ASHP InterSections ASHP InterSections

August 15, 2016

In an Anticoagulation Clinic, Unrelated Interventions Abound

Melanie Boros, Pharm.D., BCPS, meets with a patient at Cleveland Clinic Akron General's outpatient anticoagulation clinic.

Melanie Boros, Pharm.D., BCPS, meets with a patient at Cleveland Clinic Akron General’s outpatient anticoagulation clinic.

IT’S WELL KNOWN that when pharmacists guide anticoagulation treatment, patient outcomes are better. International normalized ratio (INR) levels are within the target range more of the timei and hemorrhage rates are lowerii, compared to the usual care.

But what about the care pharmacists provide in anticoagulation clinics that is not directly related to the primary purpose of the visit?

A new study published in AJHP found that pharmacists offer significant additional care outside the purview of anticoagulation by helping patients avoid adverse events and receive timely treatment for other health concerns, and by improving their continuity of careiii.

Med Rec Reveals Important Picture of Patient Health

Michael Hicho, Pharm.D., BCPS

Michael Hicho, Pharm.D., BCPS

“Pharmacists, whether they’re in the anticoagulation clinic or in any other setting, can make a significant positive impact on patients’ care if they take advantage of each interaction they have with a patient,” said primary author Michael Hicho, Pharm.D., BCPS, who was a PGY1 pharmacy practice resident at Akron General Medical Center, Akron, Ohio, at the time of the study. Dr. Hicho is currently Inpatient Clinical Manager, Pharmacy Service, at Louis Stokes Cleveland VA Medical Center, Cleveland.

“As our findings show, these interactions may not necessarily always involve starting, stopping, or adjusting a medication but can, for example, include collaboration with other healthcare providers to ensure that patients are receiving appropriate care,” he said.

Dr. Hicho drew these conclusions from a retrospective analysis of records from 5,846 pharmacist encounters with 268 patients treated at the Akron General Medical Center’s pharmacist-managed ambulatory anticoagulation clinic between January 2012 and November 2013. The clinic served patients referred by 30 physicians during the study period.

Dr. Hicho’s team classified interventions not directly related to anticoagulation into six major categories (see TABLE below) and 33 subcategories. They found that pharmacists conducted a striking 2,222 interventions not directly related to patients’ primary reasons for visiting the anticoagulation clinic. Nearly 75% of patients received four or more unrelated interventions and almost 14% received 10 or more of these interventions.

Medication reconciliation was the most common intervention not directly related to anticoagulation. During those interactions, pharmacists identified 1,591 medication list discrepancies, including inaccuracies in the medication list for 89% of these instances.

They also found 107 instances in which a patient was taking his or her medication incorrectly and an additional 74 cases in which there was a possibility a patient may have been taking his or her medication incorrectly.

The Continuity of Care Equation

According to Dr. Hicho, pharmacists helped ensure continuity of care by assessing patients’ overall health, sending physicians medical information they collected, recommending primary care physician follow-up, and, in some cases, calling a physician for an immediate onsite visit or urging patients to visit the emergency department.

Amy Rybarczyk, Pharm.D., BCPS

Amy Rybarczyk, Pharm.D., BCPS

Measuring the clinical and financial value of interventions like these is difficult, said co-author Amy Rybarczyk, Pharm.D., BCPS, Pharmacotherapy Specialist in Internal Medicine, Cleveland Clinic Akron General. “At the moment, there is no standardized method for quantifying pharmacist interventions,” said Dr. Rybarczyk, who was Dr. Hicho’s research advisor at the time of the study. “It’s hard to measure the value of ensuring that a patient gets an antibiotic for a diabetic foot infection that is detected by a pharmacist, for example. A tool like that would be beneficial for our profession to have.”

Collaborative Practice Agreement Buoyed by Findings

The team’s results were so impressive that they were included in a letter to the Ohio Legislature in support of House Bill 188, which called for an expansion of pharmacists’ services as part of collaborative practice agreements. The legislation passed in December 2015.

“We believe the comprehensive care provided to patients in our disease state management clinic helped in this effort to expand pharmacists’ clinical services,” explained Dr. Rybarczyk.

