Levalbuterol hydrochloride

Cityblock Health is one of many healthcare providers working to create a healthcare system that keeps all Americans healthy through community support and unbiased care and data. (Cityblock) During the pandemic, population-specific behavioral care expanded with a move to teletherapy through platforms like the Shine app, designed for BIPOC populations and recently acquired by Headspace Health, Safe Place for the Black community and Latinx Therapy for Latino patients. A similar shift is taking place in other branches of healthcare. Through leveraging the power of virtual care and the social insights of population health frameworks and social determinants of health, underserved care strategies are expanding. Cityblock Health, a primary care provider focused on historically marginalized and under-treated populations, is a primary example of the new model's potential. The value-based healthcare provider offers medical care, behavioral health and social services to low-income and marginalized populations, often with complex needs, in six states and Washington, D.C. Cityblock is expanding its reach with 140 new high-wage jobs being unveiled just this week after a recent announcement that the provider would expand into Indiana through a partnership with MDWise. Town Hall Ventures, a Cityblock investor, last week closed a $350 million funding round to further support similar growing platforms focused on underserved communities.  Cityblock Chief Health Officer Kameron Matthews, M.D., points to the difference between “medicine” and “health” as an example of how wellness must be viewed as especially complex in underserved communities. She used the response to the opioid epidemic as indicative of how some communities are still neglected.   “The opioid crisis is, and I hate to say this, but it has a very white face,” Matthews said. “But when you look at Black and brown communities, [providers] tend not to think of the other addictions that occur as being just as much of a public health issue, as something that needs to have resources and focused attention.” Cityblock follows a “local and personal” model to address every complex need. While virtual care is offered, physical hubs also provide patients another option for care. Patients are paired with a community health partner trained in diversity and inclusivity and often from the same community. These partners can sit in on appointments as an advocate and to offer support, act as a sounding board or just as a note taker. Through agreeing with payers to accept full risk, Cityblock puts its money where its mouth is and sees the patient as one entity, counter to the traditional medical model which Matthews says splits whole patients into siloed specialties.   “Cityblock is accountable and responsible for all the healthcare of our members, regardless of whether they receive those services from Cityblock or not,” Matthews said. “By taking full risk, we have that accountability and are therefore proactively helping those patients manage their healthcare, helping them when they get admitted to the hospital, or when they need home health services or the like. And then we partner with the insurance company to make sure that we're finding cost savings where possible," Matthews said. When Cityblock launches in Indiana, it will provide 10,000 Medicaid members with its value-based care. Other providers are viewing healthcare through similar population health frameworks to offer tailored care to underserved communities. Zócalo Health revisions community-based care   Erik Cardenas and Mariza Hardin co-founded Zócalo Health as a digital health provider by and for Latino communities. The virtual primary care provider launched in California via a public beta in July. On Oct. 11, the provider announced the launch of care open to all in California and Texas. The team plans to extend care into Washington in the future. Latino populations disproportionately face limited access to primary care services. Latino-dominated ZIP codes see, on average, one primary care physician for every 5,000 to 6,000 patients, according to Cardenas. The fact that Zócalo is the first of its kind is not a surprise considering 2% of startup investment goes to startups launched by Latinos. When designing Zócalo, Cardenas and Hardin traded the cookie-cutter care model for something reflecting the idiosyncratic needs of patients. For this reason, they make clear that treating Latino populations is not just about translating forms and not about seeing Latino Americans as a monolith. “We’ve seen a lot of health systems that really try to connect with the Latino community by simply just translating their content into Spanish,” Cardenas said. “What this highlights is the great misconception that language is the only unblock that is necessary to drive the type of behavior change that we want to see in our community. The big miss here is culture and tradition. I think what the one-size-fits-all approach by some health systems really fails to recognize is that every culture has beliefs about health, about disease, about treatment and about healthcare providers.” Cardenas points to a strong emphasis on the family as the inspiration for Zócalo. Along with a familial mindset, he imagines Western medicine being fused with innovation, tradition and history. After speaking with patients, Cadenas and Hardin found that access and proximity were primary roadblocks to care. A digital platform was needed to account for work schedules and rural settings, although they hope to see brick-and-mortar facilities on the horizon. Additionally, the role of community health workers was created and modeled after the role of the “promotor de salud,” a lay health worker in Spanish-speaking countries. Upon joining Zócalo, patients are paired with this intermediary who connects members to government or community programs to meet whatever needs Zócalo cannot. “The community has been trained for generations that healthcare is hard, hard to