41.5 million coronavirus disease 2019 (COVID-19) vaccine doses

 distributed as of this article’s press time and now more than 400,000 deaths in the United States, pandemic news is not slowing down. Check back to 

 to stay informed on the latest coronavirus-related news and research.

New MJH Life Sciences COVID-19 Coalition Webinar

Don’t miss the upcoming COVID-19 Coalition webinar focused on emerging severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants, streaming live on Tuesday, January 26 at 6 PM ET.

Medical World News: New Standards on the Information Blocking Rule

Matt Johnson, chief pharmacy officer at FDS, dives into the upcoming information blocking rule and its impact on community pharmacies.

 is available on DrugTopics.com. This month’s issue includes our feature 2021 pharmacy trends, top pipeline drugs for the year ahead, and coverage from the American Society of Health-System Pharmacists Midyear 2020 Clinical Meeting and Exhibition.

In Case You Missed It: Majority of Pharmacists Confident in COVID-19 Vaccine

The vast majority of pharmacists plan to or have received a COVID-19 vaccine, according to a survey of 570 pharmacists conducted last week by the American Pharmacists Association.

Articles

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

This Week on Drug Topics: January 25 to 29

With recent surges in popularity, FDA guidance, and state legislation within the landscape of cannabis-derived compounds, pharmacies are increasingly supplying cannabidiol (CBD) products.

Of note, CBD is only 1 of the compounds found within the cannabis plant and has no psychoactive effects; delta-9-tetrahydrocannabidiol (THC) is a different compound that does produce psychoactive effects, and marijuana is a type of cannabis plant that possesses multiple naturally occurring compounds, including CBD and THC.

Study investigators Leticia Shea, PharmD, BCACP, Anna Carnazzo, PharmD candidate, and Janelle Matura, PharmD candidate, from the Rueckert-Hartman College for Health Professions at Regis University in Denver, Colorado, documented the OTC products currently being offered by pharmacies across Colorado. The findings were presented in a poster during the Association of Health-System Pharmacists (ASHP) 2020 Midyear Clinical Meeting and Exhibition.

Survey Identifies Need for CBD Education Among Community Pharmacists

Although there are myriad CBD products marketed and sold with medical claims, there is currently only 1 CBD product that has been evaluated and approved by the FDA for safety and efficacy.

As the CBD sphere of influence expands, pharmacists should “recognize the discrepancy between these CBD products and CBD approved by the FDA,” the researchers wrote. Importantly, pharmacists should also be prepared to effectively counsel patients on the use of untested CBD products that are available in their stores.

Of the 35 pharmacies included in the study, 18 (51%) sold at least 1 CBD product. Investigators took inventory of the CBD products at the 18 chain and independent pharmacies across the state of Colorado, located in both urban and rural regions. A total of 60 CBD products were recorded.

The majority of products took the form of oral drops/pumps, balms/salves, or creams/ointments. Other CBD product forms included topical oils, bath products, gummies, lotions, patches, and pet salves and balms.

Depending on the product form – oral, topicals, or transdermal – concentrations of compounds varied. In oral products, CBD concentrations varied from 10 to 60 mg/mL, with 13 (87%) labeled as “full spectrum” and therefore likely contained active cannabinoids other than CBD. In topical products, concentration ranged from 30 mg CBD/15 mL to 1000 mg CBD. Most topical products also contained other ingredients; among these products, 32% contained menthol, 17% contained camphor, 10% willow bark extract, and 10% contained peppermint, among other ingredients. The single transdermal product offered a 20mg CBD/24h dose, according to researchers.

Researchers reported that additional studies are needed to determine the safety and efficacy of these products in regard to the formulations themselves, as well as dosing.

“The impact of drug-interactions for topically applied CBD is currently unknown as no studies have evaluated [only CBD] topical formulations in humans,” investigators wrote. “The OTC CBD market is growing, and will be important for pharmacists to be cognizant of the variety of products being sold.”

