Clinical Insights: August 4, 2020

    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

    Monjuvi® (tafasitamab-cxix) Injection – New Drug Approval – July 31, 2020 – MorphoSys AG announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi® (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). Monjuvi®, a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, has been approved under accelerated approval by the U.S. FDA based on overall response rate (ORR). Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy. <Read More> 

    Xeglyze™ (abametapir) 0.74% Lotion – New Drug Approval – July 27, 2020 – Dr. Reddy’s Laboratories Ltd. announced the approval of XeglyzeTM (abametapir) lotion, 0.74%, a 505(b)(1) NDA by the U.S. Food and Drug Administration (USFDA). The approval triggers the contractual pre-commercialization milestone of $20 million payable to Hatchtech Pty Ltd. XeglyzeTM is indicated for the topical treatment of head lice infestation in patients 6 months of age and older. The company is working to commercialize this product through partners. <Read More>

    New Formulation Approval

    No new update.

    New Indication Approval

    Epidiolex® (cannabidiol) [CBD] Oral Solution – New Expanded Indication Approval – July 31, 2020 – The U.S. Food and Drug Administration approved Epidiolex® (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older. Epidiolex® was previously approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS). This is the only FDA-approved drug that contains a purified drug substance derived from cannabis. It is also the second FDA approval of a drug for the treatment of seizures associated with TSC. <Read More>

    New Drug Shortage

    July 31, 2020

    July 30, 2020

    July 28, 2020

    July 27, 2020 

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Personalized Treatments in Pancreatic Cancer: The Progress Continues – August 3, 2020 – Although pancreatic cancer has been a historically difficult disease to treat, the emergence of novel combinations have allowed for more patients to receive later lines of therapy, and recent advances have inspired a shift to more personalized treatment approaches to improve outcomes, according to Syma Iqbal, MD. <Read More> 

    Study: Slow Start for Infliximab Biosimilars – August 3, 2020 – The uptake of infliximab biosimilars in the United States is slow but tracks closely to the experience in Europe, where after 2 years infliximab biosimilars assumed a large share of the market, according to a new study. Infliximab biosimilar uptake has lagged filgrastim biosimilar uptake, and investigators theorized providers find it easier to prescribe a change of medicine in the case of filgrastim, which is for blood cell regeneration following radiotherapy, than for infliximab, which is for rheumatoid arthritis and related conditions. They said physicians are naturally more cautious about changing medicines for chronic conditions that are well controlled with the initial medication. <Read More> 

    COPD Underdiagnosed in Older Adults, but Can Be Managed – August 3, 2020 – “Recognizing and Treating COPD in Older Adults,” the latest issue of the What’s Hot newsletter from The Gerontological Society of America, addresses what is known about the prevalence, incidence, and impact of chronic obstructive pulmonary disease (COPD) in older adults. Despite high incidence of COPD — as many as 30 million Americans are affected — many patients are not diagnosed, according to the publication. This occurs for multiple reasons, including poor awareness of symptoms among patients and providers, low suspicion of disease, and inadequate reimbursement for diagnostic tests. <Read More> 

    A Comparison of the Alpha-2-Adrenergic Receptor Agonists for Managing Opioid Withdrawal – August 3, 2020 – Lofexidine is an alpha-2-adrenergic receptor agonist distributed in the United States by US WorldMeds under license from Britannia Pharmaceuticals Limited (brand name: Lucemyra). Lofexidine was approved by the FDA in 2018 for the mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults1 and is the only non-opioid medication FDA approved for the management of opioid withdrawal. Lofexidine is not indicated for treatment of opioid use disorder (OUD, formerly known as opioid addiction). <Read More> 

    Ask the PharmD: Can Opioids and Benzodiazepines Ever be Used Together? – August 3, 2020 – Most practitioners are aware that opioids and benzodiazepines are not recommended to be prescribed concurrently. FDA issued a black box warning for concomitant use in August 2016, and both are listed on the American Geriatrics Society Beers Criteria, separately and in combination, to avoid prescribing for older patients. Despite this, concurrent prescribing occurs frequently. In certain practice settings or clinical situations, it may be appropriate to prescribe opioids and benzodiazepines together, as long as the patient is appropriately monitored and prescribed the lowest therapeutic dose for the shortest duration necessary. This combination is most often seen when treating anxiety and panic disorders, cancer pain in terminal patients, and when managing complications in palliative care. <Read More> 