access, you don’t always get good access, you have to wait, and this is different,” Hardin said. “You have a community health worker who will answer your questions at any time of day. One of our key focus areas right now is helping people understand how to use a community health worker. It’s all about communication and trust building.” Hardin says community health workers may help navigate transportation systems, schedule appointments or explain what a deductible is and what resources a patient can access. Members pay a $40 per individual or $65 per household monthly membership fee agnostic of insurance. Hardin did not want to see families divvied up between different plans. “That’s not how our culture lives,” she said. “For Latinos, healthcare lives in the family, it is the family.” Membership includes 12 physician visits per year, unlimited access to the promotor de salud through chat, video and phone. The inclusion of lab work and medications are in the works. After a few months of care in California, Zócalo is seeing patients arrive with laundry lists of previously unaddressed health needs. During appointments, patients often meet Latino-identifying and Spanish-speaking care members, a measure to avoid lingual or cultural misunderstandings. While other providers may mark patients as non-compliant when a patient doesn’t pick up a medication or misses an appointment, Zócalo works to allow patients to share the story. If they couldn’t afford the cost of care or couldn’t take time off work, the promotor de salud helps to find a solution. “For a lot of underrepresented communities, Latinos or otherwise, they’ve been left to safety net services and those safety net services are not in a position to innovate on behalf of those providers or that community,” Cardenas said. “We’re stepping up with our personal and professional experience to think about what can be done in hopes that we can build something great or a model that can be replicated. There’s room for a lot of winners in this space.” Starting at primary care, Cardenas thinks, is the space that players need to begin if they’re serious about innovating healthcare. He imagines future iterations of the Zócalo digital platform, the potential of retail clinics, community centers and pop-up clinics. “There are a lot of people using these DEI punchlines to take advantage of this opportunity that we have right now, this momentum to address the inequities that we see in healthcare,” Cardenas said. “Unfortunately, a lot of these words being spoken are just being used for that sound bite. Historically, the people using these words haven’t walked the walk. We have to take this opportunity to really do something more. It’s easy to talk about it on a panel or a stage but it’s the action that we need to see.” Retraining providers to understand race in the context of medicine   Spora Health bills itself as a telehealth primary care provider serving people of color. Chief Medical Officer Louis Capponi, M.D., told Fierce Healthcare that while self-selection creates a pool of providers who are already interested in the mission and ready to learn, the Spora Health Institute helps providers first unlearn the misconceptions of the past. The internal program includes two days of training on how to provide culturally competent care and includes everything from active listening, building trust and the clinical misconceptions of race that continue to linger. “For example, when we write a practice guideline around common dermatological conditions, we will highlight both the past misconceptions around skin tone and the frequency of certain conditions that have been traditionally more prevalent in white populations but also emphasize that condition can be prevalent or important in Black populations,” Capponi said. “We’re undoing some of the learning that has happened along the way and not relying as much on race as a key clinical indicator, because race is a construct that is artificial, and from a medical perspective is not sensitive or specific as it relates to diseases and conditions.” Spora emphasizes how external manifestations of diseases may appear different on different tones of skin, what other manifestations of an illness may be and how racism skews care. Capponi uses research to reverse engineer the training he designs. Black patients on average receive fewer pain medications and often receive the drugs later in treatment. By making Spora healthcare professionals aware of the tendency of providers to overlook the pain of certain patients, he hopes to decrease that ache of unconscious bias. “We look at the elements of a care process where people of color have had poor experiences,” Capponi said. “For example, Black Americans are interrupted earlier than white Americans in clinical encounters. So we train or retrain around that fact, but we also train around active listening. We also know that distractions are met or magnified in a virtual setting where you're interacting with the patient primarily through video. So, you really must be sure to make eye contact through the camera, use techniques to reinforce understanding of what you're hearing.” For providers and administrators outside BIPOC-focused care, Capponi first suggests self-education, then thinking about trust as a fundamental goal with all patients. Building trust in clinical trials and creating non-biased data sets   One need not time travel to find racial inequities in health. Black birthers are three times more likely to die in childbirth. Black Americans are 77% more likely to experience a lower extremity amputation instead of revascularization. Yet, what is often first mentioned in the conversation of mistrust in the U.S. healthcare system is the Tuskegee syphilis study which began in the 1930s. What is also often offered as the root for medical failure when it comes to underserved populations is biased data sets. As the co-founder of NowIncluded, an organization focused on including Black Americans in clinical trials and