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North Carolina State Profile
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EC PHARMACY UPDATE
There is currently no known activity promoting direct pharmacy access to EC.
In early 2007, NARAL Pro-Choice North Carolina conducted a survey on access to EC in North Carolina pharmacies as well as pharmacists’ knowledge and attitudes concerning EC. In June 2007, NARAL released their findings in a report titled, “Access to Emergency Contraception in North Carolina Pharmacies,” available at www.prochoicenorthcarolina.org
NARAL Pro-Choice North Carolina continues to work toward increasing access to EC in North Carolina pharmacies. NARAL remains a committed advocate for a statewide bill ensuring that survivors of sexual assault receive EC on-site in hospital emergency departments. Additionally, in spring 2007, NARAL launched efforts to study both North Carolina’s Medicaid and “Be Smart” Family Planning Waiver programs with intentions of eliminating the requirement that women must obtain a prescription for EC in order to receive Medicaid coverage.
NARAL Pro-Choice North Carolina has formed an EC task force dedicated to education and awareness building around EC. This taskforce will work with NARAL’s campus organizers at various campuses across the state to take on EC as their program initiative.
Planned Parenthood of Central North Carolina (PPCNC) joined forces with the Pharmacy Board on the Dial EC (www.DialEC.org) program, a statewide Emergency Contraception hotline (toll-free number 1-866-942-7762). All of the EC Specialists speak Spanish and have served between 300-400 women in North Carolina per month since February 2001. An evaluation of the hotline activity from February 2002 to June 30, 2003 showed that nearly 10,000 prescriptions were provided. 84% of callers received only one prescription over this time period. PPCNC has also worked with state college campuses to ensure access to EC in campus health clinics.
Planned Parenthood Health Systems operates 7 health centers: Wilmington, Raleigh, Greensboro, Winston-Salem, Charlotte, Asheville, NC and Columbia, SC. All centers offer EC at a reduced cost on a no appointment necessary, walk-in basis. They provide health education programs that focus on prevention, including EC, and have a “back up your birth control” campaign where women are encouraged get EC in advance.
CONTACTS
Fred Eckel, R.Ph.
Executive Director
North Carolina Association of Pharmacists
109 Church Street
Chapel Hill, NC 27516
919-967-2237
Fax: 919-968-9430
Fred@ncpharmacists.org
www.ncpharmacists.org
Amy Woodell
Statewide Organizer
NARAL Pro-Choice North Carolina
514 Daniels Street, #142
Raleigh, NC 27605
Phone: 919-829-9779
Fax:919-827-8779
awoodell@naralnc.org
www.ProChoiceNorthCarolina.org
Janet Combs
Executive Director
Planned Parenthood of Central North Carolina
1765 Dobbins Dr.
Chapel Hill, NC 27515
919-942-7762
Fax: 919-933-5271
www.plannedparenthood.org/ppcnc
Paige Johnson
Planned Parenthood of Central North Carolina
1765 Dobbins Dr.
Chapel Hill, NC 27515
919-942-7762
Fax: 919-933-5271
Paige.johnson@ppfa.org
Mary Carter
Hotline Manager
Planned Parenthood of Central North Carolina
P.O. Box 3258
Chapel Hill, NC 27515
919-929-5402
Fax: 919-933-5271
marycarter.fiveash@ppfa.org
www.plannedparenthood.com/ppcnc
Director of Finance and Human Resources
Planned Parenthood Health Systems, Inc.
100 S Boylan Ave
Raleigh, NC 27603
919-833-7534
fhr-pphs.raleigh@btitelecom.net
USEFUL LINKS
North Carolina Board of Pharmacy
www.ncbop.org/default3.asp
North Carolina Association of Pharmacists
www.ncpharmacists.org
North Carolina General Assembly
www.ncleg.net/homePage.pl
Planned Parenthood of Central North Carolina
www.plannedparenthood.org/ppcnc/index.asp
Planned Parenthood Health Systems, Inc
www.plannedparenthood.org/pphs/index.asp
NARAL Pro-Choice North Carolina
www.naralnc.org
PROTOCOL ENVIRONMENT
Possible Environment: Revision to Existing Authority Required
This state permits collaborative practice agreements or a similar agreement between physicians and pharmacists.
