Alabama Administrative Code
Title 420 - ALABAMA STATE BOARD OF HEALTH
Chapter 420-5-10 - NURSING FACILITIES
Section 420-5-10-.16 - Pharmacy Services
Universal Citation: AL Admin Code R 420-5-10-.16
Current through Register Vol. 42, No. 5, February 29, 2024
(1) The facility must provide routine and emergency drugs and biologicals to its residents, or obtain them under an agreement described in §483.75(h) of Title 42 Code of Federal Regulations revised 10/1/93.
(a) Procedures. A facility must provide
pharmaceutical services (including procedures that assure the accurate
acquiring, receiving, dispensing, and administering of all drugs and
biologicals) to meet the needs of each resident.
(b) Service consultation. The facility must
employ or obtain the services of a licensed pharmacist who-
1. Provides consultation on all aspects of
the provision of pharmacy services in the facility;
2. Establishes a system of records of receipt
and disposition of all controlled drugs in sufficient detail to enable an
accurate reconciliation; and
3.
Determines that drug records are in order and that an account of all controlled
drugs is maintained and periodically reconciled.
(c) Drug regimen review.
1. The drug regimen of each resident must be
reviewed at least once a month by a licensed pharmacist.
2. The pharmacist must report any
irregularities to the attending physician and the director of nursing, and
these reports must be acted upon.
(d) Storage of drugs and biologicals.
1. In accordance with State and Federal laws,
the facility must store all drugs and biologicals in locked compartments under
proper temperature controls and permit only authorized personnel to have access
to the keys.
2. The facility must
provide separately locked, permanently affixed compartments for storage of
controlled drugs listed in Schedule II of the Comprehensive Drug Abuse
Prevention and Control Act of 1976 and other drugs subject to abuse, except
when the facility uses single unit package drug distribution systems in which
the quantity stored is minimal and a missing dose can be readily
detected.
3. The facility must
maintain readily traceable records of receipt and disposition of all controlled
drugs.
(e) Destruction
of Drugs.
1. The nursing facility develops
policies and procedures for the destruction of drugs and biologicals.
2. Controlled substances and legend drugs
dispensed to residents, that are unused because the medication is discontinued,
or because the resident dies shall be destroyed within 30 days, except unused
legend drugs may be donated to a charitable clinic pursuant to Alabama
Administrative Code Chapter 420-11-11, et. seq.
3. Medications of residents transferred to a
hospital may be retained until the resident is returned to the facility. Upon
return of the resident to the facility, the physician's order will dictate
whether or not the resident is to continue the same drug regimen as previously
ordered. Medications not reordered by the physician must be
destroyed.
4. Medications ordered
to be used on an "as needed" basis shall be destroyed after 90 days if they
have not been used during that period of time. Medications shall be destroyed
upon expiration of the drug.
5.
Both controlled substances and non-controlled substances may be destroyed on
the premises or may be picked up by an environmental agency that provides such
service. Drugs to be destroyed shall not be returned to the drug store for
destruction.
6. Records must be
completed and maintained by the facility that include:
(i) Name and address of the
facility
(ii) Date of
destruction/date drugs picked up
(iii) Method used in destruction (If picked
up by an environmental agency, the record/receipt must indicate the proposed
date and method of destruction.
(iv) Prescription number, name of drug store
from which the medicine was dispensed, resident's name, name and strength of
drug destroyed, amount destroyed and reason for destruction.
7. The pharmacist will verity that
the list of drugs to be destroyed is accurate and with a Registered Nurse, will
carry out destruction. Both will sign the destruction form indicating amounts
listed are correct and have been destroyed. For destruction of controlled
substances there shall be a third witness who may be a law enforcement
official, management or supervisory personnel, i.e., administrator, LPN charge
nurse, etc. If medications are to be picked up and destroyed by an
environmental agency, the RN should verify the list of drugs to be destroyed
and should obtain a signed copy of the destruction form as a receipt.
