Clinical Insights — March 2016 Issue

    Welcome to the March edition of RxStrategies Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place.


    New Drug Approval

    Briviact® (brivaracetam) 

    February 19, 2016 – The U.S. Food and Drug Administration (FDA) approved Briviact® (brivaracetam) as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy. Read More.


    Zepatier™ (elbasvir and grazoprevir)

    January 28, 2016 – Merck announced that the U.S. Food and Drug Administration (FDA) has approved Zepatier™ (elbasvir and grazoprevir) for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype (GT) 1 or GT4 infection, with or without ribavirin (RBV), following priority review by the FDA. Zepatier™ is a once-daily, fixed-dose combination tablet containing the NS5A inhibitor elbasvir (50 mg) and the NS3/4A protease inhibitor grazoprevir (100 mg). Read More.


    New Formulation Approval

    Cetylev™ (acetylcysteine effervescent tablets)

    February 9, 2016 – Arbor Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved Cetylev™ (acetylcysteine effervescent tablets for oral solution). Cetylev™ is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion. Acetaminophen overdose is the most common poisoning reported to emergency rooms in the United States. Read More.


    Sernivo™ (betamethasone dipropionate) Topical

    February 7, 2016 – Dr. Reddy’s announced that its US subsidiary, Promius Pharma™, LLC, has received approval for Sernivo™ (betamethasone dipropionate) Spray, 0.05% from the U.S. Food and Drug Administration (FDA). Sernivo™  Spray, a prescription topical steroid, is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. The commercial launch of the product is planned for the coming quarter. Read More.


    Zembrace™ SymTouch (sumatriptan) Injection

    February 2, 2016 – Dr. Reddy’s Laboratories announced that the U.S. Food and Drug Administration (FDA) has approved Zembrace™ SymTouch™ (sumatriptan succinate) injection, a drug-device combination product intended for the treatment of acute migraine episodes, with or without aura, in adults who are inadequately managed with existing treatment regimens. Zembrace™ SymTouch is available as a prefilled, ready-to-use, single-dose disposable autoinjector containing 3 mg of sumatriptan, a selective 5-HT1B/ID receptor agonist. Read More.


    Onzetra™ Xsail™ (sumatriptan) Inhalation Powder 

    January 28, 2016 – Avanir Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Onzetra™ Xsail™ (sumatriptan nasal powder), formerly known as AVP-825, for the acute treatment of migraine with or without aura in adults. Onzetra™ Xsail™ is an intranasal medication delivery system consisting of a low-dose (22mg) of sumatriptan powder that is delivered utilizing the novel Xsail™ Breath Powered Delivery Device. Onzetra™ Xsail™ is a fast-acting dry powder formulation of sumatriptan, the most commonly prescribed migraine medication. Read More.


    Adzenys XR-ODT™ (amphetamine ER ODT) 

    January 27, 2016 – Neos Therapeutics, Inc., announced that the U.S. Food and Drug Administration (FDA) approved Adzenys XR-ODT™ for the treatment of ADHD in patients six years and older. With this approval, Adzenys XR-ODT™ is the first and only extended-release orally disintegrating tablet (ODT) for the treatment of ADHD. Read More.


    Dexilant™ SoluTab (dexlansoprazole) 

    January 27, 2016 – Takeda Pharmaceuticals U.S.A., Inc., announced that the U.S. Food and Drug Administration (FDA) approved Dexilant™ SoluTab delayed-release orally disintegrating tablets, a new formulation of dexlansoprazole that can be taken by allowing the tablet to melt in the patient’s mouth. Dexilant™ SoluTab is a proton pump inhibitor (PPI) indicated for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) and the maintenance of healed erosive esophagitis (EE) and relief of heartburn in adults 18 years and older. Dexilant™ SoluTab is a PPI with dual delayed release (DDR) technology that is designed to provide two separate releases of medication. Read More.


    New Indication Approval

    Ibrance® (palbociclib)

    February 19, 2016 – the U. S. Food and Drug Administration approved palbociclib (Ibrance®Capsules, Pfizer, Inc.) in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. Read More. 


    Daklinza™ (daclatasvir) 

    February 5, 2016 – Bristol-Myers Squibb Company announced that Daklinza™ (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3. The expanded label includes data in three additional challenging-to-treat patient populations: chronic hepatitis C virus (HCV) patients with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV. Read More.


