Students Provisionally Enrolled Due to Vaccination Requirements: Variation in State Laws and Rates.

This research examined the laws and regulations surrounding provisional enrollment in schools across the United States. Provisional enrollment refers to children who have started, but not completed, their required vaccinations and are allowed to attend school while completing their vaccinations. We found that nearly all states have laws regarding provisional enrollment, with 5 essential components to compare the laws including vaccine- and dose-specific requirements, type of personnel permitted to authorize, length of time that the children have to become up to date on their vaccinations (grace period), follow-up procedures, and consequences for noncompliance. In addition, we found that the percentage of provisionally enrolled kindergarteners varied greatly from state to state, with some states having less than 1% of provisionally enrolled kindergarteners and others having more than 8% between school years 2015-2016 and 2020-2021. We suggest that reducing the number of provisional entrants could be an alternative intervention to increase vaccination coverage.

When Adolescents Disagree with Their Vaccine-Hesitant Parents about COVID-19 Vaccination.

AbstractAs we journey into the fourth year of the COVID-19 pandemic, a majority of Americans express relief at a "return to normal," experience pandemic fatigue, or embrace the idea of living with COVID-19 in much the same way we live with the seasonal flu. But transition to a new phase of life with SARS-CoV-2 does not diminish the importance of vaccination. The US Centers for Disease Control and the Food and Drug Administration recently recommended another round of booster dose for persons age 5 and up, or an initial series for those not previously vaccinated, with an updated bivalent formula that protects against both the original virus strain and Omicron subvariants that are now the dominant source of infection. By most accounts most of the population has been or will become infected with SARS-CoV-2. Suboptimal uptake of the COVID-19 vaccines among the approximately 25 million adolescents in the United States is a significant obstacle to population coverage, public health, and the health and well-being of adolescents. A major cause of low adolescent uptake is parental vaccine hesitancy. This article discusses parental vaccine hesitancy and argues that permitting independent adolescent consent to COVID-19 vaccination should be an ethical and policy priority as we continue to confront the threat of Omicron and other variants of the coronavirus. We discuss the central role of the pediatric healthcare team in caring for adolescent patients who disagree with their parents about vaccination.

Paid Leave for Fathers: Policy, Practice, and Reform.

Policy Points Government policies that secure paid leave for all parents, regardless of gender, can reduce structural inequalities, while promoting fathers' engagement in parenting. Such policies are likely to be most effective when they secure full, or almost full wage replacement, and when they provide incentives for fathers to take leave. Organizations must also participate in the culture shift, providing workplaces that encourage paternity leave rather than reinforcing the "male breadwinner" stigma.

Perceptions and patient care needs among hepatitis B patients during COVID-19.

BACKGROUND: The novel coronavirus of 2019 (COVID-19) has been and continues to be a rapidly developing public health crisis, that has also disrupted routine and maintenance health care for people living with chronic conditions. Some of these chronic conditions also put individuals at increased risk of COVID-19 complications, particularly if the condition is not under control. For these reasons, the exploratory study reported here examined the needs and preparedness of patients at a community health organization that specifically provides hepatitis B virus (HBV) care for high-risk groups that had previously tested positive for HBV. METHODS: Current study utilized exploratory analysis of qualitative COVID-19-related statements collected during calls to a total of 44 patients reached during April and May, 2020 in the Washington D.C. area. Researchers worked with a community based non-profit organization to reach current HBV + and HCV + patients to provide retention in care and assess patient needs in maintaining management of their condition adapted to include offering medication refills, telehealth, and other resources. We gathered emergent themes, using socio-ecological framework, regarding capacity and needs for managing their chronic condition in a vulnerable population during the initial, most interrupted, time period of a global public health crisis. RESULTS: From the notes of the calls, five thematic categories emerged: COVID-19 prevention awareness, assistance program access, medical resource access, access to knowledge and awareness about assistance programs, and needs and barriers. From these five themes, providers can develop strategies to better prepare their patients and provide care to patients with chronic conditions during major disruptions. CONCLUSIONS: Future recommendations include increasing hepatitis and COVID-19 vaccine efforts, collaborating with community partners, and screening and understanding social determinants of health that affect racial and ethnic minorities.

Process evaluation of an academic-community-government partnership to reduce liver diseases attributable to hepatitis B virus.

