SECTION 310:667-39-12. Drug distribution

(a)   General. The CAH shall provide routine and emergency drugs and biologicals in a safe and accurate manner to meet the needs of the patients. The CAH may provide all drug distribution services directly with a complete licensed hospital pharmacy or a drug room. The drug room may be provided directly by the CAH or by contract with a licensed pharmacy. The medical and professional staff and the CAH pharmacist shall be responsible for oversight of drug distribution services and shall approve policies and procedures that ensure compliance with state and federal laws and minimize drug errors. If required, the CAH shall annually register with the Oklahoma State Board of Pharmacy.

(b)   Personnel.

(1)   The drug distribution service shall be directed by a pharmacist on a full-time, part-time, or consultant basis. The pharmacist shall be responsible for developing, supervising, and coordinating all activities of drug distribution in the CAH. The responsibility and authority of the pharmacist shall be clearly defined in a written job description. All compounding, packaging, labeling and dispensing of drugs and biologicals shall be performed or directly supervised by the pharmacist.

(2)   If the CAH only maintains a drug room, drugs and biologicals shall be distributed and administered only to inpatients of the CAH. The pharmacist director shall be available at least as a consultant and a registered or licensed practical nurse shall be designated in writing as the drug room supervisor to ensure drugs and biologicals are properly distributed and stored. The drug room supervisor may have other job responsibilities in the CAH as long as drug distribution services are adequately maintained.

(c)   Delivery of services.

(1)   Drugs and biologicals shall be kept in a locked storage area and distributed in accordance with applicable standards of practice, consistent with state and federal laws. Outdated, mislabeled, or otherwise unusable drugs and biologicals shall not be maintained available for patient use. Storage of drugs and biologicals shall be in accordance with the manufacturer's instructions.

(2)   Records shall be maintained of the transactions of the pharmacy or drug room to account for the receipt, distribution, disposition and destruction of all drugs and biologicals.

(3)   A record of the stock of controlled dangerous drug substances on hand shall be maintained in a manner so that the disposition of any particular item may be readily traced. All Schedule II drugs shall be maintained as specified in OAC 310:667-21-8(c).

(4)   All drugs and biologicals shall be provided to patients only upon written order of a physician or practitioner authorized by law to write a prescription, with the exception of influenza and pneumococcal polysaccharide vaccines, which may be administered per physician-approved hospital policy after an assessment for contraindications. The prescriber's original order or a copy shall be available to the pharmacy or drug room prior to distributing or dispensing the drug or biological. The order may be electronically transmitted. Methods shall be provided to ensure the reconciliation of all drugs distributed for patient administration.

(5)   Access to the pharmacy or drug room shall be restricted to authorized individuals when the pharmacist or drug room supervisor is unavailable. The CAH shall establish written procedures which permit authorized individuals access, establish methods of maintaining drug inventory and control, and require record keeping of drugs removed.

(6)   Floor stock medications shall be controlled and maintained to limit after hours access to the pharmacy or drug room. Distribution shall be in accordance with a floor stock drug list which shall be established for each floor stock area. A method shall be provided for reconciliation of floor stock drugs distributed for use in a procedure or for a particular patient. The pharmacist shall check all floor stock medication areas at least monthly to ensure records are accurate and stock continues to be suitable for use.

(7)   Drugs and biologicals not specifically prescribed as to length of time or number of doses shall be automatically stopped after a reasonable time established by the medical and professional staff.

(8)   Drug administration errors, adverse drug reactions, and incompatibilities shall be immediately reported to the attending physician or licensed independent practitioner. As appropriate, reports of errors and adverse reactions shall be made to the CAH quality assurance committee.

(9)   Abuse and loss of controlled substances shall be immediately reported to the pharmacist director and to the administrator who shall make required reports to local, State and Federal authorities. If the CAH maintains a pharmacy or drug room, the administrator, or the administrator's authorized representative, shall inventory pharmacy controlled substances and alcohol at least annually.

(10)   Information relating to drug interactions, drug therapy, side effects, toxicology, dosage, indications for use, routes of administration and poison control shall be made available by the pharmacist director to nursing service and the medical and professional staff.

(11)   Drugs and biologicals maintained by the CAH shall be based on a formulary established by the medical and professional staff.

(d)   Physical facilities. The CAH shall maintain, as appropriate, adequate facilities to ensure drugs and biologicals are safely compounded, packaged, dispensed and stored as required. Equipment and supplies shall be provided to adequately protect personnel from toxic substances and to ensure the integrity of any medication or parenteral solution.

[Source: Added at 12 Ok Reg 1555, eff 4-12-95 (emergency); Added at 12 Ok Reg 2429, eff 6-26-95; Amended at 17 Ok Reg 692, eff 12-16-99 (emergency); Amended at 17 Ok Reg 2992, eff 7-13-00; Amended at 20 Ok Reg 1664, eff 6-12-03]