AAP: Pharmacists Must Band Together and Advocate for a Seat at the Table

Cigarettes of the future could have less nicotine, making them less addictive and making it easier for smokers to quit.

The White House on June 21 published plans for future regulatory actions that include the U.S. Food and Drug Administration’s (FDA) plans to establish a maximum nicotine level to reduce the addictiveness of cigarettes.

“The goal of the potential rule would be to reduce youth use, addiction and death,” said the FDA 

“Nicotine is powerfully addictive,” FDA Commissioner Robert M. Califf, MD, said in the agency’s news release. “Making cigarettes and other combusted tobacco products minimally addictive or non-addictive would help save lives.

“The U.S. Surgeon General has reported that 87 percent of adult smokers start smoking before age 18, and about two-thirds of adult daily smokers began smoking daily by 18 years of age,” Califf said. “Lowering nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood that future generations of young people become addicted to cigarettes and help more currently addicted smokers to quit.”

The announcement did not include an exact date or schedule for proposed new rules on nicotine levels.

Each year, 480,000 people die prematurely from a smoking-attributed disease, making tobacco use the leading cause of preventable disease and death in the United States. Additionally, tobacco use costs nearly $300 billion a year in direct health care and lost productivity, according to FDA.

“While nicotine is not what makes smoking cigarettes so toxic, it’s the ingredient that makes it very hard to quit smoking,” the FDA announcement said. “Addiction to nicotine in combusted products is the main driver of sustained use of these products.”

Each year, more than half of adult cigarette smokers make a serious quit attempt, defined as quitting for at least a day, but most do not succeed due to the addictive nature of cigarettes, according to FDA.

A new nicotine product standard would make those products minimally addictive, possibly nonaddictive. That would help prevent experimenters, who mainly are youths, from starting and becoming regular smokers, said the 

 posted by the president’s Office of Information and Regulatory Affairs.

The lower levels of nicotine also would advance health equity by addressing disparities associated with cigarette smoking, dependence, and cessation, according to the federal notice.

The action is the second major regulatory step by FDA this year affecting tobacco products, and another regulatory step could be coming.

 and flavored cigars to prevent youths from starting smoking and reduce tobacco-related disease and death. Menthol adds a minty taste and aroma to cigarettes, while adding flavors such as strawberry, grape, cocoa and fruit punch appeal to youths and young adults and make cigars easier to use, according to FDA.

The FDA action deals with manufacturers, distributors, wholesalers, importers and retailers who make, distribute or sell the products. FDA “cannot and will not enforce against individual consumers for possession or use of menthol cigarettes or flavored cigars,” the agency announcement said.

FDA is in a public comment period that lasts until July 5 for that ban.

On June 22, the Wall Street Journal, citing people familiar with the matter, reported the FDA is preparing to announce its order to Juul Labs Inc. to take its e-cigarettes off the U.S. market.

This article originally appeared on Medical Economics.

Articles

Proposal follows announced ban on menthol cigarettes, flavored cigars, and e-cig ban could be coming.

FDA Considers Lowering Maximum Nicotine Levels in Cigarettes

Lauren Biscaldi is the Managing Editor of Drug Topics. 

As the World Health Organization (WHO) prepares to meet, the World Health Network has released a press release describing the current monkeypox outbreak a pandemic and urging “immediate and effective action” from country and global public health authorities.

As of June 22, were 3308 confirmed cases of monkeypox in 42 countries.

“There is no justification to wait for the monkeypox pandemic to grow further,” said World Health Network cofounder Yaneer Bar-Yam, PhD, president of New England Complex System Institute, in a press release.

 “By taking immediate action, we can control the outbreak with the least effort, and prevent consequences from becoming worse.”

“The actions needed now only require clear public communication about symptoms, widely available testing, and contact tracing with very few quarantines. Any delay only makes the effort harder and the consequences more severe,” Bar-Yam added.

