PHARMACY

FDA approves Tris Pharma’s Dyanavel XR

BY David Salazar

MONMOUTH JUNCTION, N.J. — Tris Pharma on Tuesday announced that it had received approval from the Food and Drug Administration for its Dyanavel XR (amphetamine) extended-release oral suspension. Dyanavel is indicated as a once-daily treatment for attention deficit/hyperactivity disorder in children ages 6 and older.

“Dyanavel XR is the first and only once-daily, extended-release amphetamine oral suspension for the treatment of ADHD,” Tris’ chief medical officer Dr. Sally Berry said. “Amphetamines are well-established as effective treatment for ADHD.  Dyanavel  XR offers physicians a new pediatric-friendly dosing option that couples fast onset with a long duration of effect suitable for school-aged children.”

The drug is expected to be available in 2016, the company said. 

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New drug safety alliance launches to tout REMS benefits

BY David Salazar

WASHINGTON — A new coalition of 20 healthcare organizations has come together to form the Patients Alliance for Drug Safety Protections, whose goal is to tout the public health benefits of Risk Evaluation and Management Strategies (REMS). The PADSP has also launched a website, DrugProtections.org, that explains the REMS program to patients and lists medication that are currently marketed with a REMS.

Spearheaded by the Society for Women’s Health Research (SWHR), the organization said that it formed at a time when patients, policymakers and stakeholders face a knowledge gap about the REMS system, which can ensure the safety of drugs meant to treat such illnesses as cancer or multiple sclerosis.

“Several conditions require access to treatments that may have significant risk factors. Without the protections created by REMS programs, these drugs would not be allowed on the market and patients would suffer tremendously,” SWHR president and CEO Phyllis Greenberger said. “This alliance was established in coordination with knowledgeable and experienced advocates for patients and physicians who are worried about recent efforts to weaken REMS protections, putting public health and patient access at risk.”

The members of the alliance are: the Alliance for the Adoption of Innovations in Medicine, the American Association of Kidney Patients, the American Cancer Society Cancer Action Network, the American College of Obstetricians and Gynecologists, the Association of Reproductive Health Professionals, C-Change, the Center for Lawful Access and Abuse Deterrence, the Consortium of MS Centers, the Cutaneous Lymphoma Foundation, HealthyWomen, the International Myeloma Foundation, the Leukemia & Lymphoma Society, March of Dimes, the MDS Foundation, the Multiple Myeloma Research Foundation, the National Association of Nurse Practitioners in Women's Health, the Organization of Teratology Information Specialists, Patients Rising and the Teratology Society.

“The American College of Obstetricians and Gynecologists (ACOG) is a proud member of the coalition to advance the importance of REMS as a tool to improve public health,” Dr. Mark S. DeFrancesco, president of ACOG, said. “As the nation's leading group of physicians providing health care for women, we recognize the importance of drug safety measures, particularly to prevent severe complications and birth defects that can result from inappropriate medicine distribution and use. We encourage healthcare organizations to work collaboratively to design and conduct drug studies in order to ensure that people with serious diseases have access to appropriate treatments.”

The alliance will also work to highlight the importance of REMS with Elements to Assure Safe use (ETASU) programs, and will support advocacy efforts that push to preserve patient access and strengthen REMS programs while also working to make sure that manufacturers meet safety requirements for drug designs and studies.

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Health Mart executives hit the road for next 100 Town Hall events

BY Michael Johnsen

SAN FRANCISCO – With the industry’s greater focus for pharmacies on clinical performance and patient outcomes, Health Mart is hosting its third series of Town Hall events. The “Get in Sync: Medication Synchronization” Town Hall events encourage pharmacists to consider an appointment-based model with medication synchronization, shifting them from reactive prescription filling to proactive and patient-centric. Health Mart, with more than 4,200 locally owned community pharmacies across all 50 states, will host more than 100 complimentary Town Hall CE events across the country through early 2016.
 
