6 Colo. Code Regs. § 1011-1 Chapter 04, pt. 15

Current through Register Vol. 47, No. 17, September 10, 2024

Part 15 - PHARMACY SERVICES

15.1 The pharmacy service of the hospital shall be organized and maintained primarily for the benefit of the hospital patients, and shall be operated in accordance with federal and state laws and regulations.

15.2 The pharmacy service shall be under the direct supervision of a pharmacist licensed to practice pharmacy in the State of Colorado.

15.3 Availability of Pharmacy Services

(A) The pharmacy services shall develop and implement policies and procedures ensuring convenient and prompt twenty-four (24) hour availability of drugs for administration to patients.

(B) Emergency pharmacy services shall be available twenty-four (24) hours per day, seven (7) days per week.

(C) If a pharmacist is not available on site on a twenty-four (24)-hour basis, a pharmacist shall be available on-call within thirty (30) minutes.

15.4 A pharmacist shall be responsible for compounding, preparing, labeling, transferring between containers, and dispensing drugs, including direct supervision of qualified personnel performing such tasks.

15.5 Pharmacy and Therapeutic Committee

(A) There shall be a hospital Pharmacy and Therapeutic Committee to assist in the formulation of broad professional policies regarding the evaluation, selection, procurement, distribution, use, safety procedures, minimization of drug errors, and other matters relating to drugs in hospitals.

15.6 Pharmacies shall be registered by the Colorado State Board of Pharmacy and have a current Drug Enforcement Administration registration.

15.7 The pharmacy shall maintain a current formulary of approved drugs and biologicals.

(A) The hospital shall maintain an adequate stock of the medications listed in the formulary.

(B) The hospital shall be responsible for the quality, quantity, and sources of supply of all medications.

(C) Medication stocks shall not contain outdated, unusable, or mislabeled products.

(D) The hospital shall have processes to approve and procure medications that are not on the hospital's formulary.

15.8 Current records shall be maintained that account for the receipt, distribution, disposition, and destruction of drugs and biologicals.

15.9 The receipt, distribution, administration, and disposition of controlled substances shall be readily traceable.

(A) Mechanisms shall be implemented to ensure the security of the drugs and to prevent and detect the diversion of controlled substances and other drugs that may be abused or illegally sold.

(B) When diversion is detected, appropriate corrective measures shall be implemented in accordance with hospital policy and procedure.

15.10 The hospital shall alert appropriate staff to remove any drugs or biologicals subject to a recall or discontinuation for safety reasons.

15.11 All drugs and biologicals shall be kept in a secure area to prevent unauthorized access. All controlled drugs shall be kept in a locked secure area.

15.12 Drugs and biologicals shall be stored under the proper conditions of sanitation, temperature, light, moisture, ventilation, and segregation, to maintain therapeutic integrity.

15.13 Pharmacy Policies and Procedures

(A) The pharmacy service shall develop and implement policies and procedures, based on nationally-recognized guidelines and standards of practice that address, at a minimum, the following:

(1) After-hours access, including the following requirements:

(a) If the pharmacy is not open twenty-four (24) hours, seven (7) days per week, the hospital shall have a policy and procedure regarding after-hour access to medications.

(b) The policy and procedure shall specify the personnel permitted access to the medication storage area(s).

(c) There shall be accountability for all doses of medications removed when the pharmacist is not present.

(2) The disposal of unused medications.

(3) The safe and appropriate procurement, storage, preparation, dispensing, use, tracking and control, and disposal of medications and medication delivery devices throughout the hospital.

(4) Periodic inspection of the medication storage area.

15.14 Medication Administration

(A) Prior to administration, medications shall be checked for integrity and to ensure the medication has not expired.

(B) Prior to administration, the following shall be verified: patient, time, medication, dosage, route of administration, and indication.

(C) The hospital shall develop and implement policies and procedures, based on nationally-recognized guidelines addressing, at a minimum, the following:

(1) The review of patient drug profiles.

(2) Medication monitoring.

(3) The safe administration of drugs and biologicals. Specifically, only appropriately-trained individuals who are authorized by law and the hospital shall administer medications.

(4) Monitoring and documenting the effects of medication, including but not limited to, the process for monitoring the first dose of a medication that has been identified as one with the potential for serious adverse reactions.

(5) Identification and reporting of adverse reactions, interactions, and medication errors.

(6) Self-administration of medication, including but not limited to, storage and documentation of the self-administered drugs. Patients shall only be permitted to self-administer medications pursuant to an order from a physician or licensed independent practitioner.

(7) Use of the patient's own medications. Drugs and biologicals brought into the hospital by the patient may be administered only if the medication can be accurately identified by the pharmacy, secured, and pursuant to an order from the attending physician or licensed independent practitioner.

(8) Medications brought into the hospital by practitioners to be administered to patients.

(9) The review of medication orders by a pharmacist for appropriateness.

15.15 The hospital shall ensure up-to-date resources are available to professional staff regarding the appropriate use of drugs and biologicals, including but not limited to: therapeutic use, potential adverse effects, dosage, and routes of administration.

15.16 Investigational Drugs

(A) If investigational drugs are used, policies and procedures shall be developed and implemented for their safe and proper use.

(B) Investigational drugs shall be used only:

(1) When there is written approval of an Institutional Review Board (IRB), established in accordance with federal law and regulation; and

(2) Under the supervision of a member of the medical staff and administered in accordance with an IRB approved protocol.

15.17 Compounding Medications

(A) All compounding of medications used or dispensed by the hospital shall be performed consistent with standards of safe practice applicable to both sterile and non-sterile compounding.

(B) The hospital shall develop and implement policies and procedures to ensure the safe development and storage of compounded medications and/or admixtures.

15.18 A refrigerator with thermometer and freezing compartment shall be provided for the proper storage of thermolabile products.

15.19 Facilities shall be provided for the adequate storage, preparation, and dispensing of drugs with security, proper lighting, temperature control, moisture, ventilation, and sanitation facilities.

6 CCR 1011-1 Chapter 04, pt. 15