ASHP InterSections ASHP InterSections

March 31, 2015

VA Pharmacist-Led Diabetes Clinic Dramatically Improves Patient Outcomes

Candis M. Morello, Pharm.D., CDE, FCSHP, FASHP

Candis M. Morello, Pharm.D., CDE, FCSHP, FASHP

BACK IN 2009, when the VA San Diego Healthcare System wanted to help its primary care physicians meet performance measures for diabetes as well as help its patients with diabetes improve their metabolic goals, Candis M. Morello, Pharm.D., CDE, FCSHP, FASHP, saw an opportunity to apply her knowledge as both a pharmacist and diabetes educator.

Working together with the departments of endocrinology, internal medicine, and pharmacy, she devised the Diabetes Intense Medical Management Clinic, a pharmacist-led clinic that delivers individualized diabetes care.

“The new model provides integrated care that covers not only diabetes, but hypertension, lipids, food choices, activity, mood, adherence, and motivation. We then put it all together to create a unique treatment plan for each patient,” said Dr. Morello, who is professor of clinical pharmacy and associate dean for student affairs at the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of California, San Diego (UCSD).

Achieving Multiple Goals

At its inception, the clinic sought to answer two questions. First, would 60-minute visits with a pharmacist who provided medication therapy management and tailored diabetes education help patients manage their diabetes better? Second, would the patients come away from the clinic with skills they could use for the rest of their lives in primary care settings?

“I was hoping that if we spent more time with each patient in a less rushed visit, it would meet two goals: Help patients to achieve and sustain diabetes control while lowering costs for the medical center,” said Morello.

Melissa Christopher, Pharm.D.

Melissa Christopher, Pharm.D.

Those were lofty goals considering that patients would only have three or four visits in a span of six months and Morello could be in clinic just one half-day per week. Seeing the challenge her limited hours would present with scheduling, the clinic got approval to train another pharmacist, Melissa D. Christopher, Pharm.D. After six years with the clinic, Dr. Christopher became national director for academic detailing with the VA last year.

The patient population itself presented challenges. Nearly 75 percent of the patients have at least three physical comorbidities in addition to their diabetes, and 45 percent have mental health comorbidities.

“Many patients have limited ability to do physical activity because they’re in a wheelchair or have a pain syndrome that limits their amount of walking. But activity is a component of controlling weight and blood glucose, so we had to look at different strategies, including modifying medications to compensate for what they can’t do with exercise,” said Christopher.

During her visits, Morello adjusts and prescribes medication as well as orders and interprets lab tests for diabetes, hypertension, lipids, hypothyroidism, and diabetic peripheral neuropathy. She also educates patients on what their medications do and how to take them, and on lifestyle changes that may help them achieve their goals. If necessary, patients are welcome to schedule phone calls of 10-15 minutes as well.

Care That Gets Results

In the early days of the clinic, patients had to have an A1c of at least nine percent to be referred, and the mean A1c of the first 116 patients to come to the clinic was 10.5 percent. As the clinic’s impact became apparent, physicians began referring patients with A1cs higher than 8 percent. Patients do not leave the clinic and return to primary care until they achieve their metabolic goals. Usually, they visit the clinic for six to nine months, although some have visited for a year.

At the six-month mark, the mean A1c had dropped 2.4 percent, compared to .02 percent in patients who stayed in primary care, and 79 percent of the patients in the clinic had achieved their diabetes goals. The lower A1c values for clinic patients translate into a three-year cost avoidance of $9,104 per patient compared to an estimated cost avoidance of $1,803.

The overwhelming feedback is that patients are happier.

Evidence like this is crucial when making a case for expanding the clinic or for introducing the clinic to other medical centers in the VA system, said Dr. Morello.

“You have to justify what you’re doing, and demonstrate that it will work,” she said. “We had a three-fold cost improvement while also improving patient care and diabetes control in a complex patient population. Any system should embrace those types of outcomes.”

