- UNLV and Cleveland Clinic explore expanded partnership (reviewjournal.com)
An expanded and more robust partnership might be on the horizon for UNLV and the Cleveland Clinic..."We’re definitely in talks with them about what we can do, and how much more we would like to do," said Barbara Atkinson, dean of UNLV’s new medical school. "It’s a great opportunity for both sides. There are some real synergies there."...Atkinson said she would like to see medical students rotate through the Cleveland Clinic’s neurology program...The talks will continue April 27…
- Canada Cannot Be America’s Drugstore (realclearhealth.com)
The drug importation debate, sparked by Sen. Bernie Sanders’ introduction of legislation that would allow Americans and pharmacies to import medicines not approved by the FDA from foreign countries through and including Canada, is largely focused on one key question: Are medications imported from outside the FDA’s jurisdiction safe for consumers?...Clear and compelling evidence tells us the answer is no...we haven’t even begun to address concerns from the Canadian side of this issue...Canada does not have the drug supply nor the drug distribution system to meet even a small level of U.S. demand. Additionally, it is highly unlikely that the pharmaceutical industry will increase the supply necessary for Canada to become a major exporter...Wouldn’t U.S.-based pharmaceutical companies simply increase their supply to Canada in order to meet this increased demand? The answer is likely "no," as it’s not a practical market-based response...If drug importation is legalized, the U.S. and Canadian pharmaceutical markets essentially become one. It would not be in the fiduciary or long-term interests of any pharmaceutical company to increase its supply to Canada at artificially low prices set by government fiat, which would only reduce demand for medications sold in the United States at market-based prices...If Canadian pharmacies can’t get the drugs from U.S. manufacturers to meet both domestic needs and export demands, they will turn to other countries to secure these supplies...drugs will instead flow from countries like Russia and India, where counterfeiting is ubiquitous..
- Clinical trial enrollment gets harder as patient populations shrink (biopharmadive.com)
...Enrollment is challenging across nearly all clinical trials. But for the rare disease variety, it’s often akin to finding a needle in a haystack — or in some cases a field of haystacks, if the illness is particularly uncommon. Though sponsors have over the years crafted electronic tools to resolve geographical barriers and reimbursement programs to alleviate financial burdens on patients, many of the studies’ inherent complications have yet to be fully remedied...In the most extreme cases, though, recruitment woes can squelch trials before they start or sap investor faith in a candidate...
Understanding the disease...Before researchers consider a patient for a clinical trial, they first need to determine whether he or she actually has the disease under investigation...having clinicians who understand a rare disease well enough to properly diagnose it — a resource often concentrated at universities or specialized research centers — can be a limiting factor…
Getting patients there -...identifying possible participants for a trial is the first hurdle in the race to enrollment, the next is getting them to sign on...
Making it all worth it -...Despite the immense preparation needed to enroll and conduct orphan drugs trials, many don’t have standardized endpoints...the right ones that would show the transformative nature of the therapy...
- WFI System Meets European Requirements (pharmtech.com)
Bosch’s new system for the production of water for injection, which is used in solutions for injection and infusion, uses membrane processing and ultrafiltration. Previously, it was only possible to produce WFI for the European market using distillation...the revised European Pharmacopeia monograph allows, for the first time, WFI to be obtained using other comparable processes...Pharmatec designed a WFI production unit using membrane processes that meets the requirements...from the European Medicines Agency...The generation unit employs cold membrane processing methods (i.e., reverse osmosis and electrodeionization), with an additional ultrafiltration step...Monitoring all the processes in the production chain is essential to guaranteeing the microbial quality of the water, which is why we fitted the unit with various sensors and measuring devices to monitor the water quality throughout the process and to check the individual steps...
