Section 410IAC15-1.5-7. Pharmaceutical services

 

                (a) The hospital shall have a pharmaceutical service that meets the needs of the patient and complies with requirements set forth by the Indiana board of pharmacy.

                (b) The hospital shall have a pharmacy service directed by a pharmacist, as follows:

(1) A full-time, part-time, or consulting pharmacist shall be responsible for developing, supervising, coordinating, and implementing the written policies and procedures to ensure appropriate distribution, control, therapeutic monitoring, and accountability of all drugs used in the hospital.

(2) The pharmacy service shall be administered in accordance with accepted professional standards and federal and state laws.

(3) The pharmacy service shall have an adequate number of personnel to ensure quality pharmaceutical services, including emergency services.

                (c) In order to provide patient safety, the director of pharmacy shall develop and implement written policies and procedures for the appropriate selection, control, labeling, storage, use, monitoring, and quality assurance of all drugs and biologicals.

                (d) Written policies and procedures shall be developed and implemented that include the following:

(1) Establish a formulary system with specifications for the selection and procurement of all drugs and biologicals at reasonable costs and as approved by the medical staff.

(2) Ensure the monthly inspection of all areas where drugs and biologicals are stored and which address, but are not limited to, the following:

(A) Separation of drugs designed for external use from drugs intended for internal use.

(B) Appropriate storage conditions.

(C) Detection and quarantine of outdated or otherwise unusable drugs and biologicals from general inventory pursuant to their return to the manufacturer, distributor, or destruction.

(D) Documentation and accountability for an accurate accounting of controlled substances from the time of receipt in the institution through the administration to the patient or subsequent removal from general stock and reporting of all abuses and losses of controlled substances.

(E) Security of and authorized access to all drug storage areas within the hospital, as approved by the medical staff, when the pharmacist is absent.

(F) Availability of information relating to drug interactions and information on the following:

(i) Drug therapy.

(ii) Side effects.

(iii) Toxicology.

(iv) Dosage.

(v) Indications for use.

(vi) Routes of administration.

(3) Review the use of medications with the standards developed by the medical staff, which include stop orders for scheduled drugs and biologicals not specifically prescribed as to time or number of doses.

(4) Allow for adequate drug therapy monitoring procedures to exist.

(5) Minimize medication errors and document, monitor, evaluate, and report adverse drug reactions and medication errors.

(6) Provide for the maintenance of drug and poison information materials.

(Indiana State Department of Health; 410 IAC 15-1.5-7; filed Dec 21, 1994, 9:40 a.m.: 18 IR 1272; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.: 20070613-IR-410070141RFA; readopted filed Jul 14, 2011, 11:42 a.m.: 20110810-IR-410110253RFA)