Utah State Bulletin, January 15, 2012, Vol. 2012, No. 2

NOTICES OF PROPOSED RULES DAR File No. 35571SALT LAKE CITY, UT 84116-3231or at the Division of Administrative Rules.DIRECT QUESTIONS REGARDING THIS RULE TO:♦ Robert Rolfs by phone at 801-538-6111, by FAX at 801-538-6306, or by Internet E-mail at rrolfs@utah.govINTERESTED PERSONS MAY PRESENT THEIR VIEWS ONTHIS RULE BY SUBMITTING WRITTEN COMMENTS NOLATER THAN AT 5:00 PM ON 02/14/2012THIS RULE MAY BECOME EFFECTIVE ON: 02/21/2012AUTHORIZED BY: David Patton, PhD, Executive DirectorR380. Health, Administration.R380-60. Local Health Department Emergency Protocols.R380-60-1. Authority and Purpose.(1) These emergency protocols are adopted by theDepartment under authority of Sections 58-1-307(6), (7), (8), and(9).(2) These protocols shall only be in effect during adeclared emergency as defined herein.R380-60-2 Definitions.(1) Administer - means the direct application of a drug ordevice, whether by injection, inhalation, ingestion, or by any othermeans, to the body of a human by another person.(2) Declaration of Emergency - means the declaration ofa national, state (Section 63K-4-201), local (Section 63K-4-301) orpublic health emergency (Section 26-23b-102 and R389-702-10).(3) Department - means the Utah Department of Health.(4) Dispense - means the interpretation, evaluation, andimplementation of a prescription drug order or device ornonprescription drug or device under a lawful order of a practitionerin a suitable container appropriately labeled for subsequentadministration or use.(5) Distribute - means to deliver a drug or device otherthan by administering or dispensing.(6) Emergency Use Authorization (EUA) - means theauthority of the US Food and Drug Administration (FDA) toapprove 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 ofapproved products in certain well-defined emergency situations.(7) Local Health Department - means a county ormulticounty local health department established under Utah CodeTitle 26A.(8) Strategic National Stockpile (SNS) - means a nationalrepository of antibiotics, chemical antidotes, antitoxins, life-supportmedications, IV administration, airway maintenance supplies, andmedical/surgical items.(9) Triage - for purposes of this rule means the sorting ofand allocation of treatment to patients according to prioritiesdesigned to maximize the number of survivors and optimize the useof available resources.R380-60-3 Distribution of Medication.(1) Upon the declaration of an emergency, theDepartment shall coordinate the distribution of vaccine, antiviral,antibiotic or other prescription medication that is not a controlledsubstance received from the Strategic National Stockpile or anotheremergency stockpile and delivered to local health departments forfurther distribution, dispensing and administration.(2) The local health department may distribute themedication received from the Department to emergency personneland other facilities as designated herein and within the local healthdepartment's jurisdiction.(3) If necessary to prevent or treat the disease orcondition that gave rise to, or is a consequence of the emergency,the Department or local health departments may further distribute avaccine, antiviral, antibiotic, or other medication that is not acontrolled substance received from the Strategic National Stockpileor another emergency stockpile for dispensing or directadministration 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 morethan 50 miles from any facility listed in (a) to (d).(4) The facility receiving medication from theDepartment or local health departments shall be responsible forrecord keeping as provided for in Section R380-60-6 and for thetracking, storage and the proper return, disposal or destruction ofany unused medication.(5) A facility receiving medication as provided inSubsection R380-60-3(3) must follow applicable state or Federallaw governing dispensing and administration of the medications.R380-60-4 Dispensing of Medication.(1) After receiving medication distributed by theDepartment, the medical director or other person with authority toprescribe working in a local health department, may supervise ordirect the dispensing of a vaccine, antiviral, antibiotic or otherprescription medication that is not a controlled substance, under:(a) a prescription or other lawful order by a person withauthority to prescribe,(b) the prescription procedure described in Section 58-17b-620(4),(c) other procedures described in a written protocolapproved by the medical director of the Department, or(d) other conditions justifying the dispensing of themedication without a prescription, including the terms of anEmergency Use Authorization to:(i) the contacts of a patient (contact of a patient with aphysician patient relationship);(ii) an individual working in a triage situation;(iii) an individual receiving preventative or medicaltreatment in a triage situation;(iv) an individual who does not have coverage for theprescription in the individual's health insurance plan;(v) an individual involved in the delivery of medical orother emergency services; or32 UTAH STATE BULLETIN, January 15, 2012, Vol. 2012, No. 2