The First Interchangeable Biosimilar Insulin: Insulin Glargine-yfgn

On March 23, 2020, all insulin products were reclassified as biologics instead of drugs under the Biological Price Competition and Innovation (BPCI) Act of 2009. This allows biosimilar insulin products to be manufactured when the patent expires for the reference biologic, sometimes called the originator or brand name product. A biosimilar product may not be substituted for the reference biologic at the pharmacy counter unless the biosimilar undergoes further switch trials to earn the designation as an interchangeable biosimilar. Insulin glargine-yfgn 100 units/mL is the first biosimilar insulin to attain interchangeable status with the reference insulin glargine. In the INSTRIDE 1 and INSTRIDE 2 trials, insulin glargine-yfgn has proven noninferiority regarding blood glucose reduction and adverse effect profile versus reference insulin glargine; even in the INSTRIDE 3 trial in which treatment of diabetes was switched between insulin glargine-yfgn and reference insulin glargine throughout the trial without statistically significant changes to glucose levels or adverse effects. Insulin glargine-yfgn may be substituted at the pharmacy counter without consultation with the prescriber, in accordance with state laws. In suit with other biosimilars, insulin glargine-yfgn’s list price is significantly lower than other insulin glargine products. This increases market competition leading to decreases in costs of other insulin glargine products. Many patients who could not previously afford insulin therapy may now have significantly improved access to treatment. Providers will need education to increase awareness of these new biosimilars and interchangeable biosimilar insulin products, cost benefits, and substitution allowances.

Lifesaving Medications Use By Athletic Trainers

The athletic trainer's (AT) emergency management skill set requires competency in the delivery of basic lifesaving medications. Some lifesaving medications have been a part of athletic training practice for decades, but that list has grown as ATs' practice setting has expanded - increasing the types of em ergent conditions that the AT may have to treat. The 2020 CAATE curricular standards require athletic training students be trained to administer the following: supplemental oxygen, nitroglycerine, low dose aspirin, bronchodilators, epinephrine using automated injection device, glucagon, and naloxone. Clinically, the conditions treated by these medications can be categorized as follows: cardiac, respiratory, hypoglycemia, or anaphylaxis. All ATs should know the indications, contraindications, administration methods, and the details of patient monitoring for each medication. Generally, these medications are safe, have clear indications for use, and few contraindications. While ATs are trained to administer these medications, they must consider state laws and local policies.

Early Child Marriage: Customary Law, Support System, and Unwed Pregnancy in Gorontalo

The rate of underage marriage in Gorontalo is very high, even though religion, customs and state laws prohibit it. The results of the direct interviews conducted and the observations made indicate that poverty, low levels of education and matchmaking myths may have caused this increase. Furthermore, the increasingly high level of promiscuity and weakened socio-cultural ties have led to an increase in the number of extramarital pregnancies, and forced marriage is unavoidable to maintain the dignity of the community. It was discovered that most married couples do not wed legally until they have problems in their marriage and seek a divorce. Moreover, women must also be responsible for their life choices because this paper shows that poor service practices have caused underage women to be objectified by physical, social and symbolic violence. The unavailability of a support system from the government and society makes a partner rely on the kindness of his or her parents. Therefore, it was suggested that government intervention, in the form of prevention and support systems for underage married women, must be integrated with the role of the community and religious leaders.

REVISITING CHOISE OF A STRATEGY FOR RUSSIAN LEGAL SPACE DEVELOPMENT

Автор, принимая во внимание выделяемые философами древности необходимые условия (факторы) государственного самосохранения, отмечает, что самой важной целью государства является не его собственное сохранение, а сохранение его главного ресурса - человека. Поскольку право - это регулятор (по определению) и индикатор происходящих в государстве событий, веяний (по В. О. Ключевскому), автор рассматривает один из самых тревожащих юридическое сообщество вопросов законодательной (прежде всего конституционной) перестройки - вопрос о наделении роботов правосубъектностью, что приравнивает статус робота к статусу человека. В связи с этим рассмотрены следующие вопросы: 1) необходимость стабильности для жизни людей, а следовательно, для жизни государства; 2) закон человеческого вырождения; 3) нахождение государственных законов внутри природных законов. Сделаны выводы, которые необходимо принять при разработке стратегии российского правового пространства. Знание и сохранение внутреннего равновесия (природной гармонии) - это необходимость, без которой не выживет человечество в целом. The author takes into account the warnings of ancient philosophers to deduce the necessary conditions (factors) of state self-preservation. But the most important goal of the state is not only its own preservation, but the preservation of its main resource - man. Since law is a regulator (by definition) and an indicator of events and trends taking place in the state (according to V. O. Klyuchevsky), the author considers one of the most disturbing symptoms of legislative (primarily constitutional) restructuring for the legal community - the issue of granting robots legal personality, which equates the status of a robot with the status of a person. In this connection, the following issues were considered: 1) the need for stability for the life of people, and therefore for the life of the state; 2) the law of human degeneration; 3) the finding of state laws within natural laws. The conclusions that need to be taken when developing a strategy for the Russian legal space are drawn. Knowledge and preservation of internal balance (natural harmony) is a necessity, without which humanity as a whole will not survive.