    Halaven® (eribulin mesylate) – “Orphan” Indication

    January 28, 2016 – The U. S. Food and Drug Administration has approved eribulin (Halaven® injection, Eisai Co., Ltd.) for the treatment of patients with un-resectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. The approval was based on an open-label, randomized (1:1), multicenter, active-controlled trial in 446 patients with unresectable, locally advanced or metastatic liposarcoma or leiomyosarcoma who had received at least two prior systemic chemotherapies (one of which must have included an anthracycline) and had experienced disease progression within 6 months of randomization. Read More.



    New Generic Approvals

    Generic Drug Name Generic Manufacturer/Applicant Brand Name Approval Date

    Source: http://www.fda.govDrugs/

    Metformin HCl ER Tablets (Glumetza® HCl ER) – New Generic Launch

    February 2, 2016 – Pharma Major Lupin Limited (Lupin) announced that its US subsidiary, Lupin Pharmaceuticals Inc. has launched its Metformin HCl ER Tablets, 500 mg and 1000 mg to market a generic equivalent of Santarus Inc.’s Glumetza® HCl ER Tablets, 500 mg and 1000 mg. Read More.



    New Drug Shortage

    February 22, 2016

    Tretinoin Capsules (Currently in Shortage)

    February 19, 2016

    Tretinoin Capsules (Currently in Shortage)

    February 16, 2016

    Valsartan and Hydrochlorothiazide Tablet, Film Coated (Discontinuation)

    Valsartan Tablets (Discontinuation)

    February 12, 2016

    Memantine Hydrochloride (Namenda) Unit Dose XR Capsules (Discontinuation)

    February 05, 2016

    Sodium Bicarbonate Injection, USP (Currently in Shortage)

    February 04, 2016

    Sodium Bicarbonate Injection, USP (Currently in Shortage)

    February 03, 2016

    Potassium Acetate Injection, USP (Currently in Shortage)

    Sodium Acetate Injection, USP (Currently in Shortage)



    New Drug Recall Alert

    Morphine sulfate (0.5 mg/mL, 0.9% sodium chloride)

    February 16, 2016 – The U.S. Food and Drug Administration is alerting health care professionals of a voluntary recall of morphine sulfate 0.5 mg/mL preservative free in 0.9% sodium chloride, 1 mL syringe, CII, for intravenous use made and distributed by Pharmakon Pharmaceuticals, in Noblesville, Indiana, because the product is super-potent. Pharmakon initiated the voluntary recall on February 11, 2016, after receiving laboratory results showing the product was super-potent. Read More.



    Clinical and Pharmacy News

    Giving Asthma Medication in Hospital Better Than Prescription, Study

    February 24, 2016 – Children who left the hospital with medications after treatment for asthma fared better than those given a prescription to fill, according to a recent study. Researchers at Boston Medical Center found fewer children returned to the emergency room for additional treatment within 30 days if doctors gave them medications. Doctors at the hospital had determined that more than one-third of prescriptions given to children were not filled in a timely fashion, often leading them to come back to the emergency room for treatment, spending more time and money. Read More.


    What’s Next for Retail Pharmacists?

    February 23, 2016 – The way I see it, retail pharmacists are no longer relevant in healthcare. They have allowed themselves to be relegated to the position of overeducated technicians. It didn’t have to be this way. In the 1960s, pharmacists had a chance to step up to the plate and become responsible for medical and pricing decisions, but they decided to defer to the powers that be and allowed pharmacy associations and universities to make decisions that were detrimental to the business of retail pharmacy. Read More.


    Prescription Drug Cost Growth May Be Slowing, CVS Says

    February 23, 2016 – How fast are drug prices really increasing? CVS Health CVS -0.06%, which manages the prescription drug benefits of 65 million Americans, says that it’s spending on medicines increased just 5% in 2015. That compares to an 11.8% increase seen by the firm in 2014. Read More.


    NCPA Offers Congress Recommendations to Fight Prescription Drug Abuse

    February 23, 2016 – The National Community Pharmacists Association (NCPA) endorsed a range of solutions to the prescription drug abuse epidemic and asked lawmakers to revise an overly restrictive “lock-in pharmacy” proposal limiting Medicare beneficiary access, in comments submitted to the Senate Finance Committee, which held a hearing today entitled, “Examining the Opioid Epidemic: Challenges and Opportunities.” Read More.


