Iowa Administrative Code
Agency 481 - Inspections and Appeals Department
Inspections Division
Chapter 63 - Residential Care Facility-three- to Five-bed Specialized License
Rule 481-63.16 - Drugs
Universal Citation: IA Admin Code 481-63.16
Current through Register Vol. 47, No. 6, September 18, 2024
(1)Drug storage.
a. Residents who have been
certified in writing by their primary care provider as capable of taking their
own medications may retain these medications in their bedroom, but locked
storage must be provided, with staff and the resident having access, and the
drug storage shall be kept locked when not in use. Monitoring of the storage,
administration, and documentation by the resident shall be carried out by a
person who meets the requirements of subrule 63.16(3) and is responsible for
administering medications. (II, III)
b. Drug storage for residents who are unable
to take their own medications and require supervision shall meet the following
requirements:
(1) Locked storage for drugs,
solutions, and prescriptions shall be provided. (Ill)
(2) A bathroom shall not be used for drug
storage. (Ill)
(3) The drug storage
shall be kept locked when not in use. (Ill)
(4) The drug storage key shall be secured and
available only to those employees charged with the responsibility of
administering medications. (II, III)
(5) Schedule II drugs, as defined by Iowa
Code chapter 124, shall be kept in a locked box within the locked drug storage.
(II, III)
(6) Medications requiring
refrigeration shall be kept locked in a refrigerator and separated from food
and other items. (II, III)
(7)
Drugs for external use shall be stored separately from drugs for internal use.
(II, III)
(8) All potent,
poisonous, or caustic materials shall be stored separately from drugs, shall be
plainly labeled and stored in a specific, well-illuminated cabinet, closet, or
storeroom, and shall be made accessible only to authorized persons. (I,
II)
(9) Inspection of drug storage
shall be made by the administrator or designee 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, certification
of the absence of the following: expired drugs, deteriorated drugs, improper
labeling, drugs for which there is no current primary care provider's order,
and drugs improperly stored. (Ill)
(10) Bulk supplies of prescription drugs for
multiresident use shall not be kept in a residential care facility.
(Ill)
(2) Drug safeguards.
a. All
prescribed medications shall be clearly labeled indicating the resident's full
name, primary care provider'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 primary care provider issuing the drug. Where
unit dose is used, prescribed medications shall, at a minimum, indicate the
resident's full name, primary care provider's name, name and strength of drug,
and directions for use. Standard containers shall be utilized for dispensing
drugs. (Ill)
b. Sample medications
provided by the resident's primary care provider shall clearly identify to whom
the medications belong. (Ill)
c.
Medication containers having soiled, damaged, illegible, or makeshift labels
shall be returned to the issuing pharmacist, pharmacy, or primary care provider
for relabeling or disposal. (Ill)
d. The medication for each resident shall be
kept or stored in the original containers unless the resident is participating
in an individualized medication program. (II, III)
e. Unused prescription drugs shall be
destroyed by the person in charge, in the presence of a witness, and with a
notation made on the resident's record or shall be returned to the supplying
pharmacist. (Ill)
f. Prescriptions
shall be refilled only with the permission of the resident's primary care
provider. (II, III)
g. Medications
prescribed for one resident shall not be administered to or allowed in the
possession of another resident. (I, II)
h. Instructions shall be requested from the
Iowa board of pharmacy concerning disposal of unused Schedule II drugs
prescribed for a resident who has died or for whom the Schedule II drug was
discontinued. (Ill)
i. Discontinued
medications shall be destroyed within a specified time by a responsible person,
in the presence of a witness, and with a notation made to that effect or shall
be returned to the pharmacist for destruction. Drugs listed under the Schedule
II drugs shall be destroyed in accordance with the requirements established by
the Iowa board of pharmacy. (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 resident's primary care provider, 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 possess any medications unless the primary care
provider 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 primary
care provider. (II)
m. The facility
shall establish a policy to govern the distribution of prescribed medications
to residents who are on leave from the facility. (II, III)
(1) Medications may be issued to residents
who will be on leave from a facility for less than 24 hours. Only those
medications needed for the time period that the resident will be on leave from
the facility may be issued. Non-child-resistant containers may be used.
