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Lactic acid, citric acid, and potassium bitartrate (Phexxi, Evofem Biosciences) is a prescription combination, non-hormonal contraceptive gel approved by the FDA in May 2020. The vaginal gel was found to be 86.3% effective with typical use when inserted up to 1 hour before vaginal intercourse.



The gel acts as a contraceptive by maintaining the vaginal pH within its normal range of 3.5 to 4.5, an environment too acidic for sperm to survive. This pH regulating mechanism decreases sperm viability and supports bacteria integral to the vaginal microbiome.



The gel is supplied in a package of twelve, single dose (5 grams), pre-filled applicators with an attachable plunger. The applicator should be inserted into the vagina immediately before or up to 1 hour before vaginal intercourse, with a new dose needing to be administered prior to each act of intercourse.



The most common adverse events (AEs) were vulvovaginal burning (20%) and vulvovaginal itching (11.2%). Of local AEs, 23.9% were mild, 18.7% were moderate, and 2.3% were severe. Rates of these reactions mostly decreased over time.



Women with a history of recurrent urinary tract infections or urinary tract abnormalities should not use the gel due to the 0.36% incidence of cystitis or pyelonephritis in clinical trials.



Male partners of women using the gel might also experience local AEs such as burning, itching, and pain. However, the local AEs experienced by male partners were generally mild (74.7%), while 21.4% were moderate and 3.9% were severe.



The contraceptive gel is an option for women who are seeking a non-hormonal or on-demand method of birth control. Women preferring to use multiple methods of contraception can combine the gel with diaphragms and latex, polyurethane, and polyisoprene condoms. However, it should not be used with vaginal rings.



Spermicide is also available as a vaginal gel, but it is only about 72% effective with typical use.

 Like the non-hormonal contraceptive gel, it can be used on-demand. Nonoxynol-9, the active ingredient in most spermicides, can cause vaginal irritation and increase the risk of HIV transmission.

 In a clinical trial comparing nonoxynol-9 to the , incidences of vulvovaginal itching, burning, and irritation were similar, with the non-hormonal contraceptive gel having a slightly higher incidence of vulvovaginal burning.



The contraceptive gel’s novel pH modulating mechanism is currently being studied for prevention of gonorrhea and chlamydia in the phase 2B clinical trial AMPREVENCE. Preliminary results from the 4-month study period showed a 50% relative risk reduction of chlamydia and a 78% relative risk reduction of gonorrhea. The clinical trial will move on to phase 3 later in 2020.



Although the gel will be available as a prescription only treatment in September 2020, patients may face barriers to accessing the gel during COVID-19. Evofem Biosciences plans to launch a telemedicine program to support patient and provider access to the contraceptive gel.

 Additionally, barriers to contraception access could be further mitigated by enabling pharmacists to prescribe birth control.



Thomas MA, Chappel BT, Maximos B, Culwell KR, Dart C, Howard B. A novel vaginal pH regulator: results from the phase 3 AMPOWER contraception clinical trial. 

Phexxi. Prescribing information. Evofem Biosciences; 2020. 

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208352s000lbl.pdf

https://www.hhs.gov/opa/pregnancy-prevention/birth-control-methods/spermicide/index.html

FDA. Code of Federal Regulations Title 21; April 1, 2019. 

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=201.325

Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel; March 11, 2020. 

https://clinicaltrials.gov/ct2/show/results/NCT01306331

Evofem Biosciences Reports Positive Top-Line Results from Phase 2b Study of Amphora® for Prevention of Chlamydia and Gonorrhea in Women. Evofem Biosciences; December 2, 2020. 

https://evofem.investorroom.com/2019-12-02-Evofem-Biosciences-Reports-Positive-Top-Line-Results-from-Phase-2b-Study-of-Amphora-R-for-Prevention-of-Chlamydia-and-Gonorrhea-in-Women

U.S. FDA Approves Evofem Biosciences' Phexxi™ (lactic acid, citric acid and potassium bitartrate), the First and Only Non-Hormonal Prescription Gel for the Prevention of Pregnancy. Evofem Biosciences; May 22, 2020. 

https://evofem.investorroom.com/2020-05-22-U-S-FDA-Approves-Evofem-Biosciences-Phexxi-TM-lactic-acid-citric-acid-and-potassium-bitartrate-the-First-and-Only-Non-Hormonal-Prescription-Gel-for-the-Prevention-of-Pregnancy

Articles

Lactic acid, citric acid, and potassium bitartrate is a prescription combination, non-hormonal contraceptive gel found to be 86.3% effective with typical use.

