Clinical Insights: March 24, 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

    Isturisa® (osilodrostat) Tablets – New Orphan Drug Approval – March 6, 2020 – The U.S. Food and Drug Administration announced the approval of Isturisa® (osilodrostat) oral tablets for adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease. Cushing’s disease is a rare disease in which the adrenal glands make too much of the cortisol hormone. Isturisa® is the first FDA-approved drug to directly address this cortisol overproduction by blocking the enzyme known as 11-beta-hydroxylase and preventing cortisol synthesis. <Read More>

    Durysta (bimatoprost) Implant – New Drug Approval – March 5, 2020 – Allergan received FDA approval for Durysta™ (Bimatoprost Implant). Durysta™ is the first and only intracameral biodegradable sustained-release implant to lower intraocular pressure in open-angle glaucoma or ocular hypertension patients. <Read More>

    Sarclisa® (isatuximab-irfc) Injection – New Orphan Drug Approval – March 2, 2020 – The U.S. Food and Drug Administration announced the approval of Sarclisa® (isatuximab-irfc), in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa®, administered through intravenous (IV) infusion, is a CD38-directed cytolytic antibody that works by helping certain cells in the immune system attack multiple myeloma cancer cells. <Read More>

    New Formulation Approval

    No new update

    New Indication Approval

    Opdivo® (nivolumab) – New Expanded Indication Approval – March 10, 2020 – The U.S. Food and Drug Administration granted accelerated approval to the combination of nivolumab and ipilimumab (OPDIVO and YERVOY, Bristol-Myers Squibb Co.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. <Read More> 

    Ofev® (nintedanib) – New Expanded Indication Approval – March 9, 2020 – The U.S. Food and Drug Administration announced the approval of Ofev® (nintedanib) oral capsules to treat patients with chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait). It is the first FDA-approved treatment for this group of fibrosing lung diseases that worsen over time. <Read More>

    Symtuza® (darunavir/cobicistat/emtricitabine/tenofovir) – New Expanded Indication Approval – March 2, 2020 – Janssen announces U.S. FDA approval of Symtuza® (D/C/F/TAF), the first complete darunavir-based single-tablet regimen for the treatment of HIV-1 infection. <Read More>

    New Drug Shortage

    March 23, 2020

    New Drug Recall and Safety Alerts

    Ketorolac tromethamine injection by Hikma Pharmaceuticals USA Inc. – New Drug Recall – March 4, 2020 – Hikma Pharmaceuticals PLC (Hikma, Group), announced that its subsidiary Hikma Pharmaceuticals USA Inc. (formerly known as West-Ward Pharmaceuticals Corp.; “Hikma”) is voluntarily extending its previously-announced recall of certain lots of ketorolac tromethamine injection USP 30mg/mL, 1mL fill/2mL vials to the medical facility and retail levels. The product is being recalled due to the presence of small visible particulate matters of a gelatinous/oily nature that appear black in some of the recalled lots. <Read More>

    New Generic Approval and Launch

    Zortress® (everolimus) – First-time Generic Approval – March 13, 2020 – Hikma Pharmaceuticals PLC (Hikma, Group) launches AB-rated everolimus tablets, 0.25mg, 0.50mg and 0.75mg, the generic equivalent to Zortress®, in the United States through its US affiliate, Hikma Pharmaceuticals USA Inc. <Read More>

    Dymista® (azelastine/fluticasone propionate) – First-time Generic Approval – March 2, 2020 – Apotex launches azelastine/fluticasone propionate nasal spray, the generic equivalent to Dymista®. <Read More>

    COVID-19 News

    Coronavirus (COVID-19) Update: FDA Issues first Emergency Use Authorization for Point of Care Diagnostic – March 21, 2020 – The U.S. Food and Drug Administration issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test. <Read More>

    Drug Shortage Concerns Are Top of Mind Amid COVID-19 Outbreak – March 20, 2020 – As the novel coronavirus (COVID-19) crisis continues, one key issue for pharmacists, other health care professionals, and patients is the potential for drug shortages in the United States. <Read More>

    Mask Shortage Straps Pharmacists Who Need Them to Keep Medicines Pure – March 20, 2020 – Pharmacy staff who prepare IV drugs inside hospitals are the latest health care workers decrying a shortage of masks as they scramble to prepare medicines for patients with diagnoses ranging from cancer to COVID-19. <Read More>

    Coronavirus (COVID-19) Update: FDA Allows Expanded Use of Devices to Monitor Patients’ Vital Signs Remotely – March 20, 2020 – As part of the U.S. Food and Drug Administration’s ongoing efforts to address the coronavirus outbreak (COVID-19), the agency issued a new policy that allows manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely. The devices include those that measure body temperature, respiratory rate, heart rate and blood pressure. <Read More>