8. If records of destruction are maintained
in resident's medical record, they must be retained for as long as the medical
record is kept. If a separate file of destruction records is to be maintained,
they must be retained for a period of not less than two years.
(f) Labeling of Drugs and
Biologicals.
1. All containers of medicines
and drugs shall be properly and plainly labeled, including name and strength of
drug, resident's name, ordering physician, date of filling, directions for
administration, prescription number, expiration date, number of tablets or
capsules sent and any necessary auxiliary labels. The prescription label shall
conform with any additional federal, state and local requirements.
2. Use of and labeling of generic drugs shall
comply with State Board of Pharmacy requirements.
3. When authorized substitution of a drug
takes place, there will be established policies and procedures to provide
accurate identification.
4.
Over-the-counter (non-prescription) medicines shall be plainly labeled with the
name and strength of the drug. Additional labeling information may be at the
discretion of the facility as related in its policies and procedures except
that manufacturer's labeling information must be present in the absence of
prescription labeling.
5. The
contents of all individual prescriptions shall be kept in the original
dispensed container bearing the original prescription label.
6. Procedures shall be developed to assure
proper control and labeling for medications provided a resident upon leaving
the facility on a temporary absence.
7. Unit dose medications shall be packaged
according to an acceptable format to include product name, strength, control
number, and expiration date. Procedures for utilization of the system used are
developed and approved by administration, nursing and pharmacy personnel and
must comply with federal and state regulations.
(g) Emergency medication kits will be kept in
accordance with Chapter 680-X-2 of the Alabama State Board of Pharmacy Rules
and Regulations governing institutional pharmacies.
1. Emergency kits may contain controlled
substances utilizing the following conditions:
(i) The source from which a long term care
facility may obtain controlled substances must be a DEA registered pharmacy or
practitioner.
(ii) There shall be a
maximum three day supply of any controlled substance stocked in the emergency
kit.
(iii) The responsibility for
proper control and accountability of the emergency kit shall rest with both the
nursing facility and the DEA registrant providing the drug. The facility and
the drug provider shall maintain complete and accurate records of the
controlled substances placed in the emergency kit including receipt and
disposition of the drugs as well as destruction of unused or outdated drugs
where appropriate.
(iv) Adequate
security measures shall be provided for the emergency kit (if the controlled
drugs are to be maintained within the kit) or the drugs (if they are to be
maintained in a separate area) to include double locks. Access to emergency
drugs shall be limited to those with an actual need, i.e., medication nurse
and/or director of nurses and the pharmacist.
(v) Controlled drugs maintained for emergency
use may be used only upon the written or telephone orders of the attending
physician, who must sign a telephone order as soon as possible after giving
it.
(vi) Violations in these rules
and regulations may result in the revocation, denial or suspension of the
privilege of maintaining controlled substance drugs in the emergency
kit.
(h)
"Stat" Medicine Cabinets
1. Each nursing
facility may maintain one "stat" medicine cabinet for the purpose of keeping a
minimum amount of stock medications that may be needed quickly or after regular
duty hours. If a facility wants more than one "stat" medicine cabinet, it must
be approved by the State Board of Health. The following rules apply to such a
cabinet:
(i) There shall be a minimum number
of doses of any medication in the "stat" cabinet based upon the established
needs of the facility.
(ii) There
must be a list of contents, approved by the nursing facility, giving the name
and strength of the drug and the quantity of each.
(iii) There shall be records available to
show amount received, name of resident and amount used, prescribing physician,
time of administration, name of individual removing and using the medication
and the balance on hand.
(iv) There
shall be written procedures for utilization of the "stat" medicine cabinet with
provisions for prompt replacement of used items.
(v) The pharmacist shall inspect the "stat"
medicine cabinet at least monthly replacing outdated drugs and reconciliation
of its prior usage. Information obtained shall be included in a monthly report.
Author: Patricia E. Ivie
Statutory Authority: Code of Ala. 1975, §§ 22-21-20, et seq.
Disclaimer: These regulations may not be the most recent version. Alabama may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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