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March 9, 2018

Competitive Cyclist Races to Advance Pharmacy Practice

Editor’s Note: This story is part of a special series examining the growing number of women in pharmacy leadership.

Adrenaline junkie Lindsey R. Kelley, Pharm.D., M.S., is a fat tire bike racer for a local business.

LINDSEY R. KELLEY, Pharm.D., M.S., admits that she’s one to push the envelope and challenge the status quo — probably because she’s an adrenaline junkie. “I tend to be high energy and get excited about opportunities,” she said. “I’ll jump out of an airplane given the chance.” In fact, she has done exactly that — having gone tandem parachuting in four different states. She’s also an avid cyclist who competes in cross-country mountain bike and fat tire bike racing for a local bike shop.

Dr. Kelley is the Director of Pharmacy and Ambulatory Care Services at the University of Michigan Health System in Ann Arbor, Mich., and she pushes the envelope at work, too. She is particularly passionate about creating ambulatory practice models, promoting staff development, and studying population health. Dr. Kelley is doing work in these areas with teams she manages at Michigan focused on community pharmacy, specialty pharmacy, infusion pharmacy, and oncology clinic practice.

Pushing Pharmacy Limits

For example, clinic practitioners are examining clinical and operational outcomes in an effort to create ambulatory oncology practice models that incorporate both specialist and generalist roles. “Accomplishing this would increase the number of patients that pharmacists have time to see and would ensure that each pharmacist is working at the top of their license,” Dr. Kelley said. In addition, a team focused on ambulatory management is exploring how to best triage patients to ensure that the most effective and efficient pharmacist resource provides care.

Dr. Kelley is also looking at innovations in population health. “I am interested in improving community development and other types of access,” Dr. Kelley said. “A goal is to find out how Michigan Medicine, as a large health system, might leverage its impact in the community to improve social determinants of health. If health systems started investing resources not only in healthcare services, but also in housing, education, and employment opportunities in neighborhoods surrounding institutions, it would dramatically impact population health.”

Biggest Accomplishments

In her current role, Dr. Kelley is most proud of recruiting a team that is fully engaged, incredibly competent, and consistently effective. Some turnover occurred since she started in her role five years ago, but now the team has a good balance. “I purposefully looked for people who were different learners or personality types than existing team members,” she explained. “During interviews, I was honest about what we wanted to work on and our team’s values. That gave me the ability to recruit people who understood the expectations of the role they were committing to.”

Dr. Kelley is passionate about creating ambulatory practice models, promoting staff development, and studying population health.

Dr. Kelley admits being fervent about teamwork. “Our Ambulatory Management team members meet every two weeks to ‘huddle’ — to check on how everyone is doing,” she said. “The intent is to encourage others and assist each other where we can.” The meetings started when there was a significant shortage of pharmacy technicians on the community pharmacy team. The infusion manager sent technician staff to help before and after shifts, and managers of community, oncology, and transitions of care all jumped in to fill and dispense prescriptions as well. After the crisis was resolved, Dr. Kelley found value in still holding the meetings so she could continue to identify where assistance might be needed among teams and where resources could be better utilized.

Dr. Kelley is also proud of building residency programs. She helped to start the PGY1 program at University of Pittsburgh Medical Center at Shadyside Hospital in Pittsburgh, Pa., now called UPMC Shadyside Hospital, and began the community pharmacy residency program at Michigan Medicine, now in its third year.

As a member of Michigan’s Ambulatory Care Regulatory Readiness Accreditation Committee, Dr. Kelley has given presentations to nurses and medical assistants to teach them how to lower the risk of improperly administering medications. She has also helped to put processes and systems in place to make sure that medications are ordered, stored, administered, and documented in the most safe and effective ways.

She also serves on Michigan’s Pharmacy Benefit Advisory Committee, which advises University of Michigan’s Drug Plan in making decisions about providing medications to patients and communicating with internal and external partners. “As an ambulatory leader with experience in community pharmacy, I can discuss what is happening at a user level, and how our decisions impact patients,” Dr. Kelley said.