The WHN announcement on June 22 came the day before a scheduled WHO meeting to determine a monkeypox outbreak designation. Although the organization began using the term “pandemic” to describe the COVID-19 outbreak in March 2020, the organization’s highest level of alert is typically a “public health emergency of international concern.”

Monkeypox is a rare viral illness resulting from infection with the monkeypox virus, part of the same virus family as smallpox.

 According to the CDC, symptoms are similar to smallpox but typically milder and the disease is “rarely fatal.” Symptoms may include fever, headache, muscle and back aches, swollen lymph nodes, chills, exhaustion, and a rash that looks like pimples or blisters on the face, mouth, hands, feet, chest, or genitals.

Monkeypox is spread person-to-person through direct contact with an infectious rash or bodily fluids; respiratory secretions during “prolonged face-to-face contact” or intimate physical contact; or touching items, such as clothing, that were previously in contact with an infectious rash or bodily fluids.

On May 25, the WHO released public health advice for gay, bisexual, and other men who have sex with men (MSM)

; while monkeypox is not limited to this community, a majority of early cases were identified within the community.

 The advice also noted that transgender and gender diverse individuals “may also be more vulnerable in the context of the current outbreak.”

Although there are no specific vaccines for monkeypox, 2 smallpox vaccines—Jynneos and ACAM2000—can be administered as pre-exposure prophylaxis against the disease.

 Jynneos is a non-replicating live virus administered via 2 subcutaneous injections 4 weeks apart. ACAM2000 is a live 

inoculated via pricking the skin surface.

No treatments specific to monkeypox are currently available. If infected, patients who are more likely to become severely ill—such as those who are immunocompromised—may able to receive antiviral medications like tecovirimat (Tpoxx).

Scientists across the globe have criticized the WHO response—or lack thereof—including leading scientists in Africa, who point out that monkeypox has been a regional crisis for years.

“When a disease affects developing countries, it is (apparently) not an emergency,” said Emmanuel Nakoune, acting director of the Institut Pasteur in Bangui, Central African Republic. “It only becomes an emergency when developed countries are affected.” Nakoune is currently running a trial of a treatment for monkeypox.

According to Ahmed Ogwell Ouma, acting director of the Africa Centres for Disease Control and Prevention, monkeypox cases and associated deaths across the continent have already reached “emergency levels.”

While many experts agree that the current monkeypox outbreak meets WHO criteria to be defined as an emergency, the agency is, per reports “in a precarious position after COVID[-19].”

 Many critics of the WHO response believe that a pandemic declaration—rather than an emergency declaration—in January 2020 may have led to governments taking sooner action.

“The WHO needs to urgently declare its own Public Health Emergency of International Concern (PHEIC),” said Eric Feigl-Ding, PhD, an epidemiologist, health economist, and WHN cofounder. “The lessons of not declaring a PHEIC immediately in early January 2020 should be remembered as a history lesson of what acting late on an epidemic can mean for the world.”

The World Health Network declares monkeypox a pandemic — press release. News release. World Health Network. June 22, 2022. Accessed June 23, 2022. 

https://www.worldhealthnetwork.global/monkeypoxpressrelease

Declaration of monkeypox a global pandemic. World Health Network. Published June 22, 2022. Accessed June 23, 2022. 

https://www.worldhealthnetwork.global/monkeypoxdeclaration

2022 global map & case count. CDC. Updated June 22, 2022. Accessed June 23, 2022. 

https://www.cdc.gov/poxvirus/monkeypox/response/2022/world-map.html

Rigby J. WHO eyes decision on monkeypox ‘emergency’, Africa says it’s long overdue. Reuters. Published June 23, 2022. Updated June 23, 2022. Accessed June 23, 2022. 

https://www.reuters.com/world/africa/monkeypox-emergency-decision-due-who-sparks-african-criticism-2022-06-23/

Signs and symptoms. CDC. Reviewed June 17, 2022. Accessed June 23, 2022. 

https://www.cdc.gov/poxvirus/monkeypox/symptoms.html

How it spreads. CDC. Reviewed June 17, 2022. Accessed June 23, 2022. 