    Coronavirus (COVID-19) Update: FDA Provides Guidance on Production of Alcohol-Based Hand Sanitizer to Help Boost Supply, Protect Public Health – March 20, 2020 – As part of the U.S. Food and Drug Administration’s ongoing commitment to address the coronavirus (COVID-19) pandemic, the agency has issued two guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand sanitizer products. These guidance documents will be in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020. <Read More>

    Potential Coronavirus Treatment Touted by Trump Already in Shortage, Pharmacists Say – March 19, 2020 – NEW YORK (Reuters) – An old malaria treatment that has been tried with some success against the new coronavirus and was touted by U.S. President Donald Trump at a news briefing earlier on Thursday is in short supply as demand surges amid the fast-spreading outbreak. <Read More>

    Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments – March 19, 2020 – The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the COVID-19 pandemic, which includes, among other things, facilitating medical countermeasures to treat and prevent the disease, and surveilling the medical product and food supply chains for potential shortages or disruptions and helping to mitigate such impacts, as necessary. <Read More>

    ID Pharmacists Rally Around COVID-19 Response – March 19, 2020 – As U.S. COVID-19 cases continue to rise, pharmacists who specialize in emergency medicine, critical care and infectious diseases have become vital participants in hospital-wide efforts to respond to the epidemic. <Read More>

    Study Suggests Digestive Symptoms May Be Associated with COVID-19 – March 18, 2020 – A recent study from China found that diarrhea was a prominent symptom among up to half of patients with COVID-19 during the outbreak in Wuhan. The study, which was published in The American Journal of Gastroenterology, was conducted by researchers from the Wuhan Medical Treatment Expert Group for COVID-19. Although patients with COVID-19 most commonly present with respiratory symptoms, approximately half of patients in the Wuhan outbreak presented with digestive symptoms as their chief complaint, according to the findings. <Read More>

    Telehealth Services, Online Resources Aim to Enhance Health Care Amid COVID-19 Pandemic – March 16, 2020 – Developments in telehealth and online resources have become vital tools for combatting the novel coronavirus, also known as COVID-19, demonstrating the value of pharmacists and health care providers who take advantage of the benefits these technologies offer. The current COVID-19 pandemic has sparked a surge in telemedicine and online, publicly available resources by national health institutes, health insurance companies, international corporations, and Congress in order to effectively limit exposure to and spread of COVID-19 in the United States. <Read More>

    Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics – March 16, 2020 – As part of our ongoing and aggressive commitment to address the coronavirus outbreak, the FDA updated a policy originally issued on Feb. 29 on diagnostic testing for coronavirus (COVID-19) in order to achieve more rapid testing capacity in the U.S. We believe the unprecedented policy set forth in today’s updated guidance, which addresses laboratories and commercial manufacturers, will help address these urgent public health concerns by helping to expand the number and variety of diagnostic tests, as well as available testing capabilities in health care settings, and reference and commercial laboratories. <Read More>

    Clinical and Pharmacy News

    FDA Requires New Health Warnings for Cigarette Packages and Advertisements – March 17, 2020 – The U.S. Food and Drug Administration issued a final rule to require new health warnings on cigarette packages and in cigarette advertisements. The warnings feature textual statements with photo-realistic color images depicting some of the lesser-known, but serious health risks of cigarette smoking, including impact to fetal growth, cardiac disease, diabetes and more. <Read More>

    Feds to Push for More Biosimilar Competition – March 12, 2020 – The FDA and the Federal Trade Commission (FTC) announced they will take further action to stem anticompetitive practices that are blocking biosimilars from entering the U.S. market. The practices are keeping the costs of these drugs artificially high, the regulators say. <Read More>

    Text #FlipYourScrip to Easily Donate Unused Drugs – March 10, 2020 – #FlipYourScrip, a first-of-its-kind national program for donating unused prescription drugs, is now open for business and accepting unexpired bottles of pills or capsules in order to pass them along to needy patients. The program is administered by Remedichain.org, a nonprofit based in Memphis, Tennessee. <Read More>

    Aspirin Increases Bleeding Risk in Patients on DOACs – March 10, 2020 – Orlando, Fla.—A substantial proportion of patients prescribed direct oral anticoagulant (DOAC) therapy are taking daily aspirin without an indication, increasing their risk for major bleeding, according to a study conducted at six anticoagulation clinics. <Read More>

