Department of Pharmaceutical Health Services Research (PHSR) posts displayed by tag

School of Pharmacy’s Mullins to Establish Learning Health Care Community in Baltimore

C. Daniel Mullins, PhD, professor and chair of the Department of Pharmaceutical Health Services Research (PHSR) and director of the Patient-Centered Involvement in Evaluating the Effectiveness of Treatments (PATIENTS) Program at the University of Maryland School of Pharmacy, has been awarded a $250,000 investigator-initiated grant from Merck to develop guidance for an innovative Learning Health Care Community in West Baltimore. The project, titled “Co-developing Sustainable Learning Health Care Communities Using Community-Based Participatory Research,” aims to increase collaboration between patients and health care systems and promote greater health equity across the local area.

The grant will be used to support pilot work for future grants to implement recommendations from the guidance and create healthier communities in the neighborhoods located to the west of the University of Maryland, Baltimore (UMB) campus.

“As a member of the West Baltimore community, the School of Pharmacy has a responsibility to use our expertise in pharmacy education, research, and patient care to ensure that our neighbors are living healthy lives,” says Natalie D. Eddington, PhD, FCP, FAAPS, dean and professor of the school. “Under the direction of Dr. Mullins, the faculty and staff in the PATIENTS Program have been at the forefront of this work. This new initiative represents a natural evolution in the program’s efforts to empower patients to propose questions about their health care concerns and actively participate in studies to answer them. I am excited to see how this project helps transforms the way that individuals think about and participate in their health care.”

Building on a Proven Model

For their project, Mullins and his team will build on the Learning Healthcare System model developed by the Institute of Medicine, in which “science, informatics, incentives, and culture are aligned for continuous improvement and innovation, with best practices seamlessly embedded in the delivery process and new knowledge captured as an integral by-product of the delivery experience.” While a Learning Healthcare System focuses on using the best available evidence to tailor care to each patient’s unique needs while helping educate patients throughout the delivery of that care, the Learning Health Care Community will focus on establishing partnerships with churches, organizations, health care providers, caregivers, health care systems, and other area stakeholders to actively involve patients in the community in their health care. Community leaders will be critical in facilitating patient engagement in an environment centered on comfort and trust.

“The Learning Healthcare System model is an excellent way to ensure that patients and their health care providers are using evidence-based treatments; however, the current implementation approach for this model requires that patients enter into a health care system to be active participants,” Mullins says. “We want to engage patients and other individuals currently living in the community earlier in the process to understand how we might build upon the innovations and lessons learned from Learning Healthcare Systems to help prevent, rather than just effectively treat, illness and disease.”

To assist with the development of an innovative framework for a Learning Health Care Community that effectively addresses the diverse needs of underserved communities, Mullins and his team will assemble an advisory board that includes community members, patient and caregiver advocates, health care providers, and other stakeholders to help direct the research plan. Applying principles from the field of community-based participatory research, the team will work with partners in the PATIENTS Program to co-develop an interview guide that researchers will use to conduct focus groups and key informant interviews with the residents of West Baltimore, their health care providers, and other stakeholders.

By addressing the health needs of the community, the project will help alleviate joblessness and other socioeconomic challenges affecting local residents.

“The promise of jobs has not arrived in West Baltimore, and many residents who are able to get a job have not received the appropriate physical and mental health services necessary to help them keep their job, get promoted, or benefit from other employment opportunities,” Mullins says. “Our Learning Health Care Community combines individuals’ desire for a job with the reality that getting and keeping a job requires the skills and ability to work, and this includes being physically and mentally healthy.”

Creating a Plan for the Future

The research related to this project will conclude in December 2018. Findings will be shared with the community through a patient-centered dissemination strategy developed by the research team in collaboration with its community partners. Future work related to this effort will include implementing the plan of action developed with those findings and replicating the Learning Health Care Community model in other cities across the United States.

“The Learning Health Care Community will help ensure that people living in our community have access to quality health care and also have an opportunity to participate in their care,” says Jacqueline Caldwell, president of the Greater Mondawmin Coordinating Council. “They will be able to meet with a doctor who can help them and communicate with them in their own language so that they understand how to live healthier lives.”

“Having the Learning Health Care Community in our neighborhood will allow us to learn about our disease,” adds Gail Graham, director of HIV/AIDS outreach services for Mount Lebanon Baptist Church. “Instead of letting the doctors make all of the decisions, we will be able to learn about the disease and make decisions about our own health.”

— Malissa Carroll

To learn more about a Learning Health Care Community, watch this video.

Malissa Carroll Community Service, Research, UMB NewsFebruary 1, 20180 comments
Read More

Pharmacy Seminar Addresses Pain in Older Adults

The School of Pharmacy’s Peter Lamy Center on Drug Therapy and Aging and Palliative Care Collaborative hosted a half-day seminar on Jan. 11. Titled “Pain in Older Adults and the End of Life: Opening Pandora’s Box,” the seminar brought together pharmacists, physicians, residents, nurses, social workers, and students to discuss pain — sometimes referred to as the “fifth vital sign” — in older adult populations. Learning how to best manage pain for these vulnerable patients is vital for all health care professionals and students, because appropriate pain management for this population is often seen as an onerous task.

Setting the Stage

The seminar began with an introduction from Nicole Brandt, PharmD, MBA, BCPP, BCGP, FASCP, professor in the Department of Pharmacy Practice and Science (PPS) and executive director of the Lamy Center, who thanked the event sponsors, including the Geriatrics and Gerontology Education and Research Program (GGEAR) at the University of Maryland, Baltimore (UMB), Gilchrist, Johns Hopkins Geriatric Workforce Enhancement Program (JHGWEP), and Seasons Hospice. During the first session, Brandt and co-presenter Linda Simoni-Wastila, BSPharm, MSPH, PhD, the Parke-Davis Chair in Geriatric Pharmacotherapy in the school’s Department of Pharmaceutical Health Services Research (PHSR) and director of research for the Lamy Center, spoke about the struggle to balance pain management with the risk of opioid diversion in older adults. They dispelled the myth that substance use disorders solely affect the young adult population and discussed how older adults are typically excluded from clinical research trials, which greatly limits the amount of objective, peer-reviewed data that clinicians can apply to that population. Though the academic literature concerning older adults and substance use disorder is sparse, it was encouraging to learn that the Lamy Center is actively analyzing Medicare data to delve into this problem.