    Challenges in Diagnosing Hypersensitivity Pneumonitis Addressed in Latest Guidelines – August 3, 2020 – More than 30 years after the last guidance on the clinical evaluation of hypersensitivity pneumonitis (HP), the American Thoracic Society – in collaboration with the Asociación Latinoamericana de Tórax or ALAT and the Japanese Respiratory Society – has developed new guidelines for clinicians. The guidelines are available online ahead of print in the American Journal of Respiratory and Critical Care Medicine. <Read More> 

    Society for Immunotherapy of Cancer Publishes Clinical Practice Guideline on Immunotherapy for the Treatment of Multiple Myeloma – August 3, 2020 – The Society for Immunotherapy of Cancer (SITC), the world’s leading member-driven organization dedicated solely to cancer immunotherapy, has published a clinical practice guideline specific to the use of immunotherapy for multiple myeloma, a type of blood cancer. “The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of multiple myeloma,” was developed by an expert panel of leaders in the fields of hematology, oncology, hematopathology, oncology nursing and cancer patient advocacy from across the United States. This immunotherapy-specific guideline provides oncologists and other advanced practice providers a clinical roadmap to provide optimal care for patients who have multiple myeloma. <Read More> 

    Common Drug Treatments for Chronic Pain Can do More Harm Than Good, Says NICE in Draft Guidance – August 3, 2020 – Commonly used drug treatments for chronic pain have little or no evidence that they work and shouldn’t be prescribed, National Institute for Health and Care Excellence (NICE) has said. In its draft clinical guideline on the assessment and management of chronic pain in over 16s, NICE said that people with a type of chronic pain called chronic primary pain should be offered supervised group exercise programmes, some types of psychological therapy, or acupuncture. <Read More> 

    Tips for Optimizing IV Workflow – August 3, 2020 – Integrating technology to enhance workflow can save money, prevent wasted doses, and reduce errors such as missed doses. More health systems are taking note, and IV workflow technology is becoming an integral part of pharmacy workflow in the inpatient setting. Here are quick implementation tips from three IV workflow veterans. <Read More>

    In-Person Contact is the Best Method of Destigmatizing Mental Health Conditions in Pharmacy Curricula – August 3, 2020 – In-person contact is one of the best ways to reduce existing stigma toward patients with mental illness in the field of pharmacy, according to research presented at the American Association of Colleges of Pharmacies’ Virtual Pharmacy Education 2020 conference. The issue of stigma toward patients with mental illness in pharmacy is of particular relevance due to the number of patients in the United States who have been diagnosed with a mental illness. <Read More> 

    The Role of Pharmacists in Diabetes Management During COVID-19 – August 3, 2020 – The coronavirus disease 2019 (COVID-19) pandemic has yielded concerns among those with underlying conditions. Considering the high prevalence of chronic conditions within the United States, it is important to distinguish how each disease is impacted, individually, in order to determine what patients can do to stay healthy. Patients with chronic conditions that require frequent monitoring, such as diabetes, have especially been affected over the last few months of the pandemic…Pharmacists can assist patients with diabetes to ensure they are optimally managing their condition, and to potentially minimize the risk for complications associated with COVID-19. <Read More> 

    Adapting Hospital Pharmacy Needs for Safety and Viability During the Coronavirus: Advice from Cardinal Health’s Michael D. Brown – August 3, 2020 – The coronavirus pandemic continues to present new challenges for all hospital departments — and the pharmacy is no exception. Whether it is overcoming staffing challenges from increased or decreased patient volumes, protecting personnel or establishing processes for the procurement, storage and delivery of medications, the hospital pharmacy has had to quickly adapt. The demands of the pandemic have not eased since March of this year for many hospitals, and now experts are predicting the combined events of the coronavirus and the upcoming flu season may have a particularly significant impact on our health system. <Read More> 

