PURPOSE: This rule establishes the requirements for pharmacy services and medication management in a hospital.

1. (1) Pharmacy services shall be identified and integrated within the total hospital organizational plan. Pharmacy services shall be directed by a pharmacist who is currently licensed in Missouri and qualified by education and experience. The director of pharmacy services shall be responsible for the provision of all services required in subsection (4)(G) of this rule and shall be a participant in all decisions made by pharmacy services or committees regarding the use of medications. With the assistance of medical, nursing and administrative staff, the director of pharmacy services shall develop standards for the selection, distribution and safe and effective use of medications throughout the hospital.
2. (2) Additional professional and supportive personnel shall be available for services provided. Pharmacists shall be currently licensed in Missouri and all personnel shall possess the education and training necessary for their responsibilities.
3. (3) Support pharmacy personnel shall work under the supervision of a pharmacist and shall not be assigned duties that by law must be performed by a pharmacist. Interpreting medication orders, selecting, compounding, packaging, labeling and the dispensing of medications by pharmacy staff shall be performed by or under the supervision of a pharmacist. Interpretation of medication orders by support personnel shall be limited to order processing and shall not be of a clinical nature.
4. (4) Hours shall be established for the provision of pharmacy services. A pharmacist shall be available to provide required pharmacy services during hours appropriate for necessary contact with medical and nursing staff. A pharmacist shall be on call at all other times.
5. (5) Space, equipment and supplies shall be available according to the scope of pharmacy services provided. Office or other work space shall be available for administrative, clerical, clinical and other professional services provided. All areas shall meet standards to maintain the safety of personnel and the security and stability of medications stored, handled and dispensed.
6. (6) The pharmacy and its medication storage areas shall have proper conditions of sanitation, temperature, light, moisture, ventilation and segregation. Refrigerated medication shall be stored separate from food and other substances. The pharmacy and its medication storage area shall be locked and accessible only to authorized pharmacy and supervisory nursing personnel. The director of pharmacy services, in conjunction with nursing and administration, shall be responsible for the authorization of access to the pharmacy by supervisory nursing personnel to obtain doses 19 CSR 30-20

for administering when pharmacy services are unavailable.

