2017 -- H 5469 SUBSTITUTE A

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LC001228/SUB A

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2017

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A N   A C T

RELATING TO FOOD AND DRUGS - UNIFORM CONTROLLED SUBSTANCES ACT

     

     Introduced By: Representative Joseph M. McNamara

     Date Introduced: February 15, 2017

     Referred To: House Health, Education & Welfare

     (Attorney General)

It is enacted by the General Assembly as follows:

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     SECTION 1. Sections 21-28-1.2 and 21-28-3.32 of the General Laws in Chapter 21-28

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entitled "Uniform Controlled Substances Act" are hereby amended to read as follows:

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     21-28-1.02. Definitions.

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     Unless the context otherwise requires, the words and phrases as defined in this section are

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used in this chapter in the sense given them in the following definitions:

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     (1) "Administer" refers to the direct application of controlled substances to the body of a

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patient or research subject by:

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     (i) A practitioner, or, in his or her presence by his or her authorized agent; or

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     (ii) The patient or research subject at the direction and in the presence of the practitioner

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whether the application is by injection, inhalation, ingestion, or any other means.

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     (2) "Agent" means an authorized person who acts on behalf of or at the direction of a

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manufacturer, wholesaler, distributor, or dispenser; except that these terms do not include a

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common or contract carrier or warehouse operator, when acting in the usual and lawful course of

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the carrier's or warehouse operator's business.

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     (3) "Apothecary" means a registered pharmacist as defined by the laws of this state and,

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where the context requires, the owner of a licensed pharmacy or other place of business where

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controlled substances are compounded or dispensed by a registered pharmacist; and includes

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registered assistant pharmacists as defined by existing law, but nothing in this chapter shall be

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construed as conferring on a person who is not registered as a pharmacist any authority, right, or

 

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privilege that is not granted to him or her by the pharmacy laws of the state.

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     (4) "Automated data processing system" means a system utilizing computer software and

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hardware for the purposes of record keeping.

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     (5) "Certified law enforcement prescription drug diversion investigator" means a certified

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law enforcement officer assigned by their qualified law enforcement agency to investigate

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prescription drug diversion.

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     (5)(6) "Computer" means programmable electronic device capable of multi-functions,

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including, but not limited to, storage, retrieval, and processing of information.

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     (6)(7) "Control" means to add a drug or other substance or immediate precursor to a

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schedule under this chapter, whether by transfer from another schedule or otherwise.

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     (7)(8) "Controlled substance" means a drug, substance, immediate precursor, or synthetic

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drug in schedules I -- V of this chapter. The term shall not include distilled spirits, wine, or malt

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beverages, as those terms are defined or used in chapter 1 of title 3, nor tobacco.

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     (8)(9) "Counterfeit substance" means a controlled substance which, or the container or

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labeling of which, without authorization bears the trademark, trade name, or other identifying

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mark, imprint, number, or device, or any likeness of them, of a manufacturer, distributor, or

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dispenser, other than the person or persons who in fact manufactured, distributed, or dispensed

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the substance and which thereby falsely purports or is represented to be the product of, or to have

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been distributed by, the other manufacturer, distributor, or dispenser, or which substance is

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falsely purported to be or represented to be one of the controlled substances by a manufacturer,

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distributor, or dispenser.

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     (9)(10) "CRT" means cathode ray tube used to impose visual information on a screen.

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     (10)(11) "Deliver" or "delivery" means the actual, constructive, or attempted transfer of a

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controlled substance or imitation controlled substance, whether or not there exists an agency

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relationship.

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     (11)(12) "Department" means the department of health of this state.

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     (12)(13) "Depressant or stimulant drug" means:

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     (i) A drug which contains any quantity of:

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     (A) Barbituric acid or derivatives, compounds, mixtures, or preparations of barbituric

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acid; and

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     (B) "Barbiturate" or "barbiturates" includes all hypnotic and/or somnifacient drugs,

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whether or not derivatives of barbituric acid, except that this definition shall not include bromides

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and narcotics.

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     (ii) A drug which contains any quantity of:

 

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     (A) Amphetamine or any of its optical isomers;

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     (B) Any salt of amphetamine and/or desoxyephedrine or any salt of an optical isomer of

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amphetamine and/or desoxyephedrine, or any compound, mixture, or preparation of them.