What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD. FDA. Last updated March 5, 2020. Accessed January 25, 2021. 

https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis

Carnazzo A, Matura J, Shea L. Cannabidiol (CBD) products found over-the-counter in Colorado. Presented at: American Society of Health-System Pharmacists Midyear Clinical Meeting and Exhibition. December 6-10, 2020; virtual.

Results of a study presented in a poster presentation during ASHP Midyear collected data of the available OTC CBD products being sold in Colorado pharmacies. 

OTC CBD Products Currently Available in Pharmacies 

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

The impact of cardiometabolic levels on a person’s mental health has become more elucidated in recent years. A new 

 examines the role that insulin levels as well as body mass index have on depression and psychosis later in in life.1

The researchers did a cohort study from the Avon Longitudinal Study of Parents and Children, using data from participants aged 1 to 24 years. Fasting insulin was measured at 9, 15, 18, and 24 years and body mass index measurements were performed at 1, 2, 3, 4, 7, 9, 10, 11, 12, 15, 18, and 24 years. The researchers also looked at data for a number of potential confounders including emotional and behavioral problems from childhood, smoking, physical activity, the father’s social class, and average caloric intake.

Fasting insulin level data were available for 5790 participants and body mass index data were available for 10,463 people, with a slight female majority in both categories. The researchers found that there were 5 distinct trajectories for body mass index and 3 distinct trajectories for 

 insulin. Every distinct trajectory was differentiated by mid-childhood. A persistently high fasting insulin level was linked to both a psychosis a psychosis at-risk mental state (adjusted odds ratio [aOR], 5.01; 95% CI, 1.76-13.19) and psychotic disorder (aOR, 3.22; 95% CI, 1.11-9.90). However, it was not liked to depression (aOR, 1.38; 95% CI, 0.75-2.54).

A recent study examined how insulin levels and body mass index may have ties to mental health concerns.

Cardiometabolic Issues Associated With Later Mental Health Concerns

Officials with the FDA have approved cabotegravir and rilpivirine, injectable formulation (Cabenuva; ViiV Healthcare) as a complete regimen for the treatment of HIV-1 infection in adults.

Cabotegravir and rilpivirine, injectable formulation is the first extended-release injectable drug regimen adults with HIV that is administered once per month, according to the FDA. It is indicated for treatment in adults to replace a current antiretroviral (ARV) regimen in those who are virologically suppressed on a stable ARV regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

Additionally, the FDA has approved cabotegravir, tablet formulation (Vocabria; ViiV Healthcare), which should be taken in combination with oral rilpivirine (Edurant; Janssen) for 1 month prior to starting treatment with cabotegravir and rilpivirine, injectable formulation.

Cabotegravir and rilpivirine, injectable formulation was evaluated through 2 randomized, open-label, controlled clinical trials involving 1182 adults with HIV who were virologically suppressed before treatment initiation. Prior to administering treatment with the complete injectable regimen, oral dosing of cabotegravir and rilpivirine was administered for approximately 1 month to assess tolerability.

In both studies, treatment with cabotegravir and rilpivirine, injectable formulation resulted in continued virologic suppression and no clinically relevant change from baseline in CD4+ cell counts. According to patient preference data, 9 out of 10 patients indicated preference for the injectable regimen over their previous daily oral therapy.

The most common adverse effects associated with cabotegravir and rilpivirine, injectable formulation were injection site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. Additionally, the regimen should not be used in individuals with known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in those who are not virally suppressed.

“Among the scientific community, we recognize the innovation behind Cabenuva is truly meaningful,” David Wohl, MD, professor of medicine at the University of North Carolina Institute of Global Health and Infectious Diseases in Chapel Hill, North Carolina, said in a statement. “Not only is it the first, complete long-acting regimen, which allows for a dramatic reduction in the frequency of dosing, but it also was preferred by most clinical trial participants when compared to their prior oral daily regimens. The FDA approval of Cabenuva underscores the value of community-centric research and I am pleased this new option will be available for those living with HIV."