BACKGROUND: Racial/ethnic minorities have higher incidence and mortality rates of liver cancer, or hepatocellular carcinoma, than non-Hispanic Whites. As such, the Washington-Baltimore Metropolitan Area Hepatitis B Virus (WB-HBV) Demonstration Project, a community-based participatory research (CBPR)-driven academic-community-government (ACG) partnership, was established in 2019 to address disparities and implement strategies to improve the HBV screening and vaccination infrastructure for at-risk communities. CBPR is a partnership of community members, organizational leaders, and academic researchers with a common aim to collectively share and contribute their input at every phase of the project. Herein, we describe the process evaluation of the WB-HBV Project and extract themes and insights to benefit future ACG partnerships and community-engaged research. The process evaluation has been conducted to determine whether CBPR-driven partnership and programmatic activities have been implemented as intended and have resulted in building expanded research capacity for future ACG partnership HBV community-level initiatives. METHODS: A WB-HBV Project Task Force was convened and comprised of eight organizations: four community organizations, three government organizations, and one academic institution. Through a mixed-methods process evaluation, an online survey and key informant interviews were conducted to provide context for program implementation barriers and facilitators. Descriptive statistics were conducted, and interviews were recorded, transcribed, and thematically coded. RESULTS: The survey was completed by 14 of 20 partnership members (70.0%): two academic, eight community, and four government members. Partnership members showed general agreement across 14 domains: organization and structure of meetings; trust; decisions; impact; general satisfaction; strategic planning; ACG policy impact; community-based participatory research and government; participation in meetings; assessment of participation; partnership operations and capacity; communication; challenges/limitations associated with ACG involvement; and benefits compared to challenges associated with ACG involvement. Qualitative interviews were conducted with 15 of the 20 members (75.0%): two academic, nine community, and four government members. Four themes emerged: partnership involvement, project goals and accomplishments, project challenges and barriers, and partnership involvement in government or policy. CONCLUSIONS: The process evaluation presents insights into developing strategies to enhance partnership functioning and increase the ability of present and future ACG partnerships to improve community health outcomes.

Marijuana Use and Increases in Use over Time among Young Adult College Students in the State of Georgia: Analyses of Sociocontexual Predictors.

BACKGROUND: While research has assessed correlates of marijuana use, there has been less focus on predictors of differing levels of changes in use during young adulthood, a critical period for use/escalation. OBJECTIVES: We examined changes in marijuana use and related sociocontextual predictors (e.g., earlier-onset substance use, parental use, college type). METHODS: Using data from Georgia college students (ages 18-25 years) in a 2-year, 6-wave longitudinal study (64.6% female, 63.4% White), 2-part random-effects modeling examined use at any assessment and number of days used. RESULTS: Predictors of use status at any assessment included being male (OR = 1.87, 95%CI = [1.28-2.73]), Black (OR = 1.91, 95%CI = [1.15-3.19]), earlier-onset marijuana (OR = 2.63, 95%CI = [1.70-4.06]), cigarette (OR = 2.04, 95%CI = [1.19-3.48]), and alcohol users (OR = 1.49, 95%CI = 1.00-2.22]), parental tobacco (OR = 2.14, 95%CI = [1.18-3.86]) and/or alcohol use (OR = 1.55, 95%CI = [1.09-2.20]), and attending private (vs. public) institutions (OR = 1.68, 95%CI = [1.10-2.59]). Predictors of lower likelihood of use over time included being male (OR = 0.87, 95%CI = [0.77-0.98]), earlier-onset cigarette use (OR = 0.82, 95%CI = [0.68-0.98]), parental alcohol use (OR = 0.86, 95%CI = [0.77-0.97]), and private institution students (OR = 1.17, 95%CI = [1.02-1.34]). Predictors of more days used at baseline included being male (OR = 1.77, 95%CI = [1.40-2.23]), Black (OR = 1.42, 95%CI = [1.04-1.93]), earlier-onset marijuana (OR = 2.32, 95%CI = [1.78-3.01]) and alcohol users (OR = 1.29, 95%CI = [1.01-1.66]), and parental tobacco use (OR = 1.90, 95%CI = [1.32-2.73]). Predictors of fewer days used over time included being older (OR = 0.98, 95%CI = [0.97-1.00]), parental tobacco use (OR = 0.86, 95%CI = [0.78-0.95]), and attending private institutions (OR = 0.89, 95%CI = [0.83-0.93]). CONCLUSIONS: Intervention efforts can be informed by current findings that correlates of baseline use (e.g., being male, attending private institutions) also predicted less use over time, and one's earlier use and parents' use of various substances impacted young adult use.

Liability Waivers for COVID-19: Law, Policy, and Practice.

