Clinical Insights: January 12, 2021

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

    New Drug Approval

    No new update.

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    No new update.

    New/Updated Drug Shortage

    January 11, 2021

    January 08, 2021

    January 07, 2021

    January 06, 2021

    January 05, 2021

    January 04, 2021

    New Drug Recall and Safety Alerts

    Ketorolac Tromethamine Injection, USP by Fresenius Kabi – New Voluntary Drug Recall – January 8, 2021 – Fresenius Kabi USA is voluntarily recalling a single lot of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter. Particulate matter was found in reserve sample vials. No adverse event reports have been received for the recalled lot, which was produced and sold in 2019. Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences. <Read More>

    Metformin extended-release (ER) tablets by Nostrum Laboratories – New Drug Recall Expansion – January 4, 2020 – Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued September 2020. This is an expansion of the recall initially announced on November 2, 2020. <Read More>

    New Generic/Biosimilar Approval and Launch

    Amitiza® (lubiprostone) Capsules – New Authorized Generic Approval – January 4, 2020 – Endo International plc announced that one of its operating companies, Par Pharmaceutical, Inc. (Par), has begun shipping the first authorized generic versions of Mallinckrodt’s Amitiza® (lubiprostone) 8 mcg and 24 mcg capsules. “This partnership brings the first Amitiza® generic to patients—giving them a cost-effective alternative,” said Jon Holden, Senior Vice President and General Manager, Generics at Endo. “Par is proud to be a reliable, quality supplier that can help bring that choice to patients while expanding our product portfolio.” <Read More>

    Clinical and Pharmacy News

    C. difficile: Old Disease, New Changes In Management – January 11, 2021 – Decades have passed since Clostridioides difficile infection (CDI) was first documented as the primary cause of antibiotic-associated diarrhea, but the optimal management of primary and recurrent CDI keeps evolving. For example, new data published in The New England Journal of Medicine underscore the shortcomings of advances in testing technology, suggested Sahil Khanna, MBBS, an associate professor of medicine at Mayo Clinic College of Medicine and Science, in Rochester, Minn. (2020;382[14]:1320-1330). <Read More>

    Nonclinical Workers Vaccinated at Academic Hospitals – January 11, 2021 – As some hospitals work to get their front-line staff vaccinated, several academic medical centers have started vaccinating nonclinical employees, contrary to federal guidelines, according to The New York Times. The CDC recommends first doses be offered to healthcare workers who have direct contact with COVID-19 patients and residents of long-term care facilities. The next group to be vaccinated is people age 75 and older, as well as front-line essential workers such as police officers, food and agricultural workers, manufacturing workers, grocery store workers and teachers. While the CDC is providing these recommendations to federal, state, and local governments, states have their own plans for distribution and deciding who will be first in line. <Read More>

    CDC Updates Counseling Information for Shingrix During COVID-19 Pandemic – January 11, 2021 – Pharmacists should be making every effort to ensure patients receive two doses of Shingrix within the recommended 2- to 6-month interval to prevent shingles and its complications in adults 50 years and older. Unless a patient has suspected or confirmed COVID-19 infection, this essential vaccination should not be delayed or discontinued during the pandemic. However, CDC states that counseling patients about potential adverse effects is especially important during the COVID-19 pandemic because some shingles vaccination adverse effects may be similar to symptoms of COVID-19. <Read More>

    Educating a COVID-19 Vaccination Army of Pharmacists, Technicians – January 11, 2021 – With approximately 328 million people currently living in the United States, it will take an army of health care professionals to vaccinate the country against coronavirus disease 2019 (COVID-19). In acknowledgement of the efforts necessary to help health care professionals prepare for the roll-out of a national vaccination campaign, Husson University announced that it will provide education to any licensed pharmacist, regardless of whether or not they are enrolled at Husson University. Since pharmacists, pharmacy technicians, and interns are authorized to administer COVID-19 vaccines to the public under the Public Readiness and Emergency Preparedness (PREP) Act, Husson University is offering 2 nationally approved educational options to support these professionals in their efforts on the road ahead. <Read More>

    FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff – January 8, 2021 – The U.S. Food and Drug Administration is alerting clinical laboratory staff and health care providers that the FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests, and that false negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus’s genome assessed by that test. The SARS-CoV-2 virus can mutate over time, like all viruses, resulting in genetic variation in the population of circulating viral strains, as seen with the B.1.1.7 variant. The FDA is taking additional actions to ensure authorized tests remain accurate by working with test developers and conducting ongoing data analysis to evaluate all currently authorized molecular tests. The FDA believes the risk that these mutations will impact overall testing accuracy is low. <Read More>