Patients and physicians alike have been more than satisfied with the clinic, Dr. Morello added. “The overwhelming feedback is that patients are happier, and that the clinic ultimately allows for a better primary care visit because the physicians can focus on other issues patients may have that are non-metabolic.”

The Importance of Institutional Support

Steven V. Edelman, M.D., professor of medicine at UCSD, said that although he has had a positive experience with the clinic, he’s not surprised at the outcomes.

“I was always on board with this approach,” he noted. “It only reinforces the fact that you do not have to be an endocrinologist to be a great diabetes doctor.”

Medication management, lifestyle changes like exercise and diet, and working closely with a clinical pharmacist help patients with diabetes to achieve better outcomes.

Medication management, lifestyle changes like exercise and diet, and working closely with a clinical pharmacist help patients with diabetes to achieve better outcomes.

Pharmacists already have an excellent background for an expanded role in diabetes care, Dr. Morello said. “We have the medication knowledge, the people skills, the self-care management education, and the training to integrate all of that to provide personalized care.”

Although Dr. Morello is a certified diabetes educator, she doesn’t feel that such certification is necessary.

“I’m putting together a program to train pharmacists to use our same model. As long as you get some specific training, especially about empowering patients, as well as about nutrition, dietary education, and activity so you know what works, that’s what’s important.”

Dr. Morello invites ASHP members to contact her directly at VA San Diego Healthcare if they would like assistance or advice about developing similar programs and clinics.

“We’ve already ironed the kinks out and have shown that the model works,” she said. “If we can achieve such successful outcomes in patients with high comorbidity complexity and high medication regimen complexity, it’s possible to achieve the same for any kind of patient.”

–By Terri D’Arrigo

February 25, 2013

Expansion into Prescribing at the VA

Lauren Rass, Pharm.D., a PGY1 pharmacy resident, (center left) and Lynsey Neighbors, Pharm.D., BPCS, RPD, counsel a patient.

A KEY ELEMENT of advancing pharmacy practice—and a recommendation of ASHP’s Pharmacy Practice Model Initiative—is the expansion of pharmacists’ duties to include writing medication orders.

At the Central Alabama Veterans Health Care System (CAVHCS), which serves more than 134,000 veterans in a 43-county area of Georgia and Alabama, the clinical pharmacy team has achieved this goal through a 10-year evolution.

What began with protocol-driven care in anticoagulation management has expanded into broad scopes of practice across a range of diseases and conditions. Pharmacy practice at CAVHCS now includes not only medication management, but prescribing privileges, in person and on the telephone.

Finding a Physician Champion

Expanding pharmacy practice in a health system requires strategy. When a system-wide evaluation revealed that CAVHCS wasn’t meeting its goals for lipid management, pharmacists saw an opportunity to showcase both their training and their clinical competency.

“We thought lipid management would be fairly easy to sell to management because it’s less risky than other practice areas,” said Addison Ragan, Pharm.D., BCPS, GCP, clinical pharmacy program manager. In 2002, the system opened a lipid management clinic where pharmacists had prescribing privileges under a protocol, and it wasn’t long before physicians throughout the system took notice.

“The primary care providers loved it, and they referred patients to us across the hospital setting,” said Ragan.

The following year, pharmacists moved into managing dyslipidemia in diabetes, again, under protocols. After the VA’s national clinical pharmacy leadership released guidance on dyslipidemia and diabetes and field guidance advocating broad scopes of practice, CAVHCS pharmacists worked closely with endocrinologist Neil E. Schaffner, M.D., meeting with him weekly for a roundtable discussion. The rapport that the team developed with Schaffner would later prompt him to become a physician champion for pharmacist-provided care.

Lynsey J. Neighbors, Pharm.D., BCPS, trained with Dr. Schaffner.

“He was somewhat skeptical of pharmacists stepping into this role at first, but after working with other pharmacists and later myself, he realized what pharmacists could do,” she said.

