BILL REQ. #: Z-0637.3
State of Washington | 62nd Legislature | 2012 Regular Session |
Read first time 01/11/12. Referred to Committee on Health Care & Wellness.
AN ACT Relating to authorization of electronic communication of prescription information for controlled substances; and amending RCW 69.50.101, 69.50.308, and 69.50.312.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:
Sec. 1 RCW 69.50.101 and 2010 c 177 s 1 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))) subsection (r)(5) of this section, RCW 69.50.204(a)
(12) and (34), and 69.50.206(b)(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; an osteopathic physician assistant under chapter
18.57A RCW who is licensed under RCW 18.57A.020 subject to any
limitations in RCW 18.57A.040; an optometrist licensed under chapter
18.53 RCW who is certified by the optometry board under RCW 18.53.010
subject to any limitations in RCW 18.53.010; 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 naturopathic physician under chapter 18.36A RCW
who is licensed under RCW 18.36A.030 subject to any limitations in RCW
18.36A.040; 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.))
Sec. 2 RCW 69.50.308 and 2001 c 248 s 1 are each amended to read
as follows:
(a) A controlled substance may be dispensed only as provided in
this section, except that subsections (b) through (d) of this section
shall not apply to electronic communication of prescription information
allowed under RCW 69.50.312.
(b) Except when dispensed directly by a practitioner authorized to
prescribe or administer a controlled substance, other than a pharmacy,
to an ultimate user, a substance included in Schedule II may not be
dispensed without the written prescription of a practitioner.
(1) Schedule II narcotic substances may be dispensed by a pharmacy
pursuant to a facsimile prescription under the following circumstances:
(i) The facsimile prescription is transmitted by a practitioner to
the pharmacy; and
(ii) The facsimile prescription is for a patient in a long-term
care facility. "Long-term care facility" means nursing homes licensed
under chapter 18.51 RCW, boarding homes licensed under chapter 18.20
RCW, and adult family homes licensed under chapter 70.128 RCW; or
(iii) The facsimile prescription is for a patient of a hospice
program certified or paid for by medicare under Title XVIII; or
(iv) The facsimile prescription is for a patient of a hospice
program licensed by the state; and
(v) The practitioner or the practitioner's agent notes on the
facsimile prescription that the patient is a long-term care or hospice
patient.
(2) Injectable Schedule II narcotic substances that are to be
compounded for patient use may be dispensed by a pharmacy pursuant to
a facsimile prescription if the facsimile prescription is transmitted
by a practitioner to the pharmacy.
(3) Under (1) and (2) of this subsection the facsimile prescription
shall serve as the original prescription and shall be maintained as
other Schedule II narcotic substances prescriptions.
(c) In emergency situations, as defined by rule of the state board
of pharmacy, a substance included in Schedule II may be dispensed upon
oral prescription of a practitioner, reduced promptly to writing and
filed by the pharmacy. Prescriptions shall be retained in conformity
with the requirements of RCW 69.50.306. ((A prescription for a
substance included in Schedule II may not be refilled.))
(d) Except when dispensed directly by a practitioner authorized to
prescribe or administer a controlled substance, other than a pharmacy,
to an ultimate user, a substance included in Schedule III or IV, which
is a prescription drug as determined under RCW 69.04.560, may not be
dispensed without a written or oral prescription of a practitioner.
Any oral prescription must be promptly reduced to writing. ((The))
(e) A prescription for a substance included in Schedule II may not
be refilled.
(f) Schedule III or IV prescriptions shall not be filled or
refilled more than six months after the date thereof or be refilled
more than five times, unless renewed by the practitioner.
(((e))) (g) A valid prescription or lawful order of a practitioner,
in order to be effective in legalizing the possession of controlled
substances, must be issued in good faith for a legitimate medical
purpose by one authorized to prescribe the use of such controlled
substance. An order purporting to be a prescription not in the course
of professional treatment is not a valid prescription or lawful order
of a practitioner within the meaning and intent of this chapter; and
the person who knows or should know that the person is filling such an
order, as well as the person issuing it, can be charged with a
violation of this chapter.
(((f))) (h) A substance included in Schedule V must be distributed
or dispensed only for a medical purpose.
(((g))) (i) A practitioner may dispense or deliver a controlled
substance to or for an individual or animal only for medical treatment
or authorized research in the ordinary course of that practitioner's
profession. Medical treatment includes dispensing or administering a
narcotic drug for pain, including intractable pain.
(((h))) (j) No administrative sanction, or civil or criminal
liability, authorized or created by this chapter may be imposed on a
pharmacist for action taken in reliance on a reasonable belief that an
order purporting to be a prescription was issued by a practitioner in
the usual course of professional treatment or in authorized research.
(((i))) (k) An individual practitioner may not dispense a substance
included in Schedule II, III, or IV for that individual practitioner's
personal use.
Sec. 3 RCW 69.50.312 and 1998 c 222 s 4 are each amended to read
as follows:
(1) Information concerning an original prescription for a
controlled substance included in Schedules II through V, or information
concerning a prescription refill for a controlled substance included in
Schedules III through V 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 and meet the requirements for electronic orders and
prescriptions set forth in Title 21 C.F.R. Parts 1300, 1304, 1306, and
1311 in effect on the effective date of this section if used to
transmit prescription information for controlled substances included in
Schedules II through V. 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.