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007.05.10-16. Pharmacy.

AR ADC 007.05.10-16Arkansas Administrative CodeEffective: June 17, 2024

West's Arkansas Administrative Code

Title 007. Department of Health

Division 05. Health Facility Services

Rule 10. Rules for Critical Access Hospitals in Arkansas (Refs & Annos)

Effective: June 17, 2024

Ark. Admin. Code 007.05.10-16

007.05.10-16. Pharmacy.

Currentness

All hospitals shall have adequate provision for pharmaceutical services regarding the procurement, storage, distribution and control of all medications. There shall be compliance with all federal and state regulations, including Laws and Regulations -- Arkansas State Board of Pharmacy.

A. Definitions.

1. Hospital Pharmacy means the place or places in which drugs, chemicals, medicines, prescriptions or poisons are prepared for distribution and administration for the use and/or benefit of patients in a hospital licensed by the Arkansas Department of Health. The Hospital Pharmacy shall also mean the place or places in which drugs, chemicals, medicines, prescriptions or poisons are compounded for the dispensing to hospital employees, members of the immediate families of hospital employees, patients being discharged, and other persons in emergency situations. Hospital Pharmacy shall also mean the provision of pharmaceutical services as defined in the Pharmacy Practice Act by a pharmacist to a patient of the hospital.

2. Hospital Employee means any individual employed by the hospital whose compensation for services or labor actually performed for a hospital is reflected on the payroll records of a hospital.

3. Qualified Hospital Personnel means persons other than Licensed Pharmacists who perform duties in conjunction with the overall hospital pharmaceutical services for inpatients.

4. Licensed Pharmacist means any person licensed to practice pharmacy by the Arkansas State Board of Pharmacy who provides pharmaceutical services as defined in the Pharmacy Practice Act to patients of the hospital.

5. Unit Dose Distribution System is a pharmacy-coordinated method of dispensing and controlling medications in hospitals in which medications are dispensed in single unit packages for a specific patient on orders of a physician where not more than a 24-hour supply of said medication is dispensed, delivered, or available to the patient.

6. Modified Unit Dose Distribution System is a system that meets the requirement of a “Unit Dose Distribution System,” provided that up to a 72-hour supply may be sent to the floor once a week if the system has been reviewed and approved administratively by the Arkansas State Board of Pharmacy.

B. Hospitals maintaining and using mechanical storage and delivery machines for legend drugs shall have such machines stocked only by Pharmacy Services. Drugs may be obtained from such machines only by licensed personnel in accordance with their Practice Act acting under the prescribed rules of safety procedures as promulgated by the individual hospital using said machine.

Limited amounts of Schedule II-V controlled substances may be stocked in the machines provided the following requirements are met:

1. Pharmacy Services possesses the only key necessary to stock the machine; and

2. Policies and Procedures specify the licensed personnel having access and responsibility for the medications.

The person removing a medication for administration shall record at least the patient's name and the name, strength, and amount of medication on a record that is maintained by the Pharmacy Department. The record shall also be signed by the person removing the medication. The removal of controlled substances shall comply with the record keeping requirements of Section 12, Medications. Pharmacy Services shall audit stock levels as needed to replace medications. Use of the machines shall not be to circumvent adequate pharmaceutical services.

C. Compounding, Dispensing and Distributing.

1. Compounding. The act of selecting, mixing, combining, measuring, counting, or otherwise preparing a drug or medication.

2. Dispensing. A function restricted to licensed pharmacists, which involves the issuance of:

a. One or more doses of a medication in containers other than the original, with such new containers being properly labeled by the dispenser as to content and/or directions for use as directed by the prescriber;

b. Medication in its original container with a pharmacy prepared label that carries to the patient the directions of the prescriber as well as other vital information; and/or

c. A package carrying a label prepared for nursing station use. The contents of the container may be for one patient (individual prescription) or for several patients (such as a nursing station medication container).

3. Distributing. Distributing, in the context of this regulation, refers to the movement of a medication from a central point to a nursing station medication center. The medication shall be in the originally labeled manufacturer's container or in a prepackaged container labeled according to federal and state laws and regulations, by a pharmacist or under his direct and immediate supervision.