Accountability Counts

Ragan knew that if CAVHCS pharmacists wanted to work under broad scopes of practice, they would have to demonstrate their competency in quantifiable ways. The team developed competency checklists and professional practice evaluations to determine pharmacists’ knowledge and ability. She also implemented a mentoring process to improve performance as necessary. Under this system, pharmacists evaluate their peers every quarter.

“Having an accountability system in place shows leadership that you are monitoring the clinical competency of your staff,” said Ragan. “Even if there are cases where there need to be improvements, leadership can see that you are doing your due diligence.”

Such accountability helps pharmacists be their own best advocates, she added. “We become more conscientious in our documentation because we know it will be reviewed.”

When the time came to ask for expanded scopes of practice for several pharmacists, Ragan presented the evaluations to the administration, and Schaffner wrote a letter attesting to the pharmacists’ clinical competency.

With such evidence before them, the administration saw fit to grant Ragan’s request. Now, pharmacists have expanded scopes of care that allow them to prescribe and manage medications for anticoagulation, diabetes, dyslipidemia, hypertension, pain, hypothyroidism, osteoporosis, and gout, with more opportunities on the way as Neighbors dives into the world of hepatitis C management.

Saving Time and Money

Expanded scopes of care and increased pharmacist involvement in direct patient care have been time-savers for physicians and patients alike.

“Pharmacists now titrate insulin, do follow-up, work with insulin pump patients, and handle the day-to-day management of diabetes that doesn’t always fit into a physician’s schedule,” Neighbors said. She is currently training other pharmacists to take on these new roles in diabetes care.

Other pharmacists are currently handling aftercare for heart failure patients. The pharmacists meet the patients in shared appointments with cardiologists. From there, the pharmacists follow up via telephone to discuss medications, blood pressure, and post-discharge care.

Pharmacists with this expanded scope of practice have prescribing privileges that allow them to adjust medications based on the cardiologists’ goals for treatment, particularly with respect to diuretics.

“We’re hoping that, by having pharmacists engaged in diuretic management, we will be able to prevent readmissions,” Ragan said.

Pharmacist follow-up via telephone has been a boon to patients, many of whom live in rural areas and must travel as far as 80 miles to come to one of the system’s facilities. Patients aren’t charged for the pharmacists’ telephone calls, so the saved time translates into saved money, as well—enough so that the team is now testing a video telehealth program.

But beyond that, it’s just plain easier on the patients, said Ragan. “Often they’re not feeling well,  so it’s taxing for them to travel long distances for simple changes in their medications.”

Pharmacy practice continues to expand at CAVHCS, Ragan added.

“Current scopes of practice are written to be very general and broad, and we can jump into managing disease states that we wouldn’t have been able to before without completely rewriting their scopes.”

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September 28, 2010

Frontlines at Home

Illustrated by Matt Sweitzer ©2010 ASHP

SINCE 2002, more than 425,000 veterans of the U.S. wars in Afghanistan and Iraq have been treated by the Department of Veterans Affairs (VA). That is an average of 258 new patients each day. As the system struggles to cope with the demand for services, pharmacy clinicians are coming face to face with a veteran population whose needs are strikingly different than those of veterans of previous wars and conflicts. Today’s veterans are young, many of them present with co-morbidities that include a psychological component, and 12 percent of them are women—the highest percentage of females in the system to date.

If ever there was a time for pharmacists to use their training as care providers and coordinators in tending to the nation’s wounded, that time is now. Fortunately, they are prepared: Pharmacists have been playing an integral role in care at the VA—and

in the Department of Defense (DoD), treating active-duty military personnel—since long before the U.S. launched military operations in the two current wars.

“We’ve been at the forefront of clinical pharmacy practice and have had quite a sophisticated level of practice for many years, with pharmacist-managed clinics and pharmacists embedded in primary-care teams,” said Michael Valentino, R.Ph., MHSA, chief consultant, Pharmacy Benefits Management Services, VA, Washington, D.C. “Now we are moving into some areas that require additional staffing to enhance services, such as mental health. We’re also involved with specialty clinics and centers, such as the five polytrauma centers in the system.”

