Clinical Insights — January Issue 2

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


    New Formulation Approval

    Humulin® R KwikPen® (insulin human injection) – New Formulation Approval

    January 21, 2016 – The U.S. Food and Drug Administration approved Eli Lilly and Company’s Humulin® R U-500 KwikPen®(insulin human injection) 500 units/mL, a pre-filled device containing Humulin R U-500, a highly concentrated formulation of insulin. Humulin R U-500 is the only FDA-approved insulin that is five-times more concentrated than standard U-100 insulin. This insulin is used to treat high blood sugar in people with type 1 and type 2 diabetes who need more than 200 units of insulin per day. The safety and efficacy of Humulin R U-500 used in combination with other insulins or delivered by an insulin infusion pump has not been determined. Read More.


    Emverm™ (mebendazole) – New Formulation Approval

    January 15, 2016 – Impax Laboratories, Inc., announced that the U.S. Food and Drug Administration has approved the Company’s supplemental new drug application (sNDA) for Emverm™  (mebendazole) 100 mg chewable tablets. Emverm™  is indicated for the treatment of Enterobius vermicularis (pinworm), Trichuris trichiura (whipworm), Ascaris lumbricoides (common roundworm), Ancylostoma duodenale (common hookworm), Necator americanus (American hookworm) in single or mixed infections. Pinworm is a highly contagious parasite that infects approximately 40 million people in the United States each year. Pinworm infection is three times more common than head lice. Read More.


    New Indication Approval

    Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) – New Expanded Indication Approval

    January 23, 2016 – Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival (PFS). Read More.


    Botox® (onabotulinumtoxinA) – New Indication Approval

    January 22, 2016 – Allergan plc, a leading global pharmaceutical company announced that the U.S. Food and Drug Administration (FDA) has approved Botox® (onabotulinumtoxinA) for the treatment of lower limb spasticity in adult patients to decrease the severity of increased muscle stiffness in ankle and toe muscles. Botox® is the first and only botulinum toxin product to be approved by the FDA to treat multiple muscle groups of the upper (elbow, wrist, fingers, and thumb) and lower limbs that may be impacted by spasticity. Read More.


    Kyprolis® (Carfilzomib) – New Indication Approval

    January 21, 2016 – Amgen announced that the U.S. Food and Drug Administration has approved the supplemental New Drug Application (sNDA) of Kyprolis® (carfilzomib) for Injection in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. The FDA also approved Kyprolis® as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. Read More.


    Arzerra® (ofatumumab) – New Indication Approval

    January 19, 2016 – The U.S. Food and Drug Administration approved ofatumumab (Arzerra  Injection, Novartis Pharmaceuticals Corporation) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). Ofatumumab was previously approved for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy was considered inappropriate and also for patients with CLL refractory to fludarabine and alemtuzumab. This new approval was based on demonstration of an improvement in progression-free survival (PFS) in a randomized, open-label trial comparing ofatumumab to observation in patients whose disease had a complete or partial response after at least two lines of prior therapy. Read More.


    Cosentyx® (secukinumab) – New Indication Approval

    January 15, 2016 – Novartis announced that the U.S. Food and Drug Administration has approved Cosentyx® (secukinumab) for two new indications – the treatment of adult patients with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). AS and PsA are both life-long, painful and debilitating inflammatory diseases that affect the joints and/or spine. If not treated effectively, both conditions can lead to irreversible joint and/or spinal bone damage caused by years of inflammation. Read More.


    Hiberix® (Haemophilus b conjugate [tetanus toxoid conjugate]) – New Indication Approval

    January 15, 2016 – GSK announced that the U.S. Food and Drug Administration approved an expanded age indication for Hiberix® [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)].  Hiberix® is now indicated for the immunization of children aged six weeks through four years (prior to 5th birthday) against invasive disease caused by Haemophilus influenzae type b (Hib). Hib infection is a serious disease caused by bacteria usually affecting children under the age of five, and Hib vaccination for appropriate children is routinely recommended.

    Read More.


