441—114.12(237) Drug utilization and control. The agency shall have and follow written policies and procedures governing the methods of handling prescription drugs and over-the-counter drugs within the facility. No prescription or narcotic drugs are to be allowed in the facility without the authorization of a licensed physician or authorized prescriber.
	114.12(1) Approved drugs. Only drugs which have been approved by the federal Food and Drug Administration for use in the United States may be used. No experimental drugs may be used.
	114.12(2) Prescribed by physician or other authorized prescriber. Drugs shall be prescribed by a physician licensed to practice in the state of Iowa or the state in which the physician is currently practicing, or by an advanced registered nurse practitioner or physician assistant as permitted by Iowa law, and may be prescribed only for use in accordance with dosage ranges and indications approved by the federal Food and Drug Administration.
	114.12(3) Dispensed from a licensed pharmacy. Drugs provided to residents shall be dispensed only from a licensed pharmacy in the state of Iowa in accordance with the pharmacy laws in the Code of Iowa, or from a licensed pharmacy in another state according to the laws of that state, or by a licensed physician.
	114.12(4) Locked cabinet. All drugs shall be maintained in a locked cabinet. Schedule II medications shall be maintained in a locked box within the locked cabinet. The cabinet key shall be in the possession of a staff person. A bathroom shall not be used for drug storage. A documented exception can be made by persons identified in these rules who may allow self-administered drugs as discussed in subrule 114.12(17).
	114.12(5) Medications requiring refrigeration. Medications requiring refrigeration shall be kept in a locked box in the refrigerator and separated from food and other items.
	114.12(6) Poisonous or caustic drugs. All potent poisonous or caustic drugs shall be plainly labeled, stored separately from other drugs in a specific well-illuminated cabinet, closet, or storeroom, and made accessible only to authorized persons.
	114.12(7) Prescribed medications. All prescribed medications shall be clearly labeled indicating the resident’s full name, physician’s name, prescription number, name and strength of the drug, dosage, directions for use and, date of issuing the drug. Medications shall be packaged and labeled according to state and federal guidelines.
	114.12(8) Medication containers. Medication containers having soiled, damaged, illegible or makeshift labels shall be returned to the issuing pharmacist.
	114.12(9) Medication for discharged residents. When a resident is discharged or leaves the facility, the facility shall turn over to a responsible agent Schedule II medications and prescription medications currently being administered. The facility may send nonprescription medications with the child as needed. The facility shall document in the child’s file:
	a. 	The name, strength, dosage form, and quantity of each medication.
	b. 	The signature of the facility staff person who turned over the medications to the responsible agent.
	c. 	The signature of the responsible agent receiving the medications.
	114.12(10) Unused prescription drugs. Unused prescription drugs prescribed for residents may not be kept at the facility for more 15 days after the resident has left the facility. The unused prescription drugs shall be destroyed by the facility executive director or the executive director’s designee in the presence of at least one witness. Outdated, discontinued, or unusable nonprescription medications shall also be destroyed in a similar manner. The person destroying the medication shall document:
	a. 	The resident’s name.
	b. 	The name, strength, dosage form, and quantity of each medication.
	c. 	The date the medication was destroyed.
	d. 	The names and signatures of the witness and staff person who destroyed the medication.
	114.12(11) Refills. Prescriptions shall be refilled only with the permission of the prescriber authorized under Iowa law.
	114.12(12) Use of medications. No prescription medications prescribed for one resident may be administered to or allowed in the possession of another resident.
	114.12(13) Order of authorized prescriber. No prescription medication may be administered to a resident without the order of an authorized prescriber.
	114.12(14) Patient reaction. Any unusual patient reaction to a drug shall be reported to the attending physician or prescriber immediately.
	114.12(15) Dilution or reconstitution of drugs. Dilution or reconstitution of drugs and their labeling shall be done only by a licensed pharmacist.
	114.12(16) Administration of drugs. Medications shall be administered only in accordance with the instructions of the attending physician or authorized prescriber. Medications shall be administered only by staff who have completed a medication management course. The type and amount of the medication, the time and date, and the staff member administering the medication shall be documented in the child’s record.
	114.12(17) Self-administration of drugs. There shall be written policy and procedures relative to self-administration of prescription medications by residents and only when:
	a. 	Medications are prescribed by a physician or other authorized prescriber.
	b. 	The physician or authorized prescriber provides written approval that the patient is capable of participating and can self-administer the drug.
	c. 	What is taken and when is documented in the record of the child.
	114.12(18) Obtaining nonprescription medications. Facilities shall maintain a supply of standard nonprescription medications for use for children residing at the facility. Examples of standard nonprescription medications include cough drops and cough syrups, aspirin substitutes and other pain control medication, poison antidote, and diarrhea control medication.
	a. 	All nonprescription medications kept on the premises for the use of residents shall be preapproved annually by a licensed pharmacist or an authorized prescriber.
	b. 	Facilities shall maintain a list of all preapproved nonprescription medications. The list shall indicate standard uses, standard dosages, contraindications, side effects, and common drug interaction warnings. The facility administrator or the administrator’s designee shall be responsible for determining the scope of the list and brands and types of medications included.
	c. 	Only nonprescription medications on the preapproved list shall be available for use. However, the facility administrator or the administrator’s designee, in consultation with an authorized prescriber or licensed pharmacist, may approve use of a nonprescription medication that is not on the preapproved list for a specific child.
[ARC 4793C, IAB 12/4/19, effective 1/8/20; ARC 6962C, IAB 4/5/23, effective 6/1/23]