SB 200

Session
Regular Session 2018
Title
Prescription Drug Monitoring Program, revise definitions, create a review committee, Secs. 20-2-211, 20-2-212, 20-2-214, 20-2-215 am'd.
Description

This bill would amend laws relating to the Prescription Drug Monitoring Program to revise definitions and to create a review committee that may approve the release or publication of de-identified aggregate statewide and regional health information for statistical, research, or educational purposes

Relating to the Prescription Drug Monitoring Program (PDMP); to amend Sections 20-2-211, 20-2-212, 20-2-214, and 20-2-215, Code of Alabama 1975; to revise definitions; and to create a review committee that may approve the release or publication of de-identified aggregate statewide and regional health information for statistical, research, or educational purposes.

Subjects
Prescription Drugs
View Original PDF: SB 200 - Introduced - PDF

This bill would amend laws relating to the Prescription Drug Monitoring Program to revise definitions and to create a review committee that may approve the release or publication of de-identified aggregate statewide and regional health information for statistical, research, or educational purposes

Relating to the Prescription Drug Monitoring Program (PDMP); to amend Sections 20-2-211, 20-2-212, 20-2-214, and 20-2-215, Code of Alabama 1975; to revise definitions; and to create a review committee that may approve the release or publication of de-identified aggregate statewide and regional health information for statistical, research, or educational purposes.

Section 1

Sections 20-2-211, 20-2-212, 20-2-214, and 20-2-215, Code of Alabama 1975, are amended to read as follows:

§20-2-211.

For the purposes of this article, the following terms shall have the respective meanings ascribed by this section:

(1) CERTIFYING BOARDS. Those boards designated in subdivision (3) of Section 20-2-2.

(2) CONTROLLED SUBSTANCE. Any drug or medication defined as a controlled substance within the meaning of subdivision (4) of Section 20-2-2.

(3) DEPARTMENT. The Alabama Department of Public Health.

(4) LICENSING BOARD OR COMMISSION. The board, commission, or other entity that is authorized to issue a professional license to a pharmacist or an authorized practitioner.

(5) PHARMACIST. Any person, as defined in subdivision (17) of Section 34-23-1, licensed by the Alabama State Board of Pharmacy or otherwise permitted by Alabama or federal law to practice the profession of pharmacy within this State.

(5)(6) PHARMACY. A retail establishment, as defined in subdivision (18) of Section 34-23-1, licensed by the Alabama State Board of Pharmacy.

(6)(7) PRACTITIONER or AUTHORIZED PRACTITIONER. A medical, dental, podiatric, or optometric, or veterinary medical practitioner licensed, registered, or otherwise authorized by Alabama or federal law to practice in this state and authorized to prescribe, dispense, or furnish controlled substances under the Alabama Uniform Controlled Substances Act within this state.

(7)(8) STATE HEALTH OFFICER. The executive officer of the Alabama Department of Public Health as designated in Section 22-2-8.

§20-2-212.

(a) The department is hereby authorized to establish, create, and maintain a controlled substances prescription database program. In order to carry out its responsibilities under this article, the department is hereby granted the following powers and authority:

(1) To adopt regulations, in accordance with the Alabama Administrative Procedure Act, governing the establishment and operation of a controlled substances prescription database program.

(2) To receive and to expend for the purposes stated in this article funds in the form of grants, donations, federal matching funds, interagency transfers, and appropriated funds designated for the development, implementation, operation, and maintenance of the controlled substances prescription database. The funds received pursuant to this subdivision shall be deposited in a new fund that is hereby established as a separate special revolving trust fund in the State Treasury to be known as the Alabama State Controlled Substance Database Trust Fund. No monies shall be withdrawn or expended from the fund for any purpose unless the monies have been appropriated by the Legislature and allocated pursuant to this article. Any monies appropriated shall be budgeted and allocated pursuant to the Budget Management Act in accordance with Article 4 (commencing with Section 41-4-80) of Chapter 4 of Title 41, and only in the amounts provided by the Legislature in the general appropriations act or other appropriations act.

(3) To enter into one or more contracts with the State Board of Pharmacy for the performance of designated operational functions for the controlled substances prescription database, including, but not limited to, the receipt, collection, input, and transmission of controlled substances prescription data and such other operational functions as the department may elect.

(4) To create a Controlled Substances Prescription Database Advisory Committee and an Information Release Review Committee.

(b)(1) The mission of the advisory committee Controlled Substance Prescription Database Advisory Committee is to consult with and advise the State Health Officer on matters related to the establishment, maintenance, and operation of the database, access to the database information, how access is to be regulated, and security of information contained in the database.