ViiV Healthcare will begin shipping cabotegravir and rilpivirine, injectable formulation to wholesalers and specialty distributors in the United States in February 2021, according to the company.

1. ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine, the first and only complete long-acting regimen for HIV treatment. News release. ViiV Healthcare; January 21, 2021. Accessed January 22, 2021. 

https://viivhealthcare.com/en-us/us-news/us-articles/2021/viiv-healthcare-announces-fda-approval-of-cabenuva--cabotegravir/

FDA OKs Long-Acting Injectable Drug Regimen for HIV Treatment

The number of coronavirus disease 2019 (COVID-19) cases in the United States continue to surge, with a weekly average of 185,000 daily cases and an estimated 120,000 COVID-19–related hospitalizations as of January 21, according to 

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

Study: Blood Pressure Medications Safe for Patients With COVID-19

A recent study led by University of Pennsylvania researchers reported no risk for patients continuing their blood pressure medications while hospitalized with COVID-19.

Study: Patients Report Worse Migraine Symptoms During COVID-19 Pandemic

Patients with migraines had a much worse experience during COVID-19, according to recent research.

Survey: Majority of Pharmacists Confident in COVID-19 Vaccine

Emerging SARS-CoV-2 Variants: What You Need to Know

In its next live webinar event, MJH Life Sciences™ COVID-19 Coalition will explore emerging mutations of SARS-CoV-2.

Expand Pharmacy Scope of Practice to Speed Up COVID-19 Vaccination Efforts

® interviews Naomi Lopez, director of healthcare policy at the Goldwater Institute, focusing on expanding scope of practice and COVID-19 vaccine candidates already being used in other countries.

ASHP Urges Biden to Use Federal Resources, Expand Workforce for COVID-19 Vaccinations

In a letter sent on Tuesday, ASHP urged President Joe Biden to use federal resources from the Department of Defense, the Department of Veterans Affairs, the Public Health Service Commissioned Corps, and the Federal Emergency Management Agency to activate mass vaccination sites for COVID-19.

ISMP Offers Safe Practice Recommendations to Reduce COVID-19 Vaccine Errors

The Institute for Safe Medication Practices (ISMP) provided safe practice recommendations for the administration of new COVID-19 vaccines following numerous reports of errors or hazards.

APhA: Biden’s Plan to Combat COVID-19 Is a ‘Strong Start’

President-elect Joe Biden revealed his $1.9 trillion COVID-19 proposal, which urges the need for more robust vaccination efforts.

Here's the roundup of the latest coronavirus-related news.

Coronavirus News Roundup: Majority of Pharmacists Confident in Vaccine, Pharmacy Associations Urge Biden to Expand Vaccination Workforce

A recent study led by University of Pennsylvania researchers reported no risk for patients continuing their blood pressure medications while hospitalized with coronavirus disease 2019 (COVID-19).

 compared COVID-19 patient outcomes among individuals with diabetes by either continuing or discontinuing renin-angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs).

Upwards of 49 million adults in the US take medication to treat hypertension, 83% of whom are treated with ACEIs or ARBs, according to study investigators. These 2 classes of high blood pressure medications are ubiquitous worldwide. With COVID-19 cases still surging in many places across the globe, researchers aimed to determine whether these medications affected outcomes in COVID-19 patients with hypertension and other comorbid conditions.

 was held at 20 hospitals spanning 7 countries: United States, Canada, Mexico, Sweden, Peru, Bolivia, and Argentina. A total of 152 patients 18 years and older who had been admitted to the hospital with clinical presentation of COVID-19 and were prescribed either ACEI or ARB outpatient therapy prior to admission were included in the study.