However, some modification of existing statutes and/or regulations is required to allow pharmacists to initiate EC for the general community.
Pharmacist initiation of EC would require:
- Modifying the requirement that only “Clinical Pharmacist Practitioners” be allowed to engage in collaborative practice agreements with prescribers.
PHARMACY PRACTICE ACT
Pharmacy Practice Act Regulatory and Statutory Authority
Note: The text presented below has been prepared by the American Pharmacists Association for the Pharmacy Access Partnership and reflects legislation or regulation promulgated as of June 15, 2003.
NORTH CAROLINA
Under very complex regulations jointly developed and separately promulgated by the Boards of Pharmacy and Medicine, pharmacists in any setting who meet all of the following requirements may be approved as a Clinical Pharmacist Practitioner (CPP) authorized to engage in collaborative drug therapy management:
- have either a BS and five years clinical experience, a PharmD with three years clinical experience, or residency training with two years clinical experience
- complete a certification program with 19 required elements (including administering drugs), and
- be approved by the Pharmacy Board and Medical Board
CPP’s are allowed to operate under patient- and disease-specific protocol agreements as governed by a Joint Subcommittee composed of members of the Pharmacy Board and Medical Board. The agreement can be made with only a single physician and must, most notably:
- specify the drug therapy to be provided (which may include diagnosis, drug selection, modification and substitution, and ordering tests)
- include a plan for emergencies
- provide for weekly face-to-face meetings with the physician, who must countersign all orders
The Pharmacy Board and Medical Board may impose additional restrictions on the CPP.
A copy of the signed protocol is required to be maintained at each practice site.
The CPP must renew his/her certification annually, which includes completing 35 hours of relevant CE. The physician, who must also be approved by the Medical Board, may not supervise more than three CPPs. (The Nursing Board has not promulgated related regulations.)
Statutory authority: Provided in sections governing “Clinical Pharmacist Practitioners,” and related definitions in the Pharmacy Practice Act, N.C. Gen. Stat. §§90-18.4 and §90-85.3, and section governing drug therapy management in the Medical Practice Act, N.C. Gen. Stat..§§90-6(c), 90-18(c)(3s), and 90-85.3
Regulatory authority: Provided for immunization authority in 21 N.C. Admin. Code 46.257, and in Board of Pharmacy rules governing Clinical Pharmacist Practice, N.C. Admin. Code 46.3100 and companion section under Medical Board rules, 21 N.C. Admin. Code Subchapter 32T.
NORTH CAROLINA STATUTE
Chapter 90--Medicine and Allied Occupation
ARTICLE 4A.Pharmacy.
§ 90-85.3. Definitions.
(a) “Administer” means the direct application of a drug to the body of a patient by injection, inhalation, ingestion or other means.
…
(i) “Health care provider” means any licensed health care professional; any agent or employee of any health care institution, health care insurer, health care professional school; or a member of any allied health profession.
- (r) “Practice of pharmacy” means the responsibility for: interpreting and evaluating drug orders, including prescription orders; compounding, dispensing and labeling prescription drugs and devices; properly and safely storing drugs and devices; maintaining proper records; and controlling pharmacy goods and services. A pharmacist may advise and educate patients and health care providers concerning therapeutic values, content, uses and significant problems of drugs and devices; assess, record and report adverse drug and device reactions; take and record patient histories relating to drug and device therapy; monitor, record and report drug therapy and device usage; perform drug utilization reviews; and participate in drug and drug source selection and device and device source selection as provided in G.S. 90-85.27 through G.S. 90-85.31. A pharmacist who has received special training may be authorized and permitted to administer drugs pursuant to a specific prescription order in accordance with rules adopted by each of the Boards of Pharmacy, the Board of Nursing, and the North Carolina Medical Board. The rules shall be designed to ensure the safety and health of the patients for whom such drugs are administered. An approved clinical pharmacist practitioner may collaborate with physicians in determining the appropriate health care for a patient, subject to the provisions of G.S. 90-18.3.
