2020-09-15 16:35:00Pharmacy Times®, the leading multimedia resource for pharmacy professionals, will celebrate American Pharmacists Month in October with its annual #ThankAPharmacist campaign, which recognizes pharmacists and pharmacy technicians through Twitter, Facebook and Instagram for their dedication and commitment to improving patients’ lives.
Now in its sixth year, the Pharmacy Times® #ThankAPharmacist campaign honors pharmacy professionals who, this year, are serving their communities by being on the front line during the coronavirus disease 2019 (COVID-19) pandemic. Colleagues, patients, friends and family members of outstanding pharmacists, pharmacy technicians or others in the field are encouraged to post their messages to pharmacy professionals on social media using #ThankAPharmacist or #APharmacistIs.
“For the past six years, Pharmacy Times® has been committed to honoring pharmacy professionals as vital members of the health care team who make an impact by improving the overall quality of patient care,” said John Hydrusko, vice president of Pharmacy & Healthcare Communications, LLC, the publisher of Pharmacy Times®. “Now more than ever, we look forward to supporting American Pharmacists Month this October to show appreciation for those pharmacists and pharmacy technicians who have kept their community safe and healthy while putting themselves on the front line during the pandemic.”
In its November issue, Pharmacy Times® will feature the top 10 posts showcasing the true value of pharmacists. Additionally, video submissions will be highlighted on the Pharmacy Times® Pharmacy Heroes resource center, which was launched to recognize the contributions of pharmacy staff members on the front lines of the COVID-19 pandemic.
For more information on the #ThankAPharmacist campaign, please visit Pharmacy Times® or find us on Facebook, Twitter or Instagram.
About Pharmacy Times®
Pharmacy Times® is the industry-leading multimedia pharmacy network of community, health-system, oncology and specialty pharmacy platforms, providing practical clinical and professional information that pharmacists can use in their everyday practices when counseling patients and interacting with other health care providers. Each issue and the website contain articles and features covering industry trends, medication errors, drug interactions, patient education, disease state management, patient counseling, product news, pharmacy law and more. Additionally, Pharmacy Times Continuing Education is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Pharmacy Times® is a brand of MJH Life Sciences™, the largest privately held, independent, full-service medical media company in North America dedicated to delivering trusted health care news across multiple channels.
The Impact of COVID-19 on Medical Science Liaisons 2020-09-15 16:03:00 Allen Amedume, PharmD Candidate 2021, and Prasanna Gore, BPharm, MS, PhD The disruptive effects of the coronavirus disease 2019 (COVID-19) have rippled through every facet of our health care system, from the way we live to how we work and communicate among ourselves. The pharmaceutical industry is no exception to COVID-19’s disrupting influence.
Most notably, COVID-19 has transformed the landscape for medical science liaisons (MSLs) by forcing them to rapidly adapt to the present circumstances. MSLs are the field-facing medical and scientific branch of pharmaceutical companies.
They cultivate and preserve relationships with health care professionals and key opinion leaders (KOLs). Essentially, MSLs are the bridge between pharmaceutical companies, health care professionals, and providers across the care spectrum.
They concentrate on a specific disease state or therapeutic area in line with their company’s products and ensure that these products are used effectively throughout their entire lifecycle. Furthermore, MSLs serve as a scientific resource to internal and external stakeholders by providing insights on relevant scientific information to the medical community.1
In general, most MSL teams are comprised of individuals with advanced scientific backgrounds that usually include a doctorate, such as a PharmD, PhD, or MD. Pharmacists are medication experts with a comprehensive understanding of drug therapy, patient needs, and the health care system, making them ideal for the MSL role.
According to an annual survey by the Medical Science Liaison Society, PharmD was the most common degree (40%) held by an MSL, followed by PhDs (37%).2 There are several ways that pharmacists can transition into an MSL role, such as leveraging their extensive clinical knowledge and experience, completing a post-graduate biopharmaceutical industry fellowship, or building upon their experience as a pharmaceutical sales representative.
MSLs have been significantly disrupted by the COVID-19 pandemic, given the nature of their daily operations. Although company size, disease state, and geographical location are the main determinants of how much an MSL will travel, the common underlying theme of MSL activities is field work.3
Whether it be by car or air, for many MSLs, traveling 75% of the time is not unusual.4 An MSL’s area or territory can range from a single state to an entire US region. To effectively establish and maintain relationships with KOLs, MSLs have to meet in-person frequently with their target audience.
Furthermore, MSLs regularly travel to attend internal meetings, medical conferences, and educational lectures. COVID-19 has grounded MSLs with travel restrictions and cancellation of events has effectively limited their in-person presence and networking.
The most apparent effect on MSLs is the reduced engagements with KOLs. Cultivating authentic and long-lasting relationships with KOLs is largely a function of the fundamental pharmaceutical concept of “reach and frequency.”5
MSLs generally rely on the quantity of face-to-face interactions with KOLs to disseminate important clinical information and insights about their disease area and products. Spiking COVID-19 cases around the world have left hospitals inundated and operating at full capacity. Subsequently, MSLs have restricted access to health care providers and institutions.
In these unique times, physicians need to be physicians first to patients, and therefore, have limited or no time to interact with MSLs.6 Furthermore, MSLs traveling for live meetings at health care institutions could potentially put themselves at risk, along with patients and the providers they meet, given the highly contagious nature of severe acute respiratory syndrome coronavirus 2. Many institutions have also become wary of in-person interactions and have limited the number of MSL engagements or suspended them entirely.5
COVID-19 has critically curtailed the exchange of scientific information and gathering of insights by MSLs. More than 20 scientific congresses and conferences essential to clinical data dissemination and engagement have already been postponed or cancelled.7 Moreover, clinical trials in many therapeutic areas have been disrupted, which has slowed the flow of new clinical data available for MSLs to disseminate. For example, according to GlobalData, nearly 200 companies have stopped or delayed their clinical trials because of the pandemic.8
MSLs’ job security has also been challenged by the spread of the COVID-19 pandemic. The MSL Society conducted a global study in which 46% of the 579 MSLs surveyed reported that they are concerned about job security.9
The MSL position is crucial to the information flow between industry and providers and the value they bring to the clinical drug therapy ecosystem. Despite this important role, pharmaceutical companies are being pressured by the pandemic to reduce or reimagine their field force activities, including those of MSLs.
