Session of 2000
Effective: July 1, 2000
HOUSE BILL No. 2759
An Act relating to the pharmacy act of the state of Kansas;
authorizing pharmacists to
administer drugs under certain conditions;
amending K.S.A. 1999 Supp. 65-1626 and
65-1626a and repealing the existing
sections.
Be it enacted by the Legislature of the State of Kansas:
Section 1. K.S.A. 1999 Supp.
65-1626 is hereby amended to read as
follows: 65-1626. For the purposes of this act:
(a) "Administer" means the direct
application of a drug, whether by
injection, inhalation, ingestion or any other means, to the body of
a patient
or research subject by:
(1) A practitioner or pursuant to the
lawful direction of a practitioner,
or;
(2) the patient or research subject at
the direction and in the presence
of the practitioner.; or
(3) a pharmacist as authorized in
section 3 and amendments thereto.
(b) "Agent" means an authorized person
who acts on behalf of or at
the direction of a manufacturer, distributor or dispenser but shall
not
include a common or contract carrier, public warehouseman or
employee
of the carrier or warehouseman when acting in the usual and lawful
course
of the carrier's or warehouseman's business.
(c) "Board" means the state board of
pharmacy created by K.S.A. 74-
1603 and amendments thereto.
(d) "Brand exchange" means the dispensing
of a different drug prod-
uct of the same dosage form and strength and of the same generic
name
than the brand name drug product prescribed.
(e) "Brand name" means the registered
trademark name given to a
drug product by its manufacturer, labeler or distributor.
(f) "Deliver" or "delivery" means the
actual, constructive or at-
tempted transfer from one person to another of any drug whether or
not
an agency relationship exists.
(g) "Direct supervision" means the
process by which the responsible
pharmacist shall observe and direct the activities of a pharmacy
student
or pharmacy technician to a sufficient degree to assure that all
such ac-
tivities are performed accurately, safely and without risk or harm
to pa-
tients, and complete the final check before dispensing.
(h) "Dispense" means to deliver
prescription medication to the ulti-
mate user or research subject by or pursuant to the lawful order of
a
practitioner or pursuant to the prescription of a mid-level
practitioner.
(i) "Dispenser" means a practitioner or
pharmacist who dispenses
prescription medication.
(j) "Distribute" means to deliver, other
than by administering or dis-
pensing, any drug.
(k) "Distributor" means a person who
distributes a drug.
(l) "Drug" means: (1) Articles recognized
in the official United States
pharmacopoeia, or other such official compendiums of the United
States,
or official national formulary, or any supplement of any of them;
(2) ar-
ticles intended for use in the diagnosis, cure, mitigation,
treatment or
prevention of disease in man or other animals; (3) articles, other
than
food, intended to affect the structure or any function of the body
of man
or other animals; and (4) articles intended for use as a component
of any
articles specified in clause (1), (2) or (3) of this subsection;
but does not
include devices or their components, parts or accessories, except
that the
term "drug" shall not include amygdalin (laetrile) or any livestock
remedy,
as defined in K.S.A. 47-501 and amendments thereto, if such
livestock
remedy has been registered in accordance with the provisions of
article
5 of chapter 47 of the Kansas Statutes Annotated.
(m) "Electronic transmission" means
transmission of information in
electronic form or the transmission of the exact visual image of a
docu-
ment by way of electronic equipment.
(n) "Generic name" means the established
chemical name or official
name of a drug or drug product.
(o) (1) "Institutional drug room"
means any location where prescrip-
tion-only drugs are stored and from which prescription-only drugs
are
administered or dispensed and which is maintained or operated for
the
purpose of providing the drug needs of:
(A) Inmates of a jail or correctional
institution or facility;
(B) residents of a juvenile detention
facility, as defined by the Kansas
code for care of children and the Kansas juvenile justice code;
(C) students of a public or private
university or college, a community
college or any other institution of higher learning which is
located in
Kansas; or
(D) employees of a business or other
employer.
(2) "Institutional drug room" does not
include:
(A) Any registered pharmacy;
(B) any office of a practitioner; or
(C) a location where no prescription-only
drugs are dispensed and no
prescription-only drugs other than individual prescriptions are
stored or
administered.
(p) "Medical care facility" shall have
the meaning provided in K.S.A.
65-425 and amendments thereto, except that the term shall also
include
facilities licensed under the provisions of K.S.A. 75-3307b and
amend-
ments thereto except community mental health centers and facilities
for
the mentally retarded.
(q) "Manufacture" means the production,
preparation, propagation,
compounding, conversion or processing of a drug either directly or
in-
directly by extraction from substances of natural origin,
independently by
means of chemical synthesis or by a combination of extraction and
chem-
ical synthesis and includes any packaging or repackaging of the
drug or
labeling or relabeling of its container, except that this term
shall not in-
clude the preparation or compounding of a drug by an individual for
the
individual's own use or the preparation, compounding, packaging or
la-
beling of a drug by: (1) A practitioner or a practitioner's
authorized agent
incident to such practitioner's administering or dispensing of a
drug in
the course of the practitioner's professional practice; (2) a
practitioner,
by a practitioner's authorized agent or under a practitioner's
supervision
for the purpose of, or as an incident to, research, teaching or
chemical
analysis and not for sale; or (3) a pharmacist or the pharmacist's
author-
ized agent acting under the direct supervision of the pharmacist
for the
purpose of, or incident to, the dispensing of a drug by the
pharmacist.
