Louisiana Regulations
Department of Health/Board of Pharmacy
Vol. 47, No. 2, Louisiana Register 2021-02-20 pp.247-250
PUBLICATION DATE: 02/20/2021
ACTION DATE: 02/20/2021
EFFECTIVE DATE: 02/20/2021
PUBLICATION TYPE: Register
DOCUMENT NUMBER: 2102-001
REGISTER SOURCE: Vol. 47, No. 1, Louisiana Register 2021-01-20 pp.84-86
PUBLICATION DATE: 01/20/2021
ACTION DATE: 01/20/2021
EFFECTIVE DATE: 01/20/2021
PUBLICATION TYPE: Register
DOCUMENT NUMBER: 2101-064
REGISTER SOURCE: Vol. 46, No. 09, Louisiana Register 2020-09-20 p.1332
PUBLICATION DATE: 09/20/2020
ACTION DATE: 09/20/2020
PUBLICATION TYPE: Register
DOCUMENT NUMBER: 2009-018
REGISTER SOURCE: Vol. 46, No. 07, Louisiana Register 2020-07-20 pp.1043-1044 pp.1043-1044
PUBLICATION DATE: 07/20/2020
ACTION DATE: 07/20/2020
COMMENT DEADLINE: 08/26/2020
PUBLICATION TYPE: Register
DOCUMENT NUMBER: 2008-026
REGISTER SOURCE: Vol. 46, No. 04, Louisiana Register 2020-04-20 pp.616-620
PUBLICATION DATE: 04/20/2020
ACTION DATE: 04/20/2020
COMMENT DEADLINE: 05/29/2020
PUBLICATION TYPE: Register
DOCUMENT NUMBER: 2004-070

RULE

Department of Health

Board of Pharmacy

Prescription Monitoring Program (LAC 46:LIII.Chapter 29)

In accordance with the provisions of the Administrative Procedure Act (R.S. 49:950 et seq.) and the Pharmacy Practice Act (R.S. 37:1161 et seq.), the Louisiana Board of Pharmacy has amended several sections of its chapter of rules for the state prescription monitoring program (PMP). The changes for § 2901 remove several terms and their definitions which are duplicated from the PMP law. The amendment of the definition of the term " drugs of concern " adds two drugs, promethazine when present in oral liquid formulation as well as gabapentin. The effect of adding these two drugs to that list requires pharmacies dispensing these drugs to include those dispensing transactions in their automated reports to the state PMP. The changes for § § 2903, 2907, and 2909 are to repeal these redundant sections which are duplicated from the PMP law. The change for § 2905 is to repeal that section as redundant from the pharmacy law which contains the same authority to hire staff for board operations. The addition of § 2914 relative to record retention will implement the provisions of Act 189 of the 2016 Legislature. With respect to the changes in § 2917 relative to authorized access privileges to PMP information, Paragraphs 5 and 6 implement the provisions of Act 241 of the 2017 Legislature; Paragraph 7 implements the provisions of Act 232 of the 2018 Legislature; and Paragraph 8 implements the provisions of Act 80 of the 2019 Legislature. With respect to the changes in § 2919 relative to PMP access registration procedures, Paragraph 1 implements the provisions of Act 76 of the 2017 Legislature. Moreover, while the legislation requires automatic registration for prescribers, the board has Louisiana Register Vol. 47, No. 2 February 20, 2021 248 extended the automatic registration procedures to include dispensers. With respect to the changes in § 2921 relative to methods of access to PMP information, the additions to Subsections B, E, F, G, H, K, L, and M were authorized by Act 241 of the 2017 Legislature; the addition to Subsection I was authorized by Act 232 of the 2018 Legislature; the addition to Subsection N was authorized by Act 80 of the 2019 Legislature; and the new Subsection O was authorized by Act 352 of the 2012 Legislature. This Rule is hereby adopted on the day of promulgation.