Passionate Presentations

In the second session, Danielle Doberman, MD, MPH, a hospice and palliative medicine specialist at Johns Hopkins Hospital, challenged the audience to engage patients in decisions about their own pain management. She introduced the “Ask, Tell, Ask” method that is being utilized for informed consent in certain fields. This technique allows health professionals to use their clinical expertise to guide treatment but ultimately leaves the final care decisions to the patient. By doing so, you are able to achieve realistic pain management goals and build trust with your patient.

Patient care plans are required in the long-term care setting, so Barbara Resnick, PhD, RN, CRNP, FAAN, FAANP, professor in the Department of Organization Systems and Adult Health at the School of Nursing, discussed how to motivate staff to incorporate pain management into practice. The final speaker of the day, Mary Lynn McPherson, PharmD, MA, MDE, BCPS, CPE, professor and executive director of advanced postgraduate education in palliative care in PPS, guided participants through an interactive evaluation of the risks and benefits of different pharmacologic agents for pain. The morning wrapped up with a thought-provoking town hall discussion moderated by Barbara Zarowitz, PharmD, FCCP, FCCM, BCPS, BCGP, FASCP, geriatric pharmacotherapy and clinical research consultant for the Lamy Center, concerning the challenges faced by health care professionals in pain management, gaps in research, and the troubling lack of treatment options for older adults struggling with substance use disorders.

Knowledge Gained and Future Aims

The opportunity to network with a wide variety of professionals was a welcomed component of the seminar. The melting pot of interprofessional attendees came from different academic backgrounds but were all passionate about caring for older adults. This made for a meaningful experience, as each attendee brought a unique viewpoint to the collective goal of understanding and optimizing medical treatment for older adults.

As “Pandora’s Box” was opened during the seminar, unique ways to consider and describe pain were revealed. While many realize that there are functional impacts of pain, far less understand or even recognize the emotional aspect of pain. Far too often, pain is thought of as an acute process, such as a simple stubbed toe. However, pain is truly a multicomponent experience, which can carry tremendous implications for a patient’s emotional well-being. This was a powerful emphasis that demonstrated the Lamy Center’s dedication and drive to improving not only the treatment, but also the conceptualization of pain.

The Lamy Center and the Palliative Care Collaborative continue to educate health professionals and students to meet the needs of an aging population. The center is dedicated to improving drug therapy for aging adults through innovative research, education, and clinical initiatives. Overall, it is important that we continue to advocate for legislation related to care of aging adults, establish methods to overcome current barriers, and establish partnerships among health care professionals when tackling the topic of pain in this vulnerable population.

This event was the first of a series of planned seminars to highlight these topics. If you are interested in learning more about the Lamy Center, the Palliative Care Collaborative, or upcoming events, please visit the Lamy Center website or email Brandt at

Max Ditlevson, Elias Inscoe, Rachel Lumish, Joseph Martin, and Pamela Younes

Joseph Martin Clinical Care, EducationJanuary 19, 20180 comments
Read More

Choosing the Right Health Services Research Graduate Program

All health services research graduate programs aim to provide students with the theory, practical experience, and decision-making skills needed to address a wide range of health services-related problems affecting the world. However, because this field can encompass many different areas of interest, choosing the graduate program that will help you achieve your unique professional and personal goals can be challenging.

As the graduate program coordinator for the Department of Pharmaceutical Health Services Research (PHSR) at the School of Pharmacy, I have assisted dozens of students in navigating the options available for graduate education in this dynamic field. Based on those experiences, I have come up with five tips from which I think all prospective students can benefit. It is my hope that these tips not only help you choose the advanced degree program in health services research that is right for you, but that they also help you learn more about yourself and the type of research you are interested in pursuing.

Tip No. 1: Understand Your (Research) Options

Health services research is a broad term used to describe research that examines how people gain access to health care, how much that care costs, and what happens to those individuals as a result of the care received. It incorporates elements from a number of disciplines, including pharmacy, medicine, geography, public health, public policy, economics, epidemiology, and biostatistics — just to name a few. To determine which health services research graduate program is right for you, you will need to identify which area of health services research you would like to pursue and choose a program that offers specialization in that area. The Department of Pharmaceutical Health Services Research at the School of Pharmacy offers an MS in PHSR and a PhD in PHSR that offer students the opportunity to specialize in four areas:

  • Comparative Effectiveness and Patient-Centered Outcomes Research: Research that compares different health care and treatment approaches to help patients and providers make more informed decisions.
  • Pharmaceutical Policy: Research that examines local, state, and national policies governing the development, provision, and use of medications within a health care system.
  • Pharmacoeconomics: Research that examines the trade-offs in health outcomes and costs associated with the use of therapies, devices, and adherence programs.
  • Pharmacoepidemiology: Research that analyzes the prevalence and use of pharmaceuticals in large populations as well as the health outcomes associated with medication utilization.

Tip No. 2: Location, Location, Location!

Unlike your experience as an undergraduate, which likely focused on the time that you spent in the classroom, pursuing a graduate education will present you with numerous opportunities to establish a professional network outside of the classroom through research collaborations, internships, and conferences. The location of the college or university at which you complete your advanced degree will play an important role in determining the types of professional experiences available to you. Choose a program housed within a college or university that is located in close proximity to other institutions that can help you build your professional network and advance your career after graduation.

