2018 -- H 7461

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LC004438

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2018

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A N   A C T

RELATING TO FOOD AND DRUGS -- UNIFORM CONTROLLED SUBSTANCES ACT

     

     Introduced By: Representatives Walsh, Filippi, Williams, Hull, and Lombardi

     Date Introduced: February 07, 2018

     Referred To: House Judiciary

     It is enacted by the General Assembly as follows:

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     SECTION 1. Section 21-28-3.32 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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     21-28-3.32. Electronic prescription database. [Effective January 1, 2018.].

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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; provided, however,

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that no disclosure of information relative to any person holding a medical marijuana card

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pursuant to chapter 28.6 of title 21, shall be made to any state or federal law enforcement agency

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or investigator without a valid search warrant.

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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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     (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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     (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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     (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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     (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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     (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 subsections (a)(4) and (a)(5) of this 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 upon passage.

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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 any law enforcement agency, including any certified law

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enforcement prescription drug diversion investigator or any other state or federal qualified law

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enforcement agency, to obtain a valid search warrant before accessing the electronic prescription

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data base for information about medical marijuana patients and cardholders.

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     This act would take effect upon passage.

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