Incidents of bullying have increased on students in schools. This has a negative impact such as mental health problems and risk of suicide. Interventions related to bullying are still focused on being carried out independently. Meanwhile, collaborative interventions between nurses and the school are needed to acquire maximum results in preventing and reducing the incidence of bullying. The purpose of this study is to describe school-based nursing interventions in preventing and reducing the incidence of bullying among students at school. This study used scoping review with a search strategy using the PRISMA Extension for Scoping Review process to find the articles. The PubMed, CINAHL, and Scopus electronic databases were searched. We found 12 articles from 594 articles in 3 databases which discussed nursing interventions based on school to prevent and reduce incidence of bullying in students. The studies included are design randomized control trials and quasi experiments. The samples with the range of 40–7121 respondents. We classified the school-based nursing interventions being three methods, there are Game programs, physical activity programs, training programs, and peer-group programs. The content of interventions are psychoeducation, empathy training, counseling, and self-management. This study shows that school-based nursing interventions can be an option in preventing and reducing the incidence of bullying among students at school. Prevalence of bullying on students increased every year. A survey conducted by Latitude News of 40 countries revealed cases of bullying and made Indonesia in second place after Japan with frequent cases of bullying, followed by Canada, South Korea, US and Finland . In 2016Bullying is when someone repeatedly and on purpose says or does mean or hurtful things to another person who has a hard time defending himself or herself . Other dThe negative impact of bullying on students was negative emotions such as anger, sadness, and revenge, which causes students to withdraw from the environment. In addition, the victim of cyberbullying have low self-esteem and be more sensitive of environmental responses . The worNurses as professional health workers can collaborate with schools. Nurses can carry out their roles as educators and advocates for children, youth, parents, teachers, and other communities related to actions and prevention efforts, as well as efforts to overcome bullying . Nurses Collaboration between nurses and the school is important to implement for preventing and reducing the impact of bullying on students at school. The results of previous studies showed that school-based nursing interventions can effectively raise student awareness about bullying . Other sSchool-based interventions involving nurses are important to prevent and reduce the impact of bullying on students at school. However, nurses and schools are still not exposed to information about collaborative interventions that can be carried out. Therefore, a scoping review is needed to describe school-based interventions carried out with nurses to prevent and reduce the impact of bullying on students at school.The design used in this study was scoping review. The aim of this method for discussing and exploring interesting topics and issues that are currently developing . ScopingThe articles used in this scoping review were obtained from the PubMed, CINAHL, and Scopus databases. The keywords used are: “school-based intervention OR school-based program” AND “nursing intervention OR nursing care” AND “student” AND “bullying” AND “prevent OR reduce impact”. The research question is what are the method of school-based nursing interventions to prevent and reduce the incidence of bullying among students at school?This study used the PRISMA Extension for Scoping Review (PRISM-ScR) to identify the types of interventions that can be carried out to prevent and reduce the incidence of bullying among students using school-based nursing interventions . This stData extractions were carried out by the authors to make it easier to analyze the results of the articles that have been reviewed. The data extraction process was carried out by creating a manual table. The aspects written in the extraction table were the author, year, country, research design, population and sample, procedures, interventions, and results of the study. The purpose of the authors to make an extraction table is to simplify the process of analyzing the results of the review to be used as a description of the results based on the classification of school-based nursing interventions.The authors evaluate the quality of the article used The Joanna Brigs Institute (JBI). The JBI assessment method is an instrument for measuring the quality level of articles based on the type of research. Assessment used the scoring method for each statement of the instrument and is given a value of yes, no, unclear, and not applicable. The score “yes” is given a value of 1, while the other scores are given a value of zero. The standard value of the article based on the JBI assessment for use in this study is above 75% based on the criteria and topic relevance.The articles were obtained by the authors based on the results of the selection of inclusion and exclusion criteria. Next the quality of the articles was assessed using the JBI method. The articles were then read in full and analyzed based on the extraction table by all authors. Next the authors performed data analysis with a descriptive approach. The results of data analysis are reported by classifying the results of school-based nursing interventions to prevent and reduce the negative impact of bullying on students at school.The number of articles obtained from the search database is 594 articles. After duplicating the collected articles, 521 articles were obtained. Furthermore, after elimination based on the inclusion criteria and after checking the title and abstract, 37 articles were found. We read full text and selection the articles based on exclusion criteria and relevance of topic based on purpose the study, and we found 12 articles to analyzed in this study. Authors used the JBI Critical Appraisal Tool assessment method to analyze the quality of articles and all authors gave the standard score of analyzed articles if it was above 75%, based on criteria and topic relevance .The authors wrote the review of articles in manual table to show the result of the study. The aspect in the table extraction is references, purpose, country, method, sample, intervention, and results. The analysis of the article in this study are presented as follow .There were 12 articles which discussed about school-based nursing interventions to prevent and reduce the negative impact of bullying on students in school. Most nursing interventions are carried out in developed countries . The range of samples is 40–7121 respondents. Most of the respondents came from London.This study showed that nurses and teachers need to work together for preventing and reducing the incidence of bullying in students. Nurses have the role to provide comprehensive nursing care from biological, psychological, sociological, and spiritual aspects. One of the roles of community nurses in the mental health aspect is school nurses who provide comprehensive school nursing care to improve the health of students and school employees including physical and psychological health. The role of nurses as educators to increase knowledge of bullying on students and increase student awareness of bullying incidents. Nurses also have a role as advocates to collaborate with teachers regarding policies in schools regarding bullying. In addition, nurses have a role as facilitators with teachers to guide and supervise activities carried out to prevent and reduce the impact of bullying on students. The role of the counselor as a nurse is carried out to overcome the impact of trauma experienced by students at school due to bullying in collaboration with teachers. Teachers as partners in schools form learning curricula to prevent bullying. The role of teachers and nurses is an important role to prevent and reduce the incidence of bullying in schools.The Authors have read and analyzed 12 articles, and we are classified the intervention in four methods, there were Game program, physical activity program, training program, and peer-group program. The explanation of each school-based nursing intervention method is as follows.The game program is a method of school-based nursing intervention by playing games with students at school. Collaborative Board Game is carried out for 5 weeks (1 h/session) . The nurThe SEHER program with games is a multi-component intervention that emphasizes the importance of a positive school climate, namely a supportive relationship between school members . Nurses Physical activity carried out together can increase a sense of concern for friends, so as to prevent bullying from happening to students. One method that can be carried out is Martial Arts Based Intervention carried out for 10 weeks for 50 min per week . The intACT OUT! Social Issue Theater Program is an education that is packaged through drama . ParticiTraining is an activity that is mostly carried out in school-based nursing interventions. The method used is in the form of Web-Enabled, School-Based, Preventive Intervention carried out for 10 sessions of 40 min/session . Nurses Multicomponent secondary school health promotion intervention was carried out for 4 weeks . Nurses SEHER program with education is an activity carried out for 10 weeks. This activity begins with holding workshops with all school officials, parents, and students regarding the activities to be carried out . Nurses Teaching Recovery Techniques (TRT) is a training activity conducted for 7 weeks . This acPragmatic school-based universal intervention is a training activity given to students for 8 weeks . Nurses Group activities are important to increase the sense of belonging to people. Learning Together intervention is a peer-group activity that discusses learning activities and also counseling on bullying issues . The nurThe Tutoría Entre Iguales Program (school-based intervention of peer-tutoring) is a group peer-support activity guided by a facilitator for 6 weeks . The nurThe results of this scoping review showed that school-based nursing interventions can prevent and reduce the incidence of bullying among students at school. The school-based nursing intervention methods used are game programs, physical activity programs, training programs, and peer-group programs. The activities carried out from each intervention were psychoeducation, empathy training, drama making, and peer-group.This study showed that bullying often occurs in adolescent students. Previous study have shown that bullying is more common in high school students than university students . PreviouImplementation of school-based nursing interventions is carried out in a range of 5–10 weeks. This was adjusted to the characteristics of the victims and the participants’ previous knowledge regarding bullying. Previous studies have shown that preventive interventions effective to reduce bullying behavior in students take 8 weeks ,44. BullThis study showed that incidence of bullying happened both in several developing and industrial countries. The number of incidents of bullying does not depend on the progress of a country . PreviouEfforts to prevent and overcome school-based bullying can be carried out through the Game program. Games therapy as a medium for bullying prevention are carried out by increasing student awareness regarding bullying and its effects . Nurses Bullying occurs because of a lack of student productivity in carrying out activities. School-based nursing interventions can be carried out to increase student productivity. Activities carried out in the form of theater exercises, physical activity training, and sports . The nurIncidents of bullying in students occur because of a lack of empathy for other students. Victims of bullying also find it difficult to come to terms with traumatic experiences because they have un-adaptive coping. Nurses and teachers have a role in improving students’ adaptive coping in response to stress. Teachers and nurses can carry out counseling to students or even form peer-support groups between students. A program is needed to train students’ abilities to improve coping, empathy, and problem solving . AdaptivSocial support is an important thing for victims of bullying to have. The impact experienced by victims of bullying is social isolation and feeling lonely. The existence of social support through peer support groups can increase the confidence of victims of bullying ,62. SchoSchool-based nursing interventions have an important role in preventing and reducing the impact of bullying on students. Nurses can provide comprehensive nursing care in collaboration with schools as educators, facilitators and counselors. Each program can be implemented to foster student self-confidence and awareness in students so they do not bully other students. In addition, interventions carried out by nurses can also reduce the impact of bullying such as stress, depression, and social isolation.The limitations in this study are the limited study design, namely randomized control trials and quasi experiments. Although the authors aim to obtain interventions that are accurate in preventing and reducing the impact of bullying, this study cannot discuss the results of other studies with more diverse designs. The time of publication of the articles used as literature to be reviewed in this study is also limited to the last 10 years, so the authors cannot comprehensively discuss and compare interventions carried out in the present and in the past. In addition, the database in this study is limited to 3 databases, but this study cannot find other data to be a comparison of the study results obtained.The authors found 12 articles discussed about school-based nursing interventions for preventing and reducing the negative impact of bullying on students. This study showed that intervention carried out in collaboration between health workers and the school can optimize in reducing incidence of bullying. There are three methods used for providing school-based nursing interventions are through Game programs, physical activity programs, training programs, and peer-group programs. Activities undertaken include psychoeducation, empathy training, counseling, and self-management. Interventions also require a facilitator to support and accompany participants in carrying out each activity that has been determined. The implication of this study is being a basis for nurses to provide interventions to prevent and reduce the impact of bullying that occurs on students. Another implication that can be given is the existence of policy advice for schools and health services for reducing the negative impact and incidence of bullying. The suggestion for future research is needed the randomized control trial design to analyze the effectiveness of nursing interventions carried out with a family approach in reducing the negative effects of bullying.


