Tim Jones, director of Managed Care, Elevate Provider Network, AmerisourceBergen, and Jordan Cupo, digital and web media specialist at 

 (GNP), AmerisourceBergen, discuss how pharmacists can meet patients where they are – online and in the store – during Medicare Part D open enrollment amid the coronavirus disease 2019 (COVID-19) pandemic.

Jenni Zilka, group vice president of GNP’s Field Programs and Services, AmerisourceBergen, offers 3 digital marketing considerations for independent community pharmacists.

 ThoughtSpot 2020 podcast series! As part of our partnership with GNP and AmerisourceBergen, we’re welcoming guest host Susan Lorenz-Fisher, vice president of corporate citizenship at AmerisourceBergen, who will be interviewing Gina Clark, president of the AmerisourceBergen Foundation, and Nicolette Louissant, executive director and president of Healthcare Ready, on the topic of supporting marginalized communities amid COVID-19 and natural disasters.

SingleCare Best of the Best Pharmacy Award Series

 interviews this year’s winners for the Best Pharmacist, COVID Cares, and Best Mentor awards, presented by SingleCare.

Articles

Here’s a preview of the featured content to watch for this week on Drug Topics®.

This Week on Drug Topics: October 26 to 30

Walmart has filed suit against the United States Department of Justice (DOJ) and the Drug Enforcement Administration (DEA), asking a US District Court judge to clarify the roles and responsibilities of pharmacists and pharmacies under the Controlled Substances Act (CSA), the retailer said in a news release.

Although Walmart’s pharmacies have blocked “thousands” of questionable physicians from having their opioids scripts filled by its pharmacists, “certain DOJ officials have long seemed more focused on chasing headlines than fixing the crisis,” the retailer said. “They are now threatening a completely unjustified lawsuit against Walmart, claiming in hindsight pharmacists should have refused to fill otherwise valid opioid prescriptions that were written by the very doctors that the federal government still approves to write prescriptions.”

Walmart is the third-largest pharmacy retailer in the US, with more than 5000 pharmacies nationwide. The supermarket chain has expressed its commitment to fighting the opioid epidemic, which has worsened in the last decade; overdose deaths from opioids were 4 times higher in 2018 than in 1999.

However, there is no federal law requiring pharmacists to interfere in the phyisician-patient relationship to the degree that DOJ is demanding, according to Walmart. “In fact, expert federal and state health agencies routinely say it is not allowed and potentially harmful to patients with legitimate medical needs,” Walmart said.

On one hand, DOJ is criticizing Walmart for not taking further actions to second-guess opioid presciptions; on the other, state health regulators argue that Walmart is unnecessarily meddling with physician-patient relationships, according to the news release.

“DOJ is forcing Walmart and our pharmacists between a rock and a hard place,” Walmart asserted in its statement.

The confusing dichotomy requires a federal court to clarify the roles and responsibilities of pharmacists and pharmacies, according to Walmart.

“Walmart and our pharmacists are committed to helping address the opioid crisis that has affected so many. We are proud of our pharmacists, who help patients understand the risks about opioid prescriptions, and who have refused to fill hundreds of thousands of opioid prescriptions they thought could be problematic,” Walmart added.

 was filed on October 22 in the US District Court for the Eastern District of Texas.

Walmart sues DOJ and DEA seeking clarity for pharmacists in dispensing prescription opioids. News release. Walmart; October 22, 2020. Accessed October 26, 2020. 

https://corporate.walmart.com/newsroom/2020/10/22/walmart-sues-doj-and-dea-seeking-clarity-for-pharmacists-in-dispensing-prescription-opioids

Redman R. Walmart sues DOJ over pharmacists’ role in dispensing opioid prescriptions. Supermarket News. October 23, 2020. Accessed October 26, 2020. 

https://www.supermarketnews.com/health-wellness/walmart-sues-doj-over-pharmacists-role-dispensing-opioid-prescriptions

Walmart filed a pre-emptive suit against 2 government agencies that are threatening to sue Walmart over its pharmacists filling opioid prescriptions.

