Clinical Insights: August 24, 2021

    Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy marketplace. Contact us to learn more.

    New Drug Approval

    Comirnaty™ (Pfizer-BioNTech COVID-19 Vaccine) – New Vaccine Approval – August 23, 2021 – The U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty™ (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. <Read More>

    Jemperli™ (dostarlimab-gxly f) – New Accelerated Drug Approval – August 18, 2021 – The Food and Drug Administration granted accelerated approval to dostarlimab-gxly (Jemperli™, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. The FDA also approved the VENTANA MMR RxDx Panel as a companion diagnostic device to select patients with dMMR solid tumors for treatment with dostarlimab-gxly. The efficacy of dostarlimab was evaluated in the GARNET Trial (NCT02715284), a non-randomized, multicenter, open-label, multi-cohort trial. The efficacy population consisted of 209 patients with dMMR recurrent or advanced solid tumors who progressed following systemic therapy and had no satisfactory alternative treatment. <Read More>

    TicoVac™ (tick-borne encephalitis vaccine) Injection – New Vaccine Approval – August 13, 2021 – Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Ticovac™ (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. Ticovac™ is the only FDA-approved vaccine to help protect U.S. adults and children against the TBE virus when visiting or living in TBE endemic areas. Following this FDA approval, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to discuss recommendations on the safe and appropriate use of Ticovac™. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Opdivo® (nivolumab) – New Approved Indication – August 19, 2021 – The Food and Drug Administration approved nivolumab (Opdivo®, Bristol-Myers Squibb Co.) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection. This is the first FDA approval for adjuvant treatment of patients with high-risk UC. The results supporting this approval also supported the conversion of nivolumab’s accelerated approval for advanced/metastatic UC to a regular approval. <Read More>

    New/Updated Drug Shortage

    August 20, 2021

    August 19, 2021

    August 18, 2021

    August 16, 2021

    New Drug Recall and Safety Alerts

    Monoject™ Flush Prefilled Saline Syringes by Cardinal Health – New Voluntary Recall – August 19, 2021 – Cardinal Health initiated a nationwide recall of approximately 267 million MonojectTM Flush Prefilled Saline Syringes (0.9% Sodium Chloride). The products have been found to reintroduce air into the syringe after the air has been expelled. This could result in injection of air into blood vessels and create the potential for air embolism, which can cause serious adverse health outcomes or death. <Read More>

    Chantix® (varenicline) by Pfizer – Expanded Voluntary Drug Recall – August 16, 2021 – Pfizer is voluntarily recalling an additional four lots of Chantixâ 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level. Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Pharmacies Gearing up to Administer COVID-19 Booster Shots – August 23, 2021 – Major pharmacy chains are gearing up to administer COVID-19 booster shots, following the Biden administration’s OK last week. CVS Health said in a statement that it has provided more than 30 million vaccines across the country to date, and will “immediately began offering third doses to immunocompromised individuals when authorized to do so. As we await further guidance and approval from regulatory agencies, we’re fully prepared to play a leading role in providing booster shots this fall,” CVS said. The White House said it would authorize booster vaccinations for the Pfizer-BioNTech and Moderna vaccinations beginning Sept. 20, advising vaccinated people to get the third shot about eight months after their second dose. <Read More>

    Drinking and Smoking During Pregnancy Linked With Stillbirth, NIH-Funded Study Suggests – August 23, 2021 – Drinking alcohol and smoking tobacco cigarettes throughout the first trimester of pregnancy is associated with nearly three times the risk of late stillbirth (at 28 or more weeks), compared to women who neither drink or smoke during pregnancy or quit both before the end of the first trimester, according to a study funded by the National Institutes of Health. Although prenatal smoking is known to increase stillbirth risk, the researchers conducted the study to examine how smoking combined with alcohol use might influence the risk. The researchers also confirmed the higher stillbirth risk from alcohol alone, which has been suggested by earlier, less comprehensive studies. <Read More>   