Malcolm J Broussard

Executive Director

2102#001

Title 46

PROFESSIONAL AND OCCUPATIONAL

STANDARDS

Part LIII. Pharmacists

Chapter 29. Prescription Monitoring Program

§ 2901. Definitions

A. As used in this Chapter, the following terms shall have the meaning ascribed to them unless the context clearly indicates otherwise. Delegate - a person authorized by a prescriber or dispenser who is also an authorized user as described in Section 2917 of this Chapter to access and retrieve program data for the purpose of assisting the prescriber or dispenser, and for whose actions the authorizing prescriber or dispenser retains accountability. Drugs of Concern - drugs other than controlled substances as defined by rule whose use requires tracking for public health purposes or which demonstrate a potential for abuse, including any material, compound, mixture, or preparation containing any quantity of the following substances, including its salts, esters, ethers, isomers, and salts of isomers [whenever the existence of such salts, esters, ethers, isomers, and salts of isomers is possible within the specific chemical designation]:

a. butalbital when in combination with at least 325 milligrams of acetaminophen per dosage unit.

b. naloxone.

c. promethazine when present in oral liquid formulation.

d. gabapentin.

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1011.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1345 (July 2007), amended LR 36:755 (April 2010), effective September 1, 2010, amended by LR 39:314 (February 2013), amended LR 40:1096 (June 2014), amended LR 41:684 (April 2015), amended by the Department of Health, Board of Pharmacy, LR 45:42 (January 2019), amended LR 47:248 (February 2021).

§ 2903. Authority for Program Operation

Repealed

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1004.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1345 (July 2007), repealed by the Department of Health, Board of Pharmacy, LR 47:248 (February 2021).

§ 2905. Authority to Engage Staff

Repealed

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1179.F(6).

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1346 (July 2007), repealed by the Department of Health, Board of Pharmacy, LR 47:248 (February 2021).

§ 2907. Authority to Contract with Vendors

Repealed

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1012.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1346 (July 2007), repealed by the Department of Health, Board of Pharmacy, LR 47:248 (February 2021).

§ 2909. Advisory Council Repealed

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1005.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1346 (July 2007), amended LR 39:314 (February 2013), amended LR 40:1096 (June 2014), repealed by the Department of Health, Board of Pharmacy, LR 47:248 (February 2021).

§ 2911. Reporting of Prescription Monitoring

Information

A. Each dispenser shall submit to the board information regarding each prescription dispensed for a controlled substance or drug monitored by the program.

B. - C. ...

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1011.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1346 (July 2007), amended LR 39:314 (February 2013), amended LR 41:684 (April 2015), amended by the Department of Health, Board of Pharmacy, LR 47:248 (February 2021).

§ 2914. Record Retention of Prescription Transaction Information

A. The board shall retain a minimum of five years of prescription transaction information for review by persons authorized to access such information.

B. The board shall archive all prescription transaction information not available for direct or indirect access.

C. The board shall respond to requests for archived prescription transaction information.

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1006(G).

HISTORICAL NOTE: Promulgated by the Department of Health, Board of Pharmacy, LR 47:248 (February 2021).

§ 2917. Authorized Direct Access Users of Prescription

Monitoring Information

A. The following persons may access prescription monitoring information in the same or similar manner, and for the same or similar purposes, as those persons are authorized to access similar protected health information under federal and state law and regulation:

1. - 4. ...

5. a medical examiner or coroner, or a delegate thereof, for the purpose of investigating an individual ' s death;

6. a licensed substance abuse addiction counselor providing services as part of a state-licensed substance abuse or addiction treatment program;

7. an epidemiologist with the Louisiana Department of Health for the purpose of assisting the board in analyzing prescription monitoring information in order to conduct public health evaluations to support public policy and education pursuant to an agreement with the board;

8. prescription monitoring programs, electronic health information systems, and pharmacy information systems located in other states, territories, federal districts, and federal jurisdictions, through a secure interstate data exchange system or health information exchange system approved by the board, but only in compliance with the provisions of R.S. 40:1007(G).

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1011.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1347 (July 2007), amended LR 39:315 (February 2013), amended LR 40:1095 (June 2014), amended by the Department of Health, Board of Pharmacy, LR 47:248 (February 2021).

§ 2919. Registration Procedures for Authorized Direct Access Users

A. Authorized users of prescription monitoring information, and their delegates, shall comply with the following requirements to register with the board, in order to receive the appropriate credentials to access prescription monitoring information.

1.a. A prescriber or dispenser, excluding veterinarians, shall be automatically registered as a participant in the program and shall authenticate their identity through an online process in order to activate their account.

b. An agency applicant shall file an application with the program, using the form supplied by the program for that purpose.

2. The board shall verify the prescriber or dispenser applicant is in possession of a valid license to prescribe or dispense controlled substances, or in the case of an agency application, the board shall verify agency representation.