    Task Force Releases Guidelines Redefining Sepsis to Aid in Diagnosis, Treatment

    February 23, 2016 – Physicians at the University of Pittsburgh Medical Center and University of Pittsburgh School of Medicine recently published a series of articles in the Journal of the American Medical Association to bring clarity to sepsis. In the articles, an international task force provided updated definitions for sepsis and septic shock based on research from the Clinical Research, Investigation, and Systems Modeling of Acute illness Center at Pittsburgh School of Medicine and funded in part by NIH grants. Read More.


    Putting Pharmacies in Clinics: An Innovative Approach to Improving Medication Adherence

    February 22, 2016 – The Practice Advancement Initiative (PAI) from the American Society of Health-System Pharmacists seeks to “transform how pharmacists care for patients by empowering the pharmacy team to take responsibility for medication-use outcomes.” Many of the PAI’s transformational goals involve the use of advanced technology, rethinking training programs, and the efficient use of pharmacy technicians. Read More.


    Hospitals’ Medicine Mistakes Spike, But More Mysteries Revealed

    February 19, 2016 – Hospitals have switched from handwritten prescriptions and pills in Dixie cups to computerized order entry and robotic drug dispensing, but one thing hasn’t changed over the past two decades: the small but severe risk of injuries and deaths from medication errors. In a new report, Minnesota hospitals disclosed four deaths and 10 serious injuries related to medication errors in the 12-month period ending last Oct. 6. That’s the highest total in 12 years of “adverse event” reporting in Minnesota, which remains one of only five states to publicly disclose hospital errors as part of a concerted effort to prevent them. Read More.


    New Ankylosing Spondylitis Treatment Guidelines

    February 17, 2016 – Experts at the National Institutes of Health conducted systematic reviews of the literature to address 57 clinical questions related to the treatment of patients with ankylosing spondylitis (AS) or nonradiographic axial spondyloarthritis (SpA). Read More.


    American Academy of Dermatology Issues New Guidelines of Care for Acne Treatment

    February 17, 2016 – Acne is the most common skin condition in the United States, affecting up to 50 million people every year. Fortunately for these patients, there are several treatment options available to help them manage their condition, as outlined in the American Academy of Dermatology’s new “Guidelines of care for the management of acne vulgaris.” Published online in the Journal of the American Academy of Dermatology on Feb. 17, the evidence-based guidelines cover acne treatment recommendations for both adolescents and adults. Read More.


    Moving Away from Pharmacist Efficacy and Toward Pharmacist Effectiveness: Refocusing Research that Generates Knowledge about Pharmacist-Provided Services

    February 16, 2016 – Research is critical to generating evidence and advancing knowledge. In medicine, research has led to significant discoveries regarding new drugs, disease pathways, and devices; new strategies for improving care delivery; and meaningful insights into patient behavior and engagement in their care. Research has contributed to our knowledge and understanding of the benefits and risks of medications, gaps in quality care attributed to poor medication use and management, and the integral role pharmacists can play in optimizing medication use and improving care. Read More.


    Pharmacists Can Play Important Role in Depression Screening

    February 16, 2016 – The US Preventive Services Task Force (USPSTF) recently updated its recommendations for depression screening in adults. According to the USPSTF, major depressive disorder is the leading cause of disability among adults in high-income countries. When left untreated, depression can become chronic and refractory. The USPSTF recommends that screening for depression can ultimately help reduce or eliminate depression symptoms, lower the need for related health care services, and improve the health of pregnant or postpartum patients with depression. Read More.


    7 Drug Shortage Findings Health-System Pharmacists Should Know

    February 12, 2016 – Health-system pharmacists can play a critical role in managing drug shortages to prevent medical errors and adverse events. Maryann Amirshahi, PharmD, MD, MPH, BCPS, DABAM, attending physician in the Department of Emergency Medicine at MedStar Washington Hospital Center and assistant professor of emergency medicine at Georgetown University School of Medicine, told Pharmacy Times that pharmacists can mitigate drug shortages in a multitude of ways. Read More.


    Tenofovir Resistance Higher Than Expected

    February 12, 2016 – More than half of people who still have uncontrolled HIV despite ongoing treatment have an HIV strain of the virus that is resistant to Tenofovir, a mainstay of antiretroviral therapy, according to a report published in Lancet Infectious Diseases online on Jan. 28. Read More.