    Health System-Based Specialty Pharmacy Offers Unique Advantages in HIV Care – August 23, 2021 – As medication has been developed and improved to treat HIV, so has the care team surrounding the patient. As a therapy management pharmacist who specializes in HIV medication, my role in that improved care team is to make sure patients being treated for PrEP/PEP/HIV are on appropriate regimens, manage their adverse effects, answer medication questions, and help them navigate through potential barriers to care. I feel empowered to provide a higher level of care than a retail pharmacist as part of the integrated care team within the health system that reaches from the patient’s clinic to our many resources in the specialty pharmacy. <Read More>

    ‘It’s Not Really Price Transparency’: Pharmacies Push Back on Surescripts, GoodRx Deal – August 22, 2021 – When GoodRx announced a planned integration with Surescripts, both companies touted the deal as a win for price transparency. Pharmacists, however, aren’t so sure. A group of pharmacists are pushing back against the deal, which they say doesn’t reflect the true cost of drugs, and could steer patients away from independent pharmacies. They asked Surescripts’ board to rescind it in an August 13 letter. “The deal was touted as a move towards transparency; when in fact, coupon programs are bought and paid for by the same PBM-based, opaque pricing schema the deal claims to upend,” they wrote in a copy of the letter obtained by MedCity News, which included 67 pages of signatures from independent pharmacies, and pharmacists working for hospitals and retail chains. <Read More>

    Pharmacy Middlemen Sue to Stop Rebate Transparency – August 20, 2021 – An industry group representing powerful drug middlemen has gone to court to stop a federal rule intended to bring transparency to rebates middlemen get from manufacturers. The middlemen are arguing that the rule, initiated by the Trump administration, will increase drug costs. But the group’s critics say that secretive rebates are a primary driver of drug inflation — and the profits the middlemen extract from it. The group, the Pharmaceutical Care Management Association, last week filed the suit in federal court in Washington, D.C., on behalf of companies known as pharmacy benefit managers, or PBMs. The companies are hired by payers such as Medicare, Medicaid and private health plans to administer prescription benefits. <Read More>

    Why are 86% of Pharmacists Still in the Trough? – August 20, 2021 – Although 98% of pharmacists believe new vancomycin dosing guidelines, which recommend using area under the curve (AUC) instead of trough-based dosing for certain patients, will yield superior outcomes, 86% say they are still using the older calculation in their institutions. That’s according to a new survey of more than 120 U.S. pharmacists and pharmacy leaders conducted by Sage Growth Partners and commissioned by InsightRx. Asked about future plans, 31% of the respondents said they planned to shift to AUC-based dosing, while 60% said they might do so and 10% said they would not. <Read More>

    The Pharmacy as the Center of Immunization Services for the Entire Family – August 20, 2021 – Pharmacists and pharmacy interns have been vaccinating huge swaths of the American public for the past two decades. In the last year, pharmacy technicians have joined the ranks, and pharmacy at large has been instrumental in the roll-out of the COVID-19 vaccines. Several federal and state regulatory changes, which have recently been solidified, were launched in response to the state of emergency. These changes alter the landscape of pharmacy-based immunizations from one that focused on adult influenza to one where the community pharmacy can be the vaccination hub for the entire family. Specifically, the Public Readiness and Emergency Preparedness Act allows pharmacists, pharmacy interns, and some pharmacy technicians to administer vaccines to persons three years or older. Many states followed this federal change with state legislative and regulatory changes of their own that mimic the federal regulations, therefore clearing hurdles (such as requirements of prescriptions) for pharmacies to immunize an even broader demographic. <Read More>

     Prior Authorization Ills: No Rest During COVID – August 20, 2021 – Nine of 10 physicians reported that prior authorizations (PAs) have had a negative effect on clinical outcomes for their patients, and nearly one of three (30%) reported that PAs have led to a serious adverse event for a patient in their care, according to a survey from the American Medical Association (AMA). Almost four of five respondents (79%) said patients abandon treatment due to struggles with their health insurers over treatment authorization. In the early days of the COVID-19 pandemic, such hassles eased because many payors temporarily relaxed their PA requirements “to reduce administrative burdens and support rapid patient access to needed drugs, tests and treatments,” said AMA President Susan R. Bailey, MD, in a statement accompanying the release of the survey. By the end of 2020, however, as COVID-19 cases surged, “the AMA found that most physicians were facing strict authorization hurdles that delayed patients’ access to needed care.” <Read More>

