- Shkreli’s attorney: He’s been unfairly vilified (video.cnbc.com)Valeant, Turing Slammed as Shkreli Calls Congress ‘Imbeciles’ (bloomberg.com)
Former Turing Pharmaceuticals CEO Martin Shkreli was scheduled to testify to Congress today, but exercised his 5th Amendment right to not incriminate himself. Shkreli's lawyer...
- Health officials say major Zika outbreak unlikely in Nevada (reviewjournal.com)Zika Virus (cdc.gov)
Health officials say a disease believed to have caused a major increase in birth defects among Brazilian-born babies is unlikely to flourish in Nevada, though travelers could bring it to the state...As of Thursday, 31 cases of Zika virus disease have been confirmed in the United States, but all are related to travel outside of the country, Southern Nevada Health District Disease Investigation and Intervention Specialist Tony Fredrick said. There are no known cases in Nevada...Travel could bring infected people from these regions to the Silver State, said James M. Wilson, director of the Nevada State Infectious Disease Forecast Station at the University of Nevada, Reno...Trapping efforts in Southern Nevada have not shown any sign of the Aedes species of mosquito, which is believed to have been the primary cause of most recent infections...
- Pharmacies Won’t Compound Lethal Injection for Alabama Executions (pharmacytimes.com)
Alabama recently executed its first inmate using a 3-drug cocktail containing midazolam in place of the more commonly used pentobarbital...This is because compounding pharmacies in Alabama were not willing to make pentobarbital for lethal injection...Four other states’ pharmacies also declined to compound pentobarbital for the Alabama Department of Corrections...Both the International Academy of Compounding Pharmacists and the American Pharmacists Association have issued statements discouraging pharmacists from participation in executions...IACP said compounding lethal injection drugs goes against pharmacists’ focus on healing and care. It also pointed out that state boards of pharmacy could potentially seek ramifications against a pharmacy that knowingly prepares a drug that will cause harm...With manufacturers and compounding pharmacies’ resistance, state departments of corrections may have to turn to alternative methods for executions...in April 2015, Oklahoma approved the use of nitrogen hypoxia in a gas chamber if the state could not obtain lethal injection drugs...In Utah, Governor Gary Herbert signed a law in March 2015 that allows for the use of a firing squad as a plan B.
- New CRISPR/Cas9 delivery method could offer a clinical pathway (fiercedrugdelivery.com)Therapeutic genome editing by combined viral and non-viral delivery of CRISPR system components in vivo (Abstract, sub req) (nature.com)
CRISPR/Cas9 gene editing is a rapidly developing technique that is thought to provide revolutionary new ways to manipulate genes for the treatment of a number of diseases. Delivering the CRISPR therapeutic in an efficient, safe and predictable way, though, has been difficult--to this end, researchers at UMass have created a means of administering the gene editor that could help send it to clinical trials...CRISPR/Cas9 is a natural immune system in bacteria used to protect them from foreign genetic material, and scientists have used its components to cut and repair DNA sequences to replace faulty, disease-causing portions with corrected versions...The difficulty comes about in getting the separate components to the genetic material in a target cell. Previous attempts at delivering the system through disruptive, high-powered injection has caused damage to the liver...The new delivery method involves a two-part process. The researchers loaded both the CRISPR guide RNA and the DNA template into a viral vector...A week after the first injection, the scientists deliver the Cas9 messenger RNA wrapped in lipid nanoparticles...Until now it's not been possible to deliver CRISPR/Cas9 in a way that was suitable for clinical trials. By using an RNA guide and DNA repair template delivered via viral vector followed by a Cas9 in a lipid nanoparticle, we've take a huge step forward to overcoming this hurdle.