Walmart Sues DOJ, DEA to Clarify Pharmacists’ Role in Filling Opioid Prescriptions

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

The quest to reduce antibiotic resistance and to utilize antibiotic stewardship has been one of the biggest drives in medicine over the past decade. Research into the effect of exposure to antibiotics early in life has also led to a push to reduce the use in newborns and particularly in the neonatal intensive care unit. A 

 offers the results of a comprehensive quality improvement run in a level 4 neonatal intensive care unit that had the goal of decreasing the antibiotic use rate by 20%.

The investigators ran that initiative within the context a multicenter learning collaborative that was focused on reducing the unnecessary use of antibiotics. The strategies for improvement addressed the gaps seen in the core elements of antibiotic stewardship programs. Outcomes measured included the antibiotic use rate and the percentage of infants who were discharged without any exposure to antibiotics.

At the baseline of the quality initiative, the antibiotic use rate was 27.6% and it decreased to 15.5%, which was a 43% reduction in antibiotic use. The reduction was additionally maintained for >18 months. The investigators said that changes that had the biggest effect on this decrease included a 36-hour hard stop for antibiotics, a novel guideline for early-onset sepsis evaluation among infants <35 weeks, implementing a sepsis risk calculator, and adopting a 36-hour rule-out period for sepsis evaluation.

Controlling exposure to antibiotics is important for stewardship programs, and even more so in neonatal intensive care units.

Antibiotic Stewardship in the Neonatal Intensive Care Unit

Cannabinoids are compounds found in the cannabis plant. The most well-known cannabinoids are cannabidiol (CBD) and tetrahydrocannabinol (THC). However, there are over 200 known cannabinoids, including rare cannabinoids like cannabigerol (CBG), cannabinol (CBN), tetrahydrocannabivarin (THCV), and more. These rare cannabinoids are even more potent in their medical benefits than CBD and don’t contain the psychoactive properties of THC.

By 2029, the global market for cannabinoid-based pharmaceuticals will reach 

 These rare cannabinoids are an inexpensive and natural way to work with your body. By possessing a multitude of medical benefits without the cost and adverse effects of some types of traditional medicine, rare cannabinoids will transform the pharmaceutical industry.

The endocannabinoid system (ECS) is composed of 3 main components: receptors, enzymes, and endocannabinoids. It plays a vital role in regulating a variety of functions and processes such as sleep, appetite, mood, memory, production, and fertility. Through the ECS, cannabinoids interact with our bodies and trigger beneficial effects.

Endocannabinoids are molecules made by the body; they help keep internal functions moving properly. The endocannabinoid receptors are found throughout the body, and the endocannabinoids link to them to send a signal that the ECS needs to take action. Lastly, the enzymes break down the endocannabinoids once they’ve carried out their purpose.

Rare cannabinoids act as a key supplement to endocannabinoids. Both rare cannabinoids and endocannabinoids are crucial for human health as they tap into the ECS. The ECS functions all contribute to homeostasis, the stability of the body’s internal environment.

Early studies are showing the efficacy of cannabinoids against a large variety of indications. There have been 

, which have provided a significant amount of data on their health benefits.

For example, preclinical and clinical studies 

have suggested a potential value for CBD in some neuropsychiatric disorders, including epilepsy, anxiety, and schizophrenia

.3 That’s just the tip of the iceberg of the types of benefits that cannabinoids have been shown to provide.

Along with the health benefits of cannabinoids, a new patented method of biosynthesis production produces cannabinoids at 75% to 90% less cost than the current market. This breakthrough has enabled the production of pharmaceutical-grade rare cannabinoids that are significantly cheaper, with less impact to the environment.

The traditional method of producing rare cannabinoids through plants can be harmful, since there are a lot of byproducts and toxins in them. Biosynthesis produces the safest and most effective cannabinoids, as they are the exact same molecules as what occurs in nature.

Through biosynthesis, pharmaceutical companies are uniquely positioned to be a major player in the cannabinoid space. One reason is that biosynthesis makes rare cannabinoids cheaper and safer, giving pharmaceutical companies more incentive to use them, and another reason is pharmaceutical companies can get insurance reimbursement.

Anyone interested in better health will be interested in cannabinoids. Cannabinoid-based pharmaceuticals will overtake the market as rare cannabinoids become cheaper and more plentiful.

