657—8.31  (135,147A)  Opioid antagonist dispensing by pharmacists by standing order.  An authorized pharmacist may dispense an opioid antagonist pursuant to a standing order established by the department, which standing order can be found via the board’s Web site, or pursuant to a standing order authorized by an individual licensed health care professional in compliance with the requirements of this rule. An authorized pharmacist may only delegate the dispensing of an opioid antagonist to an authorized pharmacist-intern under the direct supervision of an authorized pharmacist. Nothing in this rule prohibits a prescriber or facility from establishing and implementing standing orders or protocols under the authority granted to the prescriber or facility.
	   8.31(1) Definitions. For the purposes of this rule, the following definitions shall apply:
“Authorized pharmacist”   means an Iowa-licensed pharmacist who has completed the training requirements of this rule. “Authorized pharmacist” also includes an Iowa-registered pharmacist-intern who has completed the training requirements of this rule and is working under the direct supervision of an authorized Iowa-licensed pharmacist.
“Department”   means the Iowa department of public health.
“First responder”   means an emergency medical care provider, a registered nurse staffing an authorized service program under Iowa Code section 147A.12, a physician assistant staffing an authorized service program under Iowa Code section 147A.13, a fire fighter, or a peace officer as defined in Iowa Code section 801.4 who is trained and authorized to administer an opioid antagonist.
“Licensed health care professional”   means a person licensed under Iowa Code chapter 148 to practice medicine and surgery or osteopathic medicine and surgery, an advanced registered nurse practitioner licensed under Iowa Code chapter 152 or 152E and registered with the board of nursing, or a physician assistant licensed to practice under the supervision of a physician as authorized in Iowa Code chapters 147 and 148C.
“Opioid antagonist”   means the same as defined in Iowa Code section 147A.1 as amended by 2016 Iowa Acts, Senate File 2218.
“Opioid-related overdose”   means the same as defined in Iowa Code section 147A.1 as amended by 2016 Iowa Acts, Senate File 2218.
“Person in a position to assist”   means a family member, friend, caregiver, health care provider, employee of a substance abuse treatment facility, or other person who may be in a position to render aid to a person at risk of experiencing an opioid-related overdose.
“Recipient”   means an individual at risk of an opioid-related overdose or a person in a position to assist an individual at risk of an opioid-related overdose.
“Standing order”   means a preauthorized medication order with specific instructions from the licensed health care professional to dispense a medication under clearly defined circumstances.
	   8.31(2) Authorized pharmacist training. An authorized pharmacist shall document successful completion of an ACPE-approved continuing education program of at least one-hour duration related to opioid antagonist utilization prior to dispensing opioid antagonists pursuant to a standing order.
	   8.31(3) Additional supply. Notwithstanding a standing order to the contrary, an authorized pharmacist shall only dispense an opioid antagonist after completing an eligibility assessment and providing training and education to the recipient.
	   8.31(4) Assessment. An authorized pharmacist shall assess an individual for eligibility to receive an opioid antagonist pursuant to a standing order. In addition to the criteria identified in a standing order, an authorized pharmacist shall also take into consideration the following criteria to determine the eligibility of the recipient to receive and possess an opioid antagonist:
	      a.    	  The person at risk of an opioid-related overdose for which the opioid antagonist is intended to be administered has no known sensitivity or allergy to naloxone, unless the person at risk is not known to the recipient, including but not limited to a first responder or member of law enforcement.
	      b.    	  The recipient is oriented to person, place, and time and able to understand and learn the essential components of opioid-related overdose, appropriate response, and opioid antagonist administration.
	   8.31(5) Recipient training and education. Upon assessment and determination that an individual is eligible to receive and possess an opioid antagonist pursuant to a standing order, an authorized pharmacist shall, prior to dispensing an opioid antagonist pursuant to a standing order, provide training and education to the recipient that includes, but is not limited to, the information identified in this subrule. An authorized pharmacist shall require the recipient to attest that, if the product will be accessible to any other individual for administration, the recipient will make available to such individual all received training and education materials. An authorized pharmacist may provide to the recipient written materials that include, but may not be limited to, the information identified in this subrule, but it shall not be in lieu of direct pharmacist consultation with the recipient.
	      a.    	  The signs and symptoms of opioid-related overdose as described in the standing order.
	      b.    	  The importance of calling 911 as soon as possible and the potential need for rescue breathing.
	      c.    	  The appropriate use and directions for administration of the opioid antagonist to be dispensed pursuant to the standing order.
	      d.    	  Adverse reactions of the opioid antagonist as well as reactions resulting from opioid withdrawal following administration.
	      e.    	  The proper storage conditions, including temperature excursions, of the opioid antagonist being dispensed.
	      f.    	  The expiration date of the opioid antagonist being dispensed and the appropriate disposal of the opioid antagonist upon expiration.
	      g.    	  The prohibition of the recipient from further distributing the opioid antagonist to another individual, unless that individual has received appropriate training and education.
	      h.    	  Information about substance abuse or behavioral health treatment programs.
	   8.31(6) Labeling. Upon the determination that a recipient is eligible to receive and possess an opioid antagonist, an authorized pharmacist shall label the product pursuant to rule 657—6.10(126,155A) and subrule 8.19(8). An authorized pharmacist shall ensure that the labeling does not render the expiration date of the product illegible. The medication shall be dispensed in the name of the eligible recipient.
	   8.31(7) Reporting. A copy of the assessment form shall be submitted to the department as provided on the assessment form within seven days of the dispensing of the opioid antagonist or within seven days of a denial of eligibility.
	   8.31(8) Records. An authorized pharmacist shall create and maintain an original record of each individual assessment on forms provided by the board, regardless of the eligibility determination following assessment, and dispensing of opioid antagonists pursuant to a standing order. These records shall be available for inspection and copying by the board or its authorized agent for at least two years.
[ ARC 2827C , IAB 11/23/16, effective 11/3/16]