- 4 Strategies for Health-System Pharmacists to Optimize Care Delivery (pharmacytimes.com)
Health systems are under immense pressure to improve care quality while reducing costs under the pay-for-performance reimbursement model...The Pharmacy Forecast 2016-2020 published by the American Society of Health-System Pharmacists Foundation analyzed pharmacy trends and described strategies for health-system pharmacists to keep pace with their evolving scope of practice...Health systems and their pharmacists must plan for and react to trends in both value-based care and the pharmaceutical marketplace to ensure financial solvency and optimize patient outcomes...Here are 4 strategies for health-system pharmacists navigating new health care delivery trends:
- Pursue prescription data-sharing partnerships
- Ensure compliance with the 340B Drug Pricing Program
- Expand pharmacist services in ambulatory care clinics
- Manage the health-system’s formulary thoughtfully
- The Challenge of High Cost Drugs in Specialty Pharmacy (specialtypharmacytimes.com)
Michael Zeglinski, vice president of Specialty Pharmacy Operations at BriovaRx, discusses how expensive hepatitis C drugs have impacted the specialty landscape. (video)
- Bowing to pressure, FDA to reform painkiller approval process (reuters.com)
Bowing to pressure from lawmakers, Dr. Robert Califf...nominee to lead the Food and Drug Administration, said on Thursday the agency would reform its process for approving opioid painkillers...Last month Democratic Senator Edward Markey of Massachusetts placed a hold on Califf's nomination, preventing it from being voted on by the full Senate, until the agency agreed to convene an advisory panel to review future opioid approval decisions...The FDA said it has agreed
- ...to convene a committee before approving any new opioid that does not have abuse-deterrent properties. And it said the agency's pediatric advisory committee will make recommendations before any new labeling relating to children is approved.
- ...develop additional safety information for immediate-release opioid painkillers; strengthen the requirement for drugmakers to produce information after a drug reaches the market; and expand access to abuse-deterrent opioid drug formulations.
- ...considering making naloxone...accessible over the counter to treat opioid overdose.
- Three Southern Nevada hospitals apply to become Level 3 trauma centers (reviewjournal.com)
Three Southern Nevada hospitals have filed paperwork to become Level 3 trauma centers. But University Medical Center officials say the move could threaten their county-run hospital if the applications are approved simultaneously...Centennial Hills Hospital Medical Center, Mountain View Hospital, and Southern Hills Hospital and Medical Center applied in the fall to be designated Level 3 trauma centers, the lowest level recognized by the Southern Nevada Trauma System...St. Rose Dominican Hospital - Siena campus is so far the only Level 3 trauma center in Southern Nevada, Sunrise Hospital and Medical Center is the sole Level 2 and UMC functions as the lone level 1 facility. Trauma protocol dictates that patients with serious ailments be taken to designated trauma centers rather than standard emergency rooms...UMC sees about 12,000 patients at its Trauma Center annually. About 3,000 of those patients are moderately to severely injured. UMC advocates worry that creating three more Level 3 facilities would cause that number to dwindle, reducing the hospital's revenue and hurting its ability to train staff...Trauma center applications are first sent for review to the Southern Nevada Health District Trauma Advisory Board. Then, a recommendation is made to the Southern Nevada District Board of Health, which makes the final decision...
- USP <800> Updates Standards that Protect Health Care Workers from Hazardous Drugs (specialtypharmacytimes.com)Frequently Asked Questions: <800> Hazardous Drugs—Handling in Healthcare Settings (usp.org)
A new health care quality standard has been released to help protect both care providers and patients...The updated United States Pharmacopeia-National Formulary includes a new general chapter, <800> Hazardous Drugs – Handling in Healthcare Settings, to decrease the risk of residual exposure to potentially dangerous medications...USP <800> applies to physicians, nurses, veterinarians, pharmacists, and technicians in health care facilities that handle or store hazardous drugs to prevent and limit exposure... This new standard developed by the USP Compounding Expert Committee, which builds upon other prior publications, included insight from a panel of medical industry experts. The panel helped guide best practices, different techniques, engineering controls, and other elements for handling hazardous drugs...
- Boots changes prices after accusations of sexism (cnbc.com)
U.K. drug store Boots has bowed to pressure and cut the prices on some of its products after it emerged it was charging women more than men for similar products...An online petition started two weeks ago raised awareness of the price discrepancy between some of Boots' products. An eye cream for men cost £7.29 ($10.56) but the same product advertised to women cost £9.99 ($14.47). Meanwhile, a pack of 10 disposable razors for men cost £1.49, but a pack of eight razors for women costs £2.29...Boots said it conducted a review after the issue was brought to light and has taken action to correct the prices of its own-brand products. It also said it would speak to its suppliers and ask them to conduct a similar review of their brands..."At Boots UK, we have never operated a pricing system that discriminates against women so we were surprised and disappointed to see recent examples in the press that did not reflect our own standards,"...