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
CaroSpir® (spironolactone) – August 7, 2017 – CMP Pharma announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the company’s New Drug Application (NDA) for CaroSpir® (Spironolactone Oral Suspension, 25 mg/5mL), the first and only FDA-approved oral liquid dosage form of the potassium-sparing diuretic spironolactone. Read more.
New Formulation Approval
QVAR® Redihaler™ (beclomethasone dipropionate HFA) – August 7, 2017 – Teva Pharmaceutical Industries Ltd., announced that the U.S. Food and Drug Administration (FDA) has approved QVAR® RediHaler™ (beclomethasone dipropionate HFA) inhalation aerosol, a breath-actuated inhaler for the maintenance treatment of asthma as a prophylactic therapy in patients 4 years of age and older. QVAR® RediHaler™ is not indicated for the relief of acute bronchospasm. Read more.
New Indication Approval
Liletta® (levonorgestrel-releasing intrauterine system) – August 6, 2017 – Allergan plc and Medicines360, announced that the U.S. Food and Drug Administration (FDA) approved Medicines360’s Supplemental New Drug Application (sNDA) to extend the duration of use of Liletta® (levonorgestrel-releasing intrauterine system) 52 mg for the prevention of pregnancy for up to four years. Read more.
New Drug Shortage
August 11, 2017
- Diatrizoate Meglumine and Diatrizoate Sodium (MD-76R) Injection (Discontinuation)
August 7, 2017
- Technetium Tc99m Succimer Injection (DMSA) (Currently in Shortage)
New Drug Recall and Safety Alerts
Pravastatin Sodium Tablets by International Laboratories – August 10, 2017 – International Laboratories, LLC is voluntarily recalling one (1) Lot of Pravastatin Sodium Tablets USP 40 mg packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets. Read more.
Sterile Drug Products from Vital Rx – August 10, 2017 – The FDA is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed nationwide by Vital Rx Inc., dba Atlantic Pharmacy and Compounding, Pompano Beach, Florida, due to lack of sterility assurance. Read more.
Compounded Curcumin Emulsion Product for Injection by ImprimisRx – August 4, 2017 – Two patients administered infusions of curcumin (a component of the spice turmeric) compounded with polyethylene glycol (PEG) 40 castor oil reportedly experienced immediate hypersensitivity reactions. The PEG 40 castor oil was a component of a curcumin emulsion product compounded by a pharmacy, ImprimisRx, located in Irvine, California. Read more.
New First Time Generic
No new updates.
Clinical and Pharmacy News
When Price Dictates Treatment – August 11, 2017 – Recent data suggest that hospitals—a setting where patients and physicians are usually shielded from the effects of drug cost increases—are seeing the effects of massive price hikes in vital drugs. In a research letter published on the New England Journal of Medicine’s website, three staff members at the Cleveland Clinic, including one pharmacist, detailed the plight of hospitals facing large price hikes on nitroprusside and isoproterenol. Read more.
APhA Provides New Pharmacist Leadership Opportunities – August 10, 2017 – The American Pharmacists Association on Thursday announced a new Leadership360 Institute that provides pharmacists with opportunities to reach full leadership potential while developing management skills necessary across pharmacy settings. Read more.
Customers Sue CVS and Walgreens, Claiming PBM Collusion – August 10, 2017 – Pharmacy customers have brought two lawsuits against CVS Health and Walgreens claiming that the chains overcharged them for certain prescriptions drugs. The suits state that customers paid more out of pocket for drugs when they used their health insurance than if they had simply paid cash because of collusion with third parties such as PBMs. Read more.
Direct-acting Antivirals Help Non-specialists Effectively Manage Hepatitis C Virus – August 10, 2017 – New, direct-acting antivirals (DAAs) will allow primary care providers (PCPs) and nurse practitioners (NPs) to safely and effectively manage hepatitis C virus (HCV) in patients, according to a study. A Phase IV Pilot Study to Assess Community-Based Treatment Efficacy in Chronic Hepatitis C Monoinfection and Coinfection with HIV in the District of Columbia (ASCEND) was the first study to compare the outcomes of HCV treatment by specialists vs. nonspecialists in a real-world setting. Read more.
Pharmacy Credentialing — Challenges and Opportunities – August 9, 2017 – Under the Centers for Medicare and Medicaid Services regulations (42 CFR 455 Subpart B) to prevent provider fraud, waste and abuse, as well as to benefit patient safety, pharmacy benefit managers and payers must validate the credentials of pharmacies and any person with an ownership, control interest or managing employees within their networks. Read more.
