58-37-7.5. Controlled substance database -- Pharmacy reporting requirements --
Access -- Penalties.
(1) As used in this section:
(a) "Board" means the Utah State Board of Pharmacy created in Section 58-17b-201.
(b) "Database" means the controlled substance database created in this section.
(c) "Database manager" means the person responsible for operating the database, or the
person's designee.
(d) "Division" means the Division of Occupational and Professional Licensing created in
Section 58-1-103.
(e) "Health care facility" is as defined in Section 26-21-2.
(f) "Mental health therapist" is as defined in Section 58-60-102.
(g) "Pharmacy" or "pharmaceutical facility" is as defined in Section 58-17b-102.
(h) "Prospective patient" means a person who:
(i) is seeking medical advice, medical treatment, or medical services from a practitioner;
and
(ii) the practitioner described in Subsection (1)(h)(i) is considering accepting as a patient.
(i) "Substance abuse treatment program" is as defined in Section 62A-2-101.
(2) (a) There is created within the division a controlled substance database.
(b) The division shall administer and direct the functioning of the database in accordance
with this section. The division may under state procurement laws contract with another state
agency or private entity to establish, operate, or maintain the database. The division in
collaboration with the board shall determine whether to operate the database within the division
or contract with another entity to operate the database, based on an analysis of costs and benefits.
(c) The purpose of the database is to contain data as described in this section regarding
every prescription for a controlled substance dispensed in the state to any person other than an
inpatient in a licensed health care facility.
(d) Data required by this section shall be submitted in compliance with this section to the
manager of the database by the pharmacist in charge of the drug outlet where the controlled
substance is dispensed.
(3) The board shall advise the division regarding:
(a) establishing, maintaining, and operating the database;
(b) access to the database and how access is obtained; and
(c) control of information contained in the database.
(4) The pharmacist in charge shall, regarding each controlled substance dispensed by a
pharmacist under the pharmacist's supervision other than those dispensed for an inpatient at a
health care facility, submit to the manager of the database the following information, by a
procedure and in a format established by the division:
(a) name of the prescribing practitioner;
(b) date of the prescription;
(c) date the prescription was filled;
(d) name of the person for whom the prescription was written;
(e) positive identification of the person receiving the prescription, including the type of
identification and any identifying numbers on the identification;
(f) name of the controlled substance;
(g) quantity of controlled substance prescribed;
(h) strength of controlled substance;
(i) quantity of controlled substance dispensed;
(j) dosage quantity and frequency as prescribed;
(k) name of drug outlet dispensing the controlled substance;
(l) name of pharmacist dispensing the controlled substance; and
(m) other relevant information as required by division rule.
(5) The division shall maintain the database in an electronic file or by other means
established by the division to facilitate use of the database for identification of:
(a) prescribing practices and patterns of prescribing and dispensing controlled
substances;
(b) practitioners prescribing controlled substances in an unprofessional or unlawful
manner;
(c) individuals receiving prescriptions for controlled substances from licensed
practitioners, and who subsequently obtain dispensed controlled substances from a drug outlet in
quantities or with a frequency inconsistent with generally recognized standards of dosage for that
controlled substance; and
(d) individuals presenting forged or otherwise false or altered prescriptions for controlled
substances to a pharmacy.
(6) (a) The division shall by rule establish the electronic format in which the information
required under this section shall be submitted to the administrator of the database.
(b) The division shall ensure the database system records and maintains for reference:
(i) identification of each person who requests or receives information from the database;
(ii) the information provided to each person; and
(iii) the date and time the information is requested or provided.
(7) The division shall make rules to:
(a) effectively enforce the limitations on access to the database as described in
Subsection (8); and
(b) establish standards and procedures to ensure accurate identification of individuals
requesting information or receiving information without request from the database.