The impact of the COVID-19 pandemic has undoubtedly disrupted the MSL landscape; however, MSLs have promptly adapted to this crisis. Travel restrictions and the suspension of face-to-face interactions have driven MSLs to shift to virtual engagements. MSLs have continued to engage with KOLs and share clinical information at conferences and congresses through virtual platforms, such as Zoom and WebEx.
COVID-19 has largely contributed to the rapid adoption of digital technology within the pharmaceutical industry. Digital meeting tools have the potential to optimize all aspects of the field force operations.
Companies should re-evaluate the impact of face-to-face engagements compared with virtual engagements for KOLs, especially during this pivotal time when most health care providers and institutions have set up and become accustomed to using digital channels for engagements.
Although in-person engagements may never be completely replaced, virtual engagements can maximize the number of meetings and minimize expenditures. In the long term, MSLs should rethink their strategies to disseminate information, specifically by implementing a digital strategy in all their professional activities.10
Between travel restrictions, inaccessible KOLs, and suspended conferences, MSLs have had more flexibility to reallocate support to other functions. Medical information call centers have been experiencing heavy workload during the pandemic in the form of inquiries about access to medications, on- and off-label uses, and effects of missed or delayed medication.11
Although their routine activities have been curtailed, MSLs have refocused their efforts to on-call support for in-house medical affairs teams. Additionally, MSLs have supported teams in therapeutic areas currently strained due to COVID-19 (eg respiratory, infectious disease).
Moreover, MSLs have used their newfound availability to tend to tasks on their lingering to-do list that often get overlooked during their fast-paced schedules. Some of these tasks include spending more time reviewing scientific literature, regrouping through internal MSL team meetings, preparing slide decks, and refining their soft skills and business acumen.12
Tending to these tasks and professional development will support future engagements once MSLs resume their in-person interactions.
In conclusion, the impact of COVID-19 has disrupted industries and professions worldwide, and MSLs’ normal work routine has been impacted heavily. Fortunately for MSLs, they have begun adapting to the transformations in their daily operations by rapidly identifying, prioritizing, and implementing innovative strategies. Whether it be through adopting digital technology or other unconventional methods, MSLs will continue redefining the way they engage and spread information.
COVID-19 may have only accelerated the changes that would have inevitably occurred for MSLs. The MSL landscape is constantly evolving, and the future of its operations and interactions remain uncertain.
However, we can be confident that MSLs will always be ready to adapt and ensure that they can effectively engage with providers and KOLs to disseminate important clinical and drug therapy-related information to their audience.
- ExploreHealthCareers.org. 2020. Medical Science Liaison. [online] Available at: https://explorehealthcareers.org/career/pharmacology/medical-science-liaison/. Accessed August 13, 2020.
- MSL Society. 2020. What Is A Medical Science Liaison (MSL)? | MSL Society. [online] Available at: https://www.themsls.org/what-is-an-msl/. Accessed August 13, 2020.
- Millennial Pharma Leader. 2020. The Role Of Medical Science Liaison – Millennial Pharma Leader. [online] Available at: https://millpharmaleader.com/2019/02/11/the-role-of-medical-science-liaison/. Accessed August 13, 2020.
- H1. 2020. Part 1: A Day In The Life Of A Medical Science Liaison — H1. [online] Available at: https://learn.h1insights.com/blog/2018/8/6/an-h1-insight-a-day-in-the-life-of-a-medical-science-liaison. Accessed August 13, 2020.
- BioPharma Dive. 2020. Medical Science Liaisons Carry The Day With Key Opinion Leaders During The COVID-19 Pandemic. [online] Available at: https://www.biopharmadive.com/spons/medical-science-liaisons-carry-the-day-with-key-opinion-leaders-during-the/579739/. Accessed August 13, 2020.
- Monocl.com. 2020. COVID-19 – The Consequences Of A Pandemic On Medical Affairs. [online] Available at: https://www.monocl.com/blog/pandemic-consequences/. Accessed August 13, 2020.
- Medpagetoday.com. 2020. COVID-19: What’s Cancelled, What Isn’t. [online] Available at: https://www.medpagetoday.com/infectiousdisease/covid19/85261. Accessed August 13, 2020.
- FierceBiotech. 2020. More Than Two-Thirds of Trials Hit By COVID-19 Enrollment Halts, With Midstage Tests The Worst Affected. [online] Available at: https://www.fiercebiotech.com/biotech/more-than-two-thirds-trials-hit-by-covid-enrollment-halts-midstage-tests-worst-affected. Accessed August 13, 2020.
- Jihad Rizkallah, M., 2020. As A Result Of COVID-19, Are You Worried About Your Job Security? – THE MSL. [online] THE MSL. Available at: https://themsljournal.com/article/as-a-result-of-covid-19-are-you-worried-about-your-job-security/. Accessed August 13, 2020.
- Rajadhyaksha, V., 2020. Medical Affairs Post‑COVID 19: Are We Ready To Take The Baton?. [online] Perspectives in Clinical Research. Available at: http://www.picronline.org/showcaptcha.asp?RedirectUrl=article&issn=2229-3485;year=2020;volume=11;issue=3;spage=124;epage=127;aulast=Rajadhyaksha;type=2. Accessed August 13, 2020.
- PharmExec. 2020. How Medical Affairs Teams Need to Adapt To COVID-19 | Pharmexec. [online] Available at: https://www.pharmexec.com/view/how-medical-affairs-teams-need-adapt-covid-19. Accessed August 13, 2020.
- Linda Traylor, M., 2020. What Alternative Activities and Projects Are/Should MSLs Be Focusing On As A Result Of Travel Restrictions/Bans And Reduced KOL Engagements? – THE MSL. [online] THE MSL. Available at: <https://themsljournal.com/article/what-alternative-activities-and-projects-are-should-msls-be-focusing-on-as-a-result-of-travel-restrictions-bans-and-reduced-kol-engagements/>. Accessed August 13, 2020.
Study: Substance Use Disorders Possibly Linked to COVID-19 2020-09-15 15:56:00 Jill Murphy, Assistant Editor Researchers at the National Institutes of Health have found that individuals with substance use disorders (SUD) were more likely than those without a SUD to develop coronavirus disease 2019 (COVID-19). In addition, those with a SUD diagnosis were more likely to experience worse COVID-19 outcomes than those without a SUD, according to a press release.