There are new medical treatments that rare cannabinoids will create. Rare cannabinoids like CBG/CBGA, CBN/CBNA, THCV/THCVA, and THCA all have significant evidence of major health benefits. For example, there have been many clinical trials on CBG/CBGA indicating its potential to help fight inflammation, pain, and nausea.

Another example is THCV/THCVA, which been observed to help diabetes, pain and swelling, anxiety, and tremors from Parkinson disease and amyotrophic lateral sclerosis. Finally, CBN/CBNA is known to help insomnia, pain, and anxiety, and it works as an antibacterial and anti-convulsive agent. CBN can also increase appetite without psychoactive effects.

These are just a few examples of the 200+ known cannabinoids that will be researched over the coming years and produce additional health benefits.

, a biotech startup designing patented low-cost methods of growing high-value compounds at scale with proprietary yeasts.

1. Projected cannabinoid-based pharmaceuticals market size in the US from 2020 to 2029 (in billion US dollars). Statista. Accessed October 16, 2020. 

https://www.statista.com/statistics/588853/market-size-of-cannabinoid-pharmaceuticals-in-the-us/

2. International Association for Cannabinoid Medicines. Clinical Studies and Case Reports. Accessed October 16, 2020. 

https://www.cannabis-med.org/studies/study.php

3. Shannon S, Lewis N, Lee H, Hughes S. Cannabidiol in anxiety and sleep: a large case series. 

 2019. Doi: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6326553/

By 2029, the global market for cannabinoid-based pharmaceuticals will reach $50 billion.

How Rare Cannabinoids Are Disrupting the Pharmaceutical Industry

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), has infected an estimated 39,068,667 individuals worldwide at publishing time, and nearly 8 million Americans. The latest COVID-19-related news includes the FDA approval of remdesivir for the treatment of COVID-19, and the recent partnership between the Trump administration, CVS, and Walgreens in facilitating the distribution of COVID-19 vaccines to long term care facilities (LTCFs).

Here’s a roundup of the latest coronavirus-related news:

Pharmacists Are Key Players in Improving Vaccination Rates During Pandemic

Under normal circumstances, pharmacists are a critical component of vaccine uptake, as well as a trusted resource for patients looking to gain information and make informed decisions about the risks and benefits of vaccination. Now, with the “twindemic” of the COVID-19 and influenza season underway, the pharmacy workforce, more than ever, are positioned to support uptake of flu and COVID-19 vaccines. Read our coverage from the National Community Pharmacists Association 2020 Annual Convention for more.

FDA Approves Remdesivir for Treatment of COVID-19

Officials with the FDA have approved Gilead’s remdesivir (Veklury) for the treatment of COVID-19, making it the first FDA-approved treatment for the disease, the company announced.

HHS Clarifies Guidance for Pharmacy Interns, Techs to Administer COVID-19, Childhood Vaccines

, the Department of Health and Human Services (HHS) offered clarification on the requirements for pharmacy interns and technicians to be able to administer childhood vaccines and COVID-19 vaccines once available.

CVS Hiring 10,000 Pharmacy Techs to Support Flu, COVID-19 Response

CVS Health is hiring more than 10,000 full-time and part-time pharmacy technicians to meet the demand for flu vaccinations and, in the future, COVID-19 vaccinations.

Trump Administration to Partner With CVS, Walgreens to Provide COVID-19 Vaccines to Long-Term Care Facilities

HHS and the Department of Defense recently announced a new agreement with CVS and Walgreens to provide and administer COVID-19 vaccines to residents of LTCFs nationwide.

Here's the coronavirus-related news from this week that you should know. 

Coronavirus News Roundup: FDA Approves Remdesivir, HHS Clarifies Guidance on Pharmacy Vaccine Administration

Taking daily multivitamin and mineral (MVM) supplements containing zinc and high levels of vitamin C may boost the immune system and lessen time and severity of sickness in older adults, according to a new study.

As individuals age, vitamin and mineral deficiencies become more prevalent and are more likely to contribute to age-related immune deficiencies. Older adults often benefit from MVM supplements that are thought to boost immunity.

Investigators from Oregon State University (OSU) examined the effects of such supplements on certain immune system indicators and observed illness differences. The findings were published in 

The study included 42 healthy individuals aged 55 to 75 years old; participants were provided either an MVM supplement or an identical, inactive placebo control to take daily for 12 weeks. Prior to and after treatment, the investigators measured the participants’ blood mineral and vitamin status, immune function, immune status, and self-reported health status.