The ‘Clawback’: Another Hidden Scam Driving Up Your Prescription Prices – August 9, 2017 – In July, a Marin County woman named Megan Schultz went to her local CVS drugstore to fill a prescription for a generic drug. She forked over $164.68, the co-pay designated by her health plan. Read more.
Pharmacy Chains Make Sweeping Changes to Prevent Drug Interactions – August 9, 2017 – CVS says it has upgraded its computer alert system at pharmacies nationwide to better protect patients. Walgreens says it has provided additional training for thousands of its pharmacists. Wal-Mart, Costco and Kmart say they have taken similar safety steps. Since a Tribune investigation exposed last year how pharmacies often failed to warn patients about deadly drug combinations, leading national chains say they have made significant improvements. Read more.
NACDS Backs Bill to Require E-Prescribing of Controlled Substances – August 9, 2017 – The National Association of Chain Drug Stores (NACDS) has endorsed H.R. 3528, the Every Prescription Conveyed Securely Act, introduced by U.S. Reps. Katherine Clark (D-MA) and Markwayne Mullin (R-OK). The bill would require electronic prescribing for controlled substance medications in Medicare Part D. Read more.
Has the U.S. Biosimilar Market Reached a Tipping Point? – August 8, 2017 – The adoption of biosimilars has been very slow in the United States compared with other countries, especially in Europe; however, that could be about to change. Like generics, biosimilars have the potential to create huge costs savings by giving payers and consumers lower cost options to existing innovator brands. Read more.
Generic Drug Prices Are Falling, but Are Consumers Benefiting? – August 8, 2017 – Not all drug prices are going up. Amid the public fury over the escalating costs of brand-name medications, the prices of generic drugs have been falling, raising fears about the profitability of major generic manufacturers. Last week, Teva Pharmaceuticals reported that it had missed analysts’ earnings estimates in the second quarter and planned to lay off 7,000 workers. Read more.
NASP President Speaks About PBM Regulation and DIR Fees – August 7, 2017 – Once an attempt to identify proper Medicare reimbursement, direct and indirect remuneration (DIR) fees have gone on to have a harmful impact on specialty pharmacies and their patients, according to specialty stakeholders. Since these fees are charged after the point of sale by pharmacy benefit managers (PBMs), pharmacies may be filling prescriptions well below cost. This practice has been said to harm specialty pharmacies and their patients, who are facing complex illnesses. Read more.
How Retail Pharmacies Are Driving Down Generic Drug Prices: 3 Things to Know – August 7, 2017 – Major retail pharmacies are achieving lower generic drug prices via drug-buying partnerships with drug distributors and pharmacy benefit manufacturers, reports Reuters. Here are three things to know. Read more.
Guideline Outlines New Approach to Management of Glucocorticoid-Induced Fractures – August 7, 2017 – In an update to 2010 recommendations, the American College of Rheumatology (ACR) provided the latest guidance on the assessment of risk, prevention, and treatment of fractures for adults and special populations undergoing long-term glucocorticoid (GC) treatment. The 2017 Guideline for the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis (GIOP) made its debut in the August issue of Arthritis and Rheumatology. Read more.
340B in the News
Rural Hospitals’ Prescription Program a Necessary Lifeline – August 10, 2017 – Access to health care has never been a more important issue in West Virginia. As the health care debate continues in Washington, many here at home are wondering what is the future of health care. In rural West Virginia, there is an even more immediate threat: the closure of rural and community hospitals. Read more.
Why the Government Believes Seniors Are Paying $200 Million More For Drugs Than They Need To – August 9, 2017 – Federal health officials say a controversial program that allows hospitals to purchase drugs at deep discounts needs some fixing. The Centers for Medicare and Medicaid Services, or CMS, worry hospitals are playing fast and loose with what’s known as the 340B program by buying more expensive drugs than they have to, putting the squeeze on Medicare recipients. Read more.
Ronnie Shows: Mississippi Hospitals at Risk, but Washington can Help – August 6, 2017 – Across Mississippi, hospitals are closing or threatening to close at an alarming rate. Since 2010, our state has lost five hospitals, which, according to research, ties us for fourth worst in the United States. Another study, by the National Rural Healthcare Association, found that a whopping 79 percent of hospitals in our state are vulnerable to closure, which ranks us first in the nation. Read more.