An Overview of the Clinical
Pharmacist Practitioner in NC

by Betty H. Dennis

The Clinical Pharmacist Practitioner Act became effective July 1, 2000. This legislation acknowledged the need for Clinical Pharmacist Practitioners and the importance of collaborative practice. The successful implementation of the Act resulted from the dedicated efforts of many pharmacists and physicians, including members of a subcommittee that was appointed in 1999 to promote this initiative. Committee members included Ken Chambers, MD, John Dees, MD, John Foust, MD, and Stephen Herring, MD representing the Medical Board. Albert Lockamy, Robert Crocker, and Jack Watts represented the Pharmacy Board. Other members of the committee included Dan Garrett (Executive Director of NCPhA), David Work (Executive Director, Board of Pharmacy), Denise Stanford (attorney, Board of Pharmacy), Diane Meelheim (Medical Board), and Jim Wilson (attorney, Medical Board). Rules were developed by the North Carolina Boards of Pharmacy and Medicine and these became effective April 2001 (21 NCAC 46.3101).

Clinical Pharmacist Practitioners (CPPs) are approved by both the Boards of Pharmacy and Medicine. The application process includes documentation of credentials, practice experience, collaborative practice policies and protocols, signature of supervising physician, and a $100 fee payable to the Medical Board. The Board of Pharmacy reviews applications during monthly meetings (odd numbered months) and forwards the approvals to the Medical Board for review the next month (even numbered months). The Medical Board issues the CPP registration number and is responsible for the annual renewal process that requires 35 hours of continuing education and a renewal fee of $50.

The credentials required for CPP registration were developed after discussion and input from many sources, including the North Carolina Center for Pharmaceutical Care (NCCPC). Requirements include a North Carolina pharmacist license, agreement with supervising physician and:

• certification (BCPS, CGP) or ASHP Residency including two years clinical experience or ...
• PharmD degree with three years experience, plus completion of one NCCPC or ACPE Certificate Program or...
• BS degree with five years experience, plus completion of two certificate programs.

A Clinical Pharmacist Practitioner is defined as a "licensed pharmacist in good standing who is approved to provide drug therapy management under the direction of, or under the supervision of, a licensed physician who has provided written instructions for a patient and disease specific drug therapy which may include ordering, changing, substituting therapies or ordering tests." The Supervising Physician is held accountable for on-going supervision and evaluation of the drug therapy management performed by the CPP as defined in the physician, patient, pharmacist and disease specific written agreement that is submitted with the CPP application.

The drug therapy management protocols that are developed for the collaborative practice need to be specific in regards to the physician, pharmacist, patient and disease. The agreement must include the diagnosis and product selection by the physician and any modifications which may be permitted, dosage forms, dosage schedules and tests which may be ordered. Many CPP's have met these requirements by including specific protocols and algorithms for a specific service, such as anticoagulant monitoring. The protocols are somewhat broad and generalized to allow maximum patient specific therapy. The diagnosis of the patient is confirmed when the physician "refers" a patient to the CPP practice for specific drug therapy management services that are outlined in the protocols, and this diagnosis should be documented by the physician and the CPP. The requirement for product selection by the physician has been interpreted to be met when the physician "refers" a patient with a specific diagnosis to the CPP practice to be managed per the approved protocol(s). It is essential that the CPP develop a system of documentation for all patient assessment, education and drug therapy management.

In addition to the above, the written agreement with the Supervising Physician must include a plan for weekly quality control, review, and countersignature of orders in a face-to-face conference between the Supervising MD and the CPP. It is required that all patients be notified of the collaborative relationship. Additional details concerning the CPP requirements are available on the Board of Pharmacy web site at www.ncbop.org.

NCAP's CPP Committee promotes and supports CPP practice. Our goals are to: (1) promote and encourage pharmacists to become CPP's, (2) identify ways NCAP can support needs of current CPP's, and (3) recommend policy to the NCAP Board and House of Delegates that will further the pharmacist's role in direct patient care.