1. (7) Medication storage areas outside of the pharmacy shall have proper conditions of sanitation, temperature, light, moisture, ventilation and segregation. Refrigerated medications shall be stored in a sealed compartment separate from food and laboratory materials. Medication storage areas shall be accessible only to authorized personnel and locked when appropriate.
2. (8) The evaluation, selection, source of supply and acquisition of medications shall occur according to the hospital’s policies and procedures. Medications and supplies needed on an emergency basis and necessary medications not included in the hospital formulary shall be acquired according to the hospital’s policies and procedures.
3. (9) Records shall be maintained of medication transactions, including: acquisition, compounding, repackaging, dispensing or other distribution, administration and controlled substance disposal. Persons involved in compounding, repackaging, dispensing, administration and controlled substance disposal shall be identified and the records shall be retrievable. Retention time for records of bulk compounding, repackaging, administration, and all controlled substance transactions shall be a minimum of two (2) years. Retention time for records of dispensing and extemporaneous compounding, including sterile medications, shall be a minimum of six (6) months.
4. (10) Security and record keeping procedures in all areas shall ensure the accountability of all controlled substances, shall address accountability for other medications subject to theft and abuse and shall be in compliance with 19 CSR 30-1.030(3). Inventories of Schedule II controlled substances shall be routinely reconciled. Inventories of Schedule III–V controlled substances outside of the pharmacy shall be routinely reconciled. Records shall be maintained so that inventories of Schedule III–V controlled substances in the pharmacy shall be reconcilable.
5. (11) Controlled substance storage areas in the pharmacy shall be separately locked and accessible only to authorized pharmacy staff. Reserve supplies of all controlled substances in the pharmacy shall be locked. Controlled substance storage areas outside the pharmacy shall be separately locked and accessible only to persons authorized to administer them and to authorized pharmacy staff. SENIOR SERVICES
6. (12) Authorization of access to controlled substance storage areas outside of the pharmacy shall be established by the director of pharmacy services in conjunction with nursing and administration. The distribution and accountability of keys, magnetic cards, electronic codes or other mechanical and electronic devices shall occur according to the hospital’s policies and procedures.
7. (13) All variances involving controlled substances—including inventory, security, record keeping, administration and disposal—shall be reported to the director of pharmacy services for review and investigation. Loss, diversion, abuse or misuse of medications shall be reported to the director of pharmacy services, administration, and local, state and federal authorities as appropriate.
8. (14) The provision of pharmacy services in the event of a disaster, removal from use of medications subject to product recall and reporting of manufacturer drug problems shall occur according to the hospital’s policies and procedures.
9. (15) Compounding and repackaging of medications in the pharmacy shall be done by pharmacy personnel under the supervision of a pharmacist. Those medications shall be labeled with the medication name, strength, lot number, expiration date and other pertinent information. Record keeping and quality control, including end-product testing when appropriate, shall occur according to the hospital’s policies and procedures.
10. (16) Compounding, repackaging or relabeling of medications by nonpharmacy personnel shall occur according to the hospital’s policies and procedures. Medications shall be administered routinely by the person who prepared them, and preparation shall occur just prior to administration except in circumstances approved by the director of pharmacy, nursing and administration. Compounded sterile medications for parenteral administration prepared by nonpharmacy personnel shall not be administered beyond twenty-four
11. (24) hours of preparation. Labeling shall include the patient’s name, where appropriate, medication name, strength, beyond use date, identity of the person preparing and other pertinent information.
12. (17) Compounded sterile medications shall be routinely prepared in a suitably segregated area in a Class 100 environment by pharmacy personnel. Preparation by nonpharmacy personnel shall occur only in specific areas or in situations when immediate preparation is necessary and pharmacy personnel are unavailable and shall occur according to policies and procedures. All compounded cytotoxic/hazardous medications shall be prepared in a suitably segregated area in a Class II biological safety cabinet or vertical airflow hood. The preparation, handling, administration and disposal of sterile or cytotoxic/hazardous medications shall occur according to policies and procedures including: orientation and training of personnel, aseptic technique, equipment, operating requirements, environmental considerations, attire, preparation of parenteral medications, preparation of cytotoxic/hazardous medications, access to emergency spill supplies, special procedures/products, sterilization, extemporaneous preparations and quality control.
13. (18) Radiopharmaceuticals shall be acquired, stored, handled, prepared, packaged, labeled, administered and disposed of according to the hospital’s policies and procedures and only by or under the supervision of personnel who are certified by the Nuclear Regulatory Commission.
14. (19) A medication profile for each patient shall be maintained and reviewed by the pharmacist and shall be reviewed by the pharmacist upon receiving a new medication order prior to dispensing the medication. The pharmacist shall review the prescriber’s order or a direct copy prior to the administration of the initial dose, except in an emergency or when the pharmacist is unavailable, in which case the order shall be reviewed within seventy-two (72) hours.
15. (20) Medications shall be dispensed only upon the order of an authorized prescriber with the exception of influenza and pneumococcal polysaccharide vaccines, which may be administered per physician-approved policy/protocol after an assessment for contraindications, and only dispensed by or under the supervision of the pharmacist.
16. (21) All medications dispensed for administration to a specific patient shall be labeled with the patient name, drug name, strength, expiration date and, when applicable, the lot number and other pertinent information.
17. (22) The medication distribution system shall provide safety and accountability for all medications, include unit of use and ready to administer packaging, and meet current standards of practice.
18. (23) To prevent unnecessary entry to the pharmacy, a locked supply of routinely used medications shall be available for access by authorized personnel when the pharmacist is unavailable. Removal of medications from the pharmacy by authorized supervisory nursing personnel, documentation of medications removed, restricted and unrestricted medication removal, later review of medication orders by the pharmacist, and documented audits of medications removal shall occur according to the hospital’s policies and procedures. The nurse shall remove only amounts necessary for administering until the pharmacist is available.
19. (24) Floorstock medications shall be limited to emergency and nonemergency medications which are authorized by the director of pharmacy services in conjunction with nursing and administration. The criteria, utilization and monitoring of emergency and non-emergency floorstock medications shall occur according to the hospital’s policies and procedures. Supplies of emergency medications shall be available in designated areas.