New Non-Hormonal Contraceptive Gel Found to Be Effective

Walgreens won the ‘Digital/Mobile Health Solutions’ category in the Fierce Innovation Awards - Healthcare Edition 2020. The annual competition highlights companies that demonstrated innovative solutions that have had the greatest potential to save money, engage patients, or revolutionize the industry over the past year, according to a press release.

The company’s digital health platform, Walgreens Find Care®, helps patients navigate their health care experience virtually, including by accessing convenient in-person and virtual doctor visits to manage chronic conditions. Patients are able to access more than 40 trusted providers that together offer more than 60 services and treat more than 100 conditions.

Walgreens Find Care® can flex and expand to meet emerging and current societal and health issues, according to an email sent to 

 For example, during the coronavirus disease 2019 (COVID-19) pandemic, Walgreens was able to expand the Walgreens Find Care® platform to include new features and telehealth service providers. With guidance from the CDC, the app was able to perform the following tasks:

Help patients connect with a Walgreens COVID-19 testing site.

Allow users to assess their risk for having COVID-19 through the use of a COVID-19 risk assessment tool based on CDC guidelines.

Guide individuals to relevant COVID-19 clinical trials in their area by using the Find My Clinical Trial program.

“We are honored to win this award for the innovative ways Walgreens helps make healthcare simpler, more accessible and more convenient,” said Giovanni Monti, senior vice president of healthcare services of Walgreens Boots Alliance, in a press release. “As a company focused on providing omni-channel solutions that address barriers to healthcare, we have designed Walgreens Find Care® to be the digital ‘front door’ to an integrated healthcare and pharmacy experience. Our goal is that Americans in all communities have convenient access to personalized, high-quality care that helps them lead healthier and happier lives.”

Walgreens Find Care wins Fierce Innovation Award [email]. Sent September 14, 2020. Accessed September 21, 2020.

Walgreens Find Care® receives high honors from Fierce Healthcare. Walgreens. 

https://news.walgreens.com/press-releases/general-news/walgreens-find-care-receives-high-honors-from-fierce-healthcare.htm

. Published September 14, 2020. Accessed September 21, 2020.

Walgreens won the ‘Digital/Mobile Health Solutions’ category in the Fierce Innovation Awards - Healthcare Edition 2020. 

Walgreens Receives Honor for Digital and Mobile Health Solutions in Fierce Innovation Awards 2020

The FDA has approved fluticasone furoate, umeclidinium, and vilanterol (Trelegy Ellipta, GSK) for use in adults with asthma that remains uncontrolled despite treatment with their current maintenance therapy. This is the first and only, once-daily single inhaler triple therapy approved for the treatment of both asthma and chronic obstructive pulmonary disease (COPD), according to GSK.

Andrew Thomas, vice president of Respiratory Business Unit at GSK, said this approval holds major significance for adults with uncontrolled asthma despite treatment with their current maintenance therapy. Due to the challenges that physicians may face to train their patients and prepare them for treatments, as well as the struggle for patients to remember how to take the treatment, this therapy will make a difference.

“There have been multiple inhaler triple therapies used in asthma previously, with a combination of at least 2 inhalers with different dosing regimens,” Thomas said in an interview with 

. “With Trelegy Ellipta, it is only one inhalation a day in a triple therapy.”

The approval was based off the results of the CAPTAIN study conducted in adults 18 years of age and older whose asthma was inadequately controlled despite treatment with ICS/LABA maintenance asthma medication.