    New Generic Approvals

     Generic Drug Name  Generic Manufacturer  Brand Name Approval Date


    New Drug Shortage

     January 25, 2016

    January 14, 2016

    January 12, 2016

    January 06, 2016

    January 05, 2016

    Drug Safety Alert

    Noxafil (posaconazole) – Drug Safety Alert

    January 4, 2016 – The FDA is cautioning that differences in dosing regimens between the two oral formulations of the antifungal Noxafil (posaconazole) have resulted in dosing errors.  To help prevent additional medication errors, the drug labels were revised to indicate that the two oral formulations cannot be directly substituted for each other but require a change in dose.  Direct mg for mg substitution of the two formulations can result in drug levels that are lower or higher than needed to effectively treat certain fungal infections. Read More.

    Drug Recall Alert

    Baxter IV Solutions (0.9% Sodium Chloride, Metronidazole, Clinimix E 5/15) – Drug Recall Alert

    January 27, 2016 – Baxter is voluntarily recalling four lots of intravenous (IV) solutions to the hospital/user level due to the potential for leaking containers and particulate matter. See Firm Press Release for affected lots. Read More.


    Magnesium Sulfate in Water for Injection by Hospira – Drug Recall Alert

    January 6, 2016 – Hospira, Inc. announced a voluntary recall of one lot of MAGNESIUM SULFATE IN WATER FOR INJECTION (0.325 mEq Mg**/mL) 40 mg/mL 2g total, 50 mL (NDC: 0409-6729-24, Lot 53-113-JT, Expiry 1NOV2016) to the user level due to a confirmed customer report of an incorrect barcode on the primary bag labeling. The product has a barcode identifying the product contents on both the overwrap and on the primary container. The barcode on the overwrap is correct; however, there is potential for the primary container barcode to be mislabeled with the barcode for HEPARIN SODIUM 2000 USP UNITS/1000 mL in 0.9% SODIUM CHLORIDE INJECTION. Read More.


    Baxter IV Solutions (0.9% Sodium Chloride, 70% Dextrose) – Drug Recall Alert

    January 5, 2016 – Baxter International Inc. announced a voluntarily recall of two lots of intravenous (IV) solutions to the hospital/end user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint. The lots being recalled were distributed to customers and distributors in the United States between June 6, 2015 and December 16, 2015. Read More.

    Clinical and Pharmacy News

    Will Voters Help Control the Cost of Prescription Drugs?

    January 27, 2016 – California voters will weigh in this November on a high-stakes ballot proposition intended to help control the cost of prescription drugs — the latest attempt to limit soaring prices that have prompted public criticism nationwide. The proposition would require the state to drive a harder bargain with drug companies so it doesn’t pay more for medications than the U.S. Department of Veterans Affairs. Read More.


    Fight to Lower Drug Prices Forces Some to Switch Medication

    January 26, 2016 – Steve Miller has some customers on offer. Millions of them in fact. The chief medical officer at Express Scripts, the largest pharmacy benefit manager in the U.S., has been essentially auctioning off his 80 million customers to the drug companies that will give him the best deal. “Who wants my market share?” Miller says. “Whoever will give me the best price, I will reward you with an enormous amount of market share.” Miller is the most vocal leader in what has become a war on drug prices. Read More.


    This New Approach to Mental Healthcare Could Save Lives

    January 26, 2016 – All American adults should be screened for depression as part of their normal health-care routine, an influential panel recommended on Tuesday. The U.S. Preventive Services Task Force also singled out maternal mental illness for the first time by suggesting that women be screened during pregnancy and after childbirth. The new guidelines, updated for the first time since 2009 and published in the journal JAMA, are a recognition of the devastating toll mental illness is taking around the world. Read More.


    GAO: FDA Lacks Data to Track Expedited Drugs Post Approval

    January 25, 2016 – The FDA does not have sufficient data for systematic oversight and tracking of postmarketing safety issues for drugs it has approved, according to a new report from the Government Accountability Office. Since fiscal year 2007, drug manufacturers have submitted more than 770 requests for fast-track designation under one of the FDA’s four expedited programs, and the FDA granted about two-thirds of those requests, the GAO found. Read More.