“The lungs and cardiovascular system are often compromised in people with SUD, which may partially explain their heightened susceptibility to COVID-19,” said study co-author Nora Volkow, MD, in a press release. “Another contributing factor is the marginalization of people with addiction, which makes it harder for them to access health care services. It is incumbent upon clinicians to meet the unique challenges of caring for this vulnerable population, just as they would any other high-risk group.”
Data for the analysis were collected until June 15, 2020, from 360 hospitals across the nation. The study consisted of more than 73 million patients, of whom over 7.5 million had been diagnosed with a SUD at some point in their lives, according to the study authors.
Further, more than 12,000 were diagnosed with COVID-19, and approximately 1880 had both a SUD and a COVID-19 diagnosis on record. The types of SUDs investigated were tobacco, alcohol, opioid, cannabis, and cocaine.
The complicating effects of SUD were visible in increased adverse consequences of COVID-19, as hospitalizations and death rates of COVID-19 patients were all elevated in people with recorded SUDs compared to those without.
In addition, African Americans with a recent opioid use disorder diagnosis were more than 4 times as likely to develop COVID-19 compared to whites. The data showed that hypertension, diabetes, cardiovascular disease, and renal diseases were more prevalent among African Americans than whites with opioid use disorder, according to the study authors.
The findings of the study underscore the need to screen for and treat SUDs as a part of the strategy for controlling the pandemic. The study authors said that additional research is needed to better understand how best to treat those with SUDs who are at risk for COVID-19 and how best to provide counseling to avoid the risk of infection.
Substance use disorders linked to COVID-19 susceptibility. NIH. https://www.nih.gov/news-events/news-releases/substance-use-disorders-linked-covid-19-susceptibility. Published September 14, 2020. Accessed September 14, 2020. Share:
Hierarchy of Breast Cancer Cells May Inform Treatment Resistance 2020-09-15 15:49:00 Alana Hippensteele, Editor It may take cells in different stages of development to cause breast cancer to progress and spread, according to recent research published in eLife.
The findings demonstrated the importance of accounting for specific cell states present in a tumor in order to determine the appropriate combination of drugs necessary to eliminate all the cell states present and halt treatment resistance, according to the study authors.
The researchers noted that the variation between cell states may cause difficulties during treatment if differences in cell states are not accounted for.
“This diversity poses a problem to treating patients because particular subsets of tumor cells may be drug resistant and eventually lead to disease recurrence,” said co-lead author Syn Yeo, PhD, an instructor at the University of Cincinnati, in a press release. “One of the factors contributing to this diversity is the fact that tumor cells can exist in different cellular states, ranging from more stem-like cells that can become other cell types to more differentiated cells that have been coded to serve a purpose, or do a certain ‘job’ within the system.”
Yeo explained further that cancer cells with stem-like properties can cause drug resistance. For this reason, they are generally seen as being at the top of the tumor hierarchy with more differentiated tumor cells toward the bottom of the hierarchy.
In order to determine the tumor hierarchy structure more specifically, the researchers identified and categorized singular cells in order to understand the purpose of each cell. Yeo noted that an analysis without this specificity would have obstructed cellular details during their assessment.
“We were able to find a complex spectrum of cell states between different tumor types that can range from stem-cells to the ‘beginner cells’ to more differentiated cells,” he said. “Furthermore, depending on the lineage of the tumor, some may show a spectrum of cell states that are higher up in the hierarchy and vice versa.”
Yeo explained that these results help to clarify the direction for further research.
“These findings are important because they show we need to know more about how these specific cell states contribute to tumor growth so we can target them with combination drug therapies, potentially helping more people who may otherwise experience drug resistance,” Yeo said.
Researchers pinpoint hierarchy of breast cancer cells as potential cause for treatment resistance. Cincinnati, OH: University of Cincinnati; August 25, 2020. sciencedaily.com/releases/2020/08/200825110633.htm. Accessed September 4, 2020. Share:
Study: Mediterranean Diet May Protect Against Rheumatoid Arthritis 2020-09-15 14:00:00 Sara Karlovitch, Assistant Editor The Mediterranean diet (MD)—which is rich in olive oils, cereals, fruits, vegetables, fish, and a moderate amount of dairy, meat, and wine—may help protect against rheumatoid arthritis (RA), according to a new study published in Arthritis & Rheumatology.1
RA is an autoimmune disease with multifactorial etiology and 70% of cases affect women. RA is more common in Northern European countries than in Southern European countries. Environmental and lifestyle factors, such as diet, may help to explain this discrepancy, according to the study. Previous research has shown the MD, which is common in Southern European countries, is associated with a variety of health benefits.1
The current study included 62,629 women from France who took part in a questionnaire-based survey assessing dietary habits since 1990. Of the 62,629 women in the study, 480 developed RA.2
Overall, the MD was not associated with RA risk; however, in women who currently smoke or used to smoke, it was associated with a decreased risk. For former and current smokers who followed the MD, the risk was 383 cases per 1 million people per year. For those with a low adherence to the diet, the risk was 515 cases per 1 million people per year.2
“Although the benefits of the MD have been proven to reduce overall mortality, cardiovascular diseases, or cancers [10,22,30,31], its mechanism is not fully understood, and might include decreasing inflammation, or increasing antioxidant levels ,” the study authors wrote. “In our study, we found an inverse association between a high adherence to MD and the risk of RA only among ever-smoking women, but not among non-smoking women. These could be explained by the differences between smokers and non-smokers in RA pathophysiological mechanisms [6,32].”
The study authors added that the increased oxidant effect of smoking may be counterbalanced by the antioxidant effect by adherence to the MD. As a result, the increased risk of RA that is associated with smoking may be reduced by strong adherence to the MD.1
The study had several limitations, such as only including French women. Additionally, dietary habits were only recorded once, according to the study authors.1
- Nguyen Y, Salliot C, Et al. Mediterranean diet and risk of rheumatoid arthritis: findings from the French E3N: EPIC cohort study. Arthritis& Rheumatology. 2020. doi: 10.1102/ART.41487.
- Does the Mediterranean diet protect against rheumatoid arthritis? [News Release] Hoboken, NJ. September 10, 2020. https://www.eurekalert.org/pub_releases/2020-09/w-dtm090920.php. Accessed September 11, 2020.
