section .0100 – clinical pharmacist practitioner

Link to law: http://reports.oah.state.nc.us/ncac/title 21 - occupational licensing boards and commissions/chapter 32 - north carolina medical board/subchapter t/21 ncac 32t .0101.html
Published: 2015

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SUBCHAPTER 32t – clinical pharmacist practitioner

 

section .0100 – clinical pharmacist practitioner

 

21 NCAC 32T .0101          CLINICAL PHARMACIST PRACTITIONER

(a)  Definitions as used in the Rule:

(1)           "Medical Board" means the North

Carolina Medical Board.

(2)           "Pharmacy Board" means the North

Carolina Board of Pharmacy.

(3)           "Joint Subcommittee" means the

subcommittee composed of four members of the Pharmacy Board and four members of

the Medical Board to whom responsibility is given by G.S. 90-6(c) to develop rules

to govern the provision of drug therapy management by the Clinical Pharmacist

Practitioner in North Carolina.

(4)           "Clinical Pharmacist Practitioner or

CPP" means a licensed pharmacist 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. Only a pharmacist approved by the Pharmacy Board

and the Medical Board may legally identify himself as a CPP.

(5)           "Supervising Physician" means a

licensed physician who, by signing the CPP agreement, is held accountable for

the 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.

(6)           "Approval" means authorization by

the Medical Board and the Pharmacy Board for a pharmacist to practice as a CPP

in accordance with this Rule.

(7)           "Continuing Education or CE" is

defined as courses or materials which have been approved for credit by the

American Council on Pharmaceutical Education.

(8)           "Clinical Experience approved by the

Boards" means work in a pharmacy practice setting which includes

experience consistent with the following components as listed in Parts

(b)(2)(A), (B), (C), (D), (E), (H), (I), (J), (N), (O), and (P) of this

Rule.  Clinical experience requirements must be met only through

activities separate from the certificate programs referred to in Parts

(b)(1)(B) of this Rule.

(b)  CPP application for approval.

(1)           The requirements for application for CPP

approval include that the pharmacist:

(A)          has an unrestricted and current license to practice

as a pharmacist in North Carolina;

(B)          meets one of the following qualifications:

(i)            has earned Certification from the Board of

Pharmaceutical Specialties, is a Certified Geriatric Pharmacist as certified by

the Commission for Certification in Geriatric Pharmacy, or has completed an

American Society of Health System Pharmacists (ASHP) accredited residency

program, which includes two years of  clinical experience approved by the

Boards;

(ii)           has successfully completed the course of study

and holds the academic degree of  Doctor of Pharmacy and has three years

of clinical experience approved by the Boards and has completed a North

Carolina Center for Pharmaceutical Care (NCCPC) or American Council on

Pharmaceutical Education (ACPE) approved certificate program in the area of practice

covered by the CPP agreement; or

(iii)          has successfully completed the course of study

and holds the academic degree of Bachelor of Science in Pharmacy and has five

years of clinical experience approved by the Boards and has completed two NCCPC

or ACPE approved certificate programs with at least one program in the area of

practice covered by the CPP agreement;

(C)          submits the required application and the fee to the

Medical Board;

(D)          submits any information deemed necessary by the

Medical Board in order to evaluate the application; and

(E)           has a signed supervising physician agreement.

If for any reason a CPP

discontinues working in the approved physician arrangement, the clinical

pharmacist practitioner shall notify both Boards in writing within ten days and

the CPP's approval shall automatically terminate or be placed on an inactive

status until such time as a new application is approved in accordance with this

Subchapter.

(2)           All certificate programs referred to in

Subpart (b)(1)(B)(i) of this Rule must contain a core curriculum including the

following components:

(A)          communicating with healthcare professionals and

patients regarding drug therapy, wellness, and health promotion;

(B)          designing, implementing, monitoring, evaluating, and

modifying or recommending modifications in drug therapy to insure effective,

safe, and economical patient care;

(C)          identifying, assessing and solving

medication-related problems and providing a clinical judgment as to the

continuing effectiveness of individualized therapeutic plans and intended

therapeutic outcomes;

(D)          conducting physical assessments, evaluating patient

problems, ordering and monitoring medications and laboratory tests;

(E)           referring patients to other health professionals as

appropriate;

(F)           administering medications;

(G)          monitoring patients and patient populations

regarding the purposes, uses, effects and pharmacoeconomics of their medication

and related therapy;

(H)          counseling patients regarding the purposes, uses, and

effects of their medication and related therapy;

(I)            integrating relevant diet, nutritional and

non-drug therapy with pharmaceutical care;

(J)            recommending, counseling, and monitoring patient

use of non-prescription drugs, herbal remedies and alternative medicine

practices;

(K)          ordering of and educating patients regarding proper

usage of devices, and durable medical equipment;

(L)           providing emergency first care;

(M)         retrieving, evaluating, utilizing, and managing data

and professional resources;

(N)          using clinical data to optimize therapeutic drug

regimens;

(O)          collaborating with other health professionals;

(P)           documenting interventions and evaluating

pharmaceutical care outcomes;

(Q)          integrating pharmacy practice within healthcare

environments;

(R)          integrating national standards for the quality of

healthcare; and

(S)           conducting outcomes and other research.