D. Pharmacy and Therapeutics Committee. There is a committee of the Medical Staff to confer with the pharmacist in the formulation of policies, explained as follows:

1. A Pharmacy and Therapeutics (P&T) Committee, composed of at least one (1) physician, the Administrator or representative, the director of nursing service or representative, and the pharmacist is established in the hospital. It represents the organizational line of communication and the liaison between the Medical Staff and the pharmacist;

2. The Committee assists in the formulation of broad, professional policies regarding the evaluation, appraisal, selection, procurement, storage, distribution, use, and safety procedures in conformance with Food and Drug Administration and manufacturers' recommendations on the safe administration of drugs and all other matters relating to drugs in hospitals;

3. The Committee performs the following specific functions:

a. Serves as an advisory group to the hospital Medical Staff and pharmacist on matters pertaining to the choice of drugs;

b. Develops and approves the drug formulary and all drug lists annually and makes interim revisions as needed;

c. Establishes standards concerning the use and control of investigational drugs and research in the use of recognized drugs;

d. Evaluates clinical data concerning new drugs or preparations requested for use in the hospital;

e. Makes recommendations concerning drugs to be stocked on the nursing unit floors and emergency drug stocks; and

f. Reviews and approves drug-related policies and procedures; and

4. The Committee develops and approves policies and procedures for all nursing personnel assigned the responsibility of preparing and administering intravenous (IV) admixtures. The pharmacist shall be involved in the review of the drug order, calculations, and preparation whenever possible. The Committee should consider the appropriate category of personnel (Registered Nurse or LPN) and degree of training necessary to make judgments and calculations involved in IV admixture programs;

5. The Committee assures that medications dispensed to outpatients, Emergency Room patients and discharged patients comply with all federal and state laws and regulations;

6. The Committee meets at least quarterly and reports to the Medical Staff by written report.

E. Pharmacy Operations. The hospital has a pharmacy directed by a licensed pharmacist. The pharmacy is administered in accordance with accepted professional principles.

1. Pharmacy supervision. There is a pharmacy directed by a licensed pharmacist defined as follows:

a. The Director of Pharmacy is responsible to the administration of the hospital and Board of Pharmacy for developing, supervising, and coordinating all the activities of the Pharmacy Department and all pharmacists providing professional services in the hospital; and

b. All licensed pharmacists who provide pharmaceutical services as defined by the Pharmacy Practice Act shall practice under policies, procedures, and protocols approved by the Director of Pharmacy. These policies, procedures, and protocols shall be subject to review and approval by the Board of Pharmacy.

F. Physical Facilities. Facilities are provided for the storage, safeguarding, preparation, and dispensing of drugs, defined as follows:

1. Drugs are issued to floor units in accordance with approved policies and procedures;

2. Drug cabinets on all units shall be checked monthly by qualified pharmacy personnel. All floor stocks are properly controlled;

3. A careful determination of the functions of a department will regulate the space to be allocated, the equipment necessary to carry out the functions, and the number of personnel required to utilize the equipment and to render a given volume of service, as these functions relate to the frequency or intensity of each function or activity. Adequate equipment shall specifically relate to services rendered and functions performed by the hospital pharmacy. Equipment lists will relate to the following services and functions:

a. Medication preparation;

b. Library reference facilities;

c. Record and office procedures;

d. Sterile product manufacturing;

e. Bulk compounding (manufacturing);

f. Product control (assay, sterility testing, etc.); and

g. Product development and special formulations for medical staff.

4. Pharmacy shall maintain equipment and supplies necessary to the hospital pharmacy's safe, efficient, and economical operation and to meet the patient's needs. Pharmacy shall maintain updated drug reference resources approved by the hospital for staff use, on-line, hard-copy or both; and

5. Special locked storage space is provided to meet legal requirements for storage of controlled drugs, alcohol, and other prescribed drugs; and

G. Personnel. Personnel competent in their respective duties are provided in keeping with the size and activity of the department explained as follows:

1. The Director of Pharmacy is assisted by an adequate number of additional licensed pharmacists and other such personnel as the activities of the pharmacy may require to ensure quality pharmaceutical services; and

2. The pharmacy, depending upon the size and scope of its operations, is staffed by the following categories of personnel:

a. Chief Pharmacist (Director of Pharmacy);

b. One or more assistant chief pharmacists (Assistant Director of Pharmacy);

c. Staff pharmacists;

d. Pharmacy residents (where program has been activated);

e. Trained non-professional pharmacy helpers (qualified hospital personnel); and

f. Clerical help.