Common Cold May Jumpstart Immune System, Reducing Flu Cases 2020-09-15 13:34:00 Aislinn Antrim, Assistant Editor The most frequent cause of common colds, rhinovirus, may be able to prevent influenza by jumpstarting the body’s antiviral defenses, according to research published in The Lancet Microbe. The findings may reveal a surprising ally in the battle to minimize flu-related hospitalizations during the upcoming flu season.
Investigators at Yale studied 3 years of clinical data from more than 13,000 patients with symptoms of respiratory infection. They found that even during months when both rhinovirus and influenza were active, if the common cold virus was present then the flu virus was not.
“When we looked at the data, it became clear that very few people had both viruses at the same time,” said researcher Ellen Foxman, MD, PhD, in a press release.
These results may also explain findings during the 2009 H1N1 swine flu pandemic, when the expected surge in swine flu cases was never seen in Europe during the fall as the common cold became more widespread. Foxman added, however, that researchers do not know whether the annual seasonal spread of rhinovirus will have a similar impact on infection rates of those exposed to coronavirus disease 2019 (COVID-19).
“It is impossible to predict how 2 viruses will interact without doing the research,” she said in the release.
In order to test how the rhinovirus and influenza viruses interact, investigators created human airway tissue from stem cells that give rise to epithelial cells, which are a key target of respiratory viruses. They found that after the tissue had been exposed to rhinovirus, the influenza virus was unable to infect the tissue.
The presence of rhinovirus triggered production of the antiviral agent interferon, which is part of the early immune system response to invasive pathogens.
“The antiviral defenses were already turned on before the flu virus arrived,” Foxman said.
She added that the effect lasted for at least 5 days, and the lab has started studying whether introduction of the cold virus before infection by COVID-19 offers a similar type of protection.
Common cold combats influenza [news release]. Yale; September 4, 2020. https://news.yale.edu/2020/09/04/common-cold-combats-influenza. Accessed September 10, 2020.
Investigational Drug Found to Slow ALS Disease Progression 2020-09-15 13:16:00 Alana Hippensteele, Editor An investigational drug for treating amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, has been shown to slow the progression of the disease, according to a study published in the New England Journal of Medicine. According to the researchers, these results provide hope for a future treatment for ALS, which is a fatal disease that currently has no cure.
The oral medication tested in the trial, AMX0035, is a combination of sodium phenylbutyrate and taurursodiol. Each of these 2 drugs contained within AMX0035 target a different cell component critical to protecting against nerve damage.
During the CENTAUR trial, the researchers randomized 137 patients with ALS into groups of those receiving AMX0035 and those receiving the placebo. The researchers then observed the patients over 6 months and found that those given AMX0035 had better outcomes than those given the placebo. This assessment was based on patients’ responses to the ALS Functional Rating Scale (ALSFRS-R), a questionnaire that evaluates activities of daily living, such as ability to walk, hold a pen, or swallow food.
“The participants treated with AMX0035 demonstrated a significant slowing of ALS disease progression as measured by the ALSFRS-R. This is a milestone in our fight against ALS,” said Sabrina Paganoni, MD, PhD, principal investigator of the CENTAUR study, investigator at the Healey & AMG Center for ALS at MGH, and assistant professor of PM&R at Harvard Medical School (HMS) and Spaulding Rehabilitation Hospital, in a press release.
Additionally, senior author Merit Cudkowicz, MD, director of the Healey & AMG Center for ALS at MGH, chief of Neurology at MGH, and the Julieanne Dorn Professor of Neurology at HMS, explained in the press release that through collaboration with others, the authors of the study were able to investigate this novel approach to the problem of motor nerve cell dysfunction.
“With guidance from our team and in collaboration with our colleagues in the Northeast ALS Consortium (NEALS), Mass General Biostats and the Barrows Neurological Institute, the clinical trial moved forward quickly and carefully,” Cudkowicz said in the release. “We are proud of this important study. We are also very thankful to the participants and their families for their key role in advancing research.”
Justin Klee, one of the co-founders and co-CEOs of Amylyx Pharmaceuticals, the company that manufactures AMX0035, noted that patients with ALS and their families do not have time to wait.
“People with ALS progressively lose their ability to function and care for themselves, so we want to do everything we can to help them slow down this devastating disease,” Klee said in the press release. “We will be working with the FDA to determine next steps and the path for patients to gain access to AMX0035. We’ll continue to share our plans with the community as they develop.”
Investigational ALS drug generates promising clinical trial results. Boston, MA: Massachusetts General Hospital; September 2, 2020. eurekalert.org/pub_releases/2020-09/mgh-nad090220.php. Accessed September 14, 2020. Share:
FDA Fast Tracks Prostate Cancer Drug 2020-09-15 09:39:00 Kristi Rosa The FDA granted a fast track designation to the highly-selective N-terminal domain inhibitor EPI-7386 for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) who are resistant to standard-of-care options, according to an announcement from ESSA Pharma Inc.1
“We are pleased with the FDA’s decision to grant fast track designation for development of EPI-7386 to treat [patients with] mCRPC resistant to standard-of-care treatments,” David R. Parkinson, MD, chief executive officer of ESSA Pharma, stated in a press release. “This designation signifies recognition of the unmet medical need for new and effective treatments for this patient population. EPI-7386 may represent a promising novel treatment option for these patients and the designation offers the opportunity to interact more closely with the FDA during the development [of the agent].”
Previously, the small molecule inhibitor demonstrated preclinical activity in models of antiandrogen-sensitive and -resistant prostate cancer. Now, the safety and tolerability of EPI-7386 in patients with mCRPC who progressed on standard therapies, including second-generation antiandrogens, is under examination in a phase 1 trial (NCT04421222).
As this is a first-in-human trial, the main goal is to examine the safety of the agent and to identify a dose that can be administered to this patient population without any intolerable adverse effects (AEs).2 Other key factors that will be examined include how the amount of the drug in the blood changes over time, the effect of the agent on the disease, the impact of the drug on certain substances in the body, and the possibility of EPI-7386 being able to interact with other agents.
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Research at ESMO 2020 Highlights Significant Progress in Cancers With High Unmet Medical Need 2020-09-14 17:46:00 Alana Hippensteele, Editor Bristol Myers Squibb (BMS) announced it will present data from research spanning 15 different cancers with high unmet need at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, which will take place from September 19 to 21, 2020.
