Editor’s note: This is the first installment of a four-part commentary that will appear monthly in successive issues of the ACCP Report. See the President’s Column elsewhere in this issue for additional perspective on this commentary.

This is a wake-up call. We all know WHO we are. We are clinical pharmacists who are residency trained (and today, frequently board certified) who provide direct patient care.^1,2 ACCP President Larry Cohen discussed the importance of “the WHO” in his column last month in the ACCP Report.³ ACCP has defined a clinical pharmacist as a pharmacist who “provides patient care that optimizes medication therapy and promotes health, wellness and disease prevention. . . clinical pharmacists assume responsibility and accountability for managing medication therapy in direct patient care settings.”⁴ The pharmacy profession is actively contributing to quality patient care through clinical pharmacy services focused on identifying, resolving, and preventing medication-related problems, improving medication use, and optimizing individual therapeutic outcomes.

Now, we need to figure out WHAT, exactly, clinical pharmacists do to accomplish these ends. We know what we do in general terms, but we may not all do it the same way. We need to determine more precisely what we do and demonstrate it consistently to those outside the pharmacy profession. If we as a profession can’t concretely describe what we do and/or if we can’t deliver it consistently, how can the rest of the health care world be expected to appreciate our value?

As clinical pharmacy programs continue to expand within the health care system, one important limiting factor is a lack of consistency. This serves as a potential barrier to the successful delivery of clinical pharmacy services to patients. The diversity of clinical practice within pharmacy has also resulted in fractionation within the profession that has led to considerable variability in the scope and models of pharmacist-directed patient care embraced by national pharmacy organizations. The emergence of these different models of care, together with various types of certification, may also confuse the definition of clinical pharmacy practice and the generalists or specialists who provide that care. Patients, other health care professionals, and payers understand what to expect regarding drug fulfillment (i.e., the management of the drug order/prescription and its delivery to the patient). However, patients and their families, other health care professionals, and payer organizations do not necessarily know what to expect when a clinical pharmacist provides care to a patient. Because of this variability, it’s difficult even for an organization like ACCP to articulate what a given provider might expect if he or she collaborates with a clinical pharmacist to provide care in an inpatient or outpatient practice setting. Will the pharmacist assume responsibility for all drug therapy outcomes? That is, will he or she see the practice’s patients and identify all problems associated with patient-specific drug therapy, educate patients and monitor their therapies, and resolve their drug therapy problems? One can’t be certain.

Therefore, clinical pharmacy practice needs to be defined in a manner that can be applied across all patients, patient care settings, and types of practice. The model of practice should include the knowledge, skills, behaviors, and attitudes associated with high-quality pharmacist-directed patient care. Developing a clinical pharmacy practice model will not be easy, but it will provide a solid basis to direct the future of pharmacy education, training, and credentialing to meet the needs and expectations of patients and their families, health care professionals, payers, and society at-large. Developing this model is also necessary to ensure that the clinical pharmacist is recognized as an essential member of the team of practitioners responsible for delivering care in a reformed health care system.

Some descriptions of medication management suggest that other health professionals can deliver this care. Without a uniform and consistent practice, will pharmacists be left out of the health care picture in the future?

Establishing a Consistent Practice Model for Patient Care

A unique opportunity exists for the clinical pharmacy discipline to reach a consensus on a consistent practice. Clinical pharmacist competencies have already been developed,5 but a uniform model of clinical pharmacy practice remains elusive. This model should outline and promote a logical sequence of processes that achieves the objective of improving patient outcomes. The process should include steps—or sequenced events—that will occur every time a clinical pharmacist sees a patient, no matter the setting, the conditions that are present, or the medications involved. The model should be articulable, measurable, codeable, and researchable. Others reading a description of the practice should be able to understand it, and clinical pharmacists should be able to readily implement it.

A consistent model of clinical pharmacy practice must meet the following criteria:

• Define the clinical pharmacist’s education, training, and certification needs and requirements.
• Develop, evaluate, revise, and codify a model of practice.
• Facilitate effective coordination of medication therapy management practice among clinical pharmacists (continuity of service).
• Facilitate effective coordination of medication therapy management with other health professionals (interdisciplinary teams).
• Define reimbursement criteria, parameters, and processes.
• Measure the impact of the practice on patient care outcomes.
• Enhance research on clinical pharmacist activities and services by defining the practice and its desired outcomes.
• Provide an important additional element to quality improvement efforts by identifying clinical pharmacists’ actions that could be modified to improve patient outcomes.

