DAR File No. 39879

Health, Administration

Rule R380-60

Local Health Department Emergency Protocols

Notice of Proposed Rule

(Amendment)

DAR File No.: 39879
Filed: 10/27/2015 01:34:29 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this amendment is to add closed point of dispensing (closed POD) into "Dispensing of Medication" section and add details about controlled substances that is part of the Strategic National Stockpile into existing rule.

Summary of the rule or change:

The rule change allows local health departments to distribute controlled substances as defined in statute. It also clarifies the function of closed PODs for medication dispensing.

State statutory or constitutional authorization for this rule:

• Subsections 58-1-307(6), (7), (8), and (9)
• Title 26, Chapter 23b
• Section 26A-1-114
• Subsection 26-23b-102(6)

Anticipated cost or savings to:

the state budget:

No anticipated fiscal impact to the state budget because there are no changes in the rule requirements that are imposed by these amendments. State budget is not affected by this rule, as the medication and people administering this project are paid from federal funds.

local governments:

No anticipated fiscal impact to local governments because there are no changes in the rule requirements that are imposed by these amendments. Local budget is not affected by this rule, as the medication and people administering this project are paid from federal funds.

small businesses:

No anticipated fiscal impact to small businesses because there are no changes in the rule requirements that are imposed by these amendments. Small business budgets are not affected by this rule, as the medication and people administering this project are paid from federal funds. Small businesses are not used as closed PODs.

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

No anticipated fiscal impact to businesses because there are no changes in the rule requirements that are imposed by these amendments. Other budgets are not affected by this rule, as the medication and people administering this project are paid from federal funds.

Compliance costs for affected persons:

No anticipated fiscal impact for affected persons because there are no changes in the rule requirements that are imposed by these amendments.

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

This proposed amendment defines the terms "closed point of dispensing (closed POD)" and "receiving facility." A receiving facility is expanded to include federally recognized American Indian tribal entities and other organizations, such as closed PODs, that have a written agreement with the Department or a local health department. There is no fiscal impact to business because it makes no change to the requirements of entities governed by this rule.

Joseph Miner, MD, Executive Director

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

Health
Administration
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY, UT 84116-3231

Direct questions regarding this rule to:

• Angie Stefaniak at the above address, by phone at 801-538-6111, by FAX at , or by Internet E-mail at [email protected]

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:

12/15/2015

This rule may become effective on:

12/22/2015

Authorized by:

Joseph Miner, Executive Director

R380. Health, Administration.

R380-60. Local Health Department Emergency Protocols.

R380-60-1. Authority and Purpose.

(1) These emergency protocols are adopted by the Department under authority of Utah Code Annotated Title 26-23b and Title 26A1-114 and as outlined in the Utah Code Annotated Title [Sections ]58-1-307(6), (7), (8), and (9).

(2) These protocols shall only be in effect during a public health emergency, as defined in Utah Code Annotated Title 26-23b-102(6)[declared emergency as defined herein].

 

R380-60-2. Definitions.

(1) Administer - means the direct application of a drug or device, whether by injection, inhalation, ingestion, or by any other means, to the body of a human by another person.

(2) Controlled Substance - as defined in Utah Code Annotated Title 58-37-2.

(3) Closed Point of Dispensing (Closed POD)- A closed POD is a private location where medications are dispensed to a specific group of people.

([2]4) Declaration of Emergency - means the declaration of a national, state ( Utah Code Annotated Title[Section] 53-2a-206[63K-4-201]), local ( Utah Code Annotate[Section] Title 53-2a-208[63K-4-301]) or public health emergency ( Utah Code Annotated Title [Section] 26-23b-102 (6))[and R389-702-10)].

([3]5) Department - means the Utah Department of Health.

([4]6) Dispense - means the interpretation, evaluation, and implementation of a prescription drug order or device or nonprescription drug or device under a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration or use.

([5]7) Distribute - means to deliver a drug or device other than by administering or dispensing.

([6]8) Emergency Use Authorization (EUA) - means the authority of the US Food and Drug Administration (FDA) to approve the emergency use of drugs, devices, and medical products (including diagnostics) that were not previously approved, cleared, or licensed by FDA (hereafter, "unapproved") or the off-label use of approved products in certain well-defined emergency situations.

([7]9) Local Health Department - means a county or multicounty local health department established under Utah Code Title 26A.

(10) Receiving Facility - means a facility that is designated by the local health department to receive medications or supplies.

([8]11) Strategic National Stockpile[(SNS)] - means a national repository of antibiotics, chemical antidotes, antitoxins, life-support medications, IV administration, airway maintenance supplies, and medical/surgical items.

([9]12) Triage - for purposes of this rule means the sorting of and allocation of treatment to patients according to priorities designed to maximize the number of survivors and optimize the use of available resources.

 

R380-60-3. Distribution of Medication (Non-controlled substances).

(1) Upon the declaration of an emergency as defined in R380-60-2, the Department shall coordinate the distribution of vaccine, antiviral, antibiotic or other prescription medication that is not a controlled substance received from the Strategic National Stockpile or another emergency stockpile and delivered to local health departments for further distribution, dispensing and administration.

