2022 -- H 8297

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LC006040

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2022

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A N   A C T

RELATING TO FOOD AND DRUGS -- UNIFORM CONTROL SUBSTANCES ACT

     Introduced By: Representatives Hull, Fogarty, McLaughlin, Tanzi, and J Lombardi

     Date Introduced: May 27, 2022

     Referred To: House Health & Human Services

     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 schedules

II, III, IV, and V to any person upon a 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) 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) Hard-copy prescriptions for controlled substances in schedule II shall be filed

separately and shall not be refilled.

     (2) The director of health shall, 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 schedules II, III, IV, and V. Opioid

antagonists, including, but not limited to, naloxone, as may be further determined by rules and

regulations, shall be transmitted with controlled substances in schedules II, III, IV, and V. Provided,

information collected regarding dispensing of opioid antagonists shall be for statistical, research,

or educational purposes only. The department's rules and regulations shall require the removal of

patient, recipient, or prescriber information that could be used to identify individual patients or

recipients of opioid antagonists.

     (3) A practitioner shall sign and transmit electronic prescriptions for controlled substances

in schedules II, III, IV, and V to a pharmacy in accordance with rules and regulations as shall be

promulgated by the department and which shall require electronic transmission no sooner than

January 1, 2020, and a pharmacy may dispense an electronically transmitted prescription for these

controlled substances in accordance with the code of federal regulations, 21 C.F.R., pt. 1300, et

seq.

     (e) Subject to the rules and regulations promulgated by the department pursuant to

subsection (d)(3) of this section, 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) Subject to the rules and regulations promulgated by the department pursuant to

subsection (d)(3) of this section, a prescription 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) Subject to the rules and regulations promulgated by the department pursuant to

subsection (d)(3) of this section, 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

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as is required by subsection (a) of this section 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).

     (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 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 prescription, upon receipt by the apothecary, shall

be attached to the oral emergency prescription that 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 prescription or

emergency oral prescription and he or she makes a notation of the quantity supplied on the face of

the prescription or oral emergency prescription that 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,

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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 logbook, 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

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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 schedule 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-day (30) 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 prescriptions 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.

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     (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. Provided,

however, manufacturer prepackaged steroids and hormones in schedule III shall be exempt from

this subsection.

     (2) Prescriptions in schedules IV and V may be written for up to a ninety-day (90) supply

based on directions. No more than three hundred and sixty (360) dosage units may be dispensed at

one time.

     (n) A pharmacy shall transmit prescription information to the prescription-monitoring

database at the department of health within one business day following the dispensing of an opioid

prescription.

     (o) The pharmacist shall inform patients verbally or in writing about the proper disposal of

expired, unused, or unwanted medications, including the location of local disposal sites as listed on

the department of health website.

     (p) The pharmacist shall inform patients verbally or in writing in the proper use of any

devices necessary for the administration of controlled substances.

     (q)(1) A healthcare professional authorized to issue prescriptions shall, prior to issuing an

initial a prescription for an opioid drug, specifically discuss with the patient who is eighteen (18)

years of age or older, or the patient's parent or guardian if the patient is under eighteen (18) years

of age, the risks of developing a dependence or addiction to the prescription opioid drug and

potential of overdose or death; the adverse risks of concurrent use of alcohol or other psychoactive

medications and the patient's or the minor patient's parent or guardian's responsibility to safeguard

all medications; and, if the prescriber deems it appropriate, discuss such alternative treatments as

may be available. For patients in recovery from substance dependence, education shall be focused

on relapse risk factors. This discussion shall be noted in the patient's record.

     (2) The director of the department of health shall develop and make available to prescribers

guidelines for the discussion required pursuant to this subsection.

     (3) The discussion required under this subsection shall not be required prior to issuing a

prescription to any patient who is currently receiving hospice care from a licensed hospice.

     SECTION 2. This act shall take effect upon passage.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO FOOD AND DRUGS -- UNIFORM CONTROL SUBSTANCES ACT

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     This act would require that professionals authorized to prescribe opioid drugs discuss

addiction risks with the patient or the patient’s parent or guardian if the patient is under eighteen

(18) years of age.

     This act would take effect upon passage.

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LC006040

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