The MVM supplement used in the study contained 700 micrograms of vitamin A, 400 international units of vitamin D, 45 milligrams of vitamin E, 6.6 milligrams of vitamin B6, 400 micrograms of folate, 9.6 micrograms of vitamin B12, 1000 milligrams of vitamin C, 5 milligrams of iron, 0.9 milligrams of copper, 10 milligrams of zinc, and 110 micrograms of selenium.

Overall, the MVM group demonstrated improved vitamin C and zinc status in the blood, and illness symptoms reported in this group were less severe and shorter than those experienced by the placebo group. The same percentage of participants in each group reported symptoms, but days of sickness in the supplement group averaged fewer than 3 compared with more than 6 for the placebo group, according to the findings.

“Supplementation was associated with significantly increased circulating levels of zinc and vitamin C, and with illness symptoms that were less severe and shorter lasting,” Adrian Gombart, professor of biochemistry and biophysics in the OSU College of Science and principal investigator at the Linus Pauling Institute, said in a statement. “This supports finding that stretch back decades, even to the days of Linus Paulings’ work with vitamin C. Our results suggest more and better designed research studies are needed to explore the positive role multivitamin and mineral supplementation might play in bolstering the immune system of older adults.”

Gombart noted that, although the study was limited to self-reported data, the observed illness differences that were seen between the groups suggest that additional larger studies are warranted.

According to the investigators, further development of functional assays and larger study populations should improve detection of specific changes in immune function after supplementation in health older adults.

Bayer Consumer Care funded the study through an Institution Initiated Research grant and provided the supplements (Redoxon VI) and placebos.

Gombart A, Fantacone ML, Lowry MB, et al. The effect of a multivitamin and mineral supplement on immune function in healthy older adults: a double-blind, randomized, controlled trial. 

Multivitamin, mineral supplement linked to less-severe, shorter-lasting illness symptoms. News release. Oregon State University; August 18, 2020. Accessed October 22, 2020. 

https://today.oregonstate.edu/news/multivitamin-mineral-supplement-linked-less-severe-shorter-lasting-illness-symptoms

Daily multivitamin and mineral supplements can boost immunity in older adults and may lessen time and severity of illnesses. 

Multivitamin, Mineral Supplements May Help Reduce Illness Duration, Symptoms 

Under normal circumstances, pharmacists are a critical component of vaccine uptake, as well as a trusted resource for patients looking to gain information and make informed decisions about the risks and benefits of vaccination. Now, with the “twindemic” of the coronavirus disease 2019 (COVID-19) and influenza season underway, the pharmacy workforce, more than ever, are positioned to support vaccine uptake of flu and COVID-19 vaccines.

Last March, the US began lockdown measures and stay-at-home orders to protect the public from COVID-19 exposure. Even as restrictions slowly lifted, many Americans continued to avoid potential exposure in their social distancing efforts, which has led to decreased uptake of routine vaccinations.

A virtual session presented at the National Community Pharmacists Association (NCPA) 2020 Annual Convention held online October 18-20 tackled the effect that COVID-19 has had on vaccination rates in the United States and how pharmacists can aid in improving uptake.

The Impact of COVID-19 on Routine Vaccination

David Ha, PharmD, BCIDP, infectious diseases and antimicrobial stewardship pharmacist at Stanford Health Care, discussed the combined landscape of influenza and COVID-19 vaccination amid the pandemic and 2020-2021 flu season.

Ha explained that following the national emergency declaration on March 13, 2020, the CDC released several guidance documents highlighting pharmacies as a vital part of the health care system, as their ability to function during the pandemic is critical. However, the early recommendations included postponing and rescheduling receiving immunizations: “Suffice to say, regardless of the age group, there was a dramatic decline in pediatric and adult vaccination,” Ha said during his presentation.

This decline was documented in a CDC report published in May, in which CDC officials identified a notable decrease in routine pediatric vaccine ordering and doses administered following the national emergency declaration.2 In August, the Department of Health and Human Services made an effort to expand access by authorizing all state-licensed pharmacists the ability to order and administer childhood vaccinations during the pandemic.