(3)           The completed application for approval to

practice as a CPP shall be reviewed by the Medical Board upon verification of a

full and unrestricted license to practice as a pharmacist in North Carolina.

(A)          The application shall be approved and at the time of

approval the Medical Board shall issue a number which shall be printed on each

prescription written by the CPP; or

(B)          the application shall be denied; or

(C)          the application shall be approved with restrictions.

(c)  Annual Renewal.

(1)           Each CPP shall register annually on the

anniversary of his or her birth date by:

(A)          verifying a current Pharmacist license;

(B)          submitting the renewal fee as specified in

Subparagraph (j)(2) of this Rule;

(C)          completing the Medical Board's renewal form; and

(D)          reporting continuing education credits as specified

by the Medical Board.

(2)           If the CPP has not renewed within 30 days of

the anniversary of the CPP's birth date, the approval to practice as a CPP

shall lapse.

(d)  Continuing Education.

(1)           Each CPP shall earn 35 hours of practice

relevant CE each year approved by the Pharmacy Board.

(2)           Documentation of these hours shall be kept

at the CPP practice site and made available for inspection by agents of the

Medical Board or Pharmacy Board.

(e)  The supervising physician who has a signed agreement

with the CPP shall be readily available for consultation with the CPP; and

shall review and countersign each order written by the CPP within seven days.

(f)  The written CPP agreement shall:

(1)           be approved and signed by both the

supervising physician and the CPP and a copy shall be maintained in each

practice site for inspection by agents of either Board upon request;

(2)           be specific in regards to the physician,

the pharmacist, the patient and the disease;

(3)           specify the predetermined drug therapy

which shall include the diagnosis and product selection by the patient's

physician; any modifications which may be permitted, dosage forms, dosage

schedules and tests which may be ordered;

(4)           prohibit the substitution of a chemically

dissimilar drug product by the CPP for the product prescribed by the physician

without first obtaining written consent of the physician;

(5)           include a pre-determined plan for emergency

services;

(6)           include a plan and schedule for weekly

quality control, review and countersignature of all orders written by the CPP

in a face-to-face conference between the physician and CPP;

(7)           require that the patient be notified of the

collaborative relationship; and

(8)           be terminated when patient care is

transferred to another physician and new orders shall be written by the

succeeding physician.

(g)  The supervising physician of the CPP shall:

(1)           be fully licensed with the Medical Board

and engaged in clinical practice;

(2)           not be serving in a postgraduate medical

training program;

(3)           be approved in accordance with this

Subchapter before the CPP supervision occurs; and

(4)           supervise no more than three pharmacists.

(h)  The CPP shall wear a nametag spelling out the words

"Clinical Pharmacist Practitioner".

(i)  The CPP may be censured or reprimanded or the CPP's

approval may be restricted, suspended, revoked, annulled, denied or terminated

by the Medical Board or the Pharmacy Board and the pharmacist may be censured

or reprimanded or the pharmacist's license may be restricted, suspended,

revoked, annulled, denied, or terminated by the Pharmacy Board, in accordance

with provisions of G.S. 150B if either Board finds one or more of the

following:

(1)           the CPP has held himself or herself out or

permitted another to represent the CPP as a licensed physician;

(2)           the CPP has engaged or attempted to engage

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;

(3)           the CPP has performed or attempted to

provide medical management outside the approved drug therapy agreement or for

which the CPP is not qualified by education and training to perform;

(4)           The CPP commits any act prohibited by  any

provision of G.S. 90-85.38 as determined by the Pharmacy Board or G.S.

90-14(a)(1), (a)(3) through (a)(14) and (c) as determined by the Medical Board;

or

(5)           the CPP has failed to comply with any of

the provisions of this Rule.

Any modification of treatment for financial gain on the part

of the supervising physician or CPP shall be grounds for denial of Board

approval of the agreement.

(j)  Fees:

(1)           An application fee of one hundred dollars

($100.00) shall be paid at the time of initial application for approval and

each subsequent application for approval to practice.

(2)           The fee for annual renewal of approval, due

on the CPP's anniversary of birth date is fifty dollars ($50.00).

(3)           No portion of any fee in this Rule is

refundable.

 

History Note         Authority G.S. 90-6(c); 90-18(c)3a;

90-18.4;

Eff. April 1, 2001;

Amended Eff. March 1, 2007; October 1, 2001.