ASHP Endeavors

Dr. Kelley joined ASHP in 2003, during her third year of pharmacy school, because she wanted to attend the Midyear Clinical Meeting and participate in the Clinical Skills Competition. When she began her residency training at Abbott Northwestern Hospital in Minneapolis, Minn., she received additional support. “My preceptors and program directors promoted ASHP’s value in teaching best practices and networking with others who encounter similar practice issues,” Dr. Kelley said. “They also felt that its leadership, mentoring, and training were outstanding and would prepare me for future endeavors.” She’s also benefitted from educational opportunities such as ASHP Managers’ Boot Camp and Residency Learning System workshops, and from attending the Midyear Clinical Meetings and Summer Meetings.

Reflecting on her years of membership, Dr. Kelley feels fortunate to have served on the New Practitioner Forum Executive Committee. “We served as liaisons to advisory groups and represented the voice of new practitioners to the ASHP House of Delegates and Board of Directors,” she said. Receiving ASHP’s Distinguished Service Award in 2010 for her sustained contributions to advancing new practitioners was a highlight and honor.

As a member of the Section of Pharmacy Practice Managers Section Advisory Group on Leadership Development, Dr. Kelley helped to incorporate resources supporting human resource management, financial stewardship, and automation into a new manager tool kit. She was also among the first members to lead new networking sessions at the Midyear Clinical Meeting. And, she assisted AJHP (American Journal of Health-System Pharmacy) in prioritizing management topics for columns — increasing its value for readers.

Dr. Kelley recalls hearing Maya Angelou speak at the 2007 Midyear Clinical Meeting opening session. “The room was packed, but a woman cleared a chair so I could sit down,” she said. “We started talking, and that woman turned out to be ASHP Past President Debra Devereaux, Pharm.D. She ended up becoming a mentor, colleague, and friend. One of the things ASHP does well is to teach its members how to be excellent mentors. And Deb was certainly doing that. It was a serendipitous moment.”

Personal Leadership

Dr. Kelley, who is openly lesbian, also praises ASHP for its recent engagement around LGBT topics, citing the presence of networking sessions at the Midyear Clinical Meeting and articles in AJHP on how pharmacists can better care for transgendered patients. “I am excited that we’re having these conversations,” she said. “Part of the reason I live openly is because some people don’t feel comfortable doing that. My hope is that if a pharmacy student, resident, or practitioner who has a different sexual orientation sees that I’m a lesbian and a leader, then they will be encouraged to pursue their career goals also.”

 

By Karen Appold

 

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February 23, 2018

Health-System Cyberattacks: The Pharmacist’s Role in Prevention, Mitigation

THE THREAT OF CYBERATTACKS used to be just that— a threat. However, recent ransomware attacks targeting health systems and hospitals, among other institutions, have elevated the threat to a widespread reality. According to cybersecurity experts, pharmacy systems specifically have not yet fallen victim to such attacks, but they are vulnerable, and pharmacists should take steps to help prevent cyberattacks and mitigate their impact.

Dr. Barbara Giacomelli, Pharm.D., M.B.A.

“Pharmacy operations are increasingly reliant on technology and automation, which both raises the risk of an attack and heightens the likelihood that attacks may have an impact on patients’ health,” said ASHP member Barbara Giacomelli, Pharm.D., M.B.A., FASHP, Area Vice President at McKesson Pharmacy Optimization in Vineland, N.J.

Growing Number of Cyberattacks
In some recent ransomware attacks, hackers have prevented healthcare providers and administrators from accessing medical records, said Dr. Giacomelli, who moderated a session on cybersecurity at ASHP’s 2017 Summer Meetings and Exhibition.

In March 2016, MedStar Health, a network of 10 hospitals and 250 outpatient centers located in the Greater Washington, D.C., area, had to turn patients away after ransomware attackers blocked hospital and clinic staff from accessing medical records.

More recently, the “WannaCry” ransomware attack in May 2017 crippled systems in many countries and, most notably, hit the United Kingdom’s National Health Service, leading to cancelled surgeries and unavailable patient records. In the same attack, two medical devices in the Unites States used to monitor the injection of contrast for medical imaging had their displays obscured with a WannaCry ransom message, leading to suspension of their operation for 24 hours.

Dr. Dennison Lim, Pharm.D.

