(a) Notice of inspection. Investigators and inspectors for the Division of Pharmacy Services and Drug Control and the Department of Health are directed to make investigations and inspections and make copies of the records and orders, wherever located, of all services licensed by the department in order to determine whether or not said:

1. (1) Licensed ambulance services have violated the laws of the State of Arkansas respecting prescribing and using of narcotics and other drugs; and
2. (2) Services have violated the provisions of the law.

(b) Registration.

1. (1) A separate registration in the name of the medical director (physician) is required for each service’s licensed place of business at one (1) general physical location where controlled substances are maintained or distributed to ambulances specifically licensed to maintain drugs.

2. (2) Each registration must contain the:

   1. (A) Physician’s name;
   2. (B) Ambulance service name; and
   3. (C) Physical address at which the controlled substances are maintained or distributed.

(c) Security.

1. (1) The controlled substances storage area at the ambulance service’s physical location shall be accessible only to specifically authorized employees.

2. (2)

   1. (A) The licensee shall provide adequate security for all legend (prescription) drugs onboard all registered vehicles.
   2. (B) Schedule II drugs have a separate requirement for security that also must be complied with by the licensee.

3. (3)

   1. (A) All controlled substances shall be stored under a mounted double-lock security.
   2. (B) All other prescription drugs shall be stored under a single-lock security.

(d) Procedure in case of loss of controlled substances.

1. (1)

   1. (A) Each licensed ambulance service or medical director shall notify the Division of Pharmacy Services and Drug Control and the department immediately upon discovery of any suspected loss, theft, and/or other diversion of any controlled substance under their supervision.
   2. (B) Additionally, 21 C.F.R. § 1301.74 (c) requires notification of the Field Division Office of the Drug Enforcement Administration in writing within one (1) business day of discovery of the theft or loss.
2. (2) The original and one (1) copy of the Drug Enforcement Administration Form 106 shall be sent to the Drug Enforcement Administration Resident Office, and one (1) copy shall be sent to the Division of Pharmacy Services and Drug Control within seven (7) days.

(e) Records of controlled substances.

1. (1)

   1. (A) The ambulance service medical director is responsible for maintaining accurate and complete records of such drugs received and a record of all such drugs administered or professionally used otherwise.
   2. (B) Hospital-based ambulance services follow the hospital’s Drug Enforcement Administration registration that allows for the drugs to be supplied to the service through the hospital pharmacy where records of administration and distribution are the responsibility of the hospital.
2. (2) Patient medical records (encounter forms) and the controlled drug procurement and disposition records are the basic records of controlled drugs.

3. (3) The record shall in every case show the:

   1. (A) Date of receipt;
   2. (B) Name and address of the person or business from whom received; and
   3. (C) Kind and quantity of drugs received.

4. (4) The record shall show the:

   1. (A) Drugs administered;
   2. (B) Date of administration;
   3. (C) Name and address of the person to whom the drugs were administered; and
   4. (D) Kind and quantity of drugs.

5. (5) Patient medication records shall consist of the following:

   1. (A) Physician's order authorizing the dispensing and administration of medications (standing orders);
   2. (B) Medication administration record indicating the date, time, and signature of the paramedic or other licensed healthcare provider administering controlled drugs to the patient; and
   3. (C) The paramedic or other licensed healthcare provider notes indicating the:

(i) Date, time, and method of administration;

1. (ii) Condition of the patient before and after the controlled drugs were administered; and

   1. (iii) Signature of the paramedic or other licensed healthcare provider administering the drug.

2. (6)

   1. (A) The disposition record must reflect the:

      1. (i) Actual dosage administered to the patient;
      2. (ii) Patient’s name;
      3. (iii) Date;
      4. (iv) Time; and
      5. (v) Signature of the paramedic administering the controlled drug.
   2. (B) Any error of entry on the disposition and procurement record shall follow a policy of correction of errors and accurate accountability.
   3. (C) If the person who procures the controlled drug is not the person who administers the drug, then both persons must sign the disposition record.
3. (7) When breakage or wastage of a controlled drug occurs, the amount administered and the amount wasted must be recorded by the paramedic or other licensed healthcare provider who wasted the drug and verified by the signature of a nurse, nurse practitioner, physician’s assistant, physician, or licensed paramedic who witnessed the wastage and how it was wasted at the receiving facility.

4. (8)

   1. (A) Adequate accountability does not require the use of a specific system or form.
   2. (B) The system employed must be designed so that all requirements listed are met.

5. (9)

   1. (A) Each licensed ambulance service shall maintain inventory records in one (1) consolidated record system.
   2. (B) Records of Schedule II substances shall be maintained separately from all other records.
   3. (C) Inventories of Schedule III, IV, and V substances shall be maintained either separately from all other records or in such form that the information required is readily retrievable from the ordinary business records.
6. (10) Every record shall be kept by the registrant and be readily retrievable and available for at least two (2) years from the date of the recording for inspection and copying by authorized agents of the Division of Pharmacy Services and Drug Control or the Division of Emergency Medical Services.

(f) Surrender of unwanted controlled substances. Must be in accordance with the Drug Enforcement Administration’s regulations regarding all controlled substances:

1. (1) No longer usable due to deterioration or expired dating; or
2. (2) That are no longer used by the service.

(g) Policies and procedures manual.

1. (1) A policies and procedures manual pertaining to drug handling shall be developed and submitted to the Division of Pharmacy Services and Drug Control for approval.
2. (2) This manual shall also be submitted to the department.

3. (3) The manual shall include at a minimum the following:

   1. (A) Detailed job descriptions, duties, and responsibilities of each employee handling drugs;

   2. (B)

      1. (i) Procedures for:

(b) (b) Security of drugs;

1. (c) (c) Complete recordkeeping of drugs; and

   1. (d) (d) Availability of records for inspection.

      1. (ii) Access should be limited to one (1) person responsible for the accountability during shift;

   2. (C) Procedures in case of:

      1. (i) Loss of drugs;
      2. (ii) Diversion;
      3. (iii) Surrender of unwanted drugs; and
      4. (iv) Wastage;

   3. (D)

      1. (i) Services shall have a quality assurance process for all controlled substances that includes a routine audit process.
      2. (ii) Any discrepancies shall be immediately reported to the Emergency Medical Services Section of the department and the Drug Enforcement Administration; and
   4. (E) Policy and procedure manuals must be updated with the department annually at the time of ambulance service license renewal.

(h) Storage of pharmaceuticals by licensed ambulance services.

1. (1)

   1. (A) All pharmaceuticals shall be stored in accordance with the instructions included in the package inserts of each drug.
   2. (B) Factors such as heat, freezing, susceptibility to light, etc., are described in the insert, and all services will provide suitable storage to comply with the instructions.

2. (2)

   1. (A) Freezing is defined as storage at temperatures at or below thirty-two degrees Fahrenheit (32° F).
   2. (B) Excessive heat is defined as temperatures at or above one hundred four degrees Fahrenheit (104° F).

   3. (C) The licensee will provide protection of fluids and pharmaceuticals on units.

      1. (i) Additions to the required and optional drug lists. All additions to the optional drug list will be approved by the medical director and approved by the department prior to implementing the drug and writing into service protocols.

(j) Purchasing drugs from hospitals.

1. (1) The policy of purchasing small quantities of legend drugs from hospital pharmacies by the medical director of non-hospital-based ambulance services or EMS systems is acceptable.
2. (2) There is no requirement for hospitals to participate in this sale.