    Health Officials Ask Grocery Store Pharmacies to Help Speed COVID-19 Vaccinations – January 8, 2021 – Health officials across the U.S. are reaching out to grocery store pharmacies weeks earlier than planned to ask for help in administering COVID-19 vaccines amid a slower-than-expected rollout, The Wall Street Journal reported. Officials from South Carolina and Georgia reached out to grocery store chain Kroger this week, and the company has been giving vaccines to healthcare workers in its stores and in long-term care facilities in Alaska, West Virginia, Texas and Arkansas, the Journal reported Jan. 8. <Read More>

    Pharmacists are Moderately Satisfied With Compensation, Job Satisfaction, Survey Shows (Part 2) – January 8, 2021 – Pharmacists are moderately happy with both their compensation and jobs, according to the results of the 2020 Pharmacy Times Salary and Job Satisfaction Survey. The first article in this 3-part series covered a general overview of the survey and its respondents. In this article, we will explore the questions and answers around compensation. When asked how satisfied they are with their current annual total compensation on a scale of 1 to 7, with 1 being “not at all” and 7 being “extremely,” the average response of the 299 responding pharmacists was 4.82. These results show a slight increase in satisfaction compared with the 2019 survey, which found an average response of 4.74. <Read More>

    Multifaceted Approach Helps Control Drug Shortages, Formulary Costs – January 7, 2021 – Monitoring FDA approvals, forecasting potential price spikes, keeping ahead of drug shortages and having good team communication are activities that hospital pharmacists can do to manage high-cost medications in their formularies, according to formulary and supply-chain experts. Few laws address drug prices, according to Erin R. Fox, PharmD, the senior director of drug information and support services at the University of Utah Health, in Salt Lake City. And there’s not much help from the various regulatory agencies that have some oversight over therapeutics. For example, Medicare, the largest payor, is forbidden from negotiating prices. The Federal Trade Commission has some influence on pricing, but it focuses its pricing efforts primarily around the narrow area of antitrust laws and “pay-to-delay” deals in which brand-name and generic drug companies pay others to delay the introduction of cheaper alternatives. The FDA cannot consider drug pricing in its approval decisions. However, its approvals have indirect results on pricing, whether it is for me-too drugs, orphan drugs or those with slight changes in formulation that extend patents. <Read More>

    Pharmacist Burnout: A Cry for a Transformative Approach to Traditional Pharmacy Practice – January 7, 2021 – Challenges such as overwrought performance goals that create insurmountable stress, a lack of control coupled with a flood of new graduates willing to work for low wages to pay off student debt, and dismally low reimbursement are all driving toward one result: pharmacist burnout. The danger of attempting to deliver patient care in such taxing conditions has quickly become more concerning than rampant workplace dissatisfaction. But, with adverse drug reactions (ADR) representing the fourth leading cause of death in the United States and Canada behind heart disease, cancer, and stroke. the value of the pharmacist has never been more apparent. Why the juxtaposition? <Read More>

    HHS Announces $22 Billion in Funding to Support Expanded Testing, Vaccination Distribution – January 6, 2021 – The Department of Health and Human Services (HHS) announced two upcoming actions by the Centers for Disease Control and Prevention (CDC) to provide more than $22 billion in funding to states, localities, and territories in support of the nation’s response to the COVID-19 pandemic, as directed by the Coronavirus Response and Relief Supplemental Appropriations Act. Funding will provide critical support for testing and vaccination-related activities to jurisdictions before January 19, 2021. <Read More>

    FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines – January 4, 2021 – Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 disease in adults. As the first round of vaccine recipients become eligible to receive their second dose, we want to remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDA in order to safely receive the level of protection observed in the large randomized trials supporting their effectiveness… Suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence. <Read More>

    340B in the News

    HHS Advisory Opinion Concludes Manufacturers Must Deliver 340 B Drugs to Contract Pharmacies – January 11, 2021 – On December 30, 2020, the US Department of Health and Human Services (HHS) Office of General Counsel (OGC) released an Advisory Opinion concluding that providers participating in the 340B Program (“covered entities”) are entitled to purchase covered outpatient drugs at 340B discounted prices even when those drugs are distributed by third-party contracted pharmacies (“contract pharmacies”) on the covered entity’s behalf. The Advisory Opinion responds to drug manufacturers who have recently declined to distribute 340B drugs through contract pharmacies. <Read More>

