Md. Code Regs. 10.47.07.03

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

Section 10.47.07.03 - Dispenser Reporting

A. For each monitored prescription drug and naloxone medication dispensed, the dispenser shall report data elements required by American Society for Automation in Pharmacy (ASAP) standards in addition to the following:

(1) Identifying information for the prescription issued and drug dispensed, including:

(a) Prescription number;

(b) Date prescription was issued;

(c) Date prescription was filled;

(d) Whether the prescription was new or a refill;

(e) Number of refills ordered;

(f) Sources of payment;

(g) National Drug Code for dispensed drug;

(h) Metric quantity of drug dispensed and units;

(i) Days' supply of drug dispensed; and

(j) Date prescription was sold;

(2) Identifying information for the patient or animal owner or handler, as appropriate, including:

(a) Last name;

(b) First name;

(c) Date of birth;

(d) Gender;

(e) Telephone number;

(f) Address, including residential house or building number, apartment number, street name, state, and zip code;

(g) A patient identification number

(h) ID qualifier; and

(i) Species indication;

(3) First and Last name for the prescriber, including:

(a) For prescription monitoring data, a valid Drug Enforcement Administration registration number; or

(b) For naloxone medication data, a valid National Provider Identifier;

(4) Identifying information for the dispenser, including a valid Drug Enforcement Administration registration number; and

(5) Additional data elements consistent with the standards established by the ASAP.

B. Reporting Deadline.

(1) A dispenser shall report prescription monitoring data and naloxone medication data to the Department to include zero reports at least once every 24 hours and in accordance with procedures developed by the Department and approved by the Advisory Board on Prescription Drug Monitoring.

(2) A dispenser that suffers a mechanical, electrical, or other technical failure that, as a direct consequence, precludes the dispenser's ability to report prescription monitoring data or naloxone medication data electronically shall:

(a) Notify the Department, by a communications method approved by the Department, within 24 hours of discovery of the technical failure; and

(b) Submit a report for each monitored prescription drug and naloxone medication dispensed during the period of technical failure as soon as possible, but no later than 24 hours following reestablishment of the means of electronic reporting.

C. Waiver from Reporting Deadline.

(1) At the Secretary's discretion, a dispenser may be granted a waiver from §B of this regulation, provided that the dispenser's waiver request:

(a) Is submitted on a form or in a method approved by the Department;

(b) Is particular to a unique problem, incident or other issue that prevents the dispenser from meeting the reporting deadline; and

(c) Describes in detail and includes any available documentation of the specific circumstances that prevent the dispenser from meeting the reporting deadline.

(2) A dispenser that receives a waiver shall comply with all the terms and conditions enumerated therein, including any new reporting deadline required.

D. Means of Data Submission and Data Format. Prescription monitoring data shall be transmitted to the Department or its agent:

(1) In accordance with any procedures and guidelines established or approved by the Department, including by use of an encrypted electronic transmission method or a secure electronic reporting form; and

(2) In a format or utilizing a data standard approved by the Department.

E. Reporting of Incomplete or Inaccurate Data. Data not accepted by the Department or its agent due to inaccuracy or incompleteness shall be corrected and resubmitted to the Department no later than 3 business days after receiving notification from the Department of receipt of incomplete or inaccurate data.

F. Reporting Exemptions. The following shall be exempt from reporting prescription monitoring data to the Program:

(1) A licensed hospital pharmacy that only dispenses a monitored prescription drug for direct administration to an inpatient of the hospital;

(2) An opioid treatment service program;

(3) A veterinarian licensed under Agriculture Article, Title 2, Subtitle 3, Annotated Code of Maryland, when prescribing controlled substances for animals in the usual course of providing professional services;

(4) A pharmacy issued a waiver permit under COMAR 10.34.17.03A that provides pharmaceutical specialty services exclusively to persons living in assisted living facilities, comprehensive care facilities, and developmental disabilities facilities; and

(5) Dispensing to hospice inpatients, provided that the dispensing pharmacy has applied for and been granted a waiver by the Department pursuant to §G of this regulation.

G. Waiver for Dispensing to Hospice Inpatients.

(1) On a form or in a manner approved by the Department, a pharmacy may apply to the Department to be granted a waiver from reporting prescription monitoring data or naloxone medication data for dispensing of monitored prescription drugs to hospice inpatients, provided that:

(a) The pharmacy demonstrates, through written application, live demonstration, or any other method required by the Department, how it will distinguish dispensing to hospice inpatients from all other dispensing of monitored prescription drugs required to be reported to the Program; and

(b) The pharmacy agrees that it will be subject to unannounced, on-site inspections by the Department to verify its reporting of prescription monitoring data and naloxone medication data on customers that are not hospice inpatients.

(2) A waiver granted to a pharmacy under this regulation shall remain in effect for 2 years.

Md. Code Regs. 10.47.07.03

Regulation .03 amended effective 42:11 Md. R. 725, eff.6/8/2015; amended effective 45:20 Md. R. 918, eff. 10/8/2018; amended effective 50:8 Md. R. 338, eff. 7/20/2023