(2) The local health department may distribute the medication received from the Department to emergency personnel and other receiving facilities as designated herein and within the local health department's jurisdiction. These receiving facilities may include the following:

[(3) If necessary to prevent or treat the disease or condition that gave rise to, or is a consequence of the emergency, the Department or local health departments may further distribute a vaccine, antiviral, antibiotic, or other medication that is not a controlled substance received from the Strategic National Stockpile or another emergency stockpile for dispensing or direct administration by a:]

(a) pharmacy (including back filling of inventory);

(b) prescribing practitioner;

(c) licensed health care facility;

(d) federally qualified community health clinic; or

(e) governmental entity for use by a community more than 50 miles from any facility listed in (a) to (d)[.];

(f) federally recognized American Indian tribal entities;

(g) other organizations that have a written agreement with the Department or local health department, such as a closed POD.

([4]3) The receiving facility [receiving medication from the Department or local health departments ]shall be responsible for record keeping as provided for in [Section ]R380-60-[6]7 and for the tracking, storage and the proper return, disposal or destruction of any unused medication.

 

R380-60-4. Distribution of Medication (Controlled Substances).

[(5)](1) A receiving facility [receiving medication ]as provided in [Subsection ]R380-60-3([3]2) [must]shall follow applicable state or Federal law governing dispensing and administration of the medications.

 

R380-60-[4]5 . Dispensing of Medication.

(1) After receiving medication distributed by the Department, the medical director or other person with authority to prescribe working in a local health department, may supervise or direct the dispensing of a vaccine, antiviral, antibiotic or other prescription medication that is not a controlled substance, under:

(a) a prescription or other lawful order by a person with authority to prescribe,

(b) the prescription procedure described in Section 58-17b-620(4),

(c) other procedures described in a written protocol approved by the medical director of the Department, or

(d) other conditions justifying the dispensing of the medication without a prescription, including the terms of an Emergency Use Authorization to:

(i) the contacts of a patient (contact of a patient with a physician patient relationship);

(ii) an individual working in a triage situation;

(iii) an individual receiving preventative or medical treatment in a triage situation;

(iv) an individual who does not have coverage for the prescription in the individual's health insurance plan;

(v) an individual involved in the delivery of medical or other emergency services; or

(vi) an individual who otherwise may have a direct impact on public health.

(2) If the person dispensing the vaccine, antiviral, antibiotic or other prescription medication is not a licensed pharmacist authorized to dispense medications under Title 58 Chapter 17b, the dispensing shall be conducted according to a written protocol approved by the medical director of the Department or the local health department.

(3) If the person dispensing the vaccine, antiviral, antibiotic or other prescription medication is not licensed to dispense, they shall follow procedures described in a written protocol approved by the medical director of the Department or the local health department.

 

R380-60-[5]6 . Administration of Medication.

(1) After receiving medication distributed by the Department, the medical director or other person licensed to administer (scope of practice) working in a local health department, may supervise or direct the administration of a vaccine, antiviral, antibiotic, or other prescription medication that is not a controlled substance under:

(a) a prescription or other lawful order by a person with authority to prescribe,

(b) the prescription procedure described in Section 58-17b-620(4),

(c) other procedures described in a written protocol approved by the medical director of the Department, or

(d) conditions for administration consistent with the terms of an Emergency Use Authorization to:

(i) the contacts of a patient;

(ii) an individual working in a triage situation;

(iii) an individual receiving preventative or medical treatment in a triage situation;

(iv) an individual who does not have prescription coverage;

(v) an individual involved in the delivery of medical or other emergency services; or

(vi) an individual who otherwise may have a direct impact on public health.

(2) If the person administering the vaccine, antiviral, antibiotic, or other prescription medication is not licensed to administer, the administration shall follow procedures described in a written protocol approved by the medical director of the Department or the local health department.

 

R380-60-[6]7 . Record Keeping.

(1) Records regarding the inventory (lot number, expiration date, etc.), distribution, dispensing and administration (patient data collection) of a vaccine, antiviral, antibiotic, or other prescription medication that is not a controlled substance shall be consistent with the terms of any Emergency Use Authorization or specific Strategic National Stockpile instructions.

(2) The Department, local health department or receiving facility described in Section R380-60-3 that dispenses or administers a vaccine, antiviral, antibiotic or other prescription medication under the authorization of this Rule shall comply with the conditions of any Emergency Use Authorization and shall keep an inventory record describing the drug and the name and contact information for each individual that received the drug.

(3) If the circumstances of the emergency make it impossible to keep these inventory records, the Executive Director of the Department may grant an exception to this requirement limiting the record keeping requirement to such records as are appropriate and possible in the circumstances of the emergency.

(4) If no exception is made by the Executive Director of the Department as described in R380-60-7(3), all record keeping shall be in effect as required by Utah Administrative Rule R156-37-602.

 

KEY: public health emergency

Date of Enactment or Last Substantive Amendment: [March 7, 2012]2015

Authorizing, and Implemented or Interpreted Law: 58-1-307(6); 58-1-307(7); 58-1-307(8); 58-1-307(9)