Clinical Insights — January Issue 1

    Welcome to the first 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 Drug Approval

    Zurampic® (lesinurad)

    December 22, 2015 – The U.S. Food and Drug Administration approved Zurampic® (lesinurad) to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a type of drug approved to reduce the production of uric acid in the body. Zurampic® works by helping the kidney excrete uric acid. It does this by inhibiting the function of transporter proteins involved in uric acid reabsorption in the kidney. Read More. 

     

    Uptravi® (selexipag)

    December 21, 2015 – The U.S. Food and Drug Administration approved Uptravi® (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation. Uptravi® belongs to a class of drugs called oral IP prostacyclin receptor agonists. The drug acts by relaxing muscles in the walls of blood vessels to dilate (open) blood vessels and decrease the elevated pressure in the vessels supplying blood to the lungs. RxS Clinical Insight: Uptravi® has been approved with Orphan drug status. Read More.

     

    Bridion® (sugammadex)

    December 15, 2015 – The U.S. Food and Drug Administration approved Bridion® (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults. Read More.

     

    Vistogard® (uridine triacetate)

    December 11, 2015 – The U.S. Food and Drug Administration approved Vistogard® (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments. Read More.

     

    Alecensa® (alectinib)

    December 11, 2015 – The U. S. Food and Drug Administration granted accelerated approval to alectinib (Alecensa® capsules, Hoffmann-La Roche Inc.) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to Xalkori® (crizotinib). RxS Insight: Alecensa® has been approved with Orphan drug status. Read More.

     

    Kanuma™ (sebelipase alfa)

    December 8, 2015 – The U.S. Food and Drug Administration approved Kanuma™ (sebelipase alfa) as the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL) deficiency. Patients with LAL deficiency (also known as Wolman disease and cholesteryl ester storage disease [CESD]) have no or little LAL enzyme activity. This results in a build-up of fats within the cells of various tissues that can lead to liver and cardiovascular disease and other complications. Wolman disease often presents during infancy (around 2 to 4 months of age) and is a rapidly progressive disease. Patients with Wolman disease rarely survive beyond the first year of life. Read More.

     

    Empliciti™ (elotuzumab)

    November 30, 2015 – The U. S. Food and Drug Administration approved elotuzumab (Empliciti™, Bristol-Myers Squibb Company) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies. Elotuzumab is a monoclonal antibody directed against Signaling Lymphocyte Activation Molecule Family 7 (SLAMF7). SLAMF7 is present on myeloma cells and is also present on natural killer cells. RxS Insight: Empliciti™ has been approved with Orphan drug status. Read More.

     

    Portrazza™ (necitumumab)

    November 24, 2015 – The U.S. Food and Drug Administration approved Portrazza™ (necitumumab) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer. Portrazza™ is a monoclonal antibody that blocks activity of EGFR, a protein commonly found on squamous NSCLC tumors. Read More.

     

     

    New Formulation Approval

    Docetaxel Injection Non-Alcohol Formulation

    December 24, 2015 – Eagle Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved Docetaxel Injection, Non-Alcohol Formula for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. Eagle entered into an exclusive licensing agreement with Teikoku Pharma USA Inc. in October 2015 to market, sell and distribute Docetaxel Injection in the U.S. Docetaxel Injection is the first alcohol-free formulation approved in the U.S. Read More.

     

    Emend® (aprepitant) Oral Suspension

    December 21, 2015 – The Food and Drug Administration has approved the New Drug Application (NDA) for Emend® (aprepitant; Merck) for oral suspension for the prevention of chemotherapy induced nausea and vomiting (CINV) in patients aged ≥6 months old. Read More.

     

    Basaglar® (insulin glargine)

    December 16, 2015 – The U.S. Food and Drug Administration approved Basaglar® (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Basaglar® is the first insulin product approved through an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act. A 505(b)(2) application was submitted for Basaglar® that relied, in part, on the FDA’s finding of safety and effectiveness for Lantus (insulin glargine injection) to support approval. Read More.

     

    Otiprio™ (ciprofloxacin)

    December 11, 2015 – Otonomy, Inc., a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, announced that the U.S. Food and Drug Administration has approved Otiprio™ (ciprofloxacin otic suspension) for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement. Otiprio™ is a single-dose, physician-administered antibacterial and the first product approved by the FDA for this indication. Read More. 

