Welcome to the December edition of RxStrategies Clinical Insights, a concise communication to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place.
New Drug Approval
December 3, 2014 – The U.S. Food and Drug Administration approved Blincyto™(blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL. Precursor B-cell ALL is a rapidly growing type of cancer in which the bone marrow makes too many B-cell lymphoblasts, an immature type of white blood cell. The Philadelphia chromosome is an abnormality that sometimes occurs in the bone marrow cells of leukemia patients. The National Cancer Institute estimates 6,020 Americans will be diagnosed with ALL and 1,440 will die from the disease in 2014. Blinatumomab has five orphan designated indications according to the FDA website. Read more.
New Drug Formulations
Gardasil® 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
December 10, 2014 – The U.S. Food and Drug Administration approved Gardasil® 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil® (previously approved by the FDA), Gardasil® 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers. Gardasil® 9 is a vaccine approved for use in female’s, ages nine through 26, and males, ages nine through 15. Read more.
Kitabis™ Pak (tobramycin Inhalation Solution & PARI LC PLUS® nebulizer handset)
December 3, 2014 – The U.S. Food and Drug Administration approved PulmoFlow, Inc.’s New Drug Application for Kitabis™ Pak—a co-packaging of generic tobramycin inhalation solution with a PARI LC PLUS® Nebulizer. This is the first nebulized drug and device combination to be approved for patients with cystic fibrosis. Kitabis™ Pak is in stock and available now through PARI Respiratory Equipment, Inc. Kitabis™ Pak sets a new standard for nebulized drugs, similar to asthma and COPD inhalers where the drug and device are prescribed and dispensed together. The price of Kitabis™ Pak will be similar to the price of generic tobramycin drug alone. Read more.
Onexton™ (benzoyl peroxide and clindamycin phosphate) Gel
November 25, 2014 – Valeant Pharmaceuticals International, Inc. announced it has received approval from the U.S. Food and Drug Administration for Onexton™ Gel (clindamycin phosphate and benzoyl peroxide), 1.2%/3.75%, for the once-daily treatment of comedonal (non-inflammatory) and inflammatory acne in patients 12 and older. Acne vulgaris is a common skin disorder that affects 40 to 50 million people in the United States. Read more.
Hysingla™ ER (hydrocodone bitartrate Extended Release)
November 20, 2014 – The U.S. Food and Drug Administration approved Hysingla™ ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla™ ER has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling. Hysingla™ ER has properties that are expected to reduce, but not totally prevent, abuse of the drug when chewed and then taken orally, or crushed and snorted or injected. The tablet is difficult to crush, break or dissolve. It also forms a viscous hydrogel (thick gel) and cannot be easily prepared for injection. Read more.
New Drug Indications
December 12, 2014 – The U. S. Food and Drug Administration approved ramucirumab (Cyramza® Injection, Eli Lilly and Company) for use in combination with docetaxel for the treatment of patients with metastatic non-small cell lung cancer (NSCLC), with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving ramucirumab. Ramucirumab was previously approved as a single agent and for use in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma after disease progression on first line therapy. Read more.
December 8, 2014 – Amgen announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Xgeva® (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy. Xgevawas approved and granted Orphan Drug Designation by the FDA, which is reserved for drugs that are intended for the treatment of rare diseases affecting fewer than 200,000 people in the U.S. Read more.
December 4, 2014 – The U.S. Food and Drug Administration approved a new use for Jakafi® (ruxolitinib) to treat patients with polycythemia vera, a chronic type of bone marrow disease. Jakafi® (ruxolitinib) is the first drug approved by the FDA for this condition. Polycythemia vera occurs when too many red blood cells are made in the bone marrow. Patients may also experience an increase in white blood cells and platelets. An overabundance of blood cells can cause the spleen to swell, bleeding problems and blood clots in the veins near the skin surface (phlebitis). In addition, it puts patients at increased risk of stroke or heart attack. Read more.
New Drug Shortages
December 9, 2014
Aripiprazole (Abilify) (Discontinuation)
December 5, 2014
Disopyramide Phosphate (Norpace) Capsules (Currently in Shortage)
Methylphenidate Hydrochloride ER Capsules/Tablets (Currently in Shortage)
Methylphenidate Hydrochloride Tablets (Currently in Shortage)
December 2, 2014
Gentamicin Sulfate Injection, USP (premix products) (Discontinuation)
November 17, 2014
Trypan Blue (Membraneblue) (Currently in Shortage)
New Generic Drug
Celecoxib – New First Time Generic
December 11, 2014 – Teva Pharmaceutical Industries Ltd. announced the launch of the first FDA-approved generic equivalent to Celebrex® (celecoxib)Capsules in the United States. Teva is offering 50, 100, 200 and 400 mg strengths of Celecoxib Capsules. Read more.
