481—57.19 (135C) Drugs.
	 57.19(1) Drug storage.
	  a.   	 Residents who have been certified in writing by the physician as capable of taking their own medications, may retain these medications in their bedroom but locked storage must be provided. (III)
	  b.   	 Drug storage for residents who are unable to take their own medications and require supervision shall meet the following requirements:
	 (1) 	 A cabinet with a lock shall be provided which can be used for storage of drugs, solutions, and prescriptions; (III)
	 (2) 	 A bathroom shall not be used for drug storage; (III)
	 (3) 	 The drug storage cabinet shall be kept locked when not in use; (III)
	 (4) 	 The drug storage cabinet key shall be in the possession of the employee charged with the responsibility of administering medications; (II)
	 (5) 	 Schedule II drugs, as defined by Iowa Code chapter 204, shall be kept in a locked box within the locked medication cabinet; (II, III)
	 (6) 	 Medications requiring refrigeration shall be kept in a refrigerator and separated from food and other items; (III)
	 (7) 	 Drugs for external use shall be stored separately from drugs for internal use; (III)
	 (8) 	 All potent, poisonous, or caustic materials shall be stored separately from drugs. They shall be plainly labeled and stored in a specific, well-illuminated cabinet, closet, or storeroom and made accessible only to authorized persons; (I, II)
	 (9) 	 The drug cabinet shall have a work counter. Both the counter and cabinet shall be well-lighted; (III)
	 (10) 	 Running water shall be available in the room in which the medicine cabinet is located or in an adjacent room; (III)
	 (11) 	 Inspection of drug storage condition shall be made by the administrator and a registered pharmacist not less than once every three months. The inspection shall be verified by a report signed by the administrator and the pharmacist and filed with the administrator. The report shall include, but not be limited to, certifying absence of the following: expired drugs, deteriorated drugs, improper labeling, drugs for which there is no current physician’s order, and drugs improperly stored. (III)
	 (12) 	 Double-locked storage of Schedule II drugs shall not be required under single-unit package drug distribution systems in which the quantity stored does not exceed a three-day supply and a missing dose can be readily detected. (II)
	  c.   	 Bulk supplies of prescription drugs shall not be kept in a residential care facility unless a licensed pharmacy is established in the facility under the direct supervision and control of a pharmacist. (III)
	 57.19(2) Drug safeguards.
	  a.   	 All prescribed medications shall be clearly labeled indicating the resident’s full name, physician’s name, prescription number, name and strength of drug, dosage, directions for use, date of issue, and name and address and telephone number of pharmacy or physician issuing the drug. Where unit dose is used, prescribed medications shall, as a minimum, indicate the resident’s full name, physician’s name, name and strength of drug, and directions for use. Standard containers shall be utilized for dispensing drugs. Paper envelopes shall not be considered standard containers. (III)
	  b.   	 Medication containers having soiled, damaged, illegible, or makeshift labels shall be returned to the issuing pharmacist, pharmacy, or physician for relabeling or disposal. (III)
	  c.   	 The medication for each resident shall be kept or stored in the original containers. (II, III)
	  d.   	 When a resident is discharged or leaves the facility, the unused prescription shall be sent with the resident or with a legal representative only upon the written order of a physician. (III)
	  e.   	 Unused prescription drugs prescribed for residents who have died shall be destroyed by the person in charge with a witness and notation made on the resident’s record, or, if a unit dose system is used, such drugs shall be returned to the supplying pharmacist. (III)
	  f.   	 Prescriptions shall be refilled only with the permission of the attending physician. (II, III)
	  g.   	 No medications prescribed for one resident may be administered to or allowed in the possession of another resident. (II)
	  h.   	 Instructions shall be requested of the Iowa board of pharmacy examiners concerning disposal of unused Schedule II drugs prescribed for residents who have died or for whom the Schedule II drug was discontinued. (III)
	  i.   	 There shall be a formal routine for the proper disposal of discontinued medications within a reasonable but specified time. These medications shall not be retained with the resident’s current medications. Discontinued drugs shall be destroyed by a responsible person with a witness and notation made to that effect or returned to the pharmacist for destruction or resident credit. Drugs listed under the Schedule II drugs shall be disposed of in accordance with the provisions of the Iowa board of pharmacy examiners. (II, III)
	  j.   	 All medication orders which do not specifically indicate the number of doses to be administered or the length of time the drug is to be administered shall be stopped automatically after a given time period. The automatic stop order may vary for different types of drugs. The personal physician of the resident, in conjunction with the pharmacist, shall institute these policies and provide procedures for review and endorsement. (II, III)
	  k.   	 No resident shall be allowed to keep possession of any medications unless the attending physician has certified in writing on the resident’s medical record that the resident is mentally and physically capable of doing so. (II)
	  l.   	 No medications or prescription drugs shall be administered to a resident without a written order signed by the attending physician. (II)
	  m.   	 Each facility shall establish a policy in conjunction with a licensed pharmacist to govern distributing prescribed medication to residents who are on leave from a facility. (III)
	 (1) 	 Medication may be issued to residents who will be on leave from a facility for less than 24 hours. Notwithstanding the prohibition against paper envelopes in 57.19(2)“a,” non-child-resistant containers may be used. Each container may hold only one medication. A label on each container shall indicate the date, the resident’s name, the facility, the medication, its strength, dose, and time of administration.