     

    Vonvendi® (von willebrand factor)

    December 8, 2015 – The U.S. Food and Drug Administration approved Vonvendi®, von Willebrand factor (Recombinant), for use in adults 18 years of age and older who have von Willebrand disease (VWD). Vonvendi® is the first FDA-approved recombinant von Willebrand factor, and is approved for the on-demand (as needed) treatment and control of bleeding episodes in adults diagnosed with VWD. Read More.

     

    Bendeka™ (bendamustine hydrochloride)

    December 8, 2015 – Teva Pharmaceutical Industries Ltd. and Eagle Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved Bendeka™, (bendamustine hydrochloride) injection, a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine. Bendeka™ is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Efficacy in CLL relative to first-line therapies other than chlorambucil has not been established. Read More.

     

    QuilliChew ER™ (methyphenidate hydrochloride)

    December 7, 2015 – Pfizer announced that the U.S. Food and Drug Administration has approved QuilliChew ER™ chewable tablets. Pfizer now offers two different products for the treatment of ADHD in patients ages 6 years old and above – liquid Quillivant XR® (methylphenidate HCl) CII and new QuilliChew ER™ chewable tablets. QuilliChew ER™ is the first and only long-acting chewable methylphenidate treatment for Attention Deficit Hyperactivity Disorder (ADHD) in patients ages 6 years old and above. Read More.

     

    Fluad™ (influenza vaccine, adjuvanted)

    November 24, 2015 – The U.S. Food and Drug Administration approved Fluad™, the first seasonal influenza vaccine containing an adjuvant. Fluad™, a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B), is approved for the prevention of seasonal influenza in people 65 years of age and older. Read More.

     

     

    New Indication Approval

    Xeomin® (incobotulinumtoxinA)

    December 23, 2015 – Merz North America, U.S. affiliate of the global Merz Pharma Group, announced that Xeomin® (incobotulinumtoxinA) has received U.S. FDA approval for the treatment of upper limb spasticity (ULS) in adult patients. Read More.

     

    Keytruda® (pembrolizumab)

    December 18, 2015 – The U. S. Food and Drug Administration expanded the label to include the approval of pembrolizumab (Keytruda® Injection, Merck Sharp & Dohme Corp.) for the treatment of patients with unresectable or metastatic melanoma. This expansion now includes the initial treatment of patients with unresectable or metastatic melanoma with pembrolizumab. Read More.

     

    Gardasil® 9 (HPV 9-valent vaccine, recombinant)

    December 15, 2015 – Merck announced that the U.S. Food and Drug Administration approved an expanded age indication for Gardasil® 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), Merck’s 9-valent human papillomavirus (HPV) vaccine, to now include use in males 16 through 26 years of age, for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58, and genital warts caused by HPV types 6 and 11. Read More.

     

    Gamunex®-C (immune globulin injection [human])

    December 4, 2015 – The U.S. Food and Drug Administration approved Grifols Therapeutics Inc., Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified to include labeling revisions to the package insert for the subcutaneous route of administration in pediatric patients (ages 2 to 16 years) with primary humoral immunodeficiency. Read More.

     

    Crestor® (rosuvastatin)

    November 30, 2015 – AstraZeneca announced that the U.S. Food and Drug Administration has approved rosuvastatin to reduce total cholesterol, LDL and apolipoprotein B in pediatric patients aged 8 to 17 years with heterozygous familial hypercholesterolemia. Read More.

     

     

    New Generic Approvals

    Generic Drug Name Generic Manufacturer/Applicant Brand Name Approval Date
    IMATINIB MESYLATE TABLETS (TABLETS), 100 MG 400 MG SUN PHARMA GLOBAL FZE GLEEVEC TABLETS 12/3/15
    OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP, 0.1% USV NORTH AMERICA, INC. PATANOL OPHTHALMIC SOLUTION 12/7/15
    OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP, 0.1% APOTEX, INC. PATANOL OPHTHALMIC SOLUTION 12/7/15
    OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP, 0.1% NOVEL LABORATORIES, INC. PATANOL OPHTHALMIC SOLUTION 12/7/15
    OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP, 0.1% ZACH SYSTEM S.P.A. PATANOL OPHTHALMIC SOLUTION 12/7/15
    AMIKACIN SULFATE INJECTION USP, 250 MG/ML FRESENIUS KABI USA, LLC AMIKACIN SULFATE INJECTION USP 12/9/15
    FESOTERODINE FUMARATE EXTENDED-RELEASE TABLETS, 4 MG 8 MG ALKEM LABORATORIES LIMITED TOVIAZ EXTENDED-RELEASE TABLETS 12/10/15
    LEVETIRACETAM TABLETS 250 MG 750 MG 1000 MG SECAN PHARMACEUTICALS, INC. KEPPRA 12/16/15

    Learn more here. 

