2013 -- S 0647

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LC01825

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STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2013

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A N A C T

RELATING TO FOOD AND DRUGS - UNIFORM CONTROLLED SUBSTANCES ACT

     Introduced By: Senator Donna M. Nesselbush

     Date Introduced: March 06, 2013

     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

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“Uniform Controlled Substances Act” is hereby amended to read as follows:

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     21-28-3.18. Prescriptions. -- (a) An apothecary in good faith may sell and dispense

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controlled substances in schedule II, III, IV and V to any person upon a written valid prescription

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by a practitioner licensed by law to prescribe or administer those substances, dated and signed by

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the person prescribing on the day when issued and bearing the full name and address of the

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patient to whom, or of the owner of the animal for which the substance is dispensed and the full

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name, address and registration number under the federal law of the person prescribing, if he or

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she is required by that law to be registered. If the prescription is for an animal, it shall state the

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species of the animal for which the substance is prescribed.

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     (b) The 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) Prescriptions Hard copy prescriptions for controlled substances in schedule II shall

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be filed separately and shall not be refilled.

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     (2) The director of health may, 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 schedule II and, III and IV.

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

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and a pharmacy may dispense an electronically transmitted prescription in accordance with the

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code of federal regulations, title 21 part 1300, et seq.

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     (e) A prescription for a schedule II narcotic substance to be compounded for the direct

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administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal

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infusion may be transmitted by the practitioner or practitioner's agent to the pharmacy by

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facsimile. The facsimile will serve as the original prescription.

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     (f) A prescription written for a schedule II substance for a resident of a long term care

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facility may be transmitted by the practitioner or the practitioner's agent to the dispensing

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

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     (g) A prescription for a schedule II narcotic substance for a patient residing in a hospice

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certified by Medicare under title XVIII of the Social Security Act, 42 U.S.C. § 1395 et seq., or

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licensed by the state, may be transmitted by the practitioner or practitioner's agent to the

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dispensing pharmacy by facsimile. The practitioner or the practitioner's agent will note on the

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prescription that the patient is a hospice patient. The facsimile serves as the original written

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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 in the case of a written prescription for controlled

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substances in schedule II, except for the written signature of the person prescribing, and the

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apothecary who fills the prescription, shall immediately reduce the oral prescription to writing

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and shall inscribe the information on the written record of the prescription made. This record shall

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be filed and preserved by the proprietor of the pharmacy in which it is filled in accordance with

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the provisions of subsection (c) of this section. In no case may a prescription for a controlled

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substance listed in schedules III, IV, or V be filled or refilled more than six (6) months after the

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date on which the prescription was issued and no prescription shall be authorized to be refilled

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more than five (5) times. Each refilling shall be entered on the face or back of the prescription

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and note the date and amount of controlled substance dispensed, and the initials or identity of the

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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

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pursuant 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) of this section.

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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

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prescribing practitioner shall cause a written prescription for the emergency quantity prescribed to

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be delivered to the dispensing apothecary. The prescription shall have written on its face

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"Authorization for emergency dispensing" and the date of the oral order. The written prescription

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upon receipt by the apothecary shall be attached to the oral emergency prescription which had

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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

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

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

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supplied on the face of the written prescription or oral emergency prescription which has been

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reduced to writing. The remaining portion of the prescription may be filled within seventy-two

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(72) hours of the first partial filling, however, if the remaining portion is not, or cannot be filled

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within seventy-two (72) hours, the apothecary shall notify the prescribing practitioner. No further

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quantity may be supplied beyond 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

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illness, may be filled in partial quantities to include individual dosage units. If there is a question

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

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

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practitioner have a corresponding responsibility to assure that the controlled substance is for a

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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),

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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-

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

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method acceptable to the director. In the case of administrative proceedings, records must be

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provided in a 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

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either:

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     (i) Maintain a bound log book, 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

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prescription information entered into the computer that day has been reviewed and is correct as

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shown. The book or file must be maintained at the pharmacy employing that system for a period

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of at least two (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

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

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correct. 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

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system shall ensure that all refills are authorized by the original prescription, and that the

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maximum number of refills is not exceeded. When this automated data processing system is

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restored to operation, the information regarding prescriptions filled and refilled during the

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inoperative period, shall be entered into the automated data processing system within ninety-six

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(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

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shall 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

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verified by the registered pharmacist shall be provided by the system.

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     (l) Prescriptions for controlled substances as found in schedules II, will become void

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

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shall more than a thirty (30) day 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 prescription 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

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

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

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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)

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

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

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

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at one time.