    Contract Pharmacies and the 340B Drug Discount Program: New Litigation and an Advisory Opinion Point to Ongoing Skirmishes on the 340B Battlefield – January 8, 2021 – On December 11, 2020, five hospital groups, including the American Hospital Association (“AHA”), and an organization of hospital pharmacists representing participants in the 340B drug pricing program (“340B Program”), filed a federal lawsuit (the “340B Program Litigation”) against the U.S. Department of Health and Human Services (“HHS”) over HHS’ alleged failure to enforce 340B Program requirements that obligate pharmaceutical manufacturers to provide 340B Program prescription drug discounts to pharmacies contracted by 340B Program-participating hospitals to dispense 340B Program drugs. <Read More>

    2020 Final Price Reporting Developments: Stimulus Legislation, 340B Contract Pharmacy Advisory Opinion – January 8, 2021 – As we begin the new year, we wanted to highlight two final developments from December 2020…On Dec. 30, 2020, the Office of the General Counsel (OGC) within the U.S. Department of Health and Human Services (HHS) published “Advisory Opinion 20-06 on Contract Pharmacies Under the 340B Program” (link, accompanied by a press release). This non-binding, interpretive opinion claims that Section 340B of the Public Health Service Act requires manufacturers in the 340B program to offer 340B discounts for their covered outpatient drugs that are ordered by a covered entity through a contract pharmacy arrangement. <Read More>

    Change is on the Horizon for 340B Pharmacy Program’s Administrative Dispute Resolution Process – January 7, 2021 – The U.S. Health Resources and Services Administration (HRSA) published a final rule (the Rule) on December 14, 2020, which outlined the requirements and procedures for the 340B pharmacy program’s administrative dispute resolution (ADR) process. Effective January 13, 2021, the Rule will replace the 340B Program’s current guidelines on the informal dispute resolution process developed to resolve disputes between covered entities and manufacturers. ADR hearings will occur before a three-member panel (the Panel) selected from a six-member ADR Board comprised of two members from each of the following: the HRSA, the Centers for Medicare and Medicaid Services (CMS), and the Health and Human Services (HHS) Office of General Counsel (OGC). <Read More>

    The 340B Contract Pharmacy Saga Continues – January 6, 2021 – We will be providing an update on the “340B Contract Pharmacy Saga.” Back in September, we told you about the growing tension between the drug industry and 340B providers over the issue of contract pharmacies. We like to discuss the 340B program in this blog given the link between the Medicaid drug rebate program and 340B. To recap – starting last July, several drug manufacturers began notifying 340B covered entities of their intention to cease offering some or all of their 340B priced products to contract pharmacies. Many 340B covered entities utilize contract pharmacies to dispense discounted drugs on their behalf. 340B covered entities argue that contract pharmacies help them expand the reach of their services. Drug manufacturers, on the other hand, argue that contract pharmacies are not “covered entities” under the 340B statute (obviating any requirement to offer them 340B priced drugs), and that the growing use of contract pharmacies complicate efforts to combat issues such as drug diversion and duplicate discounts. <Read More>

    HHS Says Drugmakers Should Not Shut Off 340B Discounts to Hospitals – January 5, 2021 – The Department of Health and Human Services issued an advisory opinion stating that pharmaceutical companies are obliged to offer discounts to medical facilities providing care to low-income communities. HHS Rebukes Drug Makers For Curtailing Discounts To Hospitals That Serve Low-Income Populations. After months of controversy, the Department of Health and Human Services issued a stern rebuke to several large drug makers that have sought to curtail the discounts they offer through a federal program for safety-net hospitals and clinics. At issue is the 340B drug discount program, which requires drug makers to offer discounts that are typically estimated to be 25% to 50% — but could be much higher — on all outpatient drugs to hospitals and clinics that serve low-income populations. <Read More>

    HHS Confirms Providers’ Right to 340B Discount Pricing for Contract Pharmacies – January 5, 2021 – As a holiday gift to providers, the U.S. Department of Health and Human Services (HHS) General Counsel recently issued a strongly worded Advisory Opinion indicating that federal law requires drug manufacturers to deliver covered outpatient drugs purchased by providers at 340B discounted rates to contract pharmacies, so that contract pharmacies can dispense such drugs to patients on behalf of providers. See HHS General Counsel Advisory Opinion, dated December 30, 2020. During 2020, several manufacturers refused to deliver 340B discounted drugs to contract pharmacies, though providers had ordered and paid for the drugs. HHS issued the Advisory Opinion in response to numerous requests from both providers and manufacturers regarding the propriety of the manufacturers’ refusal to provide the drugs to contract pharmacies. <Read More>