Expanding Collaborative Practice in Primary Care to Include Clinical Pharmacists

The passage in 2010 of the Affordable Care Act (ACA) initiated the transformation of the United States healthcare system. The ACA fosters a preventive healthcare model that emphasizes primary care over acute care, funds community health initiatives, and promotes quality and value-based care. It also established the Community-Based Collaborative Care Network (CCN) Program, which is comprised of a consortium of providers. The CCN provides an opportunity for health professionals from various disciplines to work together to coordinate and integrate care more comprehensively in an interdisciplinary fashion. Given that approximately 70% of a person’s health is determined by social determinants, the traditional treatment model and often “siloed” approach is less than effective; a more comprehensive, collaborative approach holds promise. The CCN created the extraordinary opportunity for greater participation of nurse practitioners [and clinical pharmacists].(1)

In 2003, the Medicare Prescription Drug Improvement and Modernization Act was passed, which required Medicare Part D prescription drug plans to include medication therapy management (MTM) services.(2) Although 100% of Part D sponsors use pharmacists, MTM also is performed by nurses (38%), nurse practitioners (26%), and physicians (25%).(3) Following passage of the ACA, the Medication Therapy Management Empowerment Act was passed in 2011, further expanding MTM coverage under Medicare Part D.(2)

Many state agencies and pharmacy organizations have been advocating for an expanded and clinically oriented role for pharmacists.

Many state agencies and pharmacy organizations have been advocating for an expanded and clinically oriented role for pharmacists. In 2003, the American College of Clinical Pharmacy issued a position statement on collaborative drug therapy management (CDTM) and the positive impact of clinical pharmacy services on patient care.(2) In 2008, the American Society of Health-System Pharmacists (ASHP) and the ASHP Research and Education Foundation began the Pharmacy Practice Model Initiative (PPMI).(4) The PPMI encourages pharmacists to use their education and training to ensure that pharmacy services match the most urgent needs of patients and institutions, including, per Bickel et al.,(5) proactive assessment and risk mitigation of medication-use systems. The CDC has released reports about the role of pharmacists in addressing chronic diseases in states and communities via public and private partnerships.(6,7) In their most recent report,(6) the CDC notes, “Pharmacists’ education and training fully prepares them for participation in and contribution to team-based care, disease management, and the provision of wellness services. However, pharmacists’ skills may be underused, as patients and physicians are not always aware of the extent of pharmacists’ training and qualifications.” A recent publication from the American College of Cardiology advocates for inclusion of a clinical pharmacist in the delivery of efficient, high-quality care for cardiovascular disease.(8)

The National Alliance of State Pharmacy Associations has expanded upon previous research to further examine the variability between state collaborative practice agreements (CPA) laws.(9) CPAs create a formal practice relationship between a pharmacist and a healthcare provider with prescribing privileges, to allow pharmacists to manage and modify medication therapy as mutually agreed. Although there are wide variations in CPAs, the majority allow pharmacists to adjust current drug therapy, initiate new therapy, evaluate relevant labs, obtain and collect vital signs, and obtain and review a patient’s history. The length of time for which the services are authorized under a CPA depends on the state’s legal provisions and the terms of the specific agreement.

Clinical and prescribing roles traditionally have not been within the scope of practice of pharmacists; however, this may change as the federal and state governments consider how pharmacists can decrease the cost of drug therapy and improve patient outcomes. The federal pharmacist provider status bill introduced in the U.S. House of Representatives (H.R. 4190) on March 11, 2014, defers to states to decide the scope of practice for what services a pharmacist can provide and be compensated for. This legislation has placed even greater attention on the state-to-state variability with regard to pharmacists’ scope of practice. To date, whereas 38 states have granted pharmacists provider status, 12 states have not.(10) The concept of the pharmacist-provider is not a new one: in 1973, the Drug Regimen Review for nursing homes was enacted by the Department of Health Education, and Welfare, mandating monthly drug therapy reviews by pharmacists.(2) In 1974, the Indian Health Service developed the Pharmacist Practitioner Program, which allowed specially trained pharmacists to provide CDTM. Washington state CDTM legislation enacted in 1979 provided the first state-wide provision for CDTM services by pharmacists. In 1995, provision of CDTM by clinical pharmacy specialists was approved by the Veterans Health Administration, providing pharmacists a scope of practice determined by each practice site. As of December 31, 2012, at least 36 states had authorized physician-pharmacist CDTM, in any setting, to provide for an array of health conditions, including chronic diseases.(10) Nonetheless, there is great variation by state and region as to the list of health conditions authorized for CDTM and what pharmacists are allowed to do under CPAs: for example, conduct targeted physical assessments, order laboratory tests, or modify (or discontinue) drug therapy accordingly.

Maine was one of the last states to enact a collaborative practice law involving pharmacists (2013; Maine LD 1134). It is not uncommon for clinical pharmacy services in New England, and, in particular, in Maine, to lag behind the rest of the country. Maine was the 50th state to enact legislation to allow pharmacists to immunize patients, in 2013. Additionally, pharmacists do not have provider status in Maine, despite significant legislative efforts in recent years. This lag time may be due in part to an absence of pharmacy schools in the rural state of Maine, until the opening of two in 2009, both of which graduated their first classes of Doctor of Pharmacy students in 2013. In this time of rapid change in the healthcare industry, we assessed pharmacists’ experience with collaborative care practice, including their adoption of it and enthusiasm for it.

