Food insecurity among African and Hispanic American communities in America

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By Nailah John, Program Associate

Millions of Americans struggle with food insecurity—defined as limited or uncertain access to sufficient, nutritious food. People experiencing severe food insecurity skip meals or go hungry because they lack financial resources to purchase food. Food insecurity is associated with harmful consequences to physical and mental health, along with adverse behavioral and academic outcomes.

With millions of Americans out of work since mid-March 2020 due to COVID-19, low-income families and communities of color, who were already at risk for food insecurity, face even greater hardship. In March and April 2020, 48 percent of African American households and 52 percent of Hispanic households experienced food insecurity, according to data published in the American Journal of Public Health. Over many decades, discriminatory policies and practices have caused African American communities to be more likely to live in poverty, face unemployment, and have fewer financial resources, like savings or property, than their white counterparts.

Food deserts, which are common in low-income areas, have contributed to the crisis of food insecurity. Food deserts are regions where people have limited access to healthy and affordable food. In these areas, people’s nutritional options are often limited to cheaper, high-calorie, and less nutritious food. In eight of the 10 counties in the U.S. with the highest food insecurity rates, more than 60 percent of the residents are African American. Associate Professor of Kinesiology and Nutrition at Northern Illinois University, Odoms-Young, said “it is really not surprising when you consider the drivers of food insecurity: income, employment. It is also an accumulation of disadvantages that happens. I don’t think people always recognize that accumulation—how disadvantages can accumulate over generations and cause those disparities in wealth.”

African American and Hispanic American populations are disproportionately enrolled in the government Supplemental Nutrition Assistance Program (SNAP). This benefits over 35 million Americans. The Biden Administration recently allocated $1 billion to the SNAP benefits distributed each month, which will increase the food stamp benefits of approximately 25 million people. Food insecurity, unfortunately, continues to be a major problem in America, exacerbated by the effects of the pandemic, from the lack of access to reduced-cost school meals to high rates of unemployment.

Access to nutritious food is essential to creating a more healthy, sustainable, and productive society. It is, therefore, crucial that we continue to advocate for African American and Hispanic communities, which are most at risk for food insecurity.

Jeanette Contreras portrait

PBMs profit while consumers foot the bill. Policymakers must act

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By NCL Director of Health Policy Jeanette Contreras

As consumers, when we go to the pharmacy for our medications, we expect a fair price. However, there’s growing evidence that pharmacy benefit managers — or PBMs — have been impeding the savings that should be going to consumers. Consumers deserve  to share in the cost savings, and we need policymakers to step in and help make that happen.

We previously wrote about our disappointment in how PBMs have evolved from once honest brokers to becoming profit driven and greedy, now taking savings away from consumers and patients.

One avenue PBMs use to pocket savings is through pharmaceutical rebates. PBMs negotiate with companies to lock in discounts for drugs in order to secure the drugs’ placement on a list (formulary). PBMs have notoriously leveraged formularies to give greatest access to the drugs that pay the PBMs the largest rebates, leaving less expensive drugs off-limits to consumers.

A recent Senate Finance Committee report found that rebates to PBMs have significantly increased since 2013 (some as high as 70 percent). But these discounts fail to lower the patients’ out-of-pocket costs for necessary treatments, such as insulin. For one product, the manufacturer offered the PBM a 56 percent rebate – which means more than half of the savings for insulin are going to a company that doesn’t even make the lifesaving medication.

Insulin is expensive. Forbes recently reported that newer versions cost patients between $175 and $300 a vial. The story points out diabetes patients need multiple vials, the cost of which add up quickly; the total annual value of rebates and discounts for PBMs is likely to be more than $5,000 per patient. As a result, consumers lose, paying more than many of them can afford for lifesaving drugs.

Another way PBMs profit is by avoiding competition, which would drive value and savings for consumers. Three main PBMs accounted for about 60 percent of all U.S. prescription claims in 2019. And when it comes to insulin, with so few industry players, it’s no surprise that consumers again find themselves on the losing end.

We’re pleased to see that some policymakers in the states are taking steps to address these issues. In New Jersey, the state is shaking things up by creating alternatives to how it contracts with PBMs — which is, in turn, increasing competition and benefitting consumers. New Jersey residents are saving  a bundle (to the tune of $2.5 billion over five years).