Lyssavirus, the family Rhabdoviridae, is the causative agent of rabies, a contagious, deadly, and progressive neurological infection. This illness is commonly distributed worldwide and affects all warm-blooded animals. Regarding the zoonotic aspects of rabies, the prevalence of rabies was investigated in this study. Over 2 years, 188 samples were examined via the direct fluorescent antibody test (DFAT) and mouse inoculation test (MIT) techniques by using brain tissue samples. Our findings showed that 73.94% of samples were rabies positive. The highest number of samples belonged to cows and dogs, respectively. The positivity rate in cows was 71.88%, followed by dogs with a 57.78% infection rate. These findings suggested that despite the heavy monitoring protocols in Iran, rabies is still a prevalent disease, and it is advised that vaccinations and screening programs should be carried out more frequently with heavier observation.The rabies virus, which belongs to the genus  According to the International Committee on Taxonomy of Viruses (ICTV), rabies is caused by lyssaviruses, including the rabies virus and the Australian bat lyssavirus. It spreads when an infected animal (host) scratches or bites another animal or human . Rabies Unfortunately, rabies can only be diagnosed after symptoms appear. However, animal control and vaccination programs have reduced the risk of catching the disease from dogs in some regions. Thus, immunizing people before they are exposed is recommended for those at high risk, including those who work with bats or spend prolonged periods in areas of the world where rabies is common. In people who have been exposed to rabies, the rabies vaccine and sometimes rabies immunoglobulin are effective in preventing the acute disease if the person receives the treatment before the start of rabies symptoms . WashingThe Rabies Laboratory of the Pasteur Institute of Iran has been known as the national reference for rabies diagnosis since the beginning of rabies diagnostic tests in Iran. In addition, according to the national protocol, the major reference for diagnosing all suspected rabies samples in humans and domestic and wild animals is the Pasteur Institute of Iran. For example, an earlier study of rabies infection was conducted in 2015 [This study was conducted at the Shomal Pasteur Institute in the north of Iran, which is one of the four Pasteur research centers in Iran. This institute is mainly responsible for rabies monitoring across the whole country since its establishment, and the Shomal center covers the four provinces of Ardabil, Gilan, Golestan, and Mazandaran. Therefore, in this study, all suspicious samples from these provinces were considered.This experimental study was based on samples, which were received from four provinces of Iran  by the North Research Center of the Pasteur Institute of Iran in the city of Amol from March 2016 to March 2018 .Based on the protocol, the bitten domestic animals were quarantined for 15 days, and in case of rabies symptoms, they were euthanized. The brain samples were collected from suspected animals and packed in a vial containing 50% glycerin and 50% phosphate buffer saline (PBS) [Regarding wild animals, if they were trapped by veterinarians or environmental officers while showing bitten or any suspicious signs, they were first quarantined according to the same procedure, and if symptoms appeared, they were euthanized. The brain sample was sent to the laboratory. These wild animals act as a link (carrier) between wildlife and domestic animals. Furthermore, they can be the main carriers of the virus from its reservoir  to other animals.Smear preparation started by opening the received vials. A small piece (20–50 mg) of the brain was picked up with a tip and placed on a wooden spatula. An imprint of the sample was made by pressing a glass slide on the piece of the brain over the spatula. The smear was fixed in high-grade cold acetone. 0.1 ml of clarified anti-rabies nucleocapsid conjugate  was placed on the sample, and the sample was incubated at 37°C for 30 minutes. Following incubation, the smear was rinsed twice with distilled water after several minutes of being stored in PBS. The stained samples were then analyzed under a fluorescent microscope  for the presence of Negri bodies –17.μl of penicillin and 20 μl of streptomycin). Then, the skull of ten mice, 3–4 weeks old (12–14 grams), was injected with the suspension of 50 μl of the brain sample. The mice were anesthetized by ether before inoculation. For intracerebral inoculation, sterilized needles (27 and 26 gauges) were used. Next, the mice were observed daily for 28 days. Any deaths occurring during the first 4 days were regarded as nonspecific, and every dead mouse after the 4th day was considered positive, and the brain was obtained and sent for the DFAT examination [While a positive DFAT result indicates an infection, a negative result does not rule out the possibility of infection. Therefore, after microscopic observation of the negative samples, the brain tissues were prepared and the mouse inoculation test (MIT) was performed. The MIT was conducted by adding a clarified supernatant of a homogenate of the brain material in an isotonic buffered solution containing antibiotics , and the chi-square test [e levels , 22.In this study, 188 specimens were tested for rabies infection. Out of the 188 suspected wildlife specimens, 137 cases of rabies were confirmed as positive. Among these, the cow's brain tissue samples had the highest percentage, followed by dogs with 34 specimens, and the lowest proportion belonged to the horses, foxes, and camels with only one sample . JackalsComparing the samples regarding the provinces, the highest rate was in Gilan province with 86 cases, followed by Ardabil with 50 cases . Also, cThis study investigated the received samples from four provinces in the north of Iran, which consisted of ten different species. The samples were examined carefully and evaluated via the DFAT technique. After analyzing the data, it turned out that 72.87% of cases were rabies positive. Generally, animal bites can cause serious health problems , and expMost of the studied regions in this research are covered by forests and mountains, which have made it difficult to monitor rabies. In addition, all four provinces share a border with the neighboring countries of Iran, which makes it a lot harder to control animal reservoirs inside the country and decreases the possibility of controlling animals that travel between the borders. In order to control rabies and reduce human casualties, programs such as education of people and students, vaccination, and serum therapy of individuals and animals are among the most important, which, despite spending a lot of money, were not greatly successful in controlling the disease.An earlier study was also conducted on rabies epidemiology in northern Iran . As can Also, there are certain areas, where animals potentially could carry the virus , 27. TheThese results are consistently similar to those of the previous studies –41 Tabl. HoweverAccording to an earlier epidemiological study, rabies is an endemic infection in Iran, and it is a critical zoonotic disease. As was seen previously, the main transmitter of rabies is wolves. According to our findings, the incidences of rabies in animals and following humans are increasing annually. For example, more than 130000 people received postexposure prophylaxis in 2006 . Also, dNevertheless, we can hope for the eradication of rabies when either the virus is removed from animal reservoirs or animal bites are managed to be inhibited. According to our findings, a total of 96.28% of the samples sent to the laboratory by veterinary centers were of domestic animals and 77.35% of them were of cows, sheep, and goats. The major reason for this high number of farm animals among the suspected cases is the high amount of interaction between these animals and wild carriers. The other possible reason is that government supports livestock farmers to eliminate infected animals by paying compensation for preventing the entry of contaminated meat into the country's food cycle. Also, it should be noted that one of the reasons behind the low number of wild animal samples is the difficulty of tracking wild animals in remote areas.The wildlife spectrum in the northern provinces of Iran is diverse. Each region has some different carnivores. The infection of these animals with the rabies virus indicates the need for studying the density of these animals on the one hand and the need for immunization of these animals on the other hand. Countries are often attributed to low prioritization, epidemiological and operational constraints, and insufficient financial resources. Unfortunately, this was due to the lack of referral to health centers after exposure to an infected dog, which requires more information on prevention after an anomalous reminder. The disease is also prevalent in the countries of the region . FinallyThe findings of this study showed that Gilan, Ardebil, Mazandaran, and Golestan provinces had the highest rates of contamination, respectively. In the northern provinces, employing the control programs and the elimination of rabies can result in identifying the main hotspots. The findings of this study are supported by the fact that despite the wide range of annual measures against prevention, there is rabies currently. Unfortunately, the disease is still endemic with a high prevalence in Iran and is still one of the most important health challenges. It is suggested that control programs, such as vaccinations, especially in cows, and dogs, should be carried out with prophylaxis and increased community awareness of the disease to reduce and eliminate rabies disease.