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     (iii) A drug which contains any quantity of coca leaves. "Coca leaves" includes cocaine,

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or any compound, manufacture, salt, derivative, mixture, or preparation of coca leaves, except

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derivatives of coca leaves, which do not contain cocaine, ecgonine, or substance from which

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cocaine or ecgonine may be synthesized or made.

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     (iv) Any other drug or substance which contains any quantity of a substance which the

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attorney general of the United States, or the director of health, after investigation, has found to

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have, or by regulation designates as having, a potential for abuse because of its depressant or

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stimulant effect on the central nervous system.

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     (13)(14) "Director" means the director of health.

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     (14)(15) "Dispense" means to deliver, distribute, leave with, give away, or dispose of a

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controlled substance to the ultimate user or human research subject by or pursuant to the lawful

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order of a practitioner, including the packaging, labeling, or compounding necessary to prepare

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the substance for that delivery.

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     (15)(16) "Dispenser" is a practitioner who delivers a controlled substance to the ultimate

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user or human research subject.

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     (16)(17) "Distribute" means to deliver (other than by administering or dispensing) a

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controlled substance or an imitation controlled substance and includes actual constructive, or

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attempted transfer. "Distributor" means a person who so delivers a controlled substance or an

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imitation controlled substance.

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     (17)(18) "Downtime" means that period of time when a computer is not operable.

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     (18)(19) "Drug addicted person" means a person who exhibits a maladaptive pattern of

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behavior resulting from drug use, including one or more of the following: impaired control over

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drug use; compulsive use; and/or continued use despite harm, and craving.

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     (19)(20) "Drug Enforcement Administration" means the Drug Enforcement

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Administration United States Department of Justice or its successor.

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     (20)(21) "Federal law" means the Comprehensive Drug Abuse Prevention and Control

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Act of 1970, (84 stat. 1236) (see generally 21 U.S.C. § 801 et seq.), and all regulations pertaining

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to that federal act.

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     (21)(22) "Hardware" means the fixed component parts of a computer.

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     (22)(23) "Hospital" means an institution as defined in chapter 17 of title 23.

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     (23)(24) "Imitation controlled substance" means a substance that is not a controlled

 

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substance, which by dosage unit, appearance (including color, shape, size, and markings), or by

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representations made, would lead a reasonable person to believe that the substance is a controlled

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substance and, which imitation controlled substances contain substances which if ingested, could

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be injurious to the health of a person. In those cases when the appearance of the dosage unit is not

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reasonably sufficient to establish that the substance is an "imitation controlled substance" (for

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example in the case of powder or liquid), the court or authority concerned should consider, in

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addition to all other logically relevant factors, the following factors as related to "representations

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made" in determining whether the substance is an "imitation controlled substance":

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     (i) Statement made by an owner, possessor, transferor, recipient, or by anyone else in

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control of the substance concerning the nature of the substance, or its use or effect.

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     (ii) Statements made by the owner, possessor, or transferor, to the recipient that the

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substance may be resold for substantial profit.

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     (iii) Whether the substance is packaged in a manner reasonably similar to packaging of

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illicit controlled substances.

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     (iv) Whether the distribution or attempted distribution included an exchange of or

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demand for money or other property as consideration, and whether the amount of the

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consideration was substantially greater than the reasonable value of the non-controlled substance.

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     (24)(25) "Immediate precursor" means a substance:

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     (i) Which the director of health has found to be and by regulation designated as being the

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principal compound used, or produced primarily for use, in the manufacture of a controlled

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substance;

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     (ii) Which is an immediate chemical intermediary used or likely to be used in the

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manufacture of those controlled substances; and

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     (iii) The control of which is necessary to prevent, curtail, or limit the manufacture of that

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controlled substance.

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     (25)(26) "Laboratory" means a laboratory approved by the department of health as proper

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to be entrusted with controlled substances and the use of controlled substances for scientific and

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medical purposes and for the purposes of instruction.