The School of Pharmacy is one of six professional schools (dentistry, law, medicine, nursing, and social work are the others) and a graduate school located at the University of Maryland, Baltimore (UMB), a thriving center for life sciences research and community service. We are located in the fourth-largest biotechnology hub in the United States, a short drive away from prestigious institutions such as the National Institutes of Health (NIH) and the Food and Drug Administration. Many students in our MS in PHSR and PhD in PHSR programs engage in research collaborations and pursue internships with these institutions.

Tip No. 3: Follow the Funding

The amount of available financial assistance is an important consideration for any prospective graduate student when selecting the program to which he or she would like to apply. One of the reasons that the PhD in PHSR program at the School of Pharmacy remains so competitive is that we are able to offer students accepted into our program fully funded financial support, including a stipend of $25,000. When added to tuition remission, health insurance, and student fees, the total amount of support provided to each student is worth about $38,000 per year. Our students also continuously receive competitive fellowships and awards from organizations such as the American Foundation for Pharmaceutical Education and the NIH to help offset other costs that they might incur during their time in the program.

Tip No. 4: Learn from the Best

To ensure your success as a future health services researcher, you want to learn from faculty who have established themselves as national and international leaders in the field. Students enrolled in our MS in PHSR and PhD in PHSR programs benefit from a highly collegial, complementary, and collaborative atmosphere, learning from more than a dozen faculty members who are recognized experts in the areas of comparative effectiveness and patient-centered outcomes research, pharmaceutical policy, pharmacoeconomics, and pharmacoepidemiology, and who have received millions of dollars in grants and contracts from some of the world’s leading health services research organizations.

Tip No. 5: Think About the Future

You won’t be a graduate student forever. The graduate program in which you enroll should begin preparing you to enter the field as a competent researcher from the first day you attend class. As you research available programs and meet with faculty and staff, be sure to ask about the careers that students have pursued after their time in the program. Graduates of the PhD in PHSR program at the School of Pharmacy have obtained highly competitive positions in universities, pharmaceutical companies, and government agencies across the country.

Ready to Take the Next Step?

If you have done your research and are confident that the MS in PHSR or PhD in PHSR program at the School of Pharmacy is the perfect fit for you, I encourage you to begin the application process by visiting the program’s website. The deadline to submit your application for the PhD in PHSR program is Jan. 3, 2018, while the deadline for the MS in PHSR program is April 1, 2018.

If you have questions, feel free to reach out directly via email to the PhD in PHSR or MS in PHSR program. Both programs welcome your questions and comments.

Colleen Day, PHSR graduate program coordinator

Colleen Day EducationDecember 1, 20170 comments
Read More

Scholarship Awards Recognize Up-and-Coming Health Services Researchers

The Department of Pharmaceutical Health Services Research (PHSR) at the University of Maryland School of Pharmacy hosted its Graduate Program Awards Presentation and Reception on Oct. 2 to present the Donald O. Fedder Memorial Fellowship, the Harris Zuckerman Scholarship Award, and the Arthur Schwartz Memorial Scholarship to eight exceptional students in its PhD in PHSR program. The event recognized students who received the awards in the 2015-2016, 2016-2017, and 2017-2018 academic years.

“These student awards were established by individuals or families who shared special relationships with the PhD in PHSR program at the School of Pharmacy,” said Francis Palumbo, PhD, JD, professor in PHSR and director of the program. “We present these awards to outstanding students each year as a way to share their legacies with future generations of health services researchers.”

Promoting Social Justice, Pharmacy Advocacy, and Public Health

Established by Michaeline Fedder in honor of her husband Donald Fedder, DrPH, MPH, BSP, FAPhA, a public health pharmacist and longtime faculty member at the School of Pharmacy who passed away in 2010, the Donald O. Fedder Memorial Fellowship supports the training and development of a graduate student whose work focuses on social justice, pharmacy advocacy, or public health. At the event, Elisabeth Oehrlein; Melissa Ross, PhD, who graduated from the PhD in PHSR program in May 2017; and O’Mareen Spence — the 2016, 2017, and 2018 recipients of the award, respectively — had an opportunity to share their journey in the program, as well as give an overview of their current research, with members of the audience.

“Since joining this program, my work engaging patients has shown me firsthand how the experience of receiving a serious or chronic diagnosis can affect patients,” said Oehrlein, who spoke about the parallels between her research in risk factors for stroke among patients diagnosed with atrial fibrillation and the research conducted by Fedder more than 20 years ago. “Working with claims data, it can be easy to forget that there is a real person behind every diagnosis code or outcome. So when you’re working with claims, please remember that every time you see a diagnosis code for stroke, atrial fibrillation, or any other disease area that you might work in, there is a real person behind that diagnosis whose life was forever changed as a result of it. That experience can be incredibly scary. I think remembering this can help us conduct the highest quality research.”

Becoming Clinician-Researchers

The Harris Zuckerman Scholarship Award was endowed by Ilene Harris, PharmD ’83, PhD, retired professor and chair of PHSR, to assist students interested in jointly pursuing Doctor of Pharmacy (PharmD) and PhD degrees. Named in honor of her parents — Daniel Harris, MD, and Ann Harris — the scholarship provides support for the training, development, and advancement of graduate students in the PhD in PHSR program. Students Aida Kuzucan, PharmD ’15; Anna Hung, PharmD ’14; and Joey Mattingly, PharmD, MBA, who also serves as an assistant professor in the Department of Pharmacy Practice and  Science (PPS), were recognized at the event as the 2016, 2017, and 2018 recipients of the award, respectively.

Accepting the award, Mattingly spoke about his experience as a teenager and young adult watching his grandmother, whom he affectionately referred to as “mammaw,” cope with multiple chronic illnesses, particularly the expenses that she and his grandfather incurred as a result of the medications she was prescribed. Although Mattingly explained that his grandmother passed away during his first year in pharmacy school, he noted that he plans to use the funds from the scholarship award to help support his research and “help mammaws around the world.”