    CMS Final Rule Revises Medicaid Reimbursement, Drug Rebates

    January 25, 2016 – Medicaid reimbursement improvements are underway, according to a final rule from the Centers for Medicare & Medicaid Services (CMS). The rule – CMS-2345-FC – provides greater detail about Medicaid reimbursement and rebate calculation. Its goal is to promote the affordability of prescription drugs. Read More.


    Drug Shortages in EDs Have Increased More Than 400%

    January 25, 2016 – Emergency departments (EDs) are health care’s front line — in the U.S., nearly 45 out of 100 people visit an ED in any given year. But there is an issue brewing behind the scenes in emergency medical facilities, one that can’t be fixed by a simple stitch or bandage, according to an article in the Washington Post. A new study published in Academic Emergency Medicine has shown that drug shortages in EDs across the U.S. increased by more than 400% between 2001 and 2014. Read More.


    A New Prescription for Lower Drug Prices

    January 25, 2016 – Compounded-drug makers can bring inexpensive, off-patent medicines to market, if the FDA will let them. For three years in a row, according to a recent survey by health-care data company Truveris, prescription-drug prices in the U.S. have risen by double digits. More than 75% of Americans now say their top health concern is the rising price of prescription drugs, according to the Kaiser Family Foundation. Read More.


    Retail Pharmacies Move to Capture More Obamacare Dollars

    January 22, 2016 – The nation’s largest pharmacy chains are stepping up strategies that link their pharmacists with local hospitals and health systems to win a piece of a larger share of health dollars available under the Affordable Care Act. CVS Health and Walgreens Boots Alliance have formed dozens of affiliations with medical-care providers that they say are looking to manage populations of patients. Increasingly, health systems need more than just doctors and hospitals under their umbrella if they’re going to be attractive to the government and private insurance companies that pay them. Read More.


    It’s Up to Congress to Curb the High Costs of Prescription Drugs

    January 22, 2016 – U.S. Sen. Amy Klobuchar recently stopped by Children’s Hospital in Minneapolis to highlight her push to rein in the high cost of prescription drugs. Legislation championed by her would allow consumers to import cheaper medications from Canada, help generic versions of brand-name drugs get to market faster and allow the federal government to wield its mighty purchasing power to negotiate lower drug prices for Medicare seniors. Read More.


    Walmart Workers Will Receive Pay Raises

    January 21, 2015 – Walmart is increasing the wages of more than 1.2 million workers in a move that could potentially impact the numerous pharmacy technicians employed by the retail giant. Effective February 20, 2016, all Walmart and Sam’s Club employees hired before January 1, 2016, will earn at least $10 an hour. Entry-level workers hired after this date will start at an hourly wage of $9, which will be increased to the new $10-an-hour minimum once they complete the new company’s training program. Read More.


    Temple University Hospital Makes Strides in Confronting Prescription Drug Abuse

    January 21, 2016 – Prescription drug abuse has become a public health crisis in the U.S., and Temple University Hospital has made strides in confronting this critical situation. According to the Centers for Disease Control and Prevention, the U.S. death rate from prescription drug overdose now exceeds the combined rate of deaths from heroin and cocaine. In an effort to curb the rise in overdose and abuse of opioids—powerful painkillers which include Oxycontin, Percocet and Vicodin—Temple University Hospital implemented a voluntary guideline for emergency department physicians prescribing those medications. Read More.


    Employers Aim to Curb Specialty Drug Costs

    January 20, 2016 – Employers must take immediate steps to control the rising cost of specialty pharmacy as it outpaces the rest of prescription drug spending, according to a new report from Towers Perrin. The 20th Annual Towers Watson/NBGH Best Practices in Health Care Employer Survey of 487 large U.S. employers, shows that specialty pharmacy drugs are significantly driving up prescription drug spending. In particular, while pharmacy currently represents about 20% of employer-sponsored medical benefits costs, it is increasing at a rate that accounts for roughly half of medical cost inflation. Read More.


