CLINICAL PHARMACIST PRACTITIONER (CPP)

Eligibility

A Clinical Pharmacist Practitioner (CPP) is a licensed pharmacist authorized by the North Carolina Pharmacy and Medical Boards to enter into a drug therapy management agreement with a supervising physician. GS § 90-85.3(b2). CPPs may implement drug therapy after diagnosis by a supervising physician, modify drug therapy, and order laboratory tests to monitor drug therapy effectiveness. GS § 90-18.4(b). A pharmacist may not identify herself as a CPP unless the pharmacist has been approved by the Pharmacy and Medical Boards. GS § 90-18.4(a); 21 NCAC 46.3101(a)(3).

A pharmacist may qualify for a CPP credential with a combination of post-graduate education and clinical experience. The qualification pathways are found at 21 NCAC 46.3101(b)(1)(B) and are discussed in more detail in the FAQ section below.

Instructions / Information

Step 1:
Log into your profile on the Board's Licensure Gateway and submit the CPP Application. There is a $100 NON-REFUNDABLE application fee.

The application must be completed in full. Two uploads are required: (1) the completed malpractice insurance documentation form (found here); and (2) your proposed collaborative practice agreement (also known as your “protocol”).

Board staff has created a Protocol Template that that you may find helpful. (An editable version of this template will be available and posted soon. In the meantime, please email Licensing Director Missy Betz to request a Word version.)

When you are completing your CPP application, please be sure that every site and every supervising physician (primary and secondary) are listed on your online application and on your uploaded protocol. It’s important that they match. If they don’t, then additional time will be required to fix those issues.

On the uploaded protocol, please ensure that each supervising physician has signed and that each signature has been dated. The protocol will not be accepted if it is not complete.


Step 2:
Once your application has been submitted, it will be reviewed by Board staff (to verify eligibility for CPP status) and the Board’s CPP Advisory Committee (to review the proposed collaborative practice agreement for compliance with governing law). Allow 3-4 weeks for review.

During the review process, Board staff or Advisory Committee members may have questions or require further information or clarification. Missy Betz, Director of Licensing, will communicate with the applicant about deficiencies or issues identified by the Advisory Committee in the application or proposed collaborative practice agreement. Prompt responses to these questions will keep the application process moving in a timely fashion.

During the review process, revisions to the proposed collaborative practice agreement may be requested. Once made, you will need to upload the revised collaborative practice agreement into the CPP Application for final review.


Step 3:
Once the proposed collaborative practice agreement is recommended for approval by the CPP Advisory Committee, Board staff will process the application.

You will be notified of approval by email to the email address contained in the Board Licensure Gateway profile.

CLINICAL PHARMACIST PRACTITIONER FAQs

Application

Depending on the applicant’s overall qualifications, a CPP must have two (2), three (3), or five (5) years of Clinical Experience prior to approval. 21 NCAC 46.3101(b). Clinical Experience is measured as follows:

  • International Candidates: “experience” begins at the time a license to practice pharmacy in the United States is obtained.

  • Per decision of the CPP Joint Subcommittee, Advanced Pharmacy Practice Experiences (APPEs) during the final year of a pharmacy school’s PharmD program count as one year of experience.

  • Each year of residency training counts as one year of experience.

  • Each year of patient-contact pharmacy practice post-licensure counts as a year of clinical experience.


21 NCAC 46.3101(b)(2) details the minimum core curriculum required for a certificate program.

Pharmacy Rule 21 NCAC 46.3101(b)(1)(B)(ii) specifically mentions the North Carolina Center for Pharmaceutical Care (NCCPC) and the American Council on Pharmaceutical Education (ACPE) as approved providers of certificate programs in the area of practice covered by the CPP agreement:

  • ACPE-accredited courses followed by a “C” in the area of practice are acceptable. 

  • The NCCPC no longer exists.

  • It is possible that there is not an ACPE-accredited certificate program in the area of practice covered by the protocol for a specific CPP applicant. In this instance, it is up to the professional judgment of the Advisory Committee member to determine if a given certificate program is appropriate to satisfy the intent of the rule. 

  • A committee member may request a table of contents or topic list to determine the clinical appropriateness of the certificate program.

21 NCAC 46.3101(f) specifies that a CPP Agreement shall:

  • Be approved and signed by the Primary Supervising Physician, each Back-Up Supervising Physician, and the CPP. The protocol must be maintained at each practice site.

  • List the Supervising Physician-made diagnoses that the CPP can manage with drug therapy.

  • List the medication classes that the CPP can prescribe and manage.

  • List the tests that the CPP can order to monitor the effectiveness of CPP-prescribed prescription drugs.

  • Include a statement that a patient must be evaluated by a supervising physician (Primary or Back-Up) prior to referral to the CPP. A CPP may not accept “general referrals.” All patients treated by a CPP must be patients of a Supervising Physician. 21 NCAC 46.3101(a)(3)&(i).

  • Prohibit the substitution of a chemically dissimilar drug product without the written consent of a Supervising Physician.

  • Outline a pre-determined plan for emergency services.

  • Outline those scenarios in which Supervising Physician consultation will be sought, with notation of such consultation made in the medical record.

  • Provide for a schedule of meetings monthly between the Primary Supervising Physician to discuss the operation of the CPP Agreement for the first six months of the Agreement, and at least every six months afterward.