Realizing a Lifelong Dream

As the first student admitted to the PhD in PHSR program, Arthur (Artie) Schwartz demonstrated great interest in drug use and pharmaceutical marketing issues. After his death at an early age, his wife, Karen Schwartz, established the Arthur Schwartz Memorial Scholarship to provide funding for future students in the program based on academic standing and financial need. Students Jan Sieluk, MPharm, and Aakash Gandhi were celebrated as the 2016 and 2018 recipients of the scholarship, respectively.

“When I was a little kid, my father traveled to Denver and bought a huge map of the United States,” recalled Sieluk, a native of Poland whose current research focuses on the costs associated with chronic obstructive pulmonary disease (COPD) caused by alpha-1 antitrypsin deficiency, a genetic condition that can result in serious lung disease in adults or liver disease at any age. “That map ended up over my bed. I looked at it every morning when I woke up and every night before I went to bed. I knew that I needed to be part of this country. After graduating from the Medical University of Warsaw, I reached out to C. Daniel Mullins, PhD, professor and chair of PHSR. I thank him for bringing me here, nominating me for this award, and helping to make my American dream come true. I will be forever indebted to him.”

Palumbo, accompanied by each student’s mentor, presented the recipients with their awards.

“Our department is humbled by the generous support of the Fedder, Harris, and Schwartz families, whose gifts help to alleviate the financial challenges that our students must often overcome in the pursuit of their education,” Palumbo said. “The students recognized today have demonstrated remarkable drive and dedication in both their studies and research and are truly deserving of these distinguished awards. We look forward to all that they are sure to accomplish as they leave our program prepared to enter the dynamic field of health services research.”

Malissa Carroll


Malissa Carroll Education, People, UMB NewsNovember 1, 20170 comments
Read More

Study Finds Link Between Antidepressants and Type 2 Diabetes in Youths

A team of researchers from the University of Maryland School of Pharmacy and the University of Maryland School of Medicine found that current (prolonged) use of serotonin reuptake inhibitors — a major class of antidepressant medications — in children and adolescents was associated with a nearly twofold increased risk of developing Type 2 diabetes when compared to youths who formerly used (but eventually discontinued) those medications. Published in JAMA Pediatrics, this is the first population-based study that comprehensively examines pediatric patients’ risk of developing Type 2 diabetes after beginning treatment with an antidepressant.

“Antidepressants are one of the most commonly used psychotropic medication classes among youth in the United States, with serotonin reuptake inhibitors representing a majority of total antidepressant use in this population,” says Mehmet Burcu, PhD, a May 2017 graduate of the doctoral program housed within the Department of Pharmaceutical Health Services Research (PHSR) at the School of Pharmacy, who led the study for his dissertation. “These findings provide new information on the risk of a rare but serious adverse outcome that is often difficult to assess in clinical trials due to limited sample size and inadequate follow-up.”

According to Burcu and his team, there has been a marked increase in the percentage of children and adolescents in the United States who use antidepressants over the past two decades — from 1.5 percent in 1996-1998 to 2.6 percent in 2010-2012. This increase has been largely driven by a rise in the number of antidepressants prescribed by pediatricians and other primary care providers. Although a number of studies have demonstrated a link between antidepressant use and risk for Type 2 diabetes in adults, evidence of a similar risk among children and adolescents remains limited.

For their study, Burcu and his team analyzed Medicaid administrative claim files for nearly 120,000 children and adolescents between the ages 5 of and 20 from California, Florida, Illinois, and New Jersey, who initiated treatment with an antidepressant between Jan. 1, 2005, and Dec. 31, 2009, for conditions such as depressive disorder, attention-deficit/hyperactivity disorder, and anxiety disorders. Medications that patients were prescribed included serotonin reuptake inhibitors, tricyclic or other cyclic antidepressants, and other antidepressants.

The team applied rigorous design and statistical approaches to compare incident cases of diabetes in current antidepressant users to former users, rather than non-users (children and adolescents who were never prescribed an antidepressant). “This approach represented a methodological strength of our study, as the comparison of current users to non-users could potentially lead to biased estimates due to several factors, such as confounding by indication and medical care utilization intensity bias,” Burcu says.

In its analysis, the team uncovered 233 incident cases of Type 2 diabetes, of which 156 occurred during current use and 77 occurred during former use of antidepressants, demonstrating that current use of antidepressants in children and adolescents was associated with a twofold increased risk of developing Type 2 diabetes.

In addition, within current users, the team assessed the risk of incident diabetes according to duration of use, cumulative dose, and average daily dose. This secondary analysis showed that the risk for children and adolescents who were prescribed serotonin reuptake inhibitors further intensified with an increasing duration of use (long-term use), cumulative dose, and average daily dose.

“The increased risk of Type 2 diabetes following prolonged use of serotonin reuptake inhibitor antidepressants in youth is clearly supported by these findings, with the data showing a greater effect on those youths who were prescribed the medications over longer durations and at higher doses,” says Daniel J. Safer, MD, associate professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine and adjunct professor at the University of Maryland School of Medicine, who has practiced for more than 40 years in the field of child psychiatry and is a co-author of the study. “We know that long-term use of these antidepressants is not without risk, and further research on outcomes, especially for current, long-term users, is warranted to assure a favorable benefit-risk balance for patients.”

“I am proud of Dr. Burcu’s ability to use the most sophisticated methods available to address the question of whether antidepressant use in children elevates their risk for developing Type 2 diabetes,” adds Julie Zito, BSPharm, PhD, professor in PHSR, who served as Burcu’s advisor and is a co-author on the study. “The nested cohort approach that he employed offers a fair comparison of those children who are currently using an antidepressant versus those children who previously used an antidepressant. It helps reduces bias in the research, which is often a challenge with safety studies such as this.”