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     (26)(27) "Marijuana" means all parts of the plant cannabis sativa L., whether growing or

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not; the seeds of the plant; the resin extracted from any part of the plant; and every compound,

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manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin, but shall not

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include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the

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seeds of the plant, any other compound, manufacture, salt, derivative, mixture, or preparation of

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mature stalks, (except the resin extracted from it), fiber, oil or cake, or the sterilized seed from the

 

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plant which is incapable of germination.

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     (27)(28) "Manufacture" means the production, preparation, propagation, cultivation,

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compounding, or processing of a drug or other substance, including an imitation controlled

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substance, either directly or indirectly or by extraction from substances of natural origin, or

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independently by means of chemical synthesis or by a combination of extraction and chemical

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synthesis and includes any packaging or repackaging of the substance or labeling or relabeling of

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its container in conformity with the general laws of this state except by a practitioner as an

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incident to his or her administration or dispensing of the drug or substance in the course of his or

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her professional practice.

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     (28)(29) "Manufacturer" means a person who manufactures but does not include an

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apothecary who compounds controlled substances to be sold or dispensed on prescriptions.

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     (29)(30) "Narcotic drug" means any of the following, whether produced directly or

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indirectly by extraction from substances of vegetable origin, or independently by means of

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chemical synthesis or by a combination of extraction and chemical synthesis:

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     (i) Opium and opiates.

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     (ii) A compound, manufacture, salt, derivative, or preparation of opium or opiates.

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     (iii) A substance (and any compound, manufacture, salt, derivative, or preparation of it)

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which is chemically identical with any of the substances referred to in paragraphs (i) and (ii) of

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this subdivision.

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     (iv) Any other substance which the attorney general of the United States, or his or her

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successor, or the director of health, after investigation, has found to have, and by regulation

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designates as having, a potential for abuse similar to opium and opiates.

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     (30)(31) "Official written order" means an order written on a form provided for that

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purpose by the Drug Enforcement Administration under any laws of the United States making

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provision for an official form, if order forms are authorized and required by federal law, and if no

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order form is provided then on an official form provided for that purpose by the director of health.

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     (31)(32) "Opiate" means any substance having an addiction-forming or addiction-

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sustaining liability similar to morphine or being capable of conversion into a drug having

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addiction-forming or addiction-sustaining liability.

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     (32)(33) "Opium poppy" means the plant of the species papaver somniferum L., except

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the seeds of the plant.

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     (33)(34) "Ounce" means an avoirdupois ounce as applied to solids and semi-solids, and a

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fluid ounce as applied to liquids.

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     (34)(35) "Person" means any corporation, association, partnership, or one or more

 

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individuals.

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     (35)(36) "Physical dependence" means a state of adaptation that is manifested by a drug

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class specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose

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reduction, decreasing blood level of the drug, and/or administration of an antagonist.

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     (36)(37) "Poppy straw" means all parts, except the seeds, of the opium poppy, after

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mowing.

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     (37)(38) "Practitioner" means:

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     (i) A physician, osteopath, dentist, chiropodist, veterinarian, scientific investigator, or

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other person licensed, registered or permitted to distribute, dispense, conduct research with

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respect to or to administer a controlled substance in the course of professional practice or research

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in this state.

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     (ii) A pharmacy, hospital, or other institution licensed, registered or permitted to

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distribute, dispense, conduct research with respect to, or to administer a controlled substance in

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the course of professional practice or research in this state.

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     (38)(39) "Printout" means a hard copy produced by computer that is readable without the

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aid of any special device.

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     (39)(40) "Production" includes the manufacture, planting, cultivation, growing, or

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harvesting of a controlled substance.

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     (41) "Qualified law enforcement agency" means the U.S. Food and Drug Administration,

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Drug Enforcement Administration, Federal Bureau of Investigation, Office of Inspector General

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of the U.S. Department of Health & Human Services, or the Medicaid Fraud and Patient Abuse

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Unit in the Office of the Attorney General.

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      (40)(42) "Researcher" means a person authorized by the director of health to conduct a

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laboratory as defined in this chapter.

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     (41)(43) "Sell" includes sale, barter, gift, transfer, or delivery in any manner to another,

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or to offer or agree to do the same.

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     (42)(44) "Software" means programs, procedures and storage of required information

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data.