In New Hampshire, a recent study shows that the state can expect to save an estimated $17.8-$22.2 million annually thanks to legislation that will utilize a similar competitive PBM contract process.

While this is encouraging news, there is still more work to be done to bring to light the role of PBMs. Policymakers need to step in to ensure PBMs deliver savings to patients as they were originally intended to do. We’re encouraging state and federal action to review the role PBMs play in driving up costs and to address the many loopholes they use to increase profits.

Consumers — not PBMs — should come first at the pharmacy counter. Reach out to your elected officials. Share this story on social media to help raise awareness. And stay tuned as we continue the conversation.

Jeanette Contreras portrait

Expanded Medicaid coverage for postpartum care

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By NCL Director of Health Policy Jeanette Contreras

The COVID-19 pandemic has enlightened us to how the social determinants of health adversely impact maternal outcomes in low-income, medically underserved communities. Year after year, the United States continues to have the highest maternal mortality ratio among wealthy countries. In efforts to address this disparity, the American Rescue Plan Act includes a provision that allows states to expand Medicaid coverage to women for up to one year after childbirth.

The dismal maternal and infant mortality rates are directly correlated with the health disparities that disproportionately afflict black, indigenous, and women of color. A 2019 report from the Centers for Disease Control and Prevention (CDC) found that Black women were 3.3 times more likely than white women to die from pregnancy-related complications and Native American and Alaska Native women were 2.5 times more likely than white women to die within a year after childbirth.

Medicaid has traditionally been seen as a safety net for low-income pregnant women and children, providing health coverage that funds more than four in ten births in the U.S. each year. Under federal law, Medicaid must cover pregnant women with incomes up to 138 percent of the Federal Poverty Level (FPL) through 60 days postpartum. Each year, over 1.6 million women across the U.S. are effectively placed at risk for becoming uninsured when that 60-day coverage period ends.

Women who live in states that expanded Medicaid under the Affordable Care Act (ACA) are eligible to continue their health coverage through Medicaid. Additionally, the Families First Coronavirus Response Act, which passed last year, provides states with a 6.2 percent increase to the Federal Medical Assistance Percentage (FMAP) rate to cover new enrollees eligible under the ACA Medicaid expansion as long as the Public Health Emergency is in place or at least throughout 2021. However, the women living in the 14 states that have yet to expand Medicaid would find themselves uninsured.

Under the American Rescue Plan, for the next five years, states have the option to extend Medicaid and the Children’s Health Insurance Program (CHIP) eligibility to pregnant individuals for 12 months postpartum. Though each state’s Medicaid program is different, the inclusion of this provision incentivizes states to extend health care to mothers during the most vulnerable time in their lives. This increased access to health care will pave the way towards improving health disparities for our most at-risk women and infants beyond the pandemic.

Consumers face an unfair disadvantage at the pharmacy counter

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By Sally Greenberg, NCL Executive Director

Everywhere we turn these days, we find ourselves wondering if we are getting a fair deal. Americans continue to suffer the economic consequences of a year-long global health pandemic, and many of us are trying to stick to the essentials and stretch our dollars where we can. As COVID-19 has reminded us, there aren’t many issues families face that are more significant than access to health care.

Families can’t go without essential prescriptions and often wonder why the price seems to go up each time they go for a refill. In fact, we are likely paying more than necessary at the pharmacy counter, but we don’t often know — or even think to ask — why.

A variety of factors drive drug costs, some of which are obvious: the cost of research and development, distributing the product, the pharmacies’ profits – but there is one far less known cause of price increases: PBMs, short for pharmacy benefit managers.

Most people have never heard of PBMs, and PBMs like it that way. They are billion-dollar companies that control more than 80 percent of the prescription drug formularies, (formularies are the lists of drugs that a health plan allows its members to access) — in the United States.

Because of their outsized role, too often PBMs determine how much consumers, businesses, government agencies, and others pay for medicines. As originally conceived, PBMs were meant to help ensure that patients get a fair deal by:

  • working with manufacturers to ensure rebates (or savings) for medications
  • working with insurance companies to determine which medications are covered
  • working with pharmacies to set the price points and help reimburse pharmacies for dispensing prescriptions.

