Author: Peter

The…practice at pharmacies and outsourcing facilities of storing sterile compounded preparations or repackaging sterile pharmaceuticals in drug-administration syringes is actually an unapproved use of these medical devices…"FDA has not cleared or approved any syringes for stand-alone use as ‘closed container systems,’"…Syringe maker Becton, Dickinson and Company…stated that it does not test the performance of its general purpose syringes as storage containers for compounded pharmaceuticals….pharmacies that want to store their own compounded or repackaged sterile preparations in general purpose syringes have two choices:

1. "Test every drug at every concentration that you use and in every size syringe that you use" or
2. rely on the results of published stability studies "if you have the exact same syringe, the exact same concentration, and the exact same drug and you…handle it and store it just like the drug in the study was stored."

The government and private insurers have been trying for years to move away from the fee-for-service system that pays doctors and hospitals based on the volume of tests they perform and treatments they prescribe. They want to replace it with contracts that reward quality and better outcomes… changes in the reimbursement model are rippling out to manufacturers of drugs and devices…shift could help address a long-standing problem with medical advances:..benefits observed in carefully designed clinical trials don’t always materialize when a treatment is deployed in the real world…linking payment to performance, while appealing in theory, is tricky. "What metric are you going to select to measure performance?

..Florida Board of Pharmacy approved a rule change…aimed at training pharmacists to change their mindset about prescriptions for controlled substances, in a reaction that followed pleas from desperate patients unable to get pain medications…change switches the rule from a focus on reasons to reject prescriptions for highly addictive narcotics to an emphasis on ensuring that legitimate patients get the medications…"Instead of starting out with trying to find a reason to doubt a prescription, you start off with an assumption that everything in the prescription is good…rule also includes requiring pharmacists to take a two-hour, "Validation of Prescriptions for Controlled Substances" course to educate pharmacists about ensuring access to pain medications for "all patients with a valid prescription."

Las Vegas Valley's immature health care system is experiencing a prolonged growth spurt. In the aftermath of the launch of UNLV's medical school, last month MountainView Hospital got word that its internal medicine residency program had been approved by the Accreditation Council for Graduate Medical Education…. A dearth of residency programs has greatly limited the state's ability to attract and retain doctors… Many of our medical students, or other students who are from Las Vegas, had to leave the state to get their training…"This is a significant step forward in the development of medical education in the Las Vegas Valley," said MountainView CEO Chris Mowan…Thanks to MountainView and HCA (Hospital Corporation of America) for making it happen..

Brian Haug, President of Pharmacy and Managed Markets, Pharmacy Times (PTNN) This weekly video program highlights the latest in pharmacy news, product news, and more. (video)

..Hong Kong’s Nathan Road is a favorite destination for tourists from the mainland…Small, rainbow-lit drugstores have become a feature of some of Hong Kong’s most expensive neighborhoods…Their lineups include muscle rubs, painkillers, aphrodisiacs, and traditional Chinese medicines...if you ask discreetly, some will also sell you something else: cancer and hepatitis C drugs...Visitors from the mainland also prefer to buy their medicine in Hong Kong because they believe it’s less likely to be counterfeit…Cancer rates in China are soaring…Most Chinese lack prescription drug benefits and must pay out of pocket for premium medicines. The upshot: Prices for treatments from foreign drugmakers are some of the highest in the world…90 percent of cancer drug sales at pharmacies are to mainland tourists...

California wants to cap drug prices, but Big Pharma isn't having it. Amid a growing backlash over drug pricing, companies such as Johnson & Johnson and Bristol-Myers Squibb are funneling millions of dollars into stamping out a new proposal that would curb drug spending in the state…other companies including Pfizer, Eisai, Purdue Pharma, The Medicines Co., Sunovion Pharmaceuticals and Daiichi Sankyo contributed to a fund that would quash a state ballot initiative…The initiative, dubbed the California Drug Price Relief Act, would only allow government health programs to strike contracts with drugmakers at prices that are the same or lower than those paid by the Department of Veterans Affairs, which usually gets steep discounts on meds from manufacturers…

Oklahoma may have used the wrong drug during an execution…After Oklahoma executed Charles Warner…an autopsy report said that his body and containers for lethal-injection drugs were delivered to the state’s Office of the Chief Medical Examiner. Among those containers were empty vials labeled potassium acetate, even though the state’s lethal-injection protocol calls for the use of potassium chloride…potassium acetate and potassium chloride are "medically interchangeable."...The two different types of potassium appear to be equal, said David Gortler, an associate professor of pharmacology…"Potassium is potassium," Gortler said..."The pharmacology isn’t that much different between the different salts."

In what has turned into a legal trifecta for Pfizer, it has won the dismissal of a lawsuit that claimed the use of the antidepressant Zoloft (sertraline) during pregnancy caused birth defects in a child. The decision comes after Pfizer has won two jury verdicts in recent months over the same claims… Philadelphia state court Judge Mark Bernstein…granted a summary judgment…to Pfizer and dismissed the case…The dismissal came as…Bernstein also denied a request by the plaintiffs to add to the testimony of their expert…there is insufficient epidemiological evidence to link the drug to birth defects...FDA recently asked Pfizer to add information about possible links to birth defects to the Zoloft label.

Department of Health and Human Services has issued the long-awaited final rules changing the requirements of the Meaningful Use program for 2015-2017 and implementing Stage 3 of the program…[s]hift the paradigm so health IT becomes a tool for care improvement, not an end in itself,"…rule eases the reporting burdens, simplifies requirements, adds flexibility, supports interoperability and improves outcomes. It also transitions to a new and more responsive regulatory framework…moves physicians out of the Meaningful Use program into a new merit based incentive payment system..

Some of the changes include:

• Providers and state Medicaid agencies will now have until Jan. 1, 2018, to comply and prepare for the next set of system improvements
• Stage 3 will now be optional in 2017
• Stage 3 will have eight objectives; more than 60 percent require interoperability; public health reporting with have flexibility options
• APIs will be required
• Cybersecurity requirements have been strengthened
• The reporting period for 2015 will be only 90 days for all providers, for new providers in 2016 and 2017 and for any provider moving to Stage 3 of the program in 2017