Biologic-based medicines are used to treat a variety of diseases and account for around one-quarter of the worldwide pharmaceutical market. The use of biologic medications among cancer patients has resulted in substantial advancements in cancer treatment and supportive care. Biosimilar medications (or biosimilars) are very similar to the reference biologic drugs, although they are not identical. As patent protection for some of the most extensively used biologics begins to expire, biosimilars have the potential to enhance access and provide lower-cost options for cancer treatment. Initially, regulatory guidelines were set up in Europe in 2003, and the first biosimilar was approved in 2006 in Europe. Many countries, including the United States of America (USA), Canada, and Japan, have adopted Europe’s worldwide regulatory framework. The use of numerous biosimilars in the treatment and supportive care of cancer has been approved and, indeed, the count is set to climb in the future around the world. However, there are many challenges associated with biosimilars, such as cost, immunogenicity, lack of awareness, extrapolation of indications, and interchangeability. The purpose of this review is to provide an insight into biosimilars, which include various options available for oncology, and the associated adverse events. We compare the regulatory guidelines for biosimilars across the world, and also present the latest trends and challenges in medical oncology both now and in the future, which will assist healthcare professionals, payers, and patients in making informed decisions, increasing the acceptance of biosimilars in clinical practice, increasing accessibility, and speeding up the health and economic benefits associated with biosimilars. Biological therapeutic agents—or biologics—comprise a wide range of substances that are manufactured by cells or living organisms via various biological processes, such as controlled gene expression, antibody technologies, or recombinant DNA technologies . In rece®) was the first biosimilar approved in the USA in 2015. Moreover, in 2015, the FDA introduced the guidelines associated with biosimilars, addressing scientific and quality aspects in showing biosimilarity to the original product. The objective was to provide guidance about the FDA’s approach to determining biosimilarity and to assist in obtaining license for the market. Furthermore, in 2016 and 2018, the FDA issued guidance documents intended to address issues such as clinical pharmacological evidence to substantiate biosimilarity and labeling guidelines for inclusion in an application within section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)).The approach to managing and treating cancer using biological agents was initiated in 1980. The first biopharmaceutical was approved by the Food and Drug Administration (FDA) in June 1986, named Interferon alfa-2b ), which currently holds seven labels . SubsequThere are many bottlenecks that have prevented biosimilars from being completely accepted in the clinical practice to date. For instance, immunogenicity is the main concern of biosimilars, and these immune reactions tend to have side effects, with the majority of them impacting the product’s efficacy. Therefore, continuous monitoring of safety and efficacy is required in both the clinical trials and post-marketing phases . AnotherThis article’s main goal is to provide a complete summary of the biosimilars used in cancer in one place, covering the numerous biosimilar choices available to date, their respective regulatory requirements around the world, and the most common adverse events connected with them. Biosimilars’ primary advantages and disadvantages, in addition to their existing and future positions in medical oncology and the various associated challenges, are also addressed. This article will assist readers in understanding worldwide regulatory requirements and identifying regulatory loopholes, allowing authorities to alter their guidelines and streamline the clearance process while focusing on safety. We define recent patterns in the emergence of biosimilars in cancer, providing a full account of the different issues faced by pharmacovigilance experts, as well as recommendations for how to overcome them. Furthermore, this review aims to provide comprehensive knowledge about biosimilars for physicians, other healthcare professionals, payers, and patients to enable them to make informed decisions, as well as to boost biosimilars’ acceptance in clinical practice, increase their accessibility, and speed up the related health and economic benefits.In every country, cancer is a primary cause of death as well as a significant impediment to extending the average lifespan. By the end of 2020, an estimated 19.3 million new cancer cases (18.1 million excluding non-melanoma skin cancers) were diagnosed worldwide, with around 10.0 million cancer-related deaths (9.9 million excluding non-melanoma skin cancer). Breast cancer (BC) has surpassed lung cancer (11.4%) as the most frequently diagnosed malignancy among women, with an estimated 2.3 million new cases (11.7%), followed by colorectal (10.0%), prostate (7.3%), and stomach (5.6%) cancers. Lung cancer remained the most common cause of death from cancer, with a projected 1.8 million fatalities (18%), followed by colorectal (9.4%), hepatic (8.3%), gastric (7.7%), and women’s breast (6.9%) cancers. Overall, the incidence in both sexes was 2–3-fold higher in transitioned vs. transitional countries, whereas death was 2-fold higher for males and marginally higher for females. In contrast, cervical cancer and female BC death rates were substantially higher in transitioning countries than in transitioned regions . Due to demographic changes, the global burden of new cancer cases is predicted to reach 28.4 million cases in 2040, up 47% from 2020, with a greater increase in transitional countries (64–95%) versus transitioned countries (32–56%). However, increased risk factors connected with global competition and an expanding economy may worsen this impact. Efforts to develop a sustainable infrastructure for preventative measures against the spread of cancer, to reduce the financial burden of chemotherapy (CHM), and to provide cancer care in transitioning countries are critical for global cancer control .The most prevalent malignancies detected in males and females in 2021 are depicted in Cancer is more likely to occur as people get older; in the United States, 80% of all malignancies are diagnosed in people aged 55 years and older. Certain habits and other changeable variables—including obesity; smoking; alcohol consumption; viral infections such as human papillomavirus (HPV); specific chemicals such as aflatoxins, arsenic, asbestos, etc.; radiation exposure, including ultraviolet radiation from the Sun; and eating an unhealthy diet—are all contributing factors to the pathogenesis of cancer. An estimated 41 out of every 1000 males and 39 out of every 1000 females in the United States will be diagnosed with cancer at some point during their lives . HoweverSince the pathogenesis of each cancer is different, every type of cancer will require a different treatment plan. Moreover, an accurate cancer diagnosis is critical for suitable and effective treatment. Radiotherapy, CHM, and/or surgery are commonly used in the treatment of cancer. The first step in treatment is to figure out what we want to get out of it. The main objective of any cancer treatment is to either cure cancer or significantly extend the patient’s life. Another important purpose is to maximize patients’ quality of life. Support for the patient’s emotional, physical, and spiritual wellbeing, as well as palliative care in the latter stages of cancer, can help achieve this. Colorectal cancer, cervical cancer, BC, and oral cancer, for example, all have high functional recovery when detected early and treated properly. Even though cancerous cells are found in other parts of the body, several forms of cancer—including testicular seminoma and other forms of leukemia and lymphoma in adolescents—have good cure rates if adequate treatment is administered .The rising cost of cancer treatment is putting strain on national healthcare budgets, posing a threat to overall healthcare funding. The burden due to the increased cost of medicines and hospital charges continues to climb. As the prevalence of various cancers rises, cancer medications may be started earlier due to advances in early cancer identification, and treatment may be extended due to increased patient survival, further increasing the cost burden. Oncology spending increased by 15–22% in health plans from 2018 to 2019 . BiosimiThe patients are not able to pay the costs of treatment as healthcare expenses rise. Oncology biologics may cost more than USD 10,000 per month, which is nearly twice the US monthly average earnings . Due to Until the BPCIA was implemented in 2010, most biosimilars were unable to reach the market due to patent litigation. Biosimilars made up just under 2% of the entire biologics market in the United States in 2018. Both the number of FDA approvals and the use of biosimilars increased dramatically in 2019. Bevacizumab, trastuzumab, and rituximab were the top three biosimilars launched in 2019, with bevacizumab leading at 42%, followed by trastuzumab at 38% and rituximab at 20%, and their utilization is further rising . In compBiosimilars have been shown to save money in absolute terms, with higher