Ala. Admin. Code r. 420-5-17-.20

Current through Register Vol. 43, No. 02, November 27, 2024

Section 420-5-17-.20 - Medical Supplies, Pharmaceuticals And Biologicals

(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

Ala. Admin. Code r. 420-5-17-.20

New Rule: Filed August 20, 1993; effective September 23, 1993. Repealed and New Rule: Filed June 14, 2000; effective July 19, 2000. Amended: Filed June 23, 2004; effective July 28, 2004.

Statutory Authority:Codeof Ala. 1975, §§ 22-21-20, etseq.