AN ACT RELATING TO FOOD AND DRUGS - UNIFORM CONTROLLED SUBSTANCES ACT
Requires health care professionals upon issuance of initial opioid prescription to discuss with patient/parent/guardian risk of developing dependence/addiction/potential of overdose/death/adverse risks of concurrent use of alcohol/other psychoactive drugs
2017-03-02: Introduced, referred to Senate Health and Human Services
2017-03-03: Scheduled for hearing and/or consideration (03/09/2017)
2017-03-09: Committee recommended measure be held for further study
2017-05-19: Scheduled for consideration (05/23/2017)
2017-05-23: Committee recommends passage of Sub A
2017-05-24: Placed on Senate Calendar (05/30/2017)
2017-05-30: Senate passed Sub A
2017-05-31: Referred to House H.E.W.
2017-06-24: Scheduled for consideration (06/27/2017)
2017-06-27: Committee recommends passage of Sub A in concurrence
2017-06-28: Placed on the House Consent Calendar (06/28/2017)
2017-06-28: House passed Sub A in concurrence
2017-07-18: Transmitted to Governor
2017-07-19: Signed by Governor
Changes since original draft
2017 – S 0493
S TATE OF RHODE IS L AND
IN GENERAL ASSEMBLY
JANUARY SESSION, A.D. 2017
A N A C T
RELATING TO FOOD AND DRUGS - UNIFORM CONTROLLED SUBSTANCES ACT
Introduced By: Senators Archambault, Satchell, Sheehan, Nesselbush, and Sosnowski
Date Introduced: March 02, 2017
Referred To: Senate Health & Human Services
It is enacted by the GeneralAssembly as follows:
SECTION 1. Section 21-28-3.18 of the GeneralLaws in Chapter 21-28 entitled "Uniform Controlled Substances Act"is hereby amended to read as follows:
(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 shallstate the species of the animalfor 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 shallnot 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, IV, and V.
(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 federalregulations, 21 C.F.R., pt. 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 originalprescription.
(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 originalprescription.
(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 oralprescription 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 shallbe filed and preserved by the proprietor of the pharmacy in which it is filled in accordance with the provisions of subsection (c). 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
(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, 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),
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(A) Date of the partialfilling;
(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 totalquantity prescribed.
(v) Schedule II prescriptions for patients in a LTCF, or patients with a medicaldiagnosis 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 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
LC001865 - Page 4of 7 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 federallaws 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 shallcontain 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 shallbe provided by the system.
(l) Prescriptions for controlled substances as found in schedule II willbecome 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 oralliquid.
(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.
(n) A pharmacy shall transmit prescription information to the prescription-monitoring
LC001865 - Page 5of 7 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) A health care professional authorized to issue prescriptions shall, prior to issuing a prescription for a schedule II controlled dangerous substance, or any opioid drug, which is a schedule II controlled dangerous substance, discuss with a patient who is eighteen (18) years of age or older or with the patient's parent or guardian if the patient is under eighteen (18) years of age, the risks of developing a physical or psychological dependence on the controlled dangerous substance or prescription opioid drug and, if the prescriber deems it appropriate, prescribe such alternative treatments as may be available. A prescriber who engages in a discussion required pursuant to this subsection shall:
(1) Obtain from the person with whom the prescriber had the discussion a written acknowledgement that the discussion took place. The written acknowledgement shall be included in the patient's medical record and shall be on a form developed by the director of the department of health in consultation with such medical professional societies and associations as may be identified by the director. The director of the department of health shalldevelop and make available to prescribers guidelines for the discussion required pursuant to this subsection. 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 shalltake effect on September 1, 2017.
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BY THE LEGISLATIVE COUNCIL
A N A C T
RELATING TO FOOD AND DRUGS - UNIFORM CONTROLLED SUBSTANCES ACT
This act would require that a health care professional authorized to issue prescriptions, prior to issuing a prescription for a schedule II controlled dangerous substance, or any opioid drug, which is a schedule II controlled dangerous substance, discuss with a patient who is eighteen (18) years of age or older, or with the patient's parent or guardian if the patient is under eighteen (18) years of age, the risks of developing a physicalor psychologicaldependence on the controlled dangerous substance or prescription opioid drug.
This act would take effect on September 1, 2017. ======== LC001865 ========
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