https://www.cdc.gov/poxvirus/monkeypox/transmission.html

Monkeypox: public health advice for gay, bisexual, and other men who have sex with men. World Health Organization. Published May 25, 2022. Accessed June 23, 2022. 

https://www.who.int/news/item/25-05-2022-monkeypox--public-health-advice-for-gay--bisexual-and-other-men-who-have-sex-with-men

Vaccine guidance. CDC. Reviewed June 2, 2022. Accessed June 23, 2022. 

https://www.cdc.gov/poxvirus/monkeypox/clinicians/smallpox-vaccine.html

Treatment. CDC. Reviewed June 17, 2022. Accessed June 23, 2022. 

https://www.cdc.gov/poxvirus/monkeypox/treatment.html

The decision came as the World Health Organization prepared to meet on June 23. 

World Health Network Declares Monkeypox Outbreak a Pandemic

Ms. Hester is Content Specialist with Contemporary OB/GYN and Contemporary Pediatrics.

Following a review of randomized studies and real-world data from many influenza seasons, the CDC’s Advisory Committee on Immunization Practices (ACIP) will include the Seqirus FluadQuadrivalent vaccine as a preferentially recommended season influenza vaccine for individuals aged 65 years and old. This recommendation is built on the clinical benefits compared to the standard egg-based influenza vaccines. If a preferentially recommended vaccine is not available at the time of administration, any age-appropriate vaccine should be used.

To address the immunosenescence that may lead to a reduction in immune response to vaccines, the Fluad Quadrivalent vaccine uses the MF59 adjuvant to strengthen the immune response. More than 225 million doses have been administered since its approval in 1997, illustrating the safety and efficacy of the vaccine.

Gregg Sylvester, MD, Chief Health Officer at Seqirus said in a news release, "It is critical that we do everything we can to protect vulnerable populations like older adults against influenza. Today's recommendation is evidence of the ACIP's commitment to providing clear, evidence-backed guidance to protect public health. We are proud to offer one of the enhanced flu vaccines that was preferentially recommended by the ACIP for adults 65 years and above in the United States."

CDC advisory committee includes Fluad® Quadrivalent as a preferentially recommended influenza vaccine for adults 65 and older. News Release. Seqirus.June 22, 2022. Accessed June 23, 2022. 

https://www.prnewswire.com/news-releases/cdc-advisory-committee-includes-fluad-quadrivalent-as-a-preferentially-recommended-influenza-vaccine-for-adults-65-and-older-301573521.html

The preferential recommendation is built on research and real-world data 

ACIP Includes Fluad Quadrivalent as a Preferentially Recommended Influenza Vaccine for Adults Over 65 

Today, Merck announced the US Food and Drug Administration (FDA) approval of an expanded indication for its pneumococcal 15-valent conjugate vaccine (Vaxneuvance; Merck) to include children aged 6 weeks through 17 years old. The active immunization is now indicated for the prevention of invasive disease caused by 

 serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in those ages. This approval follows the December 2021 FDA Priority Review acceptance of Merck’s supplemental application.

Invasive pneumococcal disease (IPD) is an infection caused by the bacterium 

, or pneumococcus, according to the press release announcing the approval. Of the approximately 100 different types of 

, a smaller number of serotypes are responsible to IPD in children including serotypes 3, 22F, and 33F, among others. Examples of IPD include bacteremia—infection in the blood—and meningitis—infection of the coverings of the brain and spinal cord—which can result in long-term neurological complications. IPD can lead to hospitalization or death and children under the age of 2 are particularly vulnerable.

This FDA approval is based on data from 7 randomized, double-blind clinical studies examining the safety, tolerability, and immunogenicity of the company’s pneumococcal 15-valent conjugate vaccine in infants, children, and adolescents.

