No. 30757 (Amendment): R156-37. Utah Controlled Substances Act Rules

DAR File No.: 30757
Filed: 11/26/2007, 05:06
Received by: NL

RULE ANALYSIS

Purpose of the rule or reason for the change:

After further division review, additional amendments are being proposed with respect to the Controlled Substance Database.

Summary of the rule or change:

In Subsection R156-37-609(1), amendments are proposed to address necessary changes to the receipt of database information from pharmacies with all of the advancement of technology available for transmission of the required data. In Subsection R156-37-609(4), amendments are proposed to require that data be collected more frequently than in the past and explains how separate entities should comply. In Subsection R156-37-610(7), amendments are proposed to reflect the way in which the Utah Department of Health is to conduct research using the database information and due to the increasing size of the data, a larger secure computer is required.

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 anticipates it 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 Department of Health may incur some costs to ensure the use of a secure database computer system to store electronic data obtained from the Controlled Substance Database. The division does not know an amount for the secure database computer system and the Department of Health may already have such a system in place.

local governments:

The proposed amendments do not apply to local governments, therefore no costs or savings are anticipated. Proposed amendments only apply to regulated/licensed pharmacies who submit controlled substance prescription data to the Utah Controlled Substance Database and to Department of Health personnel.

small businesses and persons other than businesses:

The division anticipates there will be no costs or savings associated with this rule filing to the general public since the proposed rule amendments clarify existing provisions regarding methods of transferring data to the Controlled Substance Database, time frames and formats for transferring of data and database access by the Department of Health. The public is not responsible for submitting information to the Controlled Substance Database. That responsibility lies with the licensed pharmacy who is filling a controlled substance prescription for a member of the general public. The division anticipates there may be some additional costs to regulated/licensed pharmacies only as a result of these proposed amendments. It should be noted that some of the licensed pharmacies may be considered a "small business". The proposed amendments are increasing the submittal time of prescription data from pharmacies to the Controlled Substance Database from weekly, bi-weekly, or monthly to at least one time per week. Pharmacies may also need to reconfigure data to comply with the proposed amendments. The division is unable to determine any exact costs to licensed pharmacies due to the diverse nature and size of pharmacies involved ranging from chain size pharmacies to small, locally-owned pharmacies. The division anticipates approximately 510 licensed pharmacies will be impacted by the proposed amendments.

Compliance costs for affected persons:

The division anticipates there may be some additional costs to regulated/licensed pharmacies only as a result of these proposed amendments. The proposed amendments are increasing the submittal time of prescription data from pharmacies to the Controlled Substance Database from weekly, bi-weekly, or monthly to at least one time per week. Pharmacies may also need to reconfigure data to comply with the proposed amendments. The Division is unable to determine any exact costs to licensed pharmacies due to the diverse nature and size of pharmacies involved ranging from chain size pharmacies to small, locally-owned pharmacies. The division anticipates approximately 510 licensed pharmacies will be impacted by the proposed amendments.

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 clarifies existing provisions regarding methods of transferring data into the Controlled Substance Database, time frames and formats for such transfer of data and Database access by the Department of Health. 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:

Diana Baker at the above address, by phone at 801-530-6179, 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:

01/14/2008

This rule may become effective on:

01/21/2008

Authorized by:

F. David Stanley, Director

RULE TEXT

R156. Commerce, Occupational and Professional Licensing.

R156-37. Utah Controlled Substances Act Rules.

R156-37-609. Controlled Substance Database - Procedure and Format for Submission to the Database.

(1) In accordance with Subsections 58-37-7.5(6)(a), the format in which the information required under Section 58-37-7.5 shall be submitted to the administrator of the database is:

(a) electronic data via telephone modem;

(b) electronic data stored on floppy disk or compact disc (CD);[ or]

(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 method, including but not limited to, FTP site transfer, HyperSend; or

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

(2) The required information may be submitted on paper, if the pharmacy or pharmacy group submits a written request to the division and receives prior approval.

(3) The division will consider the following in granting the request:

(a) the pharmacy or pharmacy group has no computerized record keeping system upon which the data can be electronically recorded; or

(b) the pharmacy or pharmacy group is unable to conform its submissions to the format required by the database administrator without incurring undue financial hardship.

(4) Each pharmacy or pharmacy group [may submit the data either weekly, bi-weekly, or monthly]shall submit all data collected during the preceding seven days at least one time per week. If the data is submitted by a single pharmacy entity, the data shall be submitted in chronological order according to the date each prescription was filled. If the data is submitted by a pharmacy group, the data is required to be sorted by individual pharmacy within the group, and the data of each individual pharmacy within the group is required to be submitted in chronological order according to the date each prescription was filled.[ Any pharmacy which does not declare its intention for timely submission of data will be presumed to have chosen monthly submission.]

