Alabama Administrative Code
Title 420 - ALABAMA STATE BOARD OF HEALTH
Chapter 420-5-17 - HOSPICES
Section 420-5-17-.20 - Medical Supplies, Pharmaceuticals And Biologicals
Universal Citation: AL Admin Code R 420-5-17-.20
Current through Register Vol. 42, No. 11, August 30, 2024
(1) Each hospice care program shall arrange for provision of medical supplies, appliances, drugs, and biologicals to patients as needed for the palliation and management of the patient's terminal illness and related conditions. The program shall ensure that drugs and biologicals can be obtained at all times.
(2) Each hospice care program shall ensure that instruction is provided to patient and/or family regarding proper administration of drugs and biologicals and their side effects with documentation in the patient's record.
(3) The inpatient hospice has written policies and procedures, developed with the advice of a pharmacist, which ensures that drugs and biologicals are obtained for patients on a timely basis, they are dispensed and administered according to all federal, state and local laws, and provide for appropriate handling and control of all drugs and biologicals. Whether drugs or biologicals are obtained from community or institutional pharmacies or stocked by the hospice, the hospice is responsible for ensuring the availability of such drugs or biologicals for its patients and that pharmaceutical services are provided in accordance with accepted professional principles and all appropriate federal, state and local laws.
(4) All policies and procedures shall be reviewed and updated at least annually by at least a pharmacist, the director of nursing services, the manager and one physician.
(5) Supervision of services in the inpatient hospice. Pharmaceutical services are under the general supervision of a qualified, registered pharmacist. The pharmacist may serve the inpatient hospice on a full-time, part-time, or consultant basis.
(a) If the pharmacist is not employed
full-time, a sufficient number of hours are devoted on a regularly scheduled
visit to carry out all responsibilities. The number of hours devoted are based
on the size and needs of the hospice.
(b) The pharmacist reviews the drug regimen
of each patient on admission, every 14 days and reports any irregularities to
the individual who is authorized to make a change.
(c) The pharmacist submits a written report
each month to the medical director, director of nurses, and the manager that
defines his/her activities, drug regimen review result findings and
recommendations. There shall be documented evidence by the director of nurses
and/or the manager as to corrective action taken.
(6) Hospice Pharmacy. If the hospice has a pharmacy, a licensed pharmacist is employed to administer the pharmacy.
(a) Facilities without a pharmacy
must have provisions for promptly and conveniently obtaining prescribed drugs
and biologicals from community or institutional pharmacies.
(b) In facilities without a pharmacy but
maintaining a supply of drugs, the pharmacist is responsible for assuring the
control of all drugs and the maintenance of readily reconcilable records of
receipt and disposition.
(7) Control and Accountability. All hospices shall have written policies and procedures for the control and accountability of all drugs and biologicals throughout the hospice to prevent unauthorized use and/or distribution. Drugs and biologicals used in the hospice are obtained and dispensed and/or destroyed in compliance with federal and state laws.
(a) Hospices using experimental
drugs or biologicals shall have written procedures governing their use which
are in compliance with all laws relative to their use.
(b) The inpatient hospice shall have readily
available records of receipt and disposition (for all controlled drugs) that
provide sufficient detail to enable an accurate reconciliation.
(c) The inpatient hospice shall maintain
readily traceable control records of schedule II and III drugs which lists on
individual patient's records each type and strength of drug used along with the
following information: date, time administered, name of patient, dose,
physician's name, signature of person administering the dose and balance on
hand.
(d) The individual medication
record may serve as a record of receipt and disposition of controlled drugs
listed in schedule IV and V and drugs not subject to frequent abuse as well as
non-controlled drugs.
(8) Destruction of Drugs. Each hospice program develops written policies and procedures for the destruction of drugs and biologicals when those drugs are no longer needed by the patient. Controlled substances and legend drugs dispensed to patients, that are unused because the medication is discontinued, or because the patient 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.