Ha also discussed the similarities and differences of influenza and COVID-19 infections, outlined below:

Transmission through respiratory droplets

Group at high risk for infection include advanced age, obesity, multiple comorbidities such as diabetes, and individuals in nursing homes

Infectivity, as COVID-19 is much more contagious

Mild or asymptomatic in pediatrics for COVID-19, compared with more severe illness in pediatric patients with influenza

In describing the similarities and differences between COVID-19 and influenza, Ha mentioned the significance of similar transmission methods, as both viruses are transmitted through respiratory droplets. “This is particularly important because, potentially, some of the infection prevention strategies that we’re using to prevent the spread of COVID-19 may also secondarily work against influenza,” Ha said.

In expanding on the differences, Ha also explained that COVID-19 being more contagious than influenza may change, since the data is based on nonpharmacologic intervention, infection prevention measures, and vaccinations.

Interestingly, in Ha’s presentation of the South Hemisphere’s most recent influenza season, which aligned with the COVID-19 pandemic, the World Health Organization found very little confirmed influenza during the time of COVID-19.

“There are a number of different hypotheses of why this could be the case. Perhaps the lockdown, sheltering in place, masking, and other types of transmission prevention practices in the Southern Hemisphere countries during that time prevented influenza transmission. Perhaps as well there was a drifting in terms of testing for influenza,” Ha said.

As for the Northern Hemisphere’s guidance for its 2020-2021 flu season, the core recommendations have stayed the same: everyone 6 months or older who doesn’t have a contraindication should be getting their flu vaccine. 

The Pharmacist’s Role in COVID-19 Vaccination

Jeff Goad, PharmD, MPH, FAPhA, FCPhA, FCSHP, professor and chair in the Department of Pharmacy Practice at the Chapman University School of Pharmacy in Orange, California, homed in on the opportunities and responsibilities for pharmacists amid the pandemic, citing several reasons why “pharmacy is critical and an important player in immunizations, both now and in the future,” he said.

Goad introduced the following topics for exemplifying pharmacists’ key role in COVID-19 vaccine distribution and uptake:

Existing immunization patient relationship

“The government, the public-private partnerships, everyone is counting on pharmacy to be a major hub for distribution of the vaccine to a very large population,” Goad said during his presentation.

Pharmacists are critical players for the COVID-19 vaccine due to the massive workforce they can provide to the vaccination effort. On top of the 300,000 licensed pharmacists working in both the chain and community settings, there are also more than 62,000 student pharmacists and interns.

In addition to the sheer number of pharmacists able to administer vaccinations to the American public, pharmacists are also more accessible: 86% of the US population lives within 5 miles of a pharmacy. “A unique aspect of pharmacy that is probably going to be very important in fitting in to the lives of Americans who have to get 2 doses of a coronavirus vaccine in very short order is the ability to access those services when they want it,” Goad said, clarifying that pharmacies are often open on weekends, holidays, and later into the evening, and sometimes 24 hours a day.

Goad also presented the trend that individuals are increasingly trusting pharmacists to administer their vaccines; physicians, including all specialties, administer 34% of flu vaccinations in the US, and pharmacies administer 32%.

The presentation also touched upon the COVID-19 vaccines most likely to be authorized for distribution to the public in the United States, notably Moderna’s and Pfizer’s respective mRNA vaccines. Both will be administered in 2 doses; however, although Moderna’s vaccine requires storage at normal freezer temperatures (-20°), Pfizer’s vaccine must be stored at -70°, creating a challenge for the majority of pharmacies. However, Goad stressed that the stability data is always evolving, so paying attention to developments is key.

“Innovation always rules the day, and we have seen ultracool units being developed and potentially might be a part of vaccine distribution to eliminate the need to purchase an ultracool freezer. Stay tuned, things change fast here,” he qualified.

Although storage temperatures could potentially create a challenge for pharmacies, according to Goad, “the toughest battle is vaccine confidence.”

Goad pointed to a Gallup survey from August 7, 2020, which reported that 1 in 3 Americans would not get the COVID-19 vaccine.

According to Goad, myths are deadly to vaccine efforts, and pharmacists have the responsibility to address myths and provide accurate information to their customers.