    Interpretation of EAU Guidelines: First-Line Oral Drugs for Patients With Erectile Dysfunction – August 2, 2020 – The “Guidelines for Male Sexual Dysfunction” issued by the European Society of Urology provides diagnosis and treatment basis for patients with erectile dysfunction (ED) and premature ejaculation. Since its first release in 2000, it has been updated 7 times. Drug therapy has completely changed the diagnosis and treatment of ED. The “Guide” recommends first-line treatment for ED patients: oral drug therapy (PDE5i), vacuum device therapy, and shock wave therapy. Among them, PDE5i is popular among doctors and patients because of its rapid onset of action and convenient administration. It is widely used in clinical practice. However, the problems that need attention in its application and application process are also of concern to doctors and patients. <Read More>

    LGBTIA+ Education Should Be Incorporated Into Pharmacy Education – July 31, 2020 – It is crucial that pharmacy schools incorporate LGBTQIA+ activities into their curriculum, according to a presentation at the American Association of Colleges of Pharmacy (AACP) Annual Meeting. The presentation, “Encouraging Inclusion: Incorporating LGBTQIA+ Activities for Community and Hospital Pharmacy throughout Student Pharmacists Education Experience,” was given virtually with a live question and answer session. <Read More> 

    Cancer-Related Posttraumatic Stress Disorder: Assessment and Treatment Considerations – July 31, 2020 – Although receiving a diagnosis of cancer is often colloquially referred to as traumatic, the validity and utility of the posttraumatic stress disorder (PTSD) construct in the context of malignant disease has been debated. DSM-IV-TR considered life-threatening illness as a potential traumatic stressor, inspiring a sizable literature documenting the prevalence and correlates of cancer- related PTSD.1 However, changes to the DSM-5 PTSD criteria and more enduring conceptual issues call into question the applicability of PTSD to the cancer experience. <Read More> 

    Coronavirus (COVID-19) Update: FDA Authorizes First Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection – July 31, 2020 – The U.S. Food and Drug Administration authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies present in the individual’s blood. Both tests from Siemens, the ADVIA Centaur COV2G and Atellica IM COV2G, are what are known as “semi-quantitative” tests, meaning that they do not display a precise measurement, but estimate the quantity of a patient’s antibodies produced against infection with the virus that causes COVID-19. <Read More> 

    Microhematuria Guideline Emphasizes Risk-Stratified Approach – July 31, 2020 – A new clinical guideline for microhematuria embraces a risk-stratified approach to evaluating patients. The guideline was presented at the 2020 American Urological Association Virtual Experience by guideline panel co-chairs Daniel A. Barocas, MD, MPH, associate professor and vice chair of urology at Vanderbilt University Medical Center, Nashville, Tennessee, and Stephen A. Boorjian, MD, professor of urology at Mayo Clinic, Rochester, Minnesota. <Read More> 

    Home Infusion Pharmacies Play Critical Role in COVID-19 – July 31, 2020 – Many home infusion pharmacies are aiding patients’ transition into home life after hospitalization. This exemplifies the continuing involvement of these specialized pharmacies as frontline health care providers during the coronavirus disease 2019 (COVID-19) pandemic. Although many patients are benefiting from access to pharmacists in a variety of settings, the home infusion pharmacy arena is often overlooked, but this critical area of pharmacy care is an important piece of the health care puzzle during the pandemic. <Read More> 

    Experts Discuss Treatment Advances for Chronic Lymphocytic Leukemia – July 31, 2020 – In the Pharmacy Times® Directions in Oncology™ Insights series on chronic lymphocytic leukemia (CLL), experts Alison Duffy, PharmD, BCOP, and Cody Steeves, PharmD, BCOP, discussed current treatment recommendations and what is next for the disease state. CLL is a rare cancer of the blood and bone marrow, and although it is difficult to treat many advances have been made in the past 6 years, said Duffy, an associate professor, clinical pharmacy specialty in oncology at the University of Maryland School of Pharmacy. Earlier recommendations included single-agent chemotherapy or single-agent monoclonal antibodies, but Duffy explained that patients are increasingly receiving small molecule inhibitors, including Bruton tyrosine kinase (BTK) inhibitors. <Read More> 

