Shire gets FDA’s blessing for Motegrity
The Food and Drug Administration has green lighted Shire’s Motegrity (prucalopride), a once-daily, oral treatment option for adults with Chronic Idiopathic Constipation, or CIC.
Motegrity, a selective serotonin-4 (5-HT4) receptor agonist, provides a different class of treatment for CIC that works by enhancing colonic peristalsis to increase bowel motility.
Motegrity is expected to launch in 2019 in the United States where an estimated 35 million adults are living with CIC.
“The approval of Motegrity marks a new day in the treatment of CIC,” Shire senior vice president and chief medical officer Howard Mayer said. “This significant milestone reinforces our continued commitment to the GI community and advances our goal of addressing the unmet need of patients suffering from rare, specialized and common GI conditions.”
Stemline Therapeutics gets FDA green light for Elzonris
Stemline Therapeutics has received the Food and Drug Administration’s approval for Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm, or BPDCN in adults and in pediatric patients, two years of age and older.
BPDCN is an aggressive and rare disease of the bone marrow and blood that can affect multiple organs, including the lymph nodes and the skin. It often presents as leukemia or evolves into acute leukemia. The disease is more common in men than women and in patients 60 years and older.
“Prior to today’s approval, there had been no FDA approved therapies for BPDCN. The standard of care has been intensive chemotherapy followed by bone marrow transplantation. Many patients with BPDCN are unable to tolerate this intensive therapy, so there is an urgent need for alternative treatment options,” director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, Richard Pazdur said.
Joint PharmD/MBA programs offer students a differentiating factor
When Gregory Wellman graduated in 1982 from Ferris State University in Grand Rapids, Mich., pharmacy schools were bestowing just a bachelor in pharmacy degree. Wellman went on to the Ohio State University and earned a master’s degree and a residency as a way to obtain management training.
Fast forward to 2018: Wellman is a professor of pharmacy at Ferris State University College of Pharmacy, where he co-launched a dual PharmD/MBA concurrent program.
Wellman believes that today a PharmD/MBA degree is essential in preparing students for leadership positions in a wide variety of industries, including retail chain pharmacy, managed care, hospitals and pharmaceutical firms.
“Any of the principles that are part of business apply to being a pharmacist,” Wellman said. “We need to be a financial manager, a human resources manager and an operations manager since there are a lot of legal and regulatory components because we work in complex medication distribution systems.”
Pharmacists also have the responsibility to oversee pharmacy techs, which Wellman said means pharmacists need to understand labor laws and different aspects of managing employees equitably.
To be sure, the new crop of pharmacy students need more than just clinical expertise, thanks to changes in reimbursement models and the expansion by many pharmacy retail chains into health centers and clinics.
Pharmacy schools are realizing that the traditional business overviews they provide students is simply not enough, and they are stepping up to the plate offering dual PharmD/MBA programs.
In fact, in 2008, just 33 pharmacy schools offered a dual PharmD/MBA program. In 2013, that number rose to 46, and in 2019, 72 schools will offer this option, according to the American Association of Colleges of Pharmacy.
Students thinking about obtaining a dual degree may be hesitant about putting off their pharmacy career for more education, but many schools enable students to obtain two degrees in less time than it would take to obtain each degree separately.
For example, most of the MBA courses at Ferris are offered online, so students can complete the MBA during the four years that they are in the PharmD program.
The University of Illinois at Chicago College of Pharmacy also has a dual-degree program that offers many MBA courses online. Some students take courses in the summer, so it’s possible to complete both degrees in four years, according to Janet Engle, professor at the department of pharmacy practice and senior associate dean for professional and international affairs at UIC College of Pharmacy.
Last spring, the University of Georgia College of Pharmacy in Athens, Ga., launched a PharmD/MBA program, which has students attending pharmacy school for the first two years, the business school for one year, followed by one additional year in pharmacy school.
The University of Buffalo School of Pharmacy and Pharmaceutical Sciences and the School of Management has a five-year PharmD/MBA program that enables students to get their MBA in one year. The program currently has 32 students enrolled in various levels.
“The MBA offers an understanding of the business and financial aspects of pharmacy practice. Pharmacists run reports, but may have no idea what people do with those numbers, other than tracking results,” said Matthew Perri, director of the University of Georgia College of Pharmacy’s PharmD/MBA program and associate head and director of clinical and administrative pharmacy. “They will learn how report metrics are used in strategic planning and business analysis, and how the data we generate can impact both day-to-day decision-making and strategic decision-making. The data includes everything from inventory control to script counts, to the number of patients you gave flu shots to last year, to quality indicators.”
Pharmacists also are increasingly being relied upon to look at processes, to understand quality management and to provide guidance on how to improve systems for greater efficiency and safety.
“This takes many skills that go beyond clinical pharmacy practice, including managing a pharmacy. Managers must constantly be in the position to be able to give feedback and look for opportunities for improvement,” Perri said.
Management positions also entail being able to understand billing contracts.
“You have to be able to converse in accounting and finance language, you have to do contract management and contract negotiations. I needed to be able to read and understand billing contracts with group purchasing organizations and pharmaceutical companies,” Wellman said.
Karl Fiebelkorn, senior associate dean at the University of Buffalo School of Pharmacy and Pharmaceutical Sciences, said, “The addition of the MBA gives the students the knowledge in resource management, inventory, finance, marketing, and dealing with clients, as well as employees.”
He said the UB School of Management offers a set of electives called LeaderCORE, which focuses on polishing students’ business skills. The program also helps students to anticipate issues and problems of entrepreunership and to understand finances, such as how much money they have to borrow to open and run their own pharmacy.
Knowing how to run a pharmacy efficiently and cost-effectively is another crucial role retail pharmacists are tasked with.
Noting that many chain regional supervisors oversee some 20-to-30 pharmacies, Fiebelkorn said, “When students obtain the MBA, it opens their eyes to where to cut costs and save money in the pharmacy. An MBA teaches you efficiency. Saving seconds add up to minutes, which add up to saving hours.”
Obtaining a dual degree gives students an edge in the job market. Indeed, as more pharmacy schools opened their doors over the past few decades, employers have had more students to choose from.
According to the American Association of Colleges of Pharmacies, 14,502 PharmD degrees were conferred in 2017, up from 10,500 in 2008. Students understandably are looking to differentiate themselves in this fiercely competitive market, and they also are vying for higher-level opportunities early in their careers.
A 2017 study in the American Journal of Pharmaceutical Education, which surveyed combined pharmacy/MBA professionals, found that 85% of respondents believed that a combined degree helped in career advancement, and 90% said it made them more competitive in the job market.
Pointing out that chain-level executives have told the pharmacy school that many students don’t have enough management training, Perri said. “The MBA will fill that void. It creates an opportunity for advancement, and it will give you better skills to do a job better on a day-to-day basis from a business perspective,” she said. “It’s a great opportunity for our students to differentiate themselves in the marketplace and have skills that will be super helpful to them no matter what area of pharmacy they enter.”