savings from more recent launches when originators were more expensive, as depicted in For example, when a new product is compared to an existing standard treatment, the incremental cost-effectiveness ratio is defined as the ratio of the change in cost of a therapeutic intervention. The effect of switching interventions is referred to as incremental. The number of quality-adjusted life years (QALYs) gained by the intervention is frequently used to quantify the change in effects . This inThe economic analysis of biosimilars used in the treatment of cancer is still in its early stages around the world. However, the affordability and the cost-effectiveness of biosimilars used in oncology is actively supported by the minimal evidence available from developed nations, despite the fact that uptake and price discount rates are major factors .The use of drugs to counteract the side effects of cancer treatment is known as supportive cancer therapy. The first approved biosimilars in the European Union (EU) were supportive care therapies—filgrastim and epoetin alfa—in 2007. Many biosimilar development programs, such as those for rituximab, trastuzumab, and bevacizumab, have been launched since then. Filgrastim and epoetin are two biologic medications with considerable cancer-fighting benefits that have had their patents expire. Since 2007, the European Medicines Agency (EMA) has approved biosimilar variants of both in Europe. Using a general approach, this could expand accessibility to improve supportive patient care while also saving money, allowing the existing funding to be reassigned to new treatment areas . A numbeThe most important goal of health policy is to maintain the population’s health. Pharmaceutical therapy is the most prevalent medical treatment in modern healthcare systems. The efficacy of public health initiatives in improving the overall health of the population is strongly dependent on the performance of policies aimed at decreasing medicine prices and enhancing patient access . The WHOBiosimilars, like generic pharmaceuticals, may require an active strategy by payers to promote their use in order to receive the optimal returns for a health system. These could be in the form of payer directives, patient copayments, or physician gain-shares. Poland, Finland, Denmark, and the Netherlands have already developed national plans for moving to biosimilars. This endeavor is critical to consider now, because 9 of the world’s top 10 best-selling medications are set to lose patent protection in the next five years, with combined sales of more than USD 50 billion in 2011 . The cosBiosimilars will have a big impact in oncology on a global scale. The WHO’s model lists of essential medicines for children and adults represent medicines that are both cost-effective and vital to public health in all countries. The approval of biosimilars for filgrastim in places such as the EU, the United States, and Japan, as well as the patent expiration and anticipated impending arrival of biosimilars for trastuzumab and rituximab, has allowed all three medications to be added to the most recent WHO essential pharmaceuticals list. The WHO states that these pharmaceuticals should be available at all times in sufficient quantities and in acceptable dose forms, at a cost that the community can afford, which is critical to their inclusion in the essential drugs list .Regulatory agencies around the world—including the European Medicines Agency (EMA), the Food and Drug Administration (FDA), the Therapeutic Goods Administration (TGA) in Australia, and Health Canada in Canada—have approved a few biosimilars in the field of oncology . BiosimiThe majority of biosimilars have been marketed in Europe for various indications since 2006 for the management and treatment of cancer. The EMA is the decentralized regulatory authority in the European Union, whose framework for biosimilars is also followed by other countries. The first biosimilar approved under the EMA was Abseamed, produced by the marketing authorization holder Medice Arzneimittel Putter GmbH & Co. Kg, as depicted in BC, stomach cancer, CRC, and other malignancies can all be treated with biosimilars. They can also be used to treat cancer-related side effects such as decreased white blood cell counts, which raise the risk of infection. Various cancer-related biosimilars that have been approved globally are listed below.There are various indications associated with epoetin and its analogues, as mentioned in Filgrastim is a stimulating factor for recombinant granulocyte colonies that stimulates bone marrow for the synthesis of neutrophils. The main function of filgrastim is to facilitate the counts of peripheral blood neutrophils within a day, which further facilitate the counts of monocytes ,85. FilgRituximab was the first biosimilar monoclonal antibody, primarily authorized in Europe for oncological treatment . It is aIn 2017, the first biosimilar of trastuzumab was approved in Europe, known as Ontruzant; subsequently, the USA approved a biosimilar named Ogivri in late 2017. The indications of trastuzumab are distinctive; for example, Ontruzant can be utilized as a monotherapy or can be combined with other drugs in CHM for the management and treatment of human epidermal growth factor receptor 2 (HER2)-positive metastatic cancer, whilst Ogivri is indicated for the management and treatment of EBC, MGC, and MBC . Ogivri Bevacizumab was originally approved by the FDA in 2004 and utilized as a first-line treatment for metastatic CRC in combination with fluorouracil-based CHM; however, in 2017 and 2018, the FDA and EMA approved their first biosimilars of bevacizumab, named Mvasi and Avastin, respectively , as showA biosimilar of interferon named Roferon-A was originally approved in the USA for the management and treatment of hairy-cell leukemia, follicular n-HL, cutaneous T-cell lymphoma, chronic-phase Philadelphia-chromosome-positive myelogenous leukemia, advanced renal cell carcinoma, and stage II malignant melanoma. Interferons are a group of proteins that induce signaling processes and can be synthesized in the body in order to fight against infections such as viruses . HoweverThe rules and regulations of biosimilars are improving globally, particularly in the USA and Europe, in order to attain harmonization all over the world. There are a few main regulatory authorities, such as the EMA, FDA, and WHO, which have set up standards to determine the similarity between the reference products and biosimilars. Many regulatory agencies require comparative studies to evaluate the safety, quality, and efficacy of biosimilars in oncology. In comparison to the small-molecule drugs, biosimilars are more complex in nature, which makes them more subtle. The first regulatory authority to provide a framework for biosimilars was the EMA back in 2003, whereas the primary approval for such products was given in 2006. In 2009, the FDA standardized the specific guidelines for the approval of biosimilars . MoreoveAccording to the EMA guidelines, there is a streamlined approval process available for biosimilars that is based on preclinical and clinical studies that compare their efficacy, safety, and immunogenicity with the reference biological products . There mVarious studies are also required in the approval process, such as pharmacodynamic and pharmacokinetic data on the clinical efficacy of biosimilars, which are further evaluated by two or three groups of clinical potency and safety findings. Human studies are also required for the approval, involving the reference biological product, biosimilars, and a placebo. However, safety, immunogenicity, and efficacy can be determined by performing some specific comparative analyses. In the case of biopharmaceuticals , adverse events tend to occur after several years, so continuous surveillance is required, which is performed via post-marketing and risk management studies. In some cases, extrapolation of additional indications can be permitted, but this depends on the nature of the cases.The regulatory framework for generic medications is not adequate for the evaluation and licensing of similar biotherapeutic products (SBPs), as many nations’ regulatory agencies are well aware. The WHO’s Expert Committee is responsible for publishing the regulatory regulations “Guidelines on Evaluation of SBPs”, which standardize the biopharmaceuticals. It is mandatory for all biotherapeutics to follow this framework in order to assure the safety, quality, and efficacy of the approved biopharmaceuticals. Like the EMA, the WHO has also developed a regulatory framework for the approval of SBPs that evaluates comparative studies on the quality, non-clinical parameters, and clinical parameters with those of the original biopharmaceutical. Biosimilars must be comparable in terms of dosage and route of intervention, and they must be granted a license based on a complete registration dossier .The USA successfully set up standards via the Biologics Price Competition Act (BPCIA) for the approval of biosimilars in 2009 . For theThere are certain FDA guidelines that deal with comparative studies of biosimilars and their reference biological products that have been licensed outside USA. These studies include synthesis processes and protein complexity. However, it could be worth considering that certain elements of regulatory strategies might not be necessary. In August 2014, for biosimilars, two biologic licensing applications (BLAs) were submitted via