    Embracing Pharmacy Care Management for High-Value Care Delivery

    February 12, 2016 – The recognition of the important role of pharmacists in clinical care has been trending higher in recent years, and for good reason. Pharmacists have the right knowledge and are positioned to positively impact care in today’s quality-driven healthcare climate. Industry groups are increasingly recognizing the role of effective medication management in achieving clinical benefits and improved costs. Two important trends that are affecting patient outcomes and cost are medication adherence and the rising cost of generic and brand name drugs. Read More.


    Health System Pharmacists Empower the Team

    February 10, 2016 – The role of health-system pharmacists has evolved considerably over the last half century. No longer responsible only for compounding drugs and dispensing prescriptions, today’s health-system pharmacists are an integral part of an enterprise-wide healthcare team. Read More.


    Specialized Training Puts Pharmacists Front and Center

    February 10, 2016 – “Pharmacists help people live better, healthier lives”. As we consider how the profession of pharmacy has changed over the last 160 years – and how much it might change in the near future – I want to note the profound changes in pharmacy education over these 16 decades. Read More.


    FDA Seeks $5.1 Billion Total for FY 2017, Including Funds to Implement Food Safety Law, Improve Medical Product Safety and Quality

    February 9, 2016 – The U.S. Food and Drug Administration is requesting a total budget of $5.1 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2017 budget – an eight percent increase over the enacted budget for FY 2016. The overall request includes a net increase of $14.6 million in budget authority and $268.7 million in user fees for initiatives tied to several key areas, including the implementation of the FDA Food Safety Modernization Act (FMSA) and efforts to improve medical product safety and quality. Read More.


    New Pharmacies and PBM Growth Boost CVS Health Profits

    February 9, 2016 – Buoyed by the addition of new employer clients for its pharmacy benefit management business, Target TGT pharmacies and the Omnicare specialty pharmacy business, CVS Health CVS said profits jumped 13% in last year’s fourth quarter. Read More.


    New Depression Guidelines Offer a Drug-Free Treatment for Some Patients February 8, 2016 – While drug treatment for depression has been a life saver for many people, new research shows psychotherapy, specifically cognitive behavioral therapy, is just as effective. The findings, published Monday in the Annals of Internal Medicine, will comprise the latest evidence-based clinical guideline recommendations for depression treatment from the American College of Physicians (ACP.) Read More.


    Future Trends Affecting Pharmacy Practice

    February 8, 2016 – I have always been interested in the science of futurism. This interest started when I was a pharmacy director. Someone once told me that you should always be interested in the future because you will spend the rest of your life there. Positioning my department for the future was my concern. If I could understand the forces that were producing changes in health care and pharmacy, I could prepare my department to take advantage of new opportunities as they emerged. Read More.


    FDA’s Woodcock Fears Biosimilars Explosion

    February 5, 2016 – With nearly 60 products enrolled in the FDA’s Biosimilar Product Development (BPD) program and more on the way, the agency is anticipating surging growth in the follow-on biologic market over the coming years, said Janet Woodcock, MD, the director of the FDA’s Center for Drug Evaluation and Research, in testimony before the House Committee on Energy and Commerce’s Subcommittee on Health hearing on Thursday. Read More.


    High Costs for Drugs Used by A Few Are Starting to Add Up

    February 5, 2016 – The cystic fibrosis drug Orkambi can help people with specific genetic mutations breathe better, but treatment with the pill comes with a hefty sticker price — $259,000 a year. Orkambi, which was approved by the Food and Drug Administration last July, is expected to take almost $36 million from California’s general fund this fiscal year and next. That cost estimate doesn’t include any discounts the state may receive from drug manufacturers. Read More.


    Califf, FDA Top Officials Call for Sweeping Review of Agency Opioids Policies

    February 4, 2016 – In response to the opioid abuse epidemic, Dr. Robert Califf, the FDA’s Deputy Commissioner for Medical Products and Tobacco, along with other FDA leaders, called for a far-reaching action plan to reassess the agency’s approach to opioid medications. The plan will focus on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief. Read More.