In theory, PBMs should be lowering costs for everyone. However, as they have evolved and grown, they’ve become greedy and self-serving entities, scooping up discounts for themselves and throwing consumers under the bus. All the while, their profits continue to soar as they are all among the top Fortune 500 companies.

Sadly, PBMs have also found ways to manipulate the system and put their own profits first.

Insulin is a prime example. Diabetes patients who need their medication to survive are increasingly left with fewer options for treatment. When PBMs get involved, consumer costs increase.

One recent analysis found that the total value of rebates and discounts for insulin on an annual basis amounts to more than $5,000 per patient. Another report explained that the net price on one insulin product — what the company earns as revenue — declined by 53 percent since 2012, while the list price increased 141 percent. As the WSJ story explains, this is in part due to PBM middlemen meddling. In order to ensure formulary positions (which PBMs control), companies are paying more and more each year.

Consumers don’t know where high drug prices come from and they shouldn’t have to — the system needs to deliver affordable, accessible, safe and effective medications without any entities taking an unfair or hidden profit. The stakes are too high as we look ahead to the health challenges that millions face with the Covid pandemic.

NCL joins with many other groups, including America’s Agenda, United Food and Commercial Workers International Union, HMC Healthworks, Union of Bricklayers and Allied Craftworkers, National Community Pharmacists Association, National Alliance of State Pharmacy Associations, Diabetes Leadership Council, and Diabetes Patient Advocacy Coalition in helping to expose hidden, and frankly, indefensible profits being directed to the coffers of PBMs — money that should be redirected to bring drug prices down for patients and consumers.

Let’s all ask hard questions about PBMs’ role in our healthcare system and whether we can’t be using the profits they are taking to lower drug costs. Share this story with others. Talk with your friends and family. Ask your local pharmacist questions.

Consumers – not PBMs — should come first at the pharmacy counter. Stay tuned for more from us on this, and let’s continue the conversation.

Nancy Glick

2021 NCL Food Policy Priorities

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Nancy GlickBy Nancy Glick, Director of Food and Nutrition Policy

With the enactment of the American Rescue Plan, the new Biden Administration will bring about important changes to overcome one of the most urgent problems caused by the COVID-19 pandemic: millions of Americans are facing hunger in the U.S. and many of them are children. According to the latest Household Pulse Survey from the Census Bureau, over 25 million people do not have enough food to eat some of the time or often.[1]

Yet, this is just one of the food-related challenges encountered during the pandemic. About 110,000 restaurants have closed permanently[2], retail food prices went up an average of 3.4 percent in 2020[3], and the amount of food waste, estimated at between 30-40 percent of the food supply before the pandemic[4], has grown exponentially. Additionally, and unrelated to the pandemic, the recently released 2020-2025 Dietary Guidelines for Americans underscores an explosion of obesity and diet-related diseases in America. Some disturbing findings are that 6 in 10 adults have one or more diet-related chronic diseases and seven percent of children and teens have been diagnosed with high blood cholesterol levels.

All these problems affect the lives of all Americans, which is why the National Consumers League (NCL) will intensify our education and advocacy in 2021 to advance healthier eating, improve food safety, reduce food insecurity, and address food waste.

We focus our efforts on where we can have the most impact, taking action to:

1. Elevate portion control and balance as a consumer issue

NCL will advance the Dietary Guidelines’ recommendation to achieve a healthy balance of food choices by emphasizing the importance of portion control and ensure consumers know the recommended daily intake of calories is 2,000 per day. We also want to encourage greater use of “My Plate,” a plan developed by the U.S. Department of Agriculture (USDA) to help consumers personalize their portions for various food groups—what and how much to eat, based on one’s age, sex, height, weight, and physical activity level.[5]

2. Reduce excess sodium in the diet

NCL is greatly concerned that Americans on average consume 50 percent more sodium per day than recommended by the Dietary Guidelines. Because this increases the risk for hypertension, heart disease and heart attacks, and stroke, we will advance the goal set by the Food and Drug Administration (FDA) to lower sodium intake to 2,300 milligrams (mg) per day and encourage consumers to flavor foods with herbs and spices instead of salt, and use the Nutrition Facts label to choose products with less sodium, reduced sodium or no salt (sodium) added.

