Author: Peter

In a closely watched decision, the California Supreme Court ruled 4-3...that hundreds of out-of-state residents had the right to sue Bristol-Myers Squibb in the state court system over side effects caused by one of its drugs...At issue was the question of jurisdiction, which can be used to determine where a lawsuit may be filed. This particular ruling clarified the extent to which the drug maker needed to have a presence in California in order to be sued by people from Texas, Ohio, and 33 other states, who claim they were harmed by the Plavix blood thinner...Although Bristol-Myers may not be headquartered in California, the court determined the company conducts enough business — sales, marketing, distribution, and R&D — for state courts to serve as a venue for lawsuits filed by out-of-state residents...the ruling applies only to this particular case, the court may have hung a welcome sign that invites still more people from around the country to file lawsuits in California against drug makers...That’s because California state courts are seen as more hospitable to people who bring lawsuits against drug makers...

Gov. Brian Sandoval has called physicians, politicians and law enforcement officials to a summit meeting this week to address the national opioid epidemic’s impact on Nevada...The Prescription Drug Abuse Summit...at the MGM Grand will focus on issues that include oversight of pain management clinics, physicians’ drug prescription practices and alternatives to opioid medications..."Nevada has established policies that have become national models in prescription drug monitoring and ongoing coordination between the public and private sector. I am proud of what we have accomplished, but there is more work to be done," Sandoval said...Featured speakers at the summit will include U.S. Agriculture Secretary Tom Vilsack and Vermont Gov. Peter Shumlin…

In March and April, 56 people in the Sacramento area were hospitalized after taking Norco brand hydrocodone pills. Fifteen died...But, as we discovered, these pills were not pharmaceutical hydrocodone at all. They were counterfeits containing fentanyl that were purchased on the street. Fentanyl is an opioid far more powerful than hydrocodone...the distribution of illicitly manufactured fentanyl has risen to unprecedented levels...These...substances are generally formulated to look like others drugs – heroin or oxycodone tablets…These entirely synthetic, illicitly made "designer drugs" are designed to work on the same receptors in the body as drugs like marijuana, methamphetamine or heroin. The adulteration of counterfeit pharmaceuticals and street drugs with synthetic opioids is arguably the most worrying new trend...

The Nevada State Board of Medical Examiners has revoked the license of a physician accused of writing more than 600 fake prescriptions, providing more than 70,000 oxycodone pills for nonmedical purposes...Dr. Simmon Lee Wilcox, who practiced in Utah and Nevada, was found guilty of conspiracy to distribute the powerful pain-relieving drug and possession with intent to distribute a controlled substance...He was sentenced to 100 months — more than eight years — in federal prison and three years of supervised release...five others pleaded guilty to conspiracy to distribute oxycodone and said they conspired with Wilcox to use his license to provide the prescriptions, creating false identification documents to carry out the ruse…

This spring and summer, FDA revealed in several guidance documents what the agency thinks pharmacy compounding should look like now that the relevant provisions in federal law are firmly in place and the agency has a budget for oversight...Some of FDA's ideas, if incorporated into the final versions of the guidances, could be challenging for hospitals and health systems to implement…as hospitals continue to affiliate or form multihospital systems...a plan to centralize compounding activities may need to be reconsidered.

• Guidances, not regulations
• Limits on anticipatory compounding.
• Geographic limit on distribution.
• Address-dependent facility definition.
• No copycats of commercially available products.

A multi-million-dollar foundation donation...is not only the largest gift in the history of Renown Health but will also pave the way for a pediatrics residency program at the Reno regional medical center...The William N. Pennington Foundation donated $7.5 million to Renown Children’s Hospital to bolster pediatric care staffing...The money will be used to bring in several pediatrics specialists...a pediatric emergency medicine physician, with a pediatric neurologist and pulmonologist...Being able to establish a residency program with the University of Nevada School of Medicine...is also an important addition to the community...the university will be able to apply for a pediatrics residency program within 24 to 36 months. With Northern Nevada seeing huge growth once again as well as a corresponding increase in patient demand for services, access to healthcare remains a key problem for the area...

...the HPV vaccine is still a hard sell...A new study (funded by Merck, which sells the Gardasil HPV vaccine) finds that only 21 percent of parents believe that a law requiring vaccination for attending school is a good idea, and 54 percent disagreed with the notion of such a requirement for school entry altogether. What might make them change their minds? Well, 57 percent reported that they could live with the requirement, but only if there is an opt-out provision... the vaccines have been plagued by numerous reports of side effects. The issue prompted European regulators to investigate although they did not find evidence the vaccines cause chronic pain or dizziness. Earlier this month, meanwhile, 63 young women in Japan filed a class-action lawsuit seeking $9 million in compensation from the central government and the manufacturers over side effects, pain in various parts of their bodies, difficulty walking, and impaired eyesight…

Any program that puts more greenbacks in patients' pockets in this post-recession economy has to be viewed as a good one, right? Alas, it depends on the person you ask...Devised to shoulder some of the cost burden of prescription drugs, manufacturer co-pay card programs have been tied to improved adherence rates and reduced barriers to the discounted medications. At the same time, payers — insurers and PBMs alike — are crying foul...While some industry veterans sing the praises of co-pay assistance programs, others are eager for a more evenhanded and efficient solution that will achieve the same degree of cost savings. In fact, the co-pay card appears to be stirring the controversy pot more than ever. Indeed, the question seems to have become: What will make it boil over?

Mylan pushed the blame for high EpiPen prices onto PBMs...causing share prices to dip. Analysts say investors were mislead...In hopes of quelling patient and politician's outrage over the prices of EpiPen, Mylan pushed the blame for the high costs onto a few entities, including pharmacy benefit managers...CVS Corp. and Express Scripts...Both...saw significant drops in share price...after Mylan released an infographic explaining that PBMs, insurance companies, wholesalers and retailers all boosted the prices of EpiPen after the drug left Mylan's hands...The time to buy into PBMs could be upon us, as these are actually strong businesses that saw an unnecessary pullback…

Sara Belanger with The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network...