“We believe the comprehensive care provided to patients in our disease state management clinic helped in this effort to expand pharmacists’ clinical services.” — Amy Rybarczyk, Pharm.D., BCPS

Co-author Melanie Boros, Pharm.D., BCPS, Pharmacotherapy Specialist in Internal Medicine at Cleveland Clinic Akron General and Dr. Hicho’s research advisor at the time of study, suggested that one of the important takeaway messages is the trust that patients place in their pharmacists. “When we see a patient with a therapeutic INR, and there are no changes that need to be made to his or her anticoagulation regimen, we can still make a significant impact by simply clarifying what their dose of insulin should be or teaching them about appropriate use of nonprescription medicines, for example,” she said, adding that pharmacists are well-positioned to answer patients’ questions and proactively identify other health issues.

“Like our entire department, pharmacists in the clinic have always made it a priority to care for the whole patient,” she emphasized.

–By David Wild

i J Throm Thrombolysis 2011; 32:426-430
ii Pharmacotherapy 195; 15:732-739
iii AJHP Residents Issue 2016; 73 (Supp 3):S80-87


August 18, 2015

New Mexico Clinic Pharmacists Wield Extensive Prescribing Privileges

From left, PMG Pediatric Pharmacy Specialist Kari Bishop, Pharm.D., discusses improvements in the electronic health record system related to adult and pediatric heparin infusions with Pharmacy Anticoagulation Specialist Linda R. Kelly, Pharm.D., Ph.C., CACP.

From left, PMG Pediatric Pharmacy Specialist Kari Bishop, Pharm.D., discusses improvements in the EHR system related to adult and pediatric heparin infusions with Pharmacy Anticoagulation Specialist Linda R. Kelly, Pharm.D., PhC, CACP.

IF THEY TAKE A MOMENT to look, patients who fill prescriptions after visiting one of the ambulatory care clinics in Albuquerque’s Presbyterian Medical Group (PMG) will see that the name on the medication bottle belongs to a pharmacist.

“When I write a prescription, it’s not checked or approved by a physician because I’m recognized as a healthcare provider by my state and my health system,” said Robert Rangel, Pharm.D., BCPS, PhC, director of pharmacist clinicians and anticoagulation services with PMG, noting that state laws dictate the limits of collaborative practice.

“That changes the perception among patients and colleagues about pharmacists’ abilities to care for patients, and it means that we’re recognized as advanced practitioners.”

Independent Prescribing

Collaborative practice agreements (CPAs) under which pharmacists write prescriptions are no longer isolated experiments. But most require a physician or nurse practitioner to review and sign off on every order. That’s where PMG breaks new ground: Any of the 14 clinical pharmacists practicing in ambulatory care can independently prescribe any medication used in the scope of a primary care visit as well as manage a spectrum of common chronic disease states. Right now, that list includes diabetes, elevated lipid levels and cardiovascular disease, hypertension, asthma and COPD, and even psychiatric and thyroid conditions.

Robert Rangel, Pharm.D., BCPS, Ph.C.

Robert Rangel, Pharm.D., BCPS, Ph.C.

The current CPA emerged from an earlier version at PMG’s anti-coagulation clinic, where pharmacists had wide latitude to adjust warfarin regimens and counsel patients. Improved clinical outcomes, such as a reduction in thromboembolic events, opened the door to the current, far more expansive CPA. This new practice agreement covers 15 primary care clinics, two cardiology clinics in greater Albuquerque, and one rural clinic with plans to expand to other parts of New Mexico. All of the more than 100 PMG physicians participate in the agreement.

“We’ve seen again and again that when you put a pharmacist in a clinic, even if they’re doing something small to begin with, sooner or later they’ll be asked to do more,” said Dr. Rangel.

The effectiveness of PMG’s ambulatory care practice reveals what pharmacists could do for patients if they were granted healthcare provider status under Medicare Part B, according to Joseph M. Hill, ASHP director of federal legislative affairs.

“This story is so great because it reinforces our message that pharmacist-provided care expands patient access and is cost effective,” Hill said, noting that the collaborative nature of PMG’s CPA mirrors the evolution of new care delivery models.

Charting Improvements in Fundamental Quality Measures

Three years ago, PMG restructured its budget so that the medical group, not the pharmacy department, paid the salaries of the ambulatory care pharmacists. A year later, the chain of command shifted; now, PMG ambulatory care pharmacists report to the director of the medical group rather the pharmacy director. The impact was huge, recalled Dr. Rangel.

“We’d been working and living in the medical group’s clinic but following a different management hierarchy. We didn’t feel like we were really a part of the medical group, and they felt the same way about us. We were still outsiders,” said Dr. Rangel.

The administrative shake-up solidified the unit and led to a collegial, supportive environment. “It really sealed the deal,” said Dr. Rangel.

Pharmacists at PMG clinics help patients manage a variety of chronic conditions, including diabetes.