3. Improve the labeling of alternative sweeteners

NCL applauds FDA’s decision to include “Added Sugars” on the recently updated Nutrition Facts label but we remain concerned about how novel sweeteners are labeled. Therefore, NCL is supporting a Citizen’s Petition to FDA to ensure transparent labeling of substitute sweeteners and has joined with other consumer groups in urging FDA to stop misleading claims, such as “No Added Sugars,” “Zero Sugar,” and “Reduced Sugars.” These claims imply the new product is healthier than the original, without disclosing that the sugar reduction resulted from reformulating with artificial substances and sugar alcohols.

4. Make alcohol facts labeling mandatory

Since 2003, NCL and 75 other consumer, public health, medical and nutrition organizations have pressed the federal agency that regulates alcoholic beverages—the Treasury Department’s Bureau of Alcohol and Tobacco Tax and Trade (TTB)—to issue rules requiring an easy-to-read, standardized “Alcohol Facts” label on all beer, wine, and distilled spirits products. Currently, TTB has opted for voluntary labeling and the result is that many products remain unlabeled or carry incomplete labeling information. We are not giving up! In 2021, NCL will step up the fight to ensure complete labeling information on alcoholic beverages.

5. Require labeling of caffeine content

FDA considers 400 mg of caffeine per day as the amount not generally associated with dangerous side effects. An 8-ounce cup of coffee has about 95 mg of caffeine, a 12 ounce can of Coca-Cola has 34 mg, high caffeine drinks may have 160 mg for 16-ounces. The FDA only requires food labels to disclose that there is added caffeine in the food or beverage. This makes it hard for consumers to stay within the recommended limit because they don’t know how much caffeine is in the foods and beverages they consume. For this reason, NCL strongly believes that all products containing caffeine should be required to list the amount of caffeine per serving and per container and we will push for that requirement.

  1. Modernize food standards of identity

“Standards of identity” establish recipes for what a food product must contain, how it must be proportioned, and sometimes how it must be manufactured. However, many food standards are now 75 and even 80 years old and out of date. This is why NCL supports FDA’s action plan to modernize food standards of identity, but we are also calling attention to several food products—such as olive oil, Greek yogurt, and canned tuna—where issuing new or updated standards of identity are needed now.

7. Revise the definition of the term “healthy” and front of pack food labeling symbols

Currently, a food can be labeled “healthy” if the amount customarily consumed is low in fat, low in saturated fat, contains less than 480 mg of sodium, has a limited cholesterol, a significant amount of fiber, and at least 2 additional beneficial nutrients such as vitamins A, C, D, calcium, iron, protein or potassium. This will change because FDA recently modified how low fat will be calculated. While NCL supports this step, we will press FDA to address if and how added sugar content is calculated and will encourage FDA to adopt a “Traffic Light” labeling system to depict “healthy” on the front of the package.

8. Strengthen the food safety system

NCL will work individually and as a member of the Safe Food Coalition to make improvements in the nation’s food safety system. Priorities include finalizing FDA’s Food Traceability Proposed Rule, which would establish a standardized approach to traceability recordkeeping; expanding pathogen testing in meat and poultry products; and updating safe handling instructions labels for these products.

9. Reduce the amount of food waste

Every year, about 90 billion pounds of food goes uneaten in the US, with huge environmental and food insecurity consequences. To change this food waste crisis, NCL will raise awareness of food loss and waste and inform consumers about how they can reduce food waste in their homes and when they go out to eat.

10. Increase funding and access to federal nutrition programs

NCL will work to make permanent the 15 percent Supplemental Nutrition Assistance Program (SNAP) benefits increase now included in the American Relief Plan, while also pressing for additional funding for the National School Lunch and Breakfast Program.

Conclusion: Advancing a policy agenda that ensures transparent food labeling, improves the safety and quality of the foods people eat, reduces food insecurity, and addresses food waste is essential to improving American’s lives. The stakes are high and NCL is committed to making a difference for consumers

[1] U.S. Census Bureau. Household Pulse Survey. May 20, 2020

[2] National Restaurant Association. COVID-19 Restaurant Impact Survey V. December 2, 2020

[3] U.S. Bureau of Labor Statistics. Consumer Price Index Summary. March 10, 2021

[4] Food and Drug Administration. Food Loss and Waste. February 23, 2021

[5] The National Confectioners Association “Always a Treat” consumer education campaign is one example of how portion control can be easily utilized to control calorie consumption and achieve the dietary patterns recommended in the Dietary Guidelines. As part of this campaign, leading chocolate and candy companies have pledged that half of their individually wrapped products will be available in sizes that contain 200 calories or less per pack.