- …
- (t) “Prescription order” means a written or verbal order for a prescription drug, prescription device, or pharmaceutical service from a person authorized by law to prescribe such drug, device, or service. A prescription order includes an order entered in a chart or other medical record of a patient.
§ 90-18.4. Limitations on clinical pharmacist practitioners.
(a) Any pharmacist who is approved under the provisions of G.S.-90- 18(c)(3a) to perform medical acts, tasks, and functions may use the title “clinical pharmacist practitioner”. Any other person who uses the title in any form or holds himself or herself out to be a clinical pharmacist practitioner or to be so licensed shall be deemed to be in violation of this Article.
(b) Clinical pharmacist practitioners are authorized to implement predetermined drug therapy, which includes diagnosis and product selection by the patient's physician, modify prescribed drug dosages, dosage forms, and dosage schedules, and to order laboratory tests pursuant to a drug therapy management agreement that is physician, pharmacist, patient, and disease specific under the following conditions:
- (1) The North Carolina Medical Board and the North Carolina Board of Pharmacy have adopted rules developed by a joint subcommittee governing the approval of individual clinical pharmacist practitioners to practice drug therapy management with such limitations that the Boards determine to be in the best interest of patient health and safety.
(2) The clinical pharmacist practitioner has current approval from both Boards.
(3) The North Carolina Medical Board has assigned an identification number to the clinical pharmacist practitioner which is shown on written prescriptions written by the clinical pharmacist practitioner.
(4) The drug therapy management agreement prohibits the substitution of a chemically dissimilar drug product by the pharmacist for the product prescription by the physician without the explicit consent of the physician and includes a policy for periodic review by the physician of the drugs modified pursuant to the agreement or changed with the consent of the physician.
(c) Clinical pharmacist practitioners in hospitals and other health facilities that have an established pharmacy and therapeutics committee or similar group that determines the prescription drug formulary or other list of drugs to be utilized in the facility and determines procedures to be followed when considering a drug for inclusion on the formulary and procedures to acquire a nonformulary drug for a patient may order medications and tests under the following conditions:
- (1) The North Carolina Medical Board and the North Carolina Board of Pharmacy have adopted rules governing the approval of individual clinical pharmacist practitioners to order medications and tests with such limitations as the Boards determine to be in the best interest of patient health and safety.
(2) The clinical pharmacist practitioner has current approval from both Boards.
(3) The supervising physician has provided to the clinical pharmacist practitioner written instructions for ordering, changing or substituting drugs, or ordering tests with provision for review of the order by the physician within a reasonable time, as determined by the Boards, after the medication or tests are ordered.
(4) The hospital or health facility has adopted a written policy, approved by the medical staff after consultation with nursing administrators, concerning the ordering of medications and tests, including procedures for verification of the clinical pharmacist practitioner's orders by nurses and other facility employees and such other procedures that are in the best interest of patient health and safety.
(5) Any drug therapy order written by a clinical pharmacist practitioner or order for medications or tests shall be deemed to have been authorized by the physician approved by the Boards as the supervisor of the clinical pharmacist practitioner and the supervising physician shall be responsible for authorizing the prescription order.
(d) Any registered nurse or licensed practical nurse who receives a drug therapy order from a clinical pharmacist practitioner for medications or tests is authorized to perform that order in the same manner as if the order was received from a licensed physician. (1999-290, s. 3.)
Added by laws 1999-290, § 3, effective July 1, 2000.
Chapter 90--Medicine and Allied Occupation
Article 1 - Practice of Medicine
§ 90-6 Rules governing applicants for license, examinations, etc.; appointment of subcommittees.
...
(c) The North Carolina Medical Board shall appoint and maintain a subcommittee of four licensed physicians to work jointly with a subcommittee of the North Carolina Board of Pharmacy to develop rules to govern the performance of medical acts by clinical pharmacist practitioners, including the determination of reasonable fees to accompany an application for approval not to exceed one hundred dollars ($100.00) and for renewal of approval not to exceed fifty dollars ($50.00). The fee for reactivation of an inactive incomplete application shall be five dollars ($5.00). Rules recommended by the subcommittee shall be adopted in accordance with Chapter 150B of the General Statutes by both the North Carolina Medical Board and the North Carolina Board of Pharmacy and shall not become effective until adopted by both Boards. The North Carolina Medical Board shall have responsibility for ensuring compliance with these rules. (...1999-290, s. 1.)