Methods

We conducted a cross-sectional survey of all licensed pharmacists in the state of Maine (n = 1262) to assess their pharmacy practice needs. (Details of the Maine Pharmacy Practice Needs Assessment have been published elsewhere.(11)) In the current survey, we also assessed a few newer programs related to pharmacy practice. Using a six-point Likert scale, where 1 indicates strongly disagree and 6 means strongly agree, respondents were asked if they were familiar with Maine’s CCA, and, if so, whether they had a favorable opinion of it. Respondents also were asked if they use MTM in their practice, and, if so, whether they have a favorable opinion of it. Open-ended comments also were collected.

A cover e-mail with a link to the survey was sent in mid-October 2016, followed by two reminder e-mails. The survey was closed the first week in November. As an incentive for pharmacists to participate, a $5 gas card was offered, as well as a chance to win a $50 gift card. The survey and its administration were approved by the University Institutional Review Board.

The data from SurveyMonkey (the free software we used) were downloaded and saved in an Excel file. Descriptive statistics were used to calculate the percentage of respondents who “agreed” or “strongly agreed” with each question. The open-ended comments were read and coded by two independent reviewers.

Results

The response rate was 22% (n = 279 of 1262 Maine pharmacists). Approximately 40% of responses were from large chain retail stores, and almost 25% were from in-patient hospitals; 14% were from independent pharmacy stores. The remaining responses were from ambulatory care, long-term care, and academia. More details about the respondents can be found elsewhere.(11)

One-third of Maine pharmacists—34.6% (95% CI: 28.8 – 40.5)—were familiar with the CCA. Of those who were familiar with CCA, 61.2% (95% CI: 53.3 – 69.1) had a favorable opinion of it. Respondents indicated that physician acceptance is critical for the CCA to work (e.g., “Physician buy-in is key, and none of the physicians in Maine are familiar with clinical pharmacists in this setting. More education of providers is needed.”).

Less than 30% of respondents (29.8% [95% CI: 24.3 – 35.3]) commonly use MTM in their practice, but close to three-quarters view MTM favorably (71.4% [95% CI: 65.6 – 77.3]). Respondents believed that MTM requires a lot of time and that inadequate staffing does not allow for it. Said one respondent, “I think MTM is a good program, but we are not given enough help to spend time executing these cases and reviewing them with doctors and patients. We need more time to be able to make this program work.” Another respondent added, “ . . . I simply do not have the time to enter all the data into the clumsy [computer] program that we are given . . .” A common theme expressed by a chain pharmacist was, “MTM is great but until chains get reimbursed significantly there will not be adequate staffing to give it appropriate attention.”

Over 70% of pharmacists responding to our survey agreed that more staffing would be beneficial to their practice. Based on the open-ended comments received, most respondents felt inadequate staffing was a major obstacle for CCA and MTM to work. “Staffing levels do not allow adequate time” and “no extra staffing, poor site accommodations” were common concerns from respondents of the survey.

Discussion

Maine typically lags behind other states in the adoption of innovations in professional practice. Only one-third of Maine pharmacists have heard of Collaborative Care, even though it was specified as part of the 2010 ACA. Though speculative, Maine physicians are likely even less aware of the opportunity for collaborative care (N. Nesin, MD, personal communication, April 2017). Furthermore, and unfortunately, less than one-third of pharmacists in Maine are doing MTM. A survey of community pharmacists in West Virginia found that only 27.1% of pharmacists-in-charge report that MTM services are being provided(12); in Wisconsin, just under a third of pharmacists report using MTM.(13) Snyder and colleagues concluded that a financially viable business model is needed in order for successful pharmacist patient care services to occur.(14) In Maine, the limited knowledge and adoption of these services are likely due to the fact that the CPAs are not well established in the state. It has been suggested that physician buy-in and having specialty trained (and perhaps board-certified) clinical pharmacists are important to implement collaborative practice.(14) A study of MTM in Iowa found that physicians accepted 48% of the recommendations to alter drug therapy made by pharmacists, with the highest rates of agreement to stop or change a medication (~50%, each) and the lowest rate of agreement to start a new medication (42%).(15) Findings from our study and those from the other states can be viewed in light of the 2015 National Consumer Survey, which found that nearly two-thirds of adults taking three or more medications per day would definitely accept advice from the pharmacists to help them take medications as prescribed, and to help them save money by considering a generic alternative.(16)

Numerous studies illustrate better patient outcomes when providers and pharmacists work together, as demonstrated across several conditions, including:

• Diabetes(17-21);

• Hypertension(22, 23);

• Asthma(24);

• Medication adherence among patients with depression(25);

• Antibiotic stewardship(26);

• Cardiovascular disease(8);

• Cardiac rehabilitation(27); and

• In a medication management role in a mental health clinic.(28)