Is it a meat product or not?

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By Nailah John, Program Associate

My husband has a great desire for meatless products, so on my weekly grocery shopping visits, I find myself standing in the freezer aisle for minutes reading the confusing labels on these meatless products. Many of the labels illustrated on the front of the packages usually have an image of a burger or chicken nuggets and can be difficult to distinguish between actually meat products. The packaging displays verbiage like Chik, Steaklet, Well Carved, Chick N’Mix, and are placed in areas where grocery shoppers purchase regular meat products, which makes it all the easier for consumers to mistakenly purchase meatless products.

Plant-based burgers and faux-chicken nuggets are the new trend and many consumers either want to try it or have fallen in love with the product. According to a poll done by Gallup in 2020, 41 percent of adults in the U.S. have tried a plant-based meat product. The study illustrated that about half of Americans are familiar with a plant-based product. The overall takeaway? Plant-based products are in fact getting pretty big so their popularity is growing. Many consumers of plant-based products have expressed that they are cutting back on their meat consumption. Health, the environment, and animal welfare are all cited as major reasons why. With more and more Americans trying these plant-based products labeling should be precise, not misleading.

Many industry leaders continue to recommend that these products should not use wording like “vegan” or “vegetarian” because it may turn away potential customers. It is also suggested that putting meat-free options in a separate vegetarian section of the menu or in the vegetarian section of a grocery store could reduce sales. The term plant-based has been the alternative to the word vegan which is more appealing to the consumers.

However lucrative marketing buzz words may be, the wording and imaging for products should reflect what the consumer is purchasing. This wordplay and product placement tactics are being used to bamboozle consumers.

We all have a right to know what is in our food, how it is produced, and where it is from. We also have the right as consumers to demand clear labeling. It’s challenging to stand in a grocery store for 5 to 10 minutes just trying to be sure that the plant-based product we’re looking to buy is actually plant-based. The labels and imagery do not reflect this by showing chicken-like nuggets, burgers, meatballs, and other imagery that sends a false message to our minds. As a consumer, I no longer want to be confused. I want to be able to easily differentiate between real meat and plant-based meat products.

Jeanette Contreras portrait

La tercera vacuna trae esperanza

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By NCL Director of Health Policy Jeanette Contreras

La Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) acaba de aprobar una autorización de uso de emergencia para la vacuna de Johnson & Johnson, la tercera vacuna para combatir el coronavirus en EEUU. Aunque parece que no es tan efectiva como las otras dos, la vacuna de Johnson & Johnson ofrece una protección de 85 por ciento contra casos severos de COVID-19 y 100 por ciento de eficacia para evitar hospitalización y mortalidad, a causa del COVID-19. Con solo una dosis, esta vacuna ofrece protección de 72 por ciento contra el COVID-19 que ultimadamente ayuda controlar la pandemia en la población y alcanzar un nivel de inmunidad necesaria para regresar a la vida normal.

Una ventaja enorme de esta vacuna en términos de administración, es que se puede mantener en refrigeración normal por meses. Las otras vacunas requieren mantenimiento de temperatura súper baja en refrigeradores industriales que solo se encuentran en hospitales grandes. La vacuna de Johnson & Johnson es ideal para distribuir a comunidades rurales y en clínicas comunitarias. La aprobación de esta tercera vacuna, aumenta la disponibilidad y nos da esperanza de poder vacunar a más personas, más rápido con solo una dosis.

Sabemos que la comunidad Latina sufre de una taza de contagio más alta que otros grupos. Latinos constituyen una gran cantidad de empleados en trabajos esenciales con alto riesgo de contagio, como en la producción de comida y en puestos de trabajo de pequeños negocios. Mientras muchos esperan vacunarse, otros tendrán dudas o miedo de vacunarse. La campaña De Ti Depende nos asegura que es normal tener preguntas y ofrece información y respuestas en español para educar a la comunidad latina.

