Author: Peter

After a months-long investigation, federal officials have nailed down the source of a Burkholderia cepacia outbreak that made its way into several states and infected dozens of patients...the Centers for Disease Control and Prevention and the FDA said they had detected the B. cepacia bacteria in the water system at Florida-based CMO PharmaTech. The company had produced 10 contaminated lots of constipation drug docusate sodium before 6 distributors shipped the meds around the country. In total, 60 people in 8 states became infected...The outbreak started in late June in ventilated cystic fibrosis patients. During the investigation, CDC officials said infections could be life-threatening in patients with compromised immune systems or lung conditions.

While much of the attention over prescription drug prices is focused on consumers, a survey released on Tuesday finds that hospitals are also spending much more than in the past. Between 2013 and 2015, the average annual drug spending for patients who stay in community hospitals increased by of 23.4 percent...And on a per admission basis, hospital spending on drugs jumped nearly 39 percent, to $990...the increase in prices outpaced reimbursement rates from payers, retail spending on medicines, and the pharmaceutical price inflation...the survey found that more than 90 percent of the hospitals surveyed reported that recent price hikes for inpatient drugs had a moderate or severe effect on managing costs...The furor has put the pharmaceutical industry on the defensive as many drug makers are scrambling to justify their price hikes. Some drug makers are pointing fingers at pharmacy benefits managers, and the convoluted pricing system in which rebates that are paid to win coveted placement on lists of drugs for which insurance coverage is provided...The drugs that are increasing in price generally are not new and are off patent. There is no competition, so hospitals are forced to pay in order to make the best patient care decisions...These price increases are unsustainable for hospitals who are taking care of sicker and sicker patients…

Lynette Bradley-Baker, PhD, RPh, vice president of public affairs and engagement of the American Association of Colleges of Pharmacy, describes how pharmacy school curriculums have changed.

Someone at Nippon Fine Chemical must have been very nervous when an investigator from the US Food and Drug Administration arrived last year...In an unusual display of chutzpah, the drug and ingredients maker refused to allow the investigator to inspect its quality control laboratory at its facility in Hyogo, Japan. Employees literally formed a "shoulder-to-shoulder" barricade to prevent the FDA employee from entering…the FDA investigator reviewed customer complaints that Nippon drugs contained glass, hair, cardboard, metal — and even a black spider. But Nippon employees refused to provide the investigator with copies of documents that detailed customer complaints. The FDA letter noted that Nippon uses the same equipment and processes for drugs sold in the Japanese and US markets...As a result of these foibles, the FDA declared Nippon products to be adulterated and issued an import alert two months ago, an action that means Nippon products can be detained from entering the US...Nippon could not be reached for comment...

The National Association of Chain Drug Stores, in partnership with the Pharmacy Society of Wisconsin...announced plans to move forward with a new practice model to improve patient access to quality and efficient care, and advance pharmacy in a broader healthcare setting...The pilot project, "Advancing Community Pharmacy Quality: Leveraging Tech-Check-Tech to Expand Patient Care Services in Community Pharmacies," aims to promote better access to patient care. Specifically, the pilot will examine a new practice model that fosters collaboration across healthcare settings and employs an enhanced operational model. This new practice model holds promise in transforming the nation's healthcare system to deliver better access to clinical care by leveraging health care resources in a smarter way while ensuring patient safety and high operating standards...A key component of this model involves trained and validated pharmacy technicians completing the final check of a prescription filled by another technician, a pharmacy technician verification process known as tech-check-tech. This process allows pharmacists to reinvest the time saved by providing direct patient care services such as immunizations, disease state testing and medication therapy management, among others, which has a positive impact on overall patient outcomes...

As patients clamor for greater access to experimental medicines, a survey released Tuesday finds that just 19 percent of 100 drug makers publicly post policies about their programs for obtaining these drugs, which are known as compassionate use. Moreover, only one of those companies posted information about specific procedures for making requests...The findings underscore arguments by a growing number of patient advocacy groups and lawmakers that the process for gaining access to experimental medicines is difficult, a complaint that has generated criticism of the Food and Drug Administration and sparked social media shaming campaigns of some companies...But other say the frustration directed at the FDA is misplaced. That’s because drug makers are actually the final gatekeepers and may deny requests in order to meet strict criteria needed to win FDA approval for a medicine...The FDA should clearly state in policy how adverse events under compassionate use will affect the ongoing clinical trial process for companies. While the FDA claims that this is a rare occurrence, the reality is that the FDA’s failure to issue clear policy leaves companies in a precarious position of jeopardizing their investments. If companies had clarity from the FDA about how offering drugs under the compassionate use program would impact ongoing trials, they’d be more likely to make their policies public and, possibly, to participate.

Cosmetic Enterprises, Ltd., a growing manufacturer of cosmetic and pharmaceutical products, is planning to expand its operations into Dayton...CEL, headquartered in Pacoima, Calif., purchased a vacant 60,000-square-foot building along with an adjacent 18 acres for potential development..."During our due diligence we reviewed many different regions and states and found Nevada to be manufacturing friendly that is centrally located to our existing customer base…Cosmetic Enterprises is a great addition to Lyon County...Not only are they creating the kind of higher paying jobs that help boost the region, they will be great corporate citizens...CEL produces cosmetic and skin care products, such as shampoo, moisturizers, skin enhancing lotion and skin protecting products, using botanicals and other raw materials...

Humana says it plans to fight the Obama administration over a large reduction in the ratings of its 4-star Medicare Advantage plans for coverage starting in 2018...Star ratings are a key quality measure under Medicare, and lower ratings could result in reduced reimbursement rates for Humana...Not having 4-stars on a significant portion of your plans will hurt you financially because you will not be able to achieve the bonus reimbursement that higher rated plans receive…The company said issues resulting in reduced stars included delays in resolving enrollee complaints over claims...Clearly Humana is going to fight this...it's too early to determine what the real impact of the star rating reduction could be on Humana's earnings in 2018...They're raising the bar, in the sense that it is becoming increasingly demanding...to get the highest ratings on Medicare plans...In other words, insurers are not getting worse, but rather facing tougher comparisons...The good news is that the quality of everyone is improving, but [CMS] still wants to mark on a curve… so, by definition, not everyone can be a five-star...

Carlos Torrado, PharmD, JD, PRS explains the training pharmacists receive with respect to prescriptions for controlled substances.

Not everyone reacts to the same medication in the same way...Benedryl makes some people drowsy and others wired. Antidepressants have no affect on 38 percent of patients...Some people are more susceptible to addiction from pain medications while others get pain relief without getting hooked...MD Labs is part of a new industry called pharmacogenetics that uses genetics to map specific genes involved in the metabolism of and response to specific drugs...Ruttledge and Denis Grizelj, co-founder and CEO, began MD Labs in 2011 as a toxicology testing facility for physicians nationwide. They expanded to pharmacogenetic testing in 2014, with the development of their proprietary genetic test Rxight, which maps genes that affect more than 200 medications...Because it’s genetically based, Rxight is a once-in-a-lifetime test...Preemptive testing makes the patient’s genetically-based profile of drug reactions available to doctors and pharmacists before illness strikes and before a drug is prescribed...MD Labs contracts with Saint Mary’s Health to offer the testing and consultation at both Saint Mary’s Regional Medical Center and Saint Mary’s Medical Group Primary Care Northwest Reno...Pharmacists at those locations are Rxight Certified to administer the test and provide consultation...Nationwide the company has 100-110 employees total, which includes about 55 people in the Reno office plus a sales force in offices in Chicago and Pennsylvania...MD Labs owners see a future in which pharmacogenetics testing is routine.