“These are some of the things we need to stop right away, so that people get the correct information and can make an informed decision about the risks and benefits of vaccination. that’s our job and that’s our mission as pharmacy.”

Goad J, Ha D. What Impact did COVID-19 have on vaccination rates and how can I help improve them? Presented at: NCPA 2020 Annual Convention; online; October 18-19, 2020.

Santoli JM, Lindley MC, DeSilva MB, et al. Effects of the COVID-19 pandemic on routine pediatric vaccine ordering and administration – United States, 2020. 

HHS expands access to childhood vaccines during COVID-19 pandemic. News release. HHS; August 19, 2020. Accessed October 23, 2020. 

https://www.hhs.gov/about/news/2020/08/19/hhs-expands-access-childhood-vaccines-during-covid-19-pandemic.html

The combined landscape of flu and COVID-19 presents challenges to vaccine uptake.  

Officials with the FDA have approved Gilead’s remdesivir (Veklury) for the treatment of coronavirus disease 2019 (COVID-19), making it the first FDA-approved treatment for the disease, the company announced.

Remdesivir was granted emergency use authorization (EUA) by the FDA back in May and given to President DonaldTrump after he was diagnosed with COVID-19 earlier this month. 

Remdesivir is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. According to Gilead, remdesivir should only be administered in a hospital or in a health care setting capable of providing acute care comparable to inpatient hospital care.

Along with the approval, the FDA also issued a new EUA for the use remdesivir to treat hospitalized pediatric patients under 12 years of age weighing at least 3.5 kg or hospitalized patients weighing 3.5 kg to less than 40 kg with COVID-19 for whom use of an intravenous agent is clinically appropriate.

® conducted when remdesivir was still only authorized for emergency use, Julie Ann Justo, PharmD, infectious diseases clinical pharmacist and associate professor at the University of South Carolina College of Pharmacy, discussed the drug as a potential treatment for COVID-19.

“Originally, most people will be familiar with it as it was an investigational agent in the treatment of Ebola virus,” Dr Justo told 

®. “Remdesivir itself, its purported mechanism of action, it’s a nucleotide analogue that is going to disrupt viral replication at the RNA polymerase.”

“When the virus is inside the human cell and trying to hijack and increase its own replication, remdesivir is theorized to block that replication, starting relatively early on in the disease course of the SARS-CoV-2 virus.”

Over the past couple of months, remdesivir emerged as one of the more promising treatments for COVID-19. However, just last week, interim results from the World Health Organization's Solidary Therapeutics Trial suggested that remdesivir, along with hydroxychloroquine, lopinavir/ritonavir, and interferon regimens, appeared to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients. The purpose of the study, which spans more than 30 countries, was to examine the effects of repurposed drugs for the treatment of COVID-19.

In a statement responding to the Solidarity Trial results, Gilead said, "The emerging data appear inconsistent with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of Veklury (remdesivir)."

The FDA’s approval is based on data from 3 randomized controlled trials, including the phase 3 ACTT-1 trial, which showed that treatment with remdesivir resulted in clinically meaningful improvements across multiple outcome assessments compared with placebo in hospitalized patients with the disease.

The ACTT-1 study evaluated the efficacy and safety of a 10-day treatment course of remdesivir versus placebo in 1063 hospitalized adults with mild, moderate, or severe COVID-19 who were also receiving standard-of-care treatment.

Results of the study showed that remdesivir significantly improved time to recovery by 5 days in the overall study population (10 vs. 15 days; rate ratio, 1.29; 95% CI, 1.12 to 1.49; p<0.001) and 7 days in patients who required oxygen support at baseline (11 vs 18 days; rate ratio, 1.31; 95% CI, 1.12 to 1.52). Additionally, remdesivir reduced disease progression in patients needing oxygen, resulting in a significantly lower incidence of new mechanical ventilation or ECMO (13% vs. 23%; 95% CI, -15 to -4). In the overall patient population, there was a trend toward reduced mortality with remdesivir compared with placebo at day 29 (11.4% vs 15.2%, HR 0.73; 95% CI, 0.52 to 1.03), according to the study.