Following a 4-dose pediatric series in the pivotal study, it was shown to be noninferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) based on “serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GCMs),” according to the release. Additionally, a secondary analysis examining immune responses for the 15-valent vaccine showed that a 4-dose pediatric series were superior to PCV13 for shared serotype 3 and 2 serotypes unique to the pneumococcal 15-valent conjugate vaccine, 22F and 33F. Merck noted that randomized controlled trails assessing clinical efficacy of the pneumococcal 15-valent conjugate vaccine vs PCV13 have not been conducted.

Data supports the use of the vaccine concomitantly with other routine pediatric vaccines commonly administered and its use in special populations like preterm infants, children living with HIV or sickle cell disease, according to the release.

“Despite decreases in incidence of invasive pneumococcal disease in children, certain key serotypes continue to cause serious illness that can lead to death in children under the age of 5, with serotypes 3, 22F, and 33F responsible for more than a quarter of all invasive pneumococcal disease cases in this population,” said Steven Shapiro, DO, chairman, Department of Pediatrics, Jefferson Abington Hospital, and investigator for the PNEU-PED trial. “With the robust clinical data supporting Vaxneuvance and this FDA approval, Vaxneuvance will be an important new option to help advance protection for children.”

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to meet today on the use of the pneumococcal 15-valent conjugate vaccine in pediatric populations.

This article originally appeared on Contemporary Pediatrics.

US FDA approves Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for the prevention of invasive pneumococcal disease in infants and children. Merck. Published June 22, 2022. Accessed June 22, 2022. 

https://www.merck.com/news/u-s-fda-approves-mercks-vaxneuvance-pneumococcal-15-valent-conjugate-vaccine-for-the-prevention-of-invasive-pneumococcal-disease-in-infants-and-children/

The FDA approved the pneumococcal 15-valent conjugate vaccine for the prevention of invasive pneumococcal disease in infants and children.

Vaxneuvance approved by FDA for ages 6 weeks through 17 years

Researchers in Saudi Arabia recently detailed a unique treatment administered to a 35-year-old woman who developed eyelid ptosis after botulinum toxin injection.

Ghadah Alotaibi, MD, and colleagues from the Derma Clinic in Riyhad, Saudi Arabia, believe this is the first case of utilizing brimonidine 0.33% gel (Mirvaso Gel) to treat eyelid ptosis from cosmetic botox injection, they wrote in the 

Journal of the American Academy of Dermatology

The most common complication of botulinum toxin injection is ptosis of the upper portion of the eyelid, the researchers wrote. Eyelid ptosis can be treated with α-adrenergic eye drops. “These eye drops cause contraction of the upper portion of the tarsal muscle, known as Müller’s muscle, creating a 1- to 2 mm elevation of the upper portion of the eyelid, which is usually sufficient to make the eyelids more symmetric,” they noted.

“The main indication for α-adrenergic agonist eye drops such as apraclonidine and brimonidine is reduction of intraocular pressure in glaucoma. Although brimonidine is more selective than apraclonidine, both enhance aqueous humor uveoscleral outflow and decrease aqueous production by vasoconstriction,” the investigators added.

When these treatments are used for glaucoma, eyelid retraction appears as one of the side effects, especially with the use of apraclonidine. Apraclonidine elevates the eyelid by its effect on Müller’s muscle, which is a smooth muscle innervated by sympathetic nerves.

Investigators detailed the case of a woman who had received Botox injection to treat dynamic lines on her glabella and forehead. After 4 days, she developed right eyelid ptosis. The patient also complained of fatigue and heaviness around her right eye.

Using a fingertip, physicians applied 0.2 mg—a pea-sized amount—of 0.33% topical brimonidine gel over the upper portion of the right eyelid. One hour later, there was a significant elevation of the eyelid by 2 mm, which persisted for up to 2 hours.

“Topical brimonidine gel has a direct potent peripheral vasoconstriction activity in the small arterioles, which makes it a good treatment for erythema associated with rosacea,” investigatorswrote. “We present brimonidine gel as an adequate option for symptomatic relief following botulinum toxin-induced eyelid ptosis.”