(a) Discontinued medications and
medications of discharged, deceased and transferred patients in the inpatient
hospice shall be destroyed within a reasonable period of time not to exceed 30
days.
(b) Medications of patients
transferred from a home care hospice to a hospital or inpatient hospice may be
retained until the patient has returned. The physician's order will dictate
whether or not the patient is to use the same drug regimen as previously
ordered. Medications not ordered by the physician should be handled in
accordance with the hospice policy regarding medication destruction.
(c) Destruction of outdated, unused or
discontinued medications for patients, discharged patients, deceased patients,
or patients transferred to another hospice shall be carried out on the premises
of the inpatient hospice.
(d)
Destruction records of controlled substances in the inpatient hospice must be
completed to include:
1. Name and address of
hospice.
2. Date of
destruction.
3. Method used in
destruction.
4. Prescription
number, name of drugstore from which the medicine was dispensed, patient's
name, name and strength of drug destroyed, amount destroyed and reason for
destruction.
(e) The
pharmacist will verify that the list of drugs to be destroyed is accurate and
with the director of nurses or assistant director of nurses, will carry out
destruction. Both shall sign the destruction form indicating amounts listed are
correct and have been destroyed. There shall be a third witness who may be a
law enforcement official, management or supervisory personnel, i.e., manager,
LPN charge nurse, etc. Copies of destruction records will be maintained by the
pharmacist and the hospice.
(f)
When destruction of medications is conducted within the patient's home by the
hospice nurse, this procedure shall be witnessed by one or more
persons.
(g) When medications are
destroyed, a destruction record shall be completed for each drug destroyed and
placed in the patient's completed medical record.
(h) If a separate file of destruction records
is to be maintained, they must be retained for a period of not less than two
years.
(i) In an inpatient hospice
legend drugs and over-the-counter drugs that are not controlled drugs may be
destroyed in the same way as controlled drugs. The exception would be when the
pharmacist and director of nurses or assistant director of nurses verify and
destroy medications, a third person is not required. The records and filing
shall be the same as for controlled drugs.
(9) Labeling of Drugs and Biologicals. All containers of medicines and drugs shall be properly and plainly labeled, including name and strength of drug, patient's name, ordering physician, date of filing, 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.
(a) Use of and
labeling of generic drugs shall comply with State Board of Pharmacy
requirements.
(b) When authorized
substitution of a drug takes place, the medication administration record and
the label of the medication must contain the name of the actual drug dispensed
in accordance with state pharmacy law.
(c) When over-the-counter (non-prescription)
medicines and drugs are maintained for inpatient hospice patients, each
medication shall be plainly labeled with the patient's name, the name and
strength of the drug, and the expiration date. Additional labeling information
may be at the discretion of the hospice as related in its policies and
procedures except that manufacturer's labeling information must be present in
the absence of prescription labeling. Over-the-counter medications
(non-prescription) to be maintained as stock by the inpatient hospice shall be
labeled with the name and strength of the drug, lot and control number, and
expiration date except in those cases where the manufacturer's label is
present.
(d) In the inpatient
hospice the contents of all individual prescriptions shall be kept in the
original container bearing the original label.
(e) Procedures shall be developed to assure
proper control and labeling for medications provided a patient upon leaving the
inpatient hospice on a temporary absence.
(f) 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 management, nursing and pharmacy personnel and must
comply with federal and state requirements.
(10) Administration of Medicines and Drugs.
(a) Drugs are administered only
by licensed nursing personnel or following instruction, the patient and his
family in accordance with all federal, state and local laws.
(b) Drugs and biologicals shall not be
administered to patients unless ordered by a physician duly licensed to
prescribe drugs. Such orders shall be in writing over the physician's
signature. Medications, including over-the-counter (OTC) medications such as
aspirin, bufferin, tylenol, mild laxatives, gargles, ointments, etc., may be
administered from a "standing physician's order" provided that they shall be
reduced to writing on the physician's order sheet, signed by the individual
transcribing the order, and signed and dated by the ordering
physician.