Campañas educativas como esta son necesaria para combatir información falsa y mitos que circulan en las redes sociales. Se escuchan mitos que las vacunas en general hacen daño o que alteran o cambian el ADN. Sin embargo, está comprobado científicamente por siglos que las vacunas han salvado vidas y nos han protegido. Los Centros para el Control y la Prevención de Enfermedades (CDC, por sus siglas en inglés) tiene una página dedicada a información para derribar los mitos más frecuentes acerca de estas vacunas.

Para alentar a la población a vacunarse, muchas empresas grandes están ofreciendo tiempo pagado o incentivos financieros a los empleados que se vacunan. Por ejemplo, supermercados como Publix les da $125 y Kroger les da $100 a empleados cuando reciben la vacuna completa. Dollar General les aumenta cuatro horas de pago normal a los que se vacunan.

Gracias a la autorización de la nueva vacuna, presidente Biden afirma que para el fin de mayo habrá vacunas para todos los adultos en EEUU. Las personas que deciden vacunarse, pueden buscar información confiable en el recurso de Telemundo – PlanificaTuVacuna.com para verificar la elegibilidad de acuerdo a las órdenes de cada estado.

Getting more vaccines in arms: Trust and efficiencies

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Guest blog by Farah Towfic, PharmD, MBA, director of the U.S. Pharmacopeia COVID-19 Vaccine Handling Toolkit

In the United States, nearly 200 million doses of influenza vaccines are administered annually. Clearly, pharmacists, nurses, physicians, and other healthcare practitioners have demonstrated a successful track record of delivering robust immunization programs for many years. However, the unprecedented scale and speed at which the COVID-19 vaccinations must be delivered to curb the devastating impact of this pandemic has surfaced enormous challenges—which have been further compounded by significant vaccine supply demand.​ Never before have we had to distribute multiple doses to more than 15 billion individuals around the world, with more than 300 million in the U.S. alone.

The pandemic has also recharged the focus on vaccine hesitancy, a challenging and complex issue which, at its core, is about trust based on a person’s experience and perspective. According to the KFF COVID-19 Vaccine Monitor, a growing share of the public is open to getting vaccinated, but many of the same groups that were hesitant in December 2020, when the first COVID-19 vaccines were released, remain hesitant now. When deciding whether to get vaccinated, most people say they will likely turn to pharmacists, doctors, nurses, and healthcare providers as the source for information. The KFF COVID-19 Vaccine Monitor also notes that 85 percent of people trust their own doctor or healthcare provider at least a fair amount for reliable vaccine information.

If we are going to mitigate the impact of this pandemic, we need to help build and maintain trust in COVID-19 vaccines. As an independent, nonprofit, scientific organization, U.S. Pharmacopeia (USP) has been dedicated—for more than 200 years—to improving global health and building trust in medicine through public standards and related programs that help ensure the quality, safety, and benefit of our drugs. With our shared goals to provide patient access to quality medicines, USP is proud to be a founding member of the National Consumers League (NCL) Health Advisory Council. The Council’s informative communication and opportunities for engagement provide critical perspectives that help shape and inform USP’s strategic focus and initiatives. The Health Advisory Council also demonstrates the power of collaboration—which is a cornerstone of USP’s work.

By working together with stakeholders, partners in industry and the U.S. government, we are able to identify the COVID-19 vaccine operational challenges and also provide solutions. One of these solutions is the recently released USP COVID-19 Vaccine Handling Toolkit, which addresses gaps that slow getting shots in arms and helps healthcare practitioners safely deliver vaccines in a variety of settings.

As millions of additional doses of COVID-19 vaccines are released, the USP COVID-19 Vaccine Handling Toolkit is helping doctors, nurses, pharmacists, and other healthcare practitioners create operational efficiencies to vaccinate more people in their communities quickly and safely, all the while maintaining quality. It includes strategies in three key areas:

  • Preparation and labeling to support different practitioners preparing and administering vaccines including how to maximize the number of doses per vial and enabling pre-drawing of vaccines in advance of large immunization events.
  • Storing, handling, and transporting the vaccine to mass vaccination clinics, nursing and long-term care facilities, and more.
  • Waste prevention and disposal to support settings in preventing vaccine waste and addressing gaps for vaccine administrators in proper disposal of ancillary supplies, such as syringes.