For example, a study of patients with chronic kidney disease found that patients were significantly more likely to have a controlled blood pressure and less of risk of medication-related problems when pharmacists are involved.(22) Collaboration between physicians and pharmacists also has been shown to be effective at reducing emergency department visits and hospitalizations in patients with uncontrolled asthma over a 9-month period.(24) Another study found that implementation of a patient-centered approach to medication therapy management and reconciliation by pharmacists resulted in a decreased use of urgent care and an increased use of primary care services by nearly two-fold, which would prove important in maintaining high-quality, preventive care in a value-based manner.(29) In patients with cardiovascular disease, pharmacists improved blood pressure readings, hemoglobin A1c values, body mass index values, and lipid profiles, in addition to reducing smoking and reducing both all-cause mortality and heart failure exacerbation.(8) Patients in this study were highly satisfied with the care provided by their pharmacist provider. Lastly, in patients with diabetes, a pharmacist-provided diabetes management service resulted in lower hemoglobin A1c, low-density lipoprotein cholesterol, triglycerides, and total cholesterol, and increased high-density lipoprotein cholesterol levels, influenza rates, and appropriate eye and kidney screenings.(21) An emerging area for pharmacists’ involvement is with treatment of pain associated with cancer.(30)

Staffing and remuneration are still important barriers to provision of MTM and CDTM in some states.

Similar to our findings, Gadkari and colleagues(13) found that pharmacist workload makes it difficult for pharmacists to offer MTM even though there is a growing demand for these services. It appears that staffing and remuneration are still important barriers to provision of MTM and CDTM in some states. Community pharmacists often perform the duties that a technician could perform, which takes away from time the pharmacist could use to counsel patients. Moreover, there is little to no reimbursement for pharmacists’ cognitive services (e.g., medication education, MTM, or CDTM) in Maine, and this also hinders pharmacists from performing MTM and CDTM. Many states have resolved this issue by giving pharmacists provider status, but Maine has not done this yet. The Federally Qualified Health Centers are poised to be early adopters of the collaborative practice model, but the U.S. Health Resources and Services Administration (HRSA) has thus far not designated pharmacists as providers (N. Nesin, MD, personal communication, April 2017).

In our study, we may have underestimated those engaged in CDTM while our survey used the terms “Collaborative Care Act” and “Medication Therapy Management.” Indeed, a consortium of stakeholders recently was engaged to explore the expanding roles that pharmacists can play, and they crafted 56 recommendations (of which 80% were deemed to be high impact and high feasibility). One of the key recommendations was the need for consistent terminology.(8) For example, the American College of Clinical Pharmacy has stressed that simply providing MTM is not enough and that a new term, Comprehensive Medication Management, is preferred because it is a more holistic activity.(2) An additional reason we may have underrepresented familiarity and use of collaborative practice and MTM is that we sampled pharmacists across the state, including those working in the community setting. In fact, when we sort the data by setting, we find those who work in the hospital setting have much higher recognition of CCA (54.72%) and slightly higher use of MTM (37.04%).

Finally, the single-state sampling frame may limit the reliability of our findings, although cited studies appear to have similar results. Our results may be generalizable to other rural states that have been slow to adopt legislative changes for pharmacists. Survey research has its own limitations, including the challenge of obtaining a sufficient response rate, which may lead to selection bias. Nevertheless, we were able to obtain the views of nearly 300 Maine pharmacists and capitalize on both the quantitative and qualitative data captured to glean a picture of the current status and views of collaborative practice in our state.

The U.S. Congress currently is considering giving pharmacists provider status, and 38 states have already done so.

In summary, it is not uncommon for clinical pharmacy services in New England, and, in particular, in Maine, to lag behind the rest of the country, as discussed earlier. Thus Maine has a distance to go in terms of reaping the potential benefits of collaborative care between providers and pharmacists. The state and many providers are unaware that pharmacy has been evolving from a product-centered to a patient-centered profession for over 50 years. The literature is replete with evidence of the value of so-called “clinical pharmacists” in reducing the cost of pharmacotherapy, increasing the safety of medication use, and improving patient outcomes in a variety of settings. The U.S. Congress currently is considering giving pharmacists provider status, and 38 states have already done so. Nearly all states allow various types of CPAs between providers and certified advanced-care pharmacists. Still, there are barriers to pharmacist participation primary practice. These include political issues, insurance reimbursement, how to reconfigure the primary care business model, and—interestingly—pharmacist concerns about time needed to perform medication management, reimbursement for their time, and provider acceptance. If Maine’s citizens are to gain the substantial benefits of collaborative practice that includes pharmacist participation, the state must grant pharmacists provider status; reimburse them for cognitive, clinical services; and require third-party payers to do the same. In addition, employers must provide enough pharmacy technicians to allow pharmacists to practice at the top of their education and training. Finally, primary care providers should consider what pharmacists can bring to value-based patient care and reimbursement.

Acknowledgment: The authors thank Noah Nesin, MD, FAAFP, Vice President of Medical Affairs, Penobscot Community Health Care, Bangor, Maine, for his review and insightful suggestions for this manuscript. There was no financial support for this work.

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