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     (43)(45) "Synthetic drugs" means any synthetic cannabinoids or piperazines or any

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synthetic cathinones as provided for in schedule I.

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     (44)(46) "Ultimate user" means a person who lawfully possesses a controlled substance

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for his or her own use or for the use of a member of his or her household, or for administering to

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an animal owned by him or her or by a member of his or her household.

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     (45)(47) "Wholesaler" means a person who sells, vends, or distributes at wholesale, or as

 

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a jobber, broker agent, or distributor, or for resale in any manner in this state any controlled

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substance.

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     21-28-3.32. Electronic prescription database.

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     (a) The information contained in any prescription-drug-monitoring database maintained

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by the department of health pursuant to § 21-28-3.18 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 to, 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) To an authorized designee of the practitioner and/or pharmacist to consult the

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prescription-drug-monitoring database on the practitioner's and/or pharmacist's behalf, provided

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that:

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     (i) The designee so authorized is employed by the same professional practice or

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pharmacy;

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     (ii) The practitioner or pharmacist takes reasonable steps to ensure that such designee is

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sufficiently competent in the use of the database;

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     (iii) The practitioner or pharmacist remains responsible for ensuring that access to the

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database by the designee is limited to authorized purposes as provided for in subsections (a)(1)

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and (a)(2);

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     (iv) The practitioner or pharmacist remains responsible for ensuring access to the

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database by the designee occurs in a manner that protects the confidentiality of information

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obtained from the database and remains responsible for any breach of confidentiality;

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     (v) The practitioner or pharmacist terminates the designee's access to the database at the

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termination of the designee's employment; and

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     (vi) The ultimate decision as to whether or not to prescribe or dispense a controlled

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substance remains with the practitioner or pharmacist and is reasonably informed by the relevant,

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controlled-substance-history information obtained from the database.

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     (4) 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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     (5) By a department employee to a certified law enforcement prescription drug diversion

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investigator of a qualified law enforcement agency for use in an investigation.

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     (i) A certified law enforcement prescription drug diversion investigator shall provide to

 

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the department the following information in order to receive information from the database:

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     (A) The identification credentials assigned by the department; and

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     (B) The case number of the investigation.

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     (ii) A qualified law enforcement agency shall submit to the department quarterly reports

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of the data received by all certified law enforcement prescription drug diversion investigators in

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the qualified law enforcement agency, including, without limitation:

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     (A) Written verification that the inquiries were part of a lawful prescription drug

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diversion investigation as provided to the department through the case number of the

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investigation; and

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     (B) A brief description of each case closed during that quarter for which the qualified law

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enforcement agency used information from the database; and

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     (C) The disposition of the investigation.

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     (iii) The department shall:

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     (A) Create a verification form for use under subsection (5)(ii)(A) of this section; and

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     (B) Make the verification form available annually to the qualified law enforcement

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agency.

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     (iv) The verification form under subsection (5)(ii)(A) of this section shall be submitted to

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the department within thirty (30) days of receipt of the form by the qualified law enforcement

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agency.

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     (v) Failure to submit a verification form under subsection (5)(iv) of this section shall

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result in the immediate suspension of disclosure of information from the database by the

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department to the qualified law enforcement agency and its certified law enforcement prescription

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drug diversion investigators until a determination is made by the department to allow continued

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disclosure.

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     (vi) The director shall, beginning January 1, 2018 and annually thereafter, review

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disclosure of information pursuant to subsection (a)(5) of this section. Thereafter, the disclosure

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of information pursuant to subsection (a)(5) of this section shall automatically renew for

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successive one year terms unless the director provides written notice to:

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     (A) The qualified law enforcement agencies; and

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     (B) The speaker of the house and the president of the senate, at least sixty (60) days in

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advance of the then existing term's end, that the department wishes to discontinue providing

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information from the database pursuant to this subsection, the director may reinstitute disclosure

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by providing written notice to the same parties.

