(a) Organization.

1. (1)

   1. (A) Freestanding birthing centers shall have provisions for pharmaceutical services regarding the procurement, storage, distribution, and control of all medications.
   2. (B) The freestanding birthing center shall be in compliance with all state and federal regulations.

2. (2)

   1. (A) Pharmaceutical services shall be under the direction of a licensed pharmacist.
   2. (B) A 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.
   3. (C) The pharmacist shall make provisions that shall include but not be limited to:

(i) Development and implementation of pharmacy policies and procedures;

1. (ii) Annual review and revisions of pharmacy policies and procedures, with documentation of date or dates of review;

   1. (iii) Maintenance of medications in the freestanding birthing center to meet the needs of the population served;

      1. (iv) Maintenance of medications in the freestanding birthing center to ensure accountability; and
      2. (v) Proper storage of medications.

(b) Staffing.

1. (1) Pharmaceutical services shall be provided by a licensed pharmacist.
2. (2) This service may be provided on a consulting basis.

3. (3) Onsite consultation by the pharmacist shall be required at least monthly if medications other than those in the following categories are stored in the facility:

   1. (A) Emergency or eye prophylaxis drugs;
   2. (B) Oxytocics; and
   3. (C) Vitamin K.
4. (4) The storage of controlled substances in any manner shall require monthly onsite consultation by the pharmacist.
5. (5) When onsite consultation by the pharmacist is required monthly, documentation of each consult shall be recorded and maintained at the freestanding birthing center.
6. (6) Documentation of each consultation visit shall be recorded and maintained at the freestanding birthing center.

7. (7) Documentation of each visit shall include compliance with but not be limited to:

   1. (A) Proper drug storage;
   2. (B) Disposal of medications no longer needed, discontinued, or outdated;
   3. (C) Proof of receipt and administration of controlled substances and proper storage of such medications;
   4. (D) Verification that medications in stock conform to the specified quantities on posted lists;
   5. (E) Proper labeling; and

   6. (F) Maintenance of emergency carts or kits.

      1. (c) Policies and procedures. There shall be pharmacy policies and procedures to include but not be limited to:
8. (1) Detailed job description of the licensed pharmacist;
9. (2) Procurement of medications;
10. (3) Distribution and storage of medications;
11. (4) A listing of floor stock medications with minimum and maximum quantities to be maintained in the freestanding birthing center;
12. (5) A listing of medications with exact quantities to be maintained in emergency kits;
13. (6) Destruction of deteriorated, nonsterile, nonlabeled, or damaged medications by the pharmacist;

14. (7) Listing controlled substances to be destroyed on the proper forms and either:

    1. (A) Sending a copy of the form with the medications to the Department of Health by registered mail; or
    2. (B) Delivering the form and medications in person;
15. (8) Maintenance of all drug records for a minimum of two (2) years;
16. (9) Maintenance of medications brought to the freestanding birthing center by the patient;
17. (10) Drug recalls;

18. (11) Reporting of adverse drug reactions and medication errors to the:

    1. (A) Attending physician and/or CNM; and
    2. (B) Professional Review Committee;
19. (12) Accountability of controlled substances;
20. (13) Reporting of suspected drug loss, misuse, or diversion according to state law; and

21. (14) Use of automatic medication dispensing devices, if applicable.

    1. (d) Drug storage and security. Medications maintained at the freestanding birthing center shall be properly stored and safeguarded to ensure:
22. (1) Locked storage of all medications;
23. (2) Proper lighting and ventilation as required by manufacturer;

24. (3) Proper temperature controls with daily temperature documentation of medication refrigerators to ensure storage between:

    1. (A) Thirty-six to forty-six degrees Fahrenheit (36°F – 46°F); or
    2. (B) Two to eight degrees Celsius (2°C – 8°C);
25. (4) Separate storage of biologicals and medications from food;
26. (5) Accessibility to licensed personnel only; and
27. (6) Proper use of any automatic medication dispensing devices.

(e) Controlled substances. The following shall be adhered to in the maintenance of controlled substances in the freestanding birthing center:

1. (1) Controlled drugs shall be double-locked;

2. (2)

   1. (A) A record of the procurement and disposition of each controlled substance shall be:

      1. (i) Maintained in the freestanding birthing center; and
      2. (ii) Readily retrievable.

   2. (B) Each entry on the disposition record shall 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 licensed person administering the medication.

   3. (C) The signature shall consist of a:

      1. (i) First initial;
      2. (ii) Last name; and
      3. (iii) Title.

   4. (D) Licensed personnel who may legally administer controlled substances shall include only those personnel:

      1. (i) Authorized by their current Practice Act; and
      2. (ii) Licensed by the:

(b) (b) Arkansas State Board of Nursing.

1. (E) Any error of entry on the disposition record shall follow a policy for correction of errors and accurate accountability.

   1. (F) If the licensed person who procures medication from the double-locked security is not the licensed person who administers the medication, then both persons shall sign the disposition record;

2. (3)

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

      1. (i) Recorded by the licensed person who wasted the medication; and
      2. (ii) Verified by the signature of a licensed person who witnessed the wastage.
   2. (B) Documentation shall include how the medication was wasted.
   3. (C) In addition to the above-referenced licensed personnel, licensed pharmacists shall be allowed to witness wastage of controlled substances.
   4. (D) When a licensed person is not available to witness wastage, the partial dose shall be sent to the Division of Pharmacy Services and Drug Control of the Department of Health for destruction;

3. (4)

   1. (A) There shall be an audit each shift change of all controlled substances stocked in the freestanding birthing center that shall be:

      1. (i) Recorded by an oncoming nurse; and
      2. (ii) Witnessed by an off-going nurse.

   2. (B) Exception.

      1. (i) If only one (1) licensed nurse is on duty, an audit shall be conducted by that licensed nurse.
      2. (ii) When a second licensed nurse arrives, a second audit shall be conducted by both nurses on duty.
      3. (iii) If discrepancies are noted, the director of nursing and the pharmacy consultant shall be notified.
      4. (iv) As with the witnessing of wastage, licensed pharmacists shall be allowed to witness controlled substance audits; and
4. (5) Records generated by automatic dispensing devices shall comply with these requirements.

(f) Medications.

1. (1)

   1. (A) All verbal or telephone orders for medications shall be:

      1. (i) Received by a:

(b) (b) Certified nurse midwife; or

1. (c) (c) Registered pharmacist; and

   1. (ii) Reduced to writing into the patient's medical record.
   2. (B) Verbal or telephone orders shall be countersigned by the practitioner within twenty-four (24) hours.
   3. (C) Signed facsimile orders are acceptable provided the facsimile paper is of a permanent nature.

2. (2)

   1. (A) The freestanding birthing center:

      1. (i) May procure medications for its patients through community pharmacists; or
      2. (ii) Medications may be procured through the freestanding birthing center physician’s or CNM's registration.
   2. (B) Clinicians shall administer or shall order medications to be administered to patients while in the freestanding birthing center.