the 351(k) biosimilars strategy . ScientiIn 2008, the EMA guidelines were also adopted by the regulatory authority of Australia—the Australian Therapeutic Goods Administration (TGA). During adoption, the EMA’s requirements for the extrapolation of indications were not taken verbatim. However, the requirements for comparative studies were taken verbatim from the EMA guidelines, and some data requirements were also adopted from the International Conference on Harmonization . The refHealth Canada is a regulatory authority that standardized some guidelines for the approval of biosimilars in Canada in 2010. These guidelines were drafted in such a way that the approval process of biosimilars is entirely dependent on the similarity between the reference products and the biosimilars . A biosiThe non-Canadian reference biologic drug should be marketed in a country that has formally adopted the International Council for Harmonization (ICH) guidelines and has regulatory standards and principles for medicine evaluation, post-market surveillance activities, and comparison approaches that are comparable to those in Canada ,132.If a non-Canadian reference biologic medication is used in clinical trials in Canada, data must be submitted to meet chemistry and manufacturing  requirements under the Food and Drug Regulations, section C.05.005. Herzuma (trastuzumab) by Celltrion Healthcare (intended for metastatic and gastric cancer), Kanjinti (trastuzumab) by Amgen (intended for BC), and Mvasi (bevacizumab) by Amgen  are the biosimilars approved in Canada between 2018 and 2020. Regulatory approval of biosimilars in Canada needs to follow the same process as required by the EMA .After the USA, Japan is considered to have the second-largest pharmaceutical industry in the world. The regulatory authority of Japan is the Pharmaceutical and Medical Devices Agency (PDMA), which deals with the approval process of biosimilars and published certain guidelines in 2009 based on the EMA guidelines . In contIn the Asia-Pacific region, South Korea is another nation that is well recognized for having lower costs in its pharmaceutical industry. Its regulatory guidelines are based upon the EMA, Japan, and WHO regulations and were standardized in 2009. South Korea was the second country after Europe to provide approval for biosimilars via regulatory pathways. The patent period for biological products in South Korea is 6 years, after which biosimilars can be licensed for the approved reference products. The type of data that is required for the approval process for biosimilars mainly depends on the cases for which their use is intended. Permission for extrapolation of indication can be given to biosimilars when the re-examination period of the reference product for these indications has expired .In 2007, after Europe, India was the next country to develop norms and procedures for the approval of biosimilars. Initially, the biosimilars were approved by using the guidelines of the original biological products. In India, the Central Drugs Standard Control Organization (CDSCO) is solely responsible for new medicinal products. In India, the first biosimilar “Biovac-B” was approved for marketing in 2000 for hepatitis B, but no specific guideline was established at that time. However, after approving 20 biosimilars, India also developed regulatory guidelines for the approval of biosimilars ,149—in 2Since 2010, a number of Latin American countries have adopted biosimilar frameworks. Brazil, which has the most established frameworks, has developed two approval pathways for comparable biopharmaceuticals that differ in the evidence required for marketing authorization. In the regulatory framework, comparative studies consisting of phase I pharmacodynamic and pharmacokinetic studies must be further evaluated in phase III clinical trials depending on the type of case. Furthermore, the regulatory approval for the extrapolation of indications with reference to the original products can be given by the respective pathway. Unlike the previous pathway, the individual development pathway requires fewer clinical studies; however, the regulatory approval for extrapolation of indications cannot be permitted. Clinical data from comparative studies are mandatory for the approval of any biosimilar. Moreover, developing countries such as Mexico, Venezuela, and Colombia are also establishing their own regulatory guidelines for the approval of biosimilars .Biosimilars accounts for 40% of the biologics market in China. As cancer has become the country’s second-leading cause of death, the use of biosimilars in oncology has accelerated. However, to date, there are no specific guidelines issued by the China Food and Drug Administration (CFDA). Biosimilars are approved with respect to the regulatory framework of biological products. In the late 1990s, the regulatory guidelines for biopharmaceuticals used in oncology were developed, with a period of 6 years required for any biological product to be marketed . CertainRussia has an emerging and firm biopharmaceuticals market but does not have an optimal regulatory framework for biosimilars. There is a need to harmonize regulatory standards for Russian biologics, and for this purpose a meeting was convened by the pharmaceutical manufacturers, international regulatory authorities, and representatives of the Russian Ministry of Health in 2013. Currently, biosimilars are approved through formal legislation defining the regulatory standards with respect to interchangeability and comparative studies. The biosimilars marketed for oncology in the Russian market include rituximab, epoetin, and filgrastim; however, they have not yet been approved by any regulatory authority. The only basis for switching biosimilars is the experience of pharmacists with the appropriate original reference product previously approved in Russia. Rituximab is the only biosimilar that has undergone clinical trials in Russia .For a more vivid description, Safety is a major concern of both patients and practitioners, as biosimilars are widely used in clinical practice for the management and treatment of numerous chronic and life-threatening diseases. These products are associated with low cost in clinical practice, which results in the misconception that biosimilars are not reliable for use in the treatment of life-threatening diseases . AccordiMost biosimilars in oncology are disease-modifying monoclonal antibodies, which suggests that the regulatory consideration is either too expensive or impossible. The regulatory pathways for biosimilars essentially entail the modification of generic pathways for chemically synthesized drugs, but such guidelines have complex characteristics for biopharmaceuticals. The safety profile of biosimilars is directly dependent on their characteristics. However, generally, biopharmaceuticals, biosimilars, and biologics are considered to be safer, as they bind to and target a specific receptor or ligands on the cell membrane. Such agents can be excreted, catabolized, or converted simultaneously into sugars, amino acids, and several other natural products and then recycled. In contrast to small therapeutic molecules, biosimilars tend to not enter the cells and disturb their internal metabolism; as a result, they do not exhibit such toxic effects. However, biopharmaceutical products commonly exert systemic effects instead of pharmacodynamic effects .Biological products are usually administered intravenously; consequently, skin reactions are the most frequent adverse events. Such reactions are usually mild as well as non-specific; however, certain reactions occur due to variation in formulations, and rare side effects can be induced due to immunological and pharmacological effects . The maiDue to the limited number and duration of confirmatory clinical trials, there are equivalent chances of induction of long-term adverse events; however, numerous observational studies and post-marketing surveillance would detect such adverse events. Additionally, no safety signals have been observed even with the use of biosimilars by 400 patients in Europe in clinical practice over more than 10 years. The occurrence of immunogenic effects caused by biosimilars is considered to be their primary safety issue . In addiThis is shown by an incident in Europe involving the production of neutralizing antibodies that cross-reacted with intrinsic erythropoietin, resulting in pure red cell aplasia in approximately 200 patients treated with various epoetin alfa and epoetin beta preparations between 1998 and 2003 . The majAdditionally, numerous clinical trials on biosimilars are also conducted to ensure that there is no unexpected immunogenicity by switching a reference product to a biosimilar, or vice versa. For instance, clinical trials of biosimilars for chronic inflammatory diseases  switched patients from the original biological product to a biosimilar, and no considerable differences in immunogenicity were observed ,165,166.Since the number of clinical studies required for regulatory clearance of biosimilars is quite low, regulatory bodies such as the FDA and EMA rely heavily on post-marketing surveillance to assess the safety profile of biosimilars. However, the current pharmacovigilance system for biosimilars is not considered to be an appropriate source for reporting all of the adverse events. This is due to the lack of time and resources available to the healthcare professionals. The utmost challenge for the physicians