Cal. Code Regs. Tit. 22, § 70263 - Pharmaceutical Service General Requirements

(a) All hospitals having a licensed bed capacity of 100 or more beds shall have a pharmacy on the premises licensed by the California Board of Pharmacy. Those hospitals having fewer than 100 licensed beds shall have a pharmacy license issued by the Board of Pharmacy pursuant to Section 4029 or 4056 of the Business and Professions Code.

(b) The responsibility and the accountability of the pharmaceutical service to the medical staff and administration shall be defined.

(c) A pharmacy and therapeutics committee, or a committee of equivalent composition, shall be established. The committee shall consist of at least one physician, one pharmacist, the director of nursing service or his or her representative and the administrator or his or her representative.

(1) The committee shall develop written policies and procedures for establishment of safe and effective systems for procurement, storage, distribution, dispensing and use of drugs and chemicals. The pharmacist in consultation with other appropriate health professionals and administration shall be responsible for the development and implementations of procedures. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

(2) The committee shall be responsible for the development and maintenance of a formulary of drugs for use throughout the hospital.

(d) There shall be a system maintained whereby no person other than a pharmacist or an individual under the direct supervision of a pharmacist shall dispense medications for use beyond the immediate needs of the patients.

(e) There shall be a system assuring the availability of prescribed medications 24 hours a day.

(f) Supplies of drugs for use in medical emergencies only shall be immediately available at each nursing unit or service area as required.

(1) Written policies and procedures establishing the contents of the supply procedures for use, restocking and sealing of the emergency drug supply shall be developed.

(2) The emergency drug supply shall be stored in a clearly marked portable container which is sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs. The contents of the container shall be listed on the outside cover and shall include the earliest expiration date of any drugs within.

(3) The supply shall be inspected by a pharmacist at periodic intervals specified in written policies. Such inspections shall occur no less frequently than every 30 days. Records of such inspections shall be kept for at least three years.

(g) No drugs shall be administered except by licensed personnel authorized to administer drugs and upon the order of a person lawfully authorized to prescribe or furnish. This shall not preclude the administration of aerosol drugs by respiratory care practitioners. The order shall include the name of the drug, the dosage and the frequency of administration, the route of administration, if other than oral, and the date, time and signature of the prescriber or furnisher. Orders for drugs should be written or transmitted by the prescriber or furnisher. Verbal orders for drugs shall be given only by a person lawfully authorized to prescribe or furnish and shall be recorded promptly in the patient's medical record, noting the name of the person giving the verbal order and the signature of the individual receiving the order. The prescriber or furnisher shall countersign the order within 48 hours.

(1) Verbal orders for administration of medications shall be received and recorded only by those health care professionals whose scope of licensure authorizes them to receive orders for medication.

(2) Medications and treatments shall be administered as ordered.

(h) Standing orders for drugs may be used for specified patents when authorized by a person licensed to prescribe. A copy of standing orders for a specific patient shall be dated, promptly signed by the prescriber and included in the patient's medical record. These standing orders shall:

(1) Specify the circumstances under which the drug is to be administered.

(2) Specify the types of medical conditions of patients for whom the standing orders are intended.

(3) Be initially approved by the pharmacy and therapeutics committee or its equivalent and be reviewed at least annually by that committee.

(4) Be specific as to the drug, dosage, route and frequency of administration.

(i) An individual prescriber may notify the hospital in writing of his or her own standing orders, the use of which is subject to prior approval and periodic review by the pharmacy and therapeutics committee or its equivalent.

(j) The hospital shall develop policies limiting the duration of drug therapy in the absence of the prescriber's specific indication of duration of drug therapy or under other circumstances recommended by the pharmacy and therapeutics committee or its equivalent and approved by the executive committee of the medical staff. The limitations shall be established for classes of drugs and/or individual drug entities.

(k) If drugs are supplied through a pharmacy, orders for drugs shall be transmitted to the pharmacy either by written prescription of the prescriber, by an order form which produces a direct copy of the order or by an electronically reproduced facsimile. When drugs are not supplied through a pharmacy, such information shall be made available to the hospital pharmacist.

(l) Medications shall not be left at the patient's bedside unless the prescriber so orders. Such bedside medications shall be kept in a cabinet, drawer or in possession of the patient. Drugs shall not be left at the bedside which are listed in Schedules II, III and IV of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 as amended. If the hospital permits bedside storage of medications, written policies and procedures shall be established for the dispensing, storage and records of use, of such medications.

(m) Medications brought by or with the patient to the hospital shall not be administered to the patient unless all of the following conditions are met:

(1) The drugs have been ordered by a person lawfully authorized to give such an order and the order entered in the patient's medical record.

(2) The medication containers are clearly and properly labeled.

(3) The contents of the containers have been examined and positively identified, after arrival at the hospital, by the patient's physician or the hospital pharmacist.