In March 2002, the NCAP CPP Committee developed a survey to assess current CPP practice. The survey was mailed to the 28 CPP's who had been approved to practice, and 23 surveys (82.1%) were returned for evaluation. Data indicate that 16 CPP's currently bill for their patient care services and 18 have agreed to have a summary of their practice included on the NCAP Web site as a resource for others who are interested in developing a CPP practice.

Of the 23 survey responders, seven CPP's practice in a physician's office, six in a hospital clinic, two in a long-term care practice, with the majority practicing in ambulatory care settings. The most common credentials for CPP approval include the BS in Pharmacy degree with five years of clinical experience and completion of two approved certificate programs. Seventeen CPP's have earned the PharmD degree and nine have completed residencies.

The most common drug therapy management services provided by surveyed CPP's are for patients with diabetes, asthma, hypertension, hyperlipidemia, heart failure, anticoagulation, and pain management. Other services include protocols for smoking cessation, epilepsy, polypharmacy, COPD, osteoporosis, obesity, infectious diseases and renal disease.

Successes described by CPP's in practice include improved patient care outcomes, reimbursement for patient care services, enhanced efficiency of practice, improved continuity of care, creation of a model of practice for students and residents, recognition by physicians for patient care services, increased scope of practice and increased career opportunities. The enthusiasm of one CPP is indicated by a comment on the survey that states: "It's the most rewarding thing I've ever done professionally."

The primary barrier to CPP practice was identified as the requirement for the CPP practice to be physician-pharmacist specific, when many medical practices include multiple physicians. An interpretation of this requirement by the Board of Pharmacy has allowed a referral type practice for these sites. Physicians in a group practice can "refer" patients to the CPP collaborative practice with Supervising Physician, and then the patient can be managed per the approved disease management protocols. This referral type practice is common in healthcare and offers an option for pharmacists who work with multiple physicians. The Supervising Physician is still accountable for all drug therapy management services provided by the CPP and must agree to the specific plan of any collaborative practice.

Other barriers to CPP practice were the cost, CE requirements for annual renewal, and credentialing by the practice site or healthcare system. Challenges include clarification of insurance and billing for patient care services, gaining recognition as a healthcare provider and reimbursement for patient care by Medicare, and obtaining DEA numbers that are especially important for CPPs providing pain management services. Documentation, paperwork, and work overload were listed as daily challenges in practice.

Several suggestions are recommended to facilitate the CPP application process. It is helpful to include a cover letter with a general summary statement of the practice. Also include a statement that indicates support for the CPP application such as Clinic Director, Director of Pharmacy, P&T Committee, and Supervising Physician and copy appropriate individuals on the letter. Development of a "Scope of Practice Statement" is suggested to focus the vision and mission of the practice. Policies and procedures should include documentation and database management. Protocols for drug therapy management should be evidence-based and include provisions for management of acute exacerbations of disease.

The Clinical Pharmacist Practitioner Act opened the door for collaborative practice opportunities. Pharmacists are encouraged to contact their congressmen concerning legislative bills that are being considered by Congress that would enable pharmacists to be paid for cognitive and medication management services.

The question has been asked, "Why should I become a CPP" when I have been providing patient care services for years. Although there are many possible responses, there is agreement by many that establishment of an approved CPP practice is an investment in the future of our profession that will benefit generations of pharmacists and patients. The practice can demonstrate a model for students that can be adapted to many environments, improve patient care outcomes, and increase patient awareness of the availability of pharmaceutical care services. The CPP initiative began as a vision. It was created with the philosophy of patient focused pharmaceutical care. It is the responsibility of practitioners to make it a reality for pharmacy practice.

About the Author...
Betty H. Dennis, PharmD, MS, CDE, CPP, FASHP is a Senior Clinical Specialist, Ambulatory Care Department of Pharmacy at UNC Hospitals and a member of the North Carolina Board of Pharmacy. She can be reached via e-mail at bdennis@unch.unc.edu