The data showed that in patients with uncontrolled moderate or severe asthma on inhaled corticosteroid plus long-acting β 2-agonists, adding umeclidinium improved lung function but did not lead to a significant reduction in moderate and/or severe exacerbations. Further, these patients are recommended to use the single inhaler fluticasone furoate, umeclidinium, and vilanterol due to its favorable, high-risk benefit profile.

Thomas mentioned that not only is this treatment more convenient, but it is 100 ml of improvement in lung function to help patients feel better, breathe easier, and live a fuller life with their asthma.

“We hope that with the addition of these new indications that more adult asthmatics in the United States can get control of asthma symptoms and live better lives because of this, and the same goes for COPD patients,” Thomas said in an interview with 

. “Having this inhaler should make a big difference in the lives of those patients.”

GSK’s Trelegy Ellipta the First Once-Daily, Single Inhaler Triple Therapy Approved for Asthma [email]. Accessed September 18, 2020.

Lee LA, Bailes Z, Barnes N, et al. Efficacy and safety of once-daily single-inhaler triple therapy (FF/UMEC/VI) versus FF/VI in patients with inadequately controlled asthma (CAPTAIN): a double-blind, randomised, phase 3A trial. The Lancet Respiratory Medicine. Doi:

https://doi.org/10.1016/S2213-2600(20)30389-1

This is the first and only, once-daily single inhaler triple therapy approved for the treatment of both asthma and chronic obstructive pulmonary disease (COPD).

FDA Approves Trelegy Ellipta as First Single Inhaler Triple Therapy for Asthma

the Monitoring the Future (MTF) study showed that vaping marijuana and nicotine rose sharply in the past 3 years among college age students, or students between 19 and 22 years of age, according to a press release.

The percentage of college students who said they vaped marijuana in the past 30 days grew from 5.2% in 2017 to 14% in 2019. Additionally, the corresponding percentages for their non-college-attending peers increased from 7.8% in 2017 to 17% in 2019. 

MTF is an ongoing study of the trends in substance use by adolescents and adults in the United States, with the survey conducted by scientists at the University of Michigan’s Institute for Social Research.

The study showed that the percentage of college-age adults between 19 and 22 years of age who vaped nicotine also rose dramatically between 2017 and 2019. In 2017, 6.1% of college students and 7.9% of those not in college said they vaped nicotine in the past month, increasing to 22% and 18% in 2019, respectively. These increases in vaping marijuana and nicotine are among the largest seen for any substance use reported by the study in its 45-year history, according to the study authors.

“We are seeing an increasingly concerning trend,” said Nora D. Volkow, MD, director of NIDA in a press release. “Many young people may view vaping and cannabis use as ‘safer’, but the reality is that nicotine is highly addictive, and cannabis can also be addictive, particularly in younger adults for whom the brain is still developing.”

The results are based on data from college students 1 to 4 years beyond high school graduation who are enrolled full-time in a 2- or 4-year college in March of the given year, compared with same-age high school graduates not enrolled full-time in college.

The 2019 data also revealed a continuing high prevalence of marijuana use among 

young adults, who are 19 to 22 years of age. In 2018, 43% of this group reported using marijuana in the past year, with this percentage being unchanged in 2019. The prevalence of daily or near-daily use of marijuana (15%) was significant among those not attending college in 2019. This is compared to 5.9% of college students who reported daily or near-daily use of marijuana.

Other highlights in the survey results include the downward trend of cigarette smoking in college students, with only 7.6% of respondents reporting having smoked in the past month. Further, binge drinking has been declining gradually over the past few decades, showing no significant changes for young adults attending or not attending college. Prescription opioid misuse and amphetamine use are also shown to be on a continued decline for college students, according to the study authors.

Vaping, marijuana use in 2019 rose in college-age adults. NIH. 

https://www.nih.gov/news-events/news-releases/vaping-marijuana-use-2019-rose-college-age-adults

. Published September 15, 2020. Accessed September 16, 2020.

The 2019 survey results from the Monitoring the Future (MTF) study showed that vaping marijuana and nicotine rose sharply in the past 3 years among college age students, or students between 19 and 22 years of age.

National Study Shows Vaping, Marijuana Use in 2019 Rose in College-Age Adults

New research suggests that infants born in the fall may have a higher risk for allergic diseases such as eczema, food allergies, asthma, and hay fever.