	 (2) 	 Medication for residents on leave from a facility longer than 24 hours shall be obtained in accordance with requirements established by the Iowa board of pharmacy examiners.
	 (3) 	 Medication distributed as above may be issued only by facility personnel responsible for administering medication.
	 57.19(3) Drug administration.
	  a.   	 A properly trained person shall be charged with the responsibility of administering nonparenteral medications.
	  b.   	 The individual shall have knowledge of the purpose of the drugs, their dangers, and contraindications.
	  c.   	 This person shall be a licensed nurse or physician or shall have successfully completed a department-approved medication aide course or passed a department-approved medication aide challenge examination administered by an area community college.
	  d.   	 Prior to taking a department-approved medication aide course, the individual shall:
	 (1) 	 Successfully complete an approved residential aide course, nurse aide course, nurse aide training and testing program or nurse aide competency examination;
	 (2) 	 Be employed in the same facility for at least six consecutive months prior to the start of the medication aide course. This requirement is not subject to waiver.
	 (3) 	 Have a letter of recommendation for admission to the medication aide course from the employing facility.
	  e.   	 A person who is a nursing student or a graduate nurse may take the challenge examination in place of taking a medication aide course. This individual shall do all of the following before taking the medication aide challenge examination:
	 (1) 	 Complete a clinical or nursing theory course within six months before taking the challenge examination;
	 (2) 	 Successfully complete a nursing program pharmacology course within one year before taking the challenge examination;
	 (3) 	 Provide to the community college a written statement from the nursing program’s pharmacology or clinical instructor indicating the individual is competent in medication administration.
	  f.   	 A person who has written documentation of certification as a medication aide in another state may become a medication aide in Iowa by successfully completing a department-approved nurse aide competency examination and a medication aide challenge examination.
The requirements of paragraph “d” of this subrule do not apply to this individual.
	  g.   	 Unless the unit dose system is used, the person assigned the responsibility of medication administration must complete the procedure by personally preparing the dose, observing the actual act of swallowing the oral medication, and charting the medication. (II) In facilities where the unit dose system is used, the person assigned the responsibility must complete the procedure by observing the actual act of swallowing the medication and charting the medication. Medications shall be prepared on the same shift of the same day that they are administered, (II) unless the unit dose system is used.
	  h.   	 Injectable medications shall be administered by a qualified nurse or physician.
	  i.   	 Residents certified by their physician as capable of injecting their own insulin may do so. Insulin may be administered pursuant to “h” above or as otherwise authorized by the resident’s physician. Authorization by the physician shall:
	 (1) 	 Be in writing,
	 (2) 	 Be maintained in the resident’s record,
	 (3) 	 Be renewed quarterly,
	 (4) 	 Include the name of the individual authorized to administer the insulin,
	 (5) 	 Include documentation by the physician that the authorized person is qualified to administer insulin to that resident.
	  j.   	 An individual inventory record shall be maintained for each Schedule II drug prescribed for each resident. (II)
	  k.   	 The unit dose system may be used by the facility.
	  l.   	 In a freestanding residential care facility licensed for 15 or fewer beds, a person who has successfully completed a state-approved medication manager course may administer medications.