(a)

1. (1) All medical orders (medications and treatments) shall be:

   1. (A) Documented; and
   2. (B) Signed by the prescriber.
2. (2) Telephone/verbal orders should be used infrequently.

3. (3) When used they shall be:

   1. (A) Given only to licensed nurses; and
   2. (B) Signed by the prescriber.

(b)

1. (1) No medication shall be dispensed or administered without a written order signed by a licensed prescriber.

2. (2) A pharmacist may:

   1. (A) Receive telephone or verbal orders for medications from a prescriber; and
   2. (B) Record them on the medical record.

(c)

1. (1) Medications shall be administered by licensed nursing personnel in accordance with the current Nurse Practice Act, Arkansas Code § 17-87-101 et seq.
2. (2) Other personnel may administer medications only in accordance with their current Practice Act (e.g., respiratory, physical therapy).

(d)

1. (1) Blood transfusions and intravenous medications administered by licensed nursing personnel shall be in accordance with state law.
2. (2) If not administered by a registered nurse, only licensed nursing personnel who have documentation of training shall be permitted to administer blood transfusions and intravenous medications.

(e) There shall be an effective hospital procedure for reporting:

1. (1) Transfusion reactions; and
2. (2) Adverse medication reactions.

(f)

1. (1) All medications shall be properly labeled and stored in a specifically designated:

   1. (A) Medication cabinet;
   2. (B) Cart; or
   3. (C) Room.
2. (2) At nursing stations, medications shall only be accessible to licensed nursing personnel and pharmacists.
3. (3) In specialty units and treatment areas, medications shall only be accessible to licensed nursing personnel, pharmacists, and designated licensed personnel consistent with that unit (e.g., respiratory, physical therapy).

(g)

1. (1) Refrigeration shall be provided for the proper storage of biologicals and other medications.
2. (2) Medications shall be stored in a separate compartment or area from food.
3. (3) Employee foods and/or medications shall be stored in a separate refrigeration area.
4. (4) An internal thermometer shall be provided and checked daily, or at least weekly when the unit is closed, with documentation to ensure temperatures between thirty-six degrees and forty-six degrees Fahrenheit (36°F – 46°F) or two to eight degrees Celsius (2°C – 8°C).
5. (5) Refrigerated controlled substances shall meet the requirement for double-lock security.

(h)

1. (1) Unused or damaged medications shall be returned to the pharmacy.
2. (2) All medications with incorrect or soiled labels shall be returned to the pharmacy for relabeling.

(i)

1. (1) In addition to patients’ medical records, a record of the procurement and disposition of each controlled substance shall be maintained at each nursing and specialty unit.

2. (2) Each entry on the disposition record shall reflect the:

   1. (A) Actual dosage administered to the patient;
   2. (B) Patient’s name;
   3. (C) Date;
   4. (D) Time; and
   5. (E) Signature of the licensed person administering the medication.
3. (3) Licensed personnel who may legally administer controlled substances shall include only those personnel authorized by their current Practice Act.

4. (4) Any error of entry on the disposition record shall follow a policy for:

   1. (A) Correction of errors; and
   2. (B) Accurate accountability.
5. (5) If the licensed person who procures the medication from the double-lock security is not the licensed person who administers the medication, there shall be record of the activity conducted by each licensed person.

(j)

1. (1) When breakage or wastage of a controlled substance occurs, the amount given and the amount wasted shall be:

   1. (A) Recorded by the licensed person who wasted the medication; and
   2. (B) Verified by the signature of a licensed person who witnessed the wastage.
2. (2) Documentation shall include or policy shall delineate how the medication was wasted.
3. (3) In addition to the above referenced licensed personnel (see subsection (i) of this section), licensed pharmacists shall be allowed to witness wastage of controlled substances.

(k)

1. (1) There shall be an audit each shift change of all controlled substances stocked on the unit.

