WEST virginia legislature
2021 regular session
House Bill 2265
By Delegates Rohrbach, Pack, J., Summers, Reed, Ward, G., Forsht, Smith, Steele, Espinosa, and Worrell
[Introduced February 10, 2021; Referred to the Committee on Health and Human Resources then Government Organization]
A BILL to amend and reenact §30-5-7 and §30-5-19 of the Code of West Virginia, 1931, as amended, relating to collaborative pharmacy practice and updating rulemaking authority.
Be it enacted by the Legislature of West Virginia:
Article 5. Pharmacists, pharmacy technicians, pharmacy interns and pharmacies.
§30-5-7. Rule-making authority.
(a) The board shall propose rules for legislative approval, in accordance with the provisions of §29A-3-1 et seq. of this code, to implement the provisions of this article and §60A-2-201 et seq., §60A-3-301 et seq., §60A-8-1 et seq., §60A-9-1 et seq., and §60A-10-1 et seq. of this code, including:
(1) Standards and requirements for a license, permit, and registration;
(2) Educational and experience requirements;
(3) Procedures for examinations and reexaminations;
(4) Requirements for third parties to prepare, administer or prepare, and administer examinations and reexaminations;
(5) The passing grade on the examination;
(6) Procedures for the issuance and renewal of a license, permit, and registration;
(7) A fee schedule;
(8) Continuing education requirements;
(9) Set standards for professional conduct;
(10) Establish equipment and facility standards for pharmacies;
(11) Approve courses and standards for training pharmacist technicians;
(12) Regulation of charitable clinic pharmacies;
(13) Regulation of mail-order pharmacies: Provided, That until the board establishes requirements that provide further conditions for pharmacists who consult with or who provide pharmacist care to patients regarding prescriptions dispensed in this state by a mail-order pharmacy, the pharmacist in charge of the out-of-state mail-order pharmacy shall be licensed in West Virginia and any other pharmacist providing pharmacist care from the mail-order pharmacy shall be licensed in the state where the pharmacy is located;
(14) Agreements with organizations to form pharmacist recovery networks;
(15) Create an alcohol or chemical dependency treatment program;
(16) Establish a ratio of pharmacy technicians to on-duty pharmacist operating in any outpatient, mail order, or institutional pharmacy;
(17) Regulation of telepharmacy;
(18) The minimum standards for a charitable clinic pharmacy and rules regarding the applicable definition of a pharmacist-in-charge, who may be a volunteer, at charitable clinic pharmacies: Provided, That a charitable clinic pharmacy may not be charged any applicable licensing fees and such clinics may receive donated drugs;
(19) Establish standards for substituted drug products;
(20) Establish the regulations for E-prescribing;
(21) Establish the proper use of the automated data processing system;
(22) Registration and control of the manufacture and distribution of controlled substances within this state;
(23) Regulation of pharmacies;
(24) Sanitation and equipment requirements for wholesalers, distributers, and pharmacies;
(25) Procedures for denying, suspending, revoking, reinstating, or limiting the practice of a licensee, permittee, or registrant;
(26) Regulations on prescription paper as provided in §16-5-27 of this code;
(27) Regulations on controlled substances as provided in §60A-2-201 et seq. of this code;
(28) Regulations on manufacturing, distributing, or dispensing any controlled substance as provided in §60A-3-301 of this code;
(29) Regulations on wholesale drug distribution as provided in §60A-8-1 et seq. of this code;
(30) Regulations on controlled substances monitoring as provided in §60A-9-1 et seq. of this code;
(31) Regulations on Methamphetamine Laboratory Eradication Act as provided in §60A-10-1 et seq. of this code;
(32) Establish and maintain an official prescription paper program; and
(33) Any other rules necessary to effectuate the provisions of this article.
(b) The board may provide an exemption to the pharmacist-in-charge requirement for the opening of a new retail pharmacy or during a declared emergency.
The board, the Board
of Medicine, and the Board of Osteopathic Medicine shall jointly agree and
propose rules concerning collaborative pharmacy practice for legislative
approval in accordance with the provisions of §29A-3-1 et seq. of this
The board, with the advice of the Board of Medicine and the Board of Osteopathic Medicine, shall propose rules for legislative approval in accordance with the provisions of §29A-3-1 et seq. of this code concerning collaborative pharmacy practice.
