Senate Bill 586 History
Senate Bill No. 586
(By Senators Prezioso, McCabe, Kessler and Yoder)
[Introduced February 6, 2008; referred to the Committee on Health
and Human Resources; and then to the Committee on the Judiciary.]
providing that pharmacists may not delegate the authority to
administer vaccines; and authorizing legislative rule-making
A BILL to amend and reenact §30-5-1b of the Code of West Virginia,
1931, as amended; and to amend said code by adding thereto two
new sections, designated §30-5-6b and §30-5-30, all relating
generally to the scope of practice of pharmacists; defining
terms; authorizing pharmacists to remotely dispense and
deliver prescription drugs; authorizing pharmacists to
administer certain specified immunizations; requiring
pharmacists complete approved vaccine administration courses;
Be it enacted by the Legislature of West Virginia:
That §30-5-1b of the Code of West Virginia, 1931, as amended,
be amended and reenacted; and that said code be amended by adding
thereto two new sections, designated §30-5-6b and §30-5-30, all to read as follows:
ARTICLE 5. PHARMACISTS, PHARMACY TECHNICIANS, PHARMACY INTERNS
The following words and phrases, as used in this article, have
the following meanings, unless the context otherwise requires:
(1) "Administer" means the direct application of a drug to the
body of a patient or research subject by injection, inhalation,
ingestion or any other means.
(2) "Board of Pharmacy" or "board" means the West Virginia
State Board of Pharmacy.
(3) "Collaborative pharmacy practice" is that practice of
pharmacy where one or more pharmacists have jointly agreed, on a
voluntary basis, to work in conjunction with one or more physicians
under written protocol where the pharmacist or pharmacists may
perform certain patient care functions authorized by the physician
or physicians under certain specified conditions and limitations.
(4) "Collaborative pharmacy practice agreement" is a written
and signed agreement between a pharmacist, a physician and the
individual patient, or the patient's authorized representative who
has granted his or her informed consent, that provides for
collaborative pharmacy practice for the purpose of drug therapy
management of a patient, which has been approved by the Board of
Pharmacy, the Board of Medicine in the case of an allopathic physician or the West Virginia Board of Osteopathy in the case of
an osteopathic physician.
(5) "Compounding" means:
(A) The preparation, mixing, assembling, packaging or labeling
of a drug or device:
(i) As the result of a practitioner's prescription drug order
or initiative based on the practitioner/patient/pharmacist
relationship in the course of professional practice for sale or
(ii) For the purpose of, or as an incident to, research,
teaching or chemical analysis and not for sale or dispensing; and
(B) The preparation of drugs or devices in anticipation of
prescription drug orders based on routine, regularly observed
(6) "Confidential information" means information maintained by
the pharmacist in the patient record or which is communicated to
the patient as part of patient counseling or which is communicated
by the patient to the pharmacist. This information is privileged
and may be released only to the patient or to other members of the
health care team and other pharmacists where, in the pharmacists'
professional judgment, the release is necessary to the patient's
health and well-being; to health plans, as that term is defined in
45 CFR §160.103, for payment; to other persons or governmental
agencies authorized by law to receive the privileged information; as necessary for the limited purpose of peer review and utilization
review; as authorized by the patient or required by court order.
Appropriate disclosure, as permitted by this section, may occur by
the pharmacist either directly or through an electronic data
intermediary, as defined in subdivision (14) of this section.
(7) "Deliver" or "delivery" means the actual, constructive or
attempted transfer of a drug or device from one person to another,
whether or not for a consideration.
(8) "Device" means an instrument, apparatus, implement or
machine, contrivance, implant or other similar or related article,
including any component part or accessory, which is required under
federal law to bear the label, "Caution: Federal or state law
requires dispensing by or on the order of a physician."
(9) "Dispense" or "dispensing" means the preparation and
delivery of a drug or device in an appropriately labeled and
suitable container to a patient or patient's representative or
surrogate pursuant to a lawful order of a practitioner for
subsequent administration to, or use by, a patient.
(10) "Distribute" means the delivery of a drug or device other
than by administering or dispensing.
(11) "Drug" means:
(A) Articles recognized as drugs in the USP-DI, facts and
comparisons, physician's desk reference or supplements thereto for
use in the diagnosis, cure, mitigation, treatment or prevention of disease in human or other animals;
(B) Articles, other than food, intended to affect the
structure or any function of the body of human or other animals;
(C) Articles intended for use as a component of any articles
specified in paragraph (A) or (B) of this subdivision.
(12) "Drug regimen review" includes, but is not limited to,
the following activities:
(A) Evaluation of the prescription drug orders and patient
(I) Known allergies;
(ii) Rational therapy-contraindications;
(iii) Reasonable dose and route of administration; and
(iv) Reasonable directions for use.