is the increasing administrative burden, which can lead to incomplete electronic health records of the patients. Many systems are currently utilized by various regulatory authorities to keep the records of adverse events, such as the FDA’s Sentinel initiative, EudraVigilance, post-marketing safety registries, and integrated healthcare information systems such as ASCO CancerLinQ. Such software programs are copious sources of significant information about the safety and efficacy of biosimilars . There aThe available pre-marketing data on the clinical safety and efficacy of biosimilars are limited; consequently, the benefit–risk profiles of these agents are frequently questioned by oncologists. However, the approval of biosimilars requires comparative studies with their original biological products. Moreover, the safety profiles of biosimilars are identical to those of their original biological products, indicating that biosimilars and biologics are subject to similar regulatory aspects of pharmacovigilance in many countries . FurtherHowever, specific risk management strategies are required for biopharmaceuticals, as current post-marketing safety parameters for both chemically synthesized molecules and biopharmaceuticals are comparable. Pragmatic clinical trials, post-marketing observational studies, and spontaneous reporting systems are the main sources for the collection of safety information about biosimilars. The spontaneous reporting system acts as the imperative tool for the identification of potential safety signals, as well as the significance of immunogenicity—particularly if less severe—although additional development is still required in certain tools for the detection of potential safety issues. Furthermore, case-causality assessment in adverse drug reaction reports during spontaneous reporting is another complication related to biopharmaceuticals. Patients treated with biologics are usually on polytherapy and suffer from severe or life-threatening disorders, making the causality assessment more complicated . AnotherAnother challenge associated with pharmacovigilance of biopharmaceuticals is the variability in synthesis over certain periods of time in clinical practice. Subsequently, an important requirement is to safeguard the product and batch traceability of biopharmaceuticals in the post-marketing phase. According to regulatory agencies, healthcare professionals have to specify the brand name as well as the batch number in spontaneous case reports for the better identification of biopharmaceutical products, but this requirement is not completely adopted. Other than RMP, which is based on European Pharmacovigilance legislation, supplementary post-marketing surveillance and many other phase IV clinical studies are required for the evaluation of biosimilars and biologics. Moreover, in the USA, a Risk Evaluation and Mitigation Strategy is a mandatory requirement for manufacturers in order to analyze the safety profile of biologics and biosimilars, where the benefits must outweigh the risks .Variations in the manufacturing process of biopharmaceuticals occur frequently when these agents are marketed. Usually, these variations do not have any negative impact on the safety and efficacy profile of biopharmaceuticals; however, the instance of epoetin-induced pure red cell aplasia demonstrated that minor alterations in formulation can potentially lead to the occurrence of adverse events. As a result, continuous monitoring of biologics and biosimilars is a mandatory requirement for pharmacovigilance in order to safeguard the marketed product and the traceability of multiple batches marketed and prescribed in clinical practice. For any biopharmaceutical that has been marketed, the specific product and batch administered to the patient should be traced so that all of the adverse events can be detected and analyzed optimally.The pharmacovigilance legislation expressed in Directive 2010/84/EU, adopted by the European Parliament and Council of Ministers, declared that member states must ensure that all adequate methods should be taken to identify biologics with suspected ADRs, focusing on brand name as well as batch number . A previThe main limitation for any biopharmaceutical product in the market is that while the product name and the batch number are mentioned on the product packaging, batch numbers are not mentioned in the barcodes of particular biological products. In order to ensure the traceability of biopharmaceuticals, accurate records and data associated with brand name and batch number must be recorded at all levels . In 2020Biopharmaceutical products have widely been used as potential treatments and for palliative care in the treatment of cancers and tumors. Despite being targeted agents, biological products are higher in cost, which exacerbates the global crises in healthcare systems. Moreover, patent expiry of such biological products has facilitated the marketing of biosimilars that are lower in cost and have similar efficacy and safety profiles to the original biologics. Therefore, the treatment of cancer can be accessed by the majority of the population, with biosimilars providing novel treatments for various life-threatening and chronic diseases. Patients who were administered an infliximab biosimilar ultimately spent 12% less out of pocket than with the reference biologic, according to a Johns Hopkins study . The priCurrently, there are many countries that are still developing regulatory frameworks for the approval and licensing of biosimilars. However, more than 10 years of experience in utilizing biosimilars in places such as Europe, Canada, the USA, and Australia provides an optimistic depiction of the safety profile of biosimilars. There are many challenges associated with the underuse of biosimilars, in addition to the innumerable uses of biosimilars in oncology. Many oncologists are not aware of the advantages of using biosimilars over biologics, due to lack of safety data available in the market. Hence, there is a need to analyze and evaluate the safety profiles of biosimilars so that clinicians can become more aware of the benefits of utilizing biosimilars in clinical practice. More frequent monitoring in the clinical and post-marketing phases is required in order to ensure that these new products are safe and effective in real-world settings. Furthermore, clinicians and healthcare professionals, as well as patients, should be educated optimistically about the outlook of utilizing biosimilars in order to ensure their successful incorporation in routine oncological care.There are many medicinal products on the market that have been utilized for the management and treatment of different cancers and tumors. Some of the traditional medications involve CHM and monoclonal antibodies, but there is a need for more targeted therapies in order to treat cancer more precisely. Such targeted therapies comprise biopharmaceutical products and biologics that have been used in the field of oncology since the 1990s. However, biologics are higher in cost; consequently, there is a large population who do not receive the proper treatment, which contributes to higher fatalities due to cancer and tumors. This can be eliminated with the more frequent use of biosimilars, which are similar to the biologics in terms of safety and efficacy. The use of biosimilars by oncologists can reduce the burden of treatment among the population, while also reducing the risk of mortality due to cancer and tumors. Despite the approval of many biosimilars in the market, there are limited amounts of studies that have been conducted in the post-approval phase of the biosimilars.Biosimilars have the potential to save a lot of money for the health sector, but only if they are adopted and used in clinical practice. It can be stated that doctors are still skeptical of these biosimilar treatments, in part due to a lack of familiarity. Biosimilars are important for the future of healthcare because they boost market competition and innovation, leading to reduced prices and increased pharmaceutical availability for patients around the world. Clinicians, on the other hand, are wary about using biosimilars and do not generally endorse their usage as safe and effective treatment alternatives in patients who are already receiving bio-originator therapy. Even in the published literature, biosimilar-specific education appears to be a somewhat ignored area of focus. As a result, there is a critical requirement to raise healthcare professionals’ awareness and confidence. Additionally, educational programs should concentrate on the major areas of immunogenicity, extrapolation, and interchangeability. To develop continuous evidence-based education programs for biosimilars, efforts and incentives should be implemented. This would contribute to better knowledge of biosimilars on all levels, including clinical, molecular, and regulatory. Furthermore, to improve the knowledge of healthcare professionals, the central regulatory agencies that are formally in charge of ensuring the quality, safety, and efficacy of medicines should adopt the following points to demonstrate interchangeability when applying for approval: (a) change the paradigm for biosimilar development; (b) grant interchangeability automatically upon approval; (c) publish a position statement strongly endorsing interchangeability as a first-course initiative; and (d) harmonize the fundamental ideas of interchangeability, switching, and substitution.