     

    New Drug Shortage

    December 29, 2015

    Eptifibatide (Integrilin) Injection (Currently in Shortage)

    December 24, 2015

    Granulex Aerosol Spray (Discontinuation)

    December 18, 2015

    Eptifibatide (Integrilin) Injection (Currently in Shortage)

    Meropenem for Injection, USP (Currently in Shortage)

    December 17, 2015

    Cefotetan Disodium Injection (Currently in Shortage)

    December 14, 2015

    Acarbose Tablets (Discontinuation)

     

     

    Drug Safety Alert

    Rosiglitazone-containing Diabetes Medicines

    December 16, 2015 –  FDA is eliminating the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing type 2 diabetes medicines, which are approved as Avandia®, Avandamet®, Avandaryl®, and generics. The REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks. Read More.

     

    Baclofen from Taizhou Xinyou Pharmaceutical

    December 9, 2015 – FDA is alerting drug compounders that certain lots of baclofen active pharmaceutical ingredient (API) manufactured by Taizhou Xinyou Pharmaceutical & Chemical Co., Limited (Taizhou) Taizhou City, Zhejiang Province, China, may be at risk for contamination with particulates and should not be used to compound sterile injectable drugs. Read More.

     

    SGLT2 Inhibitors

    December 4, 2015 – An FDA safety review has resulted in adding warnings to the labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of too much acid in the blood and of serious urinary tract infections. Both conditions can result in hospitalization. Read More.

     

     

    Drug Recall Alert

    Norepinephrine Bitartrate Added to Sodium Chloride (Viaflex Bag)

    December 31, 2015 – PharMEDium Services, LLC is voluntarily recalling 29 lots of 4mg Norepinephrine Bitartrate (16mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 3 lots of 8mg Norepinephrine Bitartrate (32mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag distributed to hospital customers. They have received complaints from hospitals for products that have been found to exhibit a slight discoloration in the admixture. Read More.

     

     

    Clinical and Pharmacy News

    Patients Struggle with High Drug Prices

    December 31, 2015 – Jacqueline Racener’s doctor prescribed a new leukemia drug for her last winter that promised to roll back the cancer in her blood with only moderate side effects. Then she found out how much it would cost her: nearly $8,000 for a full year, even after Medicare picked up most of the tab. Read More.

     

    A New Rx Paradigm for Severe Hyperlipidemia

    December 30, 2015 – The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors offer a major advancement in the treatment of hypercholesterolemia in patients who cannot tolerate or who do not achieve sufficient low-density lipoprotein (LDL) reduction with statin therapy, especially those patients with familial hypercholesterolemia (FH). This article reviews the current state of hypercholesterolemia management, pharmacology and clinical outcome data for PCSK9 inhibitors, and the role of this class in contemporary care. Read More.

     

    Hospital’s Opioid Guidelines Had Significant Impact

    December 30, 2015 – An opioid prescribing guideline adopted in 2013 at Temple University Hospital in Philadelphia may provide a sneak peek at the possible impact of similar guidelines being considered by the Centers for Disease Control and Prevention (CDC). Read More.

     

    Reason for High Drug Prices: A Huge Backlog of Unapproved Generic Drugs

    December 29, 2015 – Somewhere in the depths of the Food and Drug Administration, applications for 4,300 generic drugs are awaiting approval. With growing dissatisfaction over the price of prescription drugs, that backlog has become more than a bureaucratic curiosity. Congress is furious. Hillary Clinton has raised the issue on the campaign trail. And drug makers are threatening to abandon the generics business altogether if the FDA doesn’t speed things up. Read More.

     

    Going All Digital on Controlled Substances

    December 28, 2015 – More than five years after the Drug Enforcement Administration (DEA) issued an interim final rule that legalized electronic prescriptions for controlled substances (EPCS), providers and pharmacies are slowly starting to embrace the change. Read More.

     

    How High Drug Prices Weigh on the Sickest Americans

    December 28, 2015 – The more drugs people take and the sicker they are, the more likely they are to experience problems paying for prescription medicines–or to forgo them altogether because of cost. It may not be surprising that people who use more drugs have the greatest problems paying for them. It’s also never a good thing when people with the greatest need struggle the most to pay for health care. Read More.

