House Bill 2371 History
OTHER VERSIONS -
H. B. 2371
(By Delegates Perdue, Amores and Anderson)
(Originating in the Committee on the Judiciary)
[March 28, 2005]
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 four new sections, designated §30-5-26, §30-5-27, §30-
5-28, and §30-5-29, all relating to requirements for
collaborative pharmacy practice agreements between physicians
and pharmacists, establishing locations, sunset provisions,
and granting rule making authority."
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 four new sections, designated §30-5-26, §30-5-27, §30-5-
28, and §30-5-29,
all to read as follows:
ARTICLE 5. PHARMACISTS, PHARMACY TECHNICIANS, PHARMACY INTERNS
The following words and phrases, as used in this article,
shall have the following meanings, unless the context otherwise
(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 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/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 Osteopathic Medicine in the
case of an osteopathic physician.
(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
(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
(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;
(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
(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 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.
(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
(4) (D) An individual participating in a residency or
(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
(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, as jointly approved by the Board of
Pharmacy and the Board of Medicine or the Board of Osteopathic
(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.
(27) "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 Osteopathic Medicine.
(w) (28) "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
(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
(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
(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. Pharmacist requirements to participate in a collaborative
pharmacy practice agreement.
For a pharmacist to participate in a collaborative pharmacy
practice agreement, the pharmacist must:
(a) have an unrestricted and current license to practice as a
pharmacist in West Virginia;
(b) have at least one million dollars of professional
liability insurance coverage;
(c) meet one of the following qualifications, at a minimum:
(1)earned a Certification from the Board of Pharmaceutical
Specialties, is a Certified Geriatric Practitioner, or has
completed an American Society of Health System Pharmacists(ASHP) accredited residency program, which includes two years of clinical
experience approved by the Boards;
(2) successfully completed the course of study and holds the
academic degree of Doctor of Pharmacy and has three years of
clinical experience approved by the Board and has completed an
Accreditation Council for Pharmacy Education (ACPE) approved
certificate program in the area of practice covered by the
collaborative pharmacy practice agreement; or
(3) successfully completed the course of study and holds the
academic degree of Bachelor of Science in Pharmacy and has five
years of clinical experience approved by the Boards and has
completed two ACPE approved certificate programs with at least one
program in the area of practice covered by a collaborative pharmacy
§30-5-27. 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 must be a voluntary
process, which is a physician directed approach, that is entered
into between an individual physician, an individual pharmacist and
an individual patient or the patient's authorized representative who
has given informed consent.
(b) 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 such discontinuance in the time frame and in
the manner established by joint 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. 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 thirty
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 West Virginia
Board of Pharmacy, 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.
(c) Collaborative pharmacy agreements shall not include the
management of controlled substances.
(d) A collaborative pharmacy practice agreement, meeting the
requirements herein established and in accordance with joint rules,
shall be allowed in the hospital setting, the nursing home setting,
the medical school setting and the hospital community and ambulatory
care clinics. The pharmacist shall be employed by or under contract
to provide services to such hospital, nursing home or medical
school, or hold a faculty appointment with one of the schools of
pharmacy or medicine in this state.
(e) Up to five pilot project sites in the community based
pharmacy setting which meet the requirements established in rule
shall be jointly selected by the Board of Pharmacy, Board of
Medicine and the Board of Osteopathic Medicine.
(f) For the purpose of proposing a legislative rule to clarify
and define a collaborative pharmacy practice relationship, the
Boards responsible for promulgating the rule shall establish an
advisory committee to assist them in the development and
implementation of the pharmacy collaborative practice act. The
advisory committee shall be made up of fourteen members. These
members shall include one representative appointed by the West
Virginia State Medical Association; one representative appointed by
the West Virginia Academy of Family Physicians; one representative appointed by the West Virginia Society of Osteopathic Medicine; one
representative appointed by the West Virginia School of Medicine;
one representative appointed by the Marshall University School of
Medicine; one representative appointed by the West Virginia School
of Osteopathic Medicine; two representatives appointed by the West
Virginia Pharmacy Association, one of whom shall represent chain
pharmacies and one of whom shall represent independent pharmacies;
two representatives appointed by the West Virginia Society of Health
System Pharmacists, one of whom shall represent long term care
settings and one of whom shall represent hospital pharmacists; one
representative appointed by the West Virginia School of Pharmacy;
one representative appointed by the University of Charleston School
of Pharmacy; one representative appointed by the West Virginia
Hospital Association; and one representative appointed by the West
Virginia Health Care Association. A representative of each board
with rulemaking authority shall serve as an ex officio member of the
§30-5-28. Rulemaking authority.
The Board of Pharmacy, the Board of Medicine and the Board of
Osteopathic Medicine shall jointly agree and propose rules for
legislative approval in accordance with the provisions of article
three, chapter twenty-nine-a of the code.
§30-5-29. Collaborative pharmacy practice continuation.
Pursuant to the provisions of article ten [§§4-10-1 et seq.]
chapter four of this code, pharmacy collaborative agreements in community settings shall continue to exist until the first day of
July, two thousand eight, unless sooner terminated, continued or
reestablished pursuant to that article.
Strike-throughs indicate language that would be stricken
from the present law, and underscoring indicates new language that
would be added.
§30-5-26 through 29 are new; therefore, strike-throughs and
underscoring have been omitted.