The protocol does not need to list every drug, dosage form and strength, but medication class names should be specific enough that it is clear exactly which therapies are covered by the protocol. For example, "antibiotics", “antifungals” "antiarrhythmic agents", "anticoagulants", "immunizations", and "monoclonal antibodies” are not specific enough for clarity. “Macrolides antibiotics”, “Azole antifungal agents”, “Beta-blockers”, “Factor Xa inhibitors”, and “Hepatitis B vaccinations” are examples of specific drug classes. For suggestions on how to list drug classes, referring to a drug information reference, such as the “Pharmacologic Category” of a medication in Lexicomp or Facts and Comparisons, the “Drug Classes” listing in Micromedex, or the “Drug Classification” in the AHFS Drug Classification System can be useful as well.

No. The Committee Member reviews the CPP Agreement with the application to ensure that the CPP designation is required for what the CPP Agreement is proposing to do, as well as to ensure that all required components are included in the protocol.

In general, no. After review of a CPP Application, the CPP Advisory Committee makes a recommendation to the full Board of Pharmacy concerning the application. The full Board of Pharmacy ultimately approves all CPP Applications, but does not typically engage in a second round of CPP Agreement review.

The CPP’s Supervising Physicians (Primary and Back-Up) must sign the last page of the protocol. To make changes to the list of physicians, please follow these instructions.

No. Only the last page of the protocol must be signed by all the Supervising Physicians (Primary and Back-Up).

No. 21 NCAC 46.3101(g)(2) specifies that a Supervising Physician (Primary or Back-Up) shall not be serving in a postgraduate medical training program.

No. The NC Medical Board makes this determination. The rule governing CPP practices specifies that a supervising physician shall “supervise no more than three pharmacists.” 21 NCAC 46.3101(g)(4). The CPP Joint Subcommittee has interpreted that limitation to mean that a supervising physician may not supervise more three (3) CPP full time equivalents (FTEs).

Renewal / Reinstatement

Yes. Once you’ve renewed your license to practice pharmacy, you may renew your CPP credential. Click the CPP tile in your Board Licensure Gateway profile, then click Renew. You will be redirected to the CPP renewal application. The renewal fee is $50. Follow this link for additional FAQs regarding renewal of your CPP license.

A CPP must earn 35 hours of CPP-practice relevant continuing education each year. 21 NCAC 46.3101(d).

All CPPs must, of course, earn 15 hours of qualifying continuing education to renew their license to practice pharmacy each year. 21 NCAC 46.2201. Any (or all) of those hours may count toward the CPP-specific continuing education requirement as long as they are practice-relevant.

The remaining 20 hours of CPP-specific, practice-relevant continuing education are satisfied by ACPE-accredited continuing education coursework. 21 NCAC 46.3101(a)(8). Though the CPP rule defines “continuing education” as “courses . . . approved for credit by [ACPE],” it has long been the practice to accept ACCME-accredited, practice-relevant continuing education credits for CPP credential renewal.

NOTE: ACCME-accredited continuing education does NOT satisfy the general CE requirement for pharmacist licensure renewal. Board rule specifies that three types of continuing education may be used for purposes of pharmacist license renewal: (a) CE courses approved by ACPE; (b) CE courses approved by the North Carolina Association of Pharmacists; and (c) Precepting, for at least 160 hours, a student enrolled in the University of North Carolina Eshelman School of Pharmacy, the Campbell University College of Pharmacy and Health Sciences, the Wingate University School of Pharmacy, or the High Point University Fred Wilson School of Pharmacy as part of these schools’ academic program. 21 NCAC 46.2201(e).

When a CPP discontinues working under an approved CPP Agreement, the CPP must notify the Board of Pharmacy within 10 days. The CPP approval terminates automatically and is placed on inactive status until a new CPP application and protocol are approved. 21 NCAC 46.3101(b)(1).

Practice Agreement Updates

The monthly meeting requirement does not come back into effect if there is a change in primary physicians as long as the replacing Primary Supervising Physician had previously been a Back-up Supervising Physician in the same institution for at least six months.

General

Yes. The CPP and supervising physician are responsible for ensuring that a conflict of interest does not exist, and that any laws or regulations that may be applicable (e.g., federal Stark Law or Anti-Kickback Statute; North Carolina prohibition on referral fees among health care providers) are complied with.

No. All patients that a CPP sees must be patients of a Supervising Physician (Primary or Back-Up). A CPP may not take general referrals from other physicians. 21 NCAC 46.3101(i) specifies that a CPP may be disciplined for having “engaged . . . in the provision of drug therapy management other than at the direction of, or under the supervision of, a physician licensed and approved by the Medical Board to be that CPP’s supervising physician.”

No. All patients that a CPP sees must be patients of a Supervising Physician (Primary or Back-Up). A CPP may not take referrals from PAs or NPs, even if the PA or NP is also supervised by the CPP’s supervising physician. 21 NCAC 46.3101(i) specifies that a CPP may be disciplined for having “engaged . . . in the provision of drug therapy management other than at the direction of, or under the supervision of, a physician licensed and approved by the Medical Board to be that CPP’s supervising physician.”

Yes. A CPP Agreement may include the CPP’s administration of vaccines beyond those specified in the immunizing pharmacist provisions of the Pharmacy Practice Act.

For questions about licensure as a CPP, please contact Missy Betz at 919.246.1050 or by email at mbetz@ncbop.org.