AN
ACT Relating to electronic transfer of prescription information; amending RCW
69.41.010 and 69.50.101; adding a new section to chapter 69.41 RCW; and adding
a new section to chapter 69.50 RCW.
BE IT
ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:
Sec.
1. RCW
69.41.010 and 1996 c 178 s 16 are each amended to read as follows:
As
used in this chapter, the following terms have the meanings indicated unless
the context clearly requires otherwise:
(1)
"Administer" means the direct application of a legend drug whether by
injection, inhalation, ingestion, or any other means, to the body of a patient
or research subject by:
(a)
A practitioner; or
(b)
The patient or research subject at the direction of the practitioner.
(2)
"Deliver" or "delivery" means the actual, constructive, or
attempted transfer from one person to another of a legend drug, whether or not
there is an agency relationship.
(3)
"Department" means the department of health.
(4)
"Dispense" means the interpretation of a prescription or order for a
legend drug and, pursuant to that prescription or order, the proper selection,
measuring, compounding, labeling, or packaging necessary to prepare that
prescription or order for delivery.
(5)
"Dispenser" means a practitioner who dispenses.
(6)
"Distribute" means to deliver other than by administering or
dispensing a legend drug.
(7)
"Distributor" means a person who distributes.
(8)
"Drug" means:
(a)
Substances recognized as drugs in the official United States pharmacopoeia,
official homeopathic pharmacopoeia of the United States, or official national
formulary, or any supplement to any of them;
(b)
Substances intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in man or animals;
(c)
Substances (other than food, minerals or vitamins) intended to affect the
structure or any function of the body of man or animals; and
(d)
Substances intended for use as a component of any article specified in clause
(a), (b), or (c) of this subsection. It does not include devices or their
components, parts, or accessories.
(9)
"Electronic communication of prescription information" means the
communication of prescription information by computer, or the transmission of
an exact visual image of a prescription by facsimile, or other electronic means
for original prescription information or prescription refill information for a
legend drug between an authorized practitioner and a pharmacy or the transfer
of prescription information for a legend drug from one pharmacy to another
pharmacy.
(10)
"Legend drugs" means any drugs which are required by state law or
regulation of the state board of pharmacy to be dispensed on prescription only
or are restricted to use by practitioners only.
(((10)))
(11) "Person" means individual, corporation, government or
governmental subdivision or agency, business trust, estate, trust, partnership
or association, or any other legal entity.
(((11)))
(12) "Practitioner" means:
(a)
A physician under chapter 18.71 RCW, an osteopathic physician or an osteopathic
physician and surgeon under chapter 18.57 RCW, a dentist under chapter 18.32
RCW, a podiatric physician and surgeon under chapter 18.22 RCW, a veterinarian
under chapter 18.92 RCW, a registered nurse, advanced registered nurse
practitioner, or licensed practical nurse under chapter 18.79 RCW, an
optometrist under chapter 18.53 RCW who is certified by the optometry board
under RCW 18.53.010, an osteopathic physician assistant under chapter 18.57A
RCW, a physician assistant under chapter 18.71A RCW, a naturopath licensed
under chapter 18.36A RCW, or a pharmacist under chapter 18.64 RCW;
(b)
A pharmacy, hospital, or other institution licensed, registered, or otherwise
permitted to distribute, dispense, conduct research with respect to, or to
administer a legend drug in the course of professional practice or research in
this state; and
(c)
A physician licensed to practice medicine and surgery or a physician licensed
to practice osteopathic medicine and surgery in any state, or province of
Canada, which shares a common border with the state of Washington.
(((12)))
(13) "Secretary" means the secretary of health or the
secretary's designee.
