H. B. 2371
(By Delegates Perdue, Amores and Anderson)
[Introduced February 16, 2005; referred to the
Committee on Health and Human Resources then the
Judiciary.]
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 a
new section, designated §30-5-26, all relating to requirements
for collaborative pharmacy practice agreements between
pharmacists and physicians.
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 a new section, designated §30-5-26, all 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) (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.
(b) (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 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 one or more pharmacists and one or
more physicians that provides for collaborative pharmacy practice
for the purpose of drug therapy management of patients.
(c) (5) "Compounding" means:
(1) (A) The preparation, mixing, assembling, packaging or
labeling of a drug or device:
(A) (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
dispensing; or
(B) (ii) For the purpose of, or as an incident to, research,
teaching or chemical analysis and not for sale or dispensing;
and
(2) (B) The preparation of drugs or devices in anticipation of
prescription drug orders based on routine, regularly observed
prescribing patterns.
(d) (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
pharmacist's professional judgment, the release is necessary to the
patient's health and well-being; 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.
(e) (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.
(f) (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."
(g) (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.
(h) (10) "Distribute" means the delivery of a drug or device
other than by administering or dispensing.
(i) (11) "Drug" means:
(1) (A) 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) (B) Articles, other than food, intended to affect the
structure or any function of the body of human or other animals;
and
(3) (C) Articles intended for use as a component of any
articles specified in
subsection (1) or (2) of this section
paragraphs (A) or (B) of this subdivision.
(j) (12) "Drug regimen review" includes, but is not limited
to, the following activities:
(1) (A) Evaluation of the prescription drug orders and patient
records for:
(A) (i) Known allergies;
(B) (ii) Rational therapy-contraindications;
(C) (iii) Reasonable dose and route of administration; and
(D) (iv) Reasonable directions for use.
(2) (B) Evaluation of the prescription drug orders and patient
records for duplication of therapy.
(3) (C) Evaluation of the prescription drug for interactions
and/or adverse effects which may include, but are not limited to,
any of the following:
(A) (i) Drug-drug;
(B) (ii) Drug-food;
(C) (iii) Drug-disease; and
(D) (iv) Adverse drug reactions.
(4) (D) Evaluation of the prescription drug orders and patient
records for proper use, including over use and under use and
optimum therapeutic outcomes.
(13) "Drug therapy management" means the review of drug
therapy regimens of patients by one or more pharmacists for the
purpose of evaluating and rendering advice to one or more
physicians 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 may include:
(A) Implementing, modifying, and managing drug therapy
according to the terms of the collaborative pharmacy practice
agreement;
(B) Collecting and reviewing patient histories;
(C) Obtaining and checking vital signs, including pulse, temperature, blood pressure and respiration;
(D) Ordering and evaluating, within the parameters and in
accordance with approved protocols of the collaborative pharmacy
practice agreement between the pharmacist and physician, the
results of laboratory tests directly relating to drug therapy; and
(E) Such other patient care services as may be allowed by law.
(k) (14) "Intern" means an individual who is:
(1) (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
(2) (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
(3) (C) A qualified applicant awaiting examination for
licensure; or
(4) (D) An individual participating in a residency or
fellowship program.
(l) (15) "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.
(m) (16) "Mail-order pharmacy" means a pharmacy, regardless of
its location, which dispenses greater than ten percent prescription
drugs via the mail.
(n) (17) "Manufacturer" means a person engaged in the
manufacture of drugs or devices.
(o) (18) "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) 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.
(p) (19) "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) (20) "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) (21) "Person" means an individual, corporation,
partnership, association or any other legal entity, including
government.
(s) (22) "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) (23) "Pharmacist" or "registered pharmacist" means an
individual currently licensed by this State to engage in the
practice of pharmacy and pharmaceutical care.
(u) (24) "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) "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, including limitations of the scope of
practice of the collaborating physician, and the board of pharmacy.
(v) (26) "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) (27) "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.
(28) "Practice of pharmacy" means the interpretation,
evaluation, and implementation of prescription orders; the
dispensing of prescription drug orders; participation in drug and
device selection; drug administration; drug regimen review; the
practice of telepharmacy within and across state lines; drug or
drug-related research; the provision of patient counseling and the
provision of those acts or services necessary to provide
pharmaceutical care in all areas of patient care; including, but
not limited to, collaborative pharmacy practice, and the
responsibility for compounding and labeling of drugs and devices,
proper and safe storage of drugs and devices, and maintenance of
proper records for them.
(x) (29) "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.
(y) (30) "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) (31) "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) (A) "Caution: Federal law prohibits dispensing without
prescription";
or
(2) (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.
(aa) (32) "Prescription drug order" means a lawful order of a
practitioner for a drug or device for a specific patient.
(bb) (33) "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) (34) "USP-DI" means the United States pharmacopeia-dispensing information.
(dd) (35) "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.
§30-5-26. Collaborative pharmacy practice agreement.
A pharmacist engaging in collaborative pharmacy practice shall
have on file at his or her place of practice the collaborative
pharmacy practice agreement executed by him or her and the
collaborating physician or physicians. The existence and
subsequent termination of the agreement and any additional
information the board of pharmacy may require concerning the
agreement, including the agreement itself, shall be made available
to the 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 collaboration that the physician agrees to conduct
with the pharmacist must be within the scope of the practitioner?s
current practice. The pharmacist shall advise patients or care
givers of the agreement.
NOTE: The purpose of this bill is to authorize collaborative
pharmacy practice agreements between pharmacists and physicians and
specify requirements for the agreements.
Strike-throughs indicate language that would be stricken from
the present law, and underscoring indicates new language that would
be added.
§30-5-26 is new; therefore, strike-throughs and underscoring
have been omitted.
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