To establish data reporting standards designed to capture controlled substance dispensing data from dispensing practitioners and pharmacies. The data elements in this standard include dispenser identification number, date prescription filled, ...

 

DEPARTMENT OF HEALTH

Prescription Drug Monitoring Program

RULE NO.:RULE TITLE:

64K-1.002American Society of Automation in Pharmacy Standards and Formats

PURPOSE AND EFFECT: To establish data reporting standards designed to capture controlled substance dispensing data from dispensing practitioners and pharmacies. The data elements in this standard include dispenser identification number, date prescription filled, prescription number, prescription is new or is a refill, National Drug Code for drug dispensed, quantity dispensed, number of days supply of the drug, patient identification number, patient name, patient address, patient date of birth, prescriber identification number, date prescription was issued by prescriber, person who received the prescription from the dispenser, if other that the patient, source of payment for prescription, state issued serial number. To encourage responsible prescribing by implementing provisions to help establish a limited access comprehensive electronic database system for controlled substances.

SUMMARY: Format for reporting controlled substance dispensing data to the Prescription Drug Monitoring Program.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: Based on the SERC checklist, this rulemaking will not have an adverse impact on regulatory costs in excess of $1 million within five years as established in Section 120.541(2)(a), F.S.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 893.055 FS.

LAW IMPLEMENTED: 893.055 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca R. Poston, Program Manager, 4052 Bald Cypress Way, Bin #C16, Tallahassee, Florida 32399-3250, [phone] or [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64K-1.002 American Society for Automation in Pharmacy Standards and Formats.

The format for submission to the database shall be in accordance with the Electronic Reporting Standard for Prescription Monitoring Programs of the American Society for Automation in Pharmacy (ASAP), incorporated by reference ASAP 2011 2009 version 4.21. (9/2011 11/2009). The PDMP will continue to accept reports in the ASAP 2009 version 4.1 standard for one year from the effective date of this rule, after which all reports must be made using the ASAP 2011 version 4.2 standard. The format for submission to the database if no controlled substances are dispensed shall be in accordance with the incorporated by reference ASAP Zero Report standard (09/2010). A copy of the Electronic Reporting Standard for Prescription Monitoring Programs may be obtained from the American Society for Automation in Pharmacy, 492 Norristown Road, Suite 160, Blue Bell, Pennsylvania 19422, Telephone: [phone], Website: www.asapnet.org.

Rulemaking Authority 893.055 FS. Law Implemented 893.055 FS. History–New 2-20-12, Amended__________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Rebecca R. Poston, Program Manager

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: John H. Armstrong, MD, FACS, Surgeon General and Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 30, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: November 8, 2013