NEW
SECTION. Sec. 2. A
new section is added to chapter 69.41 RCW to read as follows:
(1)
Information concerning an original prescription or information concerning a
prescription refill for a legend drug may be electronically communicated
between an authorized practitioner and a pharmacy of the patient's choice with
no intervening person having access to the prescription drug order pursuant to
the provisions of this chapter if the electronically communicated prescription
information complies with the following:
(a)
Electronically communicated prescription information must comply with all applicable
statutes and rules regarding the form, content, recordkeeping, and processing
of a prescription for a legend drug;
(b)
The system used for transmitting electronically communicated prescription
information and the system used for receiving electronically communicated
prescription information must be approved by the board. This subsection does
not apply to currently used facsimile equipment transmitting an exact visual
image of the prescription. The board shall maintain and provide, upon request,
a list of systems used for electronically communicating prescription
information currently approved by the board;
(c)
An explicit opportunity for practitioners must be made to indicate their
preference on whether a therapeutically equivalent generic drug may be
substituted;
(d)
Prescription drug orders are confidential health information, and may be
released only to the patient or the patient's authorized representative, the
prescriber or other authorized practitioner then caring for the patient, or
other persons specifically authorized by law to receive such information;
(e)
To maintain confidentiality of prescription records, the electronic system
shall have adequate security and systems safeguards designed to prevent and
detect unauthorized access, modification, or manipulation of these records.
The pharmacist in charge shall establish or verify the existence of policies
and procedures which ensure the integrity and confidentiality of prescription
information transmitted to the pharmacy by electronic means. All managers,
employees, and agents of the pharmacy are required to read, sign, and comply
with the established policies and procedures; and
(f)
The pharmacist shall exercise professional judgment regarding the accuracy,
validity, and authenticity of the prescription drug order received by way of
electronic transmission, consistent with federal and state laws and rules and
guidelines of the board.
(2)
The board may adopt rules implementing this section.
Sec.
3. RCW
69.50.101 and 1996 c 178 s 18 are each amended to read as follows:
Unless
the context clearly requires otherwise, definitions of terms shall be as
indicated where used in this chapter:
(a)
"Administer" means to apply a controlled substance, whether by injection,
inhalation, ingestion, or any other means, directly to the body of a patient or
research subject by:
(1)
a practitioner authorized to prescribe (or, by the practitioner's authorized
agent); or
(2)
the patient or research subject at the direction and in the presence of the
practitioner.
(b)
"Agent" means an authorized person who acts on behalf of or at the
direction of a manufacturer, distributor, or dispenser. It does not include a
common or contract carrier, public warehouseperson, or employee of the carrier
or warehouseperson.
(c)
"Board" means the state board of pharmacy.
(d)
"Controlled substance" means a drug, substance, or immediate
precursor included in Schedules I through V as set forth in federal or state
laws, or federal or board rules.
(e)(1)
"Controlled substance analog" means a substance the chemical
structure of which is substantially similar to the chemical structure of a
controlled substance in Schedule I or II and:
(i)
that has a stimulant, depressant, or hallucinogenic effect on the central
nervous system substantially similar to the stimulant, depressant, or
hallucinogenic effect on the central nervous system of a controlled substance
included in Schedule I or II; or
(ii)
with respect to a particular individual, that the individual represents or
intends to have a stimulant, depressant, or hallucinogenic effect on the
central nervous system substantially similar to the stimulant, depressant, or
hallucinogenic effect on the central nervous system of a controlled substance
included in Schedule I or II.
(2)
The term does not include:
(i)
a controlled substance;
(ii)
a substance for which there is an approved new drug application;
(iii)
a substance with respect to which an exemption is in effect for investigational
use by a particular person under Section 505 of the federal Food, Drug and
Cosmetic Act, 21 U.S.C. Sec. 355, to the extent conduct with respect to the
substance is pursuant to the exemption; or
(iv)
any substance to the extent not intended for human consumption before an
exemption takes effect with respect to the substance.
(f)
"Deliver" or "delivery," means the actual or constructive
transfer from one person to another of a substance, whether or not there is an
agency relationship.
(g)
"Department" means the department of health.
(h)
"Dispense" means the interpretation of a prescription or order for a
controlled substance and, pursuant to that prescription or order, the proper
selection, measuring, compounding, labeling, or packaging necessary to prepare
that prescription or order for delivery.
(i)
"Dispenser" means a practitioner who dispenses.
(j)
"Distribute" means to deliver other than by administering or
dispensing a controlled substance.
(k)
"Distributor" means a person who distributes.
(l)
"Drug" means (1) a controlled substance recognized as a drug in the
official United States pharmacopoeia/national formulary or the official
homeopathic pharmacopoeia of the United States, or any supplement to them; (2)
controlled substances intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in individuals or animals; (3) controlled
substances (other than food) intended to affect the structure or any function
of the body of individuals or animals; and (4) controlled substances intended
for use as a component of any article specified in (1), (2), or (3) of this
subsection. The term does not include devices or their components, parts, or
accessories.