“It doesn’t take a leap of the imagination to see how lack of access to critical patient care systems could be a serious patient safety issue,” said Dennison Lim, Pharm.D., a Medication Management Informaticist at Mayo Clinic in Rochester, Minn. The ransomware attacks have led to a shift in what healthcare cybersecurity has traditionally been concerned with, he explained. “For a long time, cybersecurity was thought of in terms of ensuring HIPAA compliance, but the new focus is on data integrity and intrusion prevention,” said Dr. Lim, who is an ASHP member.

HIPAA compliance remains the minimum standard of cybersecurity, but the ransomware attacks on healthcare organizations have highlighted the potential for patient safety impacts far greater than privacy violations alone.

“Ransomware attacks could play out across multiple systems throughout a healthcare organization and grind normal operations to a halt,” Dr. Lim emphasized.

Pharmacists and Cybersecurity
Since pharmacy has not traditionally been a stakeholder in information security, it can be particularly vulnerable to attacks, Dr. Lim explained. Additionally, pharmacy staff are often not experts in security risk evaluation and mitigation.

“Pharmacy is responsible for understanding the security risk within its systems and should cultivate pharmacy staff expertise in cybersecurity and engage with information technology and security departments, as well as vendors,” he urged. An effective proactive approach incorporates safety measures — including regular security assessments of systems and devices — to help prevent an attack and should also include mitigation strategies to reduce the impact of an attack on pharmacy operations and clinical practice, Dr. Lim added.

Mr. Walter Ray

Cybersecurity expert Walter Ray, Chief Information Security Officer at Augusta University Medical Center, Augusta, Ga., said a mix of reliable technology and effective processes should be used to maintain the security and integrity of the data used in the pharmacy. “You need to look at the entire process through to the administration of a medication to the patient,” said Ray. “Ask questions like ‘What controls are in place to make sure the correct dose is given?’ and ‘How do you make sure medications have been accurately reconciled?’ Every technology component throughout the process should be evaluated for security risks and locked down as much as possible.” He also suggested using a multifactor or two-step verification process for access to more sensitive systems or highly privileged accounts as well as using up-to-date secure encryption algorithms.

Although pharmacists and other healthcare staff can take steps to reduce the risk of an attack, some vulnerabilities are challenging to address completely, Ray explained. “The most frequent point of entry into a health system is by email, through a phishing attack, and it’s very difficult to get people who are task-saturated to take the time and think about whether an email is legitimate or not,” he said, noting that this was one of the entry points through which the May 2017 WannaCry ransomware attackers entered.

Nevertheless, it is important to train employees to avoid clicking on links and attachments from emails they are not expecting and to report suspected phishing emails, Ray noted. “Don’t ignore reports of phishing, as they can be useful in detecting active attacks and limiting the damage,” he added.

Reflecting on the potential for devices such as smart infusion pumps to be hacked, Ray noted that institutions considering a new device or vendor should rigorously evaluate the device’s security and make sure there is a mechanism to hold vendors accountable for correcting security vulnerabilities.

“As an increasing number of devices become connected and automated — and particularly if they’re administering a drug or are in some way regulating physical functioning — we could see additional effects on patients’ physical well-being,” Ray said. “The threat of an attack is something every health system should be thinking about.”

 

By David Wild

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February 15, 2018

AJHP’s Top 25 Articles Address Critical Practice Issues

Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP

WITH A CIRCULATION OF 45,000, ASHP’s peer-reviewed scientific journal, AJHP, is the most widely recognized and respected pharmacy journal in the world. As part of our year-end review in late 2017, the editors of AJHP assembled a list of the Top 25 most frequently accessed articles on www.ajhp.org. What they found was compelling: The articles read most by you and your colleagues address some of the most critical issues facing the profession and healthcare at large. This connection is no accident. From its early days as The Bulletin to its current iteration, AJHP has sought to provide pharmacists with the latest, most relevant practice information available.

AJHP has undergone a comprehensive transformation in recent years in both design and content, including a new approach to cutting-edge clinical topics and an enhanced digital experience. These changes represent a continuation of the journal’s vital role in equipping pharmacists to guide medication-use and healthcare delivery at the patient, population, and policy levels.

