- National Quality Forum identifies set of quality measures for rural providers (fiercehealthcare.com)NQF Releases Report Focusing on Quality and Access Issues in Rural Health (qualityforum.org)
Are rural hospitals properly tracking and reporting healthcare-associated infections like clostridium difficile? What about screening their patients in ambulatory clinics for alcohol use and abuse?...Those quality measures are among a set of suggested measures the National Quality Forum released...in an effort to put rural providers “on a pathway” to improvement...The measures are part of the NQF’s Measure Applications Partnership, created under the Affordable Care Act to provide input to the U.S. Department of Health and Human Services on the best performance measures for public reporting and performance-based payments...MAP singled out 20 measures that to fit the unique needs of rural providers and address their key concerns, such as access to care...The forum has recommended that the Centers for Medicare & Medicaid Services adopt the measures in Medicare first, and then potentially expand them to Medicare Advantage...Ensuring that rural hospitals and providers can participate in quality improvement is crucial...
- Reno and Sparks Chamber of Commerce becomes latest to offer association health plan to small businesses (thenevadaindependent.com)
The Reno and Sparks Chamber of Commerce announced...will begin offering an association health plan to its small business members in partnership with Prominence Health Plan, following in the footsteps of four other chambers of commerce in Southern Nevada that unveiled similar plans with other insurance companies last month...Small businesses that are members of the chamber will be able to purchase medical coverage through Prominence and dental, vision and life insurance through Kansas City Life...The Las Vegas Metro Chamber of Commerce and the Clark County Health Plan Association, a partnership of three smaller Southern Nevada chambers, each announced plans last month to begin offering association health plans to their members in the wake of a rule released by the Department of Labor in June loosening the rules on such plans. The new rule exempts association health plans from providing the essential health benefits required under the Affordable Care Act, eliminates restrictions based on geography and allows companies in different industries in the same region to provide coverage together...
- Walgreens mobilizes in advance of Hurricane Florence (chaindrugreview.com)CVS helps customers get ready for Hurricane Florence (chaindrugreview.com)
Walgreens is taking proactive measures to assist customers, team members and communities in the projected path of Hurricane Florence, and is preparing to fully support impacted regions in the storm’s aftermath. The company is taking the following steps:
- Prescription Drug Preparedness: In advance of the hurricane, Walgreens is underscoring the importance of prescription preparedness for its pharmacy patients in areas that may be impacted. With a State of Emergency declared in parts of North Carolina and South Carolina, pharmacists in the state can refill medications up to a 30-day supply without requiring a prescriber’s refill authorization for any non-controlled substance.
- Customer Support: Walgreens is proactively staging temporary mobile pharmacies near the region that can be deployed, if necessary, to drugstores that may be damaged or unable to reopen in a timely manner. Walgreens has also staged emergency power generators that can be deployed to drugstores in areas where there is a loss of power.
- Relief and Recovery: The company will be evaluating its philanthropic response immediately following the hurricane and intends to activate its nationwide network of stores to allow individuals to donate to the American Red Cross hurricane relief efforts, in addition to preparing to donate needed items to emergency shelters.
- The search for new drugs is coming to your house (fastcompany.com)
Virtual trials could address some of the problems that come with developing new drugs, but a host of challenges remain before they can become routine...Last October, AOBiome Therapeutics...announced the results of a 12-week clinical trial of an experimental acne drug. In the randomized double-blind and placebo-controlled trial, a topical spray containing a beneficial bacteria was shown to be safe and effective in reducing the severity and number of acne lesions, the company said...The drug must successfully go through another round of testing–what’s called a Phase III trial–before AOBiome can apply to the Food and Drug Administration for marketing approval...Volunteers for the completed trial were recruited through social media and internet advertisements, and more than 8,000 people were screened online to see if they were eligible. The resulting 372 participants received the drug or a placebo in the mail and used company-issued iPhones to take selfies of their acne, a phone app to send the photos to physician-investigators for evaluation, and video conferencing to communicate with study staff...That’s markedly different from a typical drug trial...AOBiome’s acne drug trial, there were no in-person screening interviews, and no doctor visits. The trial was entirely what people in the trade call “virtual.”...Whether virtual clinical trials are the way forward is a matter of some debate, and industry analysts say a host of challenges remain before virtual trials–which currently represent a tiny fraction of the more than 100,000 registered clinical research studies in the United States–become the norm. These include overcoming a conservative corporate culture, ensuring that the technology is easy for patients to use, managing and analyzing the enormous amount of data that round-the-clock sensors generate, and proving the data’s reliability and validity to regulators...