The BMS presentations at ESMO will highlight clinical data evaluating various novel tumor targets in early-stage pipeline therapies and novel combinations in cancers, including non-Hodgkin lymphoma, extensive-stage small cell lung cancer, diffuse large B-cell lymphoma, and glioblastoma.
In research investigating renal cell carcinoma (RCC) treatments, the company will present data on nivolumab (Opdivo) use in combination with cabozantinib (Cabometyx, Exelixis) versus sunitinib in previously untreated advanced RCC. Additionally, results will be presented from a 4-year follow-up of a phase 3 study evaluating nivolumab plus ipilimumab (Yervoy) compared with sunitinib in patients with previously untreated advanced or metastatic RCC. This follow-up is the longest from a phase 3 trial of an immunotherapy-based combination in previously untreated advanced RCC.
The company will also present first disclosures of data from several phase 3 trials investigating treatments of gastrointestinal cancers, lung cancer, and melanoma.
“New data we are presenting at ESMO will highlight the potential to change the standard of care for certain cancers, demonstrate the value our therapies can bring to patients, and showcase how we are defining the future of medicine. We are also grateful for the tireless support from and collaboration with the cancer community, especially from investigators and patients, without whom our research would not be possible,” said Samit Hirawat, MD, executive vice president, chief medical officer, global drug development, BMS, in a press release.
Bristol Myers Squibb Research at ESMO Virtual Congress 2020 Highlights Significant Progress in Cancers with High Unmet Medical Need. Princeton, NJ: Bristol Myers Squibb; September 8, 2020. news.bms.com/news/corporate-financial/2020/Bristol-Myers-Squibb-Research-at-ESMO-Virtual-Congress-2020-Highlights-Significant-Progress-in-Cancers-with-High-Unmet-Medical-Need/default.aspx. Accessed September 11, 2020. Share:
Monday Pharmaceutical Mystery: What Medication is Causing a Patient’s Cognitive Changes? 2020-09-14 16:54:00 Gunda Siska, PharmD NS is a 78-year-old male admitted to the hospital with idiopathic pancreatitis and severe nausea. He has no serious comorbidities and is a generally healthy person.
During morning rounds, your team discusses NS’s case. The nurse says that NS is having trouble sleeping at night and he has become severely confused and agitated over the past several days. It’s like he has restless leg syndrome all over his body. He thinks he’s at home, he keeps trying to use his cellphone to change the tv stations, and he’s very unsteady when he walks.
The primary care physician says that the pancreatitis has resolved and, medically speaking, NS can be released from the hospital. The social worker asks if she should start making arraignments to have NS placed in a nursing home since he has developed signs of dementia. The physicians mentions it is curious that NS was previously living independently at home prior to his hospitalization. NS has no family history of Alzheimer disease or any other type of cognitive impairment.
You are the team pharmacist and you look at the drug list for NS with your laptop computer. You see that he is on the following medications.
- Natural tears, 1 drop each eye bid
- Bimatoprost, 1gtt each eye qhs.
- Warfarin, 2 mg qhs with sips of water
- Finasteride, 5mg qhs with sips of water
- Promethazine, 25 to 50 mg IV q6h prn severe nausea and vomiting
- Acetaminophen, 650mg suppository q4h prn mild pain or fever
- Morphine, 2 mg IV q4 hours prn severe pain
You ask the team to hold off on a nursing home placement and suggest changing 1 of his medications to see if his dementia resolves. What you really want to say is, “He’s fine, he’s just having adverse effects from one particular medication. He’ll be able to go back to his normal life after 48 hours if we stop this 1 drug.”
Mystery: Which medication is causing cognitive changes in NS?
Solution: Promethazine 25 mg orally or iv q8 hours as needed for nausea.
Promethazine is an antinausea drug with anticholinergic properties. It opposes acetylcholine. Acetylcholine is an essential brain neurotransmitter that is also located in various nerve endings throughout the body. As we age, all our neurochemicals can diminish in production. Anticholinergic drugs diminish this neurochemical even more, and if it diminishes too much, cognitive impairment can set in. If these drugs are given for too long, years, the changes can become permanent.
There is a new study that discovered these drugs cause problems in healthy people who do not have risk factors or family members with dementia. This study found that people taking at least 1 anticholinergic drug were 47% more likely to develop mild cognitive impairment, which can be a precursor to dementia.1
This finding is supported by another study, published in 2019.2 This earlier investigation was a case controlled study that looked at 58,769 patients with a diagnosis of dementia and 225,574 controls who did not have dementia. It specifically evaluated people aged 55 years and older, and who had exposure to anticholinergic drugs.
The 2019 study found that approximately 10% of dementia diagnoses are attributable to anticholinergic drugs. There was nearly a 50% increased odds of dementia with the use of a strong anticholinergic drug consumed daily for 3 years.
Acetylcholine plays a role in the brain regarding cognitive function, learning and attention. It also plays a major role throughout the body in the junctions between nerves and muscles, specifically at the neuromuscular junction.
Many anticholinergic drugs work in the body to improve the lives of patients suffering from severe nausea, muscle spasms, overactive bladder, and intestinal cramping. These drugs are also used to treat depression, mood disorders, Parkinson disease, and epilepsy because they also exert an effect in the brain.
These findings highlight the importance of reducing exposure to anticholinergic drugs in middle-aged and older adults.
- Weigand AJ, Bondi MW, Thomas KR, et al. Association of anticholinergic medication and AD biomarkers with incidence of MCI among cognitively normal older adults. Neurology. Published online September 2, 2020. DOI: https://doi.org/10.1212/WNL.0000000000010643
- Coupland CAC, Hill T, Dening T, Morriss R, Moore M, Hippisley-Cox J. Anticholinergic Drug Exposure and the Risk of Dementia: A Nested Case-Control Study. JAMA Intern Med. Published online June 24, 2019. doi:10.1001/jamainternmed.2019.0677
Study: Levodopa May Reduce Blindness in Age-Related Macular Degeneration 2020-09-14 16:10:00 Sara Karlovitch, Assistant Editor Levodopa may improve vision in patients with advanced forms of age-related macular degeneration (AMD), according to a new study published in the American Journal of Medicine.
More than 15% of the age 70 and over population of the United States is living with AMD, a common cause of blindness in developed nations. Neovascular AMD (nAMD) is the abnormal growth of new blood vessels triggered by vascular endothelial growth factor (VEGF).