(2) The advisory committee shall consist of one representative designated by each of the following: organizations:

a. One representative designated by the The Medical Association of the State of Alabama.

b. One representative designated by the The Alabama Dental Association.

c. One representative designated by the The Alabama Pharmacy Association.

d. One representative designated by the The Alabama Veterinary Medicine Association.

e. The State Health Officer, or his or her designee director of the controlled substances prescription database program in the department.

f. One representative designated by the The Alabama Hospital Association.

g. The Executive Director of the Alabama State Board of Pharmacy, or his or her designee.

h. The Executive Director of the Board of Medical Examiners, or his or her designee.

i. One representative designated by the The Alabama Optometric Association.

j. One representative from each of the certifying boards established under the Alabama Uniform Controlled Substances Act.

k. One representative designated by the The Alabama Medicaid Agency.

l. One representative designated by the The Alabama Podiatry Association.

m. One representative designated by the The Alabama Department of Mental Health.

n. The Attorney General, or his or her designee.

(5)(3) If a member of the Controlled Substances Prescription Database Advisory Committee is unable to attend a meeting, the organization which appointed that member may designate one of its employees or agents as a proxy. A proxy may participate in all deliberations of the committee and vote on all questions considered by the advisory committee. Designations of a proxy must be in writing, must specify by name the individual who will serve as proxy, and must specify the date of the meeting at which the proxy is authorized to serve. There must be a separate written proxy designation for each meeting at which a proxy will serve.

(6)(4) The membership of the committee shall be The appointing authorities of the committee shall coordinate their appointments to assure the committee membership is inclusive and reflect reflects the racial, gender, geographic, urban/rural, and economic diversity of the state. The committee shall annually report to the Legislature by the second legislative day of each regular session the extent to which the committee has complied with the diversity provisions provided for in this subdivision.

(7)(5) Members of the Controlled Substances Prescription Database Advisory Committee may participate in a meeting by means of conference telephone, video conference, or similar communications equipment by means of which all persons participating in the meeting may hear each other at the same time. Participation by such means shall constitute presence in person at a meeting for all purposes, including the establishment of a quorum. Telephone or video conference or similar communications equipment shall also allow members of the public the opportunity to simultaneously listen to or observe the meetings.

(c)(1) The mission of the Information Release Review Committee is to review statistical, research, or educational requests for information, departmental research requests, or department requests regarding publication of information from the controlled substances database.

(2) The review committee shall consist of one licensed practitioner appointed by the State Board of Medical Examiners, one licensed practitioner appointed by the State Board of Dental Examiners, one licensed pharmacist appointed by the State Board of Pharmacy, one representative experienced in medical informatics or clinical research appointed by the State Health Officer, and one representative experienced in medical informatics or clinical research appointed by the Attorney General.

(3) Members of the Information Release Review Committee may receive electronically from the department, statistical, research, or educational requests for information, departmental research requests, or department requests regarding publication of information, and may respond electronically in order to provide their approval or disapproval of those requests.

§20-2-214.

(a) The following persons or entities shall be permitted access to the information in the controlled substances database, subject to the limitations indicated below:

(1) Authorized representatives of the certifying boards; provided, however, that access shall be limited to information concerning the licensees of the certifying board, however, authorized representatives from the Board of Medical Examiners may access the database to inquire about certified registered nurse practitioners (CRNPs), or certified nurse midwives (CNMs) that hold a Qualified Alabama Controlled Substances Registration Certificate (QACSC).

(2) A licensed practitioner approved by the department who has authority to prescribe, dispense, or administer controlled substances. The licensed practitioner's access shall be limited to information concerning himself or herself, registrants who possess a Qualified Alabama Controlled Substances Registration Certificate over whom the practitioner exercises physician supervision or with whom they have a joint practice agreement, a certified registered nurse practitioner and a certified nurse midwife with a Qualified Alabama Controlled Substances Registration Certificate over whom the practitioner exercises professional oversight and direction pursuant to an approved collaborative practice agreement, a current patient of the practitioner, and individuals seeking treatment from the practitioner. Practitioners shall have no requirement or obligation, under this article, to access or check the information in the controlled substances database prior to prescribing, dispensing, or administering medications or as part of their professional practice. However, the applicable licensing boards, in their discretion, may impose such a requirement or obligation by regulations.

(3) A licensed physician approved by the department who has authority to prescribe, dispense, or administer controlled substances may designate up to two employees who may access the database on the physician's behalf.