     

    FDA Approval Could Turn a Free Drug for A Rare Disease Pricey

    December 23, 2015 – The first sign something was wrong was when Sarah Shell lost 20 pounds. Then she started complaining that her legs were tired. “She began having difficulty climbing stairs, and I just thought that she was — I hate to use the word — lazy,” says Sarah’s mother, Leigh Shell. Read More.

     

    How Low Should Blood Pressure Go in Diabetes Patients?

    December 23, 2015 – High blood pressure is an established risk factor for cardiovascular events in patients with diabetes. Nevertheless, lowering blood pressure in diabetics is an area for debate, given the current controversy surrounding which patients should be prescribed blood pressure-lowering treatment and what blood pressure targets should be set for them. Read More.

     

    New Diabetes Guidelines Put Patient Front and Center

    December 23, 2016 – The 2016 updates of the American Diabetes Association’s Standards of Medical Care in Diabetes bring an enhanced focus on patient-centered care, evidence-based updates for atherosclerotic cardiovascular disease, and a dedicated section on obesity. Read More.

     

    Pharmacologic Management of Irritable Bowel Syndrome

    December 22, 2015 – Irritable bowel syndrome is complex and encompasses several subgroups, including patients with constipation-predominant symptoms and those with diarrhea-predominant symptoms. The recommendations in this guideline apply to patients who meet the diagnostic criteria for IBS. Read More.

     

    Patients Fear Spike in Price of Old Drugs

    December 22, 2015 – Fred Kellerman, a retired car salesman from Los Angeles, was bedridden with a rare neuromuscular disease when he started taking a drug in the 1990s at Duke University in North Carolina. It changed his life. “I had to have a wheelchair to get onto the airplane, but by the time I left, I could walk on,” he said. Read More.

     

    Congress Investigating CDC’s Opioid Guidelines

    December 22, 2015 – A congressional committee has launched an investigation into efforts by the Centers for Disease Control and Prevention (CDC) to develop new guidelines for the prescribing of opioid pain medication. The controversial draft guidelines discourage primary care physicians from prescribing opioids for chronic pain. As many as 11 million Americans take opioids daily for long term, chronic pain. Read More.

     

    Pharmacy Tales: The “No. 1 Priority” and The Public Good

    December 21, 2015 – Have you ever noticed that when a company finds itself in hot water, the first line in its first public statement will almost always say the same thing? No matter what the problem, you can rest assured that the public good is its “highest priority.” Read More.

     

    Health-System Consolidation and Pharmacy Practice

    December 21, 2015 – Health-system consolidation, both vertical and horizontal, is occurring at an unprecedented pace, with no indication of slowing in the near future. A total of 71 hospital deals were scheduled through August of this year; therefore, 2015 is projected to be the busiest year since the upward trend started in 2009. Between 2009-2013, there was a 14% annual increase in health-system consolidations, and the size of these deals, in revenue dollars, also grew 5-fold during the period of 2007-2013. Deloitte has presented projections involving 3 different models converging on a prediction that just 50% of current health systems will remain by 2024 due to continued consolidation. Read More.

     

    No Justification for High Drug Prices

    December 19, 2015 – There is ample evidence that drug prices have been pushed to astronomical heights for no reason other than the desire of drug makers to maximize profits. Prices in many cases far exceed what’s needed to cover the costs of research and clinical trials, and some companies have found ways to rake in profits even without shouldering the cost of drug development. Read More.

     

    IDSA Updates Candidiasis Clinical Practice Guidelines

    December 17, 2015 – The Infectious Diseases Society of America has published revised 2016 guidelines on the treatment and management of invasive Candida infection, including a recommendation that suggests a shift away from fluconazole for initial treatment. Read More.

     

    Employers Battle Drug Costs

    December 18, 2015 – At the University of Minnesota, employees with cancer face a new rule under the health plan. If they are starting on certain expensive drugs, they get just a two-week supply, half the usual amount. Before they can get two more weeks’ worth, a nurse at the university’s pharmacy partner has to confirm they are doing well enough. Read More.

     

    Hypertension: New Treatment Guidelines

    December 18, 2015 – The American Heart Association (AHA), the American College of Cardiology (ACC), and the American Society of Hypertension (ASH) recently issued new recommendations for treating hypertension in patients who have been diagnosed with coronary heart disease, stroke, or other forms of heart disease. The 3 medical organizations jointly issued a statement published in the AHA’s journal Hypertension in which they addressed treatment goals for patients with high blood pressure who also have vascular diseases. Read More. 

