PSG RxWire
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DRUGS APPROVED

FDA Urged to Remove Over-the-Counter Teething Meds for Infants

Eylea (aflibercept) Injection Receives FDA Approval for the Treatment of Diabetic Macular Edema

FDA Approves Eylea for Third Indication

Is FDA ‘Buried’ Under a Backlog of Generic Drug Applications?

New FDA process speeds approval of high-priced breakthrough drugs


PBMI E-Learning
SUMMARY OF TOP ARTICLES - AUGUST 7, 2014

Feds stop public disclosure of many serious hospital errors
USA TODAY - August 6, 2014
The federal government this month quietly stopped publicly reporting when hospitals leave foreign objects in patients' bodies or make a host of other life-threatening mistakes.

Fears of US Ebola Outbreak Spread as Experimental Serum Shows Promise
Specialty Pharmacy Times - August 5, 2014
While Ebola hemorrhagic fever continues to leave a trail of death in West Africa amid heightened concerns in the United States, an experimental treatment has shown promising results in fighting the virus.

Rx For Clarity: California Considers Bilingual Drug Labels
Kaiser Health News - July 30, 2014
Every Saturday morning, a steady stream of Chinese and Vietnamese patients line up at the Paul Hom Asian Clinic in Sacramento, Calif. Most of them speak little to no English. Patient assistance director Danny Tao says people come here to get free medical consultations and drug prescriptions. But, he says that when patients take those prescriptions to be filled, they don’t understand the instructions on the label.

Envision Pharmaceutical to Acquire MedTrak Services
Business Wire - July 30, 2014
Envision Pharmaceutical Holdings LLC, the parent company of Envision Pharmaceutical Services (EnvisionRxOptions), a national, full-service pharmacy benefit management (PBM) company, announced that it has agreed to acquire MedTrak Services, L.L.C. an independent, privately-held PBM. Terms of the transaction were not disclosed.

Prescription Drug Costs and the Specter of Rationing
Hospitals & Health Networks Daily - August 5, 2014
Many new pharmaceuticals cost nearly $100,000 a year. Insurers are complaining and patients are priced out of the market. Will this lead to another debate about rationing?

Diabetes: Drug duo helps best, study finds
Science Daily - August 4, 2014
Metformin and SGLT2 inhibitors together reduce the blood sugar levels of diabetics considerably more effectively than either drug alone. Scientists report that this is due to a synergetic mechanism.

Repurposing a drug for abdominal cancer
Science Daily - August 4, 2014
A repurposed drug originally used to treat ovarian cancer saw positive results for patients with advanced peritoneal cancers during a phase I clinical trial, researchers report.

Report: Part D premiums stay low despite fears of rising drug prices
The Hill - July 31, 2014
Medicare Part D premiums are expected to stay pretty flat in the next few years, according to a new report, despite concerns with rising cost of specialty drugs.

More on Sleeping Pills and Older Adults
New York Times - July 30, 2014
In 2013, the American Geriatrics Society put sedative-hypnotics on its first Choosing Wisely campaign list of “Five Things Physicians and Patients Should Question,” citing heightened fall and fracture risks and automobile accidents in older patients who took them. More recently, researchers at the Centers for Disease Control and Prevention and Johns Hopkins published findings that reinforce concerns about these drugs.

A Health Trade-Off That’s Here to Stay: Lower Cost, Limited Choice
New York Times - July 29, 2014
Plans sold this year in the new health insurance marketplaces were much more likely than previous ones to include what insurers call tailored or narrow networks. According to an analysis from the consulting firm McKinsey & Company, some 48 percent of plans offered in the most popular category included such features.

Malaria Growing Resistant to Drugs Used to Fight It
Drugs.com - July 30, 2014
The parasite that causes malaria is growing increasingly resistant to the drugs commonly used to fight it, according to new surveillance reports.

Press release: Medicare prescription drug premiums projected to remain low
Centers for Medicare & Medicaid Services - July 31, 2014
On the heels of the 49th anniversary of the signing of Medicare and Medicaid into law, the Centers for Medicare & Medicaid Services (CMS) projected today that the average premium for a basic Medicare Part D prescription drug plan in 2015 will increase by about $1, to an estimated $32 per month, continuing its historically low growth rate.

DEA Controls Tramadol as a Schedule IV Controlled Substance, Effective August 18, 2014
FDA Law Blog - July 2, 2014
As expected, the Drug Enforcement Administration (“DEA”) published its final rule in the Federal Register today (79 Fed. Reg. 37,623 (July 2, 2014) placing tramadol (2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol) into schedule IV of the federal Controlled Substances Act (“CSA”).

Top Medicare Prescribers for Acthar Have Links to Its Maker
New York Times - August 4, 2014
Many of Medicare’s top prescribers of the expensive specialty drug H.P. Acthar Gel have financial ties to the drug’s maker.

Express Scripts drops Zohydro, brings back Advair
Medical Marking & Media - August 4, 2014
Express Scripts unveiled its formulary exclusions for 2015 over the weekend. Amgen anemia drugs Aranesp and Epogen as well as controversial painkiller Zohydro ER were removed, along with 23 other new drugs, while GlaxoSmithKline inhaled lung medication Advair made a return to its formulary.

E-prescribing: An Rx for potentially outdated medications
Becker's Hospital Review - July 31, 2014
E-prescribing rates have hit an all-time high in the United States, with nearly 70 percent of physicians electronically prescribing medicine, according to an ONC report.

MedImmune Fights Pediatricians' New Advice
Associated Press - July 28, 2014
A costly drug given mostly to premature babies is at the center of a clash between the manufacturer and the nation's leading pediatrician's group, which recommends scaling back use of the medicine.

When Hospitals Buy Clinics, Prices Go Up
Bloomberg Businessweek - July 24, 2014
For the past four years, Pennsylvania insurance company Highmark has watched its bills for cancer care skyrocket. The increase wasn’t because of new drugs being prescribed or a spike in diagnoses. Instead, the culprit was a change that had nothing to do with care: Previously independent oncology clinics and private practices have been acquired by big hospital systems that charge higher rates, sometimes three times as much, for chemotherapy drugs.


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Pharmaceutical Strategies Group (PSG)
Office: 972-244-8388
Email: KLavitola@PSGConsults.com

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