    CVS to Acquire Schnucks’ Pharmacy Business – March 10, 2020 – Schnuck Markets plans to sell its retail and specialty pharmacy businesses to CVS Health, which then will operate the supermarket pharmacy locations under the CVS Pharmacy brand. Overall, St. Louis-based Schnucks has 110 retail pharmacy locations. Under the deal, announced Tuesday, CVS is slated to buy 99 Schnucks pharmacies and convert them to the CVS banner. In addition, CVS plans to acquire prescription files from another 11 Schnucks pharmacies and transfer them to nearby CVS Pharmacy stores. <Read More>

    FDA, FTC Put Drugmakers on Notice About Tactics to Block Biosimilars – March 9, 2020 – Claiming biosimilar drugs are inferior to their branded competitors may violate both consumer protection and antitrust laws, a top Federal Trade Commission official said Monday. Tara Koslov, chief of staff to FTC Chairman Joseph Simons, said the agency will also closely watch drugmaker activities that could delay competition, such as patent agreements in violation of antitrust laws. <Read More>

    Understaffing Leads to Mistakes, Burnout in the Pharmacy – March 5, 2020 – With recent reports that the Oklahoma Board of Pharmacy is investigating chain pharmacies for inadequate staffing levels,1 as well as a New York Times report on the dangers of understaffing,2 many pharmacists are speaking out about understaffing and stressful work environments, all of which leads to potentially dangerous errors. <Read More>

    Heparin Quality Concerns Persist – March 5, 2020 – In the wake of several reports of subtherapeutic unfractionated heparin, described in a November 2019 article in the Cardiovascular Research Foundation’s tctMD, the FDA told Pharmacy Practice News that it is closely monitoring the anticoagulant and that it believes the reports reflect natural variations in the porcine product rather than deficient quality. Nevertheless, several pharmacy experts say they are still experiencing quality problems with heparin. <Read More>

    CDER Issues New MAPP for REMS Assessment Reviews – March 3, 2020 – The US Food and Drug Administration (“FDA”) recently issued a Manual of Policies and Procedures (“MAPP”) describing how the Center for Drug Evaluation and Research (“CDER”) evaluates Risk Evaluation and Mitigation Strategy (“REMS”) submissions, as well as policies and responsibilities pertaining to that review. <Read More>

    PBMI2020: Opioid Epidemic Update, Specialty Drugs Rule, and the “Amazonification” of Health Care – March 3, 2020 – The opioid epidemic, the restructuring of the PBM industry, the lack of the “Amazonification” of health care, the increasing shift of drug expenditures to specialty drugs are some of the earlier themes of the Pharmacy Benefit Management Institute’s 2020 National Conference in Orlando. <Read More>

    First Guidelines to Address Thyroid Disease Surgery – March 2, 2020 – The American Association of Endocrine Surgeons (AAES) has issued a first-of-its-kind set of clinical guidelines for the surgical treatment of thyroid disease, offering evidence-based recommendations on the wide-ranging aspects of thyroidectomy and the management of benign as well as malignant thyroid nodules and cancer. <Read More>

    Vaccinations in Adults Clinical Practice Guidelines (ACIP, 2020) – March 2, 2020 – The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) has released an updated schedule for vaccination in adults, which includes changes for administration of several vaccines, including those for influenzahuman papillomavirus (HPV)hepatitis A and B, and meningitis B, as well as the pneumococcal 13-valent conjugate (PCV13) vaccine. <Read More>

    340B in the News 

    340B Industry Group Says No to CMS Drug Cost Survey – March 17, 2020 – 340B Health, an association of more than 1,400 public and nonprofit hospitals that participate in the federal 340B drug pricing program, is urging a federal regulatory organization to deny a request by the Centers for Medicare & Medicaid Services (CMS) to obtain drug acquisition cost data from 340B hospitals. It is also urging CMS to withdraw its proposal to do so. <Read More>

    MedPAC’s Report to Congress: Seven Takeaways – March 16, 2020 – The Medicare Payment Advisory Commission released its March 2020 report on Medicare payment policy to Congress, which includes a chapter analyzing the effects of hospital and physician consolidation in the healthcare sector. Among several other things, MedPAC was asked to analyze whether the availability of 340B drug discounts creates incentives for hospitals to choose more expensive products than they would without the program. MedPAC studied the effect of 340B market share on higher drug spending on cancer treatments between 2009 and 2017. The commission found that for two of the five cancer types studied, 340B participation boosted prices by about $300 per patient per month. However, the boost in spending attributed to 340B was much smaller than the general increase in oncology spending, which includes rising prices and the launch of new products with high drug prices. For example, cancer drug spending grew by more than $2,000 per patient month for patients with breast cancer, lung cancer, and leukemia/lymphoma. <Read More>