(8) The manager of the database shall make information in the database available only to
the following persons, in accordance with the requirements of this section and division rules:
(a) personnel of the division specifically assigned to conduct investigations related to
controlled substances laws under the jurisdiction of the division;
(b) authorized division personnel engaged in analysis of controlled substance
prescription information as a part of the assigned duties and responsibilities of their employment;
(c) employees of the Department of Health whom the director of the Department of
Health assigns to conduct scientific studies regarding the use or abuse of controlled substances,
provided that the identity of the individuals and pharmacies in the database are confidential and
are not disclosed in any manner to any individual who is not directly involved in the scientific
studies;
(d) a licensed practitioner having authority to prescribe controlled substances, to the
extent the information:
(i) (A) relates specifically to a current or prospective patient of the practitioner; and
(B) is sought by the practitioner for the purpose of:
(I) prescribing or considering prescribing any controlled substance to the current or
prospective patient;
(II) diagnosing the current or prospective patient;
(III) providing medical treatment or medical advice to the current or prospective patient;
or
(IV) determining whether the current or prospective patient:
(Aa) is attempting to fraudulently obtain a controlled substance from the practitioner; or
(Bb) has fraudulently obtained, or attempted to fraudulently obtain, a controlled
substance from the practitioner;
(ii) (A) relates specifically to a former patient of the practitioner; and
(B) is sought by the practitioner for the purpose of determining whether the former
patient has fraudulently obtained, or has attempted to fraudulently obtain, a controlled substance
from the practitioner;
(iii) relates specifically to an individual who has access to the practitioner's Drug
Enforcement Administration number, and the practitioner suspects that the individual may have
used the practitioner's Drug Enforcement Administration identification number to fraudulently
acquire or prescribe a controlled substance;
(iv) relates to the practitioner's own prescribing practices, except when specifically
prohibited by the division by administrative rule;
(v) relates to the use of the controlled substance database by an employee of the
practitioner, described in Subsection (8)(e); or
(vi) relates to any use of the practitioner's Drug Enforcement Administration
identification number to obtain, attempt to obtain, prescribe, or attempt to prescribe, a controlled
substance;
(e) in accordance with Subsection (17), an employee of a practitioner described in
Subsection (8)(d), for a purpose described in Subsection (8)(d)(i) or (ii), if:
(i) the employee is designated by the practitioner as a person authorized to access the
information on behalf of the practitioner;
(ii) the practitioner provides written notice to the division of the identity of the employee;
and
(iii) the division:
(A) grants the employee access to the database; and
(B) provides the employee with a password that is unique to that employee to access the
database in order to permit the division to comply with the requirements of Subsection (6)(b)
with respect to the employee;
(f) a licensed pharmacist having authority to dispense controlled substances to the extent
the information is sought for the purpose of:
(i) dispensing or considering dispensing any controlled substance; or
(ii) determining whether a person:
(A) is attempting to fraudulently obtain a controlled substance from the pharmacist; or
(B) has fraudulently obtained, or attempted to fraudulently obtain, a controlled substance
from the pharmacist;
(g) federal, state, and local law enforcement authorities, and state and local prosecutors,
engaged as a specified duty of their employment in enforcing laws:
(i) regulating controlled substances; or
(ii) investigating insurance fraud, Medicaid fraud, or Medicare fraud;
(h) a mental health therapist, if:
(i) the information relates to a patient who is:
(A) enrolled in a licensed substance abuse treatment program; and
(B) receiving treatment from, or under the direction of, the mental health therapist as part
of the patient's participation in the licensed substance abuse treatment program described in
Subsection (8)(h)(i)(A);
(ii) the information is sought for the purpose of determining whether the patient is using
a controlled substance while the patient is enrolled in the licensed substance abuse treatment
program described in Subsection (8)(h)(i)(A); and
(iii) the licensed substance abuse treatment program described in Subsection (8)(h)(i)(A)
is associated with a practitioner who:
(A) is a physician, a physician assistant, an advance practice registered nurse, or a
pharmacist; and
(B) is available to consult with the mental health therapist regarding the information
obtained by the mental health therapist, under this Subsection (8)(h), from the database; and
(i) an individual who is the recipient of a controlled substance prescription entered into
the database, upon providing evidence satisfactory to the database manager that the individual
requesting the information is in fact the person about whom the data entry was made.
(9) Any person who knowingly and intentionally releases any information in the database
in violation of the limitations under Subsection (8) is guilty of a third degree felony.
(10) (a) Any person who obtains or attempts to obtain information from the database by
misrepresentation or fraud is guilty of a third degree felony.
(b) Any person who obtains or attempts to obtain information from the database for a
purpose other than a purpose authorized by this section or by rule is guilty of a third degree
felony.
