GENERAL ASSEMBLY OF NORTH CAROLINA

SESSION 2013

 

 

SESSION LAW 2013-246

HOUSE BILL 832

 

 

AN ACT to protect the public's HEALTH by increasing access to immunizations and vaccines through the expanded role of immunizing pharmacists.

 

The General Assembly of North Carolina enacts:

 

SECTION 1.  G.S. 90-85.3 is amended by adding the following new subsection to read:

"(i1)      "Immunizing pharmacist" means a licensed pharmacist who meets all of the following qualifications:

(1)        Holds a current provider level cardiopulmonary resuscitation certification issued by the American Heart Association or the American Red Cross, or an equivalent certification.

(2)        Has successfully completed a certificate program in vaccine administration accredited by the Centers for Disease Control and Prevention, the Accreditation Council for Pharmacy Education, or a similar health authority or professional body approved by the Board.

(3)        Maintains documentation of three hours of continuing education every two years, designed to maintain competency in the disease states, drugs, and vaccine administration.

(4)        Has successfully completed training approved by the Division of Public Health's Immunization Branch for participation in the North Carolina Immunization Registry.

(5)        Has notified the North Carolina Board of Pharmacy and the North Carolina Medical Board of immunizing pharmacist status.

(6)        Administers vaccines or immunizations in accordance with G.S. 90-18.15B."

SECTION 2.  G.S. 90-85.3(r) reads as rewritten:

"(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. 90-18.4.is as specified in G.S. 90-85.3A."

SECTION 3.  Article 4A of Chapter 90 of the General Statutes is amended by adding a new section to read:

"§ 90-85.3A.  Practice of pharmacy.

(a)        A pharmacist is responsible 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.

(b)        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.

(c)        An immunizing pharmacist is authorized and permitted to administer drugs as provided in G.S. 90-85.15B, and in accordance with rules adopted by each of the Board of Pharmacy, the Board of Nursing, and the North Carolina Medical Board. These rules shall be designed to ensure the safety and health of the patients for whom such drugs are administered.

(d)        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. 90-18.4."

SECTION 4.  Article 4A of Chapter 90 of the General Statutes is amended by adding a new section to read:

"§ 90-85.15B.  Immunizing pharmacists.

(a)        Except as provided in subsection (b) and (c) of this section, an immunizing pharmacist may administer vaccinations or immunizations only if the vaccinations or immunizations are recommended or required by the Centers for Disease Control and Prevention and administered to persons at least 18 years of age pursuant to a specific prescription order.

(b)        An immunizing pharmacist may administer the vaccinations or immunizations listed in subdivisions (1) through (5) of this subsection to persons at least 18 years of age if the vaccinations or immunizations are administered under written protocols as defined in 21 NCAC 46 .2507(b)(12) and 21 NCAC 32U .0101(b)(12) and in accordance with the supervising physician's responsibilities as defined in 21 NCAC 46 .2507(e) and 21 NCAC 32U .0101(e), and the physician is licensed in and has a practice physically located in North Carolina:

(1)        Pneumococcal polysaccharide or pneumococcal conjugate vaccines.

(2)        Herpes zoster vaccine.

(3)        Hepatitis B vaccine.

(4)        Meningococcal polysaccharide or meningococcal conjugate vaccines.

(5)        Tetanus-diphtheria, tetanus and diphtheria toxoids and pertussis, tetanus and diphtheria toxoids and acellular pertussis, or tetanus toxoid vaccines. However, a pharmacist shall not administer any of these vaccines if the patient discloses that the patient has an open wound, puncture, or tissue tear.

(c)        An immunizing pharmacist may administer the influenza vaccine to persons at least 14 years of age pursuant to 21 NCAC 46 .2507 and 21 NCAC 32U .0101.

(d)        An immunizing pharmacist who administers a vaccine or immunization to any patient pursuant to this section shall do all of the following:

(1)        Maintain a record of any vaccine or immunization administered to the patient in a patient profile.

(2)        Within 72 hours after administration of the vaccine or immunization, notify any primary care provider identified by the patient. If the patient does not identify a primary care provider, the immunizing pharmacist shall direct the patient to information describing the benefits to a patient of having a primary care physician, prepared by any of the following: North Carolina Medical Board, North Carolina Academy of Family Physicians, North Carolina Medical Society, or Community Care of North Carolina.

