Section 481.62.15. Medication management.

         62.15(1) Medications shall be prescribed on an individual basis by one who is authorized by Iowa law to prescribe. (I, II)

            a.               Medication orders shall be correctly implemented by qualified personnel. (II)

            b.               Qualified staff shall ensure that residents are able to take their own medication. (I, II)

            c.               Each physician order allowing a resident to take their own medications shall specify whether this self-medication shall be without supervision or under the supervision of qualified staff as defined in 62.15(2). (I, II)

         62.15(2) 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 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.               Unit dose medication shall remain in the identifiable unit dose package until given to the resident. (II)

            h.               Medications that are not contained in unit dose packaging shall be set up and administered by the same person and must be administered within one hour of preparation. (II)

            i.                The person administering medications must observe and check to make sure the resident swallows oral medications and must record the date, time, amount and name of each medication given. (II)

            j.                Injectable medications shall be administered as permitted by Iowa law by a qualified nurse, physician, pharmacist, or physician assistant (PA).

            k.               Residents certified by their physician as capable of injecting their own insulin may do so. Insulin may be administered pursuant to “j” 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.

            l.                Current and accurate records must be kept on the receipt and disposition of all Schedule II drugs. (II, III)

         62.15(3) For each resident who is taking medication with or without supervision there shall be documentation on the individual’s record to include:

            a.               Name of resident, (II, III)

            b.               Name of drug, dose, and schedule, (II, III)

            c.               Method of administration, (II, III)

            d.               Drug allergies and adverse reactions, (I, II)

            e.               Special precautions, (I, II)

            f.                Documentation of resident’s continuing ability to administer own medication. (I, II)

         62.15(4) Medication counseling shall be provided for all residents in accordance with the IPP on an ongoing basis and as part of discharge planning unless contraindicated in writing by the physician with reasons and pursuant to 62.12(2)“c.” (II, III)

Each resident shall be given verbal and written information about all medications the resident is currently using, including over-the-counter medications. A suggested reference is “USPDI, Advice for the Patient.” (II, III)

The information shall include:

            a.               Name, reason for, and amount of medication to be taken; (II)

            b.               Time medication is to be taken and the reason that schedule was established; (II)

            c.               Possible benefits, risks and side effects of each medication including over-the-counter medications; (II)

            d.               The names of people in the community qualified to answer questions about medications. (II, III)

            e.               A list of available resources or agencies which may assist the resident to obtain medication after discharge. (III)

         62.15(5) 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 bedrooms. Individual locked storage shall be utilized. (II, III)

            b.               Drug storage for residents who are unable to take their own medications and require supervision shall meet the following requirements:

             (1)             Adequate size cabinet with lock which can be used for storage of drugs, solutions, and prescriptions. A locked drug cart may be used. (II, III)

             (2)             A bathroom shall not be used for drug storage. (II, III)

             (3)             The drug storage cabinet shall be kept locked when not in use. (II, III)

             (4)             The drug storage cabinet key shall be in the possession of the employee charged with the responsibility of administering medication. (III)

             (5)             Medications requiring refrigeration which are stored in a common refrigerator shall be kept in a locked box properly labeled, and separated from food and other items. (III)

             (6)             Drugs for external use shall be stored separately from drugs for internal use. External medications are those to be applied to the outside of the body and include but are not limited to salves, ointments, gels, pastes, soaps, baths, and lotions. Internal medications are those to be applied inside the body or ingested and include but are not limited to oral and injectable medications, eye drops, ear drops and suppositories. Also, eye drops and ear drops shall be separated from each other as well as from other internal and external medications. (II, III)

             (7)             All potent, poisonous, or caustic materials shall be stored in a separate room from the medications. (II, III)

             (8)             Inspection of the condition of stored drugs shall be made by the administrator and a licensed 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 need not be limited to, certifying absence of the following: expired drugs, deteriorated drugs, improper labeling, drugs for which there is no current order, and drugs improperly stored. (III)

             (9)             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 seven-day supply and a missing dose can be readily detected but must be kept in a locked medication cabinet. Quantities in excess of a seven-day supply must be double-locked. (II)

            c.               Bulk supplies of prescription drugs shall not be kept. (III)

         62.15(6) Drug safeguards.

            a.               All labels on medications must be legible. If labels are not legible, the medication shall be sent back to the dispenser as defined in Iowa Code section 147.107 for relabeling. (II, III)

            b.               The medication for each resident shall be kept or stored in the original dispensed containers. (II, III)

            c.               The facility shall adopt policies and procedures for the destruction of unused prescription drugs for residents who have died. The policies and procedures shall include, but not be limited to, the following: (III)

             (1)             Drugs shall be destroyed by the person in charge in the presence of the administrator or the administrator’s designee;

             (2)             Notation of the destruction shall be made in the resident’s chart, with signatures of the persons involved in the destruction;

             (3)             The manner in which the drugs are disposed of shall be identified (i.e., incinerator, sewer, landfill). (II, III)

            d.               The facility shall also adopt policies and procedures for the disposal of controlled substances dispensed to residents whose administration has been discontinued by the prescriber. These policies and procedures shall include, but not be limited to, the following:

             (1)             Procedures for obtaining a release from the resident;

             (2)             The manner in which the drugs were destroyed and by whom, including witnesses to the destruction;

             (3)             Mechanisms for recording the destruction;

             (4)             Procedures to be used when the resident or the conservator or guardian refuses to grant permission for destruction. (II, III)

            e.               The facility shall adopt policies and procedures for the disposal of unused discontinued medication. The procedures shall include but not be limited to:

             (1)             A specified time after which medication must be destroyed, sent back to the dispenser or placed in long-term storage;

             (2)             Procedures for obtaining permission of the resident, or the conservator or guardian;

             (3)             Procedures to be used when the resident or conservator or guardian refuses to grant permission for disposal;

             (4)             Unused discontinued medication shall be locked and shall be separate from current medication. (II, III)

            f.                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 facility, in consultation with a physician or pharmacist serving the home, shall institute policies and provide procedures. These shall be provided to all prescribers and pharmacists serving the facility and conveniently located for personnel administering medications. (III)

            g.               Residents shall not keep any prescription medication in their possession 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. Over-the-counter medications may be maintained provided they are in a locked container and pursuant to subrule 62.16(5). (I, II)

            h.               No prescription drugs shall be administered to a resident without a written order signed by a person qualified to prescribe the medication and renewed quarterly. (II)

            i.                Prescription drugs shall be reordered only with the permission of the attending prescriber. (II, III)

            j.                No medications prescribed for one resident may be administered to or allowed in the possession of another. (II)

            k.               Residents on prescribed medication may maintain over-the-counter medication pursuant to 62.15(6)“g” unless contraindicated by the physician. The facility shall request this information from the physician and document in the resident’s record. (II)

         62.15(7) Each facility shall have policies and procedures established to govern the administration of prescribed medications to residents on leave from the facility. (III)

            a.               Medication may be issued to residents who will be on leave from a facility for less than 24 hours. 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.

            b.               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.

            c.               Medication distributed as above may be issued only by facility personnel responsible for administering medication.

         62.15(8) Each RCF/PMI that administers controlled substances shall obtain annually a registration issued by the board of pharmacy pursuant to Iowa Code section 124.302(1). (III)

This rule is intended to implement Iowa Code section 135C.14.

[ARC 1050C, IAB 10/2/13, effective 11/6/13; ARC 2643C, IAB 8/3/16, effective 9/7/16; see Delay note at end of chapter]