To the researchers’ knowledge, there are no current studies on the safety of this topical gel on the eyelids.

1. Alotaibi GF, Alsukait, SF, Alsalman HH, Turkmani MG. Eyelid ptosis following botulinum toxin injection treated with brimonidine 0.33% topical gel. 

. 2022;22:96-98. Doi:10.1016/j.jdcr.2022.01.019

Eyelid ptosis can be treated with α-adrenergic eye drops.

Researchers Detail First Use of Glaucoma Drug for Eyelid Ptosis After Botox

After years of study and growth of a multibillion-dollar industry, there’s still no conclusive proof vitamin supplements are helping patients dodge heart disease and cancer.

 (USPSTF), an independent panel of national experts, updated its recommendation about the effectiveness of multivitamins to prevent cardiovascular disease and cancer in healthy, nonpregnant adults.

The result: insufficient evidence, according to the 

. The Northwestern University Feinberg School of Medicine also published a 

What works better? A healthy diet and exercise.

“Patients ask all the time, ‘What supplements should I be taking?’ They’re wasting money and focus thinking there has to be a magic set of pills that will keep them healthy when we should all be following the evidence-based practices of eating healthy and exercising,” Jeffrey A. Linder, MD, MPH, FACP, chief of general internal medicine in the department of medicine at Northwestern University Feinberg School of Medicine, said in the news release.

More than half of American adults take dietary supplements to improve or maintain overall health. In 2021, Americans spent almost $50 billion on dietary supplements, an industry that spent about $900 million on marketing, Linder and coauthors Jenny Jia, MD, MSc, and Natalie Cameron, MD, said in the editorial.

“The appeal of supplements is obvious,” the editorial said. “In theory, vitamins and minerals have antioxidative and anti-inflammatory effects that should decrease the development of cardiovascular disease and cancer. Eating fruits and vegetables is associated with decreased cardiovascular disease and cancer risk. It is reasonable to think that key vitamins and minerals could be extracted from fruits and vegetables, packaged into a pill, and people could avoid the difficulty and expense of maintaining a balanced diet.”

However, whole fruits and vegetables contain a mixture of vitamins, phytochemicals, fiber, and other nutrients that probably act synergistically to deliver health benefits. Micronutrients in isolation may act differently in the body than when packaged naturally with other dietary components, the authors said.

The supplements “are relatively unregulated” and must have disclaimers that they have “not been evaluated by the Food and Drug Administration” and they are “not intended to diagnose, treat, cure, or prevent any disease,” the editorial said.

Most people view supplements as benign preventive products, but focusing on supplements may be a potentially harmful distraction, the authors said.

Healthy eating can be a challenge when the U.S. industrialized food system does not prioritize health, said Jia, an instructor of general internal medicine and a Northwestern Medicine physician who studies the prevention of chronic diseases in low-income families through lifestyle interventions.

“To adopt a healthy diet and exercise more, that’s easier said than done, especially among lower-income Americans,” Jia said in the news release. “Healthy food is expensive, and people don’t always have the means to find environments to exercise — maybe it’s unsafe outdoors or they can’t afford a facility. So, what can we do to try to make it easier and help support healthier decisions?

The latest recommendations update the 2014 guidance and are based on a review of 84 studies since then.

Against taking beta-carotene supplements because of a possible increased risk of lung cancer

Against taking vitamin E supplements because it has no net benefit in reducing mortality, cardiovascular disease or cancer

The findings do not apply to adults with known nutritional deficiencies, and Linder noted calcium and vitamin D have been shown to prevent fractures and maybe falls in older adults.

Patients pregnant or trying to be should take supplements of folic acid and iron for health effects.

“Pregnant individuals should keep in mind that these guidelines don’t apply to them,” Cameron, a Northwestern Medicine physician, said in the news release. “Certain vitamins, such as folic acid, are essential for pregnant women to support healthy fetal development. The most common way to meet these needs is to take a prenatal vitamin. More data is needed to understand how specific vitamin supplementation may modify risk of adverse pregnancy outcomes and cardiovascular complications during pregnancy.”