Using a variety of methods to assess across semesters, the study found virtual and hybrid learning environments resulted in equally high levels of competency achievement as in-person delivery. Regardless of course delivery, students reported, with no difference across semesters, PBT directly contributed to their workforce readiness, helped with acquisition of essential workforce skills such as problem-solving, leadership, and teamwork, and led to skill and knowledge acquisition they would not have achieved in a non-PBT course. The increased emphasis on virtual learning changed the higher education landscape and the need for students to be workforce-ready with the technical and professional skills demanded by the field and offered opportunity to redesign courses with an emphasis on applied opportunities. Virtually delivered PBT is an effective, adaptable, and sustainable pedagogy worth the investment.The pandemic necessitated teaching competencies that allow public health (PH) students to be immediately workforce ready. The shift to virtual learning provided an ideal time to consider pedagogies focused on applied learning opportunities, such as practice-based teaching (PBT). This multi-year, post-test evaluation of one PBT course explored differences in students’ competency achievement immediately post-course with different modalities of delivery: fall 2019 in-person ( The outbreak of COVID-19 amplified the need for the public health (PH) system to respond immediately with a well-trained, adaptable, and ready workforce. The pandemic created challenges for not only public health in general, but for higher education as well. The public health sector in general faced funding and staffing challenges, most notably through a lack of dedicated pandemic funding for local public health and insufficient staffing to respond to the myriad of issues resulting from the pandemic  and a laThe pandemic highlighted that serving the ever-changing field of public health has always required a workforce capable of immediately applying tangible skills across content areas ,7,8,9,10Practice-based teaching (PBT) is a pedagogy long touted for its benefits but not often implemented for its perceived resource-intensive nature . PBT comPBT courses in public health and across disciplines, like traditional lecture-based courses, adhere to course learning objectives, assignment guidelines, and a syllabus to ensure students acquire the knowledge and skills to meet the requirements of the course. PBT courses contain some didactic components; however, the emphasis of time is placed on direct application of concepts both within the classroom setting and outside the classroom with discussion about the application, the interactions, meetings, and brainstorms with collaborating agencies and their stakeholders throughout the semester; the assignments that are intended for use in the field and therefore undergo numerous rounds of internal review and feedback; and, the consultations with the teaching team to tailor general course content to the specific project of focus with a number of team-building and sharing opportunities . In a PBAlthough in-person delivery of PBT was used in SPH before the pandemic began, the pandemic forced use of different and innovative delivery modalities of PBT to engage both students and collaborating agencies. The virtual and hybrid modalities used during the pandemic allowed students to gain experience in the field during a time where students struggled to access these opportunities and prompted engagement with agencies that were outside the geographic bounds of the SPH. Given that faculty at SPH have been challenged to find applied opportunities for students to implement competencies delivered in the classroom to the field during the pandemic, the use of PBT emerges as a possible solution. Evaluations of learning delivered through different in-person and virtual mechanisms have shown equally effective learning outcomes , and as PBT courses support a variety of learning styles , prepareLearning by doing is the best way to acquire skills, engage in a topic, and prepare students for job success. Faculty must create these opportunities and SPH must support this endeavor. In the past, before the pandemic, there have been barriers to shifting from traditional courses to PBT, including lack of resources, limited access to technology, difficulty securing partnerships, and resistance to change. Many of these barriers to PBT, however, are in the past because of increased access to technology, reallocation of SPH resources and supports to redesign courses, and an urgent need for the field to utilize a growing public health workforce. Given the pandemic, the cost of implementing PBT is now, in the present context of still managing the pandemic, more than ever far outweighed by the benefits .One argument against transitioning traditional courses to PBT is the time required before and during the semester to develop, implement, and participate in a PBT course . In addiDue to the use of online platforms during PBT classes, lack of technology to initiate partnerships and continually engage students with collaborators during the semester is another challenge of PBT. Meaningful engagement in PBT requires access to and familiarity with technology that allows for seamless connection and collaboration . TraditiA third barrier has been difficulty in securing partnerships. Faculty may struggle to find the right partnering agency to engage in a PBT course, thinking that it needs to be restricted to an agency with a mission that directly advances public health. This pandemic has made it clear that public health touches every sector of society. Health is a basic need , and as Finally, schools and faculty have been resistant to changing the status quo when the structure seems to be working or when the changes require a good deal of effort or resources without guarantees the changes will be effective. Whether we are ready or not, the current context of both PH programs and the field is motivating us to change our pedagogies to quickly produce competent students with prior field experience and who are workforce ready. Students have had to embrace technology as part of their learning platform given the restrictions from the COVID-19 pandemic and the resulting shift toward virtual learning and virtual workforce positions. Agencies have had to pivot and shift resources to meet the changing needs of the populations they serve ,29. FacuThere is an increased demand for prepared, experienced public health professionals in response to the changing demands of a field that is trying to serve communities’ evolving needs. As a result, there is an unprecedented urgency to adjust the way public health academic programs are facilitated to accommodate for all types of learning, whether in-person, virtual, or hybrid. While there has been a shift back to traditional ways of delivering courses, adapting to a new terrain of virtual learning and determining skills-based curricula moves beyond pedagogies that require solely in-person interactions and welcomes the scalable application of PBT in SPH, even with the commonly cited past barriers to implementing it. This results in tangible benefits for all stakeholders both in the immediate and long-term landscape with agencies from PBT courses reporting immediate and sustained benefit from the collaboration .Given the urgency for experienced PH professionals felt in response to COVID-19, students are seeking educational opportunities that allow maximum skill acquisition  regardleThe ultimate goal of PBT courses is to prepare students for success once they graduate and enter the field. Examining the value of PBT for alumni helps demonstrate the effectiveness of the modality. Alumni engagement with PBT reinforces their connection to SPH, allows them connection to and recruitment of current students, provides lifelong learning opportunities for skill redevelopment, and streamlines PBT course collaborations given their intimate learning experience with the school . For exaPBT allows collaborating agencies, which are typically under-resourced and short-staffed, access to high-quality deliverables and innovative ideas at no cost to them  during tFinally, SPH graduate programs have always sought to raise the standards of education through a variety of practice opportunities to expose students early and often to the ever-changing needs of the diverse field . This isThis study aimed to explore if there are differences in competency achievement immediate post-PBT course across different teaching modalities—virtual, hybrid, and in-person. The hypothesis is that the delivery of hybrid and virtual is just as effective as delivery in person when using a framework for the design and implementation of a PBT course. The usefulness of teaching evaluations has long been debated in general, but it is particularly important for PBT courses where conventional methods of assessment do not typically measure student achievement and application ,32,33. TTo examine the utility of PBT, we conducted a multi-year post-test evaluation of one course over three semesters with different modalities of delivery: fall 2019 in-person delivery, summer 2020 virtual delivery, and fall 2020 hybrid delivery. The course was designed and delivered according to a PBT framework; PBT STEPS  was applThe evaluation used a variety of methods to assess and compare across the semesters outside of the usual student course evaluations, as described below, to examine the course effectiveness of achieving outcomes across PBT delivery modality. The outcomes were assessed according to the course logic model , and theAbsent a user-friendly and logical road map for using PBT in public health education, the pedagogy can be difficult to implement. The PBT STEPS framework helps faculty design and teach a PBT course through securing partnerships (S), technology and training (T), engagement and implementation (E), presenting deliverables (P), and sizing up results (S)  to yieldCommunication Strategies for Public Health (SB806) is an advanced intervention planning and communications course for Master of Public Health (MPH) students at the Boston University School of Public Health, a top-ranked SPH in the country. SB806 is focused on changing the health behavior of a target population that is experiencing a problem or an influential environmental agent that influences the target population of the problem. The course leads students through a step-wise planning process  to desigSB806 is a PBT course in which groups of students work with a collaborating agency to develop a public health intervention and targeted communications strategy. The course is offered every fall, spring, and summer by the same instructor, a co-author of this manuscript, who is trained in program design, communication, and evaluation and who spent many years in public health consulting before coming to academia. To adhere to an unbiased evaluation, this course has been independently evaluated by an education evaluation consultant since 2014 and guided by a logic model. Across the three semesters of the course evaluation, course logistics differed depending on the delivery format of the course, but the assignments, content, learning objectives, and timeframe remained the same. The in-person delivery format met during the fall 2019 semester in a BUSPH classroom once per week for 3 h per class over a 14-week semester. The virtual delivery format course met during the summer 2020 semester, completely through Zoom with the instructor and all students on Zoom, twice per week for 3 h per class over 7 weeks (as is the structure of the summer offering at the SPH). The hybrid delivery format met during the fall 2020 semester and the instructor taught from a BUSPH classroom. Students could choose to attend in-person or virtually through Zoom, which was set up in the classroom. The course met once per week for three hours per class over a 14-week semester. Each semester had a maximum of 24 students.Students receive a list of problem statements and collaborating agency descriptions before the first class and are assigned a group of three to five students. They prepare a series of written assignments  and develop a communication strategy with specific media executions. The class concludes with delivery of an oral 30-min group presentation to introduce their plan. Students learn the course competencies  through The collaborating agencies in this class differ greatly but the commonality is that each has a priority area of concern related to the public health field, one or more target populations of focus to address the problem, and an overarching behavior-oriented goal to achieve. Across the three semesters in this study, collaborating agencies represented a state health department with a large staff, a local health department comprised of one director, and a national non-profit organization led by a volunteer board of directors. All primary points of contact at the collaborating agencies had previously worked with the course before as past collaborators or guest lecturers.Evaluation of student achievement was assessed in a variety of ways during the course and post-course. The combination of quantitative and qualitative