Clinical Insights: June 16, 2017

    Welcome to the weekly 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

    Fibryna® (fibrinogen – [human]) – June 7, 2017 – A human fibrinogen concentrate indicated for the treatment of acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. Read More.

    Gleolan® (aminolevulinic acid hydrochloride) – June 6, 2017 – The U.S. Food and Drug Administration (FDA) approved aminolevulinic acid hydrochloride, known as ALA HCl (Gleolan®, NX Development Corp.) as an optical imaging agent indicated in patients with gliomas (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery. Read More.

    New Formulation Approval

    Norvir® (ritonavir) – June 8, 2017 – The Food and Drug Administration (FDA) has approved a new oral powder formulation for Norvir® (ritonavir AbbVie). Norvir®, an HIV protease inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in children and adults. Read More.

    Aristada® (aripiprazole lauroxil) – June 6, 2017 – Alkermes plc announced that the U.S. Food and Drug Administration (FDA) has approved two-month Aristada® (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. ARISTADA® is now FDA-approved in four doses and three dosing duration options (441 mg, 662 mg or 882 mg once monthly, 882 mg once every six weeks and 1064 mg once every two months) and can be initiated at any dose or interval, offering an unprecedented range of flexibility to patients and healthcare providers. The new two-month dose is expected to be available in mid-June. Read More. 

    New Generic Drug Approval

    Olopatadine (Pataday®) – June 9, 2017 – Teva Pharmaceutical Industries Ltd., announced the launch of generic Pataday® (olopatadine hydrochloride ophthalmic solution) 0.2%, in the U.S. Olopatadine hydrochloride ophthalmic solution 0.2% is a mast cell stabilizer indicated for the treatment of ocular itching associated with allergic conjunctivitis. Read More.

    Emtricitabine/tenofovir disoproxil fumarate (Truvada®) – June 8, 2017 – The Food and Drug Administration announced its approval of Teva’s abbreviated new drug application the first generic of Gilead’s Truvada® (emtricitabine and tenofovir disoproxil). The drug is indicated both as a treatment for HIV-1 in combination with other antiretroviral drugs and for pre-exposure prophylaxis to prevent sexually acquired HIV infection in combination with safer sex practices. Read More. 

    New Drug Shortages/Updates

    New Drug Recall Alert

    Sodium Bicarbonate Injection 8.4 Percent USP, Neut (Sodium Bicarbonate 4 Percent Additive Solution), Quelicin (Succinylcholine Chloride Injection USP), and Potassium Phosphates Injection by Hospira – June 16, 2017 – Hospira, Inc., a Pfizer company, is voluntarily recalling 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials, 5 lots of NeutTM (Sodium Bicarbonate 4% additive solution) 5 mL vials, 5 lots of QUELICINTM (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products. Read More.

    Paliperidone Extended-Release Tablets 3mg – June 15, 2017 – Teva Pharmaceuticals USA, Inc. (Teva) initiated a voluntary recall to retail-level on 05/31/2017 for one lot of Paliperidone Extended-Release Tablets, 3mg, 90 count bottles, lot 1160682A, expiration 6/2018, NDC 0591-3693-19, that was distributed under the Actavis Pharma Inc. label. In coordination with FDA, Teva is extending this recall to the consumer/user level. This recall is being carried out due to failing test results for dissolution. Read More.

    Nitroglycerin Injection in 5 Percent Dextrose USP – Advanced Pharma, Inc. d/b/a Avella of Houston (“Advanced Pharma”) is voluntarily recalling all unexpired lots of Nitroglycerin products that were produced at Advanced Pharma’s Houston location between March 3, 2017 and May 31, 2017 to the hospital/user level. Read More.

    Eliquis® (apixaban) – June 13, 2017 – Bristol-Myers Squibb Company is voluntarily recalling one lot (#HN0063) of Eliquis 5 mg tablets to the consumer level. This lot was distributed nationwide in the U.S. to wholesalers and retail pharmacies in February 2017. Bristol-Myers Squibb is taking this precautionary measure based on a customer complaint that a bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets. Read More. 

    New Drug Safety Alert

    Opana® ER (oxymorphone) – June 8, 2017 – The U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana® ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse. Read More.

    Clinical and Pharmacy News

    Researchers Find Low Adherence of Physicians to H. Pylori Guidelines – June 15, 2017 – It was long thought that gastric ulcers and other digestive woes were brought about by stress. But in 2005, clinical fellow Barry J. Marshall and pathologist J. Robin Warren were awarded the Nobel Prize in Physiology or Medicine for recognizing the role of Helicobacter pylori in gastritis and peptic ulcer disease. Read More.

    Opioid–Benzo Combination Still Plaguing Elderly – June 15, 2017 – Denver—Up to 25 percent of commercially insured people who are prescribed opioids are placed on benzodiazepines simultaneously, despite federal safety alerts that the combination can cause potentially lethal respiratory depression, according to data presented at the 2017 Academy of Managed Care Pharmacy (AMCP) Managed Care & Specialty Pharmacy Annual Meeting. Read More.

    Lifelong Learning in Specialty Pharmacy Goes Beyond Continuing Education Requirements – June 14, 2017 – Many of us anticipated our college graduation day and looked forward to a change from the days of studying, writing papers, and taking exams. Those of us who graduated from pharmacy school had one more hurdle after graduation, sitting for the state board and pharmacy law examinations to earn an official license as a registered pharmacist. Read More. 

