DAR File No. 40916

Commerce, Occupational and Professional Licensing

Rule R156-37f

Controlled Substance Database Act Rule

Notice of Proposed Rule

(Amendment)

DAR File No.: 40916
Filed: 10/27/2016 08:41:18 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

This filing implements legislative changes and requirements regarding Controlled Substance Database (database ) access and reporting made during the 2016 General Session by S.B. 3001, Controlled Substance Database Modifications; H.B. 149, Death Reporting and Investigation Information Regarding Controlled Substances; and H.B. 150, Controlled Substance Prescription Notification.

Summary of the rule or change:

In Section R156-37f-102, adds a definition of "Originating Agency Identifier Number", which number will be used to identify the adult probation and parole officer agencies accessing the database. In Section R156-37f-203: 1) adds items to the mandatory database data fields and preferred database data fields; and 2) updates the reference to the new ASAP (American Society for Automation in Pharmacy) 4.2 format. In Section R156-37f-301: 1) adds procedures regarding database access for adult probation or parole officers employed by the Department of Corrections or a political subdivision; 2) specifies information that may be included in the accounting to an individual regarding the persons or entities who have requested or received database information about that individual; 3) adds a requirement that the written designation by a licensed practitioner allowing the practitioner's employee to obtain database information, must be manually signed by both the practitioner and the designated employee; 4) establishes procedures regarding an individual's request to the division for initiating and ceasing third-party notices when a controlled substance prescription is dispensed to that individual; and 5) makes minor technical conforming and formatting changes.

Statutory or constitutional authorization for this rule:

• Subsection 58-1-106(1)(a)
• Subsection 58-37f-301(1)

Anticipated cost or savings to:

the state budget:

The Division will incur minimal costs of approximately $75 to print and distribute the rules once the proposed amendments are made effective. The cost to the Division to implement the new standards imposed by the proposed rules should be minimal, and should be absorbed in the Division's current budget, because implementation will be handled within regular working hours and through existing Division vendors providing ongoing maintenance and support.

local governments:

The proposed amendments may impact local governments if they need to upgrade their software to meet the new standards. Such costs, if any, should be minimal since any required changes should be absorbed through the support costs paid to the local government's computer software vendor for ongoing maintenance and support. Some savings may be realized by local governments employing probation or parole officers who will be able to more easily access database information regarding a specific probationer or parolee under the officer's direct supervision. The amount of any cost or savings cannot be estimated as it will vary depending on circumstances.

small businesses:

The proposed amendments may impact small business pharmacies if they need to upgrade their pharmacy software to meet the new standards. However, the cost to these pharmacies should be minimal since most of the changes should be absorbed through the support costs these pharmacies already pay to their computer software vendor for ongoing maintenance and support. The proposed amendments may provide some cost savings for pharmacies that employ pharmacy technicians and pharmacy interns, as the new procedures will allow pharmacy technicians and pharmacy interns to access database information on behalf of a licensed pharmacist. The amount of any cost or savings cannot be estimated as it will vary depending on circumstances.

persons other than small businesses, businesses, or local governmental entities:

There are no anticipated costs or savings to persons other than businesses, small businesses, and local government entities, as the amendments only implement procedures regarding database access and database reporting requirements for businesses and government entities beyond those that may have been identified in fiscal notes associated with the legislative bills.

Compliance costs for affected persons:

There are no anticipated compliance costs or savings for affected persons, as the amendments only implement procedures regarding database access and database information reporting requirements for businesses and government entities.

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

The amendments to the rules implement legislative changes regarding the Controlled Substance Database (CSD) access and reporting made S.B. 3001, H.B. 149, and H.B. 150 (2016). The principal changes add items to the mandatory CSD data fields, add procedures regarding database access for adult probation or parole officers, specify information that may be included in the accounting to an individual regarding the persons who have received database information regarding the individual, and establish procedures regarding an individual's request to the division of initiating and ceasing third-party notice when a controlled substance prescription is dispensed to that individual. The material changes in the rules will impact pharmacies and require additional, but not excessive, expenditure of time in keeping the records for, and permitting access to, CSD information. Much of this compliance will be realized through computer software changes, which costs should not have a material effect on businesses.