Instructions shall be provided and include the date, the resident's name, the
name of the facility, and the name of the medication, its strength, dose and
time of administration. (II, III)
(2) Medication for residents on leave from a
facility for longer than 24 hours shall be obtained in accordance with
requirements established by the Iowa board of pharmacy. (II, III)
(3) Medication for residents on leave from a
facility may be issued only by facility personnel responsible for administering
medication. (II, III)
(3) Drug administration -authorized personnel.
a. A
properly trained person shall be charged with the responsibility of
administering medications as ordered by a primary care provider. (II,
III)
b. The person shall have
knowledge of the purpose of the drugs and their dangers and contraindications.
(II, III)
c. The person shall be a
licensed nurse or primary care provider or an individual who has completed the
state-approved training course in medication administration, including a
medication manager or certified medication aide. (II, III)
d. Prior to taking a department-approved
medication aide course, the person shall have a letter of recommendation for
admission to the medication aide course from the employing facility.
(Ill)
e. A person who is a nursing
student or a graduate nurse may take the medication aide challenge examination
in place of taking a course. The person shall do all of the following before
taking the challenge examination:
(1) Complete
a clinical or nursing theory course within six months before taking the
challenge examination; (III)
(2)
Successfully complete a nursing program pharmacology course within one year
before taking the challenge examination; (III)
(3) Provide to the community college a
written statement from the nursing program's pharmacology or clinical
instructor indicating that the person is competent in medication
administration. (Ill)
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 63.16(3)
"d" do not apply to this person. (Ill)
(4) Drug administration.
a. 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. In facilities
where the unit dose system is used, the person assigned the responsibility of
medication administration must complete the procedure by observing the actual
act of swallowing the oral medication and by charting the medication.
Medications shall be prepared on the same shift of the same day that they are
administered unless the unit dose system is used. (II)
b. Injectable medications shall be
administered as permitted by Iowa law by a registered nurse, licensed practical
nurse, primary care provider or pharmacist. For purposes of this subrule,
"injectable medications" does not include an epinephrine autoinjector, e.g., an
EpiPen. (II, III)
c. A resident
certified by the resident's primary care provider as capable of injecting the
resident's own insulin may do so. Insulin may be administered pursuant to
paragraph 63.16(4)"b" or as otherwise authorized by the
resident's primary care provider. (II, III) Authorization shall:
(1) Be in writing,
(2) Be maintained in the resident's
record,
(3) Be renewed
quarterly,
(4) Include the name of
the person authorized to administer the insulin,
(5) Include documentation by the primary care
provider that the authorized person is qualified to administer insulin to that
resident. (II, III)
d. A
resident may participate in the administration of the resident's own medication
if the primary care provider has certified in writing in the resident's medical
record that the resident is mentally and physically capable of participating
and has explained in writing in the resident's medical record what the
resident's participation may include.
e. An individual inventory record shall be
maintained for each Schedule II drug prescribed for each resident, with an
accurate count and authorized signatures at every shift. (II)
f. The facility may use a unit dose
system.
g. Medication aides and
medication managers may administer PRN medications without contacting a
licensed nurse or primary care provider if all of the following apply: (I, II,
III)
(1) A written order from the resident's
primary care provider specifies the purpose of the PRN medication and the
frequency, dosage and strength of the PRN medication.
(2) The resident's primary care provider
provides in writing specific criteria for administering PRN
medications.
(3) The pharmacist
assesses the resident's use of PRN medications when conducting the inspection
of drug storage as required by subparagraph
63.16(1)"b"(9).
h. The pharmacist shall assess the use of PRN
medications when conducting the inspection of drug storage as required by
subparagraph 63.16(1)"b"(9). (II, III)
i. Medications administered by an employee of
the facility shall be recorded on a medication record by the individual who
administers the medication. (I, II, III)
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