(r) "Person" means individual,
corporation, government, govern-
mental subdivision or agency, partnership, association or any other
legal
entity.
(s) "Pharmacist" means any natural person
licensed under this act to
practice pharmacy.
(t) "Pharmacist in charge" means the
pharmacist who is responsible
to the board for a registered establishment's compliance with the
laws
and regulations of this state pertaining to the practice of
pharmacy, man-
ufacturing of drugs and the distribution of drugs. The pharmacist
in
charge shall supervise such establishment on a full-time or a
part-time
basis and perform such other duties relating to supervision of a
registered
establishment as may be prescribed by the board by rules and
regulations.
Nothing in this definition shall relieve other pharmacists or
persons from
their responsibility to comply with state and federal laws and
regulations.
(u) "Pharmacy," "drug store" or
"apothecary" means premises, lab-
oratory, area or other place: (1) Where drugs are offered for sale
where
the profession of pharmacy is practiced and where prescriptions are
com-
pounded and dispensed; or (2) which has displayed upon it or within
it
the words "pharmacist," "pharmaceutical chemist," "pharmacy,"
"apoth-
ecary," "drugstore," "druggist," "drugs," "drug sundries" or any of
these
words or combinations of these words or words of similar import
either
in English or any sign containing any of these words; or (3) where
the
characteristic symbols of pharmacy or the characteristic
prescription sign
"Rx" may be exhibited. As used in this subsection, premises refers
only
to the portion of any building or structure leased, used or
controlled by
the licensee in the conduct of the business registered by the board
at the
address for which the registration was issued.
(v) "Pharmacy student" means an
individual, registered with the
board of pharmacy, enrolled in an accredited school of
pharmacy.
(w) "Pharmacy technician" means an
individual who, under the direct
supervision and control of a pharmacist, may perform packaging,
manip-
ulative, repetitive or other nondiscretionary tasks related to the
processing
of a prescription or medication order and who assists the
pharmacist in
the performance of pharmacy related duties, but who does not
perform
duties restricted to a pharmacist.
(x) "Practitioner" means a person
licensed to practice medicine and
surgery, dentist, podiatrist, veterinarian, optometrist licensed
under the
optometry law as a therapeutic licensee or diagnostic and
therapeutic
licensee, or scientific investigator or other person authorized by
law to
use a prescription-only drug in teaching or chemical analysis or to
conduct
research with respect to a prescription-only drug.
(y) "Preceptor" means a licensed
pharmacist who possesses at least
two years' experience as a pharmacist and who supervises students
ob-
taining the pharmaceutical experience required by law as a
condition to
taking the examination for licensure as a pharmacist.
(z) "Prescription" means, according to
the context, either a prescrip-
tion order or a prescription medication.
(aa) "Prescription medication" means any
drug, including label and
container according to context, which is dispensed pursuant to a
prescrip-
tion order.
(bb) "Prescription-only drug" means any
drug whether intended for
use by man or animal, required by federal or state law (including
21
United States Code section 353, as amended) to be dispensed only
pur-
suant to a written or oral prescription or order of a practitioner
or is
restricted to use by practitioners only.
(cc) "Prescription order" means: (1) An
order to be filled by a phar-
macist for prescription medication issued and signed by a
practitioner or
a mid-level practitioner in the authorized course of professional
practice;
or (2) an order transmitted to a pharmacist through word of mouth,
note,
telephone or other means of communication directed by such
practitioner
or mid-level practitioner.
(dd) "Probation" means the practice or
operation under a temporary
license, registration or permit or a conditional license,
registration or per-
mit of a business or profession for which a license, registration
or permit
is granted by the board under the provisions of the pharmacy act of
the
state of Kansas requiring certain actions to be accomplished or
certain
actions not to occur before a regular license, registration or
permit is
issued.
(ee) "Professional incompetency"
means:
(1) One or more instances involving
failure to adhere to the appli-
cable standard of pharmaceutical care to a degree which constitutes
gross
negligence, as determined by the board;
(2) repeated instances involving failure
to adhere to the applicable
standard of pharmaceutical care to a degree which constitutes
ordinary
negligence, as determined by the board; or
(3) a pattern of pharmacy practice or
other behavior which demon-
strates a manifest incapacity or incompetence to practice
pharmacy.
(ff) "Retail dealer" means a person
selling at retail nonprescription
drugs which are prepackaged, fully prepared by the manufacturer or
dis-
tributor for use by the consumer and labeled in accordance with
the
requirements of the state and federal food, drug and cosmetic acts.
Such
nonprescription drugs shall not include: (1) A controlled
substance; (2) a
prescription-only drug; or (3) a drug intended for human use by
hypo-
dermic injection.