data collection and the variety of data collection approaches allowed a more thorough assessment of student competency achievement, which assessed both technical skills as outlined in the syllabus and professional skills necessary to engage in a PBT course. The study used the following qualitative data sources:Course Documents: an exhaustive list of course documents were reviewed by the evaluator, accessed through the learning management system, and/or provided by the instructor to provide context to the course and for development of more targeted surveys and a deeper understanding of the course. These documents also serve as the foundation for the agency collaboration and rules of engagement for the semester.Group Evaluations: students complete peer evaluations at multiple timepoints throughout the semester to assess the quality of their groups’ interactions, successes and challenges in teamwork and communication, and areas for improvement. Each student provides a self-assessment and overall assessment of each group member.The study used the following quantitative data sources:n = 19), summer 2020 semester , and fall 2020 semester . Response rates were high in all three semesters.Post-Course Surveys: students completed online post-course (administered the last week of the course) surveys that were implemented in addition to the standardized student course evaluation used by the SPH. The course-specific post-course survey was constructed according to the logic model and after thorough review of the course content and goals. The post-course surveys were administered to students to assess achievement of competencies, satisfaction, and perceptions of PBT. Agreement with statements were assessed using a five-point Likert scale, with the scale ranging from strongest disagreement to strongest agreement or not important to extremely important, depending on the question stem. Post-course surveys were administered by the independent evaluator via email to students in their last class in all three cohorts: fall 2019 semester  . Likert-scale questions were examined using proportions and continuous variables were examined using means and standard deviations. Post-course means were obtained from the five-point Likert-scale questions to examine differences in post-course responses across the three semesters. Given in-person learning was the traditional form of teaching, post-test scores compared hybrid to in-person learning and virtual to in-person learning. Significant differences in post-test responses were assessed using the Whitney–Mann Wilcoxon test. Sample sizes, means, and standard deviations are reported, as are n = 39) in all three courses, most were female  with a higher proportion White/Caucasian in the fall 2019 and 2020 semesters  compared to the summer semester (0%) and under age 25  , 8 students enrolled in the summer 2020 virtual with 8 completed surveys (100% response rate), and 17 students enrolled in the fall 2020 hybrid with 15 completed surveys (88.2% response rate). Of the students responding to the post-course survey (o 37.5%) .At the post-test assessment , studentAdditionally, students were asked at post-course to reflect on the utility and value of PBT. Across all three semesters, the taught in-person, virtual, and hybrid students agreed that the time invested in taking a PBT course was worth it , that more MPH courses should use PBT , and that they appreciated the utility of the PBT course more at the end than when they had initially enrolled  . StudentThe degree to which working with a client in a PBT course impacted their workforce readiness was assessed through a series of questions . Not onlp = 0.0232).Students in the two semesters that had a virtual learning component were asked whether the virtual environment affected their development of skills and workforce readiness . A scoreIn addition to the post-course survey, other course materials were evaluated across the three semesters to understand student performance. In the course, there are three assignments with opportunities for draft review prior to submission. A review of the grading rubrics found that assignment grades were consistent, ranging from 85 to 96, with the first assignment receiving lower grades and grades getting higher with each subsequent main assignment. This grading trajectory is typical for this course and student performance was consistent with in-person, virtual, or hybrid instruction.n = 39) found no qualitative difference in how groups collaborated across the three semesters  or the level of quality collaboration that existed. Themes that emerged included that the group experience enhanced teamwork skills and allowed for personal connections with classmates but also resulted in challenges around expectations with communication response time, internal team deadlines, and competing priorities in scheduling and work. Students reported that working in groups virtually allowed for ease of finding times to meet and streamlined the sharing of drafts and ideas, but that not having a set in-person meeting time sometimes created challenges with scheduling and adhering to internal deadlines. Quality and productivity of group meetings was not found to be affected when held virtually versus in person.Aligning with the three assignments, students complete peer evaluation forms throughout the semester to evaluate themselves, the individual members of their group, and the quality of their group experiences. Group evaluations  and assigning both the course and the instructor an exceeds expectation rating. The feedback across all three semesters was consistently that the course was worth the time they invested, though the time investment was higher compared to their other courses; there was an appreciation of working directly with a collaborating agency to achieve hands-on experience; and, it allowed them to develop more concrete skills for the workforce. Student feedback also indicated that the use of a quality online platform to engage with each other and their collaborating agencies was essential to success, with students in the virtual semester commenting more heavily on this and concluding that the wrong platform would make engagement in the course much more challenging.This evaluation of PBT delivered over three semesters of an MPH intervention and communication course found that the virtual and hybrid learning environment resulted in equally high levels of competency achievement in technical skills than in-person delivery. Students across all three semesters reported the importance of PBT as a pedagogy to acquire the skills of focus in the course, with students in the virtual semester reporting a significantly higher importance of PBT to learn the skills compared to the in-person semester.Positive perceptions of the utility and value of PBT were high across the three semesters with students reporting that it was worth taking a PBT course even given the resource-intensive nature, that more MPH courses should use PBT, and that they appreciated the utility of the course more upon reflection than when they initially enrolled. Students also reported that they would not have gained the same skills or same knowledge in a traditionally taught course not using PBT. In addition, regardless of course delivery, students reported that PBT directly contributed to their workforce readiness and, in particular, helped make them more marketable, helped clarify future plans, prepared them for the workforce, enhanced their appreciation for the field, and provided networking opportunities they would not otherwise have. They also reported that the PBT course helped with the acquisition of essential workforce skills such as problem-solving skills, leadership skills, working with a team, and skills they could implement in their job. The mode of course delivery  did not significantly differ across the semesters.Our findings are consistent with other research that shows students in PBT courses, regardless of mode of delivery, demonstrate the achievement of learning objectives and acquisition of skills during the course and attribute those gains to PBT . The benThe effectiveness of the pedagogy, regardless of delivery, is evidenced by perceptions of utility and high achievement by students, as well as perceived utility by agencies and faculty both in this study and in others. The evidence of effectiveness puts many of the previously reported barriers on time and resources into perspective ,23,25 anWhile there has been increased emphasis on technology as a means of connection in the academic and professional setting, there is still a lack of resources, perhaps more now than in the past, given the economic challenges that higher educational institutions and society as a whole are facing. Even still, resources are being allocated to determine the best mechanisms for virtual learning and how the school can support those pedagogies. The pandemic has increased the need for SPH to respond with a well-trained workforce armed with skills they can immediately apply , as evidAgencies consistently have limited bandwidth, and students and faculty are still pressed with personal and professional constraints. However, the shift to virtual connection offers an opportunity to engage in new ways that could be streamlined and accessible if leveraged correctly. Allocating resources to this effort is essential  to maintThis study is one of the first on the effectiveness of achieving student competencies through PBT in a variety of delivery formats. However, there are still some limitations that may affect the generalizability of results. First, the evaluation was conducted on one PBT class focused on certain competencies and deliverables, though a variety of technical and professional skills were assessed. Second, the sample sizes within semesters were low but depended on enrollment for the course and response rates were high across all three semesters. Third, perceptions and attitudes were not controlled for in data collection or analysis and could have been heavily influenced given the context of the pandemic especially during the summer 2020 and fall 2020 semesters. Finally, our evaluation was focused only on immediate post-course feedback in students and does not evaluate follow-up skills in practice or other stakeholder engagement .There are many strengths to this evaluation. First, it was conducted by one evaluator unaffiliated with the program who examined this course across time. Second, it examined a variety of perceptions and attitudes related to the utility of PBT and the effect of virtual learning on achieving course competencies, which is a newer area of study. Third, to ensure consistency for the evaluation, the PBT course was delivered by the same faculty in all three semesters with a virtual client and using the same syllabus and assignment guidelines. Finally, collaborating agencies represented a variety of PH agencies, sectors, and issues.Virtually delivered PBT holds promise and can be as effective as in-person delivery. Future research should examine long-term outcomes of PBT post-semester to ensure it is being used in practice, regardless of delivery mode. In addition, stakeholder engagement, benefits, and challenges should be assessed for the different delivery modes. Virtual learning will remain part of our higher education landscape and the need to have a ready workforce with the technical and professional skills to apply in practice is essential. Redesigning courses is at the forefront of higher education and will become even more relevant as SPH modify and expand their offerings. Virtual learning will remain part of the higher education landscape and should be leveraged in curriculum revisions with evidence that the pedagogy is effective.Even when we return to a place where course instruction can safely occur in the classroom, virtual learning is now here to stay, not just in public health, but in all fields. It offers an opportunity to reach more students, accommodate different schedules, utilize various technologies, engage more partners, and broaden the networks in the field. PBT is not only possible to implement in the current learning environment but is essential; it mimics the virtual collaboration and problem-solving that is our new norm. It is a pedagogy that is scalable and can be employed regardless of PH discipline and, in fact, regardless of field of study. As our study shows, it is equally effective delivered in-person, virtually, or hybrid. The widespread utility of PBT is due to the foundation on which it is built—solving current problems for real agencies that have a responsibility to better serve their communities, and in the process, delivering students the competencies required by the course to meet school and accreditation standards and the field-based skills necessary for success. In higher education, there are different ways of delivering skills to make students more workforce-ready and marketable to the field, and this can be done effectively with PBT whether in-person, virtually, or hybrid. Public health is in a prime position to lead this effort, and utilizing pedagogies such as PBT allows us—academics, practitioners, educators, and researchers—to meet the field where it is and usher a new path forward.