2009 -- H 5479 SUBSTITUTE A

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LC01287/SUB A

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STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2009

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A N A C T

RELATING TO FOOD AND DRUGS -- UNIFORM CONTROLLED SUBSTANCES ACT

     Introduced By: Representatives McNamara, Guthrie, and Ehrhardt

     Date Introduced: February 12, 2009

     Referred To: House Health, Education & Welfare

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. -- (a) An apothecary in good faith may sell and dispense

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controlled substances in schedule II to any person upon a written prescription by a practitioner

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licensed by law to prescribe or administer those substances, dated and signed by the person

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prescribing on the day when issued and bearing the full name and address of the patient to whom,

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or of the owner of the animal for which the substance is dispensed and the full name, address and

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registration number under the federal law of the person prescribing, if he or she is required by that

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law to be registered. If the prescription is for an animal, it shall state the species of the animal for

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which the substance is prescribed.

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      (b) The apothecary filling the prescription shall sign his or her full name and shall write

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the date of filling 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

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

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public officer or employee engaged in the enforcement of this chapter.

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      (d) (1) Prescriptions for controlled substances in schedule II shall be filed separately and

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shall not be refilled. The form of record for prescription slips for controlled substances in

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schedule II shall consist of two (2) parts, an original and a duplicate which are required to be

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presented to the pharmacy by the ultimate user or his or her representative. Pharmacies

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dispensing controlled substances in schedule II are required to deliver to the director of health all

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duplicate copies of the prescriptions on or before the fifth day of the month following the date of

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dispensing. The prescription slip shall be a form provided by the director of health.

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      (2) The director of health may, after appropriate notice and hearing pursuant to section

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42-35-3, 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 needles and

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syringes. This system, when operational, shall negate the necessity to utilize the two-part

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prescription described in subdivision (1) of this subsection.

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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. section 1395 et seq.,

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or 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

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and 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

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

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the 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, except those listed in

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subsection (n) of this section, will become void unless dispensed within ninety (90) days of the

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original date of the prescription, and in no event shall more than a thirty (30) day supply be

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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. and cannot be

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written for more than one hundred (100) dosage units and not more than one hundred (100)

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dosage units may be dispensed at one time, unless a duly licensed practitioner shall, by

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prescription, increase the dosage units up to a maximum of three hundred (300) dosage units for

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schedules IV and V to provide a patient with up to a three (3) month supply. 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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      (m) Prescriptions written for amphetamine sulfate, dextro amphetamine sulfate,

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methamphetamine hydrochloride, methylphenidate and amphetamine mixtures, may be written

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for up to a sixty (60) day supply. In no event shall more than a sixty (60) day supply be dispensed

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at one time.

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     SECTION 2. This act shall take effect on September 1, 2009.

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LC01287/SUB A

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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 allow practitioners to write up to three (3) separate prescriptions in

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Schedule II for up to a one-month supply and allow for a ninety (90) day supply for prescriptions

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in Schedules IV and V.

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     This act would take effect on September 1, 2009.

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LC01287/SUB A

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