- This Week in Managed Care: April 21, 2017 (ajmc.com)
Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- Some vets can go to CVS ‘MinuteClinics’ for minor illnesses (hosted.ap.org)
Some ailing veterans can now use their federal health care benefits at CVS "MinuteClinics" to treat minor illnesses and injuries, under a pilot program announced...by the Department of Veterans Affairs...The new program, currently limited to the Phoenix area, comes three years after the VA faced allegations of chronically long wait times at its centers, including its Phoenix facility, which treats about 120,000 veterans...The Phoenix pilot program is a test-run by VA Secretary David Shulkin who is working on a nationwide plan to reduce veterans' wait times...Veterans would not be bound by current restrictions under the VA's Choice program, which limits outside care to those who have been waiting more than 30 days for an appointment or have to drive more than 40 miles to a facility. Instead, Phoenix VA nurses staffing the...medical center's help line will be able to refer veterans to MinuteClinics for government-paid care when "clinically appropriate."..."We believe in the MinuteClinic model of care and are excited to offer our health care services as one potential solution for the Phoenix VA Health Care System and its patients," said Tobias Barker, chief medical officer of CVS MinuteClinic...
- Genentech urges broader adoption of value-based payment models (mmm-online.com)
Researchers involved in an outcomes-based pilot between Genentech and Priority Health, a Michigan-based health insurer, argued that broader industry participation is needed for these agreements to be successful...In a study...the drugmaker and the insurer detailed the terms and challenges of the value-based program for Avastin…They also urged other organizations to continue to engage in value-based contracts, despite their inherent complexity...There are several reasons why these kinds of contracts, usually involving drugmakers taking on some degree of financial risk and payers promising prescription volume in turn for drugs that yield better outcomes for patients, have been gaining in popularity…
- The U.S. health system as a whole has been moving away from a volume-based, or fee-for-service, system to a value-based model…
- Healthcare decision makers are challenging pharmaceutical manufacturers to demonstrate the value of their medicines, not just in terms of clinical efficacy but also in terms of economic and quality-of-life outcomes…
- ...what five qualities make for a successful contract? Leadership commitment, the choice of drug (outcomes should be able to be proved within a year), agreed-upon definitions and metrics, finding a way to track data in the simplest way possible, and figuring out to address the government rules about pricing…
- Pharmacy Week in Review: April 21, 2017 (pharmacytimes.com)
Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- Nation’s First ‘Budtender’ Certified In Sacramento (sanfrancisco.cbslocal.com)
A Sacramento woman was recently certified as California’s and the nation’s first cannabis pharmacy technician or "budtender."...Shayna Schonouer isn’t just an expert on all things cannabis-related when it comes to using marijuana products to treat a medical condition. She is now the only person in the nation to hold the state-sanctioned title of "budtender."...Schonouer has just wrapped-up a two-year program making her the first graduate apprentice in the field of pharmacy cannabis technician..."She’s not a doctor, she’s not a pharmacist — but she has in this industry enough expertise to help people make informed decisions on their choices to self-medicate," explained Don Merrill, who works for the state’s Department of Industrial Relations and helps run the program...She will now work with pharmacists who offer cannabis products to patients coping with cancer or any chronic condition...It will also be her job to make sure the cannabis products coming in to shops and pharmacies are properly tested...
- Is prescription pet food better for your pet – or for the companies that make it? (sacbee.com)
A North Carolina law firm is one of the primary drivers of a class action lawsuit that alleges that prescription dog and cat food is a marketing scheme devised by pet food companies to pump up their profits...At the heart of it, the world’s largest pet food manufacturers are requiring that certain pet foods be sold by prescription even though there is no legal requirement for that prescription…requiring a prescription from a veterinarian misleads consumers, providing cover that enables pet food companies to charge excessive prices...Prescription pet food contains no drug or other ingredient not also common in non-prescription pet food...Defendants in the civil lawsuit...include the companies behind four brands of prescription pet foods that dominate the market: Hill’s Prescription Diet, Purina Pro Plan Veterinary Diets, Royal Canin Veterinary Diet and Iams Veterinary Formula...the lawsuit argues, the companies “control the sale of prescription pet food from manufacture to veterinarian to retail, which has allowed their deception and price-fixing conspiracy to be implemented and perpetuated with minimal risk of detection or defection.”...prescription pet foods “have not been evaluated by the FDA for safety, efficacy, or nutritional adequacy.”...Prescription pet food accounts for about 5 percent of the $24 billion in pet food sold in the U.S. each year...or more than $1 billion a year...Pet food...“is the only food on the planet that’s allowed to make a health claim” by the FDA...