20. (25) All medication storage areas in the hospital shall be inspected at least monthly by a pharmacist or designee according to the hospital’s policies and procedures.
21. (26) The pharmacist shall be responsible for the acquisition, inventory control, dispensing, distribution and related documentation requirements of investigational medications according to the hospital’s policies and procedures. A copy of the investigational protocol shall be available in the pharmacy to all health care providers who prescribe or administer investigational medications. The identity of all recipients of investigational medications shall be readily retrievable.
22. (27) Sample medications shall be received and distributed by the pharmacy according to the hospital’s policies and procedures.
23. (28) Dispensing of medications by the pharmacist to patients who are discharged from the hospital or who are outpatients shall be in compliance with 4 CSR 220.
24. (29) Persons other than the pharmacist may provide medications to patients leaving the hospital only when prescription services from a pharmacy are not reasonably available. Medications shall be provided according to the hospital’s policies and procedures, including: circumstances when medications may be provided, practitioners authorized to order, specific medications and limited quantities, prepackaging and labeling by the pharmacist, final labeling to facilitate correct administration, delivery, counseling and a transaction record. Final labeling, delivery and counseling shall be performed by the prescriber or a registered nurse.
25. (30) Current medication information resources shall be maintained in the pharmacy and patient care areas. The pharmacist shall provide medication information to the hospital staff as requested.
26. (31) The director of pharmacy services shall be an active member of the pharmacy and therapeutics committee or its equivalent, which shall advise the medical staff on all medication matters. A formulary shall be established which includes medications based on an objective evaluation of their relative therapeutic merits, safety and cost and shall be reviewed and revised on a continual basis. A medication use evaluation program shall be established which evaluates the use of selected medications to ensure that they are used appropriately, safely and effectively. Followup educational information shall be provided in response to evaluation findings.
27. (32) The pharmacist shall be available to participate with medical and nursing staff regarding decisions about medication use for individual patients, including: not to use medication therapy; medication selection, dosages, routes and methods of administration; medication therapy monitoring; provision of medication-related information; and counseling to individual patients. The pharmacist or designee shall personally offer to provide medication counseling when discharge or outpatient prescriptions are filled. The pharmacist shall provide requested counseling.
28. (33) Medication orders shall be initiated or modified only by practitioners who have independent statutory authority to prescribe or who are legally given authority to order medications. That authority may be given through an arrangement with a practitioner who has independent statutory authority to prescribe and who is a medical staff member. The authority may include collaborative practice agreements, protocols or standing orders and shall not exceed the practitioner’s scope of practice. Practitioners given this authority who are not hospital employees shall be approved through the hospital credentialing process. When hospital-based agreements, protocols or standing orders are used, they shall be approved by the pharmacy and therapeutics or equivalent committee.
29. (34) All medication orders shall be written in the medical record and signed by the ordering practitioner with the exception of influenza and pneumococcal polysaccharide vaccines, which may be administered per physicianapproved hospital policy/protocol after an assessment for contraindications. When medication therapy is based on a protocol or standing order and a specific medication order is not written, a signed copy of the protocol or of an abbreviated protocol containing the medication order parameters or of the standing order shall be placed in the medical record with the exception of physicianapproved policies/protocols for the administration of influenza and pneumococcal polysaccharide vaccines after an assessment for contraindications. The assessment for contraindications shall be dated and signed by the registered nurse performing the assessment and placed in the medical record. Telephone or verbal orders shall be accepted only by authorized staff, immediately written and identified as such in the medical record and signed by the ordering practitioner within a time frame defined by the medical staff.
30. (35) Medication orders shall be written according to policies and procedures and those written by persons who do not have independent statutory authority to prescribe shall be included in the quality improvement program.
31. (36) Automatic stop orders for all medications shall be established and shall include a procedure to notify the prescriber of an impending stop order. A maximum stop order shall be effective for all medications which do not have a shorter stop order. Automatic stop orders are not required when the pharmacist continuously monitors medications to ensure that they are not inappropriately continued.
32. (37) Medications shall be administered only by persons who have statutory authority to administer or who have been trained in each pharmacological category of medication they administer, and administration shall be limited to the scope of their practice. Persons who do not have statutory authority to administer shall not administer parenteral medications, controlled substances or medications that require professional assessment at the time of administration. A person who has statutory authority to administer shall be readily available at the time of administration. Training for persons who do not have statutory authority to administer shall be documented and administration by those persons shall be included in the quality improvement program. Medications shall be administrated only upon the order of a person authorized to 19 CSR 30-20

prescribe or order medications. Administration by all persons shall occur according to the hospital’s policies and procedures.

1. (38) Medications brought to the hospital by patients shall be handled according to policies and procedures. They shall not be administered unless so ordered by the prescriber and identified by the pharmacist or the prescriber.
2. (39) Medications shall be self-administered or administered by a responsible party only upon the order of the prescriber and according to policies and procedures.
3. (40) Medication incidents, including medication errors shall be reported to the prescriber and the appropriate manager. Medication incidents shall be reported to the appropriate committee. Adverse medication reactions shall be reported to the prescriber and the director of the pharmacy services. The medication administered and medication reaction shall be recorded in the patient’s medical record. Adverse medication reactions shall be reviewed by the pharmacy and therapeutics committee and other medical or administrative committees when appropriate.

AUTHORITY: sections 192.006 and 197.080, RSMo 2000 and 197.154, RSMo Supp. 2007.* This rule previously filed as 19 CSR 30-20.021(3)(G). Original rule filed June 27, 2007, effective Feb. 29, 2008. *Original authority: 192.006, RSMo 1993, amended 1995; 197.080, RSMo 1953, amended 1993, 1995; and 197.154, RSMo 2004.