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     (5)(6) 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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     (6)(7) 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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     (7)(8) To any vendor or contractor with whom the department has contracted, pursuant to

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state purchasing law and regulations in the contracting of vendors, to establish or maintain the

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electronic system of the prescription-drug-monitoring database;

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     (8)(9) 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; or

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     (9)(10) To any vendor, agent, contractor, or designee who operates an electronic health

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record or clinical-management system for the purpose of sharing data with practitioners,

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pharmacists, or licensed health care facilities or designees.

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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 practitioner's name and Drug Enforcement Administration prescriber-

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information number;

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     (3) Prescribing practitioner'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 that has been confirmed by the department, the disclosure to the patient that

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information has been obtained pursuant to subdivision subsections (a)(4) and (a)(5) of this

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section.

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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 § 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 that is required by the department to be entered

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into the prescription-drug-monitoring database, the prescribing practitioner shall inform the

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patient in writing of the existence of the prescription-drug-monitoring database; the patient's right

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to access his or her own prescription information; and the name and contact information of the

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agency 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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     (l) All practitioners shall, as a condition of the initial registration or renewal of the

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practitioner's authority to prescribe controlled substances, register with the prescription-drug-

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monitoring database maintained by the department of health.

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     (m) The prescription-monitoring program shall be reviewed prior to starting any opioid.

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A prescribing practitioner, or designee as authorized by subsection (a)(3) of this section, shall

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review the prescription-monitoring program prior to refilling or initiating opioid therapy with an

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intrathecal pump. For patients the prescribing practitioner is maintaining on continuous opioid

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therapy for pain for three (3) months or longer, the prescribing practitioner shall review

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information from the prescription-monitoring program at least every three (3) months.

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Documentation of that review shall be noted in the patient's medical record.

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     (n) The department shall improve the usefulness and value of the prescription-drug-

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monitoring database program by increasing its analytical functionality, timeliness, and scope,

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such as by:

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     (1) Utilizing data from additional data sources as permissible under state and federal

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statutes;

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     (2) Analyzing information submitted to the prescription-drug-monitoring database to

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ensure that prescription data collected from dispensing pharmacists is readily accessible for a

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given patient; to identify unusual or aberrant patterns of prescribing, dispensing, or receiving

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controlled substances; and to generate an automatic alert when such patterns arise to automate

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standard reports and to provide ad hoc reports on a real-time basis on this data as well as other

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data feeds. These reports shall comply with the patient confidentiality requirements of federal and

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state law;

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     (3) Developing regulations to ensure that prescription-drug-monitoring analyses are

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updated and disseminated regularly to appropriate officials and that summary reports are provided

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to the general assembly on or before February 1st of each year. Given the intent to decrease the

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number of Rhode Island citizens affected by opioid use, the department shall provide an interim

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report on the status of the directives included herein and any progress made as of October 1,

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2016. In the development of said regulations, the department may include any of the following

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analytical functions, within the boundaries of patient confidentiality rights under state and federal

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law:

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     (i) Consolidate raw prescription data collected from dispensing pharmacists into a single

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view of all prescriptions filled for a given patient;

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     (ii) Identify unusual or aberrant patterns of prescribing controlled substances, by relevant

 

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prescriber attributes, and generate an automatic alert when such patterns arise;

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     (iii) Identify unusual or aberrant patterns of receiving prescriptions for controlled

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substances, by relevant patient attributes, and generate an automatic alert when such patterns

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arise;

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     (iv) Identify unusual or aberrant patterns of dispensing controlled substances, by relevant

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dispenser attributes, and generate an automatic alert when such patterns arise;

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     (v) Identify and visually display linkages among prescribers, patients, and dispensers that

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can be used to detect any collusive behaviors; and

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     (vi) The department shall apply for federal funding in support of the goals and objectives

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contained in this subsection.

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     SECTION 2. This act shall take effect on January 1, 2018 and the amendments hereto

12

shall expire on January 1, 2023.

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LC001228/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

***

1

     This act would allow information contained in the prescription drug monitoring database

2

to be disclosed to a certified law enforcement drug diversion investigator of a qualified law

3

enforcement agency who has completed a certification course approved by director of the

4

department of health and certified by the police officers commission on standards and training.

5

     This act would take effect on January 1, 2018 and the amendments hereto would expire

6

on January 1, 2023.

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LC001228/SUB A

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LC001228/SUB A - Page 13 of 13