Burcu and his colleagues hope their study paves the way for further research on the biological mechanisms underlying the relationship between antidepressant use and increased risk for Type 2 diabetes in children and adolescents, noting that their results can be used to spur policy development to improve patient monitoring and ensure these medications are used safely and effectively.

Malissa Carroll Research, UMB NewsOctober 23, 20170 comments
Read More

Study Raises Ethical Concerns in Antibiotic Trials

A team of researchers led by Peter Doshi, PhD, assistant professor in the Department of Pharmaceutical Health Services Research (PHSR) at the University of Maryland School of Pharmacy, has found that randomized clinical trials for antibiotics often fail to accurately inform patients about the purpose of those trials. Published in JAMA Internal Medicine, the study raises concerns about the ethics of informed consent, specifically in antibiotic trials.

“Obtaining informed consent from potential research participants is paramount to conducting ethical research involving humans,” Doshi says. “The foundational ethical texts, like the Declaration of Helsinki and Belmont Report, are clear that the purpose of a trial must be clearly explained to participants. Our study aimed to examine how often the trial’s purpose was explained to potential participants in clinical trials for antibiotics.”

‘Superiority’ vs. ‘non-inferiority’

Clinical trials that compare an experimental therapy against an existing therapy can evaluate the “superiority” or “non-inferiority” of the potential new treatment. While superiority trials are designed to determine whether the new treatment is more effective than an older treatment, non-inferiority trials accept that a new treatment can be less effective than an older treatment if it offers an added benefit to the patient, such as fewer side effects. For the study, Doshi and his colleagues examined six superiority trials and 72 non-inferiority trials (78 trials total) from the European Medicines Agency conducted between 1991 and 2011.

“Because of the very different trade-offs between efficacy and harm, informed consent should differ between superiority and non-inferiority trials,” Doshi says. “However, to our knowledge, there has never been a systematic evaluation of the information provided to potential research participants to determine whether the information provided is sufficient to distinguish the differing study purposes of superiority and non-inferiority trials.

“If patients assume that the hypothesis of the study in which they are enrolled is a superiority trial that is actually a non-inferiority trial, or vice versa, they may incorrectly assess the balance of benefits and harms to which they may be exposed based on the study’s intended purpose.”

The issue of informed consent

Three patient investigators and two methodologists on Doshi’s research team reviewed the informed consent forms (ICFs) from 50 trials to assess whether those forms clearly communicated the intended purpose of the study to patients. The patient investigators were asked to determine if the purpose of the study was to evaluate whether a new drug was more effective than an older drug or just not substantially worse than the older drug, while the methodologists were asked to determine if the forms clearly indicated whether the trial was a superiority or non-inferiority trial.

The methodologists found that only one of the 50 trials clearly conveyed the study’s purpose, while the patient investigators identified 11 trials that conveyed the study’s purpose. From the 11 trials identified by the patient investigators, seven were found to accurately explain the purpose of the study, with four inaccurately stating the purpose when compared with the reference standard.

None of the ICFs consistently conveyed the study’s intended purpose to both the methodologists and patient investigators.

“Although all of the ICFs examined in our research included a section that described the study’s purpose, neither our patient investigators nor our experienced methodologists could determine what that purpose was for the majority of the trials,” Doshi says. “These results make it clear that investigators need further guidance on how to ensure that ICFs clearly communicate the intended purpose of a study to patients – and our paper offers some example language.”

A look at the big picture

Doshi and his colleagues also examined whether the researchers who conducted the non-inferiority trials provided justification for what benefit was hypothesized as possibly more favorable to patients than increased effectiveness. The team reviewed the protocols or statistical analysis plans (SAPs) for all of the non-inferiority trials included in their study, identifying only one trial that provided a rationale for its selection of non-inferiority criteria.

The team also assessed that the explanation study documents provided for the degree of decreased efficacy deemed “clinically acceptable” based on the study’s hypothesis; however, they found that none offered a clinical rationale for the chosen amount of decreased effectiveness, and in no case was there any mention that patient input was sought.

“Based on our results, it appears that patients enrolling in clinical trials for antibiotics are not accurately informed of their study’s intended purpose,” Doshi concludes. “In fact, because non-inferiority trials do not aim to demonstrate the superior effectiveness of new treatments and entail trade-offs of hypothesized lesser efficacy for other benefits, our study raises fundamental questions of the ethics of consent in antibiotic trials and the ethical rationale for non-inferiority hypotheses in life-threatening infections for which effective current standard-of-care therapy exists.”

Malissa Carroll Research, UMB NewsSeptember 18, 20170 comments
Read More
Shark Tank Feature

Shark Tank Competition Celebrates Pharmapreneurial Innovation

The University of Maryland School of Pharmacy hosted a Shark Tank-style competition on June 15 to showcase the pharmapreneurial talent of faculty across its Departments of Pharmaceutical Health Services Research (PHSR), Pharmacy Practice and Science (PPS), and Pharmaceutical Sciences (PSC). The competition celebrated the School’s recently launched pharmapreneurism initiative, which describes its commitment to supporting and best positioning faculty, staff, and students to achieve their career aspirations and address the nation’s health care, research, policy, and societal needs, and awarded $50,000 to three winning teams – one team from each department – to help support their pioneering projects.

“Pharmapreneurism provides the School of Pharmacy with a mechanism through which we can capitalize on our entrepreneurial spirit to improve pharmaceutical research, practice, and education in the state of Maryland, the nation, and the world,” says Natalie D. Eddington, PhD, FCP, FAAPS, dean and professor of the School. “I was awestruck by the amount of time, thought, and dedication that our faculty members put into their presentations for this Shark Tank-style competition. The innovative thinking demonstrated by our winning teams will undoubtedly drive additional pharmapreneurial endeavors across the School and help position us as the premier entrepreneurial pharmacy school in the nation.”