The perception of the basic state laws by the Constitutional Democrats during the work of the first State Duma: the ideas of Vasily Maklakov

The article gives an interpretation of the ideas of the liberal politician Vasily Maklakov on the Basic State Laws of 1906. He assessed these laws as the Russian Constitution of 1906. Vasily Maklakov gave an interpretation of the relationship between the Constitutional Democrats and the government in connection with the restriction of the rights of the State Duma. The novelty of the research lies in the analysis of the perception by the Constitutional Democrats of the Basic Russian Laws as amended on April 23, 1906. Sources on the topic include the texts of the leaders of the K-D Party – the memoirs of Vasily Maklakov and Pavel Milyukov, Maxim Vinaver, as well as the Basic State Laws of 1906, materials of the III Congress of the K-D Party. The article reveals the political views of Vasily Maklakov, characterises his communicative culture, the views of the lawyer about the reasons for the illegal actions of the Constitutional Democrats in the First State Duma, the origins of their conflict with the government. An analysis of Vasily Maklakov's ideas about the degree of constitutionality of the government's steps towards the Duma in 1906 is given, his judgements about autocracy, law and order, the need to form a parliamentary culture of deputies are revealed. It is proved that Vasily Maklakov criticised the tactics of the Constitutional Democrats s in the First State Duma in the context of the idea of legality. He saw the main mistake of his fellow party members in their ignoring of a number of legal norms prescribed in the Basic Laws.

Recognizing and Responding to Elder Mistreatment: Developing and Testing an Online Training for EMS Practitioners

Elder mistreatment is an urgent and under recognized public health concern with devastating consequences for older adults, families, and health systems. Risk for elder mistreatment has increased during the COVID-19 pandemic, further highlighting the urgency to address it. Prehospital emergency medical service (EMS) practitioners have unique opportunities to recognize signs of elder mistreatment but often lack the training and tools required to facilitate consistent identification and intervention. To address this gap, Education Development Center collaborated with a team of expert advisors and EMS practitioners to develop and pilot test Recognizing and Responding to Elder Mistreatment: An Online Training for EMS Practitioners with funding from the RRF Foundation for Aging. This training aims to prepare EMS practitioners to recognize potential mistreatment and report suspected elder mistreatment in line with state laws and their professional code of ethics. In this presentation, we will describe the iterative development process, present results from a pilot test conducted with EMS practitioners in Massachusetts and share strategies and progress for disseminating the training nationally. The pilot study utilized a pre-post design to assess changes in knowledge, attitudes, and practices at baseline, immediately after and two months following participation in the training. Results indicate statistically significant improvements in knowledge related to elder mistreatment identification and response from pre- to post-training and maintenance of these improvements two months later. Participants reported feeling more prepared to address elder mistreatment in their work as EMS practitioners and applying their new knowledge and skills during the two months following the training.

The Early 2000s

Chapter 9 tells the story of Lawrence v. Texas, the 2003 Supreme Court decision that finally struck down the remaining state laws that criminalized sodomy. In 2004 Massachusetts became the first state in the U.S. to have marriage equality, following the state supreme court decision in Goodridge v. Department of Public Health. Opponents of gay rights fought furiously to overturn marriage equality in Massachusetts, but once straight people saw that marriage equality cost them nothing, the opposition faded away. Gay rights groups in Massachusetts prevailed despite having many institutional disadvantages. In California in 2008, Proposition 8 was passed by voters to reintroduce a same-sex marriage ban.

Does Access to Bank Accounts as a Minor Improve Financial Capability? Evidence from Minor Bank Account Laws

Banking the unbanked is a common policy goal, but should this include access to bank accounts for minors? This study estimates how teenagers' access to bank accounts affects their financial development. Using variation in state laws, we show policies that permit access to independently-owned accounts increase account ownership at age 16 through age 19, although by age 24 those young adults are banked at similar rates to teens who grew up in states that do not allow minors to own accounts independently. Teens who had access to independently-owned accounts use fewer high-cost alternative financial services (like payday loans) through age 20—but are then more likely to use AFS, particularly check-cashing services, from age 21 through 24. Using credit records, we show that access to non-custodial accounts has no effects on credit scores in the short-run, but lower credit scores and more loan delinquencies at ages 21 through 24. While these state laws promote financial inclusion for teenagers, the young people who take on accounts may experience negative consequences in the longer run.