Chapter 124
2013 -- H 5756 SUBSTITUTE B
Enacted 06/24/13
A N A C T
RELATING TO FOOD
AND DRUGS - UNIFORM CONTROLLED SUBSTANCES ACT
Introduced By: Representatives McNamara, Azzinaro, Bennett, Corvese, and Handy
Date Introduced: February 28, 2013
It is enacted by the
General Assembly as follows:
SECTION 1. Section 21-28-3.18 of the General Laws in Chapter
21-28 entitled
“Uniform Controlled
Substances Act” is hereby amended to read as follows:
21-28-3.18.
Prescriptions. -- (a) An
apothecary in good faith may sell and dispense
controlled substances in schedule II, III, IV and V to
any person upon a written valid prescription
by a practitioner licensed by law to prescribe or
administer those substances, dated and signed by
the person prescribing on the day when issued and bearing
the full name and address of the
patient to whom, or of the owner of the animal for which the
substance is dispensed and the full
name, address and registration number under the federal
law of the person prescribing, if he or
she is required by that law to be registered. If the
prescription is for an animal, it shall state the
species of the animal for which the substance is prescribed.
(b) The When
filling a hard-copy prescription for a schedule II controlled substance, the
apothecary filling the prescription shall sign his or her full
name and shall write the date of filling
on the face of the prescription.
(c) The prescription shall
be retained on file by the proprietor of the pharmacy in which it
was filled for a period of two (2) years so as to be
readily accessible for inspection by any public
officer or employee engaged in the enforcement of this
chapter.
(d) (1) Prescriptions
Hard copy prescriptions for controlled substances in schedule II shall
be filed separately and shall not be refilled.
(2) The director of
health may, after appropriate notice and hearing pursuant to § 42-35-3,
promulgate rules and regulations for the purpose of adopting a
system for electronic data
transmission of prescriptions for controlled substances in
schedule II and, III and IV.
(3) A practitioner
may sign and transmit electronic prescriptions for controlled substances
and a pharmacy may dispense an electronically transmitted
prescription in accordance with the
code of federal regulations, title 21 part 1300, et seq.
(e) A prescription for a
schedule II narcotic substance to be compounded for the direct
administration to a patient by parenteral,
intravenous, intramuscular, subcutaneous, or intraspinal
infusion may be transmitted by the practitioner or
practitioner's agent to the pharmacy by
facsimile. The facsimile will serve as the original
prescription.
(f) A prescription written
for a schedule II substance for a resident of a long term care
facility may be transmitted by the practitioner or the
practitioner's agent to the dispensing
pharmacy by facsimile. The facsimile serves as the original
prescription.
(g) A prescription for a
schedule II narcotic substance for a patient residing in a hospice
certified by Medicare under title XVIII of the Social Security
Act, 42 U.S.C. § 1395 et seq., or
licensed by the state, may be transmitted by the practitioner
or practitioner's agent to the
dispensing pharmacy by facsimile. The practitioner or the
practitioner's agent will note on the
prescription that the patient is a hospice patient. The facsimile
serves as the original written
prescription.
(h) An apothecary, in
lieu of a written prescription, may sell and dispense controlled
substances in schedules III, IV, and V to any person upon an
oral prescription of a practitioner. In
issuing an oral prescription the prescriber shall furnish the
apothecary with the same information
as is required by subsection (a) of this section in
the case of a written prescription for controlled
substances in schedule II, except for the written signature of
the person prescribing, and the
apothecary who fills the prescription, shall immediately reduce
the oral prescription to writing
and shall inscribe the information on the written record
of the prescription made. This record shall
be filed and preserved by the proprietor of the pharmacy
in which it is filled in accordance with
the provisions of subsection (c) of this section. In no
case may a prescription for a controlled
substance listed in schedules III, IV, or V be filled or
refilled more than six (6) months after the
date on which the prescription was issued and no
prescription shall be authorized to be refilled
more than five (5) times. Each refilling shall be entered
on the face or back of the prescription
and note the date and amount of controlled substance
dispensed, and the initials or identity of the
dispensing apothecary.