    Recommendations for Managing Patients With Lung Cancer During COVID-19 Era – July 31, 2020 – World Lung Cancer Day, which is a global initiative for raising awareness of lung cancer, the leading cause of cancer-related deaths in the United States, strikes differently this year in light of the coronavirus disease 2019 (COVID-19) pandemic. COVID-19 has made a strenuous impact on the healthcare system, and managing patients with lung cancer, in particular, has become a major challenge in the field…In response, the European Society of Medical Oncology (ESMO) has published recommendations for the management of patients with lung cancer to maintain high-quality standards during the COVID-19 pandemic. These guidelines have been developed through the consensus of an international panel of thoracic malignancies experts in Europe and demonstrate how to best manage patients with lung cancer from staging of the initial disease through to treatment. <Read More> 

    NACDS Statement on Crucial Role of Pharmacies in Eventual COVID-19 Vaccine Deployment – July 31, 2020 – National Association of Chain Drug Stores (NACDS) President and CEO Steven C. Anderson issued the following statement regarding the nation’s ongoing preparations for the eventual deployment of COVID-19 vaccines: “By any measure, America’s pharmacies present patients and the nation with an efficient, effective and essential component of vaccine deployment. They will need to be part of the delivery plan for COVID-19 vaccines and treatments when available. <Read More> 

    NIOSH 2020: Big Changes Are Afoot! – July 30, 2020 – As of June 15, 2020, the National Institute for Occupational Safety and Health (NIOSH) has received 23 separate comments on its much-awaited document, “NIOSH List of Hazardous Drugs in Healthcare Settings, 2020.” The comments range from short paragraphs to relatively lengthy entries. The NIOSH document was published in the Federal Register May 1. <Read More> 

    Managing Chemotherapy-Induced Peripheral Neuropathy In Adult Cancers Survivors: ASCO Guidelines – July 30, 2020 – American Society of Clinical Oncology has released new guidelines for Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy in Survivors of Adult Cancers. The new guidelines have been published in the Journal of Clinical Oncology. Chemotherapy-induced peripheral neuropathy can markedly affect the quality of life (QOL) of patients. In addition, it may be detrimental to their cancer outcomes, as it may limit the amount of chemotherapy that clinicians can give. <Read More> 

    Calls for HPV Testing Alone for Cervical Cancer Screening – July 30, 2020 – Human papillomavirus (HPV) testing every 5 years should be used to screen patients ages 25 to 65 for cervical cancer, according to updated guidelines released by the American Cancer Society (ACS). The simplified guidelines state that women with a cervix should start molecular HPV testing at age 25 — 4 years later than previous guidelines suggest. If primary HPV testing is not available, either a Pap test every 3 years or cotesting (i.e., combined cytology and HPV tests) every 5 years is acceptable, according to the new recommendations published in the ACS journal CA: A Cancer Journal for Clinicians. <Read More> 

    Guidelines for Managing Chronic Cancer Pain: More Similar Than Not – July 30, 2020 – A recent article in JAMA Oncology (2018;4:1323-1324) highlighted a perceived variability between several guidelines for the management of chronic pain from the CDC, National Comprehensive Cancer Network (NCCN) and American Society of Clinical Oncology (ASCO). Now, a comparative analysis published in the Journal of the National Comprehensive Cancer Network (JNCCN 2020:18[4]):392-399) focuses on bridging the gap among clinical practice guidelines for pain management in cancer and sickle cell disease. <Read More> 

