R432-152-19. Pharmacy Services

(1) The facility shall provide routine and emergency drugs and biologicals.

(a) Drugs and biologicals may be obtained from community or contract pharmacists, or the facility may maintain a licensed pharmacy.

(b) Pharmacy services shall be under the direction and responsibility of a qualified, licensed pharmacist. The pharmacist may be employed full time by the facility or may be retained by contract.

(c) The pharmacist shall develop pharmacy service policies and procedures in conjunction with the administrator. Pharmacy policies shall address:

(i) drug orders;

(ii) labeling;

(iii) storage;

(iv) emergency drug supply;

(v) administration of medications;

(vi) pharmacy supplies; and

(vii) automatic-stop orders.

(2) The pharmacist, with input from the interdisciplinary team, shall review the drug regimen of each client at least quarterly.

(a) The pharmacist shall report any irregularities or errors in a client drug regimen to the prescribing physician and interdisciplinary team.

(b) The pharmacist shall develop and review a record of each client's drug regimen.

(3) An individual medication administration record shall be maintained for each client.

(4) As appropriate, the pharmacist shall participate in the development, implementation, and review of each client's individual program plan, either in person or through written report to the interdisciplinary team.

(5) The facility shall have an organized system for drug administration that identifies each drug up to the point of administration. The system shall assure that all medications and treatments:

(a) are administered in compliance with the physician's orders;

(b) are administered without error; and

(c) are administered by licensed medical or licensed nursing personnel.

(6) Clients shall be taught how to administer their own medications if the interdisciplinary team determines that self-administration of medications is an appropriate objective.

(a) The client's physician shall be informed of the interdisciplinary team's recommendation that self-administration of medications is an objective for the client.

(b) No client may self-administer medications until he or she demonstrates the competency to do so.

(7) Each telephone orders for medications shall be recorded immediately including the date and time of the order and the receiver's signature and title. The order must be countersigned and dated within 15 days by the person who prescribed the order.

(8) The facility shall maintain records of the receipt and disposition of all controlled drugs.

(a) Records of Schedule III and IV Drugs shall be maintained in such a manner that the receipt and disposition shall be readily traced.

(b) The facility shall, on a sample basis, periodically reconcile the receipt and disposition of all controlled drugs in schedules II through IV, drugs subject to the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C. 801 et sec., as implemented by 42 CFR Part 308.

(9) The facility shall store drugs under proper conditions of sanitation, temperature, light, humidity, and security.

(a) All controlled substances shall be secured in a manner consistent with applicable state pharmacy laws.

(b) Provision shall be made for the separate secure storage of all non-medication items such as poisonous and caustic materials.

(c) Medication containers shall be clearly labeled.

(d) Only persons authorized by facility policy shall have access to medications.

(e) Medication intended for internal use shall be stored separately from medication intended for external use.

(f) Medications stored at room temperature shall be maintained within 59 - 80 degrees F (15 to 30 degrees C); and refrigerated medications shall be maintained within 36 - 46 degrees F (2 to 8 degrees C).

(g) Medications and similar items that require refrigeration shall be stored securely and segregated from food items.

(h) Medications shall be kept in the original pharmacy container and shall not be transferred to other containers. Drugs taken out of the facility for home visits, workshops, school, etc. shall be packaged and labeled in accordance with State law by a person authorized to package medications.

(i) Clients who have been trained to self administer drugs in accordance with R432-152-19(6) may have access to keys to their individual drug supply.

(10) Labeling of drugs and biologicals shall:

(a) be based on currently accepted professional principles and practices; and

(b) include the appropriate accessory and cautionary instructions, as well as the expiration date, if applicable.

(11) The facility shall remove from use outdated drugs and drug containers with worn, illegible, or missing labels.

(12) Drugs and biologicals packaged in containers designated for a particular client shall be immediately removed from the client's current medication supply if discontinued by the physician.

(13) Drugs may be sent with the client upon discharge if so ordered by the discharging physician provided that the drugs are released in compliance with Utah pharmacy law and rules and a record of the drugs sent with the client is documented in the client's health record.

(14) Discontinued individual client drugs supplied by prescription or those which remain in the facility after discharge or death of the client shall be destroyed within one month by the facility in the following manner:

(a) All drugs shall be destroyed by the facility in the presence of the staff pharmacist or consulting pharmacist and an appointed licensed nurse employed by the facility.

(b) If one or both of these persons are not available within the month, a licensed nurse and an individual appointed by the administrator may serve as witnesses.

(c) These appointments shall be rotated periodically among responsible staff members.

(d) The name of the client, the name and strength of the drug, the prescription number, the amount destroyed, the method of destruction, the date of destruction, and the signatures of the witnesses required above shall be recorded in the client's record or in a separate log and retained for at least three years.

(15) Unless otherwise prohibited under applicable federal or state laws, individual client drugs supplied in sealed containers may be returned, if unopened, to the issuing pharmacy for disposition provided that:

(a) no controlled drugs are returned;

(b) all such drugs are identified as to lot or control number; and

(c) the signatures of the receiving pharmacist and a licensed nurse employed by the facility are recorded and retained for at least three years in a separate log which lists the name of the client, the name, strength, prescription number, if applicable, the amount of the drug returned, and the date of return.

(16) An emergency drug supply appropriate to the needs of the clients served shall be maintained in the facility.

(a) The pharmacist in coordination with the administrator shall develop an emergency drug supply policy to include the following requirements:

(i) Specific drugs and dosages to be included in the emergency drug supply shall be listed.

(ii) Containers shall be sealed to prevent unauthorized use.

(iii) Contents of the emergency drug supply shall be listed on the outside of the container and the use of contents shall be documented by nursing staff.

(iv) The emergency drug supply shall be accessible to nursing staff.

(v) The pharmacist shall inventory the emergency drug supply monthly. Used or outdated items shall be replaced within 72 hours.

(17) The pharmacy shall furnish drugs and biologicals as follows:

(a) Drugs ordered for administration as soon as possible shall be available and administered within two hours of a physician's order.

(b) Anti-infectives shall be available and administered within four hours of a physician's order.

(c) All new drug orders shall be initiated within 24 hours of the order or as indicated by the physician.

(d) Prescription drugs shall be refilled in a timely manner.

(e) Orders for controlled substances shall be sent to the pharmacy within 48 hours of the order. The order sent to the pharmacy may be a written prescription by the prescriber, a direct copy of the original order, or an electronic reproduction.