     

    CVS Completes Acquisition of Target Pharmacy and Clinic Business

    December 16, 2015 – Target Corp. expects to net $1.2 billion after taxes for the sale of its pharmacy and clinic businesses to CVS Health Corp. The $1.9 billion acquisition closed on Wednesday, the companies said. Target said fourth-quarter sales, as a result, will be down $500 million, but will not affect profits before taxes, and the company expects a pretax gain of $575 million to $775 million that will not be included in earnings per share. It said some of the $1.2 billion will be used for stock repurchases. Read More.

     

    Patient-Savvy Pharmacists Ready for Medical Homes

    December 15, 2015 – The name might be deceiving at first. A “medical home” does not refer to a tangible building, house or hospital, but rather an approach to providing comprehensive, coordinated health care. It’s a concept well aligned with the U.S. health system’s evolving emphasis on boosting the quality and efficiency of care—a challenging goal that pharmacists can help their organizations achieve. Read More.

     

    Can Compounding Pharmacies Circumvent Big Pharma?

    December 15, 2015 – One of 2015’s biggest medical stories focused on drug companies that drew criticism from doctors, hospitals, insurers and patients by buying the rights to critical generic medicines and hiking their prices. Last week, the Senate Special Committee on Aging held the first of several hearings as part of an investigation into the price increases. Read More.

     

    Hospitals Launch Specialty Pharmacies to Curb Drug Costs

    December 12, 2015 – With specialty drug spending soaring 60% in the past five years, large health systems have jumped into the specialty pharmacy business to assert some control over those costs by dispensing the drugs to their patients and covered employees. Read More.

     

    HHS Partners with 38,000 Retail Pharmacy Centers On Marketplace Enrollment

    December 11, 2015 – As the deadline for signing up for coverage starting Jan. 1 approaches, the Department of Health and Human Services on Thursday announced that HHS is collaborating with some of the nation’s largest pharmacies to connect consumers with health coverage and encourage enrollment through the Health Insurance Marketplace. Read More.

     

    Using Data to Slow Drug Cost Hyperinflation

    December 10, 2015 – This is the final installment of a four-part series on transforming pharmacy services across the continuum of care. The first article introduced the new role of pharmacies and pharmacists in hospitals and health systems. Part 2 explored the strategy of provider-owned outpatient retail pharmacies. Part 3 examined telepharmacy—using remote pharmacists to handle orders after hours and fill gaps in local resources. Read More.

     

    New Pharmacy Designs Boost Profits, Patient Care

    December 10, 2015 – Pharmacy managers who are recruited for a new site are in an excellent position to develop pharmacy services that target the needs of the people in the community. In addition to the traditional dispensing of prescriptions typically remunerated through patient co-pays and reimbursements from PBMs, some services may be offered for a professional fee. Read More.

     

    Make Your Pharmacy a Healthcare Destination

    December 10, 2015 – Independent pharmacies moving away from traditional pharmacy models are finding success by embracing an approach that focuses more on wellness. Three pharmacists shared their unique approaches to creating healthcare destinations in their communities during a recent session at the NCPA Annual Convention held in Washington D.C. in October. Read More.

     

    3 Keys to Effective Pharmacy HIT Strategy

    December 10, 2015 – There is no doubt that pharmacists should play a key role in health IT (HIT) and health information exchanges (HIE). However, some healthcare IT experts are asking what value pharmacy data brings to HIEs and what types of care delivered by pharmacists would provide value to patients if clinical data were exchanged with other healthcare providers? Read More.

     

     

    Kroger Pharmacy’s Shared EHR Pilot Project a Success

    December 10, 2015 – When a Kroger pharmacy and a doctor’s office shared access to electronic health records (EHRs), the result was improved medication adherence and efficiencies, a recent study reported. Read More.

     

    Doctors, Hospitals Condemn Out-Of-Control Drug Prices as Senate Investigation Begins

    December 9, 2015 – A Senate investigation of drug-price spikes at four companies kicked off Wednesday with specialists from all corners of the health-care system testifying that they’re powerless to manage the out-of-control prescription costs. Read More.