The day-to-day activities of a pharmacist at the VA or DoD depend on the size of the facility, whether the pharmacist is working

with inpatients or outpatients, and the pharmacist’s own specialty, he added.

In general, however, pharmacists are rising to meet challenges in several key areas: patient transition from active duty (treatment by the DoD) to veteran (treatment by the VA); mental health, particularly where there are co-morbidities; and women’s care.

Transitioning Patients

According to Valentino, whenever there are handoffs during a patient’s transition from active duty to veteran, there is potential for a glitch, mainly because the computerized systems at the DoD and the VA are not linked. Although both agencies are working on ways to rectify the disconnect, for now the transition requires pharmacists and other clinicians to do some legwork.

“The VA and DoD try to look at handoffs at the micro level, and the VA has in fact put some staff at DoD centers to help smooth transitions,” Valentino said. “Before patients are discharged [from active duty], they are advised about VA services and hooked up with providers.”

“Good patient handoff is critical,” said Lieutenant Colonel Eric M. Maroyka, Pharm.D., BCPS, pharmacy director, Fort Belvoir Community Hospital, Fort Belvoir, Va., and former U.S. Army officer in residence at ASHP. “We want to make sure that nothing gets dropped and that people don’t get lost to follow-up, with no one checking up on them for appointments and so on. We’re doing better at handing off information and plans to the VA and civilian sector.”

Mental Health and Co-Morbidities

Pharmacists who treat military personnel and veterans are seeing more patients who need behavioral health care than ever before. Part of the increase has to do with the nature of the current wars, said Maroyka.

“This is a tired military force with many of the combat troops getting deployed three or four times,” he said. “Over time, that can increase the risk of conditions like depression and post-traumatic stress disorder.”

Traumatic injuries such as loss of limbs and disfiguring burns complicate a patient’s needs, he added. “Initially, the person may seem okay with it and appear to be progressing,” said Maroyka, “but down the road, behavioral issues will trump all.”

Perhaps the greatest challenge comes from traumatic brain injuries, including concussions from blast injuries. Treatment then becomes a test of a clinical pharmacist’s skill and training.

“If there is a traumatic brain injury, then all bets are off, and you’re flying by the seat of your pants,” said Matthew A. Fuller, Pharm.D., BCPS, BCPP, FASHP, clinical pharmacy specialist in psychiatry, Louis Stokes Cleveland VA Medical Center. “You have to use what you know to treat the symptoms, especially if it is organic depression caused by head injury.”

He added that there is a dearth of published studies about patients in this particular population. “It’s frustrating,” said Fuller. “Trying to do research in that setting is next to impossible, and it is difficult to find supporting literature. We just don’t have it.”

“Co-morbidities are one of the biggest problems,” said Jennifer L. Mauldin, Pharm.D., clinical pharmacist at the James A. Haley Veterans’ Hospital in Tampa. “There are so many different specialists to refer patients to—the traumatic brain injury team, the psych team, the primary physician. I do a lot of medication reconciliation, making sure patients are on the same meds as outpatients that they were as inpatients.”

Mauldin noted the clinical challenges of co-morbidities. “For example, you might be inclined to give a patient a benzodiazepine for anxiety, but not if there’s a brain injury, because these drugs slow cognitive function,” she said. “On the other hand, a prescriber might order stimulants for a patient with a brain injury, but those can cause insomnia, which is not what someone with sleep disorders from post-traumatic stress needs.”

Patricia Oh, Pharm.D., clinical pharmacist at the Warrior Clinic of the Walter Reed Army Medical Center, Washington, D.C., said that co-morbidities present a clinical challenge to pharmacists in terms of coordinating care.

“One of the things we have to be proactive about is recognizing the signs and symptoms of co-morbidities and indicators of risk,” she said. “We’re part of a multidisciplinary team, and we need to be able to refer patients to their doctors or specialists appropriately.”