    Rare Pharmacy Emerges From Specialty: Part 1 – July 30, 2020 – Part 1 of this 3-part series explores the details of how changes in United States federal policy and advances in scientific research led to the dawn of medical breakthroughs for rare disorders…The orphan drug market has become a significant focus of specialty pharmacy as an unprecedented number of medications for rare and devastating diseases enter the US marketplace. In response, legislative changes have significantly enhanced the development of new treatment options, changing the lives of the patients with these diseases. While these agents are transforming lives, they come at a very high cost and with a multitude of challenges for patients and the health care system. Specialty pharmacies have continued to evolve to meet the needs of this challenging population and other stakeholders. <Read More>

    Remdesivir Shortages Plague Some Hospitals, Pharmacists Say – July 30, 2020 – (HealthDay)—One-third of pharmacists say they do not have enough remdesivir to treat all COVID-19 patients who are eligible for it, according to the results of a survey released by the American Society of Health-System Pharmacists (ASHP). The ASHP conducted the sixth round of surveys of its Section of Pharmacy Practice Leaders. The analysis included responses from 131 respondents (22 percent from small hospitals, 30 percent from medium hospitals, 44 percent from large hospitals, and 4 percent not from a hospital setting). <Read More> 

    Pharmacy Groups: DIR Fee Reform Needed in Drug Pricing Executive Order – July 30, 2020 – President Trump recently signed 4 executive orders on drug pricing, directing the Secretary of the Health and Human Services (HHS) Alex Azar to take action to lower costs for patients on prescription drugs. The executive order focused on pharmacy benefit managers (PBMs) and the process by which PBMs negotiate discounts, sometimes up to 50%, on the list price of drugs that work in their favor and allow them to collect large rebate checks; Medicare patients, on the other hand, continue to overpay for their medications…Several pharmacy organizations are urging the Trump Administration to do away with direct and indirect remuneration (DIR) fees in the Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen. <Read More> 

    Motivational Interviewing: Effective Communication Is Vital – July 30, 2020 – Pharmacy technicians (techs) are frequently the first point of contact when patients pick up their prescriptions or purchase OTC medications. Techs also interact with caregivers, health plans, employees from prescribers’ offices, and other stake holders in the medication-use process. Thus, effective communication is among the most important skills for techs, yet one that is often overlooked. Patients may visit the pharmacy with many questions about their medications and other issues related to their health conditions. At the same time, they may be frustrated at having to navigate the complex health care system. Techs must assuage patients’ concerns and frustrations and determine which issues should be attended to by the pharmacist. Using effective communication strategies, such as motivational interviewing (MI), can help mitigate patients’ anxiety and elicit the information needed for proper referral. It may also help to convey the message that pharmacists care. <Read More> 

    Pharmacy Groups Tell HHS That Any Action on Rebate Rule Must Involve Fixing Pharmacy DIR Fees – July 30, 2020 – APhA and other leading pharmacy groups said in a letter to HHS Secretary Alex Azar that any action on a prescription drug rebate rule must address escalating fees extracted by PBMs on behalf of plan sponsors in Medicare Part D. “We remind the Administration of the continuous and heightened impact of pharmacy DIR fees imposed by Medicare Part D plan sponsors and their PBMs on our members,” the letter stated. “Pharmacy DIR fees are growing beyond CMS’ projection of 10% year-over-year. This growth of pharmacy DIR fees is especially unsustainable during the current COVID-19 PHE when our members, representing every aspect of the pharmacy industry, care for patients, while also providing desperately needed access to COVID-19 tests and related services.” <Read More>

    A Glimpse Into the Future of Pharmacy – July 30, 2020 – With pharmacy being an ever-growing and evolving profession, health care providers must take a step back and look ahead. In the past century alone, the pharmacy profession has grown drastically by pushing the boundaries. Pharmacists, pharmacy technicians, researchers, and other health care professionals must keep pushing these boundaries to continue advancing the field of medicine and providing effective patient care. <Read More>