New medical guidance notes market booms as Americans seek good health in pills.

Using Vitamin Supplements to Avoid Heart Disease, Cancer Are 'Wasting Money' for Most 

After objections from patient groups and professional organizations, CVS Caremark has put Eliquis (apixaban) back on its formularies after removing the drug from its lists of covered drugs at the beginning of the year.

“This is about decisions between doctors and patients being respected,” said Beth Joyner Waldron, a patient advocate in North Carolina who has been critical of CVS Caremark. Referring to other patient groups and advocates, Waldron said, “This is testimony to the power of collective action.”

CVS Caremark issued a statement that said Eliquis was added back because it secured lower net cost for patients from negotiations with the drug manufacturer. “Anticoagulant therapies are among the nonspecialty products where we are seeing the fastest cost increases from drug manufacturers, and we will continue to push back on unwarranted price increases,” said the statement.

A company spokesman said Eliquis was being added to CVS Caremark’s Value Formulary along with Standard and Advanced Controlled formularies. The change takes effect July 1.

 reported the CVS Caremark formulary change on Wednesday.

Eliquis is in a class of drugs called direct oral anticoagulants (DOACs) that are taken by people to prevent blood clots. Other DOACs include Xarelto (rivaroxaban), Pradaxa (dabigatran), Savaysa (edoxaban), and Bevyxxa (betrixaban). For people with atrial fibrillation and other conditions that result in long-term clotting risk, the DOACs are now often prescribed instead of warfarin, the mainstay of anticoagulation for years, because the risk of bleeding is lower for patients taking DOACs rather than warfarin and patients on DOACs don’t need to be monitored as closely as patients on warfarin.

 showed that Medicare Part D spending on DOACs had increased 16-fold from 2011 to 2019, and that in 2019, Part D spending on DOACs reached $7.23 billion. Bristol-Myers Squibb reported in its 2021 annual report that Eliquis generated $10.76 billion last year, $6.45 billions of which were sales in the U.S.

Waldron, who was diagnosed with a venous thromboembolism about 20 years ago, has been taking Eliquis for eight years. She is insured by the North Carolina State Health Plan, which covers the state’s teachers and state employees. She says patient advocacy groups started to hear about Eliquis being dropped by CVS Caremark in October 2021 and that she received a letter as a member of the North Carolina State Health Plan about the formulary change in November 2021. She says she managed to stay on drug for a combination of reasons: She had a large supply on hand, she got a copay card from the manufacturer, and a decision the North Carolina State Health Plan to put the drug back on the formulary for its members.

The American College of Cardiology (ACC)and American Society of Hematology have been involved in pushing back on CVS Caremark’s formulary decision. In January 2022, the ACC posted a 

 on its website that the group, along with the American Society of Hematology, had met recently with CVS Caremark about its decision to prefer Xarelto — the article on the website uses the generic name, rivaroxaban — over DOACs on its formularies. The ACC articles says that CVS pointed to medical specialty guidelines, including atrial fibrillation guidelines issued jointly by the ACC, the American Society of Hematology and Heart Rhythm Society in 2019 as justifying the decision to drop Eliquis off of its formularies. But the ACC article says the 

 do not tier DOACs and their intent was to “encourage discussion between physicians and patients so an informed decision on the most appropriate medication can be made based on medical history and preferences.”

The ACC published a news story on Wednesday about CVS Caremark putting Eliquis back on its formularies. The article says that ACC and American Society of Hematology “engaged” with CVS Caremark about taking Eliquis off its formularies and “the potential impact on patients and practice staff.”

The ACC article says that the ACC and the American Society of Hematology told CVS Caremark that about the “real-world implications on patients and additional workloads for medical practices related to medication approvals, as well as the vital need for the selection of medications to be left to the patients and clinicians.”