Prednisolone Sodium Phosphate Disintegrating Tablets – New First Time Generic
December 11, 2014- Mylan Inc. announced the U.S. launch of its Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10 mg, 15 mg and 30 mg. This product is the first generic version of Shionogi’s Orapred ODT®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10 mg, 15 mg and 30 mg, and was awarded 180 days of generic drug marketing exclusivity. This product is indicated as an anti-inflammatory or immunosuppressive agent for certain conditions, as a treatment of certain endocrine conditions and for palliation of certain neoplastic conditions. Read more.
New Product Recall
Alere INRatio2 PT/INR Professional Test Strips
December 9, 2014 – Alere Inc. initiated a voluntary correction to inform U.S. users of the Alere INRatio and INRatio2 PT/INR Monitor system of certain medical conditions that should not be tested with the system (INRatio Monitor or INRatio2 Monitor and INRatio Test Strips). In certain cases, an INRatio and INRatio2 PT/INR Monitor system may provide an INR result that is clinically significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions or can occur if the instructions in the labeling for performing the test are not followed. Read more.
Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter
November 21, 2014 – Baxter International Inc. voluntarily recalled one lot of Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL to the user level, due to a complaint of mislabeling of the overpouch. Some containers of Product Code 2B0826, Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL, Lot Number P319160, Exp. 06/30/2015, NDC 0338-0709-48, were incorrectly labeled on the overpouch as Highly Concentrated Potassium Chloride Injection, 20 mEq per 100 mL. The inability to detect this overpouch mislabeling at the point of care may result in the administration of a dose lower than intended. Read more.
Drug Safety Alerts
Ziprasidone (Marketed as Geodon and Generics): Rare but Potentially Fatal Skin Reactions
December 11, 2014 – The FDA is warning the antipsychotic drug ziprasidone (marketed under the brand name Geodon® and its generics) is associated with a rare, but serious, skin reaction that can progress to affect other parts of the body. A new warning has been added to the Geodon drug label to describe the serious condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). See the FDA Drug Safety Communication for a Data Summary and additional information. DRESS may start as a rash that can spread to all parts of the body. It can include fever, swollen lymph nodes and inflammation of organs, such as the liver, kidney, lungs, heart or pancreas. DRESS also causes a higher-than-normal number of a particular type of white blood cell, called eosinophils, in the blood. DRESS can lead to death. Read more.
FDA Issues Final Rule on Changes to Pregnancy and Lactation Labeling Information for Prescription Drug and Biological Products
December 3, 2014 – The U.S. Food and Drug Administration published a final rule that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding. Read more.
Clinical and Pharmacy News
AAP Updates Bronchiolitis Management Guidelines
December 12, 2014 – Diagnosis, treatment, and prevention—three key attributes in managing bronchiolitis–were addressed in a revision of the 2006 guidelines from the American Academy of Pediatrics concerning bronchiolitis management. The report, “Clinical Practice Guideline: The Diagnosis, Management, and Prevention of Bronchiolitis,” involved a number of MDs, FAAPs, PhDs, FACMIs, MSCEs, MPHs, FACEPs and JDs, giving merit to these updated guidelines. Read more.
The Cost and Value of Drugs Part Two: Benefits and Effectiveness
December 12, 2014 – In the previous post, we established that drugs are certainly expensive. There are reasons for that. But we shouldn’t only concern ourselves with the naïve price of a drug. That would entirely miss the point. If I gave you a pill that costs $1 million that would extend your life by 20 years at peak health–should you pay for it? Based on research into cost-effectiveness, the answer should be a resounding YES. (The WHO considers a drug to be cost-effective with a cost-effectiveness ratio of up to three times GDP per capita per quality-adjusted life year (QALY) gained. This “miracle” drug would cost $50,000 per QALY gained.) Read more.