    CVS Launches Rebranding of Target Pharmacy

    February 3, 2016 – Their corporate logos share colors, their aisles share similar products — and now they’ll share floor space. Despite the similarities between their businesses, CVS Health (CVS) CEO Larry Merlo and Target (TGT) CEO Brian Cornell say they are confident that their companies will maintain distinct identities as the first CVS Pharmacy stores located inside Target celebrate a grand opening Wednesday in the Charlotte area. Read More.



    340B in the News

    CMS 340B Program Update

    February 24, 2016 – The new year has already gotten off to a busy start for health care providers that participate in the 340B Drug Pricing Program (“340B Program”) and government agencies that reimburse these providers. Following on the heels of the publication of a Medicaid Covered Outpatient Drug Final Rule (“Final Rule”), the Centers for Medicare and Medicaid Services (“CMS”) recently issued a guidance letter discussing implementation of the Final Rule and informing state Medicaid directors that, under the Final Rule, they should pay 340B Program entities no more than the 340B ceiling price (plus appropriate dispensing fees) for drugs purchased at 340B Program pricing. Read More.


    Drug Discount Program Saves Lives

    February 22, 2016 – It’s our mission to take care of whomever walks through our doors. Whether critically ill, poor or in decent health, it doesn’t matter: At Bon Secours Hospital in Baltimore, we help all of our patients get the care and medicine they need to get better and remain healthy — including our community’s most vulnerable patients. These are the men, women and children who would otherwise not be able to afford health care when they need it most. Read More.


    CMS Notifies States of AMP Rule Requirements: 340B Providers Should Take February 16, 2016 -Last week, we wrote analyzing key provisions of the Covered Outpatient Drug final rule (“Final AMP Rule”) and their impact on manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies.  We focused on the following four provisions: (i) the definition of bona fide service fees; (ii) the definition of bundled sales; (iii) the definition of retail community pharmacy; and (iv) the change in Medicaid reimbursement to reimbursement based on Actual Acquisition Cost (“AAC”).Read More.


    Alert: 340B Self-Audits: The Best Defense Is a Good Defense

    February 12, 2016 – Federally qualified health centers (FQHCs) participating in the 340B Drug Pricing Program (the “340B Program”) are subject to audits by Health Resources and Services Administration (HRSA) and the drug manufacturers who participate in the 340B Program.  FQHCs are subject to two types of audits, risked-based and targeted audits.  A targeted audit is triggered by allegations of violations of the 340B Program requirements. Read More.


    340B Hospitals Spend Less Than Other Institutions for Part B Drugs

    February 15, 2016 – A new study by an advocacy group for safety-net hospitals say that participants in the 340B drug discount program spend less per patient under Medicare Part B for drugs than hospitals outside of 340B, while still caring for a population of sicker patients. Read More.


    Doctors Urge Congress to Preserve The 340B Drug Pricing Program

    February 11, 2016 – Thousands of physicians from American safety-net hospitals signed a letter sent to Congress highlighting the importance of the 340B Drug Pricing Program. The letter asks Congress not to consider suggestions from drug industry lobbyists to restrict the impact of the drug program, which makes treatments available to low-income, uninsured and underinsured patients at extreme discounts. Read More.


    340B Guidance Riles Hospitals, Drug Makers

    February 10, 2016 – The Health Resources and Services Administration (HRSA) may have gotten it more right than wrong with its new proposed guidance on the 340B outpatient drug program.1 Hospitals and drug manufacturers, the program’s two key constituencies—long at loggerheads—are both complaining to high heaven about proposed changes. The program requires drug companies to sell medicines at deep discounts to hospitals (generally those located in rural or poor areas with significant indigent populations) that use those discounts to fund medical services they couldn’t otherwise afford. Read More.


    Three Ways to Prepare for 340B

    February 8, 2016 – Covered entities awaiting a response from the Health Resources and Services Administration (HRSA) for comments regarding the agency’s proposed “340B Drug Pricing Program Omnibus Guidance” (mega-guidance) can take meaningful steps now to increase the likelihood of being in compliance with the program by the time the final guidance goes into effect. Many anticipate a response during the fall of 2016. Read More.


    Pharma Tried to Buy Congress in 2015

    February 3, 2016 – Recently, alarming news for those advocating for a sensible health care policy arrived courtesy of Politico Pro: The pharmaceutical industry spent more than $50 million on lobbying last year alone. And, if you can believe this, that’s an increase from 2014. Read More.