    Trump White House Prepares Executive Order on Drug Pricing – June 14, 2017 – The Trump administration is drafting an executive order to rein in prescription drug prices, according to an article posted on the BioCentury  The order will instruct executive agencies to use value-based contracts for drug purchases, and to pursue trade policies that enhance the intellectual property rights of American pharmaceutical companies. Read More.

    Invokana Reduces Risk for Death From CVD – June 13, 2017 – Canagliflozin (Invokana, Janssen) significantly reduced the combined risk for death from cardiovascular disease (CVD), myocardial infarction (MI) and nonfatal stroke versus placebo in patients with type 2 diabetes mellitus and CVD. Read More.

    HIV Patients Remaining on Therapy – June 12, 2017 – HIV-positive patients are persisting with treatment more than 50 percent longer than in the past, according to researchers from Brown University, in Providence, R.I. Read More.

    Amazon, Stay Out of The Prescription Drugs Market – June 11, 2017 – Amazon hit a milestone this month after the price of one share hit U.S. $1,000 for the first time, giving it a total value of close to $500 billion. That makes it the fourth-biggest company in the U.S. in terms of market capitalization and twice the size of brick-and-mortar rival Walmart. Read More.

    Multidisciplinary Pain Treatment in the World of Opioid Guidelines – June 9, 2017 – Recent opioid treatment guidelines from the CDC and states further reinforce the implicit message—to much of the public and medical community—that pain treatment equals opioid prescribing. Read More.

    Trump’s FDA Stirs a Generic-Drug Storm – February 9, 2017 – After repeatedly sounding off on prescription-drug prices, President Donald Trump — who these days has other things on his mind — has gone largely quiet on the matter. But his FDA commissioner Scott Gottlieb is keeping the topic alive. Read More.

    How ‘Price-Cutting’ Middlemen Are Making Crucial Drugs Vastly More Expensive – June 9, 2017 – Diabetes doctor Irl B. Hirsch has watched with dismay as more of his Seattle-area patients take life-threatening steps to deal with the soaring price of insulin. Some need two vials a week of the crucial medicine, at $300 per vial. Many pay full price because they’re uninsured or enrolled in health plans with high deductibles. So they’re cutting back. Read More. 

    Polypharmacy Increases Significantly During End of Life – June 8, 2017 – Older patients are often prescribed potentially futile drugs during their last 12 months of life, thus clinical guidelines are needed to aid physicians in deciding to continue or discontinue medications near the end of life, according to findings published in The American Journal of Medicine. Read More.

    How Cleveland Clinic Saved $90 Million in Drug Costs – June 7, 2017 – A recent survey from the American Hospital Association indicated that inpatient drug expenses increased an average of 23.4 percent per year between fiscal 2013 and 2015. Despite the challenges, Cleveland Clinic has been able to rein in drug spending without harming quality, saving $90 million between 2010 and 2016, according to an article posted on the Hospitals & Health Networks website. Read More.

    Three Ways Technology Is Improving Pharmacy – June 5, 2017 – When Walmart announced an initiative in March 2017 allowing patients to fill prescriptions via its mobile app and providing express pickup service for medications, the conversation around technology in pharmacies made headline news. The message was clear: Patients have retail expectations when it comes to engaging with pharmacies. Read More.

    Drug Prices Become Target for FDA as Chief Expands Purview – June 5, 2017 – The head of the U.S. Food and Drug Administration is considering using the agency’s powers to bring more price competition to the market for generic drugs, targeting high-priced products by prioritizing the approval of additional competing treatments. Read More. 

    1 in 4 CAP Patients Fail Antibiotic Therapy – June 2, 2017 – Washington, D.C.—Approximately one in four adults prescribed an antibiotic in an outpatient setting for community-acquired pneumonia (CAP) did not respond to treatment, according to a new study. Read More. 

    340B in the News

    Patients Can Take Steps to Lower Prescription Costs – June 16, 2017 – Nobody needs to be told that prescription drug bills can consume large fractions of household incomes. But in recent years, some momentum has picked up among the public and within the government to put some sort of downward pressure on the ever-rising prices. It is unlikely that big changes will happen soon, or that a “silver bullet” piece of legislation can solve the problem, but there are steps health care consumers can take to mitigate the cost of medications. Read More.

    Dr. Neil Minkoff Explains How 340B Impacts Pharmacies and Payers Differently – June 15, 2017 – All stakeholders stand to gain from the 340B program in different ways, but they also take on different risks, like the potential impact for health plans on rebate contracts, said Neil Minkoff, MD, chief medical officer of EmpiraMed. Read More.

    Welch Bill to Reduce Prescription Drug Prices for Rural Hospitals – June 14, 2017 – Rep. Peter Welch (D-VT) has introduced bipartisan legislation to close a loophole in a federal drug discount program that is driving up the cost of prescription drugs purchased by rural hospitals and other eligible providers for their patients. The bill is the latest Welch initiative to address the escalating cost of prescription drugs for consumers and providers. Read More.

    HHS Further Delays Effective Dates of Final Rules for 340B Drug Pricing Program – June 14, 2017 – On May 19, 2017, HHS further delayed the effective dates concerning two final rules issued during the Obama administration. First, HHS delayed until October 1, 2017 the effective date of a January 5, 2017 final rule for the 340B Drug Pricing Program. Read More.

    Site Neutral Payment Reform Advocates Set Their Sights on 340B – June 3, 2017 – Some days, Kashyap Patel, MD, wonders why in the world he decided to become an oncologist. Triple board-certified in medical oncology, hematology and internal medicine, Dr. Patel has been practicing with Carolina Blood and Cancer Care, in Rock Hill, S.C., for more than 15 years. Read More.