    Will New Restrictions on Plasma Donations at the Border Lead to IG Shortages? – August 20, 2021 – For well over a year, pharmacists, physicians and patients have been anticipating the possibility of a shortage of immune globulin (IG) products, as the COVID-19 pandemic led to a significant decline in donations of the blood plasma that is the primary component of these therapies…but as Pharmacy Practice News reported in May 2021, the IG supply in the United States remained relatively robust well into this spring. However, that may change with the imposition of new restrictions on cross-border plasma donations. Because Mexico does not allow monetary compensation for plasma donations, many Mexican citizens cross the border on a regular basis to donate plasma in the United States. On June 15, the U.S. Customs and Border Patrol (CBP) agency announced that it was putting a stop to that practice and would no longer permit Mexican citizens to cross the border on temporary visas to sell blood plasma. <Read More>

    Pharmacists Hold Key to Success of COVID-19 Booster Shot Program – August 20, 2021 – This week’s recommendation by the Biden administration for booster shots to combat COVID-19 follows an earlier recommendation of a third shot for the immunocompromised and is a call to action for pharmacists to get ready for the upcoming flurry of activity. The FDA and the CDC are both great go-to sources for what is actually happening health-wise, especially in terms of COVID-19 developments. Similarly, the National Community Pharmacists Association and the American Pharmacists Association are excellent sources for pharmacist-specific news. At the same time, keep an eye on the general news because this is what your customers are watching or reading. For example, a British study reported that the COVID-19 vaccine efficacy weakens in 3 months under Delta. For people without a health care background, this news could serve as a signal to jump ahead and try to get their booster shots. <Read More>

    Health Systems Still Fighting for Specialty Access – August 20, 2021 – Health systems continue to make significant inroads into the specialty pharmacy market, with more than two-thirds of multihospital systems launching programs in a recent five-year period. But despite those gains, the sector still faces major roadblocks, including a lack of access to limited distribution drugs (LDDs) and payor contracts, according to ASHP’s inaugural National Survey of Health-System Specialty Pharmacy Practice. Still, many health systems have succeeded in overcoming those challenges, in part by leveraging the superior continuum of care they claim is a hallmark of their practice model. <Read More>

    APhA Deplores the Intimidation of Pharmacy Personnel in Missouri – August 20, 2021 – The American Pharmacists Association (APhA) released the following statement from its president, Sandra Leal, PharmD, MPH, FAPhA, CDE:  “We deplore the intimidation and verbal assaults directed toward pharmacists, pharmacy technicians, and other pharmacy personnel earlier this week at a pharmacy in Springfield, MO. “APhA strongly believes that all members of our pharmacy workforce should be safe in their work environment. We cannot state this strongly enough: Anyone who threatens or intimidates pharmacy personnel must be prosecuted to the full extent of the law. There is no place for this kind of behavior in our communities, when so many are working tirelessly to overcome the COVID-19 pandemic. <Read More>

    Failure to Conduct DUR is Basis for Negligence Suit – August 19, 2021 – Do the provisions in the Omnibus Budget Reconciliation Act of 1990 (OBRA ’90) regarding drug utilization review (DUR) by pharmacists create a basis for a lawsuit when damages result from the review not having been done? What are the legal expectations for a pharmacist regarding DURs? A pharmacist at a chain pharmacy in a Southern state dispensed amitriptyline to a young woman. Nineteen days later, a pharmacist at the same pharmacy prepared a morphine prescription for that same patient. It was picked up 2 days after that. Six days later, the patient died from an alleged fatal adverse interaction between the 2 medications she was prescribed. The deceased woman’s mother filed a lawsuit against the pharmacy. The lawsuit alleged that the pharmacy knew or should have known that the 2 medications could be fatal when mixed. <Read More>