(i)
In the case of an emergency situation as defined in federal law, an apothecary
may
dispense a controlled substance listed in schedule II upon
receiving an oral authorization of a
prescribing practitioner provided that:
(1) The quantity
prescribed and dispensed is limited to the amount adequate to treat the
patient during the emergency period and dispensing beyond the
emergency period must be
pursuant to a written prescription signed by the prescribing
practitioner.
(2) The prescription
shall be immediately reduced to writing and shall contain all the
information required in subsection (a) of this section.
(3) The prescription
must be dispensed in good faith in the normal course of professional
practice.
(4) Within seven (7)
days after authorizing an emergency oral prescription, the
prescribing practitioner shall cause a written
prescription for the emergency quantity prescribed to
be delivered to the dispensing apothecary. The prescription
shall have written on its face
"Authorization for emergency
dispensing" and the date of the oral order. The written prescription
upon receipt by the apothecary shall be attached to the
oral emergency prescription which had
earlier been reduced to writing.
(j)
(1) The partial filling of a prescription for a controlled substance listed in
schedule II
is permissible, if the apothecary is unable to supply
the full quantity called for in a written
prescription or emergency oral prescription and he or she makes a
notation of the quantity
supplied on the face of the written prescription or
oral emergency prescription which has been
reduced to writing. The remaining portion of the prescription
may be filled within seventy-two
(72) hours of the first
partial filling, however, if the remaining portion is not, or cannot be filled
within seventy-two (72) hours, the apothecary shall notify
the prescribing practitioner. No further
quantity may be supplied beyond seventy-two (72) hours without
a new prescription.
(2) (i) A prescription for a schedule II controlled
substance written for a patient in a long
term care facility (LTCF), or for a patient with a medical
diagnosis documenting a terminal
illness, may be filled in partial quantities to include
individual dosage units. If there is a question
whether a patient may be classified as having a terminal
illness, the pharmacist must contact the
practitioner prior to partially filling the prescription. Both the
pharmacist and the prescribing
practitioner have a corresponding responsibility to assure that
the controlled substance is for a
terminally ill patient.
(ii) The pharmacist must
record on the prescription whether the patient is "terminally ill"
or an "LTCF patient." A prescription that is
partially filled, and does not contain the notation
"terminally ill" or
"LTCF patient", shall be deemed to have been filled in violation of
this chapter.
(iii) For each partial
filling, the dispensing pharmacist shall record on the back of the
prescription (or on another appropriate record, uniformly
maintained, and readily retrievable),
the:
(A) Date of the partial
filling;
(B) Quantity dispensed;
(C) Remaining quantity
authorized to be dispensed; and
(D) Identification of
the dispensing pharmacist.
(iv)
The total quantity of schedule II controlled substances dispensed in all
partial fillings
must not exceed the total quantity prescribed.
(v) Schedule II
prescriptions for patients in a LTCF, or patients with a medical diagnosis
documenting a terminal illness, are valid for a period not to
exceed sixty (60) days from the issue
date, unless sooner terminated by the discontinuance of
medication.
(k) Automated data processing
systems. As an alternative to the prescription record
keeping provision of subsection (h) of this section, an
automated data processing system may be
employed for the record keeping system, if the following
conditions have been met:
(1) The system shall
have the capability of producing sight-readable documents of all
original and refilled prescription information. The term
"sight-readable" means that an authorized
agent shall be able to examine the record and read the
information. During the course of an on-
site inspection, the record may be read from the CRT,
microfiche, microfilm, printout, or other
method acceptable to the director. In the case of
administrative proceedings, records must be
provided in a paper printout form.
(2) The information
shall include, but not be limited to, the prescription requirements and
records of dispensing as indicated in subsection (h) of this
section.
