- No Syringe Is Approved as a Standalone Storage Container, FDA Says (ashp.org)
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:
- "Test every drug at every concentration that you use and in every size syringe that you use" or
- 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."
- State Change Could Help Patients Get Pain Medications (miami.cbslocal.com)
..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."
- State Level Legislative Discussions Regarding Biosimilars (pharmacytimes.com)
Nick Gentile, Director of State Grassroots Advocacy and Political Action for ASHP, discusses different legislative issues generating buzz on the state level, including biosimilars.
- Man accused of running unlicensed medical clinic in house; authorities seek patients (reviewjournal.com)Uninsured, immigrants often target of medical scams (reviewjournal.com)
A man police say posed as a doctor and treated people at an east Las Vegas Valley house has been arrested, and authorities are trying to find people who went to him for medical or dental care…Southern Nevada Health District, Las Vegas police and the FBI are requesting information from people who received services…The person who used the building identified himself as Rick Van Thiel or "Dr. Rick," health officials said, but he is not licensed to practice medicine.
- Oklahoma may have used the wrong drug to execute an inmate this year (washingtonpost.com)Arkansas judge halts 8 executions as inmates challenge law (news.yahoo.com)
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."
- Big Pharma teams up to defeat drug pricing proposal in California (fiercepharma.com)
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…
- Kentucky pharmacy PharMerica agrees to $9.25M settlement (washingtonpost.com)
..Kentucky pharmacy has agreed to pay $9.25 million to settle allegations that it solicited and received kickbacks from a manufacturer in exchange for promoting a drug with nursing home patients,… PharMerica Corp. resolves claims that it received kickbacks from Abbott Laboratories in exchange for recommending that physicians prescribe the Abbott-manufactured drug Depakote. The federal government alleged the kickbacks were disguised as rebates, educational grants and other financial support....
- Pfizer turns aside yet another case alleging Zoloft caused birth defects (fiercepharma.com)
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.
- HHS releases updated Meaningful Use rules (fierceemr.com)Fact Sheet: Electronic Health Record Incentive Program and Health IT Certification Program Final Rule (cms.gov)HHS issues rules to advance electronic health records with added simplicity and flexibility (hhs.gov)
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
- Las Vegas doctor denies sexually assaulting patients (news.yahoo.com)Vegas doctor accused of groping girl was let off after 'impulse control' classes (reviewjournal.com)
Las Vegas physician stood shackled in court and pleaded not guilty Wednesday to drugging and sexually assaulting at least 14 patients, including a 16-year-old girl whose alleged attack was videotaped…An indictment filed last week accuses Bin Minh "Ben" Chung of 24 charges including lewdness, sexual assault, administering a drug in the commission of a felony, and a kidnapping charge that could bring a life sentence if he's convicted.