Francine A. Giani, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office 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:

• Marvin Sims at the above address, by phone at 801-530-6232, by FAX at 801-530-6511, or by Internet E-mail at msims@utah.gov

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:

12/15/2016

Interested persons may attend a public hearing regarding this rule:

• 11/17/2016 11:00 AM, Heber Wells Bldg, 160 E 300 S, Conference Room 403 (fourth floor), Salt Lake City, UT

This rule may become effective on:

12/22/2016

Authorized by:

Mark Steinagel, Director

R156. Commerce, Occupational and Professional Licensing.

R156-37f. Controlled Substance Database Act Rule.

R156-37f-102. Definitions.

In addition to the definitions in Sections 58-17b-102, 58-37-2 and 58-37f-102, as used in this chapter:

(1) "ASAP" means the American Society for Automation in Pharmacy system.

(2) "DEA" means Drug Enforcement Administration.

(3) "NABP" means the National Association of Boards of Pharmacy.

(4) "NCPDP" means National Council for Prescription Drug Programs.

(5) "NDC" means National Drug Code.

(6) "ORI" means Originating Agency Identifier Number.

([6]7) "Positive identification" means:

(a) one of the following photo identifications issued by a foreign or domestic government:

(i) driver's license;

(ii) non-driver identification card;

(iii) passport;

(iv) military identification; or

(v) concealed weapons permit; or

(b) if the individual does not have government-issued identification, alternative evidence of the individual's identity as deemed appropriate by the pharmacist, as long as the pharmacist documents in a prescription record a description of how the individual was positively identified.

([7]8) "Research facility" means a facility in which research takes place that has policies and procedures describing such research.

([8]9) "Rx" means a prescription.

 

R156-37f-203. Submission, Collection, and Maintenance of Data.

(1) The format used as a guide for submission to the Database shall be in accordance with [any ]version 4.2 of the ASAP Telecommunications Format for Controlled Substances published by the American Society for Automation in Pharmacy. The Division may approve alternative formats substantially similar to this standard. This standard is further classified by the Database as follows:

(a) Mandatory Data. The following Database data fields are mandatory:

(i) pharmacy NABP or NCPDP number;

(ii) [customer ]identification number of person picking up filled prescription;

(iii) patient birth date;

(iv) patient gender code;

(v) date filled;

(vi) Rx number;

(vii) new-refill code;

(viii) metric quantity;

(ix) days supply;

(x) NDC number;

(xi) prescriber identification number;

(xii) date Rx written;

(xiii) number refills authorized;

(xiv) patient last name;

(xv) patient first name;[ and]

(xvi) patient [street ]address;

(xvii) five -[]digit zip code; and

(xviii) date sold (point of sale).

(b) Preferred Data. The following Database data fields are strongly suggested:

(i) compound code;

(ii) DEA suffix;

(iii) Rx origin code;

(iv) customer location;

(v) alternate prescriber number;[ and]

(vi) state in which the prescription is filled ;

(vii) method of payment; and

(viii) dispensing pharmacist state license number.

(c) Optional Data. All other data fields in the ASAP 4.2 Format not included in Subsections (a) and (b) are optional.

(2) Upon request, the Division will consider approving alternative formats, or adjustments to the ASAP Format, as might be necessary due to the capability or functionality of Database collection instruments. A proposed alternative format shall contain all mandatory data elements.

(3) In accordance with Subsection 58-37f-203(1)(a), the data required in Subsection (1) shall be submitted to the Database through one of the following methods:

(a) electronic data sent via a secured internet transfer method, including sFTP site transfer;

(b) secure web base service; or

(c) any other electronic method approved by the Database manager prior to submission.