As businesses reopen, the practice of asking customers to sign COVID-19 liability waivers is increasing throughout the United States. Although the courts have not yet decided the enforceability of COVID-19-related liability waivers, existing case law, as well as new executive and legislative actions, suggests that such waivers may offer some protection to businesses from liability. Nevertheless, we believe that the legal and ethical rationales underlying liability waivers are not applicable to a pandemic. We further argue that the challenging nature of and the substantial unknowns about the novel coronavirus make waivers contrary to public policy. Fears over floods of litigation appear thus far unfounded, and businesses should not be relieved from their obligation of taking reasonable safety precautions. Waivers are not a panacea to reopen businesses in an ongoing pandemic, and the ultimate protection against liability is to operate in a manner that minimizes the spread of the virus consistent with evidence-based guidelines.

The First 2 Years of Biosimilar Epoetin for Cancer and Chemotherapy-Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions.

Biosimilars are biologic drug products that are highly similar to reference products in analytic features, pharmacokinetics and pharmacodynamics, immunogenicity, safety, and efficacy. Biosimilar epoetin received Food and Drug Administration (FDA) approval in 2018. The manufacturer received an FDA nonapproval letter in 2017, despite receiving a favorable review by FDA's Oncologic Drugs Advisory Committee (ODAC) and an FDA nonapproval letter in 2015 for an earlier formulation. We discuss the 2018 FDA approval, the 2017 FDA ODAC Committee review, and the FDA complete response letters in 2015 and 2017; review concepts of litigation, naming, labeling, substitution, interchangeability, and pharmacovigilance; review European and U.S. oncology experiences with biosimilar epoetin; and review the safety of erythropoiesis-stimulating agents. In 2020, policy statements from AETNA, United Health Care, and Humana indicated that new epoetin oncology starts must be for biosimilar epoetin unless medical need for other epoetins is documented. Empirical studies report that as of 2012, reference epoetin use decreased from 40%-60% of all patients with cancer with chemotherapy-induced anemia to <5% of such patients because of safety concerns. Between 2018 and 2020, biosimilar epoetin use varied, increasing to 81% among one private insurer's patients covered by Medicare whose cancer care is administered with Oncology Analytics and to 41% with the same private insurer's patients with cancer covered by commercial health insurance and administered by the private insurer, to 0% in several Veterans Administration Hospitals, increasing to 100% in one large county hospital in California, and with yet-to-be-reported data from most oncology settings. We conclude that biosimilar epoetin appears to have overcome some barriers since 2015, although current uptake in the U.S. is variable. Pricing and safety considerations for all erythropoiesis-stimulating agents are primary determinants of biosimilar epoetin oncology uptake. IMPLICATIONS FOR PRACTICE: Few oncologists understand substitution and interchangeability of biosimilars with reference drugs. Epoetin biosimilar is new to the market, and physician and patient understanding is limited. The development of epoetin biosimilar is not familiar to oncologists.

Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions.

The EU, the USA, and Japan account for the majority of biological pharmacotherapy use worldwide. Biosimilar regulatory approval pathways were authorised in the EU (2006), in Japan (2009), and in the USA (2015), to facilitate approval of biological drugs that are highly similar to reference products and to encourage market competition. Between 2007 and 2020, 33 biosimilars for oncology were approved by the European Medicines Agency (EMA), 16 by the US Food and Drug Administration (FDA), and ten by the Japan Pharmaceuticals and Medical Devices Agency (PMDA). Some of these approved applications were initially rejected because of manufacturing concerns (four of 36 [11%] with the EMA, seven of 16 [44%] with the FDA, none of ten for the PMDA). Median times from initial regulatory submission before approval of oncology biosimilars were 1·5 years (EMA), 1·3 years (FDA), and 0·9 years (PMDA). Pharmacists can substitute biosimilars for reference biologics in some EU countries, but not in the USA or Japan. US regulation prohibits substitution, unless the biosimilar has been approved as interchangeable, a designation not yet achieved for any biosimilar in the USA. Japan does not permit biosimilar substitution, as prescribers must include the product name on each prescription and that specific product must be given to the patient. Policy Reviews published in 2014 and 2016 in The Lancet Oncology focused on premarket and postmarket policies for oncology biosimilars before most of these drugs received regulatory approval. In this Policy Review from the Southern Network on Adverse Reactions, we identify factors preventing the effective launch of oncology biosimilars. Introduction to the market has been more challenging with therapeutic than for supportive care oncology biosimilars. Addressing region-specific competition barriers and educational needs would improve the regulatory approval process and market launches for these biologics, therefore expanding patient access to these products in the EU, the USA, and Japan.

End of an era for erythropoiesis-stimulating agents in oncology.