Between March 31 and August 20, 2020, study participants were randomized to either stop (n=77) or continue (n=75) taking their ACEI or ARB medication. Patients were ranked against each other according to 4 hierarches of clinical outcomes:

length of time on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)

length of time on renal replacement therapy or inotropic or vasopressor therapy, and

area under the curve (AUC) of a modified SOFA score, incorporating the cardiac, respiratory, coagulation, and renal domains.

The mean age of patients was 62 years and 68 (45%) were female. Fifty-two percent had diabetes, 16% (24) had cardiac disease, and all participants showed a history of hypertension. ACEI therapy was slightly more common than ARB therapy among patients.

Investigators found that continuation of ACEI or ARB therapy among hospitalized COVID-19 patients had no overall effect on severity of infection and are consistent with previously published observational studies and unpublished trial evidence.

“At the start of the pandemic, patients were worried about perceived harm based on limited and incomplete information, and unfortunately, some insisted on stopping their medications. However, stopping these medications unnecessarily can increase the risk for severe complications, including heart attack and stroke,” said first author 

 an assistant professor in the division of renal-electrolyte and hypertension, and a co-principal investigator with Chirinos. “Now we have high quality evidence to support our recommendation that patients continue to take these medications as prescribed.”

Cohen JB, Hanff TC, William P, et al. Continuation versus discontinuation of renin-angiotension system inhibitors in patients admitted to hospital with COVID-19: a prospective, randomized, open-label trial. 

https://doi.org/10.1016/S2213-2600(20)30558-0

Study Finds Commonly Used Blood Pressure Medications Safe for COVID-19 Patients. News Release. Penn Medicine; January 7, 2021. Accessed January 19, 2021. 

https://www.pennmedicine.org/news/news-releases/2021/january/study-finds-commonly-used-blood-pressure-medications-safe-for-covid19-patients

Investigators compared outcomes among patients with COVID-19 and hypertension through modifying blood pressure medication use. 

Patients with migraines had a much worse experience during coronavirus disease 2019 (COVID-19), according to recent research.

Patients reported that their migraines were more frequent and severe, and said they overused analgesics, according to the article published in 

 Many also did not communicate with their neurologists.

In addition, the authors from the Ibn Sina Hospital in Kuwait, determined that patients who were infected with COVID-19 reported a worsening of their headaches while they had the virus.

The researchers administered an online, self-reported survey that included demographic, migraine-related, COVID-19-specific and overall psychosocial variables between July 15 and July 30, 2020.

In comparison to pre-pandemic period, approximately 60% of patients reported an increase in migraine frequency, 16% reported a decrease in frequency, and 10.3% transformed to chronic migraine.

A majority (64%) of patients reported that their migraine severity increased during the pandemic.

Most (61.5%) did not communicate with their neurologists.

Nearly half (46.9%) of patients reported adherence to treatment. However, 58.7% said they overused analgesics. Botox injections cancellation had a negative impact on 66.1% from those receiving it.

Only 22.5% reported visiting an emergency department for acute migraine management, “probably for fear of contracting the virus,” the authors wrote.

“We believe that poor communication with the healthcare system had forced patients to attempt self-management, by overusing analgesics or using traditional medicine which was not correlated with satisfactory headache care,” the authors wrote.

Results of a recent survey of 155 countries conducted by the World Health Organization showed that nearly half of the patients with chronic diseases failed to receive their regular medical care and medications since COVID-19 pandemic began, the authors added.

Around 4% of those surveyed were infected with COVID-19, and a majority (63.4%) reported worsening of their headaches while they had the virus.

Nearly 80% of patients said they symptoms of anxiety and/or depression during the pandemic and 78% had sleep disturbances.

Female gender, shorter disease duration, having difficulty in getting medications, lack of communication with treating neurologist, non-compliance to treatment, and working during the pandemic had a statistically significant correlation with worsening of migraine symptoms, according to the findings.

“In this survey, COVID-19 pandemic had a negative impact on patients with migraine. More than half of them experienced increase in migraine frequency and severity, in comparison to pre-pandemic period. This was understandably accompanied by overuse of analgesics and acute migraine treatments,” the authors wrote.

