2021 -- S 0306

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LC001041

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2021

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A N   A C T

RELATING TO FOOD AND DRUGS - UNIFORM CONTROL SUBSTANCES ACT

     

     Introduced By: Senators Archambault, DiPalma, Miller, Valverde, and Lawson

     Date Introduced: February 18, 2021

     Referred To: Senate Health & Human Services

     It is enacted by the General Assembly as follows:

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     SECTION 1. Section 21-28-3.18 of the General Laws in Chapter 21-28 entitled "Uniform

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Controlled Substances Act" is hereby amended to read as follows:

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     21-28-3.18. Prescriptions.

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     (a) An apothecary in good faith may sell and dispense controlled substances in schedules

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II, III, IV, and V to any person upon a valid prescription by a practitioner licensed by law to

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prescribe or administer those substances; dated and signed by the person prescribing on the day

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when issued and bearing the full name and address of the patient to whom, or of the owner of the

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animal for which, the substance is dispensed; and the full name, address, and registration number

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under the federal law of the person prescribing, if he or she is required by that law to be registered.

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If the prescription is for an animal, it shall state the species of the animal for which the substance

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is prescribed.

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     (b) When filling a hard-copy prescription for a schedule II controlled substance, the

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apothecary filling the prescription shall sign his or her full name and shall write the date of filling

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on the face of the prescription.

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     (c) The prescription shall be retained on file by the proprietor of the pharmacy in which it

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was filled for a period of two (2) years so as to be readily accessible for inspection by any public

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officer or employee engaged in the enforcement of this chapter.

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     (d)(1) Hard-copy prescriptions for controlled substances in schedule II shall be filed

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separately and shall not be refilled.

 

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     (2) The director of health shall, after appropriate notice and hearing pursuant to § 42-35-3,

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promulgate rules and regulations for the purpose of adopting a system for electronic data

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transmission of prescriptions for controlled substances in schedules II, III, IV, and V. Opioid

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

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

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

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

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

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recipients of opioid antagonists.

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

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

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

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

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

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seq.

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

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subsection (d)(3) of this section, a prescription for a schedule II narcotic substance to be

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compounded for the direct administration to a patient by parenteral, intravenous, intramuscular,

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subcutaneous, or intraspinal infusion may be transmitted by the practitioner, or practitioner's agent,

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to the pharmacy by facsimile. The facsimile will serve as the original prescription.

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

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subsection (d)(3) of this section, a prescription for a schedule II substance for a resident of a long-

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term-care facility may be transmitted by the practitioner, or the practitioner's agent, to the

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dispensing pharmacy by facsimile. The facsimile serves as the original prescription.

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

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subsection (d)(3) of this section, a prescription for a schedule II narcotic substance for a patient

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residing in a hospice certified by Medicare under title XVIII of the Social Security Act, 42 U.S.C.

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§ 1395 et seq., or licensed by the state, may be transmitted by the practitioner, or practitioner's

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agent, to the dispensing pharmacy by facsimile. The practitioner, or the practitioner's agent, will

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note on the prescription that the patient is a hospice patient. The facsimile serves as the original,

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written prescription.

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     (h) An apothecary, in lieu of a written prescription, may sell and dispense controlled

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substances in schedules III, IV, and V to any person upon an oral prescription of a practitioner. In

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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

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immediately reduce the oral prescription to writing and shall inscribe the information on the written

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record of the prescription made. This record shall be filed and preserved by the proprietor of the

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pharmacy in which it is filled in accordance with the provisions of subsection (c) of this section. In

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no case may a prescription for a controlled substance listed in schedules III, IV, or V be filled or

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refilled more than six (6) months after the date on which the prescription was issued and no

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prescription shall be authorized to be refilled more than five (5) times. Each refilling shall be

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entered on the face or back of the prescription and note the date and amount of controlled substance

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dispensed and the initials or identity of the dispensing apothecary.

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     (i) In the case of an emergency situation as defined in federal law, an apothecary may

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dispense a controlled substance listed in schedule II upon receiving an oral authorization of a

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prescribing practitioner provided that:

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     (1) The quantity prescribed and dispensed is limited to the amount adequate to treat the

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patient during the emergency period and dispensing beyond the emergency period must be pursuant

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to a written prescription signed by the prescribing practitioner.

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     (2) The prescription shall be immediately reduced to writing and shall contain all the

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information required in subsection (a).

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     (3) The prescription must be dispensed in good faith in the normal course of professional

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practice.

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     (4) Within seven (7) days after authorizing an emergency oral prescription, the prescribing

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practitioner shall cause a prescription for the emergency quantity prescribed to be delivered to the

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dispensing apothecary. The prescription shall have written on its face "authorization for emergency

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dispensing" and the date of the oral order. The prescription, upon receipt by the apothecary, shall

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be attached to the oral emergency prescription that had earlier been reduced to writing.

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     (j)(1) The partial filling of a prescription for a controlled substance listed in schedule II is

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permissible, if the apothecary is unable to supply the full quantity called for in a prescription or

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

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the prescription or oral emergency prescription that has been reduced to writing. The remaining

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portion of the prescription may be filled within seventy-two (72) hours of the first partial filling,

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however, if the remaining portion is not, or cannot be, filled within seventy-two (72) hours, the

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apothecary shall notify the prescribing practitioner. No further quantity may be supplied beyond

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seventy-two (72) hours without a new prescription.