“Med sync is a critically important opportunity for independent pharmacists to improve patient care and clinical quality measures, as well as streamline pharmacy operations and improve their bottom line,” said Steve Courtman, president, Health Mart. “However, med sync is not the end goal; it is the vehicle that will enable our pharmacies to make the transition from just filling prescriptions to taking a more proactive, patient-centric approach.”
 
Focused on helping pharmacies learn how to implement a med sync program, the interactive peer-to-peer workshops provide a comprehensive review of the benefits of medication synchronization. This includes increased operational efficiencies to free up time, reduction of expenses and increased revenues, and improved clinical performance to help gain payer recognition for quality outcomes.
 
The real strength of Health Mart – entrepreneurial, independent pharmacists looking to explore best practices – is on full display at these Town Hall events, according to Health Mart's leading executives in an interview with Drug Store News earlier this year. “It’s not unidirectional,” commented Tony Willoughby, Health Mart's chief pharmacist. “It’s that dialogue that helps feed the content. We have a vision of what we want to accomplish in the Town Halls, but just like our pharmacists have a unique ability to cater to a local patient, we try to do the same for our customers, as well as allow them to see how it works.” 
 
“It’s that kind of no-holds barred feedback that will enable Health Mart to become better than better,” Courtman added. “We talk about Health Mart making Health Mart stronger, that’s where that comes out,” he said. The feedback is additive.
 
“We’re not the innovators, our pharmacies are,” Willoughby said. “It’s taking their concepts, their ideas and trying to commercialize them or share them with the broader membership so that they can learn from each other.”
 
During these Town Hall events focused on med sync, attendees learn the seven steps to creating a med sync process that will help them transition to an appointment-based model. In addition to providing stores time-saving tips through an implementation Playbook, attendees receive practical examples of how other owners and their pharmacy teams overcame barriers of implementing med sync. 
 
For example:
 
  • At Shriver’s Health Mart Pharmacy and Coler Long Term Care, VP/COO Greg Paisley reports lower dispensing costs, improved pharmacy operations and a better work environment after implementing med sync at five locations;
  • At Tyson’s Drugs, Health Mart owner Bob Lomenick attributes 60% incremental Rx growth over the past five years to syncing more than 900 patients’ prescriptions at three locations; and
  • Derek Tengan of 5 Minute Health Mart Pharmacy exceeded CMS Five-Star Quality goals at his two retail locations for two adherence measures and high-risk medication use in the elderly since implementing med sync last year. He also showed a local health plan how managing just 10 high-risk patients with sync and medication therapy management could save them an estimated $180,000 in reduced ER visits and hospital admissions and readmissions.
 
In addition to this third series of Town Hall Meetings, Health Mart has invested heavily to help pharmacies “Get In Sync” at every step of their med sync journey with the development of the online Health Mart University Learning Experience and Med Sync Playbook. The Med Sync Learning Experience provides an online roadmap to connect pharmacies to resources and trainings from Health Mart to help them successfully implement and maximize med sync in their pharmacy. Health Mart has also created physician-facing fax templates, and patient-facing marketing materials and brand, SimpleSyncTM to help pharmacies advertise their new med sync service.
 
“We recognize one key factor that makes our customers different as independent pharmacies: they already have the relationships with their patients. Their business model, and how they operate, just needs to follow," Courtman said. "Health Mart is confident that this shift of their focus from reactive prescription filling to proactive and patient focused will improve both the health of their businesses and their patients.” 
 
Health Mart also announced that the 2016 Health Mart Healthy Living Tour will include stops at a number of “Get in Sync: Medication Synchronization” Town Hall events. Another way that Health Mart invests in helping independent pharmacists to provide their patients with positive health outcomes, the Healthy Living Tour aims to help identify people at risk for a variety of health conditions that can be better managed with the help of a pharmacist. The 2015 Tour screened thousands of people in more than 130 communities with first-time stops in Montana, North and South Dakota, Virginia and Maine.
 
 
 
 
 
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