Two other phase 3 trials, SIMPLE-Severe and SIMPLE-Moderate, examined the use of remdesivir in adult patients with severe and moderate COVID-19, respectively. In the SIMPLE-Severe study, conducted in hospitalized patients who required supplemental oxygen and who were not mechanically ventilated, the results showed that a 5-day or a 10-day treatment course of remdesivir achieved similar clinical outcomes (odds ratio 0.75; 95% CI, 0.51 to 1.12). In the SIMPLE-Moderate trial, which was conducted in hospitalized patients who did not require supplemental oxygen, the results demonstrated statistically improved clinical outcomes with a 5-day treatment course compared with standard of care (odds ratio 1.65; 95% CI, 1.09 to 2.48; p=0.017).

The odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard of care were also favorable, trending toward but not reaching statistical significance.

In terms of adverse effects (AEs), the most commonly reported AEs in study participants in the SIMPLE-Severe in either the 5-day or 10-day treatment group were nausea, AST increased, and ALT increased. In the SIMPLE-Moderate trial, the most common AE was nausea.

“I think for pharmacists, the biggest thing to remember is not to lose sight of our original purpose, which is to optimize therapy for our patients,” Dr Justo previously told 

®. “It’s very important to understand the background pharmacology of this agent, which is readily available, and the FDA factsheet that’s been provided for health care providers. I encourage pharmacists, physicians, and other folks that will be interacting with and using this medication in patients to read that and be familiar with that so they can properly both dispense the medication, administer the medication, and then also to counsel patients and families.”

1. U.S. Food and Drug Administration Approves Gilead’s Antiviral Veklury® (remdesivir) for Treatment of COVID-19. News release. Gilead; October 22, 2020. Accessed October 22, 2020. 

https://www.gilead.com/news-and-press/press-room/press-releases/2020/10/us-food-and-drug-administration-approves-gileads-antiviral-veklury-remdesivir-for-treatment-of-covid19

2. Solidarity Therapeutics Trial produces conclusive evidence on the effectiveness of repurposed drugs for COVID-19 in record time. News release. World Health Organization; October 15, 2020. Accessed October 22, 2020. 

https://www.who.int/news/item/15-10-2020-solidarity-therapeutics-trial-produces-conclusive-evidence-on-the-effectiveness-of-repurposed-drugs-for-covid-19-in-record-time

3. Gilead Sciences Statement on the Solidarity Trial. Company statement. Accessed October 22, 2020. 

https://www.gilead.com/news-and-press/company-statements/gilead-sciences-statement-on-the-solidarity-trial 

Remdesivir (Veklury; Gilead) is the first and only fully FDA-approved treatment for COVID-19. 

New data showed that Eli Lilly’s mirikizumab demonstrated safety and efficacy in treating moderate-to-severe Crohn disease, according to results from a phase 2 study.

Mirikizumab, a humanized IgG4 monoclonal antibody that binds to the P19 subunit of interleukin 23, is being studied for the treatment of immune diseases, including psoriasis, ulcerative colitis, and Crohn disease.

The phase 2 SERENITY study evaluated the safety and efficacy of multiple dosing regimens and 2 methods of administration with mirikizumab in patients with moderately to severely active Crohn disease. The study included a 12-week induction period and 40-week continued treatment period, and the primary end point was endoscopic response as determined by the proportion of patients achieving at least 50% reduction from baseline on the Simple endoscopic Score for Crohn’s Disease at week 12.

In the induction period of the study, patients were randomized across 4 treatment arms to receive placebo or 1 of 3 doses of mirikizumab intravenously (200 mg, 600 mg, or 1000 mg). Patients who showed endoscopic improvement at 12 weeks were randomized to continue treatment with mirikizumab either intravenous (IV) or subcutaneous (SC) administration, and patients who did not show endoscopic improvement at this time or who were in the placebo arm were assigned to receive mirikizumab treatment intravenously.

Nearly 60% of patients achieved endoscopic response (58.5% in the IV dosing group and 58.7% in the SC group), according to the findings. Additionally, more than 40% of patients achieved Patient Reported Outcomes (PRO) remission (46.3% in the IV group and 45.6% in the SC group).

Among those who achieved endoscopic response at week 12, 69.6% and 66.7% in the IV and SC groups, respectively, also had endoscopic response at week 52, the investigators reported. Among those with endoscopic remission at week 12, 50% and 64.3% in the IV and SC groups, respectively, also had endoscopic remission at week 52.