The CPA’s success resulted from a lot more than just managerial and financial reshuffling. Once clinical pharmacists entered the scene, across-the-board improvements in fundamental quality measures followed, such as tighter A1c control for diabetic patients and improved blood pressure and lipid levels for cardiovascular patients. “We see better numbers for all three of them when pharmacist clinicians work in ambulatory care,” said Dr. Rangel.

Though their colleagues are accustomed to the presence of pharmacists in the outpatient clinics, patients are still getting used to the idea. Many express surprise when a pharmacist walks into the exam room to chat. “The majority of patients still see pharmacists as just drug dispensers,” said Dr. Rangel. “We still have a long way to go to change that perception. However, we are getting the word out, and it is making a difference.”

Expanding Scopes of Practice for Hospital Pharmacists

Linda Kelly, Pharm.D., CACP, PhC, a pharmacy anticoagulation specialist, anticipates that a CPA will emerge on the inpatient side at PMG. “I practice to the limit of my professional license in the outpatient clinics because of the CPA, but we haven’t yet defined a comparable role for clinician pharmacists on the inpatient side,” she said.

Setting comparable scopes of practice for clinical pharmacists throughout the organization will blur the lines between inpatient and outpatient care and create a more patient-centered care model, Dr. Kelly asserts. It just makes sense, she explained, that patients receive the same level of care from pharmacists wherever they practice in the organization.

“I already conduct medication management and offer prescribing recommendations for inpatients, but I can’t write orders independently,” she said. “Expanding our role to include prescribing is a logical next step.”

Dr. Rangel cautions that pharmacists tread carefully – but confidently – when seeking to expand their roles within a health system. “We were fortunate because we had already established relationships and a solid track record in the anti-coagulation clinic,” he said. “If we had walked into a clinic and said, ‘We’re here to manage your patients with chronic diseases and write prescriptions,’ we’d have hit forceful push back.”

“It was a slow process. We used our experience in the anticoagulation clinic as our introduction, and that made the transition much easier.”

Dr. Rangel suggests starting small, finding a niche, and letting the momentum build naturally.

“If I were starting from scratch, I’d ask the medical group what they need and how we can help… maybe managing diabetic or hypertensive patients,” he said. “Often members of the care team welcome that kind of offer. And as trust builds, demand for your services will almost certainly grow.”

–By Steve Frandzel

September 23, 2011

Creating an Anticoagulation Service in a Community Pharmacy

From left, Michah Hata, Pharm.D., and Roger S. Klotz, R.Ph., BCNSP, FASCP, FACA, FCPhA

THE MEDICAL LITERATURE is filled with examples of how anticoagulation services managed by pharmacists help reduce the number of anticoagulation-related emergency room visits and hospitalizations. This, in turn, results in significant cost savings1.

Typically, these types of clinics only occur within health systems or medical group practices. But as pharmacy faculty members, I and my colleague, Micah Hata, wondered if this collaborative practice model could be implemented in a community pharmacy.

Overcoming Challenges

So, we worked with a community pharmacist owner in Arcadia, Calif., to add patient care services to his pharmacy. The pharmacy has a private area that can be used as a treatment room to provide patient confidentiality.

We faced a number of major challenges with this project, including:

• Physicians’ resistance to a community pharmacist managing their patients’ warfarin therapy,

• Patient concern about the pharmacists’ capability to manage a therapy that posed significant risk, and

• Payers’ lack of familiarity with community pharmacists’ billing under the major medical plans for services as well as pharmacist-managed medication therapy.

The first task in implementing such a service was to find a licensed physician to medically approve our warfarin management protocol. The second step was to obtain an FDA “Clinical Laboratory Improvement Amendments Waived” testing laboratory certificate so that the pharmacy could officially be recognized as a licensed laboratory. Both tasks were completed by the end of June 2009.

We then faxed a letter along with our physician referral form to the offices of four doctors in our community. The letter detailed the services we would be providing. Within two weeks, the four physicians began to refer patients to our clinic.

Two years later, we have 25 physicians who regularly refer their patients to us. The interesting thing is that we have never marketed to any physicians other than the original four. Therefore, the network of referring physicians has been developed by word-of-mouth among physicians and patients.

A Success Story

Patients have easily accepted pharmacists as providers of direct patient care services, including anticoagulation services. In fact, they have all commented on how much they prefer the pharmacy-based services. We currently have 71 active patients who utilize our services, many of whom have been with us since our debut.

Success in obtaining reimbursement from the patient’s insurance company has been the major challenge. Pharmacists were not listed as approved providers in the original Medicare Act. As a result, we cannot bill Medicare via Palmetto, Medicare’s intermediary claims processor. On the other hand, if the patient has a PPO as either a primary or secondary payer to Medicare, then we can bill the private payer.

One major payer in California initially refused to accept our claims because it had never seen pharmacists bill the major medical plan. Over time, we worked with this payer and responded to every question. We circumvented its refusal to acknowledge pharmacists as providers by starting a group practice, which the payer was willing to accept as a provider in its network.

We were finally informed that we are now listed as a provider in the payer’s network and now receive reimbursement. There are a number of other payers we are billing and from whom we receive reimbursement. Medicare Part B continues to be a problem, and we plan to inform our patients that reimbursement from Medicare is not available.

The best outcome of this new venture is that none of our patients have had problems with adverse events that necessitated a trip to the ER or admission to the hospital as a result of their anticoagulation therapy. In fact, we are now also receiving referrals for the collaborative management of diabetes Type II patients as part of our medication therapy management approach.

It’s clear from our experience that pharmacist-managed direct patient care services can be implemented in a community pharmacy.

By Roger S. Klotz, R.Ph., BCNSP, FASCP, FACA, FCPhA,  and Micah Hata, Pharm.D. Both authors are assistant professors at Western University of Health Sciences, Pomona, Cal.

1 Comparison of “Two Different Models of Anticoagulation Management Services with Usual Medical Care,” Rudd, KM, Dier,  JG; Pharmacotherapy, April 2010; 30(4): 330–338.

April 9, 2010

Preventing DVT Helps Patients and Bottom Lines

PHARMACISTS LYNDA THOMAS, Pharm.D., CACP, and Michael Palladino, Pharm.D., are part of a new wave of clinical specialists who oversee patients’ anticoagulation therapy post surgery.

Michael Palladino, Pharm.D., inpatient anticoagulation coordinator of the Jefferson Center for Vascular Diseases, speaks with a patient about the importance of DVT prevention.

They help ensure that orthopedic surgery patients don’t develop deep vein thrombosis (DVT), a potentially dangerous and often preventable condition common among orthopedic surgery patients. The best defense against DVT, anticoagulant therapy also comes with inherent risks. Leaders at Thomas Jefferson University (TJU) Hospital in Philadelphia see pharmacists as best equipped to keep patients safe post surgery.

“Warfarin is one of the top 10 drugs for medical errors,” noted Thomson, inpatient anticoagulation coordinator of the Jefferson

Center for Vascular Diseases, Thomas Jefferson University (TJU) Hospital in Philadelphia. TJU Hospital performs some 3,000 joint surgeries each year.

A New Wave

The pharmacists at TJU help to ensure that a new wave of clinical specialists who oversee patients’ anticoagulation therapy post surgery and help to ensure patients discharged on warfarin and other blood thinners transition safely home. Preventing adverse events and readmissions are key parts of their jobs.

“It’s an excellent chance for pharmacists to demonstrate the value and the return on investment from implementing these clinical services,” said Cynthia Reilly, B.S. Pharm., director of ASHP’s Practice Development Division.

Pharmacists Key to Prevention

Palladino, who is coordinator of the center’s orthopedic anticoagulation program, and Thomson focus on patient and family education around high-risk medications such  as warfarin and other bloodthinners. Their efforts helped TJU meet recent Joint Commission requirements around patient education for anticoagulant therapy.

In working with patients directly, “we’re first asking questions of the patient to get important information,” Palladino said. He added that pharmacists are best positioned to spot possible risks for each patient and to determine the drug and dose to prescribe to avoid bleeding complications or other risks.

TJU Hospital has instituted a computerized physician-order entry system, with automatic order sets prompting prescribers to assess each surgical patient for bleeding complications before offering appropriate prophylaxis anticoagulant options based on the patient’s risk.

“It’s an educational tool, as well as an order set,” Palladino said.

The pharmacists then work with patients to help them understand their medicines, the importance of follow-up monitoring, adherence, and drug-food interactions, and the potential for adverse drug reactions and drug interactions. Time is also spent calling health plans to advocate for patient needs, such as coverage for certain drugs or equipment.

Pharmacists also oversee proper care transitions for patients, scheduling labs and arranging for home health services. For the latter, pharmacists call each patient twice a week for six weeks post discharge to answer questions and ensure that each patient’s recovery goes smoothly.

“We’re transitioning patients back to the primary care physician,” said Thomson, adding that surgeons appreciate the help.

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