No. 32411 (Amendment): R156-37-609a. Controlled Substance Database - Reporting Procedure and Format for Submission to the Database for Pharmacies and Pharmacy Groups Selected by the Division for the Real Time Pilot Program

DAR File No.: 32411
Filed: 02/26/2009, 11:26
Received by: NL

RULE ANALYSIS

Purpose of the rule or reason for the change:

The Division is filing amendments to implement the data reporting rules for the Controlled Substance Database Real Time Reporting Pilot Program.

Summary of the rule or change:

Section R156-37-609a is amended to provide additional modes of electronic data transfer including email, compact discs, secured Internet transfer or FTP (File Transfer Protocol) site transfer. New Subsection R156-37-609a(5) allows any pharmacy or pharmacy group within the state of Utah to participate in the pilot program as long as the participant is able to submit the data based upon information available at the time of dispensing to the ultimate user. Information would be transferred at the time the prescription is picked up (dispensed to) the customer and not at the time it was poured and packaged.

State statutory or constitutional authorization for this rule:

Subsections 58-1-106(1)(a), 58-37-6(1)(a), and 58-37-7.5(7)

Anticipated cost or savings to:

the state budget:

The Division will incur minimal costs of approximately $50 to reprint the rule once the proposed amendments are made effective. Any costs incurred will be absorbed in the Division's current budget. The Division has been told by IT staff that any of the changes needed within the current database configuration can occur under the current budget and does not require additional monies to the Division.

local governments:

The only effect on local government would be if the government ran a pharmacy or pharmacy group that chooses to enter into the pilot program.

small businesses and persons other than businesses:

Most non-chain pharmacies fall under the category of small business. Those pharmacies wishing to participate in this voluntary pilot program would need to have software that would track and record the data at the time the patient picks up the medication rather than most current systems which are based on downloading data based on the time the prescription is filled. Implementation of these proposed amendments will help those interested and able to participate in a daily reporting to the Controlled Substance Database. This is a voluntary system so those who do not have a system that will report pick up time do not have to make any changes in their system and simply would not need to participate. If the program ever becomes mandatory, some pharmacies would incur the cost of changes to their computer system to save and transfer information at the time the patient picks up the medication. It is unknown what those costs would be.

Compliance costs for affected persons:

Most non-chain pharmacies fall under the category of small business. Those pharmacies wishing to participate in this voluntary pilot program would need to have software that would track and record the data at the time the patient picks up the medication rather than most current systems which are based on downloading data based on the time the prescription is filled. Implementation of these proposed amendments will help those interested and able to participate in a daily reporting to the Controlled Substance Database. This is a voluntary system so those who do not have a system that will report pick up time do not have to make any changes in their system and simply would not need to participate. If the program ever becomes mandatory, some pharmacies would incur the cost of changes to their computer system to save and transfer information at the time the patient picks up the medication. It is unknown what those costs would be.

Comments by the department head on the fiscal impact the rule may have on businesses:

No fiscal impact to businesses is anticipated with this rule filing, which further clarifies provisions regarding methods of transferring data into the Controlled Substance Database, as well as the time frames and formats for such transfer of data. Francine A. Giani, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Commerce
Occupational and Professional Licensing
HEBER M WELLS BLDG
160 E 300 S
SALT LAKE CITY UT 84111-2316

Direct questions regarding this rule to:

Laura Poe at the above address, by phone at 801-530-6789, by FAX at 801-530-6511, or by Internet E-mail at [e-mail]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

04/14/2009

Interested persons may attend a public hearing regarding this rule:

3/24/2009 at 9:00 AM, Heber Wells Bldg, 160 E 300 S, Conference Room 402 (fourth floor), Salt Lake City, UT

This rule may become effective on:

04/21/2009

Authorized by:

F. David Stanley, Director

RULE TEXT

R156. Commerce, Occupational and Professional Licensing.

R156-37. Utah Controlled Substances Act Rules.

R156-37-609a. Controlled Substance Database - Reporting Procedure and Format for Submission to the Database for Pharmacies and Pharmacy Groups Selected by the Division for the Real Time Pilot Program.

(1) In accordance with Subsection 58-37-7.8(8), the information required under Section 58-37-7.5 shall be submitted to the Division's database manager by licensees designated by the Division to participate in the real time reporting pilot program in the following format:

(a) electronic data via telephone modem[using the software provided by the Division or software approved by the Division]; and

(b) electronic data stored on floppy disk or compact discs (CD);[using the real time data transmission system established by the Division.]

(c) electronic data sent via electronic mail (e-mail) if encrypted and approved by the database manager;

(d) electronic data sent via a secured internet transfer methods, including, but not limited to, FTP site transfer and HyperSend; or

(e) any other electronic method preapproved by the database manager.

(2) Each pharmacy or pharmacy group shall enter and submit data required under Section 58-37-7.5 [as soon as the data is available to the pharmacy or pharmacy group]on a daily basis each day that the pharmacy or pharmacy group is open for business or the data reporting entity of the pharmacy or pharmacy group is open for business.

(3) The format for submission to the database shall be in accordance with the uniform formatting developed by the American Society for Automation in Pharmacy System (ASAP). The Division may approve alternative formats.

(4) The pharmacist-in-charge of each reporting pharmacy or pharmacy group shall be responsible for compliance with this rule.

(5) In accordance with Subsection 58-37-7.8(1)(a)(i), the pilot area is designated as the entire state of Utah. Any pharmacy or pharmacy group that submits information to the database based upon information available at the time of dispensing to the ultimate user is eligible and may participate in the Real Time Pilot Program.

 

KEY: controlled substances, licensing

Date of Enactment or Last Substantive Amendment: [September 9, 2008]2009

Notice of Continuation: March 15, 2007

Authorizing, and Implemented or Interpreted Law: 58-1-106(1)(a); 58-37-6(1)(a); 58-37-7.5(7)