(11) (a) Except as provided in Subsection (11)(d), a person may not knowingly and
intentionally use, release, publish, or otherwise make available to any other person or entity any
information obtained from the database for any purpose other than those specified in Subsection
(8). Each separate violation of this Subsection (11) is a third degree felony and is also subject to
a civil penalty not to exceed $5,000.
(b) The procedure for determining a civil violation of this Subsection (11) shall be in
accordance with Section 58-1-108, regarding adjudicative proceedings within the division.
(c) Civil penalties assessed under this Subsection (11) shall be deposited in the General
Fund as a dedicated credit to be used by the division under Subsection 58-37-7.7(1).
(d) Nothing in this Subsection (11) prohibits a person who obtains information from the
database under Subsection (8)(d) or (e) from:
(i) including the information in the person's medical chart or file for access by a person
authorized to review the medical chart or file; or
(ii) providing the information to a person in accordance with the requirements of the
Health Insurance Portability and Accountability Act of 1996.
(12) (a) The failure of a pharmacist in charge to submit information to the database as
required under this section after the division has submitted a specific written request for the
information or when the division determines the individual has a demonstrable pattern of failing
to submit the information as required is grounds for the division to take the following actions in
accordance with Section 58-1-401:
(i) refuse to issue a license to the individual;
(ii) refuse to renew the individual's license;
(iii) revoke, suspend, restrict, or place on probation the license;
(iv) issue a public or private reprimand to the individual;
(v) issue a cease and desist order; and
(vi) impose a civil penalty of not more than $1,000 for each dispensed prescription
regarding which the required information is not submitted.
(b) Civil penalties assessed under Subsection (12)(a)(vi) shall be deposited in the
General Fund as a dedicated credit to be used by the division under Subsection 58-37-7.7(1).
(c) The procedure for determining a civil violation of this Subsection (12) shall be in
accordance with Section 58-1-108, regarding adjudicative proceedings within the division.
(13) An individual who has submitted information to the database in accordance with
this section may not be held civilly liable for having submitted the information.
(14) All department and the division costs necessary to establish and operate the database
shall be funded by appropriations from:
(a) the Commerce Service Fund; and
(b) the General Fund.
(15) All costs associated with recording and submitting data as required in this section
shall be assumed by the submitting pharmacy.
(16) (a) Except as provided in Subsection (16)(b), data provided to, maintained in, or
accessed from the database that may be identified to, or with, a particular person is not subject to
discovery, subpoena, or similar compulsory process in any civil, judicial, administrative, or
legislative proceeding, nor shall any individual or organization with lawful access to the data be
compelled to testify with regard to the data.
(b) The restrictions in Subsection (16)(a) do not apply to:
(i) a criminal proceeding; or
(ii) a civil, judicial, or administrative action brought to enforce the provisions of this
section, Section 58-37-7.7, or Section 58-37-7.8.
(17) (a) A practitioner described in Subsection (8)(d) may designate up to three
employees to access information from the database under Subsection (8)(e).
(b) The division shall make rules, in accordance with Title 63G, Chapter 3, Utah
Administrative Rulemaking Act, to establish background check procedures to determine whether
an employee designated under Subsection (8)(e)(i) should be granted access to the database.
(c) The division shall grant an employee designated under Subsection (8)(e)(i) access to
the database, unless the division determines, based on a background check, that the employee
poses a security risk to the information contained in the database.
(d) The division may impose a fee, in accordance with Section 63J-1-504, on a
practitioner who designates an employee under Subsection (8)(e)(i), to pay for the costs incurred
by the division to conduct the background check and make the determination described in
Subsection (17)(c).
(18) (a) A person who is granted access to the database based on the fact that the person
is a licensed practitioner or a mental health therapist shall be denied access to the database when
the person is no longer licensed.
(b) A person who is granted access to the database based on the fact that the person is a
designated employee of a licensed practitioner shall be denied access to the database when the
practitioner is no longer licensed.
(19) A person who is a relative of a deceased individual is not entitled to access
information from the database relating to the deceased individual based on the fact or claim that
the person is:
(a) related to the deceased individual; or
(b) subrogated to the rights of the deceased individual.
Amended by Chapter 41, 2009 General Session
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Last revised: Thursday, May 28, 2009