H. Emergency Pharmaceutical Services. Through the Administrator of the hospital, the P&T Committee shall establish policies and procedures that include, but are not limited to, the following:

1. Upon admission to the Emergency Room on an outpatient basis and when examined by the physician where medications are prescribed to be administered, a record shall be kept on file in the Emergency Room admission book or a copy of the Emergency Room medication order must be kept by the pharmacist to be readily accessible, for control and other purposes, as required by these rules;

2. If the physician wishes the patient to have medication to be taken with them from the emergency room supplies, the amounts to be taken shall be sufficient to last until medication may be obtained from local pharmacies, in any case not to exceed a 48-hour supply. All state and federal laws shall be observed concerning all records, labeling, and outpatient dispensing requirements; and

3. Take home prescriptions for anti-infectives issued to patients at the time of discharge from the Emergency Room, dispensed by a pharmacist shall be quantities consistent with the medical needs of the patient.

4. Hospitals that have obtained a Continuity of Care endorsement through the Arkansas Board of Pharmacy may sell drugs and medication at retail for emergency room patients or patients upon discharge form the hospital for off-premises, personal use in an outpatient setting for either up to a thirty-one (31) day supply or a single commercially available package size as a continuation or supplement to hospital or emergency department treatment within the elements of the said agreement.

I. Pharmacy Records and Labeling. Records are kept of the transactions of the pharmacy and correlated with other hospital records where indicated. All medication shall be properly labeled. Such record and labeling requirements are as follows:

1. The pharmacy establishes and maintains, in cooperation with the accounting department, a satisfactory system of records and bookkeeping in accordance with the policies of the hospital for:

a. Maintaining adequate control over the requisitioning and dispensing of all drugs and pharmaceutical supplies; and

b. Charging patients for drugs and pharmaceutical supplies.

2. A record of procurement and disbursement of all controlled drugs is maintained in such a manner that the disposition of any particular item may be readily traced;

3. The pharmacist shall receive and provide service pursuant to the perusal of the physician's original order or a direct copy thereof, except in emergency situations wherein the pharmacist may provide service pursuant to a verbal order or to an oral or written transcription of the physician's order provided that the pharmacist shall receive and review the original or direct copy;

4. A record shall be maintained for each patient (inpatient or outpatient) containing the name of the patient, the prescribing physician, the name and strength of the drugs prescribed, the name, the quantity and the pharmacist's initials for all medications dispensed;

5. The label of each medication container prepared for administration to inpatients, shall bear the name and strength of the medication, the expiration date, and the lot or control number. The label on the medication or the container into which the labeled medication is placed shall bear the name of the patient and room number; and

6. The label of each outpatient's individual prescription medication container bears the name of the patient, prescribing physician, directions for use, and the name and strength of the medication dispensed (unless directed otherwise by the physician) and the date of dispensing.

J. Control of Toxic or Dangerous Drugs. Policies are established to control the administration of toxic or dangerous drugs with specific reference to the duration of the order and the dosage, explained as follows:

1. The Medical Staff has established a written policy that all toxic or dangerous medications not specifically prescribed as to the time or number of doses, will be automatically stopped after a reasonable time limit set by the staff;

2. The classifications ordinarily thought of as toxic or dangerous drugs are controlled substances, anticoagulants, antibiotics, oxytocics, and cortisone products; and

3. All deteriorated non-sterile, non-labeled, or damaged medication shall be destroyed by the pharmacist, with the exception of controlled substances. All controlled drugs (Schedule II, III, IV and V) shall be listed and a copy sent, along with drugs to the Arkansas Department of Health by registered mail or delivered in person for disposition.

K. Policy and Procedure Manual.

1. A policy and procedure manual pertaining to the operations of the hospital pharmacy, with updated revisions adopted by the P&T Committee of each hospital shall be prepared and maintained at the hospital.