Waldron said she knows of eight events in five states that are related to people losing coverage of Eliquis because of the CVS Caremark change. Waldron some of the events may be the result of gaps in anticoagulation therap, adding that it would take research to determine the link between the events to Eliquis formulary decision.

Waldron said Bristol-Myers Squibb representatives have told patient groups that CVS Caremark would be reversing its decision and putting Eliquis back on its formulary. “I am very relieved that Caremark has finally acknowledged it,” she said.

Waldron has filed a complaint that two phone calls she received earlier this year from CVS Health, the parent company of CVS Caremark, constituted a violation of the Health Insurance Portability and Accountability Act (HIPAA). According to Waldron, the calls indicated that someone at the company had inappropriately shared information from her medical records.

This article originally appeared on Managed Healthcare Executive.

The American College of Cardiology and patient groups pushed the PBM to reverse its decision to take Eliquis off its formularies. CVS Caremark says it changed course after negotiating a lower net price.

CVS Caremark Reverses Eliquis Decision, Puts It Back On Its Formularies

Vegan meal delivery service Daily Harvest has recalled its French Lentil and Leek Crumbles following widespread complaints of illnesses and hospitalizations among customers.

Reports have flooded social media recounting symptoms of nausea, vomiting, and liver damage after consumption; one social media user described symptoms that included “extreme fatigue, dark urine, low-grade fever, and whole-body itching with no rash.”

According to a statement posted on the company’s Instagram account,

 Daily Harvest has launched an investigation and as “working closely with the FDA and with multiple independent labs,” as well as microbiologists, toxin and pathogen experts, and allergists, to determine the root cause of the issue.

A range of gastrointestinal emergencies have been reported, including “extreme liver pain”

 on June 15 now has over 800 responses, many from customers detailing their own experiences, which included emergency room visits, endoscopies, CT scans, referrals to gastrointestinal specialists, and gallbladder removal surgery.

In late 2021, the FDA announced a plan to address potential food safety risks associated with meal delivery services.

 The agency is currently reviewing information and data collected through public comments to determine the key regulatory issues at hand.

Archie A. Daily Harvest recalls lentil dish after customers report food poisioning online. NPR. Published June 22, 2022. Accessed June 23, 2022. 

https://www.npr.org/2022/06/22/1106650999/daily-harvest-lentils-leek-food-poisoning-recall-instagram-statement

@dailyharvest. An update on our voluntary recall of French Lentil + Leek Crumbles. Instagram. June 22, 2022. Accessed June 23, 2022. 

Tenbarge K. Daily Harvest meal delivery service recalls lentil crumbles after customers report gastrointestinal emergencies. 

. Published June 19, 2022. Accessed June 23, 2022. 

https://www.nbcnews.com/news/daily-harvest-meal-delivery-service-recalls-lentil-crumbles-customers-rcna34328

Makalintal B. Daily Harvest pulls French lentil and leek crumbles following reports of serious illness. Published June 21, 2022. Accessed June 23, 2022. 

https://www.eater.com/2022/6/21/23177412/daily-harvest-recalls-french-lentil-and-leek-crumbles-following-illness-allegations

u/hann2466. Extreme stomach pain/sickness from lentil+leek crumbles. Reddit. Published June 15, 2022. Updated June 20, 2022. Accessed June 23, 2022. 

https://www.reddit.com/r/DailyHarvest/comments/vcqwxe/extreme_stomach_painsickness_from_lentilleek/

FDA in brief: As consumers order more meals and groceries online FDA plans public meeting to address food safety risks. News release. FDA. September 9, 2021. Accessed June 23, 2022. 

https://www.fda.gov/news-events/press-announcements/fda-brief-consumers-order-more-meals-and-groceries-online-fda-plans-public-meeting-address-food

Yiannas F, Keller A. FDA works to strengthen food safety protections as consumers increasingly order foods online. FDA. Published November 9, 2021. Accessed June 23, 2022. 

https://www.fda.gov/news-events/fda-voices/fda-works-strengthen-food-safety-protections-consumers-increasingly-order-foods-online

Pharmacists who encounter patients with severe gastrointestinal complains may want to stay abreast of ongoing issues with the meal delivery service. 