(3)        Except for influenza vaccines administered under G.S. 90-85.15B(b)(6), access the North Carolina Immunization Registry prior to administering the vaccine or immunization and record any vaccine or immunization administered to the patient in the registry within 72 hours after the administration. In the event the registry is not operable, an immunizing pharmacist shall report as soon as reasonably possible."

SECTION 5.  G.S. 130A-153 reads as rewritten:

"§ 130A-153.  Obtaining immunization; reporting by local health departments; access to immunization information in patient records; immunization of minors.

(a)        The required immunization may be obtained from a physician licensed to practice medicine or medicine, from a local health department. department, or in the case of a person at least 18 years of age, from an immunizing pharmacist. Local health departments shall administer required and State-supplied immunizations at no cost to uninsured or underinsured patients with family incomes below two hundred percent (200%) of the federal poverty level. A local health department may redistribute these vaccines only in accordance with the rules of the Commission.

(b)        Local health departments shall file monthly immunization reports with the Department. The report shall be filed on forms prepared by the Department and shall state, at a minimum, each patient's age and the number of doses of each type of vaccine administered.

(c)        Immunization certificates and information concerning immunizations contained in medical or other records shall, upon request, be shared with the Department, local health departments, an immunizing pharmacist, and the patient's attending physician. In addition, an insurance institution, agent, or insurance support organization, as those terms are defined in G.S. 58-39-15, may share immunization information with the Department. The Commission may, for the purpose of assisting the Department in enforcing this Part, provide by rule that other persons may have access to immunization information, in whole or in part.

(d)        A physician or local health department may immunize a minor with the consent of a parent, guardian, or person standing in loco parentis to the minor. A physician or local health department may also immunize a minor who is presented for immunization by an adult who signs a statement that he or she is authorized by a parent, guardian, or person standing in loco parentis to the minor to obtain the immunization for the minor."

SECTION 6.  Representatives of the North Carolina Academy of Family Physicians, the North Carolina Medical Society, the North Carolina Pediatric Society, the North Carolina Association of Community Pharmacists, the North Carolina Association of Pharmacists, and the North Carolina Retail Merchants Association are directed to cooperate and collaborate to recommend a minimum standard screening questionnaire and safety procedures for written protocols for vaccinations or immunizations administered under G.S. 90-85.15B(b). The questionnaire and recommended standards shall be submitted to the North Carolina Board of Medicine, the North Carolina Board of Nursing, the North Carolina Board of Pharmacy, and the Joint Legislative Oversight Committee on Health and Human Services no later than October 1, 2013. In the event agreement is not reached on a minimum standard screening questionnaire and safety procedures for written protocols by October 1, 2013, the Immunization Branch of the North Carolina Division of Public Health shall develop the questionnaire and standards and submit them to the North Carolina Board of Medicine, the North Carolina Board of Nursing, the North Carolina Board of Pharmacy, and the Joint Legislative Oversight Committee on Health and Human Services by January 1, 2014.

SECTION 7.  Notwithstanding the provisions of Sections 1 through 5 of this act, pharmacists who were qualified to administer influenza, pneumococcal, and zoster vaccines prior to the effective date of this act may continue to administer these vaccines in accordance with the provisions of 21 NCAC 46 .2507 until June 30, 2014. Notwithstanding the provisions of Sections 1 through 5 of this act, 21 NCAC 46 .2507(c)(5), 21 NCAC 32U .0101(c)(5), or any other provision of law, pharmacists who were qualified to administer influenza, pneumococcal, and zoster vaccines prior to the effective date of this act may administer the influenza vaccine to persons at least 14 years old in accordance with the provisions of 21 NCAC 46 .2507 until June 30, 2014.

SECTION 8.  Sections 1 through 5 of this act become effective October 1, 2013. The remainder of this act is effective when it becomes law.

In the General Assembly read three times and ratified this the 27th day of June, 2013.

 

 

                                                                    s/  Daniel J. Forest

                                                                         President of the Senate

 

 

                                                                    s/  Thom Tillis

                                                                         Speaker of the House of Representatives

 

 

                                                                    s/  Pat McCrory

                                                                         Governor

 

 

Approved 10:35 a.m. this 3rd day of July, 2013