This can cause fluid and blood to leak in the subretinal space of the eye. Although nAMD only accounts for 10%-15% of AMD cases, it’s responsible for 90% of the vision loss attributed to the disease, according to the study. Currently, the standard treatment is frequent anti-VEGF injections, which are effective but expensive and painful.
The study was composed of 2 parts. In the first part, 20 patients who were newly diagnosed with nAMD who never received VEGF treatment injections were given a small dose of levodopa for a month. Each week, the participants underwent evaluations by their referring retina specialist to determine whether anti-VEGF treatment was needed.
In the second part of the study, patients from part 1 as well as 14 new participants who received anti-VEGF treatment for at least 3 months before the study received escalating doses of levodopa. This was used to test the tolerance and efficacy of the drug. Participants were evaluated monthly by their referring retina specialist.
In addition to being found safe and well-tolerated, levodopa delayed anti-VEGF injection therapy while improving visual outcomes, according to the study. Retinal fluid decreased by 29% in the first month.
At the 6-month mark, the decrease was maintained and visual acuity improved to the point patients in both groups were able to read an additional line on the eye chart. This is an improvement equivalent to a change from 20/40 to 20/32.
Eleven of the 14 patients did require anti-VEFG injections, meaning that levodopa may be unlikely as a standalone treatment in newly diagnosed nAMD patients; however, they required fewer monthly treatments. In the second group, monthly anti-VEGF injections decreased by 52%.
Levodopa may improve vision in patients with macular degeneration [News Release]. Philadelphia, PA. September 10, 2020. https://www.eurekalert.org/pub_releases/2020-09/e-lmi091020.php. Accessed September 11, 2020. Share:
Positive Results Announced From Phase 3 Adult Studies Evaluating 15-valent Pneumococcal Conjugate Vaccine 2020-09-14 16:04:00 Alana Hippensteele, Editor Two phase 3 studies showed an investigational 15-valent pneumococcal conjugate vaccine (V114, Merck) was well-tolerated among patients and met the primary immunogenicity objectives.
The phase 3 Pneu-age study assessed the vaccine’s efficacy in healthy adults aged 50 years or older. The results showed that the vaccine was not inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13), according to the researchers.
In this study, the new 15-valent vaccine was found to be as successful in targeting the 13 serotypes that are currently targeted in the 13-valent version, with the V114 vaccine being superior in targeting serotypes 22F and 33F. This study also demonstrated the 15-valent vaccine was superior in targeting serotype 3, which is known to be a leading cause of invasive pneumococcal disease globally.
In the Pneu-true study, the researchers found V114 successfully demonstrated equivalent immune response across all 15 serotypes in healthy adults aged 50 years or older. In both studies, the researchers found that V114 was not only well-tolerated among patients, but the safety profile of the vaccine was comparable with the current PCV13 and consistent with the results of previous studies that assessed V114.
Merck plans to present these results and any additional phase 3 data from its clinical program to the public, allowing the data to form the basis of global regulatory licensure applications before the end of 2020.
“Diseases caused by serotypes not covered by the currently available pneumococcal conjugate vaccine are increasing worldwide and can vary by country or region. Additionally, we continue to see pneumococcal disease caused by serotypes included in the existing pneumococcal vaccines,” said Roy Baynes, MD, PhD, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, in a press release.
The pneumococcal serotypes that are not included in the current 13-valent pneumococcal conjugate vaccine, such as 22F and 33F, have been found to be associated with invasive pneumococcal disease throughout the country. These 2 serotypes, 22F and 33F, specifically cause 13% of the invasive pneumococcal disease observed in adults aged 65 years and older in the United States.
Additionally, serotype 3, which is targeted in V114, remains a leading cause of invasive pneumococcal disease in adults and children, despite the current 13-valent version in use also targeting this serotype. In total, 15% of invasive pneumococcal disease among adults aged 65 years and older is still caused by serotype 3 in the United States.
“These phase 3 data demonstrated that V114 generated a robust immune response to all 15 serotypes included in the vaccine and reinforce the potential for this investigational vaccine to help protect adults against pneumococcal disease,” Baynes said.
Baynes noted that additional research into pneumococcal disease prevention is necessary in order to target those serotypes that remain a risk factor for certain populations.
Merck Announces Positive Topline Results from Two Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine, Including Pivotal Trial. Kenilworth, NJ: Merck; September 9, 2020. merck.com/news/merck-announces-positive-topline-results-from-two-phase-3-adult-studies-evaluating-v114-mercks-investigational-15-valent-pneumococcal-conjugate-vaccine-including-pivotal-trial/. Accessed September 11, 2020. Share:
Targeting Genetic Vulnerability Could Improve Breast Cancer Treatment 2020-09-14 15:51:00 Sara Karlovitch, Assistant Editor Genetic vulnerability is present in nearly 10% of breast cancer tumors, according to a new study published in the journal Nature.
In the United Kingdom, where the study took place, more than 5000 newly diagnosed breast cancer cases carry this genetic fault. This proportion of cases is approximately double the cases caused by hereditary mutations, such as the BRCA genes, according to the study.
Investigators from University of Oxford and John Hopkins University School of Medicine in Baltimore, Maryland, discovered that cells originating from a specific subset of human breast cancer tumors can be killed using a chemical that inhibits PLK4. This enzyme is important in the centrosome, which performs important functions during cell division, according to the study.
Most cells have safety features that prevent them from losing their centrosomes; however, according to the study, these specific cancerous cells could not survive without them. Investigators also found that these cells carry a genetic abnormality known as 17q23 amplification. Cells with this abnormality are more likely to become cancerous.
“It is slightly ironic that the same thing that makes the cells more likely to become cancerous also makes them uniquely vulnerable to losing their centrosomes, but is useful to us as scientists, because it means that we may be able to selectively target this kind of cancer cell in patients without affecting their healthy cells,” Oxford’s Ross Chapman, PhD, said in the press release.
The chemical PLK4 inhibitor is not suitable for human patients, according to the study. However, they hope that this information will be useful in developing a PLK4-targeting drug with the same effect.