(gg) "Secretary" means the executive
secretary of the board.
(hh) "Unprofessional conduct" means:
(1) Fraud in securing a registration or
permit;
(2) intentional adulteration or
mislabeling of any drug, medicine,
chemical or poison;
(3) causing any drug, medicine, chemical
or poison to be adulterated
or mislabeled, knowing the same to be adulterated or
mislabeled;
(4) intentionally falsifying or altering
records or prescriptions;
(5) unlawful possession of drugs and
unlawful diversion of drugs to
others;
(6) willful betrayal of confidential
information under K.S.A. 65-1654
and amendments thereto;
(7) conduct likely to deceive, defraud or
harm the public;
(8) making a false or misleading
statement regarding the licensee's
professional practice or the efficacy or value of a drug;
(9) commission of any act of sexual
abuse, misconduct or exploitation
related to the licensee's professional practice; or
(10) performing unnecessary tests,
examinations or services which
have no legitimate pharmaceutical purpose.
(ii) "Mid-level practitioner" means an
advanced registered nurse
practitioner issued a certificate of qualification pursuant to
K.S.A. 65-1131
and amendments thereto who has authority to prescribe drugs
pursuant
to a written protocol with a responsible physician under K.S.A.
65-1130
and amendments thereto or a physician's assistant registered
pursuant to
K.S.A. 65-2896a and amendments thereto who has authority to
prescribe
drugs pursuant to a written protocol with a responsible physician
under
K.S.A. 65-2896e and amendments thereto.
(jj) "Vaccination protocol" means a
written protocol, agreed to by a
pharmacist and a person licensed to practice medicine and
surgery by the
state board of healing arts, which establishes procedures and
recordkeep-
ing and reporting requirements for administering a vaccine by
the phar-
macist for a period of time specified therein, not to exceed two
years.
Sec. 2. K.S.A. 1999 Supp. 65-1626a
is hereby amended to read as
follows: 65-1626a. (a) For the purpose of the pharmacy act of the
state
of Kansas, the following persons shall be deemed to be engaged in
the
practice of pharmacy:
(1) Persons who publicly profess to be a
pharmacist, or publicly pro-
fess to assume the duties incident to being a pharmacist and their
knowl-
edge of drugs or drug actions, or both;
(2) persons who attach to their name any
words or abbreviation in-
dicating that they are a pharmacist licensed to practice pharmacy
in Kan-
sas.
(b) "Practice of pharmacy" means the
interpretation and evaluation
of prescription orders; the compounding, dispensing and labeling of
drugs
and devices pursuant to prescription orders; the administering
of vaccine
pursuant to a vaccination protocol; the participation in
drug selection
according to state law and participation in drug utilization
reviews; the
proper and safe storage of prescription drugs and prescription
devices
and the maintenance of proper records thereof in accordance with
law;
consultation with patients and other health care practitioners
about the
safe and effective use of prescription drugs and prescription
devices; and
participation in the offering or performing of those acts,
services, oper-
ations or transactions necessary in the conduct, operation,
management
and control of a pharmacy. Nothing in this subsection shall be
construed
to add any additional requirements for registration or for a permit
under
the pharmacy act of the state of Kansas or for approval under
subsection
(g) of K.S.A. 65-1643 and amendments thereto, or to prevent
persons
other than pharmacists from engaging in drug utilization review, or
to
require persons lawfully in possession of prescription drugs or
prescrip-
tion devices to meet any storage or record keeping requirements
except
such storage and record keeping requirements as may be otherwise
pro-
vided by law or to affect any person consulting with a health care
prac-
titioner about the safe and effective use of prescription drugs or
prescrip-
tion devices.
New Sec. 3. (a) A pharmacist may
administer vaccine to a person 18
years of age or older pursuant to a vaccination protocol if the
pharmacist
has successfully completed a course of study and training, approved
by
the American council on pharmaceutical education or the board, in
vac-
cination storage, protocols, injection technique, emergency
procedures
and recordkeeping. A pharmacist who successfully completes such
a
course of study and training shall maintain proof of completion
and, upon
request, provide a copy of such proof to the board.
(b) All vaccinees will be given a written
immunization record for their
personal files. The administering pharmacist shall promptly report
a rec-
ord of the immunization to the vaccinee's primary-care provider by
elec-
tronic facsimile or mail. If the vaccinee does not have a primary
care
provider, then the administering pharmacist shall promptly report a
rec-
ord of the immunization to the person licensed to practice medicine
and
surgery by the state board of healing arts who has entered into the
vac-
cination protocol with the pharmacist. The immunization will also
be re-
ported to appropriate county or state immunization registries.
(c) A pharmacist may not delegate to any
person the authority granted
under this act to administer a vaccine.
(d) This section shall be a part of and
supplemental to the pharmacy
act of the state of Kansas.
Sec. 4. K.S.A. 1999
Supp. 65-1626 and 65-1626a are hereby re-
pealed.
Sec. 5. This act
shall take effect and be in force from and after its
publication in the statute book.