Author: Peter

Compounding pharmacy Downing Labs LLC (formerly known as NuVision Pharmacy), its co-owners, and its pharmacist-in-charge have been issued a consent decree of permanent injunction...The Texas-based company is allegedly in violation of current good manufacturing practice requirements under the Federal Food, Drug, and Cosmetic Act...Downing Labs is accused of manufacturing and distributing adulterated drugs that were made in insanitary conditions, meaning they were bad enough to endanger public health...“Despite multiple warnings to the company, Downing Labs continued to manufacture injectable drugs under insanitary conditions, putting the health and safety of patients at risk,”...“The FDA pursued appropriate and aggressive action to protect the public health.”...Downing Labs said it has worked "collaboratively and cooperatively” with the FDA to reach an agreement that will enable it to resume the production of compounded sterile medication...also noted that, as part of the consent decree, it voluntarily agreed to participate in a regular program of testing, audit, and inspection “to ensure it is achieving and exceeding its quality goals.”

Although using a patch formulation of fentanyl can have some advantages, here are 5 common problems I've encountered with it in my pharmacy practice:

1. Fentanyl patches are extremely potent
2. Lost or missing fentanyl patches should scare you
3. Fentanyl patches are meant for chronic pain
4. Fentanyl patches can cause delayed withdrawal symptoms
5. Fentanyl patches get diverted

Two days ahead of a key signup deadline, the federal government released new enrollment numbers for Nevada's health insurance exchange...Nevada Health Link had 77,411 enrollees on Wednesday, the Department of Health and Human Services reported...That means the exchange has already bested the 72,000 enrollees that bought coverage through the marketplace in all of 2015's open-enrollment period...The department said the latest numbers include existing customers who were automatically re-enrolled, though officials didn't break down how many enrollees were new versus returning...Consumers who haven't bought coverage by Jan. 31 face a federal tax of 2.5 percent of household income, or $695 per adult and $347.50 per child up to a household maximum of $2,085 — whichever is higher.

• Flash News! -Governor Brian Sandoval appointed Darla Zarley to the Board...reappointed Kirk Wentworth and Leo Basch
• Senate Bill 459 - Effective October 1, 2015, this bill addresses three primary topics: (1) the mandatory use of the Nevada PMP ( Prescription Monitoring Program) by prescribers, (2) the Good Samaritan
  Drug Overdose Act (GSDOA), and (3) next-day reporting to the PMP database.
• Discontinue Use of Chen Shwezin Sterile Drug Products, FDA Warns
• Seven Persistent Safety Gaffes in Community/Ambulatory Settings That Need to Be Resolved! (final article of a three-part series): 6. Compounded Pain Creams: High Profit Margin and Danger; 7. Clear Care: Still Causing Severe Eye Injuries Five Years Later
• Risk of Dose Confusion and Medication Errors With Avycaz, FDA Cautions
• US Compounding, Inc, Recalls All Lots of Sterile Compounded Products
• FDA Investigates the Risks of Using PainMedicine Tramadol in Young Patients
• Decreased Potency Reported in Drugs Stored in Becton-Dickinson Syringes
• MediStat Pharmacy Issues Recall of Sterile Drug Products
• DEA Number for Residents Working at a Hospital
• 2015 Pharmacist Renewal Update! - Nevada had another successful year with pharmacist renewals.

Section 340B of the Public Health Service Act requires drug manufacturers participating in the Medicaid Drug Rebate Program to sign an agreement...This...limits the price that manufacturers may charge certain covered entities for covered outpatient drugs...Drug diversion in the program is defined as a 340B drug being provided to an individual who is not an eligible outpatient of that entity and/or dispensed in an area of a larger facility that is not eligible (eg, an inpatient service or a non-covered clinic)...in 2013 that 94 audits were underway, which included 700 outpatient facilities and 1930 contract pharmacies. During these audits, drug diversion, duplicate discounts, and ineligible sites/providers were the common areas of noncompliance... Noncompliance to 340B program impacts patients’ bottom line because the more diversion that occurs, the more drug manufacturers increase prices for both public and private insurers, leading to an increase in rates and charges to patients. If HRSA were able to enforce 340B regulations and audit all hospitals on a continual basis, there would be fewer cases surrounding duplicate discounting, drug diversion, and ineligible site/providers...The 340B Program is in desperate need of stronger controls and more audits. Through proactive monitoring of drug inventory and dispensing, 340B drug diversion would decrease, leading to a decrease in drug spending.

Marc O'Connor, chief operating officer of Curant Health, discusses potential changes patients of specialty pharmacies may experience in the near future.

When shopping for a good deal, people usually want the same bargain as the next guy. And a group of AIDS activists is taking this approach in hopes of containing the rising cost of prescription drugs...In California and Ohio, they’re pushing ballot measures that would require state programs — such as Medicaid or prison systems — to pay no more for medicines than the Department of Veteran Affairs... “The goal [ballot initiatives] is to obtain lower prices, as well as gain more transparency on industry pricing, which is opaque,” said Ged Kenslea of the AIDS Healthcare Foundation...“And we’re hoping these will serve as a catalyst to other organizations or state legislators to enact similar measures in other states.”...well-intentioned, the effort may be somewhat quixotic...“These state initiatives might save a fistful of money in the short term and the first states where they are passed will get most of the benefit,”...“But the companies will find a way to compensate. So it isn’t likely to solve the problem in the long run.”...Still, the state initiatives may yet lead to change, if only because a groundswell of citizen-driven ballot measures might just force lawmakers to pay attention. In the end, getting a better deal might only be a vote away.

Patients may be more likely to retain information about their prescribed medications when the pharmacist-patient relationship becomes a 2-way conversation... A recent study published in the Journal of the American Pharmacists Association suggests that more interactive conversations between the pharmacist and patient can more than double the likelihood that the patient will understand how to take their medications properly....“The benefit of the interactive counseling technique is the fact that the patient can let the pharmacist know upfront what they know about their medications. The pharmacist can then fill in the knowledge gaps...The increased health literacy resulting from these more substantive conversations is strongly associated with greater medication adherence, which is widely considered one of the most crucial components of the value-based care model and optimized patient outcomes...This is the first real analysis to prove that [the interactive approach] works, and that the approach could be extremely important for health care in America...

“Right now we're kinda cramped, we're in a small trailer, we can't fit all of our staff yet. We actually have people who are waiting to come on board,” says Dr. Chris McDonnell...The 38,000-square foot building at 5th and Ralston will allow Northern Nevada HOPES to go from serving 600 patients to 10,000. One highlight is the dedicated pediatric pod with 12 exam rooms, two treatment rooms and a unique "care team center."..“Four care teams that will be in here and that will include a provider, a behavior health specialist, an RN, a medical assistant as well as a case manager,” says Sharon Chamberlain, CEO Northern Nevada HOPES.

BioMarin CEO Jean-Jacques Bienaime, discusses drug pricing, the sentiment of investors in biotech and his expectations for the company's Duchenne muscular dystrophy drug.