Oxford University researchers discover ‘genetic vulnerability’ in breast cancer cells [News Release] Oxford, UK. September 9, 2020. https://www.eurekalert.org/pub_releases/2020-09/uoo-our090920.php. Accessed September 10, 2020. Share:
Anticholinergic Medications Linked to Cognitive Decline 2020-09-14 15:50:00 Aislinn Antrim, Assistant Editor Although anticholinergic medications are used in a wide array of conditions, including allergies, basic colds, and hypertension, they may be associated with an increased risk of cognitive decline, especially in older adults at greater risk for Alzheimer disease, according to researchers from University of California San Diego School of Medicine.
Anticholinergic drugs include a wide range of medications and treat many conditions, both major and minor, some requiring a prescription and others available as OTC options. The drugs work by blocking acetylcholine—a type of neurotransmitter or chemical messenger known to be critical for memory function—from binding to receptors on certain nerve cells, thus inhibiting parasympathetic nerve impulses.
The study authors found that cognitively normal study participants who were taking at least 1 anticholinergic drug at baseline were 47% more likely to develop mild cognitive impairment, which is often a precursor to dementia. Study participants were tracked for up to 10 years and compared with participants who did not take such drugs.
A total of 688 adults were included in the study, evenly divided by sex with an average age of 74. No participants displayed cognitive or memory problems at the beginning of the study. One-third of the participants were taking anticholinergic drugs, with an average of 4.7 anticholinergic drugs per person. All participants were given annual comprehensive cognitive tests for up to 10 years.
“This study, led by Alexandra Weigand, suggests that reducing anticholinergic drug use before cognitive problems appear may be important for preventing future negative effects on memory and thinking skills, especially for people at greater risk for Alzheimer’s disease,” said senior author Lisa Delano-Wood, PhD, in a press release.
The investigators analyzed whether participants had biomarkers for Alzheimer disease in their cerebrospinal fluid or a well-known genetic risk factor. They found that participants with biomarkers who were taking anticholinergic drugs were 4 times more likely to develop mild cognitive impairment than participants who lacked biomarkers and were not taking the drugs.
Similarly, participants at genetic risk for Alzheimer disease who took anticholinergic medications were approximately 2.5 times more likely to develop mild cognitive impairment than those without the genetic risk factors who were not taking the medications.
“We believe this interaction between anticholinergic drugs and Alzheimer’s risk biomarkers acts in a ‘double hit’ manner,” Weigand said in a press release. “In the first hit, Alzheimer’s biomarkers indicate that pathology has started to accumulate in and degenerate a small region called the basal forebrain that produces the chemical acetylcholine, which promotes thinking and memory. In the second hit, anticholinergic drugs further deplete the brain’s store of acetylcholine. This combined effect most significantly impacts a person’s thinking and memory.”
Significantly, the authors found that although older adults metabolize anticholinergic drugs differently than younger people, anticholinergic medications were being taken at levels much higher than the lowest effective dose recommended for older adults, with 57% taken at twice the recommended dosage and 18% at least 4 times the recommended dosage.
“This points to a potential area for improvement since reducing anticholinergic drug dosages may possibly delay cognitive decline,” Weigand said. “It’s important for older adults who take anticholinergic medications to regularly consult with their doctors and discuss medication use and dosages.”
Common Class of Drugs Linked to Increased Risk of Alzheimer’s Disease [news release]. UC San Diego Health; September 4, 2020. https://health.ucsd.edu/news/releases/Pages/2020-09-04-common-class-of-drugs-linked-to-increased-risk-of-alzheimers.aspx#:~:text=A%20team%20of%20scientists%2C%20led,cognitive%20decline%2C%20particularly%20in%20older. Accessed September 10, 2020.
FDA Approves Fluticasone Furoate, Umeclidinium, Vilanterol for Treatment of Asthma 2020-09-14 15:41:00 Jill Murphy, Assistant Editor The FDA has approved the triple therapy of fluticasone furoate, umeclidinium, and vilanterol (Trelegy Ellipta, GSK) for the treatment of asthma in patients aged 18 years and older. The drug was previously approved for use in patients with chronic obstructive pulmonary disease (COPD).
The triple combination therapy is the first single inhaler triple therapy approved for the maintenance treatment of both asthma and COPD and is the only single inhaler triple therapy available for patients in a convenient once-daily inhalation in the United States, according to the press release.
The approval was based on data from the CAPTAIN study, which showed significant improvements in lung function with the use of fluticasone furoate, umeclidinium, and vilanterol compared with using only fluticasone furoate and vilanterol in a single daily dose and an easy-to-use inhaler.
The most common adverse reactions after administration of fluticasone furoate, umeclidinium, and vilanterol include hypersensitivity reactions, such as anaphylaxis, angioedema, rash, and urticaria. Further, there is an increased risk of pneumonia, as well as a worsening of infections, such as fungal and bacterial infections, for patients who take corticosteroids such as fluticasone furoate, umeclidinium, and vilanterol.
FDA approves Trelegy Ellipta as the first once-daily single inhaler triple therapy for the treatment of both asthma and COPD in the US. GSK. https://www.gsk.com/en-gb/media/press-releases/fda-approves-trelegy-ellipta-as-the-first-once-daily-single-inhaler-triple-therapy-for-the-treatment-of-both-asthma-and-copd-in-the-us/. Published September 9, 2020. Accessed September 14, 2020.
Study: Babies Born in Fall at Higher Risk for Allergic Diseases 2020-09-14 14:51:00 Aislinn Antrim, Assistant Editor New research suggests that infants born in the fall may have a higher risk for allergic diseases such as eczema, food allergies, asthma, and hay fever.
Previous research has found that food allergies are on the rise, with approximately 2 children in each classroom now allergic to at least 1 food. Researchers at National Jewish Health aimed to discover the reason behind this increase, which showed that many allergic conditions likely start with dry, cracked skin, eventually leading to a chain reaction of allergic diseases known as the atopic march.
“We looked at every child treated in our clinic, and those born in the fall were much more likely to experience all of the conditions associated with the atopic march, said lead author Jessica Hui, MD, in a press release. “Now we are learning more about why that is and we strongly believe it stems from the bacteria on the skin and how they affect the skin barrier.”
According to the study authors, the atopic march typically begins in infancy with eczema and leads to food allergies, asthma, and hay fever in later childhood. Children with eczema often have high levels of the bacteria staph aureus on their skin, which weakens the skin’s ability to keep our allergens and pathogens, according to a press release.
“When food particles are able to penetrate the skin rather than being digested, the body sees them as foreign and creates antibodies against them, which causes the child to become allergic,” Hui said.
