Senate Bill No. 264
(By Senators Kessler, Craigo, Prezioso,
Wooton, Bowman, McKenzie, Oliverio and Minard)
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[Introduced March 1, 2001; referred to the Committee on Health
and Human Resources.]
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A BILL to amend and reenact section one-b, article five, chapter
thirty of the code of West Virginia, one thousand nine hundred
thirty-one, as amended, relating to redefining practitioner as
it affects pharmacists.
Be it enacted by the Legislature of West Virginia:
That section one-b, article five, chapter thirty of the code
of West Virginia, one thousand nine hundred thirty-one, as amended,
be amended and reenacted to read as follows:
ARTICLE 5. PHARMACISTS, PHARMACY TECHNICIANS, PHARMACY INTERNS
AND PHARMACIES.
§30-5-1b. Definitions.
The following words and phrases, as used in this article,
shall have the following meanings, unless the context otherwise requires:
(a) "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.
(b) "Board of pharmacy" or "board" means the West Virginia
state board of pharmacy.
(c) "Compounding" means:
(1) The preparation, mixing, assembling, packaging or labeling
of a drug or device:
(A) 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
dispensing; or
(B) For the purpose of, or as an incident to, research,
teaching or chemical analysis and not for sale or dispensing;
(2) The preparation of drugs or devices in anticipation of
prescription drug orders based on routine, regularly observed
prescribing patterns.
(d) "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 pharmacist's
professional judgment,
such the release is necessary to the
patient's health and well-being; to
such other persons or
governmental agencies authorized by law to receive
such 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.
(e) "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.
(f) "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."
(g) "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.
(h) "Distribute" means the delivery of a drug or device other
than by administering or dispensing.
(i) "Drug" means:
(1) Articles recognized as drugs in the USP-DI, Facts and
Comparisons, Physicians Desk Reference or supplements thereto, for
use in the diagnosis, cure, mitigation, treatment or prevention of
disease in human or other animals;
(2) Articles, other than food, intended to affect the
structure or any function of the body of human or other animals;
and
(3) Articles intended for use as a component of any articles
specified in subsection (1) or (2) of this section.
(j) "Drug regimen review" includes, but is not limited to, the
following activities:
(1) Evaluation of the prescription drug orders and patient
records for:
(A) Known allergies;
(B) Rational therapy-contraindications;
(C) Reasonable dose and route of administration; and
(D) Reasonable directions for use.
(2) Evaluation of the prescription drug orders and patient
records for duplication of therapy.
(3) Evaluation of the prescription drug for interactions
and/or adverse effects which may include, but are not limited to,
any of the following:
(A) Drug-drug;
(B) Drug-food;
(C) Drug-disease; and
(D) Adverse drug reactions.
(4) Evaluation of the prescription drug orders and patient
records for proper
utilization use, including over
utilization use
and under
utilization use and optimum therapeutic outcomes.
(k) "Intern" means an individual who is:
(1) 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
(2) 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
(3) A qualified applicant awaiting examination for licensure;
or
(4) An individual participating in a residency or fellowship
program.
(l) "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
such label shall
include all information required by federal law or regulation and
state law or rule.
(m) "Mail order pharmacy" means a pharmacy, regardless of its
location, which dispenses greater than ten percent prescription
drugs via the mail.
(n) "Manufacturer" means a person engaged in the manufacture
of drugs or devices.
(o) "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(s) or
labeling or relabeling of its contents and the promotion and
marketing of
such 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.
(p) "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.
(q) "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.
(r) "Person" means an individual, corporation, partnership,
association or any other legal entity, including government.
(s) "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.
(t) "Pharmacist" or "registered pharmacist" means an
individual currently licensed by this state to engage in the
practice of pharmacy and pharmaceutical care.
(u) "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
such the pharmacy and
personnel.
(v) "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.
(w) "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.
(x) "Practitioner" means an individual currently licensed,
registered or otherwise authorized by
the jurisdiction in which he
or she practices 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.
(y) "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.
(z) "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:
(1) "Caution: Federal law prohibits dispensing without
prescription";
(2) "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.
(aa) "Prescription drug order" means a lawful order of a
practitioner for a drug or device for a specific patient.
(bb) "Prospective drug use review" means a review of the
patient's 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.
(cc) "USP-DI" means the United States
Pharmacopedia
Pharmacopeia-Dispensing Information.
(dd) "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.
NOTE: The purpose of this bill is to restrict practitioners
for whom West Virginia pharmacists may fill prescriptions to those
practitioners authorized to prescribe by any state, territory or
district of the United States. Current law permits the filling of
prescriptions by practitioners authorized to prescribe by any
jurisdiction.
Strike-throughs indicate language that would be stricken from
the present law, and underscoring indicates new language that would
be added.
This bill is recommended for passage in the 2001 regular
session by the Joint Interim Committee on Substance Use and Abuse.
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