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     SECTION 2. Chapter 21-28 of the General Laws entitled “Uniform Controlled

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Substances Act” is hereby amended by adding thereto the following section:

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     21-28-3.32. Electronic prescription database. -- (a) The information contained in any

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prescription drug monitoring database maintained by the department of health pursuant to section

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3.18 of this chapter shall be disclosed only:

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     (1) To a practitioner who certifies that the requested information is for the purpose of

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evaluating the need for or providing medical treatment for a current patient to whom the

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practitioner is prescribing or considering prescribing a controlled substance;

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     (2) To a pharmacist who certifies that the requested information is for a current client to

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whom the pharmacist is dispensing or considering dispensing a controlled substance;

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     (3) Pursuant to a valid search warrant based on probable cause to believe a violation of

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federal or state criminal law has occurred and that specified information contained in the database

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would assist in the investigation of the crime;

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     (4) To a patient who requests his or her own prescription information, or the parent or

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legal guardian of a minor child who requests the minor child's prescription information;

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     (5) To a health professional regulatory board that documents, in writing, that the

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requested information is necessary for an investigation related to licensure, renewal or

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disciplinary action involving the applicant, licensee or registrant to whom the requested

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information pertains;

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     (6) To any vendor or contractor with whom the department has contracted to establish or

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maintain the electronic system of the prescription drug monitoring database; or

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     (7) To public or private entities for statistical, research, or educational purposes, after

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removing the patient and prescriber information that could be used to identify individual patients.

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This shall not include entities receiving a waiver from the institutional review board;

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     (b) Information stored in the prescription drug monitoring database shall include only the

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following:

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     (1) Patient’s first and last name, and/or patient identification number; provided, however,

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the patient’s social security number shall not be recorded in whole or in part, patient sex, patient

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date of birth, and patient address;

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     (2) Prescribing physician’s name and drug enforcement administration prescriber

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information number;

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     (3) Prescribing physician’s office or hospital contact information;

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     (4) Prescription name, prescription number, prescription species code, national drug code

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number, prescription dosage, prescription quantity, days' supply, new-refill code, number of

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refills authorized, date the prescription was written, date the prescription was filled, payment

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type; provided, however, no credit card number shall be recorded in whole or in part; and

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     (5) The drug enforcement administration pharmacy number of the pharmacy filling the

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prescription.

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     (c) The department shall disclose any information relating to a patient maintained in the

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prescription drug monitoring database to that patient, at no cost to the patient, within thirty (30)

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business days after the department receives a written request from the patient for the information.

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This information shall include the records maintained by the department pursuant to subsection

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(e). Notwithstanding the above, the department may, at the request of the law enforcement

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agency, withhold for up to sixty (60) days following the conclusion of a law enforcement

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investigation, the disclosure to the patient that information has been obtained pursuant to

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subdivision (a)(3).

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     (d) A patient may request from the dispensing pharmacy correction of any inaccurate

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information contained within the prescription drug monitoring database in accordance with the

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procedure specified by subsection 5-37.3-5(c).

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     (e) The department shall, for the period of time that prescription information is

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maintained, maintain records of the information disclosed through the prescription drug

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monitoring database, including, but not limited to:

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     (1) The identity of each person who requests or receives information from the

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prescription drug monitoring database and the organization, if any, the person represents;

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     (2) The information released to each person or organization and the basis for its release

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under subsection (a); and

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     (3) The dates the information was requested and provided.

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     (f) Prescription information contained within the prescription drug monitoring database

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shall be removed no later than five (5) years from the date the information is entered into the

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database. Records in existence prior to the enactment of this section shall be removed no later

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than ten (10) years from the date the information is entered into the database.

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     (g) The department shall promptly notify any affected individual of an improper

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disclosure of information from the prescription drug monitoring database or a breach in the

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security of the prescription drug monitoring database that poses a significant risk of disclosure of

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patient information to an unauthorized individual.

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     (h) At the time of signing a prescription which is required by the department to be entered

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into the prescription drug monitoring database, the prescribing physician shall inform the patient

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in writing of the existence of the prescription drug monitoring database, the patient’s right to

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access their own prescription information, and the name and contact information of the agency

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operating the program.

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     (i) No person shall access information in the prescription monitoring database except to

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the extent and for the purposes authorized by subsection (a).

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     (j) In any civil action allowing a violation of this chapter, the court may award damages,

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including punitive damages, and reasonable attorneys’ fees and costs to a prevailing plaintiff, and

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injunctive and any other appropriate relief.

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     (k) Any pharmacist who, in his or her professional judgment, refuses to fill a prescription

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based on information contained within the prescription drug monitoring database shall inform the

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prescribing physician within twenty-four (24) hours.

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     SECTION 3. This act shall take effect upon passage.

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LC01825

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N A C T

RELATING TO FOOD AND DRUGS - UNIFORM CONTROLLED SUBSTANCES ACT

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     This act would require the director of the department of health, after appropriate notice

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and hearing, to promulgate rules and regulations for the purpose of adopting a system for

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electronic data transmission of prescriptions for controlled substances in schedule II, III and IV.

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     This act would take effect upon passage.

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LC01825

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