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REGS : 10.47.07 Prescription Drug Monitoring Program (ALCOHOL AND DRUG ABUSE ADMINISTRATION)

PROPOSAL
Maryland Register
Issue Date:  January 9, 2015
Volume 42 • Issue 1 • Pages 63—64
 
Title 10
DEPARTMENT OF HEALTH AND MENTAL HYGIENE
Subtitle 47 ALCOHOL AND DRUG ABUSE ADMINISTRATION
10.47.07 Prescription Drug Monitoring Program
Authority: Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland
Notice of Proposed Action
[15-016-P]
The Secretary of Health and Mental Hygiene proposes to amend Regulation .03, adopt new Regulation .04, amend and recodify existing Regulations .04 and .08 to be Regulations .05 and .09, respectively, and recodify existing Regulations .05—.07 to be Regulations .06—.08 under COMAR 10.47.07 Prescription Drug Monitoring Program.
Statement of Purpose
The purpose of this action is to establish authority for the review of prescription drug monitoring data for indications of possible misuse or abuse of a monitored prescription drug and allow reporting of possible misuse or abuse to prescribers and dispensers registered with the program; require a Technical Advisory Committee to review prescription drug monitoring data prior to being released to the prescriber or dispenser of a monitored prescription drug; remove language not required in statute; specify when data can be shared for the purpose of individual investigations; and include additional fatality review teams can receive redisclosed data.
Comparison to Federal Standards
There is no corresponding federal standard to this proposed action.
Estimate of Economic Impact
The proposed action has no economic impact.
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small businesses.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
Opportunity for Public Comment
Comments may be sent to Michele Phinney, Director, Office of Regulation and Policy Coordination, Department of Health and Mental Hygiene, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to dhmh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through February 9, 2015. A public hearing has not been scheduled.
A. For each monitored prescription drug dispensed, the dispenser shall report the following prescription monitoring data to the Department:
(1) (text unchanged)
(2) Identifying information for the patient, including:
(a)—(c) (text unchanged)
(d) [Gender] Sex;
(e) Telephone number;
[(e)] (f) (text unchanged)
[(f)] (g) A patient identification number, which may include:
(i) (text unchanged)
[(ii) A residential telephone number;]
[(iii)] (ii)[(viii)] (vii) (text unchanged)
(3)—(4) (text unchanged)
B.—G. (text unchanged)
The Program may review prescription monitoring data for indications of possible misuse or abuse of a monitored prescription drug.
A. (text unchanged)
B. Disclosure of Prescription Monitoring Data to a Prescriber, a Dispenser, or an Authorized Licensed Health Care Practitioner.
(1)—(4) (text unchanged)
(5) If the Program’s review of prescription monitoring data under Regulation .04 of this chapter indicates possible misuse or abuse of a monitored prescription drug, the Program may report the possible misuse or abuse to the prescriber or dispenser of the monitored prescription drug in a manner and form determined by the Program.
C.—G. (text unchanged)
H. Upon request, the Program may disclose prescription monitoring data to the Office of the Chief Medical Examiner, the Maryland Medical Assistance Program, the Office of the Inspector General of the Department, the Office of Health Care Quality, and the Division of Drug Control provided that the request:
(1)—(3) (text unchanged)
(4) [Includes an attestation that the request was] Is approved by the Secretary.
I. (text unchanged)
J. Technical Advisory Committee Review.
(1) Before the Program discloses prescription monitoring data under [COMAR 10.47.07.04C—E, G and H] §§C—E, G, and H of this regulation, the Technical Advisory Committee shall:
(a)—(b) (text unchanged)
(2) Notwithstanding §J(1) of this regulation, the Program may disclose prescription monitoring data to the authorized administrator of another state’s prescription drug monitoring program for disclosure to a prescriber, a dispenser, a licensed health care practitioner authorized by a prescriber or a dispenser, or a patient in a manner consistent with §§B(1)—(4) and F of this regulation.
(3) Before the Program discloses prescription monitoring data to a prescriber or dispenser under §B(5) of this regulation, the Technical Advisory Committee shall:
(a) Review any prescription monitoring data upon which the Program’s report to a prescriber or dispenser is based; and
(b) Within 10 business days of submission of the data to the Technical Advisory Committee for review, submit to the Program:
(i) Clinical guidance regarding indications of possible misuse or abuse; and
(ii) Interpretation of the prescription monitoring data that indicates possible misuse or abuse.
[(2)] (4) If the Technical Advisory Committee has not provided clinical guidance and interpretation in accordance with §J(1) or (3) of this regulation within 10 business days of submission of the request or data to the Technical Advisory Committee for review, the Department may:
(a) Proceed as if the Technical Advisory Committee does not have clinical guidance or interpretation to provide regarding the request or data at issue; and
(b) Respond to the original request for disclosure under §§C—E, G, and H of this regulation, or report potential misuse or abuse of a monitored prescription drug to a prescriber or dispenser under §B(5) of this regulation.
[(3)] (5)[(4)] (6) (text unchanged)
A.—C. (text unchanged)
D. Redisclosure of Prescription Monitoring Data.
(1) Prescription monitoring data received under Health-General Article, §21-2A-06, Annotated Code of Maryland, and Regulation .04 of this chapter may be redisclosed only:
(a) (text unchanged)
(b) For entities to which the Program has disclosed data in accordance with Regulation .05C—E and H of this chapter, to another agency cooperating with or providing support for the original data recipient’s existing, bona fide, individual investigation;
[(b)] (c) (text unchanged)
[(c) To a medical review committee established under Health-Occupations Article, §1-401(b)(3), Annotated Code of Maryland, for the purpose of reviewing information on fatal drug and alcohol overdoses and preventing overdose deaths.]
(d) To a local drug overdose fatality review team established under Health-General Article, Title 5, Subtitle 9, Annotated Code of Maryland.
(2) (text unchanged)
E.—F. (text unchanged)
JOSHUA M. SHARFSTEIN, M.D.
Secretary of Health and Mental Hygiene
 
 
 

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