“Using the strategies from the USP Vaccine Handling Toolkit for pre-drawing syringes and streamlining our processes and workflow we increased shots in arms by 50% per day,” says Patricia W. Slattum, Pharm.D., Ph.D., BCGP, a vaccine administrator with the Virginia Medical Reserve Corp and Virginia Commonwealth University.

More than 40 independent expert volunteers along with U.S. government representatives developed this toolkit that enables healthcare practitioners to benefit from consistent, scientific-based strategies developed by independent experts that close efficiency gaps across states and territories.

The USP COVID-19 Vaccine Handling Toolkit is one of several initiatives USP is undertaking to support quality and build trust in COVID-19 vaccines, treatments, and preventatives. For example, our Hand Sanitizer Toolkit, launched in spring 2020, is being used by many around the world to ensure quality preparation of this essential COVID-19 preventative.

As the nation’s pioneer consumer organization, that leads the charge on the importance of adherence to live-savings medicines, NCL plays a pivotal role in helping to build trust in vaccines. USP values the opportunity to share the COVID-19 Vaccine Handling Toolkit with NCL and looks ahead to future opportunities to partner with NCL and other stakeholders in the patient advocacy community.

As more is learned about COVID-19 vaccines, additional information will be shared in the future. We encourage NCL’s readers to sign-up for updates at https://www.usp.org/covid-19/vaccine-handling-toolkit.

About USP
USP is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. Through our standards, advocacy, and education, USP helps increase the availability of quality medicines, supplements, and food for billions of people worldwide.

Jeanette Contreras portrait

Vaccine recommendations for those who recovered from COVID-19

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By NCL Director of Health Policy Jeanette Contreras

As the United States prepares for the release of a third COVID-19 vaccine, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) meets to discuss further implementation considerations that will inform guidance for the vaccine rollout. At its March 1 meeting, ACIP dedicated a portion of the discussion to whether those who’ve recovered from the virus should still be vaccinated.

To date, there are more than 28 million confirmed cases of COVID-19, and experts estimate that the true number of individuals infected, yet not clinically confirmed, to be triple that amount, pushing the total prevalence to approximately 100 million. A recent study by the National Institutes of Health (NIH) indicates that those who’ve recovered will have a certain amount of natural immunity to the virus for up to eight months after infection, which is in line with the findings of a major British study published in early February, in which 88 percent of participants who previously tested positive for COVID-19 still had antibodies after six months.

Considering that the demand is greater than the supply, it is a difficult task to make recommendations for the equitable distribution of vaccines. For example, Spain issued recommendations that patients wait six months after diagnosis to get vaccinated if an individual is under age 55 with no major health complications. People over 55, or those with health risks that make them vulnerable to reinfection, are exempt from this delay and encouraged to be vaccinated.

Additionally, early studies are showing that immunity in individuals who had recovered and received one shot may be equal to or even exceed those not infected who had received two doses. According to the University of Maryland School of Medicine, a single dose of the Moderna or Pfizer mRNA vaccines would elicit an immune system response sufficient to provide comparable immunity to two doses in a non-infected person. On February 12, France became the first country to issue guidance recommending that people who have already recovered from COVID-19 only need to receive one dose of a vaccine, between 3 and 6 months after their infection.

Early research like this is informing public health policies in other countries. But the United States is known all over the world for its scientific rigor and reliance on randomized clinical trial data as a gold standard. In a recent blog, NIH Director Dr. Francis Collins reassures us that, should other studies support these early results, the experts at the Food and Drug Administration (FDA) and CDC will certainly consider whether one dose is enough.

The implementation of a one-dose vaccine would help to increase supply, however, the emergence of COVID-19 variants presents new challenges for curbing this pandemic. Current CDC guidance states that even if you’ve recovered from COVID-19, you should get vaccinated. Arming yourself with a vaccine will keep you and your family safe, and ultimately help to stave off new COVID-19 variants.

Preventing the spread of COVID-19: Testing & genetic sequencing efforts in response to emerging variants

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With growing concerns regarding the impact of emerging COVID-19 variants, testing and genetic sequencing are critical components of broader return-to-work, return-to-school, and public health surveillance efforts.

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