(4) A licensed certified registered nurse practitioner or a licensed certified nurse midwife approved by the department who is authorized to prescribe, administer, or dispense pursuant to a Qualified Alabama Controlled Substances Registration Certificate; provided, however, that such access shall be limited to information concerning a current or prospective patient of the certified registered nurse practitioner or certified nurse midwife.

(5) A licensed assistant to physician approved by the department who is authorized to prescribe, administer, or dispense pursuant to a Qualified Alabama Controlled Substances Registration Certificate; provided, however, that such access shall be limited to information concerning a current patient of the assistant to the physician or an individual seeking treatment from the assistant to physician.

(6) A licensed pharmacist approved by the department, provided, however, that such access is limited to information related to the patient or prescribing practitioner designated on a controlled substance prescription that a pharmacists pharmacist has been asked to fill. Pharmacists shall have no requirement or obligation to access or check the information in the controlled substances database prior to dispensing or administering medications or as part of their professional practices.

(7) State and local law enforcement authorities as authorized under Section 20-2-91, and federal law enforcement authorities authorized to access prescription information upon application to the department accompanied by a declaration that probable cause exists for the use of the requested information.

(8) Employees of the department and consultants engaged by the department for operational and review purposes to operate the controlled substances database; provided, however, that access shall be limited to operating and administering the database, conducting departmental research when approved by the review committee, and implementing a research request authorized under subsection (b).

(9) The prescription drug monitoring program of any of the other states or territories of the United States, if recognized by the Alliance for Prescription Drug Monitoring Programs under procedures developed, certified, or approved by the United States Department of Justice or the Integrated Justice Information Systems Institute or successor entity subject to or consistent with limitations for access prescribed by this chapter for the Alabama Prescription Drug Monitoring Program.

(10) Authorized representatives of the Alabama Medicaid Agency; provided, however, that access shall be limited to inquiries concerning possible misuse or abuse of controlled substances by Medicaid recipients.

(b) Subject to the approval of the review committee, the department may release or publish de-identified aggregate statewide and regional information for statistical, research, or educational purposes.

(1) Prior to being released or published, all information that identifies, or could reasonably be used to identify, a patient, a prescriber, a dispenser, or any other person who is the subject of the information, shall be removed, and at a minimum, such de-identification of the information shall comply with 45 C.F.R. §164.514(b)(2), as amended.

(2) Release of information shall be made pursuant to a written data use agreement between the requesting individual or entity and the department.

§20-2-215.

(a) The controlled substances database and all information contained therein and any records maintained by the department or by any entity contracting with the department which is submitted to, maintained, or stored as a part of the controlled substances prescription database, and any reproduction or copy of that information is hereby declared privileged and confidential, is not a public record, and is not subject to subpoena or discovery in civil proceedings. This information is considered clinical in nature, subject to medical interpretation, and may only be used for any of the following:

(1) investigatory Investigatory or evidentiary purposes related to violations of state or federal law.

(2) and regulatory Regulatory activities of licensing or regulatory boards of practitioners authorized to prescribe or dispense controlled substances.

(3) Informing pharmacists and practitioners in prescribing or dispensing controlled substances.

(4) Bona fide statistical, research, or educational purposes when information is properly de-identified as provided in this chapter.

(b) Nothing in this section shall apply to records not originating from the controlled substances database that are created or maintained in the regular course of business of a pharmacy, medical, dental, optometric, or veterinary practitioner, or other entity covered by this article and all information, documents, or records otherwise available from original sources are not to be construed as immune from discovery or use in any civil proceedings merely because such information contained in those records was reported to the controlled substances prescription database in accordance with the provisions of this article."

Section 2

This act shall become effective on the first day of the third month following its passage and approval by the Governor, or its otherwise becoming law.

No articles found.
Action Date Chamber Action
February 27, 2018SAssigned Act No. 2018-146.
February 27, 2018SEnrolled
February 27, 2018HSignature Requested
February 27, 2018SPassed Second House
February 22, 2018HMotion to Read a Third Time and Pass adopted Roll Call 433
February 22, 2018HThird Reading Passed
February 8, 2018HRead for the second time and placed on the calendar
February 1, 2018HRead for the first time and referred to the House of Representatives committee on Health
February 1, 2018SMotion to Read a Third Time and Pass adopted Roll Call 245
February 1, 2018SThird Reading Passed
January 25, 2018SRead for the second time and placed on the calendar
January 23, 2018SRead for the first time and referred to the Senate committee on Health and Human Services
2018-02-22
Chamber: House
Result: Passed
2018-02-01
Chamber: Senate
Result: Passed