Previous research has found that food allergies are on the rise, with approximately 2 children in each classroom now allergic to at least 1 food. Researchers at National Jewish Health aimed to discover the reason behind this increase, which showed that many allergic conditions likely start with dry, cracked skin, eventually leading to a chain reaction of allergic diseases known as the atopic march.

“We looked at every child treated in our clinic, and those born in the fall were much more likely to experience all of the conditions associated with the atopic march, said lead author Jessica Hui, MD, in a press release. “Now we are learning more about why that is and we strongly believe it stems from the bacteria on the skin and how they affect the skin barrier.”

According to the study authors, the atopic march typically begins in infancy with eczema and leads to food allergies, asthma, and hay fever in later childhood. Children with eczema often have high levels of the bacteria staph aureus on their skin, which weakens the skin’s ability to keep our allergens and pathogens, according to a press release.

“When food particles are able to penetrate the skin rather than being digested, the body sees them as foreign and creates antibodies against them, which causes the child to become allergic,” Hui said.

To further their research, the investigators are now conducting a clinical trial to examine a wide variety of factors that may contribute to this weakened skin barrier in infants. The study is enrolling pregnant women and following their children into early childhood to consider everything from environmental factors to genetics to medications taken and products used in the home.

“We think if we can intervene at a very young age, even right after the baby’s out of the womb, then potentially that’s a way for us to try to stop the development of this atopic march,” Hui concluded in the press release.

Potential solutions could include sealing the skin barriers of babies with eczema using wet wraps and lotions and introducing allergenic food early in life for children at risk of allergies.




Study Finds Fall Babies at Higher Risk of Lifetime of Allergic Diseases [news release]. National Jewish Health; September 9, 2020. 

http://njhealth.multimedia-newsroom.com/index.php/2020/09/09/study-finds-fall-babies-at-higher-risk-of-lifetime-of-allergic-diseases/

Researchers believe the progression of allergies begins with eczema in infancy before progressing to food allergies, asthma, and hay fever later in childhood.


Study: Babies Born in Fall at Higher Risk for Allergic Diseases

Two phase 3 studies showed an investigational 15-valent pneumococcal conjugate vaccine (V114, Merck) was well-tolerated among patients and met the primary immunogenicity objectives.

The phase 3 Pneu-age study assessed the vaccine’s efficacy in healthy adults aged 50 years or older. The results showed that the vaccine was not inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13), according to the researchers.

In this study, the new 15-valent vaccine was found to be as successful in targeting the 13 serotypes that are currently targeted in the 13-valent version, with the V114 vaccine being superior in targeting serotypes 22F and 33F. This study also demonstrated the 15-valent vaccine was superior in targeting serotype 3, which is known to be a leading cause of invasive pneumococcal disease globally.

In the Pneu-true study, the researchers found V114 successfully demonstrated equivalent immune response across all 15 serotypes in healthy adults aged 50 years or older. In both studies, the researchers found that V114 was not only well-tolerated among patients, but the safety profile of the vaccine was comparable with the current PCV13 and consistent with the results of previous studies that assessed V114.

Merck plans to present these results and any additional phase 3 data from its clinical program to the public, allowing the data to form the basis of global regulatory licensure applications before the end of 2020.

“Diseases caused by serotypes not covered by the currently available pneumococcal conjugate vaccine are increasing worldwide and can vary by country or region. Additionally, we continue to see pneumococcal disease caused by serotypes included in the existing pneumococcal vaccines,” said Roy Baynes, MD, PhD, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, in a press release.

The pneumococcal serotypes that are not included in the current 13-valent pneumococcal conjugate vaccine, such as 22F and 33F, have been found to be associated with invasive pneumococcal disease throughout the country. These 2 serotypes, 22F and 33F, specifically cause 13% of the invasive pneumococcal disease observed in adults aged 65 years and older in the United States.

Additionally, serotype 3, which is targeted in V114, remains a leading cause of invasive pneumococcal disease in adults and children, despite the current 13-valent version in use also targeting this serotype. In total, 15% of invasive pneumococcal disease among adults aged 65 years and older is still caused by serotype 3 in the United States.