One patient in each group among those who achieved endoscopic improvement at week 12 discontinued due to an adverse event (AE). Similar frequencies of treatment-emergent AEs and serious AEs were reported in IV and SC groups. The most common AEs reported were nasopharyngitis, headache, and arthralgia.

“Crohn’s disease is a serious and difficult-to-treat condition, and there is a significant need for additional treatments,” Bruce E Sands, MD, MS, Dr. Burrill B. Crohn Professor of Medicine, chief of Dr. Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai, said in a statement. “I am encouraged by the results of this study, which showed response in both symptom relief and endoscopic response and remission at 52 weeks of treatment with mirikizumab.”

According to Lilly, these phase 2 data reinforce the continued evaluation of mirikizumab in the ongoing VIVID phase 3 program as a potential treatment for Crohn disease.

Mirikizumab Shows Continued Symptom Improvement and Reduction of Intestinal Inflammation in Patients with Crohn’s Disease in 52-Week Phase 2 Trial. News release. Eli Lilly; October 12, 2020. Accessed October 13, 2020. 

https://investor.lilly.com/news-releases/news-release-details/mirikizumab-shows-continued-symptom-improvement-and-reduction

Eli Lilly reported new efficacy and safety data for mirikizumab in moderate-to-severe Crohn disease.  

Mirikizumab Improves Symptoms in Patients With Crohn Disease

, the Department of Health and Human Services (HHS) offered clarification on the requirements for pharmacy interns and technicians to be able to administer childhood vaccines and coronavirus disease 2019 (COVID-19) vaccines once available.

In early September, the Assistant Secretary for Health issued guidance authorizing state-licensed pharmacists to order and administer, and state-licensed or registered pharmacy interns acting under the supervision of the qualified pharmacist to administer, to persons ages 3 or older, 

 that have been authorized or licensed by the FDA, provided that certain conditions are met—thereby making them “covered persons” under the under the Public Readiness and Emergency Preparedness Act (PREP Act).

The latest guidance, issued on October 21, clarifies that the pharmacy intern must be authorized by the State or board of pharmacy in the State in which the practical pharmacy internship occurs. However, the authorization does not need not take the form of a license from, or registration with, the State board of pharmacy.

"Pharmacists and their staff are critical to the COVID-19 response," said Assistant Secretary for Health ADM Brett P. Giroir, MD. "Together with pediatricians and family physicians, they are ensuring that Americans receive the vaccines they need where they need it.”

NACDS and other pharmacy organizations have been 

pushing HHS to clarify the childhood vaccine guidance

, since state boards of pharmacy’ regulations on pharmacists and techs administering childhood vaccines differ.

The new guidance is “the latest in a series of extremely important steps that this Administration has taken to help empower the response of pharmacy teams on behalf of patients,” said NACDS President and CEO Steven C. Anderson in a 

 “It ultimately will make a difference in scaling the nation’s response in terms of COVID-19 testing, administering critical vaccinations, and ultimately being prepared to make available COVID-19 vaccinations when they are safe, effective and available.”

Additionally, the guidance authorizes qualified pharmacy technicians and State-authorized pharmacy interns to administer COVID-19 tests, including serology tests, that the FDA has approved, cleared, or authorized.

1. Trump Administration takes further action to expand access to vaccines, COVID-19 tests. News release. HHS; October 21, 2020. Accessed October 22, 2020. 

https://www.hhs.gov/about/news/2020/10/21/trump-administration-takes-action-further-expand-access-vaccines-covid-19-tests.html

2. NACDS welcomes HHS decision to enhance patients’ access to COVID-19 vaccinations, other vaccinations and COVID-19 Tests with wise use of pharmacy technicians and pharmacy interns. News release. NACDS; October 21, 2020. Accessed October 22, 2020. https://www.nacds.org/news/nacds-welcomes-hhs-decision-to-enhance-patients-access-to-covid-19-vaccinations-other-vaccinations-and-covid-19-tests-with-wise-use-of-pharmacy-technicians-and-pharmacy-interns.

The new guidance provides clarification on requirements for pharmacy interns and technicians to administer childhood and COVID-vaccines, as well as COVID-19 tests. 