Access to Information

Wendy Camelo Castillo, MD, MSc, PhD, assistant professor in PHSR; Danya Qato, PharmD, MPH, PhD, assistant professor in PHSR; and Linda Simoni-Wastila, BSPharm, MSPH, PhD, the Parke-Davis Chair in Geriatric Pharmacotherapy and professor in PHSR, were the first to take a bite out of the competition with their proposal for a project that would link two national health and pharmaceutical claims datasets – Medicare and Medicaid – to help researchers better understand the course of pharmaceutical access, health care utilization patterns, and health outcomes among people with disabilities.

Their ultimate goal is to use the data to establish a multidisciplinary, patient-centered research collaborative within PHSR to identify disparities in access to and quality of care in patients with disabilities and design novel approaches to overcome those disparities.

“We are thrilled to have been selected as the winning team for our department in the School’s Shark Tank competition,” says Simoni-Wastila. “Our project truly embraces the spirit of pharmapreneurism and situates us to take the lead in informing policies and programs that support the hypervulnerable population of patients with disabilities. The unique linkage of Medicare and Medicaid datasets on the national scale will allow us to map the tremendous, yet neglected needs of this population and empower us to advocate for unified efforts to bridge the gaps in their care. We will establish the School of Pharmacy as a trailblazer in disabilities research.”

Interactive Learning

Kimberly Claeys, PharmD, BCPS, assistant professor in PPS; Emily Heil, PharmD, BCPS AQ-ID, AAHIVP, assistant professor in PPS; and Neha Sheth Pandit, PharmD, BCPS, AAHIVP, associate professor and vice chair for research and scholarship in PPS, also made a splash during the competition with their proposal to develop novel, engaging training tools for students studying the spectrum of antimicrobial activity and antimicrobial stewardship using an interactive app-based platform.

Antimicrobials include any substance that kills or stops the growth of microorganisms, but causes little or no damage to the host.

In their presentation, the team noted that although digital learning tools are currently in-demand, no such tools specific to the spectrum of antimicrobial activity exist. They suggested that once these tools are developed, they could be used as educational supplements at schools of pharmacy, medicine, and nursing nationwide, with the ultimate goal of increasing student knowledge.

“All of the proposals presented at the Shark Tank competition were phenomenal, so it is truly an honor to be named the winning team for our department,” says Claeys. “With bacteria continuing to develop resistance to even the strongest antibiotics available, antimicrobial stewardship is urgently needed to help guide appropriate antimicrobial use and prescribing in all health care settings. By developing a visual-based, interactive tool to serve students across all health professions who are studying the antimicrobial spectrum, we hope to position the School of Pharmacy as an innovator in the development of app-based learning tools.”

A New Center for Research

Lastly, Angela Wilks, PhD, and Sarah Michel, PhD, professors in PSC, proved they did not have to fish for compliments with their proposal to establish a new research center at the School of Pharmacy focused on metalloprotein (proteins that require a metal ion) and metallotherapeutics research. Aptly named the Metallotherapeutics Research Center (METRC), the center would aim to improve human health and welfare locally, nationally, and internationally by identifying new metalloprotein drug targets, developing new metal therapeutics, and improving current metal-based medications.

Presenting their proposal to the audience, Wilks and Michel noted that, although metalloproteins have been implicated in a number of diseases, including cardiovascular disease, diabetes, and cancer, their function and role in these illnesses remains largely unknown. METRC brings together the expertise of numerous faculty members from PSC to not only develop new metallotherapeutics, but also to train future scientists to meet the needs of industry and government agencies in this critical field.

“Having this opportunity to share an idea that has been on our minds for some time, and to discover that others find it just as exciting as we do was tremendously gratifying,” says Wilks. “Oftentimes, expertise in metalloproteins and metallotherapeutics is siloed in traditional chemistry and biochemistry departments, where there is no access to pharmacologists, toxicologists, and pharmaceutical scientists. By disrupting this discipline-centric approach to academic departments and centers, METRC not only addresses a gap in the area of drug development and regulatory sciences, but will also position the School of Pharmacy as a nationally and internationally recognized leader in research on metals in medicine and the environment.”

Each winning team received $50,000 to help fund its proposed pharmapreneurial project. Other faculty members who participated in the competition included Susan dosReis, BSPharm, PhD, professor in PHSR; Ebere Onukwugha, MS, PhD, associate professor in PHSR; Magaly Rodriguez de Bittner, PharmD, BCPS, FAPhA, professor in PPS; Vijay Ivaturi, MS, PhD, assistant professor in PPS; Joey Mattingly, PharmD, MBA, assistant professor in PPS; Brent Reed, PharmD, BCPS-AQ Cardiology, FAHA, associate professor in PPS; Bruce Yu, PhD, professor in PSC; and James Polli, PhD, the Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics in PSC.

Malissa Carroll Education, Research, Technology, UMB NewsJuly 21, 20170 comments
Read More
Opoid Overdose Training

Empowering Students to End the Cycle of Addiction

There is no question that the opioid crisis in Maryland has reached epidemic proportions. In the first three quarters of 2016, the state reported 1,468 unintentional deaths caused by substance abuse, with a majority of the fatalities attributed to heroin and fentanyl. In the same period, there were approximately 500 deaths reported in Baltimore City alone, an increase from approximately 300 the previous year. With overdose numbers this staggering, individuals working in public health and clinical health care have started to wonder what more can they do to address this problem.

Through the Emerging Leaders program, I met an individual from the School of Nursing who invited me to join the planning committee for the Baltimore Area Health Education Center’s (BAHEC) Interdisciplinary Training on Opioid Overdose. We organized an event called “Empowering Students to End the Cycle of Addiction,” which took place on April 8, 2017. Students, staff, and faculty, representing the Graduate School and the Schools of Law, Medicine, Nursing, Pharmacy, and Social Work at the University of Maryland, Baltimore (UMB), came together to learn about the opioid epidemic in Baltimore City and to discuss their professional and personal roles in reducing opioid overdoses. Attendees also left the training certified to administer naloxone – a lifesaving drug that can reverse opioid overdoses.