“These phase 3 data demonstrated that V114 generated a robust immune response to all 15 serotypes included in the vaccine and reinforce the potential for this investigational vaccine to help protect adults against pneumococcal disease,” Baynes said.

Baynes noted that additional research into pneumococcal disease prevention is necessary in order to target those serotypes that remain a risk factor for certain populations.

Merck Announces Positive Topline Results from Two Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine, Including Pivotal Trial. Kenilworth, NJ: Merck; September 9, 2020. merck.com/news/merck-announces-positive-topline-results-from-two-phase-3-adult-studies-evaluating-v114-mercks-investigational-15-valent-pneumococcal-conjugate-vaccine-including-pivotal-trial/. Accessed September 11, 2020.

Two phase 3 studies showed an investigational 15-valent pneumococcal conjugate vaccine (V114, Merck) was well-tolerated among patients and met the primary immunogenicity objectives. 

Positive Results Announced From Phase 3 Adult Studies Evaluating 15-valent Pneumococcal Conjugate Vaccine

Contemporary Clinic spoke with Gretchen McNally, nurse practitioner of hematology at Arthur G. James Cancer Hospital, about substance use disorder in oncology patients and addiction stigma.

With her immense background in substance use and abuse, McNally started to notice patients using cocaine, alcohol, and other substances in her own experience and the poor patient outcomes rooting from it. 

This made her determined to do something to help these patients, as every encounter with a health care provider is an opportunity to improve outcomes for people with addiction, according to McNally.

McNally also discussed how nurse practitioners can support patient care during COVID-19, how to further stop the stigma surrounding addiction, and what she hopes to see for the future of nurse practitioners in the oncology landscape.

Videos

Substance Use and Addiction Stigma in Oncology Patients

The National Association of Pediatric Nurse Practitioners (NAPNAP) is hosting a TeamPeds Town Hall event, titled “COVID-19 Update and Vaccine Development,” to discuss what health care professionals should expect related to vaccine development and distribution.

“This event is an excellent and timely opportunity for health care providers, parents, caregivers and other stakeholders to break through the noise to hear the most up-to-date, evidence-based information regarding COVID-19 vaccine development and distribution from an expert pediatric nurse leader,” said NAPNAP President Jessica Peck, DNP, APRN, CPNP-PC, CNE, CNL, FAANP in a press release.

The virtual event will be hosted on Wednesday, Sept. 23 at 8 pm ET. Infectious disease and immunology expert Patsy Stinchfield, MSN, CPNP, CIC, will discuss the virus, immune response nuances, what types of platforms are being considered and how the high need global vaccine may be fairly distributed.

Stinchfield is a widely recognized specialist in vaccine-preventable diseases, having served as the first nurse voting member of the CDC’s Advisory Committee on Immunization Practices (ACIP) where she continues as a liaison representing the National Association of Pediatric Nurse Practitioners. She is a long-time member of the CDC’s ACIP Influenza Working Group, the Pediatric Schedule group and Combination Vaccine working group.

The event is available for free to both members and non-members of NAPNAP and media are encouraged to attend. Participants can RSVP by clicking here: 

https://fs12.formsite.com/NAPNAPCE/dff7s1ea4w/index.html?1599583766634

NAPNAP to host town hall on COVID-19 vaccine. NAPNAP; New York, NY: September 9, 2020 [email].

NAPNAP to Host Town Hall on COVID-19 Vaccine

Dr. Reddy’s Laboratories has launched methylphenidate hydrochloride extended-release tablets USP 18 mg, 27 mg, 36 mg, and 54 mg. The generic product is a therapeutic equivalent of Janssen’s Concerta® extended-release tablets, 18 mg, 27 mg, 36 mg, and 54 mg, according to Dr. Reddy's.1

Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged 6 years and older, adolescents, and adults up to age 65 years.2

Adverse reactions of methylphenidate hydrochloride extended-release tablets include decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decreased, irritability, and hyperhidrosis.2




Dr. Reddy’s Laboratories announces the launch of methylphenidate hydrochloride extended-release tablets USP in the US market [news release]. Hyderabad, India & Princeton, NJ; September 3, 2020: BusinessWire. 

https://www.businesswire.com/news/home/20200903005324/en

Vermes K. Mylan Launches Generic Concerta and Zovia in the US Market. 

https://www.pharmacytimes.com/news/mylan-launches-generic-concerta-and-zovia-in-the-us-market

 Published December 29, 2016. Accessed September 8, 2020.

Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of ADHD.

New Generic Methylphenidate Hydrochloride Tablets Available on the Market

Contemporary Clinic spoke with Kelli Garber, lead nurse practitioner for school-based health and the center for telehealth at the Medical University of South Carolina and NAPNAP member, about the growth of telehealth and what health care professionals and nurse practitioners should consider when using telehealth.

Garber has worked with telehealth for the past 6 years, and she has seen such an incredible change in a short period of time in this field. In light of the COVID-19 pandemic, Garber has seen dramatic changes for providers, since these providers had no other choice than to utilize this tool. 

Garber also discussed what other health care professionals and nurse practitioners should consider when using telehealth, how telehealth benefits patients, and what she hopes to see in the future for telehealth and pediatric nurse practitioners. 

The Growth of Telehealth for Health Care Professionals

With flu season approaching and continuing concerns about the coronavirus disease 2019 (COVID-19) pandemic, understanding which demographics are more likely to receive immunizations is vital. New research from the University of California at San Francisco suggests that age, insurance status, and having a personal physician are all important determinants.

According to the investigators, only 1 in 3 US adults received the flu vaccine in 2018, a statistic that could have major implications for the 2020-2021 flu season. Keeping flu-related hospitalizations as low as possible is especially important this year, as the COVID-19 pandemic threatens to overwhelm health systems.

In the study, researchers evaluated self-reported flu vaccination rates from 2018. They included data from the 2018-2019 season, which showed 61,000 deaths, and the 2018-2019 season, which showed 34,200 deaths. The data were recorded in the Behavioral Risk Factor Surveillance System, which includes more than 400,000 adults in the United States.

Perhaps most notably, the study authors found that none of the subgroups exceeded the minimum vaccination rates for herd immunity.

“To achieve herd immunity, we would need to reach about an 80% vaccination rate, but no subgroup in our study exceeded 60%,” said senior author R. Adams Dudley, MD, MBA, in a press release. “While social distancing, mask-wearing, and staying away from crowds will mitigate the spread of the flu, a dangerous type of the flu—such as the Spanish flu of 1918—could result in more than 61,000 fatalities.”

Age, insurance status, and having a personal physician were all important factors in whether an individual received their flu shot. Specifically, 22.6% of those aged 18 to 24 years received the vaccine, compared with 59.3% of those over 75 years of age.

Among patients without insurance, just 16.1% were vaccinated compared to 41.6% of those with insurance, and just 19.4% of patients without a personal physician were vaccinated compared to 43.6% with a physician.

Having a chronic condition was also linked to higher rates of immunization. Just 31.6% of those without a chronic condition were vaccinated, compared to 52.7% of those with 4 or more chronic conditions.

Variations among income groups were smaller, however. Approximately 33.9% of those with a household income of less than $15,000 were vaccinated, compared to 41.8% of those with an income of more than $50,000. Variations were also seen between states, with the lowest vaccination rates in Texas (26.4%) and the highest rates in Washington, DC (44.2%).

Finally, the researchers found lower rates among Black and Hispanic patients (33.9% and 28.9%, respectively), and among men (36.7%). White and Asian patients had rates of 41.5% and 38.3%, respectively, whereas women had a 41.6% vaccination rate.

In order to increase vaccination rates for all subgroups, the researchers recommended both short- and long-term interventions.

“We need a concerted public health campaign that includes public health officials, health care providers, and local communities, and reaches those groups most at risk for not getting vaccinated,” said first author Brandon Yan, a third-year medical student, in a press release. “And we need a proactive primary care outreach strategy to address patient concerns and provide information on how and where to get vaccinated.”

