devices had market removal discussed at Food and Drug Advisory (FDA) Advisory Committee meetings, were published by clinicians, had sales > $1 billion, were associated with CTCAE Grade 4 or 5 toxicity effects, and had either >$1 billion in settlements or >1,000 injured patients. Data sources included journals, Congressional transcripts, and news reports. We reviewed data on: 1) timing of ADR reports, Boxed warnings, and product withdrawals, and 2) patient, clinician, and manufacturer impacts. Binomial analysis was used to compare sales pre- and post-FDA Advisory Committee meetings., Findings: Twenty very serious ADRs involved fifteen drugs and one device. Legal settlements totaled $38.4 billion for 753,900 injured persons. Eleven of 18 clinicians (61%) reported harms, including verbal threats from manufacturer (five) and loss of a faculty position (one). Annual sales decreased 94% from $29.1 billion pre-FDA meeting to $4.9 billion afterwards ( p <0.0018). Manufacturers of four drugs paid $1.7 billion total in criminal fines for failing to inform the FDA and physicians about very serious ADRs. Following FDA approval, the median time to ADR reporting was 7.5 years (Interquartile range 3,13 years). Twelve drugs received Box warnings and one drug received a warning (median, 7.5 years following ADR reporting (IQR 5,11 years). Six drugs and 1 device were withdrawn from marketing (median, 5 years after ADR reporting (IQR 4,6 years))., Interpretation: Because very serious ADRs impacts are so large, policy makers should consider developing independently funded pharmacovigilance centers of excellence to assist with clinician investigations., Funding: This work received support from the National Cancer Institute (1R01 CA102713 (CLB), https://www.nih.gov/about-nih/what-we-do/nih-almanac/national-cancer-institute-nci; and two Pilot Project grants from the American Cancer Society's Institutional Grant Award to the University of South Carolina (IRG-13-043-01) https://www.cancer.org/ (SH; BS)., Competing Interests: Dr. Sartor reports grants and personal fees from AAA, personal fees from ASTELLAS, grants and personal fees from ASTRAZENECA, grants and personal fees from BAYER, personal fees from BLUE EARTH DIAGNOSTICS, INC., personal fees from EMD SERONO, grants and personal fees from ENDOCYTE, personal fees from PFIZER, grants and personal fees from PROGENICS, grants and personal fees from SANOFI, grants from INVITAE, grants and personal fees from MERCK, grants and personal fees from NOVARTIS, grants and personal fees from JANSSEN, personal fees from CONSTELLATION, personal fees from DENDREON, personal fees from BRISTOL-MYERS SQUIBB, grants from INNOCRIN, grants from SOTIO, other from NRG, other from NCI, personal fees from BRAVARIN NORDIC, personal fees from CLOVIS, personal fees from MYRIAD, personal fees from NORIA THERAPEUTICS, INC., personal fees from NOXOPHARM, personal fees from POINT BIOPHARMA, personal fees from TENEBIO, personal fees from THERAGNOSTICS, personal fees from TELIX, personal fees from CLARITY PHARMACUEITCALS, personal fees from Celegne, personal fees from FUSION, personal fees from ISOTOPEN TECHNOLOGIEN MEUNCHEN, during the conduct of the study. All other authors report no conflict., (© 2020 The Author(s).)

Biosimilar filgrastims are primarily indicated for chemotherapy-induced neutropenia prevention. They are less expensive formulations of branded filgrastim, and biosimilar filgrastim was the first biosimilar oncology drug administered in European Union (EU) countries, Japan, and the U.S. Fourteen biosimilar filgrastims have been marketed in EU countries, Japan, the U.S., and Canada since 2008, 2012, 2015, and 2016, respectively. We reviewed experiences and policies for biosimilar filgrastim markets in EU countries and Japan, where uptake has been rapid, and in the U.S. and Canada, where experience is rapidly emerging. U.S. regulations for designating biosimilar interchangeability are under development, and such regulations have not been developed in most other countries. Pharmaceutical substitution is allowed for new filgrastim starts in some EU countries and in Canada, but not Japan and the U.S. In EU countries, biosimilar adoption is facilitated with favorable hospital tender offers. U.S. adoption is reportedly 24%, while the second filgrastim biosimilar is priced 30% lower than branded filgrastim and 20% lower than the first biosimilar filgrastim approved by the U.S. Food and Drug Administration. Utilization is about 60% in EU countries, where biosimilar filgrastim is marketed at a 30%-40% discount. In Japan, biosimilar filgrastim utilization is 45%, primarily because of 35% discounts negotiated by Central Insurance and hospital-only markets. Overall, biosimilar filgrastim adoption barriers are small in many EU countries and Japan and are diminishing in Canada in the U.S. Policies facilitating improved U.S. adoption of biosimilar filgrastim, based on positive experiences in EU countries and Japan, including favorable insurance coverage; larger price discount relative to reference filgrastim pricing; closing of the "rebate trap" with transparent pricing information; formal educational efforts of patients, physicians, caregivers, and providers; and allowance of pharmaceutical substitution of biosimilar versus reference filgrastim, should be considered. IMPLICATIONS FOR PRACTICE: We reviewed experiences and policies for biosimilar filgrastims in Europe, Japan, Canada, and the U.S. Postmarketing harmonization of regulatory policies for biosimilar filgrastims has not occurred. Acceptance of biosimilar filgrastims for branded filgrastim, increasing in the U.S. and in Canada, is commonplace in Japan and Europe. In the U.S., some factors, accepted in Europe or Japan, could improve uptake, including acceptance of biosimilars as safe and effective; larger cost savings, decreasing "rebate traps" where pharmaceutical benefit managers support branded filgrastim, decreased use of patent litigation/challenges, and allowing pharmacists to routinely substitute biosimilar for branded filgrastim., Competing Interests: Disclosures of potential conflicts of interest may be found at the end of this article., (© AlphaMed Press 2019.)