     

    How Pfizer Set the Cost of Its New Drug at $9,850 a Month

    December 9, 2015 – Days before Pfizer Inc. was to set the price for a new breast-cancer drug called Ibrance, it got a surprise: A competitor raised the monthly cost of a rival treatment by nearly a thousand dollars. Three years of market research—a stretch that started almost as soon as the new treatment showed promise in the laboratory—was suddenly in doubt. After carefully calibrating the price to be close to rivals and to keep doctors and insurers happy, Pfizer was left wondering if its list price of $9,850 a month for the pills was too low. Read More.

     

    DEA to Conduct Pharmacy Diversion Awareness Conference

    December 8, 2015 –  Special Agent in Charge Gary Tuggle of the Drug Enforcement Administration’s (DEA) Philadelphia Field Division announced that the DEA will host a Prescription Drug Awareness Conference (PDAC) in Pittsburgh, Pennsylvania as part of the DEA’s ongoing 360 Strategy to address prescription opioid and heroin abuse in Western Pennsylvania. Read More.  

     

    Skyrocketing Prices for Generic Drugs Compromise Health Care

    December 8, 2015 – Many cardiac arrest patients can no longer count on getting a life-saving generic heart drug because it has become too costly for some hospitals to stock, a witness will tell a congressional committee Wednesday. The drug, isoproterenol hydrochloride, sells for $2,700 a vial, up from $50 just two years ago, Erin Fox, director of the Drug Information Service at the University of Utah Health Care, will tell members of the Senate Special Committee on Aging. Read More.

     

    Mckesson IDs 5 2016 Trends for Hospital/Health System Pharmacies

    December 7, 2015 – The McKesson Pharmacy Optimization team, a group of advisors that work with health systems to help elevate the value that pharmacy brings to the health system, has identified the top five trends that will impact hospital and health system pharmacies in 2016. Read More.

     

    Readmissions Fall After Pharmacist Home Visits

    December 7, 2015 – An innovative hospital/community pharmacy partnership aims to significantly reduce readmissions of heart failure patients and boost medication adherence. Already, the pharmacist home visit program with the Kelley-Ross Pharmacy Group in Seattle, Wash., and Virginia Mason, which operates a 336-bed acute-care hospital and regional medical centers throughout the Puget Sound area, has reduced readmissions and solved medication issues. Read More.

     

    Issues and Complexities Leading Pharmacy into 2016

    December 4, 2015 – the conversion from International Classification of Diseases, Ninth Revision (ICD-9) to ICD-10 continues to be a hot topic for hospitals, and a potential pitfall for facilities that haven’t taken the right steps to prepare for the tricky coding switch. Thus, it’s No. 1 on our list of financial and reimbursement potholes to steer clear of as we approach the new year. Read More.

     

    Progress, Hurdles in IV Sterile Compounding Arena

    December 4, 2015 – When contaminated steroid injections from the New England Compounding Center, in Massachusetts, infected more than 750 people and caused 64 deaths in 2012, many hospitals took a hard look at boosting their in-house production of compounded sterile products (CSPs). But some forward-looking health systems had already started down that path, seeking to exert greater control over the safety and cost of their drug supplies. Read More.

     

     

    340B in the News

    Report Provides an Update on the 340B Drug Pricing Program

    December 17, 2015 – Following a report earlier this year examining Medicare Part B spending by 340B institutions, the Berkeley Research Group (BRG) has released an update that provides additional details on the Medicare Part B outpatient drug spend of 340B hospitals, growth in the program, growth in Part B oncology drug spend at 340B hospitals, and reimbursement from Medicare for Part B oncology drugs 340B hospitals and community practices. Read More.

     

    MedPAC Proposal to Trim 340B Payments Appears DOA

    December 11, 2015 – The Medicare Payment Advisory Commission may not move forward with a controversial proposal that would reduce Part B drug payment rates for hospitals participating in the 340B Drug Pricing Program. Read More.

     

    New Law Excludes New Provider-based Off-Campus Outpatient Hospital Locations from OPPS

    December 10, 2015 – On November 2, 2015, President Barack Obama signed into law a bill that significantly changes how Medicare pays for outpatient services furnished at certain hospital locations. The Bipartisan Budget Act of 2015 (“BBA”) reflects a two-year budget agreement that resulted from weeks of negotiations between congressional leaders and the Administration. Read More.

     

    Vital Drug Discount Program at Risk

    December 10, 2015 – It’s our mission to take care of whomever walks through our doors. Whether in decent health, critically ill or unable to pay, it doesn’t matter. At MultiCare Regional Cancer Center, we help all of our patients get the care and medicine they need to get better and remain healthy or to support them through a terminal diagnosis. Read More.