Chapter 200

.2016 -- H 8326 Enacted 06/28/2016

A N   A C T

RELATING TO FOOD AND DRUGS - UNIFORM CONTROLLED SUBSTANCES ACT

Introduced By: Representatives Fellela, Messier, Ucci, and Lima

Date Introduced: June 10, 2016

It is enacted by the General Assembly as follows:

SECTION 1. Section 21-28-3.32 of the General Laws in Chapter 21-28 entitled "Uniform

Controlled Substances Act" is hereby amended to read as follows:

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

prescription-drug-monitoring database maintained by the department of health pursuant to § 21-

28-3.18 of this chapter shall be disclosed only:

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

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

practitioner is prescribing or considering prescribing a controlled substance;

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

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

(3) To an authorized designee of the practitioner and/or pharmacist to consult the

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

that:

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

pharmacy;

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

sufficiently competent in the use of the database;

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

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

and (a)(2) of this section;

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

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

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

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

termination of the designee's employment; and

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

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

controlled-substance-history information obtained from the database.

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

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

would assist in the investigation of the crime;

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

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

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

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

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

information pertains;

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

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

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

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

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

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

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

the following:

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

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

date of birth, and patient address;

(2) Prescribing practitioner's name and dDrug eEnforcement aAdministration prescriber

information number;

(3) Prescribing practitioner's office or hospital contact information;

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

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

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

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

(5) The dDrug eEnforcement aAdministration pharmacy number of the pharmacy filling

the prescription.

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

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

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

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

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

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

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

subdivision (a)(3)(4).

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

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

procedure specified by § 5-37.3-5(c).

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

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

monitoring database, including, but not limited to:

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

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

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

under subsection (a); and

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

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

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

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

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

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

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

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

patient information to an unauthorized individual.

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

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

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

right to access their his or her own prescription information,; and the name and contact

information of the agency operating the program.

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

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

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

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

injunctive and any other appropriate relief.

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

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

prescribing physician within twenty-four (24) hours.

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

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

monitoring database maintained by the department of health.

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

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

such as by:

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

statutes;

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

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

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

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

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

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

state law;

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

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

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

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

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

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

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

law:

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

view of all prescriptions filled for a given patient;

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

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

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

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

arise;

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

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

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

can be used to detect any collusive behaviors; and

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

contained in this subsection.

SECTION 2. This act shall take effect upon passage.

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LC006142

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