(4) In accordance with Subsection 58-37f-203(1)(a):

(a) Effective January 1, 2016, each pharmacy or pharmacy group shall submit data collected on a daily basis either in real time or daily batch file reporting. The submitted data shall be from the point of sale (POS) date.

(i) 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.

(ii) 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.

(b)(i) A Class A, B, or D pharmacy or pharmacy group that has a controlled substance license but is not dispensing controlled substances and does not anticipate doing so in the immediate future may request a waiver or submit a certification of such, in a form preapproved by the Division, in lieu of daily null reporting.

(ii) The waiver or certification must be resubmitted at the end of each calendar year.

(iii) If a pharmacy or pharmacy group that has submitted a waiver or certification under this Subsection ([5]4)(b) dispenses a controlled substance:

(A) the waiver or certification shall immediately and automatically terminate;

(B) the pharmacy or pharmacy group shall provide written notice of the waiver or certification termination to the Division within seven days of dispensing the controlled substance; and

(C) the Database reporting requirements shall be applicable to the pharmacy or pharmacy group immediately upon the dispensing of the controlled substance.

 

R156-37f-301. Access to Database Information.

In accordance with Subsections 58-37f-301(1)(a) and (b):

(1) The Division Director may designate those individuals employed by the Division who may have access to the information in the Database (Database staff).

(2)(a) A request for information from the Database may be made:

(i) directly to the Database by electronic submission, if the requester is registered to use the Database; or

(ii) by oral or written submission to the Database staff, if the requester is not registered to use the Database.

(b) An oral request may be submitted by telephone or in person.

(c) A written request may be submitted by facsimile, email, regular mail, or in person except as otherwise provided herein.

(d) The Division may in its discretion require a requestor to verify the requestor's identity.

(3) The following Database information may be disseminated to a verified requestor who is permitted to obtain the information:

(a) dispensing/reporting pharmacy ID number/name;

(b) subject's birth date;

(c) date prescription was filled;

(d) prescription (Rx) number;

(e) metric quantity;

(f) days supply;

(g) NDC code/drug name;

(h) prescriber ID/name;

(i) date prescription was written;

(j) subject's last name;

(k) subject's first name; and

(l) subject's street address;

(4)(a) Federal, state and local law enforcement authorities and state and local prosecutors requesting information from the Database under Subsection 58-37f-301(2)(k) must provide a valid search warrant authorized by the courts, which [and ]may be provided using one of the following methods:

(i) in person;

(ii) [be]by email to csdb@utah.gov;

(iii) facsimile; or

(iv) U.S. Mail.

(b) Information in the search warrant should be limited to subject's name and birth date.

(c) Information provided as a result of the search warrant shall be in accordance with Subsection (3).

(5) In accordance with Subsection 58-37f-301(2)(n), a probation or parole officer employed by the Department of Corrections or a political subdivision may have access to the database without a search warrant, for supervision of a specific probationer or parolee under the officer's direct supervision, if the following conditions have been met:

(a) a security agreement signed by the officer is submitted to the division for access, which contains:

(i) the agency's name;

(ii) the agency's complete address, including city and zip code;

(iii) the agency's ORI number;

(iv) a copy of the officer's driver's license;

(v) the officer's full name;

(vi) the officer's contact phone number;

(vii) the officer's email address; and

(b) the online database account includes the officer's:

(i) full name;

(ii) email address;

(iii) complete home address, including city and zip code;

(iv) work title;

(v) contact phone number;

(vi) complete work address including city and zip code;

(vii) work phone number; and

(viii) driver's license number.

([5]6)(a) In accordance with Subsection 58-37f-302(q), a[A]n individual may receive an accounting of persons or entities that have requested or received Database information about the individual.

(b) An individual may request the information in person or in writing by the following means:

(i) email;

(ii) facsimile; or

(iii) U.S. Mail.

