FDA committee doesn’t recommend regulatory approval for dapagliflozin
WILMINGTON, Del. — A Food and Drug Administration committee of experts has advised against approving a drug for Type 2 diabetes made by AstraZeneca and Bristol-Myers Squibb, the companies said Tuesday.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 9-6 against recommending approval for dapagliflozin, saying that data from a two-year clinical trial program that included about 6,000 people did not support the drug’s approval for use in patients along with changes to diet and exercise.
The FDA is not required to follow advisory committee votes but usually does. Shares of AstraZeneca were down about 0.6%, while Bristol’s shares were up about 0.17% Wednesday morning.
Cardinal Health’s Retail Business Conference highlights new services
LAS VEGAS — Cardinal Health on Wednesday morning announced that the wholesaler’s annual national trade show for independent pharmacies marks the largest in the event’s more than 20-year history, with nearly 7,000 attendees.
This year’s Retail Business Conference features a 100,000-sq.-ft. trade show floor, highlighting buying opportunities with more than 330 exhibitors. At the event, pharmacists can access more than 50 continuing education courses and also can access seven full- or half-day continuing pharmacy education courses on issues ranging from pharmacy-based immunization delivery to helping patients manage cardiovascular risk.
“We believe this is one of the largest gatherings of retail independent pharmacies in one place, ever,” Cardinal Health SVP retail independent sales Steve Lawrence said. “[Retail Business Conference] is an outstanding opportunity for independent pharmacy owners to network with peers from across the country, tap into more continuing education courses than they’ll find anywhere else and learn about the many ways Cardinal Health can help them improve the efficiency and profitability of their businesses.”
New services highlighted at this year’s RBC include:
Enhancements to Cardinal Health’s Front-End Product Management solution, which helps pharmacies maximize sales of nonprescription items. Pharmacy owners now can benchmark and compare their own front-of-store point-of-sale data with that of other similar-size stores with comparable demographics, giving them valuable access to the front-end management best practices of their peers;
New pharmacy business assessments of all aspects of a pharmacy’s operations, conducted by an experienced pharmacy business consultant. Following the assessment, participating pharmacies receive store-specific, actionable recommendations on everything from store aesthetics — how a store can improve its overall look and feel — to how to improve back-end accounts receivable and inventory management processes;
A new suite of human resources services that help pharmacy owners navigate all aspects of employee management. The new services provide quick-and-easy online access to hiring guides and performance management tools, specifically created to meet the needs of small business owners. Pharmacy owners also can get one-on-one, personal phone consultations about how to most appropriately address specific employee issues;
An exclusive new “gift card” program that helps independent pharmacies offer customers the convenience of purchasing gift cards for national retailers and restaurants (ranging from Macy’s to Applebee’s), while visiting their community drug store; and
Enhancements to Order Express, the new online ordering system that the company introduced at last year’s RBC. Order Express now integrates with the company’s inventory management and mobile ordering tools, providing community pharmacists an even more convenient, seamless online ordering experience.
In addition, Cardinal Health has created a program for the children of attendees at the conference, as many community pharmacists bring their families to the show. Called “Camp Cardinal Health,” the program provides children of all ages with four days of age-appropriate, on- and off-site entertainment opportunities and special events.
Multipayer patient-centered medical homes may boost health outcomes for diabetes patients
NEW YORK — A new report published in the June issue of the Joint Commission Journal on Quality and Patient Safety found that diabetes patients can benefit from multipayer patient-centered medical homes.
More than 10,000 patients — assessed by Robert Gabbay, professor of medicine at Penn State College of Medicine and director of the Penn State Institute for Diabetes and Obesity in Hershey, Pa., and colleagues — were enrolled in a broad-scale chronic care model of PCMH, a setting that aims to provide "comprehensive primary care that is coordinated and integrated across all elements of the healthcare system by a physician-led team of individuals who have an ongoing relationship with the patient and, when appropriate, the patient’s family," Gabbay said.
The researchers found that in the first year of intervention, evidence-based care guideline adherence and clinical outcomes saw improvements. For example, patients that received yearly foot assessments for neuropathy — as part of the PCMH mulitpayer initiative — significantly increased from 50% to 69%. Similarly, patients receiving annual screenings for nephropathy and diabetic retinopathy, as well as administration of pneumonia and influenza vaccines, also improved.
Additional improvements were found among high-risk patients, including:
An 8.5% absolute increase in the percentage of patients with an LDL cholesterol level under 130;
A 4% absolute increase in the percentage of patients with blood pressure under 140/90; and
A 2.5% absolute decrease in the percentage of patients with HbA1C above 9.
The first-year outcomes were pooled from 25 participating practices and 143 participating providers in the Southeast region of Pennsylvania, which focused on diabetes patients.
Gabbay noted that despite the significant health improvements among the diabetes patients, "over time, it will be important to continue to monitor the intervention to fully assess the impact of these improvements in clinical care on costs," he wrote.