No. 35571 (New Rule): Rule R380-60. Local Health Department Emergency Protocols

(New Rule)

DAR File No.: 35571
Filed: 12/23/2011 02:59:24 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

H.B. 336 (2011 General Session) Medical Professional Licensing during a Declared Emergency, sponsored by Rep. Evan Vickers, enacted by Chapter 110, Laws of Utah 2011, effective 05/10/2011, modified the Division of Occupational and Professional Licensing Act and the Pharmacy Practice Act and authorized the Department of Health to establish protocols for the distribution of medicine in a national, state, or local emergency. This rule was developed in collaboration with key partners and proposes those protocols.

Summary of the rule or change:

Section R380-60-1 makes it clear the rule only applies in a declared emergency. Section R380-60-2 sets definitions for key terms used in the rule. Section R380-60-3 sets the parameters for distribution of the medications. Section R380-60-4 sets the parameters for dispensing the medications to persons. Section R380-60-5 sets the parameters where the circumstances require administration of the medication to a person, such as a vaccine. Section R380-60-6 sets record keeping requirements.

State statutory or constitutional authorization for this rule:

• Subsections 58-1-307(6), (7), (8), (9)

Anticipated cost or savings to:

the state budget:

Responding to protect the health of the public is a core mission of the State Health Department. This rule and the legislation that authorized the rule were supported by state and local health departments. In the event of a major emergency, the costs could be significant to implement this rule, but necessary and unavoidable. The advance planning allowed by this rule and other similar measures will minimize costs to the extent possible.

local governments:

Responding to protect the health of the public is a core mission of the Local Health Departments. This rule and the legislation that authorized the rule were supported by state and local health departments. In the event of a major emergency, the costs could be significant to implement this rule, but necessary and unavoidable. The advance planning allowed by this rule and other similar measures will minimize costs to the extent possible.

small businesses:

Small health care providers and pharmacies will be benefited by this rule in the event of an emergency by having access to medications and health care expertise from public health professionals. No costs for small business are predicted.

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

Health care providers and pharmacies will be benefited by this rule in the event of an emergency by having access to medications and health care expertise from public health professionals. No costs for business are predicted.

Compliance costs for affected persons:

No compliance cost for business is predicted as state and local health departments will bear the burden of implementation. Record keeping should be within normal business practice.

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

Any significant public health emergency that would trigger the authority of this rule will have significant health and potentially financial costs. This rule and other preparations made by public health will mitigate those costs, but cannot avoid them entirely. This important rule should benefit business and citizens to recover from any such event.

David Patton, PhD, 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:

• Robert Rolfs at the above address, by phone at 801-538-6111, by FAX at 801-538-6306, 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:

02/14/2012

This rule may become effective on:

02/21/2012

Authorized by:

David Patton, Executive Director

RULE TEXT

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 Sections 58-1-307(6), (7), (8), and (9).

(2) These protocols shall only be in effect during a 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) Declaration of Emergency - means the declaration of a national, state (Section 63K-4-201), local (Section 63K-4-301) or public health emergency (Section 26-23b-102 and R389-702-10).

(3) Department - means the Utah Department of Health.

(4) 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) Distribute - means to deliver a drug or device other than by administering or dispensing.

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

(8) 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) 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.

(1) Upon the declaration of an emergency, 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 facilities as designated herein and within the local health department's jurisdiction.

(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).

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

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

 

R380-60-4 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.

 

R380-60-5 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 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 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.

 

KEY: public health emergency

Date of Enactment or Last Substantive Amendment: February 21, 2012

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

 

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