Daily Harvest Issues Widespread Recall as Reports of Gastrointestinal Emergencies Surface

Walmart to Hire 5000 Pharmacy Techs, Increase Pay

Walmart has announced initiatives to celebrate the company's pharmacy technicians, including pay increases and hiring more technicians this year.

FTC to Examine Drug Makers, PBMs Due to Insulin Prices

Rising insulin prices have led department to examine the impetus behind setting prices that many patients can't afford.

Six are currently on the market and more are in the pipeline.

Breaking Down the Numbers for Isotretinoin AEs

Recent meta-analysis takes a look at possible adverse effects of the acne medicine, their frequency and severity.

Your weekly roundup of the latest news from Drug Topics®.

News Roundup: June 20 to June 24

Children with myopia experience significantly higher levels of depression and anxiety than their peers without vision impairment, according to a recent study.

 and sponsored by nonprofit Orbis International, researchers also found that surgery to correct strabismus significantly improved symptoms of depression and anxiety in children.

The study “builds our understanding of the link between vision impairment, strabismus and children's mental health,” Orbis said in a news release.

 While there is an existing large body of work focused on the impact of vision impairment on depression and anxiety in adults, studies investigating mental health in children with vision impairment are few and have not previously been reviewed in this comprehensive way, the news release noted.

"Resilient mental health is an important requirement for children to thrive. As we see in the newly published research findings, this can be negatively impacted if a child has a vision impairment," said Nathan Congdon, director of research at Orbis International.

"With this research, Orbis has pulled together for the first time the kind of convincing evidence that can help spur governments to action on children's vision. These results are all the more compelling because the very strongest evidence we found for impact on mental health was among kids with near-sightedness, treatable with a simple pair of glasses,” Congdon added.

Researchers found that the mental health of children with vision impairment may be adversely affected because they tend to participate in fewer physical activities, have lower academic achievement and are more socially isolated.

In addition, common vision conditions like strabismus can also negatively impact children's development and maturation, “affecting not just their appearance, which can in turn affect their confidence and feelings of social belonging, but also their ability to carry out certain activities and their state of mind,” Orbis said.

The researchers reviewed nine electronic databases up to February 2021 and found vision-impaired children experienced significantly higher scores of depression (Standard Mean Difference [SMD], 0.57) and anxiety (SMD, 0.61) than children with normal sight.

Children with myopia experienced higher scores of depression (SMD, 0.59) than normally-sighted children. Strabismus surgery significantly improved symptoms of depression (SMD, 0.59; 95% CI, 0.12-1.06) and anxiety (SMD, 0.69; 95% CI, 0.24-1.14) in children.

The research has “profound implications” for health care planners when allocating resources and designing interventions to curb vision impairment, according to Orbis.

For example, in some countries, strabismus surgery is seen as a cosmetic procedure and excluded from insurance coverage, forcing families to pay out-of-pocket. “These barriers could deter patients of low socioeconomic status from seeking treatment and keep the mental health benefits of corrective surgery out-of-reach. More accessible eye care treatments will improve children's mental health and overall well-being,” Orbis said.

Additional randomized controlled trials exploring the impact of public health measures for myopia correction on mental health in children are needed, the researchers noted.

Impact of vision impairment and ocular morbidity and their treatment on depression and anxiety in children: A systematic review.

Published online May 31, 2022. doi:10.1016/j.ophtha.2022.05.020

2. New study finds children with vision impairment more likely to suffer from depression and anxiety. News release. Orbis International. June 20, 2022. Accessed June 23, 2022. 

https://www.prnewswire.com/news-releases/new-study-finds-children-with-vision-impairment-more-likely-to-suffer-from-depression-and-anxiety-301570006.html

Research highlights link between impaired vision and mental health in children.

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Children With Myopia Have Higher Levels of Depression, Anxiety