Collaborative practice agreements

November 13, 2013

When pharmacists manage drug therapy for physicians, diabetes patients see a significant improvement in key measures.

BY: Mari Edlin

Eric Ip, PharmD, CDE, a diabetes specialist and clinical pharmacist with Kaiser Permanente Mountain View Clinics, Mountain View, Calif., manages a group of patients with uncontrolled diabetes, but not through the usual medication therapy management (MTM) protocol that gained popularity under Medicare Part D. He is participating in collaborative drug therapy management, known as a collaborative practice agreement, a formal partnership between physicians and pharmacists that enables him to oversee a patient’s drug therapy.

According to the Institute of Medicine, as of February 2012, 46 states allow for some form of collaborative practice, which means that the individual state pharmacy laws allow pharmacists to “initiate, modify, and/or discontinue drug therapy pursuant to a collaborative practice agreement or protocol.”

Birth of an idea

Ip’s program was the brainchild of Sandy Chun, MD, a former chief of internal medicine at Kaiser Permanente in Mountain View, who wanted to launch a diabetes program headed by a clinical pharmacist. Just completing his post-graduate residency training with an expertise in diabetes, Ip landed the position in 2007.

Diabetes mellitus affects 25.8 million Americans, or 8.3% of the U.S. population, according to the Centers for Disease Control and Prevention.

The program’s primary objectives are to optimize glycemic and cardiovascular care for adults with both type 1 and 2 diabetes and to improve the facility’s HEDIS (Healthcare Effectiveness Data and Information Set) scores related to glycosylated hemoglobin A1c (HbA1c), blood pressure, and cholesterol.

“In addition, the partnership enhances the role of clinical pharmacists by enabling us to provide high-level services as key members of the primary care team,” he said.

How it works

Ip and one other clinical pharmacist on the team collaborate with 16 primary care physicians (PCPs). They are able to prescribe and adjust diabetes and cardiovascular medications with full autonomy; order laboratory work; administer immunizations; perform physical assessments, including foot exams; deliver dietary and physical activity recommendations; and provide diabetes self-care education.   

Ip also refers patients to specialists, such as podiatrists and ophthalmologists, and arranges preventive health screenings. He sees approximately 50 patients a week, of whom perhaps 10 are new patients, and meets face-to-face with each patient for approximately one hour. Follow-up visits usually take place over the telephone for 5 to 10 minutes, but patients may choose to meet with the pharmacist in person.   

The study

Ip coauthored a study on the benefits of adding clinical pharmacists to a healthcare management team for diabetes, published May 15, 2013, in the American Journal of Health-System Pharmacy.

The retrospective study compared the impact of clinical pharmacist interventions on short-term clinical markers, including HbA1c, low-density lipoprotein cholesterol (LDL-C) levels, and blood pressure, as well as the long-term cardiovascular risk in type 2 diabetes patients. It compared two groups of 147 patients each. The enhanced care group included a pharmacist on the primary care team; the control group was led by a PCP only. 

After 12 months, the mean HbA1c in the enhanced group decreased from 9.5% to 6.9% vs. 9.3% to 8.4% in the control group; patients in the first group were three times more likely than their counterparts to attain goals for HbA1c, LDL-C, and blood pressure. The estimated 10-year risk of congestive heart failure dropped from 16.4% to 9.3% in the enhanced group vs. 17.4% to 14.8% with the control group.

The study concluded that “the addition of a pharmacist to an HMO primary care team improved short-term surrogate markers as well as long-term cardiovascular risk in adult patients with type 2 diabetes.”

While the benefits of the collaborative model have been highlighted in studies, Ip said there was an initial hesitance on the part of PCPs to bring a clinical pharmacist on board. However, that skepticism quickly dissipated, Ip said, when they realized how he and his associate could assume some of the workload and help patients achieve positive outcomes.

Ip foresees more integration of clinical pharmacists into primary care practices, with enhanced participation in direct patient care.

AMCP support

In 2012, the board of the Academy of Managed Care Pharmacy (AMCP) approved the collaborative drug-therapy model described in one of its practice advisories, which outlined the partnership’s objectives; pharmacist responsibilities, including many of the roles assumed by Ip; benefits to stakeholders such as patients, pharmacists, physicians, and managed care organizations; and how a collaborative approach can be optimized.

In a letter dated Sept. 24, 2013, AMCP CEO Edith A. Rosato wrote:

“Whenever pharmacists are authorized to provide certain healthcare services, there are many benefits. Specifically, these benefits include, but are not limited to, reduction in overall healthcare costs, improved patient outcomes, decreased number of drug-related adverse events, improved access to primary care services, and increased patient satisfaction. The pharmacist-provided services, including preventative care services, wellness screenings, chronic disease management, immunization delivery, medication therapy management, and others, have been recognized as beneficial to increasing the overall quality of delivery and increased patient access.”

The South Carolina example

The economic downturn in 2008 helped prompt a collaborative drug-therapy initiative between pharmacists and the Good Shepherd Free Medical Clinic, a rural clinic in Clinton, S.C.

In 2009, faculty at the Presbyterian College School of Pharmacy in Clinton established a collaborative practice agreement with the clinic’s volunteer medical director and a nurse practitioner to provide medication therapy recommendations.

Unfortunately, in the absence of a full-time PCP, the program has ceased operation. However, faculty and students at Presbyterian College continue to provide dispensing services to the clinic. In addition, patients may still take advantage of a free diabetes education class.

The program has provided a model that other free clinics can emulate.

“We identified patients with type 2 diabetes who could benefit from pharmacy management in addition to medical services,” said Julie Sease, PharmD, BCPS, CDE, interim assistant dean for academic affairs at the school of pharmacy.

Students at the school joined the mix of providers in the program as volunteers for patients referred by Good Shepherd.

The patient-specific program offered ongoing follow-up for patients with uncontrolled diabetes. “In this way, we were able to keep som

e of these patients out of the emergency room and help them meet national standards for lipid levels, blood glucose, and blood pressure,” Sease said.

Adopting responsibilities similar to Ip’s, pharmacists ordered prescriptions with a physician’s permission, managed laboratory orders, educated and counseled patients on diabetes, and assessed appropriateness of drug therapy.

Of 1,159 pharmacist interventions documented by the program, 77.6% were for changes in drug therapy, 50.4% for increases in medication doses, and 28.4% for additional drugs. Most visits lasted 30 to 45 minutes.

The development of an electronic medical record at Good Shepherd promoted communication between providers and the dispensing pharmacy and documented clinical encounters. A drug formulary facilitated prescribing and helped contain costs.

What collaboration can do

Sease coauthored a study on the program that was published January 2013 in the AmericanJournal of Health-System Pharmacy. The 95 adult patients it followed were at least 18 years old, qualified for free care on the basis of income and insurance status, had a diagnosis of type 2 diabetes, and had been continuously enrolled in the program for two years.

The study measured changes in baseline HbA1c, blood pressure, and LDL, and found the following: HbA1c dropped from an average of 10.7% to 8.1%; LDL from 103.5 to 81.5; systolic blood pressure, 130.9 to 123.6; and diastolic blood pressure, from 77.9 to 74.1.

The percentage of patients reaching their goals was: HbA1c, 35.7%; systolic blood pressure, 68.4%; diastolic blood pressure, 76.8%; and LDL, 82.9%.

Based on an estimated savings of $1,118 for each patient who achieved a decrease of 1% or more in HbA1c through pharmacist management, savings were estimated at $74,906 per year.

The Tennessee program

A prospective study conducted at seven practice sites across the state of Tennessee showed similar results of pharmacist-physician collaboration for diabetes patients. The 12-month program followed 206 patients with type 2 diabetes who were 18 years or older and who had enrolled in the study between 2008 and 2010. The study tracked the percentage of patients with reduced HbA1c, the percentage achieving an HbA1c <7%, and the percentage with an uncontrolled HbA1c >9%.

Most of the participants were male (59.71%) and white (66.02%), with a median age of 59.73 years.

Patients visited a pharmacist, physician, or both for follow-up or could choose to do the consultation by phone. Pharmacists provided patient education, ordered laboratory testing, made referrals for immunization and eye examinations, and provided medication management through initiation, adjustment, and discontinuation of therapy.

Published in the June 2013 issue of The Annals of Pharmacotherapy, the results showed an average reduction in HbA1c of 1.16%. The proportion of patients with an HbA1c < 7% increased from 12.75% at baseline to 36.76%, and the percentage of patients with an HbA1c of >9% decreased from 34.15% to 16.5%.

Each of the seven practice sites had pharmacists in place, working in a collaborative manner with the physicians, before the study began. The pharmacists are affiliated with the University of Tennessee’s Health Science Center and College of Pharmacy in Knoxville.

Michelle Z. Farland, associate professor of clinical pharmacy at the college, said that outcomes were not affected by site location.

Under this program, physicians refer patients with uncontrolled diabetes to pharmacists, who ensure that they receive HbA1c testing and eye and foot exams. In addition, pharmacists oversee medication use; solve problems; oversee nonadherence and nutrition; monitor liver and kidney function; order lipid panels and immunizations; and manage conditions associated with diabetes, such as high blood pressure and cholesterol. Pharmacists present care plans to physicians and later discuss them with patients.

Tennessee does not allow pharmacists to prescribe medications. However, there has not been a push in the state for a larger role for pharmacists, Farland said.

“The collaboration enables patients to spend more time with providers to ask questions and learn how to better manage their condition,” she said.

Mari Edlin is a freelance writer in Sonoma, Calif.