    Self-Proclaimed ‘Vaccine Police’ Tells Walmart Pharmacists They ‘Could Be Executed’ for Administering Shots – August 19, 2021 – By the time Christopher Key and his half-dozen followers reached the Springfield, Mo., Walmart pharmacy counter on Monday evening, the metal shutters were nearly fully drawn. An Alabama-based anti-vaxxer who has gained a following online — where he spreads false information about the coronavirus pandemic, Key was on a mission to give the pharmacists inoculating shoppers a warning. “What they’re doing is crimes against humanity,” he said in a live stream on Facebook. “And if they do not stand down immediately, then they could be executed. They can be hung in the state.” <Read More>

    Avoiding Rx Delays Amid Oral Chemotherapy Surge – August 19, 2021 – Oral oncolytics are hardly new. Breast cancer patients have been taking tamoxifen for more than 40 years. But the pace of approval of these drugs has increased dramatically, and the complexity and cost of the newer oral therapies create challenges for patients, clinicians and health systems. Getting patients on treatment with oral oncolytics is not simple. Delays in processing these medications and initiating therapy are common and often related to insurance coverage and prior authorization, specialty pharmacy requirements and the need for financial assistance. <Read More>

    Breast Cancer, Financial Toxicity, and the Role of Specialty Pharmacy in Reducing Barriers to Care – August 19, 2021 – As health care costs rise and cost-sharing increases, treatment-associated expenses will continue to burden patients… Specialty pharmacies are uniquely positioned to help patients with breast cancer address issues of financial toxicity. Intake staff regularly interface with patients, prescribers, payers, and pharmaceutical manufacturers. Acting as an intermediary between these parties, the intake team plays a critical role advocating for treatment access and helping reduce financial toxicity. One-on-one consultations help patients understand their OOP costs and identify strategies to minimize financial burden. The intake team often enrolls the patient in manufacturer assistance co-pay programs while providing referrals to charitable organizations assisting with the nonmedical costs associated with cancer care. <Read More>

    Medication Adherence Measures Help Medicare Beneficiaries Avoid up to $46.6 Billion in Health Care Costs – August 19, 2021 – CMS reported that 3.3 million more Medicare Part D beneficiaries with complex health needs than expected between 2013-2018 received a comprehensive medication review as a part of medication therapy management. What is the impact of the 3 medication adherence measures used in the Medicare Part D Star Ratings program? Enormous. The 2021 National Impact Assessment of the Centers for Medicare & Medicaid Services (CMS) Quality Measures Report, released in June, estimates that $27–$46.6 billion in health care costs were avoided for Medicare beneficiaries between 2013 and 2018 thanks to improved patient adherence to medications for diabetes, hypertension, and cholesterol. <Read More>

    mRNA Vaccines: A Look at What’s to Come – August 19, 2021 – Whereas traditional vaccines have used live or inactivated pathogens to elicit an immune response, mRNA is responsible for cellular processes, building structures, and more. The unprecedented impact of the COVID-19 global pandemic has necessitated a rapid evolution of scientific and medical knowledge to thwart the spread of the disease. At the time of writing (July 26, 2021), more than 196 million confirmed cases have been identified globally, including over 4 million deaths; in the United States, this includes more than 34 million confirmed cases and over 611,000 deaths. Parts of the world are seeing an ebbing in new infections and deaths and an easing of certain restrictions, largely due to advances in immunology and the advent and availability of vaccines against SARS-CoV-2, the virus that causes COVID-19. <Read More>

    Advancing our Understanding of how Drug Promotion Influences Consumers and Health Care Providers – August 19, 2021 – Advertisements for prescription drugs are pervasive in the United States, and both health care providers and consumers are exposed to a tremendous amount of information promoting the benefits of these products. These ads can convey useful information about treatment options, but at times, they may also contain misleading information. Although FDA does not generally approve prescription drug advertising and promotion before it is made public, the agency is charged with regulating promotion of prescription drugs. Reviewers in CDER’s Office of Prescription Drug Promotion (OPDP) continually monitor prescription drug advertising and promotional labeling to ensure that it is neither false nor misleading, follow up on complaints about alleged promotional violations, and initiate compliance actions. <Read More>