    Value-Based Oncology Care Offers Clinical Opportunities for Pharmacists – July 29, 2020 – As of 2017, cancer death rates had dropped by 29% since 1991, primarily because of lower smoking rates, improvements in early detection, and treatment advances, according to the American Cancer Society. Cancer health care costs in 2020 are expected to reach approximately $158 billion (in 2010 dollars), which will result in a 27% increase from 2010. The Center for Medicare & Medicaid Innovation (CMMI) was established in 2010 to develop and test new payment models and to focus on improving the quality of specialty services for oncology care in physician practices and hospitals. In 2016, the CMMI established a 5-year model, known as the Oncology Care Model (OCM), to test payment methods that promote high-quality cancer care while reducing Medicare health care costs. Pharmacists can play an important role in value-based oncology care as part of the health care team to improve patient outcomes. <Read More> 

    Tip of the Week: HIPAA Intertwines With Myriad Aspects of Practice – July 29, 2020 – The Health Insurance Portability and Accountability Act (HIPAA) is 1 of many laws and regulations with which pharmacies must comply. Failing to do so can result in extraordinary fines, termination by an employer, suspension or revocation of licensure, and long-lasting career damage. In a Duke Law Journal article on prescription drug policing, the author reviews some issues that operate at the intersection of privacy law, Fourth Amendment doctrine, and public health realities triggered by the United States drug overdose epidemic. Reputable reporting sources and public health scholars frame this ongoing overdose crisis as a prescription drug overdose problem attributable to the overprescribing of opioid analgesics. The author claims that this narrative runs counter to epidemiological data, which indicate that the majority of American overdose deaths are now a result of illicit drug use and not prescription drug abuse. However, this has sparked the rapid rise of law enforcement and regulatory surveillance of prescribers and patients in the form of state prescription drug monitoring program (PDMP) databases. <Read More> 

    Embracing Pharmacy Curricula to Meet Society’s Needs – July 29, 2020 – There are many opportunities for students in the pharmacy curricula to learn about urban underserved practice learning competencies, according to a session at the American Association of Colleges of Pharmacy virtual 2020 meeting. Andy Traynor, MD, Concordia University of Wisconsin, began the session with an overview of a paper that outlined student learning competencies for urban undeserved practice using the Delphi process. Using a study called “Medical Students Attitude Towards the Underserved,” researchers examined more than 4 years of the relation of unstructured experiences and students’ attitudes toward the underserved. <Read More> 

    FDA Warns Companies Illegally Selling Hangover Remedies – July 29, 2020 – The U.S. Food and Drug Administration announced it has issued warning letters to seven companies for illegally selling unapproved products labeled as dietary supplements that claim to cure, treat, mitigate or prevent hangovers, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The warning letters were issued to: Double Wood LLC; Ebnsol Inc.; Vita Heaven LLC (doing business as Hangover Heaven); Happy Hour Vitamins; LES Labs; Mind, Body & Coal LLC; and Purple Biosciences LLC. <Read More> 

    Pharmacy Groups Push for Pharmacy-Centered Assistance in HEALS Act – July 29, 2020 – Although pharmacy organizations praised several provisions within the first version of the upcoming coronavirus economic relief package, they also found that essential pharmacy-related elements were missing. The $1 trillion Health, Economic Assistance, Liability Protection and Schools (HEALS) Act would provide additional funding for the Paycheck Protection Program (PPP), offer tax credits to businesses to offset costs of safety precautions, and protect essential small businesses from opportunistic lawsuits, said National Community Pharmacists Association CEO B. Douglas Hoey, RPh, in a news release…Scott J. Knoer, PharmD, executive vice president and CEO of the American Pharmacists Association, was “disappointed” that the HEALS Act does not yet include language designating pharmacists as providers under Medicare Part B for COVID-19 and influenza testing and immunization. <Read More> 

    Why Generics Matter More Than Ever Before in Today’s Specialty Pharmacies – July 28, 2020 – How do specialty pharmacies remain sustainable when margins are leaner than ever? It is a question often asked as pharmacies search for creative solutions to maintain profitability. Today, it can be expensive to own and operate a specialty pharmacy with shrinking margins, direct and indirect fees, and governmental impact, as well as the expense of URAC and other accreditation requirements.  Fortunately, there are solutions, including ever-increasing opportunities with generic specialty pharmaceutical products. As more alternatives to branded specialty medications become available, forward-thinking pharmacies have the choice to provide generic therapies to their patients. Yet this journey still requires careful navigation and a knowledgeable partner. <Read More>