(m)
"Drug enforcement administration" means the drug enforcement administration
in the United States Department of Justice, or its successor agency.
(n)
"Immediate precursor" means a substance:
(1)
that the state board of pharmacy has found to be and by rule designates as
being the principal compound commonly used, or produced primarily for use, in
the manufacture of a controlled substance;
(2)
that is an immediate chemical intermediary used or likely to be used in the
manufacture of a controlled substance; and
(3)
the control of which is necessary to prevent, curtail, or limit the manufacture
of the controlled substance.
(o)
"Isomer" means an optical isomer, but in RCW 69.50.101(r)(5),
69.50.204(a) (12) and (34), and 69.50.206(a)(4), the term includes any
geometrical isomer; in RCW 69.50.204(a) (8) and (42), and 69.50.210(c) the term
includes any positional isomer; and in RCW 69.50.204(a)(35), 69.50.204(c), and
69.50.208(a) the term includes any positional or geometric isomer.
(p)
"Manufacture" means the production, preparation, propagation,
compounding, conversion, or processing of a controlled substance, either
directly or indirectly or by extraction from substances of natural origin, or
independently by means of chemical synthesis, or by a combination of extraction
and chemical synthesis, and includes any packaging or repackaging of the
substance or labeling or relabeling of its container. The term does not
include the preparation, compounding, packaging, repackaging, labeling, or
relabeling of a controlled substance:
(1)
by a practitioner as an incident to the practitioner's administering or
dispensing of a controlled substance in the course of the practitioner's
professional practice; or
(2)
by a practitioner, or by the practitioner's authorized agent under the
practitioner's supervision, for the purpose of, or as an incident to, research,
teaching, or chemical analysis and not for sale.
(q)
"Marijuana" or "marihuana" means all parts of the plant
Cannabis, whether growing or not; the seeds thereof; the resin extracted from
any part of the plant; and every compound, manufacture, salt, derivative,
mixture, or preparation of the plant, its seeds or resin. The term does not
include the mature stalks of the plant, fiber produced from the stalks, oil or
cake made from the seeds of the plant, any other compound, manufacture, salt,
derivative, mixture, or preparation of the mature stalks (except the resin
extracted therefrom), fiber, oil, or cake, or the sterilized seed of the plant
which is incapable of germination.
(r)
"Narcotic drug" means any of the following, whether produced directly
or indirectly by extraction from substances of vegetable origin, or
independently by means of chemical synthesis, or by a combination of extraction
and chemical synthesis:
(1)
Opium, opium derivative, and any derivative of opium or opium derivative,
including their salts, isomers, and salts of isomers, whenever the existence of
the salts, isomers, and salts of isomers is possible within the specific
chemical designation. The term does not include the isoquinoline alkaloids of
opium.
(2)
Synthetic opiate and any derivative of synthetic opiate, including their
isomers, esters, ethers, salts, and salts of isomers, esters, and ethers,
whenever the existence of the isomers, esters, ethers, and salts is possible
within the specific chemical designation.
(3)
Poppy straw and concentrate of poppy straw.
(4)
Coca leaves, except coca leaves and extracts of coca leaves from which cocaine,
ecgonine, and derivatives or ecgonine or their salts have been removed.
(5)
Cocaine, or any salt, isomer, or salt of isomer thereof.
(6)
Cocaine base.
(7)
Ecgonine, or any derivative, salt, isomer, or salt of isomer thereof.
(8)
Any compound, mixture, or preparation containing any quantity of any substance
referred to in subparagraphs (1) through (7).
(s)
"Opiate" means any substance having an addiction-forming or
addiction-sustaining liability similar to morphine or being capable of
conversion into a drug having addiction-forming or addiction-sustaining
liability. The term includes opium, substances derived from opium (opium
derivatives), and synthetic opiates. The term does not include, unless
specifically designated as controlled under RCW 69.50.201, the dextrorotatory
isomer of 3-methoxy-n-methylmorphinan and its salts (dextromethorphan). The
term includes the racemic and levorotatory forms of dextromethorphan.
(t)
"Opium poppy" means the plant of the species Papaver somniferum L.,
except its seeds.
(u)
"Person" means individual, corporation, business trust, estate,
trust, partnership, association, joint venture, government, governmental
subdivision or agency, or any other legal or commercial entity.