- The high cost of contamination in drugs manufacturing (pharmaceutical-technology.com)
Pharmaceuticals is one of the highest value industries globally..Any contamination in the drugs manufacturing process can have a substantial financial impact, not to mention possible safety implications...Drug manufacturer Genzyme was forced to temporarily close its Massachusetts plant in 2009, halting production of the Fabrazyme and Cerezyme drugs that were at the time used by 8,000 patients globally, after a virus was found to have contaminated a bioreactor...At the time it was estimated that the incident could cost Genzyme up to $300m in lost revenue...The company was later fined $175m by the US Food and Drug Administration and wrote off more than $28.4m worth of product...
- Nevada prisons drug buyer knew firms opposed execution use (kolotv.com)
Nevada's prisons pharmacy chief says she ordered and obtained lethal injection drugs this year despite knowing drug manufacturers didn't want their products used for executions...Linda Fox's drug purchases allowed Nevada to plan its first execution since 2006 using a never-before-tried three-drug combination...She testified...that she didn't specify the end use when she obtained medications from a third-party supplier, not the drug makers...Fox was pressed by lawyers representing drug companies a day after the state's prisons chief provided sworn testimony about having trouble obtaining drugs for executions...
- Why Big Pharma Cheers Rahm Emanuel’s Exit As Chicago’s Mayor (forbes.com)
Rahm Emanuel’s surprise decision to not run again for Mayor of Chicago next year for a third term may be good news for the pharmaceutical industry, which has become a high-profile target during his tenure...Emanuel was unafraid to put U.S. pharmaceutical companies and their marketing practices in his sights despite Chicago and its suburbs being home to major drug makers that are also big employers like Abbott Laboratories and its spin off Abbvie as well as Baxter International. Other drug makers and startups call Chicago home including Horizon Pharma...Emanuel led the charge for Chicago to introduce an ordinance requiring licenses for drug sales representatives . This summer, Chicago confirmed more than 1,500 licenses, which cost $750 annually, were issued after the first year of the ordinance. Marketing without a license could result in a $1,000 fine...
- Half of Europe’s clinical trials fail to report results despite EU rule (reuters.com)
Almost half of all European-registered clinical trials - in which scientists test drug treatments, interventions or therapies in humans - have breached EU rules by failing to report results...The analysis also found that while most major pharmaceutical companies are coming close to complying with EU reporting rules for trials in people, most major academic institutes are not...European Union guidelines say that funders of clinical trials must ensure all studies entered on the EU Clinical Trials Register since 2004 have posted results there within a year of concluding...Advocates for transparency in science say enforcing the rule is necessary to ensure researchers do not bury results they consider unfavorable...We cannot make informed choices about which treatments work best, as doctors and patients, unless all results are reported...
- FDA finds another carcinogen in valsartan products (biopharmadive.com)Updated: FDA, Health Canada and EMA Spot Second Impurity in Valsartan (raps.org)
The FDA's latest round of testing has revealed an additional impurity, N-nitrosodiethylamine (NDEA) in three lots of Torrent Pharmaceuticals' recalled valsartan products. NDEA is a known animal carcinogen and a suspected human carcinogen...The source of the impurity was the valsartan active pharmaceutical ingredient from Zhejiang Huahai Pharmaceuticals. Not all products made from Zhejiang Huahai's valsartan contain the impurity, however...More than half of valsartan products are now under recall and FDA said last month more are likely...The story has now escalated. Once the FDA and EMA learned that Zhejiang Huahai discovered an additional impurity, NDEA, the authorities retested all valsartan API and products. Like NMDA, NDEA appears to be formed as a result of a specific sequence of steps in manufacturing.
- EU officials clash with Chinese firm on drug factory inspection (reuters.com)
European medicines regulators have issued a notice that an ingredient for a generic brain cancer drug made in China does not meet manufacturing standards, after inspectors were refused entry to a factory run by Jiangsu Yew Pharmaceutical Co. Ltd...is the latest example of regulatory problems with bulk pharmaceutical substances manufactured in China...Jiangsu Yew refused to allow a site inspection by Hungarian officials, acting on behalf of Europe’s drug regulatory system. The rebuttal led the EU authorities to determine that its supplies of temozolomide, used to treat brain tumors, did not comply with good manufacturing standards...The company’s export director Henry Yang told Reuters via email that the inspection was refused because Jiangsu Yew only made an intermediate product, rather than an active pharmaceutical ingredient, so an audit was not required.