(d) The board, with the advice of the Board of Medicine and the Board of Osteopathic Medicine, shall propose rules for legislative approval in accordance with the provisions of §29A-3-1 et seq. of this code to perform influenza and pneumonia immunizations on a person of 18 years of age or older. These rules shall provide, at a minimum, for the following:
(1) Establishment of a course, or provide a list of approved courses, in immunization administration. The courses shall be based on the standards established for such courses by the Centers for Disease Control and Prevention in the public health service of the United States Department of Health and Human Services;
(2) Definitive treatment guidelines which shall include, but not be limited to, appropriate observation for an adverse reaction of an individual following an immunization;
(3) Prior to administration of immunizations, a pharmacist shall have completed a board- approved immunization administration course and completed an American Red Cross or American Heart Association basic life-support training, and maintain certification in the same;
(4) Continuing education requirements for this area of practice;
(5) Reporting requirements for pharmacists administering immunizations to report to the primary care physician or other licensed health care provider as identified by the person receiving the immunization;
(6) Reporting requirements for pharmacists administering immunizations to report to the West Virginia Statewide Immunization Information;
(7) That a pharmacist may not delegate the authority to administer immunizations to any other person, unless administered by a licensed pharmacy intern under the direct supervision of a pharmacist of whom both pharmacist and intern have successfully completed all board-required training; and
(8) Any other provisions necessary to implement the provisions of this section.
(e) The Board of Medicine and the Board of Osteopathic Medicine shall propose joint rules for legislative approval in accordance with the provisions of §29A-3-1 et seq. of this code to permit a licensed pharmacist or pharmacy intern to administer immunizations in accordance with definitive treatment guidelines for immunizations promulgated by the latest notice from the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC), including, but not limited to, the CDC’s recommended immunization schedule for adults, children, and adolescents. In addition, the joint rules shall permit a licensed pharmacist or pharmacy intern to administer immunizations in accordance with definitive treatment guidelines for immunizations promulgated by the latest notice from the CDC, including, but not limited to, the CDC’s recommended immunization schedule for adults, children, and adolescents to a person age 11 through 17, with written informed parental consent when presented with a prescription from a physician and there are no contraindications to that patient receiving that vaccine. These rules shall provide, at a minimum, the same provisions contained in subsections (d)(1) through (d)(8), inclusive, of this section.
(f) All of the board’s rules in effect and not in conflict with these provisions shall remain in effect until they are amended or rescinded.
§30-5-19. Collaborative pharmacy practice agreement.
(a) A pharmacist engaging in collaborative pharmacy practice shall have on file at his or her place of practice the collaborative pharmacy practice agreement. The existence and subsequent termination of the agreement and any additional information the rules may require concerning the agreement, including the agreement itself, shall be made available to the appropriate licensing board for review upon request. The agreement may allow the pharmacist, within the pharmacist’s scope of practice pursuant to the collaborative pharmacy practice agreement, to conduct drug therapy management activities approved by the collaborating physician. The collaborative pharmacy practice agreement shall be a voluntary process, which is a physician directed approach, that is entered into between an individual physician or physician group, an individual pharmacist or pharmacists and an individual patient or the patient’s authorized representative who has given informed consent as per subsection (c).
A collaborative pharmacy practice agreement may authorize a pharmacist to
provide drug therapy management. In instances where drug therapy is
discontinued, the pharmacist shall notify the treating physician of the
discontinuance in the time frame and in the manner established by
legislative rules. Each protocol developed, pursuant to the collaborative
pharmacy practice agreement, shall contain detailed direction concerning the
services that the pharmacists may perform for that patient. The protocol shall
include, but need not be limited to:
(1) The specific drug or drugs to be managed by the pharmacist;
(2) The terms and conditions under which drug therapy may be implemented, modified or discontinued;
(3) The conditions and events upon which the pharmacist is required to notify the physician; and
(4) The laboratory tests that may be ordered in accordance with drug therapy management.
(c) All activities performed by the pharmacist in conjunction with the protocol shall be documented in the patient’s medical record. The pharmacists shall report at least every 30 days to the physician regarding the patient’s drug therapy management. The collaborative pharmacy practice agreement and protocols shall be available for inspection by the board, the West Virginia Board of Medicine, or the West Virginia Board of Osteopathic Medicine, depending on the licensing board of the participating physician. A copy of the protocol shall be filed in the patient’s medical record.
(d) Collaborative pharmacy agreements may not include the management of controlled substances.
A collaborative pharmacy practice agreement, meeting the requirements herein
established and in accordance with
joint legislative rules, shall
be allowed in the hospital setting, the nursing home setting, the medical
school setting and the hospital, community-based pharmacy setting and
ambulatory care clinics. The pharmacist shall be employed by or under contract
to provide services to the hospital, pharmacy, nursing home or medical school,
or hold a faculty appointment with one of the schools of pharmacy or medicine
in this state.
(f) Nothing pertaining to collaborative pharmacy practice shall be interpreted to permit a pharmacist to accept delegation of a physician’s authority outside the limits included in the appropriate board’s statute and rules.
NOTE: The purpose of this bill is to provide legislative rule-making authority to the Board of Pharmacy concerning collaborative pharmacy practice.
Strike-throughs indicate language that would be stricken from a heading or the present law and underscoring indicates new language that would be added.