(B) Evaluation of the prescription drug orders and patient
records for duplication of therapy.
(C) Evaluation of the prescription drug for interactions
and/or adverse effects which may include, but are not limited to,
any of the following:
(iii) Drug-disease; and
(iv) Adverse drug reactions.
(D) Evaluation of the prescription drug orders and patient records for proper use, including overuse and underuse, and optimum
(13) "Drug therapy management" means the review of drug
therapy regimens of patients by a pharmacist for the purpose of
evaluating and rendering advice to a physician regarding adjustment
of the regimen in accordance with the collaborative pharmacy
practice agreement. Decisions involving drug therapy management
shall be made in the best interest of the patient. Drug therapy
management shall be limited to:
(A) Implementing, modifying and managing drug therapy
according to the terms of the collaborative pharmacy practice
(B) Collecting and reviewing patient histories;
(C) Obtaining and checking vital signs, including pulse,
temperature, blood pressure and respiration;
(D) Ordering screening laboratory tests that are dose related
and specific to the patient's medication or are protocol driven and
are also specifically set out in the collaborative pharmacy
practice agreement between the pharmacist and physician.
(14) "Electronic data intermediary" means an entity that
provides the infrastructure to connect a computer system, hand-held
electronic device or other electronic device used by a prescribing
practitioner with a computer system or other electronic device used
by a pharmacist to facilitate the secure transmission of:
(A) An electronic prescription order;
(B) A refill authorization request;
(C) A communication; or
(D) Other patient care information.
(15) "E-prescribing" means the transmission, using electronic
media, of prescription or prescription-related information between
a practitioner, pharmacist, pharmacy benefit manager or health plan
as defined in 45 CFR §160.103, either directly or through an
electronic data intermediary. E-prescribing includes, but is not
limited to, two-way transmissions between the point of care and the
pharmacist. E-prescribing may also be referenced by the terms
"electronic prescription" or "electronic order".
(16) "Intern" means an individual who is:
(A) Currently registered by this state to engage in the
practice of pharmacy while under the supervision of a licensed
pharmacist and is satisfactorily progressing toward meeting the
requirements for licensure as a pharmacist; or
(B) A graduate of an approved college of pharmacy or a
graduate who has established educational equivalency by obtaining
a foreign pharmacy graduate examination committee (FPGEC)
certificate who is currently licensed by the board for the purpose
of obtaining practical experience as a requirement for licensure as
a pharmacist; or
(C) A qualified applicant awaiting examination for licensure; or
(D) An individual participating in a residency or fellowship
(17) "Labeling" means the process of preparing and affixing a
label to a drug container exclusive, however, of a labeling by a
manufacturer, packer or distributor of a nonprescription drug or
commercially packaged legend drug or device. Any label shall
include all information required by federal law or regulation and
state law or rule.
(18) "Mail-order pharmacy" means a pharmacy, regardless of its
location, which dispenses greater than ten percent prescription
drugs via the mail.
(19) "Manufacturer" means a person engaged in the manufacture
of drugs or devices.
(20) "Manufacturing" means the production, preparation,
propagation or processing of a drug or device, either directly or
indirectly, by extraction from substances of natural origin or
independently by means of chemical or biological synthesis and
includes any packaging or repackaging of the substance or
substances or labeling or relabeling of its contents and the
promotion and marketing of the drugs or devices. Manufacturing
also includes the preparation and promotion of commercially
available products from bulk compounds for resale by pharmacies,
practitioners or other persons.
(21) "Clinical medical home" means a clinic where a patient's
care includes the development of a plan of care, the determination
of the outcomes desired, facilitation and navigation of the health
care system, provision of follow-up and support for achieving the
identified outcomes. The clinical medical home maintains a
centralized, comprehensive record of all health related services to
provide continuity of care.
(19) (22) "Nonprescription drug" means a drug which may be
sold without a prescription and which is labeled for use by the
consumer in accordance with the requirements of the laws and rules
of this state and the federal government.
(20) (23) "Patient counseling" means the oral communication by
the pharmacist of information, as defined in the rules of the
board, to the patient to improve therapy by aiding in the proper
use of drugs and devices.
(21) (24) "Person" means an individual, corporation,
partnership, association or any other legal entity, including
(22) (25) "Pharmaceutical care" is the provision of drug
therapy and other pharmaceutical patient care services intended to
achieve outcomes related to the cure or prevention of a disease,
elimination or reduction of a patient's symptoms or arresting or
slowing of a disease process as defined in the rules of the board.
(23) (26) "Pharmacist" or "registered pharmacist" means an individual currently licensed by this state to engage in the
practice of pharmacy and pharmaceutical care.
