2016 -- S 2823

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LC004637

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2016

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A N   A C T

RELATING TO FOOD AND DRUGS -- UNIFORM CONTROLLED SUBSTANCES ACT--

REGULATION OF MANUFACTURING, DISTRIBUTING, PRESCRIBING,

ADMINISTERING, AND DISPENSING CONTROLLED SUBSTANCES

     Introduced By: Senators Archambault, Lombardi, Lynch Prata, McCaffrey, and Metts

     Date Introduced: March 23, 2016

     Referred To: Senate 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 schedule 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, including by facsimile, of prescriptions for controlled substances in schedule II, 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 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 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

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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 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. At no time, however, shall a prescription for a

controlled substance listed in Schedule II written or issued by any individual authorized by an

emergency room to issue such prescriptions, and issued as a direct result of a visit to such

emergency room, exceed such dosage and usage which would exceed its prescribed use for a

period of not more than seventy-two (72) hours without a compelling reason to do so. The

department of health shall have the authority to issue such rules and regulations promulgating

conditions which shall set the guidelines for such compelling reasons.

      (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

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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

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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-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 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.

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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.

      (2) Prescriptions in Schedule 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.

     SECTION 2. This act shall take effect upon passage.

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LC004637

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO FOOD AND DRUGS -- UNIFORM CONTROLLED SUBSTANCES ACT--

REGULATION OF MANUFACTURING, DISTRIBUTING, PRESCRIBING,

ADMINISTERING, AND DISPENSING CONTROLLED SUBSTANCES

***

     This act would limit Schedule II prescriptions issued by those authorized by emergency

rooms to issue prescriptions to a period not to exceed seventy-two (72) hours without a

compelling reason to do so.

     This act would take effect upon passage.

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LC004637

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