Long-term strategies should be validated and implemented to deliver quality care for patients with migraine, with emphasis on psychosocial well-being, the authors wrote.

1. Al-Hashel JY, Ismail II. Impact of coronavirus disease 2019 (COVID-19) pandemic on patients with migraine: a web-based survey study. 2020. 

 https://doi.org/10.1186/s10194-020-01183-6

Patients reported more frequent and severe migraines, along with overuse of analgesics. 

®, a leading multimedia resource that has served the pharmacy field for more than 160 years, and 

, a multimedia platform that provides market intelligence and solutions to C-suite executives of health plans, are pleased to announce a partnership with Scientia Pharmacy Advisors. The partnership will offer educational opportunities in the areas of clinical practice, network distribution development and utilization management in oncology pharmacy.

“We have worked with the founders of Scientia Pharmacy Advisors in several different capacities over the past decade, and we share the goal of advancing science and offering innovative health care solutions,” said Brian Haug, Executive Vice-President, Healthcare of MJH Life Sciences™, parent company of 

. “Through this collaboration, we look forward to building upon that relationship and working together to serve as a trusted resource for pharma and healthcare professionals.”

Through live and virtual formats, Scientia Pharmacy Advisors will leverage the 

 industry-leading platforms in the pharmacy and payer verticals to help guide pharma partners and other industry professionals through the complex oncology pharmacy landscape. The content will be produced quarterly and will focus on best practices necessary to provide efficient and optimal care to oncology patients across the country.

‘’The partnership will allow Scientia Pharmacy Advisors to benefit from the experience and national reach of some of the leading brands in our space, most of which we use and trust on a regular basis,” said Jeff Lombardo, PharmD, BCOP, of Scientia Pharmacy Advisors. “This alliance will allow our organization to have greater visibility, resulting in the opportunity to have a greater impact on cancer care across the country.”

Alliance will provide insight, education, and training opportunities to pharmaceutical and life sciences professionals.


Drug Topics® and Managed Healthcare Executive® Announce Partnership with Scientia Pharmacy Advisors

The vast majority of pharmacists plan to or have received a coronavirus disease 2019 (COVID-19) vaccine, according to a survey of 570 pharmacists conducted last week by the American Pharmacists Association (APhA).

Of these pharmacists, 51% have received 1 dose, 10% have received 2 doses, and 31% plan to get it as soon as it is available.

Moreover, 95% of respondents indicated they are comfortable addressing patients’ concerns about the vaccine. Vaccine hesitancy has been identified as a foreseeable roadblock to widespread immunization against COVID-19, but pharmacists can help alleviate patient concerns.

A poll conducted by The Associated Press-NORC Center of Public Affairs Research in May 2020 showed that only half of Americans are willing to receive the vaccine.

 A more recent Kaiser Family Foundation (KFF) survey suggested an increase in the share of the public (71%) who said they would definitely or probably get the COVID-19 vaccine, up from 63% in a September survey.

 However, approximately 1 quarter of the public remains vaccine hesitant.

“The rising rates of pharmacists’ confidence in the vaccine and their planned participation in vaccination activities demonstrates that pharmacists are ready, willing, and able to protect Americans against the coronavirus,” Scott J. Knoer, PharmD, MS, FASHP, executive vice president and chief executive officer of APhA, said in a statement. “Approximately 400,000 pharmacists, pharmacy technicians, and pharmacy interns have been trained for precisely this moment, and we’re ready to do the job.”

Additionally, 41% of pharmacists surveyed reported they were already administering the vaccine, 38% said they would be able to administer it as soon as it is available, and 17% were preparing to administer the vaccinations and would participate in future phases of the vaccine delivery program. Seventy-nine percent of pharmacists said staffing in their pharmacy practice is adequate to offer the vaccine.