2. (2) At nursing stations such counts shall be:

   1. (A) Recorded by the oncoming nurse; and
   2. (B) Witnessed by the offgoing nurse.
3. (3) At other units, audits shall be performed by two (2) licensed personnel.
4. (4) In each case, both licensed personnel shall sign the record with notation made as to date and time of the audit.
5. (5) If discrepancies are noted, the director of nursing, the department director, as applicable, and the director of pharmacy shall be notified.
6. (6) As with the witnessing of wastage, licensed pharmacists shall be allowed to witness controlled substance audits.
7. (7) For facilities utilizing medication dispensing systems to dispense controlled substances, the facility shall have a process and evidence available to ensure audit of controlled substances was conducted at shift change.

(o)

1. (1) When a patient is discharged, the unused portion of the patient’s medication may be sent home with the patient:

   1. (A) On direct written order of the attending physician; and
   2. (B) Only after the medication has been relabeled by the pharmacy.
2. (2) Documentation shall include the amount dispensed to the patient and quantities shall be consistent with the immediate needs of the patient.

(q)

1. (1) All medication errors and adverse drug reactions shall be reported to the attending physician.
2. (2) A copy of all medication errors and adverse drug reactions shall be sent to the director of nursing or designee, QA/PI Committee, and when appropriate to the director of pharmacy.

(r)

1. (1) Records generated by automatic medication distribution devices shall comply with this part.
2. (2) Policies and procedures for the usage of automatic medication distribution devices shall be approved administratively by the Division of Health Facilities Services prior to their usage.

(s) Drug security.

1. (1)

   1. (A) The pharmacist, with support from the Pharmacy and Therapeutics (P&T) Committee, is ultimately responsible for drug security throughout the facility.
   2. (B) Applicable licensed personnel at nursing and specialty units shall maintain the daily security of medications at their respective units.
2. (2) Access to medications shall be limited to designated licensed personnel at all times.
3. (3) Medications dispensed to nursing and specialty units shall be kept locked in accordance with all federal and state regulations.

4. (4) Emergency-type medications (“crash cart”, “crash kit”) as approved by the P&T Committee shall be secured with a breakaway seal under the following conditions:

   1. (A) The quantities of medication are limited;
   2. (B) A list of medications stocked with quantities listed is posted on the emergency cart or container;
   3. (C) The breakage of the seal clearly indicates that entry has occurred and said broken seal cannot be repaired without obvious evidence;
   4. (D) Any remaining medications shall be secured and accessible only to licensed personnel:

(i) Whenever the seal has been broken; and

1. (ii) Before a new seal is installed;

   1. (E)

      1. (i) Applicable personnel shall check the cart for the integrity of the seal each shift.
      2. (ii) Documentation shall reflect that the seal is intact.
      3. (iii) The emergency cart shall be stored in an area observable by licensed personnel;

   2. (F)

      1. (i) The quantities of a controlled substance stocked in a cart or container shall be limited to a maximum of two (2) single doses of Schedule III, IV, or V drugs.
      2. (ii) No Schedule II drugs shall be included in this stock; and
   3. (G) Pharmacy services shall check the condition of the carts or containers as part of the monthly inspections of nursing and specialty units.
2. (5) Controlled substances maintained as floor stock at nursing and specialty units shall be stored separately from other medication, under double-lock security.
3. (6) For patient safety, Schedule III, IV, and V controlled substances in unit dose packages and dispensed in quantities limited to a maximum of a two-day supply may be stored with that patient’s other medication.
4. (7) All medications shall be locked in the absence of immediate visual supervision by licensed personnel.
5. (8) When a hospital operates an outpatient pharmacy that stocks medications in various clinical areas, the stock lists, records, and security measures shall be in compliance with the requirements for nursing and specialty units.

6. (9)

   1. (A) Distribution of sample legend medications shall not be permitted by hospitals.

   2. (B) Samples are defined as any prescription-only medication that is:

      1. (i) Not intended to be sold; and
      2. (ii) Intended to promote the sale of the medication.

7. (10)

   1. (A) Medication security as provided by automatic medication distribution devices shall comply with this part.
   2. (B) Policies and procedures for security provisions shall be approved administratively by the Division of Health Facilities Services prior to usage of automatic medication distribution devices.