Preparing Students to Save Lives

The day began with an eye-opening presentation from David Richard Fowler, MD, chief medical examiner for the state of Maryland, in which he presented data on the number of overdose deaths. He discussed the implications that this public health crisis is having on his office, noting that the increase in fatalities has caused a huge strain on his office’s human resources.

Next, Miriam Alvarez, the opioid education and naloxone distribution (OEND) outreach program coordinator at Behavioral Health Systems Baltimore, provided an inspired naloxone training. She engaged the audience by asking questions about their knowledge of opioids and their ability to recognize the signs of an opioid overdose. She stressed that while opioid misuse was once considered a low income, inner-city problem, it affects individuals from all walks of life, and we should all be prepared to respond in the event that we witness an overdose.

Representing the School of Pharmacy, Fadia Shaya, PhD, MPH, professor and vice chair for academic affairs in the Department of Pharmaceutical Health Services Research (PHSR) and director of the Behavioral Health Research Team, discussed the pharmacist’s role in preventing opioid overdose. She spoke about Maryland’s naloxone standing order, which allows registered pharmacists to dispense naloxone without a prescription and discussed different measures that pharmacists and pharmacies can take to ensure that they are actively involved in preventing opioid misuse, including an explanation of the risks of prescription opioids with patients and querying the Prescription Drug Monitoring Program (PDMP) before filling a prescription. Shaya closed her presentation by mentioning a variety of public health prevention programs on which her team works related to this issue.

Making the Discussion Hit Home

Following the presentations, faculty from the medical, dental, and social work schools presented students with a case study that profiled a young man who began misusing prescription opioids following a sports injury, and subsequently developed a dependency on heroin. Faculty encouraged students to identify areas of health care intervention, which sparked a lively discussion among attendees. The event closed with Mellissa Sager, JD, staff attorney at the School of Law, presenting an overview of the Good Samaritan Law and an update from a Baltimore City Health Department representative, who described the city’s response to the opioid overdose epidemic.

This training proved to be a huge success, with more than 55 students attending the Saturday morning training to take action on this important issue. Considering the interest in this event and the urgency of this public health epidemic, the BAHEC plans to host another training in the fall. Everyone at UMB has a role to play in reducing opioid overdoses, and this event provided an opportunity for students, faculty, and staff to become more empowered to do so.

Marianne Gibson Clinical Care, Collaboration, Community Service, Education, For B'more, Global & Community Engagement, People, UMB News, University Life, USGAApril 24, 20171 comment
Read More
Sarah Tom

New Study Will Examine Environment and Dementia Risk

Sarah Tom, PhD, assistant professor in the Department of Pharmaceutical Health Services Research (PHSR) at the University of Maryland School of Pharmacy, recently received a five-year, $475,000 career development award from the National Institute on Aging to examine the relationship between individuals’ early life social environment and risk for developing Alzheimer’s disease and related dementias later in life. Incorporating data from several geographically diverse populations, the study aims to understand whether an advantaged early life social environment correlates to increased cognitive reserve and, subsequently, increased ability to buffer (protect) against symptoms associated with Alzheimer’s disease and related dementias later in life.

Advancing the Study of Dementia

Cognitive reserve is the term used to describe the ability of some individuals to function at a cognitively normal level despite the physical presence of significant disease in the brain.

“As our understanding of dementia has evolved, researchers have discovered a complex relationship between the physical presence of brain disease and the onset of symptoms associated with the disease,” says Tom. “This study is unique in its aim to understand how early life experiences can influence brain health into older adulthood. We know that brain development occurs at an accelerated rate through age five, so early life could be a sensitive period for the development of cognitive reserve. In fact, individuals with an advantage by age five might enjoy a lifelong advantage in terms of their ability to buffer against or delay the onset of symptoms for Alzheimer’s disease and other dementias.”

Dementia describes a decline in mental ability severe enough to interfere with an individual’s daily life. Alzheimer’s disease is the most common form of dementia. According to the Alzheimer’s Association, one in three seniors dies with Alzheimer’s disease or another dementia. Previous studies have uncovered a correlation between a disadvantaged early life social environment and individuals’ risk for developing Alzheimer’s disease and related dementias. However, it remains unclear whether an advantaged early life social environment correlates to increased cognitive reserve or lower levels of neuropathology (brain disease) altogether.

Studying Diverse Populations

Tom and her research team will analyze four datasets from geographically diverse populations to complete the study: the Adult Changes in Thought Study, the Honolulu Asia Aging Study, the Religious Orders Study, and the Memory and Aging Project. The data include measures related to social environment that typically indicate opportunities to build cognitive reserve, including parental education, parental occupation, height, head circumference, and number of household members. “The opportunity to work with diverse populations means that we will be able to test our hypotheses across people with varying social experiences,” says Tom.

In addition to helping Tom and her team evaluate the effect of an individual’s early life social environment on his/her cognitive reserve, the data will provide insight into the role that the adult social environment plays in building and maintaining cognitive reserve.

Helping People Stay Healthy Longer

Tom notes that she hopes one important finding from the study will be a better understanding of the factors that individuals can modify to help ensure optimal brain health later in life.

“When we think about how to prevent or delay the onset of dementia, evidence suggests that waiting until symptoms are evident is likely too late,” says Tom. “We know that what happens to us as children is an important indicator for what might happen in adulthood, and perhaps investment in early childhood development programs may make sense not only for our health in childhood, but also for our health in adulthood. We hope that the results of our study will illuminate opportunities that we can implement earlier in the life course to help decrease dementia risk in older adults.”