APhA has conducted 3 surveys about the COVID-19 vaccine since September 2020. In each successive survey, an increasing number of pharmacists said they planned to be immunized, manage the logistics of handling the vaccine, and would administer it to their patients.

Vast Majority of Pharmacists Plan to or Have Been Vaccinated, Against COVID-19, APhA Survey Finds. News release. American Pharmacists Association; January 21, 2021. Accessed January 21, 2021. 

https://www.pharmacist.com/press-release/vast-majority-pharmacists-plan-or-have-been-vaccinated-against-covid-19-apha-survey#:~:text=%E2%80%93%20More%20than%209%20in%2010,soon%20as%20it%20is%20available

Expectations for a COVID-19 vaccine. The Associated Press-NORC Center of Public Affairs Research. May 2020. Accessed January 21, 2020. 

https://apnorc.org/projects/expectations-for-a-covid-19-vaccine/

Hamel L, Kirzinger A, Muñana C, Brodie M. KFF COVID-19 Vaccine Monitor: December 2020. Kaiser Family Foundation. Published December 15, 2020. Accessed January 21, 2020. 

https://www.kff.org/coronavirus-covid-19/report/kff-covid-19-vaccine-monitor-december-2020/

A survey from APhA reported that the majority of pharmacists plan to or have received a COVID-19 vaccine. 

Survey: Majority of Pharmacists Confident in COVID-19 Vaccine 

Women’s health care providers’ may benefit from headache-specific education to improve knowledge gaps regarding the management of migraine in their patients, according to a new study.

Migraine is often underdiagnosed and inadequately treated in the primary care setting.

 In women particularly, migraine is one of the leading serious health problems, according to the Migraine Research Foundation. Of the more than 39 million Americans who suffer from migraines, 28 million are women.

 included a comprehensive survey assessing of migraine knowledge among primary care providers (PCPs), with an added section on the use of hormonal medication in patients with migraine.

Overall, 115 women’s health care providers completed the survey. Based on the findings, women’s health care providers generally recognized the prevalence of migraine, but experienced knowledge gaps regarding management.

Although 82.6% of respondents said they feel comfortable or somewhat comfortable diagnosing a migraine, only 57.9% reported routinely asking patients about headaches during annual visits. Additionally, only 6.3% were familiar with the American Academy of Neurology guidelines on preventative treatment and 17.3% were familiar with the Choosing Wisely Campaign recommendations on migraine treatment. Many reported prescribing medications known to contribute to medication overuse headache.

Notably, only 37.5% of respondents reported having migraine and headache education, and most (96.3%) indicated interest in migraine prevention and treatment, migraine associated disability, and diagnostic testing.

Only 24.3% would order imaging for a new type of headache, 35.7% for worsening headache, and 47.8% for headache with neurologic symptoms.

Respondents had limited knowledge of evidence-based, non-pharmacologic treatments for migraine (ie, biofeedback or cognitive behavior therapy), with nearly none placing referrals for these services.

Most providers were comfortable prescribing hormonal contraception (mainly progesterone only) to women with migraine without aura and with aura, and followed guidelines to limit combination hormonal contraception for patients with aura.

Pharmacists can play an important role in providing education on migraine prophylaxis for better patient outcomes in the primary care setting. A 

 presented at the American Society of Health-System Pharmacists Midyear 2020 Clinical Meeting and Exhibition indicated that pharmacists can offer provider education on drug selection and the impact of acute medication overuse, as well as identifying when migraine symptoms are not well controlled.

Verhaak AMS, Williamson A, Johnson A, et al. Migraine diagnosis and treatment: a knowledge and needs assessment of women’s health care providers. 2020. 

About migraine. Migraine Research Foundation. Accessed January 15, 2021. 

https://migraineresearchfoundation.org/about-migraine/migraine-in-women/

A study observed gaps in migraine knowledge in women’s health care providers. Pharmacists can play a role in provider education on prophylaxis and treatment. 