The Future of Pharmacy Medication Kit Storage
December 12, 2014 – Did you know that one of the Joint Commission’s most common citations for noncompliance is Medication Storage? Data from 2011 showed noncompliance in this area is 33 percent. Keeping up with proper medication storage and removing expired medications are critical for hospitals seeking accreditation from the Joint Commission. In addition, drug shortages and recalls have complicated maintaining medication kits in the hospital setting. Read more.
Study of Generic Antiepilepsy Drugs Finds Minimal Differences
December 10, 2014 – A comparison of two of the most disparate approved generic antiepileptic drugs found minimal differences when compared under rigorous testing procedures in people with epilepsy, according to research presented by a University of Cincinnati (UC) clinician-researcher. In addition, the research showed, no subjects had serious adverse effects or loss of seizure control when switching from one drug to the other. Read more.
Survey: Publix Pharmacy Ranks No. 1 Among Grocers in Overall Satisfaction
December 10, 2014 – Publix Super Markets Inc.’s pharmacy ranks highest in overall satisfaction in the supermarket segment, according to the J.D. Power 2014 U.S. Pharmacy Study. Read more.
Hyperlipidemia: Updated Guidelines Impact Counseling
December 10, 2014 – Consider this: Fats and oils accounted for approximately 45 percent of calories consumed in the 1960s; during that decade, 13 percent of adults were obese and fewer than 1 percent had diabetes. Current data indicate that fats and oils account for 33 percent of calories consumed today, yet 34 percent of Americans are obese and 11 percent have diabetes. Clearly, attempts to increase the awareness of cholesterol in the United States have not been tremendously successful (Table 1). Read more.
Many Americans on Long-Term Painkillers Take Potentially Fatal Drug Combinations
December 9, 2014 – Nearly 60 percent of patients on opioid pain treatments for long-term conditions were prescribed potentially dangerous mixtures of medications during the same time period, according to a report released today by Express Scripts. Two-thirds of patients on these medication mixtures were prescribed the drugs by two or more physicians, and nearly 40 percent filled their prescriptions at more than one pharmacy. Read more.
Hospital: Pharmacy Error Led to Patient Death
December 8, 2014 – The death of a hospital patient, who was given the wrong medication, occurred because a pharmacy worker inadvertently filled an IV bag with the wrong drug, officials at an Oregon hospital say. The mistake was one of several revealed Monday that led to the death of Loretta Macpherson, who had gone to the emergency room at St. Charles Medical Center in Bend. Officials at St. Charles Health System say Macpherson, 65, was given a paralyzing agent typically used during surgeries instead of the anti-seizure medication that was prescribed for her last week. Read more.
Cardinal Health Launches New Analytics Tool to Help Hospitals Improve Antibiotic Stewardship Efforts
December Dec. 8, 2014 – Cardinal Health today introduced a powerful new tool that gives pharmacists the ability to rapidly analyze antibiotic use trends and identify significant opportunities to improve antibiotic stewardship efforts. Almost 2 million people each year are sickened by antibiotic-resistant infections, resulting in 23,000 deaths annually. And up to 50 percent of antibiotic use in hospitals is inappropriate. Cardinal Health’s new Antibiotic Analytics dashboard helps pharmacists address these trends. It is part of Cardinal Health’s Drug Cost Opportunity Analytics software package, a web-based technology that provides data and insights to help hospital pharmacy leaders manage drug spend. Read more.
The Cost and Value of Drugs, Part One: Prices And Development Burdens
December 5, 2014 – Debates about how much we should pay for pharmaceuticals are unlikely to subside anytime soon. Drugs that cost tens of thousands of dollars, and some more than $100,000, have become ever more common, with insurers and payment benefit managers (along with Medicaid programs) beginning to balk at paying these prices, outcomes be damned! Two recent publications, a new estimate of the cost of drug development from Tufts and a thorough cost-effectiveness estimate for Harvoni from the California Technology Assessment Forum, provide an interesting context to address these issues. Read more.
Top Health Industry Issues of 2015
December 4, 2014 – The year 2015 bodes well for retail pharmacy in terms of how healthcare is evolving. Do-it-yourself health care and making the leap from mobile app to medical device were the top two trends identified by PwC’s Health Research Institute, as part of its annual Top Health Industry Issues of 2015 report. Retail pharmacy has a role to play, both in expanding its reach to patients through the over-the-counter department and health care counseling and in helping to connect the dots between health apps and self-care diagnostics. Read more.