(c) The request for information shall include the following:

(i) individuals' full name, including all aliases;

(ii) birth date;

(iii) home address;

(iv) government issued identification; and

(v) date-range.

(d) The results may be disseminated in accordance with Subsection ([14]17).

(e) The information provided in the report may include the following:

(i) the role of the person that accessed the information;

(ii) the date and a description of the information that was accessed;

(iii) the name of the person or entity that requested the information; and

(iv) the name of the practitioner on behalf of whom the request for information was made, if applicable.

([6]7) An individual whose records are contained within the Database may obtain his or her own information and records by:

(a) personally appearing before the Database staff with government-issued picture identification confirming the requester's identity; or

(b) submitting a signed and notarized request that includes the requester's:

(i) full name;

(ii) complete home address;

(iii) date of birth; and

(iv) driver license or state identification card number.

([7]8) A requester holding power of attorney for an individual whose records are contained within the Database may obtain the individual's information and records by:

(a) personally appearing before the Database staff with government-issued picture identification confirming the requester's identity; and

(b) providing:

(i) an original, properly executed power of attorney designation; and

(ii) a signed and notarized request, executed by the individual whose information is contained within the Database, and including the individual's:

(A) full name;

(B) complete home address;

(C) date of birth; and

(D) driver license or state identification card number verifying the individual's identity.

([8]9) A requestor who is the legal guardian of a minor or incapacitated individual whose records are contained within the Database may obtain the individual information and records by:

(a) personally appearing before the Database staff with government-issued picture identification confirming the requester's identity;

(b) submitting the minor or incapacitated individual's:

(i) full name;

(ii) complete home address;

(iii) date of birth; and

(iv) if applicable, state identification card number verifying the individual's identity; and

(c) submitting legal proof that the requestor is the guardian of the individual who is the subject of the request for information from the Database.

([9]10) A requestor who has a release-of-records from an individual whose records are contained within the Database may obtain the individual's information and records by:

(a) submitting a request in writing;

(b) submitting an original, signed and notarized release-of-records in a format acceptable to the Database staff, identifying the purpose of the release; and

(c) submitting the individual's:

(i) full name;

(ii) complete home address;

(iii) telephone number;

(iv) date of birth; and

(v) driver license or state identification card number verifying the identity of the person who is the subject of the request.

([10]11) An employee of a licensed practitioner who is authorized to prescribe controlled substances may obtain Database information to the extent permissible under Subsection 58-37f-301(2)([d]i)if, prior to making the request:

(a) the licensed practitioner has provided to the Division a written designation that includes the designating practitioner's DEA number and the designated employee's:

(i) full name;

(ii) complete home address;

(iii) e-mail address;

(iv) date of birth;[ and]

(v) driver license number or state identification card number; and

(vi) the written designation is manually signed by the licensed practitioner and designated employee.

(b) the designated employee has registered for an account for access to the Database and provided a unique user identification;

(c) the designated employee has passed a Database background check of available criminal court and Database records; and

(d) the Database has issued the designated employee a user personal identification number (PIN) and activated the employee's Database account.

([11]12) An employee of a business that employs a licensed practitioner who is authorized to prescribe controlled substances may obtain Database information to the extent permissible under Subsection 58-37f-301(2)([d]i) if, prior to making the request:

(a) the licensed practitioner and employing business have provided to the Division a written designation that includes:

(i) the designating practitioner's DEA number;

(ii) the name of the employing business; and

(iii) the designated employee's:

(A) full name;

(B) complete home address;

(C) e-mail address;

(D) date of birth; and

(E) driver license number or state identification card number;

(b) the designated employee has registered for an account for access to the Database and provided a unique user identification and password;

(c) the designated employee has passed a Database background check of available criminal court and Database records; and

(d) the Database has issued the designated employee a user personal identification number (PIN) and activated the employee's Database account.