Malissa Carroll Education, People, Research, UMB NewsMarch 3, 20170 comments
Read More

HSF III Electrical Work Schedule

Over the coming months, electrical ductbank work will be done to the Health Sciences Facility (HSF) III building.

Phase 1

Work will take place within the HSF III construction site with a slight narrowing of Pine Street in front of the School of Pharmacy from Oct. 24 to mid-November.

Phase 1A

Half of the Josephine Alley, Recycling Center parking lot will be closed for three months starting Oct. 24. Josephine Alley will be closed to through traffic from Nov. 1 to mid-January.

Phase 2

A section of the Lexington Street sidewalk (north side) will be closed for one week on the west side of Koesters Lot. Some parking spaces will be temporarily relocated from Nov. 1 to mid-December.

Phase 3

The Lexington Street sidewalk (south side) in front of Pascault Row and the grassy area along Pine Street will be closed to pedestrian traffic and will be open only for emergency egress from Pascault Row from November through March. Residents need to use the south entrances. One lane of parking will be lost during construction.

Phase 4

One lane of parking will also be closed along the Pine Street sidewalk (east side) from Vine Street to Fayette Street from March to May. The Fayette Street roadbed at Pine street intersection will require lane closures.

Need to Know

  • The west side of the Pine Street sidewalk will remain open at all times.
  • The south side of the Fayette Street sidewalk, adjacent to HSF III, will reopen Jan. 1 with new pedestrian lighting.
  • Demolition of the Carter Center by the hospital can start as early as January. The exact date is still to be determined.
  • This schedule may change based on weather or unforeseen site conditions.
Clare BanksBulletin Board, People, University Administration, University LifeOctober 26, 20160 comments
Read More

Beloved PHSR Professor Retires

After dedicating 16 years of her career to teaching, conducting research, and mentoring students at the University of Maryland School of Pharmacy, Francoise Pradel, PhD, professor in the Department of Pharmaceutical Health Services Research (PHSR), retired from the School at the end of December.

“Since joining the faculty at the School of Pharmacy, Dr. Pradel has proven to be an outstanding academic citizen,” says Natalie D. Eddington, PhD, FCP, FAAPS, dean and professor of the School. “She has served as the chair of numerous committees as well as director of the PhD in PHSR program on two occasions. Her pioneering research examining the environmental, behavioral, and psychosocial factors that influence patients’ health care decision-making has helped researchers around the world understand that it is patients who hold the key to ensuring that health care professionals are able to deliver effective treatments and care. I congratulate her on her retirement and wish her all the best as she begins the next chapter of her life.”

A Second Career

A native of France, Pradel is a graduate of the University of Paris XI School of Pharmacy. She and her husband owned and managed a community pharmacy before immigrating to the United States, where she earned both her master’s degree in pharmaceutical policies and evaluative sciences and her doctorate in public health from the University of North Carolina at Chapel Hill. Pradel joined the faculty at the School of Pharmacy as an assistant professor in 1999. Her most recent research examined the role of health literacy and information needs on medication adherence among kidney transplant patients.

“I remember meeting Dr. Pradel when she was a graduate student, and have always been impressed by both her excellence in research and teaching as well as her unwavering commitment to helping others,” says C. Daniel Mullins, PhD, professor and chair of PHSR. “I was thrilled when she joined the faculty at the School of Pharmacy, and was honored to serve as a mentor to her early in her career. Our department will miss her friendly smile as well as her exemplary work in public health research, training, and outreach.”

Far-Reaching Impact

Pradel was promoted to associate professor with tenure in 2005, and later to professor in 2013. She has mentored more than 20 graduate students and provided support and guidance to numerous students in the School’s Doctor of Pharmacy (PharmD) program.

“It has been a pleasure having Dr. Pradel as a colleague over the years,” says Frank Palumbo, PhD, JD, professor in PHSR and director of the PhD in PHSR program. “She has been a great friend to many of us, and was always willing to assist or collaborate with us no matter the amount of time and effort required of her. I truly wish her the best in her well-deserved retirement.”

“I feel fortunate to have been able to work with Dr. Pradel in many capacities over the past decade,” adds Michelle Campbell, PhD ’14, a social science analyst at the Food and Drug Administration and one of Pradel’s former graduate students. “As my professor, advisor, dissertation chair, and co-investigator, Dr. Pradel has mentored me both personally and professionally. She is one of the most influential people in my life, and I strive each day to be the person that she taught and expects me to be.”

Life Outside the School

In addition to her teaching and research commitments at the School, Pradel served as the state evaluator for the Maryland Strategic Prevention Framework initiative, which works to reduce underage and binge drinking and alcohol-related crashes among youth, as well as opioid misuse and overdoses. She was also involved with the International Pharmaceutical Federation (FIP), serving as a member at-large in the Pharmacy Information section of the organization’s Executive Committee.

“I have known Dr. Pradel for nearly 15 years, ” says Linda Simoni-Wastila, BSPharm, MSPH, PhD, professor and vice chair of research in PHSR. “She is a person of integrity and honesty. She also has a true public health heart, and has never lost sight of the true purpose of her work. I appreciate her generous spirit and her willingness to lend a helping hand to her colleagues when needed.”

On Dec. 11, a special reception to celebrate Pradel’s career was held at the School of Pharmacy.

“Deciding to retire after spending 16 years at this wonderful institution was incredibly bittersweet,” said Pradel. “The sense of friendship, collegiality, respect, and trust fostered among the faculty in PHSR is unlike anything that I ever experienced before coming to the School of Pharmacy. As professionals, we spend a lot of time in the office, and I feel fortunate to have spent my time at a place where I truly enjoyed coming to work each day. I hope that my colleagues continue their great work and know that I will miss them dearly as I begin the next chapter of my life.”

Malissa Carroll Education, People, UMB NewsJanuary 12, 20160 comments
Read More