- U.S. probes contracts between drugmakers, pharmacy benefit managers (reuters.com)
The U.S. Attorney's Office...is investigating contracts between drugmakers and companies that manage prescription benefits...Federal prosecutors have approached at least three companies, including Johnson & Johnson, Merck & Co and Endo International Plc, demanding information about their contracts with pharmacy benefit managers...Pharmacy benefit managers...which administer drug benefits for employers and health plans and also run large mail-order pharmacies, have been challenging the rising cost of new medications...When drugs are knocked off their formularies, patients may have to pay full price for them. PBMs often keep or dump a product depending on whether they can obtain favorable pricing.
- FDA generics backlog improves, although criticism continues (drugtopics.modernmedicine.com)
While many groups are criticizing the FDA's backlog of generic drug approvals, the agency said the situation has improved...In December 2015 alone, OGD (Office of Generic Drugs) issued 99 approvals and tentative approvals...the most approvals and tentative approvals granted in a single month since the start of the generic drug program...FDA’s Office of Generic Drugs awarded 580 generic drug approvals and 146 tentative approvals in 2015...the Campaign for Sustainable Rx Pricing...is pressing legislators to grant FDA more resources, to allow quicker processing of generic drug applications. The group's members include AARP, ASHP, numerous health plans, providers, and Walmart...The FDA faces a backlog of nearly 4,000 generic drug applications, yet approval times can be three or more years...The FDA should be provided necessary resources to clear this backlog and prioritize generic drug approval applications...
- Health facility to open in Tonopah in June (reviewjournal.com)
About 10 months after the only hospital in a 100-mile radius closed, Tonopah will welcome a new medical center, according to Northern Nevada health care group Renown Health...will open June 1 at the site of the former Nye Regional Medical Center in a partnership between Renown and the Nye County Board of Commissioners, it was announced Tuesday at a meeting of the board...The site...will use secure telehealth videoconferencing technology to connect patients with doctors, said Rich Conley, director of Renown Regional Medical Center...The technology will “help patients access primary care providers as well as more than 30 specialties...“This partnership with Nye County allowed us to create an innovative and sustainable solution for the residents of Tonopah and the surrounding communities in central Nevada,”...Renown said it is working to expand the number of services that the facility will offer by looking for an on-site advanced practitioner, hiring more support staff and expanding lab and imaging services...“It was important to us to restart health care services, and we are glad Renown stepped in to help find a solution for this community,” Nye County Commissioner Lorinda Wichman said...
- Merck fights with New Zealand over coverage of its Keytruda cancer drug (statnews.com)Pembrolizumab (pharmac.govt.nz)
A row has broken out between Merck and New Zealand over a pricey new cancer drug in the latest example of how the cost of medicines is a flashpoint between drug makers and governments...At issue is Merck’s Keytruda (pembrolizumab), one of the new oncology treatments that harness the power of the body’s immune system to battle tumors. The medicine was approved in the United States two years ago to combat melanoma and, more recently, to tackle the most common form of lung cancer. Although priced at a hefty $150,000 a year, Keytruda is largely covered by public and private payers in the US...In New Zealand, the drug was approved last fall to treat melanoma. But since then, Pharmac, the government agency that decides whether coverage will be funded, has so far refused to endorse Keytruda. The agency contends evidence is lacking to verify whether the drug helps melanoma patients live longer compared with other new melanoma treatments or standard chemotherapy.
- Federal Jury Convicts Boise Doctor Charged with Controlled Substance Delivery (dea.gov)
A Boise jury...returned guilty verdicts against Michael Minas, 50...on charges that he unlawfully distributed controlled substances outside the usual course of professional practice and not for a legitimate medical purpose…Minas illegally distributed was primarily oxycodone 30 mg, but the jury also found Minas guilty of distributing fentanyl and hydromorphone. The jury heard evidence that Minas wrote prescriptions for extraordinary dosages, such as 240, 300, and even 420 oxycodone 30 mg. They also heard evidence that he often wrote prescriptions at intervals of two or three weeks, but wrote dosage instructions on the prescriptions indicating that it was a month’s supply…Minas faces a maximum prison sentence of up to 20 years in prison, a maximum fine of $1,000,00 ($1,000,000) and at least three years of supervised release on each count of conviction.