(c) The method of
medication administration for all inpatient hospices shall ensure:
1. Patients are accurately identified prior
to administration of a drug.
2.
Physicians' orders are checked at least daily to assure that changes are
noted.
3. Drugs and biologicals are
administered as soon as possible after doses are prepared not to exceed two (2)
hours and they are administered by the same person who prepared the doses for
administration, except when unit dose systems or similar systems are used where
a licensed pharmacist has prepared the dose for administration.
4. Each patient has an individual medication
administration record (MAR) on which the dose of each drug administered shall
be properly recorded by the person administering the drug to include:
(i) Name, strength and dosage of the
medication.
(ii) Method of
administration to include site if applicable.
(iii) Times of administration.
(iv) The initials of persons administering
the medication, except that the initials shall be identified on the MAR to
identify the individual by name.
(v) Medications administered on a "PRN" or as
needed basis shall be recorded in a manner as to explain the reason for
administration and the results obtained. The hospice shall have a procedure to
define its methods of recording these medications.
(vi) Medications brought to the hospice by
the patient or other individuals for use by that patient shall be positively
identified as to name and strength, properly labeled, stored in accordance with
facility policy and shall be administered to the patient only upon the written
orders of the attending physician.
(vii) Medications shall not be retained at
the patients' bedside nor shall self-administration be permitted except when
ordered by the physician. These medications will be appropriately labeled and
safety precautions taken to prevent unauthorized usage.
(viii) Medication errors and drug reactions
are immediately reported to the director of nurses, pharmacist and physician
and an entry made in the patients' medical record and/or an incident report.
This procedure shall include recording and reporting to the physician the
failure to administer a drug and/or the refusal of a patient to take a
drug.
(d) The
nurses' station or medicine room for all inpatient hospices shall have readily
available items necessary for the proper administration and accounting of
medications. Equipment would include items such as tablet counters, graduated
measuring device, mortar and pestle (or other method to provide aseptic
technique for the crushing of medications), medicine cups, drinking cups,
sterile syringes and needles for injectables, etc.
(e) Each hospice shall have available current
reference materials that provide information on the use of drugs, side effects
and adverse reactions to drugs, and the interactions between drugs.
(11) Conformance with Physicians' Drug Orders. Each inpatient hospice shall have a procedure for at least quarterly monitoring of medication administration. This monitoring may be accomplished by a registered professional nurse or a pharmacist to assure accurate administration and recording of all medications.
(a) Each hospice shall establish procedures
for release of medications upon discharge or transfer of the patient.
Medications shall be released upon discharge or transfer only upon written
authorization of the attending physician. An entry of such release shall be
entered in the medical record to include drugs released, amounts, who received
the drugs, and signature of the person carrying out the release.
(12) Storage of Drugs and Biologicals. Procedures for storing and disposing of drugs and biologicals shall be established and implemented by the inpatient hospice.
(a) There shall be a drug or medicine
room/drug preparation area at each nurses' station of sufficient size for the
orderly storage of drugs, both liquid and solid dosage forms, and for the
preparation of medications for patient administration within the unit. In the
event that a drug cart is used for storage and administration of drugs, the
room shall be of sufficient size for storage of the cart without crowding.
1. Each drug preparation area shall have, as
a minimum, 80 square feet of floor space with an additional square foot for
each bed in excess of 50 beds per unit. Where the hospice uses a drug cart for
the storage, preparation, and administration of medications, there shall be a
storage area of sufficient size to accommodate placement of the cart.
2. There shall be a separate area or cubicle
for the storage of each patient's medications, except where a cart is used for
the administration of drugs and biologicals.
3. There shall be an operable sink provided
with hot and cold water within the medicine room or medication preparation area
for washing hands or cleaning containers used in medicine preparation. Paper
towels and soap dispenser shall be provided.
4. Sufficient artificial lighting shall be
provided and the temperature of the medicine storage area shall not be lower
than 48 degree F. or above 85 degree F. and the room must be provided with
adequate ventilation.
