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
Endari™ (L-glutamine oral powder) – July 7, 2017 – The U.S. Food and Drug Administration approved Endari (L-glutamine oral powder) for patients age five years and older with sickle cell disease to reduce severe complications associated with the blood disorder. Read More.
Triptodur™ (triptorelin) – June 30, 2017 – Arbor Pharmaceuticals, LLC and Debiopharm International SA Announce U.S. FDA Approval for Triptodur™, Triptorelin 6-month Formulation, in the Treatment of Central Precocious Puberty (CPP) Triptodur™, (triptorelin) for extended release injectable suspension, has been shown to arrest or reverse the clinical signs of puberty with once every six-month intramuscular injection (IM) dosing for children with CPP. Read More.
New Indication Approval
Vectibix® (Panitumumab) – New Expanded Indication Approval – June 29, 2017 – Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Vectibix® (panitumumab) for patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC) as first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. Read More.
New Drug Shortage
July 5, 2017
- Dexrazoxane (Zinecard) Injection (New – Currently in Shortage)
New Drug Recall Alert
Novopen Echo Insulin Delivery Device by Novo Nordisk – July 6, 2017 – Novo Nordisk is initiating a recall of insulin cartridge holders used in a small number of NovoPen Echo batches because they may crack or break if exposed to certain chemicals, like certain cleaning agents. Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of insulin which could potentially lead to high blood sugar. Read More.
News First Time Generic
Testosterone Topical Solution (Axiron® Topical Solution) – July 5, 2017 – Perrigo Company plc announced the prescription pharmaceutical launch of testosterone topical solution, 30 mg/1.5 mL (CIII), the generic equivalent to Eli Lilly and Company’s Axiron® Topical Solution, 30 mg/1.5 mL (CIII). Read More.
Clinical and Pharmacy News
Switching to Biosimilar Still Creates Concerns Among Rheumatoid Arthritis Patients – July 7, 2017 – Stakeholders are seeking to ease patient fears and concerns about being switched from a biologic to a biosimilar to treat rheumatoid arthritis (RA). The Danish Rheumatism Association launched a national plan in August 2015 and implemented through 2016. It was created to ensure patients received independent information about biosimilars and involved close monitoring of prescriptions to provide reassurance about their safety. Read More.
Up to 26% of Hospital Readmissions are Preventable and Medication-Based – July 7, 2017 – In another victory for those looking to expand the pharmacist’s role, a new study has found that having pharmacists lead an intervention in hospitals can reduce medication-related hospitalization readmissions in high-risk patients. Read More.
Handwritten Opioid Prescriptions Are More Prone to Mistakes, Researchers Find – July 7, 2017 – Handwritten orders for opioids contribute heavily to a trio of prescribing and processing errors in contrast to those created electronically, researchers have concluded at the end of a small study of opioid prescriptions filled at an outpatient pharmacy. Read More.
High Wastage of Infused Medications Found, But Fix Not Difficult – July 6, 2017 – If the experience of researchers at Duke University Medical Center is indicative of the nation as a whole, then infused medications are being wasted throughout the perioperative process. Read More.
Why Diabetes Is More Common in Rural Areas – July 6, 2017 – If you live in a rural area, there’s a greater chance that you’ll develop diabetes. In fact, the Centers for Disease Control and Prevention has identified what it calls a “diabetes belt” in 644 counties in 15 states of mostly rural portions of the Southeast and Midwest. Some of the states in the diabetes belt include Alabama, Mississippi, Louisiana and Tennessee. Read More.
Amount of Opioids Prescribed In U.S. Has Been Falling Since 2010 – July 6, 2017 – Ryan Hampton was sitting at his computer at work when he began sweating, feeling sick and unable to concentrate. He went to the bathroom, splashed water on his face and called his friend for help. That was the day he realized he was addicted to opioids. Read More.
Amgen, Teva Hikes Show Pharma Can’t Blame Rebates for All Price Increases: Analyst – July 6, 2017 – Pharma companies and pharmacy benefit managers have engaged in a back-and-forth for months over who’s to blame for high drug prices. Drugmakers say they’re raising prices largely to keep ahead of PBMs and their ever-increasing demands for rebates. Read More.
Drugmakers and Distributors Face Barrage of Lawsuits Over Opioid Epidemic – July 4, 2017 – The companies that manufacture and distribute highly addictive painkillers are facing a barrage of lawsuits for the toll their product has taken on communities across the country as the worst drug epidemic in U.S. history continues to escalate. Read More.
Generic Drug Prices Increase When Market Competition Decreases – July 3, 2017 – Decreased market competition causes generic drug prices to rise significantly, according to an article published in Annals of Internal Medicine. This trend appears likely to continue unless policies are enacted to stabilize generic drug markets in response to a decrease in competition. Read More.
Pediatric Healthcare Costs 35% Less at Community Health Centers – July 3, 2017 – Pediatric health care costs were $1,133 on average among children primarily using community health centers for care versus $1,750 among children seeing other providers, representing a 35 percent difference, a recent Geiger Gibson/RCHN Community Health Foundation Research Collaborative study showed. Read More.
Contracting a Cure for Prescription Drug Costs – July 1, 2017 – As specialty drugs siphon employers’ benefit spend, prices of more common drugs are also climbing. Can PBMs be part of the cost cure or another pain point? Read More.
Amazon Making Moves to Disrupt Health Care Industry – July 1, 2017 – Well, why shouldn’t the humongous e-commerce site turn its attention to health care? It’s affected practically every other industry. Read More.
340B in the News
Audit Lead to Millions of Dollars in Medicaid Savings – July 7, 2017 – The state collected over $160 million in drug rebates under the state’s Medicaid Drug Rebate Program after correcting problems identified by auditors from the office of State Comptroller Thomas P. DiNapoli, according to a pair of audits released last Friday. Auditors also found that more than $78 million in rebates have not been submitted to drug manufacturers, but could still be collected by the state Department of Health (DOH). Read More.