A look at the most-accessed content clearly illustrates this principle. The Top 25 list includes articles that predict future directions for practice, offer guidance for strategic planning, and examine the challenges faced by women seeking greater leadership opportunities. Also featured are discussions about the training needs of pharmacy technicians, guidelines on preventing diversion of controlled substances, and approaches for caring for diverse patient populations. The Top 25 list also contains several articles that address important clinical practice issues related to the care of the critically ill as well as patients with cancer, diabetes, infectious diseases, pulmonary hypertension, and thrombotic disorders. This collection of most frequently accessed AJHP content addresses pressing issues for our patients, for our profession, and for our times.

AJHP’s mission to advance science, pharmacy practice, and health outcomes can be realized only when pharmacists take what they’ve learned and apply those findings in their practices. The Top 25 articles, and all of AJHP’s content, can be used to:

  1. Advance ASHP members’ approaches to patient care.
  2. Support pharmacists’ and pharmacy technicians’ professional development activities and approaches to delivering patient care.
  3. Inform proposals for educational offerings at ASHP’s meetings as well as state affiliate-based educational programs.
  4. Supplement educational initiatives with students and residents in the classroom, at the bedside, and through journal clubs and seminars.
  5. Prepare for policy discussions with legislators and other policymakers at the local, state, and federal levels.

I encourage you to take some time to read or revisit the findings in these valuable articles and consider how you can use AJHP to impact patient care at your organization. The full list of the Top 25 most-accessed articles is available as a collection on www.ajhp.org.

Thank you for all that you do on behalf of your patients, and for being a member of ASHP.

Paul

January 29, 2018

Preserving 340B Is Essential to Our Most Vulnerable Patients

Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP

ORGANIZATIONS PROVIDING CARE TO MEDICALLY UNDERSERVED rely on the 340B Drug Pricing Program, and ASHP is committed to fighting ongoing threats to the program that could have serious consequences for our patients. ASHP has a long history of support for the 340B program, and many of our members have seen firsthand the benefits of the program to the patients they serve. As Congress considered overhauling the nation’s healthcare system last year, ASHP developed Principles on Healthcare Reform that included our support for the 340B program. We continue to collaborate with numerous stakeholders, including our longstanding partners at the American Hospital Association (AHA) and 340B Health, to prevent cuts to program eligibility and scope.

Last August, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule that cuts Medicare Part B reimbursement for drugs purchased through the 340B program from ASP plus 6 percent to ASP minus 22.5 percent. Along with the AHA and many other like-minded stakeholders, ASHP submitted comments to CMS opposing the cuts. In addition to the comments, ASHP lobbied on Capitol Hill to garner signatures to a Dear Colleague Letter from Congress to CMS urging the agency not to go through with the cuts. During ASHP’s annual Legislative Day in September, over 100 ASHP members met with their members of Congress to discuss, among other issues, the importance of the 340B program to their organizations and the critical role it plays in their ability to provide care to the medically underserved.

In November, CMS finalized the rule, and the reimbursement cuts were set to begin this year. AHA has filed a lawsuit challenging CMS’s authority to impose the cuts on the federal 340B program, and ASHP is supportive of AHA’s efforts. We are extremely disappointed that the rule putting the cuts in effect was finalized, and we remain committed to advocating for overturning this rule.

To that end, ASHP supports legislation (H.R. 4392) that would block the CMS-imposed cuts. Sponsored by Representatives David McKinley (R-W.V.) and Mike Thompson (D-Calif.), the bill currently has 181 co-sponsors in the House. In addition to our letter of support, ASHP has created a grassroots letter of support for our members to send using our electronic letter-writing platform.

We know that there will be additional threats to the 340B program in 2018. For example, recently introduced legislation (H.R. 4710) would impose a two-year moratorium on disproportionate share hospitals applying to become covered entities within the federal 340B program. This bill would also require additional reporting requirements, including reporting of the number of insured patients, total cost of charity care provided, reimbursement for all drugs, and a listing of all third-party vendors associated with the 340B program. ASHP has strong concerns over this legislation, and we expressed our opposition in writing to the bill’s sponsors. Similar legislation (S. 2312), was introduced in the Senate, and ASHP will oppose that bill as well.

We expect to see additional legislation later this year. The House Energy and Commerce Committee last week released a report on the 340B Drug Pricing Program. The committee has been examining the structure, operation, and oversight of the program over the past two years through stakeholder meetings, committee hearings, and document collection. Further, Committee Chairman Greg Walden (R-Ore.) has stated that there will be legislative efforts to change the 340B program this year to focus on definition, transparency, and oversight. ASHP developed an issue brief summarizing that report and the potential legislative options that may result.