5. Drugs and
biologicals, including those requiring refrigeration, shall be stored within
the medicine room or shall have separate locks if outside the medicine room.
The refrigerator shall have a thermometer and be capable of maintaining drugs
at the temperature recommended by the manufacturer of the drug.
6. No foods may be stored in the same storage
area (i.e., cupboard, refrigerator, or drawer) with drugs and biologicals. The
areas designated for drug and biological storage should be clearly
marked.
7. Medication refrigerators
shall not be used to store laboratory solutions or materials awaiting
laboratory pickup.
8. Controlled
substances listed in the Comprehensive Drug Abuse Prevention and Control Act of
1970 and its subsequent amendments, and other drugs subject to abuse, shall be
stored in separately locked, permanently affixed compartments provided for that
purpose, except under single unit package drug distribution systems in which
the quantity stored is minimal and a missing dose can be readily detected and
where drugs are stored on a drug cart.
9. The drug or medicine rooms shall be
provided with safeguards to prevent entrance of unauthorized persons including
locks on doors and bars on accessible windows.
10. Only authorized, designated personnel
shall have access to the medicine storage area.
(b) Pharmacy. If a pharmacy is to be
constructed within an inpatient hospice, plans shall be submitted to the
Alabama Department of Public Health for approval.
1. The pharmacy shall comply with the rules
and regulations of the Alabama State Board of Pharmacy governing physical and
licensing requirements of a pharmacy.
(c) Poisonous substances and/or "external use
only" drugs must be plainly labeled and stored separate from drugs and
biologicals. No poisonous substance shall be kept in the following areas:
kitchen and dining area or any public spaces or rooms. This section shall not
prohibit storage within the drug or medicine room of approved poisonous
substances intended for legitimate medicinal use, provided that such substances
are properly labeled in accordance with applicable federal and state
law.
(d) First aid supplies shall
be kept in a place readily accessible to the person or persons providing care
in the inpatient hospice.
(e)
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. The contents of
this kit will be determined by the medical staff and approved by the hospice.
The kit shall be stocked only with drugs of an emergency nature and shall not
be used as a routine source of supply for non-emergency medications.
2. There shall be a list of contents attached
to or placed inside the emergency kit stating the name and strength of the drug
and quantities/amounts available. This list shall also contain supplies and/or
equipment available in the kit.
3.
There shall be written procedures for removal of drugs from the kit, records to
be kept, method of charging for medications, and ready replacement of removed
items.
4. The pharmacist shall
inspect the emergency kit at least monthly and assure removal and replacement
of any outdated medications.
5. Any
discrepancies noted in the emergency kit shall be reported to the director of
nurses and manager through the pharmacist's monthly report.
6. Procedures shall outline the method for
obtaining emergency medications which are not stocked in the emergency
kit.
7. Emergency medication kits
may contain controlled substances utilizing the following conditions:
(i) The source from which a hospice may
obtain controlled substances must be a DEA registered pharmacy or
practitioner.
(ii) There shall be a
maximum of three doses of any controlled substance stocked in the emergency
kit.
(iii) The responsibility for
proper control and accountability of the emergency medication kit shall rest
with both the inpatient hospice and the DEA registrant providing the drug. The
hospice 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 medication 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 it has
been given.
(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.
(f) Each
hospice 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. The following rules apply to such a cabine:
1. There shall be a minimum number of doses
of any medication in the "STAT" cabinet based upon the established needs of the
hospice.
2. There must be a list of
contents, approved by the inpatient hospice, giving the name and strength of
drug and the quantity of each.
3.
There shall be records available to show amount received, name of patient and
amount used, prescribing physician, time of administration, name of individual
removing and using the medication, and the balance on hand.
4. There shall be written procedures for
utilization of the "STAT" medicine cabinet with provisions for prompt
replacement of used items.
5. 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: Jimmy D. Prince
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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