(24) (27) "Pharmacist-in-charge" means a pharmacist currently
licensed in this state who accepts responsibility for the operation
of a pharmacy in conformance with all laws and rules pertinent to
the practice of pharmacy and the distribution of drugs and who is
personally in full and actual charge of the pharmacy and personnel.
(25) (28) "Pharmacist's scope of practice pursuant to the
collaborative pharmacy practice agreement" means those duties and
limitations of duties placed upon the pharmacist by the
collaborating physician, as jointly approved by the Board of
Pharmacy and the Board of Medicine or the Board of Osteopathy.
(26) (29) "Pharmacy" means any drugstore, apothecary or place
within this state where drugs are dispensed and sold at retail or
displayed for sale at retail and pharmaceutical care is provided
and any place outside of this state where drugs are dispensed and
pharmaceutical care is provided to residents of this state.
(27) (30) "Physician" means an individual currently licensed,
in good standing and without restrictions, as an allopathic
physician by the West Virginia Board of Medicine, or an osteopathic
physician by the West Virginia Board of Osteopathy.
(28) (31) "Pharmacy technician" means registered supportive
personnel who work under the direct supervision of a pharmacist who
have passed an approved training program as described in this article.
(29) (32) "Practitioner" means an individual currently
licensed, registered or otherwise authorized by any state,
territory or district of the United States to prescribe and
administer drugs in the course of professional practices, including
allopathic and osteopathic physicians, dentists, physician's
assistants, optometrists, veterinarians, podiatrists and nurse
practitioners as allowed by law.
(30) (33) "Preceptor" means an individual who is currently
licensed as a pharmacist by the board, meets the qualifications as
a preceptor under the rules of the Board and participates in the
instructional training of pharmacy interns.
(31) (34) "Prescription drug" or "legend drug" means a drug
which, under federal law, is required, prior to being dispensed or
delivered, to be labeled with either of the following statements:
(A) "Caution: Federal law prohibits dispensing without
(B) "Caution: Federal law restricts this drug to use by, or
on the order of, a licensed veterinarian"; or a drug which is
required by any applicable federal or state law or rule to be
dispensed pursuant only to a prescription drug order or is
restricted to use by practitioners only.
(32) (35) "Prescription drug order" means a lawful order of a
practitioner for a drug or device for a specific patient.
(33) (36) "Prospective drug use review" means a review of the
patients' drug therapy and prescription drug order, as defined in
the rules of the Board, prior to dispensing the drug as part of a
drug regimen review.
(34) (37) "USP-DI" means the United States pharmacopeia-
(35) (38) "Wholesale distributor" means any person engaged in
wholesale distribution of drugs, including, but not limited to,
manufacturers' and distributors' warehouses, chain drug warehouses
and wholesale drug warehouses, independent wholesale drug trader
and retail pharmacies that conduct wholesale distributions.
§30-5-6b. Remote delivery of prescriptions; rule-making authority.
To improve patient access to prescription drugs, the board
shall propose legislative rules pursuant to article three, chapter
twenty-nine-a of this code, to permit pharmacists to remotely
dispense and deliver prescription drugs filled by a licensed
pharmacist to a patient's clinical medical home for dispensing to
the patient. The legislative rule shall provide for patient
counseling by a licensed pharmacist via telephone or video link.
§30-5-30. Administration of immunizations.
(a) A pharmacist licensed under the provisions of this article
and meeting the requirements of this section may administer the
influenza immunization to any person eighteen years of age or older
under joint legislative rules promulgated jointly by the Board of Pharmacy, the Board of Medicine and the Osteopathy Board in
accordance with the provisions of section twenty-eight of this
article. These legislative rules shall be administered by the
Board of Pharmacy.
(b) The joint legislative rules shall, at a minimum:
(1) Establish a course, or provide a list of approved courses,
in immunization administration. The courses must 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) Set forth definitive treatment guidelines, established by
a physician, which shall include, but not be limited to,
appropriate observation for an adverse reaction of an individual
following an immunization;
(3) Provide that to administer immunizations, a pharmacist
shall complete an American Red Cross or American Heart Association
basic life-support training, and maintain certification in the
same. The immunizations shall be administered in accordance with
the treatment guidelines established in the rule;
(4) Set forth continuing education requirements for
pharmacists administering immunization;
(5) Provide 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 and to the West Virginia Statewide Immunization
Information System; and
(6) Provide any other procedures necessary to implement the
provisions of this section.
(c) A pharmacist may not delegate the authority to administer
immunizations to any other person.
NOTE: The purpose of this bill is to
expand the scope of
practice of pharmacists to allow them to remotely dispense and
deliver prescription drugs and to administer certain specified
Strike-throughs indicate language that would be stricken from
the present law, and underscoring indicates new language that would
and §30-5-30 are new; therefore, strike-throughs and
underscoring have been omitted.