Long-term goals may be more difficult to achieve but are no less important, Yan said. They include making the vaccines more accessible and making them free of charge for those who are uninsured.

“The ongoing pandemic also raises the issue of whether the flu vaccine and the future COVID-19 vaccine should be mandated,” Yan said. “While a federal mandate may be difficult politically, private organizations like colleges and employers could make attendance and employment contingent on getting up-to-date with vaccines.”

COVID-19 Vaccines Are Moving Fast, But Will Americans Agree to Get Them? [news release]. University of California at San Francisco; August 26, 2020. 

https://www.ucsf.edu/news/2020/08/418296/covid-19-vaccines-are-moving-fast-will-americans-agree-get-them

Age, insurance status, and having a primary care provider are all important determinants, but short- and long-term interventions are necessary to increase vaccination rates.

Study: Rate of Flu Immunizations Could Parallel COVID-19 Vaccine Acceptance

Contemporary Clinic spoke with Lukia Beverly, pediatric nurse practitioner and co-chair of NAPNAP’s Immunization Special Interest Group, about National Immunization Awareness Month.

Beverly has seen the stigma around immunizations change in recent years, with a lot of help from the growth of social media and technology.


According to Beverly, parents are still hesitant to bring their children into their health care provider’s offices due to the fear of COVID-19 and the uncertainty surrounding the virus. However, she is still starting to see an increase in rates of the public getting their immunizations.


Beverly also discussed how HCPs can engage families to maintain CDC immunization schedules during the pandemic, how to handle parents’ concerns about immunization visits, and what she hopes to see for the future of pediatric nurse practitioners in regard to immunizations.

Contemporary Clinic spoke with Lukia Beverly, pediatric nurse practitioner and co-chair of NAPNAP’s Immunization Special Interest Group, about National Immunization Awareness Month. 

Nurse Practitioners and National Immunization Awareness Month 

People who received at least 1 flu vaccination are 17% less likely to develop Alzheimer disease over the course of their life, according to a new study by the University of Texas Health Sciences Center at Houston (UTHealth).

There are around 5.8 million people in the United States living with Alzheimer disease. Currently, there is no known treatment. Because of this, it is important to find ways of reducing the risk of Alzheimer disease.

The study was composed of 310,000 electronic health records collected through the Cerner Health Facts database, which is composed of over 600 hospitals and clinicals. The study authors hypothesized that the flu vaccine may introduce proteins needed to train the body to fight off the disease.

The study found that more frequent flu vaccinations and receiving them younger in age were associated with an even lower risk of developing Alzheimer disease. More research is still needed in order to determine how and why the flu vaccine works to prevent the condition.

"One of our theories of how the flu vaccine may work is that some of the proteins in the flu virus may train the body's immune response to better protect against [Alzheimer] disease…Providing people with a flu vaccine may be a safe way to introduce those proteins that could help prepare the body to fight off the disease. Additional studies in large clinical trials are needed to explore whether the flu shot could serve as a valid public health strategy in the fight against this disease,” said Albert Amran, the study’s first author and fourth-year medical student at McGovern Medical School at UTHealth, in a prepared statement.

Flu vaccine may reduce risk of Alzheimer's disease, new study shows [news Release]. Houston, TX; July 27, 2020: EurekAlert!. Accessed August 28, 2020

Flu vaccination may introduce proteins used by the body to learn how to fight Alzheimer disease later on. 

Study Shows Flu Vaccine May Reduce Risk of Alzheimer Disease

The FDA has approved cysteamine ophthalmic solution 0.37% (Cystadrops, Recordati Rare Diseases, Inc.) for the treatment of patients living with cystinosis. The solution is the first FDA-approved cysteamine eye drop formulation that reduces corneal crystals with dosing 4 times a day, according to Andrea Recordati, CEO of Recordati Rare Diseases.

Cystinosis is a rare genetic condition present from birth. The condition causes the build-up of cystine crystals throughout the body, which causes widespread tissue and organ damage, and significantly impacts the eyes. Patients living with cystinosis often have sensitivity to light, eye discomfort and pain. Recent developments in treatment have led to increased life expectancies of those living with the disease.