ASHP remains committed to supporting the 340B Drug Pricing Program, and we will continue to do so through assertive advocacy on Capitol Hill, grassroots advocacy, comments to federal agencies, and meetings with agency officials. Further, ASHP will continue working with other program supporters such as AHA and 340B Health to protect the program from threats, both legislative and regulatory.

Thanks so much for continuing to advocate on behalf of your patients and the profession, and for being a member of ASHP.

Sincerely,

Paul

January 8, 2018

Drug Shortages Harm Patients

Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP

ASHP AND OUR COLLEAGUES AT THE UNIVERSITY OF UTAH have been leaders in providing ASHP members, policymakers, and the entire healthcare community with timely information on drug shortages for nearly 15 years. We have also worked hand in hand with numerous stakeholders to find solutions to help minimize or prevent drug shortages. These efforts have included passing federal legislation and holding numerous multidisciplinary summits on drug shortages, with the most recent stakeholder summit taking place on November 6, 2017, at ASHP headquarters.

Today, although progress has been made, drug shortages are still significantly threatening the ability of ASHP members and their healthcare colleagues to provide care to patients. It is unacceptable in the United States that drug shortages can happen as frequently as they do — and certainly not acceptable for them to harm patients. Regardless, the problem persists and grows, with the most recent being the severe shortage of small-volume parenteral (SVP) solutions.

Soon after we became aware that an SVP shortage had emerged, ASHP and the University of Utah released a resource on the conservation and management of SVPs. This resource has proven useful to ASHP members and other providers, and its use has been encouraged by the FDA Commissioner.

We have also been working on a daily basis with the FDA, Congress, and numerous other concerned organizations to find solutions for all drug shortages and advocate for needed changes. Further, we are working to keep the entire shortage situation on the radar of the media. ASHP also immediately conducted a survey to better understand the magnitude of SVP and other shortages, and to use that survey data in our advocacy and media outreach on behalf of our members and their patients.

ASHP believes that it is time for Congress to get involved to stop this threat to safe and effective patient care. ASHP recently led the development of a congressional call to action with other key stakeholders. In that letter, ASHP and our partners asked Congress to examine the following questions to address the underlying causes of shortages:

  • Should manufacturers be required to disclose to the medical community their manufacturing sites and the products produced in those sites, in terms of volume and percentage of product line?
  • Should sole-source products be allowed to be produced in a single plant?
  • Should there be redundancy in production of critical products?
  • Should the FDA identify a list of “critical medications” that would require manufacturers to develop a reasonable contingency plan in the event of a production interruption or shutdown?
  • What incentives could be developed for other manufacturers to increase production when drug shortages occur?
  • What can be done to determine the best locations of pharmaceutical plants in addition to ensuring that backup systems can quickly accommodate needs in the event of a disaster, given there are several types of natural disasters that can occur?

We strongly believe that the current drug shortage situation is unacceptable and unsustainable. It threatens harm to patients, wastes valuable healthcare resources, causes great uncertainty, and disrupts the healthcare system. Congress should not wait to take action on drug shortages until the current crisis worsens even further. The time for leadership and action is now.

ASHP will continue to be the leader on this critical patient care and patient safety issue until we and our partners find solutions that ensure that no patient is ever affected as a result of a drug shortage. Please contact your member of Congress through ASHP’s call to action, and please continue to review ASHP’s website and other communications for updates. Also, please don’t hesitate to contact us if you have any questions or need assistance from our drug shortages staff team. ASHP is looking for both short-term relief to current shortages and long-term solutions. Therefore, fixing the drug shortage problem will remain a top priority for ASHP until meaningful and systemwide solutions are identified and implemented.

Thanks so much for being a member of ASHP, and for everything that you do for your patients.

Paul

November 10, 2017

A Resident’s Perspective on Women in Pharmacy Leadership

Editor’s Note: This story is part of a special series examining the growing number of women in pharmacy leadership.

Andrea Arriaga White, Pharm.D.