A consistent model of clinical pharmacy practice also must:

• Meet the laws and regulations for pharmacists at the state and federal levels.
• Accurately reflect the care delivered by clinical pharmacists.
• Hold clinical pharmacists accountable for patient outcomes.

Practice Models in Other Health Care Professions

Other health care professionals exhibit a consistent approach to patient care. When a patient or other health care professional interacts with a physician, nurse, physical therapist, or dentist, he or she knows exactly what to expect. Indeed, entire coding and billing processes have been built around these models of practice. Similar to this systematic approach as shown by other professions (e.g., routine dental examinations, the physician’s history and physical examination), clinical pharmacy needs to establish a uniform model of practice that patients and other health care providers can expect to occur on a routine basis.

The nursing profession has been using a systematic approach to the care of the patient, “the nursing process,” for more than 25 years. Although the process is dynamic and the steps are continually reevaluated, the basic tenets remain the same.⁶ The American Nurses Association describes the following five steps in this process: (1) assessment, (2) nursing diagnosis, (3) outcomes/planning, (4) implementation, and (5) evaluation.⁷

During the first step, assessment, nurses gather and review patient information from the patient, family, medical record, other nurses, and health care professionals (e.g., physical therapists). Data are collected through interview, observation, and physical assessment and include physiological, psychological, socioeconomic, and lifestyle factors. The nursing diagnosis is a clinical judgment of the patient’s response to actual or potential health care needs based on the nurse’s experience. The outcomes/planning step includes measurable goals for the patient based on the assessment and diagnosis steps. During implementation, nursing care provided to the patient is documented, including both longitudinal care and discharge planning. The last step is a continual evaluation of the effectiveness of nursing interventions and modifications in the original plan as needed.^7,8 This process, used by nurses in all practice settings, provides a degree of consistency to nursing care. Identified benefits of the nursing process include quality control in the provision of individualized care, professional growth, establishment of a foundation for nursing’s scope of practice, and reinforcement of professional autonomy.⁸

The American Physical Therapy Association also provides standards of practice for physical therapy. These standards outline patient care management criteria, which include (1) patient/client collaboration, (2) initial examination/evaluation/diagnosis/prognosis, (3) plan of care, (4) intervention, (5) reexamination, (6) discontinuation of intervention, and (7) communication/coordination/documentation.9 The physical therapist’s examination includes identifying the physical therapy needs of the patient, incorporating appropriate tests and measures to facilitate outcome measurement, and establishing a plan of care. The plan of care is based on examination, evaluation, diagnosis, and prognosis. It identifies goals and outcomes; describes the proposed intervention, including frequency and duration; and includes documentation.⁹

Models Based on Payers

Medications are a primary mechanism for managing health care costs by avoiding the use of other expensive and potentially unnecessary health services and improving quality of life. When consumers, payers, and regulatory agencies require more evidence documenting health care quality, the demand for process-of-care measures will grow.

Government Agencies

Medication Therapy Management (MTM) services were included in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to enhance patients’ awareness of appropriate drug use, increase adherence to medication therapy, and improve the detection of adverse events. The U.S. Department of Health and Human Services is moving to shift the nation’s health care toward a system based on value. Although the design of MTM programs within Medicare Part D is currently variable, a key to measuring the success of these programs will be uniform data collection and integration of these data to perform effective outcomes analysis.

The Centers for Medicare & Medicaid Services has efforts under way to identify MTM service best practices and raise the bar for Medicare Part D MTM programs (see the work being performed by the Patient Safety and Clinical Pharmacy Services Collaborative [PSPC]).¹⁰ The PSPC is a breakthrough effort intended to improve the quality of health care across America by integrating evidence-based clinical pharmacy services into the care and management of patients with high-risk, high-cost, complex medical conditions. Despite these nationwide efforts, the level of services provided within these initiatives lacks consistency, which further complicates the interpretation of this nationwide compilation of data regarding the care provided by clinical pharmacists.