    International Consensus Guidelines on Gum Disease Treatment Published – July 28, 2020 – The first international evidence-based treatment guidelines for gum disease—which affects 50% of all adults—are published in the Journal of Clinical Periodontology, the official publication of the European Federation of Periodontology (EFP). <Read More> 

    Twenty Elements of an Effective Pharmacy Compliance Program: A Nonexclusive List of U.S. Pharmacies’ Obligations Under Federal Law – July 28, 2020 – Pharmacies operating in the United States are subject to a host of compliance obligations under federal law. These compliance obligations touch on all aspects of pharmaceutical practice, from drug ordering and inventory management to billing public and private payors. Despite the extraordinary scope of pharmacies’ compliance obligations, federal authorities do not excuse oversights. If an audit, investigation, or whistleblower complaint reveals evidence of shortcomings in any respect, pharmacy owners and pharmacists-in-charge can expect to face significant ramifications. <Read More> 

    Influenza Vaccine Administration Safety Precautions for Pharmacy Staff: A 2020 Update – July 27, 2020 – The coronavirus disease 2019 (COVID-19) pandemic has brought many changes to the daily lives of people all over the world. Safety is the driving force behind most of these changes, which were made to decrease the spread of COVID-19. People are practicing social distancing, schools have moved to online learning, and businesses are finding new ways to operate to keep their communities safe. Pharmacies have made changes such as delivering medications to customers, requiring staff to wear masks, and stepping up cleaning and sanitation procedures. During this pandemic, patients may be more understanding of changes being made in the pharmacy, given the reasoning behind them. <Read More> 

    FDA Requiring Labeling Changes for Opioid Pain Medicines, Opioid Use Disorder Medicines Regarding Naloxone – July 23, 2020 – The U.S. Food and Drug Administration announced it is requiring that labeling for opioid pain medicine and medicine to treat opioid use disorder (OUD) be updated to recommend that as a routine part of prescribing these medicines, health care professionals should discuss the availability of naloxone with patients and caregivers, both when beginning and renewing treatment. <Read More>

    340B in the News

    Executive Order on 340B Program Is Limited, Unlikely to Take Effect but Could Signal Future Changes – July 31, 2020 – US President Donald Trump signed four executive orders implementing policies on drug pricing on July 24. One of the orders directs the secretary of the US Department of Health and Human Services (HHS) to condition future grants under Section 330(e) of the Public Health Service. Act on Federally Qualified Health Centers (FQHCs) establishing practices that ensure the 340B discount they receive on insulin and injectable epinephrine is passed through to low-income patients who lack insurance or have high co-pays or deductibles. The HHS secretary has discretion to set the standard for eligible patients. This policy is limited in scope to one category of covered entities—it does not extend to hospitals—and two categories of drugs, but is consistent with the legislative intent of the 340B program to make outpatient drugs accessible to poor and uninsured or underinsured patients of federal grantees. <Read More> 

    Appeals Court Upholds Nearly 30% Payment Cut to 340B Hospitals – July 31, 2020 – A federal appeals court has ruled the Trump administration can install nearly 30% cuts to the 340B drug discount program. The ruling Friday is the latest legal setback for hospitals that have been vociferously fighting cuts the Department of Health and Human Services (HHS) announced back in 2017. 340B requires pharmaceutical manufacturers to deliver discounts to safety net hospitals in exchange for participation in Medicaid. A hospital will pay typically between 20% and 50% below the average sales price for the covered drugs. <Read More> 

    Insulin, Epinephrine Price Breaks Unlikely Despite Trump Order – July 28, 2020 – Insulin and epinephrine costs for most Americans won’t drop under a White House plan to reroute drug discounts directly to patients, health lawyers said. The community health centers targeted in the order already sell discounted drugs to patients, and the Trump administration may not have the legal power to force deeper discounts at enough pharmacies to make a difference, lawyers said. <Read More>