In a phase 1/2a open label, controlled, randomized study across multiple centers, 15 patients were given cysteamine ophthalmic solution 0.37%. Eight participants also were part of an adaptive dose-responsive clinical trial. Corneal cystine density was assessed using 

The study found that patients receiving cysteamine ophthalmic solution 0.37% saw a 40% reduction in IVCM scores across all corneal layers 90 days after the baseline. Those in the adaptive dose-response clinical trial saw a 30% decrease in IVCM score, which was maintained through the 5-year study period.

“People living with cystinosis and their caregivers have to manage multiple medications every day. To reduce their daily burden, Recordati worked to develop a new viscous eye drop formulation for treating corneal cystine crystals,” said Recordati, in a prepared statement.

Common adverse effects associated with cysteamine ophthalmic solution was stinging, blurred vision, eye irritation, and eye redness. It is applied 4 times daily as a drop during waking hours and can be stored for up to 7 days at room temperature after opening.

U.S. FDA Approves CYSTADROPS® (Cysteamine Ophthalmic Solution) 0.37%, A New Practical Treatment Option for the Ocular Manifestations of Cystinosis (Press release) White Oak, MD, August 28, 2020 EurekAlert! Accessed August 28, 2020

Drops of cysteamine ophthalmic solution are applied 4 times a day.

FDA Approves Ophthalmic Solution for Treatment of Cystinosis

A new study from the Yale School of Public Health has found that higher rates of e-cigarette and marijuana use did not result in more e-cigarette or vaping-related lung injuries (EVALI) in the United States.

The study estimated the relationship between states’ total reported EVALI cases per capita as of January 2020, and pre-outbreak rates of adult vaping and marijuana use. The results showed higher rates of vaping and marijuana use are associated with fewer EVALI cases per capita.

“If e-cigarette or marijuana use per se drove this outbreak, areas with more engagement in those behaviors should show a higher EVALI prevalence,” said assistant professor and study author Abigail Friedman in a press release. “This study finds the opposite result. Alongside geographic clusters of high EVALI prevalence states, these findings are more consistent with locally available e-liquids or additives driving the EVALI outbreak than a widely used, nationally-available product.”

The CDC started a cross-state investigation into vaping-related lung injuries in August 2019, which confirmed more than 2800 cases and 68 deaths. In February 2020, the CDC concluded its national updates and officially classified vitamin E acetate, the additive linked to EVALI and common THC e-liquids, as the “primary cause of EVALI.”

Since the EVALI outbreak, a variety of state and federal legislative actions were passed to restrict sales of nicotine e-cigarettes, including a temporary ban on all e-cigarette sales in Massachusetts in late-2019 and bans on flavored e-cigarette sales in several states and localities, according to the study. The researchers suggest that those policies may have targeted the wrong behavior if the goal was to reduce EVALI risks.

According to Friedman, a negative relationship between EVALI prevalence and rates of pre-outbreak vaping and marijuana use suggests that well-established markets may have crowded-out the use of riskier, informally sourced e-liquids.

The 5 earliest states to legalize recreational marijuana (Alaska, California, Colorado, Oregon, and Washington) all had less than 1 EVALI case per 100,000 residents from 12 to 64 years of age. However, none of the highest EVALI-prevalence states (Utah, North Dakota, Minnesota, Delaware, Indiana) allowed recreational marijuana use.

“If this policy led some recreational marijuana smokers to switch to vaping THC, perhaps in order to avoid detection, it would have increased their likelihood of exposure to contaminated e-liquids when those came on the market. This may have contributed to the higher EVALI prevalence in those states,” said Friedman in a press release.

It may be crucial for policymakers to consider the potential unintended consequences of policies that forbid smokable marijuana while allowing THC e-liquids going forward.




Rates of e-cigarette and marijuana use not associated with larger outbreaks of vaping-related lung injuries, YSPH study finds. Yale School of Public Health. 

https://publichealth.yale.edu/news-article/26879/

. Published August 25, 2020. Accessed August 26, 2020.


The results showed higher rates of vaping and marijuana use are associated with fewer EVALI cases per capita.

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