(v)
"Poppy straw" means all parts, except the seeds, of the opium poppy,
after mowing.
(w)
"Practitioner" means:
(1)
A physician under chapter 18.71 RCW, a physician assistant under chapter 18.71A
RCW, an osteopathic physician and surgeon under chapter 18.57 RCW, a dentist
under chapter 18.32 RCW, a podiatric physician and surgeon under chapter 18.22
RCW, a veterinarian under chapter 18.92 RCW, a registered nurse, advanced
registered nurse practitioner, or licensed practical nurse under chapter 18.79
RCW, a pharmacist under chapter 18.64 RCW or a scientific investigator under
this chapter, licensed, registered or otherwise permitted insofar as is
consistent with those licensing laws to distribute, dispense, conduct research
with respect to or administer a controlled substance in the course of their
professional practice or research in this state.
(2)
A pharmacy, hospital or other institution licensed, registered, or otherwise
permitted to distribute, dispense, conduct research with respect to or to
administer a controlled substance in the course of professional practice or
research in this state.
(3)
A physician licensed to practice medicine and surgery, a physician licensed to
practice osteopathic medicine and surgery, a dentist licensed to practice
dentistry, a podiatric physician and surgeon licensed to practice podiatric
medicine and surgery, or a veterinarian licensed to practice veterinary
medicine in any state of the United States.
(x)
"Prescription" means an order for controlled substances issued by a
practitioner duly authorized by law or rule in the state of Washington to
prescribe controlled substances within the scope of his or her professional
practice for a legitimate medical purpose.
(y)
"Production" includes the manufacturing, planting, cultivating,
growing, or harvesting of a controlled substance.
(z)
"Secretary" means the secretary of health or the secretary's
designee.
(aa)
"State," unless the context otherwise requires, means a state of the
United States, the District of Columbia, the Commonwealth of Puerto Rico, or a
territory or insular possession subject to the jurisdiction of the United
States.
(bb)
"Ultimate user" means an individual who lawfully possesses a
controlled substance for the individual's own use or for the use of a member of
the individual's household or for administering to an animal owned by the
individual or by a member of the individual's household.
(cc)
"Electronic communication of prescription information" means the
communication of prescription information by computer, or the transmission of
an exact visual image of a prescription by facsimile, or other electronic means
for original prescription information or prescription refill information for a
Schedule III-V controlled substance between an authorized practitioner and a
pharmacy or the transfer of prescription information for a controlled substance
from one pharmacy to another pharmacy.
NEW
SECTION. Sec. 4. A
new section is added to chapter 69.50 RCW to read as follows:
(1)
Information concerning an original prescription or information concerning a
prescription refill for a controlled substance may be electronically
communicated to a pharmacy of the patient's choice pursuant to the provisions
of this chapter if the electronically communicated prescription information
complies with the following:
(a)
Electronically communicated prescription information must comply with all
applicable statutes and rules regarding the form, content, recordkeeping, and
processing of a prescription for a legend drug;
(b)
The system used for transmitting electronically communicated prescription
information and the system used for receiving electronically communicated
prescription information must be approved by the board. This subsection does
not apply to currently used facsimile equipment transmitting an exact visual
image of the prescription. The board shall maintain and provide, upon request,
a list of systems used for electronically communicating prescription
information currently approved by the board;
(c)
An explicit opportunity for practitioners must be made to indicate their
preference on whether a therapeutically equivalent generic drug may be
substituted;
(d)
Prescription drug orders are confidential health information, and may be
released only to the patient or the patient's authorized representative, the
prescriber or other authorized practitioner then caring for the patient, or
other persons specifically authorized by law to receive such information;
(e)
To maintain confidentiality of prescription records, the electronic system
shall have adequate security and systems safeguards designed to prevent and detect
unauthorized access, modification, or manipulation of these records. The
pharmacist in charge shall establish or verify the existence of policies and
procedures which ensure the integrity and confidentiality of prescription
information transmitted to the pharmacy by electronic means. All managers,
employees, and agents of the pharmacy are required to read, sign, and comply
with the established policies and procedures; and
(f)
The pharmacist shall exercise professional judgment regarding the accuracy,
validity, and authenticity of the prescription drug order received by way of
electronic transmission, consistent with federal and state laws and rules and
guidelines of the board.
(2)
The board may adopt rules implementing this section.