creating online health communities, Tiffany Whitlow understands when someone says they won’t participate in a trial because of mistrust. She understands why Americans of color will not give U.S. healthcare another chance. “I’m not going to say, ‘Communities of color, you have to stand up and you need to be, and if you’re not going to be, I’m just going to completely discard you,’” Whitlow said. “We’re going to continue to build and invest in those individuals because they might become the best ambassador, the best influencer for a family member who at some point needs to participate in a clinical trial because it could add years to their life.” Whitlow became interested in clinical trials after her son was given albuterol in an emergency room during an asthma attack. At the time, she did not know that, due to a set of genetic mutations found mostly in people of African ancestry, the drug is 47% less effective for African American children and 67% less effective for Puerto Rican children. She sees NowIncluded as addressing two barriers to care: increasing Black access to experimental drugs when others don't work for them and facilitating the inclusion of Black Americans in clinical trials to create less biased data. NowIncluded's parent company, Acclinate, announced a new partnership on Sept. 28 with Lightship Inc., a provider of clinical research solutions. The collaboration allows for members of NowIncluded’s online community to easily enroll in more trials. “Now is the time for us to be included in the solution,” Whitlow said. “That might mean being a part of a clinical trial. That might mean that you’re making different healthcare decisions.” Through NowIncluded creating trust with older community members, she hopes that longitudinal health strategies can trickle down through generations of Black Americans via family connections, something she calls “generational health.” Racial minorities make up nearly 40% of the U.S. population, yet 75% of subjects in 53 trials approved by the U.S. Food and Drug Administration in 2020 were white. This inequality doesn’t account for the disproportionate chronic disease burden that people of color carry.   Just under half of studies even include race in their data; 34.7% reported ethnicity, as compared to 99% that reported sex, a 2021 study found.   The research showed that while clinical trials can open doors to future treatments for diseases like pancreatic cancer, 12.4% of those diagnosed annually being Black, Black Americans are still being left out, making up 8.2% of pancreatic cancer trial participants. "Removing common barriers to clinical trial participation such as geographic constraints or logistical concerns around traveling to a site, missing time from work or coordinating childcare, helps increase access to clinical research," said David MacMurchy, CEO of Lightship, in a press release. “Sometimes, people do not know how to gain access to clinical trials. Our partnership with Acclinate leverages their established, trusted community connections, digital platform and app with Lightship's robust clinical trial infrastructure and commitment to meeting participants where they are to deliver their clinical trial." So far, 10% of the 5,000 people offered enrollment through the partnership between Acclinate and Lightship have accepted.  

While just three brand-name inhalers approved between 1986 and 2020 now face generic competition (thanks in a large part to patent thickets and companies shifting old active ingredients to new devices), the same sort of long monopoly extensions are not as prevalent for nebulizers, a new study published today in Nature Biotechnology explains. The Harvard and University of Calgary authors note that nearly one-third of brand-name nebulizer solutions, which include drugs for asthma or other conditions in an aerosol mist form, faced generic competition before expiration of FDA-listed patents, compared to just 2% of brand-name inhalers. What’s more is that when considering actual market exclusivity (i.e., “the time from brand-name drug approval to generic competition, brand-name drug discontinuation, or 31 December 2020, whichever occurred first”), 13 brand-name solutions for nebulization had a median of just 5.2 years (IQR: 3.5–10.4 years) without generic competition. In contrast, inhalers saw 17.4 years of median protection when counting hops to new devices as a single product line (IQR: 13.2–23.2 years). Brand-name inhalers making such shifts to new devices, they wrote, as to a means to obtaining a longer period of exclusivity include Merck’s Proventil and Foradil, GSK’s Ventolin, Boehringer Ingelheim’s Combivent and Atrovent, and AstraZeneca’s Pulmicort. So why the wide discrepancy between inhalers and nebulizers? First author William Feldman of Harvard Medical School told Endpoints News via email: But nebulizers also saw shorter periods of market exclusivity because of delays in the release of brand-name nebulizer solutions, Feldman , Doni Bloomfield, Reed Beall  and Aaron Kesselheim wrote. “The time between the release of inhalers and the release of the same ingredients in nebulized form has meant that certain at-risk patients lacked access to preferred forms of treatment,” they wrote. “Physicians frequently rely on nebulizers to treat asthma and COPD, because some patients may not be able to use inhalers and because some simply favor nebulizers. A recent study of Black and Latino/Latina patients with moderate-to-severe asthma, for example, found that 67% chose to use nebulizers for SABA administration.” Another concerning finding cited by the authors is a recent turn by brand name manufacturers to enantiomers of older racemic formulations — levalbuterol (an enantiomer of racemic albuterol) and arformoterol (an enantiomer of racemic formoterol) — “despite little, if any, clinical benefit associated with the newer products compared to the older ones,” they added. So how to fix this situation? The authors point to regulatory reforms, saying it’s: