Mari Edlin is a healthcare writer in Mill Valley, California. She writes frequently on pharmacy issues.

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.”

	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.

	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.   

	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.

	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 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.

	Sease coauthored a study on the program that was published January 2013 in the 

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.

	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.

, 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.

 is a freelance writer in Sonoma, Calif. 

Articles

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

Collaborative practice agreements

"It is a dynamic process, along with a patient-centered care approach, influenced by demographics and social determinants," Kennedy said during a recent annual meeting of the American Pharmacists Association.  

The Department of Health and Human Services' Office of Minority Health defines "cultural competency" as a "set of congruent behaviors, attitudes, and policies that come together in a system or agency, or among professionals, that enables effective work in cross-cultural situations."			

Patient-centered care, Kennedy emphasized, will improve communications, enhance patient satisfaction, increase adherence, and ultimately make for better outcomes.  

On the other hand, Kennedy said, lack of cultural competency may increase the cost of healthcare, discriminate against populations with disproportionately higher rates of diseases such as diabetes, cancer, and infant mortality; and open the door for malpractice suits. 

, which she recommends that providers use with all patients:				

Pharmacists who practice cultural awareness can deliver better patient care and bring about better outcomes

Cultural competency means better patient service

Pharmacists have an essential role to play in managing CMD&W through teaching, counseling, and dispensing. 

"One thing that most providers agree upon," she said, "is the need for prevention and early detection of the [associated] risk factors." This is where community pharmacists can help mitigate the causes and symptoms of CMD&W by engaging and coaching patients, in addition to imparting their knowledge about medications. 

With many drugs, adherence is a growing problem, and the medications associated with CMD&W - statins, antihypertensives, and diabetes drugs - are no exception. Nonadherence occurs in 21.3 percent of patients with diabetes, according to a retrospective cohort study of 11,532 patients.

  The study revealed that those who did not adhere to their prescribed antihypertensive, hypoglycemic, and lipid-lowering medications at least 80 percent of the time were significantly more likely to have elevated levels of HbA

 blood pressure, and LDL than were those who adhered.  

The American Pharmacists Association recommends that pharmacists collaborate with physicians to identify individuals who are not adherent and help to eliminate barriers by minimizing the number of daily doses, reducing dosing frequency, and selecting the most efficacious and cost-effective medications.  

Alan Vogenberg, RPh, a consultant pharmacist in Levittown, Penn., says that community pharmacists are at a loss, because they know what drugs patients are taking, but they don't necessarily know the diagnosis. This can make it difficult to counsel them. "The best-case scenario is developing a collaborative approach with a physician and creating a dialogue," he told 

"The pharmacist can monitor patients and report back to the physician. We can serve as teachers and help patients manage side effects or facilitate compliance. Also, don't use jargon with patients; use open-ended questions and ask patients to repeat back information to ensure they understand what has been said." 

  Tracey H. Taveira, PharmD, associate professor of pharmacy at the University of Rhode Island in Kingston, agrees with Vogenberg that as patients take more drugs as part of increasingly complex regimens, pharmacists can play an important role in medication adherence. "We are also experts at knowing what's on formulary, helping to ensure that drugs are covered, and converting doses and medications if needed," she said. 

Through an affiliation with the Veterans Affairs Medical Center in Providence, Taveira and her colleagues conducted a study of 375 veterans, using the Cardiovascular Risk Reduction Clinic model,

  a pharmacist-coordinated care model that incorporated cardiometabolic risk factors under one umbrella for treatment by clinical pharmacists overseen by a cardiologist. Participants underwent motivational interviewing geared to modifying their behavior and received frequent medication titrations, which clinical pharmacists were allowed to modify under federal regulation.  

In accordance with guidelines recommended by the American College of Cardiology/AHA and the American Diabetes Association, 70.7 percent met the discharge criteria by the end of the study period. Guideline adherence increased for total cholesterol, LDL, HDL (high-density lipoprotein), HbA

  (a measure of blood glucose over time), and systolic blood pressure. 

The term "cardiometabolic disorders" (CMD) refers to a cluster of interrelated risk factors (hypertension, elevated fasting glucose, reduced high-density lipoprotein, elevated triglycerides, and abdominal obesity) that promote the development of atherosclerotic cardiovascular disease and type 2 diabetes. With an estimated 47 million Americans facing increased risk of heart disease because of these conditions, management of patients' CMD is a priority for pharmacists.

Cardiometabolic disorders: The pharmacist's role

Brian Bertha, senior vice president of marketing for McKesson U.S. Pharmaceutical, headquartered in San Francisco, is confident that, compared to three years ago, medication therapy management (MTM) programs have picked up speed.  

He bases his opinion on three primary factors. The first is recognition that MTM need not be defined only by Part D guidelines developed by the Centers for Medicare & Medicaid Services (CMS). For example, Bertha refers to "focused MTM consultations," in which a plan using MTM leverages the expertise of a pharmacist to close a gap in care, as opposed to delivering comprehensive medication reviews. "Generally, the commercial plan populations do not have the same level of complexities as the Part D population, but do have a wide spectrum of simpler issues whose need for resolution is just as necessary; hence, the focused consultations," he said.  

Second, commercial plans do not have the same formal MTM requirements as are found under Part D and thus are more flexible. And, finally, market pressures demand that health plans continue to innovate continually to keep avoidable medical costs at bay. 

In fact, Tom Halterman, CEO of Outcomes Pharmaceutical Health Care in Des Moines, Iowa, a provider of MTM services, believes that MTM programs in the commercial sector may be held to a higher standard than those under Part D. "Since commercial-sector plans have the option of not driving MTMPs at all, they must be able to prove quality improvement and cost control stemming from the pharmacist interventions," he said. "This means pharmacists must successfully consult with prescribers to resolve drug complications and influence  patients to adhere appropriately to medication regimens." 

The commercial sector, which includes pharmacies, insurance plans, and employers, is showing off its MTM programs - not only how they work, but eligibility requirements, reimbursement, what services are offered, and, in some cases, program results.  

What started in 2006 as a Part D MTM program sponsored by HealthPartners in Minneapolis, Minn., expanded into a pilot program with the State of Minnesota the following year and then into a program for all fully insured commercial members in 2008. This year, the health insurer is offering an MTM program to its employees. 

In the pilot version, all state employees with diabetes were eligible to have their prescription copayments waived if they participated in a pharmacy counseling program and chose a HealthPartners' clinic for treatment. Members in the fully insured program had to be taking five or more unique medications and incurring more than $1,000 in pharmacy costs within a three-month period. 

Initial consultations with clinical pharmacists were hour-long drug reviews, with subsequent 30-minute meetings to discuss potential cost savings, monitor conditions affected by medications, and help prevent side effects and adverse drug events. Meetings could take place in person or by phone. As many as 84 percent of visits were face-to-face, with 16 percent by phone. Studies show that through counseling, pharmacists have been able to identify an average of two drug-related problems for each patient.  

According to Vyvy Vo, PharmD, clinical pharmacy program manager for HealthPartners, the keys to an effective MTM program are face-to-face interaction, use of an incentive, buy-in from members' physicians, and a collaborative practice agreement between pharmacists and prescribing physicians to change and modify therapies. 

HealthPartners also designed eligibility requirements for clinical pharmacists. They must have graduated from a college of pharmacy after 1996, be licensed in the state, and offer a private place for consultations. Community pharmacists in the program bill fee-for-service; the rate is currently under renegotiation. 

After the first year of the pilot, compared to nonparticipants the 300 patients in the program had 39 percent fewer emergency-room visits and 24 percent fewer hospital admissions, as well as a 137 percent improvement in meeting optimal blood pressure, cholesterol, and blood sugar levels, taking daily aspirins, and remaining tobacco-free. Cost savings revealed by a six-week study of some of the pilot participants revealed reduced expenses of $376 per patient through drug error intervention. 

Commercial medication therapy management programs are gaining in strength and popularity for medical, financial, and practical reasons. In Minnesota, a pilot program for state employees was so successful that two years later it expanded into a program for all fully insured members. Another program is in use by Minnesota Medicaid and General Mills. And in North Carolina, the Asheville Project is still going strong.