    Drug Industry Boosts Lobbying Amid Growing Scrutiny of Prices

    January 20, 2016 – The pharmaceutical industry’s top trade group increased its lobbying spending in 2015 amid intensifying scrutiny of drug prices. The Pharmaceutical Research and Manufacturers of America (PhRMA) spent $18.32 million on lobbying in 2015, up from $16.51 million in 2014, according to disclosure records. Last year was the first year that PhRMA’s lobbying spending rose since 2009, according to data from the Center for Responsive Politics. Read More.


    Experts Create New Guidelines to Improve Treatments for Cancer Patients

    January 20, 2016 – A committee of national experts, led by a Cleveland Clinic researcher, has established first-of-its-kind guidelines to promote more accurate and individualized cancer predictions, guiding more precise treatment and leading to improved patient survival rates and outcomes. These new guidelines are changing the traditional approach of cancer staging methods for cancer treatment. The new risk calculators – which will complement the existing staging system – will enable physicians to more accurately and precisely determine the best treatment for individual patients. Read More.


    Endocrine Society Issues First-Ever Guidelines for Primary Adrenal Insufficiency

    January 16, 2016 – New guidelines on the diagnosis and management of primary adrenal insufficiency stress the importance of early recognition and the need to prevent life-threatening adrenal crises in these patients. These are the first clinical practice guidelines on primary adrenal insufficiency (PAI), also known as Addison’s disease, issued by Endocrine Society (J Clin Endocrinol Metab. 2016 Jan 13:jc20151710 [Epub ahead of print]). Read More.


    Menopause Symptom Treatment Guideline Focuses on Individualized Approach

    January 16, 2016 – The Endocrine Society’s new clinical practice guideline on the treatment of menopause symptoms advocates an individualized approach based on patient preferences and risk/benefit considerations. “We wanted to focus on the treatment of symptoms of menopause,” Cynthia A. Stuenkel, MD, chair of the task force charged with drafting the guideline, said during a virtual press conference. “We, however, take a very individualized clinical approach. We want to know how bothered is that women and what does she want to do? Women vary greatly in their own personal preferences about how they would like to manage their symptoms.” Read More.


    Walmart to Close More Than 250 Stores Globally

    January 15, 2016 – Walmart said it will close 269 stores worldwide this year, including many of its smallest stores, in an unprecedented move CEO Doug McMillon characterized as being more disciplined about growth. Plans call for the company to close 154 locations in the U.S., including the company’s 102 smallest format stores, Walmart Express, which had been in pilot since 2011. Read More.


    Drugmaker Under Fire for Taxpayer-Funded Cancer Drug That Costs $129,269 A Year

    January 14, 2016 – Two nonprofit groups have petitioned the federal government to take actions to increase the competition for a cancer drug, developed by a Japanese company whose U.S. affiliate is in Northbrook, that costs $129,269 a year. The groups are asking the government to exercise its right to step in when the fruits of taxpayer-funded research are not “available to the public on reasonable terms,” according to U.S. law. Read More.


    Pharmacists Take On Medical Cannabis Dispensing Role in Three States

    January 13, 2016 – Pharmacists in Connecticut have been dispensing medical cannabis for more than a year now. The state’s medical cannabis law requires that a board-certified pharmacist be onsite to dispense the product at a medical cannabis dispensary, of which there are currently six in Connecticut. But Connecticut is not the only state with this model. Read More.


    Drugmakers Dismiss Outrage over High Prices as “Abomination”

    January 12, 2016 – The protesters carried handwritten signs accusing drug maker Gilead Sciences of greed for pricing its breakthrough hepatitis C drug at $84,000 per treatment. So it perhaps wasn’t surprising that during a panel discussion here Monday, a Gilead executive was asked how he lives with himself. Gregg Alton, the executive vice president for corporate and medical affairs, joked that he goes running. Then his tone turned serious as he talked about research, innovation, and the value of life-saving new drugs. “I sleep quite well,” he concluded. Read More.