(5) The format for submission to the database shall be in accordance with uniform formatting developed by the American Society for Automation in Pharmacy system (ASAP). The division may approve alternative formats or adjustments to be consistent with database collection instruments and contain all necessary data elements.

(6) The pharmacist-in-charge of each reporting pharmacy shall submit a report on a form approved by the division including:

(a) the pharmacy name;

(b) NABP number;

(c) the period of time covered by each submission of data;

(d) the number of prescriptions in the submission;

(e) the submitting pharmacist's signature attesting to the accuracy of the report; and

(f) the date the submission was prepared.

 

R156-37-610. Controlled Substance Database - Limitations on Access to Database Information - Standards and Procedures for Identifying Individuals Requesting Information.

(1) In accordance with Subsections 58-37-7.5(8)(a) and (b), the division director shall designate in writing those individuals within the division who shall have access to the information in the database.

(2) Personnel from federal, state or local law enforcement agencies may obtain information from the database if the information relates to a current investigation being conducted by such agency. The manager of the database may also provide information from the database to such agencies on his own volition when the information may reasonably constitute a basis for investigation relative to violation of state or federal law.

(3) In accordance with Subsections 58-37-7.5(5)(c), (6)(b), (7)(b), and (8)(d) and (e), the database manager may provide information from the database to licensed practitioners having authority to prescribe controlled substances and to licensed pharmacists having authority to dispense controlled substances. The database manager may provide the information on his own volition to accomplish the stated purposes set forth in Subsection 58-37-7.5(5).

(4) Any individual may request information in the database relating to that individual's receipt of controlled substances. Upon request for database information on an individual who is the recipient of a controlled substance prescription entered in the database, the manager of the database shall make available database information exclusively relating to that particular individual under the following limitations and conditions:

(a) The requestor seeking database information personally appears before the manager of the database, or a designee, with picture identification confirming his identity as the same person on whom database information is sought.

(b) The requestor seeking database information submits a signed and notarized request executed under the penalty of perjury verifying his identity as the same person on whom database information is sought, and providing their full name, home and business address, date of birth, and social security number.

(c) The requestor seeking database information presents a power of attorney over the person on whom database information is sought and further complies with the following:

(i) submits a signed and notarized request executed by the requestor under the penalty of perjury verifying that the grantor of the power of attorney is the same person on whom database information is sought, including the grantor's full name, address, date of birth, and social security number; and

(ii) personally appears before the manager of the database with picture identification to verify personal identity, or otherwise submits a signed and notarized statement executed by the requestor under the penalty of perjury verifying his identity as that of the person holding the power of attorney.

(d) The requestor seeking database information presents verification that he is the legal guardian of an incapacitated person on whom database information is sought and further complies with the following:

(i) submits a signed and notarized request executed by the requestor under the penalty of perjury verifying that the incapacitated ward of the guardian is the same person on whom database information is sought, including the ward's full name, address, date of birth, and social security number; and

(ii) personally appears before the manager of the database with picture identification to verify personal identity, or otherwise submits a signed and notarized statement executed by the requestor under the penalty of perjury verifying his identity as that of the legal guardian of the incapacitated person.

(e) The requestor seeking database information shall present a release-of-records statement from the person on whom database information is sought and further complies with the following:

(i) submits a verification from the person on whom database information is sought consistent with the requirements set forth in paragraph (4)(b);

(ii) submits a signed and notarized release of records statement executed by the person on whom database information is sought authorizing the manager of the database to release the relevant database information to the requestor; and

(iii) personally appears before the manager of the database with picture identification to verify personal identity, or otherwise submits a signed and notarized statement executed by the requestor under the penalty of perjury verifying his identity as that of the requestor identified in the release of records;

(5) Before data is released upon oral request, a written request may be required and received.

(6) Database information may be disseminated either orally, by facsimile or by U.S. mail.

(7) The Utah Department of Health may access Database information for purposes of scientific study regarding public health. To access information, the scientific investigator must:

(a) show the research is an approved project of the Utah Department of Health;

(b) provide a description of the research to be conducted[,] including a research protocol[s] for the project and a description of the data [needs]needed from the Database to conduct that research;

(c) provide assurances and a plan that demonstrates all Database information will be maintained securely, with access only permitted by the scientific investigator;

(d) provide for electronic data to be stored on a [stand alone]secure database computer system with access only allowed by the scientific investigator; and

(e) pay all relevant expenses for data transfer and manipulation.

 

KEY: controlled substances, licensing

Date of Enactment or Last Substantive Amendment: [October 22, 2007]2008

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)