Amended by Laws 1973, c. 92, § 2; Laws 1981, c. 665, § 1; Laws 1983, c. 53; Laws 1995, c. 94, § 9, eff. May 22, 1995; Laws 1995, c. 405, § 2, eff. Oct. 1, 1995; S.L. 1999-290, § 1, eff. Sept. 17, 1997.
§ 90-18 Practicing without license; practicing defined; penalties
. . .
(c) The following shall not constitute practicing medicine or surgery as defined in subsection (b) of this section:
. . .
(3) The practice of pharmacy by any legally licensed pharmacist engaged in the practice of pharmacy.
(3a) Practicing without license; practicing defined; penalties.
The provision of drug therapy management by a licensed pharmacist engaged in the practice of pharmacy pursuant to an agreement that is physician, pharmacist, patient, and disease specific when performed in accordance with rules and rules developed by a joint subcommittee of the North Carolina Medical Board and the North Carolina Board of Pharmacy and approved by both Boards. Drug therapy management shall be defined as: (i) the implementation of predetermined drug therapy which includes diagnosis and product selection by the patient's physician; (ii) modification of prescribed drug dosages, dosage forms, and dosage schedules; and (iii) ordering tests; (i), (ii), and (iii) shall be pursuant to an agreement that is physician, pharmacist, patient, and disease specific. (...1999-290, s. 1)
Amended by S.L. 2000-113, § 2, eff. Oct. 1, 2000; S.L. 2001-27, § 2, eff. Dec. 1, 2001.
NORTH CAROLINA REGULATIONS
NORTH CAROLINA ADMINISTRATIVE CODE
TITLE 21 - OCCUPATIONAL LICENSING BOARDS
CHAPTER 46 - BOARD OF PHARMACY
46.3101 CLINICAL PHARMACIST PRACTITIONER
(a) Definitions:
- (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 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. 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. Only a physician approved by the Medical Board may legally identify himself or herself as a supervising physician.
- (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 clinical 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, 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; or
- (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, a written endorsement from the Pharmacy Board 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, both Boards shall be notified in writing within 10 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 Part (2)(a)(ii) of the Rule must contain a core curriculum including at a minimum 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 in accordance with established standards of practice;
- (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) 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 regard 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, engaged in clinical practice, and in good standing with the Medical Board;
- (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 approval of a CPP may be restricted, denied or terminated by the Medical Board or the Pharmacy Board and the pharmacist's license may be restricted, denied, or terminated by the Pharmacy Board, in accordance with provisions of G.S. 150B if the appropriate 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 is adjudicated mentally incompetent;
- (5) the CPP's mental or physical condition renders the CPP unable to safely function as a CPP; or
- (6) 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; 90-18; 90-18.4; 90-85.3; 90-85.18; 90-85.26A; Eff. April 1, 2001 Amended Eff. October 1, 2001
SEPARATE MEDICAL BOARD REGULATIONS
TITLE 21 - OCCUPATIONAL LICENSING BOARDS
CHAPTER 32 – BOARD OF MEDICAL EXAMINERS
SUBCHAPTER 32T – CLINICAL PHARMACIST PRACTITIONER
0101 CLINICAL PHARMACIST PRACTITIONER
(a) Definitions:
. . .
- (4) “Clinical Pharmacist Practitioner or CPP” means 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. 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. Only a physician approved by the Medical Board may legally identify himself or herself as a supervising physician.
. . .
(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, 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, a written endorsement from the Pharmacy Board 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, both Boards shall be notified 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 at a minimum 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 /or laboratory tests in accordance with established standards of practice;
(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, engaged in clinical practice, and in good standing with the Medical Board;
(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.
* * *
HISTORY NOTE - Authority G.S. 90-6(c); 90-18(c)3a; 90-8.4; Eff. April 1, 2001; Amended Eff. October 1, 2001.
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