To further their research, the investigators are now conducting a clinical trial to examine a wide variety of factors that may contribute to this weakened skin barrier in infants. The study is enrolling pregnant women and following their children into early childhood to consider everything from environmental factors to genetics to medications taken and products used in the home.
“We think if we can intervene at a very young age, even right after the baby’s out of the womb, then potentially that’s a way for us to try to stop the development of this atopic march,” Hui concluded in the press release.
Potential solutions could include sealing the skin barriers of babies with eczema using wet wraps and lotions and introducing allergenic food early in life for children at risk of allergies.
Study Finds Fall Babies at Higher Risk of Lifetime of Allergic Diseases [news release]. National Jewish Health; September 9, 2020. http://njhealth.multimedia-newsroom.com/index.php/2020/09/09/study-finds-fall-babies-at-higher-risk-of-lifetime-of-allergic-diseases/. Accessed September 10, 2020.
Coordinated Approach Needed to Increase Follow-Up Care After Rapid HIV, HCV Testing 2020-09-14 14:47:00 Aislinn Antrim, Assistant Editor Only a small numberof those tested for HIV and hepatitis C virus (HCV) scheduled a follow up visit for clinical care, according to new research. The findings demonstrate a need for more coordinated approaches to help patients access testing and treatment.
The ongoing opioid epidemic and coronavirus disease 2019 (COVID-19) pandemic are both likely to cause an increase in HIV and HCV infections, according to a press release from study authors at Boston Medical Center. Drug detoxification centers may offer a much-needed option, as researchers found they have a distinct advantage over laboratory testing among hard-to-reach populations.
Investigators conducted a single-site randomized trial comparing test results delivery between laboratory-based and rapid testing for HIV and HCV at a short-term inpatient drug and alcohol detoxification center in Boston. The study included 200 participants with a history of self-reported drug use who accessed detoxification services between November 2016 and July 2017.
Among the participants, 48% tested positive for HCV and 0.5% received new positive diagnoses for HIV. During follow-up, investigators found that only 6% with positive tests were successfully linked to care, attending an HIV- or HCV-related visit within 4 months of testing.
The investigators noted that half of US state health departments and territories are prioritizing identification of acute HIV cases and are moving away from rapid testing in community-based settings. At sites such as drug detoxification centers, laboratory-based testing may see fewer diagnoses due to a lack of follow-up before result delivery, according to the study. In contrast to the 3 days required by laboratory-based testing, results for point-of-care rapid testing are available within 30 minutes.
“We currently have a cure for HCV and effective treatment for HIV,” said researcher Sabrina Assoumou, MD, MPH, in a press release. “Successfully identifying and linking patients to care at drug detoxification centers during the opioid epidemic could help decrease transmission and improve outcomes for these 2 infections.”
According to the study findings, 41 of the individuals with no record of HCV-related follow-up used other health care services. These averaged 3 visits within 4 months, of which 61% were in an emergency department.
The study authors noted that although successfully implementing HIV and HCV testing at drug detoxification centers could help identify and link patients to care, doing so would require that the test results are available to nearby health care facilities.
“We hope that these findings will encourage changes in local and national HIV and HCV testing practices and policy at non-hospital-based settings caring for populations at-risk during the opioid epidemic,” Assoumou said in the release.
She concluded that further research should investigate interventions to improve linkages to care and treatment initiation after testing in community-based settings.
Rapid HIV, HCV Testing at Drug Detoxification Centers Associated with Higher Rate of Test Result Delivery [news release]. Boston Medical Center; September 2, 2020. https://www.bmc.org/news/press-releases/2020/09/02/rapid-hiv-hcv-testing-drug-detoxification-centers-associated-higher. Accessed September 10, 2020.
Cost of PrEP May Inhibit Widespread Adoption 2020-09-14 09:27:00 Grant Gallagher While the use of preexposure prophylaxis (PrEP) against HIV has increased across the United States in recent years, the rise of PrEP costs across the health care system is yet to be fully catalogued.
Now, a team of investigators publishing in Annals of Internal Medicine have provided an estimate of out-of-pocket and third-party payments for PrEP by drawing on a database which covers more than 90% of retail pharmacy prescriptions.
The team conducted a retrospective cohort study to estimate out-of-pocket (OOP) and third-party payments using a large pharmacy database.
Data on prescriptions for the tenofovir disoproxil fumarate formulation of PrEP were taken from the IQVIA Longitudinal Prescriptions database.
“Third-party, out-of-pocket, and total payments were compared by third-party payer, classified as commercial, Medicaid, Medicare, manufacturer assistance program, or other,” study authors explained. Missing payment information was accounted for using a linear model to approximate overall PrEP payments.
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Effects of the COVID-19 Pandemic Will Have a Significant Impact on 2021 Drug Spending 2020-09-11 19:11:00 https://www.youtube.com/embed/uQMuN6imNP0?rel=0&autoplay=1&fs=0&enablejsapi=1&origin=https%3A%2F%2Fwww.pharmacytimes.com
Pharmacy Times® interviewed Steven Lucio, vice president of Pharmacy Solutions at Vizient, on the ways that the coronavirus disease 2019 (COVID-19) pandemic has affected hospital spending this year, which is projected to result in an increase in drug spending for 2021.
The discussion included how specialty drug prices are expected to change in 2021, what the expected effect of biosimilars will be on hospital spending, how spending on home infusion therapies is expected to change, and the ways that the COVID-19 pandemic has affected spending on the top 10 vaccines and what this may mean for next year.
Lucio explained that although there’s a great deal of scrutiny on potential COVID-19 vaccines, it’s critical to focus on all the vaccines available in order to make sure people do take, for example, the flu vaccine this flu season.
“It’s very important to look at what actually happened during the initial outbreak when it comes to vaccines because a lot of preventative care primary care visits did not take place because clinics were closed down. Resources were diverted to take care of the sickest people. So whether it’s the administration of vaccines or other diagnostic procedures, we’re now having to catch up with those things to make sure that as much as possible overall care is not disrupted, or we can catch up with the level of care that is required,” Lucio said.
Lucio also discussed how it might be possible to address some of the weaknesses in the pharmaceutical supply chain that are being exacerbated by the pandemic, whether there is anything pharmacists can do to prepare for the effects of some of these expected drug spending changes in 2021, and what the value of the pharmacist is in supporting health care systems when facing these upcoming challenges.