(3) The individual
pharmacist responsible for completeness and accuracy of the entries to
the system must provide documentation of the fact that
prescription information entered into the
computer is correct. In documenting this information, the
pharmacy shall have the option to
either:
(i) Maintain a bound log book, or separate file, in
which each individual pharmacist
involved in the dispensing shall sign a statement each day,
attesting to the fact that the
prescription information entered into the computer that day has
been reviewed and is correct as
shown. The book or file must be maintained at the pharmacy
employing that system for a period
of at least two (2) years after the date of last
dispensing; or
(ii) Provide a printout
of each day's prescription information. That printout shall be
verified, dated, and signed by the individual pharmacist
verifying that the information indicated is
correct. The printout must be maintained at least two (2)
years from the date of last dispensing.
(4) An auxiliary record
keeping system shall be established for the documentation of
refills, if the automated data processing system is
inoperative for any reason. The auxiliary
system shall ensure that all refills are authorized by the
original prescription, and that the
maximum number of refills is not exceeded. When this automated
data processing system is
restored to operation, the information regarding prescriptions
filled and refilled during the
inoperative period, shall be entered into the automated data
processing system within ninety-six
(96) hours.
(5) Any pharmacy using
an automated data processing system must comply with all
applicable state and federal laws and regulations.
(6) A pharmacy shall
make arrangements with the supplier of data processing services or
materials to ensure that the pharmacy continues to have
adequate and complete prescription and
dispensing records if the relationship with the supplier
terminates for any reason. A pharmacy
shall ensure continuity in the maintenance of records.
(7) The automated data
processing system shall contain adequate safeguards for security
of the records, to maintain the confidentiality and
accuracy of the prescription information.
Safeguards against unauthorized changes in data after
the information has been entered and
verified by the registered pharmacist shall be provided by the
system.
(l) Prescriptions for
controlled substances as found in schedules II, will become void
unless dispensed within ninety (90) days of the original
date of the prescription, and in no event
shall more than a thirty (30) day supply be dispensed at
any one time.
(1) In prescribing
controlled substances in schedule II, practitioners may write up to three
(3) separate prescriptions,
each for up to a one-month supply, each signed and dated on the date
written. For those prescriptions for the second and/or third
month, the practitioner must write the
earliest date each of those subsequent prescription may be
filled, with directions to the pharmacist
to fill no earlier than the date specified on the face
of the prescription.
(m) The prescriptions in
schedules III, IV, and V will become void unless dispensed
within one hundred eighty (180) days of the original date of
the prescription. For purposes of this
section, a "dosage unit" shall be defined as a
single capsule, tablet or suppository, or not more
than one five (5) ml. of an oral liquid.
(1) Prescriptions in
Schedule III cannot be written for more than one hundred (100)
dosage units and not more than one hundred (100) dosage units
may be dispensed at one time.
(2) Prescriptions in
Schedule IV and V may be written for up to a ninety (90) day supply
based on directions. No more than three hundred and sixty
(360) dosage units may be dispensed
at one time.
SECTION 2. Chapter 21-28 of the General Laws entitled
“Uniform Controlled
Substances Act” is hereby
amended by adding thereto the following section:
21-28-3.32.
Electronic prescription database. -- (a) The information contained in any
prescription drug monitoring database maintained by the department
of health pursuant to section
3.18 of this chapter shall be disclosed only:
(1) To a practitioner
who certifies that the requested information is for the purpose of
evaluating the need for or providing medical treatment for a
current patient to whom the
practitioner is prescribing or considering prescribing a
controlled substance;
(2) To a pharmacist
who certifies that the requested information is for a current client to
whom the pharmacist is dispensing or considering
dispensing a controlled substance;
(3) Pursuant to a
valid search warrant based on probable cause to believe a violation of
federal or state criminal law has occurred and that specified
information contained in the database
would assist in the investigation of the crime;
(4) To a patient who
requests his or her own prescription information, or the parent or
legal guardian of a minor child who requests the minor
child's prescription information;
(5) To a health
professional regulatory board that documents, in writing, that the
requested information is necessary for an investigation related
to licensure, renewal or
disciplinary action involving the applicant, licensee or
registrant to whom the requested
information pertains;
(6) To any vendor or
contractor with whom the department has contracted to establish or
maintain the electronic system of the prescription drug
monitoring database; or
(7) To public or
private entities for statistical, research, or educational purposes, after
removing the patient and prescriber information that could be
used to identify individual patients.