Flu Clinics Sponsored by Retail Pharmacy at the Workplace to Triple by 2017
December 4, 2014 – The number of drugstore flu clinics sponsored at the workplace is expected to triple by 2017, WorkPlace Impact recently shared with Drug Store News. Already in 2014, WorkPlace Impact delivered flu shot clinic leads from 10,000 businesses employing more than 750,000 working consumers to its pharmacy clients. Read more.
FDA Changes Label for Biogen’s Tecfidera Following Patient Death
November, 26 2014 – The U.S. Food and Drug Administration (FDA) announced the label for Biogen Idec’s multiple sclerosis (MS) drug will be updated with information about a patient’s death resulting from a rare brain infection while taking the drug. The agency issued a warning informing individuals that a patient with MS, who was being treated with Biogen’s Tecfidera (dimethyl fumarate), developed progressive multifocal leukoencephalopathy (PML), a rare and serious brain infection. Biogen already disclosed the patient had died from the brain infection in a conference call with analysts in October. Read more.
Genentech Doubles Down on Specialty Pharmacy Model
November 26, 2014 – Genentech has moved all of its cancer infusion medications to the specialty distribution chain to ensure patient safety and better inventory control. However, some hospitals are unhappy with this decision, citing several potential adverse consequences, including significantly higher drug purchasing costs, treatment delays, increased administrative burdens and a resultant strain on the manufacturer–oncology team relationship. Read more.
New Clinical Guidelines Issued for Paget’s Disease
November 24, 2014 – The Endocrine Society released a Clinical Practice Guideline for the diagnosis and treatment of Paget’s disease of the bone. The guideline will appear in the December 2014 issue of the Journal of Clinical Endocrinology and Metabolism (JCEM). The task force that authored the guideline reported a one-time intravenous (IV) infusion of Zoledronate has become the preferred treatment option; IV Zoledronate demonstrated disease remission for up to six years. Read more.
Getting the Facts Right on an Essential Drug Program
December 10, 2014 – Everyone is entitled to their own opinions, but they are not entitled to their own facts. In her op-ed, “Hospitals Manipulate Drug Program for Poor” (Issues & Insights, Nov. 12), Sally Pipes once again is generous with the former and light on the latter concerning the 340B drug discount program. From her frequent attacks, it’s hard to determine if there’s a personal vendetta or if Ms. Pipes is merely a mouthpiece for the pharmaceutical industry. Read more.
Total 340B Purchases to Reach $16B by 2019: 4 Drivers of the Program’s Growth
December 8, 2014 – Fueled in large part by participation of disproportionate share hospitals, the 340B discount drug program will rapidly expand in coming years, according to a recent whitepaper by the Berkeley Research Group. The 340B program has experienced significant growth over the last several years, with total purchases increasing from $1.1 billion in 1997 to more than $7 billion in 2013. Continuing with the growth trend, total purchases are expected to increase to more than $16 billion by 2019. Read more.
New Report Pinpoints Drivers of Rapid Growth in the 340B Program
Dec. 3, 2014 – A new white paper released today by the Berkeley Research Group and funded by the Alliance for Integrity and Reform of 340B (AIR 340B) projects the 340B program will continue to rapidly expand in coming years, fueled in large part by the participation of Disproportionate Share Hospitals (DSH) and despite a continuing decrease in the number of uninsured due to the Affordable Care Act. Read more.
We Must Protect Vital ‘340B’ Drug Discounts for Safety Net Hospitals
November 21, 2014 – Millions of Americans receive help every year from a federal program they have never heard of: the 340B drug discount program, which allows public and nonprofit safety-net hospitals to better provide both affordable medications and vital services to the underserved. I helped write the legislation that created this program and worked to expand it in the 2010 Affordable Care Act. The program has been extremely successful in reducing drug costs and helping support hospitals and clinics that provide care to the uninsured. But now, pharmaceutical industry opponents of the law are trying to rewrite history and limit 340B program eligibility for hospitals and patients—even as they charge as much as $1,000 for a single pill for some drugs. Read more.
Obama’s HHS Ignores Fraud in Discount Drug Program
November 20, 2014 – Politicians love to promise to weed out waste, fraud and abuse from federal spending, but even when it is staring them in the face they often do nothing. That’s exactly what the Department of Health and Human Services (HHS) did when confronted with the reality that a congressionally established program, to help the poor and indigent get discounted prescription drugs, was being abused by corporations to pad their bottom line. Read more.