2. The policy and procedure manual shall include at a minimum, the following:

a. Provisions for procurement, storage, distribution, and drug control for all aspects of pharmaceutical services in the hospital;

b. Specialized areas such as Surgery, Delivery, ICU and CCU units and Emergency Room stock and usage of medication shall be specifically outlined, as applicable;

c. Detailed job descriptions and duties of each employee by job title working in the Pharmacy Department shall be developed and made a part of these policies and procedures; and

d. The Pharmacy Policy and Procedure Manual shall be subject to review and approval by the Board of Pharmacy on request from the Board.

L. Employee Prescription Medication.

1. There will be a prescription on file for all prescription drugs dispensed to hospital employees and their immediate families. These records will be kept separate from all inpatient records.

2. The only person(s) entitled to have employee prescriptions filled will be the employee listed on the hospital payroll and members of their immediate family.

M. Patient Discharge Medication. Any take-home prescription dispensed to patients at time of discharge from the hospital shall be for drugs and quantities consistent with the immediate needs of the patient.

N. Licensed Pharmacist Personnel Requirements.

1. The minimum requirements for licensed pharmacists in hospitals are:

a. A general hospital, surgery and general medical care, maternal and general medical care hospital, chronic disease hospital, psychiatric hospital, and rehabilitative facility licensed for greater than 50 beds, as determined by the institution license issued by the Arkansas Department of Health, shall require the services of one pharmacist on the basis of 40 hours per week with such additional pharmacists as are necessary, in the opinion of the Arkansas State Board of Pharmacy, to perform required pharmacy duties as are necessary in keeping with the size and scope of the services of the hospital pharmacy's safe and efficient operation. Hospitals providing specialized or unique patient care services may request approval from the Arkansas State Board of Pharmacy to be exempt from the requirement of a pharmacist on duty 40 hours per week. The request for exemption shall provide adequate written documentation to justify the services of a pharmacist such hours as are necessary to perform required pharmacy services, followed by an appearance before the Arkansas State Board of Pharmacy for final approval of the request;

b. The above classified hospitals, licensed for 50 beds or less, as determined by the institution license issued by the Arkansas Department of Health, shall require the services of a pharmacist such hours as, in the opinion of the Arkansas State Board of Pharmacy and the Arkansas State Board of Health, are necessary to perform required pharmacy duties in keeping with the size and scope of the services of the hospital pharmacy safe, and efficient operation. The pharmacist shall be on site at least five days per week to perform and review pharmacy dispensing, drug utilization and drug distribution activities. A pharmacist shall be available to provide emergency services to the staff when the pharmacy is closed;

c. Recuperation Centers, Outpatient Surgery Centers and Infirmaries:

1) If the infirmary, recuperation center, or outpatient surgery center has a pharmacy department, a licensed pharmacist shall be employed to administer the pharmacy in accordance with all state and federal laws regarding drugs and drug control;

2) If the infirmary, recuperation center, or outpatient surgery center does not have a pharmacy department, it has provisions for promptly and conveniently obtaining prescribed drugs and biologicals from a community or institutional pharmacy;

3) If the infirmary, recuperation center, or outpatient surgery center does not have a pharmacy department but does maintain a supply of drugs, a licensed pharmacist shall be responsible for the control of all bulk drugs and maintain records of their receipt and disposition. The pharmacist shall dispense drugs from the drug supply, properly labeled, and make them available to appropriate nursing personnel;

4) All medication for patients shall be on individual prescription basis.

2. A pharmacist in charge, who is employed at any facility permitted by the Arkansas State Board of Pharmacy where a 40-hour work week is required, may also be the pharmacist in charge at a hospital licensed for 50 beds or less by the Arkansas Department of Health.

O. Responsibility of a Pharmacist in Hospital Pharmacy.

1. The pharmacist is responsible for the control of all medications distributed in the hospital where he practices and for the proper provision of all pharmaceutical services.