    West Virginia Sues Prescription Drug Wholesaler for ‘Flooding’ State

    January 11, 2016 – West Virginia’s attorney general has accused one of the nation’s largest pharmaceutical drug wholesalers of flooding the state with tens of millions of prescription pills in violation of state law. Attorney General Patrick Morrisey on Friday announced a lawsuit against San Francisco-based McKesson Corp. Among other things, the lawsuit alleges violations of state consumer protection laws and the Uniform Controlled Substances Act. Read More.


    Prescription Drug Prices Jumped More Than 10 Percent in 2015, Analysis Finds

    January 11, 2015 – Drug prices were big news in 2015, thanks in large part to “Pharma bro” Martin Shkreli, who drew outrage for hiking the price of a life-saving drug by 5,000 percent. Such eye-popping increases were rare. But plenty of drugs became more expensive during the past year. How much did prescription drug prices rise overall in 2015? More than 10 percent — well in excess of the U.S. inflation rate — according to an analysis released Monday by Truveris, a health-care data company that tracks drug prices. Read More.


    Drugmakers Raise Prices Despite Criticisms

    January 10, 2015 – Drugmakers didn’t let up on price increases with the start of a new year, demonstrating the industry’s pricing power in the face of mounting criticisms of prescription costs in the U.S. Pfizer Inc., Amgen Inc., Allergan PLC, Horizon Pharma PLC and others have raised U.S. prices for dozens of branded drugs since late December, with many of the increases between 9% and 10%, according to equity analysts. Read More.


    New Insights into CSTD Chemotherapy Compatibility

    January 7, 2016 – There are several changes afoot in the closed-system drug-transfer device (CSTD) arena, not the least of which is a proposed new testing method to ensure the devices don’t leak, issued by a federal agency (page 19). Given the changeable nature of this product class, Pharmacy Practice News spoke with several stakeholders about how clinicians can ensure patient and health care worker safety. Read More.


    CHEST Issues New Antithrombotic Guideline Update for Treatment of VTE Disease

    January 7, 2016 – Each year, there are approximately 10 million cases of venous thromboembolism (VTE) worldwide. VTE, the formation of blood clots in the vein, is a dangerous and potentially deadly medical condition and is a leading cause of death and disability worldwide. In this latest evidence-based guideline, Antithrombotic Therapy for VTE Disease: CHEST Guideline, from the American College of Chest Physicians, experts provide 53 updated recommendations for appropriate treatment of patients with VTE. Read More.


    Washington has Big Hopes, but Little Power, to Negotiate Drug Prices

    January 6, 2016 – It sounds simple enough: Let Medicare negotiate drug prices and help bring down prices for consumers. With growing public frustration over the price of prescription drugs, Hillary Clinton and Bernie Sanders have made that idea a centerpiece of their campaigns, and congressional Democrats have been kicking the notion around in broad terms for years. But policy experts say the candidates and lawmakers are exaggerating how much power the government actually has to drive down drug prices on a large scale. The reality is that any attempt to negotiate with drug makers would be challenging, without any guarantees of an outcome that would make a significant difference to most consumers’ bottom line. Read More.

    340B in the News

    Potential Part B Drug Payment Cuts for 340B Hospitals

    January 19, 2016 – The influential Medicare Payment Advisory Commission (MedPAC) has voted to recommend to Congress in its March report that Medicare Part B drug payment rates for 340B drugs be reduced by 10 percent for hospitals participating in the 340B Drug Pricing Program (340B Program). Currently, hospitals are paid the same rate by Medicare for drugs whether or not the drugs are purchased through the 340B Program. MedPAC will also recommend that program savings from this payment cut be redistributed to hospitals based on the amount of uncompensated care they report on Worksheet S-10 of the Medicare cost report. Read More.


    MedPAC Backs Slashing Drug Payments to 340B Hospitals

    January 14, 2016 – The Medicare Payment Advisory Commission has backed a controversial proposal to reduce Part B drug payment rates for hospitals participating in the 340B Drug Pricing Program, though members previously signaled they would oppose it. The panel voted 13-3 on Thursday to reduce the rates by 10% of the average sales price of the drugs. The move would generate about $300 million in savings that would be funneled to hospitals with some of the neediest patients. Read More.