- API repackager in hot water with FDA (fiercepharma.com)
A U.S. drug repackager is in hot water with the FDA, earning itself a warning letter by taking liberties with the expiration dates on the drugs it repackages and a having quality unit that pretty much shirked its responsibilities, even though the problems had been noted during inspections 5 years earlier...The warning letter to Apotheca Supply, which does business as Apothecares, was posted this week...the FDA said the company had extended the expiration dates...by as much as two years beyond those listed by the manufacturers without any scientific justification to do it and no stability testing that would insure the APIs would still be effective...In addition, the agency was concerned about potential for cross contamination because of its procedures...On top of that the inspector found expired cleaning products and there had been no testing to ensure that surfaces were cleaned of one product before work began on another...
- The most overtrained and under utilized profession in America (thehill.com)
In the more than thirty years I have practiced pharmacy, I have witnessed a tremendous evolution in the profession. The clinical foundation and training of a pharmacist graduating today is leaps and bounds above where I started my practice. However, one thing has not changed: a pharmacists’ role in patient care goes well beyond dispensing medications...Today, as before, many pharmacists provide patient-centered services...We are the front line of the health care team and often see patients more than any other provider. Pharmacists have become the most over-trained and under-utilized professionals in America...While doctors should remain the quarterbacks, pharmacists must be given "provider status" so the profession is able to be the integral part of the health care team we are trained to be...With provider status, pharmacists would be added to the list of Medicare providers which would not only allow for the best possible care for patients but would also ensure it is done in the most cost-effective manner...In my short time in Washington I have come to realize just how hard it can be to advance commonsense reform...a bipartisan majority of 272 members have cosponsored the Pharmacy and Medically Underserved Areas Enhancement Act introduced by Representative Brett Guthrie. This legislation simply gives pharmacists provider status...let’s move forward...to improve access to quality and affordable health care for all Americans.
- Walgreens sending medical marijuana smoke signals? (drugtopics.modernmedicine.com)What is Medical Marijuana? Clarifying Clinical Cannabis (staywell.walgreens.com)
Walgreens’ posting of a seemingly sympathetic blog about the use of medical marijuana has created quite a buzz, with some online observers speculating the retail chain has its sight on that lucrative industry...But a Walgreens spokesperson insists the chain has not taken a stance on the use of medical marijuana and cautions people against reading too much into the blog posting. Pharmacies cannot legally dispense medical marijuana...The blog, entitled "What is Medical Marijuana? Clarifying Clinical Cannabis," was written by Dahlia Sultan, who is a resident pharmacist at Walgreens and associated with the University of Illinois at Chicago...Sultan...suggests "marijuana provides pain relief in ways traditional medicines don’t" and "medical marijuana can improve appetite and relieve nausea in those who have cancer and may help relieve symptoms such as muscle stiffness in people who have multiple sclerosis."...Not surprisingly, the blog has attracted the attention of medical marijuana advocates. Some believe that pressure from giant retailers such as Walgreens could eventually convince the federal government to reclassify marijuana so that it could be dispensed by pharmacies...Jim Cohn, spokesperson for Walgreens, said that people shouldn’t read too much into the blog. "The content [of the blog] is strictly informative, and nowhere do we take any stance on the issue,"...
- Nevada’s prescription monitoring system described (kolotv.com)
The U.S Attorney prosecuting the case against Richie West and Dr. Robert Rand and seven other defendants accused of operating an illegal Oxycodone distribution and street-buying operation says he has records from the Nevada Pharmacy Board. Those records identify when and where the defendants had their prescriptions filled. The system is part of the board's Prescription Monitoring Program...It’s not a perfect system, and there are some loopholes. But it’s helped keep track and monitor those who doctor-shop looking to feed their opioid habits...“So we know who wrote the prescription, what it is, the quantity. Who the patient is that got it, and all of that including who filled it. First thing we do is send an unsolicited report to every one of those physicians, all 10 of those guys, and ladies, and every one of those pharmacies. So now all of a sudden all of those people know the patient that is sitting in that office right now has been to nine other physicians in that same week and then, game over. We don't tell them what to do. We just tell them, doc, you need to know this,” says Executive Director (Executive Secretary) for the Nevada Board of Pharmacy Larry Pinson Pharm. D...Pinson says the information in the database is sensitive. A court order is needed if law enforcement wants access to it...Pinson says the system is designed to get the patient help rather than punish him. And he admits the system is geared toward the patient.
- Pharmacy Week in Review: May 6, 2016 (pharmacytimes.com)
Mike Glaicar, Business Development: Pharmacy Times...(PTNN) This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.