Other Payers

In the United States, where employer-provided health insurance is the norm, consortia of employers are also using quality measures to assess and select health care providers. These consortia are also beginning to incorporate evidence-based measures of structure and process. But without a consistent and reproducible practice, is it likely that clinical pharmacists will be included on this list of select providers? We think not.

Conclusion

Dr. Terry McInnis, a physician involved in the leadership of the Patient-Centered Primary Care Collaborative, summarized it best in her commentary in the October 2011 ACCP Report:

For pharmacists, I believe that you have come to one of the rare crossroads that will define the future of your profession. Either you will take your place as providers of care or your numbers will dwindle…I am a physician, and I say our profession and the patients we serve need you “on the team” as clinical pharmacist practitioners. But, will you truly join us?¹¹

As President Cohen stated in last month’s presidential column, we know WHO we are. But now is the time for the clinical pharmacy discipline to reach a consensus on “the WHAT”—to determine, demonstrate consistently, and communicate clearly our practice. We will address the first step in this journey in next month’s installment of this series, where we will provide a concise review of current clinical pharmacy practice models.

^aCommittee members: Ila Harris (Chair), Beth Phillips (Vice Chair), Eric Boyce, Sara Griesbach, Charlene Hope, Denise Sokos, and Kurt Wargo.

References

1. Murphy JE, Nappi JM, Bosso JA, et al. American College of Clinical Pharmacy’s vision of the future: postgraduate pharmacy residency training as a prerequisite for direct patient care practice. Pharmacotherapy 2006;26:722–33. Available at http://www.accp.com/docs/positions/positionStatements/paper013.pdf. Accessed April 23, 2012.
2. Saseen JJ, Grady SE, Hansen LB, et al. Future clinical pharmacy practitioners should be board-certified specialists. Pharmacotherapy 2006;26:1816–25. Available at http://www.accp.com/docs/positions/whitePapers/wp_phco200612.pdf. Accessed April 23, 2012.
3. Cohen LJ. The Who. ACCP Rep 2012;31:5–6. Available at http://www.accp.com/docs/report/0412.pdf. Accessed April 23, 2012.
4. American College of Clinical Pharmacy. The definition of clinical pharmacy. Pharmacotherapy 2008;28:816–7. Available at http://www.accp.com/docs/positions/commentaries/Clinpharmdefnfinal.pdf. Accessed April 23, 2012.
5. Burke JM, Miller WA, Spencer AP, et al. Clinical pharmacist competencies. Pharmacotherapy 2008;28:806–15. Available at http://www.accp.com/docs/positions/whitePapers/CliniPharmCompTFfinalDraft.pdf. Accessed April 23, 2012.
6. Doenges ME, Moorhouse MF, eds. Application of Nursing Process and Nursing Diagnosis: An Interactive Text for Diagnostic Reasoning, 4th ed. Philadelphia: FA Davis, 2003. Available at http://faculty.ksu.edu.sa/73577/Documents/nursing%20prosses%20book.pdf. Accessed April 23, 2012.
7. American Nurses Association. The Nursing Process. Available at http://www.nursingworld.org/EspeciallyForYou/What-is-Nursing/Tools-You-Need/Thenursingprocess.html. Accessed April 23, 2012.
8. Nursing Process. Cape Fear Community College. Available at http://cfcc.edu/pn/documents/Module5.pdf. Accessed April 23, 2012.
9. American Physical Therapy Association. Criteria for Standards of Practice for Physical Therapy. Available at http://www.apta.org/uploadedFiles/APTAorg/About_Us/Policies/BOD/Practice/CriteriaforStandardsofPractice.pdf. Accessed April 24, 2012.
10. U.S. Department of Health and Human Services. Health Resources and Services Administration (HRSA). Patient Safety and Clinical Pharmacy Services Collaborative [PSPC]. Available at http://www.hrsa.gov/publichealth/clinical/patientsafety/index.html. Accessed April 19, 2012.
11. McInnis T. The most transformative force in health care or the demise of a profession? A commentary. ACCP Rep 2011;30:5–7. Available at http://www.accp.com/docs/report/1011.pdf. Accessed April 19, 2012.