([12]13) An individual who is employed in the emergency room of a hospital that employs a licensed practitioner who is authorized to prescribe controlled substances may obtain Database information to the extent permissible under Subsection 58-37f-301(2)(d) if, prior to making the request:

(a) the practitioner and the hospital operating the emergency room have provided to the Division a written designation that includes:

(i) the designating practitioner's DEA number;

(ii) the name of the hospital;

(iii) the names of all emergency room practitioners employed at the hospital; and

(iv) the designated employee's:

(A) full name;

(B) complete home address;

(C) e-mail address;

(C) date of birth; and

(D) driver license number or state identification card number;

(b) the designated employee has registered for an account for access to the Database and provided a unique user identification and password;

(c) the designated employee has passed a Database background check of available criminal court and Database records; and

(d) the Database has issued the designated employee a user personal identification number (PIN) and activated the employee's Database account.

(14) In accordance with Subsection 58-37f-301(5), an individual's requests to the division regarding third-party notice when a controlled substance prescription is dispensed to that individual, shall be made as follows:

(a) A request to provide notice to a third party shall be made in writing dated and signed by the requesting individual, and shall include the following information:

(i) the requesting individual's:

(A) birth date;

(B) complete home address including city and zip code;

(C) email address; and

(D) contact phone number; and

(ii) the designated third party's:

(A) complete home address, including city and zip code;

(B) email address; and

(C) contact phone number.

(b) A request to discontinue providing notice to a designated third party shall be made by a writing dated and signed by the requesting individual, after which the division shall:

(i) provide notice to the requesting individual that the discontinuation notice was received; and

(ii) provide notice to the designated third party that the notification has been rescinded.

(c) A requesting individual may only have one active designated third party.

(15) A licensed pharmacy technician or pharmacy intern employed by a pharmacy may obtain Database information to the extent permissible under Subsection 58-37f-301(2)(l) if, prior to making the request:

(a) the pharmacist-in-charge (PIC) has provided to the Division a written designation authorizing access to the pharmacy technician or pharmacy intern on behalf of a licensed pharmacist employed by the pharmacy;

(b) the written designation includes the pharmacy technician's or pharmacy intern's:

(i) full name;

(ii) professional license number assigned by the Division;

(iii) email address;

(iv) contact phone number;

(v) pharmacy name and location;

(vi) pharmacy DEA number;

(vii) pharmacy phone number;

(c) the written designation includes the pharmacist-in-charge's (PIC's):

(i) full name;

(ii) professional license number assigned by the Division;

(iii) email address;

(iv) contact phone number;

(d) the written designation includes the assigned pharmacist's:

(i) full name;

(ii) professional license number assigned by the Division;

(iii) email address;

(iv) contact phone number; and

(e) the written designation includes the following signatures:

(i) pharmacy technician or pharmacy intern;

(ii) pharmacist-in-charge (PIC); and

(iii) assigned pharmacist if different than the PIC.

([13]16) The Utah Department of Health may access Database information for purposes of scientific study regarding public health. To access information, the scientific investigator shall:

(a) demonstrate to the satisfaction of the Division that the research is part of an approved project of the Utah Department of Health;

(b) provide a description of the research to be conducted, including:

(i) a research protocol for the project; and

(ii) a description of the data 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 being strictly restricted to the requesting scientific investigator;

(d) provide for electronic data to be stored on a secure database computer system with access being strictly restricted to the requesting scientific investigator; and

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

([14]17) Database information that may be disseminated under Section 58-37f-301 may be disseminated by the Database staff either:

(a) verbally;

(b) by facsimile;

(c) by email;

(d) by U.S. mail; or

(e) by electronic access, where adequate technology is in place to ensure that a record will not be compromised, intercepted, or misdirected[, by electronic access].

 

KEY: controlled substance database, licensing

Date of Enactment or Last Substantive Amendment: [ January 7, ]2016

Authorizing, and Implemented or Interpreted Law: 58-1-106(1)(a); 58-37f-301(1)