Oh noted the important role that pharmacists play in ensuring that patients and their caregivers understand how to manage patient medications.

“A lot of our work has been education,” she said, “whether it’s with the patients themselves or with their non-medical attendants,” such as family members, friends, or others.

Coordinating Care in Smaller Facilities

The James A. Haley Veterans’ Hospital has one of the five polytrauma centers in the VA system, which gives it a leg up on managing care for patients with co-morbidities. However, coordinating care can be more challenging in smaller VA facilities, such as the VA Sierra Nevada Health Care System in Reno, Nev., where Scott E. Mambourg, Pharm.D., BCPS, is clinical pharmacy coordinator and residency director.

“Here we have to coordinate that care with bigger medical centers,” Mambourg said, which results in interfacility VA referrals or fee-basis to private care, depending on patient need. “It requires a lot of communication, and important functions such as medication reconciliation and monitoring for outcomes and adverse events become that much more critical.”

Virginia Torrise, Pharm.D.

He added that it can be tough for patients in rural areas to travel to the medical center. Younger veterans in rural areas often turn to private, civilian care, which can create complications for co-managed care. In response, the VA is funding rural health solutions such as telephone care and community-based outpatient clinics.

“Some veterans come to us for the prescription benefits. They will present prescriptions written by private-care providers for expensive drugs, but prescriptions have to be written by a VA provider for us to fill them,” Mambourg said. “For the VA to take that responsibility, we would need the patient’s private records, and the patient would have to be enrolled in the care of a VA primary care or specialty provider for the prescribing and monitoring of those medications.”

Women’s Health Challenges

Every VA facility has a women’s health coordinator and women’s health clinic separate from the general clinic, and female veterans may choose which clinic to go to for care. However, the main challenge in meeting women’s needs is facilities-based.

“The VA just wasn’t set up for women’s health,” said Lt. Col. Maroyka. “VAs never really handled obstetrics and gynecology or delivered babies before. The facilities weren’t designed for it.”

Now, VA and DoD pharmacists are finding themselves having discussions with patients about genetic testing and counseling pregnant patients on the relative risks of pharmacologic treatment of depression.

“As the medication experts, we have to consider what is best for both mother and child, because the drugs can affect the fetus,” said Fuller, of the Louis Stokes VA Medical Center. “If the depression isn’t severe, we can point to cognitive behavioral therapy, without drugs, especially during the first trimester. Likewise, pregnancy pushes us away from certain anticonvulsants that can normally be used for traumatic brain injury.”

Roughly 10 percent of VA facilities have clinics geared specifically toward women’s mental health issues, he added. These programs employ specialists who focus on treating female veterans who have post-traumatic stress disorder, sexual trauma (which encompasses a broad range of issues from sexual harassment to sexual assault), and other mental health issues.

A Growing Need for Pharmacists

The wars in Afghanistan and Iraq have resulted in an increased need for clinical pharmacists and clinical pharmacy specialists who can support case managers and care coordinators, said Virginia Torrise, Pharm.D., deputy chief consultant for professional practice and clinical informatics, Department of Veterans Affairs, Washington, D.C.

“VA is embracing the principles of the patient- centered medical home, and we are recommending that there be a higher number of clinical pharmacy specialists available,” she said. “It’s a great opportunity for pharmacy managers to provide guidance for what staffing is required to adequately support the medication management needs of our veterans.”

Clinical pharmacy specialists in the VA can prescribe medications and order tests within the practice setting, an expansion of scope of practice that can benefit patients, according to Torrise.

“Our specialists are highly trained professionals working at the top of their skills,” she noted, adding that VA pharmacists often treat multiple chronic diseases in primary care. “Our physicians are recognizing the excellent care that clinical pharmacists provide and seeing how these referrals free up their time for more urgent clinical needs. Our veterans are entitled to the best care, and pharmacists are key members of the clinical teams to provide this care.”

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