3. Upon verification of all requirements, the board shall issue the appropriate credential necessary to access prescription monitoring information.

4. Upon receipt of information that an authorized user no longer possesses authority to prescribe or dispense controlled substances, the program shall terminate the user ' s credentials to access prescription monitoring information. If or when the user ' s authority to prescribe or dispense controlled substances is reinstated, the program may reinstate the user ' s credentials to access prescription monitoring information.

5. Prescribers and dispensers approved for access shall be responsible for the enabling and disabling of access privileges for their delegates, as well as the supervision of their activities.

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1011.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1347 (July 2007), amended LR 40:1095 (June 2014), amended by the Department of Health, Board of Pharmacy, LR 47:249 (February 2021).

§ 2921. Methods of Access to Prescription Monitoring

Information and Audit Trail Information

A. ...

B. Designated representatives from agencies charged with administrative oversight of prescribers and dispensers of controlled substances may solicit prescription monitoring information and audit trail information from the program concerning specific investigations of prescribers or dispensers. The program may require such users to certify the legitimacy of their inquiry prior to furnishing the requested information.

C. - D. ...

E. Upon receipt of one of the following methods of application by local, state, out-of-state, or federal law enforcement or prosecutorial officials, including judiciallysupervised specialty courts within the criminal justice system that are authorized by the Louisiana Supreme Court, the program may provide prescription monitoring information and audit trail information:

1. - 3.c. ...

F. A medical examiner or coroner, or a delegate thereof, once properly registered, may solicit prescription monitoring information from the program for the purpose of investigating an individual ' s death. The program may require such users to certify the legitimacy of their inquiry prior to furnishing the requested information.

G. A licensed substance abuse addiction counselor, once properly registered, may solicit prescription monitoring information from the program for the purpose of providing services as part of a state-licensed substance abuse or addiction treatment program. The program may require such users to certify the legitimacy of their inquiry prior to furnishing the requested information.

H. Upon receipt of an administrative request from a probation or parole officer, the program may provide prescription monitoring information. The probation or parole officer must certify the request for prescription monitoring information is for the purpose of monitoring an offender ' s compliance with participation in a drug diversion program or with other conditions of probation or parole related to monitored drugs.

I. An epidemiologist with the Louisiana Department of

Health, once properly registered, may solicit prescription monitoring information from the program for the purpose of assisting the board in analyzing prescription monitoring information in order to conduct public health evaluations to support public policy and education pursuant to an agreement with the board.

J. Individuals may solicit their own prescription monitoring information and audit trail information from the program. To prevent inappropriate access to such information, the requestor shall personally appear at the program office and produce positive photo identification at the time of their request. The program shall furnish a single copy of the report responding to such request at no charge to the individual.

K. A parent, legal guardian, or legal healthcare agent may solicit prescription monitoring information and audit trail information from the program for the purpose of reviewing the history of monitored drugs dispensed to a child or an individual for whom the agent makes healthcare decisions, to the extent consistent with federal and state confidentiality laws and regulations. To prevent inappropriate access to such information, the requestor shall personally appear at the program office and produce positive photo identification at the time of their request. The program shall furnish a single copy of the report responding to such request at no charge to the individual.

L. An executor of a will or a court-appointed succession representative of an estate may solicit prescription monitoring information and audit trail information from the program for the purpose of reviewing the history of monitored drugs dispensed to a deceased individual. To prevent inappropriate access to such information, the requestor shall personally appear at the program office and produce positive photo identification at the time of their request. The program shall furnish a single copy of the report responding to such request at no charge to the individual.

M. Program personnel, once properly registered, may solicit prescription monitoring information from the program ' s database for the purpose of maintaining the database, analysis and reporting of data, compliance reviews, and responding to legitimate inquiries from authorized users or other individuals.

N. Prescription monitoring programs, electronic health information systems, and pharmacy information systems located in other states, territories, federal districts, and federal jurisdictions may access prescription monitoring information from the program through a secure interstate data exchange system or health information exchange approved by the board, but only in compliance with the provisions of R.S. 40:1007(G).

O. The board may provide prescription monitoring information to authorized users of the prescription monitoring program via a state health information exchange or other third-party conduit that has been approved by the board.

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1011.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1347 (July 2007), amended LR 39:315 (February 2013), amended LR 40:1095 (June 2014), amended by the Department of Health, Board of Pharmacy, LR 47:249 (February 2021).