Erythropoiesis-stimulating agents (ESAs) are available to treat chemotherapy-induced anemia (CIA). In 2007-2008, regulatory notifications advised of venous thromboembolism and mortality risks while the Center for Medicare and Medicaid Services' restricted ESA initiation to patients with hemoglobin <10 g/dl. In 2010, a Risk Evaluation and Mitigation Strategies required consent prior to administration. We evaluated ESA utilization from 2003 to 2012 and obtained private health insurer claims data for persons with lung, colorectal, or breast cancer from 2001 to 2012. ESA use for CIA was determined by an ESA claim after chemotherapy, up to 6 months after treatment. We identified 839,948 commercially insured patients, including 24,785 patients with ESA-treated CIA (3.2%). Darbepoetin use increased 3.9-fold from 2003 to 2007 (12.3% to 48.7%) and then decreased 95% to 2.6% by 2012. Epoetin use decreased 90% from 2003 to 2012 (30.3% to 3.1%). Between 2003 and 2012, mean epoetin dosing decreased 0.8-fold (244,979 in 2003 vs. 196,216 units in 2012), but increased 1.8-fold for darbepoetin-treated CIA (262 in 2003 to 467 µg in 2012). Among CIA patients, transfusions were low (4.5%) in 2002-2007, then increased 2.2-fold between 2008 and 2012. Safety initiatives between 2007 and 2010 facilitated reductions in ESA use combined with changes in coverage. These data show the efficacy of regulatory efforts, publication of adverse events and changes in reimbursement in reducing use of ESAs. Future studies are warranted to optimize deimplementation strategies to improve patient safety.

United States vs Safehouse: The implications of the Philadelphia supervised consumption facility ruling for law and social stigma.

In October 2019, a federal judge ruled that a Philadelphia nonprofit (Safehouse) group's plan to open the first site in the U.S. where people can use illegal opioids under medical supervision does not violate federal Controlled Substances Act, delivering a major setback to Justice Department lawyers who launched a legal challenge to block the facility. The Judge wrote that "the ultimate goal of Safehouse's proposed operation is to reduce drug use, not facilitate it," which represents the first legal decision about whether supervised injection sites can be legally permissible under U.S. law. Although supervised consumption facilities ("SCFs") remain controversial, they already exist in many countries in Europe as well as Canada, Australia, and Mexico, and evaluations of their public health impact have demonstrated the value of this practice. The decision is hailed as a public health victory and could shape the legal debate in other U.S. cities. Challenges remain as stigmatizing attitudes regarding substance use are widely accepted, culturally endorsed, and enshrined in policy. The Safehouse case shows that SCFs might be able to survive under current federal drug laws, but public understanding and support of these facilities will also be crucial for cities and states to open them.

Complexity of the Basic Reproduction Number (R0).

The basic reproduction number (R0), also called the basic reproduction ratio or rate or the basic reproductive rate, is an epidemiologic metric used to describe the contagiousness or transmissibility of infectious agents. R0 is affected by numerous biological, sociobehavioral, and environmental factors that govern pathogen transmission and, therefore, is usually estimated with various types of complex mathematical models, which make R0 easily misrepresented, misinterpreted, and misapplied. R0 is not a biological constant for a pathogen, a rate over time, or a measure of disease severity, and R0 cannot be modified through vaccination campaigns. R0 is rarely measured directly, and modeled R0 values are dependent on model structures and assumptions. Some R0 values reported in the scientific literature are likely obsolete. R0 must be estimated, reported, and applied with great caution because this basic metric is far from simple.

Regulatory and Clinical Experiences with Biosimilar Filgrastim in the U.S., the European Union, Japan, and Canada.

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

Recent progress in children's meals law in restaurants in Baltimore City and California State: Making a healthy beverage option the default choice.

In July 2018, Baltimore became the largest US city to prohibit restaurants from including sugar-sweetened beverages on kids' menus. In September 2018, California made history by becoming the first US state to require either water or milk as the default beverage with children's meals at all restaurants. Supporters of children's meals laws view them as helping to change the culture of health on beverage preferences and subtly influencing the choices of patrons. Using subtle methods of influencing children's beverage choices at restaurants, or nudges, will not on its own eradicate childhood obesity. However, the law aims to make healthier choices easier options and to influence people's choices in predictable ways without restricting their options. Evidence from a wide range of fields shows that people tend to stick with defaults and that setting beneficial defaults has high rates of acceptability. The laws in Baltimore and California, along with the other jurisdictions that have passed similar legislation, reflect a growing understanding - among restaurant owners, community members and policymakers alike - of the importance of feeding children healthy meals. They also signal that making healthier beverages the default option on children's menus is gaining strength in the US. Cities and states across the country should consider enacting similar laws as part of a greater public health initiative to combat the childhood obesity epidemic.