2. The following aspects of medication distribution and pharmaceutical service are functions involving professional evaluations or judgments and may not be performed by supportive personnel:

a. Interpretation and certification of the medication ordered. This involves a number of professional responsibilities such as the determination of:

1) Accuracy and appropriateness of dose and dosage schedule;

2) Such items as possible drug interactions, medication sensitivities of the patient, and chemical and therapeutic incompatibilities; and

3) Accuracy of entry of medication order to patient's medication profile.

b. Final certification of the prepared medication.

P. Pharmacy Technicians.

1. Pharmacy technician refers to those individuals identified by the Arkansas State Board of Pharmacy. Exclusive of pharmacy interns, who are regular paid employees of the hospital and assist the pharmacist in pharmaceutical services.

2. Supervision means that the responsible pharmacist shall be physically present to observe, direct, and supervise the pharmacy technician at all times when the pharmacy technician performs acts specified in this regulation. The supervising pharmacist is totally and absolutely responsible for the actions of the pharmacy technician.

3. The pharmacist and pharmacy technician(s) shall comply with all applicable sections of Laws and Regulations of the Arkansas State Board of Pharmacy with regards to tasks, responsibilities, duties, ratios, and supervision in the hospital setting.

4. There shall be documentation by each technician of all duties and tasks performed in the preparation and processing of medication. The pharmacist shall be responsible for the final check and verification of all technician duties and tasks. The performance, check, and verification shall be recorded on a record maintained by the department which shall include the signature, initial(s), or other identifying mark of each person.

Q. Operation of Pharmacy Department When Pharmacist is Not Present.

1. A limited supply of backup medications may be utilized for patient needs only at times when the pharmacist is not present. This stock shall be accessible only to approved licensed personnel. A record shall be maintained which identifies the medication obtained and the personnel obtaining it. The pharmacist shall then review this record when he returns to the facility to assure compliance with the physician's orders. Medications shall be replaced to stock as needed.

2. At no time will the hospital pharmacy be open and in operation unless a licensed pharmacist is physically present except:

a. Entrance may be obtained for emergency medication as set forth in the Pharmacy Policy and Procedure Manual when the pharmacy is closed outside its normal operation hours. The Medical Staff shall approve a method by which individual nursing personnel may be authorized by name and qualification to remove only one dose if the drug is not of the unit dose packaging type; or, if the medication is unit dosed, enough medication to last until the pharmacist returns can be removed. A record listing all medications obtained should be maintained, and the pharmacist shall check for compliance with the physician's orders when he returns to the facility. Controlled substances shall not be accessible unless daily counts are performed and documented; and

b. When the pharmacist is summoned away from the pharmacy and there are other qualified personnel left in the pharmacy, the personnel left in the pharmacy shall perform only those functions authorized within this regulation.

3. A pharmacist shall be available to provide medication consultation.

R. Medication Utilization. The pharmacist, with the advice and guidance of the P&T Committee, shall participate in:

1. Discussions of reports of medication errors, with trends noted, conclusions made, and recommendations suggested. If there are no errors to report, this shall be stated;

2. Discussions of adverse drug reactions with trends noted, conclusions made, and recommendations suggested. Proper reports of appropriate reactions shall be reported to the full Medical Staff and/or the FDA reporting system. If there are no adverse reactions to report, this shall be stated;

3. Reviews of results of monitoring conducted according to approved criteria for antibiotics prescribed for prophylactic and therapeutic reasons;

4. Reviews of other drug utilization in the facility, as appropriate; and

5. Formulation of an official record of each meeting maintained as minutes. The written report shall be forwarded to the P&T Committee, QA/PI Committee, and/or the Medical Staff for review and consideration, with at least a quarterly frequency.

S. Electronic Data Processing in Hospital Pharmacies. All hospitals utilizing electronic data processing systems shall comply with Laws and Regulations of the Arkansas State Board of Pharmacy.

T. Maintenance and Retention of Drug Records. All drug records, including but not limited to, purchase invoices, official dispensing records, prescription and inventory records shall be kept in such a manner that all data is readily retrievable, and shall be retained as a matter of record by the pharmacist for at least two years.

Credits

Amended Jan. 1, 2016; Feb. 5, 2021; June 17, 2024.

Current with amendments received through June 15, 2024. Some sections may be more current, see credit for details.

Ark. Admin. Code 007.05.10-16, AR ADC 007.05.10-16

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