ARC 8419C

ARC 8419C

Proposing rulemaking related to standards—drugs in emergency medical services programs and providing an opportunity for public comment

A Regulatory Analysis for this rulemaking was published in the Iowa Administrative Bulletin on August 7, 2024. A public hearing was held on the following date(s):

●August 29, 2024

Any persons who intend to attend a public hearing and have special requirements, such as those related to hearing or mobility impairments, should contact the Board and advise of specific needs.

ITEM 1.Adopt the following new481—Chapter 555:

CHAPTER 555

STANDARDS—DRUGS IN EMERGENCY MEDICAL SERVICES PROGRAMS

481—555.1(124,155A) Definitions. The definitions found in 481—Chapter 550 are incorporated by reference into these rules.

481—555.2(124) Registration required. Pursuant to Iowa Code section 124.302, an EMS program that intends to administer controlled substances in or into Iowa will obtain a controlled substances Act registration in accordance with rule 481—551.11(124). The registration will secondarily identify the medical director or pharmacy that owns the controlled substances used at the EMS program, if applicable.

481—555.3(124,155A) Identification.

555.3(1) A log of EMS program personnel who have access to prescription drugs and records will be maintained and include personnel name, unique identification used in program records, and level of certification.

555.3(2) EMS program personnel who are authorized to access replenishment drugs from an AMDS will access the AMDS using unique identification credentials.

481—555.4(124,155A) Policies and procedures. Each EMS program will, in collaboration with the medical director or pharmacy that owns the drugs used at the EMS program, establish and follow policies and procedures for the handling and utilization of prescription drugs and the storage and security of program and drug records.

481—555.5(124,155A) Storage.

555.5(1) Environmental standards. Prescription drugs in the EMS program will be stored in a manner that ensures the drugs are maintained within the environmental requirements provided in the drug labeling. Storage temperatures will be monitored and documented to prevent and detect exposure to extreme temperatures that render the drugs unusable, as determined by the drugs’ manufacturer.

555.5(2) Security. The EMS program will ensure security of prescription drugs and records to prevent and detect unauthorized access.

481—555.6(124,155A) Removal of drugs from program stock.

555.6(1) Prescription drugs will not be administered beyond the labeled expiration date and, no later than the expiration date, will be removed from EMS program stock.

555.6(2) Prescription drugs subject to a product recall will be removed from EMS program stock.

555.6(3) Prescription drugs removed from EMS program stock will be returned to the owner of the drugs, as applicable, for return to stock or for disposal, as appropriate.

481—555.7(124,155A) Administration wastage.

555.7(1) The unused portion of a controlled substance resulting from patient administration may be destroyed by the administering EMS program personnel, the medical director, or a pharmacist pursuant to EMS program policies and procedures.

555.7(2) Documentation of the administration wastage will include:

a.The signatures or unique identifications of the individual wasting and the witness,

b.The name, strength, and quantity of the substance wasted,

c.The date and manner of the wastage,

d.The identification of the patient to whom the substance was partially administered, and

e.The legibly printed first and last name(s) and title(s) of the individual(s) involved who are not identified in the EMS program identification log.

481—555.8(124,155A) Monthly inspections. The medical director or pharmacy that owns the prescription drugs used in the EMS program will ensure the completion and documentation of a monthly inspection of all such drugs maintained at the EMS program and any program substation. Inspection will include the removal of outdated or adulterated drugs. If the drugs are owned by the medical director, the monthly inspection will be conducted by the medical director, or another individual designated by the medical director, and documentation of the inspection will be maintained at the EMS program. If the drugs are owned by the pharmacy, the inspection will be conducted by a pharmacist, or another individual designated by the pharmacist, and documentation of the inspection will be maintained at the pharmacy.

481—555.9(124,155A) Records. Records required by 481—Chapter 553 and these rules will be maintained for at least two years from the date of the record or the last date of employment for personnel records and will be available for inspection and copying by the board or its authorized agent.

These rules are intended to implement Iowa Code sections 124.302 and 147.76 and chapter 155A.