ANDREA ARRIAGA WHITE, PHARM.D., IS IN HER SECOND YEAR of a PGY1/PGY2 Health-System Pharmacy Administration residency at Texas Children’s Hospital in Houston. The challenging residency program, combined with earning an M.S. in Pharmacy Administration and Leadership from the University of Houston College of Pharmacy, keeps Dr. White on the go from 7:00 a.m., when she arrives at work until 8:30 p.m., when she finishes her classes.

But working hard is nothing new for Dr. White, whose first role model was her mother, an architect originally from Honduras. Her mother’s strong work ethic enabled her to overcome the English/Spanish language barrier to ensure that Dr. White received the best education possible.

Leadership Starts at Home
“Growing up with a single mother for much of my childhood is the source of who I am today,” said Dr. White, who noted that her influential stepdad came into her life once she was a little older.

Watching her mother achieve success through long hours and dedication inspired Dr. White’s work ethic. “From as early as I can remember, working hard and the satisfaction of earning a living was instilled in me by my mother,” she added.

Dr. White’s mother and aunt were raised by her grandmother, who was also a single mother. “This sense of being a strong female, who is the provider for the family, was part of what was instilled in me at a young age,” explained. Dr. White. “No matter what, every day we made sure to sit at the dinner table together as a family: my grandmother, mother, aunt, stepdad, and me. It wasn’t perfect, but my mother and family were perfect for me. That must be what motherhood is about — the perfection of the imperfections.”

Evolution of a Leader
With such strong female role models, Dr. White has always found the concept of leadership and becoming a female leader and role model appealing. This is one of the reasons she chose to do a residency at Texas Children’s. “I’m a people person. I hope to help others feel comfortable enough to talk about their issues,” she said.

Dr. White discusses a patient’s case with Fadel Ruiz, M.D., and Erin McDade, Pharm.D., Clinical Pharmacy Specialist.

Dr. White values learning from the ground up. Her first rotation at Texas Children’s was in the NICU. “It was truly awe-inspiring to see these little neonates fight as hard as they do despite only weighing a few pounds,” she said.

Dr. White also completed a longitudinal rotation in the Pulmonary/Cystic Fibrosis Clinic, where she used her Spanish-speaking skills to translate complex medication information to patients. By speaking to patients and their families in their native language, Dr. White made it easier for them to discuss medication issues and ask questions.

Dr. White especially enjoys working with people who embrace teamwork and who invest their time and energy into the people they lead. She hopes to move into a leadership position when her residency is finished. “I want to be a positive influence in the lives of others, and I want to propel our pharmacy world forward and advocate for the profession,” she said.

ASHP Supports Women Leaders
In October 2016, Dr. White attended ASHP’s Conference for Pharmacy Leaders in Chicago and found it to be an immensely rewarding experience. During the Women in Pharmacy Leadership networking session, “we split up into groups and talked about children, life, the future,” she said. “We discussed how to keep goals and aspirations.”

They also discussed practical things, like how a petite woman like Dr. White might need to use different tactics to show she is a leader — positive, but not too soft. “It was so refreshing and eye-opening to be able to chat about these things,” she added.

Particularly helpful for Dr. White was a session at the ASHP 2016 Midyear Clinical Meeting that focused on women in pharmacy residencies. It was led by longtime ASHP leader, Sara J. White, R.Ph., M.S., FASHP. “We discussed what residents need during the transition from residency to leadership positions. It was wonderful to address these issues from a resident’s perspective,” she said. “Family and friends do not always understand how demanding a residency is and how work-life balance can get skewed.”

The Future
Although Dr. White embraces any opportunity to interact or learn from all types of pharmacy leaders, she is especially inspired by female leaders. Dr. White is particularly interested in bolstering her communication skills and demeanor so that she can be as effective a leader as possible. “How female leaders react and maintain composure in different settings has always been a great interest of mine,” she added.

In the future, Dr. White seeks to someday balance her pharmacy career and expand her family. Dr. White got married while attending Xavier University College of Pharmacy in New Orleans, La.; she and her husband do not have children… yet. “Having had my mother as a role model, I strive to work just as hard as she did to make sure my children have the best within my capabilities,” said Dr. White.

She hopes that female leaders in pharmacy can help her learn to manage a proper work-life balance. “I look to those women who have accomplished it to show me the way,” she said.

By Ann Latner

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