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     (2)(i) A prescription for a schedule II controlled substance written for a patient in a long-

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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

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a patient may be classified as having a terminal illness, the pharmacist must contact the practitioner

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prior to partially filling the prescription. Both the pharmacist and the prescribing practitioner have

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a corresponding responsibility to assure that the controlled substance is for a terminally ill patient.

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     (ii) The pharmacist must record on the prescription whether the patient is "terminally ill"

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or an "LTCF patient." A prescription that is partially filled, and does not contain the notation

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"terminally ill" or "LTCF patient", shall be deemed to have been filled in violation of this chapter.

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     (iii) For each partial filling, the dispensing pharmacist shall record on the back of the

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prescription (or on another appropriate record, uniformly maintained, and readily retrievable), the:

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     (A) Date of the partial filling;

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     (B) Quantity dispensed;

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     (C) Remaining quantity authorized to be dispensed; and

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     (D) Identification of the dispensing pharmacist.

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     (iv) The total quantity of schedule II controlled substances dispensed in all partial fillings

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must not exceed the total quantity prescribed.

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     (v) Schedule II prescriptions for patients in a LTCF, or patients with a medical diagnosis

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documenting a terminal illness, are valid for a period not to exceed sixty (60) days from the issue

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date, unless sooner terminated by the discontinuance of medication.

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     (k) Automated, data-processing systems. As an alternative to the prescription record-

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keeping provision of subsection (h) of this section, an automated, data-processing system may be

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employed for the record-keeping system if the following conditions have been met:

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     (1) The system shall have the capability of producing sight-readable documents of all

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original and refilled prescription information. The term "sight readable" means that an authorized

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agent shall be able to examine the record and read the information. During the course of an on-site

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inspection, the record may be read from the CRT, microfiche, microfilm, printout, or other method

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acceptable to the director. In the case of administrative proceedings, records must be provided in a

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paper printout form.

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     (2) The information shall include, but not be limited to, the prescription requirements and

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records of dispensing as indicated in subsection (h) of this section.

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     (3) The individual pharmacist responsible for completeness and accuracy of the entries to

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the system must provide documentation of the fact that prescription information entered into the

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computer is correct. In documenting this information, the pharmacy shall have the option to either:

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     (i) Maintain a bound logbook, or separate file, in which each individual pharmacist

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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

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book or file must be maintained at the pharmacy employing that system for a period of at least two

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(2) years after the date of last dispensing; or

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     (ii) Provide a printout of each day's prescription information. That printout shall be verified,

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dated, and signed by the individual pharmacist verifying that the information indicated is correct.

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The printout must be maintained at least two (2) years from the date of last dispensing.

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     (4) An auxiliary, record-keeping system shall be established for the documentation of

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refills if the automated, data-processing system is inoperative for any reason. The auxiliary system

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shall ensure that all refills are authorized by the original prescription and that the maximum number

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of refills is not exceeded. When this automated, data-processing system is restored to operation,

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the information regarding prescriptions filled and refilled during the inoperative period shall be

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entered into the automated, data-processing system within ninety-six (96) hours.

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     (5) Any pharmacy using an automated, data-processing system must comply with all

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applicable state and federal laws and regulations.

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     (6) A pharmacy shall make arrangements with the supplier of data-processing services or

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materials to ensure that the pharmacy continues to have adequate and complete prescription and

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dispensing records if the relationship with the supplier terminates for any reason. A pharmacy shall

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ensure continuity in the maintenance of records.

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     (7) The automated, data-processing system shall contain adequate safeguards for security

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of the records to maintain the confidentiality and accuracy of the prescription information.

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Safeguards against unauthorized changes in data after the information has been entered and verified

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by the registered pharmacist shall be provided by the system.

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     (l) Prescriptions for controlled substances as found in schedule II will become void unless

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dispensed within ninety (90) days of the original date of the prescription and in no event shall more

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than a thirty-day (30) supply be dispensed at any one time.

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     (1) In prescribing controlled substances in schedule II, practitioners may write up to three

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(3) separate prescriptions, each for up to a one-month supply, each signed and dated on the date

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written. For those prescriptions for the second and/or third month, the practitioner must write the

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earliest date each of those subsequent prescriptions may be filled, with directions to the pharmacist

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to fill no earlier than the date specified on the face of the prescription.

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     (m) The prescriptions in schedules III, IV, and V will become void unless dispensed within

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one hundred eighty (180) days of the original date of the prescription. For purposes of this section,

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a "dosage unit" shall be defined as a single capsule, tablet, or suppository, or not more than one

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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

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units and not more than one hundred (100) dosage units may be dispensed at one time. Provided,

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

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this subsection.

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

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

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one time.

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

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

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prescription.

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

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

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the department of health website.

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

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devices necessary for the administration of controlled substances.

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

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initial prescription for an opioid drug, and upon the second refill and/or upon the third prescription

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specifically discuss with the patient who is eighteen (18) years of age or older, or the patient's parent

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or guardian if the patient is under eighteen (18) years of age, the risks of developing a dependence

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or addiction to the prescription opioid drug and potential of overdose or death; the adverse risks of

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concurrent use of alcohol or other psychoactive medications and the patient's or the minor patient's

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parent or guardian's responsibility to safeguard all medications; and, if the prescriber deems it

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appropriate, discuss such alternative treatments as may be available. For patients in recovery from

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substance dependence, education shall be focused on relapse risk factors. This discussion shall be

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noted in the patient's record.

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

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guidelines for the discussion required pursuant to this subsection.

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

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

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     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

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addiction risks and when appropriate alternative treatments with patients upon the second refill

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and/or upon the third prescription.

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     This act would take effect upon passage.

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