Alabama Administrative Code › Title 420 - ALABAMA STATE BOARD OF HEALTH › Chapter 420-5-10 - NURSING FACILITIES › Section 420-5-10-.16 - Pharmacy Services

Current through Register Vol. 42, No. 9, June 28, 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