    Managing Adverse Events in Cancer Care: Addressing Blood Cell Counts and Drug Management – August 18, 2021 – A proactive approach can ensure that the patient is getting the right therapy at the right time and the right treatment plan with the least amount of waste. Specialty medications accounted for 52% of drug spend in 2020, with an increase in drugs approved to treat cancer. In fact, the FDA approved 53 new drugs last year, including 20 with indications related to oncology. A number of key strategies are available to ensure that oncology patients receive appropriate care and management. With a focus on improved individual outcomes and an enhanced patient experience, a proactive approach to patient engagement can maximize therapeutic opportunities, provide education and information, and help employers and other stakeholders create accountability and predictability around oncology drugs. <Read More>

    Five Quick Tips to Create a Transformative Advanced Pharmacy Practice Experiences Rotation – August 18, 2021 – Experienced pharmacists open their practices to students throughout the year as preceptors. They teach about their setting, best practices, and provide feedback to students on their professional skills. Often, the focus is on the educational development of the student to introduce them to the practice site and focus on direct patient care. However, what many preceptors may not realize is that in addition to learning about practice settings, all graduates of pharmacy schools in the United States must also be able to demonstrate leadership, innovation, and entrepreneurship. At the same time, pharmacy practice is rapidly changing in many settings to a more value-based care model. <Read More>

    NIH Study Shows No Significant Benefit of Convalescent Plasma for COVID-19 Outpatients With Early Symptoms – August 18, 2021 – The final results of the Clinical Trial of COVID-19 Convalescent Plasma in Outpatients (C3PO) demonstrate that COVID-19 convalescent plasma did not prevent disease progression in a high-risk group of outpatients with COVID-19, when administered within the first week of their symptoms. The trial was stopped in February 2021 due to lack of efficacy based on a planned interim analysis. The formal conclusions from the trial, which was funded primarily by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, and by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, appear in the current online issue of The New England Journal of Medicine. <Read More>

    Tip of the Week: Making the Most of Tech-Check-Tech – August 18, 2021 – As the scope and duties of pharmacists evolve, so too must their reliance on dedicated support personnel, such as pharmacy technicians. Lack of time is often among the most common barriers to pharmacists’ engagement in patient-directed services such as medication therapy management (MTM). It has been shown that new roles and responsibilities can be passed to pharmacy technicians in order to free up pharmacists’ time, which enables them to be more engaged with their patients and provide more direct patient care. A recent study revealed that the pharmacies most likely to deviate from the norm in terms of positive services output are those with positive organizational cultures and those that effectively leverage the talents of their technicians. Research shows that utilizing programs such as Tech Check Tech (TCT) can be greatly beneficial to all stakeholders in the medication dispensing and utilization process. <Read More>

    CDC Stands Up New Disease Forecasting Center – August 18, 2021 – The Centers for Disease Control and Prevention (CDC) is announcing a new center designed to advance the use of forecasting and outbreak analytics in public health decision making. Once established, the Center for Forecasting and Outbreak Analytics will bring together next-generation public health data, expert disease modelers, public health emergency responders, and high-quality communications, to meet the needs of decision makers.  The new center will accelerate access to and use of data for public health decision-makers who need information to mitigate the effects of disease threats, such as social and economic disruption. The center will prioritize equity and accessibility, while serving as a hub for innovation and research on disease modeling. <Read More>

    Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots – August 18, 2021 – Public health and medical experts from the U.S. Department of Health and Human Services (HHS) released the following statement on the Administration’s plan for COVID-19 booster shots for the American people…“The COVID-19 vaccines authorized in the United States continue to be remarkably effective in reducing risk of severe disease, hospitalization, and death, even against the widely circulating Delta variant. Recognizing that many vaccines are associated with a reduction in protection over time, and acknowledging that additional vaccine doses could be needed to provide long lasting protection, we have been analyzing the scientific data closely from the United States and around the world to understand how long this protection will last and how we might maximize this protection. The available data make very clear that protection against SARS-CoV-2 infection begins to decrease over time following the initial doses of vaccination, and in association with the dominance of the Delta variant, we are starting to see evidence of reduced protection against mild and moderate disease. <Read More>