This shall not include entities receiving a waiver
from the institutional review board.
(b) Information
stored in the prescription drug monitoring database shall include only the
following:
(1) Patient’s first
and last name, and/or patient identification number; provided, however,
the patient’s social security number shall not be recorded
in whole or in part, patient sex, patient
date of birth, and patient address;
(2) Prescribing
practitioner’s name and drug enforcement administration prescriber
information number;
(3) Prescribing practitioner’s
office or hospital contact information;
(4) Prescription
name, prescription number, prescription species code, national drug code
number, prescription dosage, prescription quantity, days'
supply, new-refill code, number of
refills authorized, date the prescription was written, date
the prescription was filled, payment
type; provided, however, no credit card number shall be
recorded in whole or in part; and
(5) The drug
enforcement administration pharmacy number of the pharmacy filling the
prescription.
(c) The department
shall disclose any information relating to a patient maintained in the
prescription drug monitoring database to that patient, at no cost
to the patient, within thirty (30)
business days after the department receives a written request
from the patient for the information.
This information shall include the records maintained
by the department pursuant to subsection
(e). Notwithstanding the
above, the department may, at the request of the law enforcement
agency, withhold for up to sixty (60) days following the
conclusion of a law enforcement
investigation, the disclosure to the patient that information has
been obtained pursuant to
subdivision (a)(3).
(d) A patient may
request from the dispensing pharmacy correction of any inaccurate
information contained within the prescription drug monitoring
database in accordance with the
procedure specified by subsection 5-37.3-5(c).
(e) The department
shall, for the period of time that prescription information is
maintained, maintain records of the information disclosed
through the prescription drug
monitoring database, including, but not limited to:
(1) The identity of
each person who requests or receives information from the
prescription drug monitoring database and the organization, if
any, the person represents;
(2) The information
released to each person or organization and the basis for its release
under subsection (a); and
(3) The dates the
information was requested and provided.
(f) Prescription
information contained within the prescription drug monitoring database
shall be removed no later than five (5) years from the date
the information is entered into the
database. Records in existence prior to the enactment of this
section shall be removed no later
than ten (10) years from the date the information is
entered into the database.
(g) The department
shall promptly notify any affected individual of an improper
disclosure of information from the prescription drug monitoring
database or a breach in the
security of the prescription drug monitoring database that
poses a significant risk of disclosure of
patient information to an unauthorized individual.
(h) At the time of
signing a prescription which is required by the department to be entered
into the prescription drug monitoring database, the
prescribing practitioner shall inform the
patient in writing of the existence of the prescription drug
monitoring database, the patient’s right
to access their own prescription information, and the
name and contact information of the agency
operating the program.
(i)
No person shall access information in the prescription monitoring database
except to
the extent and for the purposes authorized by subsection
(a).
(j) In any civil
action allowing a violation of this chapter, the court may award damages,
including punitive damages, and reasonable attorneys’ fees and
costs to a prevailing plaintiff, and
injunctive and any other appropriate relief.
(k) Any pharmacist
who, in his or her professional judgment, refuses to fill a prescription
based on information contained within the prescription drug
monitoring database shall inform the
prescribing physician within twenty-four (24) hours.
SECTION 3. This act shall take effect upon passage.
=======
LC01858/SUB B
=======