Md. Code Regs. 10.47.08.09

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.47.08.09 - Record Maintenance and Reporting

A. The Department shall maintain the following records:

(1) Information on private or public entities authorized by the Department, including:

(a) Names of entities and directors;

(b) Addresses of entities;

(c) Serial numbers of the initial authorizations;

(d) Initial authorization dates; and

(e) Dates of authorization renewals; and

(2) Information on private or public entities whose authorization has been suspended or revoked, including:

(a) Names of entities and directors;

(b) Addresses of entities;

(c) Serial numbers of the initial authorizations;

(d) Effective dates of suspensions or revocations;

(e) Reasons for suspensions or revocations; and

(f) If applicable, dates on which the approvals for authorization were reinstated

B. If providing naloxone, a private or public entity authorized by the Department shall maintain records for each individual -who has been provided naloxone, including:

(1) Full name of individual;

(2) Name of prescriber;

(3) Name and address of dispenser;

(4) Date of dispensing; and

(5) Type and dosage of naloxone dispensed.

C. Reporting Information to the Department. A private or public entity authorized by the Department shall report to the Department:

(1) Information on program operations, including:

(a) Number of individuals who have completed education and training programs;

(b) For private or public entities authorized by the Department that provide naloxone directly or by means of a voucher for redemption at a pharmacy:

(i) Form of naloxone dispensed;

(ii) Number of initial doses of naloxone dispensed; and

(iii) Number of naloxone refills dispensed; and

(c) Number and location of naloxone administrations and overdose reversals to the extent this information is reported to the private or public entity authorized by the Department;

(2) Demographic information on individuals -who participated in an education and training program, including aggregate number of individuals by:

(a) Sex;

(b) Ethnicity;

(c) Race;

(d) Age; and

(e) The specific reason to receive education and training; and

(3) Any other information required by the Department.

D. Information under §C of this regulation shall be reported by the private or public entity authorized by the Department on a monthly basis in a format specified by the Department.

Md. Code Regs. 10.47.08.09

Effective date: 41:4 Md. R. 301, eff.3/3/2014 ; recodified from Regulations .08 effective 43:18 Md. R. 1017, eff. 9/12/2016; amended and recodified from .11 effective 46:20 Md. R. 843, eff. 10/7/2019