    Opportunities Abound for Pharmacies to Administer Vaccines, So why Aren’t They? – August 17, 2021 – COVID-19 vaccination opportunities will likely be present for years to come. As of July 29, 2021, more than 38,000 community and long-term care pharmacies are administering COVID-19 vaccinations. Each of those locations enrolled in the Federal Retail Pharmacy Program (FRPP), which is an effort led by the CDC to allocate vaccines to those pharmacies who meet their requirements and can onboard through a contracted Network Administrator (chains, wholesalers, services administrative organizations, and clinically integrated networks).1,2 The FRPP program was built and implemented in parallel to the “jurisdictional” program that also allocated vaccinations through states, territories, and large metropolitan areas like New York City. The FRPP added considerable capacity to the nation’s COVID-19 vaccination efforts, generating accessibility and leveraging existing relationships and foot traffic from the millions of Americans already frequenting these pharmacies. <Read More>

    Expanding Access Takes Telepharmacy to the Next Level – August 17, 2021 – Increases in service hours, programs, and locations lead to higher patient satisfaction, and lower costs. During the COVID-19 pandemic many hospitals and health care services teams turned to telepharmacy to reduce delays in providing medications to patients while social distancing practices were in place. Hospitals quickly found that telepharmacy benefitted pharmacy services by providing patients with more efficient access to medical care and reducing costs. Thus, hospitals were able to focus more on patient care and less on logistics, which led to higher turnaround times and increased patient satisfaction. <Read More>

    Optum Quietly Adds Cash-Pay Virtual Care Services to Online Pharmacy – August 17, 2021 – Optum has quietly added multiple services to its online pharmacy, putting it in direct competition with trendy direct-to-consumer startups. The UnitedHealth Group subsidiary’s Optum Store was first launched in late 2020 and earlier this summer was expanded to include more than 800 generics at a discounted cash price and cash-pay telehealth options to allow members to access birth control, mental health medications and drugs for other common needs. Business Insider first reported on the updates. The new additions position UnitedHealth, a massive and profitable giant in the healthcare industry, against startups like Ro and Hims & Hers, which offer similar services directly to consumers. <Read More>

    Specialty Drug Dispensing: Flexibility is the Key to Success During a Crisis – August 16, 2021 – The pandemic taught the pharmacy to provide a deeper level of personalized care and communication than in the past. “Bend, but don’t break” became the fundamental operating principle at Biologics by McKesson during the COVID-19 pandemic. As an independent specialty pharmacy, Biologics by McKesson provides specialty drugs for patients who have complex diseases, require extra care, or have expensive therapies. It specializes in quick delivery, financial aid assistance, adverse effect management, and adherence support to get medications to patients. Since COVID-19 emerged, Biologics by McKesson, like many other companies, had to become more flexible. It put aside traditional ways of doing business and found new approaches to respond to the evolving health care landscape. <Read More>

    Education, Training are Essential for Successful Flu Vaccination Campaigns – August 16, 2021 – As medical professionals prepare for the first flu season following the COVID-19 pandemic, educating patients about the importance of vaccination and training pharmacy technicians about effective communication are essential to the mass vaccination campaign starting in the fall. Two recent Pharmacy Times The Perfect Consult videos explored the roles that pharmacists and technicians play in flu vaccination campaigns. Pharmacists are ideally positioned to educate patients about the impact of influenza on public health and the need for flu vaccinations. The flu causes up to 45 million illnesses, 810,000 hospitalizations, and 61,000 deaths annually, according to data from the CDC. Although the figures were significantly lower in the 2020-2021 season because of protection measures taken during the COVID-19 pandemic, vaccination ahead of the 2021-2022 season is no less important. <Read More>

    340B in the News

    Merck Gives 340B-Covered Entities Deadline to Provide Claims Data – August 19, 2021 – Pharmaceutical manufacturer Merck has given 340B-covered entities a deadline of Sept. 1 to comply with its demand that they provide 340B claims data for all claims originating from contract pharmacies, despite warnings that this action is prohibited. The Health Resources and Services Administration (HRSA) has said efforts by manufacturers to limit 340B contract pharmacies violate the Drug Pricing Program’s statute. For any covered entities that do not comply with Merck’s request, according to a letter dated August 2021, the company “will no longer voluntarily honor 340B discounts or chargebacks for contract pharmacy transactions,” unless the entity designates a single contract pharmacy of its choice to be eligible for 340B pricing. <Read More>