Regulation .09 Record Maintenance and Reporting.
Regulation .09 Record Maintenance and Reporting.LinkCopy Citation
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.