(n) The hospital shall establish a supply of medications which is accessible without entering either the pharmacy or drug storage room during hours when the pharmacist is not available. Access to the supply shall be limited to designated registered nurses. Records of drugs taken from the supply shall be maintained and the pharmacist shall be notified of such use. The records shall include the name and strength of the drug, the amount taken, the date and time, the name of the patient to whom the drug was administered and the signature of the registered nurse. The pharmacist shall be responsible for maintenance of the supply and assuring that all drugs are properly labeled and stored. The drug supply shall contain that type and quantity of drugs necessary to meet the immediate needs of patients as determined by the pharmacy and therapeutics committee.

(o) Investigational drug use shall be in accordance with applicable state and federal laws and regulations and policies adopted by the hospital. Such drugs shall be used only under the direct supervision of the principal investigator, who shall be a member of the medical staff and be responsible for assuring that informed consent is secured from the patient. Basic information concerning the dosage form, route of administration, strength, actions, uses, side effects, adverse effects, interactions and symptoms of toxicity of investigational drugs shall be available at the nursing station where such drugs are being administered and in the pharmacy. The pharmacist shall be responsible for the proper labeling, storage and distribution of such drugs pursuant to the written order of the investigator.

(p) No drugs supplied by the hospital shall be taken from the hospital unless a prescription or medical record order has been written for the medication and the medication has been properly labeled and prepared by the pharmacist in accordance with state and federal laws, for use outside of the hospital.

(q) Labeling and storage of drugs shall be accomplished to meet the following requirements:

(1) Individual patient medications, except those that have been left at the patient's bedside, may be returned to the pharmacy for appropriate disposition.

(2) All drug labels must be legible and in compliance with state and federal requirements.

(3) Drugs shall be labeled only by persons legally authorized to prescribe or dispense or under the supervision of a pharmacist.

(4) Test agents, germicides, disinfectants and other household substances shall be stored separately from drugs.

(5) External use drugs in liquid, tablet, capsule or powder form shall be segregated from drugs for internal use.

(6) Drugs shall be stored at appropriate temperatures. Refrigerator temperature shall be between 2.2°C (36°F) and 7.7°C (46°F) and room temperature shall be between 15°C (59°F) and 30°C (86°F).

(7) Drugs shall be stored in an orderly manner in well-lighted cabinets, shelves, drawers or carts of sufficient size to prevent crowding.

(8) Drugs shall be accessible only to responsible personnel designated by the hospital, or to the patient as provided in 70263(l) above.

(9) Drugs shall not be kept in stock after the expiration date on the label and no contaminated or deteriorated drugs shall be available for use.

(10) Drugs maintained on the nursing unit shall be inspected at least monthly by a pharmacist. Any irregularities shall be reported to the director of nursing service and as required by hospital policy.

(11) Discontinued individual patient's drugs not supplied by the hospital may be sent home with the patient. Those which remain in the hospital after discharge that are not identified by lot number shall be destroyed in the following manner:

(A) Drugs listed in Schedules II, III or IV of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended, shall be destroyed in the presence of two pharmacists or a pharmacist and a registered nurse employed by the hospital. The name of the patient, the name and strength of the drug, the prescription number, the amount destroyed, the date of destruction and the signatures of the witnesses required above shall be recorded in the patient's medical record or in a separate log. Such log shall be retained for at least three years.

(B) Drugs not listed under Schedules II, III or IV of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended, shall be destroyed in the presence of a pharmacist.

(r) The pharmacist shall develop and implement written quality control procedures for all drugs which are prepackaged or compounded in the hospital including intravenous solution additives. He or she shall develop and conduct an in-service training program for the professional staff to assure compliance therewith.

(s) The pharmacist shall be consulted on proper methods for repackaging and labeling of bulk cleaning agents, solvents, chemicals and poisons used throughout the hospital.

(t) Periodically, the pharmacy and therapeutics committee, or its equivalent, shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

Notes

Cal. Code Regs. Tit. 22, § 70263

1. Amendment of subsection (m) filed 3-13-80; effective thirtieth day thereafter (Register 80, No. 11).
2. Amendment of subsection (g), new subsections (g)(1) and (g)(2), and amendment of NOTE filed 11-26-96; operative 12-26-96 (Register 96, No. 48).
3. Change without regulatory effect amending subsection (a) and NOTE filed 6-16-2000 pursuant to section 100, title 1, California Code of Regulations (Register 2000, No. 24).
4. Change without regulatory effect amending subsections (c), (g), (i), (q)(8) and (r) and amending NOTE filed 3-12-2013 pursuant to section 100, title 1, California Code of Regulations (Register 2013, No. 11).

Note: Authority cited: Sections 1275 and 131200, Health and Safety Code. Reference: Sections 1276, 131050, 131051 and 131052, Health and Safety Code.

1. Amendment of subsection (m) filed 3-13-80; effective thirtieth day thereafter (Register 80, No. 11).
2. Amendment of subsection (g), new subsections (g)(1) and (g)(2), and amendment of Note filed 11-26-96; operative 12-26-96 (Register 96, No. 48).
3. Change without regulatory effect amending subsection (a) and Note filed 6-16-2000 pursuant to section 100, title 1, California Code of Regulations (Register 2000, No. 24).
4. Change without regulatory effect amending subsections